Thrombectomy system with a delivery control device

Abstract

The present invention discloses a thrombus removal system with a delivery control device, comprising: a delivery guide wire; a thrombus removal bracket with a hollow tube; a protective structure; a delivery control device for adjusting the position of the connected structure; the protective structure and the hollow tube of the thrombus removal bracket are sleeved on the delivery guide wire, one end of the thrombus removal bracket and the protective structure are fixedly connected to the first movable ring and the second movable ring respectively, the first movable ring and the second movable ring are sleeved on the first screw rod and the second screw rod of the delivery control device respectively, and the relative positions of the thrombus removal bracket and the protective structure in the blood vessel are changed by controlling the first movable ring and the second movable ring to move on the first screw rod and the second screw rod, which can fully meet the safety and effectiveness requirements of the device during clinical use.

Description

Technical Field

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

[0002] Acute stroke is a common cerebrovascular disease with an acute onset, high disability and mortality rates, and is the leading cause of disability in adults. One conventional treatment is thrombolysis, where drugs are used to dissolve blood clots in the blood vessels when the disease strikes. This approach is mainly suitable for patients with mild symptoms or small, fast-growing clots. However, for large or massive clots, drug thrombolysis is less effective. Therefore, removing the clot with a thrombectomy device to restore blood flow has become a commonly used minimally invasive interventional procedure.

[0003] Several commonly used stent retrievers in clinical practice have difficulty capturing complex clots. Even when they do, clots can easily break apart, become dislodged, and escape during retrieval, leading to cerebral infarction, myocardial infarction, pulmonary embolism, and even death in severe cases. Furthermore, existing thrombectomy device designs are prone to damaging the vascular lining, increasing the risk of reperfusion injury during mechanical thrombectomy, compromising immediate and postoperative outcomes. Summary of the Invention

[0004] The present invention provides a thrombus removal stent and thrombus removal system based on a spiral imaging wire, which can capture complex thrombi while not easily damaging the inner wall of the blood vessel during the thrombus removal process, thereby reducing the risk of vascular reperfusion injury during mechanical thrombus removal without affecting the postoperative effect. To achieve the above-mentioned purpose, the present invention provides the following technical solutions:

[0005] As one aspect of an embodiment of the present disclosure, a thrombectomy system having a delivery control device includes:

[0006] Delivery guidewire;

[0007] a thrombectomy stent with a hollow tube;

[0008] The protective structure includes a proximal imaging point, a distal imaging point, and a protective body located between the proximal and distal imaging points. The protective body is a metal mesh with mesh openings facing the thrombectomy stent.

[0009] a conveyor control device for adjusting the position of the connected structures;

[0010] The hollow tube sleeves of the protective structure and the thrombus removal bracket are connected to the delivery guide wire, and one end of the thrombus removal bracket and the protective structure are fixedly connected to the first movable ring and the second movable ring respectively. The first movable ring and the second movable ring are respectively connected to the first screw rod and the second screw rod of the delivery control device. By controlling the first movable ring and the second movable ring to move on the first screw rod and the second screw rod, the relative positions of the thrombus removal bracket and the protective structure in the blood vessel are changed.

[0011] Preferably, one end of the first screw rod is connected to the first manual handle, and the other end is connected to the first control motor.

[0012] Preferably, one end of the second screw rod is connected to the second manual handle, and the other end is connected to the second control motor.

[0013] Preferably, a first blocking ring is provided between the first screw rod and the first manual handle, and a second blocking ring is provided between the second screw rod and the second manual handle.

[0014] Preferably, a set of a first driving gear and a first driven gear that are engaged with each other is provided between the first manual handle and the first blocking ring.

[0015] Preferably, a set of a second driving gear and a second driven gear that are engaged with each other is provided between the second manual handle and the second blocking ring.

[0016] Preferably, a third blocking ring is provided between the first screw rod and the first control motor, and a fourth blocking ring is provided between the second screw rod and the second control motor.

[0017] Preferably, the inner diameters of the first movable ring and the second movable ring are adjustable.

[0018] Preferably, an introduction limit block is provided between the first movable ring and the second movable ring.

[0019] Preferably, the thrombus removal system is further provided with a battery, and the battery is used to supply power to the first control motor and / or the second control motor.

