Aneurysm embolism device

Abstract

The utility model discloses an aneurysm embolism device which comprises a micro catheter, a micro guide wire and a spring ring, the micro guide wire is inserted into a catheter cavity of the micro catheter in a penetrating mode, and the micro guide wire conveys and guides the micro catheter so as to guide the micro catheter to be inserted into an aneurysm. The spring ring is pushed into the aneurysm from a tube cavity of the micro catheter, the embolism device further comprises a flow velocity sensor used for measuring the flow velocity of blood flow in the aneurysm, and the flow velocity sensor is arranged on the micro catheter or the micro guide wire and located at the end, close to the aneurysm, of the micro catheter or the micro guide wire. According to the aneurysm embolization device, in the process of embolizing the spring ring, the blood flow speed in the aneurysm can be monitored through the flow speed sensor, so that a doctor is assisted in judging whether the spring ring needs to be continuously embolized or not and evaluating the placing effect of the spring ring, it is guaranteed that the aneurysm is effectively treated, meanwhile, excessive treatment can be reduced, and the operation accuracy is improved.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an aneurysm embolization device. Background Technology

[0002] An aneurysm is a common vascular disease, mainly caused by local lesions and damage to the arterial wall, resulting in a permanent, localized dilation. Aneurysms can occur anywhere in the arterial system. Because the aneurysm wall is thin, it is at risk of rupture at any time if not treated promptly, and the mortality or disability rate after rupture is high.

[0003] Aneurysms are often treated with coil embolization, which involves using a microcatheter to pack coils into the aneurysm, thereby stopping blood flow and achieving aneurysm occlusion. However, the success of the procedure depends on the surgeon's experience and postoperative imaging assessments (such as DSA angiography), which can lead to either insufficient or excessive coil embolization. Insufficient coil embolization will not effectively treat the aneurysm, while excessive coil embolization may cause the aneurysm to rupture and increase the patient's medical costs. Utility Model Content

[0004] The technical problem to be solved by this invention is to provide an aneurysm embolization device that can accurately control the number of coil embolizations.

[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0006] An aneurysm embolization device includes a microcatheter, a microguidewire, and a coil. The microguidewire is inserted into the lumen of the microcatheter and guides the microcatheter to be inserted into the aneurysm. The coil is pushed from the lumen of the microcatheter into the aneurysm. The embolization device also includes a flow velocity sensor for measuring the blood flow velocity within the aneurysm. The flow velocity sensor is disposed on the microcatheter or the microguidewire and located at one end of the microcatheter or the microguidewire near the aneurysm.

[0007] In some embodiments, the flow rate sensor is positioned on the microcatheter or the microwire at a distance of 1 to 3 mm from the end of the microcatheter or the microwire.

[0008] In some embodiments, the flow sensor includes a sensor body and a signal transmission line with one end connected to the sensor body, the other end of the signal transmission line being used to connect to an external processing unit, the sensor body being encapsulated on the outer surface of the microcatheter or the microwire, and the signal transmission line being embedded in the microcatheter or the microwire.

[0009] In some embodiments, the material used to encapsulate the sensor body is medical-grade parylene.

[0010] In some embodiments, the coating thickness encapsulating the sensor body is 5–10 μm.

[0011] In some embodiments, the flow velocity sensor employs one of an ultrasonic Doppler probe, a thermistor, and an optical fiber sensor.

[0012] In some embodiments, the microcatheter includes an inner layer, a middle layer, and an outer layer arranged sequentially from the inside out. The outer layer is made of a biocompatible material, the middle layer is formed of a nickel-titanium alloy or stainless steel braided mesh or a coiled spring, and the inner layer is made of a PTFE inner membrane.

[0013] In some embodiments, the microguidewire includes a core wire and an outer sheath covering the outside of the core wire. The core wire is made of ground nickel-titanium or stainless steel, and the outer sheath is a nickel-titanium or stainless steel spring or a hyaluronic acid tube.

[0014] In some embodiments, the outer casing is provided with a hydrophobic polymer coating.

[0015] In some embodiments, one or more spring coils are provided, and the spring coils are made of shape memory polymer material.

[0016] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art: In the aneurysm embolization device of this utility model, during the embolization of the coil, the blood flow velocity in the aneurysm can be monitored by a flow velocity sensor, thereby assisting the doctor in determining whether to continue embolizing the coil and evaluating the coil placement effect. While ensuring effective treatment of the aneurysm, it can also reduce overtreatment and improve the accuracy of the surgery. Attached Figure Description

[0017] Appendix Figure 1 This is a schematic diagram of the aneurysm embolization device in this embodiment during the treatment of aneurysms;

[0018] Appendix Figure 2 This is a schematic diagram of the flow rate sensor mounted on the microcatheter in the aneurysm embolization device of this embodiment;

[0019] Appendix Figure 3 This is a schematic diagram of the flow rate sensor mounted on the microguidewire in the aneurysm embolization device of this embodiment. Detailed Implementation

[0020] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.

