Medical device guidance system and method

Abstract

A guidance system for performing a percutaneous access incision, the guidance system comprising an access needle comprising a shaft portion and a tip portion at a distal end of the shaft portion, and a guide plate comprising a dermal side, an external side, an opening for receiving the access needle extending between the dermal side and the external side, and a feedback device viewable from the external side to provide an indication of a depth of the tip portion beneath the guide plate and a trajectory of the shaft portion from the opening. A method for planning the guidance of an access needle into a patient for preparing a minimally invasive surgical procedure, the method comprising determining a location of an access point on the patient, positioning a guide plate over the access point, inserting a tip portion of the access needle through the plate, and displaying guidance information on the guide plate.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 942,803, filed December 3, 2019, the entire contents of which are incorporated herein. TECHNICAL FIELD

[0003] The present document relates generally, but not by way of limitation, to surgical instruments and methods for inserting and navigating instruments used to perform percutaneous medical procedures. More particularly, but not by way of limitation, the present application relates to systems and methods for inserting and navigating minimally invasive insertion instruments, such as laparoscopic access needles. BACKGROUND

[0004] Many surgical procedures involve treating or removing subcutaneous target tissue, such as diseased or unwanted tissue or growths, located within a patient. As such, these procedures require access to the patient’s internal anatomy either via open surgery or through a smaller opening in minimally invasive surgery. In minimally invasive surgery, a surgeon navigates an insertion instrument, such as an access needle, along a trajectory into the patient’s epidermis to introduce a tip of the insertion instrument into a surgical site within the patient’s thoracic or abdominal cavity. Imaging of the patient’s anatomy can be used to plan the trajectory of the insertion needle. However, interpretation of the imaging and placement of the access needle can be difficult, such that it is sometimes an interventional radiologist rather than a surgeon performing the medical procedure who performs the placement of the access needle.

[0005] Examples of surgical instruments are described in Patent No. 4,610,663 to Rosenberg, Patent No. US 9,737,232 to Fan, and Publication No. US 2017 / 0303940 Al to Sperry et al. SUMMARY

[0006] The present inventors have recognized, among other things, that a problem that needs to be addressed in performing medical procedures includes the inconvenience that a surgeon has to utilize an interventional radiologist to perform insertion of an access needle. Use of such a specialist significantly lengthens the procedure, as the access needle is typically placed by the interventional radiologist the day before the medical procedure. Moreover, the present inventors have recognized that navigation using real-time guidance of the insertion instrument is often not feasible due to the impracticality of using imaging equipment in real-time, including exposing the patient and the surgeon to radiation. Furthermore, patient motion and respiration can make it difficult to interpret still images of the patient and real-time imaging of the patient.

[0007] The present subject matter can provide solutions to these and other problems, such as by providing systems and methods that include an instrument guide plate that can provide real-time feedback of the position and orientation of an access instrument during a placement procedure. The instrument guide plate can include hardware for displaying indicia that can be updated in real-time to indicate the position of a surgical instrument, such as an access needle. The guide plate can react directly to the presence of the access needle, such that a separate imaging system is not needed. In examples, the guide plate can also provide guidance information, such as a desired orientation of the access needle and a forbidden zone for the access needle. In examples, the guide plate can include sensors for providing indicia of the patient's tissue and anatomy. Methods of performing surgical procedures using such a guide plate are also described herein.

[0008] In an example, a guidance system for performing a percutaneous access incision can include an access needle including a shaft portion and a tip portion at a distal end of the shaft portion, and a guide plate including a dermal side, an external side, an opening for receiving the access needle extending between the dermal side and the external side, and a feedback device observable from the external side to provide an indication of a depth of the tip portion beneath the guide plate and a trajectory of the shaft portion from the opening.

[0009] In another example, a method for planning the guidance of an access needle into a patient in preparation for a minimally invasive surgical procedure includes determining a location of an access point on the patient, positioning a guide plate over the access point, inserting a tip portion of an access needle through the guide plate, and displaying guidance information on the guide plate.

[0010] In a further example, a guide plate for guiding an access needle into a patient in preparation for a minimally invasive surgical procedure includes a dermal side, an external side, an opening for receiving the access needle extending between the dermal side and the external side, and an array of light emitters surrounding the opening and observable from the external side to provide an indication of a depth of a tip portion of the access needle beneath the guide plate and a trajectory of a shaft portion of the access needle from the opening, wherein each of the light emitters of the array has a variable property.

[0011] This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application. BRIEF DESCRIPTION OF DRAWINGS

[0012] Figure 1 is a schematic view of a kidney in an abdominal cavity taken along a coronal plane.

[0013] Figure 2 is a schematic view of a kidney in an abdominal cavity taken along a transverse plane.

[0014] Figure 3 is a schematic view of a guide plate of the present disclosure for orienting an access needle into an abdominal cavity.

[0015] Figure 4 is a top view of a first example of a guide plate for providing depth and distance feedback using light emitting diodes.

[0016] Figure 5 is a side view schematic of an insertion needle inserted into a guide plate of Figure 4 at a first depth and a first orientation.

[0017] Figure 6 is a top view of a guide plate of Figure 5 illustrating visual feedback indicating the first depth and first orientation.

[0018] Figure 7 is a side view schematic of an insertion needle inserted into a guide plate of Figure 4 at a second depth and a second orientation.

[0019] Figure 8 is a top view of a guide plate of Figure 7 illustrating visual feedback indicating the second depth and second orientation.

[0020] Figure 9 is a top view of a second example of a guide plate using an ultrasound-enabled insertion needle, wherein the guide plate contains a visual display.

[0021] Figure 10 is a schematic view of an insertion needle having a transducer for interacting with a guide plate of Figure 9 .

[0022] Figure 11 is a schematic line drawing illustrating a method for inserting an access needle to perform a surgical procedure using a guide plate of the present disclosure.

