CN115054186A

CN115054186A - Interventional needle for flexible endoscope, flexible endoscope and flexible endoscope system

Info

Publication number: CN115054186A
Application number: CN202210734357.7A
Authority: CN
Inventors: 王庆兵; 李富友
Original assignee: Shanghai Keyingkang Technology Co ltd
Current assignee: Shanghai Keyingkang Technology Co ltd
Priority date: 2022-06-27
Filing date: 2022-06-27
Publication date: 2022-09-16

Abstract

The present disclosure relates to an interventional needle for a flexible endoscope, and a flexible endoscope system. An access needle for a flexible endoscope, the access needle comprising: a needle configured to be insertable into a living body via a natural or artificial channel of the living body; and a detection device disposed in the needle body and configured to detect a rotation direction and a rotation angle of a central axis of the needle body with respect to a gravitational direction.

Description

Interventional needle for flexible endoscope, flexible endoscope and flexible endoscope system

Technical Field

The present disclosure relates to the field of medical instruments, and more particularly, to an interventional needle for a flexible endoscope, and a flexible endoscope system.

Background

The flexible endoscope is a bendable endoscope, which is mainly introduced into a living body through a natural orifice of the living body, can be used for imaging, diagnosing and/or treating a diseased region in the living body, and is widely applied to the fields of gastroenterology, urology, five-sense-organ department and the like. A doctor can observe the surface characteristics of a target site (for example, a lesion such as a tumor) in a patient body by using a conventional flexible endoscope, but cannot observe the deep structure of the target site. Moreover, the flexible endoscope may rotate during the interventional therapy, so that the view angle of the image of the patient captured by the flexible endoscope is not fixed, which causes great trouble for the doctor to observe the condition in the patient. In addition, when a doctor uses the flexible endoscope to carry the interventional needle into the patient body for interventional diagnosis and treatment operations such as puncturing and the like on a target site, the operational freedom degree of the interventional needle may be limited by the attachment between the interventional needle and the flexible endoscope, and the actual needle insertion position of the interventional needle may deviate from the observation visual field of the flexible endoscope, and the interventional needle usually enters a deeper position in the patient body, so that the doctor operating the interventional needle often cannot directly see the position of the interventional needle, and cannot timely and accurately grasp the transient and variable conditions in the patient body, which causes difficulty in making a reliable judgment and decision in time, and further cannot efficiently perform diagnosis and treatment during the interventional operation.

Disclosure of Invention

The following presents a simplified summary of the disclosure in order to provide a basic understanding of some aspects of the disclosure. However, it should be understood that this summary is not an exhaustive overview of the disclosure. It is not intended to identify key or critical elements of the disclosure or to delineate the scope of the disclosure. Its sole purpose is to present some concepts of the disclosure in a simplified form as a prelude to the more detailed description that is presented later.

According to an aspect of the present disclosure, there is provided an intervention needle for a soft endoscope, wherein the intervention needle comprises: a needle configured to be insertable into a living body via a natural or artificial channel of the living body; and a detection device disposed in the needle body and configured to detect a rotation direction and a rotation angle of a central axis of the needle body with respect to a gravitational direction.

In some embodiments, the detection device may be configured to detect a rotation direction and a rotation angle of the central axis of the needle body with respect to a gravity direction by measuring acceleration due to gravity of the needle body.

In some embodiments, the interventional needle may comprise at least one imaging fiber bundle arranged in the needle body and extending longitudinally along a central axis of the needle body, a front fiber end face of the at least one imaging fiber bundle being located at the front end face of the needle body, wherein the at least one imaging fiber bundle is configured to emit imaging probe light towards a target site within the living body and to receive imaging response light from the target site for imaging the target site based on the imaging response light.

In some embodiments, each of the at least one imaging fiber bundle may be configured to individually emit imaging probe light toward a target site within the living body and receive imaging response light from the target site, and each of the at least one imaging fiber bundle may have attached at its front fiber end face an objective lens of a size comparable to that of the imaging fiber bundle.

In some embodiments, the at least one imaging fiber bundle may include two or more imaging fiber bundles disposed symmetrically in the needle about the central axis of the needle.

In some embodiments, the two or more imaging fiber bundles may be configured to determine a deviation of the needle insertion direction of the needle body from a central direction of the target site based on a distribution of signal intensities of the imaging response light among the two or more imaging fiber bundles.

In some embodiments, the at least one imaging fiber bundle may include a first constituent imaging fiber bundle configured to emit imaging probe light toward a target site within the living body and a second constituent imaging fiber bundle configured to receive imaging response light from the target site, one or more of the first constituent imaging fiber bundles may be positioned adjacent to a respective one or more of the second constituent imaging fiber bundles, and each of the second constituent imaging fiber bundles may have attached at its leading fiber end face an objective lens of a size comparable to that of the imaging fiber bundle.

In some embodiments, the first component imaging fiber bundle may include two or more imaging fiber bundles symmetrically disposed in the needle about the central axis of the needle, and the second component imaging fiber bundle may include respective two or more imaging fiber bundles symmetrically disposed in the needle about the central axis of the needle.

In some embodiments, the interventional needle may further comprise one or more illumination fibers disposed in the needle body and extending longitudinally along a central axis of the needle body, a front fiber end face of the one or more illumination fibers being located at the front end face of the needle body, wherein the one or more illumination fibers are configured to illuminate a target site within the living body.

In some embodiments, the one or more illumination fibers may include a plurality of illumination fibers configured to emit illumination light of different wavelengths from each other.

In some embodiments, the interventional needle may further comprise: one or more sets of sensing optical fibers arranged in the needle and extending longitudinally along a central axis of the needle such that a leading fiber end face of the one or more sets of sensing optical fibers is located at the leading end face of the needle, wherein each of the one or more sets of sensing optical fibers is for sensing a respective one of the parameters of the microenvironment inside the living body, each of the one or more sets of sensing optical fibers including a probe having a photoluminescent material at its leading fiber end face, the photoluminescent material being configured to have an emission spectrum that varies as a function of the respective one of the parameters, and wherein each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards and receive emission light from the photoluminescent material of the probe, so as to determine the respective one parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material.

In some embodiments, the one or more sets of sensing optical fibers may include one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a ph of the microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in ph.

In some embodiments, the needle body may have a hollow structure to provide a working channel inside the needle body, the working channel being configured to perform at least one of the following operations: delivering a medical device; delivering the drug; pumping waste liquid; and conveying the cleaning liquid.

In some embodiments, the working channel may be arranged in the needle body eccentrically with respect to a central axis of the needle body.

In some embodiments, at least one backup channel may be provided inside the needle body, the at least one backup channel being configured to perform at least one of the following: delivering a medical device; delivering the drug; pumping waste liquid; and conveying the cleaning liquid.

In some embodiments, the interventional needle may further comprise an inner needle removably disposed within the working channel of the needle body, the inner needle operable to access an interior of the target site when the needle body is navigated at or near the target site.

In some embodiments, the inner needle may comprise one or more imaging fiber bundles arranged in the inner needle, the one or more imaging fiber bundles extending longitudinally along a central axis of the inner needle and having a front fiber end face located at or near the front end face of the inner needle, each of the one or more imaging fiber bundles having attached at its front fiber end face an objective lens of a size comparable to the imaging fiber bundle, wherein the one or more imaging fiber bundles are configured to emit imaging probe light towards a target site within the living body and to receive imaging response light from the target site so as to image the target site based on the imaging response light.

In some embodiments, the inner needle may comprise one or more sets of sensing optical fibres arranged in the inner needle, the one or more sets of sensing optical fibres extending longitudinally along a central axis of the inner needle and having a leading optical fibre end face located at or near the leading end face of the inner needle, wherein each of the one or more sets of sensing optical fibres is for sensing a respective one of the parameters of the microenvironment inside the target site, each of the one or more sets of sensing optical fibres comprising a probe head having a photoluminescent material at its leading optical fibre end face, the photoluminescent material being configured to have an emission spectrum that varies with variation of the respective one of the parameters, and wherein each of the one or more sets of sensing optical fibres is configured to transmit excitation light towards and receive emission light from the photoluminescent material of the probe head, so as to determine the respective one parameter of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

In some embodiments, the one or more sets of sensing optical fibers may include one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the target site, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a ph of the microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with the ph.

In some embodiments, each of the one or more sets of sensing fibers may be each arranged in the inner needle rotationally symmetrically about the central axis of the inner needle, and wherein the inner needle may have a hollow channel for injecting a chemical ablation drug to the target site.

In some embodiments, the inner needle may be configured for thermal ablation of the target site and comprise one or more sets of temperature sensing optical fibers disposed in the inner needle, the one or more sets of temperature sensing optical fibers extending longitudinally along a central axis of the inner needle, and a leading optical fiber end face of each of the one or more sets of temperature sensing optical fibers being located at a respective one of cross-sections of the inner needle between the leading end face and a trailing end face, wherein each of the one or more sets of temperature sensing optical fibers is for sensing a temperature of a microenvironment inside the target site, each of the temperature sensing optical fibers of each set of temperature sensing optical fibers comprising a probe having a photoluminescent material at a leading optical fiber end face thereof, the photoluminescent material being configured to have an emission spectrum that varies with temperature, and wherein each temperature sensing optical fiber of each of the one or more sets of temperature sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material so as to determine a temperature of a microenvironment inside the target site based on the emission light of the photoluminescent material.

In some embodiments, a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers may be closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, and a temperature sensing optical fiber density of the first set of temperature sensing optical fibers is greater than a temperature sensing optical fiber density of the second set of temperature sensing optical fibers, the temperature sensing optical fiber density being a ratio of a number of one set of temperature sensing optical fibers to an area of the inner needle cross-section in which the front fiber end face of the set of temperature sensing optical fibers is located.

