CN220001860U - Introducer and thrombolysis device - Google Patents

Abstract

The utility model discloses an introducer and a thrombus removing device, wherein the introducer comprises: the hollow long tube and the handle structure is arranged at the proximal end of the hollow long tube; the hollow long tube includes: the guide sections are sequentially arranged along the length direction of the guide and are connected with each other; the outer diameter of the most distal guide section is greater than the outer diameter of the other sections. The distal guide section is attached to the sheath, while the proximal guide section is detached from the sheath. Thus, when the introducer is inserted into the sheath (i.e., the sheath is sleeved outside the introducer), the friction between the sheath and the introducer can be reduced, so that the introducer can be inserted into the sheath more easily.

Description

Introducer and thrombolysis device

Technical Field

The utility model relates to the technical field of medical instruments, in particular to an introducer and a thrombus taking device.

Background

Pulmonary embolism (Pulmonary Embolism, PE) is a clinical pathophysiological syndrome of pulmonary circulatory disturbance caused by an exfoliated thrombus or other substance blocking a pulmonary artery or its branches, which also often occurs in the form of complications due to the specificity of the pulmonary embolism formation mechanism.

In the prior art, an interventional instrument is generally adopted to establish a channel in a human body blood vessel, the interventional instrument establishes a conveying channel through an outer sheath system, so that a pushing and taking system is convenient to enter a blood vessel target thrombus position, and thrombus is taken by releasing a taking branch and guided out of the body through the outer sheath channel.

However, during the operation, the inventor found that, since the introducer is long, it is difficult for the doctor to insert the introducer into the sheath when inserting the long introducer into the sheath during the operation.

Disclosure of Invention

The object of the present utility model is to address the drawbacks of the prior art by providing an introducer and a thrombolysis device.

In order to solve the above-described problems, the present utility model provides an introducer including: the device comprises a hollow long tube and a handle structure arranged at the proximal end of the hollow long tube;

the hollow long tube includes: the guide sections are sequentially arranged along the length direction of the guide and are connected with each other;

the outer diameter of the most distal guide section is greater than the outer diameter of the other sections.

In contrast to the prior art, the embodiment of the utility model is characterized in that the distal guide section is attached to the sheath, and the proximal guide section is detached from the sheath. Thus, when the introducer is inserted into the sheath (i.e., the sheath is sleeved outside the introducer), the friction between the sheath and the introducer can be reduced, so that the introducer can be inserted into the sheath more easily. Meanwhile, the guide section at the distal end can be attached to the inner wall of the sheath tube, so that the guide device can drive the sheath tube to move, and the guide device plays a role in guiding the sheath tube. More importantly, the distal guide section can be attached to the inner wall of the sheath, so that blood cannot be ejected from the sheath, and the hemostatic effect is achieved.

In one embodiment, the guide section is two sections, and the outer diameter of the guide section at the distal end is larger than the outer diameter of the guide section at the proximal end;

the outer wall of the guide section at the far end is attached to the inner wall of the sheath tube, and the outer wall of the guide section at the near end and the inner wall of the sheath tube are separated by a preset distance.

In one embodiment, the predetermined distance is 0.1-0.5mm.

In one embodiment, the bending flexibility of each of the guide segments increases gradually from the proximal end to the distal end of the introducer.

In one embodiment, the introducer is operable to sheath the sheath for access to the pulmonary artery via the femoral vein, inferior vena cava, right atrium, right ventricle;

the introducer has two sections of the guide section, the distal section being located in at least the right atrium, right ventricle and pulmonary artery and partially in the inferior vena cava during surgery.

In one embodiment, the guide has two guide sections, the guide section at the distal end has a length of 400mm-500mm, and the guide section at the proximal end has a length of 570mm-670mm;

and/or, the introducer is operably sleeved with a sheath tube, the distal end of the guide section at the most distal end is a tip, and the tip is exposed outside the sheath tube.

In one embodiment, two adjacent guide pipes are connected by hot melting.

In one embodiment, each of the guide segments has the same flexibility and outer diameter throughout.

