CN116831778A

CN116831778A - Brain protection device

Info

Publication number: CN116831778A
Application number: CN202311052785.2A
Authority: CN
Inventors: 石若璘
Original assignee: Rui Song Shanghai Medical Technology Co ltd
Current assignee: Rui Song Shanghai Medical Technology Co ltd
Priority date: 2023-08-21
Filing date: 2023-08-21
Publication date: 2023-10-03

Abstract

The invention relates to a brain protection device, which comprises a bending control catheter, a first embolism protection device and a second embolism protection device, wherein the bending control catheter comprises an outer sheath tube assembly, a bending control tube assembly and an inner tube assembly, and a first cavity for installing the first embolism protection device is formed between the bending control tube assembly and the outer sheath tube assembly; a second cavity for installing a second embolic protection device is formed between the inner tube assembly and the control elbow assembly; the first embolic protection device and the second embolic protection device comprise a bracket, a filter screen main body and a pushing guide wire or a catheter; the stent is made of shape memory alloy, the stent in the first embolic protection device is arranged in a stent form similar to a flower beam-shaped structure, and the stent in the second embolic protection device is arranged in a stent form similar to a lasso structure. Compared with the prior art, the invention has the advantages of realizing the filtration and capture of the falling emboli, along with high bending performance, excellent adherence performance, complete independence of the loading and releasing functions of the catheter bending control and protecting device, and the like.

Description

Brain protection device

Technical Field

The invention relates to the field of interventional medical instruments, in particular to a brain protection device.

Background

In transcatheter aortic replacement (TAVR), a physician uses a catheter to pass through the femoral artery, through the descending aorta, through the aortic arch, through the ascending aorta, and to the aortic valve site, releasing the prosthetic valve carried by the catheter head end at the patient's native aortic valve. Replacement of a stenotic valve, otherwise caused by calcification, or a regurgitated valve due to insufficient closure, with a normally functioning prosthetic valve is performed to achieve therapeutic effects on the diseased aortic valve.

In clinic, cerebral apoplexy is one of the common complications after TAVR operation, and the incidence rate after operation is as high as 5% -8%. As shown in fig. 1, the catheter in TAVR operation may cause the removal of emboli such as plaque in blood vessel and calcification on valve during the course of delivery and the like, so that the emboli flow along with blood flow into cerebral blood vessel to cause acute cerebral apoplexy.

Existing brain protection devices typically use deflectors located within the aortic arch to block three main cerebral vessel branch openings on the aortic arch through the filter screen structure of the deflector, preventing emboli from entering the openings of each branch, such as the embolic deflector and embolic deflection system disclosed in the invention of publication No. CN113813078A, however, this method only blocks the emboli outside the cerebral vessel opening and deflects to the descending main section of the aorta, and the emboli cannot be taken out. And because the deflector is integrally arranged in the aortic arch, the structure of the deflector further causes interference to the routine access operation of the TAVR device, and when the operation faces an emergency, the brain protection device cannot be independently withdrawn before the TAVR device is not withdrawn.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide the brain protection device which can realize the filtration and capture of the falling-off emboli and has high bending performance and excellent adherence performance.

The aim of the invention can be achieved by the following technical scheme:

the brain protection device is characterized by comprising a bending control catheter, a first embolism protection device and a second embolism protection device, wherein the bending control catheter comprises an outer sheath tube assembly, a bending control tube assembly and an inner tube assembly which are sequentially sleeved at the end part of the bending control catheter, and a first cavity is formed between the bending control tube assembly and the outer sheath tube assembly; a second cavity is formed between the inner pipe assembly and the control elbow assembly; the first embolic protection device is located within the first cavity, and the second embolic protection device is located within the second cavity;

the first embolic protection device and the second embolic protection device comprise a bracket, a filter screen main body and a pushing guide wire or a catheter; the bracket is made of shape memory alloy material and comprises a bracket fixed end, a bracket transition section and a bracket opening end which are distributed in sequence; the filter screen main body comprises a filter screen tail end and a filter screen opening end, wherein the radial inward space of the filter screen tail end and the filter screen opening end are sequentially enlarged, and the filter screen opening end is connected with the support opening end;

In the first embolic protection device, the stent transition section comprises a plurality of stent wave rods distributed along the circumference, the open end of the stent comprises a plurality of connecting rods, and each connecting rod is respectively connected with two adjacent stent wave rods along the circumference direction;

in the second embolic protection device, the support transition section is of a rod-shaped structure formed by bending outwards, and the support opening end is of an annular structure formed by encircling a shape memory alloy wire.

Further, in the first embolic protection device, the tail end of the filter screen and the fixed end of the bracket are both positioned on the same side of the opening end of the filter screen;

in the second embolic protection device, the tail end of the filter screen and the fixed end of the bracket are respectively positioned at the opposite sides of the opening end of the filter screen, and the tail end of the filter screen is connected to the pushing guide wire or the guide pipe.

Further, in the first embolic protection device, both ends of each connecting rod are respectively connected with the end parts of two adjacent support wave rods along the circumferential direction, and the middle part of each connecting rod is protruded in a direction away from the fixed end of the support.

Further, the first embolic protection device and the second embolic protection device are embolic protection components having a compressed state and an expanded state, and when the embolic protection components are in the compressed state, the embolic protection components are positioned in the corresponding cavities; when the embolic protection component is in a unfolding state, the outer diameter of the opening end of the embolic protection component is matched with the size of the blood vessel to be protected, and is attached to the inner wall of the blood vessel.

Further, accuse return bend subassembly includes interconnect's accuse bend section and non-accuse bend section, non-accuse bend section is located the radial inward space of sheath pipe subassembly, the one end that the outer sheath pipe subassembly was kept away from to accuse bend section is connected with the wire drawing, and this wire drawing stretches out through the hollow region of non-accuse bend section and sheath pipe subassembly.

