Interventional needle for soft endoscope, soft endoscope, and soft endoscope system

Abstract

The present disclosure relates to an intervention needle for a flexible endoscope, a flexible endoscope, and a flexible endoscope system. An intervention needle for a flexible endoscope, the intervention needle comprising: a needle body configured to be interventable through a natural or artificial passage of a living body; and a detection device arranged 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 direction of gravity.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and more specifically, to an interventional needle for a flexible endoscope, a flexible endoscope, and a flexible endoscope system. Background Technology

[0002] Flexible endoscopes are flexible endoscopes that primarily intervene in a living body through its natural cavities. They can be used for imaging, diagnosis, and / or treatment of lesions within the body and are widely used in fields such as gastroenterology, urology, and ENT. While doctors can use existing flexible endoscopes to observe the surface features of target areas (such as tumors) within a patient's body, they cannot observe the deeper structures of those areas. Furthermore, the flexible endoscope may rotate during interventional procedures, resulting in an unstable viewing angle for the images captured within the patient's body, which significantly complicates the doctor's observation of the patient's internal condition. Furthermore, when doctors use a flexible endoscope to insert an interventional needle into a patient's body to perform interventional diagnostic and treatment procedures such as puncture at the target site, the degree of freedom of the interventional needle may be limited by the attachment between the interventional needle and the flexible endoscope. In addition, there may be a certain deviation between the actual insertion position of the interventional needle and the field of view of the flexible endoscope. Since the interventional needle usually enters a relatively deep part of the patient's body, the doctor operating the interventional needle often cannot directly see the situation at the location of the interventional needle, and cannot grasp the rapidly changing situation in the patient's body in a timely and accurate manner. This makes it difficult to make reliable judgments and decisions in a timely manner, and thus cannot efficiently carry out diagnosis and treatment during interventional surgery. Summary of the Invention

[0003] A brief overview of this disclosure is given below to provide a basic understanding of some aspects of it. However, it should be understood that this overview is not an exhaustive summary of this disclosure. It is not intended to identify key or essential parts of this disclosure, nor is it intended to limit the scope of this disclosure. Its purpose is merely to present certain concepts of this disclosure in a simplified form as a prelude to the more detailed description that follows.

[0004] According to one aspect of this disclosure, an interventional needle for a flexible endoscope is provided, wherein the interventional needle includes: a needle body configured to intervene in the living body through a natural or artificial passage; and a detection device disposed in the needle body and configured to detect the direction and angle of rotation of the central axis of the needle body relative to the direction of gravity.

[0005] In some embodiments, the detection device may be configured to detect the rotation direction and rotation angle of the central axis of the needle relative to the direction of gravity by measuring the acceleration caused by the gravity of the needle.

[0006] In some embodiments, the interventional needle may include at least one imaging fiber bundle disposed in the needle body and extending longitudinally along the central axis of the needle body, wherein the front fiber end face of the at least one imaging fiber bundle is 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 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.

[0007] In some embodiments, each of the at least one imaging fiber bundle can 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 can have an objective lens of similar size attached to its front fiber end face.

[0008] In some embodiments, the at least one imaging fiber bundle may include two or more imaging fiber bundles arranged symmetrically in the needle body about the central axis of the needle body.

[0009] In some embodiments, the two or more imaging fiber bundles may be configured to determine the deviation of the needle insertion direction from the center 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.

[0010] In some embodiments, the at least one imaging fiber bundle may include a first imaging fiber bundle configured to emit imaging probe light toward a target site within the living body and a second imaging fiber bundle configured to receive imaging response light from the target site. One or more imaging fiber bundles in the first imaging fiber bundle may be positioned adjacent to one or more corresponding imaging fiber bundles in the second imaging fiber bundle, and each imaging fiber bundle in the second imaging fiber bundle may have an objective lens of a size equivalent to that imaging fiber bundle attached to its front fiber end face.

[0011] In some embodiments, the first imaging fiber bundle may include two or more imaging fiber bundles arranged symmetrically in the needle body about the central axis of the needle body, and the second imaging fiber bundle may include corresponding two or more imaging fiber bundles arranged symmetrically in the needle body about the central axis of the needle body.

[0012] In some embodiments, the interventional needle may further include one or more illumination optical fibers arranged in the needle body and extending longitudinally along the central axis of the needle body, wherein the front fiber end face of the one or more illumination optical fibers is located at the front end face of the needle body, and wherein the one or more illumination optical fibers are configured to illuminate the target site within the living body.

[0013] In some embodiments, the one or more illumination fibers may include multiple illumination fibers configured to emit illumination light with different wavelengths from each other.

[0014] In some embodiments, the interventional needle may further include: one or more sets of sensing optical fibers arranged in the needle body and extending longitudinally along the central axis of the needle body, such that the front fiber end face of the one or more sets of sensing optical fibers is located at the front end face of the needle body, wherein each set of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the living body, each sensing optical fiber in each set of sensing optical fibers includes a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with the corresponding parameter, and wherein each sensing optical fiber in each set of sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the corresponding parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material.

[0015] In some embodiments, the set of or more sensing optical fibers may include one or more of the following: a first set of sensing optical fibers including one or more first sensing optical fibers for sensing the temperature of the microenvironment inside the living body, each of the first sensing optical fibers having a probe with a first photoluminescent material configured to have an emission spectrum that varies with temperature; a second set of sensing optical fibers including one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside the living body, each of the second sensing optical fibers having a probe with a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing the pH of the microenvironment inside the living body, each of the third sensing optical fibers having a probe with a third photoluminescent material configured to have an emission spectrum that varies with pH.

[0016] 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 a drug; aspirating waste liquid; delivering a cleaning solution.

[0017] In some embodiments, the working channel may be arranged eccentrically within the needle body about the central axis of the needle body.

[0018] In some embodiments, at least one spare channel may be provided inside the needle body, the at least one spare channel being configured to perform at least one of the following operations: delivering a medical device; delivering a drug; aspirating waste liquid; delivering a cleaning solution.

[0019] In some embodiments, the interventional needle may further include an inner needle removably disposed within the working channel of the needle body, the inner needle being operable to enter the target site when the needle body is navigated to or near the target site.

[0020] In some embodiments, the inner needle may include one or more imaging fiber bundles disposed within the inner needle, the one or more imaging fiber bundles extending longitudinally along the 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 an objective lens of a size equivalent to that imaging fiber bundle attached to its front fiber end face, 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, so as to image the target site based on the imaging response light.

[0021] In some embodiments, the inner needle may include one or more sets of sensing optical fibers disposed within the inner needle, the sets of sensing optical fibers extending longitudinally along the 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, wherein each set of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the target site, each of the sets of sensing optical fibers includes a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with the corresponding parameter, and wherein each of the sets of sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the corresponding parameter of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

[0022] In some embodiments, the set of or more sensing optical fibers may include one or more of the following: a first set of sensing optical fibers including one or more first sensing optical fibers for sensing the temperature of the microenvironment inside the target site, wherein the probe of each of the first sensing optical fibers in the first set of sensing optical fibers has a first photoluminescent material configured to have an emission spectrum that varies with temperature; a second set of sensing optical fibers including one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside the target site, wherein the probe of each of the second sensing optical fibers in the second set of sensing optical fibers has a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing the pH of the microenvironment inside the target site, wherein the probe of each of the third sensing optical fibers in the third set of sensing optical fibers has a third photoluminescent material configured to have an emission spectrum that varies with pH.

[0023] In some embodiments, each of the one or more sets of sensing optical fibers may be arranged rotationally symmetrically within the inner needle about the central axis of the inner needle, and wherein the inner needle may have a hollow channel for injecting a chemical ablation agent into the target site.

[0024] In some embodiments, the inner needle may be configured to thermally ablate the target site and includes one or more sets of temperature-sensing optical fibers disposed within the inner needle, the sets of temperature-sensing optical fibers extending longitudinally along the central axis of the inner needle, and the front fiber end face of each set of temperature-sensing optical fibers located at a corresponding cross-section of the inner needle between the front and rear ends, wherein each set of temperature-sensing optical fibers is used to sense the temperature of the microenvironment inside the target site, each temperature-sensing optical fiber including a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with temperature, and wherein each set of temperature-sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the temperature of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

[0025] In some embodiments, the first set of temperature sensing fibers in one or more sets of temperature sensing fibers may be closer to the front end face of the inner needle than the second set of temperature sensing fibers in one or more sets of temperature sensing fibers, and the temperature sensing fiber density of the first set of temperature sensing fibers is greater than the temperature sensing fiber density of the second set of temperature sensing fibers. The temperature sensing fiber density is the ratio of the number of a set of temperature sensing fibers to the area of ​​the cross-section of the inner needle where the front fiber end face of the set of temperature sensing fibers is located.

[0026] In some embodiments, the interventional needle may further include a navigation fiber bundle disposed in the needle body, the navigation fiber bundle extending longitudinally along the central axis of the needle body and having a front fiber end face located 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 from the navigation probe light, so as to locate and distinguish undesirable sites within the living body to be punctured by the interventional needle based on the navigation response light.

[0027] According to another aspect of this disclosure, a flexible endoscope is provided, the flexible endoscope including an interventional needle for a flexible endoscope as described in any of the foregoing embodiments of this disclosure.

