DEVICES AND METHODS TO IMPROVE EFFICACY AND EFFICIENCY OF LOCATING THE SACRAL FORAMINA DURING SACRAL NEUROMODULATION PROCEDURE

Abstract

A method includes: determining one or more measurements from at least one image of a sacrum of a patient; applying the determined one or more measurements with a guide device; locating the guide device on the patient's backside using a landmark; and while the guide device is located on the patient's backside, using the guide device to guide insertion of a medical element into the patient. A device for guiding medical element insertion includes: a main body with a locating feature that references a landmark on a patient; a head that is translatable along the main body 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 location and angle of insertion of a medical element into the patient.

Description

PRIORITY

This application claims priority to U.S. provisional patent application No. 63/411,904 filed Sep. 30, 2022, and U.S. provisional patent application No. 63/331,474 filed Apr. 15, 2022, the contents of both of which are incorporated by reference herein in their entirety.

FIELD OF THE INVENTION

Aspects of the present invention relate generally to medical devices and implant techniques and, more particularly, to devices and methods to improve efficacy and efficiency of locating the sacral foramina during a sacral neuromodulation procedure.

BACKGROUND

Sacral neuromodulation is a treatment for bladder and bowel dysfunction. Sacral neuromodulation involves implanting a device that provides controlled electrical stimulation to the sacral S3 spinal nerve in the patient. Prior to permanent implant, the patient undergoes an evaluation called a peripheral nerve evaluation (PNE). The evaluation involves a procedure of implanting temporary leads into the patient and then observing results for a time period such as 3 to 14 days. If results meet clinical goals, then the patient may be a candidate for receiving permanent implants for sacral neuromodulation.

Current techniques for implanting the leads during the evaluation involve identifying palpable bony landmarks on the patient and inserting a foramen needle into the patient based on the location of these bony landmarks. The objective during this procedure is to insert the foramen needle through the skin and into the S3 foramen such that an electrical stimulation lead can be provided along the sacral S3 spinal nerve. The procedure may be performed with fluoroscopic or other image guidance; however, imaging is not always available. Instead, this procedure is most often performed in the office setting under local anesthesia and without imaging.

When fluoroscopy or other imaging is not used, such as in the office setting, the physician inserts the foramen needle from outside the patient's body and into the S3 foramen based on experience and by referencing the palpable bony landmarks. Because the physician cannot see the S3 foramen when they are attempting to place the foramen needle through the S3 foramen, this procedure involves what is known as a ‘blind’ insertion. The use of palpable bony landmarks is based on normal anatomy without consideration for anatomic or pathologic variations. This may lead to improper placement of leads in an office setting and eventual failure of PNE. For example, it is often the case that plural attempts are required to locate the S3 foramen and successfully insert the foramen needle through it. Because the procedure is performed under local anesthesia, the occurrence of plural needle insertions while attempting to find the unseen S3 foramen can produce a large amount of pain in the patient. The pain can be significant enough that some patients abandon the PNE (and thus sacral neuromodulation altogether) during this procedure without ever having the leads properly placed. As such, current techniques may lead to multiple skin puncture sites which causes pain in the patient, and may result in abandonment of the procedure in some cases. Misplaced leads may also lead to a false clinical outcome and abandonment of an otherwise efficacious treatment.

SUMMARY

Implementations of the invention address the above-noted problems of the prior art by providing devices and methods that improve efficacy and efficiency of locating the sacral foramina during sacral neuromodulation procedure. Embodiments, include imaging a portion of the patient, identifying internal points of the patient in the imaging, calculating measurements based on the imaging and the identified points, transferring the measurements to a device, placing the device on and exterior to the patient using a locating feature, and guiding a medical element (e.g., a foramen needle) into the patient using an element guide of the device. In this manner, implementations of the invention help the physician more accurately locate the S3 foramen and, thus, provide an improvement over conventional techniques that are less accurate at locating the S3 foramen during a blind insertion.

In a first aspect of the invention, there is a method comprising: determining one or more measurements from at least one image of a sacrum of a patient; applying the determined one or more measurements with a guide device; locating the guide device on the patient's backside using a landmark; and while the guide device is located on the patient's backside, using the guide device to guide insertion of a medical element into the patient.

In another aspect of the invention, there is a device for guiding medical element insertion, the device comprising: a main body with a locating feature that references a landmark on a patient; a head that is translatable along the main body in a first direction; 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 location and angle of insertion of a medical element into the patient.

In another aspect of the invention, there is a computer program product comprising one or more computer readable storage media having program instructions collectively stored on the one or more computer readable storage media. The program instructions are executable to: receive at least one image of a sacrum of a patient; display the at least one image; receive user input defining points of interest in the displayed at least one image; determine one or more measurements for a medical element guide based on the points of interest and a predefined dimension of the medical element guide; and output the determined one or more measurements to a user.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Aspects of the present invention are described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention.

FIG. 1 shows an exemplary partial view of the human anatomy.

FIG. 2 shows a flowchart of an exemplary method in accordance with aspects of the invention.

FIGS. 3A and 3B show an example of a radiopaque landmark device in accordance with aspects of the invention.

FIG. 4A shows an exemplary X-ray image in which a radiopaque element of a radiopaque landmark device is visible in accordance with aspects of the invention.

FIG. 4B shows an exemplary X-ray image in which an imaging system automatically provides a scale indicator in accordance with aspects of the invention.

