Interventional diagnostic and treatment system and method of use thereof

Abstract

The present disclosure relates to an interventional system and a method of using the same. An interventional system comprises: an interventional needle module comprising an interventional needle comprising a needle body configured to be percutaneously intervented into a living body and a plurality of navigation fiber bundles arranged in the needle body and extending longitudinally along a central axis of the needle body, a front fiber end face of the navigation fiber bundles being located at a front end face of the needle body, wherein the navigation fiber bundles are configured to emit navigation probe light toward a target site within the living body and receive navigation response light from the target site; a light source module configured to provide the navigation probe light to the navigation fiber bundles; a detection module configured to detect the navigation response light from the navigation fiber bundles; and an analysis module configured to determine a deviation of a needle insertion direction of the needle body relative to a central direction of the target site based on a distribution of signal intensities of the navigation response light among the plurality of navigation fiber bundles.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and more specifically, to an interventional diagnostic and treatment system and its method of use. Background Technology

[0002] Interventional medicine is a technique that, under the guidance of imaging, uses natural or artificial channels to deliver interventional needles or their components (such as, but not limited to, percutaneous needle kits) to the lesion site for diagnosis and / or treatment. It is currently widely used clinically in areas such as tissue biopsy, tumor ablation, vascular embolization, and fistula closure. Interventional needles are typically inserted deep into the patient's body, so the physician operating the needle often cannot directly see the internal situation, nor can they accurately and promptly grasp the rapidly changing conditions within the patient's body. This makes it difficult to make reliable judgments and decisions in a timely manner, and consequently, hinders efficient diagnosis and treatment during interventional procedures. 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 diagnostic and treatment system is provided, comprising: an interventional needle module including an interventional needle, the interventional needle including a needle body configured for percutaneous intervention in a living body and a plurality of navigation fiber bundles, the plurality of navigation fiber bundles being arranged in the needle body and extending longitudinally along the central axis of the needle body, the front fiber end faces of the plurality of navigation fiber bundles being located at the front end face of the needle body, wherein the plurality of navigation fiber bundles are configured to emit navigation detection light toward a target site within the living body and receive navigation response light from the target site; a light source module configured to provide the navigation detection light to the plurality of navigation fiber bundles of the interventional needle; a detection module configured to detect the navigation response light from the plurality of navigation fiber bundles; and an analysis module configured to determine, based on the distribution of the signal intensity of the navigation response light detected by the detection module among the plurality of navigation fiber bundles, the deviation of the needle insertion direction of the needle body relative to the central direction of the target site.

[0005] In some embodiments, the plurality of navigation fiber bundles are arranged symmetrically about the central axis of the needle body, and wherein: the navigation response light from the target portion is reflected light from the target portion in response to the navigation detection light; or the navigation response light from the target portion is emitted light emitted by the target portion in response to absorbing the navigation detection light.

[0006] In some embodiments, the plurality of navigation fiber bundles are arranged rotationally symmetrically about the central axis of the needle body, each of the plurality of navigation fiber bundles is configured to individually emit navigation probe light toward a target site within the living body and receive navigation response light from the target site, the light source module is configured to provide navigation probe light to each of the plurality of navigation fiber bundles, and the detection module is configured to detect navigation response light from each of the plurality of navigation fiber bundles, wherein the intervention needle module is further configured to satisfy at least one of the following: each of the plurality of navigation fiber bundles has an objective lens of a size equivalent to that of the navigation fiber bundle attached to its front fiber end face; the front end face of the needle body is shaped such that each of the plurality of navigation fiber bundles tends to emit navigation probe light toward the target site within the living body and receive navigation response light from the target site within a corresponding azimuth angle range relative to the central axis of the needle body.

[0007] In some embodiments, the plurality of navigation fiber bundles include a first set of navigation fiber bundles for emitting navigation probe light toward a target site within the living body and a second set of navigation fiber bundles for receiving navigation response light from the target site. The light source module is configured to provide navigation probe light to each of the first set of navigation fiber bundles. The detection module is configured to detect the navigation response light from each of the second set of navigation fiber bundles. The analysis module is 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 navigation response light detected by the detection module within the second set of navigation fiber bundles. The second set of navigation fiber bundles is rotationally symmetrically arranged in the needle body about the central axis of the needle body. The second set of navigation fiber bundles includes at least one... The needle module is configured to satisfy at least one of the following: each of the second set of navigation fiber bundles has an objective lens of similar size attached to its front fiber end face; the first set of navigation fiber bundles is rotationally symmetrically distributed on a first circle about the central axis of the needle body, and the second set of navigation fiber bundles is rotationally symmetrically distributed on a second circle concentric with the first circle about the central axis of the needle body; one or more navigation fiber bundles from the first set of navigation fiber bundles are positioned adjacent to one or more corresponding navigation fiber bundles from the second set of navigation fiber bundles; the front end face of the needle body is shaped such that each of the second set of navigation fiber bundles tends to receive navigation response light from the target site within a corresponding azimuth angle range relative to the central axis of the needle body.

[0008] In some embodiments, the interventional needle module further includes: one or more sets of sensing optical fibers, the one or more sets of sensing optical fibers being 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, and each sensing optical fiber in each set of sensing optical fibers includes a probe with 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, wherein the one or more sets of sensing optical fibers... Each sensing fiber in each of a plurality of sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, wherein the light source module is configured to provide the excitation light to each sensing fiber in each of the plurality of sensing fibers, the detection module is configured to detect the emitted light from each sensing fiber in each of the plurality of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the emitted light of each sensing fiber detected by the detection module.

[0009] In some embodiments, each of the one or more sets of sensing optical fibers is arranged rotationally symmetrically about the central axis of the needle body, and wherein the one or more sets of sensing optical fibers 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.

[0010] In some embodiments, the intervention needle of the intervention needle module further includes: an optical fiber interface disposed on the rear end face of the needle body or on the side of the needle body near the rear end face, wherein all the rear fiber end faces of the plurality of navigation fiber bundles and the group or plurality of sensing fiber bundles are arranged at the optical fiber interface according to a predetermined pattern, and wherein the detection module is configured to perform spectral detection on each rear fiber end face at the optical fiber interface to obtain spectral information of the optical signal, and / or perform imaging detection to obtain intensity information of the optical signal.

[0011] In some embodiments, the needle body of the interventional needle module 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 drug; aspirating waste fluid; delivering a cleaning solution; receiving an inner needle.

[0012] In some embodiments, the interventional needle of the interventional needle module further 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.

[0013] In some embodiments, the inner needle includes 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 a fisheye lens of comparable size 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, and wherein the light source module is configured to provide the imaging probe light to the one or more imaging fiber bundles, the detection module is configured to detect the imaging response light from the one or more imaging fiber bundles, and the analysis module is configured to generate an image of the target site based on the imaging response light of each imaging fiber bundle detected by the detection module.

[0014] In some embodiments, the inner needle includes 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, and each sensing optical fiber in each set of sensing optical fibers includes a probe with 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, wherein each set of sensing optical fibers... Each sensing fiber in a set of sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, wherein the light source module is configured to provide the excitation light to each sensing fiber in each of the set of sensing fibers, the detection module is configured to detect the emitted light from each sensing fiber in each of the set of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the target portion at the front fiber end face of the sensing fiber based on the emitted light detected by the detection module for each sensing fiber.

[0015] In some embodiments, each of the one or more sets of sensing fibers is arranged rotationally symmetrically within the inner needle about the central axis of the inner needle, wherein the inner needle has a hollow channel for injecting a chemical ablation agent into the target site, and wherein the one or more sets of sensing fibers include one or more of the following: a first set of sensing fibers including one or more first sensing fibers for sensing the temperature of the microenvironment within the target site, wherein the probe of each of the first sensing fibers in the first set of sensing fibers has a first light source configured to have an emission spectrum that varies with temperature. The device comprises: a photoluminescent material; 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 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; 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 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 the pH.

[0016] In some embodiments, the inner needle is configured to perform thermal ablation on 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 within the target site, and each temperature-sensing optical fiber includes a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to emit light that varies with temperature. The spectrum, wherein each temperature sensing fiber in each of the 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, and wherein the light source module is configured to provide the excitation light to each temperature sensing fiber in each of the one or more sets of temperature sensing fibers, the detection module is configured to detect the emitted light from each temperature sensing fiber in each of the one or more sets of temperature sensing fibers, and the analysis module is configured to determine the temperature of the microenvironment inside the target portion at the front fiber end face of the temperature sensing fiber based on the emitted light of each temperature sensing fiber detected by the detection module.

[0017] In some embodiments, 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 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.

[0018] In some embodiments, the interventional needle module further includes an additional navigation fiber bundle disposed in the needle body, the additional 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 additional navigation fiber bundle is configured to emit additional navigation probe light into the living body and receive additional navigation response light originating from the additional navigation probe light, and wherein the light source module is configured to provide the additional navigation probe light to the additional navigation fiber bundle, the detection module is configured to detect the additional navigation response light from the additional navigation fiber bundle, and the analysis module is configured to locate and distinguish undesirable sites within the living body to be punctured by the interventional needle based on the additional navigation response light detected by the detection module.

