CN108403178A - One kind being used for endovascular medical treatment device - Google Patents

Abstract

It is used for endovascular medical treatment device, including slender member and expandable capsule the present invention provides one kind, the slender member includes distal ports for carrying the capsule and is adjacent to the top section of the distal ports, and the outer diameter of the top section is not more than 6Fr.It is provided by the present invention to be realized to the closure compared with thin vessels for endovascular medical treatment device.

Description

A medical device for use in blood vessels

technical field

The invention relates to a medical device used in blood vessels, in particular to a device capable of effectively blocking blood vessels under low pressure conditions, which can be used to temporarily block blood flow in blood vessels, and rely on negative pressure to suck out blood vessel thrombus or assist various types of blood vessels. The thrombectomy device completes the mechanical thrombectomy of blood vessels, or serves as an auxiliary channel for other interventional catheters or devices, etc., and belongs to the technical field of medical devices.

Background technique

As a minimally invasive treatment, intravascular interventional diagnosis and treatment have developed rapidly in recent years with the advancement of imaging equipment and the introduction and improvement of new interventional equipment. Vascular interventional doctors have been able to deal with more and more complex lesions. There are more and more cases of application, and the diseases involved are more and more extensive. However, one of the intractable problems currently faced is that when the catheter is operated in the blood vessel or the balloon, stent or occluder for interventional therapy is delivered, debris and emboli flow to the distal end of the blood vessel, resulting in occlusion of the distal blood vessel.

As a representative minimally invasive treatment method, interventional technology for cerebrovascular diseases has developed rapidly in recent years with the advancement of imaging equipment and the introduction of new interventional equipment. Neurological interventional doctors have been able to deal with more and more complex procedures. There are more and more cases of clinical application, and the types of diseases involved are becoming more and more extensive.

The treatment method of mechanical thrombectomy using a balloon-guided catheter to deliver an interventional thrombectomy device in the cerebral vessel or using a balloon-guided catheter to complete the thrombus suction has the advantages of less bleeding, less trauma, fewer complications, safety and reliability, and rapid postoperative recovery. It has become a bright spot in the treatment of acute ischemic stroke, with a higher rate of revascularization and a wider treatment time window than intravenous or arterial thrombolysis.

According to the "Chinese Expert Consensus on Acute Ischemic Stroke 2017 Edition", the key to the selection of thrombectomy access is whether to use a balloon-guided catheter and an intermediate/suction catheter; a NASA registry study included 138 patients who used a balloon catheter in 24 centers. Compared with those who did not use the balloon-guided catheter, patients with balloon-guided catheter had a higher rate of recanalization, no difference in the rate of distal embolism and ectopic embolism, and a higher rate of good clinical prognosis at 3 months; more Factor regression analysis showed that the use of balloon-guided catheters was an independent factor for good clinical prognosis. The use of intermediate catheter-assisted Solumbra technology can significantly improve the success rate of mechanical thrombectomy in MCA occlusion, and reduce the rate of distal embolization and ectopic embolization. In vitro experiments further confirmed that stent aspiration combined with intermediate/suction catheter suction can reduce the distal vascular events of hard and brittle thromboembolism, and combined with balloon guide catheter can significantly reduce the distal embolic events of fresh red thrombus, so thrombectomy The combined intraoperative use of a balloon-guided catheter and an intermediate/suction catheter may be of clinical interest.

The use of the balloon guide catheter is as follows: through standard interventional procedures, the arterial sheath is inserted percutaneously, and the thrombectomy device is assisted to reach the proximal end of the blood vessel thrombus, and the balloon is inflated to make it stick to the blood vessel wall, temporarily blocking the blood flow , to form a partial blockage; with the cooperation of external negative pressure, the thrombus retrieval device and thrombus are adsorbed into the lumen of the catheter. Then deflate the balloon of the balloon guiding catheter, withdraw the balloon guiding catheter, and take the thrombus out of the body to achieve the purpose of blood flow reconstruction.

The key issues for balloon-guided catheter-assisted interventional devices to complete mechanical thrombectomy or suction thrombus alone are: 1. The balloon can achieve effective occlusion under a small filling pressure and reduce the stimulation of the cerebral neurovascular wall. ; 2, and the balloon site has a development mark, the doctor can accurately locate the position of the balloon during the interventional operation; 3, the catheter itself should have good flexibility, and can pass through the tortuous blood vessels to reach the lesion site smoothly.

The current domestic marketed product is the Merci balloon guide catheter produced by Concentric Medical in the United States. The disadvantages are: 1. The diameter of the balloon guide catheter is large, and it is difficult to reach small blood vessels. It can only be used in conjunction with a general guide catheter or similar accessories; 2. There are too many contact points between the balloon and blood vessels, which can stimulate the blood vessels More, it is easy to cause complications such as spasm.

Therefore, those skilled in the art are striving to develop a new medical device for intravascular use.

Contents of the invention

In view of the above-mentioned defects of the prior art, the present invention provides a new medical device for intravascular use, and the technical problem to be solved is to realize the occlusion of small blood vessels.

To achieve the above objects, the present invention provides a medical device for intravascular use, comprising an elongated member including a distal end section for carrying the balloon and an inflatable balloon adjacent to the The tip segment of the distal segment, the outer diameter of the tip segment being no greater than 6Fr.

Preferably, the length of the tip section is not less than 3 mm.

Preferably, the length of the top end segment is 3mm-30cm.

Preferably, said intravascular medical device comprises a balloon guiding catheter.

Preferably, the medical device for intravascular use further includes a handle, and the elongated member further includes a proximal section for connecting with the handle and an intermediate section between the proximal section and the distal section, It is characterized in that the middle section includes at least a first section, a second section and a third section, and the first section, the second section, and the third section are arranged sequentially from the proximal end to the distal end, and the first section The hardness of the first, second and third segments are different.

Preferably, the first segment, the second segment and the third segment are sequentially adjacent.

Preferably, the hardness of the first section, the second section and the third section decrease in order.

Preferably, the intermediate section further includes a proximal connecting section for connecting with the proximal section, adjacent to the proximal end of the first section, and the hardness of the proximal connecting section is greater than that of the first section.

Preferably, the middle section further includes a distal connecting section for connecting with the distal section, adjacent to the distal end of the third section, and the hardness of the distal connecting section is smaller than that of the third section.

Preferably, the middle section includes an outer pipe of the middle section and an inner pipe of the middle section; the outer pipe of the middle section includes the first section of the outer pipe of the middle section, the second section of the outer pipe of the middle section, and the third section of the outer pipe of the middle section; The inner tube in the middle section includes the first section of the inner tube in the middle section, the second section of the inner tube in the middle section, and the third section in the middle section; the first section of the outer tube in the middle section and the first section of the inner tube in the middle section constitute the The first section of the middle section, the second section of the outer pipe of the middle section and the second section of the inner pipe of the middle section constitute the second section of the middle section, the third section of the outer pipe of the middle section and the second section of the middle section The first section of the inner tube constitutes the third section of the intermediate section.

