Medical devices with integrated instruments and related methods

Abstract

A medical device includes a tube including a lumen extending from a proximal end to a distal end of the tube; a cap at the distal end of the tube, the cap having a distal opening corresponding to the lumen; and an imaging system positioned on a distally facing surface of the cap. The medical device further includes an instrument at least partially disposed in the cavity, the instrument being 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 may be configured to move between first and second positions on the single handle to control extension and retraction of the instrument relative to the tube.

Description

Cross - reference to related applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 371,089, filed on Aug. 11, 2022, under 35 U.S.C. § 119, which is hereby incorporated by reference in its entirety. Technical Field

[0002] The present invention generally relates to medical devices. More specifically, aspects of the present invention relate to medical devices having integrated instruments and methods of using such medical devices. Background Art

[0003] Traditionally, percutaneous tracheostomy for placement of a tracheal tube and percutaneous endoscopic gastrostomy (PEG) for placement of a feeding tube are separate procedures. These separate procedures are visually guided by different types of endoscopic medical devices and are performed by different specialists at different service locations. For example, percutaneous tracheostomy can be performed by a surgeon, an intensive care pulmonologist, and / or an interventional pulmonologist at the bedside or using a bronchoscope in a bronchoscopy room. On the other hand, PEG can be performed by a surgeon or a gastroenterologist using a gastroscope in an operating room or a gastrointestinal room.

[0004] Recently, specialists can be trained to continuously perform percutaneous tracheostomy and bedside PEG on a patient in an intensive care unit or other similar environment using the same endoscopic medical device, such as a bronchoscope. These bedside environments have limited space, especially near the patient's head, where the specialist operating the bronchoscope is positioned. In addition, one or more steps of PEG may rely on an assistant (e.g., a second operator), for example, to facilitate insertion of a separate accessory device (e.g., a snare) into the bronchoscope and / or operation of the separate accessory device. However, due to the limited space in the bedside environment, insertion and / or use of a separate accessory device (e.g., a snare) can be cumbersome, for example, prolonging the procedure time, increasing the risk during the procedure, etc. Summary of the Invention

[0005] In one example, 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; and an imaging system positioned on a distally facing surface of the cap. The medical device can further include an instrument at least partially disposed within the lumen, the instrument 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 move between a first position and a second position on the single handle to control extension and retraction of the instrument relative to the tube. When the instrument actuation mechanism is in the first position, the distal end of the instrument can be retracted relative to the tube in a collapsed state. When the instrument actuation mechanism is in the second position, the distal end of the instrument can be extended relative to the tube in an expanded state.

[0006] In any of the exemplary medical devices disclosed herein, the distal end of the tube can include a hinge joint, and when the instrument actuation mechanism is in the first position, the distal end of the instrument can be positioned within the hinge joint. The single handle can further house a hinge actuation mechanism for controlling the hinge joint, wherein the hinge joint can be configured to bend away from the longitudinal axis of the tube in at least two directions.

[0007] Additionally, the instrument can extend relative to the tube via the distal opening, and the distal opening can include a clamshell shape to lock the orientation of the instrument relative to the medical device when the instrument extends. The medical device can further include a connector disposed within the single handle. The connector can include a plurality of connector ports, and a distal opening connecting the single handle to the proximal end of the tube. At least one of the plurality of connector ports can include an instrument connector port configured to receive the instrument from the instrument actuation mechanism, and the instrument received via the instrument connector port can extend into the lumen of the tube via the distal opening.

[0008] In some aspects, the instrument actuation mechanism can include an instrument actuator configured to move between a first position and a second position, a linkage, and a driver connected to the instrument actuator via the linkage, the proximal end of the instrument attached to the linkage.

[0009] In other aspects, the medical device can include a sheath at least partially disposed within the lumen. The instrument can be disposed within the sheath. The instrument actuation mechanism can include a sheath actuator that extends and retracts the sheath in which the instrument is disposed relative to the tube; and an instrument actuator that extends and retracts the instrument relative to the sheath to transition the instrument between a collapsed state and an expanded state.

[0010] In another aspect, the instrument can be a wire. A first end of the wire can be attached to a fixed point on the distally facing surface of the cap, and the wire can extend through the tube from the fixed point, through a second distal opening of the cap that is different from the distal opening corresponding to the lumen, and into the handle. A second end of the wire, opposite the first end, can 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 can form a loop in a collapsed state, with the loop at least partially contacting the distally facing surface. When the instrument actuation mechanism is in a second position, a second portion of the wire can extend through the second opening from the tube to convert the loop to an expanded state. The distally facing surface of the cap can include a recess disposed between the fixed point and the second distal opening, where the recess can be configured to receive and secure an object captured by the instrument.

[0011] In a further aspect, the instrument can be a wire. A first end of the wire can extend through the tube, through a second distal opening of the cap that is different from the distal opening corresponding to the lumen, and into the handle to attach to the instrument actuation mechanism. A second end of the wire can extend through the tube, through a third distal opening in the cap that is different from the distal opening corresponding to the lumen and the second distal opening, and into the handle to attach to the instrument actuation mechanism. When the instrument actuation mechanism is in a first position, a first portion of the wire from the second distal opening to the third distal opening can form a loop in a collapsed state, with the loop at least partially contacting the distally facing surface. When the instrument actuation mechanism is in a second position, a second portion of the wire can extend through the second opening from the tube, and a third portion of the wire can extend through the third opening from the tube to convert the loop to an expanded state.

[0012] Additionally, the single handle can further include a fluid device having a proximal end connectable 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 fluid device can be configured to supply fluid to and / or apply suction to the patient's body via the distal opening. The imaging system can include an imaging device positioned within an imaging port on the distally facing surface of the cap and an illumination device positioned within an illumination port on the distally facing surface of the cap.

[0013] In another example, 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 sheath at least partially disposed within the lumen; and an instrument disposed within the sheath, wherein the sheath and the instrument are not removable from the medical device. The medical device can further 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 can be attached to the sheath actuator, and the sheath actuator can be configured to move between a first position and a second position on the single handle to control the extension and retraction of the sheath, in which the instrument is disposed, relative to the tube via the distal opening. The proximal end of the instrument can be attached to the instrument actuator, and the instrument actuator can be configured to move between a third position and a fourth position on the single handle to control the extension and retraction of the distal end of the instrument relative to the sheath to cause the distal end of the instrument to transition between a collapsed state and an expanded state.

[0014] Any of the exemplary medical devices disclosed herein can include any of the following features. The distal end of the tube can include a hinge joint, and when the sheath actuator is in the first position, the distal end of the sheath, in which the distal end of the instrument is disposed, can be positioned within the hinge joint. The instrument can be a snare and the medical device can be configured for PEG.

