MULTI-DEGREE-OF-FREEDOM MEDICAL DEVICE HANDLE - Patent application

Abstract

The medical device may include a handle having at least one actuator, a shaft having a proximal end and a distal end connected to the handle, and a distal assembly connected to the distal end of the shaft and including an end effector. The handle may be configured to enable a user to manipulate the at least one actuator with one hand to (1) actuate the end effector, (2) rotate the end effector relative to the shaft, and (3) articulate a distal portion of the shaft.

Description

[Technical field]

[0001] Various embodiments of the present disclosure relate generally to medical device handles. Examples of the present disclosure relate to ergonomic handles that control multiple degrees of freedom of a medical device. [Background technology]

[0002] In some medical procedures, physicians are required to hold and manipulate multiple devices simultaneously. For example, during intraluminal surgery, a physician holds and manipulates a scope (e.g., endoscope) with one hand (e.g., left hand) while manipulating the scope shaft with the other hand (e.g., right hand) to position the scope within a patient's body lumen. The physician or technician then introduces an accessory device into the working channel of the scope and positions the accessory within the patient. Currently, accessories often do not have the ability to be independently and intuitively manipulated in all degrees of freedom required for accessory positioning and actuation. Also, manipulation of the scope and accessory devices can result in muscle fatigue and stress over the length of the procedure. Summary of the Invention

[0003] The present disclosure is directed to overcoming one or more of these problems or other problems in the art as set forth above. Aspects of the present disclosure relate, inter alia, to ergonomic medical device handles that allow for one-handed control of multiple degrees of freedom of a medical device in a neutral or relatively neutral position. Each of the aspects disclosed herein may include one or more of the features described in association with any other disclosed aspect.

[0004] According to one aspect of the disclosure, a medical device may include a handle having at least one actuator, a shaft having a proximal end and a distal end connected to the handle, and a distal assembly connected to the distal end of the shaft. The distal assembly may include an end effector. The handle is configured to enable a user to manipulate the at least one actuator with one hand to (1) actuate the end effector, (2) rotate the end effector relative to the shaft, and (3) articulate a distal portion of the shaft.

[0005] The medical device may include a first actuator, a second actuator, and a third actuator. The first actuator may rotate the end effector relative to the shaft. The second actuator may actuate the end effector. The third actuator may articulate the distal portion of the shaft. The first actuator may be a trigger. The second actuator may be a knob. The third actuator may be a knob. The handle may be configured such that the user can simultaneously place the index finger of one hand on the trigger, the thumb of one hand on the first knob, the middle finger of one hand on the second knob, and the palm of one hand on the handle. The handle may be configured such that, in use, the first knob faces away from the user, the second knob is located on the left side of the handle body relative to the user, and the trigger is located at the top of the handle. The medical device may include a mechanism for controlling actuation of the end effector. The mechanism may include a first rack, a pinion gear that meshes with the first rack, and a second rack that meshes with the pinion gear and is coupled to a control wire. When the first rack moves into and out of the handle body of the handle, the pinion gear rotates clockwise and counterclockwise, respectively, causing the second rack and control wire to move proximally and distally, respectively. The mechanism for controlling rotation of the end effector relative to the shaft may include a first pinion gear and a second pinion gear that meshes with the first pinion gear. The control wire may be located within the second pinion gear such that when the first pinion gear rotates clockwise and counterclockwise, the second pinion gear rotates counterclockwise and clockwise, respectively, causing the control wire to rotate. The mechanism for controlling articulation of the distal portion of the shaft may include a first control wire and a second control wire coupled to a pulley.The first control wire and the second control wire are coupled to the pulley such that the first control wire is pulled under tension when the pulley rotates clockwise and the second control wire is pulled under tension when the pulley rotates counterclockwise.

[0006] According to another aspect of the disclosure, the first actuator may be a knob, the second actuator may be a trigger, and the third actuator may be a lever. The knob, trigger, and lever may be configured such that the user can simultaneously place the index finger of one hand on the knob, the thumb of one hand on the lever, the middle finger of one hand on the trigger, and the palm of one hand on the handle. The handle may be configured such that, in use, the knob faces away from the user, the lever faces towards the user, and the trigger faces away from the user.

