Medical system including a medical imaging device having a light source and means for moving a sensor based on detection of light by the sensor - Patents.com

Abstract

A medical system (100) is disclosed that includes a medical device (110) having an imaging device configured to acquire an image of a target site and determine a location of the target site based on the image. The medical device includes a light source configured to direct light toward the location of the target site, and the medical system includes a processor (104) and a non-transitory computer-readable medium storing instructions that, when executed by the processor, move a sensor of a medical instrument (140) toward the location of the target site based on detection of light at the target site by the sensor.

Description

[Technical field]

[0001] The present invention relates to medical device tracking systems, devices, and associated methods, and more particularly, to systems, devices, and associated methods for locating one or more target sites within a patient during an endoscopic procedure to facilitate positioning of a medical device. [Background technology]

[0002] Technological advances have enabled users of medical systems, devices and methods to perform increasingly complex procedures on patients. One challenge in the field of minimally invasive surgery, such as endoscopy, among other surgical procedures, relates to cannulation of a target site within a patient's body, such as the ampulla that opens into the common bile duct. Accurate placement of a medical device at a target site within a patient is made difficult by a lack of visualization of the target site and a lack of control over the positioning of the medical device relative to the target site. Shortcomings of a medical device in providing stability to the positioning of an endoscope at a target treatment site in a patient can prolong a procedure, limit its effectiveness, 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. Summary of the Invention

[0003] The present invention relates to systems, devices, and methods for positioning a medical device at a target treatment site using a medical system that includes target identification logic. Each embodiment disclosed herein may include one or more of the features described in connection with any of the other disclosed embodiments.

[0004] According to one embodiment, the medical system includes a medical device having an imaging device configured to obtain an image of the target site. A location of the target site is determined based on the image. The medical device further includes a light source configured to direct light to the location of the target site, a processor, and a non-transitory computer readable medium storing instructions that, when executed by the processor, cause the processor to move a sensor of the medical instrument toward the location of the target site based on detection of light at the target site by the sensor.

[0005] Any of the medical systems described herein may have any one of the following features: The sensor is movable relative to the imaging device toward the location of the target site based on detection of light at the target site by the sensor. Instructions stored on the non-transitory computer readable medium cause the processor to detect a change in the position 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 a change in the position of the imaging device relative to the target site based on images periodically acquired 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 degree of change in the position. The processor is configured to determine whether the degree of change in the position exceeds a preprogrammed threshold. The light source includes a source that generates a laser beam. The imaging device includes a camera. The medical system may include a medical instrument, and the sensor includes 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 detection of light at the target site. The intensity of the photodiode signal generated by the sensor includes a greater intensity when the sensor is located a first distance from the light and a lesser intensity when the sensor is located a second distance from the light. The first distance is less than the second distance. The medical device includes a mirror configured to reflect light generated by the light source toward a location of the target site. The mirror is configured to move to redirect the light toward the location of the target site in response to a processor detecting a change in position of the imaging device relative to the target site. The mirror includes a micromirror (MEMs mirror) configured to reflect light along two axes. The mirror is disposed adjacent to the light source of the medical device. The processor is configured to generate a visual identifier along an image acquired by the imaging device that indicates the location of the target site.

[0006] According to another embodiment, a medical system includes a medical device including an imaging device configured to obtain an image of a target site and a light source configured to direct light to the target site. The medical system includes a medical instrument movable relative to the medical device. The medical instrument includes a sensor configured to detect light at the target site. The medical instrument is movable toward the target site in response to detection of light at the target site by the sensor.

[0007] Any of the medical systems described herein may have any one 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 acquired by the imaging device. The light source is configured to redirect 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.

[0008] According to another embodiment, a method of moving a medical instrument toward a target site includes acquiring an image of the target site with an imaging device. A first location of the target site is determined based on the image. The method includes transmitting light to the first location with a light source, detecting the light incident at the first location with a sensor of the medical instrument, and moving the medical instrument toward the target site based on the detection of the light incident at the first location by the sensor.

[0009] Any of the methods of using the medical systems described herein may have any one of the following steps and / or elements: The method includes acquiring an image of the target site with an imaging device to determine a second location of the target site in response to detecting movement of the medical device within the target site, redirecting light from a light source to the second location, and moving the medical instrument towards the target site based on detection of light at the second location by a sensor.

