Medical device position sensing assembly

Abstract

Medical devices are disclosed, including a medical device including a handle and a needle extending distally from the handle. The needle may be configured to be at least partially inserted into the body and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion different from the distal portion. The proximal end of the distal portion may be coupled to the distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may also include a device of a position sensing system disposed in the cavity. The device may be a transmitter device or a receiver device. The position sensing system may be configured to determine a position or orientation of the distal tip.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 366,538, filed on June 17, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to apparatus, systems and methods for medical device position sensing assemblies. More specifically, aspects of the disclosure relate to apparatus, systems and / or methods for position sensing assemblies integrated within and / or attached to medical devices for medical device position tracking. Background Art

[0004] Core needle biopsy devices are commonly used to obtain tissue samples to diagnose cancer, particularly prostate cancer. Prostate biopsy procedures are typically guided under ultrasound, where the operator can control the ultrasound probe inserted into the patient's rectum with one hand and place the core needle biopsy needle outside the perineum with the other hand. The needle may be spring-loaded (e.g., in a retracted position) when placed. When the operator is ready to perform a biopsy, the operator can activate a trigger device to advance the needle forward from the retracted position to obtain a core sample of tissue.

[0005] Setting the needle under ultrasound is difficult and requires the operator to estimate the spatial distance and orientation between the ultrasound probe in the rectum and the needle outside the perineum. For example, the operator must first estimate the trajectory of the needle based on the ultrasound image without any direct indication of where the needle is positioned relative to the anatomical structure displayed on the ultrasound image. Once the needle is inserted through the perineum, the operator aligns the ultrasound imaging plane with the needle tip in order to visualize the needle tip and place the needle in the desired position. However, if the needle is oblique to the ultrasound imaging plane, the operator may not be able to see the needle tip, and many operators prefer an oblique approach so that they can sample all areas of the prostate through a relatively small perineal area, thereby reducing the area they need to anesthetize before surgery. Once the needle is visualized and placed in the desired position, the operator can estimate the three-dimensional trajectory of the needle as it is advanced forward from the retracted position to ensure that the path that will be traversed when the needle is advanced only passes through tissue that can be safely biopsied. If the needle turns toward any critical anatomical structure, such as the rectal wall, urethra, seminal vesicle, or blood vessels, the needle may be advanced too quickly, resulting in the operator being unable to track or correct the route, resulting in critical anatomical structures being punctured, leading to patient complications. Summary of the invention

[0006] A medical device is disclosed herein, which may include a handle and a needle extending distally from the handle. The needle may be configured to be at least partially inserted into a body, and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion different from the distal portion. The proximal end of the distal portion may be coupled to the distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may also include a device for a position sensing system disposed within the cavity, the device being one of a transmitter device or a receiver device. The position sensing system may be configured to determine the position or orientation of the distal tip.

[0007] In any exemplary medical device disclosed herein, the inner surface of the proximal end of the distal portion of the core may include one or more interlocking features that correspond to one or more structural features of the distal end of the proximal portion to couple the distal portion to the proximal portion. The sheath and the core may be independently retractable into the handle, and when the sheath is retracted proximally into the handle, only the distal end of the distal portion of the core is exposed. The device of the position sensing system may be arranged in the cavity at a known distance and position relative to the distal tip.

[0008] In some aspects, the device of the position sensing system may be a receiver device, which may include a magnetic field sensor configured to detect a magnetic field generated by an external transmitter device of the position sensing system, and provide a signal indicating at least one of the position and orientation of the distal tip based on the strength of the detected magnetic field. In other aspects, the device of the position sensing system may be a transmitter device, and the transmitter device may be configured to generate a magnetic field detectable by an external receiver device of the position sensing system, and the external receiver device is configured to provide a signal indicating at least one of the position and orientation of the distal tip based on the strength of the detected magnetic field.

[0009] The proximal end of the proximal portion of the core may be hollow to receive the wire of the device of the position sensing system and guide it into the handle. The handle may include an inner plug-in board connected to the wire, which relays signals between the wire and the controller of the position sensing system via an external cable connecting the inner plug-in board and the controller. The handle may also include a compartment for receiving the wire of the device of the position sensing system from the proximal end of the proximal portion of the core. The wire may be contained in an internal cable in the compartment. The sheath and the core are independently retractable into the handle, and the handle may also include a switch configured to detect when the core is in a retracted position in the handle. The switch may detect that the core is in the retracted position, and provide a signal to the computing device to cause the generation and display of a graphical user interface, which includes at least the planned needle trajectory of the needle superimposed on the image of the target area in the body. Once the needle is at least partially inserted into the body, the graphical user interface is updated to further include: when the needle is advanced distally from the retracted position, the planned trajectory of the distal tip to the target area, and at least one of the position or orientation of the distal tip.

[0010] The medical device may also include components of a system of a position sensing system and an ultrasound imaging system, wherein the ultrasound imaging system is configured to generate an ultrasound image in an ultrasound imaging plane. The ultrasound imaging system may include an ultrasound imaging console and an ultrasound probe. Another device of the position sensing system, which is one of another transmitter device or another receiver device, may be attached to the ultrasound probe to determine at least one of the position and orientation of the distal tip relative to the ultrasound imaging plane. When the device of the position sensing system arranged in the cavity is a receiver device, the other device of the position sensing system attached to the ultrasound probe may be another receiver device. When the device of the position sensing system arranged in the cavity is a transmitter device, the other device of the position sensing system attached to the ultrasound probe may be another transmitter device.

[0011] In another example, the medical device may include a needle and a handle, the needle extending distally from the handle. The needle may be configured to be at least partially inserted into the body, and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion different from the distal portion. The proximal end of the distal portion may be coupled to the distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may also include a device for a position sensing system disposed in the cavity, the device being one of a transmitter device or a receiver device. The position sensing system may be configured to determine the position or orientation of the distal tip. The proximal end of the proximal portion of the core may be hollow to receive and proximally guide a wire of the device for the position sensing system. The handle may include a compartment for receiving a wire of the device for the position sensing system guided proximally from the core.

[0012] Any of the exemplary medical devices disclosed herein may include any of the following features. The handle may also include an inner plug-in board connected to the wire of the device of the position sensing system, the inner plug-in board relaying signals between the wire and the controller of the position sensing system via an external cable connecting the inner plug-in board and the controller. The sheath and the core are independently retractable into the handle, and the handle may also include a switch connected to the inner plug-in board, the switch being configured to detect when the core is in a retracted position in the handle.

[0013] In another example, the medical device may include a handle and a needle extending distally from the handle. The needle may be configured to be at least partially inserted into a body toward a target area, and may include a sheath and a core disposed in the sheath. The core may have a distal portion including a distal tip, and a proximal portion different from the distal portion. The proximal end of the distal portion may be coupled to the distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may also include a device for a position sensing system disposed in the cavity, the device being one of a transmitter device or a receiver device. The position sensing system may be configured to determine the position or orientation of the distal tip. When the needle is at least partially inserted into the body toward the target area, the needle may be in a retracted position in the handle. When the needle is advanced distally from the retracted position, the planned trajectory of the distal tip to the target area may be determined based on at least one of the position and orientation of the distal tip. A graphical user interface for display may be generated and provided, which overlays at least one of the position and orientation of the distal tip and the planned trajectory on an image of the target area.

[0014] Any medical device disclosed herein may have any of the following features. The medical device may be a component of a system further comprising a position sensing system and an ultrasound imaging system, the ultrasound imaging system being configured to produce an image of a target area in an ultrasound imaging plane. The ultrasound imaging system may include an ultrasound imaging console and an ultrasound probe. Another device of the position sensing system is one of a transmitter device or a receiver device, which can be attached to the ultrasound probe to determine at least one of a position and an orientation of the distal tip relative to the ultrasound imaging plane.

[0015] It should be understood that the general description described above and the detailed description below are exemplary and explanatory only and do not limit the claimed invention. As used herein, the terms "include", "comprising" or any other variations thereof are intended to cover non-exclusive inclusion, i.e., a process, method, article or device comprising a series of elements, is not limited to including these elements, and may also include other elements that are not explicitly listed or inherent to the process, method, article or device. The term "exemplary" is used in the sense of "example" rather than "ideal". The term "distal" refers to the direction away from the operator / towards the treatment site, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include a range of + / -10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0017] Figure 1A and Figure 1B An exemplary system for performing an electromagnetically navigated medical procedure using a medical device is shown.

[0018] Figures 2A-2F Shows Figure 1A and Figure 1B An exemplary needle of a medical device.

[0019] Figures 3A-3D Shows Figure 1A and Figure 1B An exemplary medical device in a neutral state.

[0020] Figures 4A-4C Shows Figure 1A and Figure 1B An exemplary medical device in a partially cocked state.

[0021] Figures 5A-5C Shows Figure 1A and Figure 1B An exemplary medical device in a fully cocked state.

[0022] Figure 6 shows a method for generating a graphical user interface to visualize Figure 1A and Figure 1B An exemplary process for determining the position and / or orientation of a medical device in an embodiment of the present invention.

