System and method for placing neurostimulation lead

Abstract

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

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 411,904, filed on September 30, 2022, and U.S. Provisional Patent Application No. 63 / 331,474, filed on April 15, 2022, which are hereby incorporated by reference in their entireties. Technical Field

[0003] This application relates to devices and methods for assisting in the placement of leads used in nerve stimulation. In an exemplary embodiment, the devices and methods relate to the placement of electrical leads used in sacral nerve modulation, and more particularly to devices and methods for locating the sacral foramina during a peripheral nerve evaluation (PNE) procedure in order to place the electrical leads of a PNE system in the proper position. Background Art

[0004] Sacral nerve modulation is used in the treatment of bladder and bowel dysfunction and involves implanting a device that provides controlled electrical stimulation to the patient's sacral S3 spinal nerve. Prior to permanent implantation, the patient undergoes a procedure called a peripheral nerve evaluation (PNE). This procedure involves implanting a temporary lead into the patient, connecting the lead to an external pulse generator, and then observing the results over a period of time, typically 3 to 14 days. If the results meet certain clinical criteria, the patient may be a candidate for an implantable pulse generator for sacral nerve modulation.

[0005] Current techniques for lead placement during the evaluation procedure involve identifying palpable bony landmarks on the patient and inserting a trocar needle into the patient based on the positions of these landmarks. The goal during this procedure is to pass the trocar needle through the skin and into the S3 foramen such that an electrical stimulation lead is provided along the sacral S3 spinal nerve. This procedure can be performed in an operating room setting using fluoroscopy or other image guidance for more accurate lead placement. However, the procedure is typically performed in an office setting under local anesthesia and without imaging. In the office setting, the placement method is essentially a "blind" insertion method as it does not rely on pictures of the patient's anatomy or fluoroscopy.

[0006] When fluoroscopy or other imaging is not used, such as in an office setting, a physician inserts a trocar through the patient's body wall into the S3 foramen based on experience and with reference to palpable landmarks. When the physician attempts to pass the trocar through the S3 foramen, the S3 foramen is not visible. The use of palpable bony or osseous landmarks is based on normal anatomy and does not account for anatomical or pathological variations. This can result in improper lead placement in an office setting and ultimately lead to failure of PNE. For example, multiple attempts are often required to locate the S3 foramen and successfully insert the trocar through the foramen. In some cases, due to multiple failed attempts to correctly place the needle, the patient may even abandon PNE (and thus sacral neuromodulation as well) without ever having the lead correctly placed. Improper lead placement can also result in suboptimal clinical outcomes and lead to premature abandonment of an otherwise effective treatment. Accordingly, there remains a need to provide improved systems and methods for PNE lead placement. Summary of the Invention

[0007] Embodiments disclosed herein relate to devices and methods for improving the efficacy and efficiency of locating sacral foramina during sacral neuromodulation. Embodiments include imaging a portion of a patient, identifying internal points of the patient in the imaging, calculating measurements based on the imaging and the identified points, transmitting the measurements to a device, positioning the device on and external to the patient using positioning features, and using an element guide of the device to guide a medical element (e.g., a trocar) into the patient. The disclosed embodiments assist a physician in more accurately locating the S3 foramen and provide an improvement over conventional techniques that are less accurate 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 based on at least one image of a patient's sacrum; applying the determined one or more measurements using a guiding device; positioning the guiding device on the patient's back using a landmark; and using the guiding device to guide insertion of a medical element into the patient when the guiding device is positioned on the patient's back.

[0009] According to another disclosed embodiment, a device for guiding insertion of a medical element includes: an elongate base having positioning features that reference a landmark on a patient; a head that is translatable along the elongate 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 an entry location and angle for inserting the medical element into the patient.

[0010] In yet another disclosed embodiment, a system and method are disclosed that include one or more computer-readable storage media having program instructions stored jointly on the one or more computer-readable storage media or on a remote cloud-based service. The program instructions are executable to: receive at least one image of a patient's sacrum; display the image; receive user input defining a point of interest in the displayed 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. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0012] Figure 2 Elements of an exemplary medical element positioning and placement system are shown.

[0013] Figure 3 An example of a radiopaque marker device is shown.

[0014] Figure 4 An example of a radiopaque marker device is shown.

[0015] Figure 5 A flowchart of an exemplary method of positioning an insertion point and placing a medical element is shown.

[0016] Figure 6 and Figure 7 An exemplary implementation of identifying points in a fluoroscopic image and processing the image for measurement is shown.

[0017] Figures 8A - 8G An exemplary needle guide device is shown.

[0018] Figure 9 An example of placing a needle guide device on a patient using positioning features is shown.

[0019] Figure 10 An example of guiding a medical element into a patient using a needle guide device is shown.

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

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

[0022] Figure 13 An example of a positioning element fixed to a patient and a needle guide device placed on the patient's back and connected to the positioning element is shown.

[0023] Figure 14Shows an example of needle insertion using a Figures 11A - 11F needle guiding device.

[0024] Figure 15 Shows a flowchart of an exemplary method of positioning and inserting a needle into a patient for placement of a PNE lead. Detailed Description

[0025] The details shown herein are only for example purposes for an illustrative discussion of the disclosed embodiments and for providing a description of the principles and concepts in an easy-to-understand manner. In this regard, no attempt has been made to show structural details in more detail than is necessary for a basic understanding, and the description in conjunction with the drawings enables those skilled in the art to clearly understand how the disclosed apparatus and methods are embodied in practice.