[0010] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the invention. [Brief description of the drawings]

[0011] [Figure 1] 1 is a schematic diagram illustrating an exemplary medical system, in accordance with an aspect of the present invention. [Diagram 2] 2 is a partial perspective view of a medical device of the medical system of FIG. 1 according to an embodiment of the present invention. [Diagram 3] 2 is a partial perspective view of a medical device of the medical system of FIG. 1 according to an embodiment of the present invention. [Figure 4] 2 is a schematic diagram illustrating the medical system of FIG. 1 positioned at a target site in a patient, according to an embodiment of the present invention. [Figure 5A] 1 is an image including localization of a target site on a patient, according to an embodiment of the present invention. [Figure 5B] 5B is an image including marking the target area of ​​FIG. 5A with a light beam, according to an embodiment of the present invention. [Figure 5C] 11 is an image including marking a target site with a light beam during movement of a medical system according to an embodiment of the present invention. [Figure 6] 2 is a block diagram illustrating an exemplary method for locating a target site using the medical system of FIG. 1 according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE PRESENT EMBODIMENTS

[0011] Embodiments of the present invention include systems, devices, and methods for locating, tracking, and steering one or more instruments or medical devices at a target site within the body. Reference will now be made in detail to aspects of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when the device is introduced into the patient. In contrast, the term "proximal" refers to the part of the device that is closest to the user when the device is placed in the patient. As used herein, the terms "comprises," "comprising," or other variations thereof are intended to cover a non-exclusive inclusion, whereby a process, method, article, or device 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 device. 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 + / - 10% of the stated value.

[0013] Embodiments of the present invention may be used to locate a target site using a medical system, such as a medical system having target identification logic. For example, some embodiments combine an imaging device and a light source with a medical device to locate a target site. The imaging device may acquire an image of the target site, and the light source may direct light to the target site in response to locating the target site based on the image. The target identification logic of the medical system may detect movement of the medical device and in response determine an adjusted position of the target site relative to the medical device, thereby redirecting light from the light source towards the location of the target site.

[0014] Embodiments of the present invention relate to devices and methods for performing various medical procedures and treating 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 "target treatment sites"). Various embodiments described herein include single use or disposable medical devices. Reference will now be made in detail to the examples of the invention described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0015] FIG. 1 illustrates a schematic diagram of an exemplary medical system 100 according to an embodiment of the present invention. The medical system 100 includes an imaging device 102, a medical device 110, and a medical instrument 140. The imaging device 102 may be communicatively connected to the medical device 110 via a cable 118. In other embodiments, the imaging device 102 may communicate wirelessly with the medical device 110. In an embodiment, the imaging device 102 is a computer system incorporating multiple hardware components that enable it to receive and monitor data, accurately display an image of one or more features (e.g., a target site), and / or process other information as described herein. The hardware components of the imaging device 102 may include at least one processor 104 and at least one memory 106.

[0016] The processor 104 of the imaging device 102 may include any computing device capable of executing machine-readable instructions, which may be stored in a non-transitory computer-readable medium, such as, for example, the memory 106 of the imaging device 102. By way of example, the processor 104 may include a controller, an integrated circuit, a microchip, a computer, and / or any other computer processing unit operable to perform the computational and logical operations necessary to execute a program. As described in more detail herein, the processor 104 is configured to perform one or more operations according to instructions, such as, for example, the target identification logic 108, stored in the memory 106.

[0017] The memory 106 of the image processing device 102 is a non-transitory computer readable medium having machine readable instructions stored therein, such as, for example, the target identification logic 108. As described in more detail below, the target identification logic 108 may include executable instructions that cause the medical device 110 to track the location of a target site to which the medical instrument 140 should lock onto and advance in order to perform one or more procedures at or near the target site. Various programming algorithms and data that aid in the operation of the medical system 100 reside in whole or in part in the memory 106. The memory 106 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), flash memory, hard drive, and / or any device capable of storing machine readable instructions. The memory 106 may include one or more data sets, such as, but not limited to, image data 109 from one or more components of the medical system 100 (e.g., the medical device 110, the medical instrument 140, etc.).