[0023] Figures 7A-7C An exemplary graphical user interface is shown.

[0024] Figure 8 An example of a computing device is shown. DETAILED DESCRIPTION

[0025] Electromagnetic (EM) navigated medical procedures may utilize EM tracking to provide information about the position and / or orientation of a medical device in a subject's anatomy, such as the position and / or orientation of a distal tip of a needle of a biopsy device. Under EM tracking, the position and / or orientation information may be fused with imaging (e.g., ultrasound imaging) performed before and during the procedure to generate and display a graphical user interface to guide the medical device through the subject's anatomy and provide a planned trajectory for the distal tip needle of the medical device as the medical device is advanced distally from a retracted position to perform a biopsy to obtain a tissue sample.

[0026] The needle of the medical device may extend distally from a handle used by an operator to hold the medical device, and may include a sheath and a core disposed in the sheath. The sheath and the core may be independently retractable into the handle, and both the sheath and the core may be in a retracted position when the medical device is inserted into the body. The core may consist of two different parts, namely a distal portion and a proximal portion. The distal portion may include a distal tip, and the proximal end of the distal portion may be coupled to the distal end of the proximal portion to define a cavity between the proximal end of the distal portion and the distal end of the proximal portion. The needle may also include a device of a position sensing system disposed in the cavity. In some aspects, the device may be a receiver device of a position sensing system including a magnetic field sensor. The magnetic field sensor may be configured to detect a magnetic field generated by an external transmitter device of the position sensing system, and provide a signal indicating the position and / or orientation of the distal tip of the needle to a controller of the position sensing system based on the strength of the detected magnetic field. In other aspects, the device can be a transmitter device of a position sensing system configured to generate a magnetic field detectable by an external receiver device of the position sensing system, wherein the external receiver device can be configured to provide a signal indicating the position and / or orientation of the distal tip of the needle to a controller based on the strength of the detected magnetic field. The proximal end of the proximal portion of the core can be hollow to receive a wire of the device of the position sensing system and guide it into the handle.

[0027] In addition to including a component that enables the sheath and core assembly of the needle to be retracted into the handle and then advanced, the handle of the medical device may also include a compartment for receiving the wire of the device of the position sensing system to allow relaxation when the needle is retracted and advanced. The wire can be connected to an inner plug-in board in the handle to relay signals between the wire and the controller of the position sensing system via an external cable of the medical device. The handle may also include a switch connected to the inner plug-in board, which is configured to detect when the needle is in a retracted position. When the retracted position is detected, a signal can be provided via the inner plug-in board to trigger an application executed on a computing device to generate and display a graphical interface for guiding the medical device. In some aspects, when the needle is positioned near at least the body (e.g., before being inserted into the body), the planned needle trajectory can be determined by the position sensing system. A graphical user interface that overlays the planned needle trajectory on an image of the target area can be generated and displayed to allow the operator to visualize and plan the trajectory of the needle (e.g., the insertion path of the planned needle). In addition, since the needle is at least partially inserted into the body and placed toward the target area, when the needle is advanced distally from the retracted position, the planned trajectory of the distal tip of the needle to the target area can be determined based on the position and / or orientation of the distal tip of the needle determined by the position sensing system. A graphical user interface can be generated and provided that overlays the position and / or orientation of the distal tip of the needle and the planned trajectory on the image of the target area for display to guide the operator of the medical device.

[0028] In some embodiments, the ultrasound probe of the system performing ultrasound imaging may include another device of the position sensing system attached thereto for determining the position and / or orientation of the distal tip of the needle relative to the ultrasound imaging plane. Thus, when the needle is advanced distally from the retracted position, the planned trajectory of the distal tip of the needle to the target area may also be determined relative to the ultrasound imaging plane.

[0029] Figure 1A A block diagram of an exemplary system 100 for performing an EM-navigated medical procedure is described. The system 100 may include a medical device 102, an imaging system 104 for visually guiding the insertion and placement of the medical device 102 in a patient, and a position sensing system 106 for determining the position and / or orientation of the medical device 102 in the patient. The position sensing system 106 may include any of the features described in U.S. Patent No. 10,782,114, issued on September 22, 2020, which is incorporated herein by reference in its entirety. The position sensing system 106 may be an EM-based tracking system comprising: one or more transmitter devices 108 for generating an electromagnetic field; one or more receiver devices 109 for detecting the generated electromagnetic field; and a controller 107, which is communicatively coupled to the transmitter device 108 and the receiver device 109, and the determination of the position and / or orientation may be based on the field strength detected by the receiver device 109, as described in more detail below.

[0030] Each of the medical device 102 and the imaging system 104 may be communicatively coupled to the position sensing system 106. Additionally, the medical device 102 and / or the imaging system 104 may include components of the position sensing system 106, such as a transmitter device 108 and / or a receiver device 109 integrated therein. The system 100 may further include a separate computing device 110 configured to enable an operator (e.g., a physician) to interact with other systems, such as the imaging system 104 and / or the position sensing system 106, to generate graphical user interface visualizations for display to the operator. Figure 1B Exemplary components of medical device 102 , imaging system 104 , and position sensing system 106 are depicted.

[0031] Also refer to Figure 1A and Figure 1B , the medical device 102 can be a biopsy device, including a needle 112 for inserting into a patient to obtain a sample of target tissue, wherein the needle 112 extends distally from a handle 114 through which an operator holds or grasps the medical device 102. The imaging system 104 can be an ultrasound imaging system including an imaging console 116 and a probe 118. The ultrasound imaging system can be a two-dimensional (2D) ultrasound imaging system or a three-dimensional (3D) ultrasound imaging system. Once the probe 118 is placed near the anatomical structure to be imaged, the probe 118 can emit sound waves into the patient's body and receive the sound waves reflected back. The probe 118 can generate an electrical signal based on the reflected sound wave, which is transmitted to a processing unit of the imaging console 116 to generate a 2D or 3D image in one or more 2D ultrasound imaging planes to be presented via a display of the imaging console 116.

[0032] In some embodiments, the medical procedure can be a prostate biopsy procedure, such as a transperineal biopsy procedure. During the prostate biopsy procedure, the probe 118 can be a transrectal ultrasound probe placed in the patient's rectum to provide a two-dimensional imaging plane pointing upward, thereby imaging the prostate. The medical device 102 can be a biopsy device with a needle 112, which is inserted into the patient through the perineum using guidance from ultrasound imaging and enters the prostate. Initially, the needle 112 of the medical device 102 can be in a retracted position when the patient is inserted. For example, at least a portion of the needle 112 can be retracted into the handle 114 using the first and second firing mechanisms. When the target area (e.g., prostate) is reached, the medical device 102 can be actuated via the handle 114 so that the needle 112 is advanced distally from the retracted position to obtain a core biopsy sample of prostate tissue. For example, the first and second firing mechanisms can be released so that the needle is advanced distally from the retracted position.

[0033] Because the entry points of the probe 118 and the needle 112 are different, the ultrasound imaging plane may be misaligned with the needle 112, and therefore, it may be difficult for the operator to visualize the needle 112 in the ultrasound image until the needle 112 is within the imaging plane (e.g., on a plane) and the probe 118 is rotated to a specific position to position the needle 112. In addition, in many cases, the operator may be trying to navigate the needle 112 to the ultrasound imaging plane at a slight angle, and, as a result, the tip of the needle 112 may not be visible. Therefore, when the medical device 102 is actuated, the operator may not be able to predict the trajectory of the distal tip of the needle 112 when the needle is advanced forward from the retracted position. In addition, when the needle 112 is embedded in the tissue, the needle 112 may bend, further increasing the complexity of trajectory prediction. If the needle 112 follows a different trajectory than predicted when it is advanced from the retracted position, the needle 112 may accidentally pierce unintended anatomical structures, such as the rectal wall, urethra, seminal vesicles and / or blood vessels, which may cause patient complications.

[0034] Therefore, in order to overcome these challenges, the position sensing system 106 can be implemented by the system 100 to determine the position and / or orientation of the needle 112. As described above, the position sensing system 106 may include a transmitter device 108 for generating an electromagnetic field and a receiver device 109 for detecting the generated electromagnetic field. In an exemplary aspect, the transmitter device 108 may be an external device 120, and the receiver device 109 may include at least one EM sensor (not shown in this figure, hereinafter referred to as a needle-type EM sensor) disposed in the needle 112 of the medical device 102 to enable tracking of the position and / or orientation of the distal end of the needle 112. In addition, the receiver device 109 may also include a probe-type EM sensor 122 that can be attached to and detached from the probe 118 to facilitate tracking of the position and / or orientation of the distal tip of the needle 112 relative to the ultrasound imaging plane, so that the position and / or orientation of the needle 112 is displayed in the imaging plane. In addition, an EM sensor (not shown in the figure, hereinafter referred to as a handle-type EM sensor) may be disposed in the handle 114 of the medical device 102. The handle-mounted EM sensor can be used to determine the state of the medical device 102 (e.g., whether the medical device 102 is in a fully fired state) based on the distance between a fixed point in the handle 114 and a needle-mounted EM sensor disposed in the needle 112, as described below. Additionally or alternatively, the handle-mounted EM sensor can be used to measure a second axis to provide six degrees of freedom instead of five degrees of freedom. Thus, a computer-generated visualization of the orientation (e.g., in addition to the position) of the tip of the needle 112 and / or the angular position of the handle 114 can be enabled. In another exemplary aspect, the transmitter device 108 that generates a magnetic field can include a needle-mounted EM sensor, a probe-mounted EM sensor 122, and / or a handle-mounted EM sensor, and the receiver device 109 that detects the magnetic field can include an external device 120.

