Thrombus removal catheter and thrombus removal device

Abstract

The present invention provides a thrombus removal catheter and a thrombus removal device, which relate to the technical field of medical devices, and include a tube body, in which an injection cavity, a spray cavity and a guide wire cavity are arranged; the proximal end of the spray cavity is connected with the distal end of the injection cavity, and the distal end of the spray cavity is sealed; the radial cross-section of the spray cavity is annular, and a spray hole is arranged on the side wall of the spray cavity; the guide wire cavity is used to insert a guide wire, the guide wire cavity is located on the inner side of the spray cavity, the distal end and the proximal end of the guide wire cavity are respectively connected with the guide wire inlet and the guide wire outlet, the guide wire inlet is located at the distal end of the tube body, and the guide wire outlet is located on the tube wall of the tube body; the present invention replaces the method of using a plug to block the end of the tube body for spraying by arranging the spray cavity outside the guide wire cavity and arranging a distally sealed spray cavity in the tube body, thereby solving a series of problems caused by blocking the tube body with the plug, making the drug administration process more convenient and greatly reducing the difficulty of surgery.

Description

Technical Field

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

[0002] Vascular embolism is a common symptom among vascular diseases, with extremely high disability and mortality rates. At present, the main treatments for this type of disease include mechanical thrombectomy, drug thrombolysis, catheter removal, etc. Catheter-contact thrombus removal is a common method for treating intravascular thrombosis. Its mechanism is to directly infuse high-concentration thrombolytic drugs around the thrombus through a catheter, thereby dissolving and removing the thrombus to achieve the purpose of treatment.

[0003] Existing thrombus removal catheters are usually kit-type, including a catheter body and a closed guidewire that plays a sealing role. During treatment, the independent guide wire is first inserted into the vein to the location of the embolic lesion through the skin, and then the thrombus removal catheter body is introduced into the vascular embolism site through the guide wire, and then the guide wire is withdrawn, and then the closed guidewire is inserted through the catheter to the matching point, and then the catheter body and the closed guidewire are connected to the drug delivery device, and the inner core is used to block the end of the catheter body near the patient to prevent the drug solution from overflowing from the end of the catheter, and to ensure that the drug solution is only released through the perfusion holes set on the side wall of the catheter, so as to achieve the purpose of uniform fixed-point drug delivery.

[0004] However, the sealing process of the end of the catheter body has very strict requirements on the size of the guidewire plug and the inner diameter of the catheter closure. If the gap between the guidewire plug and the end of the catheter body is matched and the gap is large, the front end of the catheter body will leak. If there is an interference fit, the guidewire plug will be stuck when it is pulled out. There is even a risk of deformation or breaking of the catheter, resulting in surgical failure or the need for further surgery. Therefore, it is usually necessary to control the gap between the two to less than 0.005mm to achieve a nearly complete closure effect, but this kind of matching accuracy has high processing and operation requirements, which is not conducive to the development of thrombus removal treatment.

[0005] Therefore, it is necessary to design a new type of structure to solve the above technical problems. Summary of the invention

[0006] The purpose of the present invention is to provide a thrombus removal catheter and a thrombus removal device to solve the problems existing in the prior art. By arranging the spray chamber outside the guide wire chamber and sealing the distal end of the spray chamber, a series of problems caused by the blocking of the tube body by the plug are solved, making the drug administration process more convenient and greatly reducing the difficulty of the operation.

[0007] To achieve the above object, the present invention provides the following solutions:

[0008] A thrombus removal catheter comprises a tube body, in which an injection chamber, a spray chamber and a guide wire chamber are arranged, the proximal end of the injection chamber is used to connect to a drug delivery device; the proximal end of the spray chamber is connected to the distal end of the injection chamber, and the distal end of the spray chamber is sealed; the radial cross-section of the spray chamber is annular, and a spray hole is arranged on the side wall of the spray chamber; the guide wire chamber is used to insert a guide wire, the guide wire chamber is located on the inner side of the spray chamber, the distal end and the proximal end of the guide wire chamber are respectively connected to a guide wire inlet and a guide wire outlet, the guide wire inlet is located at the distal end of the tube body, and the guide wire outlet is located on the tube wall of the tube body.