[0026] Figure 1 Shows an exemplary partial view of certain skeletal components of a human torso 10, the human torso including a sacrum 15 at the base of the spine 20 and a coccyx 25 at the base of the sacrum 15. As Figure 1 shown, the sacrum 15 includes two sets of sacral foramina or openings through which the sacral nerves pass, arranged in two vertical rows, each respectively located on one side of the medial sacral crest. In Figure 1 , foramen 31 corresponds to the S1 foramen, foramen 32 corresponds to the S2 foramen, foramen 33 corresponds to the S3 foramen, and foramen 34 corresponds to the S4 foramen. Figure 1 Only one set of sacral foramina is shown and numbered herein. A system and method are disclosed herein for precisely positioning a selected one of the foramina 31 - 34 and inserting a needle through the selected one of the foramina to access a nerve for implanting components of a sacral nerve modulation system. Embodiments regarding positioning and inserting a needle through the S3 foramen are described herein; however, the described system and method are not limited to use with the S3 foramen.

[0027] Figure 2Shows components of a medical element placement system 100, which includes an imaging system 700 that can communicate with one or more electronic devices. Although X-ray or fluoroscopic imaging is preferred, other imaging techniques that display and distinguish the internal skeletal structure of a patient can be used. The electronic device can 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 the display of the electronic device. In addition to (or as an alternative to) the display, the electronic device can provide various indications to the user via audible or visual alerts or messages. The imaging system 700 is configured to capture images of a patient who requires a PNE procedure. The medical element placement system 100 requires images taken in the anterior-posterior (or posterior-anterior) and lateral planes to provide the measurements needed to place the PNE lead in the correct position. Once the images are captured, the images from the imaging system 700 can be sent to one or more electronic devices, which are configured to run an application (e.g., software) or act in conjunction with an application that is configured to process the images and provide information that can be used to correctly position the needle guide device 805 on the patient and mark the patient as needed to identify the insertion points of the bore needles for placing the PNE leads.

[0028] In one embodiment, the application can be run using a cloud-based computing service 703 that communicates with the electronic device. The cloud-based computing service can perform the calculations required to identify the preferred needle entry points (and angles) and provide the resulting positions and angles to the electronic device. The electronic device can run the application described below with respect to Figure 6 and Figure 7 (or access a web client of the cloud-run version of the application), and the application can provide various information on a display (e.g., screen) on the screen of the electronic device. For example, the electronic device can display the coordinates (e.g., markings on the needle guide device 805) and angles for inserting the needle into the patient. The information provided by the application can then be applied to the needle guide device 805 to assist in placing and inserting the needle into the patient.

[0029] The program can also use machine learning or artificial intelligence (AI) in combination to provide enhanced image recognition capabilities. The image recognition capabilities or features can allow the program or application to automatically provide points of interest, draw or apply desired lines on the image, and calculate measurements based on the image provided to the program. The image recognition features can also provide points of interest regardless of the patient's orientation during imaging. Thus, if the patient is in a non-consistent position relative to the axis of the image, measurements can still be obtained because the AI employed is able to identify anatomical points of interest. As described above, the "drawing" of the lines may be visible to the user of the program or only inherently performed as part of the operation of the program or application that determines or calculates the required measurements and preferred positions for needle insertion.

[0030] Figure 3 and Figure 4 An example of a radiopaque marker device 305 that can be used in conjunction with imaging of a patient is shown. The imaging includes an X-ray of the patient's lateral plane, thereby showing the patient's sacrum 15 and coccyx 25. The imaging can also include one or both of the anterior-posterior (AP) plane or posterior-anterior (PA) plane of the same region (i.e., showing the patient's sacrum and coccyx). The radiopaque marker device 305 can be placed on the patient during X-ray imaging within the field of view of the imaging device 700. The radiopaque marker device 305 includes a radiotransparent housing 310 and a radiopaque element 315. The radiotransparent 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 radiotransparent housing 310. The radiotransparent housing 310 can facilitate the placement of the radiopaque marker device 305 on the patient when taking an image. 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 in conjunction with one or more X-ray images to define the scale of one or more images of the patient and to provide a reference for correctly determining the measurement values required to locate the insertion point of a needle on the patient. In a particular embodiment, the radiopaque element 315 includes a sphere having a predefined diameter such that the radiopaque marker device 305 can be placed on the patient in any orientation during imaging. Many other known marker devices can be used, such as radiopaque devices having different predefined shapes and sizes. The marker device can be fixed to the patient or to the radiographic table on which the X-ray image is taken.

[0031] Figure 5FIG. 0 shows a flowchart of an exemplary method. Step 205 includes imaging a portion of a patient. Images of the patient can be obtained while the patient is in various positions. Imaging system 700 can capture images of the patient's sacrum 15 and coccyx 25 in both the anterior-posterior (or posterior-anterior) and lateral planes. The processing software of imaging system 700 can set appropriate dimensions using a scale provided by the radiopaque marker device or imaging system 700. The processing software of imaging system 700 can automatically further manipulate the image to make it clear (e.g., modify the contrast or brightness of the image). Once transferred to an electronic device, the image can also be made further clear.

