Patent Description:
Technological developments have given users of medical systems, devices, and methods, the ability to conduct increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgeries such as endoscopy, among other surgical procedures, is associated with the cannulation of target sites within a patient, such as an ampulla opening into the common bile duct. Placement of medical devices within a patient at precise locations of target sites may be difficult due to general lack of visualization at the target site and lack of control over a positioning of the medical device at a location of the target site. The limitations of medical devices in providing stability toward positioning an endoscope at a target treatment site of a patient may prolong the procedure, limit its effectiveness, and/or cause injury to the patient due to misalignment or instability of the medical device. There is a need for devices and methods that address one or more of these difficulties or other related problems.

<CIT> relates to a surgical system with a first medical instrument that is disposed inside a body cavity and that has an observation unit and a marking unit that is capable of being positioned with respect to the body cavity, a second medical instrument that is disposed outside the body cavity and that has a treatment section and a driving unit for driving the treatment section, a distance measuring unit that measures the distance between the marking unit and the treatment section, and a control unit that controls the driving unit on the basis of the distance measured by the distance measuring unit.

<CIT> relates to a stereoscopic endoscope device including two image capture elements spaced apart from each other and disposed at a distal end of an insertion section to be inserted into a subject; an angle changing mechanism that changes a relative angle between optical axes of the image capture elements; a distance sensor that detects the distance from the image capture elements to the subject; and a controller that controls the angle changing mechanism on the basis of the distance detected by the distance sensor.

<CIT> relates to biopsy apparatuses, systems and techniques for biopsy using a biopsy pattern. Some aspects relate to moving a distal portion of a medical instrument to one or more sample locations of the biopsy pattern and guiding the instrument to obtain tissue samples from the sample locations within the biopsy pattern. Some aspects relate to obtaining the biopsy pattern and adjusting the sample locations within the biopsy pattern based on various factors such as anatomical features.

The invention is defined by the features of independent claim <NUM>.

Preferred embodiments are defined in the dependent claims <NUM>-<NUM>.

Aspects of the disclosure relate to, among other things, systems, devices, and methods for positioning a medical device at a target treatment site with a medical system including target identification logic, among other aspects. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

According to the invention as defined in independent claim <NUM>, a medical system comprises a medical device, a medical instrument movable relative to the medical device, a processor and a non- transitory computer readable medium storing instructions, the medical device including an imaging device configured to capture images of a target site, wherein a location of the target site is determined based on the images using a target identification logic of the medical system, a light source configured to direct light onto the location of the target site, a shaft having one or more lumens extending there-through that include a working lumen for receiving the medical instrument and a mirror configured to reflect the light generated by the light source toward the location of the target site, the medical instrument including a sensor with said sensor being configured to detect light generated by the light source and the processor being configured to perform one or more operations in accordance with the instructions, wherein the instructions, when executed by the processor, cause the processor to move the sensor of the medical instrument toward the location of the target site based on the sensor detecting the light at the target site.

Any of the medical systems described herein may have any of the following features. The sensor is movable relative to the imaging device toward the location of the target site based on the sensor detecting the light at the target site. The instructions stored in the non-transitory computer readable medium causes the processor to detect a change in location of the imaging device relative to the target site, determine the location of the target site relative to the imaging device, and redirect the light to the location of the target site. The processor is configured to detect the change in location of the imaging device relative to the target site based on images periodically captured by the imaging device. The processor is configured to compare the location of the target site to an original location of the target site to determine a positional variance. The processor is configured to determine whether the positional variance exceeds a preprogrammed threshold. The light source includes a source to generate a laser beam. The imaging device includes a camera. The sensor may include at least one of a photodetector, a photodiode, and a charged coupled device (CCD). The sensor is configured to generate a photodiode signal in response to detecting the light at the target site. A strength of the photodiode signal generated by the sensor includes a greater intensity when the sensor is positioned at a first distance from the light, and includes a smaller intensity when the sensor is positioned at a second distance from the light. The first distance is less than the second distance. The mirror is configured to move to redirect the light toward the location of the target site in response to the processor detecting the change in location of the imaging device relative to the target site. The mirror includes a micro-mirror (MEMs mirror) configured to reflect the light along two axes. The mirror is positioned adjacent to the light source on the medical device. The processor is configured to generate a visual identifier along the images captured by the imaging device indicative of the location of the target site.

According to the invention as defined in claim <NUM>, the medical instrument includes a sensor configured to detect the light on the target site. The medical instrument is movable toward the target site in response to the sensor detecting the light on the target site.