Further, the bending control section comprises a first bending control section and a second bending control section which are connected with each other, one end of the first bending control section, which is far away from the second bending control section, is connected with the inner tube assembly, and one end of the second bending control section, which is far away from the first bending control section, is connected with the outer sheath tube assembly;

an included angle exists between the plane where the central axis of the first bending control section is located and the plane where the central axis of the second bending control section is located; the wire drawing sets up the one end that keeps away from the second accuse bending section at first accuse bending section.

Further, when the included angle between the plane where the central axis of the first bending control section is located and the plane where the central axis of the second bending control section is located is 0 degrees, the bending control assembly is in a single plane bending control state; when the included angle between the plane where the central axis of the first bending control section is located and the plane where the central axis of the second bending control section is located is not 0 degrees, the bending control assembly is in a double-plane bending control state.

Further, the control elbow assembly can perform axial relative movement and circumferential relative rotation along the outer sheath tube assembly; the inner tube assembly can perform axial relative movement and circumferential relative rotation along the control elbow assembly.

Further, the control elbow assembly is provided with a first limit position which moves in opposite directions with the outer sheath pipe assembly, and when the outer sheath pipe assembly is positioned at the first limit position on the control elbow assembly, the joint between the outer sheath pipe assembly and the control elbow assembly is in a closed state; when the outer sheath tube assembly does not reach the first limit position on the control elbow tube assembly, the joint between the outer sheath tube assembly and the control elbow tube assembly is in a state of communicating with the outside;

the inner pipe assembly is provided with a second limit position which moves in opposite directions with the control bent pipe assembly, and when the control bent pipe assembly is positioned at the second limit position on the inner pipe assembly, the joint between the control bent pipe assembly and the inner pipe assembly is in a closed state; when the control elbow assembly does not reach the second limit position on the inner pipe assembly, the connection part between the control elbow assembly and the inner pipe assembly is in an external communication state.

Further, the bend control assembly performs bend control operation, the inner tube assembly performs opening and closing operation relative to the bend control assembly, and the bend control assembly performs opening and closing operation relative to the outer sheath tube assembly, which can be performed independently of each other.

Further, the outer sheath tube assembly, the control elbow tube assembly, the inner tube assembly, the first embolic protection device and the second embolic protection device are all provided with developing structures.

Compared with the prior art, the invention has the following advantages:

(1) The present approach provides superior apposition in the proximal direction by providing the first embolic protection device 2001 in a proximal position in the form of a stent that resembles a flower-bundle-like structure, reducing the chance that an intravascular embolic will become stuck at the edge of the filter membrane or the edge of the stent, rendering it unable to be successfully captured;

by providing the second embolic protection device 2002 relatively distally positioned in a stent-like fashion similar to a lasso structure, less axial rigidity is achieved, more flexibility and ease of bending, and high flexibility requirements for the controlled bend catheter head are accommodated.

(2) The bending control catheter is provided with cavities which can be opened and closed at the proximal end and the distal end of the bending control tube assembly, and a first embolic protection device and a second embolic protection device are respectively arranged in the cavities at corresponding positions; when in use, two independent embolic protection devices can be respectively arranged in the innominate artery branch and the left common carotid artery branch through the bending control catheter, so as to achieve the functions of filtering and catching the falling emboli in the TAVR operation. Because the main body of the embolic protection device is positioned in the branch vessel, the interference degree of the device on the operation of the TAVR device is extremely low.

(3) The invention can release the embolism protection device with thrombus filtering function in the innominate artery branch and the left common carotid artery branch respectively, prevent calcification, plaque tissue, thrombus and other falling objects caused by valve replacement from entering the cerebral vessels along with blood, thereby reducing the risk of cerebral apoplexy.

(4) The invention controls the bending control operation process of the bending control pipe assembly through the wire drawing, drives the relative motion between the inner pipe assembly and the bending control pipe assembly and the relative motion between the bending control pipe assembly and the sheath pipe assembly, and the functions of the three are completely independent from each other, so that no constraint relationship such as precedence and the like exists, for example, the relative motion between the inner pipe assembly and the bending control pipe assembly and the relative motion between the bending control pipe assembly and the sheath pipe assembly can be independently driven in the bending control operation process of the bending control pipe assembly through the wire drawing, and the income and release of two embolic protection devices are realized;

in the process of carrying out the income and the release of one embolic protection device, the income and the release of the other embolic protection device and the bending control operation of the bending control pipe assembly can be independently carried out;

therefore, doctors can perform various operation adjustments according to the operation needs at any time in the operation process without considering the states of other components, and the occurrence rate of misoperation of the instrument is reduced.

(5) When the device is used, only one structure of the bending control section of the bending control catheter is arranged in the aortic arch, and the brain protection device can realize implantation and release operations independent of a TAVR instrument, so that the interference to the TAVR surgical instrument is reduced.

Drawings

FIG. 1 is a schematic illustration of a transcatheter aortic valve replacement provided in the background of the invention;

FIG. 2a is a schematic diagram illustrating an open state of an outer sheath assembly, a control elbow assembly and an inner tube assembly according to an embodiment of the present invention;

FIG. 2b is a schematic diagram illustrating a closed state of an outer sheath assembly, a control elbow assembly and an inner tube assembly according to an embodiment of the present invention;

FIG. 3a is a schematic diagram of a first embolic protection device according to an embodiment of the present invention;

FIG. 3b is a schematic diagram of a second embolic protection device according to an embodiment of the present invention;

FIG. 4a is a schematic structural diagram of a control elbow assembly according to an embodiment of the present invention;

FIG. 4b is a schematic cross-sectional view of a control elbow assembly according to an embodiment of the present invention;

FIG. 5a is a schematic view of an inner tube assembly according to an embodiment of the present invention;

FIG. 5b is a schematic cross-sectional view of an inner tube assembly structure provided in an embodiment of the present invention;

Fig. 6a is a schematic view of a closed cavity 001 according to an embodiment of the present invention;

