Nerve stimulation device based on endoscopic imaging sensor

Abstract

The invention discloses a nerve stimulation device based on an endoscopic imaging sensor, which comprises an endoscopic imaging sensing electrode module, a tracking label, an external 3D tracking system and an external navigation system, and is characterized in that the endoscopic imaging sensing electrode module comprises a stimulation electrode and an endoscopic imaging sensor installed on the stimulation electrode; the endoscopic imaging sensor captures grayscale images and spectral data from tissue and transmits the grayscale images and spectral data to the external navigation system. According to the nerve stimulation device based on the endoscopic imaging sensor, the problem that the nerve stimulation electrode is inaccurately placed relative to the target nerve is solved, and by combining real-time imaging and navigation tools, the precision of implanting the nerve stimulation electrode is remarkably improved, discomfort is reduced, and the treatment effect is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical equipment, and in particular relates to a nerve stimulation device based on an endoscopic imaging sensor. Background Art

[0002] Existing implantable neurostimulation electrodes include stimulation contacts in the shape of metal rings (usually 2 to 4 rings). Some existing implantable neurostimulation electrodes have a cavity inside for inserting a rigid guide rod, guide wire, or electrical recording wire. An example is an implantable electrode for sacral nerve stimulation, which is inserted into the sacral foramen. This implantable electrode for sacral nerve stimulation has a cavity inside for inserting a rigid guide rod or guide wire.

[0003] Existing implantable neurostimulation electrodes do not have imaging sensors for imaging the location of nerves within tissue. As a result, these implantable neurostimulation electrodes may be placed far from the target nerve, resulting in the electrode stimulation failing to effectively activate the target nerve, leaving the patient with limited (or no) benefit from neurostimulation therapy. Summary of the invention

[0004] The main purpose of the present invention is to provide a neurostimulation device based on endoscopic imaging sensors, which solves the problem of inaccurate placement of neurostimulation electrodes relative to target nerves, which often leads to the use of excessive current, causing discomfort or pain. By combining real-time imaging and navigation tools, the present invention significantly improves the accuracy of implanted neurostimulation electrodes, reduces discomfort and improves treatment results.

[0005] To achieve the above objectives, the present invention provides a neural stimulation device based on an endoscopic imaging sensor, comprising an endoscopic imaging sensor electrode module, a tracking tag, an external 3D tracking system and an external navigation system, wherein:

[0006] The endoscopic imaging sensing electrode module includes a stimulation electrode and an endoscopic imaging sensor mounted on the stimulation electrode, wherein the endoscopic imaging sensor captures grayscale images and spectral data (using visible light and / or infrared light) from tissues and transmits the grayscale images and spectral data to the external navigation system, wherein the external navigation system performs data analysis (analyzing brightness, scattering and color data from the endoscopic sensor) to distinguish target nerves from other tissues (skin, fat, bone, muscle, etc.);

[0007] The tracking tag is installed on the endoscope imaging sensor and is combined with the external 3D tracking system for triangulation, so as to determine the specific position of the current tracking tag and transmit the specific position to the external navigation system to ensure accurate navigation of the stimulation electrode (through accurate navigation, and then according to the data feedback from the endoscope imaging sensor, the stimulation electrode is accurately navigated to the target nerve to achieve accurate electrical stimulation).

[0008] As a further preferred technical solution of the above technical solution, the endoscopic imaging sensor is placed in the cavity of the stimulation electrode, and the endoscopic imaging sensor includes a body, a first end, a second end and a plurality of imaging chips, the first end and the second end are respectively mounted at two ends of the body, and the imaging chip is mounted at the first end or the second end, wherein:

[0009] The body includes one or more light sources (such as LED, micro LED, optical fiber or vertical cavity surface emitting laser or photonic waveguide) and a protective wall of the light source. When the endoscopic imaging sensing electrode module enters human tissue, the light source illuminates the human tissue around the first end, and the imaging chip detects the grayscale image and spectral data of the light reflected by the surrounding tissue and transmits it to the external navigation system (the light source can be located at the distal tip, i.e., the first end. If the light source is located outside the endoscopic imaging sensor, the light is transmitted to the first end through the optical fiber bundle. Optionally, each light source can be equipped with an optical focusing lens and a diffusion filter and / or an interference filter and / or an absorption filter and / or a coded aperture amplitude mask and / or a phase mask, and / or a combination of lenses, filters and / or masks);

[0010] If the imaging chip is located at the second end, the reflected light is transmitted from the first end to the imaging chip located at the second end through the optical fiber bundle; if the imaging chip is located at the first end, the reflected light is directly transmitted to the imaging chip located at the first end.

[0011] As a further preferred technical solution of the above technical solution, the first end is provided with an optical focusing lens (for detecting light reflected by surrounding tissue).

[0012] As a further preferred technical solution of the above technical solution, the second end includes a passive or active tracking tag, and the tracking tag monitors the position of the stimulation electrode relative to the target nerve in combination with the external 3D tracking system. The passive tracking tag includes a radiopaque material, a permanent magnet or an RFID tag, and the active tracking tag is a tag that emits a radio frequency signal, an electromagnetic signal, an infrared light signal or an ultrasonic signal;

[0013] The external 3D tracking system is based on at least three detectors (X-ray detector, radio frequency detector, electromagnetic detector, infrared light detector or ultrasonic detector), which receive the signal strength of the tracking tag through triangulation to determine the 3D position of the tracking tag (the detectors of the external 3D tracking system are oriented relative to each other in Cartesian space at a specific angle (for example, 45° or 90°)).

[0014] As a further preferred technical solution of the above technical solution, the endoscopic imaging sensor captures the emitted spectral data, distinguishes different tissues by assigning pseudo colors to grayscale images, and distinguishes target nerves and other tissues by the different reflectivities of light in different tissues (these pseudo colors help surgeons identify and distinguish tissues and guide the accurate placement of electrodes).

[0015] As a further preferred technical solution of the above technical solution, the external navigation system also receives imaging data from a second imaging system, and the second imaging system includes X-ray computed tomography, X-ray fluoroscopy, magnetic resonance imaging (MRI) and / or ultrasound;

[0016] When the external navigation system performs data analysis, it combines the previously collected imaging data to improve the accuracy of distinguishing target nerves from other tissues (to improve the accuracy of determining the 3D position of the endoscopic imaging sensor and / or better distinguish target nerves from other tissues).

[0017] As a further preferred technical solution of the above technical solution, when the endoscopic imaging sensor is inserted into the implantable stimulation electrode, the external navigation system collects information from the endoscopic imaging sensor and the external 3D tracking system.

[0018] As a further preferred technical solution of the above technical solution, the reflected spectral data is collected by an imaging chip in an endoscope imaging sensor and used to assign different pseudo colors to the collected grayscale image. According to the ratio of the intensity within a certain frequency band to the intensity between frequency bands, the pseudo color is assigned to each pixel of the grayscale image from blue to red. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a structural schematic diagram of the endoscope imaging sensor electrode module of the present invention.

[0020] Figure 2 It is a schematic diagram of the operation of the present invention.

[0021] Figure 3 It is a schematic diagram of spectral reflectance data of different human tissues of the present invention.

[0022] Figure 4 It is a structural schematic diagram of the endoscope imaging sensor electrode module of the present invention. DETAILED DESCRIPTION

[0023] The following description is used to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments described below are only examples, and those skilled in the art can think of other obvious variations. The basic principles of the present invention defined in the following description can be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not deviate from the spirit and scope of the present invention.

[0024] In the preferred embodiment of the present invention, those skilled in the art should note that the stimulation electrodes and human tissues involved in the present invention can be regarded as prior art.

[0025] Preferred embodiments.

[0026] like Figure 1-4 As shown, the present invention discloses a neural stimulation device based on an endoscopic imaging sensor, including an endoscopic imaging sensor electrode module, a tracking tag 109, an external 3D tracking system 204 and an external navigation system 207, wherein:

[0027] The endoscopic imaging sensing electrode module includes a stimulation electrode 101 and an endoscopic imaging sensor 102 mounted on the stimulation electrode 101, wherein the endoscopic imaging sensor 102 captures grayscale images and spectral data (using visible light and / or infrared light) from tissues and transmits the grayscale images and spectral data to the external navigation system 207, and the external navigation system 207 distinguishes target nerves from other tissues (skin, fat, bone, muscle, etc.) after performing data analysis (analyzing brightness, scattering and color data from the endoscopic sensor);

[0028] The tracking tag 109 is installed on the endoscope imaging sensor 102 and is triangulated in combination with the external 3D tracking system 204 to determine the specific position of the current tracking tag 109 and transmit the specific position to the external navigation system 207 to ensure accurate navigation of the stimulation electrode 101 (through accurate navigation, and then according to the data feedback from the endoscope imaging sensor, the stimulation electrode is accurately navigated to the target nerve to achieve accurate electrical stimulation).

[0029] Specifically, the endoscopic imaging sensor 102 is placed in the cavity of the stimulation electrode 101, and the endoscopic imaging sensor 102 includes a body, a first end 107 (distal end), a second end 108 (proximal end) and a plurality of imaging chips (e.g., photodiodes), the first end 107 and the second end 108 are respectively mounted at the two ends of the body, and the imaging chip is mounted at the first end 107 or the second end 108, wherein:

[0030] The body includes one or more light sources 104 (such as LED, micro LED, optical fiber or vertical cavity surface emitting laser or photon waveguide), and a protective wall 103 of the light source 104. When the endoscope imaging sensing electrode module enters human tissue, the light source 104 illuminates the human tissue around the first end 107, and the imaging chip detects the grayscale image and spectral data of the light reflected by the surrounding tissue and transmits it to the external navigation system 207 (the light source can be located at the distal tip, i.e., the first end. If the light source is located outside the endoscope imaging sensor, the light is transmitted to the first end through the optical fiber bundle. Optionally, each light source can be equipped with an optical focusing lens and a diffusion filter and / or an interference filter and / or an absorption filter and / or a coded aperture amplitude mask and / or a phase mask, and / or a combination of lenses, filters and / or masks);

[0031] If the imaging chip is located at the second end 108 , the reflected light is transmitted from the first end 107 to the imaging chip located at the second end 108 through the optical fiber bundle 104 ; if the imaging chip is located at the first end 107 , the reflected light is directly transmitted to the imaging chip located at the first end 107 .

[0032] More specifically, the first end 107 is provided with an optical focusing lens (for detecting light reflected by surrounding tissue).

[0033] Furthermore, the second end 108 includes a passive or active tracking tag 109, and the tracking tag 109 is combined with the external 3D tracking system 204 to monitor the position of the stimulation electrode 101 relative to the target nerve. The passive tracking tag includes a radio-opaque material, a permanent magnet or an RFID tag, and the active tracking tag is a tag that emits a radio frequency signal, an electromagnetic signal, an infrared light signal or an ultrasonic signal.

[0034] The external 3D tracking system is based on at least three detectors (X-ray detector, radio frequency detector, electromagnetic detector, infrared light detector or ultrasonic detector), which receive the signal strength of the tracking tag through triangulation to determine the 3D position of the tracking tag (the detectors of the external 3D tracking system are oriented relative to each other in Cartesian space at a specific angle (for example, 45° or 90°)).

[0035] Furthermore, the endoscopic imaging sensor captures the emitted spectral data and distinguishes different tissues by assigning pseudo colors to the grayscale image, distinguishing target nerves from other tissues by taking advantage of the different reflectivity of light in different tissues (these pseudo colors help surgeons identify and distinguish tissues, guiding accurate placement of electrodes).

[0036] Preferably, the external navigation system 207 also receives imaging data from a second imaging system 211, which includes X-ray computed tomography, X-ray fluoroscopy, magnetic resonance imaging (MRI) and / or ultrasound;

[0037] When the external navigation system 207 performs data analysis, it combines the pre-collected imaging data to improve the accuracy of distinguishing target nerves from other tissues (to improve the accuracy of determining the 3D position of the endoscopic imaging sensor and / or better distinguish target nerves from other tissues).

[0038] Preferably, when the endoscopic imaging sensor 102 is inserted into the implantable stimulation electrode 101 , the external navigation system 207 collects information from the endoscopic imaging sensor 102 and the external 3D tracking system 204 .

[0039] Preferably, the endoscopic imaging sensor can also detect ultrasonic signals, can detect ultrasonic signals emitted from multiple ultrasonic sources (such as piezoelectric transducers), and can be optionally equipped with an ultrasonic focusing lens.

[0040] Preferably, the reflected spectral data is collected by an imaging chip in an endoscope imaging sensor and used to assign different pseudo colors to the collected grayscale image, with pseudo colors from blue to red being assigned to each pixel of the grayscale image based on the ratio of the intensity within a certain frequency band to the intensity between frequency bands.

[0041] Preferably, Figure 4 The distal tip 107 of the endoscopic imaging sensor 102 is shown, which is placed in the large cavity of the implantable neural stimulation electrode 101. The distal tip 107 can include an imaging chip 110. The imaging chip 110 can include a light detector matrix 111 and a light source matrix 112, which emits light to illuminate the tissue 106 around the distal tip 107. Each light detection matrix 111 can be a photodiode, such as an avalanche photodiode, a single photon avalanche photodiode, or a positive insulator negative (PIN) photodiode. Each light source matrix 112 can be a monochromatic or polychromatic light source in the visible spectrum and / or infrared spectrum, such as an LED, a micro-LED, an optical fiber, a vertical cavity surface emitting laser, or a photonic waveguide. Optionally, each light source matrix 112 can have an optical focusing lens and / or a diffusion filter and / or an interference filter and / or an absorption filter and / or a coded aperture amplitude mask and / or a phase mask and / or a combination of lenses and / or filters and / or masks.

[0042] Figure 2A surgical apparatus 200 is shown. The surgical apparatus 200 may include an implantable neurostimulation electrode and associated surgical accessories 201 with a built-in endoscopic imaging sensor, and an external 3D tracking system 204, with detectors 203 mounted through a stereotactic frame 202. The detectors 203 are oriented relative to each other in Cartesian space at a specific angle (e.g., 45° or 90°). The surgical apparatus 200 may also include an external 3D tracking system attached to an operating table 205, on which a patient's body 206 is located. The external 3D tracking system 204 may communicate with an external navigation system 207, which includes a navigation tool 208 and a display 209, by wire or wirelessly. The external navigation system 207 is operated by a surgeon 210. The external navigation system 207 may include multiple inputs, such as grayscale images and spectral data from the endoscopic imaging sensor 102, the position of the implantable neurostimulation electrode from the external 3D tracking system 204, and imaging data from a second imaging system 211 mounted on a moving beam 212. The second imaging system 211 may include X-ray computed tomography, X-ray fluoroscopy, magnetic resonance imaging (MRI), and / or ultrasound.

[0043] Figure 3 The normalized intensity (spectral reflectance data) of reflected light at each frequency is shown when the endoscopic imaging sensor 102 is inserted into different tissues (including nerves, bones, fat tissue, and muscles) in the patient's body. Among these tissues, nerves have the highest reflection intensity on band 1 (480-520nm), band 2 (540-570nm), and band 3 (600-800nm), followed by bones and then fat tissue. Such spectral reflectance data can be collected for each pixel in the endoscopic imaging sensor 102 and used to assign different pseudo colors to the collected grayscale images. According to the ratio of the intensity within a certain frequency band to the intensity between the frequency bands, the pseudo color can be assigned to each pixel of the grayscale image from blue to red. For example, the intensity between the frequency bands can be measured in the frequency range before band 1 (400-480nm), or in the frequency range between bands 1 and 2 (520-540nm), or in the frequency range between bands 2 and 3 (570-600nm). The red pseudo-color has the highest ratio of within-band intensity to between-band intensity and is most likely to represent nerve tissue. Next, the yellow or orange pseudo-color has a lower intensity ratio and is most likely to represent bone tissue. Next, the green pseudo-color has an even lower intensity ratio and is most likely to represent fat tissue. Finally, the blue pseudo-color has the lowest intensity ratio and is most likely to represent muscle tissue. Using the image from the endoscopic imaging sensor 102 in combination with the pseudo-color allows the surgeon to distinguish nerves from other tissue when inserting the implantable neural stimulation electrode 101 with the endoscopic imaging sensor 102 into the body.

[0044] It is worth mentioning that the patent application of the present invention involves that when the endoscopic imaging sensor is inserted into the implantable stimulation electrode, the external navigation system collects information from the endoscopic imaging sensor and the external 3D tracking system. Technical features such as these should be regarded as prior art, and the specific structure, working principle, and possible control method and spatial arrangement method of these technical features can be selected conventionally in the field, and should not be regarded as the inventive point of the patent of the present invention, and the patent of the present invention will not be further specifically described.

[0045] For those skilled in the art, it is still possible to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A neural stimulation device based on an endoscopic imaging sensor, characterized in that: It includes an endoscope imaging sensor electrode module, a tracking tag, an external 3D tracking system and an external navigation system, wherein: The endoscopic imaging sensor electrode module includes a stimulation electrode and an endoscopic imaging sensor mounted on the stimulation electrode, wherein the endoscopic imaging sensor captures grayscale images and spectral data from tissues and transmits the grayscale images and spectral data to the external navigation system, and the external navigation system distinguishes target nerves from other tissues after performing data analysis; The tracking tag is mounted on the endoscope imaging sensor and is triangulated in conjunction with the external 3D tracking system to determine the specific location of the current tracking tag and transmit the specific location to the external navigation system to ensure accurate navigation of the stimulation electrode.

2. A neural stimulation device based on an endoscopic imaging sensor according to claim 1, characterized in that: The endoscopic imaging sensor is placed in the cavity of the stimulation electrode, and comprises a body, a first end, a second end, and a plurality of imaging chips, wherein the first end and the second end are respectively mounted at two ends of the body, and the imaging chip is mounted at the first end or the second end, wherein: The body includes one or more light sources and a protective wall for the light sources. When the endoscope imaging sensor electrode module enters human tissue, the light source illuminates the human tissue around the first end, and the imaging chip detects the grayscale image and spectral data of the light reflected by the surrounding tissue and transmits them to the external navigation system. If the imaging chip is located at the second end, the reflected light is transmitted from the first end to the imaging chip located at the second end through the optical fiber bundle; if the imaging chip is located at the first end, the reflected light is directly transmitted to the imaging chip located at the first end.

3. A neural stimulation device based on an endoscopic imaging sensor according to claim 2, characterized in that: The first end is provided with an optical focusing lens.

4. A neural stimulation device based on an endoscopic imaging sensor according to claim 3, characterized in that: The second end includes a passive or active tracking tag, which monitors the position of the stimulation electrode relative to the target nerve in combination with the external 3D tracking system. The passive tracking tag includes a radiopaque material, a permanent magnet or an RFID tag, and the active tracking tag is a tag that emits a radio frequency signal, an electromagnetic signal, an infrared light signal or an ultrasonic signal. The external 3D tracking system is based on at least three detectors, which receive the signal strength of the tracking tag through triangulation to determine the 3D position of the tracking tag.

5. The neural stimulation device based on endoscopic imaging sensor according to claim 1, characterized in that: The endoscopic imaging sensor captures the emitted spectral data and distinguishes different tissues by assigning false colors to grayscale images, and distinguishes target nerves from other tissues by the different reflectivity of light in different tissues.

6. The neural stimulation device based on endoscopic imaging sensor according to claim 5, characterized in that: The external navigation system also receives imaging data from a second imaging system, the second imaging system including X-ray computed tomography, X-ray fluoroscopy, magnetic resonance imaging and / or ultrasound; When the external navigation system performs data analysis, it combines the previously collected imaging data to improve the accuracy of distinguishing target nerves from other tissues.

7. The neural stimulation device based on endoscopic imaging sensor according to claim 2, characterized in that: When the endoscopic imaging sensor is inserted inside the implanted stimulation electrode, the external navigation system collects information from the endoscopic imaging sensor and the external 3D tracking system.

8. The neural stimulation device based on endoscopic imaging sensor according to claim 5, characterized in that: The reflected spectral data is collected by the imaging chip in the endoscope imaging sensor and used to assign different pseudo colors to the collected grayscale images. The pseudo colors are assigned to each pixel of the grayscale image from blue to red according to the ratio of the intensity within a certain frequency band to the intensity between frequency bands.

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