Surgical guiding probe

Abstract

A guiding probe for identifying a location within an anatomical region of a patient. The guiding probe can optionally include: a graspable portion, an insertion portion, and a transmitter. The insertion portion can be coupled to the graspable portion. The insertion portion can have an elongate extent and a longitudinal axis. The insertion portion can include a flexible section and a curved section. The curved section can be positioned at a distal end of the flexible section. The transmitter can be coupled to a distal end portion of the insertion portion. The transmitter can be configured for use within the anatomical region to emit a signal that can be detected outside the patient, whereby the signal enables the location within the anatomical region to be identified outside the body for a therapy to be applied.

Description

[0001] Cross - reference to related applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 62 / 943,347, filed on Dec. 4, 2019, the entire content of which is incorporated herein by reference. Technical Field

[0003] This document relates generally but not restrictively to surgical devices, and more particularly to a surgical guidance probe having a transmitter. Background Art

[0004] Various surgical techniques have been developed for treating kidney stones. Treatment can be performed, for example, in an endoscopic or laparoscopic manner. Thus, depending on various factors including the size of the stone, the mode of treatment can be selected. If the diameter of a kidney stone is greater than about 20 mm, it is generally necessary to localize and identify the kidney stone and then a planned percutaneous nephrolithotomy can be performed. This surgery prepares for a percutaneous nephroscopy (PCNL) procedure, in which a percutaneous nephroscope needle is positioned outside the patient's body. Then, the needle is inserted from the external position through the patient's back into a target location, such as a renal calyx of the kidney. Then, various stone fragmentation devices and stone retrieval devices can be used along with the access path created by the needle.

[0005] PCNL relies on precise positioning to localize the target renal calyx (the specific surgical target) without disturbing nearby structures of the kidney, disturbing nearby structures of the kidney may adversely affect the surgical outcome. Thus, this requires a great deal of skill. Inadequate localization and access to the target renal calyx can lead to multiple access attempts, which can damage the kidney or adjacent organs, increase the surgical time, increase the cost of surgery and postoperative treatment recovery, and increase the probability of patient blood loss and complications. Summary of the Invention

[0006] The following examples and discussions illustrate various configurations of the disclosed method. In one example configuration, the proposed method uses an in - vivo transmitter and an ex - vivo detector that facilitate the desired alignment of a percutaneous nephroscope needle with a target renal calyx. The inventors of the present invention have recognized that, among other things, the foregoing challenges, which are to adequately localize and identify the target renal calyx in a positioned manner and determine an appropriate ex - vivo position for the needle such that the needle is correctly aligned with the target renal calyx, can be improved by using an in - vivo transmitter and an ex - vivo detector. Such a system and technique can provide faster and more accurate percutaneous access to the target renal calyx. This in turn reduces the risks associated with radiation visualization, the time and cost spent on the surgery, the patient blood loss due to multiple / failed access attempts, and the probability of complications due to multiple / failed access attempts.

[0007] As used herein, the term "signal" refers to any type of radiant energy or electromagnetic energy, including but not limited to light (light at any frequency or within any frequency range), sound signals (any type of sound signal detectable outside the body), etc. A "signal" can be, for example, a controlled wave or a controlled pulse. Although not specifically discussed, it is understood that a "signal" can be focused and / or amplified by any known means such as through lenses, antennas, amplifiers, etc.

[0008] Example 1 is a guiding probe for identifying a location within an anatomical region of a patient. The guiding probe can optionally include: a graspable portion, an insertion portion, and a transmitter. The insertion portion can be coupled to the graspable portion. The insertion portion can have an elongate extent and a longitudinal axis. The insertion portion can include a flexible segment and a curved segment. The curved segment can be positioned at the distal end of the flexible segment. The transmitter can be coupled to the distal portion of the insertion portion. The transmitter can be configured for use within the anatomical region to emit a signal that can be detected outside the patient, whereby the signal enables the location within the anatomical region to be identified outside the body for a therapy to be applied.

[0009] Example 2 is the guiding probe of Example 1, wherein the transmitter can be positioned at the distal tip of the insertion portion and can be configured to emit a signal along a linear path from the distal tip. The signal can pass through the patient's tissue including the epidermis along the linear path.

[0010] Example 3 is the guiding probe of Example 2, wherein the transmitter can be aligned with the longitudinal axis of the insertion portion.

