Medical devices with integrated implements and related methods

Abstract

The medical device includes a tube including a lumen extending from the proximal end to the distal end of the tube, a cap at the distal end of the tube having a distal opening corresponding to the lumen, and an imaging system disposed on a distal-facing surface of the cap. The medical device also includes an instrument disposed at least partially within the lumen and non-removable from the medical device, an instrument actuation mechanism for controlling the instrument, and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism. The instrument actuation mechanism, to which the proximal end of the instrument is attached, can be configured to be moved between first and second positions on the single handle to control extension and retraction of the instrument relative to the tube.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices. More particularly, aspects of the disclosure relate to medical devices having integrated implements and methods of using such medical devices. [Background technology]

[0002] Traditionally, percutaneous tracheostomy for endotracheal tube placement and percutaneous endoscopic gastrostomy (PEG) for feeding tube placement are separate procedures. These separate procedures are visually guided by different types of endoscopic medical devices and are performed by different medical specialists at different service sites. For example, percutaneous tracheostomy can be performed by a surgeon, critical care pulmonologist, and / or interventional pulmonologist at the bedside or in a bronchoscopy suite using a bronchoscope. On the other hand, PEG can be performed by a surgeon or gastroenterologist in an operating room or gastrointestinal suite using a gastroscope.

[0003] More recently, specialists may be trained to perform both percutaneous tracheotomy and PEG sequentially at the bedside on patients in intensive care units or other similar settings using the same endoscopic medical device, such as a bronchoscope. These bedside environments have limited space, particularly near the patient's head where the specialist operating the bronchoscope is located. Furthermore, one or more steps of the PEG procedure may rely on an assistant (e.g., a second operator) to facilitate, for example, the insertion and / or operation of a separate accessory device (e.g., a snare) into the bronchoscope. However, due to the limited space in the bedside environment, the insertion and / or use of a separate accessory device (e.g., a snare) can be cumbersome, for example, prolonging the procedure and increasing risks during the procedure. Summary of the Invention

[0004] In one embodiment, a medical device can include a tube having a proximal end and a distal end and including a lumen extending from the proximal end to the distal end; a cap at the distal end of the tube having a distal opening corresponding to the lumen; and an imaging system disposed on a distal-facing surface of the cap. The medical device can also include an instrument disposed at least partially within the lumen and non-removable from the medical device, an instrument actuation mechanism for controlling the instrument, and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism. The proximal end of the instrument can be attached to the instrument actuation mechanism, and the instrument actuation mechanism can be configured to be moved between first and second positions on the single handle to control extension and retraction of the instrument relative to the tube. The distal end of the instrument can be retracted in a retracted state relative to the tube when the instrument actuation mechanism is in the first position. The distal end of the instrument can be extended in an expanded state relative to the tube when the instrument actuation mechanism is in the second position.

[0005] In any of the example medical devices disclosed herein, the distal end of the tube may include an articulation joint, and when the instrument actuation mechanism is in a first position, the distal end of the instrument may be disposed within the articulation joint. The single handle may further house an articulation actuation mechanism for controlling the articulation joint, and the articulation joint may be configured to bend in at least two directions away from the longitudinal axis of the tube.

[0006] Additionally, an instrument may be extended relative to the tube through the distal opening, which may include a clamshell shape to fix the orientation of the instrument relative to the medical device when the instrument is extended. The medical device may further include a connector disposed within the single handle. The connector may include multiple connector ports and a distal opening connecting the single handle and the proximal end of the tube. At least one of the multiple connector ports may include an instrument connector port configured to receive an instrument from an instrument actuation mechanism, and an instrument received via the instrument connector port may extend into the lumen of the tube through the distal opening.

[0007] In some embodiments, the instrument actuation mechanism can include an instrument actuator configured to be moved between a first position and a second position, a link, and a driver to which the proximal end of the instrument is attached and connected to the instrument actuator via the link.

[0008] In another aspect, the medical device can include a sheath at least partially disposed within the lumen. An instrument can be disposed within the sheath. The instrument actuation mechanism can include a sheath actuator that extends and retracts the sheath relative to the tube in which the instrument is disposed, and an instrument actuator that extends and retracts the instrument relative to the sheath to transition the instrument between the retracted and expanded states.

[0009] In an additional aspect, the instrument may be a wire. A first end of the wire may be attached to a fixed point on the distal-facing surface of the cap, and the wire may extend from the fixed point through a second distal opening of the cap, different from the distal opening corresponding to the lumen, through a tube, and into the handle. A second end of the wire opposite the first end of the wire may be attached to the instrument actuation mechanism. When the instrument actuation mechanism is in a first position, a first portion of the wire from the fixed point to the second distal opening may form a loop in a contracted state that at least partially contacts the distal-facing surface. When the instrument actuation mechanism is in a second position, a second portion of the wire may be extended from the tube through the second opening to transition the loop to an expanded state. The distal-facing surface of the cap may include a recess disposed between the fixed point and the second distal opening, and the recess may be configured to receive and secure an object captured by the instrument.

[0010] In a further aspect, the instrument may be a wire. A first end of the wire may extend through a second distal opening in the cap, different from the distal opening corresponding to the lumen, via a tube into the handle, and be attached to the instrument actuating mechanism. A second end of the wire may extend through a third distal opening in the cap, different from the distal opening corresponding to the lumen and the second distal opening, via a tube into the handle, and be attached to the instrument actuating mechanism. When the instrument actuating mechanism is in a first position, a first portion of the wire from the second distal opening to the third distal opening may form a loop in a contracted state that at least partially contacts the distal-facing surface. When the instrument actuating mechanism is in a second position, a second portion of the wire may be extended from the tube through the second opening, and a third portion of the wire may be extended from the tube through the third opening, transitioning the loop to an expanded state.

[0011] Additionally, the single handle may further include a fluidic device having a proximal end connectable to one or more of a fluid supply and a vacuum source and a distal end connected to the proximal end of the tube. The fluidic device may be configured to supply fluid to and / or aspirate fluid from the patient's body through the distal opening. The imaging system may include an imaging device disposed within an imaging port on the distal-facing surface of the cap and an illumination device disposed within an illumination port on the distal-facing surface of the cap.

[0012] In another example, a medical device may include a tube having a proximal end and a distal end, the tube including a lumen extending from the proximal end to the distal end, a cap at the distal end of the tube having a distal opening corresponding to the lumen, a sheath at least partially disposed within the lumen, and an instrument disposed within the sheath, wherein the sheath and the instrument are non-removable from the medical device. The medical device may also include an instrument actuation mechanism including a sheath actuator and an instrument actuator, and a single handle connected to the proximal end of the tube and housing the instrument actuation mechanism. The proximal end of the sheath may be attached to the sheath actuator, which may be configured to move between first and second positions on the single handle to control extension and retraction of the sheath, with the instrument disposed relative to the tube through the distal opening. The proximal end of the instrument may be attached to the instrument actuator, which may be configured to move between third and fourth positions on the single handle to control extension and retraction of the distal end of the instrument relative to the sheath to transition the distal end of the instrument between a retracted state and an expanded state.

[0013] Any of the exemplary medical devices disclosed herein can include any of the following features: The distal end of the tube can include an articulation joint, and the distal end of the sheath in which the distal end of the instrument is disposed can be disposed within the articulation joint when the sheath actuator is in the first position. The instrument can be a snare, and the medical device can be configured to be used for PEG.

