WO2024124441A1

WO2024124441A1 - Soft driver system for intrauterine diagnosis and treatment

Info

Publication number: WO2024124441A1
Application number: PCT/CN2022/139033
Authority: WO
Inventors: 夏泽洋; 张茜卓; 梁侃慧; 王泓伟; 熊璟
Original assignee: 深圳先进技术研究院
Priority date: 2022-12-14
Filing date: 2022-12-14
Publication date: 2024-06-20

Abstract

Disclosed is a soft driver system for intrauterine diagnosis and treatment. The system comprises: a soft driver body and a supporting component. The supporting component is used for supporting and fixing the soft driver body. The soft driver body comprises a soft non-working section, a connector, and a soft working section which are connected sequentially. The connector is used for connecting the soft non-working section, a surgical instrument, and the soft working section. The soft driver body is configured to be controlled to perform a bending deformation movement in a fluid or gas driving mode. The system of the present invention has the advantages of flexibility of infinite degree of freedom and small system integration, which improves the clinical application range and efficiency.

Description

A software driver system for uterine cavity diagnosis and treatment

Technical Field

The present invention relates to the technical field of medical devices, and more specifically, to a soft drive system for uterine cavity diagnosis and treatment.

Background technique

Hysteroscopy is a minimally invasive gynecological diagnosis and treatment technology that enters the uterine cavity through the vagina and makes an intuitive diagnosis of uterine cavity diseases under the mediation of endoscopic instruments. It can perform intrauterine pathological examinations and surgeries. Hysteroscopic endoscope is the most common uterine cavity diagnosis and treatment equipment. It refers to an optical device that uses lighting, perfusion, and imaging systems to observe uterine abnormalities or lesions in a dilated state. It is usually composed of a mirror body and built-in functional mechanisms. The mirror body can be roughly divided into an operating part, an insertion part, and a front end. The operating part integrates the terminal connectors and operating components of various supporting equipment. The insertion part is a tubular structure with one or more functional channels. It can be divided into a hard mirror and a soft mirror according to the shape of the mirror body. The built-in functional mechanisms are distributed in each functional channel, including an image transmission unit, a perfusion device, a soft mirror bending drive control system, etc. The front end is equipped with a micro-camera module to illuminate the uterine cavity and collect images for external imaging. Auxiliary instruments can be inserted from the instrument channel of the mirror body itself (such as an integrated type) or the accessory channel used in conjunction (such as a split type) to perform corresponding intrauterine surgical operations.

In the prior art, hysteroscopes are mainly divided into two types: rigid and flexible. Rigid hysteroscopes have a stable structure and are often used with a variety of surgical instruments for uterine cavity treatment. They have two structures: one-piece and two-piece. The former has a fixed outer diameter, and the latter consists of a mirror body and an adapter sheath. The sheath can provide access for instruments and uterine distension media. The front end of the mirror body usually adopts an angled bevel design (mostly 30° for uterine cavity diagnosis and treatment), and the front end of the one-piece type is designed with a 22° curved tube, and the angle is pre-formed in the mirror body, or a wide-angle camera is used to expand the viewing angle of the rigid mirror.

The existing soft hysteroscope is small in size. The body of the hysteroscope is a flexible hose wrapped in medical rubber. The front end can be bent in multiple directions. It is usually used for uterine cavity examination. The insertion channel can be used to insert and remove small instruments or unidirectional perfusion to expand the uterus, and complete a small number of diagnosis and treatment operations. The insertion part is equipped with metal cables, snake bone brackets and other components. The front end contains controllable annular parts, which together with the handwheel knob of the operating part constitute the soft mirror bending drive control system. The angle knob is used to pull the soft mirror up and down to bend, and after approaching the target area, the locking knob is used to fix the angle for diagnosis and treatment.

At present, although the development of precision integration technology and electronic components can optimize the size and performance of hysteroscopes, there has been no substantial evolution in hysteroscopic technical instruments from the perspective of structural design and working mechanism. Rigid hysteroscopes always have the defects of fixed shape and single degree of freedom. Due to individual differences in uterine anatomical morphology, it is difficult to match the uterine curvature during use, and the problem of limited viewing direction of the rigid hysteroscope has not been truly solved. Soft hysteroscopes can make up for the above shortcomings, but the current bending relies on wire-driven control systems, which are complex in structure and occupy a large space. The size of the working channel is limited, resulting in few feasible procedures and cannot replace the rigid scope to complete the treatment. In addition, squeezing the cervix is inevitable during diagnosis and treatment, and rigid materials and components such as metals can easily cause damage to patients. The above problems restrict the versatility and operability of hysteroscopic instruments.