[0021] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this utility model is in use. They are used only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0022] Unless otherwise specified, the terms "proximal end" and "distal end" mentioned in this invention have the same meaning in terms of orientation. That is, in the use state, the distal end is the end away from the operator, and the proximal end is the end closer to the operator. The operator operates the aneurysm embolization device at the proximal end.

[0023] like Figure 1 As shown, the aneurysm embolization device of this invention includes a microcatheter 1, a microguidewire 2, a spring coil 3, and a flow sensor 4.

[0024] Guided by the microguidewire 2, the distal end of the microcatheter 1 is inserted into the aneurysm 500. The lumen of the microcatheter 1 also forms a delivery channel for the embolization coil 3 to pass through and be delivered into the aneurysm 500. The distal opening of the microcatheter 1 forms the outlet of the delivery channel, and the proximal opening of the microcatheter 1 forms the inlet of the delivery channel.

[0025] The microcatheter 1 comprises an inner layer, a middle layer, and an outer layer arranged concentrically from the inside out.

[0026] The inner layer uses a PTFE inner membrane (polytetrafluoroethylene inner membrane), which gives the inner surface of the microcatheter 1 good lubrication properties, thereby reducing the friction when it contacts the guidewire 2, increasing the passability of the microguidewire 2 and reducing the resistance when the microguidewire 2 passes through.

[0027] The intermediate layer is formed by a nickel-titanium alloy or stainless steel woven mesh or spring, which gives the microcatheter 2 good torsion control and support performance.

[0028] The outer layer is made of biocompatible materials, such as polyurethane, polyethylene, polytetrafluoroethylene, and nylon. This improves the pushability of the microcatheter 1 in the blood vessel 600, reduces the pushing resistance of the microcatheter 1, and also avoids direct exposure of the metal material of the middle layer, which could damage the blood vessel 600.

[0029] The microguidewire 2 is inserted into the lumen of the microcatheter 1. The microguidewire 2 is used to guide the delivery of the microcatheter 1 so that its distal end is inserted into the aneurysm 500.

[0030] The microguidewire 2 includes a core wire and an outer sheath surrounding the core wire. The core wire is made of ground nickel-titanium or stainless steel, and the outer sheath is a nickel-titanium or stainless steel spring or a hypo tube. This gives the microguidewire 2 both good flexibility and toughness.

[0031] The outer sheath is coated with a hydrophobic polymer, such as a PTFE coating or a pyrene coating. This effectively reduces the sliding friction between the microguidewire 2 and the inner wall of the blood vessel 600, reducing the possibility of damage to the inner wall of the blood vessel 600 by the microguidewire 2, while also improving the maneuverability of the microguidewire 2 through lubrication.

[0032] The spring coil 3 can be pushed from the lumen of the microcatheter 1 into the aneurysm 500 via the microguidewire 2 or other pushing mechanism. One or more spring coils 3 are provided, and the spring coil 3 is made of shape memory polymer material.

[0033] Flow sensor 4 is used to measure blood flow velocity within 500 mm of the aneurysm to assist physicians in determining whether to continue embolizing coil 3 and to evaluate the effectiveness of coil 3 placement, thereby determining the coil 3 placement strategy. Flow sensor 4 can be mounted on microcatheter 1, such as... Figure 2 As shown. The flow sensor 4 can also be mounted on the microguidewire 2, such as... Figure 3 As shown.

[0034] The flow sensor 4 is located on the microcatheter 1 or microguidewire 2 at the distal end, near the aneurysm 500. Preferably, the flow sensor 4 is positioned 1–3 mm from the tip of the microcatheter 1 or microguidewire 2. This allows for more accurate measurement of blood flow velocity within the aneurysm 500.

[0035] The flow sensor 4 includes a sensor body 41 and a signal transmission line 42. One end of the signal transmission line 42 is connected to the sensor body 41, and the other end of the signal transmission line 42 is used to connect to an external processing unit disposed outside the patient's body. The sensor body 41 is encapsulated on the outer surface of the microcatheter 1 or microwire 2, and the signal transmission line 42 is embedded in the microcatheter 1 or microwire 2.