Preferably, the first section of the inner tube in the middle section, the second section of the inner tube in the middle section, and the third section of the inner tube in the middle section at least include the first layer of the inner tube in the middle section, the second layer of the inner tube in the middle section, and the second layer of the inner tube in the middle section. Three layers, wherein the material of the first layer of the inner tube in the middle section and the third layer of the inner tube in the middle section is plastic, and the material of the second layer of the inner tube in the middle section is braided wire.

Preferably, the hardness of the first layer of the first section of the inner tube in the middle section, the first layer of the second section of the inner tube in the middle section, and the first layer of the third section of the inner tube in the middle section decrease successively, and/or the The hardness of the second layer of the first section of the inner tube in the middle section, the second layer of the second section of the inner tube in the middle section, and the second layer of the third section of the inner tube in the middle section decrease successively.

Preferably, the material of the first section of the outer tube in the middle section, the second section of the outer tube in the middle section, and the third section of the outer tube in the middle section is plastic.

Preferably, the first section of the outer tube in the middle section, the second section of the outer tube in the middle section, and the third section of the outer tube in the middle section at least include the first layer of the outer tube in the middle section, the second layer of the outer tube in the middle section, and the second layer of the outer tube in the middle section. Three layers, wherein the material of the first layer of the inner tube in the middle section and the third layer of the inner tube in the middle section is plastic, and the material of the second layer of the inner tube in the middle section is braided wire.

Preferably, the balloon has at least a first shape in a deflated state and a second shape in an expanded state, and the medical device for use in a blood vessel is configured such that when the balloon is in the second shape, the The capsule has at least a first occlusive outer surface for closely adhering to the vessel wall and occluding the blood vessel, and a second occlusive outer surface for closely adhering to the vessel wall and occluding the blood vessel; the first occlusive outer surface and The second plugging outer surfaces are positionally separated from each other.

Preferably, the outer shape of the bladder is gourd-shaped when the bladder is in the second shape.

Preferably, the bladder includes a first bladder portion and a second bladder portion, the first occluded outer surface is located on the first bladder portion, and the second occluded outer surface is located on the second bladder portion; The medical device for intravascular use is configured such that when the balloon is in the second shape, there is a third lumen and a first sub-lumen between the first balloon portion and the outer wall of the elongated member, the There is a third chamber and a second sub-chamber between the second capsule and the outer wall of the elongated member; the elongated member has one or more holes, and the third chamber and the first sub-chamber pass through the hole and the first sub-chamber The second chamber of the third chamber communicates with the second chamber, and the second sub-chamber of the third chamber communicates with the second chamber through another hole; the first sub-chamber of the third chamber and the second sub-chamber of the third chamber are independent of each other.

Preferably, said intravascular medical device further comprises radiographic markers near or closely attached to the proximal and/or distal ends of said balloon.

Preferably, the medical device for intravascular use further includes a marker that can be displayed under radiation, and the marker is a imaging material embedded in the wall of the balloon.

Preferably, the medical device for intravascular use further includes a radiographic marker located at the distal end of the tip section.

The beneficial technical effects of the present invention are as follows: 1. The balloon guiding catheter has a smaller outer diameter as a whole and can directly reach smaller blood vessels; it does not need to be used in conjunction with other guiding catheters or accessories; it reduces surgical operations and surgical costs; 2. 1. There is a certain distance between the position of the balloon in the catheter and the top of the catheter; during the operation, the balloon is still inflated at the thicker blood vessel to avoid the risk of complications caused by the expansion of the smaller blood vessel.

The idea, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings, so as to fully understand the purpose, features and effects of the present invention.

Description of drawings

Fig. 1 is a schematic sectional view of the structure of the first preferred embodiment of the intravascular medical device provided by the present invention.

FIG. 2 is a schematic longitudinal section view of a part of the middle section of the catheter used for the intravascular medical device shown in FIG. 1 .

Fig. 3 is a structural longitudinal section schematic view of the complete middle section of the catheter for the intravascular medical device shown in Fig. 1 .

FIG. 4 is a schematic cross-sectional view of the middle section of the catheter for the intravascular medical device shown in FIG. 1 .

Fig. 5 is a schematic longitudinal sectional view of the structure of the distal end section and the top end section of the catheter for the intravascular medical device shown in Fig. 1 (the balloon is in a contracted state).

Fig. 6 is a schematic longitudinal sectional view of the structure of the distal end section and the top end section of the catheter for the intravascular medical device shown in Fig. 1 (the balloon is in an inflated state).

Fig. 7 is a schematic longitudinal sectional view of the structure of the distal end section and the top end section of the catheter for the intravascular medical device shown in Fig. 1 (the expanded balloon blocks the blood vessel).

Fig. 8 is a schematic longitudinal sectional view of the structure of the proximal section and the handle of the catheter for the intravascular medical device shown in Fig. 1 .

Fig. 9 is a schematic longitudinal sectional view of the structure of the middle section of the second preferred embodiment of the intravascular medical device provided by the present invention.

Fig. 10 is a schematic cross-sectional view of the middle section of the second preferred embodiment of the intravascular medical device provided by the present invention.

Fig. 11 is a schematic longitudinal sectional view of the structure of the third preferred embodiment of the intravascular medical device provided by the present invention.

Fig. 12 is a schematic longitudinal sectional view of the structure of the fourth preferred specific embodiment of the intravascular medical device provided by the present invention.

Fig. 13 is a schematic longitudinal sectional view of the structure of the fifth preferred embodiment of the intravascular medical device provided by the present invention.

Detailed ways

The following describes several preferred embodiments of the present invention with reference to the accompanying drawings, so as to make the technical content clearer and easier to understand. The present invention can be embodied in many different forms of embodiments, and the protection scope of the present invention is not limited to the embodiments mentioned herein.

In the drawings, components with the same structure are denoted by the same numerals, and components with similar structures or functions are denoted by similar numerals. The size and thickness of each component shown in the drawings are shown arbitrarily, and the present invention does not limit the size and thickness of each component. In order to make the illustration clearer, the thickness of parts is appropriately exaggerated in some places in the drawings.

As used herein, the term "proximal end" or similar directional terms should be understood as: the end of a device or component that is closer to the user (or handle) or away from the target location of the vessel to be treated; as used herein the term " "Distal end" or similar terms describing direction should be understood as: the end of the device or component that is away from the user (or handle) or close to the target location of the blood vessel to be treated. As used herein, the term "proximal portion" should be understood as: a part of a device or component that is close to or immediately adjacent to the proximal end (not necessarily immediately adjacent); the term "distal portion" as used herein should be understood as : A part of a device or part that is close to or immediately adjacent to the distal end (not necessarily adjacent to the distal end).

