Thrombolytic Catheter Assemblies

Abstract

The present invention provides a thrombolytic catheter assembly, which relates to the field of medical device technology; it includes a catheter, a guidewire, a connector, a limiting structure, a length adjustment structure and a sealing member; one end of the catheter is connected to the connector, and the other end is connected to the limiting structure; the guidewire is located in the catheter, one end of which is connected to the length adjustment structure, and the other end passes through the limiting structure; the length adjustment structure is located in the catheter, and is used to adjust the length of the guidewire in the catheter; the sealing member is connected to one end of the guidewire passing through the limiting structure, and is limited in position with the limiting structure. According to the thrombolytic catheter assembly provided by the present invention, the catheter is connected through the limiting structure, and the sealing member is limited in position, so as to avoid deformation of the catheter caused by squeezing the catheter with the sealing member, thereby improving the blocking effect, and at the same time, when the length of the guidewire placed in the catheter is adjusted by the length, the catheter and the guidewire can be prevented from being stuck in cooperation, and the withdrawal of the sealing member is convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a thrombolytic catheter assembly. Background Art

[0002] Peripheral vascular thrombotic obstructive diseases are divided into venous thromboembolism and arterial thromboembolism. Currently, conventional thrombosis treatment methods include anticoagulation therapy, surgical treatment, and catheter thrombolysis. Among them, the mechanism of catheter thrombolysis is to directly infuse high-concentration thrombolytic drugs around the thrombus through a thrombolytic catheter to dissolve the thrombus and achieve the treatment purpose. Compared with traditional catheter embolectomy and other methods, catheter thrombolysis does not require general anesthesia, the surgical trauma is also small, and it can also avoid repeated dragging of the catheter in the blood vessel, reducing damage to the blood vessel. Therefore, it is a more ideal thrombosis treatment method.

[0003] During catheter thrombolysis, the thrombolytic catheter is usually equipped with a matching occlusion guidewire. When the thrombolytic solution is infused into the human body, the solution flows out from the outlet of the catheter to flush the thrombus-affected area and finally dissolve the thrombus. However, since the location of the thrombus-affected area is not fixed, the catheter enters the human body and passes through various curved blood vessels before finally entering the thrombus-affected area. In addition, it is necessary to prevent the elastic deformation force of the catheter from damaging the blood vessel after the catheter is withdrawn from the guide wire. Therefore, the catheter needs to be made of soft material.

[0004] Since the thrombolytic catheter is made of soft material, while the occluding guidewire is made of hard material, and their radial dimensions are different, when they are deformed while passing through the vascular channel, they will move relative to each other, causing the seal to squeeze the proximal end of the catheter, resulting in deformation of the proximal end of the thrombolytic catheter. This not only affects the occluding effect, but also causes the thrombolytic catheter and the occluding guidewire to become stuck in coordination, and even prevents the occluding guidewire from being withdrawn from the thrombolytic catheter. Summary of the invention

[0005] The object of the present invention is to provide a thrombolytic catheter assembly to solve the problems that the existing occluding guide wire and thrombolytic catheter have poor occluding effect, are prone to matching jams, and hinder the occluding guide wire from being withdrawn from the thrombolytic catheter.

[0006] In order to solve the above technical problems, the present invention provides a thrombolytic catheter assembly, and the specific technical solution is as follows:

[0007] A thrombolytic catheter assembly comprises a catheter, a guide wire, a connector, a limiting structure and a sealing member;

[0008] One end of the conduit is connected to the connecting piece, and the other end is connected to the limiting structure;

[0009] The guide wire is located in the catheter, one end of which is connected to the connector, and the other end of which passes through the limiting structure;

[0010] The sealing component is connected to one end of the guide wire passing through the limiting structure, and is limitedly matched with the limiting structure.

[0011] Furthermore, the limiting structure includes a connecting pipe and a limiting member;

[0012] One end of the connecting pipe is connected to the conduit, and the other end is sleeved outside one end of the sealing member;

[0013] The limiting member is embedded in the connecting pipe and is fixedly connected to the connecting pipe;

[0014] The sealing component is in limited position cooperation with the limiting component.

[0015] Furthermore, the hardness of the connecting pipe and the limiting member is greater than the hardness of the conduit.

[0016] Furthermore, the hardness of the limiting member is greater than the hardness of the connecting pipe.

[0017] Furthermore, the limiting member is connected to the inner wall of the connecting pipe by hot melting or bonding.