In one embodiment, the color of each guide segment is different;

and/or, the material of the introducer comprises a mixture of LDPE, barium sulfate and EVA;

and/or the EVA content of the guiding section at the far end is 50% -60%, and the EVA content of the guiding section at the near end is 25% -35%.

In one embodiment, the distal end of the hollow long tube is a conical tip, the distal end surface of the tip is a plane, and the plane is in circular arc transition with the outer annular surface of the tip;

the guide section at the most distal end is internally provided with a first channel, a second channel and a third channel, the first channel, the second channel and the third channel are sequentially arranged from the distal end to the proximal end, the inner diameter of the first channel is matched with the outer guide wire, and the inner diameter of the third channel is larger than the inner diameter of the first channel;

the second channel is a transition channel, and the inner diameter of the second channel gradually increases from the far end to the near end;

the wall thickness of the distal-most guide section is smaller at the third channel than at the first channel.

The utility model also provides a thrombus taking device, which comprises:

the above-mentioned guide;

a sheath operatively sleeved outside the introducer;

and the negative pressure device is communicated with the sheath tube.

In one embodiment, the distal end of the hollow long tube of the introducer is exposed outside the sheath, the distal end of the sheath having a chamfer;

wherein, from the distal end to the proximal end, the chamfer slope is inclined away from the axial direction of the sheath.

Drawings

FIG. 1 is a schematic view of an exemplary embolectomy device as provided herein when inserted into a human body;

FIG. 2 is an enlarged view of FIG. 1 at A provided by an embodiment;

FIG. 3 is a schematic view of the structure of the thrombus removing device in the embodiment;

FIG. 4 is a partial enlarged view of the embodiment of FIG. 3;

FIG. 5 is a schematic view of the structure of an embodiment introducer;

FIG. 6 is a schematic diagram of the structure of an embodiment introducer;

FIG. 7 is a partial cross-sectional view at the tip after the introducer and sheath are mated;

FIG. 8 is a perspective view of a cut-away view of a tapered die and a schematic structural view of a mandrel in an embodiment;

fig. 9 is a sectional view of a tapered die and a schematic structural view of a mandrel in an embodiment.

Reference numerals illustrate:

1. transfemoral vein; 2. inferior vena cava; 3. a heart; 31. right atrium; 32. a right ventricle; 33. the left atrium; 34. a left ventricle; 4. pulmonary artery; 6. an introducer; 61. a hollow long tube; 611. a guide section; 6111. a first guide section; 6112. a second guide section; 62. a handle structure; 621. a handle; 6211. a handle block; 622. a luer fitting; 63. a tip; 631. a distal end face; 632. an outer annulus; 641. a first channel; 642. a second channel; 643. a third channel; 7. a thrombus taking device; 71. a sheath; 711. chamfering; 72. a negative pressure device; 73. a hemostatic valve; 8. a conical die; 81. conical grooves; 811. a groove bottom; 812. an inner annulus; 82. a cylindrical recess; 9. a core rod; 91. a first rod segment; 92. a second rod segment; 93. and a third rod segment.

Description of the embodiments

Other advantages and effects of the present utility model will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present utility model with reference to specific examples. The utility model may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present utility model. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.

In the present utility model, when describing an introducer, "proximal" refers to the side of the introducer in the direction of the user-manipulated end, and correspondingly, "distal" refers to the side of the introducer in the direction away from the user-manipulated end.

Examples

The inventors have found that the blood pressure instability of the patient during surgery is caused by the fact that the heart 3 is divided into a right atrium 31, a right ventricle 32, a left atrium 33 and a left ventricle 34, and the pulmonary artery 4 communicates with the right ventricle 32, as shown in fig. 1 and 2. As shown in fig. 1 to 4, the current pulmonary artery 4 thrombolysis device 7 generally re-enters the pulmonary artery 4 via the femoral vein 1, the inferior vena cava 2, the right atrium 31, and the right ventricle 32, so that the introducer 6 is inserted into the femoral vein, the inferior vena cava 2, and the right atrium 31, respectively, and re-enters the pulmonary artery 4 during the operation. While there is a very large tortuous path between the right atrium 31 and the pulmonary artery 4, when the introducer 6 is in this tortuous path, a significant compressive force is applied to the heart 3 which may affect the normal systolic beating of the heart 3, thereby causing the heart 3 to fail to function properly, thereby affecting the stability of the patient's blood pressure and increasing the risk of surgery.