As used herein, the term "balloon guide catheter" should be understood as a body lumen-extendable device comprising an elongate guide catheter and carrying an inflatable balloon at its distal end. The term "guide catheter" in "balloon guide catheter" means that the device is capable of delivering other medical devices (e.g. ”; it should be noted that the device itself can perform the operation of removing obstruction in the body cavity (for example, through negative pressure suction of thrombus) without resorting to other medical devices for direct removal of obstruction. Therefore, "balloon guide catheter" should not be understood as a device that can only remove blockages in body cavities with the help of other medical devices.

1-6 show the first preferred embodiment of the intravascular medical device provided by the present invention.

As shown in FIGS. 1-6 , the device in this embodiment is used to remove thrombus, objects and/or obstructive substances from blood vessels, and the most typical application is to remove thrombus. The device comprises an elongated member 100, an inflatable balloon 200 carried by a distal section of the elongated member 100, and a handle 300 located at a proximal section of the elongated member. The device can be operated in a variety of ways for performing various treatment or other functions within the blood vessel. For example, the device can be operated in a first mode, which minimizes the device's profile to facilitate introduction into a target site within a blood vessel; it can also be operated in a second mode, for example, with a The device reaches the target thrombus site and suctions the removed thrombus into the lumen; the device can also be operated in a third mode, for example, for direct suction to remove an intravascular blockage, such as a thrombus; the device also It is possible to operate in a fourth mode, eg balloon inflation to temporarily block blood flow while angiography is performed.

The elongated member 100 is elongated overall, including a proximal section 110 , a middle section 120 , a distal section 130 , and a top section 140 . The middle section 120, the distal section 130, and the top section 140 are sized to be introduced into blood vessels, and the proximal section 110, the middle section 120, the distal section 130, and the top section 140 have interconnected first sections extending along their axes. A cavity 510 . The first lumen 510 is used to directly suck and remove blockages in blood vessels, such as thrombus, or use a device to remove the blockage to reach the target site, and suck the device after removing the blockage, or to pass through the channel for other devices.

As shown in FIG. 2 , the middle section 120 includes a middle section outer tube 121 and a middle section inner tube 122 extending along the same axis, and the first cavity 510 is the inner cavity of the middle section inner tube 122 . There is a second cavity 520 extending along the axis of the middle section 120 between the middle section outer tube 121 and the middle section inner tube 122 . The device in this specific embodiment is mainly used to remove the thrombus of intracranial blood vessel, therefore, the length of middle section 120 can be 30 centimeters-160 centimetres, and the outer diameter of middle section outer tube 121 can be 1.5 millimeters-4.0 millimeters (preferably not greater than 2 mm), the diameter of the first cavity 510 may be 0.8 mm-3.5 mm. Considering the necessary thickness of the middle section outer tube 121 and the middle section inner tube 122 and enough space for the second cavity 520, the inner diameter of the middle section outer tube 121 (i.e. the outer diameter of the second cavity 520) can be 1.45-3.95 millimeters, The outer diameter of the inner tube 122 in the middle section (ie, the inner diameter of the second cavity 520 ) may be 1.43-3.93 mm.

The main function of the middle section 120 is to deliver the distal section 130 and the top section 140 to the target position of the blood vessel, and provide the second cavity 520 to transmit the pressure to inflate the balloon 200, so the configuration of the middle section 120 mainly considers its mechanical properties.

As shown in FIG. 3 , the middle-section outer tube 121 and the middle-section inner tube 122 of the elongated member 100 for intravascular medical devices in this specific embodiment are divided into five sections. The middle section outer tube 121 is divided into extending from the proximal end to the distal end and adjacent in sequence: the middle section outer tube proximal connecting section 1214, the middle section outer tube first section 1211, the middle section outer tube second section 1212, the middle section outer tube The third section 1213 , the connecting section 1215 at the distal end of the outer tube of the middle section. Wherein, the proximal connection section 1214 of the outer tube of the middle section is connected with the outer tube of the proximal section 110 , and the distal connection section 1215 of the outer tube of the middle section is connected with the outer tube of the distal section 130 . The inner tube 122 in the middle section is divided into two parts extending from the proximal end to the distal end and adjacent in sequence: the proximal connecting section 1224 of the inner tube in the middle section, the first section 1221 of the inner tube in the middle section, the second section 1222 of the inner tube in the middle section, and the second section 1222 of the inner tube in the middle section. The third section 1223 , the connecting section 1225 at the distal end of the inner tube in the middle section. Wherein, the proximal connecting section 1224 of the inner tube in the middle section is connected to the inner tube of the proximal section 110 , and the distal connecting section 1225 of the inner tube in the middle section is connected to the inner tube of the distal section 130 .

In this specific embodiment, the length of the proximal connecting section 1214 of the outer tube of the middle section and the proximal connecting section 1224 of the inner tube of the middle section are consistent, forming the proximal connecting section of the entire middle section 120; the first section of the outer tube of the middle section 1211 It is consistent with the length of the first section 1221 of the inner tube in the middle section, forming the first section of the entire middle section 120; the second section 1212 of the outer tube of the middle section is the same as the second section 1222 of the inner tube of the middle section, forming the entire middle section The second section of 120; the third section 1213 of the middle outer tube and the third section 1223 of the middle inner tube have the same length, forming the third section of the entire middle section 120; the distal connecting section 1215 of the middle section outer tube and the middle section inner tube The length of the distal connecting section 1225 is consistent, and constitutes the distal connecting section of the entire middle section 120 . The hardness of the proximal connecting section, the first section, the second section, the third section, and the distal connecting section of the entire middle section 120 decreases sequentially. Among them, the second section and the third section are the main parts that provide the desired flexibility. Generally, for typical thrombus removal applications, the lengths of the second section and the third section are about 40-60mm respectively, more preferably , the lengths of the second and third sections are 48-52mm respectively. The proximal connecting section and the first section are the main parts that provide the desired twistability. Generally, for typical thrombus removal applications, the length of the proximal connecting section is about 80-120 mm. More preferably, the proximal connecting section The length of the segment is about 90-110mm; the length of the first segment can be configured as required.

The inventors of the present application found that in the existing devices similar to balloon guide catheters, the mechanical properties of the middle section often cannot achieve the desired effect, and its flexibility is poor, and the ability to pass through the tortuous blood vessels is poor, giving Operation brings great inconvenience. If the outer tube and the inner tube of the middle section are made of a single material, it will be difficult to achieve the desired flexibility (to facilitate reaching the predetermined position by bending the blood vessel) and twist control (to facilitate the operator to adjust the direction when using), or Materials are too expensive to be widely available. In this specific embodiment, the inventors of the present application creatively proposed a new solution, that is, to use a composite layer including braid as the material of the inner tube 122 in the middle section.

