DEVICE FOR ASSISTING IN POSITIONING AND SECURING ENDOSCOPE DURING GASTROINTESTINAL PROCEDURES - Patent application

Abstract

A medical instrument including an integral arm extending from a proximal end to a distal end and a handpiece having an actuator for controlling movement of the arm. The instrument includes an insertion tube having an arm channel for receiving the arm. Each arm includes an engagement member at its distal end made of a resilient material that assumes a natural non-linear configuration when deployed and deforms when retracted into the arm channel when retracted. The arm channels may be positioned at different radial distances from one another within the insertion tube such that the engagement members may be at a radial angle relative to one another when deployed. The arms and engagement members are movable relative to one another between at least first and second positions by rotational and / or translational movement of corresponding actuators to contact tissue or deflect a tool extended through a working channel of an endoscope.

Description

[Technical field]

[0001] [Priority claim] This application claims priority to U.S. Provisional Patent Application No. 63 / 285,241, filed December 2, 2021, and U.S. Patent Application No. 17 / 839,989, filed June 14, 2022, the entire contents of which are incorporated by reference herein.

[0002] [Statement regarding federally sponsored research or development] This invention was made with government support under award no. 1353176 from the National Science Foundation and award no. DK117813 from the National Institutes of Health. The Government has certain rights in this invention.

[0003] [Technical field] The present invention relates to devices for interfering with tissue, and more particularly to low-cost, disposable devices with integrated features for grasping, holding, and manipulating tissue or tools during intracorporeal procedures. [Background technology]

[0004] [Background of the invention] The identification and treatment of disease and injury within the gastrointestinal (GI) system is a major area of ​​health care. In the United States alone, hospitalized care for acute GI bleeding and colon cancer is estimated to cost more than $2.5 billion and $5.5 billion, respectively. Annual deaths total approximately 80,000. Identification and intervention of pathologies is typically treated in a minimally invasive manner using endoscopic techniques and devices. It is estimated that in 2009, more than 55 million endoscopic procedures were performed with endoscopic devices, of which approximately 50% were colonoscopies.

[0005] An endoscope is a minimally invasive device that allows the physician to access the gastrointestinal system through naturally occurring orifices (such as the mouth or rectum) for diagnosis and / or intervention or treatment. Endoscopes are typically flexible tubes up to 2 meters in length that incorporate deflection capabilities, optical or digital display, and several internal channels, including irrigation and illumination channels, and one or two "working" channels. Direct engagement with internal organs allows for localized diagnosis or intervention with minimal collateral damage to surrounding tissues compared to open surgery, but there are limitations to visibility and control of instruments. This is the root cause of many missed diagnoses and incomplete treatments.

[0006] Transiting the gastrointestinal (GI) system is challenging due to the complex pathways, elasticity of tissues, and surface topology of mucosal surfaces. In the lower GI tract, rugged "folds" that can be up to 1 cm high often hide lesions from the colonoscope as it is retracted. This occurs because the endoscope must be retracted beyond an area before the area becomes visible. When the endoscope is retracted beyond this point, the endoscope can no longer hold the fold, and the fold everts, obscuring the area in front of the fold. This can result in the physician failing to detect lesions in that area. Depending on the size and type of lesion, the missed diagnosis rate has been reported to be 21-31%, which translates to approximately 500,000 missed diagnoses per year. Additionally, biopsies and interventions may be affected as well, and interventions may require open surgery, increasing the risk of infection and complications from general anesthesia.

[0007] Gastrointestinal (GI) bleeding, which is caused by tissue damage, is one of the most difficult GI diseases to treat due to the complex pathway to the treatment site, the obstruction of the target view by bleeding, and the interruption of continuous treatment due to the patient's physiological movements (respiration and peristalsis). These obstacles can lead to rebleeding if they limit the maneuverability of the endoscope, insufficient treatment time for permanent hemostasis, or inaccurate placement of the treatment on the treatment target. Even if bleeding is temporarily stopped, later rebleeding or recurrent rebleeding may occur, which can lead to increased operative time and higher readmission rates. Rebleeding affects 15-20% of patients and is associated with a tenfold increased risk of mortality.

[0008] To address the problem of underdetection of gastrointestinal (GI) diseases and injuries, several new technologies and techniques have been developed. For example, the viewing angle of endoscopes has been expanded from 90 degrees to 140 degrees, and more recently to 170 degrees, decreasing the amount of superficial tissue that cannot be viewed by the endoscope. Reverse rotation and reverse bending have both been employed to bend and rotate the endoscope backwards in the GI tract to view in a retrograde direction. Separate reverse endoscopes have been developed to advance through the working channel of the colonoscope to view the colon retrogradely. However, using the working channel for this purpose reduces therapeutic capabilities since only one tool can be used at a time in one working channel. Although tools are interchangeable, the endoscope can become displaced and lose position due to loss of vision. Furthermore, patient movement, GI peristalsis, and other body movements make it very difficult to maintain position during procedures using these medical instruments. Physicians often spend minutes searching for lost targets, reducing the accuracy and effectiveness of detection, diagnosis, and treatment.

[0009] Current endoscope designs incorporate many expensive parts. For this reason, they are designed as reusable devices. However, these devices are difficult to thoroughly clean and disinfect, leading to problems with cross-contamination. Certain procedures, such as endoscopic submucosal dissection (ESD), are complex treatments that are difficult to perform and often require specialized training of the physician. During such procedures, the physician uses the working channel of the endoscope to bring (move) specialized tools to the working end of the endoscope to cut and remove tissue suspected to be malignant, creating a single flap that contains the suspicious tissue. This flap is difficult to cut and manipulate, making it inefficient or impossible to achieve the desired surgical outcome with a single device.

[0010] To solve this problem, other endoscopes incorporate additional channels or tools to aid in multitasking at the working end of the endoscope, allowing multiple manipulations of tissue simultaneously. These embodiments include the dual channel endoscope, the R-Scope, the EndoSamurai®, and the ANUBIScope. These endoscopes incorporate several miniaturized mechanisms and complex features at the distal end of the endoscope. This complexity increases the difficulty of properly cleaning and disinfecting a reusable multitasking endoscope. Furthermore, these complex and expensive features are not suitable for disposable embodiments. In the latter, keeping manufacturing costs low is a key driver of the design.

[0011] Thus, there is a need for a device that can grasp and manipulate tissue, navigate to a bleeding or surgical site, and hold in place while a procedure is being performed without adversely affecting the procedure or tissue or requiring the use of the working channel of an endoscope. There is also a need for a device that overcomes the aforementioned obstacles of complexity, cost, and cleaning, and provides improved capabilities for manipulating both anatomical tissue and other tools. Summary of the Invention

[0012] The present invention relates generally to a device that may be used to interact with tissue inside a patient's body, such as to grasp or manipulate tissue, and that may be used to assist in positioning and fixation of the distal end of a medical instrument, such as an endoscope. In one embodiment, the device may be removably attached to an endoscope in a manner that does not interfere with the working channel of the endoscope, allowing the physician to continue to fully use the working channel of the endoscope.

[0013] After the general target area in the GI tract is reached by standard manipulation and macro positioning, the device may be used to manipulate and grasp tissue, fine-tune the position of the endoscope, or move tissue. The additional control provided by the device is beneficial in a variety of GI procedures, such as removing polyps, repairing GI bleeding, sectioning tissue, etc. For example, the device of the present invention allows tissue to be moved so that it does not obstruct the lens of the endoscope, allowing the physician to better visualize the tissue and / or lesions thereon, allows folds and other biological structures to be moved out of the way of devices deployed through the working channel, or allows tissue to be grasped and retracted during a biopsy procedure.

[0014] The additional contact and / or grip provided by the present invention may also be used to maintain position or fixation of the distal tip of the endoscope, thereby overcoming other muscular contraction movements, such as peristalsis and breathing, which may interfere with the clinical procedure and lead to lost time due to repositioning the endoscope.

[0015] The device thus includes a body at a distal end and a handpiece at a proximal end. The body includes a main channel configured to receive the distal end of a medical instrument, such as an endoscope. The body may be at least partially circumferentially disposed about an exterior surface of the working end of the endoscope. Thus, the device does not interfere with the working end of the endoscope or additional medical instruments used therein.

[0016] The body also includes at least one arm channel configured to receive an arm therethrough. Preferably, there are two or more arms, each extending through a different arm channel in the body. The arms extend from a distal end of the device to a handpiece at a proximal end of the device. Each arm terminates in an engagement member at the distal end of the device and distal to the body. The engagement member is configured to engage tissue for manipulation, grasping, fixation, etc. The engagement member may be rigidly affixed to the end of the arm or may be integrally formed. Each arm may also include a bend, such as an elbow, that changes the direction or angle of the engagement member from the axis of the arm.

[0017] Each of the arms is selectively movable relative to the body, independent of the other arms. For example, each arm may be rotated by rotational motion about the arm's longitudinal axis. Each arm may also be moved longitudinally in a distal or proximal direction, collectively referred to as translational motion. As each arm moves, the attached participating member also moves. However, because a bend or elbow relative to the corresponding arm moves the participating member non-axially, rotational motion of the arm may move the attached participating member laterally across the axis of the arm. Lateral in this context may include an arcuate path.

[0018] Movement of the arms moves corresponding engagement members between a first position and a second position. In the first position, the engagement members are not in contact with tissue and may be considered an open position. In the second position, at least one of the engagement members is in contact with tissue. Furthermore, the distance between the engagement members in the second position is less than in the first position. Thus, the second position may also be referred to as a closed position. The closed position may be achieved by moving the arms by rotational motion, translational motion, or a combination of both. The distance between the engagement members may be decreased either laterally (i.e., transverse to the axis of the arms) or longitudinally. As the engagement members are brought closer together, the force they exert on the tissue they contact increases. Thus, in the second position, the engagement members may grasp, pinch, collect, hold, or otherwise support tissue between them. With sufficient force, the engagement members may grip or hold the tissue firmly enough to secure the attached endoscope in place. This can prevent slippage or loss of the target site during the medical procedure. The engagement members can be released from contact with the tissue. If desired, a reverse movement can be applied to the arms to move the engagement members to the first position, thereby releasing the tissue.