[0011] Example 4 is the guiding probe of any one or any combination of Examples 1 to 3, wherein the signal can include one of light or an ultrasonic signal.

[0012] Example 5 is the guiding probe of Example 4, wherein the light can have one of a frequency range of about 430 THz to about 770 THz or a frequency range of about 300 GHz to about 430 THz.

[0013] Example 6 is the guiding probe of any one or any combination of Examples 1 to 5, wherein the location within the anatomical region can include a calyx of the patient's kidney, and the guiding probe further includes a needle configured to make a percutaneous access incision to the calyx.

[0014] Example 7 is the guiding probe of any one of Examples 1 to 6, wherein the guiding probe can include an endoscope or the guiding probe can pass through the working channel of an endoscope.

[0015] Example 8 is a system for identifying a location within an anatomical region of a patient. The system can optionally include a guide probe and a detection device. The guide probe can optionally include a graspable portion, an insertion portion, and a transmitter. The insertion portion can be coupled to the graspable portion. The insertion portion can have an elongate extent and a longitudinal axis. The insertion portion can include a flexible section and a bend section. The bend section can be positioned at a distal end of the flexible section. The transmitter can be configured to be coupled to a distal end portion of the insertion portion. The transmitter can be configured for use within the anatomical region to emit a signal. The detection device can be located outside of the patient and can be configured to detect the signal emitted within the anatomical region, whereby the detected signal enables the location within the anatomical region to be identified outside of the body for a therapy to be applied.

[0016] Example 9 is the system of Example 8, wherein the signal can include light, and the detection device can include a camera configured to detect light emitted from the epidermis of the patient.

[0017] Example 10 is the system of Example 9, wherein the camera can be configured to detect light within a frequency range of from about 300 GHz to about 430 THz.

[0018] Example 11 is the system of Example 8, wherein the signal can include an ultrasonic signal, and the detection device can include an ultrasonic device.

[0019] Example 12 is the system of any one of Examples 8 to 11, the system optionally further including a signal generator configured to generate a signal. The signal generator can be coupled to the transmitter via a path through a working channel.

[0020] Example 13 is the system of any one or any combination of Examples 8 to 12, wherein the transmitter can be positioned at a distal tip of the insertion portion and can be configured to emit a signal along a linear path from the distal tip. The linear path can extend from the distal tip through tissue of the patient including the epidermis.

[0021] Example 14 is the system of Example 13, wherein the transmitter can be aligned with the longitudinal axis of the insertion portion, and the guide probe can include an endoscope or can pass through a working channel of an endoscope.

[0022] Example 15 is the system of any one of Examples 8 to 14, the system optionally further including an access needle having a shaft and a tip located at a distal end of the shaft. The access needle can be configured for percutaneous entry into an incision. The location within the anatomical region can include a renal calyx of the patient's kidney.

[0023] Example 16 is a method of detecting a transmitter within an anatomical region. The method may optionally include: transmitting a signal from a guide probe while the guide probe is positioned at a desired location within the anatomical region; detecting the signal outside the body; and determining an in vitro location aligned with the desired location based on the location of the detected in vitro signal and based on a linear path for the signal from the desired location to the in vitro location.

[0024] Example 17 is the method of Example 16, wherein the in vitro location may include a location on the dermis.

[0025] Example 18 is the method of any one or any combination of Examples 16 to 17, which method may optionally further include piercing through tissue from the in vitro location into the desired location derived from the signal.

[0026] Example 19 is the method of any one of Examples 16 to 18, which method may optionally further include, once the signal is detected as a line, superimposing the signal onto an ultrasound image and displaying the image on a display.

[0027] Example 20 is the method of Example 19, which method may optionally further include determining the in vitro location of the signal with reference to the location of the display and the ultrasound probe.

[0028] Example 21 is any one or any combination of Examples 1 to 21 or any element of Examples 1 to 21.

[0029] This disclosure is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive interpretation of the invention. The detailed description is included to provide additional information regarding this patent application. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In the drawings, which are not necessarily drawn to scale, like reference numerals may describe similar components in different views. Like reference numerals with different letter suffixes may represent different instances of similar components. The drawings generally illustrate, by way of example and not limitation, the various examples discussed in this document.

[0031] Figure 1 is a schematic diagram of a guide probe for identifying a location within a patient's anatomical region according to an example of the present disclosure.