[0015] In another example, 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 move between a first position and a second position on the handle; and a wire having a first end and a second end, wherein the wire can be at least partially disposed within the lumen. The first end of the wire can be attached to a fixed point on the distally facing surface of the cap and extend through the tube from the fixed point, through a second distal opening of the cap different from the distal opening corresponding to the lumen, into the handle. The 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 loop in a collapsed state, the loop at least partially contacting the distally facing surface. When the actuation mechanism is in the second position, a second portion of the wire can extend from the tube via the second opening to transition the loop to an expanded state.

[0016] Any of the exemplary medical devices disclosed herein can include any of the following features. The distally facing surface of the cap can include a recess disposed between the fixed point and the second distal opening, the recess configured to receive at least a portion of an object captured by the wire.

[0017] It is to be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory and are not restrictive of the invention, as claimed. As used herein, the term "comprising," "including" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.. The term "exemplary" is used in the sense of "example" rather than "model". The term "distal" refers to the direction away from the operator / towards the treatment location, and the term "proximal" refers to the direction towards the operator. The term "about" or similar terms (e.g., "substantially") includes values that are + / - 10% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The drawings incorporated in and constituting a part of this specification illustrate examples of the invention and, together with the detailed description, serve to explain the principles of the invention.

[0019] Figures 1A to 1D Various views of an exemplary medical device for performing a medical procedure are depicted;

[0020] Figures 2A to 2D A block diagram of another exemplary medical device for performing a medical procedure is depicted;

[0021] Figures 3A to 3C A perspective view of the distal portion of a further exemplary medical device for performing a medical procedure in various configurations is depicted;

[0022] Figure 4 Depicts the use of Figures 1A to 1D an exemplary medical device to perform an exemplary process of a medical procedure. DETAILED DESCRIPTION

[0023] As described above, experts can now be trained to use the same or a single endoscopic medical device to continuously perform percutaneous tracheostomy and bedside PEG for patients in the intensive care unit or other similar bedside settings. For example, after placing an endotracheal tube to complete a percutaneous tracheostomy, the medical device can be advanced into the stomach and operated by an expert (e.g., a first operator) to insufflate and obtain visualization required to determine the entry location. Once the entry location is determined, a needle surrounded by an introducer sheath can be inserted into the stomach, and the needle can be removed so that the sheath remains. A PEG wire can be inserted into the stomach via the sheath.

[0024] Meanwhile, an assistant (e.g., a second operator) positioned near the first operator of the medical device can feed the distal portion of an accessory device (such as a snare) separate from the medical device into the working lumen of the medical device via an access port and through a distal opening at the distal end of the medical device. The snare can be delivered in a collapsed state and can then be actuated by the second operator via a handle portion of the accessory device to expand the snare. In the expanded state, the snare can be used to capture the PEG wire when the PEG wire is inserted into the stomach via the cannula. In some cases, the second operator can also utilize controls on the handle portion of the accessory device to rotate the snare when in the expanded state to better position the snare relative to the PEG wire to be captured. However, in the limited space of an intensive care unit or other similar bedside environment, having a second operator present to assist with the insertion and operation of a separate accessory device can be cumbersome, e.g., prolonging the procedure time, increasing risks during the procedure, etc.

[0025] Accordingly, aspects of the present invention relate to a medical device having a non-removable integrated instrument that enables a single operator to control the medical device and the integrated instrument, thereby eliminating the need for a second operator to assist with the insertion and operation of the instrument during a medical procedure, such as a PEG. The medical device can include a single handle and a tube extending distally from the handle. The single handle can be sized to be grasped by an operator and can be 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. During a medical procedure, at least a distal portion of the tube can be inserted into a patient, and the tube can include at least one lumen in which the integrated instrument can be at least partially disposed. Additionally, the integrated instrument can be transitioned between a collapsed and an expanded state via the instrument actuation mechanism, e.g., on and / or integrated into the handle.

[0026] The instrument can be integrated into the medical device in various ways. In one example and as described below with reference to Figures 1A to 1C the lumen of the tube can serve as a sheath for the instrument. In this example, when the instrument actuation mechanism is actuated by a single operator of the medical device, the distal end of the instrument can extend and retract relative to the tube to transition between a collapsed and an expanded state.

[0027] In another example and as described below with reference to Figures 2A to 2D the instrument can be disposed within a sheath separate from the lumen. When a first actuator of the instrument actuation mechanism is actuated by a single operator of the medical device, the sheath having the instrument disposed therein can extend and retract relative to the tube. Then, when a second actuator of the instrument actuation mechanism is actuated by a single operator of the medical device, the instrument can extend and retract relative to the sheath to transition between a collapsed and an expanded state.

[0028] In yet another example and as described below with reference to Figures 3A to 3C the instrument can be a wire. In this further example, the first end of the wire is attached to the distal-facing surface of a cap located at the distal end of the tube at a fixed point, and the second end of the wire extends proximally into the cap (e.g., via a distal opening in the cap) and through the lumen of the tube to attach to an instrument actuation mechanism within the handle. In the collapsed state, at least a portion of the wire from the fixed point to the entry point into the cap can 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 can extend and retract via the distal opening in the cap to transition between the collapsed and expanded states. Alternatively, the cap can include another distal opening, and similar to the second end of the wire, the first end of the wire can extend into the cap (e.g., via the distal opening in the cap) and through the lumen of the tube to attach to the same or a different instrument actuation mechanism within the handle to provide bilateral actuation rather than attaching the first end of the wire to a fixed point.

[0029] Figures 1A to 1D An exemplary medical device 100 for performing a medical procedure is depicted. One example medical procedure can include a PEG performed after a percutaneous tracheostomy, where both procedures can be performed using the medical device 100. Figure 1A The medical device 100 is depicted in a first configuration, where the integrated instrument of the medical device 100 (not shown in Figure 1A is retracted and in a collapsed state. The medical device 100 can be an endoscope or other type of scope, such as a bronchoscope, ureteroscope, duodenoscope, gastroscope, endoscopic ultrasound ("EUS") scope, colonoscope, laparoscope, arthroscope, cystoscope, aspiration scope, sheath, or catheter. The medical device 100 can include a handle 102 and a tube 104 (i.e., shaft) that extends distally from the handle 102. The integrated instrument can be a device or tool, such as a snare, net, basket, forceps, grasping forceps, scissors, clip, stapler, needle, knife, electrode, cautery ring, or other similar type of instrument for acting on an object of interest during a medical procedure, etc. The instrument can be specific to the medical procedure being performed. For example, for a PEG, the instrument can be a snare for capturing a PEG wire, as discussed in more detail below. The instrument can be integrated with the medical device 100 such that the instrument cannot be removed from the medical device 100 and can be controlled by a single operator of the medical device 100 via the handle 102 to extend and retract the integrated instrument, which can cause the integrated instrument to transition between the collapsed and expanded states.

[0030] The handle 102 may include a housing 103 sized and / or shaped to be grasped by a single hand of an operator of the medical device 100, and various components of the medical device 100 may be disposed within and / or on the housing 103, as described in detail below. The proximal end 106 of the tube 104 may be attached to the handle 102 and extend distally therefrom, wherein at least the distal portion of the tube 104 may be inserted into a patient's body during a medical procedure.