[0019] A handpiece at the proximal end of the device includes controls for manipulating the arm. The handpiece includes an actuator and at least one of a rotational adjustment mechanism and / or a translational adjustment mechanism. The actuator can be actuated, such as by rotating, pivoting, or sliding, which then moves components of the rotational and / or translational adjustment mechanisms depending on which adjustment mechanism is engaged with the actuator or the manner in which the actuator is actuated.

[0020] In some embodiments, one or more of the arms may be hollow and may include a lumen extending in fluid communication through the engagement member at the distal end and a connector for attachment to a fluid reservoir at the proximal end. Irrigation and / or suction may be provided via the fluid reservoir and thus via the hollow arms and corresponding engagement members. Thus, the device may provide irrigation and / or suction without blocking the working channel of the endoscope.

[0021] In additional embodiments, the device may be integrated with an endoscope, which in some embodiments may be disposable. The device includes an integrated retractable arm that is controllable by torque wire and / or finger manipulation, with controls integrated into the device itself. The device is comprised of a distal end of the device that is inserted into the patient, and a proximal end of the device that is closest to the physician or user of the device. The proximal end of the device has a handpiece and actuators that allow control of the device during use. An insertion tube extends from the proximal end of the integrated device and terminates in a distal working end with multiple channels extending therethrough. These channels may include a working channel and channels corresponding to other typical endoscope functions.

[0022] The insertion tube may also include at least one arm channel, preferably multiple arm channels, each extending through the insertion tube. The arm channels may extend through the insertion tube from a proximal end that interfaces with the handpiece and actuator to a distal end, and may be parallel to the working channel. An arm extends through each of the arm channels. Each arm extends along the length of the tube from the proximal end to the distal end, and is flexible enough to bend, flex, and twist along the insertion tube while the device is moved through the GI tract to the target site. Thus, the arms may be flexible and made of a flexible material such as, but not limited to, Nitinol or stainless steel.

[0023] The arms can be configured to accept rotation and transmit torque along their length, such as from the proximal end to the distal end of the device. For example, the arms can be rotated by a physician at the proximal end about their longitudinal axis relative to the working end. The torque imparted by the rotation at the proximal end is propagated through the length of the arm, causing the entire arm to move. Each arm can be rotated separately by the physician independently of the other arms of the device, or multiple arms can be rotated simultaneously, if desired.

[0024] A face at the distal end of the insertion tube terminates the tube and defines an arm channel, a working channel, and an opening for any other tools integral to the device. Various layouts for the positioning of the arms on the face may allow deflection of a tool inserted through the tissue or working channel. This deflection may decouple the motion of the working end of the device from the motion of the tool. This decoupling of motion may allow for procedures such as electrosurgical cutting to be performed in a linear fashion without deflection of the working end, which may shift the physician's viewpoint. Additionally, the ability to deflect a tool extending through the insertion tube using an arm may allow a physician to simplify a procedure by using only one device rather than multiple endoscopes with various other attachments or tools used to manipulate each other's tools.

[0025] Each arm is movable longitudinally along the length of the insertion tube within its respective arm channel. Such longitudinal movement may be selectively controlled by the user using an actuator at the proximal end to extend at least a portion of each arm, such as the arm's engagement member, beyond the face of the distal end when the arm is deployed, and retract the arm to be retained within the insertion tube when retracted. Importantly, the engagement member and / or arm are made of a resilient material that is deformable to conform to the shape of the arm channel when stored within the insertion tube, and can automatically return to its original (original) undeformed shape when deployed beyond the face of the distal end of the device. This allows the arms and engagement members to be stored within the working end of the tube during insertion of the medical device or when not required for surgery, and to be simply extended from the insertion tube to achieve its original non-linear configuration when in use. The material of the engagement member or entire arm may be any metal or polymer with significant elasticity and high yield strength, such as spring steel. It may preferably be made of nickel titanium, also known as nitinol. A material with sufficient elasticity exhibits the ability to undergo significant deformation under load and return to its original shape when the external load causing the deformation is removed. When the arms or at least the participating members are extended from the arm channel, such as during use during a procedure after reaching the target location, the arms or participating members return to their original shape. This means that the arms and / or participating members are not permanently deformed even when retracted into the channel.

[0026] The device and its particular features and advantages will become more apparent from the following detailed description and by reference to the accompanying drawings. [Brief description of the drawings]

[0027] [Figure 1A] FIG. 1A is an isometric schematic diagram of one embodiment of the distal end of a device of the present invention in relation to the distal end of an endoscope. [Figure 1B]FIG. 1B is an isometric view of the device of FIG. 1A showing two engagement members cooperating laterally to grasp tissue. [Figure 1C] FIG. 1C is an isometric view of the device of FIG. 1A showing two engagement members aligned longitudinally to grasp tissue. [Diagram 2] FIG. 2 is a schematic isometric view of a second embodiment of the distal end of a device of the present invention in relation to the distal end of an endoscope, the device including a gear-like engagement member. [Figure 3A] FIG. 3A is an isometric schematic view of a third embodiment of a distal end of a device of the present invention showing a spring arm connected to an engagement member. [Figure 3B] FIG. 3B is an end view of the device of FIG. 3A. [Figure 4A] FIG. 4A is an isometric schematic view of a fourth embodiment of the distal end of a device of the present invention, showing a gear-like engagement member housed in a recess within the body of the device. [Figure 4B] FIG. 4B is an isometric view of the device of FIG. 4A, showing the two engagement members extended into an operative position. [Figure 5A] FIG. 5A is an isometric schematic view of a fifth embodiment of the distal end of a device of the present invention in relation to the distal end of an endoscope, the engagement member having a flattened configuration. [Figure 5B] FIG. 5B is an isometric view of the device of FIG. 5A, showing one engagement member rotated in preparation for insertion into a recess within the body of the device. [Figure 5C] FIG. 5C is an isometric view of the device of FIG. 5A, showing both engagement members rotated in preparation for insertion into recesses within the body of the device. [Figure 5D] FIG. 5D is an isometric view of the device of FIG. 5A, showing both engagement members housed in recesses within the body of the device. [Figure 6A] FIG. 6A is an isometric schematic view of a sixth embodiment of the distal end of a device of the present invention in relation to the distal end of an endoscope, where the engagement members are rounded. [Figure 6B] FIG. 6B is an end view of the distal end of the device of FIG. 6A. [Figure 6C] FIG. 6C is a side view of the distal end of the device of FIG. 6B, showing the engagement member housed within a recess in the body of the device. [Figure 7] FIG. 7 is an isometric schematic view of a seventh embodiment of the distal end of a device of the present invention, in relation to the distal end of an endoscope, in which the engagement members are rounded and one engagement member includes a lumen extending therethrough. [Figure 8] FIG. 8 is an isometric schematic diagram of one embodiment of a handpiece of the device. [Figure 9] FIG. 9 is an exploded view of the handpiece of FIG. [Figure 10] FIG. 10 is a plan view of the interior of the handpiece of FIG. [Figure 11A] FIG. 11A is an isometric view of one gear assembly of the handpiece of FIG. 8, showing the translation gear and track engaged to provide translational motion to the arm. [Figure 11B] FIG. 11B is an isometric view of the gear assembly of FIG. 11A showing the first and second rotary gears engaged to provide rotational motion to the arm. [Figure 12] FIG. 12 is an isometric schematic view of a second embodiment of a handpiece of the device. [Figure 13] FIG. 13 is an isometric view of the handpiece of FIG. 12 shown in relation to the proximal end of an endoscope. [Figure 14] FIG. 14 is a partial cross-sectional view of the handpiece of FIG. 12, showing a cross-section of the slider. [Figure 15] FIG. 15 is an exploded view of the handpiece of FIG. [Figure 16A] FIG. 16A is an isometric view of a further embodiment of a device of the present invention showing the proximal end, distal end and handpiece of an endoscope. [Figure 16B] FIG. 16B is an isometric view of the proximal end of the device of FIG. 16A, showing the connection between the actuator and the arm along the insertion tube. [Figure 17]FIG. 17 is a perspective view of the distal end of the device of FIG. 16A, showing the arms and their working channels. [Figure 18] FIG. 18 is a perspective view of an additional configuration of the distal end of the device of FIG. 16A, showing arm channels formed in the exterior surface of the insertion tube. [Figure 19] FIG. 19 is a partial cross-sectional view of the distal end of the device of FIG. 16A showing the arms in a deployed state. [Figure 20] FIG. 20 is a partial cross-sectional view of the distal end of the device of FIG. 16A, showing the arms in a retracted state. [Figure 21A] FIG. 21A is an isometric view of the distal end of the device of FIG. 16A, showing the engagement members fully retracted into the arm channels. [Figure 21B] FIG. 21B is an isometric view of the distal end of the device of FIG. 16A showing the engagement members partially extended from the arm channels by movement of the actuator. [Figure 21C] FIG. 21C is an isometric view of the distal end of the device of FIG. 16A showing the engagement members further extended from the arm channels by movement of the actuator. [Figure 21D] FIG. 21D is an isometric view of the distal end of the device of FIG. 16A showing the engagement members fully extended from the arm channels by movement of the actuator. [Figure 22A] FIG. 22A is an elevational view of the handpiece and actuator of the device of FIG. 16A, showing the actuator positioned to fully retract (retract) the engagement member as shown in FIG. 21A. [Figure 22B] FIG. 22B is an elevational view of the handpiece and actuator of the device of FIG. 16A, showing the actuator positioned to partially extend the engagement member from the arm channel as shown in FIG. 21B. [Figure 22C]FIG. 22C is an elevational view of the handpiece and actuator of the device of FIG. 16A, showing the actuator positioned to cause the engagement member to extend further from the arm channel as shown in FIG. 21C. [Figure 22D] FIG. 22D is an elevational view of the handpiece and actuator of the device of FIG. 16A, showing the actuator positioned to fully extend the engagement members as shown in FIG. 21D. [Figure 23A] FIG. 23A is an end view of the distal end of the device of FIG. 16A showing the engagement members fully extended and illustrating movement of the first engagement member to deflect a tool extended through the insertion tube. [Figure 23B] FIG. 23B is an end view of the distal end of the device of FIG. 23A showing the engaging members fully extended and illustrating movement of a second engaging member to deflect the tool in an additional direction. [Figure 24A] FIG. 24A is an isometric view of the distal end of the device of FIG. 16A, showing participating members that act in concert to deflect a tool extended through the insertion tube. [Figure 24B] FIG. 24B is an isometric view of the distal end of the device of FIG. 24A, showing participating members that act in concert to deflect a tool extended through the insertion tube in an additional direction. [Diagram 25] FIG. 25 is an isometric view of the handpiece and actuator of the device of FIG. 16A, illustrating the rotational and translational motion of the actuator. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Like reference characters refer to like parts throughout the several views of the drawings.