[0035] Each of the transmitter devices 108 may include an element for generating a magnetic field. For example, the transmitter device 108 may include one or more coils (eg, solenoids) and one or more circuit elements that transmit current through the coils. Thus, the coils may generate a magnetic field.

[0036] Each of the receiver devices 109 may include one or more magnetic field sensors. The magnetic field sensor may include, for example, a magnetoresistive element, such as a tunnel magnetoresistive (TMR) element, an anisotropic magnetoresistive sensing element, a giant magnetoresistive sensing element, a Hall effect sensing element, a giant magnetoresistive sensing element, a super magnetoresistive sensing element, or a semiconductor magnetoresistive element. Additionally or alternatively, the magnetic field sensor may include one or more inductive sensors (e.g., inductive coil sensors), planar coil sensors, spin Hall sensing elements (or other Hall sensing elements), or magnetic gradiometers. The magnetic field sensor of the receiver device 109 may have any characteristics of magnetic field sensors known in the art (including, for example, TMR sensors). For example, the magnetic field sensor may include a fixed layer, a tunnel layer, and a free layer. When the free layer is aligned with the fixed layer, the resistance may change.

[0037] In some examples, at least a portion of the receiver device 109, such as the probe EM sensor 122 and / or the handle EM sensor, may have a magnetic field sensor arranged in a dual axis, six degrees of freedom arrangement to enable measurement of x, y, z, roll, pitch, and yaw. For example, these portions of the receiver device 109 may include three magnetic field sensors arranged in a dual axis, six degrees of freedom arrangement to enable three-dimensional determination of the position of the imaging plane based on the measurements of x, y, z, roll, pitch, and yaw. In such an arrangement, two of the three magnetic field sensors may be oriented so that their primary sensing directions are aligned (approximately parallel) with the longitudinal axis of the corresponding device in which they are integrated. Two magnetic field sensors may be configured in a full Wheatstone bridge. A third magnetic field sensor may be arranged so that its primary sensing direction is transverse (e.g., approximately orthogonal / perpendicular) to the longitudinal axis. A third magnetic field sensor may be configured in a half Wheatstone bridge. These Wheatstone bridges may have any characteristics of Wheatstone bridges known in the art.

[0038] The position sensing system 106 may have other configurations within the scope of the present disclosure. For example, the magnetic field sensor of the receiver device 109 may adopt a three-axis configuration, wherein each of the three magnetic field sensors is arranged so that its primary sensing direction is aligned with a different axis (e.g., the primary sensing directions of the magnetic field sensors are aligned orthogonally to each other). For example, the primary sensing direction of the first magnetic field sensor may be the X-axis, the primary sensing direction of the second magnetic field sensor may be the Y-axis, and the primary sensing direction of the third magnetic field sensor may be the Z-axis. In this three-axis configuration, each magnetic field sensor may adopt a half-Wheatstone bridge configuration. In another example, the receiver device 109 may use only two magnetic field sensors to measure six degrees of freedom, wherein each of the two magnetic field sensors has a half-Wheatstone bridge configuration (or a full-Wheatstone bridge configuration). In yet another example, two magnetic field sensors may be used to measure five degrees of freedom. In such an example, the position sensing system 106 may not be able to measure roll. In another example, the receiver device 109 may implement a single magnetic field sensor and use a half-Wheatstone bridge to measure five degrees of freedom. The needle-type EM sensors may be arranged in a five-degree-of-freedom arrangement (eg, because the orientation of the needle 112 about its axis need not be determined), or in a two-axis six-degree-of-freedom arrangement.

[0039] The controller 107 may be communicatively coupled to the transmitter device 108 and the receiver device 109. For example, the controller 107 may be communicatively coupled to the external device 120, the needle EM sensor, the probe EM sensor 122, and / or the handle EM sensor. The controller 107 may be indirectly coupled to the needle EM sensor via an external cable 124 extending from the medical device 102. The controller 107 may be directly coupled to the probe EM sensor 122 via an external cable 126 extending from the probe EM sensor 122. The controller 107 may send a signal to the transmitter device 108 to cause the transmitter device 108 to initiate the generation of a magnetic field, and subsequently pause, stop, and / or restart the generation of a magnetic field. In addition, the controller 107 may receive a signal from the receiver device 109 indicating the strength of the magnetic field detected by the receiver device 109 (e.g., the voltage induced therefrom). The position and / or orientation of the distal tip of the needle 112 may be determined based on these signals, wherein, in some examples, the position and / or orientation is relative to the ultrasound imaging plane.

[0040] In embodiments where the receiver device 109 includes a needle EM sensor, a probe EM sensor 122, and / or a handle EM sensor, the controller 107 may computationally determine the position and / or orientation of the distal tip of the needle 112 of the medical device 102 based on received signals from the needle EM sensor, the signals being indicative of a voltage induced by a magnetic field generated by the external device 120 as detected by the needle EM sensor. In addition, the controller 107 may computationally determine the position and / or orientation of the distal tip of the needle 112 of the medical device 102 relative to the ultrasound imaging plane based on received signals from the needle EM sensor and the probe EM sensor 122, each of which is indicative of a voltage induced by a magnetic field generated by the external device 120 as detected by the respective EM sensor. Further, based on signals received from the handle EM sensor measuring the second axis, the controller 107 may determine the orientation (e.g., in addition to the position) of the tip of the needle 112 and the angular position of the handle 114.

[0041] In embodiments where the receiver device 109 comprises an external device 120, the controller 107 may computationally determine the position and / or orientation of the distal tip of the needle 112 based on received signals from the external device 120, wherein the signals are indicative of a voltage induced by a magnetic field generated by at least the needle EM sensor as detected by the external device 120. Furthermore, if the probe EM sensor 122 is also the transmitter device 108, the controller 107 may computationally determine the position and / or orientation of the distal tip of the needle 112 relative to the ultrasound imaging plane based on received signals from the external device 120, wherein the signals are indicative of a voltage induced by a magnetic field generated by each of the needle EM sensor and the probe EM sensor 122 as detected by the external device 120.

[0042] The independent computing device 110 can communicate with one or more other components of the system 100 (including the imaging system 104 and / or the position sensing system 106) across the electronic network 130 to receive information. For example, the computing device 110 can be communicatively coupled to the ultrasound imaging console 116 of the imaging system 104 to receive images acquired by the imaging system 104 in the ultrasound imaging plane. In addition, the computing device 110 can be communicatively coupled to the controller 107 of the position sensing system 106 to receive the position and / or orientation of the needle 112 (including its distal tip). In some examples, the received position and / or orientation of the needle 112 can be relative to the imaging plane from the controller 107. In other examples, the computing device 110 can receive a signal via the controller 107 indicating that the medical device 102 is in a fully fired state (e.g., the needle is retracted) to trigger the generation and display of a graphical user interface (GUI) that includes at least the planned trajectory of the needle 112 superimposed on the target area image of the biopsy received from the imaging system 104.

[0043] The computing device 110 may be a computer system, such as, for example, a desktop computer, a laptop computer, a tablet computer, a smartphone, a smart watch or other wearable electronic device, etc. In some embodiments, the computing device 110 may include one or more electronic applications, such as programs, plug-ins, browser extensions, etc., installed on the memory of the computing device 110. The application may be locally installed and / or accessible via a browser of the computing device 110 based on a web page. In addition, one or more components of the computing device 110, such as one of the applications, may generate or cause to be generated one or more GUIs based on instructions / information stored in the memory, instructions / information received from other systems in the system 100, and / or the like, and may cause the GUI to be displayed via a display of the computing device 110. The GUI may be, for example, a mobile application interface or a browser user interface, and may include text, input text boxes, selection controls, and / or the like. The display may include a touch screen or a display with other input systems (e.g., a mouse, a keyboard, etc.) for an operator of the computing device 110 to control the functions of the computing device 110.

[0044] As an example, an application of the computing device 110 may utilize an image received from the imaging system 104 and a position and / or orientation of the needle 112 relative to the imaging plane received from the controller 107 as input information to generate a GUI for display on the computing device 110. The GUI may display the position and orientation of the needle 112 (including its distal tip) within the imaging plane, as well as the planned three-dimensional trajectory of the needle 112 as the needle 112 is advanced from the retracted position. The trajectory may be computationally determined based at least in part on the position and orientation of the distal tip of the needle 112. As the operator further inserts the medical device 102 into the patient's body, positions it toward the target area, and actuates the medical device 102 to obtain a core biopsy sample, the GUI may be iteratively updated based on new information received from the imaging system 104 and the position sensing system 106 (e.g., based on new images and position / orientation information).