[0031] In some examples, the cap 110 may be removably attached to the distal end 108 of the tube 104. In other examples, the cap 110 may be integrated with the distal end 108 of the tube 104. Although the term "cap" is used herein, it should be understood that the present invention encompasses examples of medical devices 100 that include any type of distal tip, including a distal tip without a cap that is integrally formed with or otherwise formed on the tube 104. 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 of the tube 104 to the distal end 108. In some examples, the at least one lumen may be a working lumen. In other examples, the tube 104 may include more than one lumen (e.g., at least one other lumen in addition to the working lumen).

[0032] The distally facing surface 112 of the cap 110 may include a distal opening 114 corresponding to the at least one lumen of the tube 104 to enable one or more devices (including at least integrated instruments) to extend distally from the tube 104 through the distal opening 114 to a desired location within the patient's body. In some examples and as Figure 1A shown, the distal opening 114 may be sized and shaped (e.g., clamshell-style) to increase the surface area of the distal opening 114 to improve the fluid performance of the medical device 100. The clamshell design may also enable the cap 110 to lock the orientation of the integrated instrument relative to the medical device 100 to provide more precise and predictable rotation when the integrated instrument extends relative to the tube 104 and is in an expanded state, as discussed in more detail below. In other examples, the distal opening 114 may have a substantially circular configuration (e.g., may have a circular configuration, an oval configuration, or other type of configuration), as Figures 3A to 3C shown.

[0033] The medical device 100 may also include an imaging system located at the distal end 108 of the tube 104. The imaging system may include an imaging device 120 and one or more lighting devices 122A, 122B (collectively referred to as lighting devices 122). Accordingly, the distally facing surface 112 of the cap 110 may include an imaging port 116 for receiving the imaging device 120, and one or more lighting ports 118A, 118B (collectively referred to as lighting ports 118) for receiving the lighting devices 122. In some examples, when the medical device 100 is connected to a control unit via an external cable 124 (e.g., an umbilical cord), the imaging system may be communicatively connected and controlled by the control unit (not shown). As described in more detail below with reference to Figure 1C The wires attached to the imaging device 120 and the lighting devices 122 may extend through the tube 104 and into the handle 102 to be coupled to or encapsulated / contained within the external cable 124.

[0034] The imaging device 120 may include a camera, an imaging sensor (such as, for example, a complementary metal oxide semiconductor or CMOS sensor), a light sensor, or another image receiving device (such as, for example, an optical fiber imaging device). As described in more detail below with reference to Figure 1C The imaging device 120 may capture an image signal and transmit the image signal from the medical device 100 to the control unit for processing. The control unit may provide the processed image signal via a display device of or associated with the control unit for display as a still and / or transient image to provide visual guidance to the operator of the medical device 100 during a medical procedure. The imaging device 120 may capture an image signal in response to a control signal received from the control unit. Additionally, the medical device 100 may include an image capture control element 126 disposed on the handle 102 (e.g., in the proximal portion of the handle 102), and the imaging device 120 may capture an image signal in response to actuation of the image capture control element 126. In some cases, actuation of the image capture control element 126 may cause the captured image signal to be saved and / or recorded.

[0035] The lighting devices 122 may include any device configured to illuminate a target area within a patient (e.g., illuminate a location for a medical procedure) to facilitate imaging and other aspects of the procedure (e.g., palpation for PEG). The lighting devices 122 may include light bulbs, light emitting diodes (LEDs), one or more optical fiber cables, and light guides, etc. Although two lighting devices 122 are shown, in other examples, the medical device 100 may have only one lighting device, or may have more than two lighting devices. As described in more detail below with reference to Figure 1CMore specifically, when the medical device 100 is connected to the control unit via the external cable 124, the lighting device 122 can be controlled and / or operated based on the control signal received from the control unit. In some examples, the lighting device 122 can direct light from an external light source. For example, the external light source can include one or more LEDs, xenon, or other light sources of a lighting control system (not shown) coupled to the control unit.

[0036] The distal end 108 of the tube 104 can also include a hinge joint 109 that enables the distal end 108 and the cap 110 to bend away from the longitudinal axis A of the tube 104 in at least two directions. In some examples, the hinge joint 109 can extend to the cap 110. The operator of the medical device 100 can cause the hinge joint 109 to bend in one of the at least two directions by actuating a hinge actuator 136 (e.g., on the proximal portion of the handle 102) in a given direction. The hinge actuator 136 can be a component of the hinge actuation mechanism of the medical device 100 described in more detail below with reference to Figure 1C In some examples, when the medical device 100 is in the first configuration in which the integrated instrument is retracted relative to the tube 104 and in a collapsed state, as Figure 1A shown, the distal end of the integrated instrument can be positioned within the lumen at the distal end 108 of the tube 104 (e.g., within the hinge joint 109). This positioning of the distal end of the integrated instrument within the hinge joint 109 may increase rigidity, which may improve the pushability of the hinge joint 109 when advancing through the patient's body. In this regard, although positioning the integrated instrument within the hinge joint 109 may reduce the flexibility of the hinge joint 109, the hinge joint 109 still remains sufficiently flexible so as not to significantly affect articulation, particularly for procedures such as PEG that do not require full 180-degree articulation.

[0037] In addition to controlling the articulation of the medical device 100, the operator can also control the extension and retraction of the integrated instrument. For example, the medical device 100 can include an instrument actuator 148 that can be positioned on the handle 102. The operator of the medical device 100 can cause the medical device 100 to transition from the Figure 1A first configuration shown in Figure 1B to the Figure 1A second configuration shown in Figure 1B by moving the instrument actuator 148 from a first position 150 ( Figure 1C In some aspects, the instrument actuator 148 can be a component of the instrument actuation mechanism of the medical device 100 described in more detail below with reference to Figure 1B In the second configuration of the medical device 100 shown inFigure 1A )。The distal end 132 of the integrated instrument 128 is extended from the distal opening 114 to transition the distal end 132 from a collapsed state to an expanded state. In the expanded state, the integrated instrument 128 can act on (e.g., capture) one or more objects. In some examples, the instrument actuation mechanism can include a spring or biasing mechanism that facilitates returning the integrated instrument 128 from the second position 152 to the first position 150. Additionally or alternatively, the instrument actuation mechanism can include a locking feature that enables the instrument actuator 148 to be locked in the second position 152 to prevent the integrated instrument 128 from inadvertently retracting relative to the tube 104 and at least partially reverting to the collapsed state.

[0038] Thus, a single handle 102 of the medical device 100 can include an articulation actuation mechanism (e.g., articulation actuator 136) for controlling the bending of the articulation joint 109 and an instrument actuation mechanism (e.g., instrument actuator 148) for controlling the extension and retraction of the integrated instrument 128, such that a single operator of the medical device 100 can control both the articulation joint 109 and the integrated instrument 128. As Figure 1C most clearly shown, in addition to the articulation actuator 136 and the instrument actuator 148, each of the respective articulation actuation mechanism 134 and instrument actuation mechanism 146 includes components disposed within and / or on the housing 103 of the handle 102.