In some embodiments, the interventional needle may further comprise a navigation fiber bundle disposed in the needle body, the navigation fiber bundle extending longitudinally along a central axis of the needle body and having a front fiber end face at the front end face of the needle body, wherein the navigation fiber bundle is configured to emit navigation probe light into the living body and receive navigation response light derived from the navigation probe light so as to locate and distinguish a site inside the living body which is not expected to be penetrated by the interventional needle based on the navigation response light.

According to another aspect of the present disclosure, there is provided a flexible endoscope comprising an interventional needle for a flexible endoscope according to any of the embodiments of the preceding aspects of the present disclosure.

According to yet another aspect of the present disclosure, there is provided a flexible endoscope system comprising: the flexible endoscope according to any embodiment of the preceding aspect of the present disclosure, configured to provide an imaging picture of an inside of a living body; a control device configured to correct an imaging screen provided by the flexible endoscope based on a rotation direction and a rotation angle of a central axis of a needle body with respect to a gravity direction detected by a detection device of an intervention needle of the flexible endoscope; and a display device configured to display the imaged picture corrected by the control device.

In some embodiments, the control device may be configured to correct the imaging screen provided by the soft endoscope by rotating the imaging screen provided by the soft endoscope by the same angle as the detected rotation angle in a direction opposite to the detected rotation direction.

Other features of the present disclosure and advantages thereof will become more apparent from the following detailed description of exemplary embodiments thereof, which proceeds with reference to the accompanying drawings.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure. The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the disclosure. The following detailed description of exemplary embodiments can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

fig. 1 is a top view schematically illustrating an interventional needle for a soft endoscope according to one or more exemplary embodiments of the present disclosure;

FIG. 2 is a side view of the access needle of FIG. 1 for use with a flexible endoscope;

FIG. 3 is a diagram schematically illustrating the structure of an imaging fiber bundle in an interventional needle for a soft endoscope according to one or more exemplary embodiments of the present disclosure;

fig. 4A-4D schematically illustrate several example arrangements of imaging fiber bundles for an interventional needle of a soft endoscope, respectively, according to one or more example embodiments of the present disclosure;

fig. 5 is a top view schematically illustrating an interventional needle for a soft endoscope according to one or more exemplary embodiments of the present disclosure;

fig. 6 is a top view schematically illustrating an interventional needle for a soft endoscope according to one or more exemplary embodiments of the present disclosure;

FIG. 7 is a diagram schematically illustrating the structure of a sensing fiber in an interventional needle for a soft endoscope according to one or more exemplary embodiments of the present disclosure;

fig. 8A-8C illustrate several example photoluminescent materials used by a probe of a sensing fiber in an interventional needle for a soft endoscope of one or more example embodiments of the present disclosure;

FIG. 9 is a top view that schematically illustrates an interventional needle for a soft endoscope, in accordance with one or more exemplary embodiments of the present disclosure;

FIG. 10 is a side view that schematically illustrates an interventional needle for a soft endoscope, in accordance with one or more exemplary embodiments of the present disclosure;

FIG. 11 is a top view that schematically illustrates an interventional needle for a soft endoscope, in accordance with one or more exemplary embodiments of the present disclosure;

FIG. 12 is a top view that schematically illustrates an example inner needle for a soft endoscopic interventional needle according to one or more example embodiments of the present disclosure;

FIG. 13 is a top view that schematically illustrates another example inner needle for a soft endoscopic interventional needle in accordance with one or more example embodiments of the present disclosure;

fig. 14A and 14B are top and side views, respectively, schematically illustrating yet another example inner needle for a soft endoscopic interventional needle according to one or more example embodiments of the present disclosure;

fig. 15 is a block diagram schematically illustrating a soft endoscope system according to one or more exemplary embodiments of the present disclosure.

Detailed Description

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

The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. That is, the structures and methods herein are shown by way of example to illustrate different embodiments of the structures and methods of the present disclosure. Those skilled in the art will understand, however, that they are merely illustrative of exemplary ways in which the disclosure may be practiced and not exhaustive. Furthermore, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components.

Additionally, techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification as appropriate.

In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values.

When a doctor performs interventional diagnosis and treatment on a patient, the doctor can carry an interventional needle into the patient by using a soft endoscope, and the doctor is guided to send the interventional needle to the vicinity of a target part (for example, a lesion part such as a tumor) in the patient by means of imaging of the internal environment of the patient by using the soft endoscope. However, the flexible endoscope may rotate during the interventional procedure and may cause the observation field of the flexible endoscope and thus the imaging picture to rotate accordingly, that is, the imaging picture provided by the flexible endoscope is difficult to maintain a fixed viewing angle during the interventional procedure, which is inconvenient for the doctor to observe. Further, the degree of freedom of operation of the intervention needle may be limited by the attachment between the intervention needle and the soft endoscope, and there may also be some deviation of the actual insertion position of the intervention needle from the observation field of the soft endoscope, so that the doctor often can grasp the insertion direction and position of the intervention needle with respect to the target site only by experience and feel. In addition, the existing soft endoscope cannot image the target site in situ and in real time and monitor the microenvironment conditions inside and outside the target site, so that useful reference information cannot be provided for the instant diagnosis and treatment decision of the doctor.

To this end, the present disclosure provides, in one aspect, an intervention needle for a flexible endoscope (hereinafter simply referred to as an intervention needle) having a detection device disposed in a needle body of the intervention needle, the detection device being configured to detect a rotational direction and a rotational angle of a central axis of the needle body with respect to a direction of gravity. Therefore, the imaging picture provided by the soft endoscope can be further corrected based on the detected rotation direction and rotation angle, so that the imaging picture with a basically fixed visual angle can be provided for a doctor all the time in the interventional diagnosis and treatment process, and the doctor can conveniently observe medically and carry out corresponding operation. In the present disclosure, the "imaging screen whose angle of view is substantially fixed" may be understood as an imaging screen in which the relative positional relationship of objects present in the imaging screen is substantially maintained from the angle of view of an operator (e.g., a doctor). For example, assume that the doctor sees the first object positioned above the second object in the imaging screen, and at this time if the soft endoscope is rotated 90 ° in the clockwise direction, the doctor still sees that the first object is positioned above the second object, rather than that the first object is positioned on the right side of the second object. Thus, even if the observation field of view of the flexible endoscope is rotated, the displayed imaging screen is not rotated. Therefore, under the condition that the imaging picture basically keeps a fixed visual angle, a doctor can perform interventional diagnosis and treatment operation under a stable observation visual field, and the accuracy rate of the interventional diagnosis and treatment operation is improved, and the working efficiency is improved. In addition, an interventional needle according to some embodiments of the present disclosure may have a working channel eccentrically arranged within a body of the interventional needle, thereby enabling optimization of a spatial layout of component parts of the interventional needle and thus facilitating saving of an inner space of the interventional needle, thereby facilitating a miniaturized design of the interventional needle. When the miniaturized intervention needle is used together with the existing soft endoscope, the degree of freedom of operation thereof is less limited by the attachment between the intervention needle and the soft endoscope, and the deviation between the actual insertion position of the intervention needle and the observation field of view of the soft endoscope is also smaller. Also, the interventional needle according to some embodiments of the present disclosure may have an optical imaging function so that the inside of a living body or even the inside of a target site may be directly imaged using the interventional needle itself, and thus the interventional needle having the optical imaging function may be used as a part of a soft endoscope, eliminating the need for attachment with the soft endoscope to have a higher degree of freedom of operation, and the actual needle insertion position of the interventional needle becomes coincident with the observation field of view, and not only the surface characteristics of the target site but also the deep-level characteristics of the target site may be observed. In addition, the interventional needle according to some embodiments of the present disclosure may have an optical real-time navigation function to efficiently guide the needle insertion process of the interventional needle, and may avoid important parts such as blood vessels and organs that need to be protected in the process of the interventional needle entering the living body through a natural or artificial channel of the living body to reach a target part. Moreover, the interventional needle according to some embodiments of the present disclosure may further have a microenvironment in-situ real-time sensing function, which is capable of sensing various parameters of the microenvironment and distribution thereof outside and inside the target site in vivo in situ and in real time during the interventional needle enters the living body to the target site through a natural or artificial channel of the living body and after the interventional needle enters the target site, so as to provide a great amount of useful reference information for the instant diagnosis and treatment decision of the doctor.

An interventional needle according to various embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. It will be appreciated that other components may be present in an actual interventional needle and are not shown in the drawings and discussed herein in order to avoid obscuring the gist of the present disclosure. It should also be noted that, in this document, when referring to "front" it means a side close to the target site and away from the operator (usually a doctor), and when referring to "rear" it means a side away from the target site and close to the operator.

Fig. 1 and 2 schematically illustrate an intervention needle 100 for a soft endoscope according to one or more exemplary embodiments of the present disclosure, wherein fig. 1 is a plan view illustrating the intervention needle 100 as viewed from the front to the rear, and fig. 2 is a side view illustrating the intervention needle 100 as viewed in a direction perpendicular to the front-rear direction.

As shown in fig. 1 and 2, access needle 100 includes a needle body 102. The needle body 102 may be configured to be capable of being introduced into a living body (e.g., a human body, an animal body) via a natural or artificial channel of the living body, and has a front end face 102-1 and a rear end face 102-2 opposite to the front end face 102-1. The needle body 102 may be constructed of any suitable material, such as biomedical metal materials, including but not limited to one or more of stainless steel, synthetic fibers, carbon fibers, titanium alloys, gold, silver, and the like. It is to be understood that while fig. 1 illustrates the cross-sectional shape of the needle body 102 as circular, this is merely exemplary and not limiting and the needle body 102 can have any suitable cross-sectional shape.

