CN218009895U - Interventional needle - Google Patents

Interventional needle Download PDF

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CN218009895U
CN218009895U CN202221624409.7U CN202221624409U CN218009895U CN 218009895 U CN218009895 U CN 218009895U CN 202221624409 U CN202221624409 U CN 202221624409U CN 218009895 U CN218009895 U CN 218009895U
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navigation
needle
fiber
sensing optical
optical fibers
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李富友
王庆兵
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Shanghai Keyingkang Technology Co ltd
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Shanghai Keyingkang Technology Co ltd
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Abstract

The present disclosure relates to interventional needles. There is provided an interventional needle comprising: a needle body configured to be percutaneously insertable into a living body; and a plurality of navigation fiber bundles arranged in the needle body and extending longitudinally along a central axis of the needle body, 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 a deviation condition of a needle insertion direction of the needle body from a central direction of the target site based on a distribution condition of signal intensity of the navigation response light among the plurality of navigation fiber bundles.

Description

Interventional needle
Technical Field
The present disclosure relates to the field of medical devices, and more particularly, to an interventional needle suitable for use in interventional medicine.
Background
Interventional medicine is a technique of delivering an interventional instrument such as an interventional needle or a component thereof (such as, but not limited to, a percutaneous needle set) to a lesion site under imaging guidance for diagnosis and/or treatment thereof, and is currently in wide clinical use in the fields of tissue biopsy, tumor ablation, vascular embolization, fistula closure, and the like. The interventional needle usually enters a deeper position in the body of a patient, so a doctor operating the interventional needle often cannot directly see the situation in the body and can not timely and accurately grasp the transient condition of the patient in the body, so that reliable judgment and decision can not be made in real time, and further diagnosis and treatment during the interventional operation can not be efficiently performed.
SUMMERY OF THE UTILITY MODEL
The following presents a simplified summary of the disclosure in order to provide a basic understanding of some aspects of the disclosure. However, it should be understood that this summary is not an exhaustive overview of the disclosure. It is not intended to identify key or critical elements of the disclosure or to delineate the scope of the disclosure. Its sole purpose is to present some concepts of the disclosure in a simplified form as a prelude to the more detailed description that is presented later.
According to an aspect of the present disclosure, there is provided an interventional needle comprising: a needle configured to be percutaneously insertable into a living body; and a plurality of navigation fiber bundles arranged in the needle body and extending longitudinally along a central axis of the needle body, 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 a deviation condition of a needle insertion direction of the needle body from a central direction of the target site based on a distribution condition of signal intensity of the navigation response light among the plurality of navigation fiber bundles.
In some embodiments, the plurality of navigation fiber bundles are symmetrically disposed in the needle about the central axis of the needle.
In some embodiments, the navigation response light from the target site is a reflected light of the target site from the navigation probe light; or the navigation response light from the target site is an emission light emitted by the target site in response to absorption of the navigation probe light.
In some embodiments, the plurality of navigation fiber bundles are rotationally symmetrically disposed in the needle about the central axis of the needle, 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 attached at a front fiber end face thereof an objective lens of a size comparable to the navigation fiber bundle.
In some embodiments, the front face of the needle is shaped such that each of the plurality of navigation fiber bundles tends to emit navigation probe light to and receive navigation response light from a target site within the living body within a respective range of azimuthal angles relative to the central axis of the needle.
In some embodiments, the plurality of navigation fiber bundles includes 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, and the second set of navigation fiber bundles is arranged in the needle body rotationally symmetrically about the central axis of the needle body, the second set of navigation fiber bundles includes at least two navigation fiber bundles, each navigation fiber bundle of the second set of navigation fiber bundles having attached at a front fiber end face thereof an objective lens of a size comparable to the navigation fiber bundle.
In some embodiments, the first set of navigation fiber bundles is rotationally symmetrically distributed on a first circle about the central axis of the needle, 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, and/or one or more navigation fiber bundles from the first set of navigation fiber bundles are positioned adjacent to a respective one or more navigation fiber bundles from the second set of navigation fiber bundles, and/or the front end face of the needle is shaped such that each navigation fiber bundle of the second set of navigation fiber bundles tends to receive navigation response light from the target site within a respective range of azimuthal angles relative to the central axis of the needle.
In some embodiments, the front end face of the needle body includes a bevel extending along a perimeter of the needle body, a diameter of a front edge of the bevel is smaller than a diameter of a rear edge of the bevel, and the front fiber end faces of the plurality of navigation fiber bundles are located at the bevel of the front end face of the needle body.
In some embodiments, the interventional needle further comprises: one or more sets of sensing optical fibers arranged in the needle and extending longitudinally along a central axis of the needle such that a leading fiber end face of the one or more sets of sensing optical fibers is located at the leading end face of the needle, wherein each of the one or more sets of sensing optical fibers is for sensing a respective one of the parameters of the microenvironment inside the living body, each of the one or more sets of sensing optical fibers including a probe having a photoluminescent material at its leading fiber end face, the photoluminescent material being configured to have an emission spectrum that varies as a function of the respective one of the parameters, and wherein each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards and receive emission light from the photoluminescent material of the probe so as to determine the respective one of the parameters of the microenvironment inside the living body based on the emission light of the photoluminescent material.
In some embodiments, each set of the one or more sets of sensing fibers is each arranged in the needle rotationally symmetrically about the central axis of the needle.
In some embodiments, the one or more sets of sensing optical fibers comprise one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a ph of the microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in ph.
In some embodiments, the first photoluminescent material comprises Er 3+ Doped rare earth up-conversion nanoparticles, the second photoluminescent material comprises a benzoporphyrin-like metal complex, and the third photoluminescent material comprises a polymethine cyanine dye derivative.
In some embodiments, the interventional needle further comprises: and the optical fiber interface is arranged on the rear end face of the needle body or on a part of the side face of the needle body, which is close to the rear end face, wherein all the rear optical fiber end faces of the plurality of navigation optical fiber bundles and the one or more groups of sensing optical fibers are arranged at the optical fiber interface according to a preset rule.
In some embodiments, the needle body has a hollow structure to provide a working channel inside the needle body, the working channel configured to perform at least one of the following operations: delivering the drug; pumping waste liquid; conveying the cleaning solution; receiving the inner needle.
In some embodiments, the interventional needle further comprises an inner needle removably disposed within the working channel of the needle body, the inner needle operable to access inside the target site when the needle body is navigated at or near the target site.
In some embodiments, the inner needle comprises one or more imaging fiber bundles arranged in the inner needle, the one or more imaging fiber bundles extending longitudinally along a central axis of the inner needle and having a front fiber end face located at or near the front end face of the inner needle, each of the one or more imaging fiber bundles having attached at its front fiber end face a fisheye lens of comparable size to the imaging fiber bundle, wherein the one or more imaging fiber bundles are configured to emit imaging probe light towards a target site within the living body and to receive imaging response light from the target site so as to image the target site based on the imaging response light.
In some embodiments, the inner needle comprises one or more sets of sensing optical fibres arranged in the inner needle, the one or more sets of sensing optical fibres extending longitudinally along a central axis of the inner needle and having a leading optical fibre end face located at or near the leading end face of the inner needle, wherein each of the one or more sets of sensing optical fibres is for sensing a respective one of the parameters of the microenvironment inside the target site, each of the one or more sets of sensing optical fibres comprising a probe having a photoluminescent material at its leading optical fibre end face, the photoluminescent material being configured to have an emission spectrum that varies with variation of the respective one of the parameters, and wherein each of the one or more sets of sensing optical fibres is configured to transmit excitation light towards the photoluminescent material of the probe and to receive emission light from the photoluminescent material so as to determine the respective one of the parameters of the microenvironment inside the target site based on the emission light of the photoluminescent material.