[0039] As Figure 1C shown, the housing 103 can 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 can be attached to each other to form the housing 103. Figure 1C Depicts an internal view of the handle 102 of the medical device 100 when the first housing portion 103A is removed and the medical device 100 is in the second configuration as described with respect to Figure 1B above.

[0040] In addition to the above-described articulation actuation mechanism 134 and instrument actuation mechanism 146, a fluid device 160 and a connector 166 can also be disposed within and / or on the housing 103 of the handle 102. The connector 166 can be coupled to the proximal end 106 of the tube 104 via a distal opening 168 of the connector 166. The connector 166 can be configured to connect the components of the handle 102 to the tube 104. For example, the connector 166 can include a plurality of connector ports for conveying instruments, tools, or wires (including the integrated instrument 128) from the handle 102 to the tube 104 and / or applying fluid (e.g., gas) via the tube 104, such as for insufflation and / or aspiration. Exemplary connector ports are discussed in turn below to describe how each component from the handle 102 is connected to the tube 104 via the connector 166.

[0041] As discussed previously, the articulation actuation mechanism 134 can include an articulation actuator 136. At least a portion of the articulation actuator 136 can be disposed on the exterior of the handle 102 to enable an operator to interact with the articulation actuator 136. For example, the articulation actuator 136 can be gradually moved by the operator in a first direction (e.g., pushed upward in a proximal direction) to cause the distal end 108 of the tube 104 (including the cap 110) to gradually bend in a first direction away from the longitudinal axis A. The articulation actuator 136 can be gradually moved by the operator in a second direction opposite the first direction (e.g., pushed downward in a distal direction) to cause the distal end 108 of the tube 104 (including the cap 110) to gradually bend in a second direction away from the longitudinal axis A opposite the first direction away from the longitudinal axis A. The remaining components of the articulation actuation mechanism 134 can be positioned within the interior of the handle 102, and at least a portion of one or more of those components can extend to the distal end 108 of the tube 104. For example, an interior portion of the articulation actuator 136 can be connected to an articulation wheel 140. An articulation wire 142 can be disposed around the circumference of the articulation wheel 140. A first end of the articulation wire 142 can extend through a first articulation connector port 170A of the connector 166 via a distal opening 168 of the connector 166 into the proximal end 106 of the tube 104, and be attached to a first side of an articulation joint 109 at the distal end 108 of the tube 104. A second end of the articulation wire 142 can extend through a second articulation connector port 170B of the connector via the distal opening 168 of the connector into the proximal end 106 of the tube 104, and be attached to a second side of the articulation joint 109 at the distal end 108 of the tube 104 that is opposite the first side (to which the first end of the articulation wire 142 is attached). In some examples, one or more sets of guide elements 144 positioned distal to the articulation wheel 140 and proximal to the connector 166 can be included within the interior of the handle 102 to receive the articulation wire 142 to guide and / or hold the articulation wire 142 (e.g., to prevent entanglement and / or interference with other interior components of the handle 102). In further examples, the first articulation connector port 170A and / or the first articulation port 170B can include a seal to facilitate movement of the articulation wire 142 when the operator actuates the articulation actuator 136.

[0042] When the operator gradually moves or pushes the articulated actuator 136 in a first direction, the articulated wheel 140 can rotate in the same first direction as the movement of the articulated actuator 136, thereby pulling proximally on the first end of the articulated wire 142. Pulling the first end of the articulated wire 142 proximally may cause the first side of the articulated joint 109 to be pulled proximally, and the distal end 108 of the tube 104 (including the cap 110) to bend in a first direction away from the longitudinal axis A. Conversely, when the operator gradually moves or pushes the articulated actuator 136 in a second direction, the articulated wheel 140 can rotate in the same second direction as the movement of the articulated actuator 136, thereby pulling proximally on the second end of the articulated wire 142. Pulling the second end of the articulated wire 142 proximally may cause the second side of the articulated joint 109 to be pulled proximally, and 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 articulated actuator 136 has been described and shown as a lever mechanism that can be moved or pushed up or down, other or alternative mechanisms may also be used, such as, for example, a sliding mechanism, a rotating mechanism, a pushing mechanism, etc.

[0043] As discussed previously, the instrument actuation mechanism 146 can include an instrument actuator 148. At least a portion of the instrument actuator 148 can be disposed within a track 149 external to the housing 103 of the handle 102, such that the operator can interact with and move the instrument actuator 148 along the track 149 between a first position 150 and a second position 152 as shown respectively in Figure 1A and Figure 1B In some examples and as shown, the track 149 external to the housing 103 can follow the contour of the handle 102 in the region where the first housing portion 103A and the second housing portion 103B are joined. In other examples, the handle 102 (e.g., the first housing portion 103A or the second housing portion 103B) can include a custom slot in which the instrument actuator 148 can be disposed.

[0044] The instrument actuation mechanism 146 can also include a driver 154 within the interior of the housing 103, as shown in Figure 1C and Figure 1D The driver 154 can be connected to an interior portion of the instrument actuator 148 via a linkage 156. The linkage 156 can be a rigid linkage having a first pivot attached to the driver 154 and a second pivot attached to the interior portion of the instrument actuator 148. In some examples and as shown in Figure 1DAs shown, when the instrument actuator 148 moves between the first position 150 and the second position 152, the driver 154 can be disposed within the inner track 158 and configured to move along the inner track 158 (e.g., defined within the inner surface of the housing 103). The proximal end 130 of the integrated instrument 128 can be attached to the driver 154. The integrated instrument 128 can extend from the driver 154 into the connector 166 via the instrument connector port 172 of the connector 166, and extend into the proximal end 106 of the tube 104 via the distal opening 168 of the connector 166. Then, the integrated instrument 128 can extend from the proximal end 106 to the distal end 108 of the tube 104 within at least one lumen of the tube 104. Based on the position of the instrument actuator 148, the integrated instrument 128 can extend or retract relative to the tube 104. In some examples, the instrument connector port 172 of the connector 166 can include a seal to facilitate the extension and retraction of the integrated instrument 128 when the instrument actuator 148 is moved by the operator.

[0045] When the medical device 100 is in the first configuration in which the instrument actuator 148 is in the first position 150 (as Figure 1A shown), the distal end 132 of the integrated instrument 128 can be retracted relative to the tube 104. For example, the driver 154 and the proximal end 130 of the integrated instrument 128 can be in the most proximal position within the handle 102, and the distal end 132 of the integrated instrument 128 can be in a collapsed state and positioned within the articulated joint 109 located at the distal end 108 of the tube 104. When the instrument actuator 148 is moved by the operator between the first position 150 and the second position 152, the driver 154 and the integrated instrument 128 move correspondingly in the distal direction, causing the distal end 132 of the integrated instrument 128 to extend distally from the tube 104 via the distal opening 114 in the cap 110 and transition to the expanded state, as shown in Figure 1B the second configuration of the medical device 100. The expanded state of the integrated instrument 128 can enable an object of interest to be acted upon (e.g., captured) during a medical procedure.

