A thrombus removal device

Abstract

This invention relates to the technical field of medical devices and discloses a thrombectomy device. The thrombectomy device provided by this invention includes a delivery catheter and a suction catheter disposed within the delivery catheter; the proximal end of the delivery catheter is connected to side A of a three-way connector, and the proximal end of the suction catheter is movable within the three-way connector; the proximal end of the suction catheter is connected to a transmission rod for controlling its movement, the transmission rod extending from side B, and side C of the three-way connector is connected to the suction device. This invention solves the technical problem of using a three-way connector in a dual-catheter system for thrombectomy in existing technologies.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and in particular to a thrombus removal device. Background Technology

[0002] Currently, common mechanical thrombectomy aids include thrombectomy stents and aspiration catheters. Common aspiration catheters are used in conjunction with an aspiration pump and connecting tubing for reperfusion after stent thrombectomy or thrombolysis. Alternatively, the Advanced Aspiration-First-Pass (ADAPT) technique can be used to directly apply mechanical suction to the reperfusion catheter for thrombectomy. To achieve the most complete thrombus retrieval possible, high aspiration efficiency can be obtained when the blood vessel is completely interrupted and the catheter has a large diameter and lumen.

[0003] Patent CN107205751B discloses a thrombectomy device, including a delivery catheter, a self-expanding funnel, and a suction funnel catheter. This device allows suction from very close proximity to the thrombus using a large opening, potentially occluding the artery and stopping flow, and suctioning the entire thrombus without breaking it. However, the dual-catheter structure is complex to operate and not suitable for clinical use. This invention does not disclose how to configure the suction device within the dual-catheter configuration for suction.

[0004] Chinese utility model patent CN218220267U discloses a thrombectomy device, including a syringe, a thrombectomy unit, and a drive unit. The thrombectomy unit includes a three-way connector, a thrombus suction tube disposed within the three-way connector for aspirating thrombi, and a thrombus fragmentation guidewire disposed within the three-way connector for clearing thrombi. The syringe is connected to the thrombus suction tube, and the drive unit is connected to the thrombus fragmentation guidewire. The thrombectomy unit also includes a first chamber and a second chamber disposed within the three-way connector, dividing the three-way connector into two independent chambers. The thrombus suction tube is disposed in the first chamber, and the thrombus fragmentation guidewire is disposed in the second chamber. Although this device uses a three-way connector for aspiration, it is not used in a dual-catheter structure. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art and provide a thrombus removal device, which aims to solve the technical problem of using a three-way connector in a double catheter to aspirate thrombi in the prior art.

[0006] To achieve the above objectives, the present invention proposes a thrombectomy device, comprising a delivery catheter and an aspiration catheter disposed within the delivery catheter; the proximal end of the delivery catheter is connected to the A side port of a three-way connector, and the proximal end of the aspiration catheter is movable within the three-way connector; the proximal end of the aspiration catheter is connected to a transmission rod for controlling its movement, the transmission rod extending from the B side port, and the C side port of the three-way connector is connected to the aspiration device.

[0007] Preferably, a sealing and locking device is provided at the B-side opening to fix the transmission rod and prevent air leakage.

[0008] Preferably, the proximal end of the suction catheter is provided with a sealing ring, the outer diameter of which is larger than the inner diameter of the delivery catheter, and the sealing ring is disposed inside the tee connector.

[0009] Preferably, the sealing ring is a solid elastomer.

[0010] Preferably, the distal end of the aspiration catheter is provided with an expandable tip, which can be retracted into the delivery catheter when moved proximally, and can be released from the delivery catheter and expanded to fit tightly against the blood vessel wall when moved distally.

[0011] Preferably, when the sealing ring is moved to its farthest end, the expandable end is completely detached from the delivery conduit.

[0012] Preferably, the expandable head end is a self-expanding or assisted expansion structure.

[0013] Preferably, when the expandable head end is a self-expanding structure, it is made of shape memory or elastic material, and a coating is provided on the outside of the expandable head end.

[0014] Preferably, both the delivery conduit and the suction conduit are flexible and supportive, used for positional delivery and suction; the inner diameter of the suction conduit is 0.5-5 mm.