[0018] 1 , the medical device 110 may be configured to facilitate positioning of one or more components of the medical system 100 relative to a patient, such as, for example, a medical instrument 140. In an embodiment, the medical device 110 may be any type of endoscope and may include a handle 112, a drive mechanism 114, at least one port 116, and a shaft 120. The handle 112 of the medical device 110 may have one or more lumens (not shown) that communicate with lumens of one or more other components of the medical system 100. The handle 112 further includes at least one port 116 that opens into the one or more lumens of the handle 112. As described in more detail herein, the at least one port 116 is sized and shaped to receive one or more instruments therethrough, such as, for example, a medical instrument 140 of the medical system 100.

[0019] The shaft 120 of the medical device 110 may comprise a tube that is sufficiently resilient to selectively bend, rotate, and twist when inserted into and / or through a patient's tortuous anatomy to a target treatment site. The shaft 120 may have one or more lumens (not shown) extending therethrough, including, for example, a working lumen for receiving an instrument (e.g., medical instrument 140). In other embodiments, the shaft 120 may include additional lumens, such as a control wire lumen for receiving one or more control wires for actuating one or more distal portions / instruments (e.g., including articulation joints and elevators), a fluid lumen for delivering fluids, 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).

[0020] 1 , the medical device 110 may further include a tip 122 at the distal end of the shaft 120. In some embodiments, the tip 122 may be attached to the distal end of the shaft 120, while in other embodiments, the tip 122 may be integral with the shaft 120. For example, the tip 122 may include a cap configured to receive the distal end of the shaft 120 therein. The tip 122 may include one or more openings in communication with one or more lumens of the shaft 120. For example, the tip 122 may include a working opening 124 through which the medical instrument 140 may exit a working lumen of the shaft 120. In other embodiments, the tip 122 of the shaft 120 may include additional and / or fewer openings therein, such as, for example, fluid openings or nozzles through which fluid may be released from the fluid lumen of the shaft 120, illumination openings / windows through which light may be emitted, and / or imaging openings / windows for receiving light used by an imaging device to generate an image.

[0021] The drive mechanism 114 of the medical device 110 is disposed on the handle 112 and may include one or more knobs, buttons, levers, switches, and / or other suitable actuators. The drive mechanism 114 is configured to control at least one of deflection of the shaft 120 (e.g., by actuating a control wire), delivery of fluid, emission of illumination, and / or various imaging functions. As described in more detail herein, in some embodiments, the medical device 110 includes one or more control wires for actuating an elevator 126 of the medical device 110 at the tip 122 (see FIGS. 2-3). Thus, a user of the medical device 110 manipulates the drive mechanism 114 to apply at least one of a pulling force and a pushing force to the one or more control wires to control the position of the elevator 126 and, in turn, the position of an instrument (e.g., medical instrument 140) adjacent to the elevator 126.

[0022] 1, the medical instrument 140 of the medical system 100 includes a catheter having an elongate body 142 between a proximal end and a distal end 144. A handle 141 is at the proximal end of the elongate body 142. The elongate body 142 of the medical instrument is flexible such that the medical instrument 140 can bend, rotate, and twist when inserted into the working lumen of the medical device 110. The handle 141 of the medical instrument 140 can be configured to move, rotate, and bend the elongate body 142. Additionally, the handle 141 can define one or more ports (not shown) that are sized to receive one or more instruments through the elongate body 142 of the medical instrument 140. The medical device 110 is configured to receive the medical instrument 140 through the at least one port 116, through the shaft 120, through the working lumen, and to the working opening 124 of the tip 122. In this case, as described in more detail below, the medical instrument 140 may extend distally from the working opening 124 into the environment surrounding the tip 122 (e.g., a target treatment site on a patient, etc.). The distal end 144 of the medical instrument 140 may extend distally from the working opening 124 in response to translation of the elongated body 142 through the working lumen of the shaft 120. In other embodiments, the medical instrument 140 may include a variety of other devices beyond those shown and described herein, including, but not limited to, a guidewire, a dissecting or grasping forceps, a biopsy device, a snare loop, a needle, a dissecting blade, scissors, a retractable basket, a retrieval device, an ablation catheter and / or an electrophysiology catheter, a stent placement device, a surgical suturing device, a balloon catheter, a laser emission device, an imaging device, and / or any other suitable device.

