Non-invasive distal navigation tube structure for cerebral vascular thrombectomy

Abstract

The application relates to the technical field of medical devices, and particularly discloses a non-invasive distal navigation tube structure for cerebral vascular thrombus removal, which comprises an integrally-formed navigation distal end, a navigation proximal end and a navigation main body, and the navigation main body is located between the navigation distal end and the navigation proximal end; the navigation distal end is provided with a monitoring section, a sensor assembly is integrated in the monitoring section, and the monitoring section is connected with a fixed end of a control line; a free end of the control line extends to the navigation proximal end along the navigation tube in an axial direction; the sensor assembly is used for monitoring information in a blood vessel section in real time and feeding back the information to an external control end; and the control end controls the control line to drive the monitoring section to adjust a navigation direction in the blood vessel section after receiving the information. The navigation distal end is provided with a structure with an arc surface or a hole feature, and a self-lubricating surface is arranged on the navigation distal end, so that a step effect is eliminated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a non-invasive distal navigation tube structure for cerebral thrombectomy. Background Technology

[0002] Cerebral thrombosis is a type of ischemic cerebrovascular disease. Cerebral thrombosis can occur in any segment of cerebral blood vessels, but in clinical practice, thrombosis formed by branches of the internal carotid artery, anterior cerebral artery, and middle cerebral artery is more common.

[0003] In existing navigation tube structures for cerebral thrombectomy, the distal end is commonly designed as a wedge or cone. However, when passing through bifurcated vessels, the distal end of the wedge or cone is prone to pressing against the vessel wall, and the step effect may cause blockage. The high resistance to advancement of the curved section makes it impossible to effectively adjust the angle of the curved section, resulting in a high risk of damage to the vascular intima.

[0004] For example, the retrieved documents are as follows: Chinese invention patent CN119523573A discloses a thrombus aspiration system and a control method for the system. The intelligent control module in the system is configured to: determine the pressure difference between the proximal and distal ends based on pressure data collected by a first pressure sensor and pressure data collected by a second pressure sensor, and determine the rate of change of the pressure difference; determine the rate of change of blood flow in the aspiration catheter based on flow data collected by a flow sensor; determine the type of the aspiration medium corresponding to the current aspiration medium in the aspiration catheter based on the rate of change of pressure difference and the rate of change of flow; when the aspiration medium is blood, intermittently aspirate blood at a preset frequency while the valve in the pressure state conversion module is closed; when the aspiration medium includes a target volume of thrombus, determine a target frequency corresponding to the target volume, and while maintaining aspiration, repeatedly open and close the valve in the pressure state conversion module according to the target frequency. Although pressure sensors are provided, angle adjustment is not possible.

[0005] Therefore, there is a need to design a non-invasive distal navigation tube structure for cerebral thrombectomy that reduces the risk of vascular intimal injury. Summary of the Invention

[0006] This invention addresses the problems existing in the prior art by providing a non-invasive distal navigation tube structure for cerebral thrombectomy.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A non-invasive distal navigation tube structure for cerebral thrombectomy includes an integrally formed distal navigation end, a proximal navigation end, and a navigation body, with the navigation body located between the distal and proximal navigation ends. The distal navigation end has a monitoring segment, in which sensor components are integrated. The monitoring segment is connected to the fixed end of a control line, and the free end of the control line extends along the axial direction of the navigation tube to the proximal navigation end. The sensor components monitor and feed back information within the vascular segment to an external control end in real time. After receiving the information, the control end controls the control line to drive the monitoring segment to adjust the navigation direction within the vascular segment.

[0008] Based on the above technical solution, the monitoring segment further includes a first arc surface and a second arc surface. The first arc surface extends from the navigation body to the initial position of the navigation far end, and the second arc surface extends from the initial position of the navigation far end to the end of the navigation far end. The inner diameter of the first arc surface gradually increases along the direction from near the navigation body to far away from the navigation body, and the inner diameter of the second arc surface gradually decreases along the direction from near the end of the navigation far end. The first arc surface and the second arc surface are connected.

[0009] Based on the above technical solution, further, the areas of the end faces where the first part of the arc surface and the second part of the arc surface meet are equal, and the inner diameter of the end face where they meet is the largest.