The access needle 100 may comprise a detection device 50 arranged in a needle body 102. In some embodiments, the detection device 50 may be arranged at the front end face 102-1 of the needle 102, for example as shown in fig. 2, but this is merely exemplary and not limiting, and the detection device 50 may also be arranged at other locations in the needle 102. In some embodiments, the detection device 50 may be arranged completely inside the needle 102, such that the detection device 50 may be protected by the needle 102 to transmit an electrical signal indicative of the detection result to an analysis apparatus outside the body (such as the control device 202 described later), while being resistant to interference of the electrical signal by biological tissue and damage to the detection device 50 by the in vivo internal environment.

The detection means 50 may be configured to detect the rotational direction and the rotational angle of the central axis 102-0 of the needle body 102 with respect to the direction of gravity. The rotational direction and the rotational angle of the central axis 102-0 of the needle body 102 with respect to the direction of gravity, which are detected by the detection means 50 of the interventional needle 100, can be further used to correct the imaging picture provided by the soft endoscope to which the interventional needle 100 is applied, so that the imaging picture provided by the soft endoscope can be kept at a substantially fixed angle of view for medical observation by the doctor. In some embodiments, the flexible endoscope to which the intervention needle 100 is applied may be a flexible endoscope to which the intervention needle 100 is attached so as to be carried by it into the interior of a living body. In this case, due to the attachment between the intervention needle 100 and the flexible endoscope, the rotational direction and the rotational angle of the needle body 102 may correspond to those of the flexible endoscope, whereby an imaging screen provided by the flexible endoscope to which the intervention needle 100 is attached may be corrected based on the detected rotational direction and the rotational angle of the central axis 102-0 of the needle body 102 with respect to the direction of gravity. In some embodiments, the flexible endoscope to which the interventional needle 100 is applied may be a flexible endoscope including the interventional needle 100 as a distal end imaging portion thereof, for example, in embodiments described later, the interventional needle 100 itself may have an optical imaging function and thus may be directly a part of the flexible endoscope. In this case, the rotational direction and the rotational angle of the needle body 102 may be considered as the rotational direction and the rotational angle of the soft endoscope, whereby an imaging screen provided by the soft endoscope including the intervention needle 100 may be corrected based on the detected rotational direction and the rotational angle of the central axis 102-0 of the needle body 102 with respect to the gravity direction.

In some embodiments, the detection device 50 may be configured to detect the rotational direction and the rotational angle of the central axis 102-0 of the needle 102 with respect to the direction of gravity by measuring the acceleration due to the gravity of the needle 102. In some examples, the detection device 50 may be configured as a gravity sensor or an angular motion detector, such as a gyroscope or the like.

As already mentioned before, the interventional needle 100 according to the present disclosure may be designed with an optical imaging functionality. Specifically, in some embodiments, the interventional needle 100 may further comprise at least one imaging fiber bundle 104. Each imaging fiber bundle 104 may include a plurality of optical fibers bundled. The at least one imaging fiber bundle 104 is disposed in the needle body 102 and extends longitudinally along a central axis 102-0 of the needle body 102. For example, as shown in fig. 1, the interventional needle 100 includes eight imaging fiber bundles 104A-104h, the eight imaging fiber bundles 104A-104h having the same shape and size, but this is merely exemplary and not limiting, and the interventional needle 100 may include any suitable number, shape and/or size of imaging fiber bundles 104, see, e.g., fig. 4A-4D, 5-6, 9 and 11. Referring to fig. 2, the front fiber end face 104-1 of these imaging fiber bundles 104 is located at the front end face 102-1 of the needle body 102. Note that fig. 2 only schematically shows in dashed lines a part of some of the imaging fiber bundles 104 arranged in the needle body 102. The at least one imaging fiber bundle 104 may be configured to emit imaging probe light toward a target site within a living body and receive imaging response light from the target site to image the target site based on the imaging response light. Thus, the interventional needle 100 can image the interior of the living body with the imaging fiber bundle 104 disposed in the needle body 102 to obtain the surface features of the target site.

By providing the imaging fiber bundle 104 in the needle body 102, the interventional needle 100 itself can have an optical imaging function, so that imaging can be performed directly with the interventional needle 100 without additional optical imaging components of the flexible endoscope 201. Therefore, the interventional needle 100 with the optical imaging function itself can be a part of the flexible endoscope 201, the need for attachment with the flexible endoscope 201 is eliminated, a higher degree of freedom of operation is provided, and the actual needle insertion position and the observation field of view of the interventional needle 100 become coincident, contributing to accurate implementation of the interventional medical procedure.

In some embodiments, the imaging response light from the target site may be a reflected light of the target site to the imaging probe light. In some embodiments, the imaging responsive light from the target site may be an emission light emitted by the target site in response to absorption of the imaging probe light. In some examples, the target site may be enriched in the photoluminescent material in advance by injection or the like, and then imaging probe light including an excitation wavelength of the photoluminescent material may be emitted toward the target site via the imaging fiber bundle 104 and imaging response light emitted from the target site in response to absorption of the imaging probe light may be received, so as to image the target site based on the imaging response light.

In some embodiments, as shown in fig. 1, the at least one imaging fiber bundle 104 includes two or more imaging fiber bundles 104 arranged in the needle 102 symmetrically about a central axis 102-0 of the needle 102. The symmetrical distribution of the imaging fiber bundles 104 may facilitate the determination of the deviation of the needle insertion direction of the needle body 102 with respect to the central direction of the target site based on the distribution of the signal intensity of the imaging response light among the two or more imaging fiber bundles 104. Here, the symmetrical distribution of the imaging fiber bundle 104 may be, for example, an axisymmetric distribution, and more preferably, a rotationally symmetrical distribution. For example, the at least one imaging fiber bundle 104 may include eight imaging fiber bundles 104a-104h arranged in the needle body 102 in rotational symmetry about the central axis 102-0 of the needle body 102, i.e., one imaging fiber bundle 104 may be moved to a position where an adjacent imaging fiber bundle 104 was previously located every 45 ° rotation.

In some examples of embodiments in which the imaging response light is reflected light of the target site from the imaging probe light, the wavelength range of the imaging probe light may be determined for a characteristic absorption spectral property of the target site. For example, assuming that the target site has an absorption peak at the position of the first wavelength, imaging probe light including the first wavelength may be emitted to the target site via the imaging fiber bundle 104, and then the signal intensity of the received imaging response light at the position of the first wavelength is analyzed. If the signal intensity of the imaging response light at the location of the first wavelength is distributed among the eight imaging fiber bundles 104a-104h to be stronger at the imaging fiber bundles 104b, 104c, 104d, 104e than at the imaging fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is lower with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the first wavelength is distributed among the eight imaging fiber bundles 104a-104h to be weaker at the imaging fiber bundles 104b, 104c, 104d, 104e than at the imaging fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is above with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the first wavelength is distributed among the eight imaging fiber bundles 104a-104h as stronger at the imaging fiber bundles 104h, 104a, 104b, 104c than at the imaging fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is shifted to the right with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the first wavelength is distributed among the eight imaging fiber bundles 104a-104h such that it is weaker at the imaging fiber bundles 104h, 104a, 104b, 104c than at the imaging fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is to the left with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the first wavelength is distributed uniformly among the eight imaging fiber bundles 104a-104h, it can be said that the needle insertion direction of the needle 102 is not deviated from the central direction of the target site. And so on, the deviation of the needle insertion direction of the needle body 102 from the central direction of the target site can be determined based on the distribution of the signal intensity of the imaging response light among the eight imaging fiber bundles 104a to 104h, thereby assisting the doctor in adjusting the needle insertion direction of the needle body 102 in time, and it can be determined that the needle insertion direction of the needle body 102 is not deviated from the central direction of the target site when the signal intensity of the imaging response light is uniformly distributed among the eight imaging fiber bundles 104a to 104 h. In some examples, if the target site has absorption peaks at the locations of the plurality of wavelengths, imaging probe light including at least two wavelengths of the plurality of wavelengths may be transmitted to the target site via the imaging fiber bundle 104, and then the distribution of the absolute or relative values of the signal intensities of the received imaging response light at the locations of the at least two wavelengths among the eight imaging fiber bundles 104a-104h is analyzed. This can help to determine more accurately the deviation of the needle insertion direction of the needle body 102 from the central direction of the target site based on the distribution of the signal intensity of the imaging response light among the eight imaging fiber bundles 104a to 104 h.

In some examples of embodiments where the imaging response light is the emission light emitted by the target site in response to absorption of the imaging probe light, the target site may be enriched in the photoluminescent material in advance by injection or the like, and then the imaging probe light including the excitation wavelength of the photoluminescent material may be emitted to the target site via the imaging fiber bundle 104, and then the signal intensity of the received imaging response light at the position of the emission wavelength of the photoluminescent material is analyzed. In the case of liver tumor diagnosis, a physician usually performs an interventional operation on the liver with tumor, and a photoluminescent material, such as Indocyanine Green (ICG) dye, is usually injected before the operation. In this way, during the course of the interventional needle 100 advancing to the liver tumor, 730nm imaging probe light can be emitted via the imaging fiber bundle 104 for exciting luminescence of the ICG dye enriched in the liver tumor, and then the signal intensity of the received imaging response light at the position of the emission wavelength of the ICG dye is analyzed. If the signal intensity of the imaging response light at the position of the emission wavelength is distributed among the eight imaging fiber bundles 104a-104h to be stronger at the imaging fiber bundles 104b, 104c, 104d, 104e than at the imaging fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is on the upper side with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the emission wavelength is distributed among the eight imaging fiber bundles 104a to 104h such that it is weaker at the imaging fiber bundles 104b, 104c, 104d, 104e than at the imaging fiber bundles 104f, 104g, 104h, 104a, it can be stated that the needle insertion direction of the needle 102 is lower with respect to the central direction of the target site; if the signal intensity of the imaging response light at the position of the emission wavelength is distributed among the eight imaging fiber bundles 104a-104h stronger at the imaging fiber bundles 104h, 104a, 104b, 104c than at the imaging fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is left with respect to the central direction of the target site; if the signal intensity of the imaging response light at the location of the emission wavelength is distributed among the eight imaging fiber bundles 104a-104h to be weaker at the imaging fiber bundles 104h, 104a, 104b, 104c than at the imaging fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is shifted to the right with respect to the central direction of the target site; if the signal intensity of the imaging response light at the position of the emission wavelength is distributed uniformly among the eight imaging fiber bundles 104a to 104h, it can be said that the needle insertion direction of the needle body 102 is not deviated from the central direction of the target portion. In some examples, if the target site has emission peaks at the locations of a plurality of wavelengths, the distribution of the absolute or relative values of the signal intensity of the received imaging response light at the locations of at least two of the plurality of wavelengths among the eight imaging fiber bundles 104a-104h may be analyzed. This may help to determine more accurately the deviation of the needle insertion direction of the needle body 102 with respect to the central direction of the target site based on the distribution of the signal intensity of the imaging response light among the eight imaging fiber bundles 104a to 104 h.