This embodiment provides an introducer 6, as shown in fig. 5-6, the introducer 6 comprising: a hollow long tube 61 and a handle 621 structure 62 provided at the proximal end of the hollow long tube 61. The present embodiment allows for evacuation of the hollow tube using a handle 621 with a luer 622. Handle 621 structure 62 includes a handle 621 and a luer 622, the distal end of handle 621 being connected to the proximal end of hollow elongate tube 61, the proximal end of handle 621 being connected to luer 622. The handle 621 has two handle blocks 6211, and the two handle blocks 6211 are all perpendicular to the axis of the handle 621 and are oppositely arranged on two sides of the handle 621 along the axis of the handle 621, so that a doctor can conveniently grasp the guide 6.

Specifically, the hollow long tube 61 includes: the guide segments 611 are arranged in sequence along the length of the guide 6 and are connected to each other. The bending flexibility of each guide segment 611 gradually increases from the proximal end to the distal end of the introducer 6.

Since the introducer 6 includes multiple segments of guide segments 611, the bending flexibility of each of the guide segments 611 gradually increases from the proximal end to the distal end of the introducer 6. I.e. closer to the heart 3, the flexibility thereof is greater, thus enabling the greatest possible reduction in the pressure exerted by the introducer 6 on the heart 3 during introduction. Meanwhile, the flexibility of the proximal end of the introducer 6 is poor, so that the supporting force is strong, a doctor can push the introducer 6 conveniently, and the purpose of guiding the sheath tube 71 by the introducer 6 is achieved. In summary, the introducer 6 of the present utility model employs a gradual increase in flexibility from the proximal end to the distal end, which not only reduces compression on the heart 3, but also retains the guiding and expanding action of the introducer 6 itself.

Of course, the introducer 6 also dilates the vessel in the vessel for the purpose of introducing the sheath 71, allowing the sheath 71 to reach the destination. Since the most distal guide segment 611 is most flexible, the damage to the vessel by the introducer 6 can be reduced as the introducer 6 expands during endovascular motion.

As shown in fig. 1, during the operation, a body surface of a thigh is pierced to form a flare into a femoral vein, a guide wire is used to enter the femoral vein through the flare, and then the guide wire enters the inferior vena cava 2, the right atrium 31 and the right ventricle 32 from the femoral vein until reaching the pulmonary artery 4, so as to establish a channel in a human body.

Once the guidewire is inside the body, a preliminary passageway is established. The sheath tube 71 is sleeved on the introducer 6, the distal end of the introducer 6 is exposed outside the sheath tube 71, the introducer 6 is of a hollow structure, the introducer 6 passes through the outside of the guide wire, enters the femoral vein, the inferior vena cava 2, the right atrium 31 and the right ventricle 32 along the guide wire, and reaches the pulmonary artery 4.

When the distal end of the sheath 71 reaches the pulmonary artery 4, the introducer 6 is withdrawn from the body along the guide wire, the sheath 71 is left in the blood vessel of the human body, and the thrombus in the pulmonary artery 4 can be sucked out of the body through the sheath 71 by the suction of the negative pressure device 72 due to the fact that the proximal end of the sheath 71 is also connected with the negative pressure device 72, so that the thrombus taking is completed.

Of course, in some embodiments, the thrombus removing device 7 may further include a thrombus removing bracket, where the thrombus removing bracket enters the pulmonary artery 4 through the sheath tube 71, and some thrombus may adhere to the thrombus, and in actual operation, the thrombus removing bracket is retracted while sucking, and the thrombus removing bracket mainly plays a role of peeling off old thrombus.

Of course, it should be emphasized that the introducer 6 of this embodiment may be used not only in the thrombectomy device 7, but also in other devices, such as delivery devices for atrial shunts, occluders, etc., as desired.