[0014] In a further embodiment, a medical device can include a tube having a proximal end and a distal end, the tube including a lumen extending from the proximal end to the distal end; a cap at the distal end of the tube, the cap having a distal opening corresponding to the lumen; a handle connected to the proximal end of the tube and housing an actuation mechanism configured to be moved between a first position and a second position on the handle; and a wire having a first end and a second end, the wire at least partially disposed within the lumen. The first end of the wire can be attached to a fixed point on a distal-facing surface of the cap and can extend from the fixed point through a second distal opening of the cap different from the distal opening corresponding to the lumen, through the tube, and into the handle. A second end of the wire opposite the first end of the wire can be attached to the actuation mechanism. When the actuation mechanism is in the first position, a first portion of the wire from the fixed point to the second distal opening can form a retracted loop that at least partially contacts the distal-facing surface. When the actuation mechanism is in a second position, a second portion of the wire may be extended from the tube through the second opening to transition the loop to the expanded state.

[0015] Any of the example medical devices disclosed herein can include any of the following features: The distal-facing surface of the cap can include a recess disposed between the fixation point and the second distal opening, the recess configured to receive at least a portion of an object captured by the wire.

[0016] It will be understood that both the foregoing general description and the following Detailed Description are exemplary and explanatory only and are not limiting of the invention, as claimed. 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 device that includes a list of elements does not comprise 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," not "ideal." The term "distal" refers to a direction away from the operator / toward the treatment site, and the term "proximal" refers to a direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values of ±10% of the stated value. [Brief explanation of the drawings]

[0017] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the disclosure. [Figure 1A] 1A-1C illustrate various views of an exemplary medical device for performing a medical procedure. [Figure 1B] 1A-1C illustrate various views of an exemplary medical device for performing a medical procedure. [Figure 1C] 1A-1C illustrate various views of an exemplary medical device for performing a medical procedure. [Figure 1D] 1A-1C illustrate various views of an exemplary medical device for performing a medical procedure. [Figure 2A] FIG. 1 shows a block diagram of another exemplary medical device for performing a medical procedure. [Figure 2B] FIG. 1 shows a block diagram of another exemplary medical device for performing a medical procedure. [Figure 2C] FIG. 1 shows a block diagram of another exemplary medical device for performing a medical procedure. [Figure 2D]FIG. 1 shows a block diagram of another exemplary medical device for performing a medical procedure. [Figure 3A] 10A-10C show perspective views of a distal portion of a further exemplary medical device for performing a medical procedure in various configurations. [Figure 3B] 10A-10C show perspective views of a distal portion of a further exemplary medical device for performing a medical procedure in various configurations. [Figure 3C] 10A-10C show perspective views of a distal portion of a further exemplary medical device for performing a medical procedure in various configurations. [Figure 4] 1A-1D illustrate an exemplary process for performing a medical procedure using the exemplary medical device of FIGS. 1A-1D. DETAILED DESCRIPTION OF THE INVENTION

[0018] As briefly mentioned above, specialists may now be trained to perform both percutaneous tracheostomy and PEG sequentially at the bedside on patients in intensive care units or other similar bedside settings using the same or a single endoscopic medical device. For example, after an endotracheal tube is placed to complete the percutaneous tracheostomy, the medical device may be advanced into the stomach and manipulated by the specialist (e.g., a first operator) to obtain the insufflation and visualization necessary to determine the access site. Once the access site is determined, a needle surrounded by an outer cannula may be inserted into the stomach, and the needle may be removed, leaving the cannula in place. A PEG wire may be inserted into the stomach through the cannula.

[0019] Meanwhile, an assistant (e.g., a second operator) positioned near the first operator of the medical device may feed a distal portion of a separate accessory device, such as a snare, through the access port and through a distal opening at the distal end of the medical device into the working lumen of the medical device. The snare may be delivered in a collapsed state and then actuated by the second operator via the handle portion of the accessory device to expand the snare. In the expanded state, the snare may be used to capture the PEG wire as it is inserted into the stomach via the cannula. The second operator may also, in some cases, utilize a control on the handle portion of the accessory device to rotate the snare while in the expanded state to better position it relative to the PEG wire to be captured. However, having a second operator present to assist with the insertion and manipulation of a separate accessory device may be cumbersome in the limited space of an intensive care unit or other similar bedside environment, for example, prolonging the procedure and increasing risks during the procedure.

[0020] Accordingly, aspects of the present disclosure are directed to a medical device having a non-removable integrated instrument that allows a single operator to control the medical device and the integrated instrument, eliminating the need for a second operator to assist with instrument insertion and manipulation during a medical procedure, such as a PEG procedure. The medical device may include a single handle and a tube extending distally from the handle. The single handle may be sized to be held by the operator and configured to house various components of the medical device within and / or on the handle, including an instrument actuation mechanism for controlling the integrated instrument. At least a distal portion of the tube may be inserted into a patient during a medical procedure, and the tube may include at least one lumen within which the integrated instrument may be at least partially disposed. Furthermore, the integrated instrument may be transitioned between a retracted state and an expanded state, for example, via an instrument actuation mechanism on and / or integrated into the handle.

[0021] The instrument can be integrated into the medical device in a variety of ways. In one embodiment, the lumen of the tube may function as a sheath for the instrument, as described below with reference to Figures 1A-1C. In this embodiment, the distal end of the instrument can be extended and retracted relative to the tube to transition between a collapsed state and an expanded state when the instrument actuation mechanism is actuated by a single operator of the medical device.

[0022] In another embodiment, as described below with reference to Figures 2A-2D, the instrument may be disposed within a sheath separate from the lumen. The sheath with the instrument disposed therein may be extended and retracted relative to the tube when a first actuator of the instrument actuation mechanism is actuated by a single operator of the medical device. The instrument may then be extended and retracted relative to the sheath to transition between the retracted and expanded states when a second actuator of the instrument actuation mechanism is actuated by a single operator of the medical device.

[0023] In a further embodiment, as described below with reference to Figures 3A-3C, the instrument may be a wire. In this further embodiment, a first end of the wire is attached at an anchoring point to a distal-facing surface of a cap at the distal end of the tube, and a second end of the wire extends proximally into the cap (e.g., through a distal opening in the cap), through a lumen of the tube, and to an instrument actuation mechanism in the handle. In the retracted state, at least a portion of the wire from the anchoring point to its entry point into the cap may contact the distal-facing surface of the cap. When the instrument actuation mechanism is actuated by a single operator of the medical device, the wire may be extended and retracted through the distal opening in the cap to transition between the retracted and expanded states. Alternatively, rather than the first end of the wire being attached to a fixed point, the cap may include another distal opening, and like the second end of the wire, the first end of the wire may extend through the lumen of the tube into the cap (e.g., via the other distal opening of the cap) so as to be attached to the same or a different instrument actuation mechanism in the handle to provide bilateral actuation.

[0024] 1A-1D illustrate an exemplary medical device 100 for performing a medical procedure. One exemplary medical procedure may include percutaneous tracheotomy followed by PEG, and both procedures may be performed using the medical device 100. FIG. 1A illustrates the medical device 100 in a first configuration in which the integrated instruments (not shown in FIG. 1A ) of the medical device 100 are retracted and in a collapsed state. The medical device 100 may be an endoscope or other type of scope, such as a bronchoscope, ureteroscope, duodenoscope, gastroscope, endoscopic ultrasonography ("EUS") scope, colonoscope, laparoscope, arthroscope, cystoscope, suction scope, sheath, or catheter. The medical device 100 may include a handle 102 and a tube 104 (i.e., shaft) extending distally from the handle 102. The integrated instrument may be a device or tool such as a snare, net, basket, forceps, grasper, scissors, clip, stapler, needle, knife, electrode, cauterization loop, or other similar type of instrument for acting on a target object during a medical procedure, among other examples. The instrument may be specific to the medical procedure being performed. For example, in the case of PEG, the instrument may be a snare used to capture the PEG wire, as described in more detail below. The instrument may be integrated with the medical device 100 such that the instrument is non-removable from the medical device 100 and can be controlled via the handle 102 by a single operator of the medical device 100 to extend and retract the integrated instrument, thereby transitioning it between a retracted state and an expanded state.