FIG. 6b is a schematic view of the cavity 002 in a closed state according to one embodiment of the present invention;

FIG. 7a is a schematic diagram showing a first embolic protection component in a compressed state within a lumen 001, provided in an embodiment of the present invention;

FIG. 7b is a schematic view of a first embolic protection component according to an embodiment of the present invention in an unfolded state outside the lumen 001;

FIG. 7c is a schematic diagram showing a compressed state of a second embolic protection component within the lumen 002, provided in an embodiment of the present invention;

FIG. 7d is a schematic view of a second embolic protection component according to an embodiment of the present invention in an expanded state outside of the lumen 002;

FIG. 7e is a schematic illustration of two embolic protection components provided in an embodiment of the present invention deployed simultaneously;

FIG. 8a is a schematic diagram illustrating a bending control state in which two cavities are both open according to an embodiment of the present invention;

FIG. 8b is a schematic diagram illustrating a bending control state in which two cavities are closed according to an embodiment of the present invention;

FIG. 9a is a schematic diagram showing an open state of an outer sheath assembly, a control elbow assembly including a first control elbow section and a second control elbow section, and an inner tube assembly according to an embodiment of the present invention;

FIG. 9b is a schematic view showing a closed state of an outer sheath assembly, a control elbow assembly including a first control elbow section and a second control elbow section, and an inner tube assembly according to an embodiment of the present invention;

FIG. 10a is a schematic structural diagram of a bend control pipe assembly including a first bend control section and a second bend control section according to an embodiment of the present invention;

FIG. 10b is a schematic cross-sectional view of a bend control pipe assembly including a first bend control segment and a second bend control segment according to an embodiment of the present invention;

FIG. 11a is a schematic view of a single plane controlled bending state in an open state according to an embodiment of the present invention;

FIG. 11b is a schematic view of a single plane controlled bending state in a closed state according to an embodiment of the present invention;

fig. 12 is a schematic structural diagram of a plane 1 in which a central axis of a first bending control section is located, a plane 2 in which a central axis of a second bending control section is located, and an included angle α according to an embodiment of the present invention;

FIG. 13 is a schematic structural diagram of a first bending control section and a second bending control section under a double-plane bending control according to an embodiment of the present invention;

FIG. 14a is a schematic view showing the open state of an outer sheath assembly, a control elbow assembly including a first control section and a second control section, and an inner tube assembly according to an embodiment of the present invention;

FIG. 14b is a schematic view showing a closed state structure of an outer sheath assembly, a control elbow assembly including a first control elbow section and a second control elbow section, and an inner tube assembly according to an embodiment of the present invention;

FIG. 15 is a schematic view of a control elbow assembly including a transition section according to an embodiment of the present invention;

fig. 16 is a schematic structural diagram of a plane 1 in which a central axis of a first bending control section is located, a plane 2 in which a central axis of a second bending control section is located, and an included angle α according to an embodiment of the present invention;

FIG. 17a is a schematic diagram showing an open state of a bend control catheter under a biplane bend control according to an embodiment of the present invention;

FIG. 17b is a schematic view of a closed state of a bend-controlling catheter under a biplane bend control provided in an embodiment of the present invention;

FIG. 17c is a schematic diagram of an expanded state of two embolic protection devices in an open state, according to an embodiment of the present invention;

FIG. 18a is a schematic view of a first operating state of a brain protection device according to an embodiment of the present invention;

FIG. 18b is a schematic diagram illustrating a second operational state of a brain protection device according to an embodiment of the present invention;

in the figure, 1000, bend control catheter, 1100, outer sheath assembly, 1200, bend control assembly, 1210, bend control segment, 1211, first bend control segment, 1212, second bend control segment, 1204, non-bend control segment, 1205, bend control pull ring, 1206, wire drawing, 1300, inner tube assembly, 1301, head end, 1302, inner tube, 1303, cavity, 001, first cavity, 002, second cavity, 2000, embolic protection assembly, 2001, first embolic protection device, 2002, second embolic protection device, 2100, stent, 2101, stent fixed end, 2102, stent transition segment, 2103, stent open end, 2300, screen body, 2301, screen tail end, 2302, screen open end, 2400, push wire or catheter;

3000. Bend control catheter, 3100, outer sheath assembly, 3200, bend control assembly, 3210, bend control segment, 3211, first bend control segment, 3212, second bend control segment, 3204, non-bend control segment, 3205, bend control pull ring, 3206, wire drawing, 3207, transition segment, 3300, inner tube assembly, 3301, head end, 3302, inner tube, 4000, embolic protection assembly, 4100, fixed end, 4200, open end, 4300, screen body, 4001, first embolic protection device, 4002, second embolic protection device.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further definition or explanation thereof is necessary in the following figures.

In the description of the present application, it should be noted that, directions or positional relationships indicated by terms such as "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present application and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be constructed and operated in a specific direction, and thus should not be construed as limiting the present application.

It should be noted that the terms "first," "second," and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implying a number of technical features being indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present application, the meaning of "a plurality" is two or more, unless explicitly defined otherwise.

Furthermore, the terms "horizontal," "vertical," and the like do not denote a requirement that the component be absolutely horizontal or overhang, but rather may be slightly inclined. As "horizontal" merely means that its direction is more horizontal than "vertical", and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

Example 1

The present embodiment provides a brain protection device including:

the bend-controlling catheter 1000 is configured to control the bending,

it comprises an outer sheath tube assembly 1100 located radially outermost of the proximal end of the instrument, a control elbow assembly 1200 located in a radially inward space of the outer sheath tube assembly 1100 and located distally relative to the outer sheath tube assembly 1100, an inner tube assembly 1300 located in a radially inward space of the control elbow assembly 1200 and distally relative to the control elbow assembly 1200;

the embolic protection assembly 2000 is provided with a lumen,

which includes a first embolic protection device 2001 at a proximal end in relation to the device and a second embolic protection device 2002 at a distal end in relation to the device.