[0015] Preferably, the device further includes a developing component located at one or more locations on the distal end of the delivery conduit, the distal end of the suction conduit, the expandable end, or the sealing ring.

[0016] Compared with the prior art, the beneficial effects of the thrombus removal device provided by the present invention are as follows:

[0017] 1. The aspiration device is connected to one side of the three-way connector, the thrombectomy device is connected to the other side, and the transmission rod of the thrombectomy device is controlled by the other side. The three-way connector completes the control of the movement of the thrombectomy device and the aspiration function. The structure is simple.

[0018] 2. The suction tubing and delivery tubing are connected by a mechanical structure with a three-way connector. The distal end of the suction tubing is also connected to an expandable end, which significantly increases the stability and operability of the structure while maintaining the advantages of large-diameter suction.

[0019] 3. The tee connector makes installation of the larger diameter delivery conduit easier, and it allows for switching to the smaller diameter suction conduit during negative pressure or vacuum operations, resulting in better suction. A sealing ring is used to switch between suction pipes and ensures a seal during negative pressure or vacuum operations.

[0020] 4. The proximal end of the suction catheter is located within the tee connector. Movement proximally is restricted by the tee connector, while movement distally is blocked by the delivery catheter. This restricted movement of the suction catheter within the delivery catheter's cavity ensures more precise release and prevents a decrease in accuracy due to excessively long release distances.

[0021] The features and advantages of the present invention will be described in detail through embodiments and in conjunction with the accompanying drawings. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the delivery state of a thrombectomy device according to an embodiment of the present invention.

[0023] Figure 2 This is a schematic diagram of the aspiration state of a thrombus removal device according to an embodiment of the present invention.

[0024] Figure 3 This is a schematic diagram of the gas connection inside the tube in the delivery state of a thrombectomy device according to an embodiment of the present invention.

[0025] Figure 4 This is a schematic diagram of the gas connection inside the tube in the suction state of a thrombus removal device according to an embodiment of the present invention.

[0026] Figure 5 This is a schematic diagram of the blood clot aspiration state of a blood clot removal device according to an embodiment of the present invention.

[0027] in:

[0028] 1-Delivery conduit; 2-Suction conduit; 21-Sealing ring; 22-Expandable end; 3-T-connector; 31-Side port A; 32-Side port B; 33-Side port C; 4-Transfer rod. Implementation

[0029] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. However, it should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of the invention. Furthermore, descriptions of well-known structures and technologies are omitted in the following description to avoid unnecessarily obscuring the concept of the invention.

[0030] In the description of this invention, it should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to or indirectly connected to the other element.

[0031] In the description of this invention, it should be noted that the terms "center," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "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 invention is in use. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element 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 the invention. Furthermore, the terms "first," "second," and "third," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified. "Several" means one or more, unless otherwise explicitly specified.

[0032] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0033] Embodiments of this disclosure will now be described in detail with reference to the accompanying drawings. As used herein, the term "clinician" refers to a physician, surgeon, nurse, or any other care provider, and may include assistants. The term "proximal" will refer to the portion of the device or its components closer to the clinician, and the term "distal" will refer to the portion of the device or its components further away from the clinician.

[0034] See Figure 1 This invention provides a thrombectomy device, including a delivery catheter 1 and an aspiration catheter 2 disposed within the delivery catheter 1. The proximal end of the delivery catheter 1 is connected to the A-side port 31 of a three-way connector 3, and the proximal end of the aspiration catheter 2 is movable within the three-way connector 3. A transmission rod 4 for controlling its movement is connected to the proximal end of the aspiration catheter 2, the transmission rod 4 extending from the B-side port 32, and the C-side port 33 of the three-way connector 3 is connected to the aspiration device. By adding the three-way connector 3, a mechanical connection between the aspiration catheter 2 and the delivery catheter 1 is achieved, and the transmission rod 4 at the B-side port enables control of the movement of the aspiration catheter 2, thereby solving the problem of the complex operation of a dual-catheter structure being unfavorable for clinical use.