FIGS. 5 and 6 show exemplary implementations of identifying points in the images and processing the image for measurements in accordance with aspects of the invention.

FIGS. 7A-D show examples of a user interface (UI) of an application on a computing device in accordance with aspects of the invention.

FIGS. 8A-G show an exemplary needle guide device in accordance with aspects of the invention.

FIG. 9 shows an example of placing a needle guide device on a patient using a locating feature in accordance with aspects of the invention.

FIG. 10 shows an example of guiding a medical element into the patient using a needle guide device in accordance with aspects of the invention.

FIGS. 11A-G show an exemplary needle guide device in accordance with aspects of the invention.

FIG. 12 shows an example of a locating element affixed to a patient in accordance with aspects of the invention.

FIG. 13 shows an example of a locating element affixed to a patient and a needle guide device placed on the patient's back and connected to the locating element in accordance with aspects of the invention.

FIG. 14 shows an example of needle insertion using the needle guide device of FIGS. 11A-F in accordance with aspects of the invention.

FIG. 15 shows a flowchart of an exemplary method in accordance with aspects of the invention.

DETAILED DESCRIPTION

The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details in more detail than is necessary for the fundamental understanding of aspects of the present invention, the description taken with the drawings making apparent to those skilled in the art how several forms of the present invention may be embodied in practice.

FIG. 1 shows an exemplary partial view of certain skeletal components of a human torso 10 including the sacrum 15 at the base of the spine 20, and the coccyx 25 at the base of the sacrum 15. As shown in FIG. 1, the sacrum includes four sacral foramina numbered 31-34. In FIG. 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. Although only one group is number in FIG. 1, the sacrum 15 includes two groups of foramina 31-34, one group on each side of the median sacral crest. Implementations of the invention provide a system and method for accurately locating 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 a component of a sacral neuromodulation system. Embodiments are described herein with respect to locating and inserting a foramen needle through the S3 foramen; however, implementations of the invention are not limited to use with the S3 foramen.

FIG. 2 shows a flowchart of an exemplary method in accordance with aspects of the present invention. Step 205 includes imaging a portion of the patient. Step 210 includes identifying internal points of the patient in the imaging. Step 215 includes calculating measurements based on the imaging and the identified points. Step 220 includes transferring the measurements to a device. Step 225 includes placing the device on and exterior to the patient using a locating feature. Step 230 includes guiding a medical element (e.g., a foramen needle) into the patient using an element guide of the device. Embodiments implementing these steps will become apparent from the following figures and associated descriptions.

FIGS. 3A and 3B show an example of a radiopaque landmark device 305 that can be used with the imaging of step 205. In embodiments, the imaging includes an X-ray of the lateral plane of the patient showing both the sacrum and coccyx of the patient. The imaging may also include one or both of the anterior-posterior (AP) or posterior-anterior (PA) planes of the same area (i.e., showing the sacrum and coccyx of the patient). The imaging comprises X-ray imaging in a preferred embodiment; however, other imaging technologies that show and distinguish internal bone structure of the patient may be used. In embodiments, the radiopaque landmark device 305 is placed on the patient during the X-ray in the filed of view of the X-ray. In embodiments, the radiopaque landmark device 305 comprises a radio-transparent housing 310 and a radiopaque element 315. The radio-transparent housing 310 is composed of a material that is relatively transparent to an X-ray (or whatever imaging technology is used). Plastic may be used for the radio-transparent housing 310, for example. The radiopaque element 315 is composed of a material that is relatively opaque to an X-ray (or whatever imaging technology is used). Stainless steel may be used for the radiopaque element 315, for example. In embodiments, the radiopaque element 315 has a predefined dimension that is used with the X-ray image(s) to define a scale of the image(s) of the patient. In a particular embodiment, the radiopaque element 315 comprises a sphere of a predefined diameter so that the radiopaque landmark device 305 can be placed in any orientation on the patient during the imaging.

FIG. 4A shows an exemplary X-ray image 405 in which the radiopaque element 315 of the radiopaque landmark device 305 is visible. Because the radiopaque element 315 has a predefined diameter, this known measurement of the radiopaque element 315 may be used to define a scale for the X-ray image 405. Embodiments use this scale when calculating measurements as described herein.

FIG. 4B shows an exemplary X-ray image 410 in which the imaging system automatically provides a scale indicator 415. Some imaging systems include an automatic scaling function that provides a scale of the image. In such systems, embodiments may use the scaling provided by the imaging system and the radiopaque landmark device 305 can be omitted. In both alternatives (e.g., using the radiopaque landmark device 305 or the automatic scaling function), the image is provided with a measurement of a scale of the image, and this measurement of the scale of the image is used in calculating other measurements as described herein.

FIGS. 5 and 6 show exemplary implementations of identifying points in the image(s) and processing the image(s) for measurements that can be used at steps 210 and 215, respectively, in accordance with aspects of the invention. In embodiments, the image(s) from step 205 are uploaded to a computing device for processing. The computing device (not shown) may comprise a conventional computing device (such as a desktop computer, laptop computer, tablet computer, or smartphone, for example) that runs a specialized software (e.g., a proprietary application) in accordance with aspects of the invention. The application may be part of a computer program product as described herein. In embodiments, the computing device comprises at least a display for displaying images (e.g., X-rays taken at step 205) and a user input mechanism that permits the user to identify points in a displayed image. The display and user input mechanism may be combined in a touchscreen display, for example, that can display an image and receive user touch input defining points of interest in the image. The display and user input mechanism may be separate, for example, such as a display screen that displays an image and a mouse or trackball that controls a pointer (e.g., cursor, arrow, etc.) superimposed on the displayed image, and a button the user may depress to provide define a current location of the pointer on the image as a point of interest in the image.

