Reverse wire umbrella guide capture device for cto-pci

Abstract

This invention discloses a CTO-PCI reverse guidewire umbrella-shaped guide and capture device, including a delivery sheath, an umbrella-shaped guide mechanism, and a capture tool assembly. The capture tool assembly includes a capture device inner shaft passing through the inner lumen of the delivery sheath and a capture head located at the front end of the capture device inner shaft. The capture head is operably switchable between an open state and a retracted state to capture the reverse guidewire. The umbrella-shaped guide mechanism is located at the front end of the delivery sheath and has a contracted state and an expanded state: in the contracted state, it is housed within the delivery sheath; in the expanded state, it expands in front of the delivery sheath to form a trumpet-shaped umbrella structure. The capture head can be pushed forward from the inner lumen of the umbrella-shaped guide mechanism to the central capture area of ​​the umbrella structure. The umbrella structure gathers and guides the drifting reverse guidewire, causing it to move towards the capture area of ​​the capture head. This invention effectively solves the shortcomings of existing technologies, such as inaccurate target capture, cumbersome operation, poor adaptability, and high risk of vascular injury.

Description

Technical Field

[0001] This invention relates to the field of CTO-PCI retrograde interventional therapy, and more particularly to a CTO-PCI retrograde guidewire umbrella-shaped guide and capture device. Background Technology

[0002] Chronic total coronary artery occlusion (CTO) refers to the complete occlusion of the coronary artery lumen caused by pathological factors such as atherosclerotic plaque proliferation, fibrous connective tissue proliferation, and calcification, with the occlusion lasting for more than 3 months. Currently, percutaneous coronary intervention (PCI) is the main treatment for CTO lesions. However, due to the complete occlusion of the lesion segment, the hardened fibrous cap, and the severe calcification, as well as the concealed anatomical conditions of the distal vessels, the success rate of conventional antegrade interventional techniques (i.e., advancing the guidewire from the proximal end of the CTO lesion to the distal end to open the occluded segment) is low, only 40%-60%, which is insufficient to meet clinical treatment needs.

[0003] To address the aforementioned technical challenges, retrograde interventional techniques have emerged. Its core principle involves using the patient's own coronary collateral circulation (such as ventricular septal branches and epicardial collateral vessels) to retrogradely penetrate the occluded segment from the distal end of the lesion. This guidewire is then precisely aligned with the guiding catheter to establish a patent-retrograde pathway for coronary intervention, enabling subsequent procedures such as balloon angioplasty and stent implantation. This technique has become a core method for opening complex CTO lesions, increasing the success rate of CTO-PCI to over 80%, and is particularly suitable for complex CTO lesions after failed antegrade intervention.

[0004] In retrograde interventional procedures, the precise docking of the retrograde guidewire with the guiding catheter after successful penetration of the CTO lesion is a crucial step for the entire procedure's success. The accuracy and efficiency of docking directly determine the success or failure of the procedure and the risk of patient complications. However, in clinical practice, after the retrograde guidewire penetrates the CTO lesion, it is often difficult to accurately enter the lumen of the guiding catheter due to problems such as guidewire tip drift, poor coaxiality of the guiding catheter, and tortuous collateral vessels. Traditional guidewire capture instruments are all blindly captured during the procedure under the guidance of coronary angiography, which has drawbacks such as large capture site deviation, low capture success rate, long repeated capture time, easy damage to the coronary intima, cumbersome operation, and extremely high requirements for the operator's experience and technical level. The critical step of externally withdrawing the retrograde guidewire alone can take several hours, resulting in low surgical efficiency, high complication rate, and seriously affecting the success rate of opening CTO lesions.

[0005] Application No. 201811132125.4 discloses a guidewire capture device, comprising: a mandrel (1), and a mesh capture mechanism (2) fixedly connected to the mandrel (1), wherein the mesh capture mechanism (2) can expand into a mesh or stretch into a strip. The guidewire capture device provided in this application can assist in the reverse guidewire entering the antegrade guiding catheter, shortening the operation time, reducing radiation exposure time and contrast agent dosage; simultaneously, it can reduce the risk of instrument damage and the use of other instruments, thereby improving the success rate of the operation.

[0006] The invention with application number 201811132125.4 relies solely on a single-point blind probe to capture the retrograde guidewire at a distal capture head, without a pre-guided convergence structure. The retrograde guidewire is prone to drifting away from the capture area during the procedure, and can only be repeatedly probed and captured under angiography. The capture success rate is low, the operation is time-consuming, and repeated instrument entry and exit can easily scratch the coronary intima. Moreover, the capture tool is of a single type and cannot be adapted to retrograde guidewires of different thicknesses and shapes and tortuous coronary anatomy. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to provide a CTO-PCI reverse guide wire umbrella-shaped guide capture device with high success rate of reverse guide wire capture and low risk of vascular damage.

