Medical devices with multiple degrees of freedom and related methods

Abstract

A medical device has multiple degrees of freedom that are independent of one another. The medical device includes a handle, an end effector, and a tubular portion extending between the handle and the end effector. The end effector is configured to rotate about a first axis extending through the tubular portion without rotating the tubular portion. Also, the tubular portion is configured to rotate about the first axis with the end effector.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 946,483, filed December 11, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] Various aspects of the present invention generally relate to medical devices for manipulating and / or treating tissues during surgery. In particular, various aspects of the present invention relate to medical devices having multiple degrees of freedom and methods of performing surgery using the disclosed devices. Background Technology

[0004] Various medical techniques and devices have been developed for diagnosis and / or treatment within a patient's body, such as within the gastrointestinal (GI) tract. Endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESR), polyp removal, and mucosal resection are minimally invasive treatments for both malignant and non-malignant lesions. Endoscopic medical procedures, such as EMR, can be used to remove sessile adenomas or other unwanted tissue (e.g., tumors attached to the body surface) from the surface of an anatomical cavity. Such procedures typically require the removal of a tissue plane while preserving the integrity of the underlying tissue plane. Typically, during such medical procedures, endoscopic medical devices (such as, for example, helicopters, graspers (e.g., hemostatic forceps), radiofrequency (RF) knives, etc.) are inserted into the body through the lumen of a delivery endoscope (such as, for example, an endoscope, gastroscope, colonoscope, bronchoscope, laryngoscope, cystoscope, duodenoscope, colonoscope, ureteroscope, etc., or another device with a lumen) and used to remove tissue from the target site within the patient's body.

[0005] However, many conventional endoscopic medical devices operate with only one degree of freedom, such as insertion and withdrawal of the delivery scope. In such devices, the distal end of the delivery scope deflects from one side to the other to move the medical device from one side to the other within the body. That is, manipulation of the medical device within the body depends on the deflection of the end of the delivery scope used to insert the device into the body. Therefore, the maneuverability of endoscopic medical devices and the ability to control the device within the body can be limited. Additionally, it may be necessary for the user to hold and / or manipulate the delivery scope with one hand and hold and / or manipulate the medical device introduced into the body through the delivery scope with the other hand. Alternatively or additionally, additional medical personnel may be required to assist the user in holding and / or manipulating the delivery scope and / or the inserted medical device. These limitations can increase the duration, cost, and / or complexity of medical procedures. Embodiments of the disclosed medical devices and methods can correct some of the above-mentioned deficiencies and / or solve other aspects in the art. However, the scope of the invention is defined by the appended claims, and not by the ability to solve any particular problem. Summary of the Invention

[0006] Among other things, embodiments of the present invention relate to medical devices and methods of performing medical procedures using these medical devices. Each of the embodiments disclosed herein may include one or more of the features described in conjunction with any of the other disclosed embodiments.

[0007] In some embodiments, a medical device is disclosed. The medical device may include a handle, an end effector, and a tubular portion extending between the handle and the end effector. The end effector may be configured to rotate about a first axis extending through the tubular portion, but not to rotate the tubular portion. Furthermore, the tubular portion may be configured to rotate together with the end effector about the first axis.

[0008] Various embodiments of the disclosed medical device may alternatively or additionally include one or more of the following features: the handle may include a rotary actuator, wherein actuation of the rotary actuator causes an end effector to rotate about a first axis but not the tubular portion; the end effector may be rotatably coupled to the tubular portion such that the end effector can rotate together with the tubular portion about the first axis; the handle may include an actuating actuator configured to actuate the end effector; the medical device may also include a core wire extending through the tubular portion and coupled to the actuating actuator and the end effector, wherein actuation of the actuating actuator causes the core wire to translate within the handle; the core wire may be rotatably coupled to the actuating actuator, and wherein actuation of the rotary actuator causes the core wire to rotate within the actuating actuator; wherein a cavity in the rotary actuator may accommodate the core wire and has one of a square, rectangular, triangular, or polygonal cross-sectional shape; The thiopanole may be attached to a portion of a core wire extending through a cavity of a rotary actuator, the thiopanole having the same cross-sectional shape as the cavity; actuation of the actuator may cause the thiopanole and the core wire to translate together within the cavity of the rotary actuator; the medical device may also include (a) a hinge region connected to a distal end of the tubular portion, and (b) a steering actuator on a handle, wherein actuation of the steering actuator may cause the hinge region to bend in a first plane passing through a first axis; the medical device may also include one or more steering lines connected to the steering actuator and extending along the first plane through the hinge region, wherein actuation of the steering actuator may apply tension to at least one of the one or more steering lines to bend the hinge region in the first plane; the hinge region may include a plurality of links rotatably connected together; the one or more steering lines may include one or two steering lines.

[0009] In some embodiments, a method of using a medical device is disclosed, the medical device including a handle, an end effector, and a tubular portion extending between the handle and the end effector. The method may include rotating the end effector about a first axis extending through the tubular portion, but not rotating the tubular portion. The method may also include rotating the tubular portion together with the end effector about the first axis.

[0010] Various embodiments of the disclosed method may alternatively or additionally include one or more of the following features: the rotary end effector may include a rotary actuator on an actuating handle, and the rotary tubular portion may include a rotary handle; the method may also include inserting at least a portion of the tubular portion into a body cavity prior to the rotary end effector and the rotary tubular portion.

[0011] In some embodiments, a medical device is disclosed. The medical device may include a handle comprising a steering actuator, a rotary actuator, and an actuating actuator. The medical device may also include an end effector configured to be actuated by the actuating actuator, and a tubular portion extending between the handle and the end effector. Actuation of the rotary actuator may be configured to rotate the end effector about a first axis extending through the tubular portion without rotating the tubular portion. Furthermore, rotation of the handle may be configured to rotate the tubular portion together with the end effector about the first axis.

[0012] Various embodiments of the disclosed medical device may alternatively or additionally include one or more of the following features: the medical device may also include a core wire connected to an end effector and extending through a tubular portion, the core wire being connected to an actuating actuator and a rotary actuator such that (a) actuation of the actuating actuator causes the core wire to translate within a handle, and (b) actuation of the rotary actuator causes the core wire to rotate within the handle; the core wire may extend through a cavity in the rotary actuator, and wherein (a) the cavity may have one of a square, rectangular, triangular, or polygonal cross-sectional shape, and (b) a thiotube may be attached to a portion of the core wire extending through the cavity, the thiotube having the same cross-sectional shape as the cavity; actuation of the actuating actuator causes the thiotube to translate together with the core wire within the cavity.

[0013] It is understood that the foregoing general description and the following detailed description are merely exemplary and illustrative of the claimed invention, and not restrictive. Attached Figure Description

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the invention and, together with the description, serve to explain the principles of the invention. For simplicity and clarity of illustration, the drawings depict the general structure and / or configuration of the various embodiments described herein. Descriptions and details of well-known features and techniques may be omitted for brevity and to avoid obscuring other features. Elements in the figures are not necessarily drawn to scale. The dimensions of some features in the figures may be exaggerated relative to other features to improve understanding of exemplary embodiments. Cross-sectional views are provided for simplification to aid in illustrating the relative positioning of various regions and / or components. Those skilled in the art will understand that cross-sectional views are not drawn to scale and should not be construed as representing proportional relationships between different regions and / or components.

[0015] Figure 1 This invention illustrates a medical device for performing exemplary medical procedures.

[0016] Figure 2 Showing the use of Figure 1 An exemplary medical device used in medical procedures.

[0017] Figures 3A to 3C Show Figure 2 Different views of an exemplary handle of a traditional Chinese medicine device.

[0018] Figures 4A to 4F Show Figure 2 Different areas / components of the handle of a traditional Chinese medicine device.

[0019] Figures 5A to 5D Show Figure 2 The tubular portion of a traditional Chinese medicine device in different exemplary embodiments.