[0028] According to another aspect of this disclosure, a flexible endoscope system is provided, the flexible endoscope system comprising: a flexible endoscope according to any embodiment of the foregoing aspects of this disclosure, the flexible endoscope being configured to provide an imaging view of an internal body; a control device configured to correct the imaging view provided by the flexible endoscope based on the rotation direction and rotation angle of the central axis of the needle relative to the direction of gravity, detected by a detection device of the needle of the flexible endoscope; and a display device configured to display the imaging view corrected by the control device.

[0029] In some embodiments, the control device may be configured to correct the image provided by the flexible endoscope by rotating the image provided by the flexible endoscope in a direction opposite to the detected rotation direction by the same angle as the detected rotation angle.

[0030] Other features and advantages of this disclosure will become clearer from the following detailed description of exemplary embodiments with reference to the accompanying drawings. Attached Figure Description

[0031] The accompanying drawings, which form part of this specification, illustrate embodiments of the present disclosure and, together with the specification, 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 scope of the disclosure. The following detailed description of exemplary embodiments will be clearly understood when read in conjunction with the following drawings, wherein similar structures are indicated by similar reference numerals, and wherein:

[0032] Figure 1 This is a schematic top view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0033] Figure 2 yes Figure 1 A side view of the interventional needle used for a flexible endoscope;

[0034] Figure 3 This is a schematic diagram illustrating the structure of an imaging fiber bundle in an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure.

[0035] Figures 4A to 4D Several example arrangements of the imaging fiber bundle for an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure are illustrated respectively.

[0036] Figure 5 This is a schematic top view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0037] Figure 6 This is a schematic top view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0038] Figure 7 This is a schematic diagram illustrating the structure of a sensing fiber in an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure.

[0039] Figures 8A to 8C Several example photoluminescent materials used in probes for sensing optical fibers in interventional needles for flexible endoscopes, illustrating one or more exemplary embodiments of this disclosure;

[0040] Figure 9 This is a schematic top view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0041] Figure 10 This is a schematic side view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0042] Figure 11This is a schematic top view of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0043] Figure 12 This is a schematic top view of an example internal needle for an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0044] Figure 13 This is a schematic top view of another example internal needle for an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0045] Figure 14A and Figure 14B These are, respectively, a top view and a side view schematically illustrating yet another example of an interventional needle for a flexible endoscope according to one or more exemplary embodiments of the present disclosure;

[0046] Figure 15 This is a schematic block diagram illustrating a flexible endoscope system according to one or more exemplary embodiments of the present disclosure. Detailed Implementation

[0047] Various exemplary embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It should be noted that, unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps set forth in these embodiments do not limit the scope of the present disclosure.

[0048] The following description of at least one exemplary embodiment is merely illustrative and is in no way intended to limit the scope of this disclosure or its application or use. That is, the structures and methods herein are shown in an exemplary manner to illustrate different embodiments of the structures and methods in this disclosure. However, those skilled in the art will understand that they merely illustrate exemplary ways that can be used to implement this disclosure, and not exhaustive ways. Furthermore, the drawings are not necessarily drawn to scale, and some features may be enlarged to show details of specific components.

[0049] In addition, techniques, methods and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods and equipment should be considered part of the specification.

[0050] In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0051] During interventional procedures, doctors can use a flexible endoscope to guide an interventional needle into the patient's body. The imagery of the patient's internal environment provided by the flexible endoscope guides the doctor in placing the needle near the target site (e.g., a lesion like a tumor). However, the flexible endoscope may rotate during the procedure, causing rotation of its field of view and the resulting image. This means the image provided by the flexible endoscope is difficult to maintain a fixed perspective during intervention, hindering observation. Furthermore, the needle's maneuverability may be limited by the attachment between the needle and the flexible endoscope, and the actual insertion point may deviate from the endoscope's field of view. Therefore, doctors often rely on experience and feel to determine the needle's direction and position relative to the target site. Moreover, current flexible endoscopes cannot provide in-situ, real-time imaging of the target site or monitor the microenvironment within and outside the target area, thus failing to provide useful information for immediate diagnostic decisions.

[0052] To this end, this disclosure provides, in one aspect, an interventional needle (hereinafter referred to as the interventional needle) for a flexible endoscope, the interventional needle having a detection device disposed within the needle body, the detection device being configured to detect the rotation direction and rotation angle of the central axis of the needle body relative to the direction of gravity. Thus, the imaging image provided by the flexible endoscope can be further corrected based on the detected rotation direction and rotation angle, enabling the physician to always have a substantially fixed viewing angle during interventional procedures, facilitating medical observation and the performance of corresponding surgical operations. In this disclosure, "a substantially fixed viewing angle" can be understood as the relative positional relationship of objects presented in the imaging image remaining substantially unchanged from the operator's (e.g., physician's) perspective. For example, assuming the physician sees a first object above a second object in the imaging image, if the flexible endoscope is rotated 90° clockwise, the physician will still see the first object above the second object, not the first object to the right of the second object. Thus, even if the field of view of the flexible endoscope rotates, the presented imaging image will not rotate accordingly. Therefore, with the imaging view remaining essentially fixed, doctors can perform interventional diagnostic and treatment procedures under a stable field of vision. This not only helps improve the accuracy of interventional diagnostic and treatment procedures but also increases work efficiency. Furthermore, according to some embodiments of this disclosure, the interventional needle can have a working channel eccentrically arranged within the needle body, thereby optimizing the spatial layout of the needle's components and thus saving internal space, which is beneficial for miniaturization. When used with existing flexible endoscopes, the miniaturized interventional needle's operational freedom is less restricted by the attachment between the needle and the flexible endoscope, and the deviation between the actual insertion position of the needle and the field of vision of the flexible endoscope is also smaller. Furthermore, the interventional needle according to some embodiments of this disclosure can have optical imaging capabilities, thereby enabling direct imaging of the interior of a living organism or even the target site using the interventional needle itself. Therefore, the interventional needle with optical imaging capabilities can be used as part of a flexible endoscope, eliminating the need for attachment to a flexible endoscope and thus providing greater operational freedom. The actual insertion position of the interventional needle becomes consistent with the field of view, allowing observation not only of the surface features of the target site but also of its deeper features. In addition, the interventional needle according to some embodiments of this disclosure can have real-time optical navigation capabilities to efficiently guide the insertion process, avoiding important areas such as blood vessels and organs that need protection as the interventional needle enters the living organism through its natural or artificial channels to reach the target site.Furthermore, the interventional needle according to some embodiments of this disclosure may also have a real-time in-situ microenvironment sensing function, which can sense various parameters and their distribution of the microenvironment outside and inside the target site in situ and in real time during the process of the interventional needle entering the living body through the natural or artificial channel to reach the target site and after the interventional needle enters the target site, providing a large amount of useful reference information for doctors' immediate diagnosis and treatment decisions.

[0053] The interventional needle according to various embodiments of the present disclosure will now be described in detail with reference to the accompanying drawings. It will be understood that actual interventional needles may contain other components, but these are not shown in the drawings and will not be discussed herein to avoid obscuring the key points of the disclosure. It should also be noted that, in this document, "anterior" refers to the side closer to the target site and further away from the operator (usually the physician), and "posterior" refers to the side further away from the target site and closer to the operator.

[0054] Figure 1 and Figure 2 An interventional needle 100 for a flexible endoscope according to one or more exemplary embodiments of the present disclosure is schematically shown, wherein, Figure 1 This is a top view showing the intervention needle 100 viewed from front to back. Figure 2 This is a side view of the intervention needle 100 as viewed in a direction perpendicular to the front-back direction.

[0055] like Figure 1 and Figure 2 As shown, the interventional needle 100 includes a needle body 102. The needle body 102 can be configured to intervene in a living organism (e.g., a human or animal body) through its natural or artificial channels, 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 can be made 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, and silver. It is understood that although... Figure 1 The cross-sectional shape of the needle body 102 is illustrated as a circle, but this is merely exemplary and not limiting; the needle body 102 may have any suitable cross-sectional shape.

[0056] The intervention needle 100 may include a detection device 50 disposed within the needle body 102. In some embodiments, the detection device 50 may be disposed at the front end face 102-1 of the needle body 102, for example... Figure 2As shown, this is merely exemplary and not limiting; the detection device 50 may also be arranged at other locations within the needle body 102. In some embodiments, the detection device 50 may be arranged entirely within the needle body 102, thereby protecting the detection device 50 from interference from biological tissues and damage from the in vivo internal environment.

[0057] The detection device 50 can be configured to detect the rotation direction and rotation angle of the central axis 102-0 of the needle body 102 relative to the direction of gravity. The rotation direction and rotation angle of the central axis 102-0 of the needle body 102 relative to the direction of gravity detected by the detection device 50 of the interventional needle 100 can be further used to correct the imaging image provided by the flexible endoscope to which the interventional needle 100 is applied, so that the imaging image provided by the flexible endoscope can be kept substantially at a fixed viewing angle to facilitate medical observation by the physician. In some embodiments, the flexible endoscope to which the interventional needle 100 is applied can be a flexible endoscope to which the interventional needle 100 is attached so that it can be carried into the living body. In this configuration, due to the attachment between the interventional needle 100 and the flexible endoscope, the rotation direction and angle of the needle body 102 can correspond to the rotation direction and angle of the flexible endoscope. Therefore, the imaging provided by the flexible endoscope to which the interventional needle 100 is attached can be corrected based on the detected rotation direction and angle of the central axis 102-0 of the needle body 102 relative to the direction of gravity. In some embodiments, the flexible endoscope to which the interventional needle 100 is applied can be a flexible endoscope that includes the interventional needle 100 as its tip imaging portion. For example, in the embodiments described later, the interventional needle 100 itself can have optical imaging capabilities and thus can be directly used as part of the flexible endoscope. In this case, the rotation direction and angle of the needle body 102 can be considered to be the rotation direction and angle of the flexible endoscope, thereby allowing the imaging provided by the flexible endoscope including the interventional needle 100 to be corrected based on the detected rotation direction and angle of the central axis 102-0 of the needle body 102 relative to the direction of gravity.