Any of the medical systems described herein may have any of the following features. The medical system may include a processor configured to detect movement of the medical device relative to the target site based on images captured by the imaging device. The light source is configured to redirect the light based on the detected movement of the medical device. The medical device is an endoscope or duodenoscope, and the medical instrument is a catheter.

A method not falling within the scope of the claimed invention of moving a medical instrument toward a target site includes capturing images of the target site with an imaging device. A first location of the target site is determined based on the images. The method includes transmitting light to the first location by a light source, detecting the light incident at the first location by a sensor of the medical instrument, and moving the medical instrument toward the target site based on the sensor detecting the light incident at the first location.

Any of the methods of using the medical systems described herein do not fall within the scope of the claimed invention and may have any of the following steps and/or features. In response to detecting movement of the medical device within the target site, the method includes capturing images of the target site with the imaging device to determine a second location of the target site, redirecting the light from the light source to the second location, and moving the medical instrument toward the target site based on the sensor detecting the light at the second location.

Embodiments of the disclosure include systems, devices, and methods for locating, tracking, and/or steering one or more tools or other medical devices at a target site within the body. Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a patient. By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the patient. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," rather than "ideal. " As used herein, the terms "about," "substantially," and "approximately," indicate a range of values within +/- <NUM>% of a stated value.

Embodiments of the disclosure are used to locate a target site with a medical system having a target identification logic. According to the invention as defined in claim <NUM>, the system combines an imaging device and a light source with a medical device to locate a target site. The imaging device is configured to capture images of the target site and the light source is configured to direct light onto the target site in response to identifying a location of the target site based on the images. The target identification logic of the medical system may detect movements of the medical device and determine an adjusted location of the target site relative to the medical device in response, thereby redirecting the light from the light source toward the location of the target site.

Embodiments of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and/or any other suitable patient anatomy (collectively referred to herein as a "target treatment site"). Various embodiments described herein include single-use or disposable medical devices. Reference will now be made in detail to examples of the disclosure described above and illustrated in the accompanying drawings.

<FIG> shows a schematic depiction of an exemplary medical system <NUM> in accordance with an embodiment of this disclosure. The medical system <NUM> includes a medical device <NUM>, a medical instrument <NUM> and a processor <NUM>, which is part of an image processing device <NUM>. The image processing device <NUM> may be communicatively coupled to the medical device <NUM> via a cable <NUM>. It should be understood that in other embodiments the image processing device <NUM> may be in wireless communication with the medical device <NUM>. In embodiments, the image processing device <NUM> is a computer system incorporating a plurality of hardware components that allow the image processing device <NUM> to receive and monitor data, accurately display images of one or more features (e.g., a target site), and/or process other information described herein. Illustrative hardware components of the image processing device <NUM> includes at least one processor <NUM> and may include at at least one memory <NUM>.

The processor <NUM> of the image processing device <NUM> may include any computing device capable of executing machine-readable instructions, which may be stored on a non-transitory computer-readable medium, such as, for example, the memory <NUM> of the image processing device <NUM>. By way of example, the processor <NUM> may include a controller, an integrated circuit, a microchip, a computer, and/or any other computer processing unit operable to perform calculations and logic operations required to execute a program. As described in greater detail herein, the processor <NUM> is configured to perform one or more operations in accordance with the instructions stored on the memory <NUM>, such as, for example, a target identification logic <NUM>.

The memory <NUM> of the image processing device <NUM> is a non-transitory computer readable medium that stores machine-readable instructions thereon, such as, for example, the target identification logic <NUM>. As described in further detail below, the target identification logic <NUM> may include executable instructions that allow the medical device <NUM> to track a location of a target site for the medical instrument <NUM> to lock onto and steer toward for the performance of one or more procedures on or near the target site. It should be understood that various programming algorithms and data that support an operation of the medical system <NUM> may reside in whole or in part in the memory <NUM>. The memory <NUM> may include any type of computer readable medium suitable for storing data and algorithms, such as, for example, random access memory (RAM), read only memory (ROM), a flash memory, a hard drive, and/or any device capable of storing machine-readable instructions. The memory <NUM> may include one or more data sets, including, but not limited to, image data <NUM> from one or more components of the medical system <NUM> (e.g., the medical device <NUM>, the medical instrument <NUM>, etc.).