[0007] According to another aspect of the present disclosure, the medical device may include a mechanism for controlling actuation of the end effector, the mechanism including a first rack, a pinion gear meshing with the first rack, and a second rack meshing with the pinion gear and coupled to a control wire, the pinion gear rotating clockwise and counterclockwise when the first rack moves into and out of a handle body of the handle, respectively, thereby moving the second rack and the control wire proximally and distally, respectively.

[0008] The medical device may include a mechanism for controlling the rotation of the end effector relative to the shaft. The mechanism may include a first pinion gear, a second pinion gear meshing with the first pinion gear and fixedly coupled to a proximal end of the shaft, a third pinion gear fixedly coupled to a distal end of the shaft, and a fourth pinion gear meshing with the third pinion gear. A control wire is located within the fourth pinion gear. Clockwise and counterclockwise rotation of the first pinion gear rotates the fourth pinion gear, respectively, thereby rotating the control wire. The medical device may also include a mechanism for controlling articulation of the distal portion of the shaft. The mechanism may include a first control wire and a second control wire coupled to a pulley. The first control wire and the second control wire are coupled to the pulley such that the first control wire is pulled under tension when the pulley rotates clockwise and the second control wire is pulled under tension when the pulley rotates counterclockwise.

[0009] According to another aspect of the disclosure, the first actuator may be a knob, the second actuator may be a trigger, and the third actuator may be a lever. The knob, trigger, and lever may be configured to allow the user to simultaneously place the index finger of one hand on the knob, the thumb of one hand on the lever, the middle finger of one hand on the trigger, and the palm of the one hand on the handle. The handle may be configured such that, in use, the knob faces away from the user, the lever faces towards the user, and the trigger faces away from the user. Alternative devices may include any combination of the mechanisms described above to articulate, actuate, or rotate a distal portion of the shaft. Alternatively, the medical device may include a mechanism for controlling rotation of the end effector relative to the shaft. The mechanism may include a first pinion gear, a second pinion gear that meshes with the first pinion gear and is fixedly coupled to a proximal end of a shaft, a third pinion gear that is fixedly coupled to a distal end of a shaft, and a fourth pinion gear that meshes with the third pinion gear. The control wire may be located within the fourth pinion gear such that clockwise and counterclockwise rotation of the first pinion gear rotates the fourth pinion gear, thereby rotating the control wire. The mechanism for controlling articulation of the distal portion of the shaft may also include a first control wire and a second control wire coupled to a cam. The first control wire and the second control wire are coupled to the cam such that the first control wire is pulled in tension when the cam rotates clockwise and the second control wire is pulled in tension when the cam rotates counterclockwise.

[0010] In an alternative embodiment, the medical device may include at least one actuator. The one actuator may include a knob. The knob is coupled to the base of the handle by a ball at a distal end of the knob and a socket at a proximal end of the handle base. The knob may be configured to include a first mechanism for controlling actuation of the end effector, the first mechanism including a control wire coupled to the distal end of the knob. The control wire is coupled to the distal end of the knob such that the control wire translates in response to proximal retraction and distal pushing of the knob. The knob may also be configured to include a second mechanism for controlling rotation of the end effector relative to the shaft, the second mechanism including the control wire coupled to the distal end of the knob. The control wire is coupled to the distal end of the knob such that clockwise and counterclockwise rotation of the knob rotates the control wire, respectively. The knob may also be configured to include a third mechanism for controlling articulation of the distal portion of the shaft, the third mechanism including a first articulation wire and a second articulation wire coupled to the ball. The third mechanism is configured such that the first articulation wire is pulled into tension when the knob is moved in a first direction and the second articulation wire is pulled into tension when the knob is moved in a second direction opposite the first direction. The one actuator may be a knob coupled to the handle by a ball and socket connection. The handle may be separable from the actuator.

[0011] Another aspect of the present disclosure may include a method of operating a medical device. The method may include positioning a medical device inside a body lumen, articulating a distal portion of the shaft with the at least one actuator using one hand, rotating the end effector relative to the shaft with the at least one actuator using the one hand, and actuating the end effector with the at least one actuator using the one hand. The at least one actuator may include three actuators. The three actuators are configured such that a user can simultaneously contact the three actuators using the one hand.

[0012] Additional objects and advantages of the disclosed embodiments will be set forth in part in the description which follows, and in part will be obvious from the following description, or may be learned by practice of the disclosed embodiments. The objects and advantages of the disclosed embodiments may be realized and attained by means of the elements and combinations particularly pointed out in the claims.

