A distal filter cerebral protection device for use in cardiac surgery

Abstract

The application provides a distal filter brain protection device for use in cardiac surgery, comprising a sleeve with an inlet end and an outlet end; the sleeve is divided into 2-3 sleeve branches at the inlet end; the sleeve contains 2-3 implant sheaths; one implant sheath is introduced from each sleeve branch; the implant sheaths are all led out at the outlet end; the implant sheaths are provided with guide wires, and the front ends of the guide wires are provided with umbrella-shaped filter screen devices; the umbrella-shaped filter screen devices are provided with multiple ultrasonic emission balls containing corner reflectors to enhance the ultrasonic reflection effect of the devices. The distal filter brain protection device of the application can simultaneously provide precise filter implantation and removal for multiple blood vessels, especially two carotid arteries, in cardiac surgery, and the implantation and detailed operation process can be completed under ultrasonic monitoring.

Description

Technical fields:

[0001] This invention application relates to the field of medical device technology, and more particularly to a distal filter brain protection device for use in cardiac surgery. Background Technology

[0002] Stroke is one of the poor postoperative complications in cardiac surgery patients, with an incidence of approximately 3%-10% and a mortality rate as high as 38%. Stroke can occur during surgery, postoperatively (perioperative period), or as a late complication in cardiac surgery patients.

[0003] Most strokes occur intraoperatively, with embolic events being the most likely risk factor. Embolism caused by severe atherosclerotic aortic plaques and thrombi is closely associated with postoperative stroke. Currently, there are no commercially available intraoperative brain protection devices for cardiac surgery.

[0004] Risk factors for cardiac stroke include: (1) advanced age, peripheral artery disease, hypertension, left ventricular dysfunction, and inadequate antiplatelet therapy; (2) cardiac manipulation during clamping of the aorta, aortic cannulation and proximal anastomosis, or perioperative atrial fibrillation, which may lead to thrombus or plaque detachment; (3) intraoperative hemodynamic abnormalities (hypotension, microembolism due to platelet aggregation during cardiopulmonary bypass or formation of turbulent blood flow).

[0005] Emboli in cerebral embolism and stroke primarily originate from the heart, heart valves, and aorta. Procedures performed on these structures, such as aortic cannulation and valve repair, can induce the formation and detachment of emboli of varying sizes and types, leading to embolic brain injury ranging from latent ischemic foci to large-scale or even fatal strokes. Various devices are known to exist within blood vessels and the carotid artery to prevent emboli from dislodging into the brain. However, these antiembolic devices are not widely accepted in cardiac surgery. Due to the complexity and invasive nature of heart valves and the aorta, known devices require the insertion of additional hardware into the arterial system or aorta—a known approach for all risk-related interventions within blood vessels, including aortic dissection, hemorrhage, thrombosis, and carotid embolism and stroke.

[0006] Known intra-aortic filters capture potential embolic material released from the heart by inserting a cannula into the ascending portion of the thoracic aorta. Another device for preventing emboli from entering the brain includes a porous circulation deflector, a protective shield within the aorta that captures or diverts potential emboli distally. An additional device has also been proposed for use during aortic valve surgery, which is an intra-aortic filter catheter that captures emboli during the procedure. It has been established that intravascular filters cannot capture emboli smaller than the available pore size (currently 60-140 μm), leading to cerebral microemboli. Embolism can also occur due to poor juxtaposition of the filter to the aortic or carotid artery wall. Furthermore, the placement of the filter itself can generate cerebral emboli. Therefore, despite numerous innovations in the field—20 antithrombotic devices—the problem of cerebral embolism and stroke during cardiovascular surgery remains far from resolved.

[0007] US Patent US10537308B2 discloses an occlusion catheter device and method for preventing embolic stroke, relating to an occlusion catheter having at least one balloon and a filter screen inserted into a patient's circulatory system to deflect, capture, and remove emboli entering the brain via the carotid artery, and a method for preventing embolic stroke in the subclavian artery during embolism.

[0008] Chinese patent CN208625921U discloses a thrombosis protection device, which consists of a guidewire with an umbrella-shaped filter. The umbrella-shaped filter is supported on a Z-shaped frame and has an ellipsoidal structure with a porous membrane at the top and a blank structure at the bottom. The guidewire has an insertion head at its tip, and a contrast marker is provided between the insertion head and the umbrella-shaped filter. A contrast marker is also provided at the tail of the umbrella-shaped filter. The thrombosis protection device of this invention can be pre-implanted during interventional treatment to prevent plaque from detaching and flowing to the distal end of cerebral blood vessels, thereby reducing the occurrence of cerebral embolism.