[0025] The handle 102 may include a housing 103 sized and / or shaped to be held by one hand of an operator of the medical device 100, and various components of the medical device 100, as described in detail below, may be disposed within and / or on the housing 103. A proximal end 106 of a tube 104 may be attached to and extend distally from the handle 102, and at least a distal portion of the tube 104 may be inserted into a patient's body during a medical procedure.

[0026] In some embodiments, the cap 110 may be removably attached to the distal end 108 of the tube 104. In other embodiments, the cap 110 may be integral with the distal end 108 of the tube 104. While the term "cap" is used herein, it will be understood that the present disclosure encompasses embodiments of the medical device 100 including any type of distal tip, including a distal tip integrally formed with the tube 104 or otherwise formed without a cap. The tube 104 may include at least one lumen (not shown) for delivering one or more devices and / or wires, including integrated instruments, from the proximal end 106 to the distal end 108 of the tube 104. In some embodiments, the at least one lumen may be a working lumen. In other embodiments, the tube 104 may include two or more lumens (e.g., a working lumen plus at least one other lumen).

[0027] The distal-facing surface 112 of the cap 110 can include a distal opening 114 corresponding to at least one lumen of the tube 104 to allow one or more devices, including at least an integrated instrument, to extend distally from the tube 104 to an intended site within a patient's body through the distal opening 114. In some embodiments, as shown in FIG. 1A , the distal opening 114 can be sized and / or shaped (e.g., as a clamshell) to increase the surface area of the distal opening 114 for improved fluid performance of the medical device 100. The clamshell design can also enable the cap 110 to lock the orientation of the integrated instrument relative to the medical device 100 for more precise and predictable rotation when the integrated instrument is in an extended state, stretched relative to the tube 104, as described in more detail below. In other embodiments, the distal opening 114 can have a substantially circular configuration (e.g., a circular configuration, an oval configuration, or other similar configuration), as shown in FIGS. 3A-3C .

[0028] The medical device 100 may also include an imaging system at the distal end 108 of the tube 104. The imaging system may include an imaging device 120 and one or more illumination devices 122A, 122B (collectively, illumination device(s) 122). Accordingly, the distal-facing surface 112 of the cap 110 may include an imaging port 116 for receiving the imaging device 120 and one or more illumination ports 118A, 118B (collectively, illumination ports 118) for receiving the illumination device(s) 122. In some embodiments, the imaging system may be communicatively connected to and controlled by a control unit (not shown) when the medical device 100 is connected to the control unit via an external cable 124 (e.g., an umbilicus). As described in more detail below with reference to FIG. 1C , wires attached to the imaging device 120 and illumination device(s) 122 may extend through the tube 104 and into the handle 102 and be coupled to or enclosed / contained within the external cable 124.

[0029] The imaging device 120 may include a camera, an imaging sensor (e.g., a complementary metal-oxide semiconductor or CMOS sensor, etc.), an optical sensor, or another image receiving device (e.g., a fiber optic imaging device, etc.). As described in more detail below with reference to FIG. 1C , the imaging device 120 may acquire image signals and transmit the image signals from the medical device 100 to a control unit for processing. The control unit may provide the processed image signals for display as still and / or transient images via a display device of or associated with the control unit to provide visual guidance to an operator of the medical device 100 during a medical procedure. The imaging device 120 may acquire image signals in response to control signals received from the control unit. Additionally, the medical device 100 may include an image acquisition control element 126 disposed on the handle 102 (e.g., on a proximal portion of the handle 102), and the imaging device 120 may acquire image signals in response to actuation of the image acquisition control element 126. In some cases, actuation of the image acquisition control element 126 may cause the acquired image signals to be saved and / or recorded.

[0030] The illumination device(s) 122 may include any device configured to illuminate a target area within a patient's body (e.g., illuminate a site for a medical procedure) to facilitate imaging, among other aspects of the procedure (e.g., palpation for PEG). The illumination device(s) 122 may include, among other devices, a light bulb, light emitting diodes (LEDs), one or more fiber optic cables, and a light guide. While two illumination device(s) 122 are shown, in other embodiments, the medical device 100 may have only one illumination device or may have three or more illumination devices. As described in more detail below with reference to FIG. 1C , the illumination device(s) 122 may be controlled and / or operated based on control signals received from a control unit when the medical device 100 is connected to the control unit via an external cable 124. In some embodiments, the illumination device(s) 122 may direct light from an external light source. For example, the external light source may include one or more LED, xenon, or other light sources in a lighting control system (not shown) coupled to the control unit.

[0031] The distal end 108 of the tube 104 may also include an articulation joint 109 that allows the distal end 108 and cap 110 to bend in at least two directions away from the longitudinal axis A of the tube 104. In some embodiments, the articulation joint 109 may extend into the cap 110. An operator of the medical device 100 may bend the articulation joint 109 in one of at least two directions by actuating an articulation actuator 136 (e.g., on a proximal portion of the handle 102) in a given direction. The articulation actuator 136 may be a component of an articulation actuation mechanism of the medical device 100, which is described in more detail below with reference to FIG. 1C . In some embodiments, as shown in FIG. 1A , when the medical device 100 is in a first configuration in which the integrated instrument is retracted relative to the tube 104, the distal end of the integrated instrument may be disposed within a lumen (e.g., within the articulation joint 109) in the distal end 108 of the tube 104. This placement of the distal end of the integrated instrument within the articulation joint 109 may increase stiffness, which may improve the pushability of the articulation joint 109 as it is advanced through a patient's body. In this embodiment, placing the integrated instrument within the articulation joint 109 may reduce the flexibility of the articulation joint 109, but the articulation joint 109 remains flexible enough not to significantly affect articulation, especially for procedures such as PEG where a full 180 degrees of articulation is not required.

[0032] In addition to controlling the articulation of the medical device 100, the operator may also control the extension and retraction of the integrated instrument. For example, the medical device 100 may include an instrument actuator 148, which may be located on the handle 102. An operator of the medical device 100 can shift the medical device 100 from a first configuration shown in FIG. 1A to a second configuration shown in FIG. 1B by moving the instrument actuator 148 from a first position 150 (FIG. 1A) to a second position 152 (FIG. 1B). In some embodiments, the instrument actuator 148 may be a component of an instrument actuation mechanism of the medical device 100, which is described in more detail below with reference to FIG. 1C. In the second configuration of the medical device 100, shown in FIG. 1B, the distal end 132 of the integrated instrument 128 may be extended relative to the tube 104, for example, from the distal opening 114 (FIG. 1A). Extending the distal end 132 of the integrated instrument 128 through the distal opening 114 transitions the distal end 132 from the retracted state to the expanded state. In the expanded state, the integrated instrument 128 can act on (e.g., capture) one or more objects. In some embodiments, the instrument actuation mechanism can include a spring or biasing mechanism that allows the integrated instrument 128 to return from the second position 152 to the first position 150. Additionally or alternatively, the instrument actuation mechanism can include a locking feature that allows the instrument actuator 148 to be fixed in the second position 152, preventing the integrated instrument 128 from being unintentionally retracted relative to the tube 104 and at least partially transitioning back to the retracted state.

