Intervention needle

Abstract

This disclosure relates to interventional needles. An interventional needle is provided, comprising: a needle body configured for percutaneous intervention into a living body; and a plurality of navigation fiber bundles disposed within 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 located at the front end face of the needle body, wherein the plurality of 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, so as to determine the deviation of the needle insertion direction of the needle body relative to 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.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and more specifically, to an interventional needle suitable for interventional medicine. 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 needle is provided, comprising: a needle body configured for percutaneous intervention in a living body; and a plurality of navigation fiber bundles disposed 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 probe light toward a target site within the living body and receive navigation response light from the target site, so as to determine the deviation of the needle insertion direction of the needle body relative to 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.

[0005] In some embodiments, the plurality of navigation fiber bundles are arranged symmetrically about the central axis of the needle body within the needle body.

[0006] In some embodiments, the navigation response light from the target location is reflected light from the target location in response to the navigation detection light; or the navigation response light from the target location is emitted light emitted by the target location in response to absorbing the navigation detection light.

[0007] 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, and 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.

[0008] In some embodiments, 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 a 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.

[0009] In some embodiments, the plurality of navigation fiber bundles include a first set of navigation fiber bundles for emitting navigation detection 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 second set of navigation fiber bundles is arranged rotationally symmetrically in the needle body about the central axis of the needle body. The second set of navigation fiber bundles includes at least two navigation fiber bundles, and each of the second set 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.

[0010] In some embodiments, the first set of navigation fiber bundles is distributed rotationally symmetrically about the central axis of the needle body on a first circle, the second set of navigation fiber bundles is distributed rotationally symmetrically about the central axis of the needle body on a second circle concentric with the first circle, and / or 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, and / or the front end face of the needle body is shaped such that each navigation fiber bundle in 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.

[0011] In some embodiments, the front end face of the needle body includes a slope extending along the periphery of the needle body, the diameter of the front edge of the slope being smaller than the diameter of the rear edge of the slope, and the front fiber end faces of the plurality of navigation fiber bundles are located at the slope of the front end face of the needle body.

[0012] In some embodiments, the interventional needle further includes: one or more sets of sensing optical fibers arranged in the needle body and extending longitudinally along the central axis of the needle body, such that the front fiber end face of the one or more sets of sensing optical fibers is located at the front end face of the needle body, wherein each set of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the living body, each sensing optical fiber in each set of sensing optical fibers includes a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with the corresponding parameter, and wherein each sensing optical fiber in each set of sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the corresponding parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material.

[0013] In some embodiments, each of the one or more sets of sensing fibers is arranged in the needle body in a rotationally symmetrical manner about the central axis of the needle body.

[0014] In some embodiments, the set of or more sensing optical fibers includes 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.

[0015] In some embodiments, the first photoluminescent material includes Er 3+ The doped rare-earth upconversion nanoparticles, the second photoluminescent material includes benzoporphyrin-type metal complexes, and the third photoluminescent material includes polymethyl cyanine dye derivatives.

[0016] In some embodiments, the intervention needle 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.

[0017] In some embodiments, the needle body has a hollow structure to provide a working channel inside the needle body, the working channel being configured to perform at least one of the following operations: delivering a drug; aspirating waste liquid; delivering a cleaning solution; receiving an inner needle.

[0018] In some embodiments, the interventional needle 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.

[0019] In some embodiments, the inner needle includes one or more imaging fiber bundles disposed therein, 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, so as to image the target site based on the imaging response light.

[0020] 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, each sensing optical fiber in each set of sensing optical fibers includes a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with the corresponding parameter, and wherein each sensing optical fiber in each set of sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the corresponding parameter of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

[0021] In some embodiments, the set of or more sensing optical fibers includes one or more of the following: a first set of sensing optical fibers including one or more first sensing optical fibers for sensing the temperature of the microenvironment inside the target site, wherein the probe of each of the first sensing optical fibers in the first set of sensing optical fibers has a first photoluminescent material configured to have an emission spectrum that varies with temperature; a second set of sensing optical fibers including one or more second sensing optical fibers for sensing the oxygen concentration of the microenvironment inside the target site, wherein the probe of each of the second sensing optical fibers in the second set of sensing optical fibers has a second photoluminescent material configured to have an emission spectrum that varies with oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing the pH of the microenvironment inside the target site, wherein the probe of each of the third sensing optical fibers in the third set of sensing optical fibers has a third photoluminescent material configured to have an emission spectrum that varies with pH.