Still referring to <FIG>, the medical device <NUM> may be configured to facilitate positioning one or more components of the medical system <NUM> relative to a patient, such as, for example, the medical instrument <NUM>. In embodiments, the medical device <NUM> may be any type of endoscope and may include a handle <NUM>, an actuation mechanism <NUM>, at least one port <NUM>. According to the invention as defined in claim <NUM>, the medical device includes a shaft <NUM>. The handle <NUM> of the medical device <NUM> may have one or more lumens (not shown) that communicate with a lumen(s) of one or more other components of the medical system <NUM>. The handle <NUM> further includes the at least one port <NUM> that opens into the one or more lumens of the handle <NUM>. As described in further detail herein, the at least one port <NUM> is sized and shaped to receive one or more instruments therethrough, such as, for example, the medical instrument <NUM> of the medical system <NUM>.

The shaft <NUM> of the medical device <NUM> may include a tube that is sufficiently flexible such that the shaft <NUM> is configured to selectively bend, rotate, and/or twist when being inserted into and/or through a patient's tortuous anatomy to a target treatment site. The shaft <NUM> has one or more lumens (not shown) extending therethrough that include a working lumen for receiving instruments (e.g., the medical instrument <NUM>). In other embodiments, the shaft <NUM> may include additional lumens such as a control wire lumen for receiving one or more control wires for actuating one or more distal parts/tools (including an articulation joint and an elevator, for example), a fluid lumen for delivering a fluid, an illumination lumen for receiving at least a portion of an illumination assembly (not shown), and/or an imaging lumen for receiving at least a portion of an imaging assembly (not shown).

Still referring to <FIG>, the medical device <NUM> may further include a tip <NUM> at a distal end of the shaft <NUM>. In some embodiments, the tip <NUM> may be attached to the distal end of the shaft <NUM>, while in other embodiments the tip <NUM> may be integral with the shaft <NUM>. For example, the tip <NUM> may include a cap configured to receive the distal end of the shaft <NUM> therein. The tip <NUM> may include one or more openings that are in communication with the one or more lumens of the shaft <NUM>. For example, the tip <NUM> may include a working opening <NUM> through which the medical instrument <NUM> may exit from a working lumen of the shaft <NUM>. In other embodiments, the tip <NUM> of the shaft <NUM> may include additional and/or fewer openings thereon, such as, for example, a fluid opening or nozzle through which fluid may be emitted from a fluid lumen of the shaft <NUM>, an illumination opening/window through which light may be emitted, and/or an imaging opening/window for receiving light used by an imaging device to generate an image.

The actuation mechanism <NUM> of the medical device <NUM> is positioned on the handle <NUM> and may include one or more knobs, buttons, levers, switches, and/or other suitable actuators. The actuation mechanism <NUM> is configured to control at least one of deflection of the shaft <NUM> (through actuation of a control wire, for example), delivery of a fluid, emission of illumination, and/or various imaging functions. As described in greater detail herein, in some embodiments the medical device <NUM> includes one or more control wires for actuating an elevator <NUM> of the medical device <NUM> at the tip <NUM> (see <FIG>). Accordingly, a user of the medical device <NUM> may manipulate the actuation mechanism <NUM> to selectively exert at least one of a pulling force and a pushing force on the one or more control wires to control a position of the elevator <NUM>, and thereby control a position of an instrument adjacent to the elevator <NUM> (e.g., the medical instrument <NUM>).

Still referring to <FIG>, the medical instrument <NUM> of the medical system <NUM> may include a catheter having a longitudinal body <NUM> between a proximal end of the longitudinal body <NUM> and a distal end <NUM>. A handle <NUM> is at the proximal end of the longitudinal body <NUM>. The longitudinal body <NUM> of the medical instrument is flexible such that the medical instrument <NUM> is configured to bend, rotate, and/or twist when being inserted into a working lumen of the medical device <NUM>. The handle <NUM> of the medical instrument <NUM> may be configured to move, rotate, and bend the longitudinal body <NUM>. Further, the handle <NUM> may define one or more ports (not shown) sized to receive one or more tools through the longitudinal body <NUM> of the medical instrument <NUM>. The medical device <NUM> is configured to receive the medical instrument <NUM> via the at least one port <NUM> and through the shaft <NUM> to the working opening <NUM> at the tip <NUM> via a working lumen. In this instance, the medical instrument <NUM> may extend distally out of the working opening <NUM> and into a surrounding environment of the tip <NUM>, such as, for example, at a target treatment site of a patient as described in further detail below. The distal end <NUM> of the medical instrument <NUM> may extend distally from the working opening <NUM> in response to a translation of the longitudinal body <NUM> through the working lumen of the shaft <NUM>. It should be understood that in other embodiments the medical instrument <NUM> may include various other devices than those show and described herein, including but not limited to, a guidewire, cutting or grasping forceps, a biopsy device, a snare loop, an injection needle, a cutting blade, scissors, a retractable basket, a retrieval device, an ablation and/or electrophysiology catheter, a stent placement device, a surgical stapling device, a balloon catheter, a laser-emitting device, an imaging device, and/or any other suitable instrument.