[0045] The network 130 over which one or more components of the system 100 communicate may include one or more wired and / or wireless networks, such as a wide area network ("WAN"), a local area network ("LAN"), a personal area network ("PAN"), a cellular network (e.g., a 3G network, a 4G network, a 5G network, etc.), or the like. In one non-limiting illustrative example, the components of the system 100 may communicate and / or connect to the network 130 via a universal serial bus (USB) or other similar local low-latency connection or a direct wireless protocol. In some embodiments, the network 130 includes the Internet, and the information and data provided between the various systems occurs online. "Online" may mean connecting to or accessing source data or information from a remote location other than through other devices or networks coupled to the Internet. Alternatively, "online" may refer to connecting to or accessing an electronic network (wired or wireless) via a mobile communication network or device. The Internet is a global system of computer networks - a network of interconnected networks in which a party on a computer or other device connected to the network can obtain information from any other computer and communicate with a party on other computers or devices. The computing device 110 and one or more of the imaging system 104 and the position sensing system 106 may be connected via the network 130 using one or more standard communication protocols. The computing device 110 and one or more of the imaging system 104 and the position sensing system 106 send and receive communications with each other across the network 130, as discussed in more detail below.

[0046] Despite Figure 1A and 1BAlthough described as separate components in the system 100, it should be understood that in some embodiments, a component or portion of a component in the system 100 may be integrated or merged with one or more other components. For example, the computing device 110 need not be a separate device, but may be integrated with the imaging system 104 (e.g., the application may be executed by a processing unit of the ultrasound imaging console 116, and the GUI may be displayed via a display of the ultrasound imaging console 116), the position sensing system 106, or the like. In some embodiments, the operations or aspects of one or more components discussed above may be distributed among one or more other components. Any suitable arrangement and / or integration of the various systems and devices in the system 100 may be used.

[0047] Although specific examples throughout this disclosure relate to biopsy procedures using the medical device 102, it should be understood that the techniques according to the present disclosure can be applicable to other types of medical procedures, such as short-range therapy procedures for placing seeds, strips, or capsules containing radiation sources in a treatment area of ​​a patient's body and / or fiducial marker placement procedures for placing fiducial markers in a target area of ​​a patient's body. For example, the techniques can be applicable to any medical procedure in which a physician utilizes the distal tip of a medical device to puncture / extract or leave a substance at a specific location in a patient's body. It should also be understood that the above examples are merely illustrative. The methods and techniques of the present disclosure can be applicable to any suitable activity.

[0048] Figures 2A-2F Reference Figure 1A and Figure 1B One exemplary configuration of the needle 112 of the medical device 102 is described above. Figure 2A A side perspective view of a first configuration of needle 112 is depicted. Needle 112 may include a core 202 and a sheath 203 that are concentrically arranged, with core 202 disposed within sheath 203. The proximal end of needle 112 may extend to handle 114 (not shown). Core 202 and sheath 203 may be independently retractable within handle 114 to a given extent. Figures 3A-5C Described in more detail. When the medical device 102 is in a neutral state, the core 202 and the sheath 203 can be in a neutral position (e.g., not retracted), when the medical device 102 is in a partially fired state and a fully fired state, the sheath 203 can be in a retracted position, when the medical device 102 is in a partially fired state, the core 202 is not retracted, and when the medical device 102 is in a fully fired state, the core 202 can be in a retracted position.

[0049] In the first configuration, the core 202 is disposed in the sheath, wherein only the distal-most portion of the core 202 may extend outside the sheath 203. When the medical device 102 is in a neutral state, wherein both the core 202 and the sheath 203 are in a neutral position within the handle 114 (eg, Figures 3A-3D), or when the medical device 102 is in a fully fired state, wherein the core 202 and the sheath 203 are both in a retracted position within the handle 114 (e.g. Figures 5A-5C As described above, the core 202 can be in a position in a first configuration relative to the sheath 203.

[0050] When the medical device 102 is in a fully fired state, at least the distal portion of the needle 112 can be inserted into the patient's body toward a target area including a target tissue for biopsy. When the medical device 102 is actuated by an operator, the core 202 can be advanced distally from the retracted position to the neutral position to pierce and embed the target tissue. The sheath 203 can then be advanced distally from the retracted position to the neutral position to separate the sample from the tissue.

[0051] Figure 2B and Figure 2C An exemplary core 202 of the needle 112 is depicted. Figure 2B The core 202 is depicted in an assembled configuration. Figure 2C The core 202 is depicted in a disassembled configuration. Figure 2B and Figure 2C , the core 202 may include a proximal portion 204 and a distal portion 206 that is distinct from but may be coupled to the proximal portion 204 .

[0052] The proximal end 205 of the proximal portion 204 of the core 202 may extend distally from the handle 114 (not shown). The distal end 207 of the proximal portion 204 of the core 202 may be structurally arranged to receive the needle EM sensor 208. For example, the distal end 207 of the proximal portion 204 may include an open cavity 210 for receiving the needle EM sensor 208. In addition, although the proximal end 205 of the proximal portion 204 may be completely closed, the proximal end 205 may be hollow (like a tube) to enable a wire 209 of the needle EM sensor 208 to be received in the proximal portion 204 and guided through the proximal portion 204 and into the handle 114.

[0053] In some examples, the pin-type EM sensor 208 may be a receiver device 109 of the position sensing system 106 configured to detect the magnetic field generated by the transmitter device 108, such as in conjunction with Figure 1A and 1BAs part of the detection, the needle EM sensor 208 can measure the strength of the magnetic field (e.g., the voltage generated thereby) and provide the measurement results as a signal to the controller 107 for processing to determine the position and / or orientation of the needle 112, and in particular the distal tip of the needle 112 (e.g., the distal tip 216 of the core 202). In other examples, the needle EM sensor 208 can be a transmitter device 108 of the position sensing system 106, which is configured to generate a magnetic field that is detected by the receiver device 109, such as one or more magnetic field sensors disposed in the external device 120, whereby the receiver device 109 detects and provides the measurement results as a signal to the controller 107 for processing.

[0054] The proximal end 211 of the distal portion 206 of the core 202 may be arranged to mate with the distal end 207 of the proximal portion 204, coupling the distal portion 206 and the proximal portion 204 together with the needle EM sensor 208 enclosed therein. That is, a cavity in which the needle EM sensor 208 is disposed may be defined between the proximal end 211 of the distal portion 206 and the distal end 207 of the proximal portion 204 (and the cavity 210 thereof constitutes a part thereof). For example, the inner surface of the proximal end 211 of the distal portion 206 may include a first interlocking feature 212A and a second interlocking feature 212B, collectively referred to as the interlocking feature 212. Figure 2B As shown, the first interlocking feature 212A and the second interlocking feature 212B can correspond with the first structural feature 214A and the second structural feature 214B (collectively referred to as structural features 214) of the distal end 207 of the proximal portion 204 to connect or interlock the distal portion 206 and the proximal portion 204 to form a coupled, assembled configuration of the core 202. The coupling of the proximal portion 204 and the distal portion 206 can be further enhanced based on the arrangement of the core 202 within the sheath 203 and the mechanical constraints placed on the sheath retraction and core extension, such as Figure 2D shown and described.

[0055] The interlocking features 212 may also be used to maintain the location and position of the needle EM sensor 208 when mated with the structural features 214 of the distal end 207 of the proximal portion 204. For example, the needle EM sensor 208 may be constrained to a known location and position between the interlocking features 212 within a cavity defined between the proximal end 211 of the distal portion 206 and the distal end 207 of the proximal portion 204 (of which the cavity 210 forms a part). Alternatively, when the core 202 is manufactured, the needle EM sensor 208 may be at least temporarily adhered to the inner surface of the proximal end 211 of the distal portion 206 at a known location and position between the interlocking features 212 to facilitate handling thereof.

[0056] The known location and position of the needle EM sensor 208 may be a known distance and position relative to the distal tip of the needle 112 (e.g., the distal tip 216 of the core 202). The known distance and position of the needle EM sensor 208 relative to the tip of the needle 112 may improve the accuracy of the position and / or orientation determination performed by the position sensing system 106. Furthermore, based on the location and position of the needle EM sensor 208 being within the distal portion of the needle 112 itself, any flexing or bending of the needle 112 as it enters through tissue, for example, may be interpreted as part of the position and / or orientation determination performed by the position sensing system 106. That is, the needle 112 is not assumed to be rigid. Furthermore, since the location and position of the needle EM sensor 208 is the same across each needle 112, each needle EM sensor 208 does not need to be calibrated during the manufacturing process.

[0057] The distal end 215 of the distal portion 206 of the core 202 may include a distal tip 216 and a sample notch 218. When the core 202 is advanced distally from the retracted position to the neutral position, the distal tip 216 may pierce and embed into the target tissue. When the sheath 203 is subsequently advanced distally from the retracted position to the neutral position, the sample notch 218 may collect (e.g., clamp) a sample of the target tissue to separate the sample from the target tissue.