[0023] The detailed description is described with reference to the accompanying figures. DETAILED DESCRIPTION

[0024] Figure 1 is a schematic view of a kidney K in an abdominal cavity AC taken along a coronal plane. The coronal plane can be defined by an axis Y in a medial-lateral direction and an axis Z in a superior-inferior direction. Figure 2A schematic view of a kidney K in an abdominal cavity AC taken along a transverse plane. The transverse plane can be defined by an axis Y in a medial-lateral direction and an axis X in an anterior-posterior direction. Also discussed are Figure 1 and Figure 2 .

[0025] The abdominal cavity AC can be defined by an epidermal layer E that provides a barrier to access the kidney K. An instrument I can be inserted through the epidermal layer E and into the kidney K. The kidney K can include an outer cortex Cx, a medulla M, and a calyx Cy. Kidney stones can form in the kidney in different locations, particularly in the calyx Cy. Surgical procedures to remove kidney stones can include the use of a stone breaking and stone extraction device that is inserted through an opening in the epidermal layer E provided by an access needle. The access needle can be used to provide orientation for a guide tube, such as a laparoscope. As such, to perform a surgical procedure to remove a kidney stone, with typically only two-dimensional imaging being used, the access needle must be invisibly guided through the epidermal layer E into the kidney K and into the calyx Cy. As such, the surgeon must mentally interpret the imaging and translate the desired location and orientation information from the imaging to the patient to find the kidney and avoid other organs. As can be seen in Figure 1 , the orientation of the instrument I in a coronal plane can be affected by the location of the calyx Cy where kidney stones typically form. As can be seen in Figure 2 , the orientation of the instrument I in a transverse plane can be affected by the location of the spine Si and other organs such as the lungs, liver L, and spleen Se. Thus, the initial trajectory of the access instrument for placing the instrument I in the abdominal cavity AC is important. Movement of the patient or respiration can make placement of the access instrument more complicated.

[0026] The present disclosure provides systems and methods for providing indicia and feedback related to the location of an instrument relative to the space below an epidermal layer E and the location of the patient's anatomy. The systems and methods can include the use of a guide board that can provide real-time feedback to a surgeon or other personnel related to the orientation and depth of the instrument, particularly the tip, relative to the guide board and the patient's anatomy. Note that although the present application is described with reference to a nephrolithotomy procedure, the systems and methods of the present disclosure can be used in other procedures, such as procedures for removing tumors, including laparoscopic tumor resection procedures.

[0027] Figure 3is a schematic view of a guide plate 10 of the present disclosure for orienting an access needle 12 into the abdominal cavity beneath the skin 14 of a patient. The plate 10 can include a pad having an inner (dermal side) surface 16 that can be placed against the skin 14 and an outer (outwardly marked) surface 18 from which markings 20 can be read by an operator or user of the guide plate 10. The plate 10 can include a port 22 through which the access needle 12 can be positioned.

[0028] The guide plate 10 can be made of a uniform material, or the guide plate 10 can be made of multiple layers. The thickness t of the guide plate 10 can correspond to the construction of the guide plate 10. It can be desirable to minimize the thickness t in order to increase the pliability and flexibility of the guide plate 10 so that the guide plate 10 can conform to the contours of the skin 14. The markings 20 can be formed by one layer of the plate 10 or additional components added to the outer surface 18, as discussed in more detail with reference to Figure 5 and Figure 7 The guide plate 10 can additionally include an adhesive layer to abut the skin 14 to immobilize the guide plate 10 relative to the patient. The guide plate 10 can be configured to be disposable or reusable. As such, the guide plate 10 can include additional protective layers to encase components used to form the markings 20, such as light emitters or display screens, to facilitate cleaning and sterilization of the adhesive layer and reapplication.

[0029] The port 22 can include an opening through the guide plate 10 from the inner surface 16 to the outer surface 18. The port 22 can be reinforced with a ring 24 to provide the port 22 with a rigidity and size that matches that of the access needle 12. Thus, the inner diameter of the ring 24 can be minimized to match the size of the needle 12 to maximize the display area of the outer surface 18 and provide some retention (securing) capability of the needle 12. In the illustrated example, the access needle 12 and the port 22 are circular. However, the needle 12 and the port 22 can be provided with other shapes that match or do not match. Also, in the illustrated example, the guide plate 10 has a circular outer perimeter. However, the outer perimeter of the guide plate 10 can have other shapes. The circular outer perimeter of the guide plate 10 can be used to provide uniform information relative to the port 22; for example, all portions of the outer perimeter of the wall 28 can be equidistant from the port 22. The guide plate 10 can be sized to cover a surface area of the patient sufficient to cover the distance between a desired incision point in the patient and the location of the target tissue, such as a tumor or kidney stone, to be treated. As such, the port 24 need not be located at the center of the guide plate 10, but can be located at the periphery to maximize the distance between the access port 24 and the periphery. This configuration is useful in procedures where the general direction of the target anatomy from the entry incision is known.

[0030] The outer surface 18 can be provided with indicia 26 to facilitate interpretation of the markings 20. For example, the indicia 26 can include a grid system, a Cartesian coordinate system, a polar coordinate system, etc. The port 22 can be the origin of the coordinate system. The markings 20 can be provided on the indicia 26 to provide multiple pieces of information about the tip of the access needle 12. In particular, the markings 20 can provide: 1) an indication of the distance of the tip of the access needle 12 (not visible in the Figure 3 middle) from the port 22; 2) an indication of the trajectory of the access needle 12 relative to the port 22; and 3) an indication of the depth of the tip of the access needle 12 below the guide plate 10. The visual information provided by the markings 20 can be in the form of color-coded light or light of different intensities as discussed with reference to Figure 4 to Figure 8 , or in the form of images or illustrations provided on a display screen as discussed with reference to Figure 9 .

[0031] Figure 4 A top view of a guide plate 30 including an array 32 of light-emitting elements that can be configured to provide depth and distance feedback to a user of the guide plate 30. The guide plate 30 can include Figure 3 the example of the guide plate 10 of . The guide plate 30 can include an outer surface 34, indicia 36, and a port 38. The array 32 of light-emitting elements can include a plurality of individual light emitters arranged in an organized pattern on the outer surface 34 such that the manner in which the light emitters are illuminated or not illuminated (e.g., pattern, intensity, color) can convey visual information to the user. The indicia 36 can include a grid system, a Cartesian coordinate system, a polar coordinate system, etc., that can be configured to indicate a two-dimensional or three-dimensional space relative to the port 38.