In accordance with aspects of the invention, identifying points in the image at step 210 includes importing the one or more images from step 205 into the application running on the computing device. In embodiments, the application establishes a scale of the image(s) using either the predefined dimension of the radiopaque element 315 in the image(s) or a scale indicator (e.g., such as scale indicator 415) provided with the image(s). Step 210 may optionally comprise the application adjusting visual aspects of the image(s), such as contrast, etc. FIG. 5 shows an example of a lateral X-ray image 505 that includes a scale indicator 510 that defines a scale of the image 505.

With continued reference to FIG. 5, in accordance with aspects of the invention, the application receives user input via the computing device where the input defines points of interest in the image 505. In embodiments, there are four points of interest 521, 522, 523, and 524 that are defined by user input. The application may provide one or more messages to the user that prompt the user to provide their input for one or more of the points of interest. In embodiments, the user provides input to define the first point of interest 521 at the tip (e.g., distal end) of the coccyx in the image 505. In embodiments, in response to receiving this input, the application draws a vertical line 525 upward from the first point of interest 521. In embodiments, while the line 525 is displayed, the user provides input to define the second point of interest 522 at the intersection of the line 525 and the outer surface of the skin of the patient. In embodiments, the user provides input to define the third point of interest 523 at the center of the S3 foramen in the image 505. In embodiments, in response to receiving this input, the application draws a line 526 perpendicular to the sacrum at third point of interest 523 and upward toward the outer surface of the skin of the patient. In embodiments, while the line 526 is displayed, the user provides input to adjust or confirm that the line 526 is perpendicular to the sacrum and provides input to define the fourth point of interest 524 at the intersection of the line 526 and the outer surface of the skin of the patient.

In accordance with aspects of the invention, processing the image for measurements at step 215 comprises determining a length measurement, an angle measurement, and a depth measurement based on the points of interest defined by the user at step 210. In embodiments, the application determines the length measurement, the angle measurement, and the depth measurement based on: the coordinates (e.g., X-Y cartesian coordinates) of each of the points of interest in a coordinate system defined for the image; the scale of the image relative to the same coordinate system; and one or more predefined dimensions of a device that will be utilized as a needle guide using the determined length measurement and angle measurement. In embodiments, the one or more predefined dimensions of the device include a predefined radius of curvature of a main body of the device. In embodiments, the application uses this information (e.g., the coordinates, the scale, and the predefined dimension of the device) with one or more algorithms programmed with geometric relationships to determine: (i) a length of an arc 530 that extends between the second point 522 and the fourth point 524 where the arc has the predefined radius of curvature; (ii) an angle 535 between the line 526 and a tangent of the arc 530 at the fourth point 524; and (iii) a length of the line 526 between the third point 523 and the fourth point 524. In embodiments, the determined length of the arc 530 between the second point 522 and the fourth point 524 comprises the length measurement, the determined angle 535 comprises the angle measurement, and the determined length of the line 526 between the third point 523 and the fourth point 524 comprises the depth measurement. In embodiments, the application outputs the determined measurements to the user, e.g., via display.

FIG. 6 shows an example of a posterior-anterior (PA) X-ray image 605. In accordance with aspects of the invention, the application receives user input via the computing device where the input defines points of interest in the image 605. In embodiments, there are two points of interest 621 and 622 that are defined by user input. In embodiments, the user provides input to define the first point of interest 621 at the at the center of the S3 foramen in the image 505. In embodiments, in response to receiving this input, the application draws a line 625 that intersects the point 621 and is perpendicular to the centerline of the sacrum. In embodiments, while the line 625 is displayed, the user provides input to define the second point of interest 622 at the intersection of the line 625 and the centerline of the sacrum. In this example, the application uses the coordinates of the points 621 and 622 to determine a lateral distance between the points 621 and 622. In embodiments, the application outputs the determined measurement to the user, e.g., via display.

FIGS. 7A-D show examples of a user interface (UI) of the application on a computing device in accordance with aspects of the invention. In FIGS. 7A-D, the computing device 700 comprises a smartphone or tablet computer with a touchscreen. In FIGS. 7A-D, the computing device runs the application (or a web client that accesses a cloud-run version of the application) described above with respect to FIGS. 5 and 6, and the application causes the UI to be displayed on the screen of the computing device. FIG. 7A shows a login screen 710 of the UI where a user enters their credentials to access features of the application. FIG. 7B shows a screen 720 of the UI showing a posterior-anterior (PA) X-ray image (e.g., image 605 of FIG. 6), in which the user may provide the input to define points of interest (e.g., points 621 and 622 of FIG. 6). FIG. 7C shows a screen 730 of the UI showing a lateral X-ray image (e.g., image 505 of FIG. 5), in which the user may provide the input to define points of interest (e.g., points 521, 522, 523, and 524 of FIG. 5). FIG. 7D shows a screen 740 of the UI by which the user may provide input to configure the device based on the determined measurements (e.g., “Configure device to match these measurements”) or provide input to edit the points of interest (e.g., “Edit Markers”) in one or both of the images.