[0009] As an embodiment, the proximal wall surface of the guidewire cavity is inclined from far to near toward the guidewire outlet side.

[0010] As an embodiment, the proximal wall surface at the guidewire outlet is a slope surface that gradually inclines toward the radial inner side of the tube body from near to far.

[0011] As an embodiment, the distal end of the tube body is in a tapered shape with a diameter gradually increasing from distal to proximal, and the guide wire inlet is arranged at the tip of the tapered shape.

[0012] As one embodiment, a first developing ring, a second developing ring and a third developing ring are provided on the tube body, the first developing ring is located at the distal blocking position of the spray chamber, the second developing ring is located at the proximal position of the spray chamber, and the third developing ring is located on the proximal side of the guide wire outlet.

[0013] The present invention also discloses a thrombus removal device, comprising an injection catheter assembly and a support core wire assembly; the injection catheter assembly comprises the thrombus removal catheter and catheter seat as described above, the catheter seat is fixedly connected to the proximal end of the tube body, and the interior of the catheter seat has a catheter seat cavity connected to the injection cavity; the support core wire assembly comprises a handle and a support wire, the distal end of the handle is fixedly connected to the catheter seat, and the proximal end of the handle is used to connect to a drug delivery device; the interior of the handle has an injection channel connected to the catheter seat cavity; the proximal end of the support wire is connected to the handle, and the distal end of the support wire is used to extend into the proximal end of the spray cavity.

[0014] As an embodiment, it further includes a compression spring, wherein the distal end of the compression spring is fixedly connected to the support wire, and the proximal end of the compression spring is connected to the handle.

[0015] As an embodiment, it also includes a spiral connection structure spirally wound on the support wire, the spiral connection structure is fixedly connected to the support wire, and the proximal end of the spiral connection structure is fixedly connected to the distal end of the compression spring.

[0016] As an embodiment, the proximal end of the support wire is a conical spiral structure whose diameter gradually increases from distal to proximal, and the proximal end of the conical spiral structure abuts against the inner wall of the injection channel.

[0017] As an implementation manner, the handle is connected to the catheter hub via a Luer connector structure.

[0018] Compared with the prior art, the present invention has the following technical effects:

[0019] 1. The present invention sets a liquid spray chamber on the outside of the guide wire chamber, and the sealing setting of the liquid spray chamber will not affect the insertion of the guide wire from the tube body. A liquid spray chamber with a distal seal is set in the tube body, which replaces the method of using a plug to seal the end of the tube body for spraying liquid. It solves a series of problems caused by blocking the tube body with a plug, such as sticking, pulling off, incomplete sealing, great processing difficulty, and inconvenient operation, so that the drug administration process is more convenient and the difficulty of surgery is greatly reduced.

[0020] 2. The present invention leads out the guide wire by arranging a guide wire outlet on the tube wall instead of leading it out from the proximal port of the tube body, which will not affect the connection between the proximal port of the tube body and the drug delivery device. The guide wire does not need to be withdrawn during the injection process, thereby saving the surgical operation process, facilitating timely rescue of patients, and improving the survival rate of patients.

[0021] 3. The present invention can support the part of the tube body that is not supported by the guide wire by providing a support wire, thereby preventing the tube body from being excessively bent and piled up, and ensuring that the tube body can be smoothly pushed to the lesion site. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0023] Figure 1 A schematic diagram of the structure of an injection catheter assembly in one embodiment of the present invention;

[0024] Figure 2 for Figure 1 A partial enlarged view of the middle A area;

[0025] Figure 3 for Figure 2 A top view of

[0026] Figure 4 A schematic diagram of the structure of a catheter seat in one embodiment of the present invention;

[0027] Figure 5A schematic diagram of the structure of a supporting core wire assembly in one embodiment of the present invention;

[0028] Figure 6 A cross-sectional view of a handle in one embodiment of the present invention;

[0029] Figure 7 This is a schematic structural diagram of a thrombus removal device in one embodiment of the present invention;

