Systems and methods for nerve stimulation lead placement

Abstract

A system and method for locating and guiding a peripheral nerve assessment (PNE) lead. The system includes an X-ray system for capturing an image of a patient. The image is processed by the system and provided to the user to use a measurement device to insert a needle for placement of a lead to perform the PNE process.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and interest in U.S. Provisional Application 63 / 544,067, filed on October 13, 2023. Technical Field

[0003] This application relates to apparatus and methods for placing leads used in assistive nerve stimulation. In exemplary embodiments, the apparatus and methods relate to the placement of electrical leads used in sacral nerve modulation, and more specifically, to apparatus and methods for locating the sacral foramen during a peripheral nerve evaluation (PNE) procedure to place electrical leads of the PNE system in the appropriate position.

[0004] Sacral nerve modulation is a treatment for bladder and bowel dysfunction that involves an implanted device that delivers controlled electrical stimulation to the patient's S3 spinal nerve in the sacrum. Before receiving a permanent implant, the patient undergoes a procedure called peripheral nerve assessment (PNE). This involves implanting a temporary lead into the patient, which is connected to an external pulse generator, and then observing the results for a period of time, typically between 3 and 14 days. If the results meet certain clinical criteria, then the patient can be a candidate for receiving sacral nerve modulation using an implantable pulse generator.

[0005] Current techniques for lead placement during evaluation procedures involve identifying palpable bony or bony landmarks on the patient and inserting a foramen magnum based on the location of these landmarks. The goal during this procedure is to insert the foramen magnum through the skin and into the S3 foramen, allowing electrical stimulation of the lead to be delivered along the S3 spinal nerve of the sacrum. This procedure can be performed in an operating room setting, aided by fluorescein or other image guidance for more accurate lead placement. However, this procedure is most often performed in an office setting under local anesthesia without imaging. In an office setting, the placement method is essentially a “blind” insertion method because it does not rely on images or fluorescein of the patient’s anatomy.

[0006] When fluoroscopy or other imaging is not used, such as in an office setting, physicians rely on experience and referencing tactile landmarks to insert a pin from outside the patient's body into the S3 foramen. The S3 foramen is not visible when the physician attempts to place the pin through it. The use of tactile bone or bony landmarks is based on normal anatomy, disregarding anatomical or pathological changes. This can lead to improper pin placement in an office setting and ultimately, PNE failure. For example, it often requires multiple attempts to locate the S3 foramen and successfully insert the pin through it. In some cases, due to repeated failures to place the correct pin, the patient may even abandon PNE (and thus, sacral nerve modulation altogether) without proper pin placement. Incorrect pin placement can also lead to less than ideal clinical outcomes and premature abandonment of other effective treatments. Therefore, there remains a need and a demand for an improved system and method for PNE pin placement. Summary of the Invention

[0007] The embodiments disclosed herein relate to apparatuses and methods for improving the effectiveness and efficiency of locating the sacral foramen during sacral nerve modulation procedures. Embodiments include imaging a portion of the patient, identifying internal points within the patient in the imaging, calculating measurements based on the imaging and the identified points, transmitting the measurements to the apparatus, placing the apparatus on and outside the patient using positioning features, and guiding medical components (e.g., pinhole needles) into the patient using the apparatus's component guides. The disclosed embodiments help physicians locate the S3 foramen more accurately and provide an improvement over conventional techniques that have lower accuracy in locating the S3 foramen during blind insertion.

[0008] According to one embodiment disclosed herein, a method includes the steps of: determining one or more measurements from at least one image of a patient's sacrum; applying the determined one or more measurements with a guiding device; positioning the guiding device on the patient's back using markers; and guiding a medical element into the patient's body using the guiding device while the guiding device is positioned on the patient's back.

[0009] According to another disclosed embodiment, a device for guiding the insertion of a medical element includes: an elongated base having a positioning feature referencing a mark on a patient; a head that is translatable along the elongated base in a first direction; and a medical element guide that is translatable along the head in a second direction perpendicular to the first direction, wherein the medical element guide is configured to identify the entry position and insertion angle of the medical element into the patient's body.

[0010] In another disclosed embodiment, a system and method are disclosed, comprising one or more computer-readable storage media having program instructions commonly stored on the one or more computer-readable storage media or a remote cloud-based service. The program instructions are executable to: receive at least one image of a patient's sacrum; display at least one image; receive user input defining a point of interest in the displayed at least one image; determine one or more measurements of a medical element guide based on the point of interest and a predefined size of the medical element guide; and output the determined one or more measurements to the user. Attached Figure Description

[0011] Figure 1 An exemplary partial view of human anatomy is shown.

[0012] Figure 2 The components of an exemplary medical component positioning and placement system are shown.

[0013] Figure 3 An example of a non-transparent marking device is shown.

[0014] Figure 4 An example of a non-transparent marking device is shown.

[0015] Figure 5 A flowchart illustrating an exemplary method for locating the insertion point and placing the medical component is shown.

[0016] Figure 6 and Figure 7 An exemplary implementation is shown that identifies points in a fluorescence transillumination image and processes the image for measurement.

[0017] Figures 8A-8K An exemplary needle-guided device is shown.

[0018] Figure 9 An example of using positioning features to place a needle-guided device on a patient is shown.

[0019] Figure 10 An example of using a needle-guided device to guide a medical component into a patient's body is shown.

[0020] Figures 11A-11G An exemplary needle-guided device is shown.

[0021] Figure 12 An example of a positioning element attached to a patient is shown.

[0022] Figure 13 Examples are shown of a positioning element attached to a patient and a needle-guided device placed on the patient's back and connected to the positioning element.

[0023] Figure 14 It shows the use of Figure 11A Example of needle insertion for a needle-guided device (-F).

[0024] Figure 15 A flowchart is shown of an exemplary method for positioning and placing a needle inside a patient for the purpose of placing a PNE lead. Detailed Implementation

[0025] The details shown herein are merely illustrative and for the purpose of an illustrative discussion of the disclosed embodiments, and are presented to provide an easy-to-understand description of the principles and concepts. In this regard, no attempt is made to show structural details in more detail than necessary for a basic understanding, and the description, taken in conjunction with the accompanying drawings, makes it clear to those skilled in the art how the disclosed devices and methods will manifest in practice.

[0026] Figure 1 An exemplary partial view of certain skeletal components of the human torso 10 is shown, including the sacrum 15 located at the base of the spine 20 and the coccyx 25 located at the base of the sacrum 15. Figure 1 As shown, the sacrum 15 includes two sets of sacral foramina, or openings through which the sacral nerves pass, arranged in two vertical rows, each set located on either side of the medial sacrament. Figure 1 In the diagram, hole 31 corresponds to hole S1, hole 32 corresponds to hole S2, hole 33 corresponds to hole S3, and hole 34 corresponds to hole S4. Figure 1 Only one set of sacral foramina is shown and numbered. This document discloses a system and method for precisely locating one of the selected foramina 31-34 and inserting a needle through the selected foramina 31-34 to access a nerve for implantation of a component of a sacral nerve modulation system. Examples of this document describe the location of the foramina needle and the insertion of the foramina needle through foramina S3; however, the described system and method are not limited to use with foramina S3.

[0027] Figure 2Components of a medical component placement system 100 are shown, including an imaging system 700 capable of communicating with one or more electronic devices. While X-ray or fluoroscopic imaging is preferred, other imaging techniques that reveal and differentiate the patient's internal skeletal structures may also be used. The electronic devices may include a smartphone or other mobile device 701, a computer 702, or any other known electronic device capable of receiving input from the imaging system 700 and displaying output on a display screen of the electronic device. The imaging system 700 is configured to capture images of a patient requiring a PNE procedure. The medical component placement system 100 needs to capture images from the anterior-posterior (or posteroanterior) and lateral sides to provide the measurements required to place the PNE lead in the correct position. Once images have been captured, the images from the imaging system 700 can be sent to one or more electronic devices containing software or applications configured to process the images and provide information that can be used to correctly position the needle guide device 805 on the patient and, if necessary, to mark the patient to identify the insertion point of the needle used for placing the PNE lead. The mobile device 701 and / or computer 702 may also receive image files captured from the imaging system 700 via manual input from the user. The image file can be a file exported from the imaging system 700 (such as JPG, TIF, PNG, GIF, BMP, etc.) or a DICOM standard image.

[0028] In one embodiment, the application may run using a cloud-based computing service 703 that communicates with the electronic device. The cloud-based computing service can perform the required computations and display the output to the electronic device. The electronic device can run the following (see reference below). Figure 6 and Figure 7The application described (or a web client accessing a cloud-based version of the application) displays a UI on the screen of an electronic device. The output is then applied to a needle guiding device 805 to aid in the placement and insertion of the needle into the patient. The procedure can also incorporate artificial intelligence (AI) through image recognition features. Image recognition features can automatically identify points of interest, draw or apply desired lines to the image, and calculate measurements based on the image provided to the program. Image recognition features can also identify points of interest regardless of the patient's orientation during imaging. Therefore, measurements can still be obtained even if the patient's position relative to the image axis is inconsistent, due to the ability of the AI ​​employed to identify anatomical points of interest. As described above, the "drawing" of lines can be visible to the user of the program or performed inherently as part of the program or application's operation, which determines or calculates the desired measurements and the preferred position for needle insertion. Once the mobile device 701, computer 702, or cloud computing device 703 receives the image, image distortions can be modified or corrected (e.g., scaling, rotation, cropping, flipping, brightness / contrast adjustment, sharpening, denoising, etc.). For example, if the patient is not fully prone when the image is taken, the image can be corrected by rotation. Image distortion can also be corrected manually or based on machine learning algorithms.

[0029] Figure 3 and Figure 4An example of a radiopaque marker device 305 for patient imaging is shown. The imaging includes X-rays from the patient's side, showing the patient's sacrum 15 and coccyx 25. The imaging may also include one or both of the anterior-posterior (AP) or posterior-anterior (PA) planes of the same region (i.e., showing the patient's sacrum and coccyx). During X-ray imaging in the field of view of the imaging device 700, the radiopaque marker device 305 can be placed on the patient. The radiopaque marker device 305 includes a radiopaque housing 310 and a radiopaque element 315. The radiopaque housing 310 is composed of a material that is relatively transparent to the X-ray device (or any imaging technique used). For example, plastic can be used for the radiopaque housing 310. When taking an image, the radiopaque housing 310 provides a simple placement for placing the radiopaque marker device 305 on the patient. The radiopaque element 315 is composed of a material that is relatively opaque to X-rays (or any imaging technique used). For example, stainless steel can be used for the radiopaque element 315. The radiopaque element 315 has a predefined size that is used with one or more X-ray images to define a scale for one or more images of the patient and to provide a reference for correctly determining the measurements required to position the insertion point for the needle on the patient. In a particular embodiment, the radiopaque element 315 includes a sphere of a predefined diameter, such that the radiopaque marking device 305 can be placed on the patient in any orientation during imaging. Many other known marking devices can utilize radiopaque devices with different predetermined shapes and sizes. The marking device can be fixed to the patient or the radiopaque stage on which the X-ray images are taken.

[0030] Figure 5A flowchart of an exemplary method is shown. Step 205 includes imaging a portion of the patient. Images of the patient can be obtained in various patient positions. Imaging system 700 can capture images of the patient's sacrum 15 and coccyx 25 from the anterior / posterior (or posteroanterior) and lateral sides. The processing software of imaging system 700 can automatically set appropriate dimensions using a radiopaque marker device or a scale provided by imaging system 700. Alternatively, at step 206, a user can manually match a reference line provided by the software to a provided scale, or manually match a reference shape to a radiopaque marker, via imaging system 700. This matching procedure allows the user to correct the magnification of the received image by correlating the image pixel space with real-world measurements for appropriate processing. In another exemplary embodiment, machine learning methods can be used to automatically identify the reference line or reference shape and match it to a scale or radiopaque marker, respectively. The processing software of imaging system 700 can further automatically manipulate the image to clarify it (e.g., modify the image's contrast or brightness). The image can also be further clarified once transmitted to an electronic device.

[0031] Step 210 includes identifying internal points of the patient in the imaging to determine key measurements used in the calculation. Step 215 includes calculating measurements of the recommended insertion position of the identification needle based on the imaging and the identified points. These measurements can be used to position the components of the needle guiding device 805. The software can also calculate the needle entry angle. Minimum needle length. Minimum needle length is defined as the minimum needle length required to reach the target location (e.g., the S3 sacral foramen).

[0032] Step 220 includes transmitting the measurement calculated in step 215 to the needle guiding device 805. Step 225 includes placing the needle guiding device 805 on and outside the patient using positioning features. Step 230 includes guiding a medical component (e.g., a perforated needle) into the patient using the element guidance of device 805. Embodiments of these steps will become apparent from the following figures and related description.

[0033] Figure 6 and Figure 7An exemplary X-ray image 505 is shown, in which the radiopaque element 315 of the radiopaque marking device 305 is visible. Because the radiopaque element 315 has a predefined diameter, this known measurement of the radiopaque element 315 can be used to define a scale for the X-ray image 505. This scale can be used when calculating the measurements described herein. When the imaging system 700 is able to include an auto-scaling function that provides an image scale, a scale indicator 510 (e.g., scale lines embedded and drawn on the X-ray image) can also be provided as an alternative to the marking device 305. The scale indicator 510 can be adjusted to correspond to an image magnification selected by the user. In both alternatives (e.g., using the radiopaque marking device 305 or the auto-scaling function), the image is provided with an image scale that can be used when calculating the measurements needed to identify the position of the needle insertion required for correct lead placement. When the image scale 510 cannot be provided by the imaging system 700, a radiopaque marker must be used so that the image can still be measured correctly.

[0034] Figure 6 and Figure 7 Exemplary implementations are also shown for identifying points in one or more images and processing one or more images for measurement, respectively, at steps 210 and 215. One or more images from step 205 are uploaded to a computing device (not shown) for processing. This computing device may include an electronic device (such as a desktop computer, laptop, tablet, or smartphone, for example) running dedicated software (e.g., a proprietary application). The application may be part of the software(?) program product described herein. The device includes at least a display for displaying images (e.g., X-rays taken at step 205) and a user input mechanism allowing the user to identify points in the displayed images. The display and user input mechanism may be combined in a touchscreen display, for example, which can display images and receive user touch input defining points of interest in the images. The display and user input mechanism may be separate, for example, a display screen for displaying images and a mouse or trackball for controlling pointers (e.g., cursors, arrows, etc.) superimposed on the displayed images, and a button that the user can press to provide a definition of the pointer's current position on the image as a point of interest in the image.

[0035] The step of identifying points in the image in step 210 includes importing one or more images from step 205 into an application running on an electronic device. The application establishes a scale for the image using a predefined size of the transmissive element 315 in one or more images or a scale indicator (e.g., scale indicator 510) provided in one or more images. Step 210 may optionally include applying adjustments to visual aspects of one or more images, such as contrast. Figure 6An example of a simplified side X-ray image 505 is shown, which includes a scale indicator 510 that defines the scale of image 505.

[0036] Continue to refer to Figure 6 The application receives user input via an electronic device, where the input defines points of interest (POIs) in image 505. Four POIs 521, 522, 523, and 524 are defined by the user input. The application may provide the user with one or more messages prompting the user to provide input for one or more POIs. The user provides input to define a first POI 521 at the tip (e.g., distal end) of the coccyx in image 505. In an alternative embodiment, a machine learning method may automatically identify the tip 521 of the coccyx. In response to receiving this input, the application draws a vertical line 525 upwards from the first POI 521. When line 525 is displayed, the user provides input to define a second POI 522 at the intersection of line 525 and the outer surface of the patient's skin. In an exemplary embodiment, image edge detection may be used to automatically identify the second POI 522 to vertically identify the skin surface from the tip 521 of the coccyx. Manual user input may be provided to identify the second POI 522 to fine-tune the automatic identification described above. The user can then provide input to define a third point of interest 523 at the center of the targeted hole in image 505, in this case, the S3 sacral foramen. In response to receiving this input, a line 526 is drawn at the third point of interest 523, perpendicular to the sacrum and upwards toward the patient's outer skin surface. While the line 526 is displayed, the user provides input to adjust or confirm that the line 526 is perpendicular to the sacrum, and to define a fourth point of interest 524 at the intersection of the line 526 and the patient's outer skin surface. In an exemplary embodiment, a machine learning method can automatically identify the S3 foramen (i.e., the third point 523) using image recognition. In another exemplary embodiment, an image edge detection algorithm can be used to identify the needle entry point (i.e., the fourth point 524), where the fourth point 524 can be automatically selected at a calculated or predetermined angle to the target point 523. In another exemplary embodiment, any one of the four points of interest 521, 522, 523, and 524 can be checked or automatically adjusted via a machine learning method to provide more accurate calculations.

[0037] In cases where the image is not fully clear (i.e., S3 is not fully visible), the application can suggest the location of the S3 foramen based on other points of interest. For example, as an alternative to querying point of interest 523, the program can query the location of the L5 vertebra or S1 foramen and the tail tip of the coccyx 521. The program can then estimate the location of 523 by calculating the midpoint between the L5 vertebra or S1 foramen and the tail tip of the coccyx 521. Other alternatives may include providing an estimate of the location of the S3 foramen by providing known measurements of the average location of the S3 foramen in human anatomy (e.g., S3 is approximately 11 cm from the tip of the coccyx).

[0038] Processing the image for measurement at step 215 includes determining length, angle, and depth measurements based on points of interest defined by the user at step 210. The application determines the length, angle, and depth measurements based on one of the following: the coordinates of each point of interest in a coordinate system defined for the image (e.g., XY Cartesian coordinates); a scale of the image relative to the same coordinate system; and one or more predefined dimensions of the device used as a needle guide, employing the determined length and angle measurements. One or more predefined dimensions of the device include a predefined radius of curvature for the elongated base of the device. The application uses this information (e.g., the device's coordinates, scale, and predefined dimensions) and geometric relationships to determine: (i) the length of an arc 530 extending between second point 522 and fourth point 524, where the arc has a predefined radius of curvature; (ii) the angle 535 between line 526 and the tangent of arc 530 at fourth point 524; and (iii) the length of line 526 between third point 523 and fourth point 524. The length of the arc 530 between the determined second point 522 and the fourth point 524 includes a length measurement, the determined angle 535 includes an angle measurement, and the length of the line 526 between the determined third point 523 and the fourth point 524 includes a depth measurement. The application outputs the determined measurements to the user, for example, via a display. The angle 535 can be calculated as the angle between the extension of line 526 and the tangent "T" that is tangent to the arc 530 at point 524. In another exemplary embodiment, at step 215, any positional adjustment of any of the four points of interest (e.g., 521, 522, 523, and 524), whether manual (via the user) or automatic (via a machine learning algorithm), can automatically recalculate one or more of the length, angle, and depth measurements. A magnification correction can also be applied at the end of the measurement calculation at step 215, instead of step 206 as described above, before presenting the final measurements.

[0039] In some cases, using reference scale 510 to correct magnification may be inaccurate and difficult if no reference line is available. Using reference scale 510 may be unreliable because divergence of the source (i.e., the X-ray source) can cause significant variations in magnification, depending on the distance between the detector (i.e., the image receiver) and the imaging source, and the distance between the target (i.e., the patient or patient's spine) and the imaging source. In an exemplary embodiment, magnification correction can be performed using known measurements of the source-to-target distance (SOD) and source-to-image distance (SID) at the time of image capture. Known SOD and SID allow for magnification correction because the magnification of X-rays can be calculated as... .

[0040] The magnification factor (M) is known, allowing adjustment of the calculations for the above measurements. For example, if M is resolved to 1.3, the final calculations for the length, angle, and depth measurements can be performed by multiplying by the magnification calibration factor. (i.e., in this example) Adjustments are made to obtain the final measurements of length, angle, and depth in the interface. In another exemplary embodiment, magnification calibration can be determined using the patient's hip width. Magnification calibration factor It can be a function of the patient's hip joint width. In another embodiment, the magnification calibration factor... It can be preset based on the hip joint width range within the population. to Between. In another embodiment, the magnification calibration factor It can be preset to be based on a wider range of hip widths in the population. to The preset magnification calibration factor allows users to perform magnification correction without using a ruler or radiopaque markers. M can also be set close to the lower limit of the range (e.g., 1.15) to avoid overcompensation. In cases where adjustments are needed to ensure proper placement within the sacrum, using a lower offset value M can provide the benefit of consistent adjustment during needle insertion procedures. When using radiopaque markers, since the size of the radiopaque markers is known, magnification compensation is not required in measurement calculations.

[0041] Figure 7An example of a posteroanterior (PA) X-ray image 605 is shown. An application receives user input via a computing device, where the input defines points of interest (POIs) in image 605. Two POIs, 621 and 622, are defined by the user input. The user provides input to define a first POI 621 at the center of the S3 aperture in image 505. In response to receiving this input, the application draws a line 625 intersecting POI 621 and perpendicular to the sacral central line. When line 625 is displayed, the user provides input to define a second POI 622 at the intersection of line 625 and the sacral central line. In this example, the application uses the coordinates of points 621 and 622 to determine the lateral distance between points 621 and 622. The application outputs the determined measurements to the user, for example, via a display. The user can edit any one of the four POIs (i.e., 521, 522, 523, 524), and the program can automatically recalculate the output measurements based on one or more automatically updated points.

[0042] Figure 8A and Figure 8B An exemplary needle guiding device 805 is shown. Device 805 includes an elongated base 810, a sliding transverse member 815, and a medical element guide 820. Device 805 includes a depending portion 825 extending downward from the bottom surface of the elongated base 810. The bottom surface of the elongated base 810 has a radius of curvature 830, which is about... Figure 6 The device described is one of one or more predefined dimensions and is used in the application to determine measurements. In another embodiment, the elongated base 810 may not be fully curved or arcuate. Instead, the elongated base 810 may include a flat portion that better conforms to the topographical shape of the patient. In one embodiment, an optional flat portion is located at the end of the elongated base 810, which is positioned closer to the patient's head. The sliding lateral member 815 may also slide along this flat portion.

[0043] The elongated base 810 may include a coccyx positioning feature (e.g., a cantilever portion 825) for positioning the device 805 on a patient. The coccyx positioning feature is pressed against the coccyx, while the arcuate feature is positioned along a midline defined by the patient's sagittal plane. The arcuate feature of the elongated base 810 is a predefined arcuate geometry used by the application to determine measurements at step 215. A sliding lateral member 815 slides along the elongated base 810 and remains perpendicular to the elongated base 810. The sliding lateral member 815 can be locked in a specific position along the elongated base 810. The elongated base 810 has measurements included to position the sliding lateral member 815 at a position determined by calculations and measurements from patient imaging. The sliding lateral member 815 includes a lateral track that allows the use of a medical element guide 820. The medical element guide 820 slides laterally along the sliding lateral member 815 and remains perpendicular to the sliding lateral member 815. Lateral placement can be set based on imaging measurements or standard practices. The medical element guide 820 allows for needle placement at various angles. The medical element guide 820 allows the user to hold the needle at a defined angle during use. The medical element guide 820 and the sliding lateral member 815 are also designed to allow removal of the device while the needle is held on the patient. Markings on the needle are also used to measure the depth of needle placement. This measurement is generated during imaging measurements and can be used to locate the depth of the needle in the patient's position.

[0044] The sliding lateral member 815 is translatable relative to the elongated base 810 along its length in a first direction 841 (i.e., head-side direction) and a second direction 842 (i.e., tail-side direction) opposite to the first direction. The sliding lateral member 815 includes a locking mechanism 845 that allows a user to selectively lock (e.g., prevent) and unlock (e.g., allow) the translational movement of the sliding lateral member 815 relative to the elongated base 810. The locking mechanism may include a thumbscrew or other conventional or subsequently developed locking mechanism that can be used to selectively lock (e.g., prevent) and unlock (e.g., allow) the translational movement of one device sliding along another device. The elongated base 810 may include a mark 850 corresponding to a unit of the length measurement determined at step 215. Figure 8A In the example shown, mark 850 includes a millimeter scale from 0 to 180 along the length of the elongated base 810.

[0045] Continue to refer to Figure 8A The step of transmitting the measurement value to device 220 includes moving the sliding transverse member 815 to a position on the elongated base 810 such that the indicator 855 of the sliding transverse member aligns with the position of the length measurement value determined at step 215 on the scale of mark 850. Figure 6In this example, the length measurement is determined to be 136.8 mm. Using this exemplary length measurement, at step 220, the user moves the sliding transverse member 815 along the elongated base 810 until the indicator 855 aligns with the position corresponding to the number 136.8 on the scale of mark 850. If one of the numbers in the length measurement is not perfectly aligned with the number in mark 850, the user can insert a position for the indicator 855 between the two numbers in mark 850 that best match the length measurement. After positioning the sliding transverse member 815 on the elongated base 810 according to the length measurement, the user locks the sliding transverse member 815 relative to the elongated base 810 using the locking mechanism 845.

[0046] exist Figure 8A In the example shown, device 805 includes a medical element guide 820 movable relative to a sliding transverse member 815 in a first direction 861 and a second direction 862 opposite to the first direction, wherein the translational direction of the medical element guide 820 relative to the sliding transverse member 815 is perpendicular to the translational direction of the sliding transverse member 815 relative to the elongated base 810. Device 805 includes a corresponding locking mechanism that allows a user to selectively lock (e.g., prevent) and unlock (e.g., allow) the translational movement of each medical element guide 820 relative to the sliding transverse member 815. The locking mechanism may include a thumbscrew or other conventional or later-developed locking mechanism that can be used to selectively lock (e.g., prevent) and unlock (e.g., allow) the translational movement of one device sliding along another device. As an alternative to the locking mechanism, the sliding transverse member 815 and / or the medical element guide 820 may include a pawl that defines a predefined position of the medical element guide 820 on the sliding transverse member 815.

[0047] Each wing of the sliding lateral member 815 may include a mark 865 corresponding to a unit of lateral distance determined at step 215 (e.g., such as...). Figure 7 (as described). In Figure 8A In the example shown, mark 865 includes a millimeter scale with transverse dimensions from 10 to 40 along the sliding transverse member 815.

[0048] Continue to refer to Figure 8A Transmitting the measurement value to the device at step 220 may include moving the medical element guide 820 to a position on the wing of the sliding lateral member 815 such that the position indicator of the head of each medical element guide 820 is aligned with a position on the scale of mark 865 that matches the lateral distance determined at step 215. Figure 6In this example, the lateral distance is determined to be 20 mm. Using this exemplary length measurement, at step 220, the user moves each medical element guide 820 along the wing of the sliding lateral member 815 until the position indicator on the medical element guide 820 corresponds to the number 20 in the scale marked 865. If one of the numbers in the lateral distance is not perfectly aligned with the number in the scale marked 865, the user can insert a position for the indicator between the two numbers in the scale marked 850 that best matches the lateral distance. After positioning the medical element guide 820 on the wing of the sliding lateral member 815 according to the lateral distance, the user can lock the medical element guide 820 relative to the sliding lateral member 815.

[0049] Continue to refer to Figure 8A and Figure 8B In an embodiment, each of the medical element guides 820 includes a graduated needle guide 870 comprising a plurality of needle guide slots 875 arranged at different predefined angles. The different predefined angles are within a range of determined angle measurements most likely to include most patients. For example, the different predefined angles are in the range of 90 to 140 degrees, with one of the plurality of needle guide slots 875 arranged in 10-degree increments within this range. Each corresponding one of the plurality of needle guide slots 875 may be provided with a mark indicating the angle of the corresponding one of the plurality of needle guide slots 875. Step 220 may include selecting one of the plurality of needle guide slots 875 based on the angle measurement determined at step 215. For example, for an angle measurement of 106.5 degrees, the user would select one of the plurality of needle guide slots 875 whose angle is closest to 106.5 degrees. In the example where the needle guide slots are arranged in 10-degree increments between 90 and 140 degrees, the user would select a 110-degree angle guide slot for an angle measurement of 106.5 degrees.

[0050] Other mechanisms for guiding the pin at the selected angle can be used as alternatives to guide groove 875. For example, Figure 8GAn exemplary embodiment of device 805' is shown, wherein each of the medical element guides 820' includes a single needle groove, and the medical element guides 820' are rotatable about an axis (parallel to the directions defined by 861 and 862 relative to the sliding transverse member 815 and perpendicular to the directions defined by 841 and 842) to a plurality of different positions corresponding to different insertion angles of the needle into the patient. For example, the plurality of different positions may correspond to different insertion angles in predefined increments of 10 degrees. Thus, the angle adjustment of the medical element guides 820' can operate in the manner of an adjustable protractor attached to the sliding transverse member 815. The rotation of the medical element guides 820' relative to the sliding transverse member 815 can be selectively locked and unlocked using a locking mechanism. The elements of device 805' operate in the same manner as these elements of device 805, except that the medical element guides 820' have a single needle guide rotatable to different angles and the medical element guides 820 have a plurality of needle guides with different angles. The angle of the needle may also be determined by, for example, Figure 11A The alternative mechanism for element 1120 shown is guided. The increments of the needle guide described herein can vary depending on the procedure being performed. For example, the guide angle can be positioned in angular increments ranging from 5 to 20 degrees. Furthermore, the various guide dimensions disclosed herein can accommodate needles of various sizes, such as, for example, Gauge 20 and Gauge 19 needles. Device 805 / 805' can be composed of multipurpose polyurethane (e.g., MPU-100), nylon, or any other biocompatible material.

[0051] In the manner described above, the measurement value determined at step 215 (e.g., by the user) is transmitted to device 805. In one example, different markings on the scale of device 805 correspond to the different measurement values ​​determined at step 215. In another example, the measurement value determined at step 215 is converted into a value within a range of different markings on the scale of device 805 using a predefined conversion formula. In this way, the application can output a set of numbers (e.g., precise measurement values ​​or converted values), and the user can adjust the device based on the numbers provided in this output.

[0052] Figure 8C , 8D Views 8E and 8F show a view of device 805, in which a needle 880 is located in one of the guide slots 875 of a medical element guide 820. Figure 8CAs shown in Figure -F, the guide groove is open at its outer end, allowing the medical element guide 820 to move away from the needle 880 when the needle 880 is inserted into the patient. This allows adjustment of the placement of the medical element (needle) angle or removal of the entire device 805 from the patient after each of the medical element guides 820 has been used to insert the needle 880. The needle guide groove 875 can also engage with the needle 880 via a snap-fit ​​mechanism, allowing the needle 880 to be secured or removed from the device 805.

[0053] Reference Figure 8H An alternative embodiment device 805'' is shown, wherein the sliding lateral member is a single integral lateral member 815' with one or more lateral fixed needle insertion points. The integral member 815' provides a fixed offset from the center of the elongated base 810 for the needle insertion guide groove 875'. For example, on the left and right sides, the fixed offset may be approximately 22 mm from the center of the elongated base 810, thus having an integral lateral member 815' that is 42 mm wide. The offset may correspond to a typical or average lateral distance of the S3 hole from the center of the spine. Figure 8I An integral transverse member 815' is shown. Marker 865' and multiple needle guide slots 875' can be integrated into the integral transverse member 815'. Similar to the needle guide slots 875', the needle guide slots 875' can also engage with the pin 880 via a snap-fit, which allows the pin 880 to be secured or removed from the device 805''. This integral member reduces the number of moving parts and thus improves the stability and ease of use for the user of the device 805''. Locking mechanism 845' and indicator 855' are present in the integral transverse member 815' and function similarly to the locking mechanism 845 and indicator 855 previously described in other embodiments.

[0054] Reference Figure 8J and Figure 8K A close-up of the edge 835 of the elongated base 810 is shown. In one embodiment, such as Figure 8J As shown, edge 835 is a flat, beveled section designed to minimize patient discomfort by providing a flat edge to the patient's back, thereby reducing potential discomfort caused by sharp edges. Figure 8K The diagram shown is a simplified view of edge 835, which shows the protrusion 840 of the elongated base 810. The protrusion 840 serves both as a track along which the transverse member 815 (or 815') slides and as a means of securing the transverse member to the elongated base 810.

[0055] Figure 9 An example of placing device 805 on a patient using positioning features is shown. As described above, step 225 may include positioning the device on the patient using location features. After the measurement values ​​are transmitted to device 805 at step 220 (e.g., as referenced...), Figure 8Aand Figure 8B As shown), the user places the device 805 on the patient, i.e., on the same patient imaged at step 205. Placing the device 805 at step 220 includes positioning the device 805 on the outer surface of the patient's skin in a prone position, wherein the hanging portion 825 of the device is positioned near the patient's coccyx, and the elongated base 810 of the device 805 is aligned with the patient's spine.

[0056] Figure 10 An example of using device 805 to guide a medical component into a patient's body is shown. Figure 10 Referencing step 225 and Figure 9 The described device 805, placed on a patient, is positioned, for example, on the outer surface of the patient's skin in a prone position, with a hanging portion 825 of the device positioned near the patient's coccyx 25, and an elongated base 810 of the device 805 aligned with the patient's spine. After measurements are transmitted to the device 805 at step 220, and then the device 805 is placed on the patient at step 825, step 230 includes using the device 805 placed on the patient as a guide for inserting a needle (e.g., a perforated needle 880) into the patient's body. The user initiates the perforated needle 880 in one of the selected needle guide slots 875 (e.g., selected based on angular measurements) and inserts the perforated needle 880 through the selected guide slot into the patient's body. The position and angle of needle insertion into the patient's body are defined by the device 805, which has been adjusted based on measurements determined by the position of the S3 hole and other landmarks in the patient's imaging. Therefore, compared with conventional blind techniques, the needle insertion position and angle using the method and device of the present invention have a much higher success rate in accurately locating the patient's S3 hole 33.

[0057] The perforation needle 880 can be equipped with markings indicating the depth at which the needle is inserted into the patient. The user can use these markings to insert the needle into the patient to determine when the tip of the needle 880 approaches the nerve in the S3 foramen.

[0058] After the corresponding pin is inserted into either side of the patient in the manner described, the medical device guide 820 can move inward along the sliding transverse member 815, away from the corresponding pin, so that the device 805 can be removed from the patient. After the pin is inserted into the patient in this manner, the PNE procedure can be performed in a conventional manner. For example, a portion of the pin can be removed, and the remaining portion of the pin still in the patient can be used to insert the implantable device lead into the patient.

[0059] Figure 11A-F illustrates another example aspect of the needle-guided device 1105. Device 1105 includes an elongated base 1110, a sliding transverse member 1115, and one or two medical element guides 1120, all aligned with a reference... Figure 8A -F describes elements with similar names that operate in a similar manner. Device 1105 includes a positioning element 1125 that can be attached to an elongated base 1100. Positioning element 1125 includes a disc or other shaped structure that is attached to the patient during imaging (e.g., step 205). Positioning element 1125 can be attached to the patient using adhesives or other methods. Before imaging (e.g., in step 205), the positioning element is attached to the patient and remains fixed to the patient throughout the needle insertion procedure (e.g., step 230). Figure 12 An example of a positioning element 1125 attached to a patient is shown. Figure 11G An example of a medical component guide 1120 is shown.

[0060] The positioning element 1125 includes a radiopaque portion visible in the image. This radiopaque portion of the positioning element 1125 is based on the first point of interest and the marker, rather than... Figure 6 The coccyx tip performs point of interest identification (e.g., step 210) and image processing for measurement (e.g., step 215). In embodiments utilizing device 1105, the application is programmed with geometric relationships based on the landmark coordinates of the positioning element 1125 on the patient in the image, the coordinates of the S3 hole in the image, and the predefined dimensions of the elongated base 1110. Using this information, the application uses the geometric relationships to determine length measurements, angle measurements, and depth measurements, for example, in a manner similar to that described above but with different defined points of interest and different geometric relationships.

[0061] After determining the length, angle, and depth measurements for device 1105, the user transmits these measurements to device 1105 (e.g., at step 220). This can be performed in a manner similar to the description of step 220 for device 805. For example, the application can output numbers corresponding to the measurements along the degrees of freedom of device 1105, and the user can adjust the positions of the components of device 1105 based on these numbers. For example, the application can output a first number based on the determined length measurements, and the user can adjust the position of the sliding transverse member 1115 along the elongated base 1110 based on this number and on markings on the elongated base 1110.

[0062] After adjusting device 1105 based on the determined measurements, the user places the device on the patient using a positioning feature. In this embodiment, the positioning feature includes a positioning element 1125. An elongated base 1110 is configured to connect to the positioning element 1125, for example, via a snap-fit ​​or other connection mechanism. The portion of the elongated base 1110 connected to the positioning element 1125 may include the positioning feature of the device, and the positioning element 1125 includes a marker on the patient. Step 225 may include placing device 1105 on the patient's back while the patient is in a prone position, connecting the elongated base 1110 to the positioning element 1125 already attached to the patient's back, and aligning the elongated base with the patient's spine. Figure 13 Examples are shown of a positioning element 1125 attached to a patient and a device 1105 placed on the patient's back and connected to the positioning element 1125.

[0063] After placing device 1105 on the patient, the user uses device 1105 as a guide for inserting a needle into the patient's body. Step 230 includes the user using device 1105 as a guide for inserting a perforated needle 880 into the patient's body. Figure 11G As shown, the medical element guide 1120 may include elements defining an aperture and multiple angles, which a user can select based on determined angle measurements. The user places the tip of a needle at the aperture at the base of the medical element guide 1120 and aligns the needle 880 with one of the multiple angles on the medical element guide 1120 based on the determined angle measurements. The needle, arranged in this manner, is then inserted into the patient. Figure 14 An example of needle insertion using device 1105 as a guide is shown. The position and angle of needle insertion into the patient are defined by device 1105, which has been adjusted based on measurements determined from the location of the S3 orifice and other landmarks in the patient's imaging. Therefore, the position and angle of needle insertion using the method and device of the present invention have a much higher success rate in accurately locating the patient's S3 orifice compared to conventional blind techniques.

[0064] The devices described herein (e.g., devices 805 / 805' / 805'' / 1105) are not limited to use with perforated needles (such as perforated needle 880) and can be used to guide the insertion of other types of medical elements into a patient. For example, these devices can be used to guide the insertion of medical elements, including but not limited to perforated needles, other types of needles, leads, instruments, endoscopes, etc.

[0065] Figure 15 A flowchart of an exemplary method for locating and placing a medical component is shown. Step 1505 includes determining one or more measurements from at least one image of the patient's sacrum. In a non-limiting example, to Figure 6 and / or Figure 7 The measurement values ​​are determined in the manner described herein. Step 1510 includes applying one or more of the determined measurement values ​​using a guiding device. In a non-limiting example, the application step includes making one or more adjustments to the device 805 / 805' / 805'' / 1105 based on the determined measurement values ​​in the manner described herein. Step 1515 includes positioning the guiding device against the patient's back using markers. In a non-limiting example, positioning may be done in a manner described herein. Figures 9-10 or Figures 12-14 The procedure is performed as described. In a non-limiting example, the marker includes the patient's coccyx. In a non-limiting example, the marker includes a positioning element attached to the patient. Step 1520 includes inserting a guide needle into the patient's body using the guide device while the guide device is positioned on the patient's back. In a non-limiting example, the guide insertion can be performed in a manner that... Figure 10 or Figure 14 Execute in the manner described.

[0066] As will be understood from this disclosure, an exemplary method is disclosed, comprising the steps of: determining one or more measurements from at least one image of a patient's sacrum; applying the determined one or more measurements with a guiding device; positioning the guiding device on the patient's back using markers; and guiding a medical element into the patient's body using the guiding device while it is positioned on the patient's back.

[0067] In embodiments of the method, the boot device may be adjustable, and applying one or more determined measurements using the boot device may include adjusting the boot device based on one or more measurements.

[0068] In an embodiment of the method, the marker includes the patient's coccyx.

[0069] In embodiments of the method, the markers include positioning elements attached to the patient.

[0070] In embodiments of the method, at least one image includes an image of the patient's pelvis in a lateral view. In embodiments of the method, at least one image includes an image of the patient's pelvis in a posteroanterior plane or anterior-posterior plane. In embodiments of the method, at least one image includes an X-ray or CT scan.

[0071] In embodiments of the method, one or more measurements are determined based on user input defining at least one point of interest in an image. In embodiments of the method, the point of interest in the at least one image includes the location of a foramen in the sacrum. In embodiments of the method, one or more measurements are determined based on predefined dimensions of a guiding device.

[0072] In an embodiment of the method, a guiding device on the back of the patient defines the position and angle at which the medical element enters the patient's body.

[0073] In embodiments of the method, the medical element includes a needle.

[0074] In another disclosed embodiment, the device for guiding the insertion of a medical element may include: an elongated base having a positioning feature referencing a marker on a patient; a head that is translatable along the elongated base in a first direction; and a medical element guide that is translatable along the head in a second direction perpendicular to the first direction, wherein the medical element guide is configured to identify the entry position and insertion angle of the medical element into the patient's body.

[0075] In an embodiment of the device, the elongated base is arc-shaped with a radius of curvature.

[0076] In an embodiment of the device, a positioning feature hangs downward from an elongated base; the marker includes the patient's coccyx; and the positioning feature is configured to be positioned against the patient's coccyx when the device is placed on the patient's back.

[0077] In embodiments of the device, the markings include a positioning element attached to the patient; and the positioning features include a portion of the device connected to the positioning element. In embodiments of the device, the positioning element includes a radiopaque marker.

[0078] In embodiments of the device, the medical element includes a needle.

[0079] In embodiments of the device, the entry position and angle of the medical element into the patient's body are configured such that the medical element passes through a selected hole in the patient's sacrum.

[0080] In embodiments of the device, the medical element guide defines multiple different angles for the insertion of the medical element into the patient's body. In embodiments of the device, the multiple different angles include multiple predefined angles defined by multiple grooves in the medical element guide. In embodiments of the device, the multiple different angles are defined by multiple rotational positions of the medical element guide relative to the head.

[0081] As will be understood from this disclosure, a computer program product may be provided comprising one or more computer-readable storage media having program instructions commonly stored on the one or more computer-readable storage media, wherein the program instructions are executable to: receive at least one image of a patient's sacrum; display at least one image; receive user input defining a point of interest in the at least one displayed image; determine one or more measurements for a medical element guide based on the point of interest and a predefined size of the medical element guide; and output the determined one or more measurements to the user.

[0082] In embodiments of the computer program product, the point of interest includes: a first point located at the tip of the patient's coccyx or other landmark; and a second point located at the sacral foramen of the patient. In embodiments of the computer program product, the point of interest also includes: a third point located at the intersection of the patient's skin surface and a first line extending from the first point; and a fourth point located at the intersection of the patient's skin surface and a second line extending from the second point.

[0083] In an embodiment of the computer program product, the medical guiding element is configured to define the position and angle at which the medical element is inserted into the patient's body when the medical guiding element is located behind the patient.

[0084] Additional embodiments may include manufacturing and / or using the apparatus 805 or 1105 as described herein. Furthermore, instructions for using the apparatus 805 or 1105 described herein may be provided. These instructions may be provided in printed and / or video form.

[0085] A training platform can be provided for the disclosed methods and devices. This training platform is a software platform for doctors, sales representatives, or anyone else who needs to learn or practice the invented techniques / methods. The software platform allows users to upload simulated patients and complete measurement procedures, such as at steps 210 and 215. The software can be configured to score users based on the accuracy of their user input and provide suggestions and tips on how to improve user input. The platform can be used for virtual training and user certification. Platform administrators can deploy training modules and updates to train and update users' best practices. Platform administrators can also collect user experience and interaction data. The platform can provide educational animations for various processes and procedures. Future data collection can be post-processed and optimized on this platform.

[0086] Training models can also be provided. A training model is a physical model used to train physicians, sales representatives, physician assistants, nurses, etc., using methods and equipment 805 and / or 1105. This training model allows users to practice sacral guide placement alone or in conjunction with a virtual training platform. The training model includes the sacral structure and surrounding bony and tissue structures important to the procedure. The training model includes soft tissue stimulation structures where opacity can be adjusted to control internal visualization, allowing users to occlude or view within the model. The training model includes targets that can be touched or “hit” to confirm correct guide placement. When a target is hit, a signal can be generated to confirm correct placement. Furthermore, the model's anatomical structures can be adjusted to different levels for practice on different anatomical structures. This can be achieved by changing the bony placement to alter the required size of the stimulator. This can also be achieved by using different physical models together to represent different case complexities and scenarios.

[0087] In addition, an artificial intelligence (AI) platform can be provided. This AI platform can be configured to collect X-ray, measurement, and lead placement data from monitoring software platforms, patient success rates, etc., and use this data to optimize lead / needle placement. This data can be used to facilitate machine learning to automatically identify points of interest for needle placement, as well as measurements used for guiding the application of the tool on the patient. This data can be used to predict and optimize lead placement, thereby enabling a more efficient transition from external pulse generators (EPGs) to implantable pulse generators (IPGs).

[0088] Computer program product embodiment (“CPP embodiment” or “CPP”) is a term used in this disclosure to describe one or more storage media (also referred to as “media”) collectively included in any group of one or more storage devices that collectively include machine-readable code corresponding to instructions and / or data for performing the computer operations specified in a given CPP claim. A “storage device” is any tangible device capable of holding and storing instructions for use by a computer processor. Without limitation, a computer-readable storage medium can be an electronic storage medium, a magnetic storage medium, an optical storage medium, an electromagnetic storage medium, a semiconductor storage medium, a mechanical storage medium, or any suitable combination of the foregoing. Some known types of storage devices that include these media include: floppy disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), optical disc read-only memory (CD-ROM), digital versatile disc (DVD), memory sticks, floppy disks, mechanical encoding devices (such as punch cards or pits / platforms formed on the main surface of an optical disc), or any suitable combination of the foregoing. As used in this disclosure, computer-readable storage media should not be construed as storing transient signals themselves, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides, optical pulses through fiber optic cables, electrical signals communicated through wires, and / or other transmission media. As those skilled in the art will understand, during normal operation of the storage device, such as during access, defrauding, or garbage collection, data typically moves at some random point in time, but this does not make the storage device transient, because the data is not transient at the time of storage.

[0089] The application (e.g., software) described herein may include computational code stored on a computer-readable storage medium and executed by processing circuitry of a computing device (e.g., computing device 700) to perform the functions described herein. The computational code may include routines, programs, objects, components, logic, data structures, etc., of a specific data type that perform specific tasks or implement code for performing the functions of the embodiments described herein. The application is stored on a portable device (e.g., a USB drive). Furthermore, the application may include processing capabilities for processing image files (e.g., DICOM files). Alternatively, the application may be configured to operate in conjunction with image processing software.

[0090] It should be noted that the examples above are provided for illustrative purposes only and should in no way be construed as limiting the scope of the invention. While aspects of the invention have been described with reference to exemplary embodiments, it should be understood that the terms used herein are descriptive and explanatory, and not restrictive. Within the scope of the appended claims, changes as described and revised herein may be made without departing from the scope and spirit of this disclosure. Although embodiments of the invention have been described herein with reference to specific means, materials, and examples, the embodiments disclosed herein are not intended to be limited to the details disclosed herein; rather, embodiments of the invention extend to all functionally equivalent structures, methods, and uses, such as those within the scope of the appended claims.

Claims

1. A device for inserting a guide needle into a patient receiving sacral nerve stimulation therapy, the device comprising: An elongated base having a first set of markings configured to extend longitudinally along the patient's back, wherein the base is configured to rest near and press against the patient's coccyx; A transverse member that is slidably attached to the elongated base, wherein the transverse member includes a second set of markings; and An element guide, which is mounted to the transverse member, is configured to assist the needle in being inserted into the patient at a predetermined angle at the target location.

2. The apparatus of claim 1, further comprising an adjustable pin guide attached to the element guide.

3. The apparatus according to claim 1, wherein, The first set of markings corresponds to the distance along the elongated base from the end of the coccyx toward the head.

4. The apparatus according to claim 3, wherein, The second set of markings corresponds to the lateral distance away from the patient's spine.

5. The apparatus of claim 1 further includes a non-transparent positioning element configured to be selectively attached to the elongated base.

6. The apparatus of claim 5, wherein the first set of markers corresponds to a distance relative to the positioning element.

7. A device for guiding the insertion of a needle into a patient for sacral nerve stimulation therapy, the device comprising: An elongated base having a first set of markings configured to extend longitudinally along the patient's back, wherein the base is configured to rest near and press against the patient's coccyx; A transverse member having a second set of markings; wherein the transverse member is slidably attached to the elongated base; A guide body slidably attached to the transverse member, wherein the guide body is configured to move in a direction perpendicular to the elongated base; and The guide includes a tilting guide configured to guide the needle to a target location on the patient at a predetermined angle.

8. The apparatus of claim 7, wherein the guide includes a plurality of grooves configured to guide the needle.

9. The apparatus according to claim 8, wherein, The plurality of grooves are arranged in a fan-shaped pattern.

10. The apparatus according to claim 7, wherein, The guide body also includes a aperture located on the base of the guide body and a third set of markings set along the length of the groove on the top surface of the guide body.

11. The apparatus of claim 7 further includes a non-transmissive positioning element configured to be selectively attached to the elongated base.

12. The apparatus according to claim 11, wherein, The first set of measurement markers corresponds to the distance relative to the positioning element.

13. The apparatus according to claim 7, wherein, The first set of markings corresponds to the distance along the elongated base relative to a vertical reference line drawn from the end of the coccyx to the elongated base toward the head.

14. The apparatus according to claim 13, wherein, The predetermined angle is measured relative to a line tangent to the arc length of the device.

15. A method for marking a location on a patient for inserting a needle to place a lead for nerve stimulation therapy, the method comprising the steps of: Obtain a scaled image of the patient; Select the tip of the patient's coccyx shown in the image; A first line is applied to the image, wherein the first line extends from the tip of the coccyx to the surface of the patient's skin; A second line is applied to the image, wherein the second line extends from a target location perpendicular to the patient's sacrum to the patient's skin surface; Calculate the measurement values ​​corresponding to the locations on the patient; Retrieve the measured value; and The patient is identified using a measuring device based on the measured values.

16. The method of claim 15, wherein the method is used to identify the insertion location of a needle for placement near the S3 orifice of the patient.

17. The method of claim 15, wherein the measured value includes a distance calculated on the measuring device from the head-oriented side of the first line.

18. The method of claim 17, further comprising inserting the needle into the patient at the location of the patient orifice.

19. The method of claim 15, wherein the measured value includes a needle entry angle, wherein the calculation of the needle entry angle is derived from the second line and a line tangent to the arc length of the device.

20. The method of claim 15, wherein the measuring device comprises an elongated base having a first set of markings configured to extend longitudinally on the back of the patient and rest near the patient's coccyx; and a transverse member having a second set of markings slidably attached to the elongated base.

21. The method according to claim 15, wherein, At least one of the steps of applying the first line and applying the second line is implemented using image recognition-based AI.

22. The method according to claim 21, wherein, The application step is performed without taking into account the patient's orientation on the image.

23. A device for inserting a guide needle into a patient receiving sacral nerve stimulation therapy, the device comprising: An elongated base having a first set of markings is configured to extend longitudinally along the back of the patient, and wherein the base is configured to rest near and press against the patient's coccyx; A laterally extending, single-piece integral component slidably attached to the elongated base, wherein the laterally extending component includes a second set of markings; and The transverse member includes a plurality of guide grooves located at a fixed distance from the elongated base, wherein each of the guide grooves is configured to assist the needle in being inserted into the patient at a predetermined angle at the target location.

Images