In some embodiments, the one or more sets of sensing optical fibers comprise one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the target site, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing a ph of a microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in the ph.
In some embodiments, each of the one or more sets of sensing fibers is each arranged in the inner needle rotationally symmetrically about the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting a chemical ablation drug to the target site.
In some embodiments, the inner needle is configured for thermal ablation of the target site and comprises one or more sets of temperature sensing optical fibers arranged therein, the one or more sets of temperature sensing optical fibers extending longitudinally along a central axis of the inner needle, and a front fiber end face of each of the one or more sets of temperature sensing optical fibers being located at a respective one of cross-sections of the inner needle between the front end face and the rear end face, wherein each of the one or more sets of temperature sensing optical fibers is for sensing a temperature of a microenvironment inside the target site, each of the one or more sets of temperature sensing optical fibers comprising a probe head having a photoluminescent material at a front fiber end face thereof, the photoluminescent material being configured to have an emission spectrum that varies with temperature, and wherein each of the one or more sets of temperature sensing optical fibers is configured to transmit excitation light temperature sensing optical fibers towards the photoluminescent material microenvironment of the probe head and to receive emission light from the photoluminescent material so as to determine a temperature of the emission light inside the target site based on the photoluminescent material.
In some embodiments, a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers is closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, and a temperature sensing optical fiber density of the first set of temperature sensing optical fibers is greater than a temperature sensing optical fiber density of the second set of temperature sensing optical fibers, the temperature sensing optical fiber density being a ratio of a number of one set of temperature sensing optical fibers to an area of the inner needle cross-section where the front fiber end face of the set of temperature sensing optical fibers is located.
In some embodiments, the interventional needle further comprises an additional navigation fiber bundle arranged 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 interior of the living body and receive additional navigation response light originating from the additional navigation probe light in order to localize and distinguish a site of the interior of the living body which is not intended to be penetrated by the interventional needle based on the additional navigation response light.
Other features of the present disclosure and advantages thereof will become more apparent from the following detailed description of exemplary embodiments thereof, which proceeds with reference to the accompanying drawings.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description, serve to explain the principles of the disclosure. The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the disclosure. The following detailed description of exemplary embodiments can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:
fig. 1 is a top view schematically illustrating an interventional needle according to one or more exemplary embodiments of the present disclosure;
FIG. 2 is a side view of the access needle of FIG. 1;
fig. 3 is a diagram schematically illustrating the structure of a navigation fiber bundle in an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 4A-4D schematically illustrate several example arrangements of navigation fiber bundles of an interventional needle, respectively, according to one or more example embodiments of the present disclosure;
fig. 5A and 5B schematically show a partial side view of a front end of a body of an interventional needle according to one or more exemplary embodiments of the present disclosure, and fig. 5C schematically shows a top view of an interventional needle according to one or more exemplary embodiments of the present disclosure, respectively;
fig. 6 is a top view schematically illustrating an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 7 is a top view schematically illustrating an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 8 is a diagram schematically illustrating the structure of a sensing fiber in an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 9A-9C illustrate several example photoluminescent materials used by a probe of a sensing fiber in an interventional needle of one or more example embodiments of the present disclosure;
fig. 10 is a perspective view schematically illustrating an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 11 is a plan view schematically illustrating a fiber optic interface of an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 12 is a side view schematically illustrating an interventional needle according to one or more exemplary embodiments of the present disclosure;
fig. 13 is a top view schematically illustrating an example inner needle of an interventional needle according to one or more example embodiments of the present disclosure;
fig. 14 is a top view schematically illustrating another example inner needle of an interventional needle according to one or more example embodiments of the present disclosure;
fig. 15A and 15B are top and side views, respectively, schematically illustrating yet another example inner needle of an interventional needle according to one or more example embodiments of the present disclosure.
Detailed Description
Various exemplary embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. It should be noted that: the relative arrangement of parts and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present disclosure unless specifically stated otherwise.
The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. That is, the structures and methods herein are shown by way of example to illustrate different embodiments of the structures and methods of the present disclosure. Those skilled in the art will understand, however, that they are merely illustrative of exemplary ways in which the disclosure may be practiced and not exhaustive. Furthermore, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components.
Additionally, techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification as appropriate.
In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values.
When a doctor is performing an interventional treatment on a patient, the doctor needs to first deliver an interventional needle to a target site (for example, a lesion such as a tumor) in the patient, and then to diagnose and treat the target site. However, the conventional interventional medical treatment technology guides a doctor to deliver an interventional needle to the vicinity of a target site by means of imaging (for example, ultrasonic imaging, etc.), and thereafter the doctor can grasp the needle insertion direction and position of the interventional needle relative to the target site only by experience and hand feeling. In addition, the existing interventional diagnosis and treatment technology cannot image the target part in situ and in real time and monitor the microenvironment conditions inside and outside the target part, so that useful reference information cannot be provided for the instant diagnosis and treatment decision of doctors.
Therefore, the present disclosure provides an interventional needle which may have an optical real-time navigation function to efficiently guide an insertion process of the interventional needle, may facilitate the interventional needle to enter a target site in a desired insertion direction and position, and may avoid important parts such as blood vessels and organs which need to be protected while the interventional needle reaches the target site through percutaneous insertion into a living body. Moreover, the interventional needle disclosed by the invention can also have a microenvironment in-situ real-time sensing function, can sense various parameters of the microenvironment outside and inside the target part and distribution conditions thereof in vivo in situ and in real time in the process of the interventional needle entering the living body to the target part through the skin and in the process of the interventional needle after entering the target part, and provides a great deal of useful reference information for the instant diagnosis and treatment decision of doctors. An interventional needle according to various embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. It will be appreciated that other components may be present in an actual interventional needle and are not shown in the drawings and discussed herein in order to avoid obscuring the gist of the present disclosure. It should also be noted that, in this document, when referring to "front" it means a side close to the target site and away from the operator (usually a doctor), and when referring to "rear" it means a side away from the target site and close to the operator.
Fig. 1 and 2 schematically illustrate an interventional needle 100 according to one or more exemplary embodiments of the present disclosure, wherein fig. 1 is a top view illustrating the interventional needle 100 as viewed from front to back, and fig. 2 is a side view illustrating the interventional needle 100 as viewed in a direction perpendicular to the front-to-back direction.
As shown in fig. 1 and 2, access needle 100 may include a needle body 102. The needle body 102 can be configured to enable percutaneous access to a living subject (e.g., a human or animal body) and has an anterior face 102-1 and a posterior face 102-2 opposite the anterior face 102-1. The needle body 102 may be constructed of any suitable material, such as biomedical metal materials, including but not limited to one or more of stainless steel, synthetic fibers, carbon fibers, titanium alloys, gold, silver, and the like. It is to be appreciated that while fig. 1 illustrates the cross-sectional shape of the needle body 102 as circular, this is merely exemplary and not limiting and the needle body 102 can have any suitable cross-sectional shape.
The interventional needle 100 may also include a plurality of navigation fiber bundles 104. Each navigation fiber bundle 104 may include a plurality of optical fibers bundled. The plurality of navigation fiber bundles 104 are disposed in the needle body 102 and extend longitudinally along a central axis 102-0 of the needle body 102. For example, as shown in fig. 1, interventional needle 100 includes eight navigation fiber bundles 104a-104h, but this is merely exemplary and not limiting and interventional needle 100 may include any suitable number of navigation fiber bundles 104. Referring to fig. 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 fig. 2 only shows schematically in dashed lines a part of some navigation fiber bundles 104 arranged in the needle body 102.
The plurality of navigation fiber bundles 104 may be configured to emit navigation probe light toward a target site within a living body and receive navigation response light from the target site, so as to determine a deviation of the needle insertion direction of the needle body 102 from a center direction of the target site based on a distribution of signal intensities of the navigation response light among the plurality of navigation fiber bundles 104.