Specifically, the outer sheath tube assembly 1100, the control elbow assembly 1200 and the inner tube assembly 1300 are all hollow tubular structures, the outer sheath tube assembly 1100, the control elbow assembly 1200 and the inner tube assembly 1300 are sequentially arranged, one end of the control elbow assembly 1200 is located in a radial inward space of one end of the outer sheath tube assembly 1100, and a first cavity 001 is formed between the control elbow assembly 1200 and the outer sheath tube assembly 1100; one end of the inner tube assembly 1300 is positioned in a radial inward space of one end of the control elbow assembly 1200, and a second cavity 002 is formed between the inner tube assembly 1300 and the control elbow assembly 1200;

A first embolic protection device 2001 is located in the first cavity 001 and a second embolic protection device 2002 is located in the second cavity 002.

The control elbow assembly 1200 may achieve relative movement in the axial direction and relative rotation in the circumferential direction with respect to the sheath tube assembly 1100; the inner tube assembly 1300 may achieve relative movement in the axial direction and relative rotation in the circumferential direction with respect to the control elbow assembly 1200.

The outer sheath pipe assembly 1100, the control elbow pipe assembly 1200 and the inner pipe assembly 1300 are hollow tubular structures, the outer sheath pipe assembly 1100, the control elbow pipe assembly 1200 and the inner pipe assembly 1300 can be connected through mutual nesting, the diameters of the connecting positions of two adjacent hollow tubular assemblies are different, and the assembly with the larger diameter is sleeved outside the assembly with the smaller diameter, so that axial relative movement and circumferential relative rotation are realized; if the head end of the control elbow assembly 1200 extends beyond the head end of the outer sheath tube assembly 1100 and has the same outer diameter as the outer sheath tube assembly 1100, the remainder of the control elbow assembly 1200 extends inside the outer sheath tube assembly 1100 until the tail end of the outer sheath tube assembly 1100 is reached;

the inner tube assembly 1300 and the control elbow assembly 1200 may be similarly configured;

in use, the opening or closing of the first cavity 001 between the sheath tube assembly 1100 and the elbow control assembly 1200 can be achieved by driving the tail end of the sheath tube assembly 1100 or the elbow control assembly 1200; opening or closing of the second cavity 002 between the control elbow assembly 1200 and the inner tube assembly 1300 is accomplished by driving the tail end of the control elbow assembly 1200 or the inner tube assembly 1300.

As shown in fig. 2a and 2b, the position of the control elbow assembly 1200 relative to the sheath tube assembly 1100 has two states, a closed state and an open state; the position of the inner tube assembly 1300 relative to the control elbow assembly 1200 has two states, a closed state and an open state.

As shown in fig. 4a and 4b, the bend control tube assembly 1200 has a bend control segment 1210, and a wire strand 1206 is attached to the end of the bend control segment 1210 remote from the sheath tube assembly 1100, the wire strand 1206 protruding through a hollow region of the sheath tube assembly 1100. When the wire 1206 in the bend control assembly 1200 is pulled in the axial direction, i.e., the bending control operation, the central axis of the bend control segment 1210 bends, i.e., enters the bend control state.

As shown in fig. 3a-3b, for an embolic protection assembly 2000 comprising a stent 2100, a screen body 2300, and a push wire or catheter 2400, the stent being a collapsible and expandable hollow structure constructed of a shape memory alloy material, the stent 2100 comprising a stent fixed end 2101, a stent transition section 2102, and a stent open end 2103 in that order; the screen body 2300 includes a screen tail end 2301 and a screen open end 2302 with sequentially increasing radially inward space; the screen body 2300 is attached to a stand 2100, and the stand 2100 is connected to a push wire or catheter 2400.

As shown in fig. 3a, in the first embolic protection device 2001, the stent transition section 2102 comprises a plurality of stent struts distributed circumferentially, and the stent open end 2103 comprises a plurality of connecting rods, each connecting rod respectively connecting two stent struts adjacent in the circumferential direction; when the stent 2100 is in the deployed state, the radially inward spaces of the stent-fixed end 2101, the stent-transition section 2102 and the stent-open end 2103 increase in sequence; screen open end 2302 connects to bracket open end 2103, screen tail end 2301 and bracket fixed end 2101 being on the same side of screen open end 2302.

The proposal proposes that the bracket fixing end 2101, the bracket transition section 2102 and the bracket opening end 2103 of the bracket of the first embolic protection device 2001 are all distributed along the circumference, the radial inward space is sequentially increased, the filter screen main body 2300 is fully covered at the bracket opening end 2103 at the outermost side, and the filter screen main body is in a net bag shape under the support of the bracket opening end 2103; the full-coating design of the filter membrane to the opening end of the bracket is realized by the bracket structure, and the probability that the intravascular emboli are blocked at the edge of the filter membrane or the edge of the bracket so that the intravascular emboli cannot be successfully captured is reduced.

The screen end 2301 is on the same side of the screen open end 2302 as the stent fixed end 2101 to filter blood flow from the stent open end.

Preferably, both ends of each connecting rod are respectively connected with the end parts of two adjacent bracket wave rods along the circumferential direction, and the middle part of each connecting rod is protruded in a direction away from the bracket fixing end 2101, so that the bracket 2100 forms a structure similar to a flower beam shape on the whole, and the filter screen opening end 2302 of the filter screen main body 2300 is connected with each connecting rod; the bracket open end 2103 of the form only has partial connecting rods on the same radial plane, and the rest is a hollow area or a filter screen, so that compared with the bracket 2100 on the same radial plane, namely the annular bracket open end 2103, the bracket open end 2103 is more suitable for blood vessels with different shapes and is not easy to damage the blood vessels.

As shown in fig. 3b, in the second embolic protection device 2002, the stent transition section 2102 has a rod-like structure formed by bending outwards, and the stent open end 2103 has a ring-like structure formed by encircling a shape memory alloy wire; when the bracket 100 is in the unfolded state, the alloy screw rod is bent from the bracket fixing end 110 towards the edge direction of the bracket opening end 120; the screen end 2301 and the bracket securing end 2101 are positioned opposite the screen opening end 2302, respectively, with the screen end 2301 being attached to the push wire or catheter 2400.

