Expandable thrombolytic stent and thrombolytic device

Abstract

This utility model relates to the field of thrombolytic drug delivery devices, and discloses an expandable thrombolytic stent and a thrombolytic device. The utility model features a stent body in the shape of a near-cylindrical structure, composed of multiple parallel drug delivery catheters with an inner diameter of 0.1-1 mm, arranged around the central tube of a first slender tubular component. The inner lumen of the drug delivery catheters is connected to the drug infusion chamber of a second slender tubular component, and multiple drug injection holes are provided on the drug delivery catheters. This allows the expandable thrombolytic stent and device to expand within the thrombus during thrombolytic drug infusion, enabling optimal drug infusion and sufficient contact with the thrombus, thereby improving thrombolytic efficiency and achieving highly efficient thrombolysis. Furthermore, the multiple drug injection holes on the drug delivery catheters provide diverse thrombolytic sites for the thrombus during thrombolytic drug infusion, thus improving the targeting and efficiency of thrombolysis.

Description

Technical Field

[0001] This utility model relates to the technical field of thrombolytic drug delivery devices, and in particular to an expandable thrombolytic stent and a thrombolytic device. Background Technology

[0002] Vascular diseases are a major cause of death worldwide, and vascular embolism has become a leading contributing factor. For vascular embolism, thrombolytic therapy can rapidly dissolve thrombi, reopen blocked blood vessels, and promptly restore blood perfusion to tissues and organs, preventing irreversible damage caused by prolonged ischemia. It also has advantages such as relative ease of operation and high accessibility, making it one of the main methods for treating thromboembolism. In clinical practice, catheter-directed thrombolysis (CDT) can accurately deliver thrombolytic drugs to the thrombus site, improving drug utilization efficiency and maximizing the thrombolytic effect.

[0003] Currently, the main types of perfusion catheters used are single-port perfusion catheters or multi-port perfusion catheters similar to the "multi-port interventional catheter for venous sinus thrombosis" described in patent "CN117982198A". Both of these perfusion catheters have disadvantages such as single thrombolysis site and low thrombolysis efficiency for larger thrombi (such as pulmonary thrombosis) because the drug is administered from the center of the thrombus.

[0004] Therefore, existing technologies still need to be improved and developed. Utility Model Content

[0005] In view of the shortcomings of the prior art, the purpose of this utility model is to provide an expandable thrombolytic stent and a thrombolytic device, which aims to solve the problems of existing thrombolytic drug delivery devices having a single thrombolytic point and low thrombolytic efficiency for large-diameter thrombi.

[0006] The technical solution of this utility model is as follows:

[0007] In a first aspect, this utility model provides an expandable thrombolytic stent, comprising: a first elongated tubular component including a central tube with a central cavity for facilitating guidewire passage during surgery; a second elongated tubular component having one or more drug infusion chambers formed on its wall; a portion of the central tube passing through the second elongated tubular component and slidably connected to it, the other portion of the central tube being exposed; and a stent body, formed by multiple parallel drug delivery catheters with an inner diameter of 0.1-1 mm, in a near-cylindrical shape, the drug delivery catheters having multiple drug injection holes; the stent body being sleeved around the other portion of the central tube and communicating the inner cavity of the drug delivery catheters with the drug infusion chambers, the proximal handle end of the stent body being fixedly connected to the distal handle end of the second elongated tubular component via a connecting rod, the distal handle end of the stent body being in an expanded or contracted state. This invention features a quasi-cylindrical stent body, composed of multiple drug-eluting catheters connected in parallel, arranged around the central tube of a first slender tubular component. The inner lumen of the drug-eluting catheters is connected to the drug infusion chamber of the first slender tubular component, and multiple injection holes are provided on the drug-eluting catheters. This allows the expandable thrombolytic stent to expand within the thrombus (e.g., a large-diameter thrombus) during thrombolytic drug infusion, enabling optimal drug infusion and sufficient contact with the thrombus, thereby improving thrombolytic efficiency and achieving highly efficient thrombolysis. Furthermore, the multiple injection holes on the drug-eluting catheters provide diverse thrombolytic sites for the thrombus, improving the targeting and efficiency of thrombolysis.