[0008] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is a CTO-PCI reverse guide wire umbrella-shaped guiding and capturing device, including a delivery sheath, a retractable umbrella-shaped guiding mechanism, and a capturing tool assembly. The capturing tool assembly includes a capture inner shaft passing through the inner cavity of the delivery sheath and a capturing head located at the front end of the capture inner shaft. The capturing head is operably switchable between an open state and a retracted state to capture the reverse guide wire. The umbrella-shaped guiding mechanism has a retracted state and an extended state: in the retracted state, it is housed within the delivery sheath; in the extended state, it unfolds in front of the delivery sheath to form a trumpet-shaped umbrella structure. The capturing head can be axially pushed forward from the inner cavity of the umbrella-shaped guiding mechanism to the central capturing area of ​​the umbrella structure. The umbrella structure is used to gather and guide the drifting reverse guide wire, causing it to move towards the capturing area of ​​the capturing head.

[0009] The above-described guiding and capturing device includes an axially hollow tube passing through the inner cavity of the delivery sheath. The capturing tool assembly includes a capture outer tube, which passes through the inner cavity of the axially hollow tube, and the capture inner shaft passes through the inner cavity of the capture outer tube. The capturing head switches between an open state and a retracted state by relative axial sliding between the capture inner shaft and the capture outer tube. The umbrella-shaped guiding mechanism is connected to the front end of the axially hollow tube. By driving the axially hollow tube to move axially, the umbrella-shaped guiding mechanism is controlled to switch between a retracted state and an expanded state.

[0010] The above-described guiding and capturing device includes a control mechanism; the control mechanism includes: The handle base, the rear end of the delivery sheath is fixed to the handle base; The umbrella control knob is rotatably mounted on the handle base and is connected to the rear end of the axial hollow tube. Rotating the umbrella control knob can drive the axial hollow tube to move axially. An outer tube control assembly, connected to the rear end of the catcher outer tube, is used to drive the catcher outer tube to slide axially; The push-pull ring is fixedly connected to the rear end of the inner shaft of the catcher.

[0011] The above-described guiding and capturing device has a fixed finger ring on the handle base, and a limit-fitting return spring between the fixed finger ring and the push-pull finger ring. The return spring is fitted on the outside of the inner shaft of the capture device. The push-pull finger ring can be operated to compress the return spring and drive the inner shaft of the capture device to move forward. After the external force is removed, the return spring rebounds and drives the push-pull finger ring and the inner shaft of the capture device to move backward and reset.

[0012] The above-described guiding and capturing device, after the capturing head captures and locks the reverse guide wire, pulls the reverse guide wire into the delivery sheath by retracting the inner shaft of the capture device, and simultaneously pushes the reverse guide wire at the reverse operation end, using a push-pull combination method to complete the external extraction of the reverse guide wire.

[0013] In the process of retracting the inner shaft of the capture device described above, the reset spring releases elastic potential energy, causing the capture head to return to its retracted state, clamping the reverse guide wire, and forming a dynamic balance with the thrust of the reverse operation end pushing the reverse guide wire.

[0014] The aforementioned guiding and capturing device includes an umbrella-shaped guiding mechanism comprising an elastic support frame made of shape memory alloy and a medical polymer film covering the outside of the frame. The front end of the support frame has a rounded, blunt structure. When the umbrella-shaped guiding mechanism is unfolded, it forms a trumpet-shaped umbrella structure. The unfolded diameter of the umbrella structure continuously changes within a preset range as the umbrella-shaped guiding mechanism is displaced axially relative to the delivery sheath. The surface of the polymer film is coated with a hydrophilic coating. The delivery sheath is a thin-walled medical polymer tube with hydrophilic coatings on both its inner and outer walls. The front end undergoes a rounded, blunt, soft transition treatment, and a metal imaging ring is located near the front end.

[0015] The above-described guiding and capturing device has a capture head that is detachably connected to the front end of the inner shaft of the capture device. The device is equipped with a variety of capture heads for selection and use according to the surgical scenario. The capture heads that can be selected and used include a hollow three-dimensional multi-hole capture head, a claw-type capture head, or a snare-type capture head.

[0016] The above-described guiding and capturing device includes a hollow three-dimensional multi-hole capture head made of shape memory alloy with hollow mesh and development marks at both the rear and front ends; a claw-type capture head with a two- or three-claw configuration and rounded anti-slip teeth at the claw ends; and a snare-type capture head woven from nickel-titanium alloy wire into a closed loop with an adjustable inner diameter.

[0017] The above-described guiding and capturing device is a single-cavity coaxial integrated structure; after the umbrella-shaped guiding mechanism and the capturing tool assembly are withdrawn, the inner cavity of the delivery sheath forms a continuous operating channel for directly delivering balloons or stent interventional devices.