[0029] As shown in Figures 1A-15, at least one embodiment of the present invention relates to a device 10 that can be fitted to a medical device, such as an endoscope 2, to assist in positioning and securing the medical device 2 to a target tissue during a medical procedure. For example, Figures 1A-7 show a distal end 12 of the device 10 that can be used in conjunction with the distal end of a medical device (such as the endoscope 2 shown here) that can be inserted into a patient's body and navigated to an internal location, such as within the digestive tract, for diagnosis and / or treatment. As used herein, "distal" refers to the end closest to or inserted into the patient, and "proximal" refers to the end closest to the physician or user of the device 10.

[0030] The device 10 includes a body 20 configured to be selectively attached to a medical instrument, such as an endoscope 2. The body 20 may be made of a rigid or semi-rigid material, such as stainless steel, titanium, polycarbonate, polyetherimide, silicone, or any other biocompatible material, providing sufficient rigidity to retain its configuration, but may be flexible or resilient in certain areas to allow attachment to the endoscope 2. As shown in FIGS. 1A-2 and 5A-7, the body 20 may be configured to be disposed at least partially circumferentially around a working end 3 of the endoscope 2 located at a distal end of the endoscope 2. For example, the body 20 may include a main channel 24 that extends the length of the body 20 and is dimensioned to accommodate the working end 3 of the endoscope 2. The main channel 24 may have any diameter that allows it to receive and restrain a portion of a medical instrument, such as the endoscope 2. For example, the main channel 24 may have a diameter substantially the same as or slightly larger than the diameter of the outer surface of the endoscope 2, such that the body 20 is secured to the endoscope 2 by a friction fit. In some embodiments, as seen in FIGS. 1A-2, the body 20 may completely surround the outer surface of the working end 3 of the endoscope 2. In such embodiments, the working end 3 of the endoscope 2 may pass through the main channel 24 of the body 20 of the device 10 until the body 20 and the endoscope 2 frictionally engage each other with sufficient force to hold them stationary relative to each other. Preferably, this occurs when the end of the body 20 is coextensive with the surface 4 of the working end 3 of the endoscope 2. The friction fit between the body 20 and the endoscope 2 may be released as needed by applying a force distally to the body 20 such that the working end 3 of the endoscope 2 moves in a reverse order (reverse direction) through the main channel 24. In other embodiments, the body 20 may only partially surround the circumference of the endoscope 2 when attached. For example, the body 20 may be C-shaped or other shaped so as to be attached to the endoscope 2 by a snap-fit ​​engagement.

[0031] In some embodiments, the device 10 may also include a clip 22, as shown in FIG. 7. The clip 22 may be attached to one or both of the body 20 and the endoscope 2 to secure them together. For example, the clip 22 may be a collar or other circumferentially disposed component that may attach and constrain the body 20 to the endoscope 2 with sufficient force to secure the body 20 to the endoscope 2. In some embodiments, the clip 22 may overlap a portion of the body 20 and a portion of the endoscope 2 to provide a constraining force to secure them together. The clip 22 may be attached with a snap-fit ​​engagement, or may be circumferentially disposed around the body 20 and / or the endoscope 2 and fastened by a threaded bolt, screw, wing nut, or other suitable selective fastening mechanism that may be later removed as needed. In certain embodiments, the clip 22 may also secure a sterile sleeve (not shown) to the device 10 that surrounds the length of the endoscope 2.

[0032] Regardless of the attachment mechanism, the body 20 is attached to the endoscope 3 in a manner that does not interfere with the working end 3 of the endoscope 2. For example, when the body 20 is disposed circumferentially around the exterior of the endoscope 2, as shown in FIGS. 1A-2, the entire surface 4 of the working end 3 remains exposed. The various working channels 5 of the endoscope 2 are not obstructed by the device 10. No portion of the device 10 interacts with any of the working channels 5 of the endoscope 2, nor is there any need to do so. Thus, the working channels 5 are free to be used by the physician or operator of the endoscope 2 for various tools, lights, imaging devices, and irrigation that may be required for a particular procedure.

[0033] The body 20 may also include at least one, and preferably multiple, arm channels 26 extending therethrough. In at least one embodiment, as shown in FIGS. 1A-3, the arm channels 26 may extend along the length of the body 20 and may be parallel to the main channel 24. In other embodiments, as shown in FIG. 4B, the arm channels 26 may include any number of bends, curves, angles, or other features that may cause the arm channels 26 to deviate from a straight path. In many embodiments, the arm channels 26 may have a diameter that is disposed entirely within the body 20 of the device 10, as shown in FIGS. 1A-2. In other embodiments, as shown in FIGS. 3A-3B, the arm channels 26 may be formed in the exterior surface of the body 20 to have a partial diameter (overlap). Regardless of location, each arm channel 26 may have a diameter smaller than the diameter of the main channel 24 into which the endoscope 2 fits, although in some embodiments the diameter of the arm channel 26 may be equal to or larger than the main channel 24. Additionally, the arm channels 26 may have the same diameter as one another or may have different diameters. While there may be any number of arm channels 26, preferably the body 20 includes two arm channels 26. The arm channels 26 may be positioned equidistant from one another within the body 20, may be spaced closer to one another, or may be spaced farther from one another. However, the positions of the arm channels 26 within the body 20 are preferably fixed.

[0034] The device 10 further includes at least one, and preferably two or more, arms 30, each extending through a different one of the arm channels 26 in the body 20. Each arm 30 is elongated and extends along the length of the endoscope 2, and is flexible enough to bend, flex, and twist with the endoscope 2 as it travels through the digestive tract to the target site. Thus, the arms 30 may be parallel to the endoscope 2 over a portion, if not most, of the length of the endoscope 2 between the working end 3 and the proximal end where insertion into the patient occurs. Thus, the arms 30 may be flexible and may be made of materials such as, but not limited to, Nitinol or stainless steel. Each arm 30 may further include a bend 36 located distally from the body 20 of the device 10. The bend 36 may be a curve, angle, or elbow that changes the direction of the arm 30 such that the portion of the arm 30 that extends beyond the face 4 of the working end 3 of the endoscope 2 is no longer parallel to the endoscope 2. For example, the bends may result in a change in direction of the arm 30 up to 180°. Each arm 30 may also include a forearm 37 defined between the bend 36 and the end of the arm 30. The forearm 37 may preferably be linear, but may have any configuration. Due to the change in angle from the bend 36, the forearms 37 of the arm 30 may be positioned closer to each other or farther apart without changing the position of the remainder of the arm 30 or the position of the arm channel 26 in which they are located. In some embodiments, the arm 30, the bend 36, and the forearm 37 are all integrally formed, and the bend 36 and / or the forearm 37 are part of the arm 30. In certain embodiments, the bend 36 and / or the forearm 37 may be made of a material different from the material of the arm 30 and attached to the arm 30. For example, the bend 36 and / or the forearm 37 may be made of a harder (more rigid) material than the material of the arm 30, where the arm 30 is flexible enough to bend and flex within the digestive tract and the bend 36 and / or the forearm 37 is stiff enough to transmit movement.In some embodiments, the flexure 36 and / or forearm 37 may be rigidly attached to the arm 30 such that they cannot be removed from the arm 30. In other embodiments, one or both of the flexure 36 and / or forearm 37 may be removably attached to the arm 30, allowing different angles or materials to be selected for different procedures.

[0035] In at least one embodiment, the arms 30 can be configured to accept rotation and transmit torque along their length from the proximal end to the distal end of the device 10. For example, the arms 30 can be rotated by the physician from the proximal end about their longitudinal axis relative to the body 20. The torque applied by such rotation is propagated along the length of the torque wire to the distal end, which is also rotated by such torque. Each arm 30 can be rotated by the physician separately and independently from the other arms 30 of the device 10, or can be rotated simultaneously as desired. As seen in FIGS. 1A-1C, in at least one embodiment, the arms 30 can be defined as a torque transmitting member 32, which can be a stranded torque wire or a helical hollow stranded torque wire having an inner diameter in the range of about 0.003-0.080 inches and an outer diameter in the range of about 0.006-0.100 inches. The torque wire is designed to be flexible so that it can bend and flex through tortuous paths, making it ideal for intravascular and percutaneous routes, such as in the gastrointestinal tract and laparoscopic procedures. Although a torque wire is disclosed herein, any suitable material that transmits the applied rotation from one end of the arms 30 to the other may be used. Preferably, the arms 30 and torque transmitting members 32 may be made of stainless steel or any other suitable material that may be used for internal medical procedures.

[0036] In certain embodiments, such as that shown in FIG. 2, the arm 30 may have multiple torque transmission members 32, 34. For example, the first torque transmission member 32 may be hollow and define a lumen extending the length of the first torque transmission member 32. The hollow lumen may have a diameter sufficient to allow the passage of other materials, such as an inner diameter of 0.005 inches. For example, in some embodiments, the second torque transmission member 34 may be coaxially disposed within the hollow lumen of the first torque transmission member 32. The second torque transmission member 34 may thus have a diameter smaller than the inner diameter of the hollow lumen of the first torque transmission member 32. In such embodiments, the first torque transmission member 32 may be rotated by a physician or user to pivot the arm 30. The second torque transmission member 34 may be separate and independent of the first torque transmission member 32 and may rotate or pivot the engagement member 40 as described in more detail below. In other embodiments, the hollow lumen of the first torque transmission member 32 may be used as a fluid or material conduit, such as to provide irrigation from an external irrigation source to a target site at the working end 3 of the endoscope 2, or to provide aspiration of fluids and / or materials, such as irrigant, blood, tissue, etc., from a target site at the working end 3 of the endoscope 2. In certain embodiments, the hollow lumen of the first torque transmission member 32 may be used for both irrigation and aspiration.