[0010] Based on the above technical solution, the sensor assembly further includes a first pressure sensor and a second pressure sensor, wherein the first pressure sensor is integrated on the top of the first part of the arc surface and the second pressure sensor is integrated on the side of the second part of the arc surface.

[0011] Based on the above technical solution, further, by monitoring the pressure data of the first pressure sensor and the second pressure sensor respectively, it can be determined whether the navigation direction needs to be adjusted by bending. The judgment logic is as follows: Set a pressure threshold at the control end. When the first pressure sensor detects that the pressure data is greater than the pressure threshold, it controls the monitoring section of the first part of the arc surface to adjust its direction until the pressure data is less than the pressure threshold. Simultaneously monitor whether the pressure data monitored by the second pressure sensor exceeds the pressure threshold. If it does, adjust the rotation angle of the first or second part of the arc surface so that the pressure data monitored by the second pressure sensor is lower than the pressure threshold. Only when both the first and second pressure sensors are below the pressure threshold can it be determined that the navigation device has not caused damage to the blood vessel wall; otherwise, the direction needs to be continuously adjusted to meet the threshold.

[0012] Based on the above technical solution, at least one control line is embedded in the first part of the arc surface side and the second part of the arc surface side respectively, and the free end of each control line extends along the axial direction of the navigation tube to the near end of the navigation tube and is connected to the control end.

[0013] Based on the above technical solution, the control terminal is further located at the navigation proximal end, and the control terminal is provided with a handheld end, a first adjustment end and a second adjustment end. The handheld end is provided with a first limiting hole and a second limiting hole. The first adjustment end and the second adjustment end are respectively located in the first limiting hole and the second limiting hole. The first adjustment end is connected to the control line led out from the first part of the arc side surface, and the second adjustment end is connected to the control line led out from the second part of the arc side surface.

[0014] Based on the above technical solution, further, the location where the navigation body is connected to the remote navigation end is provided with an elastic covering part extending outward, and the covering part is annular.

[0015] Based on the above technical solution, further, the outer wall of the navigation remote end is designed with a spiral or corrugated pattern.

[0016] Based on the above technical solution, the navigation remote end is further configured as a porous elastic structure, and the pores are filled with a hydrophilic lubricating material.

[0017] Compared with the prior art, the present invention has the following beneficial effects: (1) The present invention sets up a flexible monitoring section at the remote end of the navigation system, integrates multiple sensors and connecting control lines on the monitoring section, and judges whether the remote end of the navigation system needs to operate the corresponding control lines to adjust the angle by using the data monitored by the sensors, so as to reduce the degree of damage to the blood vessel wall.

[0018] (2) The navigation end of the present invention is designed with an arc surface, hole features, an annular cover and spiral pattern, and a self-lubricating surface is provided on the navigation end. This not only eliminates the step effect, but also reduces the frictional resistance with the blood vessel wall, enhances compliance in curved blood vessels, and reduces the risk of damaging the inner wall of the aspiration catheter. Attached Figure Description

[0019] Figure 1 This is a schematic diagram illustrating the internal structure of the navigation remote terminal of the present invention; Figure 2 This is a schematic diagram of the control terminal of the present invention; Figure 3 A schematic diagram of the end structure of the navigation tube with a cover provided in this invention; Figure 4 A schematic diagram of the internal structure of the upper half of the navigation remote end of the present invention when a cover is provided; Figure label: 1. Navigation near end; 2. Navigation far end; 3. Navigation main body; 4. First part of the arc surface; 5. Second part of the arc surface; 6. Covering part; 7. First pressure sensor; 8. Second pressure sensor; 9. Control line; 10. Control end; 11. First limiting hole; 12. Second limiting hole; 13. First adjusting end; 14. Second adjusting end; 15. Positioning hole. Detailed Implementation

[0020] The present invention will be further described and illustrated below with reference to the accompanying drawings and specific embodiments. The technical features of each embodiment of the present invention can be combined accordingly, provided that there is no mutual conflict.

[0021] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0022] In the description of this invention, it should be understood that when an element is considered to be "connected" to another element, it can be a direct connection to the other element or an indirect connection, i.e., there is an intermediate element. Conversely, when an element is said to be "directly" connected to another element, there is no intermediate element.