[0018] This invention utilizes a retractable, trumpet-shaped umbrella structure at the front end to actively converge and drift the reverse guidewire, transforming the traditional blind single-point capture into area-guided fixed-point capture. This significantly improves the success rate of reverse guidewire capture and shortens the intraoperative capture time. When the umbrella structure retracts, it can also compress the guidewire tip to prevent slippage. In addition, the integrated instrument channel can replace traditional multiple types of catheters, which can reduce coronary intimal damage caused by repeated exploration, reduce surgical complications and radiation exposure for both doctors and patients, adapt to different blood vessels and guidewire conditions, and lower the operator's operating threshold. It effectively solves the shortcomings of existing technologies, such as inaccurate target capture, cumbersome operation, poor adaptability, and high risk of blood vessel damage. Attached Figure Description

[0019] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0020] Figure 1 This is a schematic diagram of the structure of the CTO-PCI reverse guide wire umbrella-shaped guide and capture device according to an embodiment of the present invention.

[0021] Figure 2 This is a schematic diagram of the delivery sheath structure according to an embodiment of the present invention.

[0022] Figure 3 This is a schematic diagram of the umbrella-shaped guide mechanism according to an embodiment of the present invention.

[0023] Figure 4 This is a schematic diagram of the umbrella-shaped guide mechanism in the open state according to an embodiment of the present invention.

[0024] Figure 5 This is a schematic diagram of the umbrella-shaped guide mechanism in its stowed state according to an embodiment of the present invention.

[0025] Figure 6 This is a front view of the control mechanism in an embodiment of the present invention.

[0026] Figure 7 This is a schematic diagram of the open state of the arc-shaped laser-engraved basket of the capture device according to an embodiment of the present invention.

[0027] Figure 8 This is an unfolded view of the arc-shaped laser-engraved basket of the capture device according to an embodiment of the present invention.

[0028] Figure 9 This is a schematic diagram of the open state of the rhomboid woven basket of the catcher according to an embodiment of the present invention.

[0029] Figure 10 This is a schematic diagram of the open state of the hollow three-dimensional multi-hole capture device according to an embodiment of the present invention.

[0030] Figure 11 This is a schematic diagram of the hollow three-dimensional multi-hole trap in the storage state according to an embodiment of the present invention.

[0031] Figure 12 This is a schematic diagram of the claw-type catcher in the open state according to an embodiment of the present invention.

[0032] Figure 13 This is a schematic diagram of the claw-type catcher in its stored state according to an embodiment of the present invention.

[0033] Figure 14 This is a schematic diagram of the snare-type catcher in the open state according to an embodiment of the present invention.

[0034] Figure 15 This is a schematic diagram of the snare-type catcher in the capture ring storage state according to an embodiment of the present invention.

[0035] Figure 16 This is a schematic diagram of the instrument delivery and positioning process in an embodiment of the present invention.

[0036] Figure 17 This is a schematic diagram of the deployment of the umbrella-shaped guide mechanism during the operation of an embodiment of the present invention.

[0037] Figure 18This is a schematic diagram illustrating the selection and placement of the capture mechanism during the operation process of an embodiment of the present invention.

[0038] Figure 19 This is a schematic diagram of the reverse guide wire advancing the umbrella-shaped surface during the operation process of an embodiment of the present invention.

[0039] Figure 20 This is a schematic diagram of the reverse guide wire entering the basket during the operation process of an embodiment of the present invention.

[0040] Figure 21 This is a schematic diagram of the reverse guide wire being captured during the operation process of an embodiment of the present invention.

[0041] Figure 22 This is a schematic diagram of the reverse guide wire being bent during the operation process of an embodiment of the present invention.

[0042] Figure 23 This is a schematic diagram of the reverse guide wire being pulled out during the operation process of an embodiment of the present invention.

[0043] Figure 24 This is a schematic diagram of the reverse guide wire being fully pulled out during the operation process of an embodiment of the present invention.

[0044] Figure 25 This is a schematic diagram of the reverse guidewire in vitro processing operation according to an embodiment of the present invention.

[0045] Explanation of reference numerals in the attached figures: 1-Delivery sheath, 11-Soft tip of delivery sheath, 12-Reconstructing ring; 2-Umbrella-shaped guiding mechanism, 21-Main tube (axial hollow tube), 22-Umbrella body, 221-Elastic memory alloy skeleton, 2211-Elastic memory alloy skeleton head end, 222-Medical polymer film; 3-Reverse guidewire; 4-Catcher outer tube; 5-Catcher, 5A-Catcher inner shaft, 5B-Catching head, 51-Hollowed three-dimensional multi-hole catcher head, 511-Catching basket, 512-Platinum-iridium alloy developing mark, 52-Claw type catcher head, 53-Catching collar; 6-Control mechanism, 61-Handle base, 62-Fixed finger ring, 63-Push-pull finger ring, 64-Reset spring; 7-Coronary artery, 71-Occluded segment of the lesion; 8-Forward guide wire. Detailed Implementation

[0046] This invention relates to the CTO-PCI retrograde guidewire umbrella-shaped guide and capture device, taking CTO-PCI retrograde interventional surgery, AGT active welcoming technology (adapted to the Antegrade Wire in a Retrograde Channel via Septal / AGT technique), and Guidezilla extension catheter clinical application scenarios as examples. All component numbers are as shown in the attached drawings.