[0008] In a preferred embodiment, the first elongated tubular component further includes a tapered head with one open end; the distal handle end of the stent body is constricted and fixedly connected to the distal handle end of the central tube and the open end of the tapered head via a connecting rod. With this configuration, the expandable thrombolytic stent of this invention controls the expansion and contraction of the stent body by controlling the sliding of the second elongated tubular component along the central tube of the first elongated tubular component, thereby changing the displacement between the second and first elongated tubular components and altering the distance between the two ends of the stent body.

[0009] In a preferred embodiment, the expandable thrombolytic stent further includes one or more collars fitted onto the stent body for controlling the expansion and contraction of the stent body. This arrangement allows for further control and adjustment of the stent body's expansion state by sliding the collars to change their positions on the stent body and dividing the stent body into stent units.

[0010] In a preferred embodiment, the collar is further used to divide the support body into multiple support units with the same or different expansion states, each support unit being independently cylindrical, spherical, or disc-shaped. This arrangement allows for further control and adjustment of the expansion state of the support body by changing the position of the collar on the support body and thus altering the shape of the support units.

[0011] In one or more embodiments, the drug delivery catheter is a metal catheter, a plastic catheter, or an alloy catheter.

[0012] Current catheter-based thrombolysis procedures require continuous thrombolysis for 2-3 days, necessitating constant monitoring and examination to assess progress and effectiveness, and timely adjustments to the treatment plan. This process is cumbersome and lacks timeliness. To address this issue, in one or more embodiments, the expandable thrombolytic stent further includes a fiber optic pressure sensor and fiber optic cable. The fiber optic pressure sensor is located on the wall of the distal end of the second elongated tubular component or on the wall of another portion of the central tube, used to sense and transmit blood pressure. The fiber optic cable is located in a fiber optic connection cavity within the cavity of the second elongated tubular component and connected to an external handle for transmitting blood pressure data. With this configuration, the expandable thrombolytic stent of this invention enables real-time monitoring of intravascular pressure (i.e., blood pressure) during thrombolysis. By monitoring pressure changes in real time, the progress of thrombolysis can be determined, thereby achieving real-time monitoring of thrombolysis progress / effectiveness.

[0013] In a preferred embodiment, the fiber optic pressure sensor is disposed on the tube wall near the handle end of another portion of the central tube.

[0014] In one or more embodiments, the expandable thrombolytic stent further includes a fiber optic sensor detection window disposed on the wall of the second elongated tubular component for receiving and displaying blood pressure data sensed by the fiber optic pressure sensor.

[0015] In one or more embodiments, the inner diameter of the second elongated tubular component is 1 to 10 mm; the outer diameter of the central tube is 0.8 to 9.8 mm.

[0016] Secondly, the present invention provides a thrombolytic device comprising: an expandable thrombolytic stent as described in any of the first aspects and a handle, the handle being connected to the near-handle end of the central tube and the second elongated tubular component.

[0017] In one or more embodiments, the handle is provided with a drug infusion connector, a venting catheter connector, and a sensor connector. The drug infusion connector is connected to the drug infusion chamber and is used to connect to an external drug delivery device for drug input. The venting catheter connector is connected to the central cavity and is used to vent air before thrombolysis. The sensor connector is used to connect to an external sensor connector for blood pressure data transmission.

[0018] Beneficial effects: The expandable thrombolytic stent and thrombolytic device of this invention features a cylindrical stent body formed by multiple parallel drug delivery catheters with an inner diameter of 0.1-1 mm connected around the central tube of a first slender tubular component. The inner lumen of the drug delivery catheters communicates with the drug infusion chamber of a second slender tubular component. Multiple injection holes are provided on the drug delivery catheters. This allows the expandable stent body to expand within the thrombus (e.g., a large-diameter thrombus) during thrombolytic drug infusion, enabling optimal drug infusion and sufficient contact with the thrombus, thereby improving thrombolytic efficiency and achieving highly efficient thrombolysis. Furthermore, the multiple injection holes on the drug delivery catheters provide diverse thrombolytic sites for the thrombus during infusion, improving the targeting and efficiency of thrombolysis. Furthermore, the expandable thrombolytic stent of this invention also includes a fiber optic pressure sensor and a fiber optic cable; the fiber optic pressure sensor is disposed on the wall of the distal end of the second elongated tubular component or on the wall of another part of the central tube, for sensing and transmitting blood pressure; the fiber optic cable is disposed in the fiber optic connection cavity within the cavity of the second elongated tubular component and connected to the external handle, for transmitting blood pressure data; with this configuration, the expandable thrombolytic stent and thrombolytic device of this invention can realize real-time monitoring of the intravascular pressure (i.e., blood pressure) to be thrombolytically treated; through real-time pressure monitoring, the progress of thrombolysis can be judged based on pressure changes, thereby realizing real-time monitoring of thrombolysis progress / effect. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the expandable thrombolytic stent provided in Embodiment 1 of this utility model;