[0033] Thus, the single handle 102 of the medical device 100 can include both an articulation actuation mechanism (e.g., articulation actuator 136) for controlling flexion of the articulation joint 109 and an instrument actuation mechanism (e.g., instrument actuator 148) for controlling extension and retraction of the integrated instrument 128, to enable a single operator of the medical device 100 to control both the articulation joint 109 and the integrated instrument 128. As shown most clearly in FIG. 1C , in addition to the articulation actuator 136 and the instrument actuator 148, each of the respective articulation actuation mechanisms 134 and instrument actuation mechanisms 146 includes components disposed within and / or on the housing 103 of the handle 102.

[0034] As shown in Figure 1C, the housing 103 may include at least a first housing portion 103A and a second housing portion 103B. The first housing portion 103A and the second housing portion 103B may be attachable to one another to form the housing 103. Figure 1C shows a view of the interior of the handle 102 of the medical device 100 when the first housing portion 103A has been removed and the medical device 100 is in a second configuration, as described with respect to Figure 1B.

[0035] In addition to the articulation actuation mechanism 134 and instrument actuation mechanism 146 described above, a fluidic device 160 and a connector 166 may also be disposed within and / or on the housing 103 of the handle 102. The connector 166 may be coupled to the proximal end 106 of the tube 104 via a distal opening 168 of the connector 166. The connector 166 may be configured to connect components of the handle 102 to the tube 104. For example, the connector 166 may include multiple connector ports for delivering instruments, tools, or wires, including the integrated instrument 128, from the handle 102 to the tube 104 and / or for supplying fluids (e.g., gases) through the tube 104, for example, for insufflation and / or suction. Exemplary connector ports are described in turn below to explain how each component from the handle 102 is connected to the tube 104 via the connector 166.

[0036] As described above, the articulation actuation mechanism 134 may include an articulation actuator 136. At least a portion of the articulation actuator 136 may be disposed external to the handle 102 to allow an operator to interact with the articulation actuator 136. For example, the articulation actuator 136 may be gradually movable by the operator in a first direction (e.g., pushed upward in a proximal direction) to gradually bend the distal end 108 of the tube 104, including the cap 110, in the first direction away from the longitudinal axis A. The articulation actuator 136 may be gradually movable by the operator in a second direction opposite the first direction (e.g., pushed downward in a distal direction) to gradually bend the distal end 108 of the tube 104, including the cap 110, in a second direction away from the longitudinal axis A that is opposite the first direction away from the longitudinal axis A. The remaining components of articulation actuation mechanism 134 may be disposed internal to handle 102, with at least a portion of one or more of these components extending to the distal end 108 of tube 104. For example, an internal portion of articulation actuator 136 may be connected to articulation wheel 140. Articulation wire 142 may be disposed around the circumference of articulation wheel 140. A first end of articulation wire 142 may extend through first articulation connector port 170A of connector 166, through a distal opening 168 of connector 166, into the proximal end 106 of tube 104, and be attached to a first side of articulation joint 109 at the distal end 108 of tube 104. A second end of articulation wire 142 may extend through second articulation connector port 170B of the connector, through distal opening 168 of connector 166, into proximal end 106 of tube 104, and be attached to a second side of articulation joint 109 opposite the first side to which the first end of articulation wire 142 is attached at distal end 108 of tube 104.In some embodiments, one or more sets of guide elements 144 located distally from articulation wheel 140 and proximal from connector 166 may be included within handle 102 to receive articulation wire 142 for guiding and / or retaining articulation wire 142 (e.g., to prevent entanglement and / or interference with other internal components of handle 102). In further embodiments, first articulation connector port 170A and / or first articulation port 170B may include a seal to facilitate movement of articulation wire 142 when an operator actuates articulation actuator 136.

[0037] When articulation actuator 136 is gradually moved or pushed upward in a first direction by an operator, articulation wheel 140 may rotate in the same first direction that articulation actuator 136 is moved, causing a first end of articulation wire 142 to be pulled proximally. Pulling the first end of articulation wire 142 proximally may cause a first side of articulation joint 109 to be pulled proximally and cause the distal end 108 of tube 104, including cap 110, to bend in the first direction, away from longitudinal axis A. Conversely, when articulation actuator 136 is gradually moved or pushed downward in a second direction by an operator, articulation wheel 140 may rotate in the same second direction that articulation actuator 136 is moved, causing a second end of articulation wire 142 to be pulled proximally. Pulling the second end of the articulation wire 142 proximally causes a second side of the articulation joint 109 to be pulled proximally, causing the distal end 108 of the tube 104, including the cap 110, to bend in a second direction away from the longitudinal axis A. Although the articulation actuator 136 has been described and shown as a lever mechanism that can move or push upward or downward, additional or alternative mechanisms may be used, such as, for example, a sliding mechanism, a rotating mechanism, a pushing mechanism, etc.

[0038] As mentioned above, the tool actuation mechanism 146 may include a tool actuator 148. At least a portion of the tool actuator 148 may be disposed within a track 149 on the exterior of the housing 103 of the handle 102 to allow an operator to interact with and move the tool actuator 148 along the track 149 between a first position 150 and a second position 152, as shown in FIGS. 1A and 1B , respectively. In some embodiments, the track 149 on the exterior of the housing 103 may follow the contour of the handle 102 in the region where the first and second housing portions 103A, 103B connect, as shown. In other embodiments, the handle 102 (e.g., the first or second housing portion 103A, 103B) may include a custom slot in which the tool actuator 148 may be disposed.

[0039] The instrument actuation mechanism 146 may also include a driver 154 within the housing 103, as shown in FIGS. 1C and 1D . The driver 154 may be connected to an internal portion of the instrument actuator 148 via a link 156. The link 156 may be a rigid link having a first pivot attached to the driver 154 and a second pivot attached to an internal portion of the instrument actuator 148. In some embodiments, as shown in FIG. 1D , the driver 154 may be configured to be positioned within and move along an internal track 158 (e.g., defined within an interior surface of the housing 103) when the instrument actuator 148 is moved between the first position 150 and the second position 152. The proximal end 130 of the integrated instrument 128 may be attached to the driver 154. The integrated instrument 128 can extend from the driver 154 through an instrument connector port 172 of the connector 166 into the connector 166 and through a distal opening 168 of the connector 166 into the proximal end 106 of the tube 104. The integrated instrument 128 can then extend within at least one lumen of the tube 104 from the proximal end 106 to the distal end 108 of the tube 104. Based on the position of the instrument actuator 148, the integrated instrument 128 can be extended or retracted relative to the tube 104. In some embodiments, the instrument connector port 172 of the connector 166 can include a seal to facilitate extension and retraction of the integrated instrument 128 when the instrument actuator 148 is moved by the operator.