[0047] like Figures 1 to 15 As shown, the CTO-PCI reverse guide wire umbrella-shaped capture device of this invention adopts a single-cavity coaxial integrated structure, including a control mechanism 6, a delivery sheath 1, a capture tool assembly, and a retractable umbrella-shaped guide mechanism 2. The capture tool assembly includes an inner shaft 5A of the capture device, a capture head 5B, and an outer tube 4 of the capture device. The umbrella-shaped guide mechanism 2 includes a main tube (axially hollow tube) 21 and an umbrella body 22. The main tube 21 passes through the inner cavity of the delivery sheath 1, the outer tube 4 of the capture device passes through the inner cavity of the main tube 21, and the inner shaft 5A of the capture device passes through the inner cavity of the outer tube 4 of the capture device. The rear ends of the delivery sheath 1, the main tube 21, the outer tube 4 of the capture device, and the inner shaft 5A of the capture device are respectively connected to the control mechanism 6. The capture head 5B is assembled at the front end of the inner shaft 5A of the capture device. The capture head 5B can switch between open and closed states by sliding axially in the inner cavity of the outer tube 4 of the capture device, relying on the inner shaft 5A of the capture device, so as to realize the reverse guide wire 3 capture.

[0048] The rear end of the umbrella-shaped guiding mechanism 2, the umbrella body 22, is fixed to the front end of the main tube 21. The umbrella body 22 has two working states: retracted and extended. In the retracted state, the umbrella body 22 is housed inside the delivery sheath 1. In the extended state, the umbrella body 22 extends out of the front end of the delivery sheath 1 and opens in front of the delivery sheath 1 to form a trumpet-shaped umbrella structure. The capture head 5B can extend forward through the inner cavity of the capture outer tube 4 and reach the central capture area of ​​the trumpet-shaped umbrella structure. The trumpet-shaped umbrella structure is used to gather and guide the drifting reverse guide wire 3 towards the capture area where the capture head 5B is located. During the process of the umbrella-shaped guiding mechanism 2 retracting into the delivery sheath 1, the umbrella body 22 clamps and limits the end of the reverse guide wire 3 and retracts into the delivery sheath 1.

[0049] In an embodiment of the present invention, the retractable umbrella-shaped guide mechanism 2 is located at the head end 1 of the inner cavity of the delivery sheath, and the umbrella-shaped structure can be expanded and contracted by axial pushing; the capture tool assembly can realize axial pushing, retraction and capture functions along the inner cavity of the umbrella-shaped guide mechanism 2, and the capture tool assembly includes a variety of capture methods to meet the needs of different surgical scenarios; through the coordinated cooperation of various components, the functions of convergence guidance, precise capture and rapid external extraction operation of the reverse guide wire 3 can be realized.

[0050] refer to Figure 6The control mechanism 6 includes a handle base 61, an umbrella control knob (not shown), an outer tube control assembly (not shown), and a push-pull ring 63. The rear end of the delivery sheath 1 is fixedly mounted on the handle base 61 and remains in a fixed position throughout. The rear end of the main tube 21 is connected to the umbrella control knob. Rotating the umbrella control knob can drive the main tube 21 to move axially along the inner cavity of the delivery sheath 1, thereby controlling the umbrella 22 to unfold or retract. The rear end of the catcher outer tube 4 is fixedly connected to the outer tube control assembly. The outer tube control assembly drives the catcher outer tube 4 to slide axially relative to the main tube 21, realizing the covering and retraction or loosening and release of the catcher head 5B. The rear end of the catcher inner shaft 5A is connected to the push-pull ring 63. A fixed ring 62 is integrally set on the handle base 61. A return spring 64 is fitted between the fixed ring 62 and the push-pull ring 63, and the return spring 64 is fitted on the outside of the catcher inner shaft 5A. Pressing the push-pull ring 63 forward compresses the return spring 64 and moves the inner shaft 5A of the capture device forward. After the external force is removed, the return spring 64 rebounds, driving the push-pull ring 63 and the inner shaft 5A of the capture device to return to their original position. The control mechanism 6 adopts an ergonomic design, with the main body made of non-slip medical rubber. The umbrella control knob, the outer tube control component, and the push-pull ring 63 are all equipped with scale markings and positioning buckles. Each control component has independent limit and its actions do not interfere with each other. It can realize the core functions of unfolding and retracting the umbrella-shaped guide mechanism, opening and locking the capture device, and axial advancement and retraction of the instrument. Each mechanism has scale markings and positioning buckles, which can realize precise control of the operation position.