[0032] Step 210 includes identifying internal points of interest related to the patient in the imaging to determine key measurements used in the calculation. Step 215 includes calculating measurements for identifying the recommended insertion position of the needle based on the imaging and the identified points. These measurements can be used to position elements of the needle guidance device 805. The software can also calculate the needle entry angle α and the minimum needle length. The minimum needle length is defined as the minimum needle length required to reach the target position (e.g., the S3 sacral foramen).

[0033] Step 220 includes transmitting the measurements calculated in step 215 to the needle guidance device 805. Step 225 includes placing the needle guidance device 805 on and external to the patient using positioning features. Step 230 includes guiding a medical element (e.g., a cannula needle) into the patient using the element guide of device 805. Embodiments of implementing these steps will become apparent from the following drawings and related description.

[0034] Figure 6 and Figure 7 FIG. 12 shows an exemplary X-ray image 505 in which the radiopaque element 315 of the radiopaque marker device 305 is visible. Since the radiopaque element 315 has a predefined diameter, this known measurement of the radiopaque element 315 can be used to define the scale of the X-ray image 505. The application can use this scale when calculating the measurements described herein. When the imaging system 700 can include an automatic scaling function that provides the image scale, a scale indicator 510 (e.g., tick marks embedded and depicted on the X-ray image) can also be provided as an alternative to the marker device 305. The scale indicator 510 can be adjusted to correspond to the image magnification selected by the user. In both of these alternatives (e.g., using the radiopaque marker device 305 or the automatic scaling function), the image is set with the scale of the image, which can be used when calculating the measurements required to identify the needle insertion position for correctly placing the lead. When the imaging system 700 cannot provide the image scale 510, a radiopaque marker must be used so that the image can still be correctly measured.

[0035] Figure 6 andFigure 7 Exemplary embodiments are also shown for identifying points in one or more images and processing one or more images for measurement values that can be used, respectively, in steps 210 and 215. The measurement values refer to the coordinates or positions of the needle insertion points on the patient. As described above, these measurement values can be transmitted to the needle guidance device 805. One or more images from step 205 are uploaded to an electronic device (not shown) for processing. The electronic device can be, for example, a desktop computer, a laptop computer, a tablet computer, or a smartphone running dedicated software (e.g., a proprietary application). The application can be part of a software program product as described herein. Alternatively, all or part of the processing can be performed in a cloud-based application.

[0036] The electronic device can include a display for displaying an image (e.g., an X-ray taken at step 205) and a user input mechanism that allows a user to identify points in the displayed image. The display and the user input mechanism can be combined in a touch screen display, for example, which can display the image and receive user touch inputs that define points of interest in the image. The display and the user input mechanism can be separate, for example, a display screen that displays the image and a mouse or trackball that controls a pointer (e.g., a cursor, an arrow, etc.) superimposed on the displayed image, and a button that the user can press to define the current position of the pointer on the image as a point of interest in the image.

[0037] 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 the electronic device. The application uses a predefined size of the radiopaque element 315 in one or more images or a scale indicator (e.g., scale indicator 510) provided in one or more images to establish the scale of one or more images. Step 210 can optionally include an application that adjusts visual aspects of one or more images, such as contrast. Figure 6 An example of a simplified lateral X-ray image 505 is shown, which includes a scale indicator 510 that defines the scale of the image 505.

[0038] Continuing reference Figure 6, the application receives user input through an electronic device. The user uses an image to identify points of interest in image 505. The user can interact with the image (e.g., via a touch screen, keyboard, template, etc.) to identify points in the image. There are four points of interest 521, 522, 523, and 524, which are defined by user input. The application can provide the user with one or more messages that prompt the user to provide their input for one or more of the points of interest. The user provides input to define the first point of interest 521 located at the front end (e.g., distal end) of the coccyx in image 505. In response to receiving this input, the application draws a vertical line 525 upward from the first point of interest 521. When line 525 is displayed, the user provides input to define the second point of interest 522 located at the intersection of line 525 and the outer surface of the patient's skin. The user provides input to define the third point of interest 523 located at the center of the target hole, in this case the S3 sacral foramen, in image 505. In response to receiving this input, the application draws a line 526 perpendicular to the sacrum and upward toward the outer surface of the patient's skin at the third point of interest 523. When line 526 is displayed, the user provides input to adjust or confirm that line 526 is perpendicular to the sacrum and provides input to define the fourth point of interest 524 located at the intersection of line 526 and the outer surface of the patient's skin.

[0039] In the case where the image is not completely clear (i.e., S3 is not fully visible), the application can suggest where to calibrate the S3 foramen based on other points of interest. For example, as an alternative to asking for point of interest 523, the program can ask for the positions of the lumbosacral joint (the junction of the L5 vertebra and S1) and the caudal front end 521 of the coccyx. The program can then estimate the position of 523 by calculating the midpoint between the lumbosacral joint and the caudal front end 521 of the coccyx. Other alternatives can include providing an estimate of the position where the S3 foramen is located by providing a known measurement of the average position of the S3 foramen in human anatomy (e.g., S3 is approximately 11 cm from the front end of the coccyx).

[0040] The methods described herein can include using image processing software. For example, an application that interacts with an electronic device can include image processing software to facilitate image processing. The image processing software can provide the user with the ability to utilize the following image-related functions: translation, zooming, windowing, scrolling, crosshairs, filtering (brightness and contrast adjustment), measurement of distance, angle, and area, image rotation / flip, etc. The above image processing functions can run in the background of the application and software without user input, or can be provided as an option to the user to manipulate the image to assist in identifying points of interest.