Referring now to <FIG>, the tip <NUM> of the shaft <NUM> is depicted with the medical instrument <NUM> omitted from the working opening <NUM>. The tip <NUM> includes the elevator <NUM> positioned adjacent to the working opening <NUM> and partially disposed within a working lumen of the shaft <NUM>. It should be understood that the elevator <NUM> is shown and described herein in an unactuated position and that actuation of the actuation mechanism <NUM> on the handle <NUM> may provide for an extension of the elevator <NUM> to an actuated position (see <FIG>). As described in further detail below, the elevator <NUM> is configured to position an instrument received through a working lumen of the shaft <NUM> (e.g., the medical instrument <NUM>) outward from the working opening <NUM> when in the actuated position.

The tip <NUM> of the medical device <NUM> further includes a light source <NUM>, an imaging device <NUM>, and a laser <NUM> positioned adjacent to the working opening <NUM> of the shaft <NUM>. In embodiments, the light source <NUM> of the medical device <NUM> is configured and operable to direct light outwardly from the tip <NUM> of the shaft <NUM> to thereby illuminate a surrounding environment of the tip <NUM>, such as, for example, a target treatment site of a patient in which the medical device <NUM> may be located in (see <FIG>). The light source <NUM> may include a light emitter, such as, for example, a light-emitting diode (LED), or the like. The imaging device <NUM> of the medical device <NUM> is configured and operable to capture images of a surrounding environment of the tip <NUM>, such as, for example, the target treatment site of a patient (see <FIG>). In some embodiments, the imaging device <NUM> may include a camera capable of high resolution imaging. It should be understood that in other embodiments the medical device <NUM> may omit the imaging device <NUM> on the tip <NUM> entirely such that a separate imaging device may be received by the medical device <NUM> through the shaft <NUM>.

Still referring to <FIG>, the laser <NUM> of the medical device <NUM> is configured and operable to generate a light/laser beam outwardly from the tip <NUM> of the shaft <NUM>. The laser <NUM> is further configured to selectively direct the light/laser beam to a predetermined location to thereby mark the predetermined location with the light/laser beam. It should be understood that the light/laser beam generated by the laser <NUM> may be independently steerable relative to the light emitted by the light source <NUM> and/or any other component of the medical system <NUM>. As described further below, a target site within a patient may be marked with a light/laser beam from the laser <NUM> for tracking a location of said target site during use of the medical system <NUM> in a procedure (see <FIG>).

According to the invention as defined in claim <NUM>, the medical device <NUM> includes a mirror which may be positioned along and/or adjacent to the tip <NUM> of the shaft <NUM>. The mirror of the medical device <NUM> may be disposed adjacent to the laser <NUM> thereby forming a unitary structure such that the mirror is coincident with a beam of light emitted by the laser <NUM>. The mirror of the medical device <NUM> is configured and operable to selectively reflect the light/laser beam generated by the laser <NUM> toward a predetermined location of a target site. The mirror of the medical device <NUM> is configured to move, pivot, translate, and/or rotate relative to the laser <NUM> and/or the tip <NUM> of the shaft <NUM> to thereby redirect the light/laser beam to a predetermined location of the target site. In embodiments, the mirror includes a micro-mirror (MEMS mirror) configured to reflect the light/laser beam along two axes (e.g., x-y directions of a coordinate axis) and/or to optical scanning angles ranging up to approximately <NUM> degrees. As described in further detail below, a predetermined location of a target site may be determined based on images (e.g., the image data <NUM>) captured by the imaging device <NUM> of the medical device <NUM>.

As shown in <FIG>, the medical instrument <NUM> is depicted extending outwardly from the tip <NUM> of the shaft <NUM> with the elevator <NUM> engaged against the longitudinal body <NUM> of the medical instrument <NUM>. With the elevator <NUM> in an actuated position, an anterior-facing surface of the elevator <NUM> engages the longitudinal body <NUM> of the medical instrument <NUM> to thereby deflect the distal end <NUM> laterally outward from the working opening <NUM>. In some embodiments, the anterior-facing surface of the elevator <NUM> has a curvature that facilitates a deflection and/or bend of the longitudinal body <NUM> of the medical instrument <NUM>. It should be appreciated that the elevator <NUM> may include various other shapes, sizes, and/or configurations than those shown and described herein without departing from a scope of the disclosure.