[0023] In the description of this invention, it should be understood that the terms "first" and "second" are used only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first" and "second" may explicitly or implicitly include at least one of those features.

[0024] Example 1 Reference Figure 1 As shown, this embodiment provides a non-invasive distal navigation tube structure for cerebral thrombectomy, which includes an integrally formed distal navigation end 2, proximal navigation end 1, and navigation body 3, with the navigation body 3 located between the distal navigation end 2 and the proximal navigation end 1. It should be noted that the position closer to the hand is the proximal end, and the position further away from the hand is the distal end.

[0025] In this embodiment, the navigation tube has a hollow internal structure, and the navigation distal end 2 is set as a flexible monitoring section. The end of the flexible monitoring section has an arc-shaped structure, preferably a hemispherical or ellipsoidal shape. By setting the arc-shaped structure, the mechanical impact on the blood vessel wall caused by the existing navigation tube tip structure can be eliminated, and as a bendable adjustment stage, the direction can be adjusted when it encounters the blood vessel wall; wherein, the hollow structure inside the navigation tube of the navigation distal end 2 allows the guide wire to pass through; Furthermore, this monitoring section can eliminate the step effect between the suction catheter and the navigation distal end 2. The specific structure is as follows: the middle part extending from the navigation body 3 to the navigation distal end 2 is designated as the first part arc surface 4, and the middle part to the end of the navigation distal end 2 is designated as the second part arc surface 5. The inner diameter of the first part arc surface 4 gradually increases along the direction closer to the navigation body 3 and farther away from the navigation body 3, while the inner diameter of the second part arc surface 5 gradually decreases along the direction closer to the end of the navigation distal end 2. The first part arc surface 4 and the second part arc surface 5 are joined to form a flexible monitoring section. The inner diameter of the joined end face is the same, the area of ​​the joined end face is equal, and the inner diameter of the joined end face is the largest. The inner diameter at this position is clearance-fitted with the inner diameter of the suction catheter, so that it can fully fit with the end of the suction navigation distal end 2 in the axial direction. When the navigation tube is withdrawn, the structure of the first part arc surface 4 forms a smooth transition with the suction catheter, eliminating the step effect and not damaging the inner wall of the suction catheter. It should be noted that, combined with the existing structure, the navigation tube is located inside the external suction catheter.