[0032] In the illustrated example, the array 32 defines a plurality of columns of light emitters extending radially from a center within the port 38, and the indicia 36 includes a Cartesian coordinate system including, for example, an X-axis and a Z-axis that can correspond to the X-axis and the Z-axis of Figure 1 and Figure 2 . The light emitters can be illuminated to correspond to the location of an instrument inserted through the port 38. In examples, each light emitter can be off (black in Figure 4 , Figure 6 and Figure 8 ) when not conveying any location information. The light emitters can be turned on to indicate the presence of an instrument below the plate 30. The brightness or color of each light emitter can convey the distance of the instrument from the plate. Figure 4The diagram illustrates sixteen columns of light emitters 40A–40P, with five light emitters per column. For example, column 40A may include light emitters 42A–42E. However, the specific number of light emitters in array 32 can vary in different embodiments depending on the interval size of the information to be obtained. Similarly, the spacing between the lines of the notation grid 36 can vary in different embodiments depending on the interval size of the information to be obtained.

[0033] As described, the guide plate 30 can be constructed in a variety of different ways to be reusable or disposable. In one example, the light emitter of array 32 may include light-emitting diodes (LEDs) mounted to a flexible circuit that includes a layer of guide plate 30. The LEDs may be sealed behind a protective layer. The flexible circuit may be coupled to an embedded or external controller that can control the operation of the LEDs based on the position of the instrument inserted into port 38. For example, the flexible circuit may include a magnetic field sensor for each of the LEDs, and the instrument may include a magnet near the distal end of the instrument. Thus, the magnetic field strength detected by each magnetic field sensor may be affected by the proximity of the distal end of the instrument to each LED. The brightness or color of each LED may be programmed to change based on the proximity of the magnet. For example, the LED may be off in the absence of a magnetic field, and on and fully bright in the presence of a nearby magnet. However, in other examples, the LEDs may be programmed to respond to different inputs, such as ultrasonic information or other proximity sensor information.

[0034] Figure 5 To insert into a first depth indicated by distance D1 and a first orientation indicated by angle α1 Figure 4 A side view of the insertion pin 46 in the guide plate 30. Figure 6 yes Figure 5 A top view of the guide plate 30, showing visual feedback 48 indicating a first depth and a first orientation. The guide plate 30 may include a backing 50, an adhesive layer 52, and a display layer 54. The insertion pin 46 may include a rod portion 56 and a tip portion 58. Simultaneously... Figure 5 and Figure 6 Let's have a discussion.

[0035] The rod 56 of the insertion pin 46 can be inserted into the port 38, such that the tip 58 is positioned at a distance D1 below the guide plate 30. The rod 56 can be at an angle α1 relative to the plane P of the guide plate 30. The array 32 of light-emitting elements can respond to the positions of the rod 56 and the tip 58. Figure 6In the example illustrated in FIG. 1, the insertion needle 46 can be positioned closest to the column 40J of the array 32 such that the light emitters of the column 40J can comprise the visual feedback 48. The column 40J can comprise the light emitters 60A-60E. The column 40J can correspond to the insertion needle 46 extending into the port 38 at an angle β1 relative to the X-axis.

[0036] The activation of at least one of the light emitters 60A-60E of the column 40J can provide an indication of the angle β1 of the shaft 56. As Figure 5 As can be seen in FIG. 2, the shaft 56 is inserted into the port 38 such that the tip 58 does not extend to the perimeter 62 of the guide plate 30. As such, all of the light emitters 60A-60E are not activated. For example, the light emitters 60E and 60D closest to the perimeter 62 are not illuminated, while the light emitters 60A-60C closest to the port 38 are activated. The degree to which the light emitters 60A-60C are activated can provide an indication of both the angle a1 and the depth D1. For example, the light emitter 60A can be activated to a first degree to indicate the presence of a portion of the shaft 56 just below the guide plate 30, and the light emitter 60C can be activated to a second degree to indicate the presence of the tip 58 further below the guide plate 30. In an example, the light emitter 60C can be brighter than the light emitter 60A to indicate where the maximum depth of the shaft 56 is and where the tip 58 is located. The light emitter 60B can be activated to a degree between the first and second degrees such that a continuous spectrum or gradual change in light emission activation can be provided. As mentioned in other examples, color can be used to indicate depth. For example, a heat map can be used where greater depths can be indicated by blue, green, yellow, and red colors.

[0037] Figure 7 For insertion into the guide plate 30 of FIG. 1 at a second depth indicated by the distance DE and a second orientation indicated by the angle a2, the insertion needle 46 can be positioned closest to the column 40K of the array 32 such that the light emitters of the column 40K can comprise the visual feedback 48. The column 40K can correspond to the insertion needle 46 extending into the port 38 at an angle β2 relative to the X-axis. Figure 5 and Figure 6 A side view schematic of the insertion needle 46 in the guide plate 30 of FIG. 1. Figure 8 For insertion into the guide plate 30 of FIG. 1 at a second depth indicated by the distance DE and a second orientation indicated by the angle a2, the insertion needle 46 can be positioned closest to the column 40K of the array 32 such that the light emitters of the column 40K can comprise the visual feedback 48. The column 40K can correspond to the insertion needle 46 extending into the port 38 at an angle β2 relative to the X-axis. Figure 7 A top view of the guide plate 30 of FIG. 1 illustrating the visual feedback 48 indicating the second depth and the second orientation. Both the Figure 7 and Figure 8 are discussed.

