An ultrasound under direction pointing device

Abstract

The application provides an under-ultrasound direction guiding device and an under-ultrasound developing method. The under-ultrasound direction guiding device comprises a conveying member and a guiding assembly. The conveying member is internally provided with a conveying cavity along a proximal-to-distal direction. The guiding assembly is adapted to be arranged in the conveying cavity. The guiding assembly comprises a positioning member arranged at the distal end of the guiding assembly. The positioning member has a positioning state under the action of an external force, in which the positioning member is separated from the conveying cavity through the distal end of the conveying cavity, so as to adapt to the positioning of the distal end of the conveying member by an external ultrasound device. In the positioning state, the cross section of the conveying member and the cross section of the positioning member are in the same plane along the proximal-to-distal direction. The cross section area of the positioning member in the positioning state is the maximum cross section area of the positioning member. An ultrasound section is determined by the maximum cross section of the positioning member and the cross section of the conveying member, so as to determine the direction of the distal end of the conveying member, and then accurate positioning is realized, and the difficulty and risk of the operation are reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an ultrasound direction guiding device and an ultrasound imaging method. BACKGROUND

[0002] With the development of medical technology, the development of transcatheter mitral valve replacement valves has become a stage for major valve manufacturers to compete. Since the physiological structure of the human mitral valve is in the shape of "D", in order to better fit the physiological structure of the human body and ensure the sealing of the replacement valve, the shape of the mitral valve replacement valve is preferably in the shape of "D".

[0003] In the common guidance of transcatheter replacement valves, common guidance includes DSA imaging and ultrasound imaging. Since DSA imaging uses X-ray fluoroscopy, it will produce radiation, which will cause great harm to the operator and the patient.

[0004] Although the ultrasound imaging method can reduce the harm to the operator and the patient, ultrasound is scanned one section at a time, so the biggest difficulty in using ultrasound as the only guiding means is that ultrasound cannot accurately determine the position of the catheter head in the heart like X-rays, which causes difficulty in accurate positioning during the operation and increases the difficulty and risk of the operation. SUMMARY

[0005] Therefore, the technical problem to be solved by the present application is that in the prior art, although the ultrasound imaging method can reduce the harm to the operator and the patient, ultrasound is scanned one section at a time, so the biggest difficulty in using ultrasound as the only guiding means is that ultrasound cannot accurately determine the position of the catheter head in the heart like X-rays, which causes difficulty in accurate positioning during the operation and increases the difficulty and risk of the operation.

[0006] Therefore, the present application provides an ultrasound direction guiding device, comprising:

[0007] a conveying member, which is provided with a conveying cavity in the direction from the proximal end to the distal end;

[0008] a guiding assembly adapted to be arranged in the conveying cavity, and the distal end of the guiding assembly is provided with a positioning member;

[0009] wherein the positioning member has a positioning state under the action of an external force, in which the positioning member is separated from the conveying cavity through the distal end of the conveying cavity, so as to adapt to the positioning of the distal end of the conveying member by an external ultrasound device;

[0010] In the positioning state, the cross section of the conveying member and the cross section of the positioning member are in the same plane in the direction from the proximal end to the distal end, and the cross sectional area of the positioning member in the positioning state is the maximum cross sectional area of the positioning member.

[0011] Optionally, the guiding component further comprises a connecting member, the connecting member is connected with the positioning member at a distal end, and the connecting member and the positioning member are arranged at an angle in the positioning state.

[0012] Optionally, the angle is 45-135 degrees.

[0013] Optionally, the angle is 90 degrees.

[0014] Optionally, the positioning member comprises a first mesh basket and a second mesh basket, and the first mesh basket and the second mesh basket are symmetrically arranged relative to a center line of the delivery cavity.

[0015] Optionally, in the positioning state, along a first direction perpendicular to a cross section of the delivery member, a cross section area of the positioning member perpendicular to the first direction first gradually increases and then gradually decreases.

[0016] Optionally, the positioning member is spherical or rugby-shaped.

[0017] Optionally, the positioning member is a high polymer or a metal material with a shape memory function, and after the positioning member is separated from the delivery cavity at a distal end of the delivery cavity, the positioning member restores the deformation to enter the positioning state.