[0019] In some embodiments, the light source module is configured to intermittently output pulsed light, and the analysis module further includes a time control component configured to control the light source module and the detection module to operate in a timing sequence with the same frequency but different phases, such that the detection module performs detection during the period when the light source module stops outputting pulsed light and stops detection during the period when the light source module outputs pulsed light.

[0020] In some embodiments, the analysis module is configured to determine the deviation of the needle insertion direction from the center direction of the target site based on the distribution of the ratio of the signal intensity of the navigation response light at two different wavelengths detected by the detection module among the plurality of navigation fiber bundles.

[0021] In some embodiments, the light source module is configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers, the detection module is configured to detect emitted light from each sensing fiber in each of the one or more sets of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the emitted light of each sensing fiber detected by the detection module at two different wavelengths; or the light source module is configured to provide a first excitation light and a second excitation light with a wavelength different from the first excitation light to each of the one or more sets of sensing fibers, the detection module is configured to detect a first emitted light from each sensing fiber in response to the first excitation light and a second emitted light in response to the second excitation light, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the first emitted light to the signal intensity of the second emitted light detected by the detection module.

[0022] In some embodiments, the interventional diagnostic and treatment system further includes: a feedback module configured to generate an adjustment suggestion for the needle insertion direction based on the deviation of the needle insertion direction relative to the center direction of the target site determined by the analysis module, and to feed back the adjustment suggestion for the needle insertion direction to the operator of the interventional needle; and to generate a parameter status report and / or treatment plan adjustment suggestion based on the parameters of the microenvironment inside the living body determined by the analysis module, and to feed back the parameter status report and / or treatment plan adjustment suggestion to the operator of the interventional needle.

[0023] According to another aspect of this disclosure, a method is provided for using an interventional diagnostic and treatment system according to any embodiment of the foregoing aspects of this disclosure, comprising: providing navigation detection light to a plurality of navigation fiber bundles in an interventional needle inserted into a living body by a light source module; emitting navigation detection light toward a target site within the living body by the plurality of navigation fiber bundles and receiving navigation response light from the target site; detecting the navigation response light from the plurality of navigation fiber bundles by a detection module; and determining, by an analysis module, a deviation of the needle insertion direction relative to the center direction of the target site based on the distribution of the signal intensity of the navigation response light detected by the detection module in the plurality of navigation fiber bundles.

[0024] 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

[0025] 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:

[0026] Figure 1 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0027] Figure 2 yes Figure 1 Side view of the interventional needle;

[0028] Figure 3 This is a schematic diagram illustrating the structure of a navigation fiber bundle in an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0029] Figures 4A to 4D Several example arrangements of the navigation fiber bundle of the intervention needle according to one or more exemplary embodiments of the present disclosure are illustrated respectively.

[0030] Figure 5A and Figure 5B Partial side views of the tip of the needle body of an interventional needle according to one or more exemplary embodiments of the present disclosure are schematically shown. Figure 5C The illustration schematically shows a top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0031] Figure 6 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0032] Figure 7 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0033] Figure 8 This is a schematic diagram illustrating the structure of a sensing optical fiber in an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0034] Figures 9A to 9C Several example photoluminescent materials used in the probe of the sensing fiber in the intervention needle of one or more exemplary embodiments of this disclosure are shown;

[0035] Figure 10 This is a schematic perspective view of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0036] Figure 11This is a schematic plan view of the fiber optic interface of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0037] Figure 12 This is a schematic side view of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0038] Figure 13 This is a schematic top view of an example internal needle of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0039] Figure 14 This is a schematic top view of another example of an inner needle of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0040] Figure 15A and Figure 15B These are schematic top and side views of another example of an internal needle of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0041] Figure 16 This is a schematic diagram illustrating an interventional diagnostic and treatment system according to one or more exemplary embodiments of the present disclosure;

[0042] Figure 17 This is a schematic diagram illustrating an example arrangement of an interventional diagnostic and treatment system according to one or more exemplary embodiments of the present disclosure;

[0043] Figure 18 A flowchart illustrating a method of using an interventional diagnostic and treatment system according to one or more exemplary embodiments of the present disclosure is shown. Detailed Implementation

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] When performing interventional procedures, doctors first need to insert an interventional needle to the target site within the patient's body (e.g., a lesion such as a tumor) before diagnosis and treatment can be performed. However, current interventional techniques often rely on imaging techniques (e.g., ultrasound imaging) to guide the doctor in placing the needle near the target site. Afterward, doctors often rely solely on experience and touch to determine the needle's direction and position relative to the target site. Furthermore, current interventional techniques cannot provide in-situ, real-time imaging of the target site or monitor the microenvironment within and outside the target site, thus failing to provide useful information for the doctor's immediate diagnostic and treatment decisions.

[0049] To this end, this disclosure provides an interventional diagnostic and treatment system and its method of use, which can provide real-time optical navigation for interventional needles to efficiently guide the needle insertion process. This facilitates the needle's entry into the target site in the desired direction and location, while also avoiding important areas such as blood vessels and organs requiring protection during the percutaneous entry into the living body. Furthermore, the interventional diagnostic and treatment system according to this disclosure can also provide in-situ real-time microenvironment sensing capabilities. It can sense various parameters and their distribution within and outside the target site in situ and in real-time during the percutaneous entry of the needle into the living body and after the needle has entered the target site, providing physicians with a wealth of useful reference information for immediate diagnostic and treatment decisions.

[0050] First refer to Figure 16 , Figure 16 An interventional diagnostic and therapeutic system 200 according to one or more exemplary embodiments of the present disclosure is shown, wherein solid arrows indicate optical coupling and dashed arrows indicate electrical coupling. Figure 16As shown, the interventional diagnostic and treatment system 200 may include an interventional needle module 202, a light source module 204, a detection module 206, and an analysis module 208. The interventional needle module 202 includes an interventional needle for performing interventional diagnostic and treatment procedures. The light source module 204 provides the required optical signals to the interventional needle module 202 to enable real-time optical navigation and / or in-situ real-time microenvironment sensing. The light source module 204 can be configured to output light of various wavelengths. In some embodiments, the light source module 204 may include a broadband light source, and selectively output light with wavelengths within a sub-range of the broadband light source's operating wavelength range using wavelength selection devices such as filters and monochromators. In some embodiments, the light source module 204 may include a combination of multiple narrow-spectrum light sources with different operating wavelength ranges, for example, it may include multiple monochromatic light sources (such as lasers) with different operating wavelengths. The light source module 204 can selectively output one or more wavelengths of light according to detection requirements. In some examples, the light source module 204 can be configured to provide light in the red or near-infrared band, such as one or more wavelengths from 635nm, 680nm, 730nm, 850nm, 980nm, and 1064nm, for use in interventional diagnosis and treatment in living organisms. Of course, other wavelengths are also feasible depending on the specific circumstances and requirements. In some embodiments, the light source module 204 may also have an interface for connecting additional light sources. This allows light sources providing the desired wavelengths to be integrated into the light source module 204 according to different detection requirements in actual application scenarios, thereby improving the system's applicability and scalability. Furthermore, the power of the light output by the light source module 204 at various wavelengths can be modulated to adapt to specific application scenarios. The detection module 206 is used to detect the optical signal from the intervention needle module 202 and may include any suitable optical detection element, including but not limited to photodetectors such as photon avalanche diodes (APDs), spectrometers such as fluorescence spectrometers and fiber optic spectrometers, imagers such as charge-coupled device (CCD) image sensors, electron multiplication CCD (EMCCD) image sensors, complementary metal-oxide-semiconductor (CMOS) image sensors, etc. The analysis module 208 is used to analyze the spectral information and / or intensity information of the optical signal detected by the detection module 206 to obtain real-time optical navigation information and / or real-time in-situ microenvironment sensing information. The analysis module 208 can be implemented by any suitable computing device, including but not limited to processors, controllers, microprocessors, computers, servers, etc. The light source module 204, detection module 206, and analysis module 208 will be further described later, along with the description of the intervention needle module 202.

[0051] The interventional needle of the interventional needle module 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.

[0052] Figure 1 and Figure 2 The illustration schematically shows an interventional needle 100 included in an interventional needle module 202 according to one or more exemplary embodiments of the present disclosure, 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.

[0053] like Figure 1 and Figure 2 As shown, the interventional needle 100 may include a needle body 102. The needle body 102 may be configured for percutaneous intervention in a living organism (e.g., a human or animal body) and has a front end face 102-1 and a rear end face 102-2 opposite to the front end face 102-1. The needle body 102 may be 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.

[0054] The intervention needle 100 may also include multiple navigation fiber bundles 104. Each navigation fiber bundle 104 may include a bundle of multiple optical fibers. The multiple navigation fiber bundles 104 are arranged in the needle body 102 and extend 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 navigation fiber bundles 104a-104h, but this is merely exemplary and not limiting; the intervention needle 100 may include any suitable number of navigation fiber bundles 104. Reference Figure 2 The front fiber end face 104-1 of these navigation fiber bundles 104 is located at the front end face 102-1 of the needle body 102. Note that... Figure 2 Parts of some of the navigation fiber bundles 104 arranged in the needle body 102 are shown schematically only with dashed lines.

