Pigtail thrombolysis catheter

Abstract

The utility model relates to the technical field of medical instruments, and discloses a pigtail thrombolysis catheter which comprises a catheter body and a plugging piece. The far end part of the tube body is curled to form a drug delivery part, the far end of the drug delivery part is provided with a tube opening, and the drug delivery part is suitable for deforming under the action of external force and restoring after the external force is removed. The multiple through holes are formed in the tube wall of the drug delivery part at intervals. The plugging piece comprises a flexible guide wire and a ball body arranged at the far end of the flexible guide wire, and the flexible guide wire is suitable for extending into the pipe body to the ball body to plug the pipe opening. Through the administration part, physical thrombus breaking and medicine thrombolysis means can be combined, the thrombus breaking progress can be accelerated to a great extent, so that an ideal clinical effect is achieved, the use mode of the tube body and the plugging piece is simple, the thrombolysis difficulty is reduced, meanwhile, the consumable cost is also reduced, and the application range is wide. And the method has good economical efficiency and potential of being suitable for wide popularization.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a pigtail thrombolytic catheter. Background Technique

[0002] The treatment principles of acute pulmonary embolism (APE) mainly include the following four points, including re-establishing blood perfusion, maintaining hemodynamic stability, improving tissue oxygenation, and preventing thrombus recurrence. For low-risk or moderately low-risk APE patients without anticoagulation contraindications, usually only oral or subcutaneous anticoagulant drugs are needed for treatment. For moderately high-risk or high-risk APE patients without thrombolysis contraindications, systemic thrombolysis (ST) treatment or interventional treatment is recommended. ST treatment can reduce the right ventricular load of patients, thereby improving the hemodynamic status of PE patients. During ST treatment, patients need to use high-dose (50 - 100 mg) thrombolytic drugs such as tissue plasminogen activator (TPA) within a short period (15 min - 2 h), resulting in a relatively high bleeding risk (9.9%) for patients, including intracranial hemorrhage (1.7%), visceral hemorrhage such as gastrointestinal hemorrhage. Therefore, many patients have contraindications to ST treatment, such as active internal bleeding, recent ischemic stroke, intracranial surgery or arterial puncture, low platelets or coagulation disorders, which easily hinder the clinical benefits of ST treatment.

[0003] According to the 2019 European Respiratory Society Clinical Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism, for moderately high-risk APE patients with persistent deterioration of hemodynamics and clinical symptoms after anticoagulant treatment, and high-risk APE patients with failed thrombolysis or unable to undergo ST treatment due to contraindications, interventional treatment should be considered. Due to the complex and changeable condition of APE, relying solely on conventional thrombolytic catheters usually cannot enable some patients to clear thrombus within a short time and cannot achieve satisfactory clinical results. Content of the Utility Model

[0004] In view of this, the utility model provides a pigtail thrombolytic catheter to solve the problem that conventional thrombolytic catheters usually cannot enable some patients to clear thrombus within a short time and cannot achieve satisfactory clinical results.

[0005] The utility model provides a pigtail thrombolytic catheter, comprising:

[0006] A tube body, the distal part of which is curled to form a drug delivery part, the distal end of the drug delivery part has a tube orifice, and the drug delivery part is adapted to deform under the action of an external force and recover after the external force is withdrawn;

[0007] Through holes, a plurality of the through holes are arranged at intervals on the tube wall of the drug delivery part;

[0008] The plugging member includes a flexible guide wire and a sphere provided at the distal end of the flexible guide wire. The flexible guide wire is adapted to extend into the tube body until the sphere plugs the tube orifice.

[0009] Optionally, the shape of the tube orifice is a reduced orifice with an inner diameter gradually decreasing from the drug administration part to the distal end.

[0010] Optionally, a plurality of the through holes are uniformly arranged in a spiral shape along the wall of the drug administration part, and the interval distance and angle between any two adjacent through holes are the same.

[0011] Optionally, the angle between any two adjacent through holes is 120 degrees.

[0012] Optionally, at least ten through holes are provided.

[0013] Optionally, at least three through holes are arranged at intervals on the inner ring surface of the drug administration part, at least three through holes are arranged on the outer ring surface of the drug administration part, at least three through holes are arranged on the first side wall between the inner ring surface and the outer ring surface of the drug administration part, and at least one through hole is arranged on the second side wall of the drug administration part opposite to the first side wall.

[0014] Optionally, the flexible guide wire and the sphere are made of nitinol alloy material.

[0015] Optionally, a male Luer connector is provided at the proximal end of the tube body, and a female Luer connector adapted to cooperate with the male Luer connector is provided at the proximal end of the flexible guide wire.