[0037] As seen in Figures 1A-7, each arm 30 includes an engagement member 40 at its distal end. Thus, the device 10 may include at least one, and preferably two or more, engagement members 40. Each engagement member 40 may be integrally formed with the respective arm 30, as shown in Figures 6A-7. In other embodiments, the engagement member 40 may be attached to a terminal end of the arm 30. In some embodiments, such as in Figures 1A-1C and 5A-5D, the engagement member 40 may be rigidly attached to a terminal end of the arm 30 such that the engagement member 40 moves with the movement of the arm 30. In other embodiments, as shown in Figures 2-4B, the engagement member 40 may be movably attached to the arm 30 such that the engagement member 40 not only moves with the arm 30, but also moves independently of or relative to the attached arm 30. For example, the engagement member 40 may rotate in a rotational motion 7 relative to the axis of the forearm 37 of the attached arm 30, as shown in Figure 2. Rotational motion 7 of the engagement members 40 relative to the attached arm 30 may originate from a second torque transmission member 34 coaxially disposed within the first torque transmission member 32. The first torque transmission member 32 provides motion to the entire arm 30. Additionally, as shown in FIG. 2, each engagement member 40 may rotate in either a clockwise or counterclockwise direction depending on the direction of torque or rotation provided by the second torque transmission member 34, and the various engagement members 40 may rotate in the same or different directions relative to one another. The various engagement members 40 may rotate simultaneously or may rotate separately.

[0038] Each engagement member 40 includes at least one surface configured to contact and facilitate engagement with a target tissue 9 located distally from the working end 3 of the endoscope 2. As used herein, "engagement" or "engagement" with tissue includes, but is not limited to, encountering, contacting, grasping, clamping, holding, supporting, restraining, gripping, hooking, adhering, and any other manner of positioning and / or retaining the device 10 at a particular location along the tissue, such as within the GI tract. The contact surface of the engagement members 40 may include any suitable geometry, such as flat, curved, angled, etc., and may have any number and configuration of extensions (convex portions) or concave portions to create frictional areas, such as ribs or dimples to enhance contact / grip capabilities. For example, as seen in FIGS. 1A-1C, engagement member 40a may include friction elements, such as extensions or ribs, on at least one contact surface to enhance engagement with target tissue 9 for better gripping. In other embodiments, engagement member 40b may be tubular and have rounded ends, as shown in FIGS. 6A-6C. In some embodiments, such as in FIG. 7, engagement member 40c may have a lumen therethrough and an opening where the lumen terminates. The lumen of engagement member 40c may be in fluid communication with the hollow lumen of first torque transfer member 32 or arm 30 to provide irrigation or suction therethrough. In other embodiments, as shown in FIGS. 2-4B, engagement member 40d may be formed with an irregular shape, such as a gear. The gear may be toothed, saw-shaped, or other shape and may have any number of teeth or extensions (e.g., 2-20 teeth) that may extend any distance from the circumference of engagement member 40d. The teeth may be sharp, blunt, or rounded at their outermost edges. In some embodiments, the gears may have a diameter, measured from the center of the gear to its radially outermost point, ranging from 0.002 to 0.30 inches, and a thickness ranging from 0.01 to 0.03 inches. In yet other embodiments, the engaging members 40e may have a substantially planar configuration and the contact surface may be planar, as shown in Figures 5A-5D. These are merely some examples and are not intended to be an exhaustive list.Participation members 40 may be made of any material suitable for use in internal medical procedures and having sufficient rigidity to withstand the applied forces and grasp tissue 9. Examples include, but are not limited to, nitinol, stainless steel, silicone, silicone rubber, plastic, and titanium.

[0039] Each arm 30 and corresponding engaging member 40 are collectively configured to be movable together. For example, rotational movement 7 of arm 30 may result in movement of corresponding engaging member 40 along a curved path, as shown in FIG. 1A. Because bend 36 breaks the plane of arm 30, engaging member 40 at the end of arm 30 is not coaxial with corresponding arm 30. Furthermore, arm 30 is flexible enough to traverse a tortuous path, but bend 36 and / or forearm 37 are rigid enough to guide and hold engaging member 40 off the axis of arm 30. In at least one embodiment, bend 36, forearm 37, and engaging member 40 are fixed relative to one another, such that rotational movement 7 of arm 30 results in sweeping movement along a curved path in lateral direction 8 perpendicular to the longitudinal axis of arm 30. As used herein, "lateral" refers to a direction perpendicular to the longitudinal direction, and may be linear or arcuate.

[0040] The engagement members 40 are movable between at least a first position and a second position. In the first (open) position, shown in FIG. 1A, the engagement members 40 are separated from one another by a first distance that is large enough such that at least one engagement member 40 is not in contact with the target tissue 9 and the engagement members 40 are not in contact with one another. In the second (closed) position, shown in FIGS. 1B and 1C, the engagement members 40 are separated from one another by a second distance that is smaller than the first distance, such that the engagement members 40 are closer to one another than they were in the first position. The engagement members 40 still do not contact one another in the second position, but at least one or both of them may engage the tissue 9 in the second position. Thus, the second distance is small enough such that the tissue 9 may be sandwiched and held between adjacent engagement members 40 in the second (closed) position. Although two positions are described herein, the participating member 40 may be movable to any number of positions, such as along a continuum or various discrete positions, which may be between the first and second positions or beyond the first and second positions.

[0041] The participating members 40 are movable by movement of the attached arm 30. The bends 36 and forearms 37 of the arms 30 are sufficiently rigid to transfer movement to the connected participating members 40 such that the participating members 40 move at least together with the bends 36 and forearms 37. Furthermore, because each arm 30 is movable independently of the other arms 30, each participating member 40 is likewise movable independently of the other participating members 40.

[0042] The arms 30 can be moved in a number of ways to move the engagement members 40. For example, in at least one embodiment shown in FIG. 1A, the arms 30 are moved by a rotational motion 7 relative to the body 20, which results in the corresponding engagement members 40 moving in a similar lateral direction 8. When opposite rotational motions 7 are applied to different arms 30, such as when a clockwise motion is applied to one arm 30 and a counterclockwise motion is applied to the other arm 30, the corresponding engagement members 40 move in opposite lateral directions. For example, when one arm 30 of FIG. 1A is rotated clockwise and the other arm 30 is rotated counterclockwise, the engagement members 40 can be moved closer to each other, as shown in FIG. 1B. As the engagement members 40 move closer to each other, the target tissue 9 between them can be grasped between the closing engagement members 40. The more the arms 30 are rotated, the more pressure the engagement members 40 exert on the target tissue 9, and the stronger the gripping force on the tissue 9. At some point, when enough force is applied and the grip on the tissue 9 is strong enough, the device 10 acts as an anchor for the endoscope 2 to prevent the tissue 9 from slipping or dislocating. The point at which grasping and / or fixation is achieved may depend, among other things, on the geometry or material of the engaging members 40 or the type or shape of the tissue 9 to be grasped. Rotation of the arms 30 in the opposite direction moves the engaging members 40 away from each other, reducing the pressure that the engaging members 40 exert on the tissue 9 and releasing the tissue 9 from the grip.

[0043] In other embodiments, as shown in FIG. 1C, a translational motion 6 may be applied to the arms 30 such that the arms 30 and corresponding engagement members 40 may be moved longitudinally relative to one another. As used herein, "translation" and "longitudinal" may be used interchangeably to refer to the axial direction of the length of the endoscope 2 that extends between the distal working end 3 and the proximal end that is located outside the patient's body during surgery. Thus, the engagement members 40 may be moved longitudinally between a first position (open position) (not shown) and a second position (closed position) shown in FIG. 1C. As before, moving the arms 30 in opposite directions relative to the body and relative to one another may move the engagement members 40 closer together or farther apart depending on the opposite movement. For example, when the most distally extending arm 30 is moved proximally and the more proximally extending arm 30 is moved distally, the space separating the respective engagement members 40 is reduced, bringing them closer together and increasing the gripping force. The converse is also true: moving the most distally extending arm 30 further distally and moving the more proximally extending arm 30 further proximally increases the space between the respective engaging members 40 and decreases the gripping force. Additionally, in some embodiments, the contact surface of the engaging members 40 when they are moved longitudinally can be a different surface than the contact surface when they are moved laterally. In other embodiments, the contact surface of the engaging members 40 can be the same surface regardless of lateral or longitudinal movement.

[0044] It should also be understood that movement of the arm 30 to achieve a desired positioning of the engagement members 40 may include a combination of translational movement 6 and rotational movement 7 of the arm 30. For example, the arm 30 may first be rotated to laterally approximate the engagement members 40, and then the arm may be translated axially to longitudinally approximate the engagement members 40. Furthermore, at least one arm 30 may be moved and another arm 30 may remain stationary to facilitate movement of the engagement members 40 between a plurality of positions, such as a first position (open position) and a second position (closed position). In other embodiments, both arms 30 may be moved relative to one another. Thus, each arm 30 may be moved any amount, degree or distance in any direction relative to the other arm 30, or may be held stationary to move the engagement members 40 between various positions to grasp, secure and release tissue 9.

[0045] The body 20 of the device 10 may further include at least one recess 28 sized to accommodate at least a portion of the engagement member 40. As shown in FIGS. 4A-7, the recess 28 may be configured to have similar dimensions as the engagement member 40. The recess 28 is preferably sized larger than the engagement member 40 to accommodate the engagement member 40. In some embodiments, the recess 28 may be smaller than the entire engagement member 40, but may be sized sufficiently to accommodate at least a portion of the engagement member 40. For example, in FIGS. 3A and 3B, each engagement member 40d may include a biasing element 42, such as a spring arm or other resiliently deformable mechanism. The recess 28 may be sized to accommodate the biasing element 42 of the engagement member 40d, but not the entire engagement member 40d.

[0046] 4A-5D, in at least one embodiment, recess 28 is sized and dimensioned to accommodate the entire participating member 40. There may be a single recess 28 that accommodates both or all participating members 40, or there may be multiple recesses 28, each sized to accommodate a corresponding participating member 40.

[0047] The engaging member 40 may be moved in and out of the recess 28 for storage during deployment or retraction of the endoscope 2 and attached device 10. Although extending the engaging member 40 from the working end 3 of the endoscope 2 during a procedure assists the practitioner in allowing the tissue 9 to be manipulated and held out of the way (so that the operation may not be impeded), the presence of the engaging member 40 in such a position may be problematic when entering and exiting a treatment site. The engaging member 40 may unintentionally snag on surrounding tissue or organs, for example, as it traverses the many turns and bends of the digestive tract, resulting in unintentional ripping or tearing of healthy tissue.