[0018] An ultrasound direction guiding method, comprising the following steps:

[0019] Step one: finding a left ventricular long axis and a two-chamber section under ultrasound;

[0020] Step two: inserting a guiding component into a delivery cavity of a delivery member, and then sending the delivery member and the guiding component into a heart;

[0021] Step three: sending a positioning member in the guiding component out of a distal end of the delivery cavity through a connecting member in the guiding component, moving the delivery member and the guiding component in four directions of front, back, left and right and clockwise and counterclockwise, and determining a pointing direction of the distal end of the delivery cavity through the positioning member;

[0022] Step four: fixing the delivery member, withdrawing the guiding component, sending an artificial replacement valve into the pointing direction of the distal end of the delivery cavity through the delivery cavity of the delivery member, and releasing the artificial replacement valve.

[0023] Optionally, the ultrasound direction guiding method is executed by the ultrasound direction guiding device.

[0024] The ultrasound direction guiding device and the ultrasound direction guiding method have the following advantages:

[0025] 1. The present application provides a kind of direction guiding device under ultrasound, comprising conveying piece and guiding component, conveying piece is equipped with conveying cavity along the proximal end to the distal direction, guiding component is suitable for being arranged in the conveying cavity, the guiding component includes positioning piece, the positioning piece is equipped at the distal end of the guiding component, wherein the positioning piece has under the action of external force, through the distal end of the conveying cavity, separate from the conveying cavity, to adapt to the positioning of the distal end of the conveying piece by external ultrasound device in positioning state;In the positioning state, along the proximal end to the distal direction, the cross section of the conveying piece and the cross section of the positioning piece are in the same plane, and the cross section area of the positioning piece in the positioning state is the maximum cross section area of the positioning piece.

[0026] The structure of the direction guiding device under ultrasound, by setting positioning piece at the distal end of guiding component, and positioning piece has under the action of external force, through the distal end of the conveying cavity, separate from the conveying cavity, to adapt to the positioning of the distal end of the conveying piece by external ultrasound device in positioning state, when positioning, by ultrasound one section one section of the cross section of positioning piece is scanned in sequence, until positioning piece is in positioning state, i.e. the cross section of the largest area of positioning piece and the cross section of conveying piece are scanned by ultrasound section, to determine an ultrasound section, to determine the direction of the distal end of conveying piece, to realize accurate positioning, reduce the difficulty and risk of operation.

[0027] 2. The present application provides a kind of direction guiding device under ultrasound, by rotating guiding device under ultrasound, when the first net basket and the second net basket are scanned by ultrasound section, there will be a section effect from small circle to large circle and then to small circle, i.e. the cross section size of the first net basket and the second net basket under different cross sections, and the 180 ° diagonal distribution of the first net basket and the second net basket can determine an ultrasound section by the cross section of the first net basket and the second net basket under the maximum cross section and the cross section of conveying piece, and the 180 ° diagonal distribution of the first net basket and the second net basket can ensure the accuracy of the direction of the first net basket and the second net basket under ultrasound cross section is easier to capture under ultrasound section. BRIEF DESCRIPTION OF DRAWINGS

[0028] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the drawings needed in the following specific embodiments or prior art description will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creating labor.

[0029] Figure 1 The structure of the direction guiding device under ultrasound provided in the embodiments of the present application is shown in the schematic view;

[0030] Figure 2 The structure of the direction guiding device under ultrasound provided in the embodiments of the present application is shown in the schematic view; Figure 1An enlarged view of the structure at the middle circle A;

[0031] Figure 3 An internal structure schematic view of the under-ultrasound direction guiding device provided in the embodiments of the present application;

[0032] Legend of reference signs:

[0033] 1-conveying member;

[0034] 2-first mesh basket;

[0035] 3-second mesh basket. DETAILED DESCRIPTION

[0036] The technical solutions of the present application will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0037] In the description of the present application, it should be noted that the orientations or positional relationships indicated by the terms “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer” and the like are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms “first”, “second”, “third” are only for the purpose of description, and cannot be understood as indicating or implying relative importance. In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0038] In the description of the present application, it should be noted that the distal end of the present application refers to the end close to the first mesh basket 2 and the second mesh basket 3, and the proximal end of the present application refers to the end away from the first mesh basket 2 and the second mesh basket 3 in the conveying member 1.