Fig. 4 shows the cross-section of the middle section inner tube 122, the middle section inner tube proximal connecting section 1224, the middle section inner tube first section 1221, the middle section inner tube second section 1222, the middle inner tube third section 1223, The connecting section 1225 at the distal end of the inner tube in the middle section adopts the structure shown in FIG. 4 . As shown in Figure 4, the inner tube 122 in the middle section is divided into three layers from the outside to the inside, namely: the first layer 1227 of the inner tube in the middle section, the second layer 1228 of the inner tube in the middle section, and the third layer 1229 of the inner tube in the middle section, Wherein, the material of the first layer 1227 of the inner tube in the middle section and the third layer 1229 of the inner tube in the middle section is plastic, and the material of the second layer 1228 of the inner tube in the middle section is braided wire.

In this specific embodiment, the weaving mode of the metal wire braid adopted by the second layer 1228 of the inner tube of the middle section is mesh weaving and spring braiding (generally, if other parameters are the same, the mesh braiding is faster than the spring braiding). The fabric is harder; the spring-like braid has better flexibility, which is good for bending. For the same weaving method, the larger the braiding wire size, the harder the braid; the higher the mesh weaving density, the harder the braid , that is, the smaller the mesh, the harder it is, that is, the larger the value of ppi, the harder the braid; for spring-like braids, the closer the distance between adjacent wires, the harder the braid), metal wire (for example, stainless steel wire) The braided fabric can provide the desired base stiffness as needed. Usually, for the desired torque control and flexibility, the hardness of the proximal connecting section 1224 of the inner tube in the middle section is relatively large, while the second section 1222 of the inner tube in the middle section, the third section 1223 of the inner tube in the middle section, and the inner tube in the middle section The hardness of the distal connecting section 1225 is relatively small, and there are at least three ways to achieve the desired gradual change in hardness. The first way is to achieve a gradual change in hardness on the second layer, using metal wires of different thicknesses, or metal wires of different materials, or using different mesh weaving densities, or using different weaving methods (for example, at the proximal end Using mesh weaving method and spring-like weaving method at the far end) can achieve the purpose of gradual change in hardness; the second method is to realize the gradual change in hardness on the first layer, for example, using plastics with different hardness; the third method The method is a combination of the first method and the second method, for example, the second layer adopts wire mesh braids with different hardness, and at the same time, the first layer adopts plastics with different hardness. The inventors of the present application unexpectedly found that a preferred specific embodiment is that the first layer of the proximal connecting section 1224 of the inner tube in the middle section is made of nylon, the first layer of the first section 1221 of the inner tube of the middle section is made of Pebax7233, and the inner tube of the middle section is made of Pebax7233. The first layer of the second section 1222 of the tube is Pebax5533, the first layer of the third section 1223 of the inner tube is Pebax4033, and the first layer of the distal connecting section 1225 of the inner tube is Pebax2533. This configuration can obtain very Ideal torsion control and compliance, at the same time, the first layer has the role of support and anti-bending. The material of the third layer 1229 of the inner tube in the middle section can be polytetrafluoroethylene (PTFE), which reduces the friction of the inner wall and allows other instruments to pass through with less resistance. A preferred embodiment is that the material of the third layer 1229 of the inner tube in the middle section is PTFEWT0.025, that is, PTFE with a wall thickness of 0.025 mm.

In this specific embodiment, the proximal connecting section 1214 of the middle outer tube, the first section 1211 of the middle outer tube, the second section 1212 of the middle outer tube, the third section 1213 of the middle outer tube, and the distal connection of the middle outer tube Section 1215 is made of plastic, eg Pebax. The main function of the middle section outer tube is support and anti-bending, like this, the middle section outer tube proximal connection section 1214, the middle section outer tube first section 1211, the middle section outer tube second section 1212, the middle section outer tube third section 1213 1. The connecting section 1215 at the distal end of the outer tube in the middle section can use Pebax with the same hardness. As a preferred solution, the proximal connection section 1214 of the middle outer tube, the first section 1211 of the middle outer tube, the second section 1212 of the middle outer tube, the third section 1213 of the middle outer tube, and the distal connection of the middle outer tube Section 1215 can use Pebax with different hardness to further enhance the performance of the hardness gradient in the middle section. The inventors of the present application unexpectedly found that a preferred specific embodiment is that the proximal connecting section 1214 of the middle section outer tube is made of nylon, the first section 1211 of the middle section outer tube is made of Pebax7233, and the second section 1212 of the middle section outer pipe is made of Pebax5533. The third section 1213 of the middle outer tube adopts Pebax4033, and the distal connecting section 1215 of the middle outer tube adopts Pebax2533. This configuration can obtain very ideal torsion control and flexibility, and at the same time, provide ideal support and bending resistance.

As shown in Figure 5, the distal section 130 includes a distal section outer tube 131 and a distal section inner tube 132, and the first cavity 510 is the lumen of the distal section inner tube 132, that is to say, the first cavity 510 along its The axis extends from the intermediate section 120 to the distal section 130 . There is a second cavity 520 extending along the axis of the distal segment 130 between the outer tube 131 of the distal segment and the inner tube 132 of the distal segment, that is to say, the second cavity 520 extends from the middle segment 120 to the distal segment along its axis 130. An inflatable balloon 200 is located outside the outer tube 131 of the distal section. As a preferred manner, the outer diameter of the outer tube 131 of the distal section can be suitably smaller than the outer diameter of the outer tube 121 of the middle section, so that when the balloon 200 shrinks, the outer diameter of the balloon part of the device is the same as the part in the whole blood vessel. The outer diameter of the device is the same or smaller, which facilitates the circulation of blood and the movement of the intravascular part of the device within the blood vessel. The outer tube 131 of the distal section and the inner tube 132 of the distal section can adopt the same material as the distal connecting section 1215 of the outer tube of the middle section and the distal connecting section 1225 of the inner tube of the middle section, for example, directly as the distal connection of the outer tube of the middle section Section 1215 and the extension of the middle section inner tube distal connection section 1225; the outer tube 131 of the far end section and the inner tube 132 of the far end section can also be connected with the outer tube distal connection section 1215 of the middle section and the inner tube distal end of the middle section The material of section 1225 is, for example, compared with the distal connecting section 1215 of the middle section outer tube and the distal connecting section 1225 of the middle section inner tube, the outer tube 131 of the distal end section and the inner tube 132 of the distal section are made of a more rigid material. These are also technologies well known in the art and will not be described in detail here.