[0048] Thus, in at least one embodiment of the device 10, the engagement member 40 may be movable in and out of the recess 28 of the body 20 of the device 10. As with the other movements described above, the engagement member 40 may be moved by controlling the movement of the corresponding arm 30, and may be moved by any combination of translational 6 and rotational 7 movements applied to the arm 30. For example, as shown in Figures 4A and 4B, the engagement member 40d may be stored in the recess 28 of the body 20 during deployment or retraction of the device 10 and endoscope 2. Upon reaching the desired target site, the engagement member 40d may be released from the recess 28 by moving the respective arm 30 in a translational motion 6 in the distal direction 14. This longitudinal movement causes the arm 30 to extend through the body 20, thereby moving the engagement member 40d outwardly from the recess 28 and the body 20. When the procedure is completed and the device 10 and endoscope 2 need to be retracted, the arm 30 may be translated in a proximal direction. When the arms 30 are retracted, the engagement members 40 retract into recesses 28 in the body 20 where they are stored during removal of the device 10 and endoscope 2. In some embodiments, as shown in Figures 3A and 3B, when the arms 30 are retracted, the biasing elements 42 retract and are housed within the recesses 28. When the arms 30 are pushed distally, the biasing elements 42 push the ends of the arms 30, causing the engagement members 40d to move away from each other.

[0049] In yet another embodiment, as shown in FIGS. 5A-5D, the arms 30 can be rotated and translated to move the gripping arms 40 in and out of the recesses 28. For example, each arm 30 can be independently rotated about its axis by the rotational motion 7 to move the engagement member 40e away from the tissue 9 and / or other engagement members 40. The rotational motion 7 can be used to manipulate the engagement member 40 into alignment with a corresponding recess 28 or portion of a recess 28 that is sized to accommodate the engagement member 40. For example, the recess 28 or portion of a recess 28 that accommodates the engagement member 40 can be configured to correspond to a particular geometry of the engagement member 40, which may be specific to a particular orientation of the engagement member 40. The rotational motion 7 can be used to position the engagement member 40 in the proper orientation to align with the molded recess 28. However, in other embodiments, recess 28 may not be shaped or configured to correspond to participating member 40, but may simply have dimensions large enough to accommodate participating member 40 regardless of the orientation of participating member 40.

[0050] Once engagement member 40 is properly oriented relative to recess 28, a proximal translation 6 can be applied to arm 30 to move engagement member 40 into recess 28, as shown in FIG. 5C. Once fully retracted, engagement member 40 can be fully retained within recess 28, as shown in FIG. 5D. In other embodiments, as shown in FIGS. 6A-6C, recess 28 can be open ended, where engagement member 40b is fully contained within recess 28 but is not fully enclosed within body 20. However, even in such embodiments, engagement member 40b does not extend beyond the distal end of the terminal end of body 20, as shown in FIG. 6C, thereby minimizing the possibility of inadvertently being dragged along or caught on tissue as endoscope 2 is deployed or retracted within the digestive tract.

[0051] As shown in Figures 8-15, the device 10 also includes a handpiece 50 at its proximal end that remains outside the patient's body during the medical procedure. The handpiece 50 is operated by a physician or user to control the arm 30 and engagement member 40 at the distal end of the device 10. In some embodiments, the handpiece 50 may be hand-held, as shown in Figure 8, or may rest on a table or other flat surface. In other embodiments, as shown in Figures 12 and 13, the handpiece 50' may be attachable to the medical instrument or endoscope 2 by an attachment mechanism 51, such as, but not limited to, a clip that connects by a snap fit or push fit, a connecting member such as a screw or pin, or other attachment method. The handpiece 50 may include a handpiece base 52 and a handpiece cover 53, which collectively form a housing that holds various other components of the handpiece 50, as shown in Figures 8 and 9, for example. Handpiece base 52 and handpiece cover 53 may be removably secured to one another by a snap fit, a push fit, screws, pins, or the like.

[0052] The proximal end of the arm 30 terminates at or within the handpiece 50. The handpiece 50 is thus configured to house a portion of the arm 30. The handpiece 50 further includes mechanisms by which a physician or operator can control the arm 30. For example, the handpiece 50 includes at least one actuator 60 connected to at least one of the arms 30 to drive the movement of that arm 30. Preferably, each arm 30 may have a dedicated actuator 60 so that the arms 30 may be easily controlled independently of one another, although in certain embodiments, a single actuator 60 may be connected to multiple arms 30 to selectively control the various arms 30 independently, even though they are interconnected. Although preferably mechanically connected, in certain embodiments, the actuators 30 may be electronically connected to the arms 30 to electronically control the movement of the arms 30, such as through a computer program that may operate servos configured for translational and / or rotational movement. Although, in at least one embodiment, the actuators 60 are thumb wheels that may be operated by a user's thumb or fingers, as shown in Figures 8-15, with each actuator 60 connected to a different arm 30. The handpiece 50, 50' may also include at least one opening 54 through a wall, such as the handpiece cover 53. Each opening 54 may be sized to receive and permit movement of an actuator 60. Thus, the actuator 60 may be located partially inside and partially outside the handpiece 50, 50' such that a physician or user may interact with the actuator 60 from outside the handpiece 50, 50'.

[0053] 9-15 show various ways in which each actuator 60 may control the rotational 6 and translational 7 motion of the arm 30. Each actuator 60 is rotatably and slidably disposed about an axle 55, which may be a thumbwheel as shown. The axle 55 may be fixed to the handpiece 50 or may be floating and free to rotate with the actuator 60 within the handpiece 50. The actuators 60 may be actuated by pivoting or rotating the actuator 60 about the axle 55. Depending on the position of the actuator 60 along the axle 55, the actuator 60 may drive either the translational or rotational motion of the arm 30.

[0054] The handpiece 50 further includes at least one of a translation adjustment mechanism 80 and a rotation adjustment mechanism 85. The translation adjustment mechanism 80 is configured to selectively provide translational motion 6 to the arm 30. In at least one embodiment, as shown in FIGS. 9-11A, the translation adjustment mechanism 80 may include a translation gear 62 secured to the actuator 60. The translation gear 62 may be a pinion having a number of teeth extending outwardly from its circumference. In other embodiments, the actuator 60 itself may include a number of teeth or other features extending from one side thereof in place of the translation gear 62. The translation adjustment mechanism 80 may also include a translation track 64 extending longitudinally parallel to the arm 30, as shown in FIG. 10. The translation track 64 may be a rack and may have a number of teeth extending from a surface thereof. In a preferred embodiment, the handpiece 50 further includes a groove 65 sized to slidably retain the translation track 64. Thus, groove 65 may be longer than translation track 64 and limit the range of movement of translation track 64. Translation gear 62 and translation track 64 are sized and configured such that their respective teeth interlock to transmit motion when one is moved relative to the other. For example, when actuator 60 is positioned along axle 55, translation gear 62 interlocks with translation track 64, and actuator 60 is rotated about axle 55, such as by rotating a thumb or finger, the rotation of actuator 60 drives rotation of translation gear 62 attached thereto. As translation gear 62 rotates, its teeth interlock with the teeth of translation track 64 to apply a force, as shown in FIG. 11A, to move translation track 64. The direction of movement of translation track 64 depends on the direction of rotation of translation gear 62, i.e., the direction of rotation of actuator 60. The translation track 64 may move through the groove 65 until it is stopped in one direction or the other by an end of the groove 65 or by a stop in the motion of the translation gear 62. As shown in Figures 9 and 10, a rigid bridge 56 is connected at one end to the translation track 64 and at the other end to the arm 30. As the translation track 64 is moved longitudinally, the bridge 56 transfers this movement to the arm 30, which is also moved longitudinally.Thus, arm 30 is moved longitudinally by translational motion 6 either distally towards the working end 3 of endoscope 2 or proximally towards handpiece 50. When translational motion 6 is no longer required, rotation of actuator 60 can be stopped and a user can slide actuator 60 along axle 55 to disengage translation gear 62 from translation track 64.

[0055] The handpiece 50 also includes a rotation adjustment mechanism 85 interconnecting the actuator 60 and the arm 30 and configured to provide the arm 30 with a rotational motion 7 upon actuation of the actuator 60. In at least one embodiment, as shown in FIGS. 9, 10, and 11B, the rotation adjustment mechanism 85 can include a first rotation gear 66 fixed to the actuator 60 on the side opposite the translation gear 62. The first rotation gear 66 can be any type of rotation gear having a plurality of teeth, such as, but not limited to, a bevel, a miter, a gear, a pinion, etc. The rotation adjustment mechanism 85 can further include a second rotation gear 68 fixed at least partially circumferentially around a portion of the arm 30 disposed within the handpiece 50. The second rotation gear 68 can also be any type of rotation gear, such as a bevel gear or a pinion, and can be the same type of gear as the first rotation gear 66 or a different type of gear. The second rotating gear 68 may be fixed to the outer circumference of the arm 30, such as by crimping, welding, gluing, or other fastening mechanisms, or may be otherwise connected such that the movement of the second rotating gear 68 is transferred to the arm 30. Thus, the actuator 60 may be slid along the axle 55 toward the rotating gears 66, 68 until the teeth of the first and second rotating gears 66, 68 mesh. In this position, when the actuator 60 is rotated, the first rotating gear 66 also rotates. The teeth of the first rotating gear 66 apply pressure to the meshed teeth of the second rotating gear 68 until the second rotating gear 68 begins to rotate. The second rotating gear 68 may include an internal extension member (not shown) received within the keyway 38 along the arm 30, as shown in FIG. 11B. The internal extension member applies a force to the keyway 38 when the second rotating gear 68 is rotated until the arm 30, through which the keyway 38 extends, begins to rotate. In this manner, rotation of the actuator 60 results in rotational movement 7 of the arm 30 .