[0020] Figures 6A to 6G Show Figure 2 Different areas / components of the hinge area in traditional Chinese medicine devices.

[0021] Figures 7A to 8B Show Figure 2 Different regions / components of the distal part of a traditional Chinese medicine device.

[0022] Figures 9A to 9D Showing what can be used Figure 2 Different embodiments of the hinge area in a medical device.

[0023] Figures 10A to 10D Showing what can be used Figure 2 Different areas / components of an exemplary steering knob in a medical device.

[0024] Figures 11A to 11G yes Figure 2 A schematic diagram of an exemplary operating mode of a traditional Chinese medicine device. Detailed Implementation

[0025] It should be noted that the descriptions set forth herein are illustrative in nature and are not intended to limit the embodiments of the subject matter or the application and use of such embodiments. Any apparatus, method, or implementation described herein as exemplary should not be construed as being more preferred or advantageous than other implementations. Rather, the term “exemplary” is used in the sense of example or “illustrative,” not “classical.” The terms “comprising,” “including,” “having,” “with,” and any variations thereof are used synonymously to indicate or describe non-exclusive inclusion. Thus, an apparatus or method using such terms includes not only those elements or steps but may also include other elements and steps not expressly listed or inherent to such apparatus and methods.

[0026] The terms “proximal” and “distal” are used herein to refer to the relative positions of components of the described medical system or device. When used herein, “proximal” means a position relatively closer to the exterior of the body or closer to a medical professional using the system or device. Conversely, “distal” means a position relatively further away from a medical professional using the system or device or closer to the interior of the body. Furthermore, as used herein, the terms “first,” “second,” etc., do not indicate any order, quantity, or importance, but are used to distinguish one element from another. Similarly, terms of relative orientation such as “top,” “bottom,” “left,” “right,” etc., are used with reference to the orientation of the structures shown in the figures described. Furthermore, the terms “a” and “an” herein do not indicate a limitation of quantity, but rather the presence of at least one of the referenced items. Additionally, all relative terms, such as “about,” “substantially,” “approximately,” etc., are used to indicate possible variations of ±10% (unless otherwise stated or specified). Furthermore, in the claims, values, limits, and ranges of values ​​(e.g., thickness ranges, etc.) represent values, limits, and / or ranges of ±10%.

[0027] Examples of the present invention include medical devices and methods of using these medical devices in medical procedures. Reference will now be made in detail to the examples described above and in the accompanying drawings. Wherever possible, the same reference numerals will be used to refer to the same or similar parts.

[0028] Figure 1 An exemplary medical procedure is shown performed at a target location within a patient's body using an exemplary medical device 500 of the present invention. Figure 2 Showing the use of Figure 1 An exemplary medical device 500 used in a medical procedure. Reference will be made to the following discussion. Figure 1 and Figure 2 Both. In some embodiments, such as Figure 1As shown, the medical device 500 can be introduced into the body through the lumen of the delivery scope 1000. Any suitable delivery scope 1000 (such as, for example, a gastroscope, colonoscope, bronchoscope, laryngoscope, cystoscope, duodenoscope, colonoscope, ureteroscope, catheter, etc.) can be used to introduce the medical device 500 into the body. In some embodiments, the medical device 500 may be configured to be inserted into the body through a delivery scope having, for example, a lumen with a diameter of 2.8 mm. As previously stated, it is not necessary to insert the medical device 500 into the body using the delivery scope 1000. For example, it is conceivable that in some embodiments, the medical device 500 may be inserted directly into the body (e.g., without using a delivery scope). The disclosed medical device 500 can be used to perform any suitable medical procedure at any suitable location in the patient's anatomy (such as, for example, parts of the large intestine, small intestine, cecum, esophagus, other parts of the gastrointestinal tract, cardiovascular, reproductive, etc.). For example, one or more medical devices 500 can be used to visualize, cut, excise, stimulate, treat, remove, connect, and / or manipulate target tissue in an intraluminal space, or facilitate its treatment.

[0029] During a medical procedure, the delivery scope 1000 can be inserted into the patient's body through a natural opening (mouth, rectum, etc.) or an incision, and pushed in so that its distal end 1000A is located at the desired working site (e.g., tissue injury). Then, the end effector 120, located at the most distal end of the medical device 500, is inserted into the lumen of the delivery scope 1000 through its proximal end and pushed in so that the end effector 120 extends beyond the distal end 1000A of the delivery scope 1000 into the body. For example, see reference... Figure 1 and Figure 2 The XYZ coordinate system shown illustrates that when the medical device 500 is pushed into the delivery mirror 1000 from the proximal end, the end effector 120 of the medical device 500 moves out of the distal end 1000A of the delivery mirror 1000 in the -X direction. That is, the translation of the end effector 120 of the medical device 500 along the X-axis at the working site is achieved by pushing the medical device 500 into and pulling it out of the delivery mirror 1000. Typically, the translation of the end effector 120 in the YZ plane (i.e., movement in the Y or Z direction, referred to herein as side-to-side movement) is achieved by moving the distal end 1000A of the delivery mirror 1000 from one side to the other. In other words, manipulation of conventional medical devices inserted into the body via the delivery mirror is primarily achieved via manipulation of the delivery mirror. Conversely, in some embodiments of the present invention, the disclosed medical device 500 can be manipulated independently of the delivery mirror 1000 at the target site (e.g., movement toward and away from tissue, movement from one side to the other, rotation, actuation, etc.). Therefore, the various aspects of the disclosed medical device 500 can provide the user with the ability to independently control some or all of the position, orientation, movement, and actuation of the medical device 500, independent of the delivery mirror 1000.

[0030] Typically, the disclosed medical device 500 may include any type of end effector 120 suitable for the medical procedure being performed. For example, the disclosed medical device 500 may include an end effector 120 in one or more forms, such as a clamp, vibrator, gripper, camera, illumination device, needle, scalpel, scissors, forceps, electrosurgical scalpel (e.g., endoscopic submucosal dissector), etc. However, for simplicity, in the following discussion, the end effector 120 with a gripper configuration will be used to describe aspects of the invention. It should be noted, however, that the concepts described with reference to a gripper can be applied to endoscopic medical devices 500 having any type of end effector 120. Components of the medical device 500 may be made of or comprise any suitable biocompatible material, such as, for example, metallic materials, plastic materials, shape memory metals (such as nitinol), shape memory polymers, polymers, or any combination of biocompatible materials.

[0031] refer to Figure 2 The medical device 500 may include a proximal manipulation portion 100 and a distal insertion portion 200. The manipulation portion 100 includes a handle 10 having controls for manipulating the medical device 500, for example, within a patient's body. The handle 10 is configured to be held by a user (medical professional, etc.) during use of the device 500 and can be configured according to Human Factors Interface Design (HFID) principles. The insertion portion 200 includes a flexible tubular portion 50 (or core) extending from the handle 10 to a distal portion 250 of the device 500. It should be noted that the distal portion 250... Figure 2 The portion is exaggerated to clearly illustrate its structural features. The flexibility of the tubular portion 50 allows it to bend and flex as the device 500 is introduced into the body via the delivery mirror 1000. Among other areas, the distal portion 250 of the device 500 includes an articulated region 60, a rotating region 90, and an end effector 120. These regions of the distal portion 250 will be described in detail later.

[0032] The handle 10 includes a body 12 that connects to the tubular portion 50 at the sleeve cap 20. The body 12 includes a gripping portion 11, generally shaped to be held by a user's hand (left or right). The body 12 also supports control devices, actuators, or actuators that can be used to manipulate the distal portion 250 of the device 500 and the end effector 120. In the following discussion, these actuators will be referred to as "knobs." However, it should be noted that referring to actuators as knobs is merely for convenience and not as an indication of their geometry. In some embodiments, the actuators on the handle 10 may include a first actuator (referred to herein as a steering knob 14), a second actuator (referred to herein as a rotary knob 16), and a third actuator (referred to herein as an actuation knob 16).