FIGS. 8A and 8B show an exemplary needle guide device 805 in accordance with aspects of the invention. In embodiments, the device 805 includes a main body 810, a sliding square head 815, and medical element guides 820. In embodiments, the device 805 comprises a depending portion 825 that extends downward from a bottom surface of the main body 810. In embodiments, the bottom surface of the main body 810 has a radius of curvature 830 that is one of the one or more predefined dimension of the device described with respect to FIG. 5 and used in the application to determine measurements.

In embodiments, the main body 810 comprises a coccyx locating feature (e.g., the depending portion 825) that is used to locate the device 805 on to the patient. In embodiments, the coccyx locating feature is pressed against the coccyx while the arced feature is located along the midline defined by the sagittal plane of the patient. In embodiments, the arced feature of the main body 810 is a predefined arc geometry that is used by the application for determining measurements at step 215. In embodiments, the sliding square head 815 slides along the main body 810 and remains square to the main body 810. In embodiments, the sliding square head 815 can be locked at a specific location along the main body 810. In embodiments, the main body 810 has measurements included to set the sliding square head 815 at the location determined by the calculations and measurements from patient imaging. In embodiments, the sliding square head 815 includes lateral rails that allow for the use of the medical element guide 820. In embodiments, the medical element guide 820 slides laterally along the sliding square head 815 and remains square to the sliding square head 815. The lateral placement can be set based on imaging measurements or standard practices. The medical element guide 820 allows for needle placement at various degrees. The medical element guide 820 allows the user to fix the needle at a defined angle in use. In embodiments, the medical element guide 820 and the sliding square head 815 are also designed to allow removal of the device while needles remain with the patient. In embodiments, marks on the needle are also used to measure the depth of the needle placement. In embodiments, this measurement is generated during image measurements and can be used to located depth of the foramen needle in the patient.

In accordance with aspects of the invention, the sliding square head 815 may be moved translationally relative to the main body 810 in a first direction 841 and a second direction 842 opposite the first direction along a length of the main body 810. In embodiments, the sliding square head 815 comprises a locking mechanism 845 that permits a user to selectively lock (e.g., prevent) and unlock (e.g., permit) the translational movement of the sliding square head 815 relative to the main body 810. The locking mechanism may comprise a thumb screw or other conventional or later developed locking mechanism that can be used to selectively lock (e.g., prevent) and unlock (e.g., permit) the translational movement of one device sliding along another device. In embodiments, the main body 810 includes indicia 850 that correspond to units of the length measurement determined at step 215. In the example shown in FIG. 8A, the indicia 850 comprise a scale of millimeters from 0 to 180 along the length of the main body 810.

With continued reference to FIG. 8A, in accordance with aspects of the invention, transferring the measurements to the device at step 220 comprises moving the sliding square head 815 to a position on the main body 810 such that an indicator 855 of the sliding square head coincides with a location in the scale of the indicia 850 that matches the length measurement determined at step 215. In the example of FIG. 5, the length measurement is determined to be 136.8 mm. Using this exemplary length measurement, at step 220 the user would move the sliding square head 815 along the main body 810 until the indicator 855 coincides with a location corresponding to the number 136.8 on the scale of the indicia 850. In situations where the number of the length measurement does not align exactly with one of the numbers of the indicia 850, the user may interpolate a position for the indicator 855 between two numbers of the indicia 850 that best matches the length measurement. After positioning the sliding square head 815 on the main body 810 according to the length measurement, the user locks the sliding square head 815 relative to the main body 810 using the locking mechanism 845.

In the example shown in FIG. 8A, the device 805 includes medical element guides 820 that may be moved translationally relative to the sliding square head 815 in a first direction 861 and a second direction 862 opposite the first direction, where the direction of translation of the medical element guides 820 relative to the sliding square head 815 is perpendicular to the direction of translation of the sliding square head 815 relative to the main body 810. In embodiments, the device 805 comprises respective locking mechanisms that permit a user to selectively lock (e.g., prevent) and unlock (e.g., permit) the translational movement of each medical element guide 820 relative to the sliding square head 815. The locking mechanism may comprise a thumb screw or other conventional or later developed locking mechanism that can be used to selectively lock (e.g., prevent) and unlock (e.g., permit) the translational movement of one device sliding along another device. Alternative to locking mechanisms, the sliding square head 815 and/or the medical element guides 820 may comprise detents that define predefined locations of the medical element guides 820 on the sliding square head 815. In embodiments, each wing of the sliding square head 815 includes indicia 865 that correspond to units of the lateral distance determined at step 215 (e.g., as described at FIG. 6). In the example shown in FIG. 8A, the indicia 865 comprise a scale of millimeters from 10 to 40 along the transverse dimension of the sliding square head 815.

With continued reference to FIG. 8A, in accordance with aspects of the invention, transferring the measurements to the device at step 220 may comprise moving the medical element guides 820 to positions on the wings of the sliding square head 815 such that a position indicator of each medical element guide 820 head coincides with a location in the scale of the indicia 865 that matches the lateral distance determined at step 215. In the example of FIG. 5, the lateral distance is determined to be 20 mm. Using this exemplary length measurement, at step 220 the user would move each medical element guide 820 along its wings of the sliding square head 815 until a position indicator on the medical element guide 820 coincides with a location corresponding to the number 20 in the scale of the indicia 865. In situations where the number of the lateral distance does not align exactly with one of the numbers of the indicia 865, the user may interpolate a position for the indicator between two numbers of the indicia 850 that best matches the lateral distance. After positioning the medical element guides 820 on the wings of the sliding square head 815 according to the lateral distance, the user may lock the medical element guides 820 relative to the sliding square head 815.