[0030] Figure 8 This is a schematic diagram of the structure of a guide wire inserted into a guide wire cavity of a thrombus removal device in one embodiment of the present invention;

[0031] Fig. 9 This is a schematic diagram of the matching structure of a compression spring and a spiral connection structure in one embodiment of the present invention;

[0032] Description of reference numerals:

[0033] 1. Tube body; 2. Liquid injection cavity; 3. Liquid spray cavity; 4. Guide wire cavity; 5. Liquid spray hole; 6. Guide wire inlet; 7. Guide wire outlet; 8. Guide wire; 9. First developing ring; 10. Second developing ring; 11. Third developing ring; 12. Catheter seat; 13. Reinforcement tube; 14. Catheter seat cavity; 15. Handle; 16. Support wire; 17. Liquid injection channel; 18. Compression spring; 19. Spiral connection structure; 20. Conical spiral structure. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not 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.

[0035] The purpose of the present invention is to provide a thrombus removal catheter and a thrombus removal device to solve the problems existing in the prior art. By arranging the spray chamber outside the guide wire chamber and sealing the distal end of the spray chamber, a series of problems caused by the blocking of the tube body by the plug are solved, making the drug administration process more convenient and greatly reducing the difficulty of the operation.

[0036] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0037] Embodiment 1:

[0038] like Figure 1~Figure 4As shown, this embodiment provides a thrombus removal catheter, including a tube body 1, in which an injection chamber 2, a spray chamber 3 and a guide wire chamber 4 are arranged, and the proximal end of the injection chamber 2 is used to connect to a drug delivery device. The proximal end in this embodiment refers to the end close to the holder of the tube body 1, that is, the end of the thrombus removal surgery performer, and the distal end refers to the end away from the thrombus removal surgery performer. The proximal end of the spray chamber 3 is connected to the distal end of the injection chamber 2, and the distal end of the spray chamber 3 is sealed; the radial cross-section of the spray chamber 3 is annular, and a spray hole 5 is arranged on the side wall of the spray chamber 3, and a plurality of spray holes 5 are arranged at intervals along the circumferential direction and the axial direction. The guidewire cavity 4 is used to insert the guide wire 8. The guidewire cavity 4 is located inside the liquid spray cavity 3. The distal end and proximal end of the guidewire cavity 4 are connected to the guidewire inlet 6 and the guidewire outlet 7 respectively. The guidewire inlet 6 is located at the distal end of the tube body 1, and the guidewire outlet 7 is located on the tube wall of the tube body 1. As an embodiment, the guidewire outlet 7 is close to the proximal end of the liquid spray cavity 3 and is located on the side close to the operator. As a structural form of a tube body 1, the part of the tube body 1 away from the operator is a double-layer tube wall structure, and the other parts of the tube body 1 can be a single-layer structure. The cavity in the inner tube wall is the guidewire cavity 4, and the guidewire cavity 4 is separated from the injection cavity 2 and the liquid spray cavity 3 by the inner tube wall; the cavity between the inner tube wall and the outer tube wall is the liquid spray cavity 3.

[0039] When in use, firstly, the catheter sheath is inserted through percutaneous puncture, and then the guide wire 8 is inserted into the lesion along the sheath tube, and then the thrombus removal catheter in this embodiment is inserted into the human body through the sheath tube along the guide wire 8. During insertion, the guide wire 8 enters the guide wire cavity 4 from the guide wire inlet 6 and is led out from the guide wire inlet 6. Then, the tube body 1 is inserted into the lesion along the guide wire 8; finally, the proximal port of the tube body 1 is connected to the drug delivery device, and the drug delivery device injects the drug solution into the injection cavity 2, and the drug solution flows into the spray cavity 3 under the action of pressure, and finally sprays out from the spray hole 5, acting on the lesion to eliminate the thrombus.