[0058] In some embodiments, the detection device 50 may be configured to detect the rotation direction and rotation angle of the central axis 102-0 of the needle body 102 relative to the direction of gravity by measuring the acceleration caused by the gravity of the needle body 102. In some examples, the detection device 50 may be configured as a gravity sensor or an angular motion detector, such as a gyroscope.

[0059] As previously mentioned, the interventional needle 100 according to this disclosure can be designed to have optical imaging capabilities. Specifically, in some embodiments, the interventional needle 100 may further include at least one imaging fiber bundle 104. Each imaging fiber bundle 104 may include a bundle of multiple optical fibers. The at least one imaging fiber bundle 104 is arranged in the needle body 102 and extends longitudinally along the central axis 102-0 of the needle body 102. For example, as Figure 1 As shown, the intervention needle 100 includes eight imaging fiber bundles 104a-104h, which have the same shape and size. However, this is merely exemplary and not limiting. The intervention needle 100 may include any suitable number, shape, and / or size of imaging fiber bundles 104, for example, see [reference needed]. Figures 4A to 4D , Figures 5 to 6 , Figure 9 and Figure 11 . refer to Figure 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... Figure 2 Only a portion of some imaging fiber bundles 104 arranged in the needle body 102 is schematically shown with dashed lines. At least one imaging fiber bundle 104 can be configured to emit imaging probe light toward a target site within the living body and receive imaging response light from that target site, so as to image the target site based on the imaging response light. Thus, the interventional needle 100 can use the imaging fiber bundles 104 disposed in the needle body 102 to image the interior of the living body to obtain the surface features of the target site.

[0060] By incorporating an imaging fiber bundle 104 within the needle body 102, the interventional needle 100 itself can possess optical imaging capabilities, allowing for direct imaging without the need for additional optical imaging components in the flexible endoscope 201. Therefore, the interventional needle 100 with optical imaging capabilities can function as part of the flexible endoscope 201, eliminating the need for attachment to the flexible endoscope 201, providing greater operational freedom, and ensuring that the actual insertion position of the interventional needle 100 aligns with the field of view, thus facilitating the accurate implementation of interventional diagnostic and therapeutic procedures.

[0061] In some embodiments, the imaging response light from the target region may be reflected light from the imaging probe light by the target region. In some embodiments, the imaging response light from the target region may be emitted light emitted by the target region in response to absorbing the imaging probe light. In some examples, the target region may be pre-enriched with photoluminescent material by means such as injection, and then imaging probe light including the excitation wavelength of the photoluminescent material may be emitted towards the target region via the imaging fiber bundle 104, and the imaging response light emitted by the target region in response to absorbing the imaging probe light may be received, so as to image the target region based on the imaging response light.

[0062] In some embodiments, such as Figure 1 As shown, the at least one imaging fiber bundle 104 includes two or more imaging fiber bundles 104 arranged symmetrically within the needle body 102 about the central axis 102-0 of the needle body 102. The symmetrical distribution of the imaging fiber bundles 104 facilitates determining the deviation of the needle insertion direction of the needle body 102 from the central direction of the target location 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 bundles 104 can be, for example, an axially symmetric distribution, and more preferably, a rotationally symmetric distribution. For example, the at least one imaging fiber bundle 104 may include eight imaging fiber bundles 104a-104h arranged rotationally symmetrically within the needle body 102 about the central axis 102-0 of the needle body 102, meaning that every 45° rotation allows one imaging fiber bundle 104 to be moved to the position previously held by an adjacent imaging fiber bundle 104.

[0063] In some examples of embodiments where the imaging response light is the reflected light from the imaging probe light at the target site, the wavelength range of the imaging probe light can be determined based on the characteristic absorption spectral properties of the target site. For example, assuming the target site has an absorption peak at a first wavelength, an imaging probe light including the first wavelength can 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 first wavelength position can be analyzed. If the signal intensity of the imaging response light at the first wavelength position is distributed as follows among the eight imaging fiber bundles 104a-104h: stronger at imaging fiber bundles 104b, 104c, 104d, and 104e than at imaging fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle body 102 is lower than the center direction of the target area; if the signal intensity of the imaging response light at the first wavelength position among the eight imaging fiber bundles 104a-104h is distributed as follows: weaker at imaging fiber bundles 104b, 104c, 104d, and 104e than at imaging fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle body 102 is higher ... If the signal intensity of the imaging fiber bundles 104h, 104a, 104b, and 104c is stronger than that of the imaging fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the right relative to the center direction of the target area. If the signal intensity of the imaging response light at the first wavelength position is distributed among the eight imaging fiber bundles 104a-104h such that it is weaker at the imaging fiber bundles 104h, 104a, 104b, and 104c than at the imaging fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the left relative to the center direction of the target area. If the signal intensity of the imaging response light at the first wavelength position is distributed uniformly among the eight imaging fiber bundles 104a-104h, it indicates that the insertion direction of the needle body 102 is not deviated from the center direction of the target area. Similarly, the deviation of the needle insertion direction of the needle body 102 from the center 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-104h. This helps the doctor to adjust the needle insertion direction of the needle body 102 in a timely manner. Furthermore, when the signal intensity of the imaging response light is evenly distributed among the eight imaging fiber bundles 104a-104h, it can be determined that the needle insertion direction of the needle body 102 has not deviated from the center direction of the target site.In some examples, if the target region has absorption peaks at multiple wavelengths, imaging probe light including at least two of the multiple wavelengths can be emitted towards the target region via imaging fiber bundle 104. The absolute or relative value of the signal intensity of the received imaging response light at the positions of the at least two wavelengths is then analyzed among the eight imaging fiber bundles 104a-104h. This can help to more accurately determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target region based on the distribution of the signal intensity of the imaging response light among the eight imaging fiber bundles 104a-104h.

[0064] In some examples of embodiments where the imaging response light is the emitted light emitted by the target site in response to the absorption of the imaging probe light, the target site can be pre-enriched with photoluminescent material by means such as injection. Then, imaging probe light including the excitation wavelength of the photoluminescent material can be emitted towards the target site via the imaging fiber bundle 104, and the signal intensity of the received imaging response light at the emission wavelength of the photoluminescent material can be analyzed. Taking the diagnosis and treatment of liver tumors as an example, doctors usually need to perform interventional surgery on the liver with tumors. Before the surgery, a photoluminescent material, such as the clinically approved Indocyanine Green (ICG) dye, is generally injected. Thus, as the interventional needle 100 moves towards the liver tumor, a 730nm imaging probe light can be emitted via the imaging fiber bundle 104 to excite the ICG dye enriched in the liver tumor to emit light, and the signal intensity of the received imaging response light at the emission wavelength of the ICG dye can be analyzed. If the signal intensity of the imaging response light at the emission wavelength is distributed as follows among the eight imaging fiber bundles 104a-104h: stronger at imaging fiber bundles 104b, 104c, 104d, and 104e than at imaging fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle 102 is slightly upward relative to the center of the target area. If the signal intensity of the imaging response light at the emission wavelength is distributed as follows among the eight imaging fiber bundles 104a-104h: weaker at imaging fiber bundles 104b, 104c, 104d, and 104e than at imaging fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle 102 is slightly downward relative to the center of the target area. If the signal intensity of the imaging response light at the emission wavelength is distributed as follows among the eight imaging fiber bundles 104a-104h: weaker at imaging fiber bundles 104b, 104c, 104d, and 104e than at imaging fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle 102 is slightly downward relative to the center of the target area. If the signal intensity of the imaging fiber bundles 104h, 104a, 104b, and 104c is stronger than that of the imaging fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is to the left relative to the center direction of the target area. If the signal intensity of the imaging response light at the emission wavelength position is distributed among the eight imaging fiber bundles 104a-104h such that it is weaker at the imaging fiber bundles 104h, 104a, 104b, and 104c than at the imaging fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is to the right relative to the center direction of the target area. If the signal intensity of the imaging response light at the emission wavelength position is distributed uniformly among the eight imaging fiber bundles 104a-104h, it indicates that the insertion direction of the needle body 102 is not deviated from the center direction of the target area.In some examples, if the target region has emission peaks at multiple wavelengths, the distribution of the absolute or relative values ​​of the signal intensity of the received imaging response light at at least two of the multiple wavelengths within the eight imaging fiber bundles 104a-104h can be analyzed. This can help to more accurately determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target region based on the distribution of the signal intensity of the imaging response light within the eight imaging fiber bundles 104a-104h.

[0065] Therefore, the interventional needle 100 can also achieve real-time optical navigation through the imaging fiber bundle 104. This not only helps the doctor navigate the interventional needle 100 to the vicinity of the target site, but also helps the doctor confirm whether the insertion direction and position of the interventional needle 100 are appropriate. Two or more symmetrically arranged imaging fiber bundles 104 can also additionally or alternatively achieve the following function: during operation, the field of view of a single imaging fiber bundle 104 may be obstructed. Therefore, two or more symmetrically arranged fiber bundles 104 can reduce the possibility of the field of view being completely obstructed, making the operator's field of view more comprehensive, stable and clear.