[0058] Figure 2D Depicted along Figure 2A A cross-sectional view of the needle 112 in a first configuration, taken along line 219 in FIG. 2 , shows an exemplary internal configuration of the needle 112 , wherein the core 202 is in an assembled configuration having a needle EM sensor 208 disposed in a cavity defined by a coupled proximal portion 204 and a distal portion 206 , and the core 202 is disposed within a sheath 203 . Figure 2E Depicted in Figure 2D 200. A full cross-sectional view of the needle 112 in the first configuration is taken at a point along line 220 in FIG. As shown, the outer diameter of the core 202 can be smaller than the outer diameter and inner diameter of the sheath 203, such that an annular space is formed between the outer diameter of the core 202 and the inner diameter of the sheath 203. The annular space enables the sheath 203 and the core 202 to be independently retracted and advanced without friction. As a non-limiting example, the outer diameter and inner diameter of the sheath 203 can be approximately 0.063 inches and approximately 0.051 inches, respectively, and the outer diameter of the core 202 can be approximately 0.040 inches. The outer diameter of the needle EM sensor 208 can be smaller than the inner diameter of the core 202, wherein the distal end 207 of the proximal portion 204 is coupled to the proximal end 211 of the distal portion 206. Continuing with the above non-limiting example, the outer diameter of the needle EM sensor 208 can be approximately 0.018 inches.

[0059] Figure 2FA side perspective view of the needle 112 in the second configuration is depicted. When the medical device 102 is in a partially fired state prior to actuation of the medical device 102, the core 202 can be positioned in the second configuration relative to the sheath 203, wherein the sheath 203 is in the retracted position and the core 202 is in the initial neutral position. The core 202 can also be positioned in the second configuration relative to the sheath 203 after the medical device 102 is actuated to collect target tissue (e.g., after the core 202 and the sheath 203 are advanced distally from the retracted position to the initial neutral position), the medical device 102 has been removed from the body, and the sheath 203 is returned to the retracted position to release the target tissue sample from the sampling slot 218.

[0060] The extent to which the sheath 203 can be retracted proximally relative to the core 202 may be mechanically limited. For example, as shown in the second configuration, the sheath 203 cannot be retracted proximally beyond the distal end 215 of the distal portion 206 of the core 202. Thus, in any given state of the medical device 102, the proximal end 211 of the coupled distal portion 206 and the distal end 207 of the proximal portion 204 remain disposed within the sheath 203, thereby reinforcing the coupling therebetween.

[0061] Although in Figures 2A-2F 14, the core 202 of the needle 112 is described as being composed of two separate parts 204, 206 coupled to each other to surround the needle EM sensor 208, but other configurations of the core 202 and the needle EM sensor 208 may also be implemented. For example, in one alternative configuration, the core 202 may be a uniform solid core and the needle EM sensor 208 may be in the form of a coil wrapped around the outer diameter of the core 202. In some examples, the outer diameter of the core 202 may include a notch for receiving the coil, such that the coil is of equal diameter to the core 202. In addition, the proximal end of the core 202 may include a groove or notch for receiving the wire of the needle EM sensor 208 and guiding it into the handle 114. In another alternative configuration, the needle EM sensor 208 may be in the form of a coil wrapped around the outer diameter of the sheath 203. In some examples, the outer diameter of the sheath 203 may include a notch for receiving the coil, such that the coil is of equal diameter to the sheath 203.

[0062] Figures 3A-5C The interaction of the needle 112 and handle 114 assembly of the medical device 102 in various device states is described, including a neutral state, a partially fired state, and a fully fired state.

[0063] Figures 3A-3D The medical device 102 is depicted in a neutral state. Figure 3A 1 depicts an overall external view of the medical device 102 in a neutral state. In a first configuration, the core 202 and sheath 203 of the needle 112 extend distally from the handle 114, wherein only the distal-most portion of the core 202 (e.g., the distal tip 216) may extend beyond the sheath 203, as shown in FIG. Figure 2A The core 202 and the sheath 203 may be located in a neutral position within the handle 114. An external cable 124 extending from the proximal end of the handle 114 may communicatively couple a needle EM sensor 208 positioned within the core 202 of the needle 112 to the controller 107 of the position sensing system 106.

[0064] Figure 3B Another external view of the medical device 102 is shown in a neutral state, wherein only the proximal portion of the needle 112 is shown extending distally from the handle 114, and the device 102 is shown in a neutral state. Figure 3A The position of the medical device 102 is rotated approximately 90 degrees. Figure 3C It is along Figure 3B A cross-sectional view taken along line 302 in FIG. 1 is used to illustrate the interaction of the components of handle 114 with each other and with needle 112 . Figure 3D After removing the housing 304 of the handle 114, Figure 3B An exploded view of the handle 114 is shown in FIG.

[0065] Also refer to Figure 3C and Figure 3D , the components of the handle 114 may include a housing 304 that surrounds at least a portion of a frame 306 that supports first and second firing mechanisms for independently retracting the core 202 and sheath 203 of the needle 112 into the handle 114; a connector 308 for the frame 306; a first firing actuator 310 associated with retraction of the sheath 203; a second firing actuator 312 associated with retraction of the core 202; and one or more trigger devices, such as a rear trigger device 314 and a side trigger device 316, for actuating the medical device 102 when fully fired.

[0066] The frame 306 may include a first subframe 306A and a second subframe 306B, which are coupled to each other by a connector 308 to form the frame 306. The first subframe 306A may include a distal lumen 318A and a proximal lumen 320A separated by a separation wall 322A. The distal lumen 318A may support a first firing mechanism associated with the sheath 203. For example, the distal lumen 318A may be configured to receive a sheath slider 324 and a sheath spring 326, wherein the sheath spring 326 is inserted between the sheath slider 324 and the separation wall 322A. The sheath slider 324 may be fixed to the proximal end of the sheath 203. A portion of the sheath slider 324 may protrude from the first subframe 306A and be connected to the first firing actuator 310 so that the sheath slider 324 can be moved to a firing position to retract the sheath 203 when the first firing actuator 310 is activated. The sheath slider 324 may have a locking feature 327 at the proximal end, and the separating wall 322A may include a locking hole 328A, which is configured to receive the locking feature 327 of the sheath slider 324 when the sheath slider 324 moves to the firing position based on the actuation of the first firing actuator 310, as shown in FIG. Figure 4C and Figure 5C shown.

[0067] The proximal inner cavity 320A can support a second firing mechanism associated with the core 202. For example, the proximal inner cavity 320A can be configured to receive a core slider 330 and a core spring 332, wherein the core spring 332 is inserted between the core slider 330 and the end wall 334A. The core slider 330 can be fixed to the proximal end of the core 202. A portion of the core slider 330 can protrude from the first subframe 306A and be connected to the second firing actuator 312, so that when the second firing actuator 312 is actuated, the core slider 330 moves to the firing position to retract the core 202. Figure 5C As shown, the proximal end of the core slider 330 may have a locking feature 336, and the end wall 334A may include a locking hole 338A, which is configured to receive the locking feature 336 of the core slider 330 when the core slider 330 is moved to the firing position based on the actuation of the second firing actuator 312. The second firing mechanism can be fired after the first firing mechanism or fired at the same time as the first firing mechanism. Before both the first firing mechanism and the second firing mechanism are fired, the operator cannot actuate the medical device 102.

[0068] The second subframe 306B can be a mirror image of the first subframe 306A discussed above to form the frame 306. For example, the second subframe 306B can include a distal lumen 318B and a proximal lumen 320B (separated by a separating wall 322B having a keyhole 328B) that are mirror images of the distal lumen 318A and the proximal lumen 320A (separated by a separating wall 322A having a keyhole 328A). In addition, the second subframe 306B can include an end wall 334B having a keyhole 338B that is a mirror image of the end wall 334A having the keyhole 338A of the first subframe 306A. Therefore, when the first sub-frame 306A and the second sub-frame 306B are connected via the connector 308, the frame 306 includes a distal inner cavity 318 formed by distal inner cavities 318A, 318B, a proximal inner cavity 320 formed by proximal inner cavities 320A, 320B, a separation wall 322 with a locking hole 328 formed by separation walls 322A, 322B with corresponding locking holes 328A, 328B, and an end wall 334 with a locking hole 338 formed by end walls 334A, 334B with corresponding 338A, 338B.

[0069] The stopper 339 may be located between the distal lumen 318 and the proximal lumen 320 and extend through the opening in the separating wall 322. The stopper 339 may be a silicone stopper that collides with the second firing mechanism after the second firing mechanism is released from the firing position based on actuation of one of the trigger devices, such as the rear trigger device 314 and / or the side trigger device 316. The kinetic energy from the collision temporarily compresses the stopper 339 to cause the locking feature 327 of the sheath slider 324 to be released from the locking hole 328A, thereby allowing the first firing mechanism to be released before the stopper 339 rebounds to a position that does not prevent the locking feature 327 of the sheath slider 324 from being captured again in the locking hole 328A the next time the first firing mechanism is fired.