[0026] In other embodiments, sensor components can be integrated into the flexible monitoring section of the navigation remote end 2. By monitoring the pressure data between the sensor components and the inner wall of the blood vessel during navigation, the end of the navigation remote end 2 can have environmental perception and autonomous deformation capabilities, thereby achieving active obstacle avoidance and guidance. Specifically, a sensor assembly is integrated within the monitoring section. This sensor assembly is preferably composed of multiple pressure sensors. More preferably, a pressure sensor is integrated within the top of the first arc surface 4, designated as the first pressure sensor 7; and a pressure sensor is integrated within the bottom side of the second arc surface 5, designated as the second pressure sensor 8. When the navigation tube moves within the blood vessel section, the pressure data of the first pressure sensor 7 and the second pressure sensor 8 are monitored respectively to determine whether the navigation direction needs to be adjusted by bending. Furthermore, the judgment logic is as follows: A pressure threshold is set. When the pressure data detected by the first pressure sensor 7 is greater than the pressure threshold, the monitoring segment of the first part of the arc surface 4 is adjusted until the pressure data is less than the pressure threshold. At this time, it is necessary to monitor whether the pressure data detected by the second pressure sensor 8 exceeds the pressure threshold. If it does, the rotation angle of the first part of the arc surface 4 or the second part of the arc surface 5 needs to be adjusted so that the pressure data detected by the second pressure sensor 8 is lower than the pressure threshold. Only when both pressure sensors are simultaneously below the pressure threshold can it be determined that the navigation terminal 2 has not caused damage to the blood vessel wall. Otherwise, the direction needs to be continuously adjusted to meet the threshold. It should be noted that this pressure threshold is a reasonable range for routine blood vessel wall damage, or it can be set based on actual clinical experience. Furthermore, at least one control line 9 is embedded in the first and second arc-shaped sides of the monitoring segment, respectively. The free end of each control line 9 extends axially to the navigation proximal end 1 and connects to the control end 10. The control end 10 is detachably located in the navigation proximal end 1. Preferably, the control line 9 is made of high-strength stainless steel or nickel-titanium alloy wire. The angle of the monitoring segment is adjusted by controlling the control end 10, so that the distal end of the catheter can actively aim at the eccentric thrombus or the thrombus in the bifurcation vessel. With the help of the aspiration tube, the thrombus can be covered by aspiration from multiple angles on the front and side. The catheter can selectively enter the target branch at the bifurcation of the vessel, avoiding accidental entry into non-disease vessels, which helps to improve the safety of the operation. Preferably, the control end 10 is located at the navigation proximal end 1. The control end 10 includes a handheld end, a first adjustment end 13, and a second adjustment end 14. The handheld end has a first limiting hole 11 and a second limiting hole 12. The first adjustment end 13 and the second adjustment end 14 are respectively located within the first limiting hole 11 and the second limiting hole 12, and can move within the corresponding limiting holes to adjust different angles. The control line 9 located on the first part of the arc surface is connected to the first adjustment end 13, and the control line 9 located on the second part of the arc surface is connected to the second adjustment end 14. By controlling the first adjustment end 13 or the second adjustment end 14, the corresponding control line 9 is controlled, thereby controlling the flexible monitoring segment of the navigation distal end 2 to achieve the angle adjustment effect; furthermore, combined with... Figure 2 As shown, by pulling the corresponding control line 9 back or loosening it forward, the tension of the corresponding control line 9 can be controlled, thereby controlling the angle of the flexible monitoring section. The tension of two control lines 9 can also be controlled simultaneously to achieve the final angle adjustment. Furthermore, multiple positioning holes 15 can be provided between the first limiting hole 11 and the second limiting hole 12. The multiple positioning holes 15 are connected to the first limiting hole 11 and the second limiting hole 12. When the position of the corresponding control line 9 meets the adjustment angle, the corresponding adjustment end can be positioned at the corresponding or near the positioning hole 15. It should be noted that the number of positioning holes 15 is set according to actual needs, and when the first adjustment end 13 and the second adjustment end 14 are located in the corresponding positioning hole 15, positioning is achieved through the abutment effect.

[0027] In other embodiments, refer to Figure 3 and Figure 4 As shown, an elastic cover 6 is also provided at the navigation remote end 2. The navigation body 3 is connected to the navigation remote end 2 and the cover 6 with elastic properties is provided on the outer periphery. The cover 6 is preferably designed as a ring so that it covers and sucks the end of the navigation remote end 2 in the axial direction to eliminate the step effect. Specifically, an annular cover 6 extends outward from the proximal end of the navigation distal end 2, with an axial length (outer diameter of the navigation tube) of 1-2 mm and a radial extension exceeding the outer diameter of the suction conduit by 0.1-0.3 mm. The cover 6 is made of a low-hardness material and is integrally formed with the distal end, and the edges can be chamfered. The hardness can be selected as 20D-30D. When the navigation tube and the suction conduit are assembled, the cover 6 naturally covers the end face of the suction navigation distal end 2, forming a smooth transition. Since the cover 6 has elastic deformation properties, it allows the navigation tube to move axially within the suction conduit without scratching the inner wall of the suction conduit.

[0028] In other embodiments, a hydrophilic lubricating layer is coated on the navigation distal end 2 to form a self-lubricating surface, reducing frictional resistance with the blood vessel wall and enhancing compliance in tortuous blood vessels.

[0029] In other embodiments, the navigation terminal 2 can also be configured as a porous elastic structure, with hydrophilic lubricating material filled in the pores to form a self-lubricating surface, so that the navigation terminal 2 can move more easily in the blood vessels without damaging them. Specifically, the aperture of the hole structure on the outer wall of the navigation remote end 2 is preferably 50-200μm, and the pores are filled with a hydrophilic lubricating material such as polyvinylpyrrolidone; the porous elastic structure can be designed as an axial groove, a radial annular groove, or an irregular mesh to minimize the contact area with the blood vessel wall.