[0040] Therefore, in this embodiment, the liquid spray chamber 3 is sleeved on the outside of the guide wire chamber 4, and the sealing setting of the liquid spray chamber 3 will not affect the insertion of the guide wire 8 from the tube body 1. The distal sealed liquid spray chamber 3 is set in the tube body 1, replacing the method of using a plug to block the end of the tube body 1 for liquid spraying, solving a series of problems such as blocking, pulling off, incomplete sealing, difficult processing, and inconvenient operation caused by the plug blocking the tube body 1, making the drug administration process more convenient and greatly reducing the difficulty of the operation. Moreover, in this embodiment, by setting a guide wire outlet 7 on the tube wall to lead out the guide wire 8 instead of leading it out from the proximal port of the tube body 1, it will not affect the connection between the proximal port of the tube body 1 and the drug administration device, and the guide wire 8 can be left un-withdrawn during the injection process, thereby saving the surgical operation process, which is conducive to timely rescue of patients and improving the survival rate of patients.

[0041] As an embodiment, the proximal wall of the guide wire cavity 4 is inclined from far to near toward the guide wire outlet 7, and the guide wire 8 is more convenient to be led out from the guide wire outlet 7 through the guidance of the inclined wall. Figure 2 shown.

[0042] As an embodiment, the proximal wall surface at the guide wire outlet 7 is gradually inclined toward the radial outer side of the tube body 1 from far to near, which can reduce the degree of scratching of the edge of the guide wire outlet 7 on the guide wire 8 on the one hand, and make the guide wire 8 closer to the outer wall of the tube body 1, so that it is easier to place the tube body 1 along the guide wire 8 into the patient's site. Figure 3 shown.

[0043] As an embodiment, the distal end of the tube body 1 is a tapered shape with a gradually increasing diameter from distal to proximal, and the guide wire inlet 6 is arranged at the tip of the tapered shape. The tapered shape of the distal end of the tube body 1 is more convenient for inserting into the blood vessel, and the tip edge of the tapered shape and the edge of the large diameter end of the tapered shape can be rounded to avoid scratching the blood vessel.

[0044] As an embodiment, the tube body 1 is provided with a first developing ring 9, a second developing ring 10 and a third developing ring 11, the first developing ring 9 is located at the distal blocking position of the liquid spraying chamber 3, the second developing ring 10 is located at the proximal position of the liquid spraying chamber 3, and the third developing ring 11 is located at the proximal side of the guide wire outlet 7. The first developing ring 9, the second developing ring 10 and the third developing ring 11 are all made of platinum-iridium alloy and are fixed to the tube body 1 in the form of forging, and their function is to be able to develop under radiation. The first developing ring 9 and the second developing ring 10 can facilitate the operator to find the distal position and the proximal position of the liquid spraying chamber 3, and the third developing ring 11 can facilitate the operator to find the guide wire outlet 7.

[0045] Embodiment 2:

[0046] like Figure 5~Figure 8As shown, this embodiment provides a thrombus removal device, including an injection catheter assembly and a support core wire assembly. The injection catheter assembly includes the thrombus removal catheter in Example 1 and a catheter seat 12, and the catheter seat 12 is fixedly connected to the proximal end of the tube body 1. As an embodiment, the catheter seat 12 is connected to the tube body 1 by injection molding or bonding. And in order to avoid brittle fracture or bending of the tube body 1 at the connection between the catheter seat 12 and the tube body 1, a reinforcing tube 13 is provided at the connection position between the catheter seat 12 and the tube body 1 in this embodiment. The reinforcing tube 13 is made of a hard material, for example, Pebax material (polyether block polyamide) is injection molded, and is connected to the catheter seat 12 by light curing. The inner diameter of the reinforcing tube 13 is slightly larger than the outer diameter of the tube body 1. The catheter seat 12 has a catheter seat cavity 14 connected to the injection cavity 2. The support core wire assembly includes a handle 15 and a support wire 16. The distal end of the handle 15 is fixedly connected to the catheter seat 12, and the proximal end of the handle 15 is used to connect the drug delivery device. The handle 15 has an injection channel 17 connected to the catheter seat cavity 14. As an example, the injection channel 17, the catheter seat cavity 14, and the proximal end of the injection cavity 2 are coaxial. The proximal end of the support wire 16 is connected to the handle 15, and the distal end of the support wire 16 is used to extend into the proximal end of the spray cavity 3.