[0023] 2, the distal end 122 of the shaft 120 is depicted with the medical instrument 140 omitted from the working opening 124. The distal end 122 includes an elevator 126 disposed adjacent the working opening 124 and partially disposed within the working lumen of the shaft 120. The elevator 126 is shown and described herein in an unactuated position, and upon actuation of the drive mechanism 114 of the handle 112, the elevator 126 can be extended to a driven position (see FIG. 3). As will be described in more detail below, when in the driven position, the elevator 126 is configured to position an instrument (e.g., the medical instrument 140) received through the working lumen of the shaft 120 outwardly from the working opening 124.

[0024] The tip 122 of the medical device 110 further includes a light source 128, an imaging device 130, and a laser 132 disposed adjacent the working opening 124 of the shaft 120. In embodiments, the light source 128 of the medical device 110 is configured and operable to direct light outwardly from the tip 122 of the shaft 120, thereby illuminating an environment surrounding the tip 122, such as, for example, a target treatment site on a patient where the medical device 110 may be located (see FIGS. 5A-5C). The light source 128 may include a light emitter, such as, for example, a light emitting diode (LED) or the like. The imaging device 130 of the medical device 110 is configured and operable to capture images of the environment surrounding the tip 122, such as, for example, a target treatment site on a patient (see FIGS. 5A-5C). In some embodiments, the imaging device 130 may include a camera capable of high resolution imaging. In other embodiments, the medical device 110 may omit the imaging device 130 on the tip 122 entirely, such that a separate imaging device is received by the medical device 110 through the shaft 120 .

[0025] 2, the laser 132 of the medical device 110 is configured and operable to generate a light / laser beam outwardly from the tip 122 of the shaft 120. In some embodiments, the laser 132 is further configured to selectively direct the light / laser beam to a predetermined location, thereby marking the predetermined location with the light / laser beam. The light / laser beam generated by the laser 132 may be independently steerable relative to the light emitted by the light source 128 and / or any other components of the medical system 100. As described further below, a target site within a patient's body may be marked with the light / laser beam from the laser 132 to track the location of the target site during use of the medical system 100 in a procedure (see FIGS. 5A-5C).

[0026] In some embodiments, the medical device 110 may further include a mirror disposed along and / or adjacent to the tip 122 of the shaft 120. The mirror of the medical device 110 may be disposed adjacent to the laser 132 to form a unitary structure such that the mirror is aligned with the beam of light emitted by the laser 132. In embodiments, the mirror of the medical device 110 selectively reflects the light / laser beam generated by the laser 132 toward a predetermined location at the target site. The mirror of the medical device 110 moves, pivots, translates, or rotates relative to the laser 132 and / or the tip 122 of the shaft 120 to thereby redirect the light / laser beam to a predetermined location at the target site. In embodiments, the mirror includes a micromirror (MEMS mirror) configured to reflect the light / laser beam along two axes (e.g., x and y coordinate directions) and at an optical scan angle ranging up to about 32 degrees. As described in more detail below, the predetermined location of the target site may be determined based on images (eg, image data 109 ) acquired by an imaging device 128 of the medical device 110 .

[0027] As shown in FIG. 3, the medical instrument 140 is depicted extending outward from the distal end 122 of the shaft 120 with the raiser 126 engaged with the elongated body 142 of the medical instrument 140. When the raiser 126 is in the driving position, the front surface of the raiser 126 engages the elongated body 142 of the medical instrument 140, thereby deflecting the distal end 144 laterally outward from the working opening 124. In some embodiments, the front surface of the raiser 126 has a curvature that facilitates deflection and / or bending of the elongated body 142 of the medical instrument 140. The raiser 126 may include various shapes, sizes, and / or configurations other than those shown and described herein without departing from the scope of the present invention.

[0028] The medical instrument 140 further includes a sensor 146 disposed along the elongate body 142 adjacent the distal end 144. In embodiments, the sensor 146 may be located on both or one of the distal-facing and distal-most faces of the medical instrument 140. The sensor 146 of the medical instrument 140 is configured to detect one or more objects, properties, characteristics, and / or features present at and / or proximate the distal end 144 of the medical instrument 140. By way of example, in some embodiments, the sensor 146 may be configured to detect light, such as light generated by the light source 128 of the medical device 110. In other embodiments, the sensor 146 may be configured to detect light / laser beam generated by the laser 132 of the medical device 110, such as a point on the target site where the light / laser beam 132 is incident. The sensor 146 may include at least one of a photodetector, a photodiode, a charge-coupled device (CCD), and various other suitable detectors.