[0046] As discussed previously, in some examples, the distal opening 114 can be sized and / or shaped to lock the orientation of the integrated instrument 128 in the expanded state relative to the medical device 100 to facilitate rotation of the integrated instrument 128. For example, when the integrated instrument 128 is a snare, the widest portion 115 of the distal opening 114 can receive and secure the wire of the snare (e.g., at least partially based on the radial strain of the wire of the snare), such that rotation of the medical device 100 corresponds to rotation of the snare. As a result, if an operator desires to rotate the snare to achieve a better position to capture an object of interest, such as a PEG wire during PEG, the operator can simply rotate the medical device 100 with his hand in the desired direction (e.g., rather than having to actuate a separate rotation control mechanism), and the snare will rotate correspondingly.

[0047] Once the object of interest is positioned relative to the integrated instrument 128 such that the object of interest can be captured (e.g., once 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 collapsed state and at least partially retract the integrated instrument 128 relative to the tube 104. In some cases, based on the size and / or shape of the object of interest, the integrated instrument 128 may not be able to return to the fully collapsed state and / or fully retract into the tube 104 via the distal opening 114. In such cases, the instrument actuator 148 can be moved from the first position 150 toward the second position 152 until the object of interest contacts a point on the distally 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 can be a single-use or disposable device and can thus be discarded once removed. Although the instrument actuator 148 is described herein as a sliding machine hook that can move between the first position 150 and the second position 152, additional or alternative mechanisms can be used, such as, for example, rotational machinery, push mechanisms, lever mechanisms, and the like.

[0048] During the entire medical procedure, an imaging system (including imaging device 120 and illumination device 122) located at the distal end 108 of the tube 104 can be used to provide visualization of the procedure to the operator. As previously described, when the medical device 100 is connected to the control unit via the external cable 124, the imaging device 120 and the illumination device 122 can transmit and / or receive signals from the control unit (not shown). The signals can be transmitted and / or received by the imaging device 120 via the first line 121 or cable (optical fiber or another type of cable) that communicatively couples the imaging device 120 to the control unit. The signals can be transmitted and / or received by the illumination device 122 via the second line 123 or cable (optical fiber or another type of cable) that communicatively couples the illumination device 122 to the control unit. The first line 121 attached to the imaging device 120 and the second line 123 attached to the illumination device 122 can extend proximally through the tube 104 to the handle 102 via the distal opening 168 of the connector 166. Then, the first line 121 and the second line 123 can leave the handle 102 via the imaging system connector port 174 of the connector 166, and the imaging system connector port 174 feeds the first line 121 and the second line 123 into the external cable 124 via the imaging system entry port 125 of the housing 103 ( Figure 1A , Figure 1B and Figure 1C ). In some examples, the imaging system connector port 174 can include a seal to facilitate feeding (e.g., by holding) the first line 123 and the second line 123 into the external cable 124.

[0049] During a medical procedure, the fluid device 160 can also be used for insufflation and / or applying suction, etc. The proximal end 162 of the fluid device 160 can include an umbilical tube (not shown) positioned outside the housing 103, which can be connected to a fluid supply source (not shown), and the distal end 164 of the fluid device 160 can be connected to the fluid connector port 176 of the connector 166. As a result, the fluid supplied from the fluid supply source can be directed through the fluid device 160, enter the connector 166 via the fluid connector port 176, and enter the tube 104 via the distal opening 168 of the connector 166, where the fluid can further travel through the tube 104 to supply the fluid to the patient's body via the distal opening 114. Additionally and / or alternatively, the proximal end of the fluid device 160 can be connected, for example, via an umbilical tube to a vacuum source (not shown) to apply suction and enable the fluid from the patient's body to be suctioned into the tube 104 via the distal opening 114. As discussed previously, the distal opening 114 can be sized and shaped (e.g., clamshell-style) to increase the surface area of the distal opening 114 to improve the fluid performance of the medical device 100. For example, the increased surface area of the clamshell-style size and shape on a generally circular design can allow for the supply of fluid and / or the application of suction at a greater rate and / or pressure.

[0050] In some embodiments, the medical device 100 may be configured to receive accessory devices, tools, and / or instruments that are separate from the medical device 100 (e.g., not integrated within and / or controlled by the medical device 100). In such an example, the exterior of the housing 103 may include a working lumen access 180 that is connected to a working lumen connector port 178 of a connector 166 within the interior of the housing 103. The working lumen connector port 178 may receive accessory devices, tools, and / or instruments inserted into the medical device 100 via the working lumen access 180 for delivery via a distal opening 168 of the connector 166 into a working lumen of the tube 104. In some examples, the working lumen may be the same lumen in which the integrated instrument 128 is disposed, fluid is supplied, and / or aspiration is applied. In other examples, the tube 104 may include more than one working lumen, and the working lumen access 180 may provide access to a first working lumen, where the integrated instrument 128 is located in a second working lumen. Fluid and / or aspiration may be delivered and / or applied through one or both of the first and second working lumens. The accessory device, tool, and / or instrument may extend distally through the working lumen of the tube 104 and through a distal opening 114 to a desired location within a patient's body. The accessory device, tool, and / or instrument may then be operated using controls of the respective accessory device, tool, and / or instrument and removed from the medical device 100 once the associated tasks or steps of a medical procedure are completed. In some embodiments, when the integrated instrument 128 is the only instrument required or anticipated for a medical procedure, the medical device 100 may not include the working lumen access 180 because such an access is not necessary, and the connector 166 may not include the working lumen connector port 178.

[0051] Now refer to Figure 4 , using Figures 1A to 1DAn exemplary process 400 for performing a medical procedure using a medical device 100 may include steps 402 to 410. The medical procedure performed using the medical device 100 may include an exemplary PEG procedure after percutaneous tracheostomy. At step 402, the process 400 includes inserting at least a distal portion of the tube 104 of the medical device 100 into a patient. To perform a PEG procedure after percutaneous tracheostomy, the distal portion of the tube 104 (including the distal end 108) may be advanced by an operator of the medical device 100 into the patient's stomach. The operator may be positioned near the patient's head. In some aspects, a insufflation technique may be performed, in which a fluid supply source may be connected to the proximal end 162 of the fluid device 160 (e.g., the umbilical tube) to force gas through the fluid device 160, into the tube 104 via the connector 166, and into the patient's stomach via the distal opening 114. The insufflation may cause the juxtaposition of the stomach wall and the abdominal wall. The medical device 100 may be connected to the control unit via an external cable 124, and the tube 104 may be positioned within the stomach such that the illumination device 122 of the imaging system may emit light towards the abdominal wall to allow for transmitted illumination of light through the abdominal wall, which may be sensed outside the body.

