WO2020238561A1

WO2020238561A1 - Real-time high-resolution puncture guiding system

Info

Publication number: WO2020238561A1
Application number: PCT/CN2020/088303
Authority: WO
Inventors: 简小华; 曹钰华
Original assignee: 苏州希声科技有限公司
Priority date: 2019-05-30
Filing date: 2020-04-30
Publication date: 2020-12-03
Also published as: CN110051386A

Abstract

A real-time high-resolution puncture guiding system. The puncture guiding system comprises a system host (2) and a guide needle capable of electrically communicating with the system host (2). The guide needle comprises a cylindrical support body having a proximal end and a distant end, a forward-looking detection unit disposed on an end face of the distal end of the support body, a side-looking detection unit disposed on the peripheral surface of the support body and close to the distal end of the support body, and a connecting unit for electrically communicating the forward-looking detection unit and the side-looking detection unit with the system host (2). A working channel (10) is further formed in the support body. The puncture guiding system can effectively solve the problem of inability to perform high-frequency high-resolution imaging on deep tissue due to that the existing ultrasound guided puncture device can perform monitoring and give guidance only outside the body; by integrating forward-looking detection, side-looking detection and the working channel (10), not only imaging of a region in front of a needle body but also imaging in a side-looking direction of the needle body can be achieved, the picture/injection direction and precision can be guided and observed in real time.

Description

A real-time high-resolution puncture guidance system

Technical field

The invention relates to a real-time high-resolution puncture guidance system.

Background technique

At present, puncture sampling, catheter placement, fluid aspiration, drug injection and nerve block under ultrasound guidance are advanced clinical diagnosis and treatment techniques that are becoming more and more popular in clinical practice. Existing methods mostly use extracorporeal ultrasound probes (B-ultrasound) to image the lesion area that needs puncture or anesthetized nerves, and then insert the puncture needle, and use ultrasound imaging to observe the insertion position of the puncture needle in real time to achieve sampling or blocking of the target Hysteresis; due to the use of extracorporeal ultrasound probes, the penetration depth is relatively shallow, which makes it impossible to use high-resolution high-frequency ultrasound probes for deep tissue fine structure imaging (such as nerves). Although there are also proposals to optimize the design of the reflection part structure on the puncture needle, it is still difficult to accurately locate the area where the puncture is deeper or the puncture part is small.

In addition, there are also some miniaturized ultrasound probes (such as patent 201210063587.1) or a micro ultrasound probe (patent 201710084155.1) built into the puncture needle for puncture guidance, but the former probe and the puncture needle are still separated, which can detect lesions with a small operating space, such as Intracranial puncture is still inconvenient; the latter is directly integrated, but there is no working channel, so it can only puncture and cannot perform operations such as sampling and injection. Moreover, it has only a front view image and cannot be used for relative positioning. For example, how deep is the puncture and the angle It is impossible to observe the surrounding tissues.

Summary of the invention

The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a real-time high-resolution puncture guidance system.

To solve the above technical problems, the technical solutions adopted by the present invention are as follows:

A real-time high-resolution puncture guidance system. The puncture guidance system includes a system host and a guide needle that can be electrically connected to the system host. The guide needle includes a cylindrical support with a proximal end and a distal end, and is arranged on the distal end of the support The front-view detection unit on the upper side, the side-view detection unit arranged on the outer peripheral surface of the support and close to the distal end of the support, the connection unit that electrically connects the front-view detection unit and the side-view detection unit with the system host, and there is also A working channel is provided, and the working channel penetrates the support body along the length extension direction of the support body, and at least one working channel is provided; the cross-sectional shape of the working channel in the length extension direction is circular, rhombus, or ellipse; There are multiple working channels, and the cross-sectional areas in the length direction of the multiple working channels are the same or different; the forward-looking detection unit includes a plurality of first micro ultrasonic probes, and the plurality of first micro ultrasonic probe arrays are arranged in one or more Group; a plurality of first miniature ultrasonic probes are arranged in a linear array, or in a circular array, or in a planar array, or in a convex array; the side-view detection unit includes a plurality of second A miniature ultrasound probe, a plurality of second miniature ultrasound probe arrays are arranged in one or more groups; the plurality of second miniature ultrasound probes are arranged in a linear array, or in a circular array, or in a planar array, Or arranged in a convex array; the connection unit includes a connection cable electrically connected to the front-view detection unit or the side-view detection unit, and a connector connected to the connection cable. The connection cable is embedded in the support body and the connector Set on the outer periphery of the support body; the support body includes a filler body, an outer shell fixedly supported on the outer periphery of the filler body, and the filler body is composed of epoxy resin, rubber or UV glue; the system host includes an ultrasonic probe excitation power module and an ultrasonic signal receiving module , Acquisition module, processing circuit module, image display module, information processing software module.

A real-time high-resolution puncture guidance system. The puncture guidance system includes a system host and a guide needle that can be electrically connected to the system host. The guide needle includes a cylindrical support with a proximal end and a distal end, and is arranged on the distal end of the support The front-view detection unit on the upper side, the side-view detection unit arranged on the outer peripheral surface of the support and close to the distal end of the support, the connection unit that electrically connects the front-view detection unit and the side-view detection unit with the system host, and there is also A working channel is provided, and the working channel penetrates the supporting body along the extending direction of the length of the supporting body, and at least one working channel is provided.

Preferably, the cross-sectional shape of the working channel in the direction of its length extension is circular, rhombus, or ellipse.

Preferably, multiple working channels are provided, and the cross-sectional areas in the length direction of the multiple working channels are the same or different.

Preferably, the forward-looking detection unit includes a plurality of first micro ultrasonic probes, and the plurality of first micro ultrasonic probe arrays are arranged in one or more groups.

Preferably, the plurality of first miniature ultrasonic probes are arranged in a linear array, or in a circular array, or in a planar array, or in a convex array.

Preferably, the side-view detection unit includes a plurality of second micro ultrasonic probes, and the plurality of second micro ultrasonic probe arrays are arranged in one or more groups.

Preferably, the plurality of second miniature ultrasound probes are arranged in a linear array, or in a circular array, or in a planar array, or in a convex array.

Preferably, the connection unit includes a connection cable electrically connected to the front-view detection unit or the side-view detection unit, and a connector connected to the connection cable. The connection cable is embedded in the support body, and the connector is provided on the outer periphery of the support body. on.

Preferably, the supporting body includes a filling body and an outer shell fixedly supported on the periphery of the filling body, and the filling body is composed of epoxy resin, rubber or UV glue.

Preferably, the system host includes an ultrasonic probe excitation power supply module, an ultrasonic signal receiving module, an acquisition module, a processing circuit module, an image display module, and an information processing software module.

Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art:

The real-time high-resolution puncture guidance system of the present invention can effectively solve the problem that the existing ultrasound-guided puncture device can only monitor and guide outside the body and cannot perform high-frequency and high-resolution imaging of deep tissues. It uses integrated forward-looking detection and side-view detection. And the working channel can image the front area of the needle body and the side view direction of the needle body, and can realize real-time guided observation of the puncture/injection direction and accuracy, and can also avoid damage to surrounding tissues. It can easily puncture deep tissues and pore structure areas that were difficult to penetrate in the past, which can greatly improve the flexibility, accuracy and scope of puncture diagnosis and treatment.