With continued reference to FIGS. 8A and 8B, in embodiments each of the medical element guides 820 includes a graduated needle guide 870 including plural needle guide slots 875 arranged at different predefined angles. In embodiments, the different predefined angles are within a range that is most likely to include the determined angle measurement of most patients. For example, the different predefined angles are within a range of 90 degrees to 140 degrees with a discrete one of the plural needle guide slots 875 arranged at increments of 10 degrees within this range. Each respective one of the plural needle guide slots 875 may be provided with indicia that indicates the angle of the respective one of the plural needle guide slots 875. In embodiments, step 220 comprises selecting one of the plural 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 the one of the plural needle guide slots 875 that has an angle closest to 106.5 degrees. In an example in which the needle guide slots are arranged at 10 degree increments between 90 degrees and 140 degrees, the user would select the 110 degrees angle guide slot for an angle measurement of 106.5 degrees.

FIG. 8G shows an exemplary embodiment of the device 805′ in which each of the medical element guides 820′ includes a single needle slot and the medical element guide 820′ is rotatable around an axis that is parallel to the directions defined by 861 and 862 and perpendicular to the directions defined by 841 and 842 relative to the sliding square head 815 to plural different positions that correspond to different insertion angles of a needle into the patient. The plural different positions may correspond to different insertion angles in predefined increments of 10 degrees, for example. In this manner, the angle adjustment of the medical element guide 820′ may function in the manner of an adjustable protractor that is affixed to the sliding square head 815. The rotation of the medical element guides 820′ relative to the sliding square head 815 may be selectively locked and unlocked using a locking mechanism. In embodiments, the elements of the device 805′ function in the same manner as those elements of the device 805 with the exception that the medical element guide 820′ having a single needle guide that is rotatable to different angles and the medical element guide 820 having plural needle guides at different angles.

In the manner described above, measurements determined at step 215 are transferred to the device 805. In one example, the scales of the different indicia on the device 805 correspond to the scales of the different measurements determined at step 215. In another example, the measurements determined at step 215 are converted to values within the range of scales of the different indicia on the device 805 using predefined conversion formulas. In this manner, the application may output a set of numbers (e.g., the exact measurements or the converted values), and the user may adjust the device based on the numbers provided in this output.

FIGS. 8C, 8D, 8E, and 8F show views of the device 805 with a foramen needle 880 in one of the guide slots 875 of one of the medical element guides 820. As shown in FIGS. 8C-F, the guide slots are open on an outer end so that the medical element guide 820 can be moved away from the foramen needle 880 when the foramen needle 880 is inserted into the patient body. This permits adjusting the placement of the medical element (needle) angle or removing the entire device 805 from the patient after foramen needles 880 have been inserted using each of the medical element guides 820.

FIG. 9 shows an example of placing the device 805 on the patient using a locating feature in accordance with aspects of the invention. In embodiments, step 225 described above comprises locating the device of the patient using a location feature. In embodiments, after transferring the measurements to the device 805 at step 220 (e.g., as described with respect to FIGS. 8A and 8B), the user places the device 805 on the patient, i.e., the same patient that was imaged at step 205. In embodiments, placing the device 805 at step 220 comprises positioning the device 805 on the outer surface of the skin of the patient who is in a prone position with the depending portion 825 of the device positioned adjacent to the coccyx of the patient and the main body 810 of the device 805 aligned with the spine of the patient.

FIG. 10 shows an example of guiding a medical element into the patient using the device 805 in accordance with aspects of the invention. FIG. 10 shows the device 805 placed on the patient as described with respect to step 225 and FIG. 9, e.g., with the device 805 on the outer surface of the skin of the patient who is in a prone position, with the depending portion 825 of the device positioned adjacent to the coccyx 25 of the patient, and the main body 810 of the device 805 aligned with the spine of the patient. In embodiments, after transferring the measurements to the device 805 at step 220 and then placing the device 805 on the patient at step 825, step 230 comprises using the device 805 placed on the patient as a guide for inserting a needle (e.g., a foramen needle 880) into the patient. In embodiments, the user starts the foramen needle 880 in the selected one of the needle guide slots 875 (e.g., selected based on the angle measurement) and inserts the foramen needle 880 through this selected guide slot and into the patient. The location and angle of the needle insertion into the patient are defined by the device 805, which has been adjusted based on measurements determined from the location of the S3 foramen and other landmarks in this patient's imaging. Due to this, the location and angle of the needle insertion using the inventive method and device has a much higher rate of success of accurately locating the S3 foramen 33 in the patient compared to conventional blind techniques.

The foramen needle 880 may be provided with indicia that indicate a depth of insertion of the needle into the patient. The user may insert the foramen needle into the patient using the depth of insertion indicia to determine when the tip of the foramen needle 880 is close to the nerve in the S3 foramen.

In embodiments, after inserting a respective foramen needle on either side of the patient in the manner described, the medical element guides 820 may be moved inward along the sliding square head 815 away from the respective foramen needles, such that the device 805 may be removed from the patient. After inserting the foramen needles in the patient in this manner, the PNE procedure may proceed in a conventional fashion. For example, portions of the foramen needles may be removed and remaining portions of the foramen needles still in the patient may be used to insert implantable device leads into the patient.