[0052] An operator positioned near the patient's abdomen for placing a PEG tube, also referred to as the PEG operator (e.g., typically an operator different from the operator of the medical device 100) may palpate the abdominal wall. The palpation may be captured by the imaging device 120 of the imaging system, and the corresponding image processed by the control unit may be displayed on a display device of or associated with the control unit to allow visualization and confirmation of the puncture location. The PEG operator may insert a needle with a trocar into the puncture location, for example, using visualization from the imaging system (e.g., the imaging device 120 and the illumination device 122) of the medical device 100. The needle may be removed, and the PEG wire may be inserted by the PEG operator via the trocar.

[0053] At 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 and transition to an expanded state. For example, prior to or concurrently with inserting the PEG line, an operator of the medical device 100 can move the instrument actuator 148 from the first position 150 to the second position 152 such that the driver 154 correspondingly moves the 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 line, e.g., when it is inserted into the stomach via the cannula. The operator of the medical device 100 can rotate the medical device 100 (e.g., the handle 102 and the tube 104) as needed to correspondingly rotate the integrated instrument 128 to better position the distal end 132 of the integrated instrument 128 relative to the PEG line.

[0054] At step 406, process 400 includes using the distal end 132 of the integrated instrument 128 in the expanded state to capture an object of interest (e.g., a PEG line). In some examples, the operator of the medical device 100 can rotate, extend, or retract or otherwise manipulate the integrated instrument 128 to position the object within and / or adjacent to the distal end 132 of the integrated instrument 128.

[0055] At step 408, process 400 includes moving the instrument actuation mechanism (e.g., instrument actuator 148) from the second position (i.e., second position 152) toward the 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 and transition to at least a partially collapsed state. For example, once the PEG line is captured with the distal end 132 of the integrated instrument 128, the operator of the medical device 100 can 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 at least a partially collapsed state, which can help secure the PEG line. At step 410, process 410 can include removing the medical device 100 from the patient's body. For example, the entire medical device 100 can be removed from the patient's body, which also removes the PEG line from the patient's body. Any remaining steps of the procedure (e.g., not using the medical device 100) can be completed. The medical device 100 can be a single-use device that is subsequently discarded.

[0056] The above-described process 400 is provided only as an example and may include additional, fewer, different, or differently arranged steps than those depicted in Figure 4 and described above. Moreover, the steps of process 400 may be performed with one or more of the medical devices described herein (i.e., medical device 200 or medical device 300).

[0057] Based on integrating the integrated instrument 128 and the instrument actuation mechanism 146 into the medical device 100 (e.g., as opposed to a conventional separate attachment device having a separate control that is inserted into and fed through the working lumen of the medical device 100), there is no longer a need for an assistant to operate the medical device 100 (although a second operator located near the patient's abdomen may still be utilized to place the PEG tube). A single operator of the medical device 100 may actuate the instrument actuator 148 of the instrument actuation mechanism 146 to extend and retract the integrated instrument 128 relative to the tube 104 to transition between collapsed and expanded states and / or rotate the medical device 100 to rotate the integrated instrument 128. In some service environments, such as in an intensive care unit bedside environment where there is limited space for two operators to stand side by side, especially near the patient's head, eliminating the assistant for operating the medical device 100 may be crucial.

[0058] Although the specific application of the medical device 100 described herein is associated with a PEG procedure following percutaneous tracheostomy, the medical device 100 is not limited to this application. For example, the medical device 100 may be used for any procedure in which an instrument that is typically a separate device or attachment is inserted into and delivered to a location within a patient through the working lumen of the medical device. As a specific example, the medical device 100 may be used to perform a foreign body retrieval procedure. For example, a patient may have swallowed an object, such as, for example, a paperclip, and the medical device 100 may have an integrated snare, basket, net, or other similar instrument that may be used to retrieve the object.

[0059] Figures 2A to 2D A block diagram of another exemplary medical device 200 for performing a medical procedure is depicted. The medical device 200 is similar to the medical device 100, except that the medical device 200 includes a sheath 202 that is separate from the lumen of the tube 104 and the integrated instrument 128 is disposed within the sheath 202. The sheath 202 may be a hollow tubular member having a first proximal opening and a second distal opening. Based on including the sheath 202, the medical device 200 also has a different instrument actuation mechanism 204 for controlling the extension and retraction of the sheath 202 and the integrated instrument 128 (e.g., replacing the instrument actuation mechanism 146 of the medical device 100).

[0060] The actuation mechanism 204 can include a sheath actuator 206 disposed within a sheath track 208, and the sheath actuator 206 can be coupled to the proximal end of the sheath 202. The coupling can include direct coupling or indirect coupling (e.g., via one or more intermediate structures). The sheath actuator 206 can be in a first position 210 within the sheath track 208 ( Figure 2A and Figure 2B ) and a second position 212 ( Figure 2C and Figure 2D ) to extend and retract the sheath 202, which has the integrated instrument 128 disposed therein, relative to the tube 104. The actuation mechanism 204 can further include an instrument actuator 214 disposed within an instrument track 216, and the instrument actuator 214 can be coupled to the proximal end 130 of the integrated instrument 128. The instrument actuator 214 can be in a third position 218 within the instrument track 216 ( Figure 2A 、 Figure 2B and Figure 2C ) and a fourth position 220 ( Figure 2D ) 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 collapsed state and an expanded state. The instrument track 216 can be a portion of the sheath track 208 defined by the sheath actuator 206 (e.g., the instrument track 216 can be surrounded by the sheath actuator 206).

[0061] Figure 2A Depicts a top view of the medical device 200 in a first configuration, and Figure 2B depicts a side view thereof. In the first configuration of the medical device 200, the sheath actuator 206 can be in the first position 210 within the sheath track 208, and the instrument actuator 214 can be in the third position 218 within the instrument track 216. As a result, in the first configuration of the medical device 200, both the sheath 202 and the integrated instrument 128 are retracted relative to the tube 104, and the integrated instrument 128 is retracted relative to the sheath 202, e.g., in a collapsed state. The distal end 203 of the sheath 202 can be positioned at the distal end 108 of the tube 104 (e.g., within the articulation joint 109).

[0062] Figure 2CDepicts a top view of the medical device 200 in a second configuration after the operator moves the sheath actuator 206 within the sheath track 208 from a first position 210 to a second position 212. In the second configuration, as a result of the operator's movement, at least the distal end 203 of the sheath 202 in which the integrated instrument 128 is disposed can extend relative to the tube 104. For example, the sheath 202 can extend distally beyond the tube 104 via the distal opening 114 in the cap 110. Based on the instrument actuator 214 remaining in the third position 218 within the instrument track 216, when the medical device 200 is in the second configuration, the distal end 132 of the integrated instrument 128 can remain retracted relative to the sheath 202 in a collapsed state.

[0063] Figure 2D Depicts a top view of the medical device 200 in a third configuration after the operator moves the instrument actuator 214 within the instrument track 216 from a third position 218 to a fourth position 220 (and simultaneously the sheath actuator 206 remains in the second position 212). In the third configuration, at least the distal end 132 of the integrated instrument 128 can extend relative to the sheath 202 and can transition from a collapsed state to an expanded state. For example, the distal end 132 of the integrated instrument 128 can extend distally from the distal end 203 of the sheath 202 via the distal opening in the sheath 202.