Description of the drawings

Figure 1 is a schematic diagram of the lateral cross-sectional structure of the guide needle of the present invention;

2 is a schematic diagram of the main structure of the guide needle of the present invention (the first miniature ultrasonic probe is arranged in a linear array into two groups, and the working channel has one);

Figure 3 is a schematic diagram of the main structure of the guiding needle of the present invention (the first miniature ultrasonic probe is arranged in a linear array into two groups, and there are two working channels);

4 is a schematic diagram of the main structure of the guide needle of the present invention (the first micro ultrasonic probe is arranged in a planar array, and the working channel has one);

Figure 5 is a schematic diagram of the main structure of the guiding needle of the present invention (the first miniature ultrasonic probes are arranged in a planar array, with three working channels);

Figure 6 is a schematic diagram of the overall structure of the puncture guidance system of the present invention;

Among them: 10, working channel; 11, outer shell; 100, filler; 121, connecting cable; 122, connector; t1, the first micro ultrasonic probe; t2, the second micro ultrasonic probe; 2. the system host; 200 , External cable; 201, probe connector; q1, front-view detection area; q2, side-view detection area.

Detailed ways

The present invention will be further described in detail below with reference to the drawings and specific embodiments.

As shown in Figures 1 to 6, a real-time high-resolution puncture guidance system. The puncture guidance system includes a system host 2, a guide needle that can be electrically connected to the system host 2, and the guide needle includes a cylindrical shape with a proximal end and a distal end. The support body (the proximal end refers to the end close to the user, which is used for human hand holding operations, and the proximal end is outside the inserted tissue during use; the distal end represents the end inserted into the tissue during use), located at the far end of the support The front-view detection unit on the end surface, the side-view detection unit arranged on the outer peripheral surface of the support body and close to the distal end of the support body, and the connection unit that electrically connects the front-view detection unit and the side-view detection unit with the external system host 2 ；

Specifically, the supporting body includes a filling body 100 and an outer shell 11 fixedly supported on the outer periphery of the filling body 100. The filling body 100 is composed of epoxy resin, rubber or UV glue; the outer shell 11 is made of stainless steel or plastic with a certain hardness and supporting shape. Made of materials. The diameter can be the same as the head and tail, or the head can be slightly smaller (the distal end) for better puncture operation.

Further, the forward-looking detection unit includes a plurality of first micro ultrasonic probes t1, and the plurality of first micro ultrasonic probes t1 are arrayed into one or more groups. The plurality of first miniature ultrasonic probes t1 are arranged in a linear array, or in a circular array, or in a planar array, or in a convex array. A linear array is equivalent to being arranged in a line on the distal surface (as shown in Figure 2 and Figure 3); a circular array is equivalent to being arranged in a circular shape on the distal surface, and a planar array is The arrangement is flat (as shown in Figure 4 and Figure 5), and the convex shape is a plurality of probes arranged together to form a convex shape.

There is a protective layer at the front end of the first micro ultrasonic probe t1 to protect the probe from being damaged during the insertion process and to facilitate subsequent clinical disinfection treatment. The center frequency range of the first micro ultrasonic probe t1 is (>0.5MHz); in addition, for high To distinguish and identify the target tissue structure, the first miniature ultrasound probe t1 can be a high-frequency ultrasound probe. The material of the first micro ultrasonic probe t1 may be piezoelectric ceramic, or piezoelectric single crystal, or 1-3 piezoelectric composite material, or piezoelectric film, or CMUT.

Further, the side-view detection unit includes a plurality of second micro ultrasonic probes t2, and the plurality of second micro ultrasonic probes t2 are arrayed into one or more groups. The plurality of second miniature ultrasonic probes t2 are arranged in a linear array (the linear represents a linear arrangement around the periphery of the support body, and the linear may be closed or non-closed), or in a circular array Arrangement (ring means the arrangement in the form of a ring), or arranged in a planar array (planar means that it is arranged in a curved shape around the periphery of the support), or arranged in a convex array ( The convex shape is that a plurality of probes are arranged and gathered together to form a convex shape).