In some embodiments, the navigation response light from the target site may be a reflected light of the navigation probe light by the target site. In some examples, the wavelength range of the navigation probe light may be determined for a characteristic absorption spectral property of the target site. For example, assuming that the target site has an absorption peak at the position of the first wavelength, the navigation probe light including the first wavelength may be emitted to the target site via the navigation fiber bundle 104, and then the signal intensity of the received navigation response light at the position of the first wavelength is analyzed. If the signal intensity of the navigation response light at the position of the first wavelength is distributed among the plurality of navigation fiber bundles 104 in a manner that the signal intensity is stronger at the navigation fiber bundles 104b, 104c, 104d, 104e than at the navigation fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is lower relative to the center direction of the target portion; if the signal intensity of the navigation response light at the position of the first wavelength is distributed among the plurality of navigation fiber bundles 104 in a manner that the signal intensity is weaker at the navigation fiber bundles 104b, 104c, 104d, 104e than at the navigation fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is on the upper side with respect to the center direction of the target portion; if the signal intensity of the navigation response light at the first wavelength is distributed among the plurality of navigation fiber bundles 104 in a manner that the signal intensity is stronger at the navigation fiber bundles 104h, 104a, 104b, 104c than at the navigation fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is more right with respect to the center direction of the target portion; if the signal strength of the navigation response light at the position of the first wavelength is distributed among the plurality of navigation fiber bundles 104 in such a way that it is weaker at the navigation fiber bundles 104h, 104a, 104b, 104c than at the navigation fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is to the left with respect to the center direction of the target site; if the signal intensity of the navigation response light at the first wavelength is uniformly distributed among the plurality of navigation fiber bundles 104a to 104h, it can be said that the needle insertion direction of the needle body 102 is not deviated from the central direction of the target portion. By analogy, the deviation of the needle insertion direction of the needle body 102 from the central direction of the target site can be determined based on the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles 104, so as to assist the doctor to adjust the needle insertion direction of the needle body 102 in time, and the needle insertion direction of the needle body 102 can be determined not to deviate from the central direction of the target site when the signal intensity of the navigation response light is uniformly distributed among the plurality of navigation fiber bundles 104. In some examples, if the target site has absorption peaks at the locations of the plurality of wavelengths, navigation probe light including at least two wavelengths of the plurality of wavelengths may be emitted to the target site via the navigation fiber bundle 104, and then a distribution of absolute or relative values of signal intensities of the received navigation response light at the locations of the at least two wavelengths among the plurality of navigation fiber bundles 104 is analyzed. This may help to determine more accurately the deviation of the needle insertion direction of the needle body 102 with respect to 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.
In some embodiments, the navigation response light from the target site may be an emission light emitted by the target site in response to absorption of the navigation probe light. In some examples, the target site may be enriched with the photoluminescent material in advance by injection or the like, and then the navigation probe light including the excitation wavelength of the photoluminescent material may be emitted to the target site via the navigation fiber bundle 104, and then the signal intensity of the received navigation response light at the position of the emission wavelength of the photoluminescent material is analyzed. In the case of liver tumor diagnosis, the intervention of the tumor-bearing liver by a doctor is usually required, and a photoluminescent material, such as Indocyanine Green (ICG) dye, which is clinically approved, is generally injected before the operation. In this way, during the course of the interventional needle advancing to the liver tumor, 730nm navigation probe light can be emitted via the navigation fiber bundle for exciting the ICG dye enriched in the liver tumor to emit light, and then the signal intensity of the received navigation response light at the position of the emission wavelength of the ICG dye is analyzed. If the signal intensity of the navigation response light at the position of the emission wavelength is distributed among the plurality of navigation fiber bundles 104 in a manner that the signal intensity is stronger at the navigation fiber bundles 104b, 104c, 104d, 104e than at the navigation fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is higher relative to the central direction of the target site; if the signal strength of the navigation response light at the position of the emission wavelength is distributed among the plurality of navigation fiber bundles 104 such that it is weaker at the navigation fiber bundles 104b, 104c, 104d, 104e than at the navigation fiber bundles 104f, 104g, 104h, 104a, it can be said that the needle insertion direction of the needle body 102 is lower with respect to the central direction of the target site; if the signal strength of the navigation response light at the position of the emission wavelength is distributed among the plurality of navigation fiber bundles 104 such that it is stronger at the navigation fiber bundles 104h, 104a, 104b, 104c than at the navigation fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is to the left with respect to the center direction of the target site; if the signal intensity of the navigation response light at the position of the emission wavelength is distributed among the plurality of navigation fiber bundles 104 in a manner that the signal intensity is weaker at the navigation fiber bundles 104h, 104a, 104b, 104c than at the navigation fiber bundles 104d, 104e, 104f, 104g, it can be said that the needle insertion direction of the needle body 102 is more right with respect to the center direction of the target site; if the signal intensity of the navigation response light at the position of the emission wavelength is uniformly distributed among the plurality of navigation fiber bundles 104a to 104h, it can be said that the needle insertion direction of the needle body 102 is not deviated from the central direction of the target site. In some examples, if the target site has emission peaks at the locations of the plurality of wavelengths, the distribution of the absolute or relative values of the signal intensity of the received navigation response light at the locations of at least two of the plurality of wavelengths among the plurality of navigation bundles 104 may be analyzed. This may help to determine more accurately the deviation of the needle insertion direction of the needle body 102 with respect to the central direction of the target site based on the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles 104.
Thus, the interventional needle 100 realizes an optical real-time navigation function through the navigation fiber bundle 104, which not only helps the doctor to navigate the interventional needle 100 to the vicinity of the target site, but also helps the doctor to confirm whether the insertion direction and position of the interventional needle are proper.
In addition, the navigation fiber bundle 104 can also be used to locate and distinguish important parts in the living body, such as blood vessels and organs, which are not expected to be penetrated by the interventional needle 100, so as to avoid surgical accidents. For example, the navigation fiber bundle 104 may also be configured to emit additional navigation probe light into the living body and receive additional navigation response light derived from the additional navigation probe light, so as to locate and distinguish a portion or important portion of the living body interior that is not expected to be penetrated by the interventional needle 100 based on the additional navigation response light. In some embodiments, the additional navigation response light may be an emission light emitted by the significant portion in response to absorption of the additional navigation probe light, e.g. different significant portions may be enriched in advance by means of injection or the like with different photoluminescent materials having different emission spectra. In some embodiments, the additional navigation response light may be a reflected light of the important part to the additional navigation probe light, e.g. different important parts may have different absorption spectra. The additional navigation probe light including the absorption wavelength unique to each important part can be emitted in turn through the navigation fiber bundle 104 in a polling manner so as to perform location identification on each important part in turn, and the additional navigation probe light including a plurality of absorption wavelengths common to a plurality of important parts can be emitted through the navigation fiber bundle 104 and the relative values of the signal intensities of the received additional navigation response light at the plurality of absorption wavelengths can be analyzed so as to perform location identification on each important part. For example, for a venous blood vessel and an arterial blood vessel (both of which are significantly different in color), 680nm and 850nm additional navigation probe light may be alternately emitted via the navigation fiber bundle 104, since the venous blood vessel has a first ratio of the absorption intensity at 680nm to the absorption intensity at 850nm, and the arterial blood vessel has a second ratio of the absorption intensity at 680nm to the absorption intensity at 850nm, which is different from the first ratio, whereby it is possible to judge whether it is a venous blood vessel or an arterial blood vessel based on the ratio of the signal intensity at 680nm to the signal intensity at 850nm of the additional navigation response light, and guide the doctor to avoid them when operating the interventional needle 100.