[0056] In at least one embodiment, the actuator 60 is movable along the axle 55 to a first or second position and selectively engages either the translation adjustment mechanism 80 or the rotation adjustment mechanism 85. Thus, rotational and translational motions can be applied to the arm 30 independently of one another. However, in some embodiments, the axle 55 can be of a length short enough that both the translation gear 62 and the first rotation gear 66 simultaneously mesh with the translation track 64 and the second rotation gear 68, respectively. In such embodiments, both translational and rotational motions can be achieved simultaneously, although the directions can be coupled. For example, depending on the configuration of the actuator 60, the translation gear 62, and the first rotation gear 66, a translational motion 6 can result in a distal direction from a rotation of the actuator 60 in one direction, and a counterclockwise rotational motion 7 can also result. This is merely one example, and any combination of translational and rotational motion directions is possible depending on the various configurations of the actuator 60, the translation gear 62, and the first rotation gear 66. Also, control of one arm 30 has been described above with reference to one actuator 60. It should be understood that although each actuator 60 may similarly control each associated arm 30, each actuator may be actuated independently of the other for selective and independent control.

[0057] 14 and 15, a rotational adjustment mechanism 85' can include at least one arm 30 that is glued or otherwise permanently secured to an actuator 60', such as at a proximal end of a terminal end of the arm 30. Thus, application of a force to the actuator 60' to rotate the actuator 60' also rotates the associated arm 30 in the same direction. Thus, a clockwise rotation of the actuator 60' can cause a clockwise rotation of the attached arm 30, and a counterclockwise rotation of the actuator 60' can cause a counterclockwise rotation of the attached arm 30.

[0058] In the embodiment of Figures 14 and 15, the translation adjustment mechanism 80' may include a slider 74 having an elongated length disposed longitudinally within the handpiece 50'. The actuator 60' may be movably connected to the slider 74, which may form a guide for selective longitudinal movement of the actuator 60'. An arm 30 joined to the actuator 60' also forms part of the translation adjustment mechanism 80', such that translational movement 6 of the actuator 60' along the slider 74 is transferred to the attached arm 30, which likewise moves according to the same translational movement 6. The distance of the possible translational movement 6 is limited by the length of the slider 74, which may in turn be limited by the length of the handpiece 50'.

[0059] In some embodiments, as shown in FIG. 15, the actuator 60′ may include an actuator channel 78 extending therethrough, such as extending longitudinally therethrough. The actuator channel 78 may be configured to correspond to the shape and dimensions of the slider 74 such that the actuator channel 78 may receive and retain the slider 74 therein. Thus, the actuator channel 78 may have a diameter or outer diameter that is greater than the diameter of the slider 74. In some embodiments, the slider 74 may be tubular and the actuator channel 78 may be the negative (complementary) shape of the corresponding tubular shape. The slider 74 is preferably longer than the actuator 60′, such that the slider 78 may extend completely through and beyond the end of the actuator 60′.

[0060] In certain embodiments, the actuator 60' may be keyed or may have a polarized configuration. Thus, the actuator 60' may include a key 77, which may be an extension (protrusion) of any shape. The key 77 may extend from an outer surface of the actuator 60' or may extend into the inside of the actuator channel 78 as shown in FIG. 15. Thus, the key 77 may also define a portion of the actuator channel 78 in certain embodiments. Regardless of the configuration, the key 77 may assist in transferring at least one of the rotational motion 7 or the translational motion 6 from the actuator 60' to the arm 30 attached thereto. For example, when the actuator 60' is rotated, the key 77 may press against a slider 74 disposed within the actuator channel 78 to apply additional torque to rotate the attached arm 30. Also, the corresponding matching configuration of the key 77 and the actuator channel 78 may assist in guiding the actuator 60' along the slider 74. Indeed, the slider 74 may include a slot 76 extending along at least a portion of the length of the slider 74 and configured to slidably receive and retain a key 77 of the actuator 60' therein.

[0061] The actuator 60' may also have an actuator lumen 79 therethrough. The actuator lumen 79 may be aligned with and in fluid communication with a hollow lumen of an arm 30, such as the hollow first torque transmission member 32 described above. The actuator lumen 79 may connect the hollow lumen of the first torque transmission member 32 with a fluid reservoir located outside the device 10, for example to provide irrigation and / or suction. The actuator lumen 79 may thus be fluidly connected with a tube 58, which is connected to a connector port 59 for accessing the fluid reservoir, as shown in Figures 12, 13 and 15. In certain embodiments, the actuator channel 78 may be concentrically disposed around the actuator lumen 79, for example at least partially circumferentially (cylindrically) disposed around the actuator lumen 79.

[0062] Additional Embodiments As shown in Figures 16A-25, an additional embodiment of the present invention relates to a device 110 that includes a medical instrument 102, such as an endoscope, and at least one integrated arm 130. The integrated arm 130 assists in both positioning and securing the medical instrument 102 to a target tissue during a medical procedure, and in manipulating a tool 108 that is inserted through a working channel 105 of the device 110. In such an embodiment, the medical instrument 102 may be, but need not be, disposable. Various features from the previous disclosure may be interchanged with features of the device 110 of the embodiment, such as, but not limited to, any of the hand pieces 50, 50' described above may be used with the additional embodiment 110. The hand piece 150 of the embodiment may include additional controls for a torque wire or finger controls, which may be integrated with the device 110 itself. Due to the integration of the arms 130 within the insertion tube 116 of the device 110, the channels required for the arms 130 described herein may be smaller than typical instrument channels, improving surgical functionality without significantly impacting the size of the device. The device 110 may also include traditional endoscopic functions such as, but not limited to, deflection, back bending, lighting, and irrigation.

[0063] FIG. 16A shows an overview of one embodiment of a device 110, preferably disposable, showing the distal end 112 of the device 110. The distal end 112 may be inserted into a patient's body for diagnosis and / or treatment and navigated to an internal location, such as within the digestive tract. As used herein, "distal" refers to the end closest to the patient or the end that is inserted into the patient, while "proximal" refers to the end closest to the physician or user of the device 110. The device 110 includes an insertion tube 116, which extends from the distal end 112 to a proximal end 114, has an elongated length, and is the portion of the device that travels within the patient's body. A handpiece 150 at the proximal end 114 and a portion of the insertion tube 116 remain external to the patient even during a medical procedure. This allows the device to be controlled (externally) during use.

[0064] The distal end 112 of the insertion tube 116 terminates in a surface 104, as shown in FIG. 17, which includes openings for the working channel 105, arm channel 126, and any other tools 108 integrated with the device 110. In some embodiments, the surface 104 can be planar and form a surface that is substantially perpendicular to the channels that terminate therein, while in some embodiments, the surface 104 can be angled relative to the length of the insertion tube 116. The surface 104 can be circular, as shown in FIG. 17, irregularly sized (shaped), as shown in FIG. 18, or any geometric shape that accommodates the various tools 108 and channels 105, 126 of the device 110, but generally has the same diameter or outer diameter configuration as the insertion tube 116.

[0065] The insertion tube 116 may include at least one arm channel 126, and preferably multiple arm channels 126, therethrough. In at least one embodiment, as seen in FIGS. 16A-17, the arm channels 126 may extend from the proximal end 114 through the insertion tube 116, interface with the hand piece 150 and actuator 160, extend to the distal end 116, terminate at the surface 104, and be parallel to the working channel 105. In other embodiments, the arm channels 126 may include any number of bends, curves, angles, or other features that may cause the arm channels 126 to deviate from a straight path. In many embodiments, each arm channel 126 may have a diameter smaller than the diameter of the insertion tube 116 and be completely disposed within the insertion tube 116 of the device 110, as shown in FIGS. 16A-17 and 19. In other embodiments, as shown in FIG. 18, the arm channels 126 may be formed in the outer surface of the insertion tube 116, and the tube may not be circular, but may have portions extending therefrom to accommodate the arm channels 126. The arm channels 126 may have the same diameter as one another, or may have different diameters, and may be any diameter sufficient to accommodate the arms and torque wires 130. While there may be any number of arm channels 126, preferably the tube 116 includes two arm channels 126. The arm channels may also be referred to herein as torque wire channels. The arm channels 126 may be disposed equidistant from one another within the tube 1160, as shown in FIGS. 17 and 18, may be spaced closer together, as shown in FIGS. 23A-24B, or may be spaced farther apart from one another. As described in more detail below, the different spacing between the arm channels 126 allows the multiple arms 130 disposed therein to interact differently with one another when deflecting an instrument 108 inserted through the working channel 105 of the tube 116 or when deflecting tissue during a medical procedure.

[0066] The arm channels 126 may terminate at any relative location along the surface 104, such as, but not limited to, 180 degrees from each other as defined by the lumen center of the arm channels 126 and the center of the surface 104. As shown in FIG. 17, the arm channels 126 that are 180 degrees from each other are positioned on opposite sides of the surface 104. The arm channels may be positioned at different radial distances from each other within the insertion tube such that the participating members are at a radial angle relative to each other upon deployment. In other embodiments, the arm channels 126 may be positioned in a variety of other layouts that may be advantageous for particular applications and procedures. For example, the arm channels 126 may terminate at the surface 104 in a layout other than 180 degrees from one another, i.e., any layout between 1 degree and 180 degrees, such as, but not limited to, 170 degrees, 160 degrees, 150 degrees, 140 degrees, 135 degrees, 130 degrees, 120 degrees, 110 degrees, 100 degrees, 90 degrees, 80 degrees, 70 degrees, 60 degrees, 50 degrees, 45 degrees, 40 degrees, 30 degrees, 20 degrees, 10 degrees, and 5 degrees. One exemplary layout is shown in FIGS. 24A and 24B, where the arm channels 126 are at approximately 40 degrees relative to one another. As described in more detail below, this example and various other layouts may allow for multi-axis (e.g., but not limited to, two-axis) deflection or rotational deflection of the tool 108 that may be inserted through the working channel 105 of the insertion tube 116.