As shown in fig. 2, there is a very large curve from the inferior vena cava 2 to the right atrium 31 and right ventricle 32, and to the pulmonary artery 4, so it is more preferable that the guiding segment 611 is two, and that the guiding segment 611 at the distal end is located at least in the right atrium 31, right atrium 32 and pulmonary artery 4, and partly in the inferior vena cava 2 during operation. Since the distal guiding segment 611 is the softest, the curvature of the guiding segment 611 may be large without causing significant stress to the heart 3.

In addition, since the curvature is small from the femoral vein to the inferior vena cava 2, the introducer 6 does not need to be over-bent, and the stiffer proximal guide section 611 may be in the femoral vein and part of the inferior vena cava 2. At the same time, the stiffer guide section 611 has a higher stiffness, which facilitates the physician's proximal manipulation of the introducer 6, allowing the introducer 6 to guide the sheath 71 into the pulmonary artery 4.

In addition, it is more preferable that the diameter of the most distal guide section 611 is larger than the diameter of each other guide section 611, as shown in fig. 5 and 6, for example, when the guide sections 611 are two sections, the outer diameter of the most distal guide section 611 is larger than the outer diameter of the most proximal guide section 611.

The introducer 6 is operatively sleeved with a sheath tube 71, and the outer wall of the distal guide section 611 is attached to the inner wall of the sheath tube 71, and the outer wall of the proximal guide section 611 and the inner wall of the sheath tube 71 are spaced apart from each other by a predetermined distance, preferably, the predetermined distance is 0.1-0.5mm.

Specifically, in the present embodiment, the guiding section 611 is divided into two sections, namely, a first guiding section 6111 at the proximal end and a second guiding section 6112 at the distal end. The outer wall of the second guide section 6112 is attached to the inner wall of the sheath 71, and the outer wall of the first guide section 6111 is spaced apart from the inner wall of the sheath 71 by a predetermined distance, which is optimal when the predetermined distance reaches 0.1-0.5mm.

The proximal guide section 611 gradually separates from the sheath 71 due to the fit between the distal guide section 611 and the sheath 71. Thus, when the introducer 6 is inserted into the sheath 71 (i.e., the sheath 71 is sleeved outside the introducer 6), the friction between the sheath 71 and the introducer 6 can be reduced, so that the introducer 6 can be more easily inserted into the sheath 71. At the same time, since the distal guide segment 611 can be attached to the inner wall of the sheath 71, this results in the guide 6 being able to move the sheath 71, acting as a guide sheath 71. More importantly, the distal guide segment 611 is capable of fitting against the inner wall of the sheath 71, which prevents blood from being ejected from the sheath 71 and thus acts as a hemostasis.

Of course, in some embodiments, the guide section 611 may be three or four sections or more, with the most distal guide section 611 having the largest diameter and the middle guide section 611 having the smallest diameter and the most proximal guide section 611 having the medium diameter when divided into three sections.

In addition, the flexibility of the first guide segment 6111 is lower than the flexibility of the second guide segment 6112, and the second guide segment 6112 is located in the inferior vena cava 2, the right atrium 31, and the pulmonary artery 4, and the first guide segment 6111 is located in the femoral vein and the inferior vena cava 2. To achieve this, it is preferable that the length of the second guide section 6112 is 400mm to 500mm and the length of the first guide section 6111 is 570mm to 670mm. When the lengths of the first and second guide segments 6111, 6112 reach this value, the second guide segment 6112 is located in the inferior vena cava 2, the right atrium 31, the right ventricle 32, and the pulmonary artery 4, and the first guide segment 6111 is located in the femoral vein and the inferior vena cava 2.

In addition, as shown in fig. 6 and 7, the distal end of the guide section 611 at the most distal end is a tip 63, and the tip 63 is exposed outside the sheath 71, so that the introducer 6 can move in the blood vessel through the tip 63 to perform the functions of guiding the sheath and dilating the blood vessel. In this embodiment, the distal end of the second guiding section 6112 is a tip 63, and since the flexibility of the second guiding section 6112 is high, the flexibility of the tip 63 is also high, so that the damage of the introducer 6 to the blood vessel can be effectively reduced.