[0051] refer to Figure 3 The umbrella-shaped guiding mechanism 2 comprises an elastic memory alloy skeleton 221 and a medical polymer film 222 covering the outside of the skeleton. When not unfolded, it conforms to the inner wall of the delivery sheath 1 in a retracted state. When unfolded, it forms a trumpet-shaped umbrella structure. The ends 2211 of the elastic memory alloy skeleton 221 are rounded and blunted. After the umbrella body 22 is opened, it makes flexible contact with the blood vessel wall. The diameter of the trumpet-shaped umbrella structure continuously changes within a preset range with the axial displacement of the umbrella-shaped guiding mechanism relative to the delivery sheath 1, achieving stepless adjustment to adapt to coronary vessels of different diameters and reduce the risk of vascular compression. The surface of the medical polymer film 222 is coated with a hydrophilic coating to prevent the reverse guide wire 3 from adhering to the umbrella surface.

[0052] The core function of the umbrella-shaped guide mechanism 2 is to gather and guide, confining the head of the free-drifting reverse guide wire 3 within the umbrella-shaped guide mechanism's coverage area, and guiding it to move towards the center point of the capture tool assembly. The umbrella-shaped guide mechanism 2 slides in conjunction with the inner cavity of the delivery sheath 1, and can be quickly deployed, retracted, and stored by operating the handle.

[0053] Reference Figure 2The delivery sheath 1 is a thin-walled medical polymer component with a super-slippery hydrophilic coating on both the inner and outer walls. The front end of the delivery sheath 1 is provided with a blunt arc-shaped soft end 11, which can reduce the frictional resistance of pushing and retracting the device in the coronary artery 7 and avoid damage to the coronary intima. The inner lumen of the sheath provides storage space for the umbrella surface of the retractable umbrella-shaped guide mechanism, and at the same time provides a precise axial delivery track for the guide mechanism.

[0054] A metal contrast ring 12 is fixedly placed near the tip of the delivery sheath 1, which enables precise instrument positioning under coronary angiography. The delivery sheath 1 can replace conventional guiding catheters and Guidezilla extension catheters to form an intraoperative access route. Subsequent stents and balloons can be directly delivered to the lesion site through the lumen of the delivery sheath 1 without the need to replace other interventional devices.

[0055] like Figures 7 to 15 As shown, the capture head 5B has a replaceable modular structure. Depending on the surgical conditions, the capture head 5B can be equipped with one of three types of capture heads: a hollowed-out three-dimensional multi-hole capture head 51, a claw-type capture head 52, or a snare-type capture head 53. These three types of capture heads 5B are independently packaged in a matching instrument box and can be disassembled and fixed to the front end of the inner shaft 5A of the capture device as needed before surgery. Among them, the hollowed-out three-dimensional multi-hole capture head 51 is the preferred tool, suitable for most CTO-PCI reverse guidewire capture scenarios.

[0056] like Figures 7 to 11 As shown, the hollowed-out three-dimensional porous capture head 51 is made of medical-grade elastic memory alloy with flexible connecting rods. The capture basket 511 is shaped by weaving or laser three-dimensional cutting, and the mesh can be either diamond-shaped or arc-shaped, forming a hollowed-out three-dimensional porous structure. When opened, it is C-shaped or cylindrical. Platinum-iridium alloy imaging targets 512 are fixed at both the proximal and distal ends of the hollowed-out three-dimensional porous capture head 51 for easy imaging positioning. All ends of the capture basket 511 are rounded. The porous structure allows the reverse guide wire 3 to enter the basket from any mesh opening, and the capture basket 511 can be closed and fixed to the reverse guide wire 3.

[0057] After the capture basket 511 is unfolded, the mesh size is moderate. The reverse guide wire 3 can enter through any mesh and be captured securely by closing the basket. At the same time, the porous structure can greatly increase the probability of the reverse guide wire 3 entering the mesh and improve the capture efficiency. The main tube 21 is a flexible and bendable structure, which is suitable for clinical operation scenarios involving tortuous coronary collateral vessels.

[0058] like Figure 12 and Figure 13 As shown, the claw-type capture head 52 can be divided into two configurations: two-claw and three-claw, and adopts a flexible medical alloy structure design. The end of the capture claw 521 is equipped with a rounded anti-slip tooth structure, which locks the coarse-gauge reverse guide wire 3 after closing, effectively preventing capture slippage. It is suitable for capturing coarse-diameter, straight / bent-end reverse guide wires 3, and has strong capture stability.

[0059] like Figure 14 and Figure 15 As shown, the snare-type capture head 53 is woven from super-elastic nickel-titanium alloy wire to form a closed-loop capture ring 531. The inner diameter of the ring can be adjusted by the control mechanism 6. The outer wall of the wire is smoothed to avoid scratching the guidewire and blood vessel. It is suitable for capturing reverse guidewires with small diameter, straight or bent ends. The flexible capture of the reverse guidewire is achieved by the contraction of the ring, reducing the risk of guidewire bending and breakage.

[0060] In the initial state, the umbrella-shaped guide mechanism 2 of the present invention is stored in the head end of the delivery sheath; each capture head 5B is independently packaged in the instrument kit packaging box, and the appropriate tool can be selected according to clinical needs before use. In the initial state, the basket, capture claw and collar are all closed; the handle of the control mechanism 6 is in the initial scale position to ensure precise control during operation.