The present solution proposes that the stent 2100 of the second embolic protection device 2002 is actually made of a composite braided wire, and the two ends of the wire are connected together and then bent to form a stent fixed end 2101 and a stent transition section 2102; part of the middle section of the metal wire is bent and shaped into an arc-shaped ring to form an opening end 2103; similar to a lasso configuration overall, the contracted configuration of the stent 2100 resembles the lasso being installed into a round tube, creating a U-shaped profile within the tube. The expanded state of the stent 2100 is to push the lasso out, and the shape is restored due to the elasticity of the metal itself.

In the compressed state, the stent structure of the proposal can contain at most two strands of braided wires in the same section along the radial direction of the catheter, so the stent structure has smaller axial rigidity, namely, the stent structure is softer and is easy to bend, so that the embolic protection device of the invention is easier to move in the conveying catheter with bending.

The screen end 2301 and the stent attachment end 2101 are positioned opposite the screen opening end 2302 to filter blood flow from the stent attachment end.

The stent 2100 is made by heat setting a single or multiple braided strands of memory alloy wire. The diameter of the open end 2103 of the stent is matched with the diameter of the blood vessel to be protected, and the damage to the blood vessel caused by overlarge supporting force is avoided under the condition that enough radial supporting force is provided to ensure that the stent can be fully unfolded and attached in the blood vessel.

The present approach reduces the chance that an intravascular embolic will become stuck at the edge of the filter membrane or the edge of the stent, rendering it unable to be successfully captured, by providing the first embolic protection device 2001 in a proximally-located configuration in the form of a stent that resembles a flower-beam-like structure, providing more superior apposition in the proximal direction;

by providing the second embolic protection device 2002 relatively distally positioned in a stent-like fashion similar to a lasso structure, less axial rigidity is achieved, more flexibility and ease of bending, and adaptation to the higher bending performance requirements of the controlled bend catheter head.

For the first embolic protection device 2001 located in the first lumen 001, the stent fixation end 2101 is connected to a separate push wire or push catheter, for example, the proximal end of the push wire may be connected to the handle of the device; in the deployed state of the primary embolic protection device 2001, the primary embolic protection device 2001 is converted to a compressed state, known as loading of the embolic protection device or retrieval of the embolic protection device, by pushing the guidewire to draw the primary embolic protection device 2001 and the outer sheath tube assembly 1100 relative to each other in the primary lumen 001, gradually reducing its outer diameter until the outer sheath tube assembly 1100 fully receives the primary embolic protection device 2001 in the primary lumen 001. Conversely, by manipulating the relative movement of the sheath tube assembly 1100 and the primary embolic protection device 2001, the primary embolic protection device 2001 is pushed out of the primary lumen 001 and the compressed state is transitioned to the deployed state, which is referred to as the release of the embolic protection device.

For the second embolic protection device 2002 located in the second lumen 002, the stent fixation end 2101 thereof is attached to the inner tube portion of the inner tube assembly 1300; in the deployed state of the second embolic protection device 2002, the outer diameter of the inner tube assembly 1300 is gradually reduced by pulling the inner tube assembly 1300 and the control elbow assembly 1200 to move relatively in the second cavity 002 until the control elbow assembly 1200 fully receives the second embolic protection device 2002 in the second cavity 002, and the second embolic protection device 2002 is converted into a compressed state, i.e. loading of the embolic protection device or retrieval of the embolic protection device. Conversely, by manipulating the relative movement of the inner tube assembly 1300 and the control elbow assembly 1200, the second embolic protection device 2002 is pushed out of the second cavity 002 and the compressed state is transitioned to the expanded state, which is referred to as the release of the embolic protection device.

As shown in fig. 6a, the control elbow assembly 1200 has an extreme position 1 that is reached when relative distal-to-proximal movement is performed axially with respect to the sheath tube assembly 1100. When the relative position of the control elbow assembly 1200 and the sheath tube assembly 1100 is at the extreme position, the control elbow assembly 1200 and the sheath tube assembly 1100 are in a closed state. When the position of the control elbow assembly 1200 relative to the sheath tube assembly 1100 is further distal from the extreme position, the control elbow assembly 1200 is in an open state with the sheath tube assembly 1100. There is a tubular cavity 001 between the inner diameter of the sheath tube assembly 1100 and the outer diameter of the non-bend-controlling section 1204 of the bend-controlling assembly 1200. When the control elbow assembly 1200 and the sheath tube assembly 1100 are in a closed state, the distal side of the cavity 001 is not in communication with the outside; when the control elbow assembly 1200 and the sheath tube assembly 1100 are in an open state, the distal side of the cavity 001 is in communication with the outside;

As shown in fig. 7a and 7b, the first embolic protection device 2001 is positioned entirely within the cavity 001 in a compressed state, the first embolic protection device 2001 is coupled to a separate push guidewire or push catheter 2400, the proximal end of the push guidewire or push catheter 2400 is coupled to the handle of the instrument, and loading and release of the first embolic protection device 2001 is accomplished by pushing the push guidewire or catheter to draw the first embolic protection device 2001 into relative motion with respect to the outer sheath tube assembly 1100.