[0030] In another embodiment, the outer wall of the navigation distal end 2 can be designed as a spiral or corrugated shape to break the single geometric feature of the conical structure; and the surface morphology of the distal end should avoid forming a large surface contact with the inner wall of the blood vessel as much as possible to reduce the coefficient of friction between it and the blood vessel wall.

[0031] In another embodiment, the navigation tube is integrally injection molded using medical-grade polyurethane or polyether block amide, and the navigation distal end 2 can be made of a material with lower hardness to enhance cushioning, such as thermoplastic polyester elastomer.

[0032] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A non-invasive distal navigation tube structure for cerebral thrombectomy, characterized in that: It includes a one-piece integrated navigation remote end, navigation proximal end, and navigation main body, with the navigation main body located between the navigation remote end and the navigation proximal end; The navigation system has a monitoring section at the far end, which integrates sensor components. The monitoring section is connected to the fixed end of the control line, and the free end of the control line extends along the axis of the navigation tube to the near end of the navigation system. The sensor components monitor and feed back information within the blood vessel segment to an external control terminal in real time. After receiving the information, the control terminal controls the control line to adjust the navigation direction of the monitoring segment within the blood vessel segment.

2. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 1, characterized in that: The monitoring segment includes a first arc surface and a second arc surface. The first arc surface extends from the navigation body to the initial position of the navigation far end, and the second arc surface extends from the initial position of the navigation far end to the end of the navigation far end. The inner diameter of the first arc surface gradually increases along the direction from the navigation body to the distance from the navigation body, and the inner diameter of the second arc surface gradually decreases along the direction from the end of the navigation far end. The first arc surface and the second arc surface are connected.

3. The non-invasive distal navigation tube structure for cerebral vascular thrombectomy according to claim 2, characterized in that: The areas of the end faces where the first part of the arc surface and the second part of the arc surface meet are equal, and the inner diameter of the end face where they meet is the largest.

4. A non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 2 or 3, characterized in that: The sensor assembly includes a first pressure sensor and a second pressure sensor, with the first pressure sensor integrated on the top of the first partial arc surface and the second pressure sensor integrated on the side of the second partial arc surface.

5. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 4, characterized in that: By monitoring the pressure data from the first pressure sensor and the second pressure sensor respectively, it is determined whether the navigation direction needs to be adjusted by bending. The judgment logic is as follows: Set a pressure threshold at the control end. When the first pressure sensor detects that the pressure data is greater than the pressure threshold, it controls the monitoring section of the first part of the arc surface to adjust its direction until the pressure data is less than the pressure threshold. Simultaneously monitor whether the pressure data monitored by the second pressure sensor exceeds the pressure threshold. If it does, adjust the rotation angle of the first or second part of the arc surface so that the pressure data monitored by the second pressure sensor is lower than the pressure threshold. Only when both the first and second pressure sensors are below the pressure threshold can it be determined that the navigation device has not caused damage to the blood vessel wall; otherwise, the direction needs to be continuously adjusted to meet the threshold.

6. A non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 2 or 3, characterized in that: At least one control line is embedded in the first part of the arc surface and the second part of the arc surface, respectively. The free end of each control line extends along the axial direction of the navigation tube to the near end of the navigation tube and is connected to the control end.

7. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 6, characterized in that: The control terminal is located near the navigation end and includes a handheld end, a first adjustment end, and a second adjustment end. The handheld end has a first limiting hole and a second limiting hole. The first adjustment end and the second adjustment end are located inside the first limiting hole and the second limiting hole, respectively. The first adjustment end is connected to the control line led out from the side of the first part of the arc surface, and the second adjustment end is connected to the control line led out from the side of the second part of the arc surface.

8. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 1, characterized in that: The navigation body is provided with an elastic covering portion extending outward from the location where it connects to the remote navigation device, and the covering portion is annular.

9. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 1, characterized in that: The outer wall of the navigation terminal is designed with a spiral or corrugated pattern.

10. The non-invasive distal navigation tube structure for cerebral thrombectomy according to claim 1, characterized in that: The navigation remote end is configured as a porous elastic structure, and the pores are filled with a hydrophilic lubricating material.

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