[0018] Furthermore, the connecting pipe comprises a first portion, a diameter-changing portion and a second portion which are arranged in sequence;

[0019] The first part is connected to the conduit, and the second part is sleeved on one end of the sealing member; the radial dimension of the first part is greater than the radial dimension of the second part;

[0020] The radial dimension of the diameter-changing portion gradually decreases from the first portion to the second portion;

[0021] The limiting member is at least partially located in the diameter-changing portion.

[0022] Furthermore, the length adjustment structure includes a spring; the spring is sleeved on the guide wire, and one end of the spring is connected to the guide wire.

[0023] Furthermore, one end of the connecting pipe close to the sealing member is provided with a chamfer.

[0024] Furthermore, from one end of the conduit close to the limiting structure to the end away from the limiting structure, the conduit is sequentially provided with a first developing portion, a plurality of liquid outlet hole groups, a second developing portion and a plurality of gauge portions; wherein the shapes of the gauge portions are different.

[0025] Furthermore, each of the liquid outlet hole groups includes a plurality of liquid outlet holes, and the plurality of liquid outlet holes are arranged at intervals along the circumference of the conduit.

[0026] According to the thrombolytic catheter assembly provided by the present invention, the catheter is connected by a limiting structure, and the seal is limited to avoid deformation of the catheter caused by squeezing the catheter with the seal, thereby improving the blocking effect. At the same time, when the length of the guide wire placed in the catheter is adjusted by length, the catheter and the guide wire are prevented from being stuck, and the withdrawal of the seal is facilitated. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 A schematic diagram of the structure of a thrombolytic catheter assembly provided in an embodiment of the present invention (I);

[0029] Figure 2 A schematic diagram of the structure of a thrombolytic catheter assembly provided by an embodiment of the present invention (II);

[0030] Figure 3 A schematic diagram of the internal structure of a thrombolytic catheter assembly provided in an embodiment of the present invention;

[0031] Figure 4 for Figure 3 A magnified view of part a;

[0032] Figure 5 A schematic structural diagram of a seal and a guide wire of a thrombolytic catheter assembly provided in an embodiment of the present invention.

[0033] icon:

[0034] 100-catheter; 110-liquid outlet; 120-first sealing surface; 130-second step section; 140-first developing part; 150-second developing part; 160-gauge length part; 200-guide wire; 300-connecting piece; 400-sealing piece; 410-sealing head; 420-end; 500-limiting structure; 510-connecting tube; 511-first part; 512-diameter reducing part; 513-second part; 514-first step section; 515-chamfer; 520-limiting piece; 521-second sealing surface; 600-reinforcement tube; 700-length adjustment structure; 800-hook. DETAILED DESCRIPTION

[0035] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0036] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0037] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0038] Combined with Figure 1 , 2 As shown in Figure 5, this embodiment provides a thrombolytic catheter assembly for use in catheter thrombolysis. The thrombolytic catheter assembly of this embodiment includes functional components such as a catheter 100, a guide wire 200, a connector 300, a seal 400, a limiting structure 500, and a length adjustment structure 700.

[0039] Among them, the catheter 100 of this embodiment is generally made of polymer materials, and the seal 400 is generally made of metal or alloy materials. When the thrombolytic catheter assembly is assembled, one end of the catheter 100 is connected to the connector 300, and the other end of the catheter 100 is connected to the seal 400, and the end of the catheter 100 connected to the seal 400 is a tip structure. The length adjustment structure 700 of this embodiment is located in the catheter 100 and is used to adjust the length of the guide wire 200 located in the catheter 100. Preferably, the length adjustment structure 700 of this embodiment can be a spring, which is sleeved on the guide wire 200, one end of which is connected to the guide wire 200, and the other end is connected to the connector 300. The length of the guide wire 200 located in the catheter 100 is adjusted by the expansion and contraction of the spring.

[0040] The tip structure is generally formed integrally with the catheter 100 , so the technical problem in the background technology will occur, that is, the tip structure is easily deformed under the extrusion of the seal 400 , which reduces the sealing effect and causes the catheter 100 and the sealing guide wire 200 to become stuck, and is not conducive to the withdrawal of the seal 400 .

[0041] Therefore, the present embodiment adds a limiting structure 500, which is connected to the catheter 100 through the limiting structure 500, and realizes the limitation of the seal 400, so as to avoid the seal 400 and the catheter 100 being squeezed against each other and causing deformation of the catheter 100, thereby improving the blocking effect, preventing the catheter 100 and the blocking guide wire 200 from being stuck in cooperation, and facilitating the withdrawal of the seal 400. The specific structural form of the limiting structure 500 is given in the following description.