[0066] Additionally, in some embodiments, each of the at least one imaging fiber bundle 104 can 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. For example, as Figure 1 As shown, each imaging fiber bundle 104a-104h has both light emission and light reception functions. In some embodiments, each imaging fiber bundle 104a-104h may have an objective lens 104-3 of similar size attached to its front fiber end face 104-1. For example, the objective lens 104-3 may be a miniature objective lens with a diameter in the range of, for example, 0.3 mm to 1 mm, such as a fisheye lens. Figure 3 An example structure of an imaging fiber bundle 104 is shown, having a front fiber end face 104-1 and a rear fiber end face 104-2. An objective lens 104-3 is mounted on the front fiber end face 104-1 to facilitate light collection by the imaging fiber bundle 104. In embodiments where each of the at least one imaging fiber bundle 104 has both light emission and light reception functions, in some examples, some or all of the at least one imaging fiber bundle 104 may be arranged symmetrically (e.g., rotationally symmetrically) about the central axis 102-0 of the needle body 102.

[0067] Alternatively, the light emission function and the light reception function can be performed by different imaging fiber bundles 104. In some embodiments, the at least one imaging fiber bundle 104 may include a first imaging fiber bundle configured to emit imaging probe light toward a target site within a living organism and a second imaging fiber bundle configured to receive imaging response light from the target site. That is, the first imaging fiber bundle is used to perform the light emission function, while the second imaging fiber bundle is used to perform the light reception function. For example, refer to... Figure 4A (For clarity, the detection device 50 is not shown here to avoid obscuring the focus.) The first imaging fiber bundle may include imaging fiber bundles 104a, 104c, 104e, and 104g (which, for illustrative purposes, may be referred to as the transmitting imaging fiber bundle and are indicated by a left-hand shading in the figure), while the second imaging fiber bundle may include imaging fiber bundles 104b, 104d, 104f, and 104h (which, for illustrative purposes, may be referred to as the receiving imaging fiber bundle and are indicated by a right-hand shading in the figure). The second imaging fiber bundle may, for example, include at least two imaging fiber bundles. In some examples, some or all of the at least two imaging fiber bundles of the second imaging fiber bundle may be arranged symmetrically about the central axis 102-0 of the needle body 102, for example, axially symmetrically or rotationally symmetrically in the needle body 102. As previously mentioned, the deviation of the needle insertion direction of the needle body 102 from the central direction of the target area can be determined similarly based on the distribution of the signal intensity of the imaging response light among the symmetrically arranged imaging fiber bundles in the second imaging fiber bundle, which will not be elaborated further here. Each imaging fiber bundle in the second imaging fiber bundle may, for example, have an objective lens 104-3 of similar size attached to its front fiber end face to facilitate light collection. The number and arrangement of the imaging fiber bundles in the first imaging fiber bundle can be configured in any suitable manner. For example, the suitability of the configuration of the first imaging fiber bundle can be simply determined as follows: with the insertion needle 100 positioned perpendicular to the mirror surface in front of it, light of the same intensity is transmitted to each transmitting imaging fiber bundle in the first imaging fiber bundle, and the emitted light intensity of each receiving imaging fiber bundle in the second imaging fiber bundle is determined to be the same. If so, the configuration of the first imaging fiber bundle can be considered suitable. In some examples, the first imaging fiber bundle can be configured such that the relative positional relationship between the receiving imaging fiber bundles and each transmitting imaging fiber bundle is the same among the receiving imaging fiber bundles in the second imaging fiber bundle.

[0068] In some embodiments, the first imaging fiber bundle may include two or more imaging fiber bundles symmetrically arranged in the needle body 102 about the central axis 102-0 of the needle body 102, and the second imaging fiber bundle may include corresponding two or more imaging fiber bundles symmetrically arranged in the needle body 102 about the central axis 102-0 of the needle body 102. In some examples, the first imaging fiber bundle may be symmetrically distributed on a first circle about the central axis 102-0 of the needle body 102, and the second imaging fiber bundle 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 imaging fiber bundles are each symmetrically distributed on the same circle), for example, referencing Figure 4A and Figure 4B Alternatively, the first circle may have a larger or smaller diameter than the second circle, for example, see reference. Figure 4C and Figure 4D , among which, Figures 4A to 4D The first and second circles are indicated by dashed lines, and for clarity, the detection device 50 is not shown in either. In some embodiments, one or more transmitting imaging fiber bundles from the first imaging fiber bundle may be positioned adjacent to one or more receiving imaging fiber bundles from the second imaging fiber bundle. For example, in Figure 4B In this configuration, each receiving imaging fiber bundle is positioned adjacent to two corresponding transmitting imaging fiber bundles; Figure 4C In this configuration, four receiving imaging fiber bundles are positioned adjacent to a corresponding transmitting imaging fiber bundle; Figure 4D In this configuration, each receiving imaging fiber bundle is positioned adjacent to a corresponding transmitting imaging fiber bundle.

[0069] In some embodiments, such as Figure 5As shown (the detection device 50 is not shown for clarity), the interventional needle 100 may further include a navigation fiber bundle 105 disposed in the 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 detection light into the living body and receive navigation response light from the navigation detection light, so as to locate and distinguish, based on the navigation response light, areas or important sites inside the living body that are not desired to be punctured by the interventional needle 100, such as blood vessels, organs, etc., to avoid surgical accidents. In some embodiments, the navigation response light may be emitted light emitted by important sites in response to the absorption of the navigation detection light, for example, different important sites may be pre-enriched with different photoluminescent materials with different emission spectra by means of injection or other methods. In some embodiments, the navigation response light may be reflected light from the important sites to the navigation detection light, for example, different important sites may have different absorption spectra. The navigation fiber bundle 105 can be used to alternately emit navigation probe light, including absorption wavelengths unique to each important site, to locate and identify each important site in turn. Alternatively, the navigation fiber bundle 105 can emit navigation probe light including multiple absorption wavelengths common to multiple important sites and analyze the relative values ​​of the signal intensities of the received navigation response light at the multiple absorption wavelengths to locate and identify each important site. For example, for veins and arteries (which have distinctly different colors), the navigation fiber bundle 105 can alternately emit navigation probe light at 680nm and 850nm. Since veins have a first ratio of absorption intensity at 680nm to absorption intensity at 850nm, while arteries have a second ratio different from the first ratio, the ratio of the signal intensity of the navigation response light at 680nm to the signal intensity at 850nm can be used to determine whether it is a vein or an artery, guiding the doctor to avoid them when operating the interventional needle 100. In some embodiments, the imaging fiber bundle 104 mentioned above can also be used as the navigation fiber bundle 105 here. That is, the imaging fiber bundle 104 can also be used to perform the function of guiding the interventional needle 100 to avoid critical areas. For example, the imaging fiber bundle 104 can alternately emit imaging probe light and navigation probe light to alternately perform the functions of imaging the target area and guiding the interventional needle 100 to avoid critical areas. The arrangement embodiment of the navigation fiber bundle 105 can be similar to the arrangement embodiment of the imaging fiber bundle 104, and will not be described again here.

[0070] Various embodiments of the interventional needle 100 with in-situ real-time microenvironment sensing capabilities will be described below. For example... Figure 6As shown (the detection device 50 is not shown for clarity), in some embodiments, the interventional needle 100 may alternatively or additionally include one or more sets of sensing optical fibers 106, which are arranged in the needle body 102 and extend longitudinally along the central axis 102-0 of the needle body 102, such that the front fiber end face 106-1 of the one or more sets of sensing optical fibers 106 is located at the front end face 102-1 of the needle body 102, so as to directly contact the microenvironment inside the living body. Each set of sensing optical fibers 106 can be used to sense a corresponding parameter of the microenvironment inside the living body. Each sensing optical fiber in each set of sensing optical fibers 106 may include a probe with a photoluminescent material located at its front fiber end face 106-1, the photoluminescent material being configured to have an emission spectrum that varies with the corresponding parameter. Each sensing fiber in one or more sets of sensing fibers 106 can be configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine a corresponding parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material. In some embodiments, each set of sensing fibers 106 can be arranged symmetrically about the central axis 102-0 of the needle body 102. The symmetrical arrangement of the sensing fibers can facilitate the analysis of the distribution of parameters of the microenvironment. In some examples, the one or more sets of sensing fibers 106 can be distributed rotationally symmetrically on one or more concentric circles. In some examples, two or more sets of sensing fibers 106 can be distributed on the same circle. In some embodiments, the one or more sets of sensing fibers 106 can be distributed on the same circle as the at least one imaging fiber bundle 104 (e.g., Figure 6 The sensing fiber (indicated by the dashed line in the diagram) is located on or distributed across different concentric circles. The sensing fiber can be, for example, a single optical fiber, which can be much thinner than the imaging fiber bundle.