As shown in fig. 6b, the limit position 2 is reached when the inner tube assembly 1300 is axially moved relative to the elbow assembly 1200 from distal to proximal. When the relative position of the inner tube assembly 1300 with respect to the control elbow assembly 1200 is at the limit position, the inner tube assembly 1300 and the control elbow assembly 1200 are in a closed state. When the position of the inner tube assembly 1300 relative to the control elbow assembly 1200 is further distal from the extreme position, the inner tube assembly 1300 and the control elbow assembly 1200 are in an open state. There is a tubular cavity 002 between the inner diameter of the bend control section 1210 of the bend control tube assembly 1200 and the outer diameter of the inner tube 1302 of the inner tube assembly 1300. When the inner tube assembly 1300 and the control elbow assembly 1200 are in a closed state, the distal side of the cavity 002 is not in communication with the outside; when the inner tube assembly 1300 and the control elbow assembly 1200 are in an open state, the distal end side of the cavity 002 is communicated with the outside;

As shown in fig. 7c and 7d, the second embolic protection device 2002 is integrally located in the cavity 002 in a compressed state, and the push wire or catheter 2400 to which the second embolic protection device 2002 is connected is herein the inner tube 1302 of the inner tube assembly 1300, and loading and release of the second embolic protection device 2002 is achieved by pushing the inner tube assembly 1300 to push the second embolic protection device 2002 out of the second cavity 002 in the bending control section 1210 or into the second cavity 002.

As shown in fig. 8a and 8b, the bending control section 1210 of the bending control tube assembly 1200 can perform bending control operation by pulling the wire drawing 206 regardless of whether the relative positions between the outer sheath tube assembly 1100, the bending control tube assembly 1200, and the inner tube assembly 1300 are in the extreme positions 1 and 2, i.e., whether they are in the closed state or the open state. The second embolic protection assembly passively flexes within the control elbow assembly 1200 as the control elbow segment 1210 flexes.

Preferably, a bending control pull ring 1205 is connected to the end of the bending control segment 1210 away from the outer sheath tube assembly 1100, and the wire drawing 1206 is connected to the bending control pull ring 1205.

Preferably, as shown in fig. 5a and 5b, inner tube assembly 1300 includes a head end 1301, an inner tube 1302 located in a radially inward space of control elbow assembly 1200. Radially inward of head end 1301 and inner tube 1302 is a cavity 1303 for passage of a guidewire.

As a preferred embodiment, as shown in fig. 9a, 9b and fig. 10a, 10b, the bending control segment 1210 may further comprise a first bending control segment 1211 and a second bending control segment 1212 connected to each other, wherein an end of the first bending control segment 1211 remote from the second bending control segment 1212 is connected to the inner tube assembly 1300, and an end of the second bending control segment 1212 remote from the first bending control segment 1211 is connected to the outer sheath tube assembly 1100;

an included angle exists between the plane in which the central axis of the first bending control section 1211 is located and the plane in which the central axis of the second bending control section 1212 is located; the wire drawing 1206 is disposed at an end of the first bending control segment 1211 remote from the second bending control segment 1212.

The included angle between the plane where the central axis of the first bending control section 1211 and the plane where the central axis of the second bending control section 1212 is located is correspondingly set during the production of the multi-plane bending control catheter, and the multi-plane bending control catheter with the corresponding included angle can be selected according to the actual use requirement.

As shown in fig. 11a and 11b, when the bending control segment 1210 comprises a first bending control segment 1211 and a second bending control segment 1212, the bending control catheter is not affected to perform the functions described in claim 10 and claim 11.

When the bending control segment 1210 includes the first bending control segment 1211 and the second bending control segment 1212, an angle α may exist between the plane 1 in which the axis line of the first bending control segment 1211 is in the bending control state and the plane 2 in which the axis line of the second bending control segment 1212 is in the bending control state. As shown in fig. 11a and 11b, when the included angle α=0°, the bending-control catheter is in a single plane bending-control state; as shown in fig. 12 and 13, when the included angle α is not equal to 0 °, the bending control catheter is in a biplane bending control state.

As a preferred embodiment, the various parts of the sheath tube assembly 1100, the elbow control assembly 1200, the inner tube assembly 1300, and the embolic protection assembly 2000 may be provided with a developing ring, a developing polymer material, etc. for developing under X-rays according to practical requirements. The parts where development setting is necessary are: the distal end of the sheath tube assembly 1100 and the proximal end of the bend control segment 1210 of the bend control assembly 1200 are used to show the open and closed state of the bend control assembly 1200 and the sheath tube assembly 1100; the distal end of the bend control section 1210 of the bend control assembly 1200 and the head end 1301 of the inner tube assembly 1300 are used to display the open and closed state of the bend control assembly 1200 and the inner tube assembly 1300; the open end and the fixed end of the two embolic protection components are used for displaying the compression and expansion states of the embolic protection components and the position relation relative to the blood vessel.

An alternative embodiment of the above scheme is described below.

The brain protection device described in this example includes:

the bend-controlling catheter 3000 is provided with a guide tube,

an outer sheath tube assembly 3100 located radially outermost of the proximal end of the instrument; a control elbow assembly 3200 located in a radially inward space of the outer sheath tube assembly 3100 and at a distal end relative to the outer sheath tube assembly 3100; an inner tube assembly 3300 located in a radially inward space of the control elbow assembly 3200 and distal to the control elbow assembly 3200.

In conjunction with the embolic protection assembly 4000,

comprising a first embolic protection device 4001 at a proximal end in a relative position and a second embolic protection device 4002 at a distal end in a relative position.

The control elbow assembly 3200 can realize relative motion along the axial direction and relative rotation along the circumferential direction relative to the sheath tube assembly 3100; the inner tube assembly 3300 may achieve relative movement in the axial direction and relative rotation in the circumferential direction with respect to the control elbow assembly 3200.

As shown in fig. 14a and 14b, the position of the elbow control assembly 3200 relative to the sheath tube assembly 3100 has two states, a closed state and an open state; the position of inner tube assembly 3300 relative to elbow control assembly 3200 has two states, a closed state and an open state.

The bend control assembly 3200 has a bend control segment 3210, the bend control segment 3210 being further divided into a first bend control segment 3211 and a second bend control segment 3212. When the wire drawing 3206 in the bend control assembly 3200 is pulled along the axial direction, i.e. the bend control operation, the central axes of the first bend control segment 3211 and the second bend control segment 3212 are bent, i.e. enter a bend control state.