[0042] The connecting piece 300 of this embodiment is a Luer connector as shown in the figure, which is used to connect an external device. The drug solution is injected into the Luer connector through the external device, and the drug solution enters the catheter 100 through the Luer connector.

[0043] The catheter 100 of this embodiment is provided with a plurality of liquid outlets 110, which can be formed by laser cutting, and the total area of ​​the liquid outlets 110 is 0.5 square millimeters to 1.0 square millimeters, preferably 0.7 square millimeters. The cross-sectional shape of the liquid outlet 110 is a rectangular structure or other shapes.

[0044] Specifically, a plurality of liquid outlet holes 110 form a plurality of liquid outlet hole groups, and each liquid outlet hole group includes a plurality of liquid outlet holes 110 spaced apart circumferentially along the catheter 100. As a preferred implementation of this embodiment, in order to facilitate uniform drug delivery, a plurality of liquid outlet hole groups can be spaced apart evenly along the axial direction of the catheter 100.

[0045] Combined with Figure 5 As shown, the seal 400 and the guide wire 200 of the present embodiment are preferably connected as one piece, one end of the seal 400 of the present embodiment is connected to the guide wire 200, and forms a conical sealing head 410 to seal one end of the catheter 100, and the other end of the seal 400 is provided with a spherical end cap 420, and the end cap 420 and the rod body of the seal 400 are formed by wire winding welding.

[0046] The guide wire 200 of this embodiment is located in the catheter 100, one end of which is connected to the connector 300 (i.e., the Luer connector), and the other end passes through the limiting structure 500 and is connected to the sealing member 400. As a preferred implementation of this embodiment, the portion of the guide wire 200 of this embodiment placed in the Luer connector is provided with a hook 800 for limiting, and a spring is sleeved on the guide wire 200, one end of the spring is connected to the hook of the guide wire 200, and the other end is connected to the Luer connector or the catheter 100. After assembly, the spring is preferably in a compressed state. This design is due to the fact that the bending or movement of the catheter will cause the length of the catheter and the guide wire 200 to change, and the amount of this change can be adjusted by the compression of the spring to ensure that the end of the catheter away from the Luer connector is blocked by the sealing member 400.

[0047] Combined with Figure 3 and 4 As shown, the limiting structure 500 of the present embodiment includes a connecting tube 510 and a limiting member 520. The limiting member 520 is hot-melt connected or bonded to the inner wall of the connecting tube 510. One end of the connecting tube 510 of the present embodiment is connected to the catheter 100, and the other end is sleeved outside one end of the sealing member 400. The limiting member 520 of the present embodiment is embedded in the connecting tube 510 and fixedly connected to the connecting tube 510. The connection method of the limiting member 520 and the connecting tube 510 is preferably welding, and of course it can also be bonding, as long as the limiting member 520 can be tightly connected to the catheter 100 and has a certain connection stability.

[0048] The limiting member 520 of this embodiment is provided with a through hole (not shown in the figure) for the guide wire 200 to pass through. One end of the guide wire 200 passes through the through hole and is connected to the sealing member 400, so that the sealing member 400 of this embodiment is limitedly matched with the limiting member 520.

[0049] Different from the existing catheter 100, the catheter 100 of this embodiment does not form the above-mentioned tip structure during processing, but uses the connecting tube 510 as the tip structure of the catheter 100, and the connecting tube 510 and the catheter 100 are separately molded. This design is due to the inventor's discovery that the tip structure of the existing thrombolytic catheter and the catheter 100 are integrally molded, and the tip structure and the catheter 100 have the same hardness, which cannot meet the requirement of a harder tip part. At the same time, it cannot be independently molded, which increases the product failure rate.

[0050] Separately molding the catheter 100 and the connecting tube 510 as the tip structure can solve this problem well. The material of the connecting tube 510 can be selected to be a material with relatively high hardness, so that the hardness of the connecting tube 510 is greater than the hardness of the catheter 100, thereby preventing the catheter 100 from deforming. Moreover, since the connecting tube 510 and the catheter 100 are separate structures, when the connecting tube 510 is unqualified, the connecting tube 510 is scrapped separately, thereby ensuring the qualified rate of the product and further guaranteeing the product quality.