[0071] In some embodiments, the set or multiple sets of sensing optical fibers 106 may include one or more of the following: a first set of sensing optical fibers, including one or more first sensing optical fibers for sensing the temperature of the microenvironment inside a living organism, each of the first sensing optical fibers having a probe with a first photoluminescent material configured to have an emission spectrum that varies with temperature; a second set of sensing optical fibers, including one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside a living organism, each of the second sensing optical fibers having a probe with a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration; and a third set of sensing optical fibers, including one or more third sensing optical fibers for sensing the pH of the microenvironment inside a living organism, each of the third sensing optical fibers having a probe with a third photoluminescent material configured to have an emission spectrum that varies with pH. For example, refer to... Figure 6 The intervention needle 100 may include a first set of sensing optical fibers 1061a, 1061b, 1061c, 1061d for sensing temperature, a second set of sensing optical fibers 1062a, 1062b for sensing oxygen concentration, and a third set of sensing optical fibers 1063a, 1063b for sensing pH. Although Figure 6 The illustration shows each group of sensing fibers as comprising four or two sensing fibers, but this is merely exemplary and not limiting; each group of sensing fibers may include any suitable number of sensing fibers. When each group of sensing fibers includes multiple sensing fibers distributed at different locations, it helps to determine the distribution of the corresponding parameter. As a non-limiting example, the first photoluminescent material may include Er 3+ Doped rare earth upconversion nanoparticles (such as Figure 8A As shown, the core is Er 3+ Doped rare-earth nanoparticles, with an outer shell to enhance luminescence properties, form core-shell structured NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles. For example, 980 nm excitation light can be transmitted to them via a first sensing fiber, and the temperature change in the microenvironment can be determined based on the change in the ratio of the signal intensity at 525 nm and 545 nm in their emission spectrum. The second photoluminescent material can include benzo[a]porphyrin-based metal complexes (such as...). Figure 8B As shown, for example, 635 nm excitation light can be transmitted to it via a second sensing fiber, and then the change in oxygen concentration in the microenvironment can be determined based on the change in its emission intensity, and the third photoluminescent material may include polymethyl cyanine dye derivatives (such as... Figure 8C As shown, for example, excitation light at 635 nm and 680 nm can be transmitted to it via a third sensing fiber, and the change in pH can be determined based on the change in the ratio of the emission intensities under the two excitation conditions. (Reference) Figure 7The sensing fiber 106 may include a front fiber end face 106-1 and a rear fiber end face 106-2, with a probe 106-3 formed on the front fiber end face 106-1. For example, a photoluminescent material can be premixed with a polymer matrix material and then added to a cylindrical hollow mold for curing to obtain the probe 106-3. The probe 106-3 is then fused and assembled onto one end of the fiber to obtain the sensing fiber 106. The polymer matrix material may include, for example, polymethyl methacrylate, polyethyleneimine, polyvinyl alcohol, etc. These polymer materials have good biocompatibility and can organically fuse with the fiber to form a thin layer that modifies the fiber surface, achieving biofunctionalization. The sensing fiber prepared according to this disclosure can have excellent detection performance indicators, such as temperature detection better than ±1 degree Celsius, oxygen concentration detection better than ±1%, and pH detection better than ±0.1%.

[0072] Through these sensing optical fibers 106, the state and distribution of various parameters of the local microenvironment in the living body where the tip surface 102-1 of the needle body 102 is located can be obtained in situ in real time. This helps guide doctors to make reliable diagnostic and treatment decisions in a timely manner. For example, when the oxygen concentration is found to be too low, doctors cannot use photodynamic therapy to treat the tumor and need to use other therapies instead.

[0073] In some embodiments, such as Figure 9 and Figure 10 As shown, the needle body 102 may 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: deliver a drug (e.g., a drug for treatment / hemostasis); deliver a cleaning fluid (e.g., saline solution, for cleaning dirt / washing wounds, etc.); aspirate waste fluid (e.g., dirty cleaning fluid, spilled blood, etc.); deliver a medical device (e.g., an inner needle described below).

[0074] In some embodiments, such as Figure 11As shown, the working channel 102-4 can be arranged eccentrically in the needle body 102 about the central axis 102-0 of the needle body 102. Here, "eccentric arrangement" can be understood as: in the cross-section of the intervention needle 100, the central axis 102-0 of the needle body 102 and the central axis 102-40 of the working channel 102-4 are arranged offset. By eccentrically arranging the working channel 102-4 in the needle body 102, other components of the intervention needle 100 (e.g., detection device 50, imaging fiber bundle 104, navigation fiber bundle 105, sensing fiber 106, and illumination fiber 103 and spare channel 107, which will be described below) can be concentrated on the side of the needle body 102 away from the working channel 102-4. As a result, the spatial layout of the components of the intervention needle 100 can be optimized, so that, while keeping the other components of the intervention needle 100 and their dimensions unchanged, compared to a working channel arranged centrally in the needle body 102 (e.g., a centrally arranged working channel 102-4), the spatial layout of the components of the intervention needle 100 can be optimized. Figure 9 As shown), the eccentrically arranged working channel 102-4 (as shown) Figure 11 The needle 100 (as shown) can have a larger cross-sectional area, thus providing more operating space. From another perspective, while keeping the cross-sectional area of ​​the working channel 102-4 constant, the needle body 102 of the interventional needle 100 can be constructed to be smaller, which is beneficial for the miniaturization design of the interventional needle 100. When used with existing flexible endoscopes, the miniaturized interventional needle 100 is less restricted in its operational freedom by the attachment between the interventional needle 100 and the flexible endoscope, and the deviation between the actual insertion position of the interventional needle 100 and the field of view of the flexible endoscope is also smaller, thereby allowing for more accurate interventional diagnostic and therapeutic procedures.

[0075] In some embodiments, such as Figure 9 and Figure 11 As shown, at least one spare channel 107 can be provided inside the needle body 102 (in Figure 9 and Figure 11 In the embodiments described, a backup channel is exemplarily shown, but this is not limiting, and any suitable number of backup channels 107 can be provided as needed. The at least one backup channel 107 can, for example, be configured to perform at least one of the following operations: delivering a medical device; delivering a drug; aspirating waste liquid; delivering cleaning fluid. The at least one backup channel 107 can be configured to cooperate with the working channels 102-4. For example, in... Figure 9 In the embodiments described, the working channel 102-4 can be used to transport cleaning fluid, while the standby channel 107 can be used to pump out waste liquid. For example... Figure 9 and Figure 11 As shown, the at least one backup channel 107 can be constructed to be narrower than the working channel 102-4.

[0076] Understandable, although Figure 9 and Figure 11 The cross-sectional shape of the working channel 102-4 is illustrated as circular and the cross-sectional shape of the spare channel 107 is illustrated as elliptical, but this is merely exemplary and not limiting; the working channel 102-4 and the spare channel 107 can have any suitable cross-sectional shape and size. Furthermore, Figure 11 The eccentric arrangement of the working channel 102-4 in the needle body 102 is merely exemplary and not restrictive. The working channel 102-4 may also be arranged in other positions in the needle body 102 as needed.

[0077] In some embodiments, such as Figure 9 and Figure 11 As shown, the interventional needle 100 may further include one or more illumination optical fibers 103, which are arranged in the needle body 102 and extend longitudinally along the central axis 102-0 of the needle body 102. The front fiber end face of the one or more illumination optical fibers 103 is located at the front end face 102-1 of the needle body 102. The one or more illumination optical fibers 103 can be configured to illuminate a target area within the living body. The illumination optical fiber 103 may be, for example, a single optical fiber, which can be much thinner than the imaging fiber bundle 104, thus allowing multiple illumination optical fibers 103 to be arranged at multiple locations within the needle body 102. In some embodiments, the one or more illumination optical fibers 103 may include multiple illumination optical fibers 103 configured to emit illumination light with different wavelengths. For example, the wavelength ranges of the illumination light from the multiple illumination optical fibers 103 may differ from each other but partially overlap to collectively form a wider wavelength range. The light transmitted through the illumination fiber 103, compared to the imaging probe light transmitted through the imaging fiber bundle 104, may have at least one of the following characteristics: greater brightness, wider color gamut, or higher color saturation. Therefore, the illumination fiber 103 can illuminate the field of view of the imaging fiber bundle 104, which is beneficial for improving the imaging quality of the imaging fiber bundle 104.

[0078] In some embodiments, the intervention needle 100 may further include an optical fiber interface (not shown), which may be disposed on the rear end face 102-2 of the needle body 102 or on a portion of the side of the needle body 102 near the rear end face 102-2. For example, the rear fiber end faces of all the optical 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 optical fiber interface according to a predetermined pattern. For example, all the rear fiber end faces may be arranged in an array at the optical fiber interface. With such an arrangement, it is convenient to detect signals from each rear fiber end face by imaging the optical fiber interface, and it is also convenient to couple the desired light into each rear fiber end face. In some examples, the rear fiber end faces of the optical fibers for emitting light may be arranged together at the optical fiber interface, and the rear fiber end faces of the optical fibers for receiving light may be arranged together, so as to input light into and output light from the optical fibers of the intervention needle 100. In some examples, the intervention needle 100 may include a first fiber optic interface with a rear fiber optic end face for emitting light and a second fiber optic interface with a rear fiber optic end face for receiving light. The fiber optic interfaces can be optically coupled to a light source device and a light detection device outside the living organism using suitable optical transmission components such as fiber optic connectors and optical cables.

[0079] In some embodiments, the intervention needle 100 may further include a wire interface (not shown), which may be disposed on the rear end face 102-2 of the needle body 102 or on a portion of the side of the needle body 102 near the rear end face 102-2. For example, the rear end face of a wire for conducting electrical signals from the detection device 50 may be disposed at the wire interface. The wire interface may be electrically coupled to an external analytical device, such as the control device 202 described later, using suitable electrical conductive components such as electrical connectors or cables.