The function of navigating the interventional needle to the target site and the function of avoiding the interventional needle from the important site may be alternately performed by causing the navigation fiber bundles 104 to alternately emit the navigation probe light and the additional navigation probe light, and some of the navigation fiber bundles 104 (e.g., navigation fiber bundles 104a, 104c, 104e, 104 g) may also be caused to perform the function of navigating the interventional needle to the target site and other of the navigation fiber bundles 104 (e.g., navigation fiber bundles 104b, 104d, 104f, 104 h) may be caused to perform the function of avoiding the important site. In some embodiments, the navigation fiber bundles 104a-104h may be made to perform only the function of navigating the interventional needle to the target site, and additionally include additional navigation fiber bundles to perform the function of avoiding the interventional needle from a significant site. For example, referring to fig. 6, the interventional needle 100 may further comprise additional navigation fiber bundles (e.g. four additional navigation fiber bundles 105 in fig. 6) arranged in the needle body 102, the additional navigation fiber bundles 105 extending longitudinally along the central axis 102-0 of the needle body and having an anterior fiber end face 105-1 located at the anterior end face 102-1 of the needle body 102. The additional navigation fiber bundle 105 may be configured to emit additional navigation probe light into the interior of the living body and to receive additional navigation response light originating from the additional navigation probe light in order to locate and distinguish a site in the interior of the living body which is not intended to be penetrated by the interventional needle 100 based on the additional navigation response light. The embodiment of the arrangement of the additional navigation fiber bundle 105 can be similar to the embodiment of the arrangement of the navigation fiber bundle 104, and is not described in detail here.
Referring back to fig. 1, the plurality of navigation fiber bundles 104 may be arranged so as to determine a deviation of the needle insertion direction of the needle body 102 with respect to the center direction of the target site based on a distribution of signal intensities of the navigation response light among the plurality of navigation fiber bundles 104. As shown in fig. 1, in some embodiments, the plurality of navigation fiber bundles 104 may be symmetrically disposed in the needle 102 about a central axis 102-0 of the needle 102. The symmetrical distribution of the navigation fiber bundles may facilitate the determination of the deviation of the needle insertion direction of the needle body 102 with respect to the central direction of the target site based on the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles 104. The symmetrical distribution of the navigation fiber bundles may be an axisymmetric distribution, and more preferably may be a rotationally symmetrical distribution. In some embodiments, the plurality of navigation fiber bundles 104 may be arranged in the needle 102 rotationally symmetric about a central axis 102-0 of the needle 102, and each navigation fiber bundle 104 of the plurality of navigation fiber bundles 104 may be configured to individually emit navigation probe light toward a target site within a living body and receive navigation response light from the target site. As shown in fig. 1, the navigation fiber bundles 104a-104h are arranged rotationally symmetrically with respect to the central axis 102-0 of the needle body 102, i.e. each 45 ° rotation may move one navigation fiber bundle to a position where an adjacent navigation fiber bundle was previously located. Each of the navigation bundles 104a-104h has both light emitting and light receiving functions. In some embodiments, each navigation fiber bundle 104a-104h may have attached to its front fiber-optic endface 104-1 an objective lens of a size comparable to that of the navigation fiber bundle. The objective lens may be, for example, a micro objective lens having a diameter of about 0.3 mm. FIG. 3 shows an exemplary configuration of the navigation fiber bundle 104, the navigation fiber bundle 104 having a front fiber-optic end face 104-1 and a rear fiber-optic end face 104-2, and an objective lens 104-3 mounted on the front fiber-optic end face 104-1 for facilitating light collection by the navigation fiber bundle 104.
On the other hand, it is also possible to cause the light emitting function and the light receiving function to be performed by different navigation fiber bundles, respectively. 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 a living body and a second set of navigation fiber bundles for receiving navigation response light from the target site. That is, the first group of navigation fiber bundles is used to perform a light emitting function, and the second group of navigation fiber bundles is used to perform a light receiving function. For example, referring to fig. 4A, a first set of navigation fiber bundles may include navigation fiber bundles 104b, 104d, 104f, 104h (which may be referred to as transmit navigation fiber bundles for purposes of illustration and indicated by left-diagonal shading in the figure), while a second set of navigation fiber bundles may include navigation fiber bundles 104A, 104c, 104e, 104g (which may be referred to as receive navigation fiber bundles for purposes of illustration and indicated by right-diagonal shading in the figure). In some examples, the second set of navigation fiber bundles may be symmetrically arranged with respect to a central axis 102-0 of the needle body 102, such as rotationally symmetrically arranged in the needle body 102. The second set of navigation fiber bundles may include at least two navigation fiber bundles. Each navigation fiber bundle of the second set of navigation fiber bundles may have attached at its front fiber end face, for example, an objective lens of a size comparable to the navigation fiber bundle for facilitating light collection. The number and arrangement of the navigation bundles in the first set of navigation bundles may take any suitable configuration. For example, whether the configuration of the first group of navigation fiber bundles is proper can be simply judged as follows: the interventional needle is positioned in front of the reflecting mirror surface in a manner of being perpendicular to the reflecting mirror surface, the light with the same intensity is transmitted to each transmitting navigation fiber bundle in the first group of navigation fiber bundles, whether the emergent light intensity of each receiving navigation fiber bundle in the second group of navigation fiber bundles is the same or not is determined, and if yes, the configuration mode of the first group of navigation fiber bundles can be considered to be proper. In some examples, the first set of navigation fiber bundles may be configured such that the relative positional relationship of the receive navigation fiber bundles to the respective transmit navigation fiber bundles is the same between the respective receive navigation fiber bundles in the second set of navigation fiber bundles. In some examples, the first set of navigation fiber bundles may be distributed on a first circle rotationally symmetric about the central axis 102-0 of the needle body 102 and the second set of navigation fiber bundles may be distributed on a second circle concentric with the first circle rotationally symmetric about the central axis 102-0 of the needle body 102. The first circle may have the same diameter as the second circle (i.e., the first and second sets of navigation fiber bundles are rotationally symmetrically distributed on the same circle), for example, with reference to fig. 4A and 4B, or the first circle may have a larger or smaller diameter than the second circle, for example, with reference to fig. 4C and 4D, wherein the first and second circles are indicated by dotted lines in fig. 4A to 4D. In some embodiments, one or more transmit navigation fiber bundles from the first set of navigation fiber bundles may be positioned adjacent to a respective one or more receive navigation fiber bundles from the second set of navigation fiber bundles. For example, in fig. 4B, each receive navigation fiber bundle is positioned adjacent to a respective two transmit navigation fiber bundles; in FIG. 4C, four receive navigation fiber bundles are positioned adjacent to a respective one of the transmit navigation fiber bundles; in fig. 4D, each receiving navigation fiber bundle is positioned adjacent to a respective one of the transmitting navigation fiber bundles.
Additionally, in some embodiments, the front face 102-1 of the needle 102 can be shaped such that each navigation fiber bundle of the second set of navigation fiber bundles tends to receive navigation response light from the target site within a respective range of azimuthal angles relative to the central axis 102-0 of the needle 102. In some embodiments, the front 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 to a target site within a living body within a respective azimuthal 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 emitting and light receiving functionality, the front 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 to and receive navigation response light from a target site within a respective range of azimuthal angles relative to the central axis 102-0 of the needle body 102. The azimuthal plane may be understood as a plane parallel to the cross section of the interventional needle 100. In this way, it is advantageous that the distribution of the signal intensity of the navigation response light among the plurality of navigation fiber bundles more accurately reflects the deviation of the needle insertion direction of the needle body 102 with respect to the center direction of the target site. Fig. 5A-5C show several non-limiting exemplary shapes of the front face 102-1 of the needle body 102 shaped for this purpose.