[0035] See Figure 1 and Figure 2 In an optional embodiment, a sealing locking device is provided at the B-side opening 32 to fix the transmission rod 4 and prevent air leakage. Figure 1 The structure is designed to open the sealing locking device. Figure 2 This is a structure for locking with a sealing mechanism. During locking, side port 32 is sealed, preventing air circulation between the inside and outside of side port 32, thus ensuring better suction performance. The sealing mechanism can be any sealing structure, such as a valve switch structure.

[0036] See Figure 1 and Figure 2 In an optional embodiment, a sealing ring 21 is provided at the proximal end of the suction conduit 2. The outer diameter of the sealing ring 21 is larger than the inner diameter of the delivery conduit 1, and the sealing ring 21 is disposed within the tee connector 3. The tee connector 3 facilitates the installation of the larger-diameter delivery conduit 1, and allows for better suction by switching to the smaller-diameter suction conduit 2 during negative pressure or vacuum extraction. The sealing ring 21 enables the switching of the suction conduit and provides a seal during negative pressure or vacuum extraction. Figure 3 This is the state where the expandable end is not fully extended from the delivery conduit 1, and the sealing ring 21 does not seal the gap between the delivery conduit 1 and the suction conduit 2. At this time, the air is connected everywhere (as shown by the arrow), and the air pressure is equal. Figure 4 The expandable tip is fully extended out of the delivery catheter 1. The sealing ring 21 seals the gap between the delivery catheter 1 and the aspiration catheter 2. At this time, the blood vessel → aspiration catheter → three-way connector C side is the only cavity (connected as shown by the arrow). The aspiration device at C can create a vacuum or negative pressure state at the three-way connector 3.

[0037] In an optional embodiment, the sealing ring 21 is a solid elastomer, which provides a better sealing effect.

[0038] See Figure 1 and Figure 2 In an optional embodiment, the distal end of the aspiration catheter 2 is provided with an expandable tip 22. The expandable tip 22 can be moved proximally and retracted within the delivery catheter 1 for convenient delivery. Moving the expandable tip 22 distally allows it to be released from the delivery catheter 1 and expanded to fit snugly against the blood vessel wall, increasing the contact area, blocking blood flow, and improving thrombus aspiration while reducing blood loss. Furthermore, repeated contraction and release facilitate finding the most suitable aspiration position for optimal aspiration results.

[0039] See Figure 2In an optional embodiment, when the sealing ring 21 is moved to its furthest end, the dilatant end 22 is completely detached from the delivery catheter 1. The dilatant end 22 can better expand and adhere to the blood vessel wall, blocking blood flow within the blood vessel.

[0040] In an optional embodiment, the expandable head end 22 is a self-expanding or assisted expansion structure.

[0041] In an optional embodiment, when the dilatant tip 22 is a self-expanding structure, it is made of shape memory or elastic material, and a membrane is provided on the outer side of the dilatant tip 22. Preferably, the membrane is made of an elastic material over a metal skeleton. After the dilatant tip 22 is fully released, it adheres tightly to the blood vessel wall, preventing blood flow on both sides of the dilatant tip 22 within the blood vessel, facilitating thrombus removal and reducing blood loss.

[0042] In an optional embodiment, both the delivery conduit 1 and the aspiration conduit 2 are flexible and supportive for positional delivery and aspiration. The inner diameter of the aspiration conduit 2 is 0.5-5 mm.

[0043] In an optional embodiment, a developing component is further included, located at one or more locations on the distal end of the delivery conduit 1, the distal end of the suction conduit 2, the expandable end 22, or the sealing ring 21. The developing component tracks the release position, improving release accuracy.

[0044] Specific work process:

[0045] The clinician first inserts a microcatheter along a blood vessel into the appropriate location within the body. Then, the aspiration catheter 2 is advanced to the corresponding location along with the delivery catheter 1. The proximal end of the delivery catheter 1 is connected to a three-way connector 3, and the proximal end of the aspiration catheter 2 is within the three-way connector 3. A delivery rod 4, extending from the three-way connector 3, is attached to the proximal end of the aspiration catheter 2 for controlling its movement. The three-way connector 3 is located outside the body. Alternatively, the three-way connector 3 and the delivery catheter 1 can be integrated, allowing both catheters to be inserted together into the appropriate location within the body.