[0022] In some embodiments, each of the one or more sets of sensing fibers is arranged rotationally symmetrically in the inner needle about the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting a chemical ablation drug into the target site.

[0023] 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 being located at a corresponding cross-section of the inner needle between the front and rear ends, wherein each set of temperature-sensing optical fibers is used to sense the temperature of the microenvironment inside the target site, each temperature-sensing optical fiber including a probe with a photoluminescent material located at its front fiber end face, the photoluminescent material being configured to have an emission spectrum that varies with temperature, and wherein each set of temperature-sensing optical fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the temperature of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

[0024] 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.

[0025] In some embodiments, the interventional needle 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 from the additional navigation probe light, so as to locate and distinguish undesirable sites within the living body to be punctured by the interventional needle based on the additional navigation response light.

[0026] 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

[0027] 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:

[0028] Figure 1 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0029] Figure 2 yes Figure 1 Side view of the interventional needle;

[0030] 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;

[0031] 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.

[0032] Figure 5A and Figure 5BPartial 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;

[0033] Figure 6 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0034] Figure 7 This is a schematic top view of an intervention needle according to one or more exemplary embodiments of the present disclosure;

[0035] 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;

[0036] 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;

[0037] Figure 10 This is a schematic perspective view of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0038] Figure 11 This 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;

[0039] Figure 12 This is a schematic side view of an interventional needle according to one or more exemplary embodiments of the present disclosure;

[0040] 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;

[0041] 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;

[0042] 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. Detailed Implementation

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] To this end, this disclosure provides an interventional needle with real-time optical navigation to efficiently guide its insertion process. This facilitates the needle's entry into the target site in the desired direction and position, while also avoiding vital areas such as blood vessels and organs requiring protection during percutaneous entry into the living body. Furthermore, the interventional needle according to this disclosure also possesses 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 and after the needle's percutaneous entry into the living body, providing a wealth of useful reference information for physicians' immediate diagnostic and treatment decisions. The interventional needles according to various embodiments of this disclosure will now be described in detail with reference to the accompanying drawings. It is understood that actual interventional needles may contain other components, but to avoid obscuring the key points of this disclosure, these components are not shown in the drawings and will not be discussed herein. It should also be noted that in this document, "anterior" refers to the side closer to the target site and farther from the operator (usually the physician), and "posterior" refers to the side farther from the target site and closer to the operator.

[0049] Figure 1 and Figure 2 An intervention needle 100 according to one or more exemplary embodiments of the present disclosure is schematically illustrated, 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.

[0050] 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.

[0051] 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 1As 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.

[0052] 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 the target site, so as 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 among the plurality of navigation fiber bundles 104.