In the example shown in FIG. 5A, the front face 102-1 of the needle body 102 includes a bevel 102-11 extending along the perimeter of the needle body 102, the front edge of the bevel 102-11 has a diameter that is smaller than the diameter of the rear edge of the bevel 102-11, and the front fiber end faces of the plurality of navigation fiber bundles 104 are located at the bevel 102-11 of the front face 102-1 of the needle body 102. For example, the front fiber end faces 104a-1, 104e-1 of the navigation fiber bundles 104a, 104e are shown in FIG. 5A at the bevel 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 surface of each navigation fiber bundle 104 distributed thereon is more prone to emit light into the space in the azimuth angle range opposite to the inclined surface portion of the navigation fiber bundle 104 and/or receive light from the space in the azimuth angle range opposite to the inclined surface portion of the navigation fiber bundle 104. The inclined surfaces 102-11 may be, for example, the sides of a truncated cone or the sides of a truncated pyramid or pyramid, or have any other suitable shape. Further, while FIG. 5A illustrates the bevel 102-11 as having a constant angle of inclination throughout the bevel 102-11, this is merely exemplary and not limiting, and the bevel 102-11 may also be configured to have a varying angle of inclination, e.g., may include a curved or bent face.
In the example shown in FIG. 5B, the front 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 disposed on the front face 102-1 of the needle body 102 around the boss 102-12. 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 prone to transmit light to and/or receive light from the space within the azimuth angle range subtended by the nearest boss-side portion of the navigation fiber bundle 104. The bosses 102-12 may be, for example, truncated or conical or truncated or pyramidal, or have any other suitable shape. For example, as further shown in fig. 5C, the boss 102-12 may have a plurality of radial protrusions that may separate the leading fiber end faces of the respective navigation fiber bundles 104 from one another such that the leading fiber end face of each navigation fiber bundle 104 is more prone to transmit light to and/or receive light from a space within an azimuthal range defined by two radial protrusions adjacent to that navigation fiber bundle 104. For example, the height of the radial protrusion may be constant or may decrease as the circumference of the needle body 102 is approached. Furthermore, the radial protrusion does not necessarily have to extend to the circumference of the needle body 102.
A number of embodiments have been described above with respect to the optical navigation function of the interventional needle 100. Various embodiments of an interventional needle with microenvironment in situ real time awareness functionality will be described below. As shown in fig. 7, in some embodiments the interventional needle 100 may alternatively or additionally also comprise one or more sets of sensing optical fibers 106, the one or more sets of sensing optical fibers 106 being arranged in the needle body 102 and extending longitudinally along the central axis 102-0 of the needle body 102 such that a 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 for direct contact with the microenvironment inside the living body. Each of the one or more sets of sensing optical fibers 106 may be for sensing a respective one of the parameters of the microenvironment inside the living body. Each sensing fibre of each set of sensing fibres may comprise a probe having a photoluminescent material at a front fibre end face thereof, the photoluminescent material being configured to have an emission spectrum which varies with a variation of the respective one parameter. Each sensing optical fiber of each of the one or more sets of sensing optical fibers may be configured to transmit excitation light towards the photoluminescent material of the probe and to receive emission light from the photoluminescent material in order to determine a respective one of the parameters of the microenvironment inside the living body based on the emission light of the photoluminescent material. In some embodiments, each of the one or more sets of sensing fibers 106 may be each symmetrically disposed in the needle 102 about the central axis 102-0 of the needle 102. The symmetrical arrangement of the sensing fibers may facilitate analysis of the distribution of parameters of the microenvironment. In some examples, the one or more sets of sensing fibers 106 may each be rotationally symmetrically distributed on a respective one or more concentric circles. In some examples, two or more of the one or more sets of sensing fibers 106 may be distributed on the same circle. In some embodiments, the one or more sets of sensing fibers 106 may be distributed on the same circle (as indicated by the dashed lines in fig. 7) as the plurality of navigation fiber bundles, or on different concentric circles. The sensing fiber may be, for example, a single fiber, which may be much thinner than the navigation fiber bundle.
In some embodiments, the one or more sets of sensing optical fibers may include one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, a probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a change in the oxygen concentration; and a third set of sensing optical fibers including one or more third sensing optical fibers for sensing a ph of a microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in the ph. For example, referring to FIG. 7, in contrast to FIG. 1, interventional needle 100 of FIG. 7 further includes a first set of sensing fibers 1061a-1061d for sensing temperature, a second set of sensing fibers 1062a-1062b for sensing oxygen concentration, and a third set of sensing fibers 1063a-1063b for sensing pH. As a non-limiting example, the first photoluminescent material may include Er 3+ Doped rare earth upconversion nanoparticles (core Er, as shown in FIG. 9A) 3+ The outer layer of the doped rare earth nano particle is coated with a shell layer to enhance the luminescence property, so that NaYF with a core-shell structure is formed 4 :Yb,Er@NaLuF 4 Up-converting the nanoparticles; for example, can be viaThe first sensing fiber transmits 980nm excitation light thereto and then determines a change in temperature in the microenvironment based on a change in the ratio of signal intensities at 525nm and 545nm in its emission spectrum), the second photoluminescent material may comprise a benzoporphyrin-like metal complex (as shown in fig. 9B, for example, 635nm excitation light may be transmitted thereto via the second sensing fiber and then a change in oxygen concentration in the microenvironment is determined based on a change in its emission intensity), and the third photoluminescent material may comprise a polymethine cyanine dye derivative (as shown in fig. 9C, for example, 635nm excitation light and 680nm excitation light may be transmitted thereto via the third sensing fiber and then a change in ph value may be determined based on a change in the ratio of emission intensities under both excitation light conditions). Referring to FIG. 8, the sensing fiber 106 can include a front fiber-optic endface 106-1 and a rear fiber-optic endface 106-2, with the probe 106-3 formed on the front fiber-optic endface 106-1. For example, the photoluminescent material and the polymer matrix material may be premixed, and then added into a cylindrical hollow mold to be cured and formed to obtain a probe, and then the probe is fusion-assembled at one end of the optical fiber to obtain the sensing optical fiber. The polymer matrix material can include, for example, polymethacrylic acid, polyethyleneimine, polyvinyl alcohol, etc., and the polymer material has good biocompatibility and can be organically fused with the optical fiber to form a thin layer to modify the surface of the optical fiber and realize biological functionalization. The sensing optical fiber prepared by the present disclosure may have excellent detection performance indexes, for example, temperature detection superior to ± 1 ℃ may be realized, oxygen concentration detection superior to ± 1%, and ph detection superior to ± 0.1.
Through the sensing optical fibers, the states and distribution conditions of various parameters of the local microenvironment of the living body where the front end surface of the needle body 102 is located can be obtained in situ and in real time, so that the method is beneficial to guiding doctors to make reliable diagnosis and treatment decisions in real time. For example, when the oxygen concentration is found to be too low, the physician cannot treat the tumor with photodynamic therapy, and needs to switch to other therapies.
In some embodiments, the access needle may further comprise a fiber optic interface, which may be provided on the rear end face 102-2 of the needle body 102 or on a portion of a side of the needle body 102 close to the rear end face 102-2. For example, fig. 10 shows a perspective view of one example of an access needle in which the fiber optic interface 102-3 is disposed on a portion of the side of the needle body 102 proximate the rear face 102-2. All rear fiber end faces of the plurality of navigation fiber bundles 104 (and additional navigation fiber bundles 105, if any) and the one or more sets of sensing fibers (if any) are arranged at the fiber interface 102-3 in a predetermined regular pattern. For example, all of the rear fiber end faces may be arranged at the fiber optic interface 102-3 in an array, as shown in FIG. 11, with the rear fiber end faces in the array belonging 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 in order from left to right and from top to bottom. With this arrangement, it is convenient to detect the signal from each rear fiber-optic endface by imaging the fiber-optic interface, and also to couple the desired light into each rear fiber-optic endface. It is to be appreciated that while fig. 11 illustrates the fiber optic interface as having a circular shape, this is merely exemplary and not limiting and the fiber optic interface may have any suitable shape. In some examples, the rear fiber end faces of the optical fibers for emitting light may be arranged together and the rear fiber end faces of the optical fibers for receiving light may be arranged together at the fiber interface to input light to and output light from the optical fibers of the interventional needle.