[0041] Image processing software can be specialized for processing image files (e.g., DICOM files) commonly associated with fluoroscopic images. Digital Imaging and Communications in Medicine (DICOM) is an international standard for medical images and related information. DICOM defines the medical image formats in which data and quality required for clinical use can be exchanged. The processing software can provide the ability to create 3D reconstruction models of the patient and the patient's skeletal structure to assist in localizing the sacral foramina and preferred needle entry points. Additionally, the image processing software can be configured to anonymize and de-identify any patient details retained in the image such that the image can be used for machine learning and AI applications.

[0042] Processing the image for measurement in step 215 includes determining length measurements, angle measurements, and depth measurements based on the points of interest defined by the user in step 210. The application determines the length measurements, angle measurements, and depth measurements based on: the coordinates of each point of interest in the coordinate system defined for the image (e.g., X-Y Cartesian coordinates); the scale of the image relative to the same coordinate system; and one or more predefined dimensions of a device that will be used as a needle guide. One or more predefined dimensions of the device include a predefined radius of curvature of the elongated base of the device. The application uses this information (e.g., coordinates, scale, and predefined dimensions of the device) as input to an algorithm or program that employs established geometric and trigonometric formulas and calculations to determine: (i) the length of arc 530 extending between a second point 522 and a fourth point 524, where the arc has a predefined radius of curvature; (ii) the angle 535 between line 526 and the tangent to arc 530 at the fourth point 524; and (iii) the length of line 526 between a third point 523 and the fourth point 524. The determined length of arc 530 between the second point 522 and the fourth point 524 includes the length measurement, the determined angle 535 includes the angle measurement, and the determined length of line 526 between the third point 523 and the fourth point 524 includes the depth measurement. The application outputs the determined measurements to the user, e.g., via a display. The angle 535 can be calculated as the angle between an extension of line 526 and a tangent "T" that is tangent to the circular arc 530 at point 524.

[0043] Figure 7An example of a posterior-anterior (PA) X-ray image 605 is shown. When the user identifies a point of interest in image 605, the application receives user input via a computing device. The user can interact with the image (e.g., via a touchscreen, keyboard, template, etc.) to identify additional points of interest 621, 622 on the image. The first additional point of interest 621 is located at the center of the S3 foramen in image 505. In response to receiving this input from the user, the application draws a line 625 that intersects point 621 and is perpendicular to the sacral centerline. When line 625 is displayed, the user identifies a second additional point of interest 622 located at the intersection of line 625 and the sacral centerline. 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 measurement to the user, e.g., via a display. The user can edit any one or more of the points of interest (i.e., 521, 522, 523, 524, 621, 622), and the program can automatically recalculate the measurements output based on the updated one or more points. The step of identifying additional points of interest can be omitted, and the application can assume a standard distance in the range of approximately 20 to 25 mm based on published studies or surveys.

[0044] Figure 8A and Figure 8B An exemplary needle guidance device 805 is shown. Device 805 includes an elongate base 810, a sliding lateral member 815, and a medical element guide 820. Device 805 includes a pendant portion 825 that extends downward from the bottom surface of the elongate base 810. The bottom surface of the elongate base 810 has a radius of curvature 830 that is relative to Figure 6 one of one or more predefined dimensions of the described device, and an application for determining measurements. In another embodiment, the elongate base 810 may not be fully curved or arcuate. Instead, the elongate base 810 may include a flat portion that better conforms to the topographical shape of the patient. In one embodiment, the optional flat portion is located at the end of the elongate base 810 that is closer to the patient's head. The sliding lateral member 815 can also slide along this flat portion.

[0045] The elongated base 810 may include a coccyx positioning feature (e.g., the overhang portion 825) for positioning the device 805 onto a patient. The coccyx positioning feature bears against the coccyx while the arcuate feature is positioned along the midline defined by the sagittal plane of the patient. The arcuate feature of the elongated base 810 is a predefined arcuate geometry that the application uses to determine measurements in step 215. The sliding lateral member 815 slides along the elongated base 810 and remains perpendicular to the elongated base 810. The sliding lateral member 815 may be locked at a specific position on the elongated base 810. The elongated base 810 has measurements that include setting the sliding lateral member 815 at a position determined by calculations and measurements based on 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. The lateral placement may be set based on imaging measurements or standard practice. The medical element guide 820 allows needles to be placed at different angles. The medical element guide 820 allows the user to fix the needle at a defined angle during use. The medical element guide 820 and the sliding lateral member 815 are also designed to allow the removal of the device 805 while the needle remains with the patient. Marks on the needle are also used to measure the depth of needle placement. The measurement is generated during image measurement and can be used to position the depth of the bore needle within the patient.

[0046] The sliding lateral member 815 may be translated relative to the elongated base 810 in a first direction 841 (i.e., the cephalic direction) and a second direction 842 (i.e., the caudal direction) opposite the first direction along the length of the elongated base 810. The sliding lateral member 815 includes a locking mechanism 845 that allows the 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 wing screw or other conventional or later-developed locking mechanisms that may 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 an identification 850 corresponding to the unit of the length measurement determined in step 215. In Figure 8A the example shown, the identification 850 includes a millimeter scale from 0 to 180 along the length of the elongated base 810.