[0055] The plurality of navigation fiber bundles 104 can be configured to emit navigation detection light toward a target site within the living body and receive navigation response light from that target site. A light source module 204 can be configured to provide navigation detection light to the plurality of navigation fiber bundles 104. A detection module 206 can be configured to detect the navigation response light from the plurality of navigation fiber bundles 104. An analysis module 208 can be configured to determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the signal intensity of the navigation response light detected by the detection module 206 within the plurality of navigation fiber bundles 104. In some embodiments, the analysis module 208 can be configured to determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the ratio of the signal intensity of the navigation response light at two different wavelengths detected by the detection module 206 within the plurality of navigation fiber bundles 104.

[0056] In some embodiments, the navigation response light from the target location may be the reflected light from the navigation probe light at the target location. In some examples, the wavelength range of the navigation probe light can be determined based on the characteristic absorption spectral properties of the target location. For example, assuming the target location has an absorption peak at a first wavelength, the light source module 204 can provide navigation probe light including the first wavelength to the navigation fiber bundle 104 and emit navigation probe light including the first wavelength towards the target location via the navigation fiber bundle 104. Then, the detection module 206 can detect the navigation response light from the navigation fiber bundle 104 to determine the signal intensity of the received navigation response light at the first wavelength and transmit the determined signal intensity of the navigation response light from each navigation fiber bundle 104 at the first wavelength to the analysis module 208. The analysis module 208 can be configured to perform the following analysis: If the signal intensity of the navigation response light at the first wavelength position is distributed among the plurality of navigation fiber bundles 104 such that it is stronger at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, then the insertion direction of the needle body 102 can be determined to be lower than the center direction of the target area; if the signal intensity of the navigation response light at the first wavelength position is distributed among the plurality of navigation fiber bundles 104 such that it is weaker at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, then the insertion direction of the needle body 102 can be determined to be higher than the center direction of the target area; if the signal intensity of the navigation response light at the first wavelength position is distributed among the plurality of navigation fiber bundles 104... If the distribution of the signal intensity of the navigation response light at the first wavelength position is stronger at navigation fiber bundles 104h, 104a, 104b, and 104c than at navigation fiber bundles 104d, 104e, 104f, and 104g, then the insertion direction of the needle body 102 is determined to be to the right relative to the center direction of the target area. If the distribution of the signal intensity of the navigation response light at the first wavelength position among the multiple navigation fiber bundles 104 is weaker at navigation fiber bundles 104h, 104a, 104b, and 104c than at navigation fiber bundles 104d, 104e, 104f, and 104g, then the insertion direction of the needle body 102 is determined to be to the left relative to the center direction of the target area. If the distribution of the signal intensity of the navigation response light at the first wavelength position among the multiple navigation fiber bundles 104 is uniform at navigation fiber bundles 104a-104h, then the insertion direction of the needle body 102 is determined to be not deviated from the center direction of the target area. Similarly, the analysis module 208 can determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target part based on the distribution of the signal intensity of the navigation response light detected by the detection module 206 in the plurality of navigation fiber bundles 104.This allows doctors to adjust the insertion direction of the needle 102 in a timely manner until the signal intensity of the navigation response light is uniformly distributed among the plurality of navigation fiber bundles 104. In some examples, if the target site has absorption peaks at multiple wavelengths, the light source module 204 can provide navigation probe light including at least two of the plurality of wavelengths to the navigation fiber bundles 104, and emit navigation probe light including at least two of the plurality of wavelengths towards the target site via the navigation fiber bundles 104. Then, the detection module 206 can detect the navigation response light from the navigation fiber bundles 104 to determine the signal intensity of the received navigation response light at the positions of the at least two wavelengths, and transmit the determined signal intensity to the analysis module 208. The analysis module 208 can determine the deviation of the insertion direction of the needle 102 from the center direction of the target site based on the distribution of the absolute or relative value (e.g., ratio) of the signal intensity of the navigation response light at the positions of the at least two wavelengths among the plurality of navigation fiber bundles 104.

[0057] In some embodiments, the navigation response light from the target site can be emitted light emitted by the target site in response to the absorption of navigation probe light. In some examples, the target site can be pre-enriched with photoluminescent material by means such as injection. Then, the light source module 204 can provide navigation probe light including the excitation wavelength of the photoluminescent material to the navigation fiber bundle 104 and emit navigation probe light including the excitation wavelength of the photoluminescent material to the target site via the navigation fiber bundle 104. Then, the detection module 206 can detect the navigation response light from the navigation fiber bundle 104 to determine the signal intensity of the received navigation response light at the position of the emission wavelength of the photoluminescent material, and transmit the determined signal intensity to the analysis module 208. The analysis module 208 can determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the signal intensity of the navigation response light at the emission wavelength detected by the detection module 206 among the plurality of navigation fiber bundles 104. 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 usually injected. In this way, as the interventional needle moves towards the liver tumor, the light source module 204 can provide 730nm navigation probe light to the navigation fiber bundle 104 and emit 730nm navigation probe light towards the liver tumor through the navigation fiber bundle, thereby exciting the ICG dye enriched in the liver tumor to emit light. Then, the detection module 206 can detect and determine the signal intensity of the received navigation response light at the emission wavelength of the ICG dye.The analysis module 208 can be configured to perform the following analyses: If the signal intensity of the navigation response light at the emission wavelength position is distributed among the plurality of navigation fiber bundles 104 such that it is stronger at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, then the insertion direction of the needle body 102 can be determined to be slightly higher than the center direction of the target area; if the signal intensity of the navigation response light at the emission wavelength position is distributed among the plurality of navigation fiber bundles 104 such that it is weaker at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, then the insertion direction of the needle body 102 can be determined to be slightly lower than the center direction of the target area; if the signal intensity of the navigation response light at the emission wavelength position is distributed among the plurality of navigation fiber bundles 104... If the signal intensity of the navigation response light at the emission wavelength is stronger at navigation fiber bundles 104h, 104a, 104b, and 104c than at navigation fiber bundles 104d, 104e, 104f, and 104g, then the insertion direction of the needle body 102 is determined to be to the left of the center direction of the target area. If the signal intensity of the navigation response light at the emission wavelength is weaker at navigation fiber bundles 104h, 104a, 104b, and 104c than at navigation fiber bundles 104d, 104e, 104f, and 104g, then the insertion direction of the needle body 102 is determined to be to the right of the center direction of the target area. If the signal intensity of the navigation response light at the emission wavelength is uniform at navigation fiber bundles 104a-104h, then the insertion direction of the needle body 102 is determined to be not deviated from the center direction of the target area. This allows doctors to adjust the insertion direction of the needle 102 in a timely manner until the signal intensity of the navigation response light is uniformly distributed among the plurality of navigation fiber bundles 104. In some examples, if the photoluminescent material contained in the target site has emission peaks at multiple wavelengths, the detection module 206 can detect the navigation response light from the navigation fiber bundles 104 to determine the signal intensity of the received navigation response light at at least two of the multiple wavelengths, and transmit the determined signal intensity to the analysis module 208. The analysis module 208 can determine the deviation of the insertion direction of the needle 102 from the center direction of the target site based on the distribution of the absolute or relative value (e.g., ratio) of the signal intensity of the navigation response light at the at least two wavelengths among the plurality of navigation fiber bundles 104.In some examples, if the photoluminescent material contained in the target area can emit light in response to multiple different excitation wavelengths, the light source module 204 can provide navigation probe light including at least two of the multiple different excitation wavelengths to the navigation fiber bundle 104, and emit navigation probe light including one of the at least two excitation wavelengths towards the target area via the navigation fiber bundle 104. Then, the detection module 206 can detect the navigation response light from the navigation fiber bundle 104 in response to each of the at least two excitation wavelengths to determine the signal intensity of the received navigation response light, and transmit the determined signal intensity to the analysis module 208. The analysis module 208 can determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target area based on the distribution of the absolute or relative value (e.g., ratio) of the signal intensity of the navigation response light in response to each of the at least two excitation wavelengths among the multiple navigation fiber bundles 104.

[0058] Therefore, by setting a navigation fiber bundle 104 in the intervention needle 100 of the intervention needle module 202 and combining it with the corresponding operations of the light source module 204, the detection module 206 and the analysis module 208, the optical real-time navigation function is realized. This can not only help doctors navigate the intervention needle 100 to the vicinity of the target site, but also help doctors confirm whether the insertion direction and position of the intervention needle are appropriate.

