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.

What is claimed: 
     
         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.