[0009] The patent proposes setting imaging markers on a filter for pre-implantation during interventional treatment of thrombosis protection devices, but the specific structure and usage of the imaging markers are not clearly disclosed.

[0010] Based on the above description of the prior art, it can be seen that among the disclosed technologies concerning distal cerebral vascular filters in cardiac surgery, none disclose a device for simultaneously implanting filters into multiple cardiovascular vessels. Filter implantation and positioning generally require harmful and complex positioning methods such as contrast agents and X-rays.

[0011] In view of the above-mentioned shortcomings of the existing technology, this invention application is hereby filed. Summary of the Invention

[0012] The purpose of this invention is to provide a distal filter brain protection device for use in cardiac surgery.

[0013] To achieve the objective of this invention, the technical solution provided by this invention is as follows:

[0014] A distal filter brain protection device for use in cardiac surgery is provided, comprising a cannula having an inlet end and an outlet end; the cannula is divided into 2-3 cannula branches at the inlet end; the cannula accommodates 2-3 implantable sheaths; one of the implantable sheaths is introduced from each cannula branch; the implantable sheaths are all exited at the cannula outlet end; each implantable sheath is equipped with a guidewire, and an umbrella-shaped filter device is provided at the tip of the guidewire.

[0015] The cannula is a hollow tube, and the 2-3 implantable sheaths are accommodated in the hollow tube; or the cannula is a solid tube with 2-3 channels, each branch of the cannula having one channel, and each channel accommodating one implantable sheath.

[0016] The sleeve is provided with a sleeve bending section, which is a retractable and steerable structure formed by stacking the outer walls of the sleeve.

[0017] The end of the sleeve branch is equipped with a one-way valve.

[0018] The cannula is 10-100cm long and 5-20mm in diameter; the guidewire is 0.1-0.5mm in diameter; and the implant sheath is 2-10mm in diameter.

[0019] The umbrella-shaped filter device includes a stopper disposed at the end of the guide wire; an umbrella-shaped filter; a support ring disposed at the open end of the umbrella-shaped filter; a rotating tube between the closed end of the umbrella-shaped filter and the stopper; and one or more connecting wires connecting the stopper and the support ring.

[0020] The umbrella-shaped filter has a diameter of 4-12 mm when opened; the pore size of the umbrella-shaped filter is 100-120 micrometers; the umbrella-shaped filter is preferably made of polyurethane material.

[0021] The umbrella-shaped filter device also includes a head cone and a spring head coil arranged sequentially outside the closed end of the umbrella-shaped filter, away from the guide wire.

[0022] One or more metal ultrasonic positioning balls are provided between the spring head coil and the closed end of the umbrella-shaped filter, on the rotating tube, or between the stopper and the guide wire.

[0023] The ultrasonic positioning ball is provided with one or more corner reflectors for enhancing ultrasonic wave reflection signals. The corner reflector is a recess formed by three planes intersecting perpendicularly in pairs.

[0024] The remote filter brain protection device also includes an ultrasonic transmitter, an ultrasonic signal receiver, a signal processing device, and a display device.

[0025] The distal filter brain protection device also includes a guidewire torsion device.

[0026] The distal filter brain protection device also includes a removal sheath.

[0027] The ultrasonic transmitter, ultrasonic signal receiver, signal processing device, and display device in this application can be integrated into the same system / device as the remote filter brain protection device, and can be implemented using the ultrasonic transmitter, ultrasonic signal receiver, signal processing device, and display device from other existing ultrasonic positioning systems.

[0028] The diameter of the ultrasonic positioning ball in this application is slightly larger than the diameter of the rotating tube and guidewire but smaller than the diameter of the implanted sheath. Preferably, there are at least three corner reflector structures on it, with multiple corner reflectors evenly distributed on the reflector ball.

[0029] The length, diameter, and position of the turning part of the cannula in this application are designed based on the general size of the heart and adjacent blood vessels. It can also be customized before surgery according to the special needs of children, people with vascular malformations, etc.

[0030] The beneficial effects of this invention are:

[0031] (1) The structure of this application, consisting of a flexible cannula and multiple implantable sheaths, allows for convenient and precise simultaneous implantation and removal of filters for multiple blood vessels, especially two carotid arteries, during cardiac surgery. The protective effect and ease of operation are superior to existing devices.