In summary, existing hysteroscopic instruments have problems such as large outer diameter and limited operation, which makes it difficult to meet clinical application needs.

Summary of the invention

The purpose of the present invention is to overcome the defects of the above-mentioned prior art and provide a soft drive system for uterine cavity diagnosis and treatment. The system comprises: a soft drive body and a support component, the support component is used to support and fix the soft drive body, the soft drive body comprises a soft non-working segment, a connector and a soft working segment connected in sequence, the connector is used to connect the soft non-working segment, the surgical instrument and the soft working segment, and the soft drive body is configured to control its bending deformation movement by fluid or gas driving.

In one embodiment, the soft driver body is a long tubular multi-cavity structure of superelastic soft material, with a working channel, a driving pipeline and an image transmission channel arranged inside, wherein the image transmission channel and the working channel penetrate the soft driver body along the long axis, the image transmission channel is equipped with a camera for optical observation, and the deformation movement of the soft driver body is controlled by inputting a fluid driving source into the driving pipeline.

In one embodiment, a first channel and a second channel are provided at one end of the connector, the first channel is used to insert surgical instruments, the second channel is used to connect the non-working section of the software, and the diameter of the second channel is larger than the first channel. A third channel is provided at the other end of the connector for connecting the working section of the software, and the working section of the software is used to carry an image transmission cable and is provided with a driving pipeline.

In one embodiment, the supporting component is a rigid structure that plays a supporting and fixing role.

In one embodiment, the soft actuator body material is a super elastic material such as silicone.

In one embodiment, the driving pipeline is equipped with a driving cable connected to a fluid driving control system, and the image transmission channel is equipped with a camera carrying a light source and an image transmission cable.

In one embodiment, the software working section includes a software non-driving chamber section, a software driving chamber section and a camera section, wherein:

The software non-driving chamber section includes a working channel, a driving pipeline and an image transmission channel, and the working channel runs through the software driving chamber section and the camera section, and the driving pipeline runs through the software non-driving chamber section and the software driving chamber section;

The software driving chamber section includes the working channel, the driving pipeline and the image transmission channel, and the driving pipeline in this section is in a semi-open state, and can form a closed driving chamber after being connected to an external driving system;

The camera section includes the working channel and the camera channel, and the camera channel is used for placing a camera carrying a light source.

In one embodiment, the working channel is configured to change the diameter size by active or passive driving.

In one embodiment, the soft driver body is prepared by 3D printing technology or soft demoulding technology.

In one embodiment, the driving pipeline is provided as one or more.

Compared with the prior art, the advantage of the present invention is that it provides a soft drive system that can be used for uterine cavity diagnosis and treatment, combines soft robotics technology with endoscope technology, and adopts soft drive and soft material processing methods, so that the hysteroscopic technical instrument has unlimited freedom of flexibility and system small integration (small size, compact structure), thereby improving the scope and efficiency of clinical application.

Further features and advantages of the present invention will become apparent from the following detailed description of exemplary embodiments of the present invention with reference to the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

FIG1 is a schematic diagram of a soft driver system for uterine cavity diagnosis and treatment according to one embodiment of the present invention;

FIG2 is an enlarged schematic diagram of part A in FIG1 according to an embodiment of the present invention;

3 is a cross-sectional view of different working sections of a soft drive body according to an embodiment of the present invention;

FIG4 is a schematic diagram of contraction and expansion of a working channel according to an embodiment of the present invention;

In the accompanying drawings: 1-support component; 2-software non-working section; 3-software working section; 4-channel for inserting surgical instruments; 5-channel for connecting the software non-working section; 6-channel for connecting the software working section; 7-channel for carrying image transmission cables (power cord of endoscope) and drive channels (drive source input and output pipelines); 8-working channel, used to carry surgical instruments; 9-image transmission cable channel, used to carry the power cord of the camera; 10-drive source input and output channel, used to carry the rear end input and output pipeline of the drive chamber; 11-drive chamber (or called drive chamber, drive pipeline); 12-camera channel, used to carry the camera.