5-7 illustrate the distal section 130 and balloon 200 of the elongated member 100 in this embodiment. In FIG. 3 , the balloon 200 is in the first shape in the contracted state; in FIG. 4 , the balloon 200 is in the second shape in the expanded state; in FIG. 5 , the balloon 200 is in the second shape in the expanded state and occludes the blood vessel.

As shown in FIGS. 5 and 6 , the balloon 200 includes a proximal connection portion 210 , a distal connection portion 220 and an expandable portion 230 . The function of the proximal connection part 210 and the distal connection part 220 is to connect with the distal section 130 and/or the top section 140, so that the third chamber 530 is closed relative to the outside of the balloon 200, so that the inflatable part 230 is under pressure. To expand. There are many ways to connect the proximal connecting portion 210 and the distal connecting portion 220 of the capsule 200 to the distal end section 130 and/or the top end section 140, for example, adhesive bonding, interference fit, laser welding, Sonic welding, fusion, tight knotting, tight fit through other connectors (such as hoop, wire or polymer wire binding) or/and adhesive bonding.

The bladder 200 is expandable when subjected to pressure from the inner side, that is, the bladder 200 has at least two shapes, a first shape in a deflated state (FIG. 5) and a second shape in an expanded state (FIGS. 6 and 7). . When the balloon 200 is in the first shape, the elongated member 100 and the balloon 200 as a whole are adapted to move within the blood vessel; when the balloon 200 is in the second shape, the balloon 200 functions to occlude the blood vessel.

When the balloon 200 is in an inflated state, there is a third lumen 530 between the inflatable part 230 and the outer tube 131 of the distal section. The third cavity 530 communicates with the second cavity 520 through one or more holes 133 on the outer tube 131 of the distal end section, so that the pressure from the handle 300 is transmitted to the expansion part 230 and the outer portion of the distal section through the second cavity 520 between the tubes 131 so that the balloon 200 is inflated. The pressure to inflate the bladder 200 may be hydraulic or pneumatic, preferably hydraulic (eg contrast agent or saline). The bladder 200 may be molded, blown or otherwise fabricated from a single tubular material. The proximal connection portion 210 and the distal connection portion 220 of the balloon 200 may be thick enough and/or rigid enough to provide an adequate seal; thinner to provide the desired expanded shape. Alternatively, the proximal connecting portion 210 , the distal connecting portion 220 and the expandable portion 230 of the balloon 200 can also be of the same thickness, in which case, the desired expanded shape can also be provided.

The bladder 200 may be made of an elastic material, such as a compliant or semi-compliant bladder. The compliant or semi-compliant bladder can expand to various sizes and/or shapes depending on the amount and/or pressure of fluid within the third lumen 530 . The bladder 200 can also be made of a substantially inelastic material, eg, a non-compliant bladder, which when inflated expands to a predetermined size independent of pressure (after adding a minimum volume and/or pressure to achieve the predetermined size). One benefit of a non-compliant balloon is that, even with relatively high pressures, the balloon 200 does not expand beyond a predetermined size, thus creating an undesirably strong compression of the inner wall of the blood vessel. One benefit of the compliant balloon is that when the pressure to inflate the balloon 200 is released, the balloon 200 can collapse against the outer wall of the outer tube 131 of the distal section, making the outer diameter of the balloon portion of the entire device as small as possible, The flow of blood and movement of the intravascular portion of the device within the vessel is facilitated. This embodiment is preferably a compliant bladder, for example made of silicone, PU, TPU or the like.

As shown in FIG. 6 and FIG. 7 , in this embodiment, when the inflatable part 230 of the balloon 200 is in the inflated state, the balloon 200 is in close contact with the inner wall 400 of the blood vessel, thereby blocking the blood vessel.

In this particular embodiment, the device also includes a marker 240 . The role of the marker 240 is to display the position of the capsule 200 under radiation (such as X-ray), and its material can be selected from metals or metal alloys with better biocompatibility or stability, such as platinum group metals (such as platinum-iridium alloys), Gold, etc. or polymer materials with added developing materials (such as barium salts (BaSO4, etc.), bismuth salts (BiOCl, etc.), etc.). Alternatively, the material of the capsule 200 may also be a polymer material added with a developing material (such as barium salt (BaSO4, etc.), bismuth salt (BiOCl, etc.), etc.).

In this specific embodiment, as shown in FIGS. 6 and 7 , the marker 240 is ring-shaped and sleeved on the outer wall of the outer tube 131 of the distal end, and the marker 240 is located between the capsule 200 and the outer tube 131 of the distal end. In other words, when the balloon 200 is in an inflated state, the marker 240 is located inside the third cavity 530 . Obviously, as a variation of this specific embodiment, the ring-shaped marker 240 sleeved on the outer wall of the outer tube 131 of the distal end section can also be located outside the third cavity 530 , for example, outside the balloon 200 . Alternatively, the marker 240 can also be directly sleeved on the outside of the proximal connecting portion 210 and/or the distal connecting portion 220 of the capsule 200. In this case, the marker 240 can also be used as a tight band to help the capsule 200 connect with the distal end. A closed connection between the outer walls of the end-section outer tube 131 . Whether it is located outside the third cavity 530 or inside the third cavity 530, the markers 240 are preferably close to or close to both ends of the capsule 200, that is, close to or close to the proximal connecting portion 210 and the distal end. end connector 220 . In this specific embodiment, there are two ring-shaped markers 240 , which are respectively close to the proximal connecting portion 210 and the distal connecting portion 220 . Such an arrangement can show the location of the capsule 200 very clearly on the radiograph. Obviously, as a modification of this specific embodiment, more ring-shaped markers 240 may also be provided, for example, ring-shaped markers are arranged at positions corresponding to the maximum outer diameter of the balloon 200 when inflated.