Therefore, the interventional needle 100 can also realize an optical real-time navigation function through the imaging optical fiber bundle 104, which not only helps a doctor to navigate the interventional needle 100 to the vicinity of a target part, but also helps the doctor to confirm whether the needle insertion direction and position of the interventional needle 100 are proper or not. The symmetrically arranged two or more imaging fiber bundles 104 may additionally or alternatively perform the following functions: during operation, the field of view of a single imaging fiber bundle 104 may be obscured, and thus, a symmetrical arrangement of two or more fiber bundles 104 may reduce the likelihood of the field of view being completely obscured, resulting in a more complete, stable, and clear field of view for the operator.

Additionally, in some embodiments, each of the at least one imaging fiber bundle 104 may be configured to individually emit imaging probe light toward a target site within a living body and receive imaging response light from the target site. For example, as shown in FIG. 1, each imaging fiber bundle 104a-104h has both light emitting and light receiving functionality. In some embodiments, each imaging fiber bundle 104a-104h may have attached to its front fiber end face 104-1 an objective lens 104-3 of a size comparable to that of the imaging fiber bundle. For example, the objective lens 104-3 may be a micro objective lens, such as a fish-eye lens, having a diameter in the range of, for example, 0.3mm to 1 mm. Fig. 3 shows an exemplary configuration of the imaging fiber bundle 104, the imaging fiber bundle 104 having a front fiber-end face 104-1 and a rear fiber-end face 104-2, and an objective lens 104-3 mounted on the front fiber-end face 104-1 for facilitating light collection by the imaging fiber bundle 104. In embodiments where each of the at least one imaging fiber bundle 104 has both light emitting and light receiving functionality, in some examples, some or all of the at least one imaging fiber bundle 104 may be disposed in the needle 102 symmetrically (e.g., rotationally symmetrically) about the central axis 102-0 of the needle 102.

On the other hand, it is also possible to have the light emitting function and the light receiving function performed by different imaging fiber bundles 104, respectively. In some embodiments, the at least one imaging fiber bundle 104 may include a first component imaging fiber bundle configured to emit imaging probe light toward a target site within a living body and a second component imaging fiber bundle configured to receive imaging response light from the target site. That is, the first constituent image fiber bundle is used to perform a light emitting function, and the second constituent image fiber bundle is used to perform a light receiving function. For example, referring to fig. 4A (where, for clarity, the detection device 50 is not shown so as to obscure the emphasis herein), the first constituent imaging fiber bundle may include

imaging fiber bundles

104A, 104c, 104e, 104g (which may be referred to as transmitting imaging fiber bundles for purposes of illustration and indicated by left diagonal shading in the figure), while the second constituent imaging fiber bundle may include

imaging fiber bundles

104b, 104d, 104f, 104h (which may be referred to as receiving imaging fiber bundles for purposes of illustration and indicated by right diagonal shading in the figure). The second constituent imaging fiber bundle may include, for example, at least two imaging fiber bundles. In some examples, some or all of the at least two imaging fiber bundles of the second constituent imaging fiber bundle may be symmetrically arranged about a central axis 102-0 of the needle 102, e.g., axially or rotationally symmetrically arranged in the needle 102. As described above, the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site can be similarly determined based on the distribution of the signal intensity of the imaging response light among the symmetrically arranged imaging fiber bundles in the second group of imaging fiber bundles, and will not be described herein again. Each imaging fiber bundle of the second set of imaging fiber bundles may have attached at its front fiber end face, for example, an objective lens 104-3 of a size comparable to the imaging fiber bundle for facilitating light collection. The number and arrangement of imaging fiber bundles in the first set of imaging fiber bundles may take any suitable configuration. For example, whether the first constituent image fiber bundle is properly arranged can be simply judged as follows: the interventional needle 100 is positioned in front of the reflecting mirror surface perpendicular to the reflecting mirror surface, transmits light with the same intensity to each transmitting imaging fiber bundle in the first group of imaging fiber bundles and determines whether the emergent light intensity of each receiving imaging fiber bundle in the second group of imaging fiber bundles is the same, and if so, the configuration mode of the first group of imaging fiber bundles can be considered to be proper. In some examples, the first constituent imaging fiber bundles may be configured such that the relative positional relationship of the receive imaging fiber bundles to the respective transmit imaging fiber bundles is the same between the respective receive imaging fiber bundles in the second set of imaging fiber bundles.

In some embodiments, the first constituent image fiber bundle may include two or more imaging fiber bundles symmetrically disposed in the needle 102 about a central axis 102-0 of the needle 102, and the second constituent image fiber bundle may include respective two or more imaging fiber bundles symmetrically disposed in the needle 102 about the central axis 102-0 of the needle 102. In some examples, the first constituent image fiber bundles may be symmetrically distributed on a first circle about the central axis 102-0 of the needle body 102, and the second constituent image fiber bundles may be symmetrically distributed on a second circle concentric with the first circle about the central axis 102-0 of the needle body 102. The first circle may have the same diameter as the second circle (i.e. the first and second constituent image fiber bundles are each symmetrically distributed on the same circle), for example with reference to fig. 4A and 4B, or the first circle may have a larger or smaller diameter than the second circle, for example with reference to fig. 4C and 4D, wherein the first and second circles are indicated by dashed lines in fig. 4A to 4D and the detection means 50 are not shown for the sake of clarity. In some embodiments, one or more transmit imaging fiber bundles from the first constituent imaging fiber bundles may be positioned adjacent to a respective one or more receive imaging fiber bundles from the second constituent imaging fiber bundles. For example, in fig. 4B, each receive imaging fiber bundle is positioned adjacent to a respective two transmit imaging fiber bundles; in fig. 4C, four receive imaging fiber bundles are positioned adjacent to a respective one of the transmit imaging fiber bundles; in fig. 4D, each receive imaging fiber bundle is positioned adjacent to a respective one of the transmit imaging fiber bundles.

In some embodiments, as shown in fig. 5 (detection device 50 is not shown for clarity), interventional needle 100 may further comprise a navigation fiber bundle 105 disposed in needle body 102. The navigation fiber bundle 105 may extend longitudinally along the central axis 102-0 of the needle body 102 and have a front fiber end face 105-1 located at the front end face 102-1 of the needle body 102. The navigation fiber bundle 105 may be configured to emit navigation probe light into the living body and receive navigation response light derived from the navigation probe light, so as to locate and distinguish a portion or important portion, such as a blood vessel, an organ, or the like, in the living body, which is not expected to be penetrated by the interventional needle 100, based on the navigation response light, so as to prevent a surgical accident. In some embodiments, the navigation response light may be an emission light emitted by the significant site in response to absorption of the navigation probe light, e.g. different significant sites may be enriched in advance by means of injection or the like with different photoluminescent materials having different emission spectra. In some embodiments, the navigation response light may be a reflected light of the important part to the navigation probe light, for example, different important parts may have different absorption spectra. The navigation probe light including the unique absorption wavelength of each important part can be emitted in turn through the navigation optical fiber bundle 105 in a polling manner so as to perform location identification on each important part in turn, and the navigation probe light including a plurality of absorption wavelengths commonly owned by a plurality of important parts can also be emitted through the navigation optical fiber bundle 105 and the relative values of the signal intensities of the received navigation response light at the plurality of absorption wavelengths are analyzed so as to perform location identification on each important part. For example, for a venous blood vessel and an arterial blood vessel (both of which are significantly different in color), 680nm and 850nm navigation probe light may be alternately emitted via the navigation fiber bundle 105, and since the absorption intensity of the venous blood vessel to 680nm has a first ratio to the absorption intensity to 850nm and the absorption intensity of the arterial blood vessel to 680nm has a second ratio different from the first ratio to the absorption intensity to 850nm, it is possible to judge whether it is a venous blood vessel or an arterial blood vessel based on the ratio of the signal intensity of the navigation response light at 680nm to the signal intensity at 850nm and guide the doctor to avoid them when operating the interventional needle 100. In some embodiments, the imaging fiber bundle 104 mentioned in the foregoing may also be used as the navigation fiber bundle 105 herein, that is, the imaging fiber bundle 104 may also be used to perform a function of causing the interventional needle 100 to avoid the important part, for example, a function of imaging the target part and a function of causing the interventional needle 100 to avoid the important part may be alternately performed by causing the imaging fiber bundle 104 to alternately emit the imaging probe light and the navigation probe light. The arrangement embodiment of the navigation fiber bundle 105 can be similar to that of the imaging fiber bundle 104, and is not described in detail here.