[0020] Figure 2 for Figure 1 A magnified view of a portion of the image.

[0021] Figure 3 This is a schematic diagram of an expandable thrombolytic stent provided in Embodiment 2 of this utility model.

[0022] Figure 4 This is a schematic diagram of another expandable thrombolytic stent provided in Embodiment 2 of this utility model.

[0023] Figure 5This is a schematic diagram of the exploded structure of the thrombolytic device provided in Embodiment 3 of this utility model.

[0024] Explanation of reference numerals in the attached drawings: 1. First slender tubular component; 2. Second slender tubular component; 3. Stent body; 4. Slip ring; 5. Fiber optic sensor detection window; 10. Expandable thrombolytic stent; 11. Central tube; 12. Conical head; 20. Handle; 21. Injection connector; 22. Drainage catheter connector; 23. Sensor connector; 31. Drug delivery catheter; 32. Injection port; 100. Thrombolytic device. Detailed Implementation

[0025] This utility model provides an expandable thrombolytic stent and a thrombolytic device. To make the purpose, technical solution, and effects of this utility model clearer and more explicit, the following provides a more detailed description of this utility model. It should be understood that the specific embodiments described herein are merely illustrative of this utility model and are not intended to limit this utility model.

[0026] Example 1

[0027] See Figure 1-2 This embodiment provides an expandable thrombolytic stent 10, comprising: a first elongated tubular component 1, including a central tube 11 with a central cavity for facilitating guidewire passage during surgery; a second elongated tubular component 2, the wall of which has one or more drug infusion chambers; a portion of the central tube 11 extends through the second elongated tubular component 2 and is slidably connected to it, while the other portion of the central tube 11 is exposed; and a stent body 3, which is formed by multiple drug catheters 31 with an inner diameter of 0.1-1 mm connected in parallel and is cylindrical, with multiple drug infusion holes 32 on each drug catheter 31; the stent body 3 is fitted around the other portion of the central tube 11 and communicates the inner cavity of the drug catheters 31 with the drug infusion chambers, the proximal end of the stent body 3 is fixedly connected to the distal end of the second elongated tubular component 2 by a connecting rod, and the distal end of the stent body 3 is in an expanded or contracted state.

[0028] The expandable thrombolytic stent provided in this embodiment has a cylindrical stent body formed by multiple parallel drug delivery catheters with an inner diameter of 0.1-1 mm connected around the central tube of the first slender tubular component. The inner lumen of the drug delivery catheters is connected to the drug infusion chamber of the second slender tubular component, and multiple drug injection holes are provided on the drug delivery catheters. This allows the expandable thrombolytic stent to expand inside the thrombus (e.g., a large-diameter thrombus) during thrombolytic drug infusion, enabling drug infusion at the optimal location and ensuring sufficient contact between the drug and the thrombus, thereby improving thrombolytic efficiency and achieving high-efficiency thrombolysis. Furthermore, the multiple drug injection holes on the drug delivery catheters provide diverse thrombolytic sites for the thrombus, improving the targeting and efficiency of thrombolysis.