[0013] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present disclosure, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a side view of a medical device according to an embodiment of the present disclosure. [Figure 2A-2B] 2A and 2B are perspective views of a medical device according to an embodiment of the present disclosure. [Diagram 3] FIG. 3 is a perspective view of a user holding the medical device of FIGS. 2A and 2B according to an embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional side view of the medical device of FIGS. 2A and 2B according to an embodiment of the present disclosure. [Diagram 5] 5 is a side cross-sectional view of an enlarged portion of the medical device of FIG. 4 according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a side cross-sectional view of a portion of the medical device of FIG. 4 according to an embodiment of the present disclosure. [Figure 7] 7A and 7B are perspective views of an alternative embodiment of a medical device handle according to aspects of the present disclosure. [Figure 8] FIG. 8 is a perspective view of a user holding the medical device of FIGS. 7A and 7B according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a side cross-sectional view of the medical device of FIGS. 7A and 7B according to an embodiment of the present disclosure. [Figure 10] FIG. 10 is a perspective view of a user holding a medical scope and an alternative embodiment medical device in accordance with aspects of the present disclosure. [Figure 11] FIG. 11 is a side view of the medical device of FIG. 10 according to an embodiment of the present disclosure. [Figure 12] 12 is a side cross-sectional view of a portion of a handle of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 13] FIG. 13 is a perspective view of a portion of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 14] 14 is a partial cross-sectional side view of a portion of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 15] 15A and 15B are partial cross-sectional side views of a portion of the medical device of FIG. 11 according to an embodiment of the present disclosure. [Figure 16] 16A, 16B, and 16C are perspective views of an alternative handle embodiment of the medical device of FIG. 11 according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Aspects of the present disclosure include devices and methods that allow for a neutral or relatively neutral hand posture (e.g., an ergonomic, natural hand position with the wrist and fingers generally at or near rest) on a medical device handle, while providing a handle that controls multiple degrees of freedom at the distal end of the device to enable treatment at a target tissue site within a subject (e.g., a patient). In embodiments, the handle is configured such that a single position of the hand on the handle may control up to five degrees of freedom of the device.

[0016] The medical device may be introduced into the body without or through a delivery device. The delivery device may be a catheter, a scope (such as an endoscope, bronchoscope, colonoscope, etc.), a tube, or a sheath, and may be inserted into a body cavity or lumen, such as the GI tract, through a natural orifice. The orifice may be, for example, the nose, the mouth, or the anus. The placement may be any part of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Also, the delivery and placement may be within the GI tract, a natural orifice or body lumen, or other body lumen or organ accessible through a body incision.

[0017] Reference will now be made in detail to the aspects of the present disclosure. Examples of aspects of the present disclosure are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers are used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the part of the device that is furthest from the user when the device is introduced into a patient. In contrast, the term "proximal" refers to the part of the device that is closest to the user when the device is placed within a subject. As used herein, the terms "comprises", "comprising", or any other variants thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or device that includes a list of elements does not necessarily include only those elements, but may include other elements not expressly listed, or other elements inherent to such process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "ideal". As used herein, the terms "about", "substantially", and "approximately" indicate a range of values ​​within + / - 10% of the stated value.

[0018]

[0003] Examples of the present disclosure relate to devices and methods for performing various medical procedures and / or treatments of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the gastrointestinal tract, and / or any other suitable portion of a patient's anatomical structure (collectively referred to herein as the "target treatment site"). Various examples described herein include single use or disposable medical devices. Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0019] 1 is a schematic diagram of a medical system 1000 according to an embodiment of the present disclosure. The system may be comprised of a medical device 1010 and a delivery device 1055. The medical device 1010 includes a proximal end 1060 and a distal end 1030. A handle 1070, including one or more actuators 1090, 1091, 1092, is located at or adjacent to the proximal end 1060. A shaft 1050 of the device 1010 extends from a distal end of the handle 1070 to a distal end 1030 of the device 1010. The distal end 1030 includes a distal articulatable portion 1020 of the shaft 1050 and an end effector 1025, which are further described herein.