[0033] refer to Figure 2During use of the device 500, the steering knob 14 can be used to turn or move the end effector 120 and distal end of the device 500 from one side to the other (e.g., in any direction in the YZ plane). The rotation knob 16 can be used to rotate the end effector 120 independently of the distal portion 250, for example, about the X-axis. And, the actuation knob 18 can be used to actuate, for example, to open and close the end effector 120. The end effector 120 (along with the distal end of the device 500) can be moved in the X-direction by moving the handle 10 (e.g., by pushing the device 500 in and out of the delivery mirror 1000). And, as will be described in more detail later, the tubular portion 50 can be rotated about the X-axis, for example, by rotating the handle 10 (which would cause the distal portion 250 and the end effector 120 to rotate together).

[0034] It should be noted that, although Figure 2 The specific form of the handle 10 is shown, but this is merely exemplary. Generally, the handle 10 can have any form, and its control knobs can have any suitable form and be located in any position. In some embodiments, the shape of the handle 10 and the positions of the steering knob 14, rotary knob 16, and actuation knob 18 on the handle 10 can be determined based on HFID principles. In some embodiments, when the gripping portion 11 of the handle 10 is gripped by the user's hand, the thumb can be used to activate the steering knob 14, the middle finger can be used to activate the actuation knob 18, and the index finger can be used to activate the rotary knob 16. In other possible modifications, in some embodiments, the positions of the rotary knob 16 and actuation knob 18 on the handle 10 can be interchanged. It should be noted that the actuation system on the disclosed handle 10 (e.g., steering knob 14, rotary knob 16, and actuation knob 18) has many advantages compared to the actuation systems of known medical devices and endoscopes. One advantage is that some or all of the disclosed actuators (e.g., steering knob 14, rotary knob 16, and / or actuation knob 18) enable long strokes of steering lines 32, 34, and / or pull lines 36, which translates into more movement at the distal end of the device 500. Another advantage is that the actuators of the disclosed handle 10 offer mechanical advantages compared to known devices and endoscope actuation systems with limited mechanical advantages. These increased mechanical advantages reduce the force and effort required to actuate the actuators.

[0035] Figures 3A to 3C This is an illustration of a different view of an exemplary handle 10 of device 500. The body 12 of handle 10 may include two parts or two halves - a first part 12A and a second part 12B - which, when combined, form two opposite sides of handle 10. Figure 3A This is a side view of the handle 10, where the second part 12B is shaded to illustrate the components and features within the handle 10. Furthermore, Figure 3B and Figure 3CThese are side views of the first and second parts 12A and 12B of the handle 10, respectively. Reference will be made in the following discussion. Figures 3A to 3C When the first part 12A and the second part 12B are combined to assemble the handle 10, the pin 24A on the first part 12A engages with the corresponding pin groove 24B in the second part 12B (e.g., forming an interference fit) to connect the two parts together. The two parts 12A and 12B can be joined together by other means, such as press fitting or gluing. The first and second parts 12A and 12B include recesses or cavities configured to support the steering knob 14, the rotary knob 16, and the actuation knob 18. When assembling the handle 10: the steering knob 14 is supported between the cavities 14A and 14B of the first and second parts 12A and 12B; the rotary knob 16 is supported in the cavities 16A and 16B of the first and second parts 12A and 12B; and the actuation knob 18A is supported between the cavities 18A and 18B of the first and second parts 12A and 12B. The first and second parts 12A, 12B also include external (e.g., male) threads 20A, 20B configured to engage with corresponding threads on the sleeve cap 20 to connect the sleeve cap 20 to the handle 10.

[0036] refer to Figure 3A Steering lines 32 and 34 extend from the end immediately adjacent to the sleeve cap 20 through a recessed path on the body 12 of the handle 10 to reach the steering knob 14. One end of each of steering lines 32 and 34 is connected to the steering knob 14, and the opposite end of each of steering lines 32 and 34 is connected to the distal portion 250 of the device 500. Figure 2 The hinge cap 68 in ) (see Figure 7A Typically, steering lines 32 and 34 can be connected to the steering knob 14 and hinge cap 68 in any suitable manner, such as, for example, by crimping, welding, using fasteners, mechanical locking features, knotting, etc. (See reference) Figure 3B and Figure 3C The first portion 12A includes steering cable grooves 32A and 34A, and the second portion 12B includes steering cable grooves 32B and 34B, which together are configured to receive steering cables 32 and 34 when the handle 10 is assembled. In some embodiments, the first portion 12A may include pins 22A located on the steering cable grooves 32A and 34A, and the second portion 12B may include correspondingly positioned recesses 22B configured to receive these pins 22A when the handle 10 is assembled. The pins 22A may include a lateral path or slot 22C at their base (see [link to relevant documentation]). Figure 4B It extends above the steering line grooves 32A and 34A to allow the steering lines 32 and 34 to pass through it.

[0037] Figure 4A This is an enlarged view of the part of the main body 12 that supports the steering knob 14. Figure 4BThis is an enlarged view of the first part 12A of the main body 12. (See image below.) Figure 4A As shown, pivot 26 protrudes outward from the opposite side surface of steering knob 14. When handle 10 is assembled with steering knob 14 located in steering knob cavities 14A, 14B of first and second portions 12A, 12B, pivot 26 will be received in the first and second portions 12A, 12B (see Figure 14A, 14B). Figure 4A The recesses 26A and 26B on the surface (see) Figure 3B , 3C In the process of assembling the handle 10, the extension 14C of the steering knob 14 protrudes from the body 12 of the handle 10. To actuate the steering knob 14, the user can apply force (push or pull) to the extension 14C to rotate the steering knob 14 about its pivot 26 (e.g., ...). Figure 4A (As indicated by the double-headed arrows). When the steering knob 14 is actuated or rotated about its pivot 26, the force (e.g., tension) generated on the steering lines 32, 34 causes the links in the hinge region 60 of the device 500 to rotate about their respective pivots, and causes the distal end of the device 500 to move from one side to the other. For example, as shown by the double-headed arrows. Figure 11A and Figure 11B As illustrated, when the steering knob 14 is rotated in one direction (e.g., clockwise), a pull (or tension) is applied to one of the steering lines (e.g., steering line 32). And, when the steering knob 14 is rotated in the opposite direction (e.g., counterclockwise), a pull is applied to the other steering line (e.g., steering line 34). The hinge direction is controlled by the position of steering line 32 or 34 pressed against the steering knob 14. When steering line 32 is pressed into hole 14E and steering line 34 is pressed into hole 14D, clockwise rotation of the steering knob 14 places steering line 32 under tension. In another concept, if the pressing positions are reversed, with steering line 32 pressed into hole 14D and steering line 34 in hole 14E, then clockwise rotation of the steering knob 14 places steering line 34 under tension. As will be described in more detail later, when tension is applied to the steering line 32, the articulation region 60 bends (or curves) in the direction of the steering line 32, and when tension is applied to the steering line 34, the articulation region 60 bends in the direction of the steering line 34. The bending of the articulation region 60 caused by the actuation of the steering knob 14 causes the end effector 120 at the distal end of the device 500 to move from one side to the other.

[0038] In some embodiments, similar to body 12, steering knob 14 may also include a first portion 14A' and a second portion 14B' that can be joined together to form steering knob 14. Figure 4C and 4D The first and second portions 14A' and 14B' of the steering knob 14 in an exemplary embodiment are shown. Figure 4CAs shown, the first portion 14A' of the steering knob 14 may include holes or cavities 14D and 14E configured to receive locking features (not shown) of the steering lines 32, 34 and connect the steering lines 32, 34 to the steering knob 14. The second portion 14B' of the steering knob 14 may include recessed areas 14D' and 14E' configured to receive locking features of the steering lines 32, 34 received in the cavities 14D and 14E of the first portion 14A'. In some embodiments, these locking features may include a crimp, a locking nut, or another feature attached to the end of each of the steering lines 32, 34. The locking feature of each steering line 32, 34 may engage with a different one of the cavities 14D and 14E to connect both steering lines 32, 34 to the steering knob 14.