In some embodiments, the needle body 102 may have a hollow structure to provide a working channel inside the needle body 102, which may be configured to perform at least one of the following operations: delivery of drugs (e.g., drugs for treatment/hemostasis, etc.); delivering a cleaning fluid (e.g., physiological saline solution for cleaning dirt, sore surface, etc.); aspirating waste fluids (e.g., dirty wash fluid, spilled blood, etc.); receiving the inner needle. For example, referring to fig. 12, the needle body 102 is hollow to provide a working channel 102-4 therein. In the example of fig. 12, the access needle further comprises an inner needle 110 removably arranged within the working channel 102-4 of the needle body 102. The inner needle 110 may be constructed of any suitable material, such as a biomedical metallic material, including, but not limited to, one or more of stainless steel, synthetic fiber, carbon fiber, titanium alloy, gold, silver, and the like. The inner needle 110 may be formed of the same material as the needle body 102. The inner needle 110 is operable to access the interior of a target site as the needle body 102 is navigated at or near the target site. Generally, the needle body 102 may stop moving when moving to a position of about 2mm near the target site, and then the inner needle 110 may be inserted into the target site by pushing the inner needle 110. The inner needle 110 may be configured similarly to the various embodiments described above with respect to the needle body 102. The design of the inner needle 110 may also differ from the needle body 102 by some amount, taking into account practical clinical requirements and functional complementarity to the needle body 102. For example, in one aspect, considering that the inner needle 110 forms a nested structure with the needle body 102, when the needle insertion direction of the needle body 102 is determined by using the navigation fiber bundle in the needle body 102, the needle insertion direction of the inner needle 110 is also substantially determined accordingly, so that the navigation fiber bundle may not be additionally arranged on the inner needle 110 for navigation positioning of the inner needle 110; in another aspect, inner needle 110 can be designed to perform different functions for different treatment modes. Several example inner needles are described below in connection with fig. 13, 14, 15A, and 15B.
In some embodiments, as shown in FIG. 13, the inner needle 110 may include one or more imaging fiber bundles 112 disposed in the inner needle 110, the one or more imaging fiber bundles 112 extending longitudinally along a 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 attached at its front fiber end face 112-1 a fisheye lens of comparable size to the imaging fiber bundle. The one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within a living body and receive imaging response light from the target site to image the target site based on the imaging response light. The imaging response light may be reflected light (e.g., direct imaging) or emitted light (e.g., fluorescence imaging) from the imaging probe light. Such an inner needle 110 may be referred to as an imaging inner needle. The imaging fiber bundle of the imaging inner needle 110 may not have a sensing function and is only used for real-time in-situ imaging. The imaging fiber bundle 112 may include a bundled plurality of fibers, which may be thicker than the aforementioned sensing fibers but thinner than the navigation fiber bundle. Commercially available imaging fiber bundles can be used in the imaging inner needle 110. In some embodiments, the imaging fiber bundle of the imaging inner needle 110 may be, for example, a near infrared imaging fiber bundle, and the imaging probe light may include, for example, light having a wavelength of 1064 nm. It will be appreciated that other wavelength ranges of the imaging probe light are possible. The imaging inner needle 110 may be, for example, based on 22G (international standard needle gauge) non-invasive needle modification, which uses wide-angle retinal technology and beam shaping technology to perform optical reconstruction imaging on a target part, and can be used for real-time tissue microstructure imaging of a hyperfine region. In some embodiments, each imaging fiber bundle 112 may be configured to individually emit imaging probe light toward a target site within a living body and receive imaging response light from the target site, i.e., each imaging fiber bundle has both light emitting and light receiving functionality. In some embodiments, a portion of the one or more imaging fiber bundles 112 may be configured to emit imaging probe light toward a target site within a living body and another portion of the imaging fiber bundles may be configured to receive imaging response light from the target site, i.e., the light emitting function and the light receiving function are performed by different imaging fiber bundles. The imaging fiber bundles 112 may be arranged in any suitable manner, for example, in an array, as shown in fig. 13.
In some embodiments, as shown in FIG. 14, the inner needle 110 may include one or more sets of sensing fibers 116 disposed in the inner needle 110, the one or more sets of sensing fibers 116 extending longitudinally along the central axis 110-0 of the inner needle 110 and having a leading fiber end face 116-1 located at or near the leading end face 110-1 of the inner needle 110. Each of the one or more sets of sensing fibers 116 may be used to sense a respective one of the parameters of the microenvironment inside the target site. Each sensing optical fiber of each set of sensing optical fibers 116 may include a probe having a photoluminescent material at a front fiber end face 116-1 thereof, which photoluminescent material may be configured to have an emission spectrum that varies with a variation of the respective one parameter. Each sensing optical fiber of each of the one or more sets of sensing optical fibers 116 may be configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine the respective one of the parameters of the microenvironment inside the target site based on the emission light of the photoluminescent material. The sensing fiber 116 disposed in the inner needle 110 may be similar to the sensing fiber 106 disposed in the needle body 102, as previously described, and thus, a detailed description thereof may be omitted. Such an inner needle 110 may be referred to as an interventional inner needle. Since the needle 102 does not typically enter inside the target site, the sensing fibers 106 arranged in the needle 102 cannot sense parameters of the microenvironment inside the target site. While interventional inner needle 110 may penetrate into the target site, parameters of the local microenvironment inside the target site may be sensed in situ in real time with sensing fibers 116 disposed in interventional inner needle 110. In some embodiments, for example, with reference to fig. 14, the one or more sets of sensing fibers 116 may include one or more of: a first set of sensing optical fibers comprising one or more first sensing optical fibers 1161a-1161d for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature; a second set of sensing optical fibers comprising one or more second sensing optical fibers 1162a, 1162b for sensing oxygen concentration of the microenvironment inside the target site, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with variations in oxygen concentration; and a third set of sensing optical fibers comprising one or more third sensing optical fibers 1163a, 1163b for sensing the ph of the microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with the ph. In some examples, the interventional inner needle 110 may also be adapted based on a 22G non-invasive needle, and thus may be deployed at multiple sites in the living body based on the characteristics of the non-invasive needle, thereby providing a tool basis for studying microenvironment linkages or monitoring physiological conditions. In some embodiments, each set of sensing optical fibers 116 of the one or more sets of sensing optical fibers 116 may each be disposed in the interventional inner needle 110 symmetrically (e.g., rotationally symmetrically) about a central axis 110-0 of the interventional inner needle 110. The symmetrical arrangement of the sensing fibers may facilitate analysis of the distribution of parameters of the microenvironment. In some embodiments, the interventional inner needle 110 may also have a hollow channel 110-4, for example for injecting chemical ablation drugs (e.g., alcohol, etc.) to the target site for chemical ablation.