FIGS. 11A-F show aspects of another example of a needle guide device 1105 in accordance with aspects of the invention. In embodiments, the device 1105 includes a main body 1110, sliding square head 1115, and one or two medical element guides 1120, all of which operate in a similar manner as those similarly named elements described with respect to FIGS. 8A-F. In embodiments, the device 1105 includes a locating element 1125 that is connectable to the main body 1110. In embodiments, the locating element 1125 comprises a disc or other shaped structure that is affixed to the patient during the imaging (e.g., step 205). The locating element 1125 may be affixed to the patient using adhesive or other methods. In embodiments, the locating element is affixed to the patient prior to imaging (e.g., at step 205) and remains fixed to the patient throughout needle insertion (e.g., at step 230). FIG. 12 shows an example of the locating element 1125 affixed to the patient. FIG. 11G shows an example of the medical element guide 1120 in accordance with aspects of the invention.

In embodiments, the locating element 1125 comprises a radiopaque portion that is visible in the imaging. In embodiments, the identifying points of interest (e.g., step 210) and processing the image for measurements (e.g., step 215) are performed based on the radiopaque portion of the locating element 1125 for the first point of interest and landmark rather than the tip of the coccyx as described at FIG. 5. In embodiments that utilize the device 1105, the application is programmed with geometric relationships that are based on the landmark coordinates of the locating element 1125 on the patient in the image, the coordinates of the S3 foramen in the image, and the predefined dimensions of the main body 1110. Using this information, the application uses the geometric relationships to determine a length measurement, an angle measurement, and a depth measurement, e.g., in a manner similar to that described above but with different use defined points of interest and with different geometric relationships.

In embodiments, after determining the length measurement, an angle measurement, and a depth measurement for the device 1105, the user transfers these measurements to the device 1105 (e.g., at step 220). This may be performed in a manner similar to the description of step 220 with device 805. For example, the application may output numbers that corresponds to measurements along the degrees of freedom of the device 1105, and the user may adjust the positions of the elements of the device 1105 based on these numbers. For example, the application may output a first number that is based on the determined length measurement, and the user may adjust the position of the sliding square head 1115 along the main body 1110 based on this number and based on indicia on the main body 1110.

In embodiments, after adjusting the device 1105 based on the determined measurements, the user places the device on the patient using the locating feature. In this embodiment, the locating feature comprises the locating element 1125. In embodiments, the main body 1110 is configured to connect to the locating element 1125, e.g., via snap fit or other connection mechanism. In embodiments, a portion of the main body 1110 that connects to the locating element 1125 comprises a locating feature of the device and the locating element 1125 comprises a landmark on the patient. In embodiments, step 225 comprises placing the device 1105 on the patient's back while the patient is in a prone position, connecting the main body 1110 to the locating element 1125 that is already affixed to the patient's back, and aligning the main body with the spine of the patient. FIG. 13 shows an example of the locating element 1125 affixed to the patient and the device 1105 placed on the patient's back and connected to the locating element 1125.

In embodiments, after placing the device 1105 on the patient, the user utilizes the device 1105 as a guide for inserting a needle into the patient. In embodiments, step 230 comprises the user using the device 1105 as a guide for inserting a foramen needle 880 into the patient. As can be seen in FIG. 11G, the medical element guide 1120 may comprise an element that defines an aperture and plural angles that the user can select based on the determined angle measurement. In embodiments, the user puts the tip of the needle at the aperture at a base of the medical element guide 1120 and aligns the foramen needle 880 with a selected one of plural angles on the medical element guide 1120 based on the determined angle measurement. The needle arranged in this manner is then inserted into the patient. FIG. 14 shows an example of needle insertion using the device 1105 as a guide. The location and angle of the needle insertion into the patient are defined by the device 1105, which has been adjusted based on measurements determined from the location of the S3 foramen and other landmarks in this patient's imaging. Due to this, the location and angle of the needle insertion using the inventive method and device has a much higher rate of success of accurately locating the S3 foramen in the patient compared to conventional blind techniques.

The devices described herein (e.g., devices 805/805′/1105) are not limited to use with a foramen needle (such as foramen needle 880) and may be used to guide the insertion of other types of medical elements into the patient. For example, the devices may be used to guide insertion of medical elements including but not limited to foramen needles, other types of needles, leads, instruments, scopes, etc.

FIG. 15 shows a flowchart of an exemplary method in accordance with aspects of the invention. Block 1505 includes determining one or more measurements from at least one image of a sacrum of a patient. In a non-limiting example, the measurements are determined in the manner described at FIGS. 5 and/or 6. Block 1510 includes applying the determined one or more measurements with a guide device. In a non-limiting example, the applying comprises making one or more adjustments to the device 805/805′/1105 based on the determined one or more measurements in the manner described herein. Block 1515 includes locating the guide device on the patient's backside using a landmark. In non-limiting examples, the locating may be performed in the manner described at FIGS. 9-10 or FIGS. 12-14. In a non-limiting example, the landmark comprises the patent's coccyx. In a non-limiting example, the landmark comprises a locating element affixed to the patient. Block 1520 includes, while the guide device is located on the patient's backside, using the guide device to guide insertion of a needle into the patient. In non-limiting examples, the guiding insertion may be performed in the manner described at FIG. 10 or FIG. 14.