[0039] It should be noted that the geometry, shape, and features of the steering knob 14 described above are merely exemplary. Typically, the steering knob 14 can have different shapes, for example, as shown in reference... Figures 10A to 10D As described. In some embodiments, the steering knob 14 may be configured as a joystick or a columnar component with surface features to increase grip strength. As will be appreciated by those skilled in the art, any type of actuation device suitable for selectively applying tension to the steering lines 32, 34 can be used as the steering knob of the handle 10. Generally, any type of wire (single strand, multi strand, etc.) made of any material (e.g., stainless steel, nitinol, nylon, etc.) having any size can be used as the steering lines 32, 34. In some embodiments, the steering lines 32, 34 may be coated with or comprise a sheath made of a different material (e.g., a lubricating material). Since steering lines 32, 34 that can be used with endoscopic medical devices are known in the art, they will not be described in detail herein.

[0040] Return to reference Figure 3A In addition to the steering lines 32 and 34, the core wire or pull wire 36 (or control element) also extends through the body 12 of the handle 10. The dimensions of the channels through which the pull wire 36 and the steering lines 32, 34 extend on the handle 10 can be configured to allow these wires to pass freely through their respective channels without interference. In some embodiments, tubes made of a lubricating material such as, for example, polytetrafluoroethylene (PTFE) may be provided or attached to some or all of these channels to facilitate free movement of the wires therein. Like the steering lines 32, 34, the pull wire 36 may also comprise any type of wire (single strand, multi strand, etc.) having any size and made of any material (e.g., stainless steel, nitinol, nylon, etc.). In some embodiments, the pull wire 36 may be coated with or comprise a sleeve made of a different material (e.g., a lubricating material).

[0041] A pull cord 36 can be connected to both the rotary knob 16 and the actuation knob 18. At its proximal end, the pull cord 36 is fixedly connected (or attached) to a sleeve 42, which is rotatably connected to the actuation knob 18. That is, the sleeve 42 is connected to the actuation knob 18 such that it can rotate with the square sleeve 38 in the rotary knob 16 and translate with the actuation knob 18. The pull cord 36 can be attached to the sleeve 42 in any manner (welding, crimping, gluing, etc.). In some embodiments, the pull cord 36 can be crimped to the sleeve 42. The sleeve 42 can be rotatably positioned in the actuation knob 18 in any manner. The pull cord 36 extends distally from the handle 10 through the sleeve cap 20 to the distal portion 250 of the device 500 (see...). Figure 2 At its distal end, a pull wire 36 is connected to an end effector 120 such that the end effector 120 is operated (e.g., opening and closing in an embodiment where the end effector 120 is a gripper) when the actuation knob 18 is moved forward (i.e., to the distal side) and backward (i.e., to the proximal side).

[0042] The pull cord 36 also extends through the channel 16C in the rotary knob 16. In some embodiments, the channel 16C may have a square cross-sectional shape. A sodium hypochlorite tube with a corresponding shape (e.g., a square sodium hypochlorite tube 38) may be slidably positioned in the channel 16C. That is, the square sodium hypochlorite tube 38 is configured to slide back and forth in the channel 16C of the rotary knob 16. The square sodium hypochlorite tube 38 may be fixedly connected (e.g., crimped) to the pull cord 36 extending therethrough. Due to the square cross-sectional shape of the channel 16C and the sodium hypochlorite tube 38, when the rotary knob 16 is rotated, the sodium hypochlorite tube 38 and the pull cord 36 rotate together with the rotary knob 16, thereby causing the end effector 120 to rotate independently of the distal shaft 250. Since the sodium hypochlorite tube 38 is slidably connected to the rotary knob 16, when the actuation knob 18 moves back and forth, the sodium hypochlorite tube 38 and the pull cord 36 translate together with the actuation knob 18 in the rotary knob 16. Since the sleeve 42 is rotatably connected to the actuation knob 18, when the rotary knob 16 is rotated, the pull wire 36 and the sleeve 42 rotate in the actuation knob 18.

[0043] It should be noted that the specific configuration of the sodium hypochlorite tube 38 and channel 16C described above is merely exemplary, and many variations are possible. For example, although the cross-sectional shape of channel 16C and sodium hypochlorite tube 38 is described as square, this is only exemplary. Typically, channel 16C and sodium hypochlorite tube 38 can have any suitable non-circular shape (triangular, polygonal, hexagonal, rectangular, etc.). It should also be noted that the connection of the pull cable 36 to the rotary knob 16 described above is merely exemplary. Typically, the pull cable 36 can be connected to the rotary knob 16 in any way, such that the pull cable 36 rotates with the rotary knob 16 and translates with the actuation knob 18.

[0044] Similar to the turn knob 14, the rotary knob 16 may also have two parts or two halves, which combine to form a complete rotary knob 16 when the handle 10 is assembled. It should be noted that... Figure 3A Half of the rotating knob 16 is shown. Figure 2 The complete rotary knob 16 is shown. The two halves of the rotary knob 16 may have mating features that engage with each other to connect the two halves together when the handle 10 is assembled. When the handle 10 is assembled, these mating features also help align the two portions 12A and 12B of the body 12 together. In some embodiments, such as Figure 3A As shown, these mating features may include a pin 16A and cavities 16B of corresponding shapes (in the two halves of the rotary knob 16), which engage with each other to connect the two halves of the rotary knob 16 together when the handle 10 is assembled. Reference Figure 2 The outer surface of the rotary knob 16 may have features (e.g., grooves, etc.) that provide a grip for the user during use. It should be noted that while the rotary knob 16 is shown in a cylindrical form with grooves (or a dial) on its surface, this is merely exemplary. As will be appreciated by those skilled in the art, the rotary knob 16 may have any suitable form.

[0045] The actuation knob 18 enables a user to operate or actuate the end effector 120 of the device 500. For example, in an embodiment where the end effector 120 is a gripper having jaws that open and close when actuated, the actuation knob 18 can be used to open and close the jaws. For example, moving the actuation knob 18 proximally closes the jaws, and moving it in the opposite distal direction opens the jaws (or vice versa). The actuation knob 18 includes a cavity or slot 18A that serves as a user interface (e.g., a finger interface). In use, the user can insert their fingers through the slot 18A and pull and push the actuation knob 18 proximally and distally to actuate the end effector 120. The travel of the actuation knob 18 (i.e., the stroke of the actuation knob 18) Figure 3AThe length marked A in the figure can allow the jaws to open and close by different amounts. For example, moving the actuation knob 18 by a distance of 1 / 3A can open and close the jaws of the end effector 120 by a smaller amount than moving the jaws A. The body 12 of the handle 10 (e.g., the first portion 12A and the second portion 12B of the body 12) and the actuation knob 18 have correspondingly positioned mating features that engage with each other to allow the actuation knob 18 to move within a predefined path (e.g., a linear path, etc.) in the handle 10. These mating features may include a linear cavity 18B on the actuation knob 18 and mating protrusions 12C on the first and second portions 12A, 12B of the body 12 that fit into the cavity 18B. For example, when the handle 10 is assembled, the protrusions 12C of the first and second portions 12A, 12B engage to form a single protrusion that fits into the elongated cavity 18B of the actuation knob 18 (see figure). Figure 3B , Figure 3C This allows the actuation knob 18 to slide along the path defined by the cavity 18B. The actuation knob 18 may also include additional features (e.g., protrusions, cavities, etc.) that cooperate with corresponding features on the handle body 12 to align the actuation knob 18 on the handle 10.