[0067] The device 110 further includes at least one arm 130, and preferably two or more arms 130, each of which is selectively movable and extends through a different arm channel 126 of the insertion tube 116. As with the previous embodiment, each arm 130 is elongated, extends along the length of the tube 116, and is flexible enough to bend, flex, and twist with the tube 116 and arm channel 126 as the device 110 travels through the GI tract to the target site. Thus, the arms 130 may be parallel to the tube 116 over a portion (if not most) of the length of the device 110 between the working end 103 and the proximal end 104. Thus, the arms 130 may be flexible and fabricated from materials such as, but not limited to, Nitinol or stainless steel. As shown in Figures 16B, 19 and 20, each arm 130 may include both a torque wire portion 132 extending along its length and an engagement member 140 at its distal end. The torque wire portion 132 and engagement member 14 of the arm 130 may be formed of a single material in some embodiments and may be formed of different materials and joined together in other embodiments. In some embodiments, the engagement member 140 may be securely attached to the torque wire portion 132 of the arm 130 by any means suitable for a given material, such as, but not limited to, adhesives, welding, heating, screwing, clamping, etc. In other embodiments, the engagement member 140 may be removably attached to the arm 130 and different angles or materials may be selected for different procedures. For the avoidance of doubt, the torque wire 132 and engagement member 140 collectively define the arm 130. Reference to either the torque wire 132 or engagement member 140 with respect to the arm 130 refers to the remainder of the respective arm 130.

[0068] In at least one embodiment, the engaging member 140 may be made of a harder (rigider) material than the material of the torque wire portion 132, where the arms 130 are flexible enough to bend and flex with the tube 116 as the device 110 is navigated through the GI tract, and the engaging member 140 is stiff enough to transmit the motion. For example, in at least one embodiment, the torque wire portion 132 may be a stranded torque wire or a helical hollow stranded torque wire having an inner diameter in the range of about 0.003-0.080 inches and an outer diameter in the range of about 0.006-0.100 inches. Meanwhile, the engaging member portion 140 may be made of a resilient material that has a non-linear original (original) natural shape, such as, but not limited to, curved or angled, but may be temporarily deformed or deflected to another shape and return to its natural state when the deforming pressure is removed. For example, such elastic material can be any metal or polymer with significant elasticity and high yield strength, such as spring steel, but is preferably made from nickel titanium, also known as Nitinol. A material with significant elasticity exhibits the ability to undergo significant deformation under load and return to its original shape when the external load causing the deformation is removed. For example, Nitinol can deform 10-30 times more than a normal metal, but still return to its original shape. There are two different but similar variations of Nitinol, superelastic Nitinol and shape memory Nitinol, both of which can be used in the engagement members 140 or the deployable arms 130. A particular material and geometry combination that achieves the right balance between flexibility and stiffness is needed to be flexible enough to be retracted (withdrawn) and yet stiff enough to provide the necessary force to manipulate tissue and instruments as required by the procedure upon deployment. In some embodiments, each engagement member 140 can include a straight section at its end. The straight portion extends past any curves or angles in arm 130 to the terminal end of arm 130 .

[0069] When deployed, the material of the arms 130 and / or their engaging members 140 may return to their original shape and assume their natural configuration, which may preferably be a curved configuration, such as an amount ranging from 20° to 180°. In at least one embodiment, the natural configuration of the distal ends of the arms 130 and / or engaging members 140 may be generally J-shaped or hook-shaped, as shown in FIGS. 17 and 19, although other curved or angled configurations are envisioned. Despite this elastic change in configuration upon exiting the arm channel 126, the distal ends of the arms 130 and / or engaging members 140 are sufficiently rigid to be useful in grasping, holding, retaining, deflecting, etc., tissue or surgical tools and instruments inserted through the working channel 105 or other channels 105 of the device 110 during a medical procedure. If desired, each arm 130 can be extended out of its respective arm channel 126 by selectively moving the respective arm 130 translationally (106) in the distal direction 112. This longitudinal movement extends the arm 130 through the insertion tube 116 and results in movement of the arm 130 outwardly from the arm channel 126 and beyond the face 104 of the working end 103.

[0070] The arms 130 may have a diameter smaller than the diameter of their respective arm channels 126 to permit movement of the arms 130 within the arm channels 126. The torque wire portion 132 and engagement member portion 140 of the arms 130 may have the same diameter as one another in some embodiments and may have slightly different diameters in other embodiments. The arms 130 may be selectively movable through the arm channels 126, such as by translational movement along the length of the insertion tube 116, such that the engagement member 140 of the arms 130 is extended outwardly from the working end 103 of the device 110 for use during a procedure.

[0071] Each arm 130 extends through a different arm channel 126 and can be selectively moved longitudinally along the arm channel 126 by translational movement 106 of a corresponding actuator 160 at the proximal end 114 to extend at least a portion of the arm 130 beyond the surface 104 at the distal end 112 of the insertion tube 116. For example, the engagement members 140 can extend beyond the surface 104 when the arms 130 are deployed in an extended position and can be retained within the insertion tube 116 when the arms 130 are retracted in a retracted position. There can be any number of extended and retracted positions along a continuum, each with a different amount that the engagement members 140 extend beyond the surface 104 or are retracted within the arm channel 126, ranging from none of the engagement members 140 being extended or retracted to all of the engagement members 140 being extended or retracted. Upon leaving the arm channel 126 at face 104, the engagement member 140 assumes its natural relaxed state, which may be a curved or angled configuration depending on the material properties of the engagement member portion 140, and the engagement member 140 is no longer parallel to the distal end 112. For example, the change in orientation of the engagement member 140 may be up to 180° relative to the insertion tube 116 upon deployment. The torque wire portion 132 of the arm 130 may remain within the insertion tube 116 and transfer motion from the actuator 160 and / or handpiece 150 throughout the arm 130 to the engagement member 140.

[0072] During insertion, or when not needed for a given procedure, the arms 130 may be retracted and the engagement members 140 may be stored within the arms channel 126. This position is referred to herein as the "retracted" or "retracted" position, and these terms are used interchangeably. FIGS. 20 and 21A show an embodiment of the device in which the arms 130 may be retracted and stored within the arms channel 126 during insertion and retraction of the insertion tube 116 relative to the target site, or at any stage of the procedure in which it is desirable for the arms 130 to be retracted. During retraction, the engagement members 140 may be at least partially straightened to conform to the arms channel 126, or may be retained completely therein. However, the engagement members 140 are formed from a resilient material that may return to a curved or angled state when redeployed.

[0073] Due to the angular change of engagement members 140 when deployed, engagement members 140 can be positioned closer or farther apart relative to one another without significant change in the position of the remainder of arms 130, torque wire portions 132, or the arm channels 126 in which they are disposed. Arms 130 can rotate (107) and translate (106) to position engagement members 140 relative to tissue at a surgical site or relative to a surgical instrument exiting working channel 105, as shown in Figures 21A-24B and described in more detail herein.

[0074] FIG. 21A illustrates an embodiment of the arm 130 in a fully retracted (retracted) or stored state. FIG. 21D illustrates an embodiment of the arm 130 in a deployed state. FIG. 21A illustrates the arm 130 in a retracted state, fully retracted within the arm channel 126. This retracted state occurs when the actuator 160 at the proximal end 114 is translated (106) away from the distal end 112 of the tube 116, as shown in FIG. 22A. FIGS. 21B and 22B illustrate the working end 103 as the user pushes the actuator 160 from the proximal end 114 of the arm 130, pushing the engagement member 140 out of the channel 126 at the distal end 112. FIG. 21C illustrates the working end 103 as the user continues to push the arm 130 from the proximal end 114 toward the distal end 112, extending the engagement member 140 from the arm channel 126. In the deployed state, the arms 130 may be manipulated longitudinally and rotationally to position the engagement members 140 relative to tissue at or surrounding the target surgical site to hold or move the tissue out of the way of the surgical site, or to deflect or guide the surgical tool 108 deployed along the working channel 105 of the insertion tube 116 when performing surgery. Conversely, once the procedure is complete, the arms 130 may be retracted (retracted) into the arm channel 126, such as when the arms 130 are functional and the physician prepares to remove the endoscope, and the engagement members 140 may deflect from their natural curved or J-shape to follow the arm channel 126 as they are retracted back into the arm channel 126. Thus, the engagement members 140 may deform when retracted into the channel 126, and may return to their curved or J-shape when deployed from the channel 126.

[0075] In some embodiments, the torque wire 132 and corresponding engagement member 140 of each of the arms 130 may be collectively configured to be movable together. For example, as shown in Figures 23A and 23B, rotational movement 107 of the arm 130 may result in corresponding movement of both the torque wire 132 and engagement member 140 along a curved path.

[0076] The engagement member 140 may be retracted by any combination of translational motion 106 and rotational motion 107 applied to the arm 130 by controlling the movement of the corresponding actuator 160. This motion applied to the arm 130 at the proximal end 114 causes the entire arm 130, engagement member 140 and torque wire 132 to move through the insertion tube 116 toward the proximal end 114 of the device, whereby at least a portion of the arm 130 is retracted within the arm channel 126. Upon bringing the arm 130 into the arm channel 126, the arm 130 and engagement member 140 are temporarily deformed so that they substantially conform to the shape of the arm channel 126 and no longer extend from the working end 105 and do not interfere with the use of a tool used in combination with the device 110. In some embodiments, the arm 130 may be translated in the proximal direction 114 as the arm 130 is retracted.

[0077] As shown in Figures 16A, 16B, 22A-22D, and 25, the device 110 also includes a handpiece 150 at the proximal end 114 that remains outside the patient's body during a medical procedure. The handpiece 150 is operated by a physician or user to control the actions at the distal end of the device 110. In some embodiments, the handpiece 150 may be hand-held or rest on a table or other flat surface. In other embodiments, the handpiece 150 may be attached to a frame or other structure. The handpiece 150 may include one or more actuators 160 in communication with the arms 130, such as torque wires 132. Preferably, each arm 130 is in communication with and controlled by a separate actuator 160. In one embodiment, the actuators 160 may be rotated clockwise or counterclockwise to achieve the rotational movement 107 of the arms 130. Translational motion 106 may also be accomplished by the same actuator 160 translating it inward and outward from the handpiece 150 , causing the entire arm 130 to move toward or away from the proximal end 114 .

[0078] The handpiece 150 may also include one or more inlets to an instrument channel 105 that may be used in combination with other endoscopic tools during a procedure, as shown in FIG. 16A. These inlets may be of any form that allows a physician to hold the handpiece 150 and effectively manipulate the actuator 160. Additional channels may extend through the insertion tube 116 and connect to other tool devices via a connector 159 of the handpiece 150, as shown in FIG. 16A. Examples include, but are not limited to, LEDs or other light sources, water nozzles, suction ports, viewing lenses, or any other tools that may assist the physician in using the device during a procedure. These tools may terminate at the proximal end 114 and may be connected to a power source, a water source, or any other necessary input or output.