[0080] Refer again Figure 10In some embodiments, the interventional needle 100 may further include an inner needle 110 removably disposed within the working channel 102-4 of the needle body 102. The inner needle 110 may be made 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, and silver. The inner needle 110 may be formed of the same material as the needle body 102. The inner needle 110 is operable to enter the target site when the needle body 102 is navigated to or near the target site. Generally, the needle body 102 may stop moving when it has moved to a position approximately 2 mm near the target site, and then the inner needle 110 is inserted into the target site by pushing it. Because the eccentric arrangement of the working channel 102-4 of the interventional needle 100 according to some embodiments of the present disclosure allows such a working channel 102-4 to provide a larger operating space, the inner needle 110 can have a greater degree of operational freedom within such a working channel 102-4. For example, it can not only achieve linear motion, but also nonlinear motion such as rotation and swing, thereby allowing the doctor to control the inner needle 110 to perform complex and diverse operations.

[0081] The inner needle 110 can be configured similarly to the various embodiments of the needle body 102 described above. Considering practical clinical needs and functional complementarity with the needle body 102, the design of the inner needle 110 can also differ somewhat from that of the needle body 102. For example, considering that the inner needle 110 and the needle body 102 form a nested structure, when the insertion direction of the needle body 102 is determined using the imaging fiber bundle 104 and / or navigation fiber bundle 105 in the needle body 102, the insertion direction of the inner needle 110 is also essentially determined accordingly. Therefore, it is not necessary to additionally arrange fiber bundles on the inner needle 110 for navigation and positioning. On the other hand, the inner needle 110 can be designed to achieve different functions for different diagnostic and treatment modes. The following will combine... Figure 12 , Figure 13 , Figure 14A and Figure 14B Several exemplary inner needles 110 are introduced.

[0082] In some embodiments, such as Figure 12As shown, the inner needle 110 may include one or more imaging fiber bundles 112 disposed within the inner needle 110. These imaging fiber bundles 112 extend longitudinally along the central axis 110-0 of the inner needle 110 and have a front fiber end face 112-1 located at or near the front end face 110-1 of the inner needle 110. In some examples, each of the one or more imaging fiber bundles 112 may have an objective lens, such as a fisheye lens, of similar size attached to its front fiber end face 112-1. The one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within a living organism and receive imaging response light from the target site, so as 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) derived from the imaging probe light. Such an inner needle 110 may be referred to as an imaging inner needle 110. The imaging fiber bundles 112 of the imaging inner needle 110 may not have sensing functionality and may only be used for real-time in-situ imaging. The imaging fiber bundle 112 may comprise multiple bundled optical fibers, which may be thicker than the aforementioned sensing fibers but thinner than the imaging fiber bundle 104 and / or navigation fiber bundle 105. Commercially available imaging fiber bundles may 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, for example, include light with a wavelength of 1064 nm. It is understood that imaging probe light in other wavelength ranges is also feasible. The imaging inner needle 110 may, for example, be a modified 22G (international standard needle specification) non-invasive needle, employing wide-angle retinal technology and beam shaping technology to optically reconstruct imaging of the target site, and can be used for real-time tissue microstructure imaging in ultra-fine regions. In some embodiments, each imaging fiber bundle 112 may be configured to individually emit imaging probe light toward the target site in vivo and receive imaging response light from the target site, i.e., each imaging fiber bundle 112 has both light emission and light reception 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 the living body, while another portion of the imaging fiber bundles 112 may be configured to receive imaging response light from the target site; that is, the light emission and light reception functions are performed by different imaging fiber bundles 112. These imaging fiber bundles 112 can be arranged in any suitable manner, for example, in an array, such as... Figure 12 As shown.

[0083] By setting the imaging inner needle 110, the intervention needle 100 can obtain deep features of the target area by inserting the imaging inner needle 110 into the target area and using the imaging fiber bundle 112 set in the imaging inner needle 110 to image the inside of the target area.

[0084] In some embodiments, such as Figure 13 As shown, the inner needle 110 may include one or more sets of sensing optical fibers 116 arranged within the inner needle 110. These sets of sensing optical fibers 116 extend longitudinally along the central axis 110-0 of the inner needle 110 and have a front fiber end face 116-1 located at or near the front end face 110-1 of the inner needle 110. Each set of sensing optical fibers 116 can be used to sense a corresponding parameter of the microenvironment within the target site. Each sensing optical fiber 116 may include a probe with a photoluminescent material located at its front fiber end face 116-1. The photoluminescent material may be configured to have an emission spectrum that varies with the corresponding parameter. Each sensing optical fiber in each set of sensing optical fibers 116 may be configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the corresponding parameter of the microenvironment within the target site based on the emitted light of the photoluminescent material. The sensing fiber 116 arranged in the inner needle 110 can be similar to the sensing fiber 106 arranged in the needle body 102 described above, and will not be elaborated further here. Such an inner needle 110 can be referred to as an interventional inner needle 110. Since the needle body 102 typically does not penetrate the target area, the sensing fiber 106 arranged in the needle body 102 cannot sense the parameters of the microenvironment inside the target area. However, the interventional inner needle 110 can penetrate the target area, so the sensing fiber 116 arranged in the interventional inner needle 110 can be used to sense the parameters of the local microenvironment inside the target area in situ in real time. In some embodiments, for example, refer to... Figure 13The set of one or more sensing optical fibers 116 may include one or more of the following: a first set of sensing optical fibers, including one or more first sensing optical fibers 1161a-1161d for sensing the temperature of the microenvironment inside the target site, wherein the probe of each of the first sensing optical fibers has a first photoluminescent material configured to have an emission spectrum that varies with temperature; a second set of sensing optical fibers, including one or more second sensing optical fibers 1162a, 1162b for sensing the oxygen concentration of the microenvironment inside the target site, wherein the probe of each of the second sensing optical fibers has a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration; and a third set of sensing optical fibers, including one or more third sensing optical fibers 1163a, 1163b for sensing the pH of the microenvironment inside the target site, wherein the probe of each of the third sensing optical fibers has a third photoluminescent material configured to have an emission spectrum that varies with pH. In some examples, the interventional needle 110 can also be modified based on a 22G non-invasive needle, thus allowing for needle placement at multiple sites in vivo based on the characteristics of the non-invasive needle, providing a tool basis for studying the interconnectedness of the microenvironment or monitoring physiological states. In some embodiments, each of the one or more sets of sensing fibers 116 can be arranged symmetrically (e.g., rotationally symmetrically) about the central axis 110-0 of the interventional needle 110. The symmetrical arrangement of the sensing fibers can facilitate the analysis of the distribution of parameters in the microenvironment. In some embodiments, the interventional needle 110 can also have a hollow channel 110-4, for example, for injecting a chemical ablation agent (e.g., alcohol, etc.) into the target site for chemical ablation. In some examples, the hollow channel 110-4 can be arranged concentrically about the central axis 110-0 of the interventional needle 110, for example, as Figure 13 As shown. In some examples, the hollow channel 110-4 can also be arranged eccentrically about the central axis 110-0 of the interventional needle 110. This optimizes the spatial layout of the components of the interventional needle 110, allowing the eccentrically arranged hollow channel 110-4 to have a larger cross-sectional area while keeping the other components and their dimensions constant, thus providing more operating space. From another perspective, the interventional needle 110 can be constructed smaller while keeping the cross-sectional area of ​​the hollow channel 110-4 constant, which is beneficial for miniaturization. When used with the needle body 102 of the interventional needle 100, the miniaturized interventional needle 110 offers greater operational freedom while keeping the cross-sectional area of ​​the working channel 102-4 constant, and allows the working channel 102-4 and even the entire needle body 102 to be constructed smaller.

[0085] In some embodiments, the inner needle 110 can be configured to perform thermal ablation on the target site. Such an inner needle can be referred to as a thermal ablation inner needle 110. The thermal ablation inner needle 110 can, for example, be a radiofrequency ablation needle. Since temperature distribution monitoring is crucial during the operation of the thermal ablation inner needle 110, therefore... Figure 14A As shown, the thermal ablation inner needle 110 may include one or more sets of temperature sensing optical fibers 1161 arranged within 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. Further reference Figure 14B Each of the one or more sets of temperature-sensing optical fibers 1161 has a front fiber end face 1161-1 located at a corresponding cross-section (as shown by dashed lines A, B, C, D, E, F) of the inner needle 110 between the front end face 110-1 and the rear end face 110-2. Each of the one or more sets of temperature-sensing optical fibers 1161 can 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 with a photoluminescent material located at its front fiber end face 1161-1, the photoluminescent material being configured to have an emission spectrum that varies with temperature. Each temperature-sensing optical fiber in each of the one or more sets of temperature-sensing optical fibers 1161 is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the temperature of the microenvironment inside the target site based on the emitted light of the photoluminescent material. The output power of the thermal ablation inner needle 110 can be controlled based on the determined temperature, thereby stabilizing the microenvironment temperature of the target area near the desired temperature. The temperature sensing fiber 1161 can be similar to the aforementioned first sensing fiber 1061a for sensing temperature, and will not be described again here. In some embodiments, if the first set of temperature sensing fibers in one or more sets of temperature sensing fibers 1161 is closer to the front end face of the inner needle than the second set of temperature sensing fibers in one or more sets of temperature sensing fibers, then the temperature sensing fiber density of the first set of temperature sensing fibers can be greater than that of the second set of temperature sensing fibers. The temperature sensing fiber density refers to the ratio of the number of a set of temperature sensing fibers to the area of ​​the cross-section of the inner needle where the front fiber end face of that set of temperature sensing fibers is located. For example, as... Figure 14BAs shown, the density of temperature-sensing optical fibers at cross-section C is greater than that 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 optical fiber does not necessarily need to be exposed on the surface of the inner needle 110, but can be located inside the inner needle 110. Furthermore, the thermal ablation inner needle 110 can also be modified based on a 22G non-invasive needle, thereby allowing needle placement at multiple important sites during thermal ablation to form a thermal ablation temperature monitoring circle, guiding the efficient execution of the thermal ablation procedure. When monitoring reveals that a lesion does not meet the temperature requirements for thermal ablation, the thermal ablation inner needle 110 can be replaced with the previously mentioned... Figure 13 The described interventional needle 110 is used to perform chemical ablation by injecting alcohol or the like through the hollow channel 110-4 of the interventional needle 110.