As shown in FIG. 5 , in this particular embodiment, the tip section 140 has a first cavity 510 , that is, the first cavity 510 extends from the distal section 130 to the tip section 140 along its axis. The distal end of the first lumen 510 of the tip section 140, ie the first lumen 510, faces the opening inside the inner tube through which the thrombus and/or other instruments used to remove the thrombus enter and exit the first lumen 510. The function of the top section 140 is to serve as the topmost end of the elongated member 100 , and its proximal end is connected to the distal end of the outer tube 131 of the distal section and the inner tube 132 of the distal section. In this specific embodiment, the tip section 140 includes two parts, the first part is the top section 141 of the tip section, and the other part is the proximal connecting section 142 of the tip section. Wherein, the proximal connecting portion 142 of the top end section can be used as an extension of the distal section 130 , that is, the proximal connecting portion 142 of the top end section and the distal section 130 can be processed as a whole. In this way, the proximal end connection portion 142 of the tip section is also divided into an outer tube and an inner tube, and also has a second lumen 520 . The function of the top part 141 of the top section is to connect the outer tube and the inner tube of the proximal connection part 142 of the top section, and to close the second cavity 520 . The material of the proximal end connecting portion 142 of the top end section is preferably a material with a lower hardness but a certain degree of elasticity; thus, the blood vessel is better protected when the elongated member is pushed into the curved section of the blood vessel; specific materials such as Pebax2533, Pebax3533 , TPU3585A and TPU3595A, etc. In order to allow the operator to judge the position of the device in the blood vessel, the proximal connecting part 142 of the tip section can also be provided with markers, such as the previously mentioned metal or metal alloy with better biocompatibility or stability, such as platinum Group metal (such as platinum-iridium alloy), gold, etc. or the material of the top part 140 is a polymer material with added developing material (such as barium salt (BaSO4, etc.), bismuth salt (BiOCl, etc.), etc.).

In this specific embodiment, the outer diameter of the top section is not greater than 6Fr (Fr is the unit of the catheter, 3F=3mm circumference, and because the circumference=3.14×diameter, so the diameter 1Fr≈0.33mm), the length of the top section is 3mm ~ 30cm. The advantage of this setting is: the top section has a smaller outer diameter, can directly reach smaller blood vessels, and does not need to be used in conjunction with other guide catheters or accessories, reducing surgical operations and surgical costs; in addition, the capsule has a certain distance from the top of the catheter. During the operation, the balloon is still inflated at the thicker blood vessel, avoiding the risk of complications caused by inflating the smaller blood vessel.

As shown in Figure 8, in this specific embodiment, the proximal section 110 includes a proximal section outer tube 111 and a proximal section inner tube 112, and the first cavity 510 is the lumen of the proximal section inner tube 112, that is to say , the first lumen 510 extends along its axis from the proximal segment 110 to the intermediate segment 120 . There is a second cavity 520 extending along the axis of the proximal section 110 between the proximal section outer tube 111 and the proximal section inner tube 112, that is to say, the second cavity 520 extends from the proximal section 110 to the middle section along its axis 120.

The main function of the proximal section 110 is to connect the handle 300 and provide access from the first lumen 510 and the second lumen 520 of the handle 300 . As shown in Figure 6, the handle is used to hold and manipulate the entire device, for example, to advance the elongated member 100 and balloon 200 to a target location within the blood vessel. The handle has at least two chambers isolated from each other, one chamber communicates with the first chamber 510 of the elongated member 100 for removing thrombus; the other chamber communicates with the second chamber 520 of the elongated member 100 for providing pressure so that The balloon 200 is inflated and the pressure is removed causing the balloon 200 to deflate. In order to accomplish this function, the handle 300 needs to be connected to another device through an interface, for example, a device that generates negative pressure (such as a syringe, a filling device, a vacuum pump, etc., for the first chamber 510) and a device that provides hydraulic pressure or air pressure (such as A syringe, filler, etc. is used for the second chamber 520). The configurations of the proximal section 110 and the handle 300 are well known in the art and will not be described in detail here.

The medical device used in the blood vessel in this particular embodiment can be directly inserted into the blood vessel from the skin through a puncture or an incision, or the device also utilizes one or more other instruments to enter the blood vessel, for example, an introducer sheath (catheter and the balloon pass inside the introducer sheath, or the introducer sheath passes through the first lumen of the catheter), the guide wire (the catheter and the balloon pass outside the guide wire, and the guide wire is located in the first lumen). Monitor the position of the marker 240 under the irradiation of radiation. When the target position is reached, push the syringe to provide hydraulic pressure or air pressure to expand the balloon 200 to block the blood vessel, and perform the operation of removing the thrombus, for example, turn on the vacuum pump to suck the thrombus. After the aspiration is complete, the syringe is withdrawn causing the liquid or gas in the second chamber 520 to flow back, causing the balloon 200 to deflate. Finally the entire device is withdrawn from the blood vessel. During this process, reagents can also be delivered through the first lumen 510 to the target location in the blood vessel, or other instruments for directly removing the thrombus can be delivered.

Fig. 9 and Fig. 10 show the second preferred embodiment of the medical device for intravascular provided by the present invention.

The device in this embodiment has the same structure as the bladder 200 and handle 300 of the first embodiment, the main difference being the structure of the elongated member 100 .

In this particular embodiment, the elongated member 100 also includes a proximal section 110 , a middle section 120 , a distal section 130 , and a tip section 140 . The proximal section 110 , the middle section 120 , and the distal section 130 also include an inner tube and an outer tube, and also have a first lumen 510 and a second lumen 520 . The outer pipe 121 of the middle section and the inner pipe 122 of the middle section are also divided into five sections. The middle section outer tube 121 is divided into extending from the proximal end to the distal end and adjacent in sequence: the middle section outer tube proximal connecting section 1214, the middle section outer tube first section 1211, the middle section outer tube second section 1212, the middle section outer tube The third section 1213 , the connecting section 1215 at the distal end of the outer tube of the middle section. The inner tube 122 in the middle section is divided into two parts extending from the proximal end to the distal end and adjacent in sequence: the proximal connecting section 1224 of the inner tube in the middle section, the first section 1221 of the inner tube in the middle section, the second section 1222 of the inner tube in the middle section, and the second section 1222 of the inner tube in the middle section. The third section 1223 , the connecting section 1225 at the distal end of the inner tube in the middle section.

The structure of the middle section inner tube 122 in this specific embodiment is the same as that of the first specific embodiment, the difference is the structure of the middle section outer tube 121 .

Fig. 10 shows the cross section of the middle section outer tube 121 in this embodiment, the middle section outer tube proximal connection section 1214, the middle section outer tube first section 1211, the middle section outer tube second section 1212, the middle outer tube The third section 1213 of the tube and the connecting section 1215 at the distal end of the outer tube in the middle section all adopt the structure shown in FIG. 10 . As shown in Figure 10, the middle section outer tube 121 is divided into three layers from the outside to the inside, namely: the first layer 1217 of the middle section outer tube, the second layer 1218 of the middle section outer tube, the third layer 1219 of the middle section outer tube, Wherein, the material of the first layer 1217 of the middle section outer tube and the third layer 1219 of the middle section outer tube is plastic, and the material of the second layer 1218 of the middle section outer tube is wire braid.