[0039] Embodiment 1

[0040] The present embodiment provides an under-ultrasound direction guiding device, which comprises a conveying member 1, a first mesh basket 2 and a second mesh basket 3. Figures 1 to 3As shown, the delivery member 1 is provided with a delivery cavity in the proximal-to-distal direction, and the guide assembly is arranged in the delivery cavity. The guide assembly comprises a positioning member and a connecting member. When positioning the distal pointing direction of the delivery member 1, the operator operates the connecting member at the proximal end of the delivery cavity in the delivery member 1, and sends the positioning member fixedly connected at the distal end of the connecting member out of the distal end of the delivery cavity, so that the ultrasound can scan the positioning member and the delivery member 1, and the distal pointing direction of the delivery member 1 is positioned by the positioning member, so that the positioning member enters the positioning state. The proximal-to-distal direction is the direction from the bottom to the top of the delivery member 1 in Figure 1 .

[0041] In this embodiment, the delivery member 1 is in a cylindrical shape, and the distal end is provided with an arc-shaped chamfer. The delivery member 1 is provided with a delivery cavity along the axis in the center, and the two ends of the delivery cavity are arranged in an open manner through the inside of the delivery member 1, so as to facilitate the delivery of the object from the proximal end to the distal end of the delivery member 1 through the delivery cavity. The material of the delivery member 1 is high polymer, braided tube or metal material.

[0042] In this embodiment, as shown in Figure 3 , the positioning member comprises a first basket 2 and a second basket 3, and the proximal end of each of the first basket 2 and the second basket 3 is fixedly connected with a connecting member. The proximal end of the connecting member is arranged outside the delivery member 1 after penetrating through the delivery cavity in the inside of the delivery member 1, so that the operator can control the first basket 2 and the second basket 3 through the proximal end of the connecting member.

[0043] Further, the first basket 2 and the second basket 3 are made of high polymer or metal material with shape memory function, and can be made by laser cutting the pipe material and heat treatment, or made by braiding the wire material and shaping. The first basket 2 and the second basket 3 are guided to be spherical in the natural state. Since the first basket 2 and the second basket 3 are made of high polymer or metal material with shape memory function, when the first basket 2 and the second basket 3 are delivered through the delivery cavity in the inside of the delivery member 1, the first basket 2 and the second basket 3 can be folded and placed in the inside of the delivery cavity. Then, the connecting member fixedly connected with the proximal end of the first basket 2 and the second basket 3 can be used to apply a force to the first basket 2 and the second basket 3 in the distal direction, until the first basket 2 and the second basket 3 are pushed out of the distal end of the delivery cavity, and the first basket 2 and the second basket 3 can restore their set spherical shape by themselves. The first basket 2 and the second basket 3 are made of memory metal or high polymer material, and are processed by laser cutting or wire braiding. When the first basket 2 and the second basket 3 are delivered, the volume can be compressed to enter a very small delivery cavity for convenient delivery.

[0044] In this embodiment, as shown in Figure 3As shown, the first mesh basket 2 and its connecting piece are set at a 90-degree angle at the far end of the conveying cavity, that is, the first mesh basket 2 is bent 90 degrees to the left relative to the axis of the conveyor 1. Similarly, the second mesh basket 3 is bent 90 degrees to the right relative to the axis of the conveyor 1, so that the first mesh basket 2 and the second mesh basket 3 are symmetrically arranged with respect to the axis of the conveyor 1. The connecting pieces connected to the proximal ends of the first mesh basket 2 and the second mesh basket 3 are fixedly connected by crimping, welding, bonding or other connection methods, so that the first mesh basket 2 and the second mesh basket 3 can always maintain a symmetrical state.

[0045] Because in existing technologies, ultrasound scans one section at a time, by rotating the guiding device under ultrasound, when the ultrasound section scans the first basket 2 and the second basket 3, there will be a section effect of small circle to large circle and then back to small circle. That is, the cross-sectional size of the first basket 2 and the second basket 3 under different cross-sections. Since the first basket 2 and the second basket 3 are diagonally distributed at 180°, an ultrasound section can be determined by the cross-sections of the first basket 2 and the second basket 3 at the maximum cross-section and the cross-section of the conveying component 1. At this time, the positioning component is in the positioning state. That is, in the positioning state, along the direction from the proximal end to the distal end, the cross-section of the conveying component 1 and the cross-section of the positioning component are on the same plane. This plane is the ultrasound section determined above, and the area of ​​the positioning component cross-section in the positioning state is the maximum area of ​​the positioning component cross-section.

[0046] When the guiding device is moved through the four directions of anterior, posterior, left, and right, as well as clockwise and counterclockwise, under the long axis of the left ventricle and the two chambers, the cross-sections of the first basket 2 and the second basket 3 at the maximum cross-sectional area and the cross-section of the conveying component 1 can be found to determine that the direction pointed to by the distal end of the conveying component 1 in the guiding device is pointing to the corresponding physiological structure.