[0064] Once the object of interest is positioned relative to the distal end 132 of the integrated instrument 128 in the expanded state (i.e., within the distal end 132), the operator can move the instrument actuator 214 from the fourth position 220 toward the third position 218. The movement of the instrument actuator 214 from the fourth position 220 toward the third position 218 can cause the distal end 132 of the integrated instrument 128 to at least partially retract relative to the sheath 202 and cause the distal end 132 of the integrated instrument 128 to transition from the expanded state to at least a partially collapsed state to secure the object of interest. In some examples, the operator can move the sheath actuator 206 from the second position 212 toward the first position 210 simultaneously or sequentially before removing the entire medical device 200 from the patient's body to cause the sheath 202 and the integrated instrument 128 to at least partially retract relative to the tube 104. Alternatively, the operator can instead remove the entire medical device 200 from the patient's body without causing the sheath 202 and the integrated instrument 128 to partially retract relative to the tube 104. In some examples, the medical device 200 can include one or more locking features to secure 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).

[0065] By including a dedicated sheath, such as sheath 202 in which integrated instrument 128 is disposed within medical device 200, the operating domain can be expanded to include the length of sheath 202, which can be up to the length of handle 102, and the length of integrated instrument 128 when extending 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 at least a partially collapsed state, sheath 202 can assist in achieving a tighter and / or more secure closure of the object of interest by integrated instrument 128 within the collapsed state. In these respects, when medical device 200 is removed from a patient's body, sheath 202 can assist in providing a more secure grip on the object of interest.

[0066] Medical device 200 can be used to perform a medical procedure using similar steps described above with reference to Figure 4 process 400. One or more additional steps can be included, as described above, taking into account the differences in instrument actuation mechanism 204 of medical device 200.

[0067] Figures 3A to 3C A perspective view of a distal portion of a further exemplary medical device 300 for performing a medical procedure is depicted. Medical device 300 is similar to Figures 1A to 1D medical device 100 described therein, except that the integrated instrument is wire 302, which forms a loop or snare that can be transitioned between a collapsed state and an expanded state using an instrument actuation mechanism, such as instrument actuation mechanism 146, based on integrating wire 302 within medical device 300. Although the term "wire" is used herein for wire 302, it should be understood that the present invention also includes cables, threads, or other similar structures. For example, the most distal end 304 of wire 302 can be attached to the distally facing surface 112 of cap 110 at a fixed point 306. Wire 302 can extend from fixation at 306 through an opening 308 in cap 110 into tube 104. In some examples, opening 308 can correspond to a wire lumen separate from the lumen corresponding to distal opening 114. In other examples, opening 308 can be connected to the same lumen corresponding to opening 114. Wire 302 can continue to extend from tube 104 through the distal opening 168 of connector 166 into handle 102 and exit via instrument connector port 172, where the proximal most end of wire 302 (not shown) is to be attached to driver 154 ( Figure 1C and Figure 1D ). As previously referenced Figures 1A to 1DAs described, the driver 154 may be connected to the inner portion of the instrument actuator 148 by a linkage 156. Thus, when the instrument actuator 148 is moved by an operator between a first position 150 and a second position 152, the driver 154 and the wire 302 move accordingly to extend and / or retract a portion of the wire 302 through the opening 308, so that the loop or snare formed by the wire 302 at the distal end of the medical device 300 is switched between a collapsed state and an expanded state. In some examples, the portion of the wire 302 within the tube 104 and / or the handle 102 (e.g., the portion of the wire 302 that is positioned more proximally and does not extend through the opening 308 when the wire 302 is in a fully expanded state) may be enclosed within a compression cable.

[0068] In the medical device 300, the opening 308 may be an opening separate from the distal opening 114, and the wire 302 extends through the opening 308. Additionally, in some examples and as Figures 3A to 3C shown, the fixed point 306 and the opening 308 may be positioned equidistantly on either side of the distal opening 114 and offset from the distal opening 114, which may help prevent the wire 302 from blocking the distal opening 114. Thus, other accessory devices, tools, or instruments separate from the medical device 300 that can be used in a medical procedure may be inserted into the working cavity passage 180, through the working cavity connector port 178 via the connector 166, and into the tube 104 via the distal opening 168 of the connector 166, e.g., as discussed above with respect to Figure 1C Then, the other accessory devices, tools, or instruments may extend through the tube 104 to be delivered to the intended location within the patient's body via the distal opening 114 without being blocked by the wire 302. Additionally, the fluid supplied via the fluid device 160 and / or the applied suction is not blocked by the wire 302. Furthermore, the wire 302 does not impair the visibility of the imaging device 120 and / or the illumination of the lighting device 122.

[0069] Figure 3A The distal portion of the medical device 300 in a first configuration is depicted, where the loop or snare formed by the wire 302 is in a collapsed state, e.g., based on the instrument actuator 148 being in the first position 150. For example, in the collapsed state, the portion of the wire 302 extending between the distal end 304 of the wire 302 and the opening 308 may at least partially contact the distally facing surface 112 of the cap 110. Figure 3BDepicts the distal portion of the medical device 300 in a second configuration, where the loop or snare formed by line 302 is in an expanded state, e.g., based on movement of the instrument actuator 148 from a first position 150 to a second position 152. For example, movement of the instrument actuator 148 to the second position 152 causes the driver 154 to move line 302 distally accordingly, such that the portion of line 302 previously positioned within the distal end 108 of the tube 104 extends distally from the opening 308 to transition line 302 to the expanded state (e.g., form a larger loop or snare). Once the operator positions an object of interest relative to line 302 in the expanded state, the operator can move the instrument actuator 148 from the second position 152 toward the first position 150 to transition line 302 back to at least a partially collapsed state (as Figure 3A shown) to assist in securing the object with line 302. For example, in the partially collapsed state, line 302 can secure the object such that the object at least partially contacts the distally facing surface 112 of the cap 110.

[0070] Figure 3C Depicts an alternative configuration of the distally facing surface 112. In this alternative configuration, the distally facing surface 112 can include a longitudinal recess 310 positioned between the fixed point 306 and the opening 308. The recess 310 can be configured to receive at least a portion of an object 312 retrieved during a medical procedure (such as a PEG line during 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 to allow the distally facing surface 112 to have a larger cross-sectional area to contact the object 312 to assist in providing a more secure grip on the object 312 when subsequently removing the medical device from the patient.