Because the main function of the outer tube of the middle section is to provide support and anti-bending, therefore, in this specific embodiment, the weaving method of the wire braid used in the second layer 1218 of the outer tube of the middle section is non-mesh weaving, a kind of A preferred embodiment is a spring-like braid, ie the braid is primarily composed of spring-like metal wires (eg, stainless steel wires) cross-linked. The first layer 1217 of the outer tube in the middle section can be made of plastics with the same hardness, such as Pebax, or plastics with different hardness. A preferred embodiment is to use plastics with different hardness. The first layer of the proximal connecting section 1214 of the outer tube of the middle section is made of nylon, the first layer of the first section 1211 of the outer tube of the middle section is made of Pebax7233, and the second layer of the outer tube of the middle section is used. The first layer of section 1212 adopts Pebax5533, the first layer of the third section 1213 of the outer tube of the middle section adopts Pebax4033, and the first layer of the outer tube of the middle section distal connecting section 1215 adopts Pebax2533. This configuration can further strengthen the middle section. Properties of hardness gradients. The material of the third layer 1219 of the outer tube in the middle section can be polytetrafluoroethylene (PTFE), which reduces the friction of the inner wall. A preferred embodiment is that the material of the third layer 1219 of the inner tube in the middle section can be PTFE WT0.025.

Fig. 11 shows a third preferred embodiment of the medical device for intravascular use provided by the present invention.

The device in this embodiment has the same structure as the elongated member 100 and the handle 300 of the first embodiment, the main difference being the structure of the bladder 200 .

In this particular embodiment, the bladder 200 also has two shapes, a first shape in a deflated state (not shown in the figure) and a second shape in an expanded state (Fig. 7). Likewise, when the balloon 200 is in the first shape, the elongated member 100 and the balloon 200 as a whole are adapted to move within the blood vessel; when the balloon 200 is in the second shape, the balloon 200 functions to occlude the blood vessel.

As shown in FIG. 11 , in this specific embodiment, when the inflatable portion 230 of the balloon 200 is in an inflatable state, the inflatable portion 230 has two locations where blood vessels can be blocked. Because the occlusion is mainly achieved by the close fit between the outer surface of the expandable part 230 and the inner wall 400 of the blood vessel, the expandable part 200 has a first occlusive outer surface 231 that is close to the blood vessel wall and occludes the blood vessel, and is used for The second occluded outer surface 232 that closely adheres to the vessel wall and occludes the blood vessel, the first occluded outer surface 231 and the second occluded outer surface 232 are separated from each other in position, that is to say, the first occluded outer surface 231 And there is a fourth cavity 540 between the second occlusion outer surface 232 and the inner wall 400 of the blood vessel that is close to it. The outer shape of the capsule 200 shown in FIG. 11 is gourd-shaped as a whole. The so-called "gourd shape" means that, from the appearance point of view, the main body of the capsule 200 has two spherical or almost spherical parts. The gourd-shaped pouch may be easier to manufacture than other shapes, but obviously, according to the principles provided by this specific embodiment, the pouch 200 may also be of other shapes. For example, the first plugging outer surface 231 and the second plugging outer surface 232 are closer to a plane than to a spherical surface.

Compared with the first specific embodiment, the device in this specific embodiment utilizes two positions separated from each other to block the blood vessel, which has the advantage of reducing the compression and stimulation of the inner wall of the blood vessel to reduce the occurrence of complications .

For example, in a typical situation, the inner diameter of the blood vessel to be treated with thrombus is about 6 mm. In the prior art, the balloon 200 has only one part to block the blood vessel, for example, from the appearance, the whole balloon 200 has only one sphere. In this case, in order to achieve the desired occlusion effect, when the sac is in the expanded second shape, the outer diameter of the sac usually reaches about 7mm, the length of the sac usually reaches about 8mm, and the area of the occlusion surface usually It is about 311mm ² .

In this specific embodiment, two parts are used to block the blood vessel, which is much more efficient than one part. In this way, the outer diameter, width and area of the blocking surface can be greatly reduced, thereby greatly reducing the impact on the blood vessel. Compression and irritation of the inner walls of blood vessels. The inventors of the present application unexpectedly found that, for a typical inner diameter of a blood vessel of about 6 mm, when the balloon 200 is inflated to an outer diameter of 7 mm, an ideal occlusion effect can be achieved if the length of the balloon 200 is configured to be 10-14 mm. At this time, the area of one of the first sealing outer surface 231 and the second sealing outer surface 232 is about 100˜160 mm ² . The inventors of the present application further found that for blood vessels with larger inner diameters, for example, when the balloon 200 is inflated to an outer diameter of 9mm, if the length of the balloon 200 is configured to be 10-16mm, an ideal occlusion effect can be achieved; When the balloon 200 is inflated to an outer diameter of 10 mm, if the length of the balloon 200 is configured to be 10-18 mm, an ideal blocking effect can be achieved. In the prior art, a single occlusion surface compresses a certain continuous position of the blood vessel, which greatly stimulates the blood vessel; however, multiple capsules compress different positions of the blood vessel, which reduces the continuous stimulation of the blood vessel and reduces the vascular stress response, thereby reducing the complication.

For a compliant bladder, in order to expand into the desired gourd shape, the bladder 200 can be configured to have a less expandable middle portion, for example, a thicker wall in the middle portion, or a less expandable material, or, The middle part is embedded with a developing material (such as barium salt (BaSO4, etc.), bismuth salt (BiOCl, etc.), etc.) and the like.

Fig. 12 shows a fourth preferred embodiment of the medical device for intravascular use provided by the present invention.

The device in this embodiment has the same structure as the elongated member 100 and the handle 300 of the third embodiment, the main difference being the structure of the bladder 200 .

In this specific embodiment, the balloon 200 also has a first sealing outer surface 231 that is close to the blood vessel wall and blocks the blood vessel, and a second sealing outer surface 232 that is used to be close to the blood vessel wall and block the blood vessel, The shapes and dimensions of the first sealing outer surface 231 and the second sealing outer surface 232 provided in the first specific embodiment are also applicable to this specific embodiment.

The difference from the first specific embodiment is that the bladder 200 in this specific embodiment is divided into a first bladder portion 201 and a second bladder portion 202 . Wherein, the first sealing outer surface 231 is located in the first capsule portion 201 , and the second sealing outer surface 232 is located in the second capsule portion 202 . When the first bag portion 201 is in the inflated state, there is a third chamber first sub-cavity 531 between the first bag portion 201 and the outer tube 131 of the distal end; when the second bag portion 202 is in the inflated state, the second bag portion There is a third lumen and a second sub-chamber 532 between the outer tube 131 of the distal section and the outer tube 202 . The first sub-chamber 531 of the third chamber and the second sub-chamber 532 of the third chamber are two independent chambers, that is to say, the first capsule portion 201 and the second capsule portion 202 combine the first sub-chamber 531 and the The third chamber and the second sub-chamber 532 are hermetically isolated into two chambers. The third chamber, the first sub-chamber 531 and the second chamber 520 communicate through the hole on the outer tube 131 of the distal end, and the third chamber, the second sub-chamber 532 and the second cavity 520 also pass through the outer tube 131 of the distal end The other holes on the handle are communicated, so that the pressure from the handle 300 is transmitted through the second cavity 520 to between the expansion part 230 and the outer tube 131 of the distal section, so that the first bag part 201 and the second bag part 202 are inflated. Therefore, "the first sub-chamber of the third chamber and the second sub-chamber of the third chamber are independent of each other" mentioned here does not mean that there is no communication between the first sub-chamber of the third chamber and the second sub-chamber of the third chamber (they are independent of each other). Indirect communication through the second chamber 520 ), but for the capsule 200 itself, the third chamber, the first sub-chamber and the third chamber, the second sub-chamber are separated into two independent chambers by the wall of the capsule. The pressure to inflate the first bladder portion 201 and the second bladder portion 202 can also be hydraulic pressure or air pressure, preferably air pressure.