Various embodiments of interventional needle 100 with microenvironment in situ real-time awareness functionality will be described below. As shown in fig. 6 (for clarity, the detection device 50 is not shown), in some embodiments the interventional needle 100 may also alternatively or additionally comprise one or more sets of sensing optical fibers 106, the one or more sets of sensing optical fibers 106 being arranged in the needle body 102 and extending longitudinally along the central axis 102-0 of the needle body 102 such that the front fiber end faces 106-1 of the one or more sets of sensing optical fibers 106 are located at the front end face 102-1 of the needle body 102 so as to be in direct contact with the microenvironment inside the living body. Each of the one or more sets of sensing optical fibers 106 may be for sensing a respective one of the parameters of the microenvironment inside the living body. Each sensing fiber of each set of sensing fibers 106 may include a probe head having a photoluminescent material at a front fiber end face 106-1 thereof, the photoluminescent material being configured to have an emission spectrum that varies as a function of the respective one parameter. Each sensing optical fiber of each set of sensing optical fibers 106 of the one or more sets of sensing optical fibers 106 may be configured to transmit excitation light towards the photoluminescent material of the probe and to receive emission light from the photoluminescent material in order to determine a respective one of the parameters of the microenvironment inside the living body based on the emission light of the photoluminescent material. In some embodiments, each set of sensing fibers 106 of the one or more sets of sensing fibers 106 may each be disposed symmetrically in the needle 102 about the central axis 102-0 of the needle 102. The symmetrical arrangement of the sensing fibers may facilitate analysis of the distribution of parameters of the microenvironment. In some examples, the one or more sets of sensing fibers 106 may each be rotationally symmetrically distributed on a respective one or more concentric circles. In some examples, two or more of the one or more sets of sensing fibers 106 may be distributed on the same circle. In some embodiments, the one or more groups of sensing fibers 106 may be distributed on the same circle (as indicated by the dashed line in fig. 6) as the at least one imaging fiber bundle 104, or on different concentric circles. The sensing fiber may be, for example, a piece of fiber, which may be much thinner than the imaging fiber bundle.

In some embodiments, the one or more sets of sensingThe optical fiber 106 may include one or more of the following: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a change in the oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing a ph of the microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in the ph. For example, referring to fig. 6, interventional needle 100 may include a first set of

sensing fibers

1061a, 1061b, 1061c, 1061d for sensing temperature, a second set of

sensing fibers

1062a, 1062b for sensing oxygen concentration, and a third set of

sensing fibers

1063a, 1063b for sensing ph. Although each set of sensing fibers is illustrated in fig. 6 as including four or two sensing fibers each, this is merely exemplary and not limiting, and each set of sensing fibers may include any suitable number of sensing fibers. When each set of sensing fibres comprises a plurality of sensing fibres distributed at different locations, it is helpful to determine the distribution of the respective one of the parameters. As a non-limiting example, the first photoluminescent material may include Er ³⁺ Doped rare earth upconversion nanoparticles (core Er as shown in FIG. 8A) ³⁺ The outer layer of the doped rare earth nano particle is coated with a shell layer to enhance the luminescence property, so that NaYF with a core-shell structure is formed ₄ :Yb,Er@NaLuF ₄ Up-converting the nanoparticles; for example, 980nm excitation light may be transmitted thereto via the first sensing optical fiber, and then a change in temperature in the microenvironment is determined based on a change in the ratio of signal intensities at 525nm and 545nm in its emission spectrum), and the second photoluminescent material may comprise a benzoporphyrin-like metal complex (as shown in fig. 8B)For example, excitation light of 635nm may be transmitted thereto via the second sensing optical fiber, and then a change in oxygen concentration in the microenvironment is determined based on a change in emission intensity thereof), and the third photoluminescent material may include a polymethine cyanine dye derivative (as shown in fig. 8C, for example, excitation light of 635nm and excitation light of 680nm may be transmitted thereto via the third sensing optical fiber, respectively, and then a change in ph value may be determined based on a change in a ratio of emission intensities under the two excitation light conditions). Referring to FIG. 7, the sensing fiber 106 may include a front fiber-optic endface 106-1 and a rear fiber-optic endface 106-2, with the probe 106-3 formed on the front fiber-optic endface 106-1. For example, the photoluminescent material and the polymer matrix material may be premixed, added into a cylindrical hollow mold, and cured to form the probe 106-3, and then the probe 106-3 is fusion-assembled at one end of the optical fiber to obtain the sensing optical fiber 106. The polymer matrix material can include, for example, polymethacrylic acid, polyethyleneimine, polyvinyl alcohol, etc., and these polymer materials have good biocompatibility and can be organically fused with the optical fiber to form a thin layer to modify the surface of the optical fiber, thereby realizing biological functionalization. The sensing optical fiber prepared by the method can have excellent detection performance indexes, such as temperature detection better than +/-1 ℃, oxygen concentration detection better than +/-1% and pH detection better than +/-0.1.

Through the sensing optical fibers 106, the states and distribution conditions of various parameters of the in-vivo local microenvironment where the front end surface 102-1 of the needle body 102 is located can be known in situ and in real time, thereby being beneficial to guiding doctors to make reliable diagnosis and treatment decisions in real time. For example, when the oxygen concentration is found to be too low, the physician cannot treat the tumor with photodynamic therapy, and needs to switch to other therapies.

In some embodiments, as shown in fig. 9 and 10, the needle body 102 can have a hollow structure to provide a working channel 102-4 inside the needle body 102. In some embodiments, the working channel 102-4 may be configured to perform at least one of the following operations: delivery of drugs (e.g., drugs used for therapeutic/hemostatic purposes, etc.); delivering a cleaning fluid (e.g., physiological saline solution for cleaning dirt, sore surfaces, etc.); aspirating waste fluids (e.g., soiled cleaning fluids, spilled blood, etc.); delivering a medical device (e.g., an inner needle as described below).

In some embodiments, as shown in fig. 11, the working channel 102-4 may be disposed in the needle body 102 eccentrically with respect to the central axis 102-0 of the needle body 102. Here, "eccentrically arranged" can be understood as: in the cross-section of access needle 100, central axis 102-0 of needle body 102 is arranged offset from central axis 102-40 of working channel 102-4. By the eccentric arrangement of the working channel 102-4 in the needle body 102, the other components of the interventional needle 100, such as the detection device 50, the imaging fiber bundle 104, the navigation fiber bundle 105, the sensing fiber 106, and, as will be described below, the illumination fiber 103, the back-up channel 107, may be arranged centrally in the needle body 102 on the side remote from the working channel 102-4. Thereby, the spatial layout of the component parts of the interventional needle 100 can be optimized such that the eccentrically arranged working channel 102-4 (as shown in fig. 11) can have a larger cross-sectional area than the centrally arranged working channel in the needle body 102 (as shown in fig. 9) and thus a larger operating space can be provided, while the other component parts of the interventional needle 100 and their dimensions remain unchanged. On the other hand, with the cross-sectional area of working channel 102-4 remaining constant, needle body 102 of access needle 100 can be constructed smaller, which facilitates a compact design of access needle 100. When the miniaturized interventional needle 100 is used together with an existing flexible endoscope, the degree of freedom of operation thereof is less likely to be restricted by the attachment between the interventional needle 100 and the flexible endoscope, and the deviation between the actual needle insertion position of the interventional needle 100 and the observation field of view of the flexible endoscope is also smaller, whereby the interventional medical procedure can be performed more accurately.

In some embodiments, as shown in fig. 9 and 11, at least one spare channel 107 can be provided inside the needle body 102 (shown as one spare channel in the embodiment of fig. 9 and 11 for illustrative purposes, but this is not limiting and any suitable number of spare channels 107 can be provided depending on the circumstances). The at least one backup tunnel 107 may for example be configured for performing at least one of the following operations: delivering a medical device; delivering the drug; pumping waste liquid; and conveying the cleaning liquid. The at least one backup channel 107 may be configured to cooperate with the working channel 102-4. For example, in the embodiment of FIG. 9, working channel 102-4 may be used to deliver cleaning fluid while backup channel 107 may be used to draw waste fluid. As shown in fig. 9 and 11, the at least one spare channel 107 may be configured to be narrower than the working channel 102-4.

It will be appreciated that while fig. 9 and 11 illustrate the cross-sectional shape of working channel 102-4 as circular and the cross-sectional shape of backup channel 107 as oval, this is merely exemplary and not limiting and that working channel 102-4 and backup channel 107 may have any suitable cross-sectional shape and size. Furthermore, the eccentric arrangement of the working channel 102-4 in the needle body 102 in fig. 11 is only exemplary and not limiting, and the working channel 102-4 can also be arranged in other positions of the needle body 102 according to the actual need.

In some embodiments, as shown in fig. 9 and 11, the interventional needle 100 may further comprise one or more illumination fibers 103, the one or more illumination fibers 103 being arranged in the needle body 102 and extending longitudinally along the central axis 102-0 of the needle body 102, a front fiber end face of the one or more illumination fibers 103 being located at the front end face 102-1 of the needle body 102, wherein the one or more illumination fibers 103 may be configured for illuminating a target site within a living body. The illumination fiber 103 may be, for example, one fiber, which may be much thinner than the imaging fiber bundle 104, so that a plurality of illumination fibers 103 may be arranged at a plurality of positions within the needle body 102. In some embodiments, the one or more illumination fibers 103 may include a plurality of illumination fibers 103 configured to emit illumination light of different wavelengths from each other. For example, the wavelength ranges of the illumination light of the plurality of illumination fibers 103 may be different from each other but partially overlapping to collectively constitute a wide wavelength range. The light conducted by the illumination fiber 103 may, for example, have at least one of the following: stronger brightness, wider color gamut, higher color saturation. Thereby, the illumination fiber 103 may illuminate the field of view of the imaging fiber bundle 104, which is advantageous for improving the imaging quality of the imaging fiber bundle 104.