[0046] As explained above, the actuation knob 18 includes a sleeve 42 to which a pull cable 36 is attached. The sleeve 42 is rotatably fixed in a cavity 18C formed in the actuation knob 18. The sleeve 42 is positioned in the cavity 18C such that (a) when the rotary knob 16 is rotated, the sleeve 42 and the pull cable 36 can rotate together in the actuation knob 18, and (b) when the actuation knob 18 is translated (proximal and distal), the sleeve 42 and the pull cable 36 move together with the actuation knob 18. It should be noted that... Figure 3A The form of the actuation knob 18 shown is merely exemplary, and the medical device 500 may include an actuation knob 18 having any suitable form.

[0047] As explained above, the pull cable 36 and steering cables 32, 34 of the handle 10 extend through the tubular portion 50 to the distal portion 250 of the device 500. The handle 10 is connected to the tubular portion 50 using a sleeve cap 20. Figure 4E This is an illustration of an exemplary sleeve cap 20 connecting the handle 10 and the tubular portion 50. Furthermore, Figure 4F This is a cross-sectional view of the sleeve cap 20 in an exemplary embodiment. (See example...) Figure 4EAs shown, in some embodiments, the threaded screw (e.g., a female threaded screw) of the sleeve cap 20 may engage with a corresponding threaded screw (e.g., a male threaded screw) of the handle body 12 to connect the handle 10 to the tubular portion 50. It should be noted that although the sleeve cap 20 is described as being attached to the handle 10 using a threaded screw, this is merely exemplary. Typically, the sleeve cap 20 can be attached to the handle 10 in any manner (the male threaded screw on the sleeve cap 20 engages with the female threaded screw of the handle 10 using a pin or the like). When the sleeve cap 20 is connected to the handle 10, the central channel 28 of the sleeve cap 20 is in fluid communication with the channel of the handle 10, through which the pull line 36 and the steering lines 32, 34 extend. The channel 28 has a stepped configuration, wherein the first portion 28A immediately adjacent to the handle 10 has a larger width / diameter, and the second portion 28B adjacent to the tubular portion 50 has a smaller width / diameter. Figure 4F In the embodiment of the sleeve cap 20 shown, the first portion 28A of the channel 28 has a square (or rectangular) shape and a larger width; the second portion 28B has a tubular shape and a smaller width (or diameter).

[0048] The proximal end of the tubular portion 50 is connected to the wire sleeve 40, and the distal end of the tubular portion 50 is connected to the hinge portion 60 in the distal portion 250 of the device 500. In some embodiments, the wire sleeve 40 may be securely attached (e.g., crimped) to the proximal end of the tubular portion 50. The wire sleeve 40 may be positioned in the first portion 28A of the sleeve cap 20 (see...). Figure 4E The wire sleeve 40 may have a shape or form similar to that of the first portion 28A of the channel 28 (in which the wire sleeve 40 is positioned). That is, in embodiments where the first portion 28A is square or rectangular, the wire sleeve 40 also has a corresponding square or rectangular shape. The outer width of the wire sleeve 40 may be smaller than the width of the first portion 28A (of the channel 28) and larger than the width of the second portion 28B, such that when the sleeve cap 20 is attached to the handle 10, the smaller width of the second portion 28B prevents the wire sleeve 40 (and the tubular portion 50) from separating from the sleeve cap 20. Because the width of the first portion 28A is greater than the width of the wire sleeve 40, there is a gap or space between the wire sleeve 40 and the sleeve cap 20 in the channel 28. Figure 4E As indicated by the double-headed arrows, when the cannula cap 20 is connected to the handle 10, the channel in the handle 10 and the first portion 28A of the channel 28 together form a combined channel, which has a wider width than the wire sleeve 40. For example, when the device 500 is inserted into the cavity of the delivery mirror 1000, this combined channel allows the wire sleeve 40 and the tubular portion 50 to translate freely (e.g., linearly) within the distal ends of the cannula cap 20 and the handle 10. This ability of the wire sleeve 40 and the tubular portion 50 to translate freely in this way allows the tubular portion 50 to extend through the tortuous cavity of the delivery mirror 1000 without causing tension therein.

[0049] Steering cables 32, 34 and pull cable 36 extend from handle 10 through tubular portion 50. Cables 32, 34, and 36 extend through tubular portion 50 such that they can move relative to each other and independently of each other (rotation, translation, etc.). For example, when steering knob 14 is turned to apply tension to steering cables 32, 34, these steering cables 32, 34 can translate within tubular portion 50 (i.e., translate relative to tubular portion 50). Similarly, when rotation knob 16 is turned to rotate pull cable 36, and when actuation knob 18 is translated to translate pull cable 36, pull cable 36 can rotate and translate within tubular portion 50 without moving tubular portion 50.

[0050] As explained above, in some embodiments, such as Figure 4F As shown, the first portion 28A of the channel 28 (of the sleeve cap 20) has a square or rectangular shape. In some such embodiments, the wire sleeve 40 positioned in the first portion 28A may also have a corresponding square (or rectangular) shape, such that when the handle 10 is rotated, the wire sleeve 40 and the tubular portion 50 connected to the wire sleeve 40 also rotate with the handle 10. It should be noted that, generally, the first portion 28A of the channel 28 and the wire sleeve 40 may have any shape (e.g., triangular, polygonal, etc.) that allows the handle 10 to rotate so that the tubular portion 50 rotates.

[0051] As explained above, the distal end of the pull wire 36 is connected to the end effector 120, and the distal end of the tubular portion 50 is connected to the hinge portion 60 (see...). Figure 2 Because the pull wire 36 extending through the tubular portion 50 is not connected to the cable sleeve 40, when the handle 10 is rotated, the cable sleeve 40, the tubular portion 50, the distal portion 250, and the distal assembly 120 rotate together. Figure 11B and Figure 11C As schematically shown, a user can rotate the steering knob 14 (e.g., clockwise) to articulate laterally, and the handle 10 can rotate together with the distal portion 250 of the articulation to reach the target tissue. Similarly, when the knob 16 is rotated to rotate the cable 36, the cable 36 rotates within the tubular portion 50, but the tubular portion 50 itself does not rotate. Therefore, rotation of the knob 16 causes the cable 36 and the end effector 120 to rotate independently of the tubular portion 50, and rotation of the handle 10 causes the articulation region 60 to rotate together with the end effector 120. As explained later, rotating the articulation region 60 allows the end effector 120 to move from one side to the other in different directions in the YZ plane.

[0052] Figure 5AThe diagram illustrates the structure of a tubular portion 50 in an exemplary embodiment. The tubular portion 50 includes a multi-cavity elongated member 52 positioned within a coil 54. The coil 54 may comprise stainless steel or another suitable material (e.g., nitinol) that provides sufficient rigidity to the tubular portion 50. In some embodiments, the coil 54 may comprise wire wound around the elongated member 52. In some embodiments, the coil 54 may be used without the multi-cavity elongated member 52, thus allowing the guide wires 32, 34 and the pull wire 36 to pass through the coil 54, for example, as shown in the diagram. Figure 5D As shown. In some embodiments, the coil 54 may be attached to the outer surface of the elongated member 52, for example, by crimping, adhesive, heat shrinking, etc. The dimensions (thickness, etc.) and / or the shape (pitch, etc.) of the coil 54 may depend on the desired stiffness of the tubular portion 50. The elongated member 52 may include cavities 56A, 56B, and 56C extending therethrough. Directional lines 32, 34 and pull wire 36 may extend from the handle 10 through these cavities 56A, 56B, 56C to the distal portion 250 of the device 500. For example, as Figure 5A As shown, turning lines 32 and 34 may extend through cavities 56A and 56B, respectively, and pull line 36 may extend through cavity 56C. Typically, these cavities 56A to 56C may be larger (e.g., slightly larger) than the lines extending through the respective cavities, such that these cavities exert minimal interference on the lines passing through them. In some embodiments, tube 52 may be made of a lubricating material (such as, for example, PTFE, ...). Made of elastomers, silicone resins, etc. to reduce friction between the tube and the wires (turning wires and pull wires 32, 34, 36) passing through it.