In some embodiments, the inner needle 110 may be configured for thermal ablation of the target site. Such an inner needle may be referred to as a thermal ablation inner needle. The thermal ablation inner needle 110 may be, for example, a radiofrequency ablation needle. Since temperature distribution monitoring is important during operation of the thermal ablation inner needle, as shown in fig. 15A, the thermal ablation inner needle 110 may include one or more sets of temperature sensing optical fibers 1161 arranged in the inner needle 110, the one or more sets of temperature sensing optical fibers 1161 extending longitudinally along the central axis 110-0 of the inner needle 110. With further reference to fig. 15B, the front fiber end face 1161-1 of each of the one or more sets of temperature sensing fibers 1161 is located at a respective one of the cross-sections (as indicated by dashed lines a, B, C, D, E, F) of the inner pin 110 from the front end face 110-1 to the rear end face 110-2. Each of the one or more sets of temperature sensing optical fibers 1161 may be used to sense the temperature of the microenvironment inside the target site. Each temperature sensing optical fiber 1161 in each set of temperature sensing optical fibers 1161 may include a probe head at its front optical fiber end face 1161-1 having a photoluminescent material that may be configured to have an emission spectrum that varies with temperature. Each temperature sensing optical fiber of each of the one or more sets of temperature sensing optical fibers 1161 is configured to transmit excitation light toward the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine a temperature of a microenvironment inside the target site based on the emission light of the photoluminescent material. The output power of the thermal ablation inner needle may be controlled based on the determined temperature to stabilize the microenvironment temperature of the target site around a desired temperature. The temperature sensing fiber 1161 may be similar to the first sensing fibers 1061a, 1161a for sensing temperature, and thus the description thereof is omitted here. In some embodiments, if a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers 1161 is closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, the temperature sensing optical fiber density of the first set of temperature sensing optical fibers may be greater than the temperature sensing optical fiber density of the second set of temperature sensing optical fibers. The temperature sensing optical fiber density refers to the ratio of the number of a group of temperature sensing optical fibers to the area of the cross section of the inner needle where the front optical fiber end face of the group of temperature sensing optical fibers is located. For example, as shown in fig. 15B, the temperature sensing fiber density at cross-section C is greater than the temperature sensing fiber density at cross-section D. Since the thermal conductivity of the material forming the inner needle 110 is generally good, the front fiber end face of the temperature sensing fiber does not have to be exposed to the surface of the inner needle 110, but may be located inside the inner needle 110. In addition, the thermal ablation inner needle 110 can also be adapted based on a 22G non-invasive needle, whereby the needle can be deployed at multiple important sites during the thermal ablation process, thereby forming a thermal ablation temperature monitoring loop to guide the efficient deployment of the thermal ablation procedure. When monitoring reveals that a lesion does not meet the temperature requirements for thermal ablation, the thermal ablation inner needle may be replaced with the interventional inner needle described previously with respect to fig. 14 and chemical ablation may be performed by injecting alcohol or the like through the hollow channel of the interventional inner needle.
It is to be understood that the above description in connection with fig. 13, 14, 15A and 15B are only a few non-limiting examples of the inner needle 110 that can be used in combination with the needle body 102. The inner needle 110 may be designed based on any embodiment or combination of the present disclosure according to actual needs. The inner needle 110 may be longer than the needle body 102, and an optical fiber interface may be similarly provided at the rear end surface 110-2 of the inner needle 110 or a portion of the side surface of the inner needle 110 near the rear end surface 110-2 for arranging the rear optical fiber end surfaces of the optical fibers in the inner needle 110 in a predetermined rule.
The interventional needle according to various embodiments of the present disclosure can guide the needle insertion process of the interventional needle by using the in-situ real-time optical navigation function, and can also sensitively monitor in-situ real-time by using the photoluminescence probe, extract the numerical values and distribution conditions of the parameters such as temperature, oxygen concentration, pH value and the like of the microenvironment in the living body and the target part in high fidelity by using the optical fiber, and feed back the treatment intensity and effect of the diagnosis and treatment means such as thermotherapy, chemotherapy and the like in time, so that a doctor can adjust the diagnosis and treatment strategy in real time. Furthermore, the navigation fiber bundle, the imaging fiber bundle and the various sensing fibers of the interventional needle according to various embodiments of the present disclosure are all disposed within the needle body or the inner needle, and thus may enter into a living body using an interventional channel of the interventional needle and be protected by the interventional needle, so that an optical signal caused by a slight change of a microenvironment may be transferred to an analysis apparatus outside the body, while interference of biological tissues with the optical signal may be resisted.
The terms "left," "right," "front," "back," "top," "bottom," "over," "under," "upper," "lower," and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments of the disclosure described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein. For example, features described as "above" other features may be described as "below" other features at this time when the device in the figures is turned upside down. The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the relative spatial relationships may be interpreted accordingly.
In the description and claims, an element being "on," "attached to," "connected to," coupled to, "or contacting" another element may be directly on, attached to, connected to, coupled to or contacting the other element or intervening elements may be present. In contrast, when an element is referred to as being "directly on," directly attached to, "directly connected to," directly coupled to "or" directly contacting "another element, there are no intervening elements present. In the description and claims, one feature may be "adjacent" another feature, and may mean that one feature has a portion that overlaps with or is above or below the adjacent feature.
As used herein, the word "exemplary" means "serving as an example, instance, or illustration," and not as a "model" that is to be reproduced exactly. Any implementation exemplarily described herein is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, the disclosure is not limited by any expressed or implied theory presented in the technical field, background, utility model content, or the detailed description.
As used herein, the term "substantially" is intended to encompass any minor variation resulting from design or manufacturing imperfections, device or component tolerances, environmental influences, and/or other factors. The word "substantially" also allows for differences from a perfect or ideal situation due to parasitics, noise, and other practical considerations that may exist in a practical implementation.
In addition, "first," "second," and like terms may also be used herein for reference purposes only, and thus are not intended to be limiting. For example, the terms "first," "second," and other such numerical terms referring to structures or elements do not imply a sequence or order unless clearly indicated by the context.
It will be further understood that the terms "comprises" and/or "comprising," when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
In the present disclosure, the term "providing" is used broadly to encompass all ways of obtaining an object, and thus "providing an object" includes, but is not limited to, "purchasing," "preparing/manufacturing," "arranging/setting," "installing/assembling," and/or "ordering" the object, and the like.
As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.
Those skilled in the art will appreciate that the boundaries between the above described operations merely illustrative. Multiple operations may be combined into a single operation, single operations may be distributed in additional operations, and operations may be performed at least partially overlapping in time. Moreover, alternative embodiments may include multiple instances of a particular operation, and the order of operations may be altered in various other embodiments. However, other modifications, variations, and alternatives are also possible. The aspects and elements of all embodiments disclosed above may be combined in any manner and/or in combination with aspects or elements of other embodiments to provide multiple additional embodiments. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.
Although some specific embodiments of the present disclosure have been described in detail by way of example, it should be understood by those skilled in the art that the foregoing examples are for purposes of illustration only and are not intended to limit the scope of the present disclosure. The various embodiments disclosed herein may be combined in any combination without departing from the spirit and scope of the present disclosure. It will also be appreciated by those skilled in the art that various modifications may be made to the embodiments without departing from the scope and spirit of the disclosure. The scope of the present disclosure is defined by the appended claims.

Claims (22)

1. An access needle, comprising:
a needle configured to be percutaneously insertable into a living body; and
a plurality of navigation fiber bundles disposed in the needle body and extending longitudinally along a central axis of the needle body, front fiber end faces of the plurality of navigation fiber bundles being located at a 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 a deviation condition of the needle insertion direction of the needle body from a center direction of the target site based on a distribution condition of signal intensity of the navigation response light among the plurality of navigation fiber bundles.
2. The access needle of claim 1, wherein the plurality of navigation fiber bundles are symmetrically disposed in the needle body about the central axis of the needle body.
3. The access needle of claim 1,
the navigation response light from the target site is a reflected light of the navigation probe light by the target site; or
The navigation response light from the target site is an emission light emitted by the target site in response to absorption of the navigation probe light.
4. The interventional needle of claim 1,
wherein the plurality of navigation fiber bundles are arranged in the needle body rotationally symmetrically about the central axis of the needle body,
wherein 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
wherein each of the plurality of navigation fiber bundles has attached at its front fiber end face an objective lens of a size comparable to the navigation fiber bundle.