[0036] The material used to encapsulate the sensor body 41 can be medical-grade parylene (Parylene C), and the coating thickness of the encapsulated sensor body 41 is 5–10 μm. This encapsulation of the sensor body 41 ensures that the sensor body 41 is not easily separated from the microcatheter 1 or microwire 2, while also ensuring that the placement of the flow sensor 4 does not affect the flexibility of the microcatheter 1 and microwire.

[0037] The flow sensor 4 can be an ultrasonic Doppler probe, which emits / receives ultrasonic waves and calculates blood flow velocity through frequency shift.

[0038] The flow sensor 4 can also be a thermal sensor, which measures blood flow velocity through the principle of thermal diffusion.

[0039] The flow sensor 4 can also be an optical fiber sensor, which uses the phase change of the optical signal to detect the blood flow velocity.

[0040] The operating principle of this aneurysm embolization device is as follows:

[0041] (1) The microcatheter 1 is guided and delivered through the microguidewire 2 so that the distal end of the microcatheter 1 is inserted into the aneurysm 500.

[0042] (2) Retract the microguidewire 2;

[0043] (3) The spring coils 3 are pushed one by one from the lumen of the microcatheter 1 into the aneurysm 500 through the microguidewire 2 or other pushing mechanism. During the process of pushing the spring coils 3 one by one, the blood flow velocity in the aneurysm 500 is monitored by the flow velocity sensor 4. When the blood flow velocity in the aneurysm 500 reaches the set threshold, the operation is completed.

[0044] During this process, when the flow sensor 4 is placed on the microcatheter 1, since the distal end of the microcatheter 1 is always inserted into the aneurysm 500 during embolization, the flow sensor 4 is also located within the aneurysm 500, enabling it to monitor the blood flow velocity within the aneurysm 500 in real time. When the flow sensor 4 is placed on the microguidewire 2, since the microguidewire 2 is withdrawn from the aneurysm 500 during the embolization of the coils 3, the flow sensor 4 is also withdrawn from the aneurysm 500. Therefore, after embolizing a certain number of coils 3, the microguidewire 2 needs to be inserted back into the aneurysm 500 to monitor the blood flow velocity within the aneurysm 500 using the flow sensor 4.

[0045] (4) After the surgery, the blood flow velocity within the aneurysm can be monitored again by the flow velocity sensor 4 to verify the blood flow blocking effect.

[0046] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. An aneurysm embolisation device, characterised in that: The embolization device comprises a microcatheter, a microguide wire and a spring coil, the microguide wire is inserted into the lumen of the microcatheter, the microguide wire guides the microcatheter to be inserted into an aneurysm, the spring coil is pushed into the aneurysm from the lumen of the microcatheter, the embolization device further comprises a flow rate sensor for measuring the blood flow rate in the aneurysm, the flow rate sensor is arranged on the microcatheter or the microguide wire and located at the end of the microcatheter or the microguide wire close to the aneurysm.

2. The aneurysm embolisation device of claim 1, wherein: The arrangement position of the flow rate sensor on the microcatheter or the microguide wire is 1-3mm away from the tip of the microcatheter or the microguide wire.

3. The aneurysm embolisation device of claim 1, wherein: The flow rate sensor comprises a sensor body and a signal transmission line connected to one end of the sensor body, the other end of the signal transmission line is used for connecting with an external processing unit, the sensor body is encapsulated on the outer surface of the microcatheter or the microguide wire, and the signal transmission line is embedded in the microcatheter or the microguide wire.

4. The aneurysm embolisation device of claim 3, wherein: The material for encapsulating the sensor body is medical-grade parylene.

5. The aneurysm embolisation device of claim 3, wherein: The coating thickness for encapsulating the sensor body is 5-10μm.

6. The aneurysm embolisation device of claim 1, wherein: The flow rate sensor adopts one of an ultrasonic Doppler probe, a thermal sensor and an optical fiber sensor.

7. The aneurysm embolisation device of claim 1, wherein: The microcatheter comprises an inner layer, an intermediate layer and an outer layer arranged in sequence from inside to outside, the outer layer is made of biocompatible material, the intermediate layer is formed by a nickel-titanium alloy or a stainless steel braided mesh or a coiled spring, and the inner layer adopts a ptfe inner film.

8. The aneurysm embolisation device of claim 1, wherein: The microguide wire comprises a core wire and a sheath arranged outside the core wire, the core wire is made of ground nickel-titanium or stainless steel, and the sheath is a nickel-titanium or stainless steel spring or a hypotube.

9. The aneurysm embolisation device of claim 8, wherein: The sheath is provided with a hydrophobic polymer coating.

10. The aneurysm embolisation device of claim 1, wherein: The spring coil is provided with one or more, and the spring coil is made of a shape memory polymer material.

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