The medical instrument <NUM> further includes a sensor <NUM> positioned along the longitudinal body <NUM> adjacent to the distal end <NUM>. In embodiments, the sensor <NUM> may be located on a distally-facing surface and/or a distal-most surface of the medical instrument <NUM>. The sensor <NUM> of the medical instrument <NUM> is configured to detect one or more objects, properties, characteristics, and/or features present at and/or proximate to the distal end <NUM> of the medical instrument <NUM>. The configured to detect the light/laser beam generated by the laser <NUM> of the medical device <NUM>, for example a point on a target site on which the light/laser beam <NUM> is incident. The sensor <NUM> may include at least one of a photodetector, a photodiode, a charged coupled device (CCD), and/or various other suitable detectors.

In embodiments, the sensor <NUM> includes a four-quadrant photodiode configured to convert light into an electrical current. As described in greater detail herein, in embodiments the sensor <NUM> is configured and operable to identify a predetermined location of a target site in response to detecting a light/laser beam directed by the laser <NUM> onto that target site (see <FIG>). In some embodiments, the sensor <NUM> may be positioned along a proximal end of the longitudinal body <NUM> adjacent to the handle <NUM> of the medical instrument <NUM> with a fiber that is communicatively coupled to the sensor <NUM> positioned adjacent to the distal end <NUM>. In this instance, the distal end <NUM> of the medical instrument <NUM> may have a relatively smaller profile. It should be understood that in other embodiments the medical instrument <NUM> may omit the sensor <NUM> on the distal end <NUM> entirely such that a separate sensing device may be received by the medical instrument <NUM> through the longitudinal body <NUM>, such as, for example, via one or more guidewires.

Referring now to <FIG> in conjunction with the flow diagram of <FIG>, an exemplary method <NUM> of using the medical system <NUM> to locate and access a target site is schematically depicted. Said method does not fall within the claimed subject-matter and does not form part of the invention. The depiction of <FIG> and the accompanying description below is not meant to limit the subject matter described herein to a particular method.

At step <NUM> and as shown in <FIG>, the medical device <NUM> of the medical system <NUM> may be inserted within a patient's body <NUM>. The shaft <NUM> of the medical device <NUM> is guided through a digestive tract of the patient <NUM> by inserting the tip <NUM> into a nose or mouth (or other suitable natural body orifice) of the patient's body <NUM>. In embodiments, the medical device <NUM> is inserted through a gastrointestinal tract of the patient's body <NUM>, including an esophagus <NUM>, a stomach <NUM>, and into a small intestine <NUM> until reaching a target treatment site. It should be appreciated that a length of the shaft <NUM> may be sufficient so that a proximal end of medical device <NUM> (including the handle <NUM>) is external of the patient's body <NUM> while the tip <NUM> of the medical device <NUM> is internal to the patient's body <NUM>. While this disclosure , which does not fall within the scope of the claimed invention, relates to the use of the medical system <NUM> in a digestive tract of the patient's body <NUM>, it should be understood that the features of this disclosure could be used in various other locations (e.g., other organs, tissue, etc.) within the patient's body <NUM>.

The shaft <NUM> of the medical device <NUM> may extend into the patient's body <NUM> until it reaches a position in which tools disposed within the medical device <NUM> can access the target treatment site, such as the medical instrument <NUM> of the medical system <NUM>. In examples in which the medical device <NUM> is used to access and visualize aspects of the pancreatico-biliary system, this position may be, for example, the duodenum of the small intestine <NUM>. In such examples, a target site may be the ampulla/papilla of Vater <NUM> located in a portion of the duodenum of the small intestine <NUM>. It should be understood that the ampulla/papilla of Vater <NUM> generally forms an opening where the pancreatic duct and the common bile duct <NUM> empty into the duodenum of the small intestine <NUM>, with the hepatic ducts and the gall bladder emptying into the common bile duct <NUM>.

Still referring to <FIG>, with the tip <NUM> of the shaft <NUM> located proximate to the target site (e.g., the ampulla of Vater <NUM>), the medical instrument <NUM> of the medical system <NUM> may be slidably received within the medical device <NUM> to thereby position the distal end <NUM> proximate to the target site. Advancement of the medical instrument <NUM> into the port <NUM> and through the shaft <NUM> to the tip <NUM> may be provided in response to actuation of the handle <NUM>. It should be understood that in other embodiments the medical instrument <NUM> may be received through the medical device <NUM> prior to an insertion of the shaft <NUM> through the patient body <NUM> at step <NUM>.