Detailed ways

Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be noted that the relative arrangement of components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless otherwise specifically stated.

The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses.

Technologies, methods, and equipment known to ordinary technicians in the relevant art may not be discussed in detail, but where appropriate, the technologies, methods, and equipment should be considered as part of the specification.

In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary and not limiting. Therefore, other examples of the exemplary embodiments may have different values.

It should be noted that like reference numerals and letters refer to similar items in the following figures, and therefore, once an item is defined in one figure, it need not be further discussed in subsequent figures.

The present invention provides a soft uterine cavity diagnosis and treatment system, comprising a soft driver body and a rigid structure that plays a supporting and fixing role. The soft driver body is composed of a soft non-working section and a soft working section that are connected in sequence. For example, the soft driver body is a long tubular structure made of superelastic soft material, and is provided with a plurality of cavities, including a drive unit cavity, an image transmission channel and a working channel, etc., wherein the image transmission channel and the working channel penetrate the soft driver body along the long axis. The image transmission channel is equipped with a camera for optical observation, and the deformation movement of the soft driver body is controlled by inputting a fluid driving source into the drive cavity. The diameter of the working channel is variable, and a uterine distension medium is injected according to the diagnosis and treatment needs, or different types of surgical instruments are inserted for diagnosis and treatment. After the diagnosis and treatment, the turbid liquid can flow out through the working channel.

Specifically, as shown in FIG1 , the provided soft drive system for intrauterine diagnosis and treatment mainly includes a support component 1 and a soft drive body, wherein the soft drive body includes a soft non-working segment 2 and a soft working segment 3. The support component 1 is used to support and fix the soft drive body, and the support component 1 can adopt a rigid structure, and the material of the soft drive body can be a superelastic soft material such as silicone. Part A in FIG1 is used to connect the soft non-working segment 2 and the soft working segment 3, or is called a connector.

FIG2 is an enlarged schematic diagram of the connector shown in part A of FIG1. The connector is used to connect the non-working section 2 of the software, the surgical instrument and the working section 3 of the software. The small hole 4 is used to insert the surgical instrument, the large hole 5 is used to connect the non-working section 2 of the software, and the hole 6 set at the other end of the connector is used to connect the working section 3 of the software. The non-working section 2 of the software is mainly used to carry the image transmission cable and the drive pipeline, and the working section 3 of the software needs to enter the body for diagnosis and treatment operations.

FIG3 is a cross-sectional view of different working sections of the software driver body. The cross-sectional view B-B shows the software non-working section 2, which only includes a channel 7, which is mainly used to carry the image transmission cable and the drive pipeline. The software working section 3 is mainly divided into three parts, which are the software non-drive cavity section (cross-sectional view C-C), the software drive cavity section (cross-sectional view D-D) and the camera section (cross-sectional view E-E) from left to right in FIG3.

The soft non-driven chamber section (cross-sectional view C-C) includes three channels. The uppermost channel in Figure 3 is the working channel 8 in the contracted state. If the surgical operation is performed, this working channel 8 needs to be expanded. The expanded shape is shown on the right side of Figure 4. The channel 10 on the right side of the center in Figure 3 is the driving channel. The channel 9 at the bottom of Figure 3 is for passing the image transmission cable.

The soft body driving chamber section (section view D-D) is similar to the soft body non-driving chamber section (section view C-C). The only difference is that the through channel 10 on the right side of the center of the original section view C-C for passing the driving pipe has become a closed driving chamber 11, which serves as the main bending driving unit for deformation during the soft body diagnosis and treatment operation.

The camera section (section view E-E) includes two channels. The upper channel 8 in Figure 3 is still a working channel in the contracted state, which is consistent with the soft body non-driven cavity section (section view C-C) and the soft body driven cavity section (section view D-D). The lower channel 12 in Figure 3 is used to place the camera carrying the light source.

Figure 4 is a schematic diagram of the working channel 8 in the contracted and expanded states. The software working section has a working channel, so the camera section (section view E-E) is taken as an example for specific demonstration. In the left figure, the working channel is in a contracted state, and in the right figure, the working channel is in an expanded state.