[0020] The beneficial effects of the present invention are as follows: the thrombectomy stent and the protective structure are respectively connected to the delivery control device, and the relative positions of the thrombectomy stent and the protective structure in the blood vessel are controlled by starting the first control motor and / or the second control motor on the delivery control device, or adjusting the first manual handle and / or the second manual handle, while fully meeting the safety and effectiveness requirements of the device during clinical use.

[0021] The adjustable inner diameters of the first movable ring and the second movable ring can meet the locking requirements of delivery guidewires or hollow tubes with different outer diameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1This is a schematic diagram of the overall structure of the delivery control device in the thrombectomy system;

[0023] Figure 2 Schematic diagram of the overall structure of the thrombectomy system with a delivery control device;

[0024] Figure 3 Schematic diagram of the overall structure of the thrombectomy stent with an iso-density hollow design for the distal hypotube;

[0025] Figure 4 Schematic diagram of the overall structure of the thrombectomy stent with a variable density hollow design at the distal hypotube;

[0026] Figure 5 This is a partially enlarged schematic diagram of a hypotube with an equal-density hollow design;

[0027] Figure 6 A partially enlarged schematic diagram of a hypotube designed for variable density hollowing;

[0028] Figure 7 Schematic diagram of the protective structure of an umbrella-shaped structure woven with metal wire;

[0029] Figure 8 Schematic diagram of the protective structure of an elliptical structure woven together by a polymer film and nickel-titanium wire;

[0030] Figure 9 A partial enlarged schematic diagram of the protective body of the umbrella-shaped structure woven with metal wire;

[0031] Figure 10 A partially enlarged schematic diagram of the elliptical structure protecting the main body woven together with polymer film and nickel-titanium wire. DETAILED DESCRIPTION

[0032] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0033] In this embodiment, the definitions of "proximal end" and "distal end" are: "proximal end" generally refers to the end of the medical device that is close to the operator during normal operation, and "distal end" generally refers to the end of the medical device that first enters the patient's body during normal operation.

[0034] This embodiment provides a thrombus removal system with a delivery control device. Figure 1-2, including: a delivery guide wire 301; a thrombectomy stent 200 with a hollow tube; a protective structure 300; a delivery control device 100, which is used to adjust the position of the connected structures; the protective structure 300 and the hollow tube of the thrombectomy stent 200 are connected to the delivery guide wire 301, and one end of the thrombectomy stent 200 and the protective structure 300 are fixedly connected to the first movable ring 106 and the second movable ring 114 respectively, and the first movable ring 106 and the second movable ring 114 are respectively connected to the first screw rod 105 and the second screw rod 113 of the delivery control device 100. By controlling the first movable ring 106 and the second movable ring 114 to move on the first screw rod 105 and the second screw rod 113, the relative positions of the thrombectomy stent 200 and the protective structure 300 in the blood vessel are changed, which can effectively remove the thrombus while protecting the distal blood vessel. The operation is simple and quick, and can fully meet the safety and effectiveness requirements of the device during clinical use.

[0035] In this embodiment, one end of the first screw rod 105 is connected to the first manual handle 101 and the other end is connected to the first control motor 108. One end of the second screw rod 113 is connected to the second manual handle 109 and the other end is connected to the second control motor 117.

[0036] In this embodiment, a first blocking ring 104 is provided between the first screw rod 105 and the first manual handle 101 , and a second blocking ring 112 is provided between the second screw rod 113 and the second manual handle 109 .

[0037] In this embodiment, a first driving gear 103 and a first driven gear 102 are interlocked between the first manual handle 101 and the first blocking ring 104. A second driving gear 111 and a second driven gear 110 are interlocked between the second manual handle 109 and the second blocking ring 112.

[0038] In this embodiment, a third blocking ring 107 is provided between the first screw rod 105 and the first control motor 108 , and a fourth blocking ring 115 is provided between the second screw rod 113 and the second control motor 117 .

[0039] In this embodiment, the inner diameters of the first movable ring 106 and the second movable ring 114 are adjustable to meet the locking requirements of delivery guidewires 301 or hollow tubes with different outer diameters.