In some embodiments, rotation of the tip <NUM> near the target site may be desirable to facilitate positioning the working opening <NUM> toward a location of the target site. For example, it may be desired that the distal end <NUM> of the medical instrument <NUM> reach the ampulla/papilla of Vater <NUM> when deflected outwardly from the working opening <NUM> by the elevator <NUM> (<FIG>). In this instance, the tip <NUM> of the shaft <NUM> may be rotated until the working opening <NUM>, in which the medical instrument <NUM> may exit the medical device <NUM>, is facing the ampulla/papilla of Vater <NUM>. Rotation of the tip <NUM> and/or the shaft <NUM> may be provided in response to actuating the actuation mechanism <NUM> on the handle <NUM>, and/or by rotating all of the handle <NUM>, and identification of a relative orientation and/or position of the tip <NUM> may be provided in response to actuating the imaging device <NUM> on the tip <NUM>.

At step <NUM>, with the working opening <NUM> on the tip <NUM> facing the target site, a surrounding environment of the target site may be illuminated in response to actuating the light source <NUM>. It should be understood that in other embodiments the light source <NUM> may already be actuated to direct light outwardly from the tip <NUM>, such as, for example, prior to and/or as the medical device <NUM> is inserted into the patient body <NUM> at step <NUM>.

At step <NUM>, with the target site illuminated by the lighting source <NUM>, the processor <NUM> of the image processing device <NUM> executes the target identification logic <NUM> to actuate the imaging device <NUM> of the medical device <NUM>. Accordingly, the imaging device <NUM> captures images of the target site. With the imaging device <NUM> facing the target site (e.g., the ampulla of Vater <NUM>), images of a location of the target site may be obtained by the medical device <NUM> and communicated to the image processing device <NUM> for storing in the memory <NUM> as image data <NUM>.

At step <NUM> and referring to <FIG>, with the image data <NUM> received from the medical device <NUM> and stored within the memory <NUM>, the processor <NUM> of the image processing device <NUM> executes the target identification logic <NUM> to determine a first location 52A of the target site (e.g., the ampulla of Vater <NUM> within the small intestine <NUM>) relative to the imaging device <NUM> on the tip <NUM>. The processor <NUM> analyzes the image data <NUM> captured by the imaging device <NUM> and determines a coordinate position of the target site relative to the tip <NUM>, pursuant to executing the machine-readable instructions of the target identification logic <NUM>. Alternatively, in other embodiments a user of the medical system <NUM> may manually identify the first location 52A of the target site based on the image data <NUM>, such as, for example, via a touch-screen user interface display (not shown) that is communicatively coupled to the image processing device <NUM>.

In some embodiments, the processor <NUM>, when executing the target identification logic <NUM>, may generate a visual identifier at the first location 52A (e.g., highlights, geometric figures, arrows, and the like) to thereby visually designate the first location 52A of the target site for reference. As seen in <FIG>, the visual identifier of the first location 52A may include a box and/or "X" superimposed on the images of the target site for purposes of visually designating the target site in the image data <NUM>. The visual identifier of the first location 52A may be displayed on a user interface display (not shown) that is communicatively coupled to the image processing device <NUM>. Alternatively, in other embodiments a user of the medical system <NUM> may manually mark the first location 52A of the target site with a visual identifier based on the image data <NUM>, such as, for example, via a touch-screen user interface display (not shown) that is communicatively coupled to the image processing device <NUM>. In this instance, the processor <NUM> may analyze the image data <NUM> to determine the first location 52A of the target site in accordance with the manual mark and/or identification by the user of the medical system <NUM> for continued tracking in subsequent images of the target site.

At step <NUM> and referring to <FIG>, with the first location 52A of the target site determined relative to the tip <NUM>, the processor <NUM> of the image processing device <NUM> executes the target identification logic <NUM> to mark the first location 52A of the target site with a light/laser beam <NUM> by actuating the laser <NUM> of the medical device <NUM>. The processor <NUM> actuates the mirror of the medical device <NUM> to reflect the light/laser beam <NUM> generated by the laser <NUM> to redirect the light/laser beam <NUM> toward the first location 52A of the target site, pursuant to executing the machine-readable instructions of the target identification logic <NUM>.

