Carotid bypass shunt with distal embolic protector

Abstract

This invention belongs to the field of medical device technology, specifically a carotid artery bypass catheter with a distal embolization protector. Addressing the problems of high risk of cerebral infarction due to plaque detachment during existing carotid endarterectomy procedures, as well as the cumbersome nature of current composite surgical procedures and reliance on specialized operating room conditions, this invention proposes the following solution: It includes a bypass catheter body and a distal embolization protection mechanism, connected together; it also includes a proximal end and a distal end. By integrating blood bypass and distal embolization protection functions into one unit, this invention allows surgeons to perform the procedure independently in a regular operating room without relying on a composite operating room. While establishing intraoperative blood bypass, it effectively intercepts potentially detached plaques or thrombi, significantly reducing the risk of postoperative acute cerebral infarction, decreasing disability and mortality rates, and simplifying the surgical procedure while shortening anesthesia and surgical time.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a carotid artery bypass tube with a distal embolization protector. Background Technology

[0002] Carotid endarterectomy (CEA) is an effective treatment for carotid artery stenosis and a preventative measure against ischemic stroke. The greatest risk of this procedure is that the manipulation during the procedure may cause carotid plaque or thrombus to detach. These detached pieces can travel into the brain via the bloodstream, potentially triggering an acute ischemic stroke and leading to serious complications such as hemiplegia, aphasia, or even death. Currently, routinely used carotid bypass devices only provide temporary intraoperative blood flow pathways to ensure blood supply to distal brain tissue; they do not possess the structural ability to intercept or capture detached plaques or thrombi. To prevent plaque detachment during surgery, existing techniques require an interventional procedure in a hybrid operating room to insert a distal embolization protector (commonly known as a "protective umbrella"), followed by carotid endarterectomy, with the protector removed before the end of the procedure. This cumbersome process significantly prolongs anesthesia and surgical time, increasing surgical risks and medical costs. Furthermore, most hospitals in my country lack hybrid operating rooms capable of simultaneously performing interventional and open surgeries, limiting the widespread application of this safety strategy.

[0003] In existing technologies, carotid endarterectomy carries a high risk of cerebral infarction due to plaque detachment, and the current composite surgical procedures are cumbersome and dependent on special operating room conditions. To address these issues, we propose a carotid bypass tube with a distal embolization protector. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies, such as the high risk of cerebral infarction due to plaque detachment during carotid endarterectomy, the cumbersome nature of existing composite surgical procedures, and the reliance on special operating room conditions. Therefore, this invention proposes a carotid bypass tube with a distal embolization protector.

[0005] The carotid artery bypass catheter with distal embolization protector provided in this application adopts the following technical solution: A carotid artery bypass catheter with a distal embolization protector includes a bypass catheter body and a distal embolization protection mechanism, wherein the bypass catheter body and the distal embolization protection mechanism are connected; further comprising: The proximal and distal ends are connected to the two ends of the bypass tube body, respectively. The proximal and distal ends are used for insertion into the proximal and distal sides of the carotid artery, respectively. The distal embolization protection mechanism includes a filter-type protective umbrella, which is set inside the distal end. The filter-type protective umbrella is used to intercept plaques that detach from the surgical area and move toward the distal end.

[0006] Furthermore, the distal embolism protection mechanism also includes a delivery conduit and a guidewire, with the filter-type protective umbrella housed within the delivery conduit and the guidewire connected to the filter-type protective umbrella.

[0007] Furthermore, the outer wall of the delivery conduit is provided with a depth scale, which is used to quantitatively indicate the insertion depth.

[0008] Furthermore, the filter-type protective umbrella is provided with two positioning markers, which are used for development under X-ray fluoroscopy.

[0009] Furthermore, the body of the diversion tube is provided with a guide channel for guiding the guide wire through.

[0010] Furthermore, the distal embolism protection mechanism is inserted before the diversion tube body and its filter-type protective umbrella is deployed, with the distal end of the diversion tube body located on the proximal side of the filter-type protective umbrella after insertion.

[0011] Furthermore, the filter-type protective umbrella is composed of a shape memory alloy frame for interventional surgery and a polymer filter membrane, and its maximum outer diameter after unfolding matches the inner diameter of the target carotid artery.

[0012] Furthermore, the distal embolization protection mechanism also includes a retrieval catheter, which is slidably sleeved on the outside of the guidewire and is used to push distally after the operation to wrap around and retract the filter-type protective umbrella.

[0013] In summary, this application includes at least one of the following beneficial technical effects: 1. This approach, by adding an embolization protector to the distal end of the bypass tube, can effectively intercept small plaques or thrombi that may detach during key steps of carotid endarterectomy (such as incision, dissection, and suturing), directly reducing the risk of postoperative acute cerebral infarction and decreasing disability and mortality rates. 2. This solution integrates the functions of blood diversion and remote protection into a convenient combination component, eliminating the need for interventional surgery in a hybrid operating room followed by open surgery. It can be performed independently by a surgeon in a regular operating room, significantly shortening anesthesia and surgical time. 3. This solution establishes protection at the same time as the transfer, covering the entire high-risk operation phase, providing operators with a safer operating environment, and facilitating the wider and safer implementation of CEA procedures.