[0029] In an embodiment, the sensor 146 includes a four-segment photodiode configured to convert light into electrical current. As described in more detail herein, in an embodiment, the sensor 146 locates a predetermined location of the target site in response to detecting a light / laser beam directed by the laser 132 to the target site (see FIGS. 5A-5C). In some embodiments, the sensor 146 may be disposed along the proximal end of the elongated body 142 adjacent the handle 141 of the medical instrument 140, with a fiber communicatively connected to the sensor 146 disposed adjacent the distal end 144. In this case, the distal end 144 of the medical instrument 140 may have a relatively small profile. In another embodiment, the medical instrument 140 may omit the sensor 146 on the distal end 144 entirely, such that a separate sensing device is received by the medical instrument 140 through the elongated body 142, such as, for example, via one or more guidewires.

[0030] 4-5C in conjunction with the flow diagram of FIG 6, an exemplary method 200 of using the medical system 100 to locate and access a target site is generally depicted. The depictions of FIG 4-6 and the accompanying description below are not intended to limit the subject matter described herein to any particular method.

[0031] At step 202, as shown in FIG. 4, the medical device 110 of the medical system 100 is inserted into the patient's body 10. The shaft 120 of the medical device 100 is guided through the gastrointestinal tract of the patient 10 by inserting the tip 122 into the nose or mouth (or other suitable natural body orifice) of the patient's body 10. In an embodiment, the medical device 110 is inserted through the gastrointestinal tract of the patient's body 10, including into the esophagus 12, stomach 16, and small intestine 18, until the target treatment site is reached. The length of the shaft 120 may be sufficient such that the proximal end of the medical device 110 (including the handle 112) is external to the patient's body 10 when the tip 122 of the medical device 110 is internal to the patient's body 10. Although the present invention relates to the use of the medical system 100 in the gastrointestinal tract of the patient's body 10, features of the present invention may be used at various other sites (e.g., other organs, tissues, etc.) within the patient's body 10.

[0032] The shaft 120 of the medical device 110 may extend into the patient's body 10 until it reaches a location where an instrument disposed within the medical device 110, such as the medical instrument 140 of the medical system 100, can access a target treatment site. In an embodiment where the medical device 110 is used to access and visualize elements of the biliary-pancreatic system, this location may be, for example, the duodenum of the small intestine 18. In such an embodiment, the target site may be the ampulla / papilla of Vater 22, which is located in a portion of the duodenum of the small intestine 18. The ampulla / papilla of Vater 22 forms the opening where the pancreatic duct and common bile duct 20 drain into the duodenum of the small intestine 18, and the hepatic duct and gallbladder drain into the common bile duct 20.

[0033] 4, once the tip 122 of the shaft 120 is positioned proximate to the target site (e.g., ampulla of Vater 22), a medical instrument 140 of the medical system 100 may be slidably received within the medical device 110 to position a distal end 144 proximate to the target site. Advancement of the medical instrument 140 through the port 106 and through the shaft 120 to the tip 122 may be performed in response to actuation of the handle 142. In another embodiment, the medical instrument 140 may be received through the medical device 110 prior to inserting the shaft 120 into the patient's body 10 at step 202.

[0034] In some embodiments, rotation of the tip 122 near the target site may be desirable to facilitate positioning of the working opening 124 towards the location of the target site. For example, it may be desired to reach the ampulla / papilla of Vater 22 when the distal end 144 of the medical instrument 140 is deflected outwardly from the working opening 124 by the elevator 126 (FIG. 3). In this case, the tip 122 of the shaft 120 is rotated until the working opening 124 through which the medical instrument 140 may exit the medical device 110 faces the ampulla / papilla of Vater 22. Rotation of the tip 122 and / or shaft 120 is performed in response to actuating the drive mechanism 114 of the handle 112 and / or by rotating all of the handle 112, and determination of the relative orientation and / or position of the tip 122 is performed in response to actuating the imaging device 130 on the tip 122.