Preferably, each guide segment 611 has the same flexibility and outer diameter throughout, i.e., each guide segment 611 is formed by extrusion. For example, in this embodiment, the first guide segment 6111 and the second guide segment 6112 are formed by extrusion molding, so that the outer diameter and flexibility of each portion of the first guide segment 6111 are the same, and the outer diameter and flexibility of each portion of the second guide segment 6112 are the same. The flexibility of the first guide segment 6111 is lower than the flexibility of the second guide segment 6112, and the outer diameter of the first guide segment 6111 is smaller than the outer diameter of the second guide segment 6112. Preferably, the outer diameter of the second guide section 6112 is 5.65mm-5.75mm and the outer diameter of the first guide section 6111 is 5.45mm-5.55mm.

After the guide segments 611 are formed, the guide segments 611 are connected together by heat fusion. Since the guide sections 611 are connected together by hot melting, the connection between the two guide sections 611 is smoother, and the step of protruding ribs is avoided between the guide sections 611 at both ends. Of course, in some embodiments, a common connection may be used, as shown in fig. 5 and 6, where a step is formed between the two guide segments 611.

More preferably, the guide segments 611 are each of a different color so that during the manufacturing process, it can be seen at a glance that the segment is the more flexible segment and that the segment is the less flexible segment, thereby facilitating the manufacturing of the connection. Meanwhile, after the manufacturing is finished, the inspection personnel can conveniently inspect to see whether the length of the section with high flexibility meets the required standard. Of course, in some embodiments, the colors may also be identical.

In addition, in this embodiment, the material of the guide section 611 includes a blend of LDPE, barium sulfate, or EVA. In the actual production process, the flexibility of the guiding section 611 can be adjusted by adjusting the ratio of EVA, for example, the EVA content of the guiding section 611 at the distal end is 50% -60%, the EVA content of the guiding section 611 at the proximal end is 25% -35%, that is, the EVA content of the second guiding section 6112 is 50% -60%, and the EVA content of the first guiding section 6111 is 25% -35%.

In addition, as shown in fig. 6 and 7, the distal end of the hollow long tube 61 is conical, and the distal end of the hollow long tube 61 is the distal end of the guide section 611 located at the most distal end. As shown in fig. 4 and 7, the distal end of the hollow long tube 61 is a conical tip 63, and the distal end surface 631 of the tip 63 is a plane which makes a circular arc transition with the outer annular surface 632 of the tip 63. Since the distal end surface 631 of the tip 63 is planar and the arc transitions between the distal end surface 631 and the outer annular surface 632 of the tip 63, this results in a very rounded tip 63, which effectively prevents the tip 63 from stabbing the heart 3.

In addition, as shown in fig. 7, the most distal guide segment 611 has therein a first channel 641, a second channel 642 and a third channel 643, the first channel 641, the second channel 642 and the third channel 643 being arranged in sequence from distal to proximal, and the inner diameter of the first channel 641 being adapted to an external guidewire, the inner diameter of the third channel 643 being larger than the inner diameter of the first channel 641. The second passageway 642 is a transition passageway with an inner diameter of the second passageway 642 gradually increasing from the distal end to the proximal end. The wall thickness of the distal-most guide segment 611 at the third channel 643 is less than the wall thickness at the first channel 641.

Since the inner diameter of the first channel 641 is adapted to the external guide wire, that is, the inner wall of the first channel 641 is mutually attached to the outer wall of the guide wire, the guide 6 can smoothly run along the guide wire through the first channel 641 to play a guiding role, and most importantly, blood can be prevented from entering the guide 6 to play a hemostatic role.

In addition, since the wall thickness at the third channel 643 is smaller than the wall thickness at the first channel 641, and the wall thickness at the second channel 642 is gradually reduced, the tip 63 and the guide section 611 can also maintain sufficient flexibility. The introducer 6 is prevented from puncturing the blood vessel and the heart 3.

In addition, in some embodiments, only the diameter of the first guide segment 6111 may be greater than the diameter of the second guide segment 6112, or only the flexibility of the first guide segment 6111 may be less than the flexibility of the second guide segment 6112. These two may be two side-by-side embodiments.