[0038] The shaft 56 of the insertion needle 46 can be inserted into the port 38 such that the tip 58 is positioned a distance D2 below the guide plate 30, where D2 is greater than D1 of FIG. 1. The shaft 56 can be at an angle a2 relative to the plane of the guide plate 30, where a2 is less than a1. In Figure 5 Figure 7 ​In the example illustrated, the insertion pin 46 can be positioned closest to column 40L of array 32, such that the light emitter of column 40L can include visual feedback 64. Column 40L can include light emitters 66A to 66E. Column 40L can correspond to the insertion pin 46 extending into port 38 at an angle β2 relative to the X-axis, where β2 is less than β1.

[0039] Activation of at least one of the light emitters 66A to 66E in column 40L can provide an indication of the angle β2 of the rod 56. For example... Figure 7 As can be seen, the rod 56 is inserted into the port 38 such that the tip 58 extends to the periphery 62 of the guide plate 30. Thus, all the light emitters 66A-66E can be activated to some extent. For example, the light emitter 60E closest to the periphery 62 and the light emitter 60A closest to the port 38 can be activated in opposite ways to indicate the depth and orientation of the rod 56. The degree to which the light emitters 66A-66D are activated can provide an indication of both angle α2 and depth D2. For example, light emitter 66A can be activated to a first degree to indicate the presence of the portion of the rod 56 just below the guide plate 30, and light emitter 60E can be activated to a second degree to indicate the presence of the tip 58 further below the guide plate 30. In the example, light emitter 60E can be brighter than light emitter 60A to indicate where the maximum depth of the rod 56 is and where the tip 58 is located. The light emitters 60B to 66D can be activated to varying degrees between a first level and a second level, thereby providing a continuous spectrum or a gradual change in light emission activation.

[0040] The light emitter of array 32 can be updated in real time to indicate the position and depth of tip 58 below plane P of guide plate 30. Therefore, the surgeon can manipulate lever 56, and the surgeon can receive signals from tip 58 located on the patient's skin 14. Figure 3 The distance below is indicated. In the example, mark 36 could include a scale that converts the light emitter's markings into actual length. For example, refer to... Figure 8 The light emitters 66A-66E are configured such that black can indicate a depth of zero, and white can indicate the full length of the rod 56 between the tip 58 and the handpiece (not shown). In other examples, the rod 58 may be provided with markings corresponding to depth, and markings from the guide plate may be used to provide confirmed depth information as well as orientation (e.g., angles α1 and β1) information. In another example, one of the light emitters may be pre-activated to a desired intensity or color to provide the surgeon with target depth and orientation information for guiding the tip 58. Thus, the guide plate 30 can be configured to provide both passive and active guidance information. Furthermore, see below. Figure 9 and Figure 10As discussed, the guide plates of the present disclosure can additionally be configured to provide passive anatomical information and active anatomical information.

[0041] Figure 9 A top view of a guide plate 70 including a visual display, the guide plate used in conjunction with a sensor-enabled, e.g., ultrasound-enabled, insertion needle 72. The guide plate 70 can include a display screen 74 extending between a port 76 and a perimeter 78. The guide plate 70 can be connected to a controller 80. The controller 80 can be connected to the guide plate 70 via a cable 82, or the controller 80 can be directly incorporated into the guide plate 70. The insertion needle 72 can include a tip 84 and a shaft 86. Figure 3 A top view of a guide plate 10 according to embodiments of the present disclosure. The guide plate 70 can include a display screen 74 extending between a port 76 and a perimeter 78. The guide plate 70 can be connected to a controller 80. The controller 80 can be connected to the guide plate 70 via a cable 82, or the controller 80 can be directly incorporated into the guide plate 70. The insertion needle 72 can include a tip 84 and a shaft 86.

[0042] The display screen 74 can include a layer of the guide plate having a shape identical to the shape of the guide plate 70. The display screen 74 can be positioned above the adhesive layer and the electronic layer and below the protective layer. The display screen 74 can include an active display unit, such as a liquid crystal display, a plasma screen, an organic light emitting diode display, or the like. As such, the display screen 74 can be configured to display images from different inputs using the controller 80. For example, the controller 80 can receive inputs from the sensor-enabled insertion needle 72. The controller 80 can interpret information contained in at least one of an electronic signal, a digital signal, and a mechanical signal from the sensor 96( Figure 10 ) and the controller 80 displays an image on the display screen 74. The information from the sensor-enabled insertion needle 72 can be used to interpret the position and orientation of the shaft 86 and to generate an image of the tissue and anatomical structures surrounding the insertion needle 72. For example, the display screen 74 can show a kidney 88, a spine 90, an instrument 92, and a boundary 94.

[0043] Figure 10 A schematic view of an insertion needle or access needle 72 having a sensor 96 for interacting with the guide plate 70 according to embodiments of the present disclosure. The insertion needle 72 can include a tip 84, a shaft 86, a sensor 96, a lumen 97, and a handpiece 98. The insertion needle 72 can be configured for use with any of the guide plates disclosed herein. Figure 9 A schematic view of an insertion needle or access needle 72 having a sensor 96 for interacting with the guide plate 70 according to embodiments of the present disclosure. The insertion needle 72 can include a tip 84, a shaft 86, a sensor 96, a lumen 97, and a handpiece 98. The insertion needle 72 can be configured for use with any of the guide plates disclosed herein.

[0044] The shaft 86 can extend from a proximal end 99P to a distal end 99D. The handpiece 98 can be positioned at or near the proximal end 99P and can include any suitable means configured to facilitate the insertion needle 72. In other examples, the handpiece 98 can be omitted. The tip 84 can be positioned at the distal end 99D of the shaft 86. The tip 84 can be integral with the shaft 86, or the tip 84 can be a separate piece. The tip 86 can include any suitable means for facilitating the piercing of tissue, such as the skin, e.g., the epidermal layer E( Figure 1 andFigure 2 The tip 86 can include a sharp point, such as a needle point, or the tip 86 can include a sharp blade, such as a scalpel or a razor blade. The lumen 97 can be configured to extend the length of the insertion needle 72. The lumen 97 can extend through the handpiece 98, the shaft 86, and the tip 84. However, the lumen 97 can extend from the side of the shaft 86 without extending through the handpiece 98. Likewise, the lumen 97 can be configured to extend from the precise distal end of the tip 84 to more closely track the incision point created by the tip 84, but for purposes of illustration, the lumen 97 is shown offset. After the insertion needle 72 has been positioned in the patient at the desired location and orientation, the lumen 97 can be used to insert other instruments into the patient. For example, a guide wire can be placed into the lumen 72 to mark the path of the insertion needle 72. Thereafter, the insertion needle 72 can be removed while the guide wire remains in place. The guide wire can then be used to guide other instruments, such as a dilator tube and a laparoscope tube, to the surgical site defined by the insertion needle 72.