The embolic protection assembly 4000 comprises a fixed end 4100, an open end 4200, a screen body 4300, and a push wire or catheter; the screen body 4300 in the expanded state is generally net-shaped, having a maximum radial diameter near the open end 4200 and being connected to the open end 4200. The screen body allows blood flow to pass through but the larger diameter emboli cannot pass through the mesh of the screen. The open end 4200 is used to conform to the inner wall of a blood vessel in the deployed state. The diameter of the open end of the first jersey protection device 4001 is preferably 15-18mm; the diameter of the open end of the second embolic protection device 4002 is preferably 10-12mm.

The bracket transition section of the first jersey protection device 4001 comprises a plurality of bracket wave rods distributed along the circumference, the opening end of the bracket comprises a plurality of connecting rods, and each connecting rod is respectively connected with two adjacent bracket wave rods along the circumferential direction; the two ends of each connecting rod are respectively connected with the end parts of two adjacent support wave rods along the circumferential direction, and the middle parts of the connecting rods are protruded in the direction away from the fixed ends of the supports, so that the supports form a structure similar to a flower beam shape on the whole;

the transition section of the bracket of the second latch protection device 4002 is a rod-shaped structure formed by outwards bending, and the open end of the bracket is an annular structure formed by encircling shape memory alloy wires; the bracket is made of a composite braided metal wire, and the two ends of the metal wire are connected together and then bent to form a bracket fixed end and a bracket transition section; part of the middle section of the metal wire is bent and shaped into an arc-shaped ring to form an open end; similar overall to a lasso construction.

The screen body 4300 is preferably made of a polymeric film material by laser drilling, and the pore size of the holes is preferably 80 microns to 180 microns to ensure that blood flow is unobstructed while emboli do not leak. The fixed end 4101 of the first plug protection device is connected with the head end of the pushing guide wire by crimping, and the fixed end 4102 of the second plug protection device is connected with a pushing catheter by bonding, in this embodiment, the pushing catheter is the inner tube of the inner tube assembly 3300. In this embodiment, developing structures developed under X-rays are attached to the open ends and the fixed ends of the two embolic protection devices, so as to show the deployment state of the embolic protection devices and the relative positions of the embolic protection devices and the blood vessels.

The sheath tube assembly 3100 is formed of a woven metal tube with an outer polymer layer, and has a developing structure at the distal end for developing under X-rays for determining and controlling the closed state of the elbow assembly 3200.

The configuration of bend control assembly 3200 is shown in fig. 15a and 15b and includes a bend control segment 3210 (first and second bend control segments 3211 and 3212), a non-bend control segment 3204 located in a radially inward space of sheath tube assembly 3100, a bend control tab 3205 located at a distal end of first bend control segment 3211, a wire strand 3206 connected to bend control tab 3205, and a transition segment 3207 located at a proximal end of second bend control segment 3212. The first bending control segment 3211 is formed by a metal braided tube with a polymer outer layer. The second bending control segment 3212 is a hypotube made of a laser cut stainless steel tube, and the bending of the hypotube has a limit position. As shown in fig. 16, an included angle α between the wire-embedding direction of the wire drawing of the first bending control segment 3211 and the back rib direction of the hypotube of the second bending control segment 3212 is not 0 in the circumferential direction, so as to realize biplane bending control. Non-controlled bending section 3204 is made of a relatively hard nylon material and has good tensile compression and torsion resistance. The bending control pull ring 3205 is made of precious metal with a developing function, such as platinum or platinum tungsten alloy, and is fixed at the distal end of the first bending control section 3211 in a hot melting manner. The wire 3206 is fixed to the pull ring 3205 by welding. The transition section 3207 is located in a space radially inward of the sheath tube assembly 3100 in the closed state, and serves as a core at the transition joint of the sheath tube assembly 3100 and the elbow control assembly 3200, preventing the catheter from breaking off from the joint. The transition section 3207 is rigidly connected to the metallic hypotube of the second bending control section 3212. The second bending control segment 3212 conforms to the outer diameter of the outer sheath tube assembly 3100 to prevent the segment 3212 from entering the radial space of the outer sheath tube assembly 3100 during the closing process, such that the second bending control segment fails to achieve the bending control function in the closed state.

Inner tube assembly 3300 includes a head end 3301, an inner tube 3302 positioned in a radially inward space of elbow control assembly 3200. Radially inward of the head end 3301 and the inner tube 3302 is a guidewire lumen 3303. The material of the head end 3301 is noble metal with development function such as platinum or platinum tungsten alloy, the maximum outer diameter of the head end 3301 is smaller than the inner diameter of the distal end of the first bending control section 3211, and in a closed state, the head end 3301 is completely hidden in the space inside the first bending control section 3211. The closed state of bend control assembly 3200 is determined by comparing the relative positions of head end 3301 and bend control tab 3205 under X-rays. The inner tube 3302 is made of nylon with harder marks, and has good tensile compression resistance and torsion resistance.

As shown in fig. 17a, 17b and 17b, the brain protection device described in this embodiment can implement the bending control operation and the loading and releasing operation of the two embolic protection components independently of each other.

As shown in fig. 18a and 18b, the brain protection device described in this embodiment may be implemented via radial access, controlled bending of the catheter assembly such that the distal end of the control elbow assembly enters the left common carotid artery. After the catheter has been completed with the access, the first and second embolic protection devices are released, respectively. The first embolic protection device filters emboli in the innominate artery, and the second embolic protection device filters emboli in the left common carotid artery, thereby achieving the function of blocking the falling emboli from entering the cerebral vasculature during TAVR procedures.

The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention by one of ordinary skill in the art without undue burden. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.