[0053] It should be noted that, although Figure 5A The specific configurations of cavities 56A to 56C in the elongated member 52 are shown, but this is merely exemplary. Typically, cavities 56A to 56C can be arranged in any configuration in the elongated member 52. Figure 5B and Figure 5C An exemplary elongated member 52 is shown, having cavities arranged in different configurations. Figure 5B In the embodiments, cavities 56A to 56C are arranged in a substantially triangular shape. Figure 5C In the embodiments described, cavities 56A to 56C are arranged in a linear configuration. It should be noted that these configurations are exemplary, and other configurations of cavities 56A to 56C are possible. It should also be noted that although cavities 56A and 56B are shown to have substantially the same dimensions, and cavity 56C is shown to be larger than cavities 56A and 56B, this is merely exemplary. Typically, these cavities can have any size (the same size or different sizes).

[0054] refer to Figure 2 At the distal end of the tubular portion 50, the tubular portion 50 is connected to the hinge region 60 of the distal portion 250. Figures 6A to 6CDifferent views of an exemplary embodiment of the hinge region 60 are shown. Figure 6A A perspective view of the hinge region 60 in a bent configuration is shown. Figure 6B and Figure 6C Side views of the proximal and distal regions of the hinge region 60 are shown respectively. The hinge region 60 enables the end effector 120 of the medical device 500 to move from one side to the other in the YZ plane (see...). Figure 2 and Figure 6C The hinged region 60 includes a proximal cap 62, a distal cap 66, and a plurality of links 64 positioned between the proximal cap 62 and the distal cap 66. The plurality of links 64 are stacked on top of each other and connected together such that each link 64 is rotatable relative to the adjacent link 64. Figure 6D and Figure 6E A perspective view of the opposite end faces of the proximal cap 62 is shown. Figure 6F and Figure 6G A perspective view of the opposite ends of link 64 is shown.

[0055] like Figure 6B and Figure 6E As can be seen, the proximal end of the proximal cap 62 is attached to the distal end of the tubular portion 50, and its distal end includes a recess 62D. For example... Figure 6F and Figure 6G As best shown, the distal end of link 64 includes a recess 64D and its proximal end includes a protruding region 64C. A plurality of links 64 of the hinge region 60 are assembled such that the protruding region 64C of one link 64 is positioned in the recess 64D of an adjacent link 64. The mating surfaces of the protruding region 64C and the recess 64D are curved, such that each link 64 is configured to rotate about its adjacent link 64. At its proximal end, the protruding region 64C of link 64 is similarly fitted into the recess 62D of the proximal cap 62, such that the link 64 is configured to rotate about the proximal cap 62. For example, the top surface 64F of the protruding region 64C of link 64 may have a shape and / or curvature corresponding to the shape and / or curvature of the recess 62D, the base 62F, and the 62F' of the proximal cap 62 and link 64. When link 64 is assembled with proximal cap 62, the curvature of the top surface 64F and the bases 62F, 62F' allows link 64 to rotate relative to each other. Distal cap 66 is similarly connected to link 64 (see...). Figure 6C ).

[0056] Passages 62A, 62B, and 62C pass through the proximal cap 62 (see...) Figure 6D and Figure 6E ), pathways 64A, 64B and 64C pass through each link 64 (see Figure 6F and Figure 6G ), Pathways 66A, 66B and 66C pass through distal cap 66 (see Figure 6CEnd caps 62 and 66 and link 64 are arranged such that passages 62A, 64A, and 66A are aligned to form aligned channels, passages 62B, 64B, and 66B are aligned to form aligned channels, and passages 62C, 64C, and 66C are aligned to form aligned channels. Two steering lines 32 and 34 and a pull line 36 pass through these aligned channels in the articulated region 60. For example, steering line 32 passes through the channel formed by passages 62A, 64A, and 66A, steering line 34 passes through the channel formed by passages 62B, 64B, and 66B, and pull line 36 passes through the channel formed by passages 62C, 64C, and 66C.

[0057] refer to Figure 6C The hinge cap 68 is connected to the hinge region 60 on the distal side of the distal cap 66. The turning lines 32 and 34, which pass through the alignment channel of the hinge region 60, are attached to the hinge cap 68. Figure 7A An enlarged view of the distal portion 250 of the device 500 is shown, revealing the hinge cap 68. Furthermore, Figure 7B A hinge cap 68 is shown in an exemplary embodiment. The hinge cap 68 also includes passages 68A, 68B, and 68C aligned with alignment channels of the hinge region 60. Directional lines 32, 34 and a pull line 36 extending from the hinge region 60 are guided through these passages 68A, 68B, and 68C. Directional lines 32, 34 are attached to the hinge cap 68 as the pull line 36 passes through passage 68C. In some embodiments, such as Figure 7A As shown, the turning lines 32 and 34 can be attached to the hinge cap 68 using a crimping fitting (e.g., crimping fitting 32') or a welded fitting.

[0058] When tension is applied (or the steering line is pulled) to one of the steering lines 32, 34 by turning the steering knob 14, link 64 rotates, causing the articulated region 60 to bend in the direction of the pulled steering line. Although not strictly necessary, in some embodiments, the channels through which the steering lines 32, 34 pass in the articulated region 60 may be positioned relative to each other (e.g., spaced approximately 180° apart). For example, as Figure 6CAs shown, the steering lines 32 and 34 in the hinge region 60 can be aligned along the Z-axis. In such an embodiment, when the steering line 34 is pulled (or tension is applied to the steering line 34), the hinge region 60 bends toward the steering line 34, causing the end effector 120 to move in the -Z direction. And, when the steering line 32 is pulled, the hinge region 60 bends toward the steering line 32, causing the end effector 120 to move in the +Z direction. That is, actuation of the steering knob 14 will cause the end effector 120 to move along the Z-axis. To move the end effector 120 along, for example, the Y-axis, the handle 10 can be rotated 90° so that the tubular portion 50 and the hinge region 60 rotate by the same angle, aligning the steering lines 32, 34 along the Y-axis. When the steering lines 32, 34 are aligned along the Y-axis, actuation of the steering knob 14 will cause the end effector 120 to move along the Y-axis. Similarly, the end effector 120 can be moved in any direction in the YZ plane by rotating the handle 10 to align the steering lines 32, 34 (in the articulated region 60) in the desired direction and actuating the steering knob 14. It should be noted that since the rotation of the tubular portion 50 (and the articulated region 60) is independent of the rotation of the cable 36, the rotation of the cable and the rotation of the tubular portion are independent of each other when the articulated region 60 is rotated by rotating the handle 10. When the handle 10 is rotated, the tubular portion rotates together with the distal region 250 and the end effector 120. When the knob is rotated 16, the cable 36 rotates, which only rotates the end effector 120, but does not rotate the tubular portion 50 and the distal region 250, as... Figure 11E and Figure 11F As shown schematically.

[0059] refer to Figure 6C A pull wire 36 extending from the hinge cap 68 passes through the bushing 80 and the U-clamp 90 and is connected to the end effector 120, for example, via a four-bar linkage (or another suitable mechanism (not shown)). As those skilled in the art will recognize, the four-bar linkage mechanism can be configured to open and close the jaws of the end effector 120 in response to the back-and-forth translation of the pull wire 36 along the X-axis. Since four-bar linkages and other suitable mechanisms that actuate the end effector in response to the translation of the pull wire 36 are known in the art, they are not described herein.

[0060] Refer again Figure 6CThe end effector 120 is connected to the distal end of the U-clamp 90. The U-clamp 90 is connected to the bushing 80, allowing it to rotate about the X-axis on the bushing 80. Rotation of the U-clamp 90 on the bushing 80 allows the end effector 120 to rotate independently of the hinge region 60, along with the cable 36. That is, when the rotary knob 16 of the handle 10 is turned to rotate the cable 36, the end effector 120 connected to the distal end of the cable 36 also rotates. The U-clamp 90, rotatably connected to the bushing 80, allows the end effector 120 to rotate independently of the actuation region 60 of the device 500.