At step <NUM> and still referring to <FIG>, with the light/laser beam <NUM> of the laser <NUM> directed (e.g., by the mirror) to the first location 52A of the target site (e.g., the ampulla of Vater <NUM>), the medical instrument <NUM> may be moved toward the target site in response to sensor <NUM> detecting the light/laser beam <NUM>. The handle <NUM> of the medical instrument <NUM> may be actuated to automatically translate the longitudinal body <NUM> through a working lumen of the shaft <NUM> to position the distal end <NUM> adjacent to the target site. Accordingly, the medical device <NUM> tracks the first location 52A of the target site to allow the medical instrument <NUM> to lock onto the first location 52A with the sensor <NUM> and autonomously steer the distal end <NUM> toward the target site to perform one or more procedures thereon, such as, for example, cannulate the ampulla duct opening <NUM> of the common bile duct <NUM>.

With the sensor <NUM> positioned along the distal end <NUM>, the sensor <NUM> is configured to generate a feedback in response to detecting the incidence of the light/laser beam <NUM> onto the target site, relative to the distal end <NUM>. In some embodiments, the sensor <NUM> includes a photodiode configured to convert the light/laser beam <NUM> into an electrical current such that the feedback generated by the sensor <NUM> includes a photodiode signal transmitted to a user of the medical instrument <NUM>. A strength of the photodiode signal generated by the sensor <NUM> may be indicative of a spatial (e.g., three-dimensional) proximity of the sensor <NUM> to the point of incidence of the light/laser beam <NUM>. Accordingly, with the light/laser beam <NUM> directed to the first location 52A of the target site, it should be understood that a strength of the photodiode signal generated by the sensor <NUM> may increase as a distance between the distal end <NUM> of the medical instrument <NUM> and the target site decreases as the sensor <NUM> may detect the light/laser beam <NUM> in a relatively close proximity.

It should be further understood that a strength (e.g., intensity variation) of the photodiode signal generated by the sensor <NUM> may decrease as a distance between the distal end <NUM> of the medical instrument <NUM> and the target site increases, as the sensor <NUM> may detect the light/laser beam <NUM> in a relatively further proximity. Although the sensor <NUM> in embodiments described herein includes a photodiode or CCD that is configured to generate a feedback in response to detecting the light/laser beam <NUM> in the form of a photodiode signal, it should be appreciated that various other suitable sensors and/or forms of feedback may be generated by a sensor on the medical instrument <NUM> without departing from a scope of this disclosure.

In some embodiments, the medical instrument <NUM> may include a processor and memory similar to the processor <NUM> and the memory <NUM> of the image processing device <NUM> shown and described above. In this instance, the processor of the medical instrument <NUM>, when executing target identification logic stored on the memory of the medical instrument <NUM>, may provide for autonomous steering of the medical instrument <NUM> relative to the first location 52A of the target site by tracking the light/laser beam <NUM> with the sensor <NUM>. In other embodiments, the medical instrument <NUM> may be manually navigated to the first location 52A of the target site by a user of the medical system <NUM> by visually tracking a position of the distal end <NUM> relative to the first location 52A via a user interface display (not shown). In this instance, a user may visually navigate the distal end <NUM> of the medical instrument <NUM> toward the visual identifier generated by the light/laser beam <NUM>. By way of illustrative example only, the distal end <NUM> of the medical instrument <NUM> may be displayed on a user interface display by a visual identifier, such as, for example, cross-hairs superimposed on the user interface display that are indicative of a position of the distal end <NUM>. Further, the feedback generated by the sensor <NUM> may be utilized in addition to and/or in lieu of the user interface display for manually steering the medical instrument <NUM> toward the first location 52A of the target site.

In some instances, the medical device <NUM> of the medical system <NUM> may move, intentionally and/or inadvertently, relative to the target site during a procedure as the medical instrument <NUM> moves toward the target site at step <NUM>. Such movements may occur due to difficulties in maintaining the medical device <NUM> stable during a procedure. In this instance, a position of the target site (e.g., the ampulla of Vater <NUM>) relative to the tip <NUM> of the shaft <NUM> and/or the distal end <NUM> of the medical instrument <NUM> may be modified and/or vary relative to an initial corresponding position between the target site and the medical device <NUM>. Accordingly, the image data <NUM> initially obtained by the medical system <NUM> at step <NUM> may include inaccuracies and/or deficiencies in providing a current location of the target site (e.g., the ampulla of Vater <NUM>). As a result, continued movement of the distal end <NUM> of the medical instrument <NUM> toward the first location 52A, as initially determined by the processor <NUM> of the imaging processing device <NUM> at step <NUM>, may not allow a user of the medical system <NUM> to adequately access the target site.

