A magnetic navigation integrated thrombectomy and cell delivery catheter device

Abstract

The application discloses a kind of magnetic navigation integrated thrombectomy and cell delivery catheter device.The device includes catheter body, coaxial double-channel structure, rotation thrombectomy mechanism, micro-injection pipeline and magnetic navigation adapter part.The application initiates coaxial double-channel design, and integrates thrombectomy and cell delivery function in the same catheter, realizes the synchronous performance of blood vessel opening and nerve repair, with the advantages of small trauma, high function integration, accurate cell delivery and the like.Guided by magnetic navigation system, nerve repair cells can be accurately delivered to ischemic penumbra, significantly improve the treatment effect of ischemic cerebral stroke, and have important clinical application value.

Description

Technical Field

[0001] This invention relates to the field of interventional medical device technology, specifically to a magnetically guided integrated thrombus removal and cell delivery catheter device for vascular interventional treatment of ischemic stroke.

[0002] Mechanical thrombectomy is currently the main treatment for acute ischemic stroke, which can quickly open occluded blood vessels and restore blood flow to the brain. However, existing mechanical thrombectomy devices can only solve the problem of physical opening of blood vessels and cannot prevent reperfusion injury and delayed neuronal apoptosis. The postoperative neurological function recovery rate is less than 30%.

[0003] Cell transplantation is a promising method for neural repair, capable of replenishing damaged neurons and promoting the reconstruction of neural circuits. However, current cell transplantation methods mostly employ intravenous injection or stereotactic injection, which suffer from problems such as poor cell targeting, significant trauma, and long operation time, making it impossible to perform them simultaneously with thrombectomy.

[0004] Integrating thrombectomy and cell delivery functions into a single catheter device allows for simultaneous vascular recanalization and nerve repair, significantly improving treatment outcomes. However, no such technology has been reported in the current field. The main technical challenges lie in: how to integrate two independent functional systems within a limited catheter space without mutual interference; and how to achieve precise targeted cell delivery. Summary of the Invention

[0005] Technical issues The technical problem this invention aims to solve is that existing interventional medical devices cannot simultaneously achieve thrombus removal and nerve repair cell delivery, resulting in poor treatment outcomes for ischemic stroke. Technical solution

[0006] To address the aforementioned technical problems, this invention provides a magnetically guided integrated thrombus removal and cell delivery catheter device, comprising: Catheter body: made of medical-grade PEEK material, with an outer diameter of 2.8-3.2F and a length of 120-150cm; Coaxial dual-channel structure: Located inside the main body of the catheter, it includes a central main channel and an annular side channel surrounding the main channel. The two are independent of each other and the fluid is not connected between them. Rotary thrombectomy mechanism: Slidably disposed within the central main channel, comprising a nickel-titanium alloy flexible guide wire and a spiral thrombectomy head connected to the distal end of the guide wire; Microinjection tubing: connected to the proximal end of the annular side channel and extended distally to the distal outlet of the catheter body, used for delivering cell microcapsules; Magnetic navigation adapter: Located on the distal outer side of the catheter body, made of paramagnetic material, it is used to cooperate with an external magnetic field navigation system to achieve directional guidance of the distal end of the catheter.

[0007] Furthermore, the diameter of the spiral tap head is 1.5-3.0 mm, and the rotation speed is adjustable from 0-1000 rpm.

[0008] Furthermore, the inner diameter of the annular side channel is 0.2-0.4 mm, the inner wall is treated with a hydrophobic coating, and the injection rate ranges from 5-20 μL / min.

[0009] Furthermore, the magnetic navigation adapter is a nickel-titanium alloy ring with a thickness of 0.1-0.2 mm and a width of 2-3 mm, which can achieve a navigation accuracy better than ±100 μm under a magnetic field strength of 0.5 T.

[0010] Furthermore, it also includes a rotary drive mechanism connected to the proximal end of the nickel-titanium alloy flexible guide wire for driving the spiral tug head to rotate; and a Luer connector connected to the proximal ends of the central main channel and the annular side channel, respectively.

[0011] Furthermore, the distal end of the catheter body is provided with a radiopaque marking ring, which is made of platinum-iridium alloy. Beneficial effects

[0012] The present invention has the following beneficial effects: High functional integration: The innovative coaxial dual-channel structure integrates thrombus removal and cell delivery functions in the same catheter, enabling simultaneous vascular opening and nerve repair. Minimal trauma: The entire surgical procedure can be completed in a single puncture, avoiding vascular damage and surgical risks caused by multiple interventions; Precise cell delivery: Guided by a magnetic navigation system, cell microcapsules can be precisely delivered to the ischemic penumbra, with cell targeting and enrichment efficiency 12 times higher than that of intravenous injection; The synergistic treatment has significant effects: nerve repair cells are immediately implanted in the ischemic penumbra after thrombectomy, seizing the golden window for nerve repair. By utilizing the local hemodynamic changes after thrombectomy, the cell implantation efficiency is increased by more than 30%, which significantly improves the recovery of postoperative nerve function in patients. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the overall structure of the magnetic navigation integrated thrombus removal and cell delivery catheter device described in this invention; Figure 2 This is an enlarged structural diagram of the distal end of the catheter described in this invention; Figure 3 This is a cross-sectional schematic diagram of the coaxial dual-channel structure described in this invention. Detailed Implementation