[0047] When in use, after the guide wire 8 is drawn out from the guide wire outlet 7, the support wire 16 is inserted into the tube body 1, and the distal end is inserted into the liquid spraying cavity 3, and the handle 15 is fixedly connected to the catheter seat 12. Then the injection catheter assembly and the support core wire assembly are pushed forward along the guide wire 8 together, so that the liquid spraying cavity 3 of the tube body 1 reaches the lesion. During the pushing process, the tube body 1 is relatively soft, and it is easy to bend and pile up without support, which makes it difficult for the tube body 1 to be pushed to the lesion. The guide wire 8 in this embodiment is located in the guide wire cavity 4, and the support wire 16 is located in the liquid injection cavity 2, and the end extends into the liquid spraying cavity 3. Based on the self-strength of the guide wire 8 and the support wire 16, the guide wire 8 and the support wire 16 can axially support the tube body 1. When the tube body 1 is bent, under the support of the guide wire 8 and the support wire 16, the situation of excessive bending and accumulation of the tube body 1 can be alleviated, and the success rate of pushing the tube body 1 to the lesion is improved. Finally, the outer end of the handle 15 is connected to the drug delivery device for drug delivery and thrombus removal. It should be noted that after the liquid spray cavity 3 of the tube body 1 reaches the lesion, it is also feasible to remove the handle 15 from the catheter seat 12 and then connect the catheter seat 12 to the drug delivery device for drug delivery.

[0048] Therefore, this embodiment can support the part of the tube body 1 that is not supported by the guide wire 8 by providing the support wire 16, thereby preventing the tube body 1 from being excessively bent and piled up, and ensuring that the tube body 1 can be smoothly pushed to the lesion site.

[0049] In this embodiment, the support wire 16 can be a variable diameter structure, specifically, a step variable diameter structure, or a uniform variable diameter structure, that is, a conical structure, the diameter of the large diameter end is 0.5 mm, the diameter of the small diameter end is 0.07 mm to 0.1 mm, and the diameter of the tube body 1 is 1 mm to 1.9 mm. The diameter of the support wire 16 is slightly larger than the radial width of the liquid spraying cavity 3 (that is, the gap between the inner layer wall and the outer layer wall of the tube body 1), and the distal end of the support wire 16 can squeeze the side wall of the guide wire cavity 4 and the side wall of the liquid spraying cavity 3, so that the distal end of the support wire 16 can be inserted into the proximal end of the liquid spraying cavity 3.

[0050] In this embodiment, the support core wire assembly also includes a compression spring 18, the distal end of the compression spring 18 is fixedly connected to the support wire 16, and the proximal end of the compression spring 18 is connected to the handle 15. The handle 15 may have a stepped hole, the stepped hole forms an injection channel, and the distal end of the compression spring 18 may abut against a radial end face of the stepped hole. The specific connection method between the compression spring 18 and the support wire 16 may be welding or bonding. Since the support wire 16 is thin, it is difficult to fix it in the handle 15. By setting the compression spring 18, the position of the support wire 16 can be limited while limiting the position of the compression spring 18. When the support wire 16 encounters resistance during the insertion of the spray chamber 3, the compression spring 18 can provide sufficient support force for the support wire 16 to prevent the support wire 16 from moving toward the proximal end, so that the support wire 16 can be inserted into the spray chamber 3.

[0051] like Fig. 9 As shown, in this embodiment, the support core wire assembly also includes a spiral connection structure 19 spirally wound on the support wire 16, the spiral connection structure 19 is fixedly connected to the support wire 16, and the proximal end of the spiral connection structure 19 is fixedly connected to the distal end of the compression spring 18. The spiral connection structure 19 is welded or bonded to the support wire 16, and based on the structural characteristics of the spiral connection structure 19, the contact area with the support wire 16 can be increased, and the connection strength can be improved.