[0029] Example 2

[0030] See Figure 3-4 This embodiment provides an expandable thrombolytic stent 10, comprising: a first elongated tubular component 1, including a central tube 11 with a central cavity and a tapered head 12 with one open end, the central cavity facilitating guidewire passage during surgery; a second elongated tubular component 2, the wall of which has one or more drug infusion chambers; a portion of the central tube 11 extends through the second elongated tubular component 2 and is slidably connected to it, the other portion of the central tube 11 being exposed; and a stent body 3, composed of multiple inner diameter... The drug delivery tubes 31, each 0.1-1 mm in diameter, are connected in parallel and are cylindrical in shape. Each drug delivery tube 31 has multiple injection holes 32. The support body 3 is fitted around another part of the central tube 11 and connects the inner cavity of the drug delivery tube 31 with the drug infusion cavity. The proximal end of the support body 3 is fixedly connected to the distal end of the second slender tubular component 2 via a connecting rod. The distal end of the support body 3 is constricted and is fixedly connected to the distal end of the central tube 11 and the opening end of the conical head 12 via a connecting rod.

[0031] In addition to the beneficial effects of the expandable thrombolytic stent provided in Embodiment 1, the expandable thrombolytic stent provided in this embodiment changes the distance between the two ends of the stent body by controlling the displacement between the second slender tubular component and the first slender tubular component along the central tube of the first slender tubular component, thereby controlling and adjusting the expansion and contraction of the stent body, that is, realizing controllable expansion of the stent body.

[0032] It should be understood that the "near-handle end" refers to the end of the central tube and the second elongated tubular component that is closer to the handle in the axial direction when the handle is connected to the end of the central tube and the second elongated tubular component away from the support body; similarly, the "far-handle end" refers to the end of the central tube and the second elongated tubular component that is farther from the handle in the axial direction when the handle is connected to the end of the central tube and the second elongated tubular component away from the support body.

[0033] In one or more preferred embodiments, the stent body 3 is formed by three or more drug delivery catheters 31 connected in parallel. Theoretically, the more drug delivery catheters constituting the stent body, the greater the coverage density of thrombolysis sites provided by the stent body, and the better the thrombolysis effect; however, currently, due to the influence of the diameter of the drug delivery catheters, it is preferred that the stent body composed of 3-6 drug delivery catheters has a better thrombolysis effect; more preferably, the stent body composed of 6 drug delivery catheters has the best thrombolysis effect; in the future, with the development of technology, the number of drug delivery catheters constituting the stent body may be even greater.

[0034] In one or more preferred embodiments, the expandable thrombolytic stent 10 further includes one or more collars 4, which are sleeved on the stent body 3 for controlling the expansion and contraction of the stent body 3. This arrangement allows for changing the position of the collars on the stent body by sliding them, thus dividing the stent body into stent units and further controlling and adjusting the expansion state of the stent body. For example, Figure 3 The expandable thrombolytic stent 10 shown is provided with a collar 4. The collar 4 is currently located at the far handle end of the stent body 3. When the collar 4 moves along the central tube toward the center of the stent body 3, the expansion and contraction of the stent body 3 can be further controlled and adjusted.

[0035] Furthermore, the collar 4 is also used to divide the support body into multiple support units with the same or different expansion states, each support unit being independently cylindrical, spherical, or disc-shaped. This arrangement allows for further control and adjustment of the expansion state of the support body by changing the position of the collar on the support body and thus altering the shape of the support units. For example, Figure 3 The expandable thrombolytic stent 10 shown includes a collar 4, which is currently located at the distal end of the stent body 3. As the collar 4 moves along the central tube towards the center of the stent body 3, it can divide the stent body 3 into two stent units with the same or different expansion states, thereby further controlling and adjusting the expansion and contraction of the stent body 3. Another example... Figure 4The expandable thrombolytic stent 10 shown has three collars 4, one of which is currently located at the distal end of the stent body 3, and the other two collars 4 are located at 1 / 3 and 2 / 3 of the length of the stent body 3, respectively. This divides the stent body 3 into three stent units with the same expansion state, each stent unit being spherical. Preferably, the number of collars 4 is 1 to 5.

[0036] In one or more embodiments, the drug delivery catheter 31 is a metal catheter, a plastic catheter, or an alloy catheter. For example, the metal catheter may be a tantalum catheter, tungsten catheter, titanium catheter, cobalt catheter, chromium catheter, etc.; the plastic catheter may be a silicone rubber catheter, polyurethane (PU) catheter, polytetrafluoroethylene (PIFE) catheter, polyethylene (PE) catheter, polypropylene (PP) catheter, polyvinyl fluoride (PVC) catheter, polymethyl methacrylate (PMMA) catheter, polyterephthalate (PET) catheter, nylon (PA) catheter, polycarbonate (PC) catheter, etc.; the alloy catheter may be a nickel-titanium alloy catheter, a cobalt-chromium alloy catheter, a titanium alloy catheter, stainless steel catheter, etc. In a preferred embodiment, the drug delivery catheter is a nickel-titanium alloy catheter; this nickel-titanium alloy catheter has better biocompatibility, corrosion resistance, strength, and flexibility, and therefore produces fewer side effects on the body when used as a drug delivery catheter for thrombolytic administration.