The front end of the second micro ultrasonic probe t2 has a protective layer to protect the probe from damage during insertion, and it is also convenient for subsequent clinical disinfection treatment. The center frequency range of the second micro ultrasonic probe t2 is (>0.5MHz); in addition, for high To distinguish and identify the target tissue structure, the second miniature ultrasound probe t2 can be a high-frequency ultrasound probe. The material of the second miniature ultrasonic probe t2 may be piezoelectric ceramic, or piezoelectric single crystal, or 1-3 piezoelectric composite material, or piezoelectric film, or CMUT.

In this example, the support body is also provided with a working channel 10 that penetrates the support body along the length of the support body. The working channel 10 is a working channel 10 for passing puncture needles, tissue puncture samplers, puncture injection needles, etc. . The cross-sectional shape of the working channel 10 in the extending direction of its length may be circular, rhombic, or elliptical. The working channel 10 can be opened one, or two, or more according to actual diagnosis and treatment needs. The working channel 10 can be coaxial with the support body or have a certain offset. When there are more than one, each The cross-sectional area in the length direction of the working channels 10 may be the same or different. That is, when the working channels 10 are circular, the apertures may be the same or different.

In addition, the connection unit includes a connection cable 121 electrically connected to the front-view detection unit or the side-view detection unit, and a connector 122 connected to the connection cable 121;

The connecting cable 121 is embedded in the support body. The connecting cable 121 is the power excitation line and the echo signal transmission line of the probe array. It can be a very thin coaxial cable, a flexible fpcb sheet, or a flexible printed circuit. Wait;

The connector 122 is arranged on the peripheral surface of the support body and located at the tail (near the proximal end) of the needle body. It is matched with the external probe connector 201 and is connected to the system host 2 through the external cable 200. The system host 2 includes an ultrasonic probe excitation power supply module, an ultrasonic signal receiving module, an acquisition module, a processing circuit module, an image display module, and an information processing software module. The image display module can simultaneously display the front view and side view images, and indicate the spatial three-dimensional relative position.

The use of the puncture guide system of the present invention is as follows: First, the sterilized guide needle needle body is connected to the system host 2 through the connector, the guide needle needle body is put into the external analog or the water container, and the guide needle is activated by the system Each forward-looking detection unit and side-view detection unit work (the forward-looking detection unit has a forward-looking detection area q1 after working, and the side-view detection unit has a side-view detection area q2 after working). According to the feedback image, ensure that each detection unit is on The probes are working normally. Then, the needle body is slowly inserted into the body to the lesion area through the puncture sheath (as an accessory). According to the front view and side view images, adjust the insertion angle and orientation at the right time, and fix the position of the guide needle body after reaching the target area. Using the working channel 10, insert a sampler for sampling, or a syringe for nerve block and other treatments. After completing the operation, take out the guide needle, stop the work of each probe, disconnect, and disinfect for the next use.

In summary, the real-time high-resolution puncture guidance system of the present invention can effectively solve the shortcomings of existing ultrasound-guided puncture devices that can only monitor and guide outside the body and cannot perform high-frequency and high-resolution imaging of deep tissues. It uses integrated forward vision Detection, side-view detection and working channel, which can image the front area of the needle body and the side-view direction of the needle body, and realize real-time guided observation of the puncture/injection direction and accuracy, and avoid damage to surrounding tissues . It can easily puncture deep tissues and pore structure areas that were difficult to penetrate in the past, which can greatly improve the flexibility, accuracy and scope of puncture diagnosis and treatment.

The present invention has been described in detail above, and its purpose is to allow those skilled in the art to understand the content of the present invention and implement it, but it cannot limit the scope of protection of the present invention. Anything done in accordance with the spirit of the present invention, etc. The effect changes or modifications shall be covered by the protection scope of the present invention.

