Patent Application
20230329750
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.
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.
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.
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.
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.
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.
With continued reference to
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.
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
With continued reference to
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With continued reference to
With continued reference to
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.
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.
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
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.
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
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.
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.
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.
| Number | Date | Country | |
|---|---|---|---|
| 63331474 | Apr 2022 | US | |
| 63411904 | Sep 2022 | US |