[0051] As a preferred implementation of this embodiment, the hardness of the connecting tube 510 and the stopper 520 of this embodiment is greater than the hardness of the catheter 100, and the hardness of the stopper 520 of this embodiment is greater than the hardness of the connecting tube 510, so as to prevent the connecting tube 510 and the stopper 520 from being deformed, and ensure the blocking and limiting effects. Specifically, the material of the connecting tube 510 of this embodiment can be a polymer material with a hardness greater than that of the catheter 100, and the stopper 520 of this embodiment can be a metal or non-metal material that is not easily deformed, preferably a metal material, and the material of the stopper 520 is required to ensure that even if a large force is used to push and pull the sealing member 400, it will not cause the guide wire 200 to squeeze the catheter and deform, and prevent the sealing head 410 of the guide wire 200 from being partially embedded in the interior of the catheter, so as to avoid affecting the guide wire 200 from being pulled out of the catheter.

[0052] As a preferred implementation of this embodiment, the connecting pipe 510 and the conduit 100 of this embodiment are surface sealed to ensure sealing. Specifically, the inner wall of the conduit 100 of this embodiment is provided with a first sealing surface 120, and correspondingly, the outer wall of the stopper 520 of this embodiment is provided with a second sealing surface 521 that is sealed with the first sealing surface 120; in the axial direction perpendicular to the stopper 520, the cross-sections of the first sealing surface 120 and the second sealing surface 521 of this embodiment are both circular, so as to ensure that the surface seal of the conduit 100 and the connecting pipe 510 can cover the entire connection area of ​​the two.

[0053] Combined with Figure 4 As shown, the connecting tube 510 of the present embodiment includes a first portion 511, a diameter-reducing portion 512 and a second portion 513 which are arranged in sequence; the first portion 511 of the present embodiment is connected to the catheter 100, and the second portion 513 is sleeved on one end of the sealing member 400; wherein, the radial dimension of the first portion 511 of the present embodiment is greater than the radial dimension of the second portion 513, and the radial dimension of the diameter-reducing portion 512 gradually decreases from the first portion 511 to the second portion 513; the limiting member 520 is at least partially located in the diameter-reducing portion 512, so that the inner diameter dimension of the second portion 513 can be adapted to the outer diameter dimension of the sealing member 400, thereby facilitating the cooperation between the sealing member 400 and the limiting member 520.

[0054] In order to achieve the connection between the catheter 100 and the connecting tube 510 and ensure the stability of the two after the two are combined, the inner wall of the connecting tube 510 at one end away from the sealing member 400 is provided with a first step section 514, or in other words, a stepped catheter is formed at one end of the connecting tube 510, and the wall thickness of the first step section 514 is less than the wall thickness of the connecting tube 510 except the first step section 514.

[0055] Correspondingly, the outer wall of the end of the catheter 100 of this embodiment away from the connecting piece 300 is provided with a second step section 130, or in other words, one end of the catheter 100 forms another stepped catheter, and the wall thickness of the second step section 130 is smaller than the wall thickness of the catheter 100 except the second step section 130; the first step section 514 is mounted on the second step section 130, and the two are connected by welding or bonding.

[0056] Of course, the outer wall of the connecting tube 510 may form the first step section 514, and the inner wall of the conduit 100 may form the second step section 130, and the two may be overlapped. The drawings of this embodiment do not show this connection method.

[0057] As a preferred implementation of this embodiment, a chamfer 515 is provided at one end of the connecting tube 510 of this embodiment close to the sealing member 400. The chamfer 515 extends from the outermost end of the inner wall of the connecting tube 510 to the outermost end of the outer wall. The setting of the chamfer 515 can prevent the thrombolytic catheter assembly from scratching the blood vessel when entering the blood vessel.

[0058] Based on the above structure, the inventors found that the existing thrombolytic catheter has no marking point or gauge portion 160 on the catheter 100, and it is impossible to know the length of the catheter penetrating into the human body without an X-ray machine. Therefore, this embodiment makes further improvements to the structure of the catheter 100.

[0059] Combined with Figure 2 As shown, from one end of the conduit 100 close to the limiting structure 500 to the other end away from the limiting structure 500, the conduit 100 is sequentially provided with a first developing portion 140, a plurality of liquid outlet hole groups, a second developing portion 150 and a plurality of gauge portions 160, wherein the first developing portion 140, the second developing portion 150 and the gauge portion 160 are all annular structures.