[0079] The device 110 described herein is used in practice by a physician who inserts the insertion tube 116 into a patient to control the arm 130 (and therefore the engagement member 140). This control may be achieved via one or more actuators 160 in the handpiece 150 of the device 110, as shown in Figure 25, allowing translational 106 and rotational 107 movement of the arm.

[0080] In at least one embodiment, the arms 130 can be configured to accept rotation and transmit torque along their length from the proximal end 114 to the distal end 112 of the device 110. For example, the arm 130 can be rotated about its longitudinal axis relative to the working end 103 by a physician at the proximal end 114 manipulating the handpiece 150 and actuator 160. The torque applied by such rotation (107) is propagated through the length of the torque wire 132 to the engagement member 140 at the distal end of the arm 130, causing the entire length of the arm 130 to be rotated by such torque. Each arm 30 can be rotated by the physician separately and independently from the other arms 30 of the device 110, or can be rotated simultaneously, if desired.

[0081] The engagement member 140 may be retracted and deployed by the physician via the actuator 160 and may be used to manipulate tissue, tools inserted through the working channel 105 of the tube 116, or any other tools or objects that may be involved in a particular procedure. As shown in FIG. 25 , the actuator 160 may be manipulated in multiple directions to cause corresponding movement of the arm 130 of the device 110. For example, the actuator 160 may be pushed toward the distal end 112 of the device 110, away from the physician, causing the arm 130 to translate (106) through the tube 116 and push the engagement member 140 through the arm channel 126 and past the face 104 of the working end 103, causing the engagement member 140 to be released from the arm channel 126. The actuator 160 may be pulled toward the physician, toward the proximal end 114 of the device 110, to translate (106) the arm 130 proximally within the tube 116 and move the engagement member 140 back into the arm channel 126. The translational movement 106 of the actuator 160 results in a corresponding translational movement 106 of the associated engagement member 140, as shown in Figures 21A-21D and 22A-22D. The rotational movement 107 of the actuator 160 may correspond to a substantially similar rotational movement 107 of the arm 130, including the torque wire 132 and the engagement member 140 interconnected thereto. The actuator 160 may move, for example, in a clockwise or counterclockwise direction, resulting in a clockwise or counterclockwise rotational movement 107 of each of the corresponding engagement members 140. The rotational movement 107 of the participating member 140 corresponding to the rotational movement 107 of the actuator 160 is shown in Figures 23A-24B.

[0082] 23A and 23B, as well as various other layouts, may allow a tool 108 disposed through the working channel 105 of the device 110 to be deflected along at least one axis relative to its working end 103. These exemplary layouts may also allow the tool 108 to be rotationally deflected about the lumen center of the working channel 105. Deflection of the tool 108 is accomplished by translational movement 106 of the engagement members 140 along the arm channel 126 and / or rotational movement 107 of the engagement members 140 about the center of rotation, and combinations thereof, which correspond to where the engagement members 140 exit the arm channel 126. This combination of motion may move the engagement members 140 closer to or farther from one another to allow contact and deflection of tissue and / or tools at the working end of the device. For example, the engagement members 140 may be moved to a first position that is farther from one another compared to a second position that is closer to one another. These may engage and deflect tissue and / or tool 108 in either a first or second position, or even other positions, depending on the desired movement and position of the tissue or tool. For example, in the exemplary configuration shown in Figures 23A and 23B, a counterclockwise rotation of one arm 130 may deflect the tip of the separate tool 108 in a first direction along a first axis, as shown in Figure 23A. Although not shown, a translational motion 106 and / or a rotational motion 107 about the center of rotation of the engagement member 140 may also rotationally deflect the tip of the separate tool 108 in a clockwise or counterclockwise direction about the lumen center of the working channel 105. Deflection of the tool 108, whether axial or rotational, may allow for decoupling of motion between the working end 103 of the device 110 and the tool 108, and may move a manipulable portion of the tool 108 extending from the face 104 of the device 110 relative thereto. This separation can allow operations such as, but not limited to, linear electrosurgical cutting without deflection of the working end 103, which can shift the surgeon's viewpoint.Additionally, the ability to deflect the tool 108 extending through the device 110 using the arms 130 and / or engagement members 140 may allow the physician to streamline the surgery / procedure by using only one device 110, rather than using multiple endoscopes with various other attachments or tools 108 to manipulate each other's tools. As shown in FIG. 23B, it is also possible to deflect the tip of the tool 108 in another direction or axis by rotating the arm 130 in a clockwise direction. The other direction or axis may be at any angle relative to the first direction (or axis), but is substantially perpendicular to the first direction, at least in the embodiment shown in FIGS. 23A and 23B. Deflection of the tool 108 may be accomplished by using a single arm 130 or multiple arms 130 positioned to allow fine adjustment and deflection of the tool 108. The arms 130 of the device 110 may work in concert and may rotate together or independently in a clockwise and / or counterclockwise direction to deflect a tool in nearly any direction relative to the working end 103 of the device 110, as shown in Figures 23A-24B. Any (or all) of the arms 130 may be rotationally movable in the clockwise and counterclockwise directions, and may be translationally movable in the proximal or distal directions to achieve such deflection.

[0083] Since many modifications, variations and changes of detail may be made to the preferred embodiment described, all matters in the foregoing description and all matters shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense, The scope of the present invention should be determined by the appended claims and their legal equivalents.

Claims

1. a proximal end and an opposite distal end; an elongated tube extending between said proximal and distal ends defining a length thereof and having a distal surface at said distal end; an arm channel extending through the elongate tube along the length and terminating at the distal face of the tube; an arm extending through the arm channel and receivably held within the arm channel; Equipped with the arm has an engagement member at one end thereof made of a resilient material; The arm is connected to the arm channel. (i) at least one extended position defined by at least a portion of the participating member extending beyond the distal surface of the tube and having a non-linear configuration; (ii) at least one retracted position defined by the participating member being fully retained within the arm channel and temporarily deforming to conform to the shape of the arm channel; can be selectively moved between A medical device characterized by:

2. The engaging member is made from one of Nitinol and stainless steel. The medical device according to claim 1 .

3. The engagement member has a curved configuration in the at least one extended position. The medical device according to claim 1 .

4. The curved configuration of the engagement member ranges from 20° to 180°. The medical device according to claim 3 .

5. The arm is at least one of: (i) translatably movable; and (ii) rotatably movable relative to the arm channel. The medical device according to claim 1 .

6. two arm channels extending through the elongate tube spaced apart from one another and terminating at different locations along the distal surface; Two arms; Further comprising: Each of the two arms extends through a different one of the arm channels and is selectively and independently movable relative to the other one of the arms. The medical device according to claim 1 .

7. The arm channels terminate 180 degrees from each other on the distal surface. The medical device according to claim 6 .

8. The arm channels terminate within 90 degrees of each other on the distal surface. The medical device according to claim 6 .

9. Each of the arms includes an engagement member at a distal end thereof; at least one of the arms is movable relative to the other of the arms by at least one of a rotational movement and a translational movement between a first position in which the participating members of the two arms are spaced apart by a first distance and a second position in which the participating members of the two arms are spaced apart by a second distance; The second distance is less than the first distance. The medical device according to claim 6 .

10. The two engagement members collectively contact and deflect at least one of tissue and a tool proximate the distal end in the second position. The medical device according to claim 9 .

11. a working channel extending through the elongated tube from the proximal end to the distal end substantially parallel to the arm channel and configured to slidably receive a tool therein; Further comprising: The working channel terminates at the distal surface of the elongate tube proximate the arm channel to enable the engagement member to contact and deflect the tool upon actuation. The medical device according to claim 1 .

12. rotation of the arm in a first direction deflects at least one of: (i) the tool; and (ii) tissue proximate the distal end in a corresponding direction; Rotation of the arm in a second direction deflects at least one of (i) the tool and (ii) the tissue in a corresponding direction. The medical device according to claim 11.

13. The arm includes two arms. Rotation of the first arm moves in a first direction; The rotation of the second arm moves in a second direction; (i) the rotation of the first arm causes the first arm to deflect at least one of the tool and the tissue in the first direction; and (ii) the rotation of the second arm causes the second arm to deflect at least one of the tool and the tissue in the second direction. The medical device according to claim 12 .

14. An actuator at the proximal end of the medical device. Further comprising: The actuator is attached to the arm, (i) a translational movement toward the distal end to move the arm to the at least one extended position; (ii) a translational movement away from the distal end to move the arm to the at least one retracted position; and (iii) a rotational movement to rotate the arm about an axis of the arm; is selectively movable by The medical device according to claim 1 .

15. The device is disposable The medical device according to claim 1 .

16. the arm includes a torque wire extending from the proximal end of the medical instrument to the engagement member; the torque wire is interconnected with an actuator at the proximal end; The torque wire and the participating members are either (i) formed from a single continuous piece of material, or (ii) formed from different materials that are bonded together where the participating members contact the torque wire. The medical device according to claim 1 .

17. a handpiece disposed at the proximal end of the medical instrument; an actuator movably connected to the handpiece and the arm; Further comprising: the handpiece having a working channel defined within the elongated tube and configured to slidably receive a tool therein; The actuator is selectively movable to move the arm relative to the arm channel. The medical device according to claim 1 .

18. 13. A method of using the medical device of claim 1, comprising: inserting the distal end of the elongated tube into a patient and advancing the distal end to a target site within the patient; translating the arm distally to the at least one extended position; manipulating the arm in at least one of a translational and a rotational motion to cause the engagement member to engage at least one of: (i) tissue at the target site; and (ii) a tool disposed proximate the engagement member at the target site; translating the arm proximally to the at least one retracted position; removing the elongated tube from the patient; A method comprising:

19. The engaging step includes contacting and deflecting, with the engaging member, at least one of: (i) tissue at the target site; and (ii) a tool disposed proximate the engaging member at the target site.

20. The method of claim 18, further comprising:

20. The deflecting step includes moving the tissue or the tool in at least one of a first direction and a second direction.

20. The method of claim 19 .

21. the first direction and the second direction are axial directions, The first direction is along a different axis than the second direction.

21. The method of claim 20.

22. Connecting one of a suction port and an irrigation port to a connection at the proximal end of the medical device. Further comprising: The connection is in fluid communication with a working channel defined within the elongate tube.

20. The method of claim 18 .

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