[0032] Figure 2 is a schematic diagram of an endoscope configured as a guide probe for identifying a location within a patient's anatomical region according to an example of the present disclosure.

[0033] Figure 3 is a schematic diagram of a system including a guide probe and an in vitro detector according to an example of the present disclosure.

[0034] Figure 4is an ultrasonic image of an organization and an ultrasonic signal having a linear path according to an example of the present disclosure.

[0035] Figure 5 is a first ultrasonic probe configured to facilitate alignment and puncture of a needle for PCNL according to an example of the present disclosure.

[0036] Figure 6A and Figure 6B illustrates a second ultrasonic probe configured to facilitate alignment and puncture of a needle for PCNL according to an example of the present disclosure.

[0037] Figure 7 is a schematic diagram of a system according to an example of the present disclosure, in which a guiding probe emits light in the visible frequency range and having an amplitude visible to the human eye outside the body.

[0038] Figure 8 is a schematic diagram of a system according to an example of the present disclosure, in which a guiding probe emits light having a frequency range and amplitude captured by a camera located outside the body.

[0039] Figure 9 is a method for detecting a guiding probe in vivo according to an example of the present disclosure. Detailed Description

[0040] The present disclosure relates to a surgical device including a guiding probe and related systems and methods. Although described with reference to PCNL for treating kidney stones, it should be recognized that the devices, systems, methods, and techniques of the present disclosure are not limited to this type of surgery. In fact, the devices, systems, methods, and techniques can be used in any surgery that relies on precise targeting of a specific surgical goal without disturbing nearby anatomical structures.

[0041] In the present disclosure, relative terms such as "about", "substantially", or "essentially" are used to indicate a possible variation within ±10% of the stated numerical value or within ±10° of the numerical value.

[0042] Figure 1 is a schematic diagram of a guiding probe 10 manipulated within a patient's kidney K according to an example of the present disclosure. The guiding probe 10 may include an insertion portion 12 and a transmitter 14. The guiding probe 10 may include other portions, such as a graspable portion 15 and / or an actuator (not shown). The guiding probe 10 may be used as part of a system 16 including a signal generator 18 and a signal path 20.

[0043] As Figure 1As shown, the guiding probe 10 can be configured to enter the kidney K via the ureter U and can be manipulated within the kidney K to emit a signal S for identifying an in-situ target location (sometimes simply referred to herein as the target location or location) for treating kidney stones. The in-situ target location can include an anatomical structure for entry by a needle (not shown), such as a renal calyx C. The target location can be related to an extracorporeal puncture location on the dermis. The insertion portion 12 can be configured as a tube or shaft having an elongated extent and a longitudinal axis LA. The insertion portion 12 can provide a working channel 22 for a signal path 20 and other components for manipulating the distal end portion of the guiding probe 10, such as an actuator.

[0044] To enter the kidney K via the ureter U, the insertion portion 12 can be appropriately sized and can have a flexible section 24. The insertion portion 12 can also have a curved section 26 at the distal end of the flexible section 24. As Figure 1 shown, the curved section 26 can be configured to be manipulable to bend within and adjacent to the kidney K so as to position the distal tip of the probe 10 within the kidney K, for example, in alignment with or adjacent to one or more of the renal calyces C. One of the one or more renal calyces C can be the target location for a needle for PCNL as previously described and can be selected based on the location of the kidney stone. The positioning of the probe 10 within the kidney K and at the target location (e.g., in alignment with or adjacent to one or more of the renal calyces C) can be facilitated by endoscopic imaging and, for example, with the support of X-ray imaging.

[0045] The transmitter 14 can be coupled to the insertion portion 12, such as by circumferentially positioning around the distal end portion of the curved section 26 or positioning within the distal end portion of the curved section 26. Thus, the transmitter 14 can be positioned at or adjacent to the distal tip of the guiding probe 10 and can be configured to emit a signal S that is, for example, aligned with the longitudinal axis LA of the insertion portion 12. As discussed further subsequently in detail, the signal S can be, but is not limited to, visible light, infrared light, or a sound signal, such as an ultrasonic signal. As discussed further subsequently, the signal S can have a sufficient amplitude that can be detected extracorporeally. As discussed subsequently, the detected signal can be used to identify the target location and can be used to identify an appropriate extracorporeal location on the patient's dermis that is linearly aligned with the target location.