[0060] After the thrombolytic catheter is inserted into the human body, the first developing switch, the second developing switch and the liquid outlet 110 are all located in the human body, and the gauge portion 160 is located outside the human body. The different shapes or patterns of the gauge portion 160 can indicate the distance of the first developing portion 140. In this way, the doctor can determine the length of the catheter entering the human body through the gauge portion 160 on the catheter that has not entered the human body, thus avoiding the use of an X-ray machine to determine the length of the catheter entering the human body, thereby preventing X-rays from harming the human body.

[0061] As a preferred implementation of this embodiment, in the axial distance from the second developing section 150 to the first developing section 140, the area of ​​a single liquid outlet 110 gradually decreases to ensure uniform injection force of the thrombolytic agent in the catheter under pressure. Under a specific pressure, the liquid injection height of each liquid outlet 110 is consistent.

[0062] As a preferred implementation of this embodiment, the catheter 100 of this embodiment is connected to the Luer connector via a reinforcing tube 600. The reinforcing tube 600 prevents the connection between the catheter and the Luer connector from bending. The catheter 100 and the reinforcing tube 600 are injection molded into one piece.

[0063] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A thrombolytic catheter assembly, characterized in that: It comprises a catheter (100), a guide wire (200), a connecting piece (300), a limiting structure (500), a length adjustment structure (700) and a sealing piece (400); One end of the conduit (100) is connected to the connecting piece (300), and the other end is connected to the limiting structure (500); The guide wire (200) is located in the catheter (100), one end of which is connected to the length adjustment structure (700) and the other end of which passes through the limiting structure (500); The length adjustment structure (700) is located in the catheter (100) and is used to adjust the length of the guide wire (200) in the catheter (100); The sealing member (400) is connected to one end of the guide wire (200) passing through the limiting structure (500), and is in limiting cooperation with the limiting structure (500); The limiting structure (500) comprises a connecting pipe (510) and a limiting member (520); One end of the connecting tube (510) is connected to the conduit (100), and the other end is sleeved outside one end of the sealing member (400); the limiting member (520) is embedded in the connecting tube (510) and fixedly connected to the connecting tube (510); the sealing member (400) and the limiting member (520) are in position-limiting cooperation; The inner wall of the end of the connecting pipe (510) away from the sealing member (400) is provided with a first step section (514), and the wall thickness of the first step section (514) is smaller than the wall thickness of the connecting pipe (510) in the area other than the first step section (514); the outer wall of the end of the conduit (100) away from the connecting member (300) is provided with a second step section (130), and the wall thickness of the second step section (130) is smaller than the wall thickness of the conduit (100) in the area other than the second step section (130); the first step section (514) is sleeved on the second step section (130), and the two are connected to each other; The hardness of the connecting tube (510) and the limiting member (520) is greater than the hardness of the catheter (100), and the hardness of the limiting member (520) is greater than the hardness of the connecting tube (510).

2. The thrombolytic catheter assembly according to claim 1, characterized in that: The limiting member (520) is connected to the inner wall of the connecting pipe (510) by hot melting or bonding.

3. The thrombolytic catheter assembly according to claim 1, characterized in that: The connecting pipe (510) comprises a first portion (511), a diameter-changing portion (512), and a second portion (513) which are arranged in sequence; The first part (511) is connected to the conduit (100), and the second part (513) is sleeved on one end of the sealing element (400); the radial dimension of the first part (511) is greater than the radial dimension of the second part (513); The radial dimension of the diameter-changing portion (512) gradually decreases in a direction from the first portion (511) to the second portion (513); The limiting member (520) is at least partially located within the diameter-changing portion (512).

4. The thrombolytic catheter assembly according to any one of claims 1 to 3, characterized in that: The length adjustment structure (700) comprises a spring; the spring is sleeved on the guide wire (200), one end of the spring is connected to the guide wire (200), and the other end is connected to the connecting piece (300).

5. The thrombolytic catheter assembly according to claim 1, characterized in that: One end of the connecting pipe (510) close to the sealing element (400) is provided with a chamfer (515).

6. The thrombolytic catheter assembly according to any one of claims 1 to 3, characterized in that: From one end of the conduit (100) close to the limiting structure (500) to the other end away from the limiting structure (500), the conduit (100) is provided with a first developing portion (140), a plurality of liquid outlet hole groups, a second developing portion (150) and a plurality of gauge portions (160) in sequence; wherein the gauge portions (160) have different shapes.

7. The thrombolytic catheter assembly according to claim 6, characterized in that: Each of the liquid outlet holes (110) groups comprises a plurality of liquid outlet holes (110), and the plurality of liquid outlet holes (110) are arranged at intervals along the circumference of the conduit (100).

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