[0045] A sensor 96 can be incorporated into the structure of the insertion needle 72. The sensor 96 can be contained in the shaft 86 or the tip 84. The sensor 96 can be located at or proximate to the tip 84, or the sensor 96 can be located at a predetermined or known distance from the tip 84. In an example, the tip 84 can be constructed from the sensor such that a separate sensor and tip are not used. The sensor 96 can include a device configured to provide an indication of the location of the tip 84. The sensor 96 can include a passive or active sensor. In an example, the tip 84 can include a magnet that continuously emits a passive magnetic signal. In another example, the sensor 96 can include an ultrasonic transducer that selectively emits an active signal. In other examples, the sensor 96 can include a position sensor or a proximity sensor, such as a capacitive sensor or a photoelectric sensor. In further implementations, the sensor 96 can include a combination of different sensors. The controller 80 can be configured to receive the output of the sensor 96 directly or indirectly by using additional receiving components. For example, the controller 80 can be connected to a magnetic field sensor (e.g., a Hall effect sensor or a microelectromechanical system (MEMS) sensor) associated with the light emitter of the guide plate 30. In Figure 10 In implementations of the sensor 96, the sensor 96 can be configured as an ultrasonic transducer, the output of which can be read by the controller 80.

[0046] Returning to Figure 9 , the insertion needle 72 can be inserted into the port 76 such that the tip 84 is located behind (relative to the direction of insertion) the guide plate 30. The controller 80 can be configured to determine the location of the tip 84 based on the position of the guide plate 30. For example, the controller 80 can be configured to determine the location of the tip 84 based on the position of the guide plate 30 relative to the insertion needle 72. The controller 80 can be configured to determine the location of the tip 84 based on the position of the guide plate 30 relative to the insertion needle 72 and the known distance between the guide plate 30 and the tip 84. The controller 80 can be configured to determine the location of the tip 84 based on the position of the guide plate 30 relative to the insertion needle 72 and the known distance between the guide plate 30 and the tip 84 and the known distance between the insertion needle 72 and the tip 84. The controller 80 can be configured to determine the location of the tip 84 based on the position of the guide plate 30 relative to the insertion needle 72 and the known distance between the guide plate 30 and the tip 84 and the known distance between the insertion needle 72 and the tip 84 and the known distance between the insertion needle 72 and the guide plate 30. Figure 9The guide plate 70 can detect the presence of the sensor 96, and the guide plate 70 can activate the display screen 74 to show a visual representation of the rod 54, which serves as the instrument 92. Similarly, the ultrasound output of the sensor 96 can be used to obtain images of anatomical structures, such as the liver and spine, and to show a visual representation of the kidney 88 and spine 90 on the display screen 74. Thus, the guidance system provided by the guide plate 70 and the insertion needle 72 can provide a visual marker of the position of the tip 84 within the patient's body relative to the patient's anatomical structures. Furthermore, as shown in the reference... Figure 11 The guidance information discussed, relating to the desired orientation of the insertion needle 72 and the locations where the insertion needle 72 should not be positioned—such as prohibited areas indicated by boundary 94—can be included in the surgical plan, which can be visually displayed on display screen 74.

[0047] Figure 11 This is a line diagram of a method 100 for performing surgical procedures according to this disclosure. Surgical procedures may include open surgery or minimally invasive surgery. However, this disclosure is particularly applicable to procedures in which surgical instruments are inserted without visualization, such as laparoscopic surgery. Figure 11 This discussion is based on percutaneous nephrolithotomy (PCNL) performed laparoscopically, in which a laparoscope is inserted into a tube containing a dilator and an insertion needle. In PCNL, kidney stones (pyrenal stones) are removed from the kidney after being broken into smaller pieces suitable for retrieval through the tube. Kidney stones of various shapes and sizes typically form in the calyces of the kidney. Therefore, it is desirable to guide the retrieval instruments to the calyces to minimize the need for movement and repositioning of the removal instruments or the generation of a second insertion needle. Although Figure 11 The procedure is described with reference to kidney stone removal surgery, but the system and method disclosed herein can be used for other surgeries, such as those for removing tumors, including laparoscopic tumor resection.

[0048] At step 102, medical images of the patient can be obtained. Medical images can be taken to obtain views of the patient's anatomy, including the surgical site where instruments will be positioned. Specifically, the patient's abdominal cavity can be imaged to obtain views of the kidneys and the location of kidney stones within the kidneys. These views can be taken along multiple planes, such as the coronal plane (…). Figure 1 YZ plane), transverse plane ( Figure 2 The imaging can be captured in the Y-plane and sagittal plane. Three-dimensional imaging can also be obtained. Available imaging types include X-ray, computed tomography (CT) scans, magnetic resonance imaging (MRI), and ultrasound. Imaging can be obtained at the site where the surgery will be performed, such as in a hospital or outpatient facility.