[0040] In this embodiment, an introduction limit block 116 is provided between the first movable ring 106 and the second movable ring 114 for limiting the position of the hollow tube and the delivery guide wire 301 to ensure concentricity.

[0041] In this embodiment, the thrombus removal system is further provided with a battery 118 , and the battery 118 is used to supply power to the first control motor 108 and / or the second control motor 117 .

[0042] In some embodiments, the hollow tube of the thrombectomy stent 200 is connected to the delivery guide wire 301, and one end of the thrombectomy stent 200 is fixedly connected to the first movable ring 106, which is connected to the first screw rod 105 of the delivery control device 100. By controlling the movement of the first movable ring 106 on the first screw rod 105, the thrombectomy stent 200 is controlled to move on the delivery guide wire 301, thereby achieving a change in the relative position of the thrombectomy stent 200 in the blood. Figure 3 In this embodiment, the thrombus removal stent 200 comprises a proximal hollow tube 201, a distal hypotube 202, a first imaging point 203, a second imaging point 205, and a stent body 204 mounted on the hypotube. The proximal hollow tube 201 is constructed from either a medical stainless steel single-lumen tube or a multi-strand spiral hollow tube, enhancing the stent's adherence to the vessel wall and preventing displacement. The distal hypotube 202 utilizes a uniform or variable-density "hollowed-out" design to enhance its flexibility and ease of passage.

[0043] In some embodiments, both ends of the thrombus removal bracket 200 contain a first developing point 203 and a second developing point 205 of platinum-iridium alloy, the length of the first developing point 203 and the second developing point 205 are 0.5 to 2.0 mm, and can be fixed by UV glue, dry adhesive or soldering or a combination thereof.

[0044] In some embodiments, the stent body 204 contains two to six spiral developing filaments, which are spirally wound along the length of the distal hypotube 202. The developing filaments can be made of a platinum-iridium alloy, a platinum-tungsten alloy, a platinum-nickel alloy, or gold wire. The stent body 204, composed of multiple spiral developing filaments, is a retractable structure. The distal and proximal ends of the stent body 204 have an "umbrella-shaped" design, with a greater mesh density at the distal end than at the proximal end. In a natural state, the outer diameter of the two ends after expansion is larger than that of the middle section, effectively enhancing the embedding and capture of thrombi.

[0045] In some embodiments, the hollow tube of the protective structure 300 is connected to the delivery guide wire 301, and one end of the protective structure 300 is fixedly connected to the second movable ring 114. The second movable ring 114 is connected to the second screw rod 113 of the delivery control device 100. By controlling the second movable ring 114 to move on the first screw rod 105 and the second screw rod 113, the protective structure 300 is controlled to move on the delivery guide wire 301, thereby achieving a change in the relative position of the protective structure 300 in the blood. Figure 7 —10. In this embodiment, the protection structure 300 includes a proximal development point 304, a distal development point 306, and a protection body 305 located between the proximal development point 304 and the distal development point 306.

[0046] In some embodiments, the protective body 305 is a metal mesh with mesh openings, the mesh openings of the metal mesh facing the thrombus removal stent 200 , and the metal mesh of the protective body 305 can be a nickel-titanium wire braided design, a multi-nickel-titanium wire umbrella design, or a polymer plastic film.

[0047] In some embodiments, a nickel-titanium wire braiding design is used, and an "umbrella-shaped" structure is obtained through heat setting. The braiding density at the distal end of the braided mesh is greater than that at the proximal end, which can effectively prevent the escape of blood clots.

[0048] In other embodiments, a combination of nickel-titanium wire and a polymer film is employed. The wire diameter ranges from 0.02 to 0.30 mm, preferably 0.05 to 0.10 mm. The wire is formed into an elliptical shape using a mold. A thin film layer is provided at the distal end of the protective body 305. The polymer film is made of one of silicone, polyurethane, and polyetheramide block copolymer, and has a thickness of 0.01 to 0.05 mm. The outer surface of the film layer contains mesh holes, which can have the same pore size, different pore sizes, or a combination thereof. The mesh density near the distal end of the umbrella structure is greater than that at the proximal end, effectively preventing the escape of thrombi.