[0047] Continuing to refer Figure 8A , the step of transmitting the measurement value to the device 220 includes moving the sliding lateral member 815 to a certain position on the elongated base 810 such that the indicator 855 of the sliding lateral member coincides with the position on the scale of the identification 850 that matches the length measurement value determined in step 215. In Figure 6In the example, the length measurement is determined to be 136.8 mm. Using this exemplary length measurement, at step 220, the user moves the sliding lateral member 815 along the elongated base 810 until the indicator 855 coincides with the position corresponding to the number 136.8 on the scale of the identifier 850. In the case where the number of the length measurement does not exactly align with one of the numbers of the identifier 850, the user can insert the position of the indicator 855 that most closely matches the length measurement between two numbers of the identifier 850. After positioning the sliding lateral member 815 on the elongated base 810 according to the length measurement, the user locks the sliding lateral member 815 relative to the elongated base 810 using the locking mechanism 845.

[0048] In Figure 8A In the example shown, the device 805 includes a medical element guide 820 that is translatably movable relative to the sliding lateral member 815 in a first direction 861 and a second direction 862 opposite the first direction, where the translation direction of the medical element guide 820 relative to the sliding lateral member 815 is perpendicular to the translation direction of the sliding lateral member 815 relative to the elongated base 810. The device 805 includes a corresponding locking mechanism that allows the 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 lateral member 815. The locking mechanism can include a wing screw or other conventional or later-developed locking mechanisms 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 lateral member 815 and / or the medical element guide 820 can include stoppers that define predefined positions of the medical element guide 820 on the sliding lateral member 815.

[0049] Each wing of the sliding lateral member 815 can include an identifier 865 (e.g., as Figure 7 shown) corresponding to the unit of the lateral distance determined at step 215. In Figure 8A the example shown, the identifier 865 includes a millimeter scale from 10 to 40 along the lateral dimension of the sliding lateral member 815.

[0050] Continuing to refer to Figure 8A , transmitting the measurement value to the device at step 220 can 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 coincides with the position on the scale of the identifier 865 that matches the lateral distance determined at step 215. In Figure 6In the example, the lateral distance is determined to be 20 mm. Using this exemplary length measurement, at step 220, the user will move each medical element guide 820 along the wing of the sliding lateral member 815 until the position indicator on the medical element guide 820 coincides with the position corresponding to the number 20 in the scale of the identifier 865. In the case where the number of the lateral distance does not exactly align with one of the numbers of the identifier 865, the user can insert the position of the indicator that best matches the lateral distance between the two numbers of the marker 850. 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.

[0051] Continuing to refer Figure 8A and Figure 8B , in an embodiment, each medical element guide 820 includes a graded needle guide 870, which includes a plurality of needle guide slots 875 arranged at different predefined angles. The different predefined angles are within a range that is most likely to include the determined angle measurements of most patients. For example, the different predefined angles are in the range of 90 degrees to 140 degrees, where the discrete needle guide slots among the plurality of needle guide slots 875 are arranged at 10-degree increments within this range. Each corresponding needle guide slot among the plurality of needle guide slots 875 can be provided with an identifier indicating the angle of the corresponding one of the plurality of needle guide slots 875. Step 220 can 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 will select the needle guide slot among 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 at 10-degree increments between 90 degrees and 140 degrees, for an angle measurement of 106.5 degrees, the user will select the 110-degree angle guide slot.

[0052] Other mechanisms for guiding the needle at the selected angle can be used to replace the guide slots 875. For example, Figure 8GAn exemplary embodiment of the device 805' is shown, where each medical element guide 820' includes a single needle slot, and the medical element guide 820' can be rotated relative to the sliding lateral member 815 about an axis parallel to the direction defined by 861 and 862 and perpendicular to the direction 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 at a predefined increment of 10 degrees. In this way, the angle adjustment of the medical element guide 820' can function in the manner of an adjustable protractor fixed to the sliding lateral member 815. A locking mechanism can be used to selectively lock and unlock the rotation of the medical element guide 820' relative to the sliding lateral member 815. The elements of the device 805' function in the same manner as the elements of the device 805, except that the medical element guide 820' has a single needle guide that can be rotated to different angles, while the medical element guide 820 has a plurality of needle guides at different angles. The angle of the needle can also be guided by an alternative mechanism (such as Figure 11A the element 1120 shown in

[0053] . The increments of the needle guides described herein can be appropriately varied according to the procedure being performed. For example, the guide angle can be positioned at angle increments in the range of 5 to 20 degrees. In addition, the various guides disclosed herein can be sized to accommodate various sizes, such as 20-gauge needles and 19-gauge needles.

[0054] Figure 8C , Figure 8D , Figure 8E and Figure 8F show views of the device 805, where the bore needle 880 is located in one of the guide slots 875 of one of the medical element guides 820. As Figures 8C - 8F shown, the guide slot opens at the outer end, such that when the bore needle 880 is inserted into the patient, the medical element guide 820 can be moved away from the bore needle 880. This allows adjustment of the placement of the medical element (needle) angle or removal of the device 805 from the patient after inserting the bore needle 880 using each medical element guide 820.

[0055] Figure 9An example of placing the device 805 on a patient using positioning features is shown. The above step 225 may include using the positioning features to position the device for the patient. After transmitting the measurement values to the device 805 in step 220 (e.g., as described with respect to Figure 8A and Figure 8B ), the user places the device 805 on the patient, i.e., the same patient imaged at step 205. Placing the device 805 in step 220 includes positioning the device 805 on the outer surface of the skin of the patient in the prone position, where the overhanging portion 825 of the device is positioned adjacent to the coccyx of the patient and the elongated base 810 of the device 805 is aligned with the spine of the patient.