[0053] 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, navigation probe light including the first wavelength can be emitted to the target location via the navigation fiber bundle 104, and then the signal intensity of the received navigation response light at the first wavelength position can be analyzed. 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, it can be said that the insertion direction of the needle body 102 is lower than the center direction of the target part; 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, it can be said that the insertion direction of the needle body 102 is higher ... lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that it is lower than the center direction of the target part, it can be said that If the signal intensity of the navigation response light at the first wavelength position is stronger at the navigation fiber bundles 104h, 104a, 104b, and 104c than at the navigation fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the right relative to the center direction of the target area. If the signal intensity of the navigation response light at the first wavelength position is distributed among the multiple navigation fiber bundles 104 such that it is weaker at the navigation fiber bundles 104h, 104a, 104b, and 104c than at the navigation fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the left relative to the center direction of the target area. If the signal intensity of the navigation response light at the first wavelength position is distributed uniformly among the multiple navigation fiber bundles 104 from navigation fiber bundles 104a to 104h, it indicates that the insertion direction of the needle body 102 is not deviated from the center direction of the target area. Similarly, the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site can be determined based on the distribution of the signal intensity of the navigation response light among the multiple navigation fiber bundles 104. This helps the doctor to adjust the needle insertion direction of the needle body 102 in a timely manner. Furthermore, when the signal intensity of the navigation response light is evenly distributed among the multiple navigation fiber bundles 104, it can be determined that the needle insertion direction of the needle body 102 has not deviated from the center direction of the target site.In some examples, if the target area has absorption peaks at multiple wavelengths, navigation probe light, including at least two of the multiple wavelengths, can be emitted towards the target area via the navigation fiber bundle 104. The distribution of the absolute or relative values ​​of the signal intensity of the received navigation response light at the positions of the at least two wavelengths within the multiple navigation fiber bundles 104 can then be analyzed. This can help to more accurately determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target area based on the distribution of the signal intensity of the navigation response light within the multiple navigation fiber bundles 104.

[0054] 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 the navigation probe light. In some examples, the target site can be pre-enriched with photoluminescent material by means such as injection, and then navigation probe light including the excitation wavelength of the photoluminescent material can be emitted towards the target site via the navigation fiber bundle 104. The signal intensity of the received navigation response light at the emission wavelength of the photoluminescent material can then be analyzed. Taking the diagnosis and treatment of liver tumors as an example, doctors usually need to perform interventional surgery on the liver with tumors. Before the surgery, a photoluminescent material, such as the clinically approved Indocyanine Green (ICG) dye, is generally injected. Thus, during the movement of the interventional needle towards the liver tumor, a 730nm navigation probe light can be emitted via the navigation fiber bundle to excite the ICG dye enriched in the liver tumor to emit light, and then the signal intensity of the received navigation response light at the emission wavelength of the ICG dye can be analyzed. If the signal intensity of the navigation response light at the emission wavelength is distributed as follows among the plurality of navigation fiber bundles 104: stronger at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle body 102 is slightly upward relative to the center direction of the target area; if the signal intensity of the navigation response light at the emission wavelength is distributed as follows among the plurality of navigation fiber bundles 104: weaker at navigation fiber bundles 104b, 104c, 104d, and 104e than at navigation fiber bundles 104f, 104g, 104h, and 104a, it indicates that the insertion direction of the needle body 102 is slightly downward ... If the signal intensity of the navigation response light at the emission wavelength position is stronger at the navigation fiber bundles 104h, 104a, 104b, and 104c than at the navigation fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the left relative to the center direction of the target area. If the signal intensity of the navigation response light at the emission wavelength position is distributed among the multiple navigation fiber bundles 104 such that the signal intensity at the navigation fiber bundles 104h, 104a, 104b, and 104c is weaker than that at the navigation fiber bundles 104d, 104e, 104f, and 104g, it indicates that the insertion direction of the needle body 102 is biased to the right relative to the center direction of the target area. If the signal intensity of the navigation response light at the emission wavelength position is distributed uniformly among the multiple navigation fiber bundles 104 from navigation fiber bundles 104a to 104h, it indicates that the insertion direction of the needle body 102 is not deviated from the center direction of the target area.In some examples, if the target site has emission peaks at multiple wavelengths, the distribution of the absolute or relative values ​​of the signal intensity of the received navigation response light at at least two of the multiple wavelengths within the multiple navigation fiber bundles 104 can be analyzed. This can help to more accurately determine the deviation of the needle insertion direction of the needle body 102 from the center direction of the target site based on the distribution of the signal intensity of the navigation response light within the multiple navigation fiber bundles 104.

[0055] Thus, the interventional needle 100 achieves real-time optical navigation through the navigation fiber bundle 104, which can not only help doctors navigate the interventional needle 100 to the vicinity of the target site, but also help doctors confirm whether the insertion direction and position of the interventional needle are appropriate.