[0032] (2) The device of this application enhances the ultrasonic reflection effect by setting multiple ultrasonic positioning balls with corner reflectors, so that the implantation and detailed operation of the device can be completed under ultrasonic monitoring. The operability and safety are significantly better than existing contrast agents and X-rays. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0034] Figure 2 This is a schematic diagram of the structure of the umbrella-shaped filter screen of the present invention;

[0035] Figure 3 This is a schematic diagram of the ultrasonic positioning ball of the present invention.

[0036] In the attached diagram: 1 is guidewire, 2 is umbrella-shaped filter, 3 is support ring, 4 is stopper, 5 is connecting wire, 6 is ultrasonic positioning ball, 7 is corner reflector, 8 is head cone, 9 is spring head coil, 10 is implantation sheath, 11 is cannula, 11-1 is cannula bend, 11-2 is cannula branch, 12 is one-way valve, 13 is umbrella-shaped filter device, 14 is extraction sheath, 15 is guidewire torsion device, 16 is ultrasonic transmitter head, 17 is ultrasonic signal receiver, 18 is signal processing device and display device, and 101 is rotating tube. Detailed Implementation

[0037] The technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings.

[0038] Example 1

[0039] Figure 1 This is a schematic diagram of the overall structure of the present invention. Figure 2 This is a schematic diagram of the umbrella-shaped filter device of the present invention. Figure 3 This is a schematic diagram of the structure of the ultrasonic positioning ball of the present invention, as shown below. Figure 1 , 2 As shown in Figure 3, a distal filter brain protection device for cardiac surgery according to the present invention includes:

[0040] A cannula 11 having an inlet end and an outlet end; the cannula 11 is divided into 2-3 cannula branches 11-2 at the inlet end; the cannula 11 accommodates 2-3 implantation sheaths 10; one implantation sheath 10 is introduced from each cannula branch 11-2; all implantation sheaths 10 are exited at the cannula outlet end; each implantation sheath 10 is equipped with a guide wire 1, and the front end of the guide wire 1 is provided with an umbrella-shaped filter device 13.

[0041] The cannula 11 is a hollow tube, and the 2-3 implantable sheaths 10 are accommodated in the hollow tube; or the cannula 11 is a solid tube with 2-3 channels, each cannula branch 11-2 has one channel, and each channel accommodates one implantable sheath.

[0042] The cannula 11 is provided with a cannula bending portion 11-1, which is a retractable and steerable structure formed by stacking the outer wall of the cannula; this allows the operating position of the implanted sheath / guidewire to be flexibly changed.

[0043] The end of the cannula branch is equipped with a one-way valve 12 to provide fixation of the implanted sheath / guidewire during operation.

[0044] The cannula 11 has a length of 10-100cm and a diameter of 5-20mm; the guidewire has a diameter of 0.1-0.5mm; and the implantation sheath has a diameter of 2-10mm.

[0045] The length of the cannula 11 is suitable for intervention into the heart from the ascending aorta, and by appropriate deflection of the cannula bend 11-1, two implanted sheaths 10 are respectively delivered into the left and right carotid arteries to release filters at appropriate portions in the left and right carotid arteries.

[0046] The umbrella-shaped filter device 13 includes a stopper 4 disposed at the end of the guide wire 1; an umbrella-shaped filter 2; a support ring 3 disposed at the open end of the umbrella-shaped filter 2; a rotating tube 101 between the closed end of the umbrella-shaped filter 2 and the stopper; and one or more connecting wires 5 connecting the stopper 4 and the support ring 3.

[0047] The umbrella-shaped filter 2 has a diameter of 4-12 mm when opened; the pore size of the umbrella-shaped filter 2 is 100-120 micrometers; the umbrella-shaped filter 2 is made of polyurethane material.

[0048] The umbrella-shaped filter device 13 also includes a head cone 8 and a spring head coil 9 arranged sequentially outside the closed end of the umbrella-shaped filter 2 away from the guide wire.

[0049] When not in use, the umbrella-shaped filter 2 in the aforementioned umbrella-shaped filter device 13 is stored in the implantation sheath 10. After the cannula 11 is positioned appropriately, the implantation sheath 10 is pushed forward to the position where the filter is placed. The guidewire torsion device 15 is used to twist the guidewire 1 to push the umbrella-shaped filter device 13 out of the implantation sheath. The umbrella-shaped filter 2 opens under the force of blood flow. The stopper 4 and the connecting wire 5 control the opening range of the umbrella-shaped filter 2. During implantation, the head cone 8 and the spring tip coil 9 play a role in protecting blood vessels and assisting in positioning. When it is necessary to remove the filter, a removal sheath 14 with a diameter larger than the implantation sheath is inserted, the umbrella-shaped filter device 13 is put on, and then it is removed.