[0056] Figure 10 An example of guiding a medical element into a patient using the device 805 is shown. Figure 10 An example of the device 805 placed on a patient as described in steps 225 and Figure 9 is shown. For example, the device 805 is located on the outer surface of the skin of the patient in the prone position, the overhanging portion 825 of the device is positioned adjacent to the coccyx 25 of the patient, and the elongated base 810 of the device 805 is aligned with the spine of the patient. After transmitting the measurement values to the device 805 in step 220 and then placing the device 805 on the patient in step 825, step 230 includes using the device 805 placed on the patient as a guide for inserting a needle (e.g., the foramen needle 880) into the patient. The user initiates the foramen needle 880 in a selected one of the needle guide slots 875 (e.g., selected according to the angle measurement value) and inserts the foramen needle 880 through the selected guide slot into the patient. The position and angle of the needle inserted into the patient are defined by the device 805, which has been adjusted according to the measurement values determined based on the positions of the S3 foramen and other landmarks in the patient's image. Therefore, compared with traditional blind techniques, the position and angle of needle insertion using the method and device of the present invention have a higher success rate in accurately positioning the S3 foramen 33 in the patient's body.

[0057] The foramen needle 880 may be provided with an identification indicating the depth of insertion of the needle into the patient. The user can use the insertion depth identification to determine when the front end of the foramen needle 880 approaches the nerve in the S3 foramen while inserting the foramen needle into the patient.

[0058] After inserting the corresponding foramen needle into either side of the patient in the manner described, the medical element guide 820 can be moved inward away from the corresponding foramen needle along the sliding lateral member 815, so that the device 805 can be removed from the patient. After inserting the foramen needle into the patient in this manner, the PNE procedure can be carried out in a conventional manner. For example, a part of the foramen needle can be removed and the remaining part of the foramen needle still in the patient can be used to insert an implantable device lead into the patient.

[0059] Figures 11A - 11FShows aspects of another example of a needle guidance device 1105. The device 1105 includes an elongate base 1110, a sliding lateral member 1115, and one or two medical element guides 1120, all of which operate in a manner similar to the similarly named elements described with respect to Figures 8A - 8F Those described. The device 1105 includes a positioning element 1125 that can be connected to the elongate base 1110. The positioning element 1125 includes a disk or other shaped structure that is fixed to the patient during imaging (e.g., step 205). The positioning element 1125 can be fixed to the patient using an adhesive or other method. The positioning element is fixed to the patient before imaging (e.g., at step 205) and remains fixed to the patient throughout the needle insertion process (e.g., at step 230). Figure 12 Shows an example of the positioning element 1125 fixed to the patient. Figure 11G Shows an example of the medical element guide 1120.

[0060] The positioning element 1125 includes a radiopaque portion that is visible in the image. Identifying the point of interest (e.g., step 210) and processing the image for the measurement values (e.g., step 215) are based on the radiopaque portion of the positioning element 1125 for the first point of interest and the landmark points rather than Figure 6 The front end of the coccyx described in. In an embodiment of using the device 1105, the application is programmed with geometric relationships that are based on the landmark point coordinates of the positioning element 1125 on the patient in the image, the coordinates of the S3 foramen in the image, and the predefined dimensions of the elongate base 1110. Using this information, the application uses geometric relationships to determine length measurements, angle measurements, and depth measurements, e.g., in a manner similar to that described above, but using different defined points of interest and different geometric relationships.

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

[0062] After adjusting the device 1105 based on the determined measurement values, the user places the device on the patient using the positioning features. In this embodiment, the positioning features include the positioning element 1125. The elongate base 1110 is configured to be connected to the positioning element 1125, for example, by snap fit or other connection mechanism. The portion of the elongate base 1110 that is connected to the positioning element 1125 may include the positioning features of the device, and the positioning element 1125 includes a fiducial on the patient. Step 225 may include placing the device 1105 on the patient's back while the patient is in the prone position, connecting the elongate base 1110 to the positioning element 1125 that has been secured to the patient's back, and aligning the elongate base with the patient's spine. Figure 13 An example of the positioning element 1125 secured to the patient and the device 1105 placed on the patient's back and connected to the positioning element 1125 is shown.

[0063] After placing the device 1105 on the patient, the user utilizes the device 1105 as a guide for inserting a needle into the patient. Step 230 includes the user using the device 1105 as a guide for inserting the bore needle 880 into the patient. As Figure 11G shown, the medical element guide 1120 may include an element that defines an aperture and a plurality of angles that the user can select based on the determined angle measurement values. The user places the front end of the needle in the aperture at the base of the medical element guide 1120 and aligns the bore needle 880 with a selected angle among the plurality of angles on the medical element guide 1120 based on the determined angle measurement values. The needle arranged in this manner is then inserted into the patient. Figure 14 An example of needle insertion using the device 1105 as a guide is shown. The position and angle of the needle inserted into the patient are determined by the device 1105, which has been adjusted based on the measurement values determined from the positions of the S3 foramen and other fiducials in the imaging of the patient. Thus, compared to traditional blind methods, the position and angle of needle insertion using the methods and devices of the present invention have a higher success rate for accurately locating the S3 foramen within the patient.