One advantage of dividing the bladder 200 into a first bladder portion 201 and a second bladder portion 202 is that it is relatively easy to manufacture. In the first specific embodiment, the capsule 200 is gourd-shaped as a whole. When the capsule 200 is in a contracted state, the capsule 200 should be as close as possible to the outer wall of the outer tube of the distal end section and the outer diameter of the capsule 200 should be as close as possible. When the balloon 200 is in the inflated state, the balloon 200 should expand to the desired gourd shape; to achieve this, whether it is elastic or non-elastic material, the production cost is generally relatively high. In this specific embodiment, the bladder 200 is divided into independent first bladder portion 201 and second bladder portion 202, and in the inflated state, the first bladder portion 201 and the second bladder portion 202 only need to expand into approximately spherical shapes. , it is much easier to realize this than in the first specific implementation manner. During manufacture, the first balloon portion 201 and the second balloon portion 202 may be manufactured separately, and then separately connected to the outer wall of the outer tube of the distal end section. That is to say, the first balloon part 201 and the second balloon part 202 have respective proximal connection parts, distal connection parts and inflatable parts. In this case, the first capsule portion 201 and the second capsule portion 202 can actually be regarded as two independent capsules. The first balloon portion 201 and the second balloon portion 202 may also be manufactured in one piece and connected together to the outer wall of the outer tube of the distal section. That is to say, the first capsule part 201 and the second capsule part 202 have a proximal connection part, a distal connection part, an intermediate connection part (the first capsule part 201 and the second capsule part 202 share), the first capsule part 201 and the second capsule part 202 as a whole. The inflated portion of the first bladder portion and the inflated portion of the second bladder portion. The connection between the first capsule portion 201 and the second capsule portion 202 and the outer tube of the distal section can also adopt the method provided in the first specific embodiment, for example, through adhesive bonding, interference fit, sonic welding, Connections are made by fusing, tightly knobbing, snugly fitting through other connectors, etc.

As in the first embodiment, the distal segment 130 of the elongate member 100 of the device in this embodiment also carries a marker 240 . The marker 240 is also ring-shaped and sleeved on the outer wall of the outer tube 131 at the distal end. In this embodiment, there are three markers 240, all of which are located on the outside of the capsule 200 (including the first capsule portion 201 and the second capsule portion 202), wherein two markers 240 are closely attached to the proximal end of the capsule 200 and At the distal end, another marker 240 is located in the middle of the first capsule portion 201 and the second capsule portion 202 , so that the positions of the first capsule portion 201 and the second capsule portion 202 can be clearly displayed under radiation.

Fig. 13 shows a fifth preferred embodiment of the medical device for intravascular use provided by the present invention.

The intravascular medical device in this embodiment has the same structure as the elongated member 100 and the handle 300 in the third preferred embodiment, the main difference lies in the structure and position of the marker 240 .

In this specific embodiment, the marker 240 is a strip-shaped developing material (such as barium salt (BaSO4, etc.), bismuth salt (BiOCl, etc.), etc.), which is embedded in the capsule wall of the capsule 200 . As balloon 200 expands, marker 240 expands with it. Such a marking method is obviously more conducive to the operator to observe the position and expansion state of the bladder 200 .

Apparently, the device provided in the above-mentioned fourth embodiment can also be deformed in this manner, that is, the developing material is embedded into the capsule wall of the capsule 200 , which will not be described in detail here.

Claims (10)

1. A medical device for intravascular use, comprising an elongate member comprising a distal section for carrying said capsule and a tip section adjoining said distal section, and an inflatable balloon, It is characterized in that the outer diameter of the top end section is not larger than 6Fr. 2. The medical device for intravascular use according to claim 1, wherein the length of the tip section is not less than 3 mm. 3 . The medical device for intravascular use according to claim 1 , wherein the length of the tip section is 3 mm to 30 cm. 4 . 4. The intravascular medical device according to claim 1, wherein the intravascular medical device comprises a balloon guiding catheter. 5. The medical device for intravascular use according to claim 1, wherein the medical device for intravascular use further comprises a handle, and the elongated member further comprises a proximal end for connecting with the handle segment and an intermediate segment between the proximal segment and the distal segment, wherein the intermediate segment at least includes a first segment, a second segment and a third segment, and the first segment, the second segment , and the third section are arranged sequentially from the proximal end to the distal end, and the hardness of the first section, the second section and the third section are different. 6. The medical device for intravascular use according to claim 5, wherein the first section, the second section and the third section are adjacent to each other in sequence. 7. The medical device for intravascular use as claimed in claim 5, wherein the hardness of the first segment, the second segment and the third segment decrease sequentially. 8. The medical device for intravascular use according to claim 5, wherein the intermediate section further comprises a proximal connection section for connecting with the proximal section, adjacent to the proximal end of the first section , the hardness of the proximal connecting section is greater than the hardness of the first section. 9. The medical device for intravascular use according to claim 5, wherein the middle section further comprises a distal connecting section for connecting with the distal section, adjacent to the distal end of the third section , the hardness of the distal connecting section is less than the hardness of the third section. 10. The medical device for intravascular use as claimed in claim 5, wherein the middle section comprises an outer tube of the middle section and an inner tube of the middle section; the outer tube of the middle section comprises a first section of the outer tube of the middle section , the second section of the middle section outer pipe, the third section of the middle outer pipe; the middle section inner pipe includes the first section of the middle section inner pipe, the second section of the middle section inner pipe, and the third section of the middle inner pipe; the middle section The first section of the outer tube and the first section of the inner tube of the middle section constitute the first section of the middle section, and the second section of the outer tube of the middle section and the second section of the inner pipe of the middle section constitute the first section of the middle section. The second section, the third section of the middle section outer pipe and the first section of the middle section inner pipe constitute the third section of the middle section.