[0056] In addition, the navigation fiber bundle 104 can also be used to locate and distinguish areas inside 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 avoid 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 from the additional navigation detection light, so as to locate and distinguish areas inside 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. In some embodiments, the additional navigation response light can be the emission light emitted by the 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 the reflected light of the important site to the additional navigation detection light; for example, different important sites may have different absorption spectra. The navigation fiber bundle 104 can be used to alternately emit additional navigation probe light, including absorption wavelengths unique to each important site, to locate and identify each important site in turn. Alternatively, the navigation fiber bundle 104 can emit additional navigation probe light including multiple absorption wavelengths common to multiple important sites, and the relative values ​​of the signal intensities of the received additional navigation response light at the multiple absorption wavelengths can be analyzed to locate and identify each important site. For example, for veins and arteries (which have significantly different colors), additional navigation probe light at 680nm and 850nm can be alternately emitted via 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 ratio, the ratio of the signal intensity of the additional navigation response light at 680nm to the signal intensity at 850nm can be used to determine whether it is a vein or an artery, guiding the doctor to avoid them when operating the interventional needle 100.

[0057] The functions of guiding the interventional needle to the target site and guiding the interventional needle to avoid critical sites can be alternately performed by having the navigation fiber bundles 104 alternately emit navigation probe light and additional navigation probe light. Alternatively, some navigation fiber bundles 104 (e.g., navigation fiber bundles 104a, 104c, 104e, 104g) can perform the function of guiding the interventional needle to the target site, while others (e.g., navigation fiber bundles 104b, 104d, 104f, 104h) can perform the function of guiding the interventional needle to avoid critical sites. In some embodiments, navigation fiber bundles 104a-104h can perform only the function of guiding the interventional needle to the target site, and additional navigation fiber bundles can be included to perform the function of guiding the interventional 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 contains 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 from the additional navigation probe light, so as to locate and distinguish undesirable sites within the living tissue that are not intended to be pierced by the interventional needle 100 based on the additional navigation response light. An embodiment of the arrangement of the additional navigation fiber bundles 105 can be similar to an embodiment of the arrangement of the navigation fiber bundles 104, and will not be described further here.

[0058] Return to reference Figure 1 The 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, 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. Figure 1As 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.

[0059] 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. For example, see reference... 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 the transmitting navigation fiber bundles and are indicated by a 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 the receiving navigation fiber bundles and are indicated by a 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 within the needle body 102. The second set of navigation fiber bundles may include at least two navigation fiber bundles. Each navigation fiber bundle in the second set may, for example, have an objective lens of a size equivalent to that of the navigation fiber bundle 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 set of navigation fiber bundles can be simply determined 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 set of navigation fiber bundles, and determine whether the emitted light intensity of each receiving navigation fiber bundle in the second set of navigation fiber bundles is the same. If so, the configuration of the first set of navigation fiber bundles can be considered suitable. In some examples, the first set 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 set of navigation fiber bundles. In some examples, the first set 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 set 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 sets 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 4D In this configuration, each receiving navigation fiber bundle is positioned adjacent to a corresponding transmitting navigation fiber bundle.

[0060] 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 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.

[0061] 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 5A The 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.

[0062] 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.

[0063] Several embodiments of the optical navigation function of the intervention needle 100 have been described above. Various embodiments of the intervention needle with in-situ real-time microenvironment sensing function 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 can be configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine a corresponding parameter of the microenvironment inside the living body based on the emitted light of the photoluminescent material. In some embodiments, each of the one or more sets of sensing fibers 106 may be arranged symmetrically about the central axis 102-0 of the needle body 102. The symmetrical arrangement of the sensing fibers can facilitate the analysis of the distribution of parameters 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.