[0059] In addition, the navigation fiber bundle 104 can also be used to locate and distinguish internal sites within the living body that are not intended to be pierced by the interventional needle 100, such as blood vessels, organs, and other important sites, to prevent surgical accidents. For example, the navigation fiber bundle 104 can also be configured to emit additional navigation detection light into the living body and receive additional navigation response light originating from the additional navigation detection light. The light source module 204 can also be configured to provide additional navigation detection light to the navigation fiber bundle 104. The detection module 206 can also be configured to detect the additional navigation response light. Furthermore, the analysis module 208 can also be configured to locate and distinguish internal sites within the living body that are not intended to be pierced by the interventional needle 100, or important sites, based on the additional navigation response light detected by the detection module 206. In some embodiments, the additional navigation response light can be emitted light by an important site in response to the absorption of the additional 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 additional navigation response light can be reflected light from the important site to the additional navigation detection light. For example, different important sites may have different absorption spectra. The light source module 204 can be polled to provide additional navigation detection light to the navigation fiber bundle 104 in turn, and the navigation fiber bundle 104 can then emit additional navigation detection light, including absorption wavelengths unique to each important part, in turn to locate and identify each important part. Alternatively, the light source module 204 can be polled to provide additional navigation detection light to the navigation fiber bundle 104, and the navigation fiber bundle 104 can emit additional navigation detection light, including multiple absorption wavelengths common to multiple important parts, and the relative values ​​of the signal strength of the received additional navigation response light at the multiple absorption wavelengths can be analyzed to locate and identify each important part. For example, for veins and arteries (which have distinctly different colors), the light source module 204 can alternately provide and emit additional navigation detection light at 680nm and 850nm to the navigation fiber bundle 104. 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, the analysis module 208 can determine whether it is a vein or an artery based on the ratio of the signal intensity of the additional navigation response light at 680nm to the signal intensity at 850nm, as detected by the detection module 206. The analysis results can be used to guide physicians to avoid these vessels when operating the interventional needle 100.

[0060] The system can alternately perform the functions of guiding the intervention needle to the target site and guiding the intervention needle to avoid critical sites by alternately providing navigation probe light and additional navigation probe light to the navigation fiber bundle 104 via the light source module 204, and thus alternately emitting navigation probe light and additional navigation probe light via the navigation fiber bundle 104. Alternatively, some navigation fiber bundles 104 (e.g., navigation fiber bundles 104a, 104c, 104e, 104g) can be used to perform the function of guiding the intervention needle to the target site, while other navigation fiber bundles 104 (e.g., navigation fiber bundles 104b, 104d, 104f, 104h) can be used to perform the function of guiding the intervention needle to avoid critical sites. In some embodiments, navigation fiber bundles 104a-104h can only perform the function of guiding the intervention needle to the target site, and additional navigation fiber bundles can be included to perform the function of guiding the intervention needle to avoid critical sites. For example, refer to... Figure 6 The intervention needle 100 may also include an additional navigation fiber bundle (e.g., arranged in the needle body 102) Figure 6 The needle body comprises four additional navigation fiber bundles 105, each extending longitudinally along the central axis 102-0 of the needle body and having a front fiber end face 105-1 located at the front end face 102-1 of the needle body 102. The additional navigation fiber bundles 105 can be configured to emit additional navigation probe light into the living tissue and receive additional navigation response light originating from the additional navigation probe light. A light source module 204 can be configured to provide the additional navigation probe light to the additional navigation fiber bundles. A detection module 206 can be configured to detect the additional navigation response light from the additional navigation fiber bundles. An analysis module 208 can be configured to locate and distinguish undesirable sites within the living tissue that are not intended to be penetrated by the interventional needle based on the additional navigation response light detected by the detection module. The arrangement of the additional navigation fiber bundles 105 can be similar to that of the navigation fiber bundles 104, and will not be described further here. In some examples, the light source module 204 can be configured to provide additional navigation probe light to the additional navigation fiber bundles 105 simultaneously with the navigation probe light provided to the navigation fiber bundles 104. In some examples, the light source module 204 can be configured to alternately provide navigation probe light to the navigation fiber bundle 104 and additional navigation probe light to the supplementary navigation fiber bundle 105. In some examples, the detection module 206 can be configured to detect the additional navigation probe light from the supplementary navigation fiber bundle 105 while simultaneously detecting the navigation response light from the navigation fiber bundle 104. In some examples, the detection module 206 can be configured to alternately detect the navigation response light from the navigation fiber bundle 104 and the additional navigation probe light from the supplementary navigation fiber bundle 105.

[0061] Return to reference Figure 1The plurality of navigation fiber bundles 104 can be arranged to facilitate determining the deviation of the needle insertion direction of the needle body 102 from the center direction of the target location based on the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles 104. Figure 1 As shown, in some embodiments, the plurality of navigation fiber bundles 104 can be arranged symmetrically in the needle body 102 about the central axis 102-0 of the needle body 102. The symmetrical distribution of the navigation fiber bundles can facilitate determining the deviation of the needle insertion direction of the needle body 102 from the central direction of the target site based on the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles 104. The symmetrical distribution of the navigation fiber bundles can be axisymmetric, and more preferably rotationally symmetric. In some embodiments, the plurality of navigation fiber bundles 104 can be arranged rotationally symmetrically in the needle body 102 about the central axis 102-0 of the needle body 102, and each of the plurality of navigation fiber bundles 104 can be configured to individually emit navigation probe light toward the target site within the living body and receive navigation response light from the target site. In such an embodiment, the light source module 204 can be configured to provide navigation detection light to each of the plurality of navigation fiber bundles 104, and the detection module 206 can be configured to detect navigation response light from each of the plurality of navigation fiber bundles 104. Figure 1 As shown, the navigation fiber bundles 104a-104h are arranged rotationally symmetrically about the central axis 102-0 of the needle body 102, meaning that every 45° rotation allows one navigation fiber bundle to be moved to the position previously held by an adjacent navigation fiber bundle. Each navigation fiber bundle 104a-104h performs both light emission and light reception functions. In some embodiments, each navigation fiber bundle 104a-104h may have an objective lens of similar size attached to its front fiber end face 104-1. For example, this objective lens may be a miniature objective lens with a diameter of approximately 0.3 mm. Figure 3 An example structure of a navigation fiber bundle 104 is shown, which has 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 navigation fiber bundle 104.

[0062] Alternatively, the light emission and light reception functions can be performed by different navigation fiber bundles. In some embodiments, the plurality of navigation fiber bundles may include a first set of navigation fiber bundles for emitting navigation probe light toward a target site within the living body and a second set of navigation fiber bundles for receiving navigation response light from the target site. That is, the first set of navigation fiber bundles is used to perform the light emission function, while the second set of navigation fiber bundles is used to perform the light reception function. The light source module 204 may be configured to provide navigation probe light to each of the first set of navigation fiber bundles, the detection module 206 may be configured to detect the navigation response light from each of the second set of navigation fiber bundles, and the analysis module 208 may be configured to determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the signal intensity of the navigation response light detected by the detection module 206 in the second set of navigation fiber bundles. For example, refer to Figure 4AThe first set of navigation fiber bundles may include navigation fiber bundles 104b, 104d, 104f, and 104h (which, for illustrative purposes, may be referred to as transmitting navigation fiber bundles and are indicated by left-hand shading in the figure), while the second set of navigation fiber bundles may include navigation fiber bundles 104a, 104c, 104e, and 104g (which, for illustrative purposes, may be referred to as receiving navigation fiber bundles and are indicated by right-hand shading in the figure). In some examples, the second set of navigation fiber bundles may be arranged symmetrically about the central axis 102-0 of the needle body 102, for example, rotationally symmetrically arranged within the needle body 102. The second set of navigation fiber bundles may include at least two navigation fiber bundles. In some embodiments, each navigation fiber bundle in the second set of navigation fiber bundles may have an objective lens of comparable size attached to its front fiber end face to facilitate light collection. The number and arrangement of the navigation fiber bundles in the first set of navigation fiber bundles can be configured in any suitable manner. For example, the suitability of the configuration of the first group of navigation fiber bundles can be determined simply as follows: Position the insertion needle perpendicular to the reflector surface in front of it; transmit light of the same intensity to each transmitting navigation fiber bundle in the first group via the light source module 204; and determine via the detection module 206 whether the emitted light intensity of each receiving navigation fiber bundle in the second group is the same. If so, the configuration of the first group of navigation fiber bundles is considered suitable. In some examples, the first group of navigation fiber bundles can be configured such that the relative positional relationship between the receiving navigation fiber bundles and each transmitting navigation fiber bundle is the same among the receiving navigation fiber bundles in the second group. In some examples, the first group of navigation fiber bundles can be distributed rotationally symmetrically about the central axis 102-0 of the needle body 102 on a first circle, and the second group of navigation fiber bundles can be distributed rotationally symmetrically about the central axis 102-0 of the needle body 102 on a second circle concentric with the first circle. The first circle can have the same diameter as the second circle (i.e., the first and second groups of navigation fiber bundles are distributed rotationally symmetrically on the same circle), for example, refer to... 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 them Figures 4A to 4D The first and second circles are indicated by dashed lines. In some embodiments, one or more transmitting navigation fiber bundles from the first set of navigation fiber bundles may be positioned adjacent to one or more receiving navigation fiber bundles from the second set of navigation fiber bundles. For example, in Figure 4B In this configuration, each receiving navigation fiber bundle is positioned adjacent to two corresponding transmitting navigation fiber bundles; Figure 4C In this configuration, four receiving navigation fiber bundles are positioned adjacent to a corresponding transmitting navigation fiber bundle; Figure 4DIn this configuration, each receiving navigation fiber bundle is positioned adjacent to a corresponding transmitting navigation fiber bundle.