[0061] The following is in conjunction with the appendix Figures 16 to 25 Detailed description of the complete surgical procedure for this device: Step 1 - Instrument transport and positioning, such as Figure 16 As shown: The umbrella-shaped capture device (delivery sheath 1 and retracted umbrella-shaped guide mechanism 2) in its initial state is guided into the patient's coronary artery 7 via the antegrade guidewire 8. The delivery sheath 1 is positioned under angiographic imaging with the help of the contrast ring 12 of the delivery sheath 1. The tip of the delivery sheath 1 is advanced to the target capture site 1-2 cm proximal to the CTO lesion entry (lesion occlusion segment 71). After positioning is completed, the antegrade guidewire 8 is withdrawn.

[0062] Step 2 - The umbrella-shaped guide mechanism unfolds, as follows: Figure 17 As shown: Rotate the umbrella control knob on the control mechanism 6 to push the main tube 21 forward, push the umbrella body 22 out from the inside of the delivery sheath 1 and open it to form a trumpet-shaped umbrella structure. After confirming with the angiography image that the umbrella body 22 does not compress the blood vessel wall and covers the drift area of ​​the reverse guide wire 3, fasten the positioning buckle on the control mechanism 6 to lock the umbrella shape of the umbrella-shaped guide mechanism 2.

[0063] Step 3 - Selecting and inserting the capture tool, such as Figure 18As shown: Based on the intraoperative guidewire specifications and the degree of vascular tortuosity, select the corresponding capture head 5B and assemble it at the front end of the inner shaft 5A of the capture device. In conventional scenarios, the arc-shaped laser-engraved capture head 51 with hollow three-dimensional multi-hole design can be directly used. After selecting the capture head 5B, assemble it at the front end of the inner shaft 5A of the capture device. After assembly, insert the entire inner shaft 5A of the capture device with the capture head 5B into the inner cavity of the outer tube 4 of the capture device from the rear end. Then, connect the rear ends of the outer tube 4 of the capture device and the inner shaft 5A of the capture device to the outer tube control component and the push-pull finger ring 63 of the control mechanism 6, respectively. After assembly, lock the initial positions of each component. During operation, keep the outer tube 4 of the capture device fixed in position. Using coronary angiography images, press the push-pull ring 63 forward to compress the return spring 64, which is fitted between the fixed ring 64 and the push-pull ring 63, and store its energy. Simultaneously, the push-pull ring 63 drives the inner shaft 5A of the capture device to slide forward axially. The capture head 5B protrudes from the opening of the outer tube 4 and naturally opens due to its own elasticity (the hollow three-dimensional multi-hole capture basket 51 opens, the snare 53 expands, and the claw-type capture device 52 opens). The opened capture head 5B is then conveyed and positioned to the center capture area of ​​the trumpet-shaped umbrella structure of the umbrella-shaped guide mechanism 2. In this state, if the pressure on the push-pull ring 63 is removed, the return spring 64 rebounds, pulling the inner shaft 5A of the capture device backward. During the backward repositioning process of the inner shaft 5A, the capture head 5B returns to its retracted state, clamping the reverse guide wire 3.

[0064] Step 4 - Guiding and capturing of the reverse guide wire, such as Figure 19 As shown: The operator slightly adjusts the direction and distance of the reverse guidewire 3 at the reverse operation end, moving it towards the umbrella area of ​​the umbrella-shaped guide mechanism 2. Utilizing the converging effect of the umbrella film 22, the guidewire tip is guided to the center point of the capture head 5B. After confirming that the tip of the reverse guidewire 3 has entered the capture area of ​​the capture head 5B, the operator operates the outer tube control component of the control mechanism 6, causing the capture device outer tube 4 to move forward. Simultaneously, the pressure of the push-pull ring 63 is released, the compressed return spring 64 rebounds, and pulls the push-pull ring 63, pulling the capture device inner shaft 5A and the capture head 5B backward relative to the capture device outer tube 4. Through the bidirectional relative movement of the capture device outer tube 4 moving forward and the capture head 5B moving backward, the capture head 5B is squeezed and closed by the port of the capture device outer tube 4, locking the reverse guidewire 3. After locking, the capture head is held in place by the rebound force of the return spring 64, without the need for continuous manual pressing of the ring.

[0065] Step 5 - Confirm the bending limit and position of the reverse guide wire, such as Figures 20 to 22As shown: After confirming, based on coronary angiography images, that the retrograde guidewire 3 has been captured by the capture tool, and that there is no intimal damage to the coronary artery 7, no breakage or knotting of the retrograde guidewire 3, or other device malfunctions, the umbrella control knob is rotated in the reverse direction, causing the main tube 21 to retract backward. The umbrella body 22 gradually contracts and enters the delivery sheath 1. During the contraction process, the trumpet-shaped umbrella structure compresses the end of the retrograde guidewire 3, causing the end of the retrograde guidewire 3 to bend, further ensuring that the retrograde guidewire 3 is firmly captured and preventing it from falling off during retraction. If a single capture fails, it is not necessary to withdraw the entire device; simply adjusting the umbrella control knob to change the opening diameter of the trumpet-shaped umbrella structure allows for repeated captures.