[0064] 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 7 The 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 properties, form core-shell structured NaYF4:Yb,Er@NaLuF4 upconversion nanoparticles. For example, 980 nm excitation light can be transmitted to them via a first sensing fiber, and the temperature change in the microenvironment can be determined based on the change in the ratio of the signal intensity at 525 nm and 545 nm in their emission spectrum. The second photoluminescent material can include benzo[a]porphyrin-based metal complexes (such as...). Figure 9B As shown, for example, 635 nm excitation light can be transmitted to it via a second sensing fiber, and then the change in oxygen concentration in the microenvironment can be determined based on the change in its emission intensity, and the third photoluminescent material may include polymethyl cyanine dye derivatives (such as... Figure 9C As shown, for example, excitation light at 635 nm and 680 nm can be transmitted to it via a third sensing fiber, and the change in pH can be determined based on the change in the ratio of the emission intensities under the two excitation conditions. (Reference) Figure 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%.

[0065] 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.

[0066] In some embodiments, the interventional needle 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 (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 optic interface, and the desired light can be easily coupled into each rear fiber end face. It is understandable that, although... Figure 11 The fiber optic interface is illustrated as having a circle, but this is merely exemplary and not limiting; the fiber optic interface can have any suitable shape. In some examples, the rear fiber end faces of the fiber optic cables for emitting light can be arranged together at the fiber optic interface, and the rear fiber end faces of the fiber optic cables for receiving light can be arranged together to allow light to be input to and output from the fiber optic cable of the insertion needle.

[0067] In some embodiments, the needle body 102 may have a hollow structure to provide a working channel inside the needle body 102, the working channel being configured to perform at least one of the following operations: delivering medication (e.g., medication for treatment / hemostasis); delivering cleaning fluid (e.g., saline solution for cleaning dirt / washing wounds); aspirating waste fluid (e.g., dirty cleaning fluid, spilled blood, etc.); receiving 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 also includes an inner needle 110 removably disposed within the working channel 102-4 of the needle body 102. The inner needle 110 can be made of any suitable material, such as biomedical metallic materials, including but not limited to one or more of stainless steel, synthetic fibers, carbon fibers, titanium alloys, gold, and silver. The inner needle 110 can 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 can 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 can 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.

[0068] 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, the one or more imaging fiber bundles 112 extending longitudinally along the central axis 110-0 of the inner needle 110 and having 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, so as to image the target site based on the imaging response light. The imaging response light may be reflected light (e.g., direct imaging) or emitted light (e.g., fluorescence imaging) derived from the imaging probe light. Such an inner needle 110 may be referred to as an imaging inner needle. The imaging fiber bundles of the imaging inner needle 110 may not have sensing functionality and may only be used for real-time in-situ imaging. The imaging fiber bundle 112 may comprise multiple bundled optical fibers, which may be thicker than the aforementioned sensing fiber but thinner than the navigation fiber bundle. Commercially available imaging fiber bundles may be used in the imaging inner needle 110. In some embodiments, the imaging fiber bundle of the imaging inner needle 110 may be, for example, a near-infrared imaging fiber bundle, and the imaging probe light may, for example, include light with a wavelength of 1064 nm. It is understood that imaging probe light in other wavelength ranges is also feasible. The imaging inner needle 110 may, for example, be a modified 22G (international standard needle specification) non-invasive needle, employing wide-angle retinal technology and beam shaping technology to optically reconstruct imaging of the target site, and can be used for real-time tissue microstructure imaging in ultra-fine regions. In some embodiments, each imaging fiber bundle 112 may be configured to individually emit imaging probe light toward the target site in vivo and receive imaging response light from the target site, i.e., each imaging fiber bundle has both light emission and light reception functions. In some embodiments, a portion of the one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within the living body, while another portion may be configured to receive imaging response light from the target site; that is, the light emission and light reception functions are performed by different imaging fiber bundles. These imaging fiber bundles 112 can be arranged in any suitable manner, for example, in an array, such as... Figure 13 As shown.

[0069] 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 site. 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, so as to determine the corresponding parameter of the microenvironment within the target site based on the emitted light of the photoluminescent material. The sensing fiber 116 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 14The 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.