[0040] When the medical device 100 is in a first configuration with the instrument actuator 148 in a first position 150 (shown in FIG. 1A ), the distal end 132 of the integrated instrument 128 may be retracted relative to the tube 104. For example, the driver 154 and the proximal end 130 of the integrated instrument 128 may be in a proximal-most position within the handle 102, and the distal end 132 of the integrated instrument 128 may be in a retracted state and disposed within the articulation joint 109 at the distal end 108 of the tube 104. When the instrument actuator 148 is moved between the first position 150 and the second position 152 by an operator, the driver 154 and the integrated instrument 128 move distally accordingly, extending the distal end 132 of the integrated instrument 128 distally from the tube 104 through the distal opening 114 of the cap 110 and transitioning it to an expanded state, as shown in the second configuration of the medical device 100 in FIG. 1B . The expanded state of the integrated tool 128 can allow it to act on (eg, capture) an object of interest during a medical procedure.

[0041] As previously mentioned, in some embodiments, distal opening 114 may be sized and / or shaped to secure the orientation of integrated instrument 128 in the expanded state relative to medical device 100 to facilitate rotation of integrated instrument 128. For example, if integrated instrument 128 is a snare, widest portion 115 of distal opening 114 may receive and secure the wire of the snare (e.g., based at least in part on the radial strain of the snare wire), allowing rotation of medical device 100 to correspond to rotation of the snare. As a result, if an operator desires to rotate the snare to achieve a better position for capturing an object of interest, such as a PEG wire, during PEG, the operator may simply rotate medical device 100 with their hand in the desired direction (e.g., rather than having to actuate a separate rotation control mechanism), and the snare will rotate accordingly.

[0042] Once the target object is positioned relative to the integrated instrument 128 to permit capture of the target object (e.g., the object is within or at least partially surrounded by the distal end 132 of the integrated instrument 128 in the expanded state), the instrument actuator 148 can then be moved from the second position 152 toward the first position 150 to at least partially transition the integrated instrument 128 back to the retracted state and at least partially retract the integrated instrument 128 relative to the tube 104. In some cases, the integrated instrument 128 may not be able to return to the fully retracted state and / or fully retract back into the tube 104 via the distal opening 114 based on the size and / or shape of the target object. In such cases, the instrument actuator 148 can be moved from the first position 150 toward the second position 152 to the point where the target object contacts the distal-facing surface 112 of the cap 110. The entire medical device 100 can then be removed from the patient. In some cases, the medical device 100 may be a single-use or disposable device and therefore may be disposed of once removed. Although the instrument actuator 148 is described herein as a sliding mechanism that is movable between a first position 150 and a second position 152, additional or alternative mechanisms may be used, such as, for example, a rotating mechanism, a pushing mechanism, a lever mechanism, etc.

[0043] Throughout the medical procedure, an imaging system at the distal end 108 of the tube 104, including the imaging device 120 and the illumination device(s) 122, can be utilized to provide operator visualization of the procedure, among other aspects. As mentioned above, the imaging device 120 and the illumination device(s) 122 may send and / or receive signals from a control unit (not shown) when the medical device 100 is connected to the control unit via an external cable 124. The signals may be sent and / or received by the imaging device 120 via a first wire 121 or cable (fiber optic or another type of cable) that communicatively couples the imaging device 120 to the control unit. The signals can be sent and / or received by the illumination device(s) 122 via a second wire(s) 123 or cable (fiber optic or another type of cable) that communicatively couples the imaging and illumination device(s) 122 to the control unit. A first wire 121 attached to the imaging device 120 and a second wire(s) 123 attached to the illumination device(s) 122 may extend proximally through the tube 104 and into the handle 102 via a distal opening 168 of the connector 166. The first wire 121 and the second wire(s) 123 can then exit the handle 102 via an imaging system connector port 174 of the connector 166, which feeds the first wire 121 and the second wire(s) 123 to an external cable 124 via an imaging system access port 125 of the housing 103 ( FIGS. 1A , 1B, and 1C ). In some embodiments, the imaging system connector port 174 may include a seal to facilitate feeding (e.g., by retaining) the first wire 123 and the second wire(s) 123 into the external cable 124.

[0044] During a medical procedure, fluidic device 160 may also be utilized to apply insufflation and / or suction, among other examples. Proximal end 162 of fluidic device 160 may include an umbilicus (not shown) disposed outside housing 103 that is connectable to a fluid supply source (not shown), and distal end 164 of fluidic device 160 may be connected to a fluid connector port 176 of connector 166. As a result, fluid provided from the fluid supply may be directed through fluidic device 160, via fluid connector port 176, into connector 166, and via distal opening 168 of connector 166 into tube 104, where the fluid may further travel through tube 104 and deliver the fluid to the patient's body via distal opening 114. Additionally and / or alternatively, the proximal end of fluidic device 160 may be connectable to a vacuum source (not shown), e.g., via the umbilicus, to apply suction, allowing fluid from the patient's body to be drawn into tube 104 via distal opening 114. As previously mentioned, the distal opening 114 may be sized and / or shaped (e.g., as a clamshell) to increase the surface area of the distal opening 114 for improved fluid performance of the medical device 100. For example, the increased surface area of a clamshell size and shape over a substantially circular design may allow for the delivery of fluid and / or the application of suction at a greater rate and / or pressure.

[0045] In some embodiments, medical device 100 can be configured to accept accessory devices, tools, and / or instruments that are separate from medical device 100 (e.g., not integrated within and / or controlled by medical device 100). In such examples, the exterior of housing 103 can include a working lumen access 180 connected to a working lumen connector port 178 of connector 166 inside housing 103. Working lumen connector port 178 can accept accessory devices, tools, and / or instruments that are inserted into medical device 100 via working lumen access 180 for delivery into the working lumen of tube 104 via distal opening 168 of connector 166. In some examples, the working lumen can be the same lumen in which integrated instruments 128 are positioned, fluids are supplied, and / or suction is applied. In other examples, tube 104 may include two or more working lumens, and working lumen access 180 may provide access to a first working lumen, with integrated instrument 128 residing in the second working lumen. Fluid and / or suction may be delivered and / or applied through one or both of the first and second working lumens. Accessory devices, tools, and / or instruments may be extended distally through the working lumens of tube 104 through distal opening 114 to an intended site within the patient's body. The accessory devices, tools, and / or instruments may then be manipulated using the controls of the respective accessory devices, tools, and / or instruments and removed from medical device 100 once the associated task or step of the medical procedure is complete. In some embodiments, if integrated instrument 128 is the only instrument required or intended for a medical procedure, medical device 100 may not include working lumen access 180, and connector 166 may not include working lumen connector port 178, as such access is not required.

[0046] 4, an exemplary process 400 for performing a medical procedure using the medical device 100 of FIGS. 1A-1D can include steps 402-410. The medical procedure performed using the medical device 100 can include an exemplary PEG procedure followed by a percutaneous tracheotomy. In step 402, the process 400 includes inserting at least a distal portion of the tube 104 of the medical device 100 into a patient's body. To perform the PEG procedure followed by a percutaneous tracheotomy, the distal portion of the tube 104 (including the distal end 108) can be advanced into the patient's stomach by an operator of the medical device 100. The operator can be located near the patient's head. In some embodiments, an insufflation technique can be performed, in which a fluid source can be connected to the proximal end 162 (e.g., an umbilicus) of the fluidic device 160 to force gas through the fluidic device 160, into the tube 104 via the connector 166, and into the patient's stomach via the distal opening 114. Insufflation can bring the stomach wall into apposition (approximation) with the abdominal wall. The medical device 100 can be connected to a control unit via an external cable 124, and the tube 104 can be positioned within the stomach so that the illumination device(s) 122 of the imaging system can emit light towards the abdominal wall, allowing transillumination of light through the abdominal wall that is perceptible outside the body.