[0063] Additionally, in some embodiments, the front end face 102-1 of the needle body 102 may be shaped such that each of the second set of navigation fiber bundles tends to receive navigation response light from the target site within a corresponding azimuth angle range relative to the central axis 102-0 of the needle body 102. In some embodiments, the front end face 102-1 of the needle body 102 may also be shaped such that each of the first set of navigation fiber bundles tends to emit navigation probe light toward the target site within the living body within a corresponding azimuth angle range relative to the central axis 102-0 of the needle body 102. Similarly, if each of the plurality of navigation fiber bundles has both light emission and light reception functions, the front end face 102-1 of the needle body 102 may be shaped such that each of the plurality of navigation fiber bundles tends to emit navigation probe light toward the target site within the living body and receive navigation response light from the target site within a corresponding azimuth angle range relative to the central axis 102-0 of the needle body 102. The azimuth plane can be understood as a plane parallel to the cross-section of the intervention needle 100. In this way, the distribution of the signal intensity of the navigation response light among the multiple navigation fiber bundles 104 can more accurately reflect the deviation of the needle insertion direction of the needle body 102 from the center direction of the target part. Figures 5A to 5C Several non-limiting example shapes of the front end face 102-1 of the needle body 102 formed for this purpose are shown.

[0064] exist Figure 5A In the example shown, the front end face 102-1 of the needle body 102 includes a slope 102-11 extending along the periphery of the needle body 102. The diameter of the front edge of the slope 102-11 is smaller than the diameter of the rear edge of the slope 102-11, and the front fiber end faces of the plurality of navigation fiber bundles 104 are located at the slope 102-11 of the front end face 102-1 of the needle body 102. For example, Figure 5A The diagram shows the front fiber end faces 104a-1 and 104e-1 of the navigation fiber bundles 104a and 104e located at the inclined surface 102-11 of the front end face 102-1 of the needle body 102. Due to the presence of the inclined surface 102-11, the front fiber end faces of each navigation fiber bundle 104 distributed thereon tend to emit light into and / or receive light from the space within the azimuth angle range directly opposite the inclined surface portion of the navigation fiber bundle 104. The inclined surface 102-11 can be, for example, the side surface of a frustum or cone, or the side surface of a truncated pyramid or pyramid, or have any other suitable shape. Furthermore, although Figure 5AThe inclined plane 102-11 is illustrated as having a constant tilt angle at all points on the inclined plane 102-11, but this is merely exemplary and not limiting. The inclined plane 102-11 can also be configured to have varying tilt angles, for example, it may include a curved or bent surface.

[0065] exist Figure 5B In the example shown, the front end face 102-1 of the needle body 102 includes a boss 102-12, and the front fiber end faces of the plurality of navigation fiber bundles 104 can be arranged around the boss 102-12 on the front end face 102-1 of the needle body 102. Due to the presence of the boss 102-12, the front fiber end face of each navigation fiber bundle 104 distributed on the front end face 102-1 is more inclined to emit light into and / or receive light from the space within the azimuth angle range directly opposite the side portion of the nearest boss of the navigation fiber bundle 104. The boss 102-12 can be, for example, a frustum or cone, or a truncated pyramid, or have any other suitable shape. For example, further as Figure 5C As shown, the bosses 102-12 may have multiple radial protrusions that separate the front fiber end faces of each navigation fiber bundle 104 from each other, such that the front fiber end face of each navigation fiber bundle 104 is more inclined to emit light into and / or receive light from the space defined by the azimuth angle range of the two adjacent radial protrusions of the navigation fiber bundle 104. For example, the height of the radial protrusions may be constant or may decrease as they approach the perimeter of the needle body 102. Moreover, the radial protrusions do not necessarily have to extend to the perimeter of the needle body 102.

[0066] Several embodiments of the intervention needle 100 regarding optical navigation functions have been described above. Various embodiments of the intervention needle 100 regarding in-situ real-time microenvironment sensing functions will be described below. For example... Figure 7As shown, 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 may include 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. Each sensing optical fiber in each set of sensing optical fibers 106 can be configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material. The light source module 204 can be configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers 106, the detection module 206 can be configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers 106, and the analysis module 208 can be configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the emitted light detected by the detection module 206. In some embodiments, the light source module 204 can be configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers 106, the detection module 206 can be configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers 106, and the analysis module 208 can be configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the emitted light of each sensing fiber detected by the detection module 206 at two different wavelengths. In some embodiments, the light source module 204 may be configured to provide a first excitation light and a second excitation light with a wavelength different from the first excitation light to each sensing fiber in each of the one or more sets of sensing fibers 106, the detection module 206 may be configured to detect a first emission light from each sensing fiber in response to the first excitation light and a second emission light in response to the second excitation light, and the analysis module 208 may be configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the first emission light to the signal intensity of the second emission light detected by the detection module 206.

[0067] In some examples, the light source module 204 can be configured to provide navigation probe light to the navigation fiber bundle 104 while simultaneously providing corresponding excitation light to each set of sensing fibers 106. In some examples, the light source module 204 can be configured to alternately provide navigation probe light to the navigation fiber bundle 104 and corresponding excitation light to each set of sensing fibers 106. In some examples, the detection module 206 can be configured to detect emitted light from each set of sensing fibers 106 while simultaneously detecting navigation response light from the navigation fiber bundle 104. In some examples, the detection module 206 can be configured to alternately detect navigation response light from the navigation fiber bundle 104 and emitted light from each set of sensing fibers 106.

[0068] In some embodiments, each of the one or more sets of sensing fibers 106 may be arranged symmetrically, for example, rotationally symmetrically, about the central axis 102-0 of the needle body 102. Symmetrical arrangement of the sensing fibers can facilitate analysis of the distribution of parameters in the microenvironment. In some examples, the one or more sets of sensing fibers 106 may be distributed rotationally symmetrically on one or more corresponding concentric circles. In some examples, two or more sets of sensing fibers 106 may be distributed on the same circle. In some embodiments, the one or more sets of sensing fibers 106 may be distributed on the same circle as the plurality of navigation fiber bundles (e.g., ...). Figure 7 The sensing fiber (indicated by the dashed line in the diagram) is located on or distributed across different concentric circles. For example, the sensing fiber can be a single optical fiber, which can be much thinner than a bundle of navigation fibers.

[0069] In some embodiments, the set or multiple sets of 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 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 7 Compared to Figure 1 , Figure 7The intervention needle 100 further includes a first set of sensing optical fibers 1061a-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 acidity / alkalinity. As a non-limiting example, the first photoluminescent material may include Er 3+ Doped rare earth upconversion nanoparticles (such as Figure 9A As shown, the core is Er 3+ Doped rare-earth nanoparticles, with an outer shell to enhance luminescence performance, form core-shell structured NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles. For example, 980nm excitation light can be provided by the light source module 204 to the first sensing fiber, and then transmitted from the first sensing fiber to the first photoluminescent material located at its front fiber end face. Then, the analysis module 208 can determine the temperature change in the microenvironment based on the change in the ratio of the signal intensity at 525nm and 545nm of the emission spectrum of the first photoluminescent material. The second photoluminescent material may include benzo[a]porphyrin-type metal complexes (such as...). Figure 9B As shown, for example, excitation light of 635 nm can be provided by the light source module 204 to the second sensing fiber and then transmitted from the second sensing fiber to the second photoluminescent material. Then, the analysis module 208 can determine the change in oxygen concentration in the microenvironment based on the change in the emission intensity of the second photoluminescent material. The third photoluminescent material may include polymethyl cyanine dye derivatives (such as...). Figure 9C As shown, for example, excitation light of 635 nm and 680 nm can be provided by the light source module 204 to the third sensing fiber, and then transmitted by the third sensing fiber to the third photoluminescent material, respectively. The analysis module 208 can then determine the change in pH based on the change in the ratio of the emission intensities under the two excitation light conditions. (Reference) Figure 8 The 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. The probe is then fused and assembled onto one end of the fiber to obtain the sensing fiber. 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%.

[0070] These sensing optical fibers allow for real-time, in-situ monitoring of the status and distribution of various parameters in the local microenvironment of the in vivo environment where the tip of the needle 102 is located. This helps guide doctors to make reliable diagnostic and treatment decisions promptly. For example, if 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.

[0071] In some embodiments, the intervention needle 100 may further include a fiber optic interface, 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, Figure 10 A perspective view of an example interventional needle is shown, wherein the fiber optic interface 102-3 is disposed on a portion of the side of the needle body 102 near the rear end face 102-2. All rear fiber end faces of the plurality of navigation fiber bundles 104 (and, if any, additional navigation fiber bundles 105) and the one or more sets of sensing fibers 106 (if any) are arranged at the fiber optic interface 102-3 according to a predetermined pattern. For example, all rear fiber end faces may be arranged in an array at the fiber optic interface 102-3, such as... Figure 11 As shown, the rear fiber end faces in this array, from left to right and from top to bottom, belong to the navigation fiber bundles 104a-104h, the first sensing fibers 1061a-1061d, the second sensing fibers 1062a-1062b, and the third sensing fibers 1063a-1063b, respectively. With this arrangement, signals from each rear fiber end face can be easily detected by imaging the fiber interface, and desired light can be easily coupled into each rear fiber end face. For example, the light source module 204 can be configured to illuminate the fiber interface 102-3 to selectively couple light into some or all of the rear fiber end faces. For example, the detection module 206 can be configured to perform spectral detection on each rear fiber end face at the fiber interface 102-3 to obtain spectral information of the optical signal and / or perform imaging detection to obtain intensity information of the optical signal. In some examples, the detection module 206 can perform surface imaging of the entire fiber interface 102-3 to simultaneously detect the signal intensity at all rear fiber end faces. In some examples, the detection module 206 may include a scanning assembly for scanning each rear fiber endface at the fiber optic interface 102-3 to detect the signal spectrum and / or intensity at each rear fiber endface. The scanning assembly may include, for example, a high-speed / low-speed galvanometer system, a three-dimensional controllable displacement stage, and related optical elements.