[0066] Step 6 - External guidewire extraction, such as... Figures 23 to 24 As shown: Combining coronary angiography images, after confirming that the reverse guidewire 3 has been folded in half, the relative positions of the capture head 5B and the umbrella-shaped guide mechanism 2 are locked. The capture tool (capturer 5, capturer outer tube 4, and umbrella-shaped guide mechanism 2) is slowly retracted along the inner channel of the delivery sheath 1. During the retraction process, the reverse guidewire 3 is pushed simultaneously at the reverse operation end. The external extraction operation of the reverse guidewire 3 is completed by a push-pull combination, further reducing damage to the blood vessel. After the reverse guidewire 3 reaches the outside of the body, the push-pull ring 63 is pressed forward again to compress the reset spring 64, which drives the capturer inner shaft 5A and the capture head 5B to extend forward. The capture head 5B extends forward out of the opening of the capturer outer tube 4. The capture head 5B opens by its own elasticity, releasing the clamp on the reverse guidewire, and realizing the separation and release of the reverse guidewire 3 by the capture tool. At this time, the ring 63 is pressed for the second time to temporarily compress the reset spring 64 to drive the capturer inner shaft 5A and the capture head 5B to extend forward and release, without maintaining the capture state.

[0067] Step 7 - Subsequent Operation Connection: After the capture tools (capture device 5, capture device outer tube 4 and umbrella-shaped guide mechanism 2) are withdrawn, the delivery sheath 1 can be used to continue the conventional reverse PCI operation procedure to complete subsequent coronary intervention operations such as establishing the forward operation track of the reverse guidewire 3 and implanting the coronary stent, without the need for additional instrument replacement, achieving seamless connection with the existing operation procedure.

[0068] During use, the device features four coaxially arranged tubing layers: delivery sheath 1, main tube 21, capture device outer tube 4, and capture device inner shaft 5A. The control mechanism 6 allows for independent control in each zone, with the umbrella opening and closing, and the capture head opening and locking operating independently. All components in contact with blood vessels have blunted ends and hydrophilic coatings on the contact surfaces, structurally preventing complications such as coronary intimal abrasion and vascular dissection. The previously time-consuming external operation of the reverse guidewire 3 is reduced to 2-3 minutes, decreasing X-ray radiation dose for both doctors and patients. Simultaneously, the three types of replaceable capture heads significantly improve adaptability to different anatomical conditions, reducing the operator's learning curve and the difficulty of clinical translation.

[0069] The advantages of this invention over the prior art are as follows: Compared to the existing technology CN109331321A, which relies solely on single-point blind capture with a capture head, lacks a pre-guided structure, and has a limited capture method, the embodiments of this invention utilize a retractable umbrella-shaped guiding mechanism and multiple types of replaceable capture heads to form a dual precision structure of "umbrella guidance + multi-tool capture." This optimizes traditional single-point target capture into a trumpet-shaped umbrella structure with planar coverage guidance, actively retracting drifting guide wires. This overcomes the shortcomings of existing technologies, such as the lack of a guiding structure, easy deviation of guide wires from the capture area, and repeated blind probes damaging the coronary intima, significantly improving the success rate of guide wire capture under complex coronary anatomy conditions. This invention preferably uses a hollow, three-dimensional, multi-porous capture head. The honeycomb multi-porous basket allows the guide wire to enter through any mesh opening for encapsulation and capture. Combined with two types of replaceable capture heads—claw-type and snare-type—this invention overcomes the shortcomings of the prior art, such as a single capture structure, inability to adapt to reverse guide wires of varying thicknesses and shapes, resulting in a wider range of clinical applicability. When the umbrella body retracts and closes, it can compress and limit the guidewire tip, locking it in conjunction with the capture head for double anti-dislodgement, solving the problem of existing capture structures relying solely on the capture head for clamping and the guidewire easily slipping during retraction. During guidewire externalization, a push-pull coordinated approach of distal pushing and proximal retraction is used, improving upon the shortcomings of the previous device, which only involves unidirectional traction, poor coaxiality of long-distance tortuous guidewires, and easy damage to blood vessels during traction. This can shorten the original guidewire externalization operation from several hours to two or three minutes, significantly reducing surgical time and decreasing X-ray exposure and intraoperative complication risks for both doctors and patients. This device adopts a four-layer, single-lumen, coaxial, integrated structure, replacing multiple separate instruments such as traditional guiding catheters and Guidezilla extension catheters. This solves the shortcomings of the previous device, which could not simultaneously function as an intraoperative catheter access and required frequent instrument changes. It is equipped with an integrated control mechanism with graduations and positioning buckles, allowing for independent modular control of umbrella body extension and retraction and capture head opening and closing, ensuring precise and convenient operation and reducing the operator's operational threshold and technical learning and transformation costs.