As will be understood from the present disclosure a first aspect of the invention provides for a method comprising: determining one or more measurements from at least one image of a sacrum of a patient; applying the determined one or more measurements with a guide device; locating the guide device on the patient's backside using a landmark; and while the guide device is located on the patient's backside, using the guide device to guide insertion of a medical element into the patient.

In embodiments of the method, the guide device may be adjustable and applying the determined one or more measurements with the guide device may comprise adjusting the guide device based on the one or more measurements.

In embodiments of the method, the landmark comprises the patent's coccyx.

In embodiments of the method, the landmark comprises a locating element affixed to the patient.

In embodiments of the method, the at least one image comprises an image of a pelvis of the patient in a lateral plane. In embodiments of the method, the at least one image comprises an image of the pelvis of the patient in a posterior-anterior plane or an anterior posterior plane. In embodiments of the method, the at least one image comprises an X-ray or a CT scan.

In embodiments of the method, the one or more measurements are determined based on user input defining points of interest in the at least one image. In embodiments of the method, the points of interest in the at least one image comprise a location of a foramen in the sacrum. In embodiments of the method, the one or more measurements are determined based on a predefined dimension of the guide device.

In embodiments of the method, the guide device on the patient's backside defines a location and an angle of entry of the medical element into the patient's body.

In embodiments of the method, the medical element comprises a needle.

As will be understood from the present disclosure another aspect of the invention provides for a device for guiding medical element insertion, the device comprising: a main body with a locating feature that references a landmark on a patient; a head that is translatable along the main body 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 location and angle of insertion of a medical element into the patient.

In embodiments of the device, the main body is arced with a radius of curvature.

In embodiments of the device, the locating feature depends downward from the main body; the landmark comprises the patient's coccyx; and the locating feature is configured to be located against the patient's coccyx when the device is placed on the patient's backside.

In embodiments of the device, the landmark comprises a locating element affixed to the patient; and the locating feature comprises a portion of the device that connects to the locating element. In embodiments of the device, the locating element comprises a radiopaque marker.

In embodiments of the device, the medical element comprises a needle.

In embodiments of the device, the entry location and angle of the medical element into the patient are configured to cause the medical element to pass through a selected foramen in the patent's sacrum.

In embodiments of the device, the medical element guide defines plural different angles for the angle of insertion of the medical element into the patient. In embodiments of the device, the plural different angles comprise plural different predefined angles that are defined by plural grooves in the medical element guide. In embodiments of the device, the plural different angles are defined by plural rotational locations of the medical element guide relative to the head.

As will be understood from the present disclosure another aspect of the invention provides for a computer program product comprising one or more computer readable storage media having program instructions collectively stored on the one or more computer readable storage media, where the program instructions are executable to: receive at least one image of a sacrum of a patient; display the at least one image; receive user input defining points of interest in the displayed at least one image; determine one or more measurements for a medical element guide based on the points of interest and a predefined dimension of the medical element guide; and output the determined one or more measurements to a user.

In embodiments of the computer program product the points of interest include: a first point at a tip of the patient's coccyx or other landmark; and a second point at a foramen in the patient's sacrum. In embodiments of the computer program product the points of interest further include: a third point at an intersection of a surface of the patient's skin and a first line extending from the first point; and a fourth point at an intersection of the surface of the patient's skin and a second line extending from the second point.

In embodiments of the computer program product the medical guide element is configured to define a location and angle of insertion of a medical element into the patient while the medical guide element is located on the patient's backside.

Additional aspects of the invention include manufacturing and/or using the device 805 or 1105 as described herein. Even further aspects of the invention include providing instructions for using the device 805 or 1105 as described herein. The instructions may be at least one of printed and video.

Additional aspects of the invention include a training platform. In embodiments, the training platform is a software platform for doctors, sales reps, or any other person that needs to learn or practice the invented technique/method. The software platform allows users to upload mock patients and go through the measurement process, e.g., at steps 210 and 215. The software can be configured to grade the user on the accuracy of their user inputs and offer suggestions and tip on how to improve user input. The platform can be used to train and certify users virtually. The platform administrator can deploy training modules and updates to train and update users on the best practices. The platform administrator can also collect data on user experience and interaction. The platform can provide educational animations for various processes and procedures. Future data collection may be employed in this platform of later processing and optimization.

Additional aspects of the invention include a training model. In embodiments, the training model is a physical model used to train doctors, sales reps, physician assistances, nurses, etc., using the methods and devices 805 and/or 1105. The training model allows users to practice placement of the sacral lead alone or in use with the virtual training platform. In embodiments, the training model includes the sacral bone structure as well as surrounding bone and tissue structure important to this procedure. In embodiments, the training model includes a soft tissue simulating structure where the opacity can be adjusted to control internal visualization allowing users to block or see within the model. In embodiments, the training model includes targets that can be hit to confirm property placement of the leads. When a target is hit a signal can be produced to confirm the proper placement. Additionally, the model anatomy can be adjusted to different levels to practice on different anatomies. This may be achieved by changing bone placement to change the dimensions needed to place the stimulator. This may also be achieved with different physical models altogether to represent different case complexities and scenarios.

Additional aspects of the invention include an artificial intelligence (AI) platform. In embodiments, AI platform is configured to collect X-ray, measurement, and lead placement data that is achieved by the software platform, success rate of patients, etc., and to use this information to optimize placements and to create machine learning to automatically identify points of interest placements and resulting measurements. This data can be used to predict and optimize placement of leads resulting in more efficient conversions to full implants.