[0071] As referenced above Figures 3A to 3CAs described, the medical device 300 has unilateral actuation controlled via the instrument actuation mechanism 146. With unilateral actuation, the entire length of the wire 302 required to transition the wire 302 from the collapsed state to the expanded state extends from the opening 308, which can result in a longer stroke length for the instrument actuator 148. To reduce the stroke length (e.g., by half), the medical device 300 can be modified to have bilateral actuation. In such an alternative aspect, instead of the distal end 304 of the wire 302 being attached to the distally facing surface 112 at the fixed point 306, the distally facing surface 112 can include another opening at the location of the fixed point 306, and the distal end 304 of the wire 302 can extend through the other opening into the tube 104. For clarity, when describing the bilateral actuation alternative, the distal end 304 of the wire 302 is now referred to as the second end of the wire 302, which is opposite the first end of the wire 302 that was previously referred to as the proximal end of the wire 302. The second end of the wire 302 can continue to extend from the tube 104 through the distal opening 168 of the connector 166 into the handle 102 and out through the instrument connector port 172, where the second end of the wire 302 is then attached to the instrument actuation mechanism.

[0072] In some examples, the second end of the wire 302 can be attached to the same instrument actuation mechanism as the first end of the wire 302. For example, both the first end and the second end of the wire 302 can be attached to the actuator 154 of the instrument actuation mechanism 146 ( Figure 1C and Figure 1D ). Thus, the operator can move a single instrument actuator 148 to extend the wire 302 distally from both the opening 308 and the other opening simultaneously to transition the wire 302 to the expanded state with a stroke length that is half as long.

[0073] In other examples, the handle 102 can include another instrument actuation mechanism similar to the instrument actuation mechanism 146, where the first end of the wire 302 can be attached to the instrument actuation mechanism 146 and the second end of the wire 302 can be attached to the other instrument actuation mechanism. The operator can actuate two separate instrument actuation mechanisms to extend the wire 302 from the opening 308 and the other opening to transition the wire 302 to the expanded state with a stroke length that is half as long. In some examples, the two separate instrument actuation mechanisms can be actuated simultaneously to extend substantially equal amounts of the wire 302 from each of the opening 308 and the other opening. In other examples, the two separate instrument actuation mechanisms can be actuated separately to selectively extend different amounts of the wire 302 from each of the opening 308 and the other opening (e.g., to expand the position of the loop formed by the wire 302 relative to the opening, where a greater amount of the wire 302 extends from that opening to, for example, better access an object).

[0074] The medical device 300 can be used using the above reference Figure 4Perform a medical procedure by the same or similar steps described in process 400. In some examples, as part of at least one of steps 406, 408, and / or 410, an object of interest (e.g., a PEG wire) captured at step 406 may be retained within recess 310. Additionally, in examples where the 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), at steps 404 and 408, one and / or both of the instrument actuation mechanisms may be moved between a first and a second position.

[0075] Although the principles of the present invention are described with reference to illustrative examples directed to a particular application, it should be understood that the present invention is not limited thereto. Those of ordinary skill in the art and those who are able to obtain the teachings provided herein will recognize that additional modifications, applications, and substitutions of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be regarded as limited by the foregoing description.

Claims

1. A medical device, which comprises: 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, the cap having a distal opening corresponding to the lumen; an imaging system positioned on the distally facing surface of the cap; an instrument at least partially disposed in the lumen, the instrument being 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, wherein the proximal end of the instrument is attached to the instrument actuation mechanism, and the instrument actuation 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, wherein when the instrument actuation mechanism is in the first position, the distal end of the instrument is retracted relative to the tube in a collapsed state, and wherein when the instrument actuation mechanism is in the second position, the distal end of the instrument extends relative to the tube in an expanded state.

2. The medical device according to claim 1, wherein the distal end of the tube includes a hinge joint, and when the instrument actuation mechanism is in the first position, the distal end of the instrument is positioned within the hinge joint.

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

4. The medical device according to any one of claims 1 to 3, wherein the instrument extends relative to the tube via the distal opening, and the distal opening includes a clamshell shape to lock the orientation of the instrument relative to the medical device when the instrument extends.

5. The medical device according to any one of claims 1 to 4, further comprising a connector disposed within the single handle, wherein the connector includes: a plurality of connector ports, wherein at least one of the plurality of connector ports includes an instrument connector port configured to receive the instrument from the instrument actuation mechanism; and a distal opening that connects the single handle to the proximal end of the tube, wherein the instrument received via the instrument connector port extends into the lumen of the tube via the distal opening.

6. The medical device according to any one of claims 1 to 5, wherein the instrument actuation mechanism includes an instrument actuator, a linkage, and a driver configured to move between the first position and the second position, the driver being connected to the instrument actuator via the linkage, and the proximal end of the instrument being attached to the linkage.

7. The medical device according to any one of claims 1 to 5, further comprises: a sheath at least partially disposed within the lumen, wherein the instrument is disposed within the sheath.

8. The medical device according to claim 7, wherein the instrument actuation mechanism includes: A sheath actuator that extends and retracts the sheath in which the instrument is disposed relative to the tube; and An instrument actuator that extends and retracts the instrument relative to the sheath to transition the instrument between the collapsed state and the expanded state.

9. The medical device according to any one of claims 1 to 5, wherein: The instrument is a wire, A first end of the wire is attached to a fixed point on the distally facing surface of the cap, The wire extends from the fixed point through the tube, through a second distal opening of the cap that is different from the distal opening corresponding to the cavity, and into the handle, and A second end of the wire opposite the first end of the wire is attached to the instrument actuation mechanism.

10. The medical device according to claim 9, wherein: When the instrument actuation mechanism is in the first position, a first portion of the wire from the fixed point to the second distal opening forms a loop in the collapsed state, the loop at least partially contacting the distally facing surface; and When the instrument actuation mechanism is in the second position, a second portion of the wire extends from the tube through the second opening to transition the loop to the expanded state.

11. The medical device according to claim 10, wherein, The distally facing surface of the cap includes a recess disposed between the fixed point and the second distal opening, the recess being configured to receive and secure an object captured by the instrument.

12. The medical device according to any one of claims 1 to 5, wherein: The instrument is a wire, A first end of the wire extends through the tube, through a second distal opening of the cap that is different from the distal opening corresponding to the cavity, and into the handle to be attached to the instrument actuation mechanism, and A second end of the wire extends through the tube, through a third distal opening in the cap that is different from the distal opening corresponding to the cavity and the second distal opening, and into the handle to be attached to the instrument actuation mechanism.

13. The medical device according to claim 12, wherein: When the instrument actuation mechanism is in the first position, a first portion of the wire from the second distal opening to the third distal opening forms a loop in the collapsed state, the loop at least partially contacting the distally facing surface; and When the instrument actuation mechanism is in the second position, a second portion of the wire extends from the tube through the second opening, and a third portion of the wire extends from the tube through the third opening to transition the loop to the expanded state.

14. The medical device according to any one of claims 1 to 13, wherein, The single handle further includes a fluid device having a proximal end connectable 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 fluid device being configured to supply fluid to or apply suction to a patient's body via the distal opening.

15. The medical device according to any one of claims 1 to 14, wherein, the imaging system includes an imaging device positioned within an imaging port on the distally facing surface of the cap, and an illumination device positioned within an illumination port on the distally facing surface of the cap.

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