[0046] When delivering the delivery catheter 1 and the suction catheter 2, in Figure 3 The pressure in all parts is equal, facilitating delivery. The delivery position is monitored by a imaging component, and delivery is stopped when the device is close to the thrombus.

[0047] When releasing the dilatation tip 22, keep the delivery catheter 1 stationary and push the delivery rod 4 distally until the sealing ring 21 abuts against the gap between the delivery catheter 1 and the aspiration catheter 2. At this point, the dilatation tip 22 is fully released and adheres tightly to the blood vessel wall. Figure 4The transfer rod 4 is secured and sealed via the sealing locking device at side port 32. A suction device (which can be a pump or syringe) at side port 33 is used to reduce the pressure inside the tee connector 3 to less than the pressure on the thrombus side. At this time, the air connection within the lumen is as follows: Figure 4 .

[0048] During the release of the expandable end 22, the delivery rod 4 can be kept stationary while the delivery conduit 1 is moved proximally. The subsequent process is the same as pushing the delivery rod 4 distally. Both methods can determine the specific suction position by repeatedly retracting the expandable end 22.

[0049] like Figure 5 As shown, after the dilatation tip 22 is released, the thrombus is close to the blood vessel. The dilatation tip 22 blocks the blood flow on both sides of the blood vessel. The suction device at the C-side port 33 of the three-way connector 3 draws the thrombus into the suction catheter 2. The inner diameter of the suction catheter 2 is preferably 2mm to facilitate the suction of the thrombus.

[0050] After the suction is completed, release the suction device, open the B side port 32, retract the transmission rod 4 or move the delivery tube 1 forward, retract the expandable head end 22 into the delivery tube 1, and remove the device from the body to complete the entire suction process.

[0051] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions or improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A thrombectomy device, comprising a delivery catheter (1) and an aspiration catheter (2) disposed within the delivery catheter (1); characterized in that: The proximal end of the delivery conduit (1) is connected to the A side port (31) of the three-way connector (3), and the proximal end of the suction conduit (2) can move within the three-way connector (3); the proximal end of the suction conduit (2) is connected to a transmission rod (4) for controlling its movement, the transmission rod (4) extends out from the B side port (32), and the C side port (33) of the three-way connector (3) is connected to the suction device; A sealing locking device is provided at the B side opening (32) to fix the transmission rod (4) and prevent air leakage; The distal end of the aspiration catheter (2) is provided with an expandable tip (22). The expandable tip (22) can be retracted into the delivery catheter (1) when it moves proximally, and can be released from the delivery catheter (1) and expanded to fit tightly against the blood vessel wall when it moves distally. The proximal end of the suction catheter (2) is provided with a sealing ring (21), the outer diameter of the sealing ring (21) is larger than the inner diameter of the delivery catheter (1), and the sealing ring (21) is located inside the tee connector (3); when the sealing ring (21) moves to the farthest end, the expandable end (22) is completely detached from the delivery catheter (1).

2. The thrombus removal device as described in claim 1, characterized in that: The sealing ring (21) is a solid elastomer.

3. The thrombus removal device as described in claim 1, characterized in that: The expandable head end (22) is a self-expanding or assisted expansion structure.

4. The thrombectomy device as described in claim 3, characterized in that: When the expandable head end (22) is a self-expanding structure, it is made of shape memory or elastic material, and a film is provided on the outside of the expandable head end (22).

5. The thrombus removal device as described in claim 1, characterized in that: Both the delivery conduit (1) and the suction conduit (2) are flexible and supportive, and are used for positional delivery and suction; the inner diameter of the suction conduit (2) is 0.5-5 mm.

6. The thrombectomy device as described in claim 1, characterized in that: It also includes a developing component located at one or more of the distal ends of the delivery conduit (1), the distal ends of the suction conduit (2), the expandable end (22), or the sealing ring (21).

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