Examples

The present embodiment provides a manufacturing method of the introducer 6, including the steps of:

the plurality of guide segments 611 are formed by extrusion molding, and each guide segment 611 has different flexibility, however, it is preferable that the outer diameter of each guide segment 611 is different.

In practice, the flexibility of each guide segment 611 may be adjusted by adjusting the EVA content.

The guide segments 611 are then arranged in a manner that the flexibility gradually increases and/or the outer diameter gradually increases in a distal to proximal direction, and the guide segments 611 are then heat welded together to form the hollow long tube 61.

Finally, the handle 621 structure 62 is attached to the proximal end of the hollow elongated tube 61, although such attachment may be adhesive or thermal fusion.

In the above-described production process, the guide segments 611 having different flexibility and outer diameter can be obtained in a very simple manner by extrusion, and the guide segments 611 are thermally welded together to form one guide 6 having gradually varying flexibility and outer diameter. The manufacturing method is simple, and the yield of the guide 6 can be greatly improved.

Of course, in some embodiments, it is also possible to integrally form the guide 6 with a gradually changing flexibility and outer diameter, but it is very difficult to manufacture the guide by integrally forming the guide.

In addition, after the guide segments 611 are thermally fused, the method further includes the steps of: with the tapered die 8, as shown in fig. 8 and 9, the tapered die 8 has a conical recess therein, and the distal end of the hollow long tube 61 is inserted into the conical recess 81, thereby forming a conical tip 63 at the distal end of the hollow long tube 61. The shape of the conical die 8 may be any other shape, and for the convenience of clamping, the conical die 8 has a cylindrical shape.

Preferably, as shown in fig. 8 and 9, a mandrel 9 may be further included, where the mandrel 9 can be inserted into the guide segment 611 at the most distal end, i.e., the second guide segment 6112, and the mandrel 9 includes: the first rod segment 91, the second rod segment 92 and the third rod segment 93 are connected in sequence from distal end to proximal end, the first rod segment 91, the second rod segment 92 and the third rod segment 93.

Wherein the outer diameter of the first rod segment 91 is smaller than the outer diameter of the third rod segment 93, and the outer diameter of the second rod segment 92 gradually increases from the direction of the first rod segment 91 to the direction of the third rod segment 93; the outer diameter of the first rod segment 91 is adapted to the outer diameter of the outer guide wire.

As shown in fig. 8 and 9, the conical mold 8 has a conical recess 81 and a cylindrical recess 82 connected to a bottom 811 of the conical recess 81, the bottom 811 of the conical recess 81 being a plane which transitions in circular arc with an inner circumferential surface 812 of the conical recess 81, the inner diameter of the cylindrical recess 82 being adapted to the first rod segment 91.

During processing, the mandrel 9 may be inserted into the second guide segment 6112 first, with the distal end of the first rod segment 91 exposed from the distal end of the guide segment 611 at the most distal end, i.e., from the distal end of the second guide segment 6112. The second guide segment 6112 is then inserted into the tapered die 8 together with the mandrel 9, with the first rod segment 91 partially positioned within the cylindrical recess 82. The tapered die 8 and the core rod 9 are heated, and the distal end of the second guide section 6112 is formed into the shape of the tip 63 described in the first embodiment by the extrusion of the tapered die 8 and the core rod 9. Thereby allowing the tip 63 of the hollow long tube 61 to function as hemostasis, and also allowing the tip 63 to maintain sufficient flexibility.

Since the distal end of second guide segment 6112 is cylindrical in nature and after insertion into tapered mold 8, excess material is compressed inwardly to form first channel 641, which first channel 641 has a small inside diameter for hemostasis. While first channel 641 also exhibits a conical shape with a wall thickness that is sufficiently thick to allow for expansion and guidance of tip 63.

Of course, it should be noted that in some embodiments, the mandrel 9 and the tapered die 8 may be heated first, and then the second guide segment 6112 may be fixed between the mandrel 9 and the tapered die 8.

The present utility model also provides a thrombus removing device 7, as shown in fig. 3 and 4, the thrombus removing device 7 includes: the introducer 6, the sheath 71 and the negative pressure device 72 in the above embodiment, the sheath 71 can be fitted over the outside of the introducer 6, and the negative pressure device 72 communicates with the proximal end of the sheath 71.