In some embodiments, access needle 100 may further include a fiber optic interface (not shown) that may be disposed on the rear face 102-2 of needle body 102 or on a portion of a side of needle body 102 that is proximal to rear face 102-2. For example, the rear fiber end faces of all fibers (illumination fiber 103, imaging fiber bundle 104, navigation fiber bundle 105, sensing fiber 106) of the needle body 102 may be arranged at the fiber interfaces in a predetermined rule. For example, all of the rear fiber end faces may be arranged in an array at the fiber interface. With this arrangement, it is convenient to detect the signal from each rear fibre-optic endface by imaging the fibre-optic interface, and also to couple the desired light into each rear fibre-optic endface. In some examples, the rear fiber end faces of the optical fibers for emitting light may be arranged together and the rear fiber end faces of the optical fibers for receiving light may be arranged together at the fiber interface to input light to and output light from the optical fibers of the interventional needle 100. In some examples, the interventional needle 100 may comprise a first fiber optic interface provided with a rear fiber optic end face of an optical fiber for emitting light and a second fiber optic interface provided with a rear fiber optic end face of an optical fiber for receiving light. The fiber optic interface may be optically coupled to the light source device and the light detection device outside the living body using a suitable optical transmission member such as a fiber optic connector, a fiber optic cable, or the like.

In some embodiments, access needle 100 may further include a wire interface (not shown) that may be disposed on the rear face 102-2 of needle body 102 or on a portion of the side of needle body 102 that is proximal to rear face 102-2. For example, a rear end face of an electric wire for conducting an electric signal from the detection device 50 may be arranged at the electric wire interface. The wire interface may be electrically coupled to an analysis apparatus external to the living body, such as the control device 202 described later, using an appropriate electrically conductive member such as an electrical connector, a cable, or the like.

Referring again to fig. 10, in some embodiments, access needle 100 can further include an inner needle 110 removably disposed within working channel 102-4 of needle body 102. Inner needle 110 may be constructed of any suitable material, such as biomedical metallic materials, including but not limited to one or more of stainless steel, synthetic fibers, carbon fibers, titanium alloys, gold, silver, and the like. The inner needle 110 may be formed of the same material as the needle body 102. The inner needle 110 is operable to access the interior of a target site as the needle body 102 is navigated at or near the target site. Generally, the needle body 102 may stop moving when moving to a position of about 2mm near the target site, and then the inner needle 110 may be inserted into the target site by pushing the inner needle 110. Since such a working channel 102-4 may provide a larger operation space due to the eccentric arrangement of the working channel 102-4 of the interventional needle 100 according to some embodiments of the present disclosure, the inner needle 110 may have a larger degree of operational freedom within such a working channel 102-4, for example, not only linear motion but also non-linear motion such as rotation, oscillation, and the like, thereby allowing a physician to control the inner needle 110 to perform a complicated and diversified operation.

The inner needle 110 may be configured similarly to the various embodiments described above with respect to the needle body 102. The design of the inner needle 110 may also differ from the needle body 102 by some amount, taking into account practical clinical requirements and functional complementarity to the needle body 102. For example, in one aspect, considering that the inner needle 110 forms a nested structure with the needle body 102, when the needle insertion direction of the needle body 102 is determined by the imaging fiber bundle 104 and/or the navigation fiber bundle 105 in the needle body 102, the needle insertion direction of the inner needle 110 is also substantially determined accordingly, so that the fiber bundle may not be additionally arranged on the inner needle 110 for navigation positioning of the inner needle 110; in another aspect, inner needle 110 can be designed to perform different functions for different treatment modes. Several exemplary inner needles 110 are described below in connection with fig. 12, 13, 14A, and 14B.

In some embodiments, as shown in FIG. 12, the inner needle 110 may include one or more imaging fiber bundles 112 disposed in the inner needle 110, the one or more imaging fiber bundles 112 extending longitudinally along the central axis 110-0 of the inner needle 110 and having a leading fiber end face 112-1 located at or near the leading end face 110-1 of the inner needle 110. In some examples, each of the one or more imaging fiber bundles 112 may have attached at its front fiber end face 112-1 an objective lens, such as a fish-eye lens, of comparable size to the imaging fiber bundle. The one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within a living body and receive imaging response light from the target site to image the target site based on the imaging response light. The imaging response light may be reflected light (e.g., direct imaging) or emitted light (e.g., fluorescence imaging) from the imaging probe light. Such an inner needle 110 may be referred to as an imaging inner needle 110. The imaging fiber bundle 112 of the imaging inner needle 110 may not have a sensing function and is only used for real-time in-situ imaging. The imaging fiber bundle 112 may include a plurality of fibers bundled, which may be thicker than the aforementioned sensing fibers but thinner than the imaging fiber bundle 104 and/or the navigation fiber bundle 105. Commercially available imaging fiber bundles can be used in the imaging inner needle 110. In some embodiments, the imaging fiber bundle 112 of the imaging inner needle 110 may be, for example, a near-infrared imaging fiber bundle, and the imaging probe light may include, for example, light having a wavelength of 1064 nm. It will be appreciated that other wavelength ranges of the imaging probe light are possible. The imaging inner needle 110 may be, for example, based on 22G (international standard needle gauge) non-invasive needle modification, which uses wide-angle retinal technology and beam shaping technology to perform optical reconstruction imaging on a target part, and can be used for real-time tissue microstructure imaging of a hyperfine region. In some embodiments, each imaging fiber bundle 112 may be configured to individually emit imaging probe light toward a target site within a living body and receive imaging response light from the target site, i.e., each imaging fiber bundle 112 has both light emitting and light receiving functions. In some embodiments, a portion of the one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within a living body and another portion of the imaging fiber bundles 112 may be configured to receive imaging response light from the target site, i.e., the light emitting function and the light receiving function are performed by different imaging fiber bundles 112. The imaging fiber bundles 112 may be arranged in any suitable manner, for example, in an array, as shown in fig. 12.

By providing the inner imaging needle 110, the interventional needle 100 can obtain deep features of the target site by introducing the inner imaging needle 110 inside the target site and imaging the inside of the target site with the imaging fiber bundle 112 provided in the inner imaging needle 110.

In some embodiments, as shown in FIG. 13, the inner needle 110 may include one or more sets of sensing fibers 116 disposed in the inner needle 110, the one or more sets of sensing fibers 116 extending longitudinally along the central axis 110-0 of the inner needle 110 and having a leading fiber end face 116-1 located at or near the leading end face 110-1 of the inner needle 110. Each of the one or more sets of sensing optical fibers 116 may be for sensing a respective one of the parameters of the microenvironment inside the target site. Each sensing optical fiber 116 in each set of sensing optical fibers 116 may include a probe having a photoluminescent material at its front fiber end face 116-1, which photoluminescent material may be configured to have an emission spectrum that varies with a variation of the respective one parameter. Each sensing optical fiber of each of the one or more sets of sensing optical fibers 116 may be configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine the respective one of the parameters of the microenvironment inside the target site based on the emission light of the photoluminescent material. The sensing fiber 116 disposed in the inner needle 110 may be similar to the sensing fiber 106 disposed in the needle body 102, as previously described, and thus, a detailed description thereof may be omitted. Such an inner needle 110 may be referred to as an interventional inner needle 110. Since the needle 102 does not typically enter the interior of the target site, the sensing fibers 106 disposed in the needle 102 cannot sense parameters of the microenvironment inside the target site. While interventional inner needle 110 may penetrate into the target site, parameters of the local microenvironment inside the target site may be sensed in situ in real time with sensing fibers 116 disposed in interventional inner needle 110. In some embodiments, for example, referring to fig. 13, the one or more sets of sensing fibers 116 may include one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers 1161a-1161d for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers 1162a, 1162b for sensing oxygen concentration of a microenvironment inside the target site, a probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation of oxygen concentration; and a third set of sensing optical fibers comprising one or more third sensing

optical fibers

1163a, 1163b for sensing a ph of a microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with ph. In some examples, the interventional inner needle 110 may also be adapted based on a 22G non-invasive needle, and thus may be deployed at multiple sites in the living body based on the characteristics of the non-invasive needle, thereby providing a tool basis for studying microenvironment linkages or monitoring physiological conditions. In some embodiments, each set of sensing fibers 116 of the one or more sets of sensing fibers 116 may each be disposed symmetrically (e.g., rotationally symmetrically) in the interventional inner needle 110 about a central axis 110-0 of the interventional inner needle 110. The symmetrical arrangement of the sensing fibers may facilitate analysis of the distribution of parameters of the microenvironment. In some embodiments, the interventional inner needle 110 may also have a hollow channel 110-4, for example for injecting chemical ablation drugs (e.g., alcohol, etc.) to the target site for chemical ablation. In some examples, hollow channel 110-4 may be concentrically arranged about a central axis 110-0 of interventional inner needle 110, for example as shown in fig. 13. In some examples, hollow channel 110-4 may also be disposed eccentrically with respect to a central axis 110-0 of interventional inner needle 110. Thereby, the spatial layout of the components of the interventional inner needle 110 can be optimized, so that the eccentrically arranged hollow channel 110-4 can have a larger cross-sectional area and thus can provide a larger operation space, while the other components of the interventional inner needle 110 and their dimensions remain unchanged. On the other hand, in the case where the cross-sectional area of the hollow channel 110-4 is kept constant, the interventional inner needle 110 can be constructed smaller, which is advantageous in terms of the miniaturized design of the interventional inner needle 110. A miniaturized interventional inner needle 110, when used with the needle body 102 of an interventional needle 100, may on the one hand have a higher degree of operational freedom with the cross-sectional area of the working channel 102-4 remaining constant and on the other hand may allow the working channel 102-4 and even the entire needle body 102 to be constructed smaller.