[0016] Optionally, the tube body is made of thermoplastic polyamide material, and a stainless steel braided mesh extending along the length direction of the tube body is embedded in the tube wall.

[0017] Beneficial effects:

[0018] The pigtail thrombolysis catheter provided by the present utility model includes: a tube body and a plugging member. The distal part of the tube body is curled to form a drug administration part. The distal end of the drug administration part has a tube orifice. The drug administration part is adapted to deform under the action of an external force and recover after the external force is withdrawn. A plurality of through holes are arranged at intervals on the wall of the drug administration part. The plugging member includes a flexible guide wire and a sphere provided at the distal end of the flexible guide wire. The flexible guide wire is adapted to extend into the tube body until the sphere plugs the tube orifice.

[0019] When in use, after making a vascular incision, the tube body can be inserted into the blood vessel through a guiding wire until the drug delivery part is placed at the thrombus site. Then, the guiding wire can be withdrawn, and the distal end of the flexible wire is inserted into the tube body until the sphere blocks the tube orifice. After that, thrombolytic drugs can be injected into the tube body through a high-pressure syringe. The thrombolytic drugs will be sprayed onto the thrombus site through multiple through-holes on the drug delivery part, which can not only crush the thrombus by the spraying pressure of the thrombolytic drugs but also dissolve the thrombus through the thrombolytic drugs. In addition, during the use process, the drug delivery part in the shape of a pigtail can be rotated to crush large-volume thrombi. Through the spraying pressure and stirring, large-volume thrombi can be broken into multiple small-volume thrombi, which improves the effective action area of the thrombolytic drugs and speeds up the thrombolysis efficiency.

[0020] By combining the above physical thrombus crushing and drug thrombolysis methods, the thrombus crushing progress can be greatly accelerated, thus achieving an ideal clinical effect. Moreover, the use methods of the above tube body and the plugging member are simple, which reduces the thrombolysis difficulty and also reduces the consumable cost, having good economy and the potential for wide promotion. Description of the Drawings

[0021] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figure 1 Structural schematic diagram of the catheter according to an embodiment of the present invention;

[0023] Figure 2 Structural schematic diagram of the drug delivery part according to an embodiment of the present invention;

[0024] Figure 3 Structural schematic diagram of the plugging member according to an embodiment of the present invention.

[0025] Explanation of the reference numerals in the drawings:

[0026] 1. Tube body; 11. Drug delivery part; 111. Through-hole; 12. Tube orifice; 21. Flexible wire; 22. Sphere; 3. Female Luer connector. Detailed Embodiments

[0027] In order to make the purpose, technical solution and advantages of the embodiment of the utility model clearer, the technical solution in the embodiment of the utility model will be clearly and completely described below in conjunction with the drawings in the embodiment of the utility model. Obviously, the described embodiment is a part of the embodiment of the utility model, not all the embodiments. Based on the embodiment of the utility model, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the utility model.

[0028] like Figure 1 , Figure 2 and Figure 3 As shown, this embodiment provides a pigtail thrombolytic catheter, including: a tube body 1 and a blocking member.

[0029] The distal end of the tube body 1 is curled to form a medication portion 11, which is in the shape of a pigtail. The distal end of the medication portion 11 has a tube opening 12. The medication portion 11 is suitable for being deformed under the action of an external force, and returning to the pigtail shape after the external force is removed. The medication portion 11 can be turned into a straight tube under the action of an external force of a guide wire, so that the medication portion 11 can be smoothly placed in the thrombus position. After the guide wire is withdrawn, the medication portion 11 returns to the pigtail shape under the action of its own elastic force.

[0030] A plurality of through holes 111 are arranged at intervals on the side wall of the dosing portion 11. The plurality of through holes 111 are evenly arranged at intervals on the side wall of the dosing portion 11. Such an arrangement can increase the coverage angle of the thrombolytic drug sprayed through the plurality of through holes 111 as much as possible when the dosing portion 11 is curled. Furthermore, when the thrombolytic drug is injected into the tube body 1 using a high-pressure syringe, the spraying and breaking-up effect of the thrombolytic drug can also be improved.

[0031] The blocking member includes a flexible guide wire 21 and a sphere 22 arranged at the distal end of the flexible guide wire 21. The flexible guide wire 21 is suitable for extending into the tube body 1 until the sphere 22 blocks the tube mouth 12. The mechanical strength of the flexible guide wire 21 is not sufficient to affect the deformation of the dosing part 11, thereby ensuring that the injection angle of the through hole 111 on the dosing part 11 is not affected. The sphere 22 can block the tube mouth 12 to ensure that the thrombolytic drug can only be sprayed out through multiple through holes 111, thereby ensuring the coverage area after the thrombolytic drug is sprayed and improving the drug thrombolytic effect.