[0061] Figure 8A A cross-sectional view shows the bushing 80 and the U-shaped clamp 90 connected together. From Figure 8A As can be seen, bushing 80 is a basic cylindrical component with multiple spaced slits at its distal end. The slits reduce the stiffness of bushing 80 at its distal end and allow the proximal end of U-clamp 90 to be fitted onto the distal end of bushing 80. Collar 82 defines the distal end of bushing 80. U-clamp 90 has a cylindrical region with an undercut 92 (or groove) at its proximal end. The cylindrical proximal end of U-clamp 90 is fitted over the distal end of bushing 80, wherein bushing collar 82 is positioned in the undercut 92 of U-clamp. The bushing 80 and U-clamp 90 are sized to allow U-clamp 90 to rotate freely on bushing 80. The distal end of U-clamp 90 includes a pair of flanges 94 (or arms) having cavities 98 extending laterally through its distal end. The jaws of end effector 120 are connected to the cavities 98 of flanges 94.

[0062] As those skilled in the art will recognize, different embodiments of the disclosed medical device may include many variations of the features described above. For example, in some embodiments, such as Figure 8B As shown, the proximal end of the U-shaped clip 90' may have a slit to reduce its stiffness (or increase its flexibility) and to allow the U-shaped clip 90' to be fitted over the distal end of the bushing 80'.

[0063] In some embodiments, the disclosed medical device may include a hinge region having a form different from that described above. Figures 9A to 9D Different exemplary configurations of the articulated area that can be used in a publicly disclosed medical device are shown. In some embodiments, such as Figure 9A As shown, the hinge region 60A of the disclosed medical device 500 may be made of a flexible material (such as, for example, It is formed of an elastomer, flexible PTFE, or other biocompatible flexible material. In some embodiments, the hinge region 60A may be a columnar or substantially columnar member with a constant (or substantially constant) outer diameter. Figure 9AAs shown, the pathways for the steering line and push line extend longitudinally through a flexible material. As previously described with reference to hinge region 60, steering lines 32, 34 and push line 36 extend through the corresponding pathways of hinge region 60A. When one of the steering lines 32, 34 is pulled, the flexible hinge region 60A bends in the direction of the pulled steering line. The elasticity of the material forming hinge region 60A allows it to return to its original shape (e.g., linear) when the force on the pulled steering line is released.

[0064] In some embodiments, such as Figure 9B As shown, the hinge region 60B can be formed by cutting alternating slits in a columnar (or substantially columnar) member to make it flexible. In some embodiments, the columnar member may be formed of a biocompatible metal. However, this is not necessary. Figure 9B As shown, adjacent slits on the hinge region 60B can be spaced apart along the longitudinal axis of the column member and can face opposite directions. A longitudinal passage can be formed through the column member for use with steering lines and push lines. Although Figure 9B The image shows a slit with a triangular cross-section, but this is merely an example. Typically, these slits can have any shape. Figure 9A In the hinge region 60A, when one of the turning lines 32 and 34 of the hinge region 60B is pulled, the flexible hinge region 60B bends in the direction of the pulled turning line. Furthermore, when the turning line is released, the elasticity of the material (used to form the hinge region 60B) allows the hinge region 60B to return to its original shape (e.g., linear).

[0065] In some embodiments, such as Figure 9C As shown, the hinge region 60C may have a helical shape. In some embodiments, an elongated member with a helical shape may be formed (by any process) and an end cap with a columnar shape may be attached to the opposite end of the helical elongated member (in... Figure 9C (Only one end is visible). In some embodiments, the central portion of the elongated member (e.g., the portion between the two ends) may be machined (or otherwise machined) to have a helical shape. The articulation region 60C may be formed of any biocompatible material (e.g., metal, etc.). Passages for the steering lines 32, 34 and the push line 36 may then be formed longitudinally through the elongated member. In some embodiments, the central channel of the helical elongated member may be used to extend the push line 36, and the longitudinal passage may be formed by the helical members for the steering lines 32, 34. The helical shape of the central portion of the articulation region 60C may impart flexibility to this portion of the articulation region 60C. When one of the steering lines 32, 34 is pulled, the flexible helical portion of the articulation region 60C bends in the direction of the pulled steering line. And, when the pulled steering line is released, the helical portion returns to its original shape.

[0066] In some embodiments, the articulation region 60D may be formed by providing longitudinally spaced slits or slots through columnar (or substantially columnar) members. The columnar members may be formed of any biocompatible material, the slots may have any shape, and the slots may be spaced at any distance. Typically, the columnar members of the articulation region 60D may be flexible. Flexibility may be achieved through the material (used to form the articulation region 60D) and / or the shape and spacing of the slots. Longitudinal channels may be formed by flexible columnar members for the steering lines 32, 34 and the pull line 36. As in each of the articulation regions 60A to 60C, a centrally located passage may be used to allow the push line 36 to pass through, and a smaller passage on either side of the central passage may be used to allow the steering lines 32, 34 to pass through. Furthermore, when one of the steering lines 32, 34 is pulled, the flexible articulation region 60D bends in the direction of the pulled steering line. And, when the pulled steering line is released, the articulation region 60D returns to its original shape.

[0067] In some embodiments, the steering knob 14, the rotary knob 16, and / or the actuation knob 18 may have different forms than those described above. Figure 10A The following are examples of medical devices 500 with different configurations of the steering knob 140. Figure 10C A steering knob 140, separate from the medical device 500, is shown. The steering knob 140 includes multiple supports 140A (e.g., thumb supports) for rotation of the steering knob 140. A wire retainer 144 (see...) Figures 10A to 10B It is connected to the steering knob 140, such that rotation of the steering knob 140 causes the line retainer 144 to rotate. Figure 10B A line retainer 144 is shown in an exemplary embodiment. Steering lines 32, 34 of the device 500 are connected to the line retainer 144. The line retainer 144 includes a disc-shaped support region 144A having a shaft 144B extending therefrom. The shaft 144B of the support region 144A is connected to a steering knob 140 (e.g., using fasteners, adhesives, friction, etc.). The support region 144A includes features that engage with corresponding features on the proximal ends of the steering lines 32, 34 to connect the steering lines 32, 34 to the line retainer 144. These features of the support region 144A may include holes or cavities 144C that receive crimping members 146 attached to the ends (e.g., proximal ends) of the steering lines 32, 34. Figure 10D This is a schematic illustration of an exemplary crimp member 146 attached to the ends of turn lines 32 and 34. Figure 10DAs shown, the ends of the steering lines 32 and 34 are inserted into the cavity 146A of the crimping member 146 and one or more lateral forces F are applied to deform the surface of the crimping member 146 and fix the crimping member 146 to the steering lines 32 and 34. Then, the crimping member 146 is supported in the cavity 144C, and the steering lines 32 and 34 extend through the passage in the body 12 of the handle 10 to the distal portion 250 of the device 500, as previously described.

[0068] In some embodiments, such as Figure 10A As shown, the proximal ends of the steering lines 32, 34 may be wound around the support region 144A of the line retainer 144, wherein the crimping member 146 is located at its proximal end supported in the cavity 144C. The support region 144A may include a channel 144D for receiving the wound steering lines 32, 34. In some embodiments, as Figure 10A As shown, the proximal ends of steering lines 32 and 34 may form a loop around the support region 144A. Although not required, wrapping the proximal ends of steering lines 32 and 34 around the support region 144A reduces the likelihood of kinking in these lines 32 and 34 during operation. As previously described, rotation of the steering knob 140 in one direction applies tension (or force) to one steering line (e.g., steering line 32), and rotation of the steering knob 140 in the opposite direction applies tension to the other steering line (e.g., steering line 34).