[0035] Once the working opening 124 of the tip 122 is pointed at the target site, in step 204, the environment surrounding the target site may be illuminated in response to activation of the light source 128. In another embodiment, the light source 128 is already activated to direct light outwardly from the tip 122, such as, for example, before and / or when the medical device 110 is inserted into the patient's body 10 in step 202.

[0036] In step 206, once the target site is illuminated by the light source 128, the processor 104 of the imaging device 102 executes the target identification logic 108 to drive the imaging device 130 of the medical device 110. The imaging device 130 thus acquires an image of the target site. Once the imaging device 130 is directed at the target site (e.g., the ampulla of Vater 22), an image of the location of the target site may be acquired by the medical device 110 and communicated to the imaging device 102 for storage in the memory 106 as image data 109.

[0037] 5A, at step 208, once the image data 109 is received from the medical device 110 and stored in the memory 106, the processor 104 of the imaging device 102 executes the target identification logic 108 to determine a first location 52A of the target site (e.g., the ampulla of Vater 22 in the small intestine 18) relative to the imaging device 130 on the tip 122. The processor 104 analyzes the image data 109 acquired by the imaging device 130 in accordance with executing the machine-readable instructions of the target identification logic 108 to determine a coordinate location of the target site relative to the tip 122. Alternatively, in another embodiment, a user of the medical system 100 may manually identify the first location 52A of the target site based on the image data 109, such as via a touch screen user interface display (not shown) communicatively connected to the imaging device 102.

[0038] In some embodiments, the processor 104, when executing the target identification logic 108, may generate a visual identifier (e.g., highlight, geometric shape, arrow, and the like) at the first location 52A to visually indicate the first location 52A of the target site for reference. As shown in FIG. 5A, the visual identifier at the first location 52A may include a box and / or an "X" that is superimposed on an image of the target site to visually indicate the target site in the image data 109. The visual identifier at the first location 52A may be displayed on a user interface display (not shown) communicatively connected to the image processor 102. Alternatively, in another embodiment, a user of the medical system 100 may manually mark the first location 52A of the target site with a visual identifier based on the image data 109, such as via a touch screen user interface display (not shown) communicatively connected to the image processor 102. In this case, the processor 104 may analyze the image data 109 to determine the first location 52A of the target area according to at least one of a manual mark and an identifier by a user of the medical system 100 for continuous tracking in subsequent images of the target area.

[0039] 5B, in step 210, once the first location 52A of the target site relative to the tip 122 is determined, the processor 104 of the imaging device 102 executes the target identification logic 108 to drive the laser 132 of the medical device 110 to mark the first location 52A of the target site with a light / laser beam 134. The processor 104, in accordance with executing the machine-readable instructions of the target identification logic 108, drives a mirror of the medical device 110 to reflect the light / laser beam 134 generated by the laser 132 and redirect the light / laser beam 132 towards the first location 52A of the target site.

[0040] 5B, at step 212, once the light / laser beam 134 of the laser 132 is directed (e.g., by a mirror) to a first location 52A of the target site (e.g., ampulla of Vater 22), the medical instrument 140 may move toward the target site in response to detection of the light / laser beam 132 by the sensor 146. The handle 141 of the medical instrument 140 drives the elongated body 142 to automatically translate through the working lumen of the shaft 120 to position the distal end 144 adjacent to the target site. Thus, the medical instrument 110 tracks the first location 52A of the target site and uses the sensor 146 to lock onto the medical instrument 140 at the first location 52A and autonomously steer the distal end 144 toward the target site to perform one or more procedures at the target site, such as cannulating the ampulla duct opening 22 of the common bile duct 20.

[0041] When the sensor 146 is positioned along the distal end 144, the sensor 146 is configured to provide feedback to the distal end 144 in response to detecting the incidence of the light / laser beam 132 at the target site. In some embodiments, the sensor 146 includes a photodiode configured to convert the light / laser beam 134 into an electrical current such that the feedback by the sensor 146 includes a photodiode signal that is transmitted to a user of the medical instrument 140. The strength of the photodiode signal generated by the sensor 146 may indicate the spatial (e.g., three-dimensional) proximity of the sensor 146 to the point of incidence of the light / laser beam 134. Thus, when the light / laser beam 134 is directed to the first location 52A of the target site, the strength of the photodiode signal generated by the sensor 146 may increase as the distance between the distal end 144 of the medical instrument 140 and the target site decreases because the sensor 146 detects the light / laser beam 132 in relatively close proximity.