[0072] Understandable, although Figure 11The fiber optic interface is illustrated as having a circular shape, but this is merely exemplary and not limiting; the fiber optic interface can have any suitable shape. In some examples, the fiber optic interface can take the form of a fiber optic connector, such as, but not limited to, a multi-fiber push-in (MPO) connector or other multi-fiber connectors. In some examples, the rear fiber end faces of the fibers for emitting light can be arranged together at the fiber optic interface, and the rear fiber end faces of the fibers for receiving light can be arranged together to input light to and output light from the fiber optic interface of the insertion needle. In some examples, the rear fiber end faces of the fibers for emitting light can be arranged at a first fiber optic interface, and the rear fiber end faces of the fibers for receiving light can be arranged at a second fiber optic interface, different from the first fiber optic interface. In some examples, the rear fiber end faces of different types of fibers can be arranged at different fiber optic interfaces; for example, the rear fiber end face of the navigation fiber bundle can be arranged at the first fiber optic interface, and the rear fiber end face of the sensing fiber can be arranged at a second fiber optic interface, different from the first fiber optic interface.

[0073] Figure 17 An example arrangement of an interventional diagnostic and therapeutic system 200 is schematically depicted, wherein the interventional needle module consists of Figure 10 The interventional needle in the middle represents... Figure 17 In this embodiment, the probe light signal emitted by the light source module 204 is reflected by the dichroic mirror 212 to the fiber optic interface 102-3, thereby entering the corresponding optical fiber. The response light signal from the optical fiber is transmitted through the dichroic mirror 212 to the detection module 206, and the detection module 206 transmits the detection result of the response light signal to the analysis module 208 for analysis. Although in Figure 17 The optical path is configured such that the probe light signal is reflected by the dichroic mirror 212 while the response light signal is transmitted, but the reverse is also possible. Alternatively, in some embodiments, the optical paths for the probe light signal and the response light signal can be completely separated without using a dichroic mirror. For example, when the navigation fiber bundle in the intervention needle 100 is arranged as follows... Figure 4A In the arrangement shown, the rear fiber end faces of the first group of navigation fiber bundles 104b, 104d, 104f, and 104h can be placed at the first fiber optic interface, and the rear fiber end faces of the second group of navigation fiber bundles 104a, 104c, 104e, and 104g can be placed at the second fiber optic interface. Then, the light source module 204 can be optically coupled to the first fiber optic interface via a first optical cable, and the detection module 206 can be optically coupled to the second fiber optic interface via a second optical cable. Additionally, although not shown in the figure, the system can also include various optical elements to optimize the optical path. For example, one or more lenses can be placed between the dichroic mirror 212 and the fiber optic interface 102-3 and / or between the dichroic mirror 212 and the detection module 206 to shape the beam. A filter can also be placed in front of the detection module 206 to filter out stray light interference such as scattered signals from the light output of the light source module 204.

[0074] Besides arranging a filter before the detection module 206, this disclosure provides other methods to avoid interference from the scattering signal of the light output by the light source module 204. In some embodiments, the light source module 204 can be configured to intermittently output pulsed light, and the analysis module 208 can further include a timing control component configured to control the light source module 204 and the detection module 206 to operate at the same frequency but different phases, such that the detection module 206 performs detection during the period when the light source module 204 stops outputting pulsed light and stops detection during the period when the light source module 204 outputs pulsed light. This method can be called a time-resolved method, which can fundamentally avoid the occurrence of the scattering signal of the light output by the light source module 204 during the detection period. The timing control of the light source module 204 can be achieved, for example, by timing control of the power supply of the light source module 204, such as by using a transistor-to-transistor (TTL) trigger device to achieve intermittent output. Of course, intermittent output can be achieved by setting a light-blocking plate at the light output port of the light source module 204 and controlling the opening and closing time sequence of the light-blocking plate, or by any other suitable method. Timing control of the detection module 206 can be achieved, for example, by setting a light-blocking plate (e.g., a chopper) at the light input port of the detection module 206 and controlling the opening and closing time sequence of the light-blocking plate, or by controlling the timing of the power supply to the detection module 206, or by using a detector with better time-resolved detection performance, or by any other suitable method. Relatively speaking, time-resolved methods are more suitable for photoluminescent materials with an afterglow lifetime longer than the shortest operating cycle achievable by the light source module 204 and the detection module 206 (e.g., photoluminescent materials pre-injected into the target area, photoluminescent materials included in the probe of the sensing fiber). For example, as mentioned above... Figure 9B In the described scenario of oxygen concentration sensing in the microenvironment, the analysis module 208 can control the operation timing of the light source module 204 and the detection module 206 according to the time-resolved method. First, the light source module 204 provides 635nm excitation light to the second sensing fiber, which then transmits the light to the second photoluminescent material, benzo[a]porphyrin-type metal complex. Then, during the period when the light source module 204 stops outputting excitation light, the detection module 206 detects the emission light of the benzo[a]porphyrin-type metal complex. Thus, the analysis module 208 can determine the change in oxygen concentration in the microenvironment based on the intensity change of the emission light of the benzo[a]porphyrin-type metal complex detected by the detection module 206.

[0075] Furthermore, as mentioned earlier, the analysis module 208 can be configured to perform analysis based on the relative values ​​or ratios of the intensities of the optical signals at two wavelengths. In this case, the analysis results of the analysis module 208 are less susceptible to noise interference. This method can be called the intensity ratio method. Relatively speaking, the intensity ratio method is more suitable for situations where the response spectrum (emission spectrum or reflection spectrum) has multiple peaks or where the photoluminescent material has multiple excitation wavelengths. For example, as mentioned earlier... Figure 9C In the described microenvironment pH sensing scenario, the analysis module 208 can perform a ratio analysis on the intensity of the emitted light from the third photoluminescent material, polymethyl cyanine dye derivative, detected by the detection module 206, under excitation light of 635 nm provided by the light source module 204 and under excitation light of 680 nm provided by the light source module 204. The real-time pH of the microenvironment is determined by comparing this ratio with the working curve obtained during standard experiments. Furthermore, when the response spectrum has only one peak, if the intensity ratio method is to be used, the ratio of the signal intensities at two different wavelengths on that peak can be selected for analysis.

[0076] The intensity ratio method can effectively reduce system-induced fluctuations, and it can be combined with time-resolved methods to further reduce the impact of background interference. For example, as mentioned earlier... Figure 9A In the described microenvironment temperature sensing scenario, the analysis module 208 can control the operation timing of the light source module 204 and the detection module 206 according to the time-resolved method. First, the light source module 204 provides 980nm excitation light to the first sensing fiber, which then transmits the light to the first photoluminescent material NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles. Then, during the period when the light source module 204 stops outputting excitation light, the detection module 206 detects the emission light of the NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles. The analysis module 208 can then perform a ratio analysis of the emission intensity at 525nm and 545nm of the emission spectrum of the NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles detected by the detection module 206, and determine the real-time temperature of the microenvironment by comparing it with the working curve obtained during standard experiments.

[0077] Further reference Figure 17In some embodiments, the interventional diagnostic and treatment system 200 may further include a feedback module 210. The feedback module 210 may be configured to generate an adjustment suggestion for the insertion direction of the needle 102 based on the deviation of the insertion direction of the needle 102 from the center direction of the target site, as determined by the analysis module 208, and to feed back the adjustment suggestion to the operator of the interventional needle 100. The feedback module 210 may also be configured to generate a parameter status report and / or treatment plan adjustment suggestion based on parameters of the microenvironment within the living body determined by the analysis module 208, and to feed back the parameter status report and / or treatment plan adjustment suggestion to the operator of the interventional needle 100. For example, when the analysis module 208 determines that the oxygen concentration is too low, the feedback module 210 may feed back a parameter status report including the oxygen concentration value and a treatment plan adjustment suggestion to abandon photodynamic therapy for tumor treatment. The feedback module 210 may be implemented by any suitable computing device, including but not limited to processors, controllers, microprocessors, computers, servers, etc. Feedback module 210 may include any suitable output device, such as, but not limited to, a display (such as a cathode ray tube (CRT) or liquid crystal display (LCD)), a speaker, etc., to output various feedback.