[0046] The guiding probe 10 can be part of the aforementioned system 16. The signal generator 18 can be a separate device or can be coupled to and / or be part of the guiding probe 10. The signal generator 18 can be configured to generate a signal S that is conveyed along the insertion portion 12 via the signal path 20 to the transmitter 14.

[0047] Figure 2 illustrates an example of an endoscope 101, which can be configured as a guiding probe as previously referred to Figure 1 and discussed or can be used in combination with a guiding probe Figure 1 . Thus, in some examples, the endoscope can be, for example, a device separate from the guiding probe and can be configured to provide an access path for the insertion portion 12 and the emitter 12. Figure 2 is an example of an endoscope 101 that includes a guiding probe. The endoscope 101 can be used with a system 16 (e.g., a separate generator device) as previously described. It should be noted that although Figure 2 the endoscope 101 is described as having certain components and features, these components and features are optional and it should be noted that they do not exist in all examples. The guiding probe as previously discussed and illustrated does not require these components and features. Thus, for example, the endoscope does not need to have visualization / imaging capabilities, as further described in the example with reference to Figure 2 .

[0048] As Figure 2 shown, the endoscope 101 can include an insertion portion 102 and an operating section 103. The operating section 103 can be provided on the proximal direction side of the insertion section 102. The insertion section 102 can be configured to be inserted into a patient's blood vessel. One end of a general cable 104 can be connected to the operating section 103. A mirror connector 105 can be provided at the other end of the general cable 104. The mirror connector 105 can be connected to an image processing unit 107, such as an image processor. One end of an optical guiding tube 108 can be connected to the mirror connector 105. The other end of the optical guiding tube 108 can be connected to a light source unit 109.

[0049] The image processing unit 107 and the light source unit 109 can be electrically connected to a control unit 110, such as a personal computer configured to control the entire system of the endoscope 101. In addition, a display unit 111, such as a display, and an input unit 112, such as a keyboard or a mouse, can be electrically connected to the control unit 110.

[0050] The insertion section 102 may include an elongated insertion body 113 that may extend along a longitudinal axis C. The insertion body 113 may include a transmitter 14 provided on a distal end portion, an active bending portion 116 provided on the proximal side of the transmitter 14, a passive bending portion 117 that may be provided on the proximal side of the active bending portion 116 and configured to bend passively when subjected to an external force, a first flexible portion 118 that may be provided on the proximal side of the passive bending portion 117, and a second flexible portion 119 that may be provided on the proximal side of the first flexible portion 118. The active bending portion 116 may be connected to the passive bending portion 117 through a bending tube connection portion 121. In addition, the passive bending portion 117 may be connected to the first flexible portion 118 through an intermediate connection portion 122. Further, the first flexible portion 118 may be connected to the second flexible portion 119 through a flexible tube connection portion 123.

[0051] The endoscope 101 may have various motional and / or imaging capabilities known in the art. Thus, according to some examples, the endoscope 101 may have a motor 175 for manipulating, for example, the bending portion 117. The endoscope 101 may have an image processing unit 107 configured to detect the brightness of an image of an object. The control unit may include various units (also referred to as sections). These units may include an orientation relationship detection section configured to detect the relationship between the insertion direction of the insertion section 102 and the extending direction of the lumen based on various criteria including the detection results in the brightness detection section. The units may include a motor control section that may be configured to control the rotational drive of the motor 175 based on various criteria. The control unit 110 may include, for example, a transmitter control section 195 configured to control the operation of the transmitter 14 to actuate a signal S( Figure 1 ). The transmitter control section 195 may be operably connected or otherwise associated with one or more of the various units or criteria according to a desire.

[0052] Figure 3 A schematic diagram of a system 200 for identifying a position (here, at, adjacent to, or aligned with a renal calyx C) within an anatomical region (here, the kidney K) of a patient is shown. The system 200 may include a guide probe 10 having an insertion portion 12 and a transmitter 14 as previously discussed, a detection device 202, a computer 204, and a display 206.

[0053] As Figure 3As described, the detection device 202 can be located outside the patient's body, such as in contact with or spaced apart from the patient's dermis D. The detection device 202 can be configured to detect a signal S emitted within the anatomical region. This can be accomplished by the operation of a computer 204. The detection device 202 can be operatively electrically coupled to the computer 204 and a display 206 to process the output of the detection device 202 and provide desired data to a surgeon or other user, the desired data including a visual image of the signal S detected by the detection device 202 on the display 206, the visual image corresponding to the in-situ location of the signal S. According to various examples, the detection device 200 can be an ultrasound device configured to detect ultrasound signals from the emitter 14, the human eye configured to detect visible light such as through the dermis D, or a camera configured to detect light such as infrared light. Each of these various detection devices will be illustrated and discussed subsequently.