[0042] Because the sensor 146 detects the light / laser beam 132 in relatively far proximity, the strength (e.g., intensity change) of the photodiode signal generated by the sensor 146 may decrease as the distance between the distal end 144 of the medical instrument 140 and the target site increases. The sensor 146 in the embodiments described herein includes a photodiode or CCD configured to provide feedback in response to detection of the light / laser beam 132 in the form of a photodiode signal, although a variety of other suitable sensor and / or feedback forms may be generated by the sensor of the medical instrument 140 without departing from the scope of the present invention.

[0043] In some embodiments, the medical instrument 140 may include a processor and memory similar to the processor 104 and memory 106 of the image processing device 102 shown and described above. In this case, the processor of the medical instrument 140 may perform autonomous steering of the medical instrument 140 to the first location 52A of the target site by tracking the light / laser beam 134 with the sensor 146 when executing target identification logic stored in the memory of the medical instrument 140. In another embodiment, the medical instrument 140 may be manually guided to the first location 52A of the target site by a user of the medical system 100 by visually tracking the position of the distal end 144 relative to the first location 52A via a user interface display (not shown). In this case, the user may visually guide the distal end 144 of the medical instrument 140 towards the visual identifier generated by the light / laser beam 132. As merely an illustrative example, the distal end 144 of the medical instrument 140 may be displayed on the user interface display by a visual identifier, such as, for example, crosshairs superimposed on the user interface display, indicating the location of the distal end 144. Further, feedback generated by the sensor 146 may be utilized to manually steer the medical instrument 140 toward the first location 52A of the target site in addition to and / or in the alternative to the user interface display.

[0044] In some cases, the medical device 110 of the medical system 100 may intentionally and / or accidentally move relative to the target site during the procedure when the medical instrument 140 is moving toward the target site in step 212. Such movement may occur due to difficulties in maintaining the medical device 110 stable during the procedure. In this case, the location of the target site (e.g., ampulla of Vater 22) relative to the tip 122 of the shaft 120 and / or the distal end 144 of the medical instrument 140 may be altered or changed relative to an initial corresponding position between the target site and the medical device 110. Thus, the image data 109 initially acquired by the medical system 100 in step 206 may include inaccuracies and / or deficiencies in providing a current location of the target site (e.g., ampulla of Vater 22). As a result, continuing to move the distal end 144 of the medical instrument 140 toward the first position 52A as initially determined by the processor of the imaging processing device 102 in step 208 may prevent the user of the medical system 100 from properly accessing the target site.

[0045] 5C, in response to detection of movement of the medical device 110 relative to the target site (e.g., ampulla of Vater 22) by the processor 104 of the imaging device 102, the processor 104 may execute the target identification logic 108 to drive the imaging device 130 to obtain updated image data 109 of the target site. In some embodiments, when the processor 104 of the imaging device 102 executes the target identification logic 108, it determines whether the medical device 110 has moved relative to the target site by periodically acquiring images using the imaging device 130 for comparison with the image data 109 stored in the memory 106 in step 206. Thus, movement of the medical device 110 relative to the target site is based on determining that the degree of change in position between the first position 52A and the detected position of the target site is equal to or greater than a preprogrammed threshold value (e.g., millimeters, micrometers, nanometers, etc.).

[0046] In this case, when it is determined that the recorded location of the first location 52A has changed relative to the location of the target site detected through the periodically acquired images, the processor 104 of the image processing system 102 repeats steps 206, 208, 210, and 212 of the above-described method 200. The processor 104 executes the target identification logic 108 to acquire an image (e.g., image data 109) of the target site at step 206, determine a second location 52B of the target site (e.g., ampulla of Vater 22) at step 208, and mark the second location 52B with the light / laser beam 134 at step 210. The method 200 performs these steps substantially similar to those illustrated and described above to facilitate locating the target site using the medical system 100 according to the new second location 52B of the target site.