[0070] The first firing actuator 310 may include an outer portion 340 accessible to an operator of the medical device 102 and an inner portion 342 extending within the housing 304. The outer portion 340 may include one or more gripping features 344 to allow the operator to better grip when moving the first firing actuator 310 proximally toward the proximal end of the handle 114 to convert the medical device 102 from the neutral state to the partially fired state, as described with reference to Figures 4A-4C The inner portion 342 can be connected to the sheath slider 324 so that when the outer portion 340 of the first firing actuator 310 moves proximally toward the proximal end of the handle 114, the sheath slider 324 compresses the sheath spring 326 proximally toward the separation wall 322. In addition, as described below, the outer portion 340 can be hollow to receive at least a portion of the second firing actuator 312 and the connector 308.

[0071] The second firing actuator 312 can include an outer portion 346 accessible to an operator of the medical device 102 and an inner portion 348 extending within the housing 304. In some examples, when the medical device 102 is in the neutral state, the outer portion 346 of the second firing actuator 312 can be disposed within the outer portion 340 of the first firing actuator 310. When the outer portion 340 of the first firing actuator 310 is moved proximally toward the proximal end of the handle 114 to convert the medical device 102 from the neutral state to the partially fired state, the outer portion 346 can be exposed and accessible to the operator. The inner portion 348 can be connected to the core slider 330 so that the core slider 330 compresses the core spring 332 proximally toward the end wall 334 when the outer portion 346 of the second firing actuator 312 is moved proximally toward the proximal end of the handle 114.

[0072] Within the handle 114, the wires 209 of the needle EM sensor 208 may be routed out of the proximal portion 204 of the core 202 and connected to the inner board 350. The inner board 350 may be an electrical interface that routes the signals from the wires 209 to the controller 107 of the position sensing system 106 via the external cable 124 that is also connected to the inner board 350. Between the proximal portion 204 of the core 202 and the inner board 350, the wires 209 may be housed in an internal cable 352 that provides greater bend resistance to minimize kinking and mechanical fatigue when the core 202 is retracted and advanced.

[0073] In addition, the handle 114 may include a service loop compartment 354 (e.g., a hollow cavity) located between the frame 306, the inner portion 342 of the first firing actuator 310, and the housing 304. The internal cable 352 can be routed from the proximal portion 204 of the core 202 to the inner plug-in board 350 through the service loop compartment 354. The service loop compartment 354 allows a given length of the internal cable 352 to accumulate and form a service loop to provide the internal cable 352 with freedom of movement or relaxation (e.g., to prevent tension) when the core 202 is retracted and advanced. In addition, by forming a service loop in a dedicated service loop compartment 354, when the medical device 102 is fired, causing the core 202 to advance forward, thereby causing the internal cable 352 to advance forward, the internal cable 352 can be smoothly advanced forward without getting stuck on any other components in the handle 114.

[0074] In addition, the switch 356 can be directly connected to the inner board 350 (e.g., via welding) and housed within the first subframe 306A. The switch 356 can be a mechanically actuated electrical switch configured to detect when the second firing mechanism associated with the core 202 is fired, thereby determining when the medical device 102 is in a fully fired state, such as Figure 5A-C. In some examples, the switch 356 can be wired between two erasable programmable read-only memories (EPROMs). Each EPROM can be read as a different device ID. The device ID can be provided to the controller 107 as a signal via the external cable 124, and the controller 107 can forward the signal to the computing device 110, where the application executed on the computing device 110 can be programmed to identify different device IDs as a fully fired state or an incompletely fired (e.g., neutral or partially fired) state of the medical device 102. In some examples, based on the identification of the fully fired state, the application of the computing device 110 can use the image received from the imaging system 104 and the position and / or orientation of the distal tip of the needle 112 relative to the imaging plane received from the controller 107 as input to generate a GUI for display on the computing device 110. For example, at least the planned needle trajectory for the needle 112 can be overlaid on the image of the target tissue, as shown. Fig. 7A In other examples, switch 356 and / or any alternatives to switch 356 discussed below may be omitted so that at least the planned needle trajectory is always displayed in the GUI overlaid on the image of the target tissue (e.g., even if the medical device 102 is not fully fired).

[0075] In other examples, the switch 356 is replaced by a different switch for detecting when the second firing mechanism is in a neutral position (e.g., unfired). This different switch can be located near any moving part in the handle 114. In addition, the switch 356 can be replaced by a sensor configured to measure the position or proximity of the moving part of the handle 114, including an optical sensor, a magnetic sensor, a capacitive sensor, an ultrasonic sensor, or an electromagnetic induction sensor. Further, the application executed on the computing device 110 itself can detect the change of the medical device 102 from the neutral state to the fully fired state, or vice versa, by measuring the speed of the needle EM sensor 208.

[0076] Figures 4A-4C The medical device 102 is depicted in a partially fired state. The medical device 102 can be in a partially fired state when a first firing mechanism associated with the sheath 203 is in a fired position in the distal lumen 318 and a second firing mechanism associated with the core 202 is in a neutral position in the proximal lumen 320. Figure 4A Depicted is an overall external view of the medical device 102 in a partially fired state. The needle 112 extending distally from the handle 114 may be in a position as referenced Figure 2F A second configuration is described in which the distal end 215 of the distal portion 206 of the core 202 is exposed when the sheath 203 is in the retracted position within the handle 114 . Figure 4BAnother external view of the medical device 102 is shown in a partially fired state, wherein only the proximal portion of the needle 112 is shown extending distally from the handle 114, and the device 102 is shown in a partially fired state. Figure 4A The position of the medical device 102 is rotated approximately 90 degrees. Figure 4C It is along Figure 4B A cross-sectional view taken along line 402 in FIG. 1 is provided to illustrate the interaction of the components of handle 114 with each other and with needle 112 in a partially fired state.

[0077] Also refer to Figures 4A-4C When the operator of the medical device 102 moves the outer portion 340 of the first firing actuator 310 proximally (e.g., using the grip feature 344) toward the proximal end of the handle 114, the portion of the sheath slider 324 connected to the inner portion 342 of the first firing actuator 310 can move the sheath slider 324 and the proximal end of the sheath 203 connected to the sheath slider 324 toward the separation wall 322 to cause the sheath 203 to retract from the neutral position to the retracted position. This movement compresses the sheath spring 326 and causes the locking feature 327 of the sheath slider 324 to enter through the lock hole 328 to lock the first firing mechanism in the firing position. The proximal movement of the outer portion 340 of the first firing actuator 310 can cause the outer portion 346 of the second firing actuator 312 and the connector 308 to be exposed.

[0078] Figures 5A-5C The medical device 102 is depicted in a fully fired state. The medical device 102 can be in a fully fired state when a first firing mechanism associated with the sheath 203 and a second firing mechanism associated with the core 202 are in firing positions in the distal lumen 318 and the proximal lumen 320, respectively. Figure 5A 1 and 10. Depicted is an overall external view of the medical device 102 in a fully fired state. The core 202 and sheath 203 of the needle 112 extending distally from the handle 114 can be in a first configuration, wherein only the distal portion of the core 202 (e.g., the distal tip 216) can extend through the sheath 203, as shown in reference Figure 2A Furthermore, when the medical device 102 is in a fully fired state, both the core 202 and the sheath 203 may be in a retracted position within the handle 114 . Figure 5B Another external view of the medical device 102 is shown in a fully fired state, wherein only the proximal portion of the needle 112 is shown extending distally from the handle 114, and the medical device 102 is shown in FIG. Figure 5A The position of the medical device 102 in FIG. 1 is rotated approximately 90 degrees. Figure 5C It is along Figure 5B A cross-sectional view taken along line 502 in Figure 5 is provided to illustrate the interaction of the components of handle 114 with each other and with needle 112 in a fully fired state.

[0079] Also refer to Figures 5A-5C , upon the operator's movement of the outer portion 340 of the first firing actuator 310 (e.g., using the grip feature 344) toward the distal end of the handle 114 to lock the first firing mechanism to the reference Figures 4A-4C Following or simultaneously with the firing position, the operator can drive the outer portion 346 of the second firing actuator 312 toward the proximal end of the handle 114 to lock the second firing mechanism in the firing position. Since the outer portion 346 of the second firing actuator 312 is now disposed within the outer portion 340 of the first firing actuator 310, the proximal driving of the outer portion 346 of the second firing actuator 312 can result in only the connector 308 being exposed.

[0080] When the operator drives the outer portion 346 of the second firing actuator 312, the portion of the core slider 330 connected to the inner portion 348 of the second firing actuator 312 can move the core slider 330 and the proximal end of the core 202 connected to the core slider 330 toward the end wall 334 to cause the core 202 to retract from the neutral position to the retracted position. This movement compresses the core spring 332 and causes the locking feature 336 of the core slider 330 to enter through the locking hole 338 to lock the second firing mechanism in the firing position.

[0081] In some example aspects, the switch 356 can detect the second firing mechanism in the fired position and cause a signal indicating the fully fired state of the medical device 102 to be provided to the controller 107 and ultimately to the computing device 110 via the inner board 350 to cause a GUI to be generated and displayed to facilitate use of the medical device 102 in a medical procedure. Since the outer portion 346 of the second firing actuator 312 is now disposed within the outer portion 340 of the first firing actuator 310, proximal driving of the outer portion 346 of the second firing actuator 312 can result in only the connector 308 being exposed.