[0032] During use, after creating a vascular incision, the tube body 1 can be inserted into the blood vessel by guiding a guide wire until the drug delivery part 11 is placed at the thrombus site. Then, the guide wire can be withdrawn, and the distal end of the flexible guide wire 21 is inserted into the tube body 1 until the sphere 22 blocks the tube orifice 12. After that, thrombolytic drugs can be injected into the tube body 1 through a high-pressure syringe. The thrombolytic drugs will be sprayed onto the thrombus site through multiple through-holes 111 on the drug delivery part, which can not only crush the thrombus through the injection pressure of the thrombolytic drugs but also dissolve the thrombus through the thrombolytic drugs. In addition, during use, the drug delivery part in the shape of a pigtail can be rotated to crush large-volume thrombi. Through the injection pressure and agitation, large-volume thrombi can be broken into multiple small-volume thrombi, increasing the effective action area of the thrombolytic drugs and accelerating the thrombolysis efficiency.

[0033] By combining the above-mentioned physical thrombus fragmentation and drug thrombolysis methods, the progress of thrombus fragmentation can be greatly accelerated, thus achieving an ideal clinical effect. Moreover, the structures of the above-mentioned tube body 1 and the blocking member are simple, reducing the difficulty of thrombolysis operation and also reducing the consumable cost, having good economy and the potential for wide promotion.

[0034] It should be noted that in this embodiment, the "proximal end" and "distal end" are defined according to the distance between the structure and the operator. The end close to the operator is defined as the "proximal end", and the end far from the operator is defined as the "distal end".

[0035] As Figure 2 shown, in this embodiment, the shape of the tube orifice 12 is a reduced opening with a gradually decreasing inner diameter from the drug delivery part 11 to the distal end, and the diameter of the sphere 22 is larger than the diameter of the distal end of the reduced opening, so that the sphere 22 can block the tube orifice 12.

[0036] In another implementation manner of this embodiment, the diameter of the drug delivery part 11 gradually decreases from the proximal end to the distal end, and the diameter of the sphere 22 is larger than the diameter of the distal end of the drug delivery part 11, so that the sphere 22 can gradually contact and block the through-holes 111 in the moving direction in a gradient manner during the movement, thus facilitating the control of the injection of thrombolytic drugs through the corresponding through-holes 111 in a gradient to deal with thrombi of different shapes, densities, and sizes.

[0037] As Figure 2 shown, in this embodiment, the multiple through-holes 111 are arranged uniformly along the wall of the drug delivery part 11 in a spiral shape, and the interval distance and angle between any two adjacent through-holes 111 are the same. With this setting, when the drug delivery part 11 returns to the pigtail shape, the multiple through-holes 111 can evenly cover multiple angles around the drug delivery part 11, expanding the spraying angle range of the thrombolytic drugs, improving the thrombolysis effect of the thrombolytic drugs, and at the same time, there is no need to rotate the drug delivery part 11 frequently, reducing the discomfort of the patient.

[0038] As Figure 2As shown, in this embodiment, at least ten through holes 111 are provided. The at least ten through holes 111 are arranged in a spiral shape and evenly along the wall of the drug delivery part 11. Moreover, the interval distance and angle between any two adjacent through holes 111 are the same, so that the at least ten through holes 111 can evenly spray thrombolytic drugs in a 360-degree range centered on the drug delivery part 11 in the entire blood vessel area.

[0039] As Figure 2 shown, in this embodiment, the interval between any two adjacent through holes 111 is 120 degrees. For example, the multiple through holes 111 of the drug delivery part 11 are arranged in a spiral shape, and the interval between any two adjacent through holes 111 from the proximal end to the distal end is 120 degrees. The thrombolytic drug flows from the proximal end to the distal end of the drug delivery part 11. When thrombolytic drugs are sprayed from all the through holes 111, the drug delivery part 11 sprays thrombolytic drugs in a 360-degree coverage manner to the thrombus area, improving the thrombolysis efficiency. When cooperating with a high-pressure syringe, the thrombus fragmentation efficiency can also be improved.