[0047] In another embodiment, the imaging device 102 of the medical system 100 may be communicatively connected to a remote station (not shown) to dynamically update the target identification logic 108 stored in the memory 106. As an illustrative example, the imaging device 102 is operable to receive neural network data from a remote station (e.g., a computer server) via, for example, a wired and / or wireless connection. The neural network data received by the imaging device 102 may include supplemental image data 109 recorded from multiple previous procedures, devices, systems, etc., similar to the image data 109 shown and described above. Such image data may be from multiple different patients, acquired longitudinally, and of the same or similar patient anatomy. The supplemental image data 109 may be stored in the memory 106 and utilized by the processor 104 of the imaging device 102 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 22 in the small intestine 18, the ampulla duct opening 22 of the common bile duct 20, etc.

[0048] In an embodiment, the processor 104 of the imaging device 102, when executing the machine-readable instructions of the target identification logic 108, may reference the supplemental image data 109 when analyzing the image data 109 acquired by the imaging device 130 of the medical device 110 to determine a first location 52A of a target site (e.g., the ampulla of Vater 22 within the small intestine 18). Thus, the supplemental image data 109 may facilitate determining the coordinate location of a target site relative to the medical device 110 during a procedure by providing the imaging device 102 with additional data for artificial learning of the size, shape, and / or configuration of similar target sites.

[0049] Each of the above devices, assemblies, and methods can be used to detect, mark, and track the location of a target site. By providing a medical assembly, a user can precisely interact with the patient's tissue during the procedure using artificial intelligence software in the imaging device, allowing the user to reduce overall procedure time, increase efficiency of the procedure, and avoid unnecessary harm to the patient's body resulting from a lack of control over the movement and positioning of the medical device when accessing the patient's target tissue.

[0050] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and method without departing from the scope of the present invention. The disclosed apparatus may include various suitable computer systems and / or computing units incorporating multiple hardware components, such as a processor and a non-transitory computer-readable medium, that cause the apparatus to perform one or more operations during operations according to those described herein. Other aspects of the present disclosure will be apparent to those skilled in the art from consideration of the present specification and practice of the features disclosed herein. The present specification and examples are intended to be considered as illustrative only.

Claims

1. an imaging device for acquiring an image of a target area, the location of the target area being determined based on the image; and a light source configured to direct light to the location at the target site; A medical device comprising:

1. A medical system comprising: a processor; and a non-transitory computer readable medium storing instructions that, when executed by the processor, cause the processor to: move a medical instrument sensor toward the location of the target site based on detection of the light at the target site by a sensor, detect a change in position of the imaging device relative to the target site, determine the position of the target site relative to the imaging device, and redirect the light to the location of the target site.

2. The medical system of claim 1 , wherein the sensor is movable relative to the imaging device toward the location of the target site based on detection of the light at the target site by the sensor.

3. the processor is configured to detect a change in position of the imaging device relative to the target area based on images periodically acquired by the imaging device; The medical system of claim 1 or 2, wherein the processor is configured to compare the position of the target site to an original position of the target site to determine a degree of change in position.

4. The medical system of claim 3 , wherein the processor is configured to determine whether the position gradient exceeds a preprogrammed threshold.

5. The medical system of any one of claims 1 to 4, wherein the light source includes a source that generates a laser beam and the imaging device includes a camera.

6. The medical system of any one of claims 1 to 5, further comprising a medical instrument, wherein the sensor includes at least one of a photodetector, a photodiode, and a charge-coupled device (CCD).

7. The medical system of any one of claims 1 to 6, wherein the sensor is configured to generate a photodiode signal in response to detection of the light at the target site.

8. a strength of the photodiode signal generated by the sensor includes a greater strength when the sensor is located a first distance from the light and a lesser strength when the sensor is located a second distance from the light; The medical system of claim 7 , wherein the first distance is less than the second distance.

9. The medical system of any one of claims 1 to 8, wherein the medical device includes a mirror configured to reflect the light generated by the light source towards the location of the target site.

10. 10. The medical system of claim 9, wherein the mirror is configured to move to redirect the light toward the location of the target site in response to the processor detecting a change in position of the imaging device relative to the target site.

11. The medical system of claim 9 or 10, wherein the mirror comprises a micromirror (MEMs mirror) configured to reflect the light along two axes.

12. The medical system of any one of claims 9 to 11, wherein the mirror is positioned adjacent to the light source of the medical device.

13. The medical system of any one of claims 1 to 12, wherein the processor is configured to generate a visual identifier along with an image acquired by the imaging device that indicates the location of the target site.

Images