[0049] In step 104, the target anatomical structure in the image can be identified. For example, the kidney K (K12) can be identified. Figure 1) and kidney stones within the kidney. The location of the kidney stone can be recorded and converted into a three-dimensional coordinate position, such as a three-dimensional coordinate position with respect to the X, Y, and Z planes defined in Figure 1 and Figure 2 X, Y, and Z planes defined in

[0050] At step 106, an incision point within the patient can be determined. The incision point can be a location on the patient's epidermis at which an access instrument, such as instrument I Figure 1 and Figure 2 ), access needle 12 Figure 3 ), access needle 46 Figure 5 and Figure 7 ), and insertion needle 72 Figure 10 ) can be positioned to reach a target anatomical structure, such as a calyx of the kidney, without intersecting any anatomical structures that are not intended to receive the access needle, such as the spine, liver, and lungs. The location of the incision point can be recorded and converted into a three-dimensional coordinate position, such as a three-dimensional coordinate position with respect to the X, Y, and Z planes defined in Figure 1 and Figure 2 X, Y, and Z planes defined in

[0051] At step 108, a trajectory of the insertion instrument can be determined. For example, a three-dimensional coordinate system can be used to determine a trajectory between the target anatomical structure and the incision point. The trajectory of the instrument can be recorded and converted into a three-dimensional coordinate position, such as a three-dimensional coordinate position with respect to the X, Y, and Z planes defined in Figure 1 and Figure 2 X, Y, and Z planes defined in

[0052] In other examples, the incision point can be determined by first planning a trajectory from the target anatomical structure to the epidermis (e.g., steps 106 and 108 can be performed in reverse order). In either example, the trajectory can be drawn to avoid intersecting other anatomical structures of the patient, such as the spine, liver, spleen, etc. Thus, forbidden zones, such as the area isolated by boundary 94 in Figure 9 can be identified and recorded in the three-dimensional coordinate system.

[0053] At step 110, a surgical plan including information specific to the patient and the target anatomical structure can be saved for use in performing the medical procedure. The surgical plan can include the location of the target anatomical structure, the incision, the insertion instrument trajectory, and the forbidden zones. All of this information can be recorded as a visual marker that can be configured for display on a guide board for observation by a surgeon during the course of the surgical procedure.

[0054] The surgical plan can be saved electronically on a computer or machine-readable medium. The term "machine-readable medium" can include any medium that is capable of storing, encoding, or carrying instructions that can be executed by a machine and that cause the machine to perform any one or more of the techniques of the present disclosure, or that are capable of storing, encoding or carrying data structures used by or associated with such instructions. Non-limiting machine-readable medium examples include solid-state memories, and optical and magnetic media. In an example, the machine can be an embodiment of a guide sheet described herein, such as guide sheets 10, 30, and 70, or controller 80. In other examples, the machine can be a surgical imaging system, a surgical navigation system, or a personal computer, among others. In an example, the surgical plan can be stored in a format for rendering a visual display, to include indicia indicating a patient, an anatomical structure, a target location, an incision location, a forbidden zone, and an insertion instrument trajectory.

[0055] Steps 102-110 can describe a method of planning a surgical procedure. In particular, the steps can describe a method of planning an insertion of a laparoscope for performing a PCNL procedure using an insertion needle or access needle.

[0056] At step 112, a guide sheet, such as one or more of guide sheets 10, 30, and 70, can be aligned with the patient. In particular, the planned incision point of the patient can be aligned with an opening in the guide sheet, such as ports 24, 38, and 76. Ports 24, 38, and 76 can thus be used as registration points to register the coordinate system of the anatomical structure with the patient. For example, the planned incision point can be visually located on the exterior of the patient by comparison with imaging. Accordingly, the guide sheet can be placed on the patient to register the indicia (e.g., coordinate system provided by indicia 26 or 36) with the patient. The patient can be appropriately anesthetized for performing the insertion procedure.

[0057] At step 114, the guide sheet can be attached to the patient. Step 114 can be optional. For example, for a disposable sheet, the guide sheet can be attached by an adhesive backing provided on the guide sheet, or for a reusable guide sheet, the guide sheet can be attached by an adhesive liquid applied to the back of the guide sheet. In an example using ultrasound, a gel can be applied to the back of the guide sheet to facilitate reception of ultrasound signals. In an example, the adhesive liquid can be an ultrasound gel.

[0058] At step 116, a tip of an instrument can be placed at the registration point. As mentioned, ports 24, 38, and 76 can be used as registration points. Placing a tip of an instrument at a registration point can register the instrument with the patient and the coordinate system of the surgical plan. However, other registration points on the guide sheet can be used.

[0059] At step 118, the tip of the instrument can be placed at the opening of the guide plate in preparation for insertion into the patient.

[0060] At step 120, a guide marker can be displayed on the guide plate. As discussed, the guide marker can provide visual information related to the position of the inserted instrument and the patient's anatomy, as well as information related to the surgical plan, such as the desired final orientation of the inserted instrument.

[0061] At step 122, the inserted instrument can be oriented according to the guide marker provided on the guide plate. For example, the axis of the inserted instrument can be aligned along the axis shown in the guide plate.

[0062] At step 124, the guide information can be updated, if necessary, to show the position of the guide instrument and display updated placement instructions.

[0063] At step 126, the inserted instrument can be further guided into the patient according to the updated guide information.

[0064] Steps 120-126 can be repeated as necessary to move the inserted instrument to the desired position.

[0065] At step 128, the tip of the inserted instrument can reach the desired position, such as at the target anatomical structure where the surgical procedure will be performed.

[0066] At step 130, the surgical procedure can be performed. For example, a guide wire can be placed through the inserted instrument, and the inserted instrument can be removed. Subsequently, a dilator can be placed through the entry portal using the guide wire until the incision reaches the desired diameter for receiving a laparoscopic tube. At this point, the surgical procedure can be performed, such as treating cancerous tissue or kidney stones by using a resection device or a fragmentation device.

[0067] At step 132, the instruments used in placing the entry portal, e.g., the guide plate and the insertion needle, can be cleaned and sterilized for subsequent reuse if the instruments are configured as reusable devices.

[0068] The benefits of the systems and methods of the present disclosure can be manifested, for example, as: 1) reduced time between entry instrument placement and performance of the surgical procedure using the portal (incision) provided by the entry instrument, 2) reduced dependence on interventional radiologists, 3) reduced need for a second entry portal to access other areas of the patient's anatomy, 4) increased accuracy of entry portal placement, 5) reduced need for a second entry portal due to improper placement of the first entry portal, and 6) reduced dependence on real-time imaging systems during entry portal placement.