[0054] As previously discussed, the system 200 can include a signal generator 18 configured to generate a signal S and a path 20 through the working channel of the insertion portion 12. As previously discussed, the emitter 14 can be aligned with the longitudinal axis of the insertion portion 12 or otherwise configured to emit the signal S such that the signal S is aligned with the longitudinal axis of the insertion portion 12. The emitter 14 can be positioned at the distal tip of the insertion portion 12 and can be configured to emit the signal S along an entry path AP from the distal tip. In fact, the entry path AP for the signal S is used herein to relate the external position for needle puncture to the in-situ position. As Figure 3 shown, the entry path AP can be substantially linear in nature and can extend from the distal tip / emitter 14 located at the in-situ position through tissue including the patient's kidney K and through the dermis D to be detected by the detection device 202.

[0055] Figure 4 A display 204 is shown displaying an image developed using an ultrasound device. The image shows the entry path AP of the signal S (here an ultrasound signal) as a line on the image. This line can allow the surgeon to see the entry path to that location (e.g., a desired renal calyx) from an external position. In other words, the emitted ultrasound signal can be superimposed on an anatomical map or image to provide the surgeon with information about the location and the appropriate puncture location for entry to that location. The map or image can be pre-generated using previous images (e.g., previous images generated using known imaging techniques and modalities such as contrast, ultrasound, etc.).

[0056] Figure 5Illustrates an ultrasound probe 208 according to a first example. The probe 208 can be configured to couple with an access needle 210 having a shaft 212 and a tip 214 at a distal end of the shaft, and to mount or otherwise hold the access needle 210. The access needle 210 can be configured for percutaneous access incisions as part of a PCNL as previously discussed. It should be noted that in Figure 5 the case of the probe 208 configuration, the surgeon can use a linear path of the signal S ( Figure 4 the line in) to support the identification of the location where the needle 210 is used for puncture. However, in Figure 5 the case of the configuration of the probe 208 in, the surgeon may not be able to directly puncture along the line while the probe 208 is held in a position to display the line. Instead, alternative solutions can be employed, such as marking the dermis with the estimated position of the line, estimating the extracorporeal position by slight displacement or known distance displacement of the probe, or making a puncture near the line.

[0057] Figure 6A and Figure 6B provide examples of ultrasound devices, specifically examples of an ultrasound probe 300 of an ultrasound device. The ultrasound probe 300 can be configured to have an aperture 302 ( Figure 6A ) to facilitate positioning and puncture using the needle 210. Through Figure 6A and 6B the ultrasound probe 300 configurations, the needle 210 can be aligned with the line for puncture without having to use the alternative solutions employed with the Figure 5 device.

[0058] Figure 7 Illustrates a system 400 in which the signal S of an in-vivo transmitter is light in a frequency range of about 430 THz to about 770 THz. Thus, the signal S can be emitted with sufficient amplitude to travel through tissue and the signal S is in a frequency range visible to the human eye 402. The signal S (here light) following the linear path previously discussed and illustrated can pass through tissue and can indicate the position on the dermis D for puncture. This position on the dermis D can provide proper alignment and access to the position of the transmitter. Human tissue is light-diffusing, so the signal S can be visible through the human body including the dermis D. According to some examples, materials can be used to assist in the visualization of the linear path of light. For example, light-diffusing materials (diffusive translucent gels, smoke) can be placed on the dermis D or adjacent to the dermis D extracorporeally to assist in visualization.

[0059] Figure 8System 500 shows that the signal S of the in-vivo transmitter is light in a frequency range outside the visible frequency range. Thus, the signal S can be infrared light having a frequency range of, for example, about 300 GHz to about 430 THz. The system 500 can include a camera 502 configured to capture light within an appropriate frequency range (here, about 300 GHz to about 430 THz). Then, the camera 502 or another device can be configured to display an image captured by the camera 502 to a surgeon. Infrared light has good transparency through human tissue and can be observed through the infrared-sensitive camera 502. According to Figure 8 Some examples of the system 500, materials can be used to assist in the visualization of the linear path of the light.