[0049] In some embodiments, 3 to 6 developing spring coils or developing rings are evenly distributed in the circumferential direction of the protective structure 300, the developing material includes one or more of platinum-iridium alloy, platinum-tungsten alloy, and gold, the outer diameter of the wire is 0.02 to 0.05 mm, and the length of the developing ring is 0.5 to 2.0 mm.

[0050] In some embodiments, the delivery guide wire 301 connected to the proximal imaging point 304 between the protection structure 300 and the thrombus removal stent 200 is a distal tapered area 303. The distal tapered area 303 adopts a one-segment or multi-segment taper design, which has good tracking performance and torque transmission.

[0051] In some embodiments, the section of the delivery guidewire 301 between the distal tapered region 303 and the thrombus retriever stent 200 is the proximal guidewire end 302. The proximal guidewire end 302 can be made of medical-grade 304V or 316L stainless steel round wire. The outer surface of the proximal guidewire end 302 also includes a guidewire outer surface coating. The coating can be made of polytetrafluoroethylene or parylene, which are very smooth and improve the overall flexibility of the guidewire.

[0052] In some embodiments, the proximal developing point 304 or the distal developing point 306 is a developing metal ring or spring coil, with a developing point length of 1.0 to 2.0 mm. The proximal developing point 304 and the distal developing point 306 are secured using one or a combination of UV glue, adhesive, or soldering. The developing material can be one of platinum-iridium alloy, platinum-tungsten alloy, gold wire, platinum-nickel alloy, and tungsten alloy.

[0053] In some embodiments, the thrombectomy system further includes a head-end developing section 307 connected to the other end of the distal developing point 306. The head-end developing section 307 can be designed with a developing spring coil. The coil length is 5.0 to 10 mm, the round wire diameter is 0.04 to 0.10 mm, preferably 0.04 to 0.06 mm, and the developing material is platinum-iridium alloy or platinum-tungsten alloy. The ends of the coil are secured with one or a combination of UV glue, smooth adhesive, or soldering.

[0054] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A thrombectomy system with a delivery control device, characterized in that: include: Delivery guidewire; a thrombectomy stent with a hollow tube; The protective structure includes a proximal imaging point, a distal imaging point, and a protective body located between the proximal and distal imaging points. The protective body is a metal mesh with mesh openings facing the thrombectomy stent. a conveyor control device for adjusting the position of the connected structures; The hollow tubes of the protective structure and the thrombus removal bracket are connected to the delivery guide wire, and one end of the thrombus removal bracket and the protective structure are fixedly connected to the first movable ring and the second movable ring respectively, and the first movable ring and the second movable ring are respectively connected to the first screw rod and the second screw rod of the delivery control device, and the relative positions of the thrombus removal bracket and the protective structure in the blood vessel are changed by controlling the first movable ring and the second movable ring to move on the first screw rod and the second screw rod; one end of the first screw rod is connected to the first manual handle, and the other end is connected to the first control motor; one end of the second screw rod is connected to the second manual handle, and the other end is connected to the second control motor.

2. The thrombus removal system with a delivery control device according to claim 1, characterized in that: A first blocking ring is provided between the first screw rod and the first manual handle, and a second blocking ring is provided between the second screw rod and the second manual handle.

3. The thrombus removal system with a delivery control device according to claim 2, characterized in that: A set of a first driving gear and a first driven gear that are engaged with each other is provided between the first manual handle and the first blocking ring.

4. A thrombus removal system with a delivery control device according to claim 1 or 2, characterized in that: A set of second driving gear and second driven gear that are engaged with each other is provided between the second manual handle and the second blocking ring.

5. The thrombus removal system with a delivery control device according to claim 4, characterized in that: A third blocking ring is provided between the first screw rod and the first control motor, and a fourth blocking ring is provided between the second screw rod and the second control motor.

6. The thrombus removal system with a delivery control device according to claim 1, characterized in that: The inner diameters of the first movable ring and the second movable ring are adjustable.

7. The thrombus removal system with a delivery control device according to claim 6, characterized in that: An introduction limit block is provided between the first movable ring and the second movable ring.

8. The thrombus removal system with a delivery control device according to claim 1, characterized in that: The thrombus removal system is further provided with a battery, and the battery is used to power the first control motor and / or the second control motor.

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