[0069] Various examples and illustrations

[0070] Example 1 is a guidance system for performing a percutaneous access incision, the guidance system comprising: an access needle comprising a shaft portion and a tip portion at a distal end of the shaft portion; and a guidance plate comprising a dermal side, an external side, an opening to receive the access needle extending between the dermal side and the external side, and a feedback device viewable from the external side to provide an indication of a depth of the tip portion beneath the guidance plate and a trajectory of the shaft portion from the opening.

[0071] In Example 2, the subject matter of Example 1 optionally includes, wherein the feedback device comprises: an arrangement of light emitters surrounding the opening.

[0072] In Example 3, the subject matter of Example 2 optionally includes, wherein each light emitter of the array comprises a light emitting diode.

[0073] In Example 4, the subject matter of any one or more of Examples 2-3 optionally includes, wherein the light emitters of the array are disposed in a pattern having regular intervals.

[0074] In Example 5, the subject matter of Example 4 optionally includes, wherein the regular intervals correspond to discrete lengths of the tip portion positioned laterally from the opening.

[0075] In Example 6, the subject matter of any one or more of Examples 2-5 optionally includes, wherein each light emitter of the array has a variable brightness, wherein the brightness of each light emitter is configured to correspond to a distance of the tip portion beneath the guidance plate.

[0076] In Example 7, the subject matter of any one or more of Examples 2-6 optionally includes, wherein a plurality of the light emitters of the array have a variable color, wherein the color of each light emitter is configured to correspond to a distance of the tip portion beneath the guidance plate.

[0077] In Example 8, the subject matter of any one or more of Examples 1-7 optionally includes, wherein the tip portion comprises a magnetic element; and each light emitter of the array comprises a magnetic sensor.

[0078] In Example 9, the subject matter of any one or more of Examples 1-8 optionally includes a controller incorporated into the guidance plate, the controller configured to activate the feedback device to provide a visual indication of the depth of the tip portion and the trajectory of the shaft portion.

[0079] In Example 10, the subject matter of Example 9 optionally includes, wherein the access needle comprises a proximity sensor readable by the controller.

[0080] In Example 11, the subject matter of any one or more of Examples 9-10 can optionally include wherein the feedback device is configured to provide a representation of the patient's anatomy under the guide plate.

[0081] In Example 12, the subject matter of Example 11 can optionally include wherein the feedback device is configured to provide a forbidden zone in the representation of the patient's anatomy under the guide plate.

[0082] In Example 13, the subject matter of any one or more of Examples 11-12 can optionally include wherein the feedback device includes a display screen that surrounds the opening, wherein the controller is configured to operate the display screen to provide a visual indication of the depth of the tip and the trajectory of the shaft.

[0083] In Example 14, the subject matter of any one or more of Examples 9-13 can optionally include wherein the access needle further includes an ultrasound transducer in communication with the controller and configured to provide anatomical information to the feedback device.

[0084] Example 15 is a method for planning the introduction of an access needle into a patient in preparation for a minimally invasive surgical procedure, the method comprising: determining a location of an access point on the patient; positioning a guide plate over the access point; inserting a tip of an access needle through the plate; and displaying guidance information on the guide plate.

[0085] In Example 16, the subject matter of Example 15 can optionally include wherein determining a location of an access point on the patient comprises drawing a trajectory of the access needle on an image of the patient.

[0086] In Example 17, the subject matter of any one or more of Examples 15-16 can optionally include wherein positioning the guide plate over the access point comprises adhering the guide plate to the patient.

[0087] In Example 18, the subject matter of any one or more of Examples 15-17 can optionally include wherein inserting a tip of an access needle through the plate comprises: inserting the tip through an opening in the plate that surrounds the access point; and guiding the access needle into the patient in accordance with the guidance information.

[0088] In Example 19, the subject matter of any one or more of Examples 15-18 can optionally include wherein displaying guidance information on the guide plate comprises displaying an indication of the depth of the tip under the guide plate and the trajectory of the shaft from the access point.

[0089] In Example 20, the subject matter of Example 19 optionally includes, wherein displaying the indication of the depth and the trajectory comprises changing a color of individual light emitters of the array of light emitters of the guide pad in response to movement of the tip under the pad, wherein the color of each light emitter is configured to correspond to a distance of the tip under the guide pad.

[0090] In Example 21, the subject matter of any one or more of Examples 19-20 optionally include, wherein displaying the indication of the depth and the trajectory comprises changing a light intensity of individual light emitters of the array of light emitters of the guide pad in response to movement of the tip under the pad, wherein the light intensity of each light emitter is configured to correspond to a distance of the tip under the guide pad.

[0091] In Example 22, the subject matter of any one or more of Examples 19-21 optionally include, wherein displaying the indication of the depth and the trajectory comprises showing an image on a display screen of the guide pad that corresponds to an orientation of the access needle.

[0092] In Example 23, the subject matter of Example 22 optionally includes emitting an ultrasound signal from the access needle to generate anatomical information for display on the display screen.

[0093] In Example 24, the subject matter of any one or more of Examples 15-23 optionally include, wherein displaying the guidance information on the guide pad comprises displaying an anatomical structure of the patient relative to the guide pad.

[0094] In Example 25, the subject matter of Example 24 optionally includes, wherein displaying the guidance information on the guide pad comprises displaying a forbidden zone in the anatomical structure on the guide pad.

[0095] Example 26 is a guide pad for guiding an access needle into a patient in preparation for a minimally invasive surgical procedure, the guide pad comprising: a dermal side; an outer side; an opening for receiving the access needle, the opening extending between the dermal side and the outer side; and an array of light emitters surrounding the opening and observable from the outer side to provide an indication of a depth of a tip of the access needle under the guide pad and a trajectory of a shaft of the access needle from the opening, wherein each of the light emitters of the array has a variable property.

[0096] In Example 27, the subject matter of Example 26 optionally includes, wherein the variable property comprises a color or a light intensity.

[0097] In Example 28, the subject matter of any one or more of Examples 26-27 optionally include, wherein the variable property of each light emitter is configured to vary as a function of a distance of a magnetic object of the access needle from the dermal side.