[0047] An operator for placing the PEG tube, also referred to as a PEG operator (e.g., typically a different operator from the operator of medical device 100), positioned near the patient's abdomen may palpate the abdominal wall. This palpation may be captured by imaging device 120 of the imaging system, and corresponding images processed by the control unit may be displayed on a display device of or associated with the control unit to enable visualization and confirmation of the puncture site. The PEG operator may insert a needle with an outer cannula into the puncture site, for example, using visualization from the imaging system of medical device 100 (e.g., imaging device 120 and illumination device(s) 122). The needle may be removed, and a PEG wire may be inserted through the cannula by the PEG operator.

[0048] In step 404, process 400 includes moving an instrument actuation mechanism (e.g., instrument actuator 148) from a first position (i.e., first position 150) to a second position (i.e., second position 152) to extend the distal end 132 of the integrated instrument 128 relative to the tube 104, transitioning it to an expanded state. For example, before or during insertion of a PEG wire, an operator of medical device 100 can move instrument actuator 148 from first position 150 to second position 152, causing driver 154 to correspondingly move integrated instrument 128 (e.g., integrated snare) to extend the distal end 132 of the integrated instrument 128 distally relative to the tube 104. Extending the distal end 132 of the integrated instrument 128 relative to the tube 104 can transition the distal end 132 to an expanded state to capture the PEG wire, for example, as the PEG wire is inserted into the stomach via a cannula. The operator of the medical device 100 may rotate the medical device 100 (e.g., the handle 102 and tube 104) as needed to better position the distal end 132 of the integrated tool 128 relative to the PEG wire, thereby rotating the integrated tool 128 accordingly.

[0049] In step 406, the process 400 includes capturing an object of interest (e.g., a PEG wire) using the distal end 132 of the integrated instrument 128 in the expanded state. In some examples, the operator of the medical device 100 can rotate, extend, retract, or otherwise manipulate the integrated instrument 128 to position the object within and / or adjacent the distal end 132 of the integrated instrument 128.

[0050] In step 408, process 400 includes moving the instrument actuation mechanism (e.g., instrument actuator 148) from a second position (e.g., second position 152) toward a first position (e.g., first position 150) to at least partially retract the distal end 132 of the integrated instrument 132 relative to the tube 103, transitioning it to an at least partially retracted state. For example, once the PEG wire is captured at the distal end 132 of the integrated instrument 128, the operator of medical device 100 may move the instrument actuator 148 from the second position 152 toward the first position 150 such that the integrated instrument 128 is at least partially retracted relative to the tube 104 (e.g., retracted toward the distal end 108). At least partially retracting the integrated instrument 128 relative to the tube 104 can help return the distal end 132 of the integrated instrument 128 to an at least partially retracted state, which can help secure the PEG wire. In step 410, process 410 may include removing medical device 100 from the patient's body. For example, the entire medical device 100 may be removed from the patient, thereby also removing the PEG wire from the patient. Any remaining steps of the procedure (e.g., in which medical device 100 is not used) may be completed. Medical device 100 may be a single-use device that is then disposed of.

[0051] The above-described process 400 is provided merely as an example and may include additional, fewer, different, or differently arranged steps relative to those shown in Figure 4 and described above. Additionally, the steps of process 400 may be performed using one or more of the medical devices described herein (i.e., medical device 200 or medical device 300).

[0052] Based on the integration of the integrated instrument 128 and instrument actuation mechanism 146 into the medical device 100 (as opposed to, for example, a conventional separate accessory device having a separate control inserted into and fed through the working lumen of the medical device 100), an assistant is no longer required to operate the medical device 100 (although a second operator positioned near the patient's abdomen can still be utilized to place the PEG tube). A single operator of the medical device 100 can actuate the instrument actuator 148 of the instrument actuation mechanism 146 to retract and extend the integrated instrument 128 relative to the tube 104 to transition between the retracted and expanded states, and / or rotate the medical device 100 to rotate the integrated instrument 128. The elimination of an assistant to operate the medical device 100 can be important in certain service environments, such as an intensive care unit bedside environment, where space for two operators side by side is limited, especially near the patient's head.

[0053] While a particular application of medical device 100 described herein is associated with a PEG procedure following percutaneous tracheotomy, medical device 100 is not limited to this application. For example, medical device 100 may be used for any procedure in which an instrument, typically a separate device or accessory, is inserted and delivered to a site within a patient's body through a working lumen of the medical device. As one particular example, medical device 100 may be used to perform a foreign body retrieval procedure. For example, a patient may have swallowed an object, such as a paper clip, and medical device 100 may have an integrated snare, basket, net, or other similar instrument that can be used to retrieve the object.

[0054] 2A-2D show block diagrams of another exemplary medical device 200 for performing a medical procedure. Medical device 200 is similar to medical device 100, except that medical device 200 includes a sheath 202 that is separate from the lumen of tube 104 in which integrated instrument 128 is disposed. Sheath 202 may be a hollow tubular member having a first proximal opening and a second distal opening. Based on the inclusion of sheath 202, medical device 200 also includes a different instrument actuation mechanism 204 (e.g., replacing instrument actuation mechanism 146 of medical device 100) for controlling extension and retraction of sheath 202 and integrated instrument 128.

[0055] The actuation mechanism 204 may include a sheath actuator 206 disposed within the sheath track 208, which may be coupled to the proximal end of the sheath 202. The coupling may include a direct coupling or an indirect coupling (e.g., via one or more intermediate structures). The sheath actuator 206 is movable within the sheath track 208 between a first position 210 (FIGS. 2A and 2B) and a second position 212 (FIGS. 2C and 2D) to extend and retract the sheath 202, having the integrated instrument 128 disposed therein, relative to the tube 104. The actuation mechanism 204 may also include an instrument actuator 214 disposed within the instrument track 216, which may be coupled to the proximal end 130 of the integrated instrument 128. The instrument actuator 214 is movable between a third position 218 (FIGS. 2A, 2B, and 2C) and a fourth position 220 (FIG. 2D) within the instrument track 216 to extend and retract at least the distal end 132 of the integrated instrument 128 relative to the sheath 202 to transition the distal end 132 between a retracted state and an expanded state. The instrument track 216 may be a portion of the sheath track 208 defined by the sheath actuator 206 (e.g., the instrument track 216 may be surrounded by the sheath actuator 206).

[0056] 2A shows a top view and FIG. 2B shows a side view of medical device 200 in a first configuration. In the first configuration of medical device 200, sheath actuator 206 may be in a first position 210 within sheath track 208, and instrument actuator 214 may be in a third position 218 within instrument track 216. As a result, in the first configuration of medical device 200, both sheath 202 and integrated instrument 128 are retracted relative to tube 104, with integrated instrument 128 being retracted relative to sheath 202, e.g., in a collapsed state. The distal end 203 of sheath 202 may be disposed at the distal end 108 of tube 104 (e.g., within articulation joint 109).

[0057] 2C shows a top view of the medical device 200 in the second configuration after the operator has moved the sheath actuator 206 from the first position 210 to the second position 212 within the sheath track 208. In the second configuration, at least the distal end 203 of the sheath 202, in which the integrated instrument 128 is disposed, may be extended relative to the tube 104 as a result of the movement by the operator. For example, the sheath 202 may extend distally beyond the tube 104 through the distal opening 114 of the cap 110. Based on the instrument actuator 214 remaining in the third position 218 within the instrument track 216, the distal end 132 of the integrated instrument 128 may remain retracted relative to the sheath 202 in a collapsed state when the medical device 200 is in the second configuration.