[0014] This invention integrates blood diversion and distal embolization protection into one unit, allowing surgeons to perform the procedure independently in a regular operating room without relying on a hybrid operating room. While establishing intraoperative blood diversion, it effectively intercepts plaques or thrombi that may detach, significantly reducing the risk of postoperative acute cerebral infarction, decreasing disability and mortality rates, and simplifying the surgical procedure while shortening anesthesia and surgical time. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the main structure of a carotid artery bypass tube with a distal embolization protector proposed in this invention; Figure 2 This is a schematic diagram of the distal embolization protection mechanism of a carotid artery bypass tube with a distal embolization protector proposed in this invention.

[0016] Reference numerals: 1. Transfer tube body; 2. Distal embolization protection mechanism; 3. Distal end; 4. Proximal end; 5. Delivery tube; 6. Depth scale; 7. Guide wire; 8. Positioning marker; 9. Filter-type protective umbrella; 10. Recovery tube. Detailed Implementation

[0017] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0018] Example Reference Figure 1 and Figure 2 A carotid artery bypass catheter with a distal embolization protector includes a bypass catheter body 1 and a distal embolization protector 2, the bypass catheter body 1 and the distal embolization protector 2 being connected; it also includes: The proximal end 2 and the distal end 3 are respectively connected to the two ends of the bypass tube body 1. The proximal end 2 and the distal end 3 are respectively used to insert into the proximal and distal sides of the carotid artery. The distal embolization protection mechanism 2 includes a filter-type protective umbrella 9, which is disposed in the distal end 12. The filter-type protective umbrella 9 is used to intercept plaques that detach from the surgical area and move toward the distal end.

[0019] In this embodiment, the distal embolization protection mechanism 2 further includes a delivery conduit 5 and a guidewire 7. A filter-type protective umbrella 9 is housed within the delivery conduit 5. The guidewire 7 is connected to the filter-type protective umbrella 9. A depth scale 6 is provided on the outer wall of the delivery conduit 5. The depth scale 6 is used to quantitatively indicate the insertion depth. Two positioning markers 8 are provided on the filter-type protective umbrella 9. The positioning markers 8 are used for imaging under X-ray fluoroscopy. A guide channel is provided inside the diverter tube body 1. The guide channel is used to guide the guidewire 7 through. A guidewire retainer is provided on the side of the guide channel to maintain its position. With a relatively fixed displacement, the distal embolization protection mechanism 2 is inserted and unfolds its filter-type protective umbrella 9 before the bypass tube body 1. The distal end 3 of the bypass tube body 1 is located on the proximal side of the filter-type protective umbrella 9 after insertion. The filter-type protective umbrella 9 is composed of a memory alloy frame for interventional surgery and a polymer filter membrane. Its maximum outer diameter after unfolding matches the inner diameter of the target carotid artery. The distal embolization protection mechanism 2 also includes a retrieval catheter 10, which is slidably sleeved on the outside of the guidewire 7 and is used to push distally after the operation to wrap and shrink the filter-type protective umbrella 9.