[0020] The medical device 1010 may be introduced into the body via a delivery device 1055. The delivery device 1055 may include a port 1085 located at or adjacent to the proximal end of a lumen 1065 (e.g., working channel) within the delivery device 1055. The delivery device 1055 may be a catheter, a scope (endoscope, bronchoscope, colonoscope, etc.), a tube, a sheath, etc., and may be inserted into a body cavity or lumen, e.g., the GI tract, via a natural orifice. The medical devices described herein may have any structure that may be made from biocompatible materials, including biocompatible polymers, rubbers, plastics, etc.

[0021] Continuing with reference to FIG. 1 , the actuators 1090, 1091, 1092 of the handle 1070 control various functions at the distal end 1030. These actuators may include knobs, triggers, buttons, switches, pneumatic controls, or other actuators known in the art. The handle 1070 and actuators 1090, 1091, 1092 may enable multiple degrees of freedom for the medical device 1010. For example, the actuator 1090 may control the actuation (e.g., opening and closing) of the end effector 1025. The actuator 1091 may control the articulation (bending) of the distal end 1030. The actuator 1092 may control the rotation of the end effector 1025 relative to the shaft 1050. Any combination of actuators and degrees of freedom are within the scope of the embodiments of the present disclosure. Additionally, the medical device 1010 may be configured such that a user can rotate the handle 1070 to rotate the entire medical device 1010 relative to the delivery device 1055. Additionally, the medical device 1010 can be configured to move relative to the delivery device 1055 by a user moving the handle 1070 back and forth, causing the medical device 1010 to translate within the lumen 1065 .

[0022] The shaft 1050 of the medical device 1010 may be a tube having a length sufficient to access a site within the body. The shaft 1050 may also be flexible enough to traverse tortuous anatomy. The shaft 1050 may be made from a flexible material, a rigid material, or any combination thereof.

[0023] Distal end 1030 is located at or adjacent to the distal end of shaft 1050. Distal end 1030 consists of a distal articulatable portion 1020 (e.g., an articulation joint) of shaft 1050 and an end effector 1025. Transition zone 1040 is located proximal to distal articulatable portion 1020 of shaft 1050 and provides a transition between this articulatable portion and a more proximal portion of shaft 1050. These components within transition zone 1040 (e.g., components at the proximal end of portion 1020 to the more proximal portion of shaft 1050) can be bonded by adhesive, ultrasonic welding, or any other means known in the art.

[0024] The end effector 1025 may include various components, including multiple tools or parts that are connected to other parts of the medical device 1010 to enable various functions of the tools. Exemplary tools include, but are not limited to, tissue graspers, knives, biopsy forceps, scissors, retrieval devices (such as nets or baskets), electrocautery tools, and the like. As described above and in more detail below, various handle actuators (e.g., actuators 1090, 1091, 1092) and associated mechanisms can control the articulation of the articulating portion 1020 and the actuation of the end effector 1025 (e.g., opening / closing). Connections between the actuators and distal components, such as one or more elongate members 1080 (wires, cables, and the like), transfer the actuation of the actuators to respective functions at the distal end 1030.

[0025] 2A and 2B show an exemplary medical device 10 including a handle 11. The handle 11 includes a handle body 18 and three actuators: an actuator / trigger 12 and knobs 14, 16. A strain relief 20 provides an interface between the handle 11 and a shaft (not shown). The actuator 12 is on a proximal end of the handle 11 and can control the actuation (e.g., opening / closing motion) of an end effector 1025 illustrated in FIG. 1. For example, the end effector (not shown) can be opened (or otherwise actuated) by moving the actuator 12 away from the handle body 18, and the end effector can be closed (or otherwise actuated) by moving a lever into the handle body 18. Note that alternative actions are also within the scope of this embodiment. For example, the end effector can be opened by moving the actuator 12 into (distal to) the handle body 18, and the end effector can be closed by moving the actuator 12 away from the handle 11.

[0026] The knob 14 is located on the front of the handle 11, e.g., on the side of the handle that faces away from the user when the device 10 is in use. The knob 14 is perpendicular to a central axis of the device 10 that extends from the shaft of the device 10 through the strain relief 20 to the top of the handle body 18 and proximate to the actuator 12. The knob 14 can control the rotational movement of the end effector 1025 illustrated in FIG. 1. For example, rotating the knob 14 to the left can rotate the end effector in a counterclockwise motion, rotating the knob 14 to the right can rotate the end effector in a clockwise motion, and vice versa.