[0082] Once inserted into the patient and positioned relative to the target tissue using guidance from the GUI, the medical device 102 can be actuated using one of the trigger devices, such as the rear trigger device 314. The force generated by the operator pressing the rear trigger device 314 can cause the locking feature 336 of the core slider 330 to release from the lock hole 338 to allow the second firing mechanism to be released from the locked position. The release of the second firing mechanism advances the core 202 of the needle 112 from the retracted position to the distal side to penetrate and embed into the target tissue. After the second firing mechanism is released from the firing position, the second firing mechanism can collide with the stopper 339, wherein the kinetic energy from the collision temporarily compresses the stopper 339, thereby releasing the locking feature 327 of the sheath slider 324 from the lock hole 328 to allow the first firing mechanism to be released from the firing position. The release of the first firing mechanism advances the sheath 203 of the needle 112 from the retracted position to the distal side to cut off the sample of the target tissue collected by the sampling groove 218 of the core 202. The operator can then remove the medical device 102 from the patient. In order to retrieve the sample of the target tissue collected in the sampling groove 218, the medical device 102 can be restored to a partially fired state, such as Figures 4A-4C described.

[0083] Despite Figures 3A-5C 102, but in some examples, the medical device 102 may include a control element (e.g., a switch) that physically limits the stroke length of the first and second firing mechanisms within the distal lumen 318 and the proximal lumen 320. The control element allows the operator to adjust the stroke length to correspond to a given biopsy sample length associated with the procedure at hand. In addition, the control element may be connected to an electrical switch that can communicate the given biopsy sample length to an application executed on the computing device 110. In some examples, where the handle 114 includes a handle-type EM sensor disposed therein, the control element may be further coupled to the handle-type EM sensor to measure the distance to the needle-type EM sensor to determine the position of the control element and the stroke length. The GUI generated by the application can interpret and provide a needle trajectory reflecting the given biopsy sample length.

[0084] In addition, although not Figures 3A-5C , but the handle 114 may also include a reference Figure 1A and Figure 1B A handle-type EM sensor is described.

[0085] Figure 6 An exemplary process 600 is described to generate a graphical user interface to visualize the position and / or orientation of a medical device 102, and in particular, the distal tip of a needle 112 of the medical device 102. In some examples, the process 600 can be performed by the computing device 110 based on information received from other components of the system 100, such as the imaging system 104 and the position sensing system 106.

[0086] After inserting at least a portion of the needle 112 of the medical device 102 into the patient, at step 602, the process 600 may include receiving a signal from one or more receiver devices 109 indicating the strength of the magnetic field generated by the transmitter device 108 as detected by the one or more receiver devices 109 (e.g., a voltage induced by the magnetic field). At least one of the receiver device 109 or the transmitter device 108 includes an EM sensor located within the needle 112 (e.g., a needle EM sensor 208 located at a fixed position within the core 202). In one example, the receiver device 109 may include the needle EM sensor 208 and the probe EM sensor 122 (and optionally a handle EM sensor), and the transmitter device 108 may include the external device 120. In another example, the receiver device 109 may include the external device 120, and the transmitter device 108 may include the needle EM sensor 208 and the probe EM sensor 122 (and optionally a handle EM sensor).

[0087] At step 604, process 600 may include determining a position and / or orientation of a distal tip of needle 112 (e.g., distal tip 216 of core 202) based on the received signal. In some embodiments, the position and / or orientation of the distal tip may be further determined relative to an ultrasound imaging plane of imaging system 104. For example, by including probe EM sensor 122 as part of position sensing system 106, the received signal may indicate a position and orientation of the distal tip of needle 112 relative to the imaging plane.

[0088] At step 606, process 600 may include determining a planned trajectory for the distal tip of needle 112 when medical device 102 is actuated to cause needle 112 to be advanced distally, based on the position and / or orientation of the distal tip of needle 112 determined in step 604. In some examples, determining the planned trajectory may be based on the position and / or orientation of the distal tip of needle 112 and a transformation matrix describing a spatial relationship between needle EM sensor 208 and medical device 102. For example, the transformation matrix may include a number describing a 3D positional offset between the distal tip of needle 112 and a magnetic center of needle EM sensor 208, and a 2D (or 3D, if needle EM sensor 208 is a six-degree-of-freedom sensor) rotational offset between an axis of needle 112 and an axis of needle EM sensor 208.

[0089] In some examples, the transformation matrix may be determined by the dimensional offsets incorporated into the design of the needle 112, and thus the transformation matrix is ​​applied to all medical devices 102 that include a needle 112 of a given design. Additionally or alternatively, a calibration method may be performed on each medical device 102, wherein the medical device 102 and / or a calibration tool is physically moved and tracked in order to make measurements, thereby allowing the algorithm to infer the spatial relationship between the needle EM sensor 208 and the medical device 102. One non-limiting illustrative calibration method may be a pivot calibration, wherein the medical device 102 is rotated and / or pivoted about the distal tip of the needle 112 while the distal tip is held in a fixed position.

[0090] Additionally, in examples where probe-type EM sensor 122 is included as part of position sensing system 106, and signals from probe-type EM sensor 122 indicate the position and orientation of the distal tip of needle 112 relative to the imaging plane, the trajectory may be further determined based on the spatial relationship between probe 118 and probe-type EM sensor 122. Similar calibration may be performed to allow the algorithm to infer the spatial relationship between probe-type EM sensor 122 and probe 118.

[0091] At step 608, process 600 may include receiving an image of the target region from imaging system 104. For example, the image may be an ultrasound image acquired in an imaging plane by imaging system 104. The target region may be a region including target tissue from which a sample is obtained.

[0092] At step 610, process 600 may include generating a graphical user interface (GUI) that overlays the position and / or orientation of the distal tip of needle 112 determined at step 604 and the planned trajectory of the distal tip of needle 112 determined at step 606 on the image received at step 608. At step 612, process 600 may include providing the GUI for display on a display device, such as a display of computing device 110.

[0093] As the operator further inserts the medical device 102 into the patient toward the target area to place the needle 112, and activates the medical device 102 to obtain a core biopsy sample, the process 600 may be repeated periodically to update the GUI. In addition, while the process 600 describes the generation of a GUI following the insertion of the needle 112 into the patient, additional GUIs may be generated prior to the insertion, which display the planned needle trajectory depicting the expected path of the needle 112 to the target area overlaid on the image of the target area to help guide the insertion of the needle 112. In some examples, at least a portion of the planned needle trajectory may remain displayed on the GUI generated and displayed in steps 610 and 612. Figures 7A-7C Examples of GUIs are illustrated and described.

[0094] Thus, some embodiments may generate a graphical user interface to visualize the position and / or orientation of the medical device 102. The above process 600 is provided as an example only and may include more Figure 6 More, fewer, different or differently arranged steps as described in.

[0095] In this disclosure, various operations may be described as being Figure 1A and 1B 100. However, it should be understood that in various embodiments, various components of the exemplary system 100 described above may execute instructions or perform operations, including the operations described above. Operations performed by a device may be considered to be performed by a processor, actuator, or the like associated with the device. In addition, it should be understood that in various embodiments, various steps may be added, omitted, and / or rearranged in any suitable manner.

[0096] Fig. 7A -C describes an exemplary graphical user interface generated and displayed during a medical procedure. Fig. 7A An exemplary graphical user interface 700A generated prior to insertion of the needle 112 is depicted. The graphical user interface 700A may include a first ultrasound image 702 of a target area (e.g., a target biopsy area) associated with a medical procedure from the imaging system 104. A planned needle trajectory 704 including an intended or desired path of the needle 112 once inserted into the patient may be overlaid on the first ultrasound image 702 to guide an operator of the medical device 102. For example, visualizing the planned needle trajectory 704 may allow the operator to accurately plan the placement of the needle 112 to reach the target area and minimize unnecessary trauma caused by repeated punctures of the needle 112.

[0097] Figure 7BAn exemplary graphical user interface 700B generated using process 600 after insertion of needle 112 and before actuation of medical device 102 (e.g., before a user actuates rear trigger 314 or side trigger 316) is described. When needle 112 is inserted into the patient, medical device 102 is in a fully fired state, with core 202 and sheath 203 of needle 112 both in a retracted position. Graphical user interface 700B may include a second ultrasound image 706 of the target area, including the position and orientation of needle 112 (including its distal tip) relative to the ultrasound imaging plane as it approaches the target area. The planned needle trajectory 704 may remain superimposed on the second ultrasound image 706. In addition, a biopsy path indicator 708 may be superimposed on the second ultrasound image 706. Biopsy path indicator 708 can be aligned with a portion of the planned needle trajectory 704 and correspond to the planned trajectory of needle 112 (e.g., determined at step 606 of process 600) when medical device 102 is actuated to cause needle 112 to advance distally from a retracted position (e.g., core 202 followed by sheath 203).