[0069] It should be noted that although an exemplary embodiment of the medical device 500 having two steering lines 32, 34 has been described above, this is not a limitation. Generally, the device 500 of the present invention may include any number (e.g., 1, 3, 4, etc.) of steering lines arranged around its hinge region (60, 60A, etc.). These steering lines may be arranged around the hinge region in any configuration (e.g., angularly spaced). For example, in some embodiments, the medical device 500 may include only a single (i.e., one) steering line. In some embodiments, a single steering line can be used to bend the hinge region of the device 500 in different directions by using the steering line in conjunction with the rotation of the handle 10. For example, when the handle 10 is positioned in a first configuration (e.g., in…), Figure 2 When the steering line is pulled (as shown), the articulation region of the device 500 bends in a first direction (e.g., in the +Y direction). Furthermore, rotating the handle 10 (e.g., 180°) to rotate the articulation region, followed by pulling the same steering line, bends the articulation region in the opposite direction (e.g., in the -Y direction).

[0070] In some embodiments, three steering lines may be spaced apart at an angle of approximately 120° around the hinge region. And, in some embodiments, four steering lines may be spaced apart at an angle of approximately 90° around the hinge region. These four steering lines may be actuated by the same or different steering knobs. For example, a first pair of relatively positioned (e.g., spaced 180° apart) steering lines may be attached to and actuated by a first steering knob, and a second pair of relatively positioned steering lines may be attached to and actuated by a second steering knob. Applying tension to a steering line causes the hinge region to bend in the direction of the pulled steering line.

[0071] As explained above, the exemplary medical device 500 of the present invention has multiple independent degrees of freedom that are separate from each other. Specifically, in various embodiments of the device 500, the independent degrees of freedom include (refer to...) Figure 2 The end effector 120 can be actuated using an actuation knob 18 (e.g., turned on and off); (b) the end effector 120 can be moved in the YZ plane using a steering knob 14 (e.g., left and right, up and down); (c) the end effector 120 can be rotated using a rotation knob 16 (clockwise and counterclockwise about the X-axis); (d) the coil or tubular portion 50 of the device 500 can be rotated by rotating a handle 10 (clockwise and counterclockwise about the X-axis); and (e) the end effector 120 can be moved in the X direction by moving the handle 10 in the X direction. Furthermore, each of these degrees of freedom is independent and separate from each other. During an exemplary medical procedure using the disclosed device 500, the multiple independent degrees of freedom of the device 500 enable its end effector 120 to be manipulated independently of any desired manner from the delivery mirror used to introduce the device 500 into the patient.

[0072] Exemplary medical procedures (e.g., endoscopic mucosal resection) using the exemplary disclosed medical device 500 will now be described. Since such medical procedures are well known in the art, the procedures described below will only highlight aspects of the exemplary features of the disclosed device. Reference will be made to the following discussion. Figure 1 , Figure 2 , Figure 3A and Figure 6CThe delivery scope 1000 (e.g., an endoscope) can be inserted into the patient's body (e.g., inserted through the mouth into the patient's upper gastrointestinal tract) and positioned so that its distal end is adjacent to the target tissue. The endoscopic medical device 500 can be inserted into the body through the lumen of the delivery scope 1000, and its end effector 120 is suitably positioned adjacent to the target tissue. Initially, the steering lines 32, 34 in the hinge region 60 of the device 500 can be aligned along, for example, the Y-axis. When in this orientation, the steering knob 14 can be actuated (or rotated) to bend the actuation region 60 and move the end effector 120 along the Y-axis. That is, turning the steering knob 14 in one direction will bend the hinge region 60, causing the end effector 120 to move in the +Y direction, and turning the steering knob 14 in the opposite direction will bend the hinge region 60 in the opposite direction, causing the end effector 120 to move in the -Y direction. The rotary knob 16 can now be turned to independently rotate the end effector 120. Since the rotation of the end effector 120 is separate from the rotation of the tubular portion 50 and the hinge region 60, operation of the rotary knob 16 causes the end effector 120 to rotate, but does not change, for example, the bending shape of the hinge region 60. The handle 10 can be rotated, for example, 90°, to rotate the hinge region 60 by the same angle and align the steering lines 32, 34 along the Z-axis. The steering knob 14 can now be actuated to bend the hinge region 60 along the Z-axis, thereby moving the end effector 120 along this axis. At any time during this process, the actuation knob 18 can be activated to open and close the jaws of the end effector 120. The handle 10 can be moved in the + / -X direction, which will cause the end effector 120 to translate in the + / - direction (in and out of endoscope 1000), as... Figure 11G As illustrated in the diagram.

[0073] It should be noted that typical medical procedures using device 500 may include many known additional (or alternative) steps, which have been omitted in the above description for the sake of brevity. Any of the above steps may be omitted or modified, or other steps may be added, as long as the intended function of the disclosed medical device 500 remains substantially unchanged. Furthermore, although a certain order is described or implied in the described medical procedures, it is generally not necessary to perform these steps in the stated order. Moreover, the procedures described may be incorporated into more comprehensive medical procedures not described herein.

[0074] Although the principles of the invention have been described herein with reference to illustrative aspects for specific applications, it should be understood that the invention is not limited thereto. Those skilled in the art and who have access to the teachings provided herein will recognize that additional modifications, applications, aspects, and equivalents fall within the scope of the aspects described herein. Therefore, the invention should not be considered limited to the foregoing description.

Claims

1. A medical device comprising: a handle including an actuation actuator and a rotation actuator; an end effector, wherein the actuation actuator is configured to actuate the end effector; a tubular portion extending between the handle and the end effector, wherein the end effector is configured to rotate about a first axis extending through the tubular portion without rotating the tubular portion, and the tubular portion is configured to rotate with the end effector about the first axis; and a core wire extending through the tubular portion, wherein the core wire is coupled to the end effector and rotatably coupled to the actuation actuator, wherein a cavity in the rotation actuator houses the core wire, the cavity having a polygonal cross-sectional shape; wherein actuation of the actuation actuator translates the core wire in the cavity, and actuation of the rotation actuator rotates the core wire in the actuation actuator, wherein a hypotube is attached to a portion of the core wire extending through the cavity of the rotation actuator, the hypotube having the same cross-sectional shape as the cavity, and the hypotube is located between a proximal end of the cavity and a distal end of the cavity.

2. The medical device of claim 1, wherein actuation of the rotation actuator rotates the end effector about the first axis without rotating the tubular portion.

3. The medical device of claim 1 or 2, wherein the end effector is rotatably coupled to the tubular portion such that the end effector is rotatable with the tubular portion about the first axis.

4. The medical device of claim 1, wherein actuation of the actuation actuator causes the hypotube to translate with the core wire in the cavity of the rotation actuator.

5. The medical device of claim 1, further comprising (a) an articulation region coupled to a distal end of the tubular portion, and (b) a steering actuator on the handle, wherein actuation of the steering actuator bends the articulation region in a first plane that passes through the first axis.

6. The medical device of claim 5, further comprising one or more steering wires coupled to the steering actuator and extending through the articulation region along the first plane, wherein actuation of the steering actuator applies tension to at least one of the one or more steering wires to bend the articulation region in the first plane.

7. The medical device of claim 6, wherein the articulation region comprises a plurality of links rotatably coupled together.

8. The medical device of claim 6 or 7, wherein the articulation region comprises a flexible elongate member having a plurality of passageways extending longitudinally therethrough.

9. The medical device of any one of claims 6-7, wherein the one or more steering wires comprises exactly one steering wire.

10. The medical device of any one of claims 6-7, wherein the one or more steering wires comprises exactly two steering wires, wherein the rotation actuator is located between the exactly two steering wires. ​ 11. The medical device of claim 1, the cavity having a rectangular cross-sectional shape.

12. The medical device of claim 11, the cavity having a square cross-sectional shape.

13. The medical device of claim 1, the cavity having a triangular cross-sectional shape.

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