In some embodiments, the inner needle 110 may be configured for thermal ablation of the target site. Such an inner needle may be referred to as a thermal ablation inner needle 110. The thermal ablation inner needle 110 may be, for example, a radiofrequency ablation needle. Since temperature distribution monitoring is important during operation of the thermal ablation inner needle 110, as shown in fig. 14A, the thermal ablation inner needle 110 may comprise one or more sets of temperature sensing optical fibers 1161 arranged in the inner needle 110, the one or more sets of temperature sensing optical fibers 1161 extending longitudinally along the central axis 110-0 of the inner needle 110. With further reference to FIG. 14B, the front fiber end face 1161-1 of each of the one or more sets of temperature sensing optical fibers 1161 is located at a respective one of the cross-sections (as indicated by the dashed line A, B, C, D, E, F) of the inner pin 110 from the front end face 110-1 to the rear end face 110-2. Each of the one or more sets of temperature sensing optical fibers 1161 may be used to sense the temperature of the microenvironment inside the target site. Each temperature sensing optical fiber 1161 in each set of temperature sensing optical fibers 1161 may include a probe head at its front optical fiber end face 1161-1 having a photoluminescent material that may be configured to have an emission spectrum that varies with temperature. Each temperature sensing optical fiber of each of the one or more sets of temperature sensing optical fibers 1161 is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine a temperature of a microenvironment inside the target site based on the emission light of the photoluminescent material. The output power of the thermal ablation inner needle 110 may be controlled based on the determined temperature, thereby stabilizing the microenvironment temperature of the target site around the desired temperature. The temperature sensing fiber 1161 may be similar to the first sensing fiber 1061a for sensing temperature, and thus the description thereof is omitted here. In some embodiments, if a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers 1161 is closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, the temperature sensing optical fiber density of the first set of temperature sensing optical fibers may be greater than the temperature sensing optical fiber density of the second set of temperature sensing optical fibers. The temperature sensing optical fiber density refers to the ratio of the number of a group of temperature sensing optical fibers to the area of the cross section of the inner needle where the front optical fiber end face of the group of temperature sensing optical fibers is located. For example, as shown in fig. 14B, the temperature sensing fiber density at cross-section C is greater than the temperature sensing fiber density at cross-section D. Since the thermal conductivity of the material forming the inner needle 110 is generally good, the front fiber end face of the temperature sensing fiber does not have to be exposed to the surface of the inner needle 110, but may be located inside the inner needle 110. In addition, the thermal ablation inner needle 110 can also be adapted based on a 22G non-invasive needle, whereby the needle can be deployed at multiple important sites during the thermal ablation process, thereby forming a thermal ablation temperature monitoring loop to guide the efficient deployment of the thermal ablation procedure. When monitoring finds that a certain lesion does not meet the temperature requirement for thermal ablation, the thermal ablation inner needle 110 may be replaced with the interventional inner needle 110 described previously with respect to fig. 13, and chemical ablation is performed by injecting alcohol or the like through the hollow channel 110-4 of the interventional inner needle 110.

It is to be understood that what has been described above in connection with fig. 12, 13, 14A and 14B are merely a few non-limiting examples of inner needles 110 that may be used in combination with the needle body 102. The inner needle 110 may be designed based on any embodiment or combination of the present disclosure according to actual needs. The inner needle 110 may be longer than the needle body 102, and an optical fiber interface may also be provided at the rear end surface 110-2 of the inner needle 110 or a portion of the side surface of the inner needle 110 near the rear end surface 110-2 for arranging the rear optical fiber end surfaces of the optical fibers in the inner needle 110 in a predetermined rule.

The interventional needle for the soft endoscope according to various embodiments of the present disclosure may facilitate correction of an imaging picture provided by the soft endoscope by providing therein a detection device for detecting rotation, so that it is possible to provide a doctor with an imaging picture having a substantially fixed angle of view all the time during an interventional procedure, so as to facilitate medical observation and development of a corresponding surgical operation by the doctor. The interventional needle for a soft endoscope according to various embodiments of the present disclosure may also eccentrically arrange the working channel therein, so that the spatial layout of the component parts of the interventional needle can be optimized, thereby facilitating the construction of a working channel having a larger cross-sectional area or facilitating the miniaturized design of the interventional needle. In addition, the interventional needle for a soft endoscope according to various embodiments of the present disclosure may have an optical imaging function itself to directly serve as an imaging part of the soft endoscope, thereby avoiding the use of an existing soft endoscope for imaging and a complicated assembly of an interventional needle for interventional medical procedures, and may maintain good consistency of an insertion orientation and an observation field of the interventional needle. Moreover, the interventional needle for the soft endoscope according to various embodiments of the present disclosure can guide the needle insertion process of the interventional needle by using the in-situ real-time optical navigation function, and can also utilize the photoluminescence probe to sensitively monitor in-situ real time and extract the numerical values and distribution conditions of the parameters such as temperature, oxygen concentration, pH value and the like of the microenvironment in the living body and the target part with high fidelity by using the optical fiber, and feed back the treatment intensity and effect of the diagnosis and treatment means such as thermotherapy, chemotherapy and the like in time, so that the doctor can adjust the diagnosis and treatment strategy in real time. In addition, the illuminating optical fiber, the navigation optical fiber bundle, the imaging optical fiber bundle and the various sensing optical fibers of the interventional needle according to various embodiments of the present disclosure are all disposed within the needle body or the inner needle of the interventional needle, and thus may enter into a living body using an interventional channel of the interventional needle and be protected by the interventional needle, so that an optical signal caused by a slight change in a microenvironment may be transferred to an analysis apparatus outside the body, while interference of biological tissues with the optical signal may be resisted.

In another aspect, the present disclosure also provides a flexible endoscope that may include an interventional needle 100 according to any of the embodiments of the foregoing aspects of the present disclosure.

In still another aspect, the present disclosure also provides a soft endoscope system that may include a soft endoscope having the intervention needle 100 according to any of the embodiments of the foregoing aspects of the present disclosure and configured to provide an imaging screen of an inside of a living body, a control device configured to correct the imaging screen provided by the soft endoscope based on a rotation direction and a rotation angle of a central axis of a needle body with respect to a gravity direction detected by a detection device of the intervention needle of the soft endoscope, and a display device configured to display the imaging screen corrected by the control device.

For example, fig. 15 shows a soft endoscope system 200 according to one or more exemplary embodiments of the present disclosure. As shown in fig. 15, the flexible endoscope system 200 may include a flexible endoscope 201, a control device 202, and a display device 203. The soft endoscope 201 may include the interventional needle 100 according to any of the embodiments of the foregoing aspects of the present disclosure, and is configured to provide an imaging picture of the inside of a living body. As mentioned before, the interventional needle 100 may comprise a detection device 50, said detection device 50 being configured to detect a rotational direction and a rotational angle of a central axis 102-0 of a needle body 102 of the interventional needle 100 with respect to a direction of gravity. The control device 202 may be configured to correct the imaging screen provided by the flexible endoscope 201 based on the rotational direction and the rotational angle of the central axis 102-0 of the needle body 102 with respect to the direction of gravity, which are detected by the detection device 50 of the interventional needle 100 of the flexible endoscope 201. The display device 203 may be configured to display the imaged picture corrected by the control device 202. Here, the control apparatus 202 may be implemented by any suitable computing device, including but not limited to a processor, a controller, a microprocessor, a computer, a server, and the like. The Display device 203 may be implemented by any suitable Display apparatus, including but not limited to displays such as Cathode Ray Tubes (CRTs), Liquid Crystal Displays (LCDs), and the like.

In some embodiments, the control device 202 may be configured to correct the imaging screen provided by the soft endoscope 201 by rotating the imaging screen provided by the soft endoscope 201 by the same angle as the detected rotation angle in a direction opposite to the detected rotation direction. For example, when the detection device 50 detects that the central axis 102-0 of the needle body 102 is rotated by 90 ° in the clockwise direction with respect to the direction of gravity, the control device 202 may correct the imaging picture provided by the soft endoscope 201 by rotating the imaging picture provided by the soft endoscope 201 by 90 ° in the counterclockwise direction. Thus, even if the flexible endoscope 201 rotates during the interventional procedure, the flexible endoscope system 200 can provide the doctor with an imaging screen that substantially maintains a fixed angle of view on the display device 203. That is, the imaging picture provided by the soft endoscope system 200 according to the present disclosure does not change in view angle with the posture change of the soft endoscope 201 during its intervention inside the living body, which provides a doctor with convenience in understanding the imaging picture efficiently and accurately to observe the condition inside the patient.

The terms "left," "right," "front," "back," "top," "bottom," "over," "under," "upper," "lower," and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments of the disclosure described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. For example, features described originally as "above" other features may be described as "below" other features when the device in the figures is inverted. The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationships may be interpreted accordingly.

In the description and claims, an element being "on," "attached to," "connected to," coupled to, "or contacting" another element may be directly on, attached to, connected to, coupled to or contacting the other element or intervening elements may be present. In contrast, when an element is referred to as being "directly on," directly attached to, "directly connected to," directly coupled to "or" directly contacting "another element, there are no intervening elements present. In the description and claims, one feature may be "adjacent" another feature, and may mean that one feature has a portion that overlaps with or is above or below the adjacent feature.

As used herein, the word "exemplary" means "serving as an example, instance, or illustration," and not as a "model" that is to be replicated accurately. Any implementation exemplarily described herein is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, the disclosure is not limited by any expressed or implied theory presented in the technical field, background, brief summary or the detailed description.

As used herein, the term "substantially" is intended to encompass any minor variation resulting from design or manufacturing imperfections, device or component tolerances, environmental influences, and/or other factors. The word "substantially" also allows for differences from a perfect or ideal situation due to parasitics, noise, and other practical considerations that may exist in a practical implementation.

In addition, "first," "second," and like terms may also be used herein for reference purposes only, and thus are not intended to be limiting. For example, the terms "first," "second," and other such numerical terms referring to structures or elements do not imply a sequence or order unless clearly indicated by the context.