[0098] Figure 7C An exemplary graphical user interface 700C generated after actuating the medical device 102 is described. When the medical device 102 is actuated, the needle 112 is advanced distally from its retracted position to collect a biopsy sample of the target area. The graphical user interface 700C may include a third ultrasound image 710 of the target area, including the position and orientation of the needle 112 (including its distal tip) relative to the ultrasound imaging plane after the needle 112 has been advanced distally from the retracted position (e.g., along the path indicated by the biopsy path indicator 708). Although a portion of the planned needle trajectory 704 may remain superimposed on the third ultrasound image 710 (e.g., the portion extends beyond the distal tip of the needle 112 when actuated), the biopsy path indicator 708 may be replaced by the needle 112 itself, which has been advanced distally along the path indicated by the biopsy path indicator 708.

[0099] Despite Figures 7A-7C106 , but various other visual schemes may be employed in a GUI generated using information from the imaging system 104 and the position sensing system 106 . As one example, the position of the distal tip of the needle 112 (e.g., the distal tip 216 of the core 202) may be highlighted or otherwise emphasized with a distinct visual marker so that an operator of the medical device 102 can more easily recognize when the distal tip is not on the image plane. Additionally or alternatively, other visual indicators, such as color, outline, or flashing markers, may be used to indicate when the position of the needle 112 is not on the ultrasound imaging plane to notify the operator that the trajectory of the needle 112 will not pass through the tissue cross section currently displayed on the GUI. To further assist the operator, when the operator rotates the probe 118, the needle 112 and the intersection of the trajectory of the needle 112 with the ultrasound plane may be highlighted to assess the tissue volume. In some examples, based on the information received from the imaging system 104 and the position sensing system 106 , an application of the computing device 110 may generate a three-dimensional representation of the tip of the probe 118, the ultrasound imaging plane, and the needle 112. This representation can be displayed to show the operator the position of the needle 112 relative to the ultrasound imaging plane. In addition, as the user rotates the probe 118, the application of the computing device 110 can calculate a 3D reconstruction of the tissue based on the images acquired by the imaging system 104 to allow the operator to visualize the entire volume of interest to identify areas for biopsy and / or examine structures to be avoided during the biopsy procedure. The volume of interest can include the volume around the trajectory of the needle 112, or the entire area shown in the ultrasound image.

[0100] Figure 8 One example of a computer 800 is described. Figure 8 1-7C . For example, according to an exemplary embodiment of the present disclosure, the computer 800 can be configured as a computing device 110, a controller 107 of a position sensing system 106, a processing unit of an ultrasound imaging console 116, and / or one of the other devices in the present disclosure. In various embodiments, any system herein can be a computer 800, including, for example, a communication interface 820 for packet data communications. The computer 800 can communicate with one or more other computers 800 using an electronic network 825. The electronic network 825 may include a wired or wireless network similar to the network 130 shown in FIG. 1 .

[0101] The computer 800 may also include a central processing unit ("CPU") in the form of one or more processors 802 for executing program instructions 824. The program instructions 824 may include instructions for running applications on the computing device 110 (e.g., if the computer 800 is the computing device 110). The program instructions 824 may include instructions for performing one or more operations to generate an ultrasound image (e.g., if the computer 800 is a processing unit of an ultrasound imaging console 116 of the imaging system 104). The program instructions 824 may include instructions for performing one or more position and / or orientation determination operations (e.g., if the computer 800 is a controller 107 of the position sensing system 106). The computer 800 may include an internal communication bus 808 and a drive unit 806 (e.g., a read-only memory (ROM), a hard disk drive (HDD), a solid state disk drive (SDD), etc.), which may store data on a computer-readable medium 822, although the computer 800 may receive programs and data via network communications. The computer 800 may also have a memory 804 (e.g., random access memory (RAM)) storing instructions 824 for performing the techniques described herein, although the instructions 824 may be temporarily or permanently stored in other modules of the computer 800 (e.g., the processor 802 and / or the computer readable medium 822). The computer 800 may also include a user input / output port 812 and / or a display 810 to connect input and output devices such as a keyboard, mouse, touch screen, monitor, display, etc. Various system functions can be implemented in a distributed manner on many similar platforms to distribute the processing load. Alternatively, the system can be implemented by appropriately programming one computer hardware platform.

[0102] The program aspects of the technology can be considered as "products" or "articles of manufacture", which are usually in the form of executable code and / or related data, and are present or embodied on some machine-readable medium. "Storage" media include any or all tangible storage of computers, processors or the like and their related modules, such as various semiconductor memories, tape drives, disk drives and the like, which can provide non-temporary storage for software programming at any time. All or part of the software may sometimes be communicated through the Internet or various other telecommunications networks. Such communications can, for example, enable the software to be loaded from one computer or processor to another computer or processor. Therefore, another medium that may carry software elements includes optical waves, radio waves, and electromagnetic waves, such as using physical interfaces between local devices, through wired and fiber optic fixed line networks, and various wireless links. The physical elements that carry these waves, such as wired or wireless links, fiber optic links, etc., can also be considered as the medium that carries the software. Unless specifically limited to non-temporary, tangible "storage" media, terms such as computer or machine "readable media" used in this article refer to any medium that participates in providing instructions to the processor for execution.

[0103] Although the principles of the present disclosure are described herein with reference to illustrative examples of specific applications, it should be understood that the present disclosure is not limited thereto. After obtaining the teachings provided herein, those of ordinary skill in the art will recognize additional modifications, applications, and equivalent substitutes, which all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the above description.

Claims

1. A medical device comprising: handle; and a needle extending distally from the handle, wherein the needle is configured to be at least partially inserted into the body, and the needle comprises: sheath; A core disposed in the sheath, the core having: a distal portion including a distal tip; and a proximal portion distinct from the distal portion, wherein a proximal end of the distal portion is coupled to a distal end of the proximal portion to define a cavity therebetween; and A device of a position sensing system is disposed in the cavity, wherein the device is one of a transmitter device or a receiver device, and the position sensing system is configured to determine a position or orientation of the distal tip.

2. The medical device according to claim 1, wherein: An inner surface of the proximal end of the distal portion of the core includes one or more interlocking features that correspond with one or more structural features of the distal end of the proximal portion to couple the distal portion to the proximal portion.

3. The medical device according to any one of claims 1 or 2, wherein: The sheath and the core are independently retractable into the handle, and when the sheath is proximally retracted into the handle, only the distal end of the distal portion of the core is exposed.

4. The medical device according to any one of claims 1 to 3, wherein: The device of the position sensing system is arranged in the cavity at a known distance and position relative to the distal tip.

5. The medical device according to any one of claims 1 to 4, wherein: The device of the position sensing system is a receiver device, which includes a magnetic field sensor, which is configured to detect a magnetic field generated by an external transmitter device of the position sensing system and provide a signal indicating at least one of the position or orientation of the distal tip based on the strength of the detected magnetic field.

6. The medical device according to any one of claims 1 to 4, wherein: The device of the position sensing system is a transmitter device, and the transmitter device is configured to generate a magnetic field that can be detected by an external receiver device of the position sensing system, and the external receiver device is configured to provide a signal indicating at least one of the position or orientation of the distal tip based on the strength of the detected magnetic field.

7. The medical device according to any one of claims 1 to 6, wherein: The proximal end of the proximal portion of the core is hollow to receive a lead of a device of a position sensing system and guide it into the handle.

8. The medical device according to claim 7, wherein: The handle includes an interposer connected to the wires, the interposer relaying signals between the wires and a controller of the position sensing system via an external cable connecting the interposer and the controller.

9. The medical device according to claim 7 or 8, wherein: The handle includes a compartment for receiving a lead of a device of the position sensing system from a proximal end of the proximal portion of the core.

10. The medical device according to claim 9, wherein: The wires are housed in an internal cable within the compartment.

11. The medical device according to any one of claims 1 to 10, wherein: The sheath and core are independently retractable into the handle, the handle including a switch configured to detect when the core is in a retracted position in the handle.

12. The medical device according to claim 11, wherein: When the switch detects that the core is in the retracted position, a signal is provided to a computing device to cause generation and display of a graphical user interface including at least a planned needle trajectory for the needle overlaid on an image of the target area within the body.

13. The medical device according to claim 12, wherein: Once the needle is at least partially inserted into the body, the graphical user interface is updated to further include a planned trajectory of the distal tip to the target area as the needle is advanced distally from the retracted position, and at least one of a position or orientation of the distal tip.

14. The medical device according to any one of claims 1 to 13, wherein: The medical device is a component of a system further comprising a position sensing system and an ultrasound imaging system, the ultrasound imaging system being configured to generate an ultrasound image in an ultrasound imaging plane, wherein the ultrasound imaging system comprises: Ultrasound imaging console; and An ultrasound probe, wherein a further device of a position sensing system, being one of a further transmitter device or a further receiver device, is attachable to the ultrasound probe to determine at least one of a position or an orientation of a distal tip relative to an ultrasound imaging plane.

15. The medical device of claim 14, wherein: When the device of the position sensing system arranged in the cavity is a receiver device, the other device of the position sensing system attached to the ultrasound probe is another receiver device; and When the device of the position sensing system arranged in the cavity is a transmitter device, the other device of the position sensing system attached to the ultrasound probe is another transmitter device.

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