[0086] It is understandable that the above combination Figure 12 , Figure 13 , Figure 14A and Figure 14B The description only presents a few non-limiting examples of inner needles 110 that can be used in combination with needle body 102. The inner needle 110 can be designed based on any embodiment of this disclosure or a combination thereof, according to actual needs. The inner needle 110 may be longer than the needle body 102, and an optical fiber interface may be provided on the rear end face 110-2 of the inner needle 110 or on the side of the inner needle 110 near the rear end face 110-2 for arranging the rear optical fiber end face of the optical fiber in the inner needle 110 according to a predetermined pattern.

[0087] The interventional needle for flexible endoscopes according to various embodiments of this disclosure, by incorporating a detection device for detecting rotation, facilitates the correction of the imaging image provided by the flexible endoscope. This ensures that the physician is provided with an imaging image with a substantially fixed viewing angle throughout the interventional procedure, facilitating medical observation and surgical operations. The interventional needle for flexible endoscopes according to various embodiments of this disclosure can also have an eccentrically arranged working channel, optimizing the spatial layout of the needle's components. This allows for the construction of a working channel with a larger cross-sectional area or facilitates miniaturization of the needle. Furthermore, the interventional needle for flexible endoscopes according to various embodiments of this disclosure can itself possess optical imaging capabilities, serving directly as the imaging component of the flexible endoscope. This avoids the use of complex components in existing flexible endoscopes for imaging and interventional needles for interventional procedures, while maintaining good consistency between the needle's insertion orientation and the field of view. Furthermore, the interventional needles for flexible endoscopes according to various embodiments of this disclosure can utilize in-situ real-time optical navigation to guide the needle insertion process. They can also sensitively monitor in-situ in real-time using a photoluminescence probe and extract, with high fidelity, the values ​​and distribution of parameters such as temperature, oxygen concentration, and pH within the microenvironment and target site within the living body using optical fibers. This allows for timely feedback on the treatment intensity and effects of diagnostic and therapeutic methods such as hyperthermia and chemotherapy, enabling physicians to adjust treatment strategies promptly. In addition, the illumination fiber, navigation fiber bundle, imaging fiber bundle, and various sensing fibers of the interventional needles according to various embodiments of this disclosure are all arranged within the needle body or inner needle of the interventional needle. Therefore, they can enter the living body through the interventional channel of the needle and are protected by the needle, thereby transmitting optical signals caused by subtle changes in the microenvironment to external analytical devices while resisting interference from biological tissues.

[0088] In another aspect, this disclosure also provides a flexible endoscope that may include an interventional needle 100 according to any of the foregoing embodiments of this disclosure.

[0089] In another aspect, this disclosure also provides a flexible endoscope system, which may include a flexible endoscope having an interventional needle 100 according to any of the foregoing embodiments of this disclosure and configured to provide an imaging view of the interior of a living body, a control device configured to correct the imaging view provided by the flexible endoscope based on the rotation direction and rotation angle of the central axis of the needle relative to the direction of gravity detected by a detection device of the interventional needle of the flexible endoscope, and a display device configured to display the imaging view corrected by the control device.

[0090] For example, Figure 15 A flexible endoscope system 200 according to one or more exemplary embodiments of the present disclosure is shown. Figure 15As shown, the flexible endoscope system 200 may include a flexible endoscope 201, a control device 202, and a display device 203. The flexible endoscope 201 may include an interventional needle 100 according to any embodiment of the foregoing aspects of this disclosure and is configured to provide an image of the interior of a living body. As previously described, the interventional needle 100 may include a detection device 50 configured to detect the direction and angle of rotation of the central axis 102-0 of the needle body 102 relative to the direction of gravity. The control device 202 may be configured to correct the image provided by the flexible endoscope 201 based on the direction and angle of rotation of the central axis 102-0 of the needle body 102 relative to the direction of gravity 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 image corrected by the control device 202. Here, the control device 202 may be implemented by any suitable computing device, including but not limited to processors, controllers, microprocessors, computers, servers, etc. The display device 203 can be implemented by any suitable display device, including but not limited to displays such as cathode ray tubes (CRTs) and liquid crystal displays (LCDs).

[0091] In some embodiments, the control device 202 can be configured to correct the image provided by the flexible endoscope 201 by rotating the image in the opposite direction to the detected rotation by the same angle as the detected rotation angle. For example, when the detection device 50 detects that the central axis 102-0 of the needle body 102 has rotated 90° clockwise relative to the direction of gravity, the control device 202 can correct the image provided by the flexible endoscope 201 by rotating the image in the counterclockwise direction by 90°. Thus, even if the flexible endoscope 201 rotates during interventional diagnosis and treatment, the flexible endoscope system 200 can provide the doctor with an image on the display device 203 that maintains a substantially fixed viewing angle. That is, the image provided by the flexible endoscope system 200 according to this disclosure no longer changes in viewing angle with the posture change of the flexible endoscope 201 during its intervention inside the living body, which facilitates the doctor's efficient and accurate understanding of the image to observe the patient's internal condition.

[0092] The terms “left,” “right,” “front,” “back,” “top,” “bottom,” “upper,” “lower,” “high,” “lower,” etc., used in the specification and claims, if present, are for descriptive purposes and not necessarily for describing unchanging relative positions. It should be understood that such terms are interchangeable where appropriate, enabling the embodiments of this disclosure described herein to operate, for example, in orientations different from those shown or otherwise described herein. For example, when the device in the drawings is reversed, a feature previously described as “above” other features may now be described as “below” other features. The device may also be oriented in other ways (rotated 90 degrees or in other orientations), in which case the relative spatial relationships will be interpreted accordingly.

[0093] In the specification and claims, when an element is described as being "on top of," "attached" to, "connected" to, "coupled" to, "coupled to," or "in contact with" another element, the element may be directly located on top of, directly attached to, directly connected to, directly coupled to, directly coupled to, or directly in contact with the other element, or one or more intermediate elements may be present. Conversely, when an element is described as being "directly" located on top of, directly attached to, directly connected to, directly coupled to, directly coupled to, or directly in contact with another element, no intermediate elements are present. In the specification and claims, when a feature is arranged "adjacent" to another feature, it may mean that a feature has a portion overlapping with the adjacent feature or a portion located above or below the adjacent feature.

[0094] As used herein, the term "exemplary" means "serving as an example, instance, or illustration," and not as a "model" to be precisely copied. Any implementation described herein by example is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, this disclosure is not limited to any theory expressed or implied as given in the art, background, summary of the invention, or detailed description.

[0095] As used herein, the term "substantially" means any minor variation resulting from design or manufacturing defects, device or component tolerances, environmental influences, and / or other factors. The term "substantially" also allows for differences from the perfect or ideal situation due to parasitic effects, noise, and other practical considerations that may exist in the actual implementation.

[0096] Additionally, terms such as “first,” “second,” etc., may be used in this document for reference purposes only and are not intended to be limiting. For example, unless the context clearly indicates otherwise, the words “first,” “second,” and other such numerical terms relating to structures or elements do not imply order or sequence.

[0097] It should also be understood that when the term “including / contains” is used herein, it indicates the presence of the indicated feature, whole, step, operation, unit and / or component, but does not preclude the presence or addition of one or more other features, wholes, steps, operations, units and / or components and / or combinations thereof.

[0098] In this disclosure, the term “provide” is used broadly to cover all ways of obtaining an object, and therefore “provide an object” includes, but is not limited to, “purchasing,” “preparing / manufacturing,” “arranging / setting up,” “installing / assembling,” and / or “ordering” an object.

[0099] As used herein, the term “and / or” includes any and all combinations of one or more of the listed items in association. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of this disclosure. As used herein, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise.

[0100] Those skilled in the art will recognize that the boundaries between the above operations are merely illustrative. Multiple operations may be combined into a single operation, a single operation may be distributed among additional operations, and operations may be performed with at least partial overlap in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be changed in various other embodiments. However, other modifications, variations, and substitutions are equally possible. Aspects and elements of all the embodiments disclosed above may be combined in any way and / or in combination with aspects or elements of other embodiments to provide multiple additional embodiments. Therefore, this specification and the accompanying drawings should be considered illustrative rather than restrictive.

[0101] While specific embodiments of this disclosure have been described in detail by way of example, those skilled in the art should understand that the examples are for illustrative purposes only and not intended to limit the scope of this disclosure. The various embodiments disclosed herein can be combined in any way without departing from the spirit and scope of this disclosure. Those skilled in the art should also understand that various modifications can be made to the embodiments without departing from the scope and spirit of this disclosure. The scope of this disclosure is defined by the appended claims.