[0058] 2D shows a top view of medical device 200 in a third configuration after the operator moves instrument actuator 214 from third position 218 to fourth position 220 within instrument track 216 (and while sheath actuator 206 remains in second position 212). In the third configuration, at least distal end 132 of integrated instrument 128 may be extended relative to sheath 202 and may be transitioned from a retracted state to an expanded state. For example, distal end 132 of integrated instrument 128 may extend distally from distal end 203 of sheath 202 through a distal opening in sheath 202.

[0059] Once the object of interest is positioned against (i.e., within) the distal end 132 of the integrated instrument 128 in the expanded state, the operator may move the instrument actuator 214 from the fourth position 220 toward the third position 218. Movement of the instrument actuator 214 from the fourth position 220 toward the third position 218 may at least partially retract the distal end 132 of the integrated instrument 128 relative to the sheath 202, transitioning the distal end 132 of the integrated instrument 128 from the expanded state to an at least partially retracted state, and secure the object of interest. In some examples, the operator may simultaneously or sequentially move the sheath actuator 206 from the second position 212 toward the first position 210 to at least partially retract the sheath 202 and the integrated instrument 128 relative to the tube 104 before removing the entire medical device 200 from the patient. Alternatively, the operator can instead remove the entire medical device 200 from the patient without partially retracting the sheath 202 and integrated instrument 128 relative to the tube 104. In some examples, the medical device 200 may include one or more locking mechanisms for locking the sheath actuator 206 and / or the instrument actuator 214 in a given position (e.g., in one of the first position 210 or the second position 212, or in one of the third position 218 or the fourth position 220, respectively).

[0060] By including a dedicated sheath, such as sheath 202, in which integrated instrument 128 is disposed within medical device 200, the operative field can be expanded to include the length of sheath 202, which can be up to the length of handle 102, as well as the length of integrated instrument 128 when extended distally from sheath 202. Additionally, after distal end 132 of integrated instrument 128 is at least partially retracted relative to sheath 202 and transitioned to an at least partially retracted state, sheath 202 may help enable tighter and / or more secure closure of the target object by integrated instrument 128 in the retracted state. In these aspects, sheath 202 can help provide a more secure grip on the target object when medical device 200 is being removed from the patient.

[0061] The medical device 200 may be used to perform a medical procedure using similar steps as described above with reference to process 400 of Figure 4. One or more additional steps may be included to account for differences in the instrument actuation mechanism 204 of the medical device 200 as described above.

[0062] 3A-3C show perspective views of a distal portion of a further exemplary medical device 300 for performing a medical procedure. The medical device 300 is similar to the medical device 100 described in FIGS. 1A-1D , except that the integrated instrument is a wire 302 that forms a loop or snare that can transition between a contracted state and an expanded state using an instrument actuation mechanism, such as instrument actuation mechanism 146, based on the integration of the wire 302 within the medical device 300. While the term “wire” is used herein for the wire 302, it will be understood that the present disclosure also encompasses cables, threads, or other similar structures. For example, the distal-most end 304 of the wire 302 may be attached to the distal-facing surface 112 of the cap 110 at an anchoring point 306. The wire 302 may extend from the anchoring point 306 into the tube 104 through an opening 308 in the cap 110. In some embodiments, the opening 308 may correspond to a wire lumen that is separate from the lumen to which the distal opening 114 corresponds. In other embodiments, opening 308 may connect to the same lumen that opening 114 corresponds to. Wire 302 may continue to extend from tube 104 through distal opening 168 of connector 166 into handle 102 and exit through instrument connector port 172, where a proximal-most end (not shown) of wire 302 is attached to driver 154 ( FIGS. 1C and 1D ). As discussed above with reference to FIGS. 1A-1D , driver 154 may be connected to an interior portion of instrument actuator 148 by link 156. Thus, when instrument actuator 148 is moved by the operator between first position 150 and second position 152, driver 154 and wire 302 move accordingly to extend and / or retract a portion of wire 302 through opening 308, transitioning the loop or snare formed by wire 302 at the distal end of medical device 300 between a retracted state and an expanded state. In some embodiments, the portion of the wire 302 within the tube 104 and / or handle 102 (e.g., the portion of the wire 302 that is located more proximally and does not extend from the opening 308 when the wire 302 is in a fully expanded state) may be encapsulated within a compression cable.

[0063] In medical device 300, opening 308 through which wire 302 extends may be a separate opening from distal opening 114. Additionally, in some embodiments, as shown in FIGS. 3A-3C , fixation point 306 and opening 308 may be positioned equidistant on either side of distal opening 114 and offset from distal opening 114, which may help prevent wire 302 from blocking distal opening 114. Accordingly, other accessory devices, tools, or instruments separate from medical device 300 that may be utilized for a medical procedure may be inserted through connector 166 via working lumen connector port 178, into working lumen access 180, and into tube 104 via distal opening 168 of connector 166, as described above with respect to FIG. 1C . The other accessory device, tool, or instrument may then be extended through tube 104 for delivery to an intended site within the patient's body via distal opening 114 without being obstructed by wire 302. Additionally, fluid delivered and / or suction applied via fluidic device 160 will not be impeded by wire 302. Furthermore, wire 302 will not impair the visibility of imaging device 120 and / or the illumination of illumination device(s) 122.

[0064] 3A shows the distal portion of medical device 300 in a first configuration, with the loop or snare formed by wire 302 in a retracted state, for example, based on instrument actuator 148 being in first position 150. For example, in the retracted state, the portion of wire 302 extending between distal end 304 of wire 302 and opening 308 may at least partially contact distal-facing surface 112 of cap 110. FIG. 3B shows the distal portion of medical device 300 in a second configuration, with the loop or snare formed by wire 302 in an expanded state, for example, based on instrument actuator 148 being moved from first position 150 to second position 152. For example, movement of the instrument actuator 148 to the second position 152 causes the driver 154 to correspondingly move the wire 302 distally, such that a portion of the wire 302 previously positioned within the distal end 108 of the tube 104 extends distally from the opening 308, transitioning the wire 302 to an expanded state (e.g., forming a larger loop or snare). Once the operator places an object of interest against the wire 302 in the expanded state, the operator can then move the instrument actuator 148 from the second position 152 toward the first position 150 to transition the wire 302 back to an at least partially retracted state (as in FIG. 3A ) to help secure the object with the wire 302. For example, in the partially retracted state, the wire 302 can secure the object such that the object at least partially contacts the distal-facing surface 112 of the cap 110.

[0065] 3C shows an alternative configuration of the distal-facing surface 112. In this alternative configuration, the distal-facing surface 112 can include a longitudinal recess 310 disposed between the anchoring point 306 and the opening 308. The recess 310 can be configured to receive at least a portion of an object 312 to be retrieved during a medical procedure, such as a PEG wire in a PEG. In some examples, the recess 310 can be sized and / or shaped to correspond to the size and / or shape of the object 312. The recess 310 can help allow a larger cross-sectional area of the distal-facing surface 112 to contact the object 312, which can then help provide a more secure grip of the object 312 when the medical device 300 is removed from the patient.