After the introducer 6 is withdrawn from the sheath 71, the negative pressure device 72 may be used to withdraw thrombus from the pulmonary artery 4.

As shown in fig. 3, the negative pressure device 72 is a suction tube connected to the sheath tube 71 via a hose, and a hemostatic valve 73 may be further connected to the tail end of the sheath tube 71.

In addition, as shown in fig. 4 and 7, in order to make the distal end of the sheath 71 closely contact with the introducer 6 and prevent the distal end of the sheath 71 from puncturing the blood vessel, the distal end of the sheath 71 has a chamfer 711, and the chamfer 711 is inclined away from the axial direction of the sheath 71 from the distal end to the proximal end.

It should be noted that some details in the foregoing embodiments are common, and in order to avoid repetition, details that are set forth in detail in one embodiment are omitted in another embodiment, but the technical details may still be applied to other embodiments.

The specific embodiments described herein are offered by way of example only to illustrate the spirit of the utility model. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the utility model or exceeding the scope of the utility model as defined in the accompanying claims.

Claims (12)

1. An introducer for a thrombolytic device, the introducer comprising: the device comprises a hollow long tube and a handle structure arranged at the proximal end of the hollow long tube;

the hollow long tube includes: the guide sections are sequentially arranged along the length direction of the guide and are connected with each other;

the outer diameter of the most distal guide section is greater than the outer diameter of the other sections.

2. The introducer of claim 1, wherein the guide section is two-piece, the outer diameter of the guide section at the distal end being greater than the outer diameter of the guide section at the proximal end;

the outer wall of the guide section at the far end is attached to the inner wall of the sheath tube, and the outer wall of the guide section at the near end and the inner wall of the sheath tube are separated by a preset distance.

3. The introducer of claim 2, wherein the predetermined distance is 0.1-0.5mm.

4. The introducer of claim 1, wherein the bending flexibility of each of the guide segments increases gradually from the proximal end to the distal end of the introducer.

5. The introducer of claim 4, wherein the introducer is externally operable to sheath a sheath that is operable to guide the sheath into the pulmonary artery via the femoral vein, inferior vena cava, right atrium, right ventricle;

the introducer has two sections of the guide section, the distal section being located in at least the right atrium, right ventricle and pulmonary artery and partially in the inferior vena cava during surgery.

6. The introducer of claim 1, wherein the introducer has two sections of the guide section, the guide section at the distal end having a length of 400mm-500mm and the guide section at the proximal end having a length of 570mm-670mm;

and/or, the introducer is operably sleeved with a sheath tube, the distal end of the guide section at the most distal end is a tip, and the tip is exposed outside the sheath tube.

7. The introducer of claim 1, wherein adjacent lengths of the guide tubes are connected by heat staking.

8. The introducer of claim 7, wherein each of the guide segments has the same flexibility and outer diameter throughout.

9. The introducer of claim 1, wherein each of the guide segments is of a different color.

10. The introducer of claim 1, wherein the distal end of the hollow elongated tube is a conical tip, the distal end face of the tip being a plane, the plane transitioning through an arc of a circle with the outer annular surface of the tip;

the guide section at the most distal end is internally provided with a first channel, a second channel and a third channel, the first channel, the second channel and the third channel are sequentially arranged from the distal end to the proximal end, the inner diameter of the first channel is matched with the outer guide wire, and the inner diameter of the third channel is larger than the inner diameter of the first channel;

the second channel is a transition channel, and the inner diameter of the second channel gradually increases from the far end to the near end;

the wall thickness of the distal-most guide section is smaller at the third channel than at the first channel.

11. A thrombolytic device, comprising:

an introducer as claimed in any one of claims 1 to 10;

a sheath operatively sleeved outside the introducer;

and the negative pressure device is communicated with the sheath tube.

12. The thrombectomy device of claim 11, wherein a distal end of the hollow long tube of the introducer is exposed outside the sheath, the distal end of the sheath having a chamfer;

wherein, from the distal end to the proximal end, the chamfer slope is inclined away from the axial direction of the sheath.