[0047] In this embodiment, in the positioning state, that is, after the first basket 2 and the second basket 3 are pushed out from the far end of the conveying cavity, along the first direction of the maximum area cross-section of the vertical conveying member 1, the first direction is vertical. Figure 3 In the direction of the cross-section of the transmission component, the cross-sectional area of ​​the positioning component perpendicular to the first direction gradually increases and then gradually decreases. This arrangement makes it easier for the first basket 2 and the second basket 3 to be captured under ultrasonic cutting, facilitating operator operation and positioning.

[0048] In some other embodiments, the first basket 2 and the second basket 3 may also be shaped like a rugby ball.

[0049] In some other embodiments, the first basket 2 is bent to the left at an angle ranging from 45 to 135 degrees relative to the axis of the conveyor 1, while the second basket 3 is bent to the right at an angle ranging from 45 to 135 degrees relative to the axis of the conveyor 1.

[0050] The device for guiding direction under ultrasound provided by the embodiment can ensure the accuracy of the direction of the first net basket 2 and the second net basket 3 under the ultrasound section, and the first net basket 2 and the second net basket 3 are easier to capture under the ultrasound section, which is convenient for the operator to operate and position, and can determine the direction of the instrument under ultrasound without damaging the original physiological structure, guide the instrument to cooperate with the corresponding physiological structure, and has the advantages of precision, no radiation and no contrast agent compared with the common DSA imaging and ultrasound imaging in the prior art.

[0051] Embodiment 2

[0052] The embodiment provides a method for imaging under ultrasound, and the method comprises the following steps:

[0053] Step one: find the left ventricular long axis and the two heart cavity sections under ultrasound;

[0054] Step two: insert the guiding assembly into the delivery cavity of the delivery member 1, and then insert the delivery member 1 and the guiding assembly into the heart;

[0055] Step three: send the positioning member in the guiding assembly out of the distal end of the delivery cavity through the connecting member in the guiding assembly, move the delivery member 1 and the guiding assembly in the forward, rear, left and right directions and clockwise and counterclockwise directions, and determine the pointing direction of the distal end of the delivery cavity through the positioning member;

[0056] Step four: fix the delivery member 1, withdraw the guiding assembly, then send the artificial replacement valve into the pointing direction of the distal end of the delivery cavity through the delivery cavity of the delivery member 1, and release the artificial replacement valve.

[0057] Obviously, the above embodiment is only an example for clear illustration, and does not limit the implementation. Based on the above description, other different forms of changes or variations can be made by those skilled in the art. Here, all the implementation modes are not enumerated, and the obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. An ultrasonic directional guidance device, characterized in that, include: The conveying component has a conveying cavity extending from the proximal end to the distal end. A guide assembly is adapted to pass through the conveying cavity, the guide assembly including a positioning element disposed at the distal end of the guide assembly; The positioning component is positioned such that, under the action of an external force, it detaches from the delivery cavity at its distal end to adapt to an external ultrasonic device for positioning the distal end of the delivery component. In the positioning state, along the proximal to distal direction, the cross-section of the conveying component and the cross-section of the positioning component are in the same plane, and the area of ​​the positioning component cross-section in the positioning state is the maximum cross-sectional area of ​​the positioning component; The guiding component further includes a connector, the distal end of which is connected to the positioning component, and in the positioning state, the connection between the positioning component and the connector is set at an angle. The positioning component includes a first net basket and a second net basket, which are symmetrically arranged with respect to the center line of the conveying cavity.

2. The ultrasonic directional guidance device according to claim 1, characterized in that, The included angle is 45-135 degrees.

3. The ultrasonic directional guidance device according to claim 2, characterized in that, The included angle is 90 degrees.

4. The ultrasonic directional guidance device according to claim 1, characterized in that, In the positioning state, along the first direction perpendicular to the cross-section of the conveying component, the cross-sectional area of ​​the positioning component perpendicular to the first direction first gradually increases and then gradually decreases.

5. The ultrasonic directional guidance device according to claim 4, characterized in that, The positioning element is spherical or rugby ball-shaped.

6. The ultrasonic directional guidance device according to claim 5, characterized in that, The positioning element is a polymer or metal material with shape memory function. After the positioning element leaves the conveying cavity at the far end, the positioning element restores its deformation and enters the positioning state.

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