[0037] In one or more embodiments, the expandable thrombolytic stent 10 further includes a fiber optic pressure sensor and fiber optic cable; the fiber optic pressure sensor is disposed on the wall of the distal handle end of the second elongated tubular component, or on the wall of another part of the central tube (the other part being the area covered by the stent body), for sensing and transmitting blood pressure; the fiber optic cable is disposed in the fiber optic connection cavity within the cavity of the second elongated tubular component 2 and connected to the external handle for transmitting blood pressure data. Blood pressure changes instantaneously after successful thrombolysis, such as a downward fluctuation in blood pressure near the handle end of the stent body due to sudden blood flow, and an upward fluctuation in blood pressure at the center and distal handle ends of the stent body. With this configuration, the expandable thrombolytic stent of this invention enables real-time monitoring of intravascular pressure (i.e., blood pressure) for thrombolysis; through real-time pressure monitoring, the thrombolysis progress is judged based on pressure changes, thereby achieving real-time monitoring of thrombolysis progress / effect (the expandable thrombolytic stent of this invention can monitor thrombolysis in real time); furthermore, this configuration solves the problems of cumbersome operation and unreliable timeliness in existing catheter-based thrombolysis procedures.

[0038] In a preferred embodiment, the fiber optic pressure sensor is disposed on the tube wall near the handle end of another portion of the central tube. As mentioned above, blood pressure changes the instantaneously after successful thrombolysis when blood flow is restored, and the blood pressure in the area covered by the handle end of the stent body changes first. Therefore, placing the fiber optic pressure sensor at this defined location will detect the blood pressure change immediately.

[0039] See Figure 1 In one or more embodiments, the expandable thrombolytic stent 10 further includes a fiber optic sensor detection window 5 disposed on the wall of the second elongated tubular component 2 for receiving and displaying blood pressure data sensed by the fiber optic pressure sensor.

[0040] In one or more embodiments, the inner diameter of the second elongated tubular component 2 is larger than the outer diameter of the central tube 11; the inner diameter of the second elongated tubular component 2 is 1 to 10 mm; and the outer diameter of the central tube 11 is 0.8 to 9.8 mm.

[0041] Example 3

[0042] This utility model embodiment provides a thrombolytic device 100, which includes: an expandable thrombolytic stent 10 as described in any of embodiments 1 to 2 above. Figure 5 The expandable thrombolytic stent in the thrombolytic device shown is an expandable thrombolytic stent provided in Embodiment 2, and the handle 20 is connected to the near-handle end of the central tube 11 and the second elongated tubular component 2.

[0043] In one or more embodiments, the handle 20 is provided with a drug infusion connector 21, a venting catheter connector 22, and a sensor connector 23; the drug infusion connector 21 communicates with the drug infusion chamber and is used to connect to an external drug delivery device for drug input; the venting catheter connector 22 communicates with the central cavity and is used to vent air before thrombolysis; the sensor connector 23 is used to connect to an external sensor connector for blood pressure data transmission. For example, the venting catheter connector 22 can be used to inject saline solution before the dilatational thrombolytic stent of this invention enters the blood vessel to vent air from the device.