5. The access needle of claim 4 wherein the front face of the needle body is shaped such that each of the plurality of navigation fiber optic bundles tends to emit navigation probe light to and receive navigation response light from a target site within the living body within a respective range of azimuthal angles relative to the central axis of the needle body.
6. The interventional needle of claim 1,
wherein the plurality of navigation fiber bundles includes 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, and
wherein the second set of navigation fiber bundles is arranged in the needle body in a rotational symmetric manner with respect to the central axis of the needle body, the second set of navigation fiber bundles comprises at least two navigation fiber bundles, and each navigation fiber bundle in the second set of navigation fiber bundles is attached with an objective lens having a size corresponding to the navigation fiber bundle at a front fiber end face thereof.
7. The access needle of claim 6,
wherein the first set of navigation fiber bundles is rotationally symmetrically distributed on a first circle about the central axis of the needle body, 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 set of navigation fiber bundles are positioned adjacent to a corresponding one or more navigation fiber bundles from the second set of navigation fiber bundles, and/or
Wherein the front face of the needle is shaped such that each navigation fiber bundle of the second set of navigation fiber bundles tends to receive navigation response light from the target site within a respective azimuthal range relative to the central axis of the needle.
8. The access needle of claim 1, wherein the front end face of the needle body includes a bevel extending along a perimeter of the needle body, a diameter of a front edge of the bevel is smaller than a diameter of a rear edge of the bevel, and the front fiber end faces of the plurality of navigation fiber bundles are located at the bevel of the front end face of the needle body.
9. The access needle of claim 1, further comprising:
one or more sets of sensing optical fibers disposed in the needle body and extending longitudinally along a central axis of the needle body such that forward fiber end faces of the one or more sets of sensing optical fibers are located at a forward end face of the needle body,
wherein each of the one or more sets of sensing optical fibers is for sensing a respective one of the parameters of the microenvironment inside the living body, each of the sensing optical fibers of the set includes a probe head having a photoluminescent material at a front fiber end face thereof, the photoluminescent material being configured to have an emission spectrum that varies as a function of the respective one of the parameters, and
wherein each sensing optical fiber of each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and to receive emission light from the photoluminescent material in order to determine the respective one of the parameters of the microenvironment inside the living body based on the emission light of the photoluminescent material.
10. The access needle of claim 9, wherein each of the one or more sets of sensing fibers are each disposed in the needle body rotationally symmetric about the central axis of the needle body.
11. The interventional needle of claim 9, wherein the one or more sets of sensing optical fibers comprise one or more of:
a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the living body, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature;
a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the living body, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and
a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a pH of a microenvironment inside the living body, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with a change in pH.
12. An interventional needle as defined in claim 11, wherein the first photoluminescent material comprises Er 3+ Doped rare earth up-conversion nanoparticles, the second photoluminescent material comprises a benzoporphyrin-like metal complex, and the third photoluminescent material comprises a polymethine cyanine dye derivative.
13. The access needle of claim 9, further comprising:
an optical fiber interface arranged on the rear end face of the needle body or on the part of the side face of the needle body close to the rear end face,
wherein all rear fiber end faces of the plurality of navigation fiber bundles and the one or more groups of sensing fibers are arranged at the fiber interface according to a predetermined rule.
14. The access needle of claim 1, wherein the needle body has a hollow structure to provide a working channel inside the needle body, the working channel configured to perform at least one of: delivering the drug; pumping waste liquid; conveying the cleaning solution; receiving the inner needle.
15. The access needle of claim 14, further comprising an inner needle removably disposed within the working channel of the needle body, the inner needle operable to access inside the target site when the needle body is navigated at or near the target site.
16. The interventional needle of claim 15, wherein the inner needle comprises one or more imaging fiber bundles disposed therein, the one or more imaging fiber bundles extending longitudinally along a central axis of the inner needle and having an anterior fiber end face located at or near the anterior end face of the inner needle, each of the one or more imaging fiber bundles having attached at its anterior fiber end face a fisheye lens of comparable size to the imaging fiber bundle,
wherein the one or more imaging fiber bundles are configured to emit imaging probe light toward a target site within the living body and receive imaging response light from the target site to image the target site based on the imaging response light.
17. The interventional needle of claim 15, wherein the inner needle comprises one or more sets of sensing optical fibers arranged therein, the one or more sets of sensing optical fibers extending longitudinally along a central axis of the inner needle and having a leading optical fiber end face located at or near a leading end face of the inner needle,
wherein each of the one or more sets of sensing fibres is for sensing a respective one of the parameters of the microenvironment inside the target site, each of the sensing fibres of the set of sensing fibres comprises a probe head at a front fibre end face thereof having a photoluminescent material configured to have an emission spectrum that varies with the variation of the respective one of the parameters, and
wherein each sensing optical fiber of each of the one or more sets of sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine the respective one of the parameters of the microenvironment inside the target site based on the emission light of the photoluminescent material.
18. The interventional needle of claim 17, wherein the one or more sets of sensing optical fibers comprise one or more of:
a first set of sensing optical fibers comprising one or more first sensing optical fibers for sensing a temperature of a microenvironment inside the target site, the probe of each first sensing optical fiber of the first set of sensing optical fibers having a first photoluminescent material configured to have an emission spectrum that varies with changes in temperature;
a second set of sensing optical fibers comprising one or more second sensing optical fibers for sensing an oxygen concentration of a microenvironment inside the target site, the probe of each second sensing optical fiber of the second set of sensing optical fibers having a second photoluminescent material configured to have an emission spectrum that varies with a variation in the oxygen concentration; and
a third set of sensing optical fibers comprising one or more third sensing optical fibers for sensing a pH of a microenvironment inside the target site, the probe of each third sensing optical fiber of the third set of sensing optical fibers having a third photoluminescent material configured to have an emission spectrum that varies with pH.
19. The interventional needle of claim 17, wherein each of the one or more sets of sensing fibers are each arranged in the inner needle rotationally symmetric about the central axis of the inner needle, and wherein the inner needle has a hollow channel for injecting chemoablative drug to the target site.
20. The interventional needle of claim 15, wherein the inner needle is configured for thermal ablation of the target site and comprises one or more sets of temperature sensing optical fibers arranged therein, the one or more sets of temperature sensing optical fibers extending longitudinally along a central axis of the inner needle, and a leading optical fiber end face of each of the one or more sets of temperature sensing optical fibers being located at a respective one of cross-sections of the inner needle between a leading end face and a trailing end face thereof,
wherein each of the one or more sets of temperature sensing optical fibres is for sensing a temperature of a microenvironment inside the target site, each temperature sensing optical fibre of the set of temperature sensing optical fibres including a probe at a front fibre end face thereof having a photoluminescent material configured to have an emission spectrum that varies with temperature, and
wherein each temperature sensing optical fiber of each of the one or more sets of temperature sensing optical fibers is configured to transmit excitation light towards the photoluminescent material of the probe and receive emission light from the photoluminescent material to determine a temperature of a microenvironment inside the target site based on the emission light of the photoluminescent material.
21. The interventional needle of claim 20, wherein a first set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers is closer to the front end face of the inner needle than a second set of temperature sensing optical fibers of the one or more sets of temperature sensing optical fibers, and a temperature sensing optical fiber density of the first set of temperature sensing optical fibers is greater than a temperature sensing optical fiber density of the second set of temperature sensing optical fibers, the temperature sensing optical fiber density being a ratio of a number of one set of temperature sensing optical fibers to an area of the inner needle cross-section in which the front fiber end face of the set of temperature sensing optical fibers is located.
22. The access needle of 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 a 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 interior and receive additional navigation response light derived from the additional navigation probe light so as to locate and distinguish a site of the living body interior that is not expected to be penetrated by the interventional needle based on the additional navigation response light.
CN202221624409.7U 2022-06-27 2022-06-27 Interventional needle Active CN218009895U (en)

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