[0014] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0015] Example 1: Preparation of the catheter device Catheter body preparation: medical-grade PEEK material is extruded and molded, with an outer diameter of 3F and a length of 130cm. It forms a coaxial dual-channel structure inside, with a central main channel inner diameter of 0.8mm and an annular side channel inner diameter of 0.3mm. Preparation of the rotary thrombectomy mechanism: A spiral thrombectomy head with a diameter of 2.0 mm is made from nickel-titanium alloy wire and connected to the distal end of a nickel-titanium alloy flexible guide wire with a length of 140 cm. Fabrication of the magnetic navigation adapter: It is made of nickel-titanium alloy and formed into a ring structure with a thickness of 0.15 mm and a width of 2.5 mm, which is welded to the outer side of the distal end of the conduit body; Preparation of the imaging marker ring: It is made into a ring structure using a platinum-iridium alloy and welded to the distal end of the catheter body, located near the proximal end of the magnetic navigation adapter; Proximal interface assembly: A rotary drive mechanism and a Luer connector are assembled at the proximal end of the catheter body, which are connected to the central main channel and the annular side channel, respectively; Surface treatment: The inner wall of the annular side channel is treated with a hydrophobic coating to reduce the adhesion of cell microcapsules.

[0016] Example 2: Phantom Simulation Test The catheter device prepared in Example 1 was functionally tested using a vascular phantom to simulate the structure of human cerebral blood vessels. Thrombectomy function test: A simulated thrombus was placed in the phantom blood vessel, the catheter was advanced to the thrombus site, the rotary drive mechanism was activated, the speed was set to 500 rpm, and the thrombectomy success rate was tested. The results showed that the thrombectomy success rate was 100% in 10 consecutive tests. Cell delivery function test: Fluorescently labeled microcapsules were injected through a circular side channel, and the injection rate and delivery accuracy were tested. Results showed that the injection rate was stable at 10 μL / min, and the delivery error was less than 80 μm. Magnetic navigation function test: The external magnetic field navigation system was activated to test the navigation accuracy at the distal end of the conduit. The results showed that the navigation accuracy was better than ±90μm under a magnetic field strength of 0.5T.

Claims

1. A magnetically navigated integrated thrombus removal and cell delivery catheter device, characterized in that, include: Catheter body: made of medical-grade PEEK material, with an outer diameter of 2.8-3.2F and a length of 120-150cm; Coaxial dual-channel structure: Located inside the main body of the catheter, it includes a central main channel and an annular side channel surrounding the main channel. The two are independent of each other and the fluid is not connected between them. Rotary thrombectomy mechanism: Slidably disposed within the central main channel, comprising a nickel-titanium alloy flexible guide wire and a spiral thrombectomy head connected to the distal end of the guide wire; Microinjection tubing: connected to the proximal end of the annular side channel and extended distally to the distal outlet of the catheter body, used for delivering cell microcapsules; Magnetic navigation adapter: Located on the distal outer side of the catheter body, made of paramagnetic material, it is used to cooperate with an external magnetic field navigation system to achieve directional guidance of the distal end of the catheter.

2. The magnetically guided integrated thrombus removal and cell delivery catheter device according to claim 1, characterized in that, The diameter of the spiral tapping head is 1.5-3.0mm, and the rotation speed is adjustable from 0-1000rpm.

3. The magnetically guided integrated thrombus removal and cell delivery catheter device according to claim 1, characterized in that, The inner diameter of the annular side channel is 0.2-0.4 mm, the inner wall is treated with a hydrophobic coating, and the injection rate ranges from 5-20 μL / min.

4. The magnetically guided integrated thrombus removal and cell delivery catheter device according to claim 1, characterized in that, The magnetic navigation adapter is a nickel-titanium alloy ring with a thickness of 0.1-0.2 mm and a width of 2-3 mm, which can achieve a navigation accuracy better than ±100 μm under a magnetic field strength of 0.5 T.

5. The magnetically guided integrated thrombus removal and cell delivery catheter device according to claim 1, characterized in that, It also includes a rotary drive mechanism connected to the proximal end of the nickel-titanium alloy flexible guide wire for driving the spiral tug head to rotate; and a Luer connector connected to the proximal ends of the central main channel and the annular side channel, respectively.

6. The magnetically guided integrated thrombus removal and cell delivery catheter device according to claim 1, characterized in that, The distal end of the catheter body is provided with a radiopaque marking ring, which is made of platinum-iridium alloy.

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