A computer program product embodiment (“CPP embodiment” or “CPP”) is a term used in the present disclosure to describe any set of one, or more, storage media (also called “mediums”) collectively included in a set of one, or more, storage devices that collectively include machine readable code corresponding to instructions and/or data for performing computer operations specified in a given CPP claim. A “storage device” is any tangible device that can retain and store instructions for use by a computer processor. Without limitation, the computer readable storage medium may 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 mediums include: diskette, hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or Flash memory), static random access memory (SRAM), compact disc read-only memory (CD-ROM), digital versatile disk (DVD), memory stick, floppy disk, mechanically encoded device (such as punch cards or pits/lands formed in a major surface of a disc) or any suitable combination of the foregoing. A computer readable storage medium, as that term is used in the present disclosure, is not to be construed as storage in the form of transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide, light pulses passing through a fiber optic cable, electrical signals communicated through a wire, and/or other transmission media. As will be understood by those of skill in the art, data is typically moved at some occasional points in time during normal operations of a storage device, such as during access, de-fragmentation or garbage collection, but this does not render the storage device as transitory because the data is not transitory while it is stored.

In embodiments, an application (e.g., software) as described herein may comprise computing 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 computing code may include routines, programs, objects, components, logic, data structures, and so on that perform particular tasks or implement particular data types that the code uses to carry out the functions of embodiments of the invention as described herein.

It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of implementations of the present invention. While aspects of the present invention have been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present disclosure in its aspects. Although implementations of the present invention have been described herein with reference to particular means, materials and embodiments, implementations of the present invention are not intended to be limited to the particulars disclosed herein; rather, implementations of the present invention extend to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.

Claims

1. A method, comprising:

determining one or more measurements from at least one image of a sacrum of a patient;

applying the determined one or more measurements with a guide device;

locating the guide device on the patient's backside using a landmark; and

while the guide device is located on the patient's backside, using the guide device to guide insertion of a medical element into the patient.

2. The method of claim 1, wherein:

the guide device is adjustable; and

applying the determined one or more measurements with the guide device comprises adjusting the guide device based on the one or more measurements.

3. The method of claim 1, wherein the landmark comprises the patent's coccyx.

4. The method of claim 1, wherein the landmark comprises a locating element affixed to the patient.

5. The method of claim 1, wherein the at least one image comprises an image of a pelvis of the patient in a lateral plane.

6. The method of claim 5, wherein the at least one image comprises an image of the pelvis of the patient in a posterior-anterior plane or an anterior posterior plane.

7. The method of claim 5, wherein the at least one image comprises an X-ray or a CT scan.

8. The method of claim 1, wherein the one or more measurements are determined based on user input defining points of interest in the at least one image.

9. The method of claim 8, wherein the points of interest in the at least one image comprise a location of a foramen in the sacrum.

10. The method of claim 8, wherein the one or more measurements are determined based on a predefined dimension of the guide device.

11. The method of claim 1, wherein the guide device on the patient's backside defines a location and an angle of entry of the medical element into the patient's body.

12. The method of claim 1, wherein the medical element comprises a needle.

13. A device for guiding medical element insertion, the device comprising:

a main body with a locating feature that references a landmark on a patient;

a head that is translatable along the main body 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 location and angle of insertion of a medical element into the patient.

14. The device of claim 13, wherein the main body is arced with a radius of curvature.

15. The device of claim 13, wherein:

the locating feature depends downward from the main body;

the landmark comprises the patient's coccyx; and

the locating feature is configured to be located against the patient's coccyx when the device is placed on the patient's backside.

16. The device of claim 13, wherein:

the landmark comprises a locating element affixed to the patient; and

the locating feature comprises a portion of the device that connects to the locating element.

17. The device of claim 13, wherein the medical element comprises a needle.

18. The device of claim 13, wherein the entry location and angle of the medical element into the patient are configured to cause the medical element to pass through a selected foramen in the patent's sacrum.

19. The device of claim 13, wherein the medical element guide defines plural different angles for the angle of insertion of the medical element into the patient.

20. The device of claim 19, wherein the plural different angles comprise plural different predefined angles that are defined by plural grooves in the medical element guide.

21. The device of claim 19, wherein the plural different angles are defined by plural rotational locations of the medical element guide relative to the head.

22. The device of claim 16, wherein the locating element comprises a radiopaque marker.

23. A computer program product comprising one or more computer readable storage media having program instructions collectively stored on the one or more computer readable storage media, the program instructions executable to:

receive at least one image of a sacrum of a patient;

display the at least one image;

receive user input defining points of interest in the displayed at least one image;

determine one or more measurements for a medical element guide based on the points of interest and a predefined dimension of the medical element guide; and

output the determined one or more measurements to a user.

24. The computer program product of claim 23, wherein the points of interest include:

a first point at a tip of the patient's coccyx or other landmark; and

a second point at a foramen in the patient's sacrum.

25. The computer program product of claim 24, wherein the points of interest further include:

a third point at an intersection of a surface of the patient's skin and a first line extending from the first point; and

a fourth point at an intersection of the surface of the patient's skin and a second line extending from the second point.

26. The computer program product of claim 23, wherein the medical guide element is configured to define a location and angle of insertion of a medical element into the patient while the medical guide element is located on the patient's backside.