[0070] In some embodiments, the inner needle 110 can be configured to perform thermal ablation on the target site. Such an inner needle can be referred to as a thermal ablation inner needle. 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 15A As shown, the thermal ablation inner needle 110 may include one or more sets of temperature sensing optical fibers 1161 arranged within the inner needle 110, the one or more sets of temperature sensing optical fibers 1161 extending longitudinally along the central axis 110-0 of the inner needle 110. Further reference Figure 15BEach of the one or more sets of temperature-sensing optical fibers 1161 has a front fiber end face 1161-1 located at a corresponding cross-section (as shown by dashed lines A, B, C, D, E, F) of the inner needle 110 between the front end face 110-1 and the rear end face 110-2. Each of the one or more sets of temperature-sensing optical fibers 1161 can be used to sense the temperature of the microenvironment inside the target site. Each temperature-sensing optical fiber 1161 in each set of temperature-sensing optical fibers 1161 may include a probe with a photoluminescent material located at its front fiber end face 1161-1, the photoluminescent material being configured to have an emission spectrum that varies with temperature. Each temperature-sensing optical fiber in each of the one or more sets of temperature-sensing optical fibers 1161 is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine the temperature of the microenvironment inside the target site based on the emitted light of the photoluminescent material. The output power of the thermal ablation inner needle can be controlled based on the determined temperature, thereby stabilizing the microenvironment temperature of the target area near the desired temperature. The temperature sensing fiber 1161 can be similar to the aforementioned first sensing fibers 1061a and 1161a used for temperature sensing, and will not be described again 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 a group of temperature sensing fibers 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, as... Figure 15B As shown, the density of temperature-sensing optical fibers at cross-section C is greater than that at cross-section D. Since the thermal conductivity of the material forming the inner needle 110 is generally good, the front fiber end face of the temperature-sensing optical fiber does not necessarily need to be exposed on the surface of the inner needle 110, but can be located inside the inner needle 110. Furthermore, the thermal ablation inner needle 110 can also be modified based on a 22G non-invasive needle, thereby allowing needle placement at multiple important sites during thermal ablation to form a thermal ablation temperature monitoring circle, guiding the efficient execution of the thermal ablation procedure. When monitoring reveals that a lesion does not meet the temperature requirements for thermal ablation, the thermal ablation inner needle can be replaced with the previously selected... 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.

[0071] It is understandable that the above combination Figure 13 , Figure 14 , Figure 15A and Figure 15BThe 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.

[0072] According to various embodiments of this disclosure, the interventional needles can utilize in-situ real-time optical navigation to guide the needle insertion process. They can also use photoluminescence probes to sensitively monitor in-situ in real-time and extract, with high fidelity, the values ​​and distribution of parameters such as temperature, oxygen concentration, and pH within the microenvironment and target site within the living body. This allows for timely feedback on the treatment intensity and effectiveness of therapies such as thermotherapy and chemotherapy, enabling physicians to adjust treatment strategies promptly. Furthermore, the navigation fiber bundle, imaging fiber bundle, and various sensing fibers of the interventional needles according to various embodiments of this disclosure are all arranged within the needle body or inner needle. Therefore, they can enter the living body through the interventional channel of the needle and are protected by the needle, thereby transmitting optical signals caused by subtle changes in the microenvironment to external analytical devices while resisting interference from biological tissues.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] While specific embodiments of this disclosure have been described in detail by way of example, those skilled in the art should understand that the examples are for illustrative purposes only and not intended to limit the scope of this disclosure. The various embodiments disclosed herein can be combined in any way without departing from the spirit and scope of this disclosure. Those skilled in the art should also understand that various modifications can be made to the embodiments without departing from the scope and spirit of this disclosure. The scope of this disclosure is defined by the appended claims.