At step <NUM> and referring to <FIG>, in response to the processor <NUM> of the image processing device <NUM> detecting a movement of the medical device <NUM> relative to the target site (e.g., the ampulla of Vater <NUM>), the processor <NUM> may execute the target identification logic <NUM> to actuate the imaging device <NUM> to obtain updated image data <NUM> of the target site. In some embodiments, the processor <NUM> of the image processing device <NUM>, when executing the target identification logic <NUM>, may be configured to determine whether the medical device <NUM> has moved relative to the target site by periodically capturing images with the imaging device <NUM> for comparison to the image data <NUM> stored in the memory <NUM> at step <NUM>. Accordingly, movement of the medical device <NUM> relative to the target site may be based on determining that a positional variance between the first location 52A and a detected position of the target site is equal to or greater than a preprogrammed threshold (e.g., a millimeter(s), a micrometer(s), a nanometer(s), etc.).

In this instance, upon determining that a recorded position of the first location 52A varies relative to a detected position of the target site via the periodically-captured images, the processor <NUM> of the image processing system <NUM> repeats steps <NUM>, <NUM>, <NUM>, and <NUM> of the method <NUM> described above. The processor <NUM> executes the target identification logic <NUM> to capture images (e.g., image data <NUM>) of the target site at step <NUM>, determine a second location 52B of the target site (e.g., the ampulla of Vater <NUM>) at step <NUM>, and mark the second location 52B with the light/laser beam <NUM> at step <NUM>. It should be understood that the method <NUM> performs these steps substantially similar to those shown and described above to facilitate locating the target site with the medical system <NUM> in accordance with the new, second location 52B of the target site.

In other embodiments, the image processing device <NUM> of the medical system <NUM> may be communicatively coupled to a remote station (not shown) for purposes of dynamically updating the target identification logic <NUM> stored on the memory <NUM>. By way of illustrative example, the image processing device <NUM> may be operable to receive neural network data from a remote station (e.g., a computer server), such as, for example, via a wired and/or wireless connection. The neural network data received by the imaging processing device <NUM> may include supplemental image data <NUM>, similar to the image data <NUM> shown and described above, recorded from a plurality of prior procedures, devices, systems, etc. Such image data may be from a plurality of different patients, acquired over time, of the same or similar patient anatomy. The supplemental image data <NUM> may be stored in the memory <NUM> and utilized by the processor <NUM> of the image processing device <NUM> to artificially determine and/or identify common physical properties and/or characteristics of one or more target sites, such as, for example, the ampulla of Vater <NUM> within the small intestine <NUM>, the ampulla duct opening <NUM> of the common bile duct <NUM>, etc..

In the embodiment, the processor <NUM> of the image processing device <NUM>, when executing the machine-readable instructions of the target identification logic <NUM>, may reference the supplemental image data <NUM> when analyzing the image data <NUM> captured by the imaging device <NUM> of the medical device <NUM> to determine the first location 52A of the target site (e.g., the ampulla of Vater <NUM> within the small intestine <NUM>). Accordingly, it should be appreciated that the supplemental image data <NUM> may facilitate determining a coordinate position of a target site relative to the medical device <NUM> during a procedure by providing the image processing device <NUM> additional data for artificial learning of a size, shape, and/or configuration of similar target sites.

Each of the aforementioned devices, assemblies, and methods may be used to detect, mark and track a location of a target site. By providing a medical assembly, a user may accurately interact with a patient's tissue using artificial intelligence software in an image processing device during a procedure, allowing a user to reduce overall procedure time, increase efficiency of procedures, and avoid unnecessary harm to a patient's body caused by lack of control over a motion and positioning of a medical device when accessing target tissue of a patient.

Claim 1:
A medical system (<NUM>), comprising a medical device (<NUM>), a medical instrument (<NUM>) movable relative to the medical device, a processor (<NUM>) and a non-transitory computer readable medium (<NUM>) storing instructions,
the medical device (<NUM>) including:
an imaging device (<NUM>) configured to capture images of a target site, wherein a location of the target site is determined based on the images using a target identification logic of the medical system;
a light source (<NUM>) configured to direct light onto the location of the target site;
a shaft (<NUM>) having one or more lumens extending therethrough that include a working lumen for receiving the medical instrument (<NUM>); and
a mirror configured to reflect the light generated by the light source (<NUM>) toward the location of the target site,
the medical instrument (<NUM>) including a sensor (<NUM>), said sensor being configured to detect light generated by the light source (<NUM>),
the processor (<NUM>) being configured to perform one or more operations in accordance with the instructions, wherein the instructions, when executed by the processor, cause the processor to move the sensor (<NUM>) of the medical instrument (<NUM>) toward the location of the target site based on the sensor (<NUM>) detecting the light at the target site.