[0020] The implementation principle in this embodiment is as follows: During use, following standard carotid endarterectomy (CEA) requirements, the skin, subcutaneous tissue, and carotid sheath are incised layer by layer to fully expose the target carotid artery. Blood flow to the proximal and distal ends of the carotid artery is temporarily blocked. A suitable puncture point is selected on the distal (intracranial) side of the carotid artery, and guidewire 7 is introduced. The delivery catheter 5 in the distal embolization protection mechanism 2 is pushed along guidewire 7 to the predetermined depth. At this time, the filter-type protective umbrella 9 is in a retracted state and completely housed inside the delivery catheter 5. Under X-ray fluoroscopy, by observing the depth scale 6 on the outer wall of the delivery catheter 5 and the two positioning markers 8 on the filter-type protective umbrella 9, the device's arrival at the target position (e.g., level with the second or first cervical vertebra) is accurately determined, and the position is confirmed to be free of obstructions. After the initial procedure, the guidewire 7 is fixed and the delivery catheter 5 is withdrawn. The filter-type protective umbrella 9 automatically expands radially due to the elasticity of its shape memory alloy frame, adhering to the inner wall of the distal side 3 of the carotid artery to form an interception barrier. The guide channel inside the bypass tube body 1 is slowly pushed along the guidewire 7. The proximal end 4 of the bypass tube body 1 is placed into the proximal side of the carotid artery, and its distal end 3 is placed into the distal side of the carotid artery, ensuring that the distal end 3 is located on the proximal side of the expanded filter-type protective umbrella 9 (i.e., upstream of the protective umbrella). The carotid artery occlusion is released, and blood flows from the proximal end 4 to the distal end 3 through the bypass tube body 1, establishing a temporary blood flow pathway to ensure perfusion of the distal brain tissue. With the bypass tube body 1 effectively maintaining the distal blood supply, the surgeon can safely cut the carotid artery, completely dissect and remove the catheter. Plaques, any tiny plaque fragments or thrombi within the arterial lumen, if dislodged during the procedure, will move towards the distal end 3 with the blood flow direction and be captured by the deployed filter-like protective umbrella 9, thus preventing them from entering the cranium and causing cerebral infarction. After completing carotid endarterectomy and vascular suturing, the bypass tube body 1 is first withdrawn. Then, the retrieval catheter 10 in the distal embolization protection mechanism 2 is pushed distally along the guidewire 7. When the tip of the retrieval catheter 10 completely covers the filter-like protective umbrella 9, the umbrella is forced to contract radially and is drawn into the retrieval catheter 10, simultaneously encapsulating the captured plaques or thrombi. Finally, the guidewire 7, the retrieval catheter 10, and the filter-like protective umbrella 9 contained within it are withdrawn from the body together. Hemostasis is achieved by compression or suturing the puncture site. In actual operation, the guidewire 7, the retrieval catheter 10, and the filter-like protective umbrella 9 are withdrawn together. The proximal end of guidewire 7 always extends outside the patient's body and is reliably fixed using conventional interventional techniques to prevent accidental slippage into the blood vessel during the procedure and the risk of migration. The specific steps are as follows: After the filter-type protective umbrella 9 is fully deployed within the distal side 3 of the carotid artery, the proximal end of guidewire 7 is led out from the guiding channel on the proximal end 4 side of the bypass tube body 1 and passes through the skin puncture point or surgical incision. At this time, the operator uses a catheter fixator with a sealing valve to clamp guidewire 7 to ensure that it is tension-free and does not shift. The proximal port of the guiding channel can be pre-fabricated with an elastic sealing membrane (such as silicone material). This sealing membrane can maintain smooth sliding when the guidewire passes through and effectively prevent blood from leaking out along the guiding channel. After the bypass tube body 1 is inserted and a blood bypass pathway is established, guidewire 7 remains in the guiding channel.Its proximal end remains fixed externally throughout the procedure. Because the guiding channel and the main blood flow channel of the bypass tube are isolated from each other, the presence of the guidewire does not interfere with blood flow or induce thrombosis. Thus, stable intraoperative blood flow is achieved throughout the procedure, and the distal embolization protection mechanism 2 effectively intercepts detached plaques, significantly reducing the risk of postoperative cerebral infarction. Furthermore, the entire procedure does not require reliance on a hybrid operating room.

[0021] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A carotid artery bypass tube with a distal embolization protector, comprising a bypass tube body (1) and a distal embolization protection mechanism (2), characterized in that: The shunt tube body (1) is connected to the distal embolization protection mechanism (2); it also includes: The proximal end (2) and the distal end (3) are respectively connected to the two ends of the bypass tube body (1). The proximal end (2) and the distal end (3) are respectively used to insert the proximal side and the distal side of the carotid artery. The distal embolization protection mechanism (2) includes a filter-type protective umbrella (9). The filter-type protective umbrella (9) is set in the distal end (12). The filter-type protective umbrella (9) is used to intercept plaques that fall off from the surgical area and move toward the distal end.

2. The carotid artery bypass catheter with distal embolization protector according to claim 1, characterized in that: The distal embolism protection mechanism (2) also includes a delivery conduit (5) and a guide wire (7). The filter-type protective umbrella (9) is housed in the delivery conduit (5), and the guide wire (7) is connected to the filter-type protective umbrella (9).

3. A carotid artery bypass catheter with distal embolization protection device according to claim 2, characterized in that: The outer wall of the delivery conduit (5) is provided with a depth scale (6), which is used to quantitatively indicate the insertion depth.

4. A carotid artery bypass catheter with distal embolization protection device according to claim 3, characterized in that: The filter-type protective umbrella (9) is provided with two positioning markers (8), which are used for development under X-ray fluoroscopy.

5. A carotid artery bypass catheter with distal embolization protection device according to claim 4, characterized in that: The main body (1) of the diverter tube is provided with a guide channel, which is used to guide the guide wire (7) through.

6. A carotid artery bypass catheter with distal embolization protection according to claim 5, characterized in that: The distal embolism protection mechanism (2) is inserted into and unfolds its filter-type protective umbrella (9) before the diversion tube body (1), and the distal end (3) of the diversion tube body (1) is located on the proximal side of the filter-type protective umbrella (9) after insertion.

7. A carotid artery bypass catheter with distal embolization protection device according to claim 6, characterized in that: The filter-type protective umbrella (9) is composed of a memory alloy frame for interventional surgery and a polymer filter membrane, and its maximum outer diameter after unfolding matches the inner diameter of the target carotid artery.

8. A carotid artery bypass catheter with distal embolization protection device according to claim 7, characterized in that: The distal embolization protection mechanism (2) also includes a retrieval catheter (10), which is slidably sleeved on the outside of the guidewire (7) and is used to push distally after the operation to wrap and shrink the filter-type protective umbrella (9).

Images