[0027] The knob 16 is located on a side of the handle 11, for example, on the left side of the handle body 18 when the device 10 is in use. The plane of rotation of the knob 16 is parallel or substantially parallel to the central axis of the device 10. The knob 16 can control the direction of articulation of the distal end 1030 illustrated in FIG. 1. For example, rotating the knob 16 clockwise can result in left articulation of the distal end, rotating the knob 16 counterclockwise can result in right articulation of the distal end, and vice versa. The device can also be articulated up or down in a similar manner depending on the attachment location of the steering wire to the distal end.

[0028] The handle 11 may include any combination or subset of the actuator 12 and the knobs 14, 16. Each of the actuators 12 and the knobs 14, 16 may perform any of the various functions described herein. For example, the handle 11 may include only the actuator 12 and the rotation knob 14, or any other subset or combination. As another example, the actuator 12 may control the articulation of the distal end 1030 (shown in FIG. 1), the knob 14 may control the actuation (e.g., open / close movement) of the end effector 1025 (shown in FIG. 1), and the knob 16 may control the rotation of the distal end 1030 (shown in FIG. 1). Any combination of these is within the scope of the present disclosure.

[0029] FIG. 3 illustrates how a user 22 may grip the medical device 10, specifically the handle 11, with one hand. With the thumb, the user 22 may control the clockwise and counterclockwise rotation of the knob 16. With the middle finger, the user 22 may control the left and right rotation of the knob 14. With the index finger, the user 22 may control the inward and outward movement of the actuator 12. The actuator 12 is angled slightly away from the central axis of the device to allow for a neutral, ergonomic grip for the user 22. With the remaining fingers and palm, the user 22 may grip the handle body 18. As shown, during use, the knob 14 faces away from the user 22, the knob 16 is on the left side of the handle body 18, and the actuator 12 is located at the top of the handle body 18.

[0030] FIG. 4 shows the components inside the handle body 18 and is a cross-section of the handle 10 of FIGS. 2A and 2B. The actuator 12 includes a slot 13 and an extension 15. The slot 13 can be of various shapes and sizes to allow a user to insert a finger through the slot 13. For example, the slot 13 can be oval, circular, square, rectangular, etc. as shown. The extension 15 extends into the handle body 18 and includes a linear rack 24 along the distal most end of the extension 15 opposite the end having the slot 13. The rack 24 meshes with the pinion gear 26 such that the pinion gear 26 rotates clockwise and counterclockwise, respectively, when the actuator 12 is moved in and out of the handle body 18 (through the slot in the top of the handle body 18). The pinion gear 26 meshes with a movable rack 28, which is coupled to the control wire 30 in a manner that allows rotational movement of the wire 30 relative to the rack 28 while restricting movement of the control wire 30 along its axis relative to the rack 28. As the pinion gear 26 rotates, the rack 28 moves up and down (depending on the direction of rotation of the pinion gear 26) within the handle body 18. As the rack moves up and down, the wire 30 moves with it.

[0031] Continuing to refer to FIG. 4, the knob 14 is fixedly coupled to a pinion gear 48. The pinion gear 48 meshes with a pinion gear 50, which is coupled to a control wire 30. The control wire 30 is coupled to the gear 50 such that the wire 30 can translate up and down within the gear 50 and also rotate with the gear 50. For example, a crimp having a square profile can be secured to the wire 30 between the wire 30 and the gear 50. The gear 50 can have a square bore in its center to receive the square crimp. Rotation of the gear 50 rotates the crimp and the wire 30. Thus, when the knob 14 rotates, the pinion gear 48 rotates in the same or similar rotational direction, causing an opposite rotation of the pinion gear 50 and the wire 30.

[0032] FIG. 5 shows a close-up view of the interaction between the rack 24, the pinion gear 26, and the rack 28. The rack 24 is comprised of a plurality of extensions 36 (e.g., teeth) and a plurality of recesses 38 (e.g., valleys) that mesh with a plurality of recesses 42 and a plurality of extensions 40 on the pinion gear 26, respectively. Additionally, the plurality of extensions 40 and the plurality of recesses 42 of the pinion gear 26 mesh with a plurality of recesses 46 and a plurality of extensions 44 of the rack 28. The rack