It should be noted that, without violating the spirit and scope of the present invention, those skilled in the art may make appropriate changes or modifications to the above embodiments. For example, there may be one or more drive cavities that penetrate the soft drive body along the long axis. The drive cavity morphology may be cylindrical or a specific shape obtained by morphological calculation. The drive cavity, image transmission channel, and working channel may have a variety of radial spatial distribution modes. The fluid drive source may be a gas or a liquid. The method for preparing the soft drive body may adopt 3D printing molding technology or soft demolding technology. For another example, the variable diameter working channel drive mode may be an active drive or a passive drive, which is compatible with gynecological auxiliary instruments of different outer diameters, and can also provide for the entry and exit of uterine distension media and turbid tissue fluid.

In summary, in order to solve the problem that the existing hysteroscopic technical instruments have limited degrees of freedom and cannot have both small size and multi-functions, the present invention is aimed at clinical uterine cavity diagnosis and treatment scenarios and provides a software driver system for uterine cavity diagnosis and treatment. The system is a new integrated software instrument structure that can effectively reduce the size of the instrument, has integrated diagnosis and treatment performance, and can expand clinical applications.

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

1) Different from the existing rigid material hysteroscope, the soft driver for uterine cavity diagnosis and treatment proposed in the present invention adopts superelastic soft material, which has natural biological tissue contact safety, and with the development of soft material processing and preparation technology, the size of the device can be further reduced.

2) Different from the existing rigid hysteroscope, the soft driver proposed in the present invention can be bent and deformed, and is flexible to operate, so as to achieve full coverage of the uterine cavity surgical field.

3) Different from the existing soft hysteroscope, the present invention uses a fluid soft drive method, which improves the internal space utilization of the instrument and greatly simplifies the instrument structure. It can effectively expand the diameter of the working channel and facilitate the entry of larger-sized surgical instruments to carry out intrauterine disease treatment.

4) It has been verified through experiments that the software driver provided by the present invention has both the diagnostic and therapeutic functions of hysteroscopy.

Embodiments of the present invention have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the marketplace, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein. The scope of the present invention is defined by the appended claims.

Claims

A soft drive system for uterine cavity diagnosis and treatment comprises: a soft drive body and a supporting component, wherein the supporting component is used to support and fix the soft drive body, the soft drive body comprises a soft non-working segment, a connector and a soft working segment connected in sequence, the connector is used to connect the soft non-working segment, the surgical instrument and the soft working segment, and the soft drive body is configured to adopt a fluid or gas driving method to control its bending deformation movement.
The system according to claim 1 is characterized in that the soft driver body is a long tubular multi-cavity structure of superelastic soft material, with a working channel, a driving pipeline and an image transmission channel arranged inside, wherein the image transmission channel and the working channel penetrate the soft driver body along the long axis, the image transmission channel is equipped with a camera for optical observation, and the deformation movement of the soft driver body is controlled by inputting a fluid driving source into the driving pipeline.
According to the system according to claim 1, a first channel and a second channel are provided at one end of the connector, the first channel is used to insert surgical instruments, the second channel is used to connect the non-working section of the software, and the diameter of the second channel is larger than that of the second channel, and a third channel is provided at the other end of the connector for connecting the working section of the software, and the non-working section of the software is used to carry an image transmission cable and is provided with a drive pipeline.
The system according to claim 1, characterized in that the supporting member is a rigid structure that plays a supporting and fixing role.
The system according to claim 1 is characterized in that the soft actuator body material is a superelastic material.
The system according to claim 2 is characterized in that the drive pipeline is equipped with a drive cable connected to the fluid drive control system, and the image transmission channel is equipped with a camera carrying a light source and an image transmission cable.
The system according to claim 1, characterized in that the software working section includes a software non-driven chamber section, a software driven chamber section and a camera section, wherein:

The software non-driving chamber section includes a working channel, a driving pipeline and an image transmission channel, and the working channel runs through the software driving chamber section and the camera section at the same time, and the driving pipeline runs through the software non-driving chamber section and the software driving chamber section;

The software driving chamber section includes the working channel, the driving pipeline and the image transmission channel, and the driving pipeline in the software driving chamber section is in a semi-open state, and forms a closed driving chamber after being connected with an external driving system;

The camera section includes the working channel and the camera channel, and the camera channel is used for placing a camera carrying a light source.
The system according to claim 7 is characterized in that the working channel is configured to change the diameter size by active drive or passive drive.
The system according to claim 1 is characterized in that the soft driver body is prepared by 3D printing molding technology or soft demolding technology.
The system according to claim 7, characterized in that the driving pipeline can be set to one or more.