[0044] In summary, the expandable thrombolytic stent and thrombolytic device provided by this invention features a cylindrical stent body formed by multiple parallel drug delivery catheters with an inner diameter of 0.1-1 mm connected around the central tube of a first slender tubular component. The inner lumen of the drug delivery catheters is connected to the drug infusion chamber of the first slender tubular component, and multiple drug injection holes are provided on the drug delivery catheters. This allows the expandable thrombolytic stent and thrombolytic device to expand within the thrombus (e.g., a large-diameter thrombus) during thrombolytic drug infusion, enabling optimal drug infusion and sufficient contact with the thrombus, thereby improving thrombolytic efficiency and achieving highly efficient thrombolysis. Furthermore, the multiple drug injection holes on the drug delivery catheters provide diverse thrombolytic sites for the thrombus during thrombolytic drug infusion, thus improving the targeting and efficiency of thrombolysis. Furthermore, the expandable thrombolytic stent of this invention also includes a fiber optic pressure sensor and a fiber optic cable; the fiber optic pressure sensor is disposed on the wall of the distal end of the second elongated tubular component or on the wall of another part of the central tube, for sensing and transmitting blood pressure; the fiber optic cable is disposed in the fiber optic connection cavity within the cavity of the second elongated tubular component and connected to the external handle, for transmitting blood pressure data; with this configuration, the expandable thrombolytic stent and thrombolytic device of this invention can realize real-time monitoring of the intravascular pressure (i.e., blood pressure) to be thrombolytically treated; through real-time pressure monitoring, the progress of thrombolysis can be judged based on pressure changes, thereby realizing real-time monitoring of thrombolysis progress / effect.

[0045] It should be understood that the application of this utility model is not limited to the examples above. Those skilled in the art can make improvements or modifications based on the above description, and all such improvements and modifications should fall within the protection scope of the appended claims.

Claims

1. An expandable thrombolytic stent, characterized in that, include: The first elongated tubular component includes a central tube with a central cavity that facilitates the passage of a guidewire during surgery; The second slender tubular component has one or more drug infusion cavities formed on its tube wall; A portion of the central tube extends through and is slidably connected to the second elongated tubular component, while the other portion of the central tube is exposed; and The stent body is composed of multiple drug delivery catheters with an inner diameter of 0.1-1 mm connected in parallel and is in a near-cylindrical shape. The drug delivery catheters have multiple drug injection holes. The stent body is sleeved around another part of the central tube and connects the inner lumen of the drug delivery catheters with the drug infusion chamber. The proximal handle end of the stent body is fixedly connected to the distal handle end of the second slender tubular component by a connecting rod. The distal handle end of the stent body is in an expanded or contracted state.

2. The expandable thrombolytic stent according to claim 1, characterized in that, The first elongated tubular component also includes a tapered head with one end open; The distal handle end of the support body is constricted and is fixedly connected to the distal handle end of the central tube and the open end of the conical head via a connecting rod.

3. The expandable thrombolytic stent according to claim 2, characterized in that, The expandable thrombolytic stent also includes one or more collars, which are sleeved on the stent body and used to control the expansion and contraction of the stent body.

4. The expandable thrombolytic stent according to claim 3, characterized in that, The collar is also used to divide the support body into multiple support units with the same or different expansion states, each support unit being independently cylindrical, spherical or disc-shaped.

5. The expandable thrombolytic stent according to claim 1, characterized in that, The drug delivery tube is a metal tube, a plastic tube, or an alloy tube.

6. The expandable thrombolytic stent according to claim 1, characterized in that, The expandable thrombolytic stent also includes a fiber optic pressure sensor and fiber optic cable; the fiber optic pressure sensor is disposed on the wall of the distal end of the second elongated tubular component or on the wall of another part of the central tube, for sensing and transmitting blood pressure; the fiber optic cable is disposed in the fiber optic connection cavity within the cavity of the second elongated tubular component and connected to the external handle for transmitting blood pressure data.

7. The expandable thrombolytic stent according to claim 6, characterized in that, The fiber optic pressure sensor is mounted on the tube wall near the handle end of another part of the central tube.

8. The expandable thrombolytic stent according to claim 6, characterized in that, The expandable thrombolytic stent also includes a fiber optic sensor detection window disposed on the wall of the second elongated tubular component, for receiving and displaying blood pressure data sensed by the fiber optic pressure sensor.

9. The expandable thrombolytic stent according to any one of claims 1-8, characterized in that, The inner diameter of the second slender tubular component is 1~10mm; the outer diameter of the central tube is 0.8~9.8mm.

10. A thrombolytic device, characterized in that, include: The expandable thrombolytic stent and handle as described in any one of claims 1-9, wherein the handle is connected to the proximal end of the central tube and the second elongated tubular component.

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