Claims

1. An interventional needle for insertion into a living body via a flexible endoscope, characterized in that, The interventional needle includes: A needle body configured to intervene in a living organism via its natural or artificial channels; and A detection device is disposed within the needle body and configured to detect the direction and angle of rotation of the central axis of the needle body relative to the direction of gravity by measuring the acceleration caused by the gravity of the needle body. The interventional needle includes multiple imaging fiber bundles arranged within the needle body and extending longitudinally along the central axis of the needle body. The front fiber end faces of the multiple imaging fiber bundles are located at the front end face of the needle body. The multiple imaging fiber bundles are configured to emit imaging probe light toward a target site within the living organism and receive imaging response light from the target site, so as to image the target site based on the imaging response light. The plurality of imaging fiber bundles includes a first imaging fiber bundle and a second imaging fiber bundle configured to receive imaging response light from the target region. The first imaging fiber bundle and the second imaging fiber bundle are arranged opposite to each other about the central axis of the needle body, such that: When the imaging response light from the target site is a reflection of the imaging probe light from the target site, if the signal strength of the imaging response light at the first imaging fiber bundle is stronger than the signal strength at the second imaging fiber bundle, then the insertion direction of the needle body deviates from the center direction of the target site towards a first direction, where the first direction is the direction of the first imaging fiber bundle relative to the central axis of the needle body; or If the imaging response light from the target site is emitted by the target site in response to absorbing the imaging probe light, and if the signal strength of the imaging response light at the first imaging fiber bundle is stronger than the signal strength at the second imaging fiber bundle, then the insertion direction of the needle body deviates from the center direction of the target site toward a second direction, which is the direction in which the second imaging fiber bundle is located relative to the central axis of the needle body.

2. The interventional needle according to claim 1, characterized in that, The detection device is configured as a gravity sensor or an angular motion detector.

3. The interventional needle according to claim 1, characterized in that, Each of the plurality of imaging fiber bundles 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 plurality of imaging fiber bundles has an objective lens of a similar size attached to its front fiber end face.

4. The interventional needle according to claim 1, characterized in that, The plurality of imaging fiber bundles include a first imaging fiber bundle configured to emit imaging probe light toward a target site within the living body and a second imaging fiber bundle configured to receive imaging response light from the target site. One or more imaging fiber bundles in the first imaging fiber bundle are positioned adjacent to one or more corresponding imaging fiber bundles in the second imaging fiber bundle, and each imaging fiber bundle in the second imaging fiber bundle has an objective lens of a size equivalent to that imaging fiber bundle attached to its front fiber end face.

5. The interventional needle according to claim 4, characterized in that, The first imaging fiber bundle includes two or more imaging fiber bundles arranged symmetrically in the needle body about the central axis of the needle body, and the second imaging fiber bundle includes corresponding two or more imaging fiber bundles arranged symmetrically in the needle body about the central axis of the needle body.

6. The interventional needle according to claim 1, characterized in that, The interventional needle also includes one or more illumination optical fibers, which are arranged in the needle body and extend longitudinally along the central axis of the needle body. The front fiber end face of the one or more illumination optical fibers is located at the front end face of the needle body, wherein the one or more illumination optical fibers are configured to illuminate the target area within the living body.

7. The interventional needle according to claim 6, characterized in that, The one or more illumination fibers include multiple illumination fibers configured to emit illumination light with different wavelengths from each other.

8. The interventional needle according to claim 1, characterized in that, The interventional needle also includes: One or more sets of sensing optical fibers are arranged in the needle body and extend longitudinally along the central axis of the needle body, such that the front fiber end face of the one or more sets of sensing optical fibers is located at the front end face of the needle body. Each of the one or more sets of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the living body. Each sensing optical fiber in each set includes a probe with a photoluminescent material located at its front fiber end face. The photoluminescent material is configured to have an emission spectrum that varies with the corresponding parameter. Each sensing fiber in one or more sets of sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine a corresponding parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material.

9. The interventional needle according to claim 8, characterized in that, The set or more sets of sensing optical fibers include one or more of the following: The first set of sensing optical fibers includes one or more first sensing optical fibers for sensing the temperature of the microenvironment inside the living body, and the probe of each first sensing optical fiber in the first set of sensing optical fibers has a first photoluminescent material configured to have an emission spectrum that varies with temperature. The second set of sensing optical fibers includes one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside the living body, and the probe of each second sensing optical fiber in the second set of sensing optical fibers has a second photoluminescent material configured to have an emission spectrum that varies with the oxygen concentration. as well as The third set of sensing fibers includes one or more third sensing fibers for sensing the pH of the microenvironment inside the living organism, and each of the third sensing fibers in the third set of sensing fibers has a probe with a third photoluminescent material configured to have an emission spectrum that varies with pH.

10. The interventional needle according to claim 1, characterized in that, The needle body has 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 a drug; aspirating waste liquid; delivering a cleaning solution.

11. The interventional needle according to claim 10, characterized in that, The working channel is eccentrically arranged in the needle body about the central axis of the needle body.

12. The interventional needle according to claim 10, characterized in that, At least one spare channel is provided inside the needle body, the at least one spare channel being configured to perform at least one of the following operations: delivering a medical device; delivering a drug; aspirating waste liquid; delivering a cleaning solution.

13. The interventional needle according to claim 10, characterized in that, The interventional needle also includes an inner needle removably disposed within the working channel of the needle body, the inner needle being operable to enter the target site when the needle body is navigated to or near the target site.

14. The interventional needle according to claim 13, characterized in that, The inner needle includes one or more imaging fiber bundles disposed within the inner needle. These one or more imaging fiber bundles extend longitudinally along the central axis of the inner needle and have 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 has an objective lens of comparable size attached to its front fiber end face. 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, so as to image the target site based on the imaging response light.

15. The interventional needle according to claim 13, characterized in that, The inner needle includes one or more sets of sensing optical fibers arranged within it, the sets of sensing optical fibers extending longitudinally along the 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. In this embodiment, each of the one or more sets of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the target area. Each sensing optical fiber in each set includes a probe with photoluminescent material located at its front fiber end face. The photoluminescent material is configured to have an emission spectrum that varies with the corresponding parameter. Each sensing fiber in one or more sets of sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine a corresponding parameter of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

16. The interventional needle according to claim 15, characterized in that, The set or more sets of sensing optical fibers include one or more of the following: The first set of sensing optical fibers includes one or more first sensing optical fibers for sensing the temperature of the microenvironment inside the target site, and the probe of each first sensing optical fiber in the first set of sensing optical fibers has a first photoluminescent material configured to have an emission spectrum that varies with temperature. The second set of sensing optical fibers includes one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside the target site, and the probe of each second sensing optical fiber in the second set of sensing optical fibers has a second photoluminescent material configured to have an emission spectrum that varies with the oxygen concentration. as well as The third set of sensing optical fibers includes one or more third sensing optical fibers for sensing the pH of the microenvironment inside the target site, wherein the probe of each third sensing optical fiber in the third set of sensing optical fibers has a third photoluminescent material configured to have an emission spectrum that varies with pH.

17. The interventional needle according to claim 15, characterized in that, Each of the one or more sets of sensing optical fibers is arranged rotationally symmetrically within the inner needle about the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting a chemical ablation drug into the target site.

18. The interventional needle according to claim 13, characterized in that, The inner needle is configured to perform thermal ablation on the target area and includes one or more sets of temperature-sensing optical fibers disposed within the inner needle. These sets of temperature-sensing optical fibers extend longitudinally along the central axis of the inner needle, and the front fiber end face of each set of temperature-sensing optical fibers is located at a corresponding cross-section of the inner needle between the front and rear ends. Each of the one or more sets of temperature-sensing optical fibers is used to sense the temperature of the microenvironment inside the target area. Each temperature-sensing optical fiber in each set includes a probe with photoluminescent material located at its front fiber end face. The photoluminescent material is configured to have an emission spectrum that varies with temperature. Each temperature sensing fiber in one or more sets of temperature sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the temperature of the microenvironment inside the target part based on the emitted light of the photoluminescent material.

19. The interventional needle according to claim 18, characterized in that, The first set of temperature sensing fibers in one or more sets of temperature sensing fibers is closer to the front end face of the inner needle than the second set of temperature sensing fibers in one or more sets of temperature sensing fibers, and the temperature sensing fiber density of the first set of temperature sensing fibers is greater than that of the second set of temperature sensing fibers. The temperature sensing fiber density is the ratio of the number of a set of temperature sensing fibers to the area of ​​the cross-section of the inner needle where the front fiber end face of the set of temperature sensing fibers is located.

20. The interventional needle according to claim 1, characterized in that, The interventional needle also includes a navigation fiber bundle disposed within the needle body, the navigation fiber bundle extending longitudinally along the central axis of the needle body and having a front fiber end face located at the front end face of the needle body. The navigation fiber bundle is configured to emit navigation probe light into the living body and receive navigation response light from the navigation probe light, so as to locate and distinguish undesirable sites inside the living body that are not intended to be penetrated by the interventional needle based on the navigation response light.

21. A flexible endoscope, characterized in that, The flexible endoscope includes an interventional needle according to any one of claims 1 to 20.

22. A flexible endoscope system, characterized in that, The flexible endoscope system includes: The flexible endoscope of claim 21 is configured to provide an imaging view of the interior of a living body; A control device configured to correct the imaging image provided by the flexible endoscope based on the rotation direction and angle of the central axis of the needle relative to the direction of gravity, detected by the detection device of the needle of the flexible endoscope; and A display device configured to display an image corrected by the control device.

23. The flexible endoscope system according to claim 22, characterized in that, The control device is configured to correct the image provided by the flexible endoscope by rotating the image in the opposite direction to the detected rotation direction by the same angle as the detected rotation angle.

Images