[0050] One or more metal ultrasonic positioning balls 6 (not all feasible locations are shown in the figures) are provided between the spring head coil and the closed end of the umbrella-shaped filter, on the rotating tube, or between the stopper and the guide wire. One or more corner reflectors 7 are provided on the ultrasonic positioning balls 6 to enhance the ultrasonic wave reflection signal. The corner reflectors 7 are recesses formed by three planes intersecting perpendicularly in pairs.

[0051] The remote filter brain protection device also includes an ultrasonic transmitter 16, an ultrasonic signal receiver 17, a signal processing device, and a display device 18, for transmitting and receiving ultrasonic signals and displaying them visually on a screen to guide the filter placement and removal process.

[0052] The distal filter brain protection device also includes a guide wire torsion device 15.

[0053] The distal filter brain protection device also includes a removal sheath 14.

[0054] The described embodiments are only some, not all, of the embodiments in this application. All other embodiments obtained by those skilled in the art based on the embodiments in this application without inventive effort are within the scope of protection of this application.

Claims

1. A distal filter brain protection device for providing filter implantation and removal for two carotid arteries during cardiac surgery, characterized in that, It includes a cannula with an inlet end and an outlet end; the cannula branches into two cannula branches at the inlet end; the cannula accommodates implantable sheaths introduced from the two cannula branches; one implantable sheath is introduced from each cannula branch; the implantable sheaths exit from the cannula outlet end; each implantable sheath contains a guidewire, and an umbrella-shaped filter device is provided at the tip of the guidewire in the direction of the cannula outlet end; wherein the cannula is provided with a cannula bend, the cannula bend being a retractable steering structure formed by stacking the outer walls of the cannula; the cannula is deflected by the cannula bend to deliver the implantable sheaths introduced from the two cannula branches into the left and right carotid arteries respectively to release the filter in the left and right carotid arteries.

2. The distal filter brain protection device according to claim 1, wherein the cannula is a hollow tube, the implantable sheath is accommodated in the hollow tube, and each branch of the cannula has an implantable sheath; or the cannula is a solid tube with a channel, each branch of the cannula has a channel, and each channel accommodates an implantable sheath.

3. The distal filter brain protection device according to claim 1 or 2, wherein the end of the sleeve branch is equipped with a one-way valve.

4. The distal filter brain protection device according to claim 1 or 2, wherein the cannula is 10-100cm long and 5-20mm in diameter; the guidewire is 0.1-0.5mm in diameter; and the implanted sheath is 2-10mm in diameter.

5. The distal filter brain protection device according to claim 1, wherein the umbrella-shaped filter device includes a stop disposed at the end of the guide wire; an umbrella-shaped filter; a support ring disposed at the open end of the umbrella-shaped filter; a rotating tube between the closed end of the umbrella-shaped filter and the stop; and one or more connecting wires connecting the stop and the support ring.

6. The distal filter brain protection device according to claim 5, wherein the umbrella-shaped filter has a diameter of 4-12 mm when opened; the pore size of the umbrella-shaped filter is 100-120 micrometers, and the umbrella-shaped filter is made of polyurethane material.

7. The distal filter brain protection device according to claim 5 or 6, wherein the umbrella-shaped filter device further includes a head cone and a spring head coil arranged sequentially outside the closed end of the umbrella-shaped filter in the direction away from the guide wire.

8. The distal filter brain protection device according to claim 7, wherein one or more metal ultrasonic positioning balls are provided between the spring head coil and the closed end of the umbrella-shaped filter, on the rotating tube, or between the stopper and the guide wire.

9. The distal filter brain protection device according to claim 8, wherein one or more corner reflectors for enhancing ultrasonic wave reflection signals are provided on the ultrasonic positioning ball, and the corner reflectors are recesses formed by three planes intersecting perpendicularly in pairs.

10. The remote filter brain protection device according to claim 1, wherein the remote filter brain protection device further comprises an ultrasonic transmitter, an ultrasonic signal receiver, a signal processing device, and a display device.

11. The distal filter brain protection device according to claim 1, wherein the distal filter brain protection device further comprises a guidewire torsion device.

12. The distal filter brain protection device according to claim 1, wherein the distal filter brain protection device further includes a removal sheath.

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