[0098] In Example 29, the subject matter of Example 28 optionally includes a magnetic field sensor associated with each of the light emitters of the array.

[0099] In Example 30, the subject matter of any one or more of Examples 26-29 optionally include a controller incorporated into the guide plate, the controller configured to: enable a first subset of the light emitters to provide a visual indication of a forbidden zone in the patient's anatomy; and enable a second subset of the light emitters to provide a visual indication of a depth of the tip and a trajectory of the shaft.

[0100] Each of these non-limiting examples can exist independently, or can be combined in various permutations or combinations with one or more of the other examples.

[0101] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the application can be practiced. These embodiments are also referred to as "examples." Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0102] In this document, the terms "a" or "an" are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of "at least one" or "one or more." In this document, the term "or" is used to refer to a nonexclusive or, such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. In this document, the terms "including" and "comprising" are used as synonymous for the respective terms "containing" and "comprising," respectively. Additionally, in the appended claims, the terms "including" and "comprising" are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms "first," "second," and "third," etc. are not construed as implying a numerical requirement for their objects. Limitation 1

[0103] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used as well, which can become apparent upon review of the above description. The Abstract is provided to allow a quick determination of the disclosure's purpose. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features can be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This should not be interpreted as intending that an unclaimed aspect is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Therefore, the following claims are hereby incorporated into the Detailed Description, where each claim by itself is stood as a separate embodiment. The scope of the application should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

1. A guidance system for performing percutaneous access incisions, the guidance system comprising: The insertion needle includes: rod section; The tip, located at the distal end of the rod; and Sensors; and Guide plate, the guide plate comprising: Genuine leather side; outer part; An opening for receiving the insertion needle, the opening extending between the dermal side and the lateral side; and A feedback device, viewable from the outer side, provides indication of the depth of the tip below the guide plate and the trajectory of the rod from the opening, the feedback device comprising: An array of multiple optical emitters, wherein: Each of the multiple rows of light emitters extends along a radial axis that extends through the opening; Each of the multiple rows of optical emitters is axially spaced from each other along one of the radial axes; and The multiple rows of light emitters are spaced apart from each other circumferentially relative to the opening; and A coordinate system, which is displayed on the guide plate and is visible from the outer side, includes an X-axis and a Z-axis on the guide plate; Each of the multiple light emitters in the array changes its characteristics in response to proximity to the sensor to provide an angle of one of the multiple arrays relative to the X-axis and a distance along the one of the multiple arrays between the column and the opening.

2. The guidance system according to claim 1, wherein, Each of the light emitters in the array includes a light-emitting diode.

3. The guidance system according to claim 1, wherein, The coordinate system indicates coordinates relative to the coordinate system obtained from the patient's imaging.

4. The guidance system according to any one of claims 1 to 3, wherein, Each of the light emitters in the array has a variable brightness, which includes an on, off, and multiple discrete brightness levels between on and off, wherein the brightness of each light emitter is configured to correspond to the distance of the tip below the guide plate.

5. The guidance system according to any one of claims 1 to 3, wherein, The characteristic of multiple light emitters in the array is that they have variable colors, wherein the color of each light emitter is configured to correspond to the distance of the tip below the guide plate.

6. The guidance system according to any one of claims 1 to 3, wherein: The sensor includes a magnetic element; and Each of the light emitters in the array includes a magnetic sensor attached to the guide plate, such that each light emitter can independently and directly respond to the position of the sensor.

7. The guidance system according to any one of claims 1 to 3, further comprising a controller incorporated in the guide plate, the controller being configured to enable the feedback device to provide visual indication of the depth of the tip and the trajectory of the rod.

8. The guidance system according to claim 7, wherein, The sensor includes a proximity sensor that can be read by the controller.

9. The guidance system according to claim 7, wherein, The feedback device is configured to provide a representation of the patient's anatomical structures beneath the guide plate.

10. The guidance system according to claim 9, wherein, The feedback device is configured to provide a restricted area in the representation of the patient's anatomy below the guide plate.

11. The guidance system according to claim 9, wherein, The feedback device includes: A display screen surrounding the opening, wherein the controller is configured to operate the display screen to provide a visual indication of the depth of the tip and the trajectory of the rod.

12. The guidance system according to claim 7, wherein, The insertion needle also includes an ultrasonic transducer that communicates with the controller and is configured to provide anatomical information to the feedback device.

13. A guide plate for guiding an insertion needle into a patient in preparation for minimally invasive surgery, the guide plate comprising: Genuine leather side; outer part; An opening for receiving an insertion needle extends between the dermal side and the outer side; as well as Feedback device, the feedback device providing indication of the depth of the tip of the insertion needle below the guide plate and the trajectory of the shaft of the insertion needle from the opening, the feedback device comprising: An array of multiple optical emitters, in which Each of the multiple rows of light emitters extends along a radial axis that extends through the opening; Each of the multiple rows of optical emitters is axially spaced from each other along one of the radial axes; and The multiple rows of light emitters are spaced apart from each other circumferentially relative to the opening; and A coordinate system, which is displayed on the guide plate and is visible from the outer side, includes an X-axis and a Z-axis on the guide plate; Each of the multiple rows of light emitters changes its characteristics in response to proximity to the sensor of the insertion needle, providing an angle of one of the rows relative to the X-axis and a distance along the one of the rows between the row and the opening.

14. The guide plate according to claim 13, wherein, Each of the light emitters in the array has variable characteristics, including color or light intensity.

15. The guide plate according to claim 14, wherein, The variable characteristics of each light emitter are configured to vary according to the distance of the magnetic object entering the needle from the side of the dermis.

16. The guide plate of claim 15, further comprising a magnetic field sensor associated with each of the light emitters in the array.

17. The guide plate according to any one of claims 13 to 16, further comprising a controller coupled to the guide plate, the controller being configured to: Activate a first subset of the light emitters to provide visual indication of forbidden areas in the patient's anatomy; and A second subset of the light emitters is activated to provide a visual indication of the depth of the tip and the trajectory of the rod.

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