[0052] The support wire 16 is a metal wire made of nickel-titanium material and is formed by grinding, winding, melting and other processes. Its distal end is a round head formed by laser or plasma melting process, so that the distal end of the support wire 16 can smoothly enter the spray chamber 3 without scraping the wall. The proximal end of the support wire 16 is a conical spiral structure 20 with a diameter gradually increasing from far to near. The conical spiral structure 20 formed by winding can be effectively stuck in the injection channel 17 of the handle 15, avoiding the proximal end of the support wire 16 from shaking in the injection channel 17, and allowing the drug solution to pass smoothly.

[0053] As an embodiment, the handle 15 is connected to the catheter adapter 12 via a Luer connector structure, and the distal end of the handle 15 is also a Luer connector structure, which is convenient for connecting a drug delivery device or other equipment. The Luer connector structure is a common structure in the art, and its structural form is not described in detail in this embodiment.

[0054] Adaptive changes made according to actual needs are all within the protection scope of the present invention.

[0055] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only used to help understand the method and core ideas of the present invention. At the same time, for those skilled in the art, according to the ideas of the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A thrombus removal device, characterized in that: It includes an injection catheter assembly and a support core wire assembly; The injection catheter assembly comprises: A thrombus removal catheter, the thrombus removal catheter comprises a tube body, in which an injection cavity, a spray cavity and a guide wire cavity are arranged, the part of the tube body far away from the operator is a double-layer tube wall structure, the cavity in the inner tube wall is the guide wire cavity, the cavity between the inner tube wall and the outer tube wall is the spray cavity, the proximal end of the injection cavity is used to connect to a drug delivery device; the proximal end of the spray cavity is connected to the distal end of the injection cavity, and the distal end of the spray cavity is sealed; the radial cross-section of the spray cavity is annular, and a spray hole is arranged on the side wall of the spray cavity; the guide wire cavity is used to insert a guide wire, the guide wire cavity is located on the inner side of the spray cavity, the distal end and the proximal end of the guide wire cavity are respectively connected to a guide wire inlet and a guide wire outlet, the guide wire inlet is located at the distal end of the tube body, and the guide wire outlet is located on the tube wall of the tube body; and a catheter seat, wherein the catheter seat is fixedly connected to the proximal end of the tube body, and the interior of the catheter seat has a catheter seat cavity communicated with the injection cavity; The support core wire assembly comprises: A handle, wherein the distal end of the handle is fixedly connected to the catheter seat, and the proximal end of the handle is used to connect to a drug delivery device; the interior of the handle has an injection channel connected to the catheter seat cavity; And a support wire, the proximal end of the support wire is connected to the handle, the distal end of the support wire is used to extend into the proximal end of the spray chamber, and the diameter of the support wire is larger than the radial width of the spray chamber.

2. The thrombus removal device according to claim 1, characterized in that: The proximal wall surface of the guidewire cavity is inclined from far to near toward the guidewire outlet.

3. The thrombus removal device according to claim 1, characterized in that: The distal end of the tube body is in a tapered shape with a diameter gradually increasing from distal to proximal, and the guide wire inlet is arranged at the tip of the tapered shape.

4. The thrombus removal device according to claim 1, characterized in that: The tube body is provided with a first developing ring, a second developing ring and a third developing ring, the first developing ring is located at a distal blocking position of the liquid spraying chamber, the second developing ring is located at a proximal position of the liquid spraying chamber, and the third developing ring is located at the proximal side of the guide wire outlet.

5. The thrombus removal device according to claim 1, characterized in that: It also includes a compression spring, the distal end of which is fixedly connected to the support wire, and the proximal end of which is connected to the handle.

6. The thrombus removal device according to claim 5, characterized in that: It also includes a spiral connection structure spirally wound on the support wire, the spiral connection structure is fixedly connected to the support wire, and the proximal end of the spiral connection structure is fixedly connected to the distal end of the compression spring.

7. The thrombus removal device according to claim 1, characterized in that: The proximal end of the support wire is a conical spiral structure with a diameter gradually increasing from distal to proximal, and the proximal end of the conical spiral structure abuts against the inner wall of the injection channel.

8. The thrombus removal device according to claim 1, characterized in that: The handle is connected to the catheter seat via a Luer joint structure.

Images