[0070] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A CTO-PCI reverse guide wire umbrella-shaped guiding and capturing device, comprising a delivery sheath and a capturing tool assembly, the capturing tool assembly comprising a capturing inner shaft passing through the inner cavity of the delivery sheath and a capturing head disposed at the front end of the capturing inner shaft, the capturing head being operable to switch between an open state and a retracted state to capture the reverse guide wire; characterized in that, The device includes a retractable umbrella-shaped guide mechanism having a retracted state and an extended state: in the retracted state, it is housed within the delivery sheath; in the extended state, it unfolds in front of the delivery sheath to form a trumpet-shaped umbrella structure, and the capture head can be axially pushed forward from the inner cavity of the umbrella-shaped guide mechanism to the central capture area of ​​the umbrella structure; the umbrella structure is used to gather and guide the drifting reverse guide wire, causing it to move toward the capture area of ​​the capture head.

2. The guiding and capturing device according to claim 1, characterized in that, The system includes an axially hollow tube passing through the inner cavity of the delivery sheath. The capture tool assembly includes a capture outer tube, which passes through the inner cavity of the axially hollow tube, and a capture inner shaft passing through the inner cavity of the capture outer tube. The capture head switches between an open state and a retracted state by relative axial sliding between the capture inner shaft and the capture outer tube. An umbrella-shaped guide mechanism is connected to the front end of the axially hollow tube. By driving the axially hollow tube to move axially, the umbrella-shaped guide mechanism is controlled to switch between a retracted state and an expanded state.

3. The guiding and capturing device according to claim 2, characterized in that, Includes a control mechanism; the control mechanism includes: The handle base, the rear end of the delivery sheath is fixed to the handle base; The umbrella control knob is rotatably mounted on the handle base and is connected to the rear end of the axial hollow tube. Rotating the umbrella control knob can drive the axial hollow tube to move axially. An outer tube control assembly, connected to the rear end of the catcher outer tube, is used to drive the catcher outer tube to slide axially; The push-pull ring is fixedly connected to the rear end of the inner shaft of the catcher.

4. The guiding and capturing device according to claim 3, characterized in that, The handle base is provided with a fixed finger ring, and a limit assembly return spring is provided between the fixed finger ring and the push-pull finger ring. The return spring is fitted on the outside of the inner shaft of the catcher. The push-pull finger ring can be operated to compress the return spring and drive the inner shaft of the catcher to move forward. After the external force is removed, the return spring rebounds and drives the push-pull finger ring and the inner shaft of the catcher to move backward and reset.

5. The guiding and capturing device according to claim 4, characterized in that, After the capture head captures and locks the reverse guide wire, the reverse guide wire is pulled into the delivery sheath by retracting the inner shaft of the capture device. At the same time, the reverse guide wire is pushed synchronously at the reverse operation end. The external extraction of the reverse guide wire is completed by using a push-pull combination method.

6. The guiding and capturing device according to claim 5, characterized in that, During the retraction of the inner shaft of the capture device, the reset spring releases elastic potential energy, causing the capture head to return to its retracted state, clamping the reverse guide wire, and forming a dynamic balance with the thrust of the reverse operation end pushing the reverse guide wire.

7. The guiding and capturing device according to claim 1, characterized in that, The umbrella-shaped guiding mechanism includes an elastic support frame made of shape memory alloy and a medical polymer film covering the outside of the frame; the front end of the support frame has a rounded and blunt structure, and the umbrella-shaped guiding mechanism forms a trumpet-shaped umbrella structure after unfolding. The unfolding diameter of the umbrella structure continuously changes within a preset range with the axial displacement of the umbrella-shaped guiding mechanism relative to the delivery sheath; the surface of the polymer film is coated with a hydrophilic coating; the delivery sheath is a thin-walled medical polymer tube with hydrophilic coatings on both its inner and outer walls, and its front end is treated with a rounded and blunt soft transition, and a metal imaging ring is provided near the front end.

8. The guiding and capturing device according to claim 1, characterized in that, The capture head is detachably connected to the front end of the inner shaft of the capture device. The device is equipped with a variety of capture heads for selection and use according to the surgical scenario. The capture heads that can be selected and used include a hollow three-dimensional multi-hole capture head, a claw-type capture head, or a snare-type capture head.

9. The guiding and capturing device according to claim 8, characterized in that, The hollow three-dimensional multi-hole capture head is made of shape memory alloy and has hollow mesh. It has development marks at both the rear and front ends. The claw-type capture head has a two-claw or three-claw configuration, and the claw ends are provided with rounded anti-slip teeth. The snare-type capture head is made of nickel-titanium alloy wire woven into a closed loop, and the inner diameter of the loop is adjustable.

10. The guiding and capturing device according to claim 1, characterized in that, The device is a single-cavity coaxial integrated structure; after the umbrella-shaped guiding mechanism and the capture tool assembly are withdrawn, the inner cavity of the delivery sheath forms a continuous operating channel for directly delivering balloons or stent interventional devices.

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