[0040] As Figure 2 shown, in this embodiment, at least three through holes 111 are arranged at intervals on the inner ring surface of the drug delivery part 11, at least three through holes 111 are arranged on the outer ring surface of the drug delivery part 11, at least three through holes 111 are arranged on the first side wall between the inner ring surface and the outer ring surface of the drug delivery part 11, and at least one through hole 111 is arranged on the second side wall of the drug delivery part 11 opposite to the first side wall. Thus, with the rotation of the drug delivery part 11, multiple through holes 111 can spray thrombolytic drugs at a coverage angle of 360 degrees, and directly deliver the thrombolytic drugs to the thrombus by local high-pressure spraying, thereby reducing the dosage of thrombolytic drugs and reducing the risk of major organ hemorrhages such as cerebral hemorrhage and gastrointestinal bleeding caused by thrombolysis.

[0041] As Figure 3 shown, in this embodiment, the flexible guide wire 21 and the sphere 22 are made of nitinol alloy material. The nitinol alloy material has characteristics such as shape memory property, superelasticity, corrosion resistance, and toxicity resistance, which can avoid affecting the shape of the drug delivery part 11 and can stably block the pipe orifice 12 at the same time.

[0042] As Figure 3 shown, in this embodiment, a male Luer connector is provided at the proximal end of the tube body 1, and a female Luer connector 3 that cooperates with the male Luer connector is provided at the proximal end of the flexible guide wire 21. The cooperation of the male Luer connector and the female Luer connector 3 can facilitate the operator to determine that the sphere 22 blocks the pipe orifice 12 in place, and is also conducive to docking with a syringe to facilitate injecting liquid into the tube body 1.

[0043] As Figure 1As shown, in this embodiment, the tube body 1 is made of 72D Pebax material. The Pebax material is a block copolymer composed of a rigid polyamide block and a soft polyether block. 72D Pebax is a model of the Pebax material. The 72D Pebax material has the characteristics of high elasticity and recovery performance, and is suitable for application scenarios where the administration part 11 needs to be deformed multiple times. A stainless steel braided mesh extending along the length direction of the tube is embedded in the tube wall of the tube body 1. The stainless steel braided mesh is woven with double wires. The diameter of the stainless steel wire is 0.06 mm, with 16 spindles, a lead of 3.1 mm, and the material is 304v stainless steel, and the tensile strength is above 900 MP.

[0044] Although the embodiments of the present invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A pigtail thrombolytic catheter, characterized in that: include: The distal end of the tube body (1) is curled to form a drug delivery portion (11), the distal end of the drug delivery portion (11) is provided with a tube opening (12), and the drug delivery portion (11) is adapted to deform under the action of an external force and to restore after the external force is removed; A through hole (111), wherein a plurality of the through holes (111) are arranged at intervals on the tube wall of the medication portion (11); The blocking member comprises a flexible guide wire (21) and a ball (22) arranged at the distal end of the flexible guide wire (21), wherein the flexible guide wire (21) is suitable for extending into the tube body (1) to the ball (22) to block the tube opening (12).

2. The pigtail thrombolytic catheter according to claim 1, characterized in that: The shape of the tube opening (12) is a constriction whose inner diameter gradually decreases from the medication portion (11) toward the distal end.

3. The pigtail thrombolytic catheter according to claim 1, characterized in that: The plurality of through holes (111) are evenly arranged in a spiral shape along the tube wall of the medication portion (11), and the spacing distance and angle between any two adjacent through holes (111) are the same.

4. The pigtail thrombolytic catheter according to claim 3, characterized in that: The interval between any two adjacent through holes is 120 degrees.

5. The pigtail thrombolytic catheter according to claim 3, characterized in that: At least ten through holes are provided.

6. The pigtail thrombolytic catheter according to claim 5, characterized in that: The inner annular surface of the dosing portion (11) is provided with at least three through holes (111) at intervals, the outer annular surface of the dosing portion (11) is provided with at least three through holes (111), the first side wall between the inner annular surface and the outer annular surface of the dosing portion (11) is provided with at least three through holes (111), and the second side wall of the dosing portion (11) opposite to the first side wall is provided with at least one through hole (111).

7. The pigtail thrombolytic catheter according to claim 1, characterized in that: The flexible guide wire (21) and the ball (22) are made of nickel-titanium alloy material.

8. The pigtail thrombolytic catheter according to claim 1, characterized in that: The proximal end of the tube body (1) is provided with a male Luer connector, and the proximal end of the flexible guide wire (21) is provided with a female Luer connector (3) that cooperates with the male Luer connector.

9. The pigtail thrombolytic catheter according to claim 1, characterized in that: The tube body (1) is made of 72DPebax material, and a stainless steel braided mesh extending along the length direction of the tube body (1) is embedded in the tube wall of the tube body (1).

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