[0060] Figure 9 Method 600 for detecting a transmitter of a guiding probe in the body according to an example is shown. The method 600 can emit a signal 602 from the guiding probe when the guiding probe is in the body and positioned at a desired location. The method 600 can detect the signal 604 outside the body. The method 600 can determine an in-vitro position 606 aligned with the desired position based on the position of the detected in-vitro signal and based on the linear path of the signal from the desired position to the in-vitro position. The method 600 can optionally include where the probe is an endoscope and the signal is emitted from the distal tip position of the endoscope. The method 600 can also include accessing the signal recognition position in the body by piercing through tissue from the in-vitro position. The signal can include either light or an ultrasonic signal having a sufficient amplitude that can be detected outside the body. The in-vitro position can include a position on the dermis. The method 600 can superimpose the signal on an ultrasonic image and display the image once the signal is detected as a line. The method 600 can determine the in-vitro position of the signal with reference to the positions of the display and the ultrasonic probe.

[0061] Various annotations

[0062] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. By way of illustration, the drawings show specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples". Such examples can include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. Additionally, the inventors also contemplate examples using any combination or permutation of those elements (or one or more aspects of those elements) shown or described with respect to a particular example (or one or more aspects of a particular example) or with respect to other examples (or one or more aspects of other examples) shown or described herein.

[0063] In this document, as is common in patent documents, the term "a" or "an" is used to include one or more than one, regardless of any other instances or uses of "at least one" or "one or more". In this document, unless otherwise indicated, the term "or" is used to mean non-exclusive, such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "comprising" and "in" are used as the plain English equivalents of the corresponding terms "including" and "wherein". Additionally, in the appended claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after this term in the claim is still considered to fall within the scope of the claim. Further, in the following claims, the terms "first", "second", "third", etc. are used only as labels and are not intended to impose numerical requirements on their objects.

[0064] The above description is intended to be illustrative, not restrictive. For example, the above examples (or one or more aspects of the examples) may be used in combination with each other. For instance, other embodiments may be used by those of ordinary skill in the art after reviewing the above description. The abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure. The abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Additionally, in the above detailed description, various features may be combined to simplify the disclosure. This should not be construed as meaning that any disclosed features not claimed are necessary for any claim. Rather, the inventive subject matter may lie in less than all of the features of a particular disclosed embodiment. Accordingly, the appended claims are hereby incorporated into the detailed description as examples or embodiments, where each claim stands on its own as a separate embodiment, and it is contemplated that such embodiments may be combined with each other in various combinations or permutations. The scope of the present invention should be determined with reference to the appended claims and the full scope of equivalents to such claims.

Claims

1. A system for identifying a location within an anatomical region of a patient, the system comprising: A display; A guiding probe, the guiding probe comprising: A graspable portion; An insertion portion coupled to the graspable portion, the insertion portion having an elongate extent and a longitudinal axis, wherein the insertion portion includes a flexible section and a curved section, wherein the curved section is positioned distally of the flexible section; and A transmitter coupled to a distal end portion of the insertion portion, the transmitter configured for use within the anatomical region to transmit an ultrasonic signal, wherein the transmitter is positioned at a distal tip of the insertion portion and configured to transmit the ultrasonic signal along a linear path from the distal tip, wherein the linear path extends from the distal tip through tissue of the patient including the epidermis; and An ultrasonic device located external to the patient and configured to detect the ultrasonic signal transmitted within the anatomical region, whereby the ultrasonic signal, when detected, enables the location within the anatomical region to be identified externally and the ultrasonic device to be positioned relative to the anatomical region; An access needle having a shaft and a tip at a distal end of the shaft, wherein the access needle is configured for percutaneous access to an incision; A processor configured to superimpose the ultrasonic signal as a line on an ultrasonic image displayed on the display, wherein the line is displayed prior to the percutaneous access incision and the access needle is configured to be positioned using the displayed line, wherein the ultrasonic device includes one or more components for guiding the access needle during the percutaneous access incision.

2. The system according to claim 1, further comprising a signal generator configured to generate the ultrasonic signal, wherein, The signal generator is coupled to the transmitter via a path through the working channel.

3. The system according to claim 1, wherein, The transmitter is aligned with the longitudinal axis of the insertion portion, and the guiding probe includes an endoscope or a working channel through the endoscope.

4. The system according to claim 1, wherein, The location within the anatomical region includes a renal calyx of the patient's kidney.

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