Claims

1. The brain protection device is characterized by comprising a bending control catheter (1000), a first embolic protection device (2001) and a second embolic protection device (2002), wherein the bending control catheter (1000) comprises an outer sheath tube assembly (1100), a bending control tube assembly (1200) and an inner tube assembly (1300) which are sequentially sleeved and connected at the end parts, and a first cavity (001) is formed between the bending control tube assembly (1200) and the outer sheath tube assembly (1100); a second cavity (002) is formed between the inner tube assembly (1300) and the control elbow assembly (1200); -said first embolic protection device (2001) is located within said first cavity (001), and said second embolic protection device (2002) is located within said second cavity (002);

the first embolic protection device (2001) and the second embolic protection device (2002) each comprise a stent (2100), a screen body (2300), and a push wire or catheter (2400); the bracket (2100) is made of shape memory alloy and comprises a bracket fixed end (2101), a bracket transition section (2102) and a bracket open end (2103) which are distributed in sequence; the filter screen main body (2300) comprises a filter screen tail end (2301) and a filter screen open end (2302), wherein the space of the filter screen tail end (2301) and the filter screen open end (2302) are sequentially enlarged in the radial direction, and the filter screen open end (2302) is connected with the bracket open end (2103);

In the first embolic protection device (2001), the stent transition section (2102) comprises a plurality of stent wave rods distributed along the circumference, the stent open end (2103) comprises a plurality of connecting rods, and each connecting rod is respectively connected with two adjacent stent wave rods along the circumference direction;

in the second embolic protection device (2002), the stent transition section (2102) is a rod-shaped structure formed by bending outwards, and the stent open end (2103) is an annular structure formed by encircling a shape memory alloy wire.

2. A brain protection device according to claim 1, wherein in said first embolic protection device (2001), said screen tail end (2301) and said holder fixed end (2101) are both located on the same side of the screen open end (2302);

in the second embolic protection device (2002), the screen tail end (2301) and the bracket fixed end (2101) are respectively positioned at opposite sides of the screen opening end (2302), and the screen tail end (2301) is connected to the pushing guide wire or catheter (2400).

3. A brain protecting device according to claim 1, wherein in said first embolic protecting device (2001), both ends of each connecting rod are respectively connected to end portions of two stent wave rods adjacent in a circumferential direction, and a middle portion of each connecting rod is protruded in a direction away from a stent fixed end (2101).

4. The brain protection device according to claim 1, wherein the first embolic protection device (2001) and the second embolic protection device (2002) are embolic protection components (2000) having a compressed state and an expanded state, the embolic protection components (2000) being located within corresponding cavities when the embolic protection components (2000) are in the compressed state; when the embolic protection assembly (2000) is in the deployed state, the outer diameter of the open end of the embolic protection assembly (2000) is matched with the size of the blood vessel to be protected and conforms to the inner wall of the blood vessel.

5. The brain protection device according to claim 1, wherein the control elbow assembly (1200) comprises a control elbow section (1210) and a non-control elbow section (1204) which are connected to each other, the non-control elbow section (1204) is located in a radial inward space of the outer sheath tube assembly (1100), a wire drawing (1206) is connected to an end of the control elbow section (1210) away from the outer sheath tube assembly (1100), and the wire drawing (1206) extends through the non-control elbow section (1204) and a hollow region of the outer sheath tube assembly (1100).

6. The brain protection device according to claim 5, wherein the bending control segment (1210) comprises a first bending control segment (1211) and a second bending control segment (1212) connected to each other, wherein an end of the first bending control segment (1211) remote from the second bending control segment (1212) is connected to the inner tube assembly (1300), and wherein an end of the second bending control segment (1212) remote from the first bending control segment (1211) is connected to the outer sheath tube assembly (1100);

An included angle exists between a plane where the central axis of the first bending control section (1211) is located and a plane where the central axis of the second bending control section (1212) is located; the wire drawing (1206) is arranged at one end of the first bending control section (1211) far away from the second bending control section (1212).

7. The brain protection device according to claim 6, wherein said control elbow assembly (1200) is in a single plane control elbow state when an angle between a plane in which a central axis of said first control elbow section (1211) is located and a plane in which a central axis of said second control elbow section (1212) is located is 0 degrees; when the included angle between the plane of the central axis of the first bending control section (1211) and the plane of the central axis of the second bending control section (1212) is not 0 degrees, the bending control assembly (1200) is in a biplane bending control state.

8. The brain protection device according to claim 1, wherein said control elbow assembly (1200) is axially and circumferentially relatively movable along the sheath tube assembly (1100); the inner pipe assembly (1300) can perform axial relative movement and circumferential relative rotation along the control elbow assembly (1200);

the control elbow assembly (1200) is provided with a first limit position which moves opposite to the outer sheath tube assembly (1100), and when the outer sheath tube assembly (1100) is positioned at the first limit position on the control elbow assembly (1200), the joint between the outer sheath tube assembly (1100) and the control elbow assembly (1200) is in a closed state; when the outer sheath pipe assembly (1100) does not reach the first limit position on the control elbow assembly (1200), the joint between the outer sheath pipe assembly (1100) and the control elbow assembly (1200) is in a communication state with the outside;

The inner pipe assembly (1300) is provided with a second limit position which moves towards the control bent pipe assembly (1200), and when the control bent pipe assembly (1200) is positioned at the second limit position on the inner pipe assembly (1300), the joint between the control bent pipe assembly (1200) and the inner pipe assembly (1300) is in a closed state; when the control elbow assembly (1200) does not reach the second limit position on the inner pipe assembly (1300), the connection part between the control elbow assembly (1200) and the inner pipe assembly (1300) is in an external communication state.

9. The brain protection device according to claim 1, wherein the control elbow assembly (1200) performs a control elbow operation, the inner tube assembly (1300) performs an opening and closing operation with respect to the control elbow assembly (1200), and the control elbow assembly (1200) performs an opening and closing operation with respect to the outer sheath tube assembly (1100), which may be performed independently of each other.

10. The brain protection device according to claim 1, wherein the sheath tube assembly (1100), the control elbow assembly (1200), the inner tube assembly (1300), the first embolic protection device (2001) and the second embolic protection device (2002) are each provided with a visualization structure.