[0066] 3A-3C, the medical device 300 has one-sided actuation controlled via the instrument actuation mechanism 146. With one-sided actuation, the entire length of the wire 302 needed to transition the wire 302 from the retracted state to the expanded state extends from the opening 308, which may result in a longer stroke length for the instrument actuator 148. To reduce the stroke length (e.g., by half), the medical device 300 may be modified to have two-sided actuation. In such an alternative embodiment, instead of the distal end 304 of the wire 302 being attached to the distal-facing surface 112 at the fixed point 306, the distal-facing surface 112 may include another opening at the fixed point 306, and the distal end 304 of the wire 302 may extend into the tube 104 through the other opening. For clarity, when describing the bilateral actuation alternative, the distal end 304 of the wire 302 will be referred to herein as the second end of the wire 302, the second end of the wire 302 being opposite the first end of the wire, which was previously referred to as the proximal-most end of the wire 302. The second end of the wire 302 may continue to extend from the tube 104 into the handle 102 via the distal opening 168 of the connector 166 and exit via the instrument connector port 172, where the second end of the wire 302 is then attached to the instrument actuation mechanism.

[0067] In some embodiments, the second end of wire 302 may be attached to the same instrument actuation mechanism as the first end of wire 302. For example, both the first and second ends of wire 302 may be attached to driver 154 of instrument actuation mechanism 146 (FIGS. 1C and 1D). Thus, an operator may move a single instrument actuator 148 to extend wire 302 distally out of both opening 308 and the other opening simultaneously, transitioning wire 302 to the extended state at half the stroke length.

[0068] In other embodiments, the handle 102 may include another instrument actuation mechanism similar to the instrument actuation mechanism 146, with a first end of the wire 302 attached to the instrument actuation mechanism 146 and a second end of the wire 302 attached to the other instrument actuation mechanism. The operator may actuate two separate instrument actuation mechanisms to extend the wire 302 from the opening 308 and the other opening, transitioning the wire 302 to an extended state at half its stroke length. In some embodiments, the two separate instrument actuation mechanisms may be actuated simultaneously to extend substantially equal amounts of the wire 302 from each of the opening 308 and the other opening. In other embodiments, the two separate instrument actuation mechanisms may be actuated individually to selectively extend different amounts of the wire 302 from each of the opening 308 and the other opening (e.g., to extend a loop formed from the wire 302 toward a location in the opening where a greater amount of the wire 302 is extended to better access the object, for example).

[0069] Medical device 300 may be used to perform a medical procedure using the same or similar steps as described above with reference to process 400 of Figure 4. In some embodiments, the object of interest (e.g., a PEG wire) captured in step 406 may be retained in recess 310 as part of at least one of steps 406, 408, and / or 410. Additionally, in embodiments in which handle 102 includes two separate instrument actuation mechanisms (e.g., instrument actuation mechanism 146 and another instrument actuation mechanism similar to instrument actuation mechanism 146), one and / or both of the instrument actuation mechanisms may be moved between a first position and a second position in steps 404 and 408.

[0070] While the principles of the present disclosure have been described herein with reference to illustrative embodiments for particular applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize that additional modifications, adaptations, and equivalent substitutions are all within the scope of the embodiments described herein. Accordingly, the present invention should not be deemed limited by the foregoing description.

Claims

1. It is a medical device, A tube having a proximal end and a distal end, and including a lumen extending from the proximal end to the distal end, Having a distal opening corresponding to the lumen, and a cap at the distal end of the tube, An imaging system is placed on the distal surface of the cap, An instrument that is at least partially placed within the lumen and is not removable from the medical device, A device operating mechanism for controlling the aforementioned device, A single handle connected to the proximal end of the tube and housing the device operating mechanism, Equipped with, The proximal end of the instrument is attached to the instrument operating mechanism, and the instrument operating mechanism is configured to move between a first position and a second position on the single handle to control the extension and retraction of the instrument relative to the tube. The distal end of the device is retracted relative to the tube when the device operating mechanism is in the first position. The distal end of the instrument is extended in an expanded state relative to the tube when the instrument operating mechanism is in the second position. Medical devices.

2. The medical device according to claim 1, wherein the distal end of the tube includes an articular joint, and when the device operating mechanism is in the first position, the distal end of the device is located within the articular joint.

3. The medical device according to claim 2, wherein the single handle further houses a joint movement mechanism for controlling the joint, and the joint is configured to bend in at least two directions away from the longitudinal axis of the tube.

4. The instrument is extended toward the tube through the distal opening, The distal opening is, A medical device according to any one of claims 1 to 3, comprising a clamshell shape for fixing the orientation of the instrument relative to the medical device when the instrument is extended.

5. The single handle further comprises a connector located within the single handle, the connector being A plurality of connector ports, wherein at least one of the plurality of connector ports includes a device connector port configured to receive the device from the device operating mechanism, A distal opening connecting the single handle and the proximal end of the tube, wherein the instrument received via the instrument connector port extends into the lumen of the tube through the distal opening, including, A medical device according to any one of claims 1 to 3.

6. The aforementioned device operating mechanism, A medical device according to any one of claims 1 to 3, comprising: an instrument actuator configured to move between a first position and a second position; a link; and a driver to which the proximal end of the instrument is attached and which is connected via the link to the instrument actuator.

7. The medical device according to any one of claims 1 to 3, further comprising a sheath at least partially disposed within the lumen, wherein the instrument is disposed within the sheath.

8. The aforementioned device operating mechanism, A sheath actuator that extends and retracts the sheath on which the aforementioned device is arranged relative to the tube, An apparatus actuator for extending and retracting the apparatus relative to the sheath in order to transition the apparatus between the retracted state and the extended state, Equipped with, The medical device according to claim 7.

9. The aforementioned device is a wire, The first end of the wire is attached to a fixing point on the distal surface of the cap. The wire extends from the fixing point through a second distal opening of the cap, which is different from the distal opening corresponding to the lumen, into the handle via the tube. The second end of the wire, opposite to the first end, is attached to the device operating mechanism. A medical device according to any one of claims 1 to 3.

10. When the device operating mechanism is in the first position, the first portion of the wire from the fixed point to the second distal opening forms the decomposed loop that at least partially contacts the distal surface. When the device operating mechanism is in the second position, the second portion of the wire extends out of the tube through the second opening to transition the loop to the expanded state. The medical device according to claim 9.

11. The medical device according to claim 10, wherein the distal surface of the cap has a recess located between the fixing point and the second distal opening, and the recess is configured to receive and fix an object captured by the instrument.

12. The aforementioned device is a wire, The first end of the wire extends through the tube into the handle, passing through a second distal opening of the cap that is different from the distal opening corresponding to the lumen, and is attached to the instrument operating mechanism. The second end of the wire extends through the tube into the handle, passing through the distal opening corresponding to the lumen and a third distal opening of the cap that is different from the second distal opening, and is attached to the instrument operating mechanism. A medical device according to any one of claims 1 to 3.

13. When the device operating mechanism is in the first position, the first portion of the wire from the second distal opening to the third distal opening forms the degenerated loop that at least partially contacts the distal surface, When the device operating mechanism is in the second position, the second portion of the wire extends out of the tube through the second opening, and the third portion of the wire extends out of the tube through the third opening, causing the loop to transition to the expanded state. The medical device according to claim 12.

14. The single handle mentioned above is The fluid device further comprises a proximal end that can be connected to one or more of a fluid supply source and a vacuum source, and a distal end connected to the proximal end of the tube, The medical device according to any one of claims 1 to 3, wherein the fluid device is configured to perform one or more of the following: supplying fluid to a patient's body through the distal opening, and aspirating fluid from the patient's body through the distal opening.

15. The medical device according to any one of claims 1 to 3, wherein the imaging system includes an imaging device disposed in an imaging port on the distal surface of the cap and an illumination device disposed in an illumination port on the distal surface of the cap.

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