[0078] In some embodiments, the needle body 102 of the interventional needle 100 of the interventional needle module 202 may have a hollow structure to provide a working channel inside the needle body 102. This working channel may be configured to perform at least one of the following operations: deliver medication (e.g., medication for treatment / hemostasis); deliver cleaning fluid (e.g., saline solution for cleaning dirt / washing wounds); aspirate waste fluid (e.g., dirty cleaning fluid, spilled blood, etc.); receive the inner needle. For example, see reference... Figure 12 The needle body 102 is hollow to provide a working channel 102-4 therein. Figure 12In the example, 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. The inner needle 110 may be configured similarly to the various embodiments of the needle body 102 described above. The design of the inner needle 110 may also differ from that of the needle body 102, taking into account practical clinical needs and functional complementarity with the needle body 102. For example, on the one hand, 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 by the navigation fiber bundle in the needle body 102, the insertion direction of the inner needle 110 is also basically determined accordingly. Therefore, it is not necessary to additionally arrange a navigation fiber bundle 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 13 , Figure 14 , Figure 15A and Figure 15B Here are some examples of inner needles.

[0079] In some embodiments, such as Figure 13As shown, the inner needle 110 may include one or more imaging fiber bundles 112 disposed within the inner needle 110. These one or more 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 a fisheye lens of comparable 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. The light source module 204 may be configured to provide imaging probe light to the one or more imaging fiber bundles 112, the detection module 206 may be configured to detect the imaging response light from the one or more imaging fiber bundles 112, and the analysis module 208 may be configured to generate an image of the target site based on the imaging response light detected by the detection module 206 for each imaging fiber bundle 112. The imaging response light can be reflected light (e.g., direct imaging) or emitted light (e.g., fluorescence imaging) originating from the imaging probe light. Such an inner needle 110 can be referred to as an imaging inner needle. The imaging fiber bundle of the imaging inner needle 110 may not have sensing functionality, but is only used for real-time in-situ imaging. The imaging fiber bundle 112 may include multiple bundled optical fibers, which may be thicker than the aforementioned sensing fibers but thinner than the navigation fiber bundle. Commercially available imaging fiber bundles can be used in the imaging inner needle 110. In some embodiments, the imaging fiber bundle of the imaging inner needle 110 may, for example, be a near-infrared imaging fiber bundle, and the imaging probe light may, for example, be light with a wavelength of 1064 nm provided by a light source module 204 including a near-infrared light source. 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 area, and can be used for real-time microstructural imaging of ultra-fine regions. In some embodiments, each imaging fiber bundle 112 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; that is, each imaging fiber bundle performs both light emission and light reception functions. In some embodiments, a portion of the one or more imaging fiber bundles 112 can be configured to emit imaging probe light toward a target site within the living body, while another portion can 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. These imaging fiber bundles 112 can be arranged in any suitable manner, for example, in an array, such as... Figure 13 As shown.

[0080] In some embodiments, such as Figure 14As 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 area. Each sensing optical fiber in each set of sensing optical fibers 116 may include a probe with a photoluminescent material located at its front fiber end face 116-1. The photoluminescent material can 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 can be configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material. The light source module 204 can be configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers, the detection module 206 can be configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers, and the analysis module 208 can be configured to determine a corresponding parameter of the microenvironment inside the target portion at the front fiber end face of the sensing fiber based on the emitted light of each sensing fiber detected by the detection module 206. In some embodiments, the light source module 204 can be configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers 116, the detection module 206 can be configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers 116, and the analysis module 208 can be configured to determine a corresponding parameter of the microenvironment inside the target portion at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the emitted light of each sensing fiber detected by the detection module 206 at two different wavelengths. In some embodiments, the light source module 204 may be configured to provide a first excitation light and a second excitation light with a wavelength different from the first excitation light to each sensing fiber in each of the one or more sets of sensing fibers 116, the detection module 206 may be configured to detect a first emission light from each sensing fiber in response to the first excitation light and a second emission light from each sensing fiber in response to the second excitation light, and the analysis module 208 may be configured to determine a corresponding parameter of the microenvironment inside the target portion at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the first emission light to the signal intensity of the second emission light detected by the detection module 206.

[0081] The sensing fiber 116 disposed in the inner needle 110 can be similar to the sensing fiber 106 disposed 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. Since the needle body 102 usually does not enter the target site, the sensing fiber 106 disposed in the needle body 102 cannot sense the parameters of the microenvironment inside the target site. However, the interventional inner needle 110 can be inserted into the target site, so the sensing fiber 116 disposed in the interventional inner needle 110 can be used to sense the parameters of the local microenvironment inside the target site in situ in real time. In some embodiments, for example, refer to Figure 14 The 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 base for studying microenvironmental linkages 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 chemical ablation drugs (e.g., alcohol, etc.) into the target site for chemical ablation.

[0082] In some embodiments, the inner needle 110 can be configured for thermal ablation of a target site. Such an inner needle can be referred to as a thermal ablation inner needle. 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, therefore... Figure 15AAs 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 15B 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 area. 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. The light source module 204 can be configured to provide excitation light to each temperature sensing fiber in each of the one or more sets of temperature sensing fibers 1161. The detection module 206 can be configured to detect the emitted light from each temperature sensing fiber in each of the one or more sets of temperature sensing fibers 1161. The analysis module 208 can be configured to determine the temperature of the microenvironment inside the target site at the front fiber end face of each temperature sensing fiber based on the emitted light detected by the detection module 206. The output power of the thermal ablation needle can be controlled based on the determined temperature, thereby stabilizing the microenvironment temperature of the target site near the desired temperature. For example, the feedback module 210 can generate a temperature status report and treatment plan adjustment suggestions indicating the desired output power of the thermal ablation needle based on the temperature determined by the analysis module 208. The temperature sensing fiber 1161 can be similar to the aforementioned first sensing fibers 1061a and 1161a for sensing temperature, and the aforementioned time-resolved method and / or intensity ratio method can also be applied, which will not be elaborated further here. In some embodiments, if the first group of temperature-sensing fibers in one or more groups of temperature-sensing fibers 1161 is closer to the front end face of the inner needle than the second group of temperature-sensing fibers in one or more groups of temperature-sensing fibers, then the temperature-sensing fiber density of the first group of temperature-sensing fibers can be greater than the temperature-sensing fiber density of the second group of temperature-sensing fibers. The temperature-sensing fiber density refers to the ratio of the number of temperature-sensing fibers in one group to the area of ​​the cross-section of the inner needle where the front fiber end face of that group of temperature-sensing fibers is located. For example... Figure 15BAs 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, forming a thermal ablation temperature monitoring circle to guide the efficient execution of the thermal ablation surgery. When the analysis module 208 detects that a lesion does not meet the temperature requirements for thermal ablation, the feedback module 210 can provide the following treatment plan adjustment suggestions: replace the thermal ablation inner needle with the previously mentioned... Figure 14 The described interventional needle is used to perform chemical ablation by injecting alcohol or other substances through the hollow channel of the interventional needle.

[0083] It is understandable that the above combination Figure 13 , Figure 14 , Figure 15A and Figure 15B 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 similarly, 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 faces of the optical fibers in the inner needle 110 according to a predetermined pattern.

[0084] The interventional diagnostic and treatment system according to various embodiments of this disclosure can guide the insertion process of the interventional needle using in-situ real-time optical navigation. It 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 in the microenvironment within the living body and target site using optical fibers. This allows for timely feedback on the treatment intensity and effects of diagnostic and treatment methods such as thermotherapy and chemotherapy, enabling doctors to adjust treatment strategies in real time. Furthermore, the navigation fiber bundle, imaging fiber bundle, and various sensing fibers of the interventional needle according to various embodiments of this disclosure are all arranged within the needle body or inner needle. Therefore, the interventional needle can enter the living body through its interventional channel and is 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.

[0085] This disclosure also provides, in another aspect, a method for using the interventional diagnostic and therapeutic system 200 according to the foregoing various embodiments. For example... Figure 18As shown, a method 300 for using the interventional diagnostic and treatment system 200 may include: at step S302, a light source module 204 provides navigation detection light to a plurality of navigation fiber bundles 104 in the interventional needle 100 entering the living body; at step S304, the plurality of navigation fiber bundles 104 emit navigation detection light toward a target site within the living body and receive navigation response light from the target site; at step S306, a detection module 206 detects the navigation response light from the plurality of navigation fiber bundles 104; and at step S310, an analysis module 208 determines the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the signal intensity of the navigation response light detected by the detection module 204 among the plurality of navigation fiber bundles 104. Embodiments of method 300 may be similar to the various embodiments previously described with respect to the interventional diagnostic and treatment system 200, and will not be repeated here.

[0086] 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.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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 diagnostic and treatment system, comprising: The interventional needle module includes an interventional needle, wherein the interventional needle comprises: The needle body is configured for percutaneous intervention in living tissue, and Multiple navigation fiber bundles are arranged within the needle body and extend longitudinally along the central axis of the needle body, with the front fiber end faces of the multiple navigation fiber bundles located at the front end face of the needle body. The plurality of navigation fiber bundles are configured to emit navigation detection light toward a target location within the living body and receive navigation response light from the target location. The plurality of navigation fiber bundles include a plurality of first navigation fiber bundles and a plurality of second navigation fiber bundles configured to receive navigation response light from the target location, wherein the first navigation fiber bundles in the plurality of first navigation fiber bundles and the corresponding second navigation fiber bundles in the plurality of second navigation fiber bundles are arranged opposite to each other about the central axis of the needle body. A light source module is configured to provide the navigation detection light to the plurality of navigation fiber bundles of the intervention needle; A detection module is configured to detect the navigation response light from the plurality of navigation fiber bundles; and The analysis module is configured to determine the deviation of the needle insertion direction from the center direction of the target location based on the distribution of the signal intensity of the navigation response light detected by the detection module among the plurality of navigation fiber bundles. The analysis module is configured as follows: When the navigation response light from the target location is a reflection of the navigation detection light from the target location, the needle insertion direction is determined to deviate from the direction of the first navigation fiber bundle relative to the center direction of the target location, based on the fact that the signal intensity of the navigation response light is stronger at the first navigation fiber bundle than at the second navigation fiber bundle; or When the navigation response light from the target site is emitted by the target site in response to absorbing the navigation detection light, the needle insertion direction is determined to deviate from the center direction of the target site relative to the direction where the second navigation fiber bundle is located relative to the central axis of the needle, based on the fact that the signal intensity of the navigation response light is stronger at the first navigation fiber bundle than at the second navigation fiber bundle. The plurality of first navigation fiber bundles and the plurality of second navigation fiber bundles are arranged rotationally symmetrically about the central axis of the needle body.

2. The interventional diagnostic and treatment system according to claim 1, wherein, The plurality of navigation fiber bundles are arranged symmetrically about the central axis of the needle body.

3. The interventional diagnostic and treatment system according to claim 1, in, The plurality of navigation fiber bundles are arranged rotationally symmetrically about the central axis of the needle body within the needle body. Each of the plurality of navigation fiber bundles is configured to individually emit navigation probe light toward a target site within the living body and receive navigation response light from the target site. The light source module is configured to provide navigation probe light to each of the plurality of navigation fiber bundles, and the detection module is configured to detect the navigation response light from each of the plurality of navigation fiber bundles. The interventional needle module is further configured to satisfy at least one of the following: Each of the plurality of navigation fiber bundles has an objective lens of similar size attached to its front fiber end face. The front end face of the needle is shaped such that each of the plurality of navigation fiber bundles tends to emit navigation detection light toward the target site within the living body and receive navigation response light from the target site within a corresponding azimuth angle range relative to the central axis of the needle.

4. The interventional diagnostic and treatment system according to claim 1, in, The plurality of navigation fiber bundles include a first set of navigation fiber bundles for emitting navigation probe light toward a target site within the living body and a second set of navigation fiber bundles for receiving navigation response light from the target site. The light source module is configured to provide navigation probe light to each of the first set of navigation fiber bundles. The detection module is configured to detect the navigation response light from each of the second set of navigation fiber bundles. The analysis module is 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 navigation response light detected by the detection module within the second set of navigation fiber bundles. The second set of navigation fiber bundles is arranged rotationally symmetrically within the needle body about its central axis, and the second set of navigation fiber bundles includes at least two navigation fiber bundles. The interventional needle module is further configured to satisfy at least one of the following: Each of the second group of navigation fiber bundles has an objective lens of similar size attached to its front fiber end face. The first group of navigation fiber bundles is distributed symmetrically about the central axis of the needle body on a first circle, and the second group of navigation fiber bundles is distributed symmetrically about the central axis of the needle body on a second circle concentric with the first circle; One or more navigation fiber bundles from the first group of navigation fiber bundles are positioned adjacent to one or more corresponding navigation fiber bundles from the second group of navigation fiber bundles. The front end face of the needle is shaped such that each of the second set of navigation fiber bundles tends to receive navigation response light from the target location within a corresponding azimuth angle range relative to the central axis of the needle.

5. The interventional diagnostic and treatment system according to claim 1, wherein, The interventional needle of the interventional needle module further 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 organism. 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 each of the 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. The light source module is configured to provide the excitation light to each sensing fiber in each of the one or more sets of sensing fibers, the detection module is configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the emitted light of each sensing fiber detected by the detection module.

6. The interventional diagnostic and treatment system according to claim 5, wherein, Each of the one or more sets of sensing optical fibers is arranged rotationally symmetrically within the needle body about the central axis of the needle body, and wherein the one 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 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 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.

7. The interventional diagnostic and treatment system according to claim 5, wherein, The interventional needle of the interventional needle module further includes: The fiber optic interface is located on the rear end face of the needle body or on the side of the needle body near the rear end face. In this configuration, all the rear fiber end faces of the plurality of navigation fiber bundles and the group or plurality of sensing fiber bundles are arranged at the fiber interface according to a predetermined pattern, and The detection module is configured to perform spectral detection on each rear fiber end face at the fiber optic interface to obtain spectral information of the optical signal, and / or perform imaging detection to obtain intensity information of the optical signal.

8. The interventional diagnostic and treatment system according to claim 1, wherein, The interventional needle of the interventional needle module 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: drug delivery; waste fluid aspiration; cleaning fluid delivery; and receiving the inner needle.

9. The interventional diagnostic and treatment system according to claim 8, wherein, The interventional needle of the interventional needle module further includes: An inner needle is 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.

10. The interventional diagnostic and treatment system according to claim 9, wherein, The inner needle includes 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 a fisheye 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 region within the living organism and receive imaging response light from the target region. The light source module is configured to provide the imaging probe light to the one or more imaging fiber bundles, the detection module is configured to detect the imaging response light from the one or more imaging fiber bundles, and the analysis module is configured to generate an image of the target region based on the imaging response light of each imaging fiber bundle detected by the detection module.

11. The interventional diagnostic and treatment system according to claim 9, wherein, 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. 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 each of the 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. The light source module is configured to provide the excitation light to each sensing fiber in each of the one or more sets of sensing fibers, the detection module is configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the target portion at the front fiber end face of the sensing fiber based on the emitted light detected by the detection module for each sensing fiber.

12. The interventional diagnostic and treatment system according to claim 11, wherein, Each of the one or more sets of sensing optical fibers is arranged rotationally symmetrically within the inner needle about its central axis, wherein the inner needle has a hollow channel for injecting a chemical ablation agent into the target site, and wherein the one 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 in the microenvironment within the target site. Each second sensing optical fiber in the second set has a probe with a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration. 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.

13. The interventional diagnostic and treatment system according to claim 9, wherein, 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. The light source module is configured to provide the excitation light to each temperature sensing fiber in each of the one or more groups of temperature sensing fibers, the detection module is configured to detect the emitted light from each temperature sensing fiber in each of the one or more groups of temperature sensing fibers, and the analysis module is configured to determine the temperature of the microenvironment inside the target portion at the front fiber end face of the temperature sensing fiber based on the emitted light detected by the detection module.

14. The interventional diagnostic and treatment system according to claim 13, wherein, 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.

15. The interventional diagnostic and treatment system according to claim 1, wherein, The interventional needle module further includes an additional navigation fiber bundle disposed in the needle body, the additional 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 additional navigation fiber bundle is configured to emit additional navigation probe light into the living organism and receive additional navigation response light originating from the additional navigation probe light. The light source module is configured to provide the additional navigation probe light to the additional navigation fiber bundle, the detection module is configured to detect the additional navigation response light from the additional navigation fiber bundle, and the analysis module is configured to locate and distinguish undesirable sites within the living body to be punctured by the interventional needle based on the additional navigation response light detected by the detection module.

16. The interventional diagnostic and treatment system according to claim 1, wherein, The light source module is configured to intermittently output pulsed light, and the analysis module further includes a time control component. The time control component is configured to control the light source module and the detection module to operate in a timing sequence with the same frequency but different phases, such that the detection module performs detection during the period when the light source module stops outputting pulsed light and stops detection during the period when the light source module outputs pulsed light.

17. The interventional diagnostic and treatment system according to claim 1, wherein, The analysis module is configured to determine the deviation of the needle insertion direction from the center direction of the target location based on the distribution of the ratio of the signal intensity of the navigation response light at two different wavelengths detected by the detection module among the plurality of navigation fiber bundles.

18. The interventional diagnostic and treatment system according to claim 5, wherein, The light source module is configured to provide excitation light to each sensing fiber in each of the one or more sets of sensing fibers, the detection module is configured to detect the emitted light from each sensing fiber in each of the one or more sets of sensing fibers, and the analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the emitted light of each sensing fiber detected by the detection module at two different wavelengths; or The light source module is configured to provide a first excitation light and a second excitation light with a wavelength different from the first excitation light to each sensing fiber in each of the one or more sets of sensing fibers. The detection module is configured to detect a first emission light from each sensing fiber in response to the first excitation light and a second emission light from each sensing fiber in response to the second excitation light. The analysis module is configured to determine a corresponding parameter of the microenvironment inside the living body at the front fiber end face of the sensing fiber based on the ratio of the signal intensity of the first emission light to the signal intensity of the second emission light detected by the detection module.

19. The interventional diagnostic and treatment system according to claim 5, further comprising: The feedback module is configured as follows: Based on the deviation of the needle insertion direction from the center direction of the target site determined by the analysis module, an adjustment suggestion for the needle insertion direction is generated and fed back to the operator of the interventional needle. Based on the parameters of the microenvironment inside the living body determined by the analysis module, a parameter status report and / or treatment plan adjustment suggestions are generated, and the parameter status report and / or treatment plan adjustment suggestions are fed back to the operator of the interventional needle.

Images