Claims

A real-time high-resolution puncture guidance system, characterized in that: the puncture guidance system includes a system host, a guide needle that can be electrically connected to the system host, and the guide needle includes a cylindrical support having a proximal end and a distal end Body, a forward-looking detection unit arranged on the distal end surface of the support body, a side-view detection unit arranged on the outer peripheral surface of the support body and close to the distal end of the support body, and the forward-looking detection unit A connecting unit electrically connected to the side-view detection unit and the system host, the support body is also provided with a working channel, the working channel penetrates the support body along the length extension direction of the support body, and the working channel is at least One is provided; the cross-sectional shape of the working channel in the direction of its length extension is circular, or rhombus, or elliptical; the working channel is provided with multiple, and multiple working channels are in the length direction The cross-sectional area is the same or different; the forward-looking detection unit includes a plurality of first micro ultrasonic probes, and the plurality of first micro ultrasonic probe arrays are arranged in one or more groups; The linear array is arranged, either in a circular array, or in a planar array, or in a convex array; the side-view detection unit includes a plurality of second miniature ultrasonic probes, and a plurality of the The second micro ultrasonic probe arrays are arranged in one or more groups; a plurality of the second micro ultrasonic probes are arranged in a linear array, or in a circular array, or in a planar array, or in a convex shape The connection unit includes a connection cable electrically connected to the front-view detection unit or the side-view detection unit, and a connector connected to the connection cable, and the connection cable is buried in the Inside the support body, the connector is provided on the outer periphery of the support body; the support body includes a filler body, an outer shell fixedly supported on the outer periphery of the filler body, and the filler body is made of epoxy resin, rubber or UV Glue composition; the system host includes an ultrasonic probe excitation power module, an ultrasonic signal receiving module, an acquisition module, a processing circuit module, an image display module, and an information processing software module.
A real-time high-resolution puncture guidance system, characterized in that: the puncture guidance system includes a system host, a guide needle that can be electrically connected to the system host, and the guide needle includes a cylindrical support having a proximal end and a distal end Body, a forward-looking detection unit arranged on the distal end surface of the support body, a side-view detection unit arranged on the outer peripheral surface of the support body and close to the distal end of the support body, and the forward-looking detection unit A connecting unit electrically connected to the side-view detection unit and the system host, the support body is also provided with a working channel, the working channel penetrates the support body along the length extension direction of the support body, and the working channel is at least There is one set.
The real-time high-resolution puncture guidance system according to claim 2, wherein the cross-sectional shape of the working channel in the length extension direction is circular, rhombus, or ellipse.
The real-time high-resolution puncture guidance system according to claim 3, wherein the working channel is provided with multiple, and the multiple working channels have the same or different cross-sectional areas in the length direction.
The real-time high-resolution puncture guidance system according to claim 2, wherein the forward-looking detection unit comprises a plurality of first micro ultrasonic probes, and the plurality of first micro ultrasonic probe arrays are arranged in one or more groups .
The real-time high-resolution puncture guidance system according to claim 5, wherein a plurality of the first miniature ultrasound probes are arranged in a linear array, or in a circular array, or in a planar array, Or arranged in a convex array.
The real-time high-resolution puncture guidance system according to claim 5, wherein the side-view detection unit comprises a plurality of second micro ultrasonic probes, and the plurality of second micro ultrasonic probe arrays are arranged in one or more groups .
The real-time high-resolution puncture guidance system according to claim 7, wherein the plurality of second miniature ultrasound probes are arranged in a linear array, or in a circular array, or in a planar array, Or arranged in a convex array.
The real-time high-resolution puncture guidance system according to claim 2, wherein the connection unit comprises a connection cable electrically connected to the forward-looking detection unit or the side-view detection unit, and is connected to the connection cable The connecting head is embedded in the support body, and the connecting head is provided on the peripheral surface of the support body.
The real-time high-resolution puncture guidance system according to claim 2, characterized in that: the support body comprises a filler body, an outer shell fixedly supported on the outer periphery of the filler body, and the filler body is made of epoxy resin, rubber or UV Glue composition.
The real-time high-resolution puncture guidance system according to claim 2, wherein the system host includes an ultrasound probe excitation power module, an ultrasound signal receiving module, an acquisition module, a processing circuit module, an image display module, and an information processing software module.