Claims

1. An interventional needle, comprising: The needle body is configured to allow for percutaneous intervention in living tissue; as well as 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 site within the living body and receive navigation response light from the target site, so as 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 among the plurality of navigation fiber bundles. 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. The first navigation fiber bundles in the plurality of first navigation fiber bundles and 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, such that: When the navigation response light from the target location is a reflection of the navigation detection light from the target location, the signal intensity of the navigation response light at the first navigation fiber bundle is stronger than that at the second navigation fiber bundle, indicating that the needle insertion direction of the needle body deviates from the center direction of the target location toward the direction where the first navigation fiber bundle is located relative to the central axis of the needle body; 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 signal intensity of the navigation response light is stronger at the first navigation fiber bundle than at the second navigation fiber bundle, indicating that the needle insertion direction of the needle body deviates from the center direction of the target site toward the direction where the second navigation fiber bundle is located relative to the central axis of the needle body. 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 needle 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 needle 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 the target site within the living body and receive navigation response light from the target site. Each of the plurality of navigation fiber bundles has an objective lens of similar size attached to its front fiber end face.

4. The interventional needle according to claim 3, wherein, 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.

5. The interventional needle according to claim 1, in, The plurality of navigation fiber bundles include a first set of navigation fiber bundles for emitting navigation detection 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 second group of navigation fiber bundles is arranged in the needle body in a rotationally symmetrical manner about the central axis of the needle body. The second group of navigation fiber bundles includes at least two navigation fiber bundles, and each navigation fiber bundle in the second group of navigation fiber bundles has an objective lens of equivalent size attached to its front fiber end face.

6. The interventional needle according to claim 5, in, 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, and / or Wherein, 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, and / or 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.

7. The interventional needle according to claim 1, wherein, The front end face of the needle body includes a slope extending along the perimeter of the needle body, the diameter of the front edge of the slope is smaller than the diameter of the rear edge of the slope, and the front fiber end faces of the plurality of navigation fiber bundles are located at the slope of the front end face of the needle body.

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

9. The interventional needle according to claim 8, wherein, Each of the one or more sets of sensing optical fibers is arranged in the needle body in a rotationally symmetrical manner about the central axis of the needle body.

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

11. The interventional needle according to claim 10, wherein, The first photoluminescent material includes Er 3+ The doped rare-earth upconversion nanoparticles, the second photoluminescent material includes benzoporphyrin-type metal complexes, and the third photoluminescent material includes polymethyl cyanine dye derivatives.

12. The interventional needle according to claim 8, further comprising: 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. The multiple navigation fiber bundles and the rear fiber end faces of the one or more sets of sensing fibers are arranged at the fiber interface according to a predetermined pattern.

13. The interventional needle according to claim 1, wherein, The needle body has a hollow structure to provide a working channel inside the needle body, the working channel being configured to perform at least one of the following operations: delivering a drug; aspirating waste liquid; delivering a cleaning solution; receiving an inner needle.

14. The interventional needle of claim 13 further comprises 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.

15. The interventional needle according to claim 14, 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 site within the living body and receive imaging response light from the target site, so as to image the target site based on the imaging response light.

16. The interventional needle according to claim 14, 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. In this embodiment, each of the one or more sets of sensing optical fibers is used to sense a corresponding parameter of the microenvironment inside the target area. Each sensing optical fiber in each set includes a probe with photoluminescent material located at its front fiber end face. The photoluminescent material is configured to have an emission spectrum that varies with the corresponding parameter. Each sensing fiber in one or more sets of sensing fibers is configured to transmit excitation light toward the photoluminescent material of the probe and receive emitted light from the photoluminescent material, so as to determine a corresponding parameter of the microenvironment inside the target site based on the emitted light of the photoluminescent material.

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

18. The interventional needle according to claim 16, wherein, Each of the one or more sets of sensing optical fibers is arranged rotationally symmetrically within the inner needle about the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting a chemical ablation drug into the target site.

19. The interventional needle according to claim 14, 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, so as to determine the temperature of the microenvironment inside the target part based on the emitted light of the photoluminescent material.

20. The interventional needle according to claim 19, 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.

21. The interventional needle according to claim 1, further comprising 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. in, The additional navigation fiber bundle is configured to emit additional navigation probe light into the living body and receive additional navigation response light from the additional navigation probe light, so as to locate and distinguish undesirable sites within the living body that are not intended to be penetrated by the interventional needle based on the additional navigation response light.

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