It will be further understood that the terms "comprises/comprising," "includes" and/or "including," when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

In the present disclosure, the term "providing" is used broadly to encompass all ways of obtaining an object, and thus "providing an object" includes, but is not limited to, "purchasing," "preparing/manufacturing," "arranging/setting," "installing/assembling," and/or "ordering" the object, and the like.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

Those skilled in the art will appreciate that the boundaries between the above described operations merely illustrative. Multiple operations may be combined into a single operation, single operations may be distributed in additional operations, and operations may be performed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be altered in various other embodiments. However, other modifications, variations, and alternatives are also possible. The aspects and elements of all embodiments disclosed above may be combined in any manner and/or in combination with aspects or elements of the other embodiments to provide multiple additional embodiments. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the foregoing examples are for purposes of illustration only and are not intended to limit the scope of the present disclosure. The various embodiments disclosed herein may be combined in any combination without departing from the spirit and scope of the present disclosure. It will also be appreciated by those skilled in the art that various modifications may be made to the embodiments without departing from the scope and spirit of the disclosure. The scope of the present disclosure is defined by the appended claims.

Claims

1. An access needle for a flexible endoscope, the access needle comprising:

a needle configured to be insertable into a living body via a natural or artificial channel of the living body; and

a detection device disposed in the needle body and configured to detect a rotation direction and a rotation angle of a central axis of the needle body with respect to a gravitational direction.

2. The intervention needle for a soft endoscope of claim 1, wherein the detection device is configured to detect a rotation direction and a rotation angle of a central axis of the needle body with respect to a gravity direction by measuring an acceleration due to gravity of the needle body.

3. The intervention needle for a soft endoscope of claim 1, comprising at least one imaging fiber bundle disposed in the needle body and extending longitudinally along a central axis of the needle body, a front fiber end face of the at least one imaging fiber bundle being located at a front end face of the needle body,

wherein the at least one imaging fiber bundle is configured to emit imaging probe light toward a target site within the living body and receive imaging response light from the target site so as to image the target site based on the imaging response light.

4. The interventional needle for a soft endoscope according to claim 3, wherein each of the at least one imaging fiber bundle is configured to individually emit imaging probe light toward a target site within the living body and receive imaging response light from the target site, and each of the at least one imaging fiber bundle has attached at a front fiber end face thereof an objective lens of a size comparable to the imaging fiber bundle.

5. The intervention needle for a soft endoscope of claim 4, wherein the at least one imaging fiber bundle comprises two or more imaging fiber bundles disposed symmetrically in the needle body about the central axis of the needle body.

6. The intervention needle for a soft endoscope of claim 5, wherein the two or more imaging fiber bundles are configured to determine a deviation of the needle insertion direction of the needle body from a central direction of the target site based on a distribution of signal intensity of the imaging response light among the two or more imaging fiber bundles.

7. The interventional needle for a soft endoscope according to claim 3, wherein the at least one imaging fiber bundle includes a first constituent imaging fiber bundle configured to emit imaging probe light toward a target site within the living body and a second constituent imaging fiber bundle configured to receive imaging response light from the target site, one or more imaging fiber bundles of the first set of imaging fiber bundles are positioned adjacent to a corresponding one or more imaging fiber bundles of the second set of imaging fiber bundles, and each imaging fiber bundle of the second set of imaging fiber bundles has attached at a front fiber end face thereof an objective lens of a size comparable to the imaging fiber bundle.

8. The intervention needle for a soft endoscope of claim 7, wherein the first component of imaging fiber bundles comprises two or more imaging fiber bundles disposed symmetrically in the needle body about the central axis of the needle body, and the second component of imaging fiber bundles comprises a respective two or more imaging fiber bundles disposed symmetrically in the needle body about the central axis of the needle body.

9. The intervention needle for a soft endoscope of claim 1, further comprising one or more illumination fibers disposed in the needle body and extending longitudinally along a central axis of the needle body, a front fiber end face of the one or more illumination fibers being located at the front end face of the needle body, wherein the one or more illumination fibers are configured to illuminate a target site within the living body.

10. The intervention needle for a soft endoscope of claim 9, wherein the one or more illumination fibers comprise a plurality of illumination fibers configured to emit illumination light of wavelengths different from each other.

11. The interventional needle for a soft endoscope as defined in claim 1, further comprising:

one or more sets of sensing optical fibers disposed in the needle and extending longitudinally along a central axis of the needle such that front fiber end faces of the one or more sets of sensing optical fibers are located at a front end face of the needle,

wherein each of the one or more sets of sensing optical fibers is for sensing a respective one of the parameters of the microenvironment inside the living body, each of the sensing optical fibers of the set includes a probe head having a photoluminescent material at a front fiber end face thereof, the photoluminescent material being configured to have an emission spectrum that varies as a function of the respective one of the parameters, and

wherein each sensing optical fiber of each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and to receive emission light from the photoluminescent material in order to determine the respective one of the parameters of the microenvironment inside the living body based on the emission light of the photoluminescent material.

12. The interventional needle for a soft endoscope of claim 11, wherein the one or more sets of sensing optical fibers comprise one or more of:

a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, a probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature;

a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and

a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a pH of a microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in pH.

13. The intervention needle for a soft endoscope of claim 1, wherein the needle body has a hollow structure to provide a working channel inside the needle body, the working channel configured to perform at least one of the following operations: delivering a medical device; delivering the drug; pumping waste liquid; and conveying the cleaning liquid.

14. The intervention needle for a soft endoscope of claim 13, wherein the working channel is disposed in the needle body eccentrically with respect to a central axis of the needle body.

15. The intervention needle for a soft endoscope of claim 13, wherein at least one backup channel is provided inside the needle body, the at least one backup channel configured to perform at least one of the following operations: delivering a medical device; delivering the drug; pumping waste liquid; and conveying the cleaning liquid.

16. The access needle for a soft endoscope of claim 13, further comprising an inner needle removably disposed within the working channel of the needle body, the inner needle operable to enter inside the target site when the needle body is navigated at or near the target site.

17. The interventional needle for a soft endoscope according to claim 16, wherein the inner needle includes one or more imaging fiber bundles disposed therein, the one or more imaging fiber bundles extending longitudinally along a central axis of the inner needle and having a leading fiber end face located at or near a leading end face of the inner needle, each of the one or more imaging fiber bundles having attached at its leading fiber end face an objective lens of a size comparable to the imaging fiber bundle,

wherein the one or more imaging fiber bundles are configured to emit imaging probe light toward a target site within the living body and receive imaging response light from the target site to image the target site based on the imaging response light.

18. The interventional needle for a soft endoscope of claim 16, wherein the inner needle comprises one or more sets of sensing optical fibers disposed therein, the one or more sets of sensing optical fibers extending longitudinally along a central axis of the inner needle and having a leading optical fiber end face located at or near a leading end face of the inner needle,

wherein each of the one or more sets of sensing fibres is for sensing a respective one of the parameters of the microenvironment inside the target site, each of the sensing fibres of the set of sensing fibres comprises a probe head at a front fibre end face thereof having a photoluminescent material configured to have an emission spectrum that varies with the variation of the respective one of the parameters, and

wherein each sensing optical fiber of each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine the respective one of the parameters of the microenvironment inside the target site based on the emission light of the photoluminescent material.

19. The interventional needle for a soft endoscope of claim 18, wherein the one or more sets of sensing optical fibers comprise one or more of:

a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature;

a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the target site, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and

a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a pH of a microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with pH.

20. The interventional needle for a soft endoscope according to claim 18, wherein each of the one or more sets of sensing optical fibers is arranged in the inner needle in rotational symmetry with respect to the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting a chemical ablation drug to the target site.

21. The interventional needle for a soft endoscope of claim 16, wherein the inner needle is configured for thermal ablation of the target site and comprises one or more sets of temperature sensing optical fibers arranged therein, the one or more sets of temperature sensing optical fibers extending longitudinally along a central axis of the inner needle, and a leading optical fiber end face of each of the one or more sets of temperature sensing optical fibers being located at a respective one of cross-sections of the inner needle between a leading end face and a trailing end face thereof,

wherein each of the one or more sets of temperature sensing optical fibres is for sensing the temperature of the microenvironment inside the target site, each temperature sensing optical fibre of the one or more sets of temperature sensing optical fibres comprises a probe head at a front fibre end face thereof having a photoluminescent material configured to have an emission spectrum that varies with temperature, and

wherein each temperature sensing optical fiber of each of the one or more sets of temperature sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine a temperature of a microenvironment inside the target site based on the emission light of the photoluminescent material.

22. The interventional needle for a soft endoscope according to claim 21, wherein a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers is closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, and a temperature sensing optical fiber density of the first set of temperature sensing optical fibers is greater than a temperature sensing optical fiber density of the second set of temperature sensing optical fibers, the temperature sensing optical fiber density being a ratio of a number of one set of temperature sensing optical fibers to an area of the inner needle cross-section in which the front optical fiber end face of the set of temperature sensing optical fibers is located.

23. The intervention needle for a soft endoscope of claim 1, further comprising a navigation fiber bundle disposed in the needle body, the navigation fiber bundle extending longitudinally along a central axis of the needle body and having a front fiber end face at a front end face of the needle body,

wherein the navigation fiber bundle is configured to emit navigation probe light into the living body interior and receive navigation response light derived from the navigation probe light so as to locate and distinguish a site of the living body interior which is not expected to be penetrated by the interventional needle based on the navigation response light.

24. A flexible endoscope, characterized in that it comprises an intervention needle for a flexible endoscope according to any one of claims 1 to 23.

25. A flexible endoscope system, comprising:

the flexible endoscope of claim 24, configured to provide an imaged picture of a living body interior;

a control device configured to correct an imaging screen provided by the flexible endoscope based on a rotation direction and a rotation angle of a central axis of a needle body with respect to a gravity direction detected by a detection device of an intervention needle of the flexible endoscope; and

a display device configured to display the imaged picture corrected by the control device.

26. The soft endoscope system according to claim 25, wherein the control device is configured to correct the imaging screen provided by the soft endoscope by rotating the imaging screen provided by the soft endoscope by the same angle as the detected rotation angle in a direction opposite to the detected rotation direction.