[0064] The devices described herein (e.g., device 805 / 80571105) are not limited to use with bore needles (e.g., bore needle 880) and can be used to guide the insertion of other types of medical elements into the patient. For example, the device can be used to guide the insertion of medical elements including but not limited to bore needles, other types of needles, leads, instruments, endoscopes, etc.

[0065] Figure 15 A flowchart of an exemplary method for positioning and placing a medical element is shown. Step 1505 includes determining one or more measurement values based on at least one image of the patient's sacrum. In a non-limiting example, the measurement values are in Figure 6 and / or Figure 7Determined in the manner described. Step 1510 includes applying the determined one or more measurement values using a guiding device. In a non-limiting example, the applying step includes making one or more adjustments to device 805 / 805’ / 1105 in the manner described herein based on the determined one or more measurement values. Step 1515 includes positioning the guiding device on the dorsal side of the patient using a landmark. In a non-limiting example, the positioning can be performed in the manner Figures 9 - 10 or Figures 12 - 14 described. In a non-limiting example, the landmark includes the patient's coccyx. In a non-limiting example, the landmark includes a positioning element fixed to the patient. Step 1520 includes, when the guiding device is on the dorsal side of the patient, using the guiding device to guide a needle into the patient. In a non-limiting example, the guiding of the insertion can be performed in the manner Figure 10 or Figure 14 described.

[0066] It can be understood from the present disclosure that an exemplary method is disclosed, which includes the following steps: determining one or more measurement values based on at least one image of the patient's sacrum; applying the determined one or more measurement values using a guiding device; positioning the guiding device on the dorsal side of the patient using a landmark; and when the guiding device is on the dorsal side of the patient, using the guiding device to guide a medical element into the patient.

[0067] In an embodiment of the method, the guiding device can be adjustable, and applying the determined one or more measurement values using the guiding device can include adjusting the guiding device based on the one or more measurement values.

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

[0069] In an embodiment of the method, the landmark includes a positioning element fixed to the patient.

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

[0071] In an embodiment of the method, one or more measurement values are determined based on a user input defining a point of interest in at least one image. In an embodiment of the method, the point of interest in the image includes the position of a foramen in the sacrum. In an embodiment of the method, one or more measurement values are determined based on a predefined size of the guiding device.

[0072] In an embodiment of the method, the guiding device on the dorsal side of the patient defines the position and angle of entry of the medical element into the patient.

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

[0074] In another disclosed embodiment, a device for guiding the insertion of a medical element may include: an elongate base having positioning features that reference landmarks on a patient; a head that is translatable along the elongate 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 an entry position and an angle at which the medical element is inserted into the patient.

[0075] In an embodiment of the device, the elongate base is arcuate with a radius of curvature.

[0076] In an embodiment of the device, the positioning features depend from the elongate base; the landmark includes the patient's coccyx; and the positioning features are configured to be positioned against the patient's coccyx when the device is placed on the patient's back side.

[0077] In an embodiment of the device, the landmark includes a positioning element fixed to the patient; and the positioning features include a portion of the device that is connected to the positioning element. In an embodiment of the device, the positioning element includes a radiopaque marker.

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

[0079] In an embodiment of the device, the entry position and angle at which the medical element enters the patient are configured such that the medical element passes through a selected foramen in the patient's sacrum.

[0080] In an embodiment of the device, the medical element guide defines a plurality of different angles for the angle at which the medical element is inserted into the patient. In an embodiment of the device, the plurality of different angles include a plurality of different predefined angles defined by a plurality of grooves in the medical element guide. In an embodiment of the device, the plurality of different angles are defined by a plurality of rotational positions of the medical element guide relative to the head.

[0081] It can be understood from the present disclosure that a computer program product can be provided that includes one or more computer-readable storage media having program instructions collectively stored on the one or more computer-readable storage media, wherein the program instructions can be executed to: receive at least one image of a patient's sacrum; display the image; receive user input defining a point of interest in the displayed image; determine one or more measurements of the medical element guide based on the point of interest and a predefined dimension of the medical element guide; and output the determined one or more measurements to the user.

[0082] In an embodiment of a computer program product, the points of interest include: a first point located at the front end of the patient's coccyx or other landmark; and a second point located at the patient's sacral foramen. In an embodiment of the computer program product, the points of interest further include: a third point at the intersection of the patient's skin surface and a first line extending from the first point; and a fourth point 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 guidance element is configured to define the position and angle at which a medical element is inserted into the patient when the medical guidance element is located on the dorsal side of the patient.

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

[0085] A training platform may be provided for the disclosed methods and devices. The training platform is a software platform for doctors, sales representatives, or any other person who needs to learn or practice the techniques / methods of the present invention. The software platform allows users to upload simulated patients and go through the measurement process, such as in steps 210 and 215. The software may be configured to score the user based on the accuracy of the user input and provide suggestions and tips on how to improve the user input. The platform may be used for virtual training and certifying users. The platform administrator may deploy training modules and updates to train and update users on best practices. The platform administrator may also collect data on user experiences and interactions. The platform may provide educational animations for various processes and procedures. Future data collection may be used for subsequent processing and optimization of the platform.

[0086] A training model may also be provided. The training model is a physical model for training doctors, sales representatives, physician assistants, nurses, etc. in using the methods and devices 805 and / or 1105. The training model allows users to practice placing the sacral lead individually or in conjunction with a virtual training platform. The training model includes the sacral structure as well as the surrounding bone and tissue structures that are important for the procedure. The training model includes a soft tissue simulation structure where the opacity can be adjusted to control internal visualization, allowing the user to block or view the contents within the model. The training model includes targets that can be contacted or "hit" to confirm correct placement of the lead. When a target is hit, a signal may be generated to confirm correct placement. Additionally, the model anatomy can be adjusted to different levels to practice on different anatomies. This can be achieved by changing the bone placement to change the dimensions required for placing the stimulator. This can also be achieved with completely different physical models to represent different case complexities and scenarios.

[0087] In addition, an AI platform can be provided. The AI platform can be configured to collect X-ray, measurement, and lead placement data obtained from a monitoring software platform, 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 and result measurements for using guiding tools on patients. This data can be used to predict and optimize lead placement, thus more effectively transitioning from an external pulse generator (EPG) to an implantable pulse generator (IPG).

[0088] The applications (such as software) described herein can include computing code stored on a computer-readable storage medium and executed by a processing circuit of a computing device (such as computing device 700) to perform the functions described herein. The computing code can include routines, programs, objects, components, logic, data structures, etc., that perform specific tasks or implement specific data types for which the code is used to perform the functions of the embodiments described herein. The application can be stored on a portable device (such as a USB drive). In addition, the application can include processing capabilities for processing image files (such as DICOM files). Alternatively, the application can be configured to operate in cooperation with image processing software.

[0089] It should be noted that the above examples are for illustrative purposes only and are in no way to be construed as limiting the embodiments of the present invention. While various aspects of the present invention have been described with reference to exemplary embodiments, it should be understood that the words used herein are descriptive and illustrative words, not limiting words. Changes can be made within the scope of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present disclosure. While the embodiments of the present invention have been described herein with reference to specific means, materials, and embodiments, the embodiments disclosed herein are not intended to be limited to the specific embodiments disclosed herein; rather, the embodiments of the present invention extend to all functionally equivalent structures, methods, and uses, such as within the scope of the appended claims.

Claims

1. An apparatus for guiding a needle into a patient for sacral nerve stimulation therapy, the apparatus comprising: An elongate base having a first set of markings, the elongate base being configured to extend longitudinally along the patient's back, and wherein the base is configured to be placed adjacent to and pressed against the patient's coccyx; A lateral member slidably attached to the elongate base, wherein the lateral member includes a second set of markings; and An element guide mounted to the lateral member, the element guide being configured to assist in inserting the needle into the patient at a target location at a predetermined angle.

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

3. The device according to claim 1, wherein The first set of markings corresponds to a distance cephalad along the elongate base from the end of the coccyx.

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

5. The apparatus of claim 1, further comprising a radiopaque positioning element configured to be selectively attached to the elongate base.

6. The device according to claim 5, wherein, The first set of markings corresponds to a distance relative to the positioning element.

7. An apparatus for guiding a needle for sacral nerve stimulation therapy into a patient, the apparatus comprising: An elongate base having a first set of markings, the elongate base being configured to extend longitudinally along the patient's back, and wherein the base is configured to be placed adjacent to and pressed against the patient's coccyx; A lateral member having a second set of markings; wherein the lateral member is slidably attached to the elongate base; A guide body slidably attached to the lateral member, wherein the guide body is configured to move in a direction perpendicular to the elongate base; and Wherein the guide body includes an angled 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 body 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 pattern.

10. The device according to claim 7, wherein, The guide body further includes an orifice located at the base of the guide body and a third set of markings located along the length of the groove on the top surface of the guide body.

11. The apparatus of claim 7, further comprising a radiopaque positioning element configured to be selectively attached to the elongate base.

12. The device according to claim 11, wherein, The first set of measurement markings corresponds to a distance relative to the positioning element.

13. The device according to claim 7, wherein, The first set of markings corresponds to a distance cephalad along the elongate base relative to a vertical reference line extending from the end of the coccyx to the elongate base.

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

15. A method for marking a location on a patient for inserting a needle for placing a lead for nerve stimulation therapy, the method comprising the steps of: Obtaining a scaled image of the patient; Selecting the front end of the patient's coccyx shown in the image; Applying a first line on the image, wherein the first line extends from the front end of the coccyx to the surface of the patient's skin; Apply a second line on the image, wherein the second line extends from a target position perpendicular to the patient's sacrum to the surface of the patient's skin; Calculate a measurement corresponding to a position on the patient; Retrieve the measurement; and Use a measuring device to mark the patient based on the measurement.

16. The method according to claim 15, wherein, The method is used to identify an insertion position of a needle for placing a lead adjacent to the S3 foramen of the patient.

17. The method according to claim 15, wherein, The measurement includes a calculated distance cephalad from the first line on the measuring device.

18. The method according to claim 17, further comprising inserting the needle at the position into the patient to the foramen of the patient.

19. The method according to claim 15, wherein, The measurement 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 of the device.

20. The method according to claim 15, wherein The measuring device includes an elongate base and a lateral member, the elongate base having a first set of markings, the elongate base being configured to extend longitudinally across the patient's back and be placed adjacent to the patient's coccyx, and the lateral member having a second set of markings, the lateral member being slidably attached to the elongate 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 completed using AI based on image recognition.

22. The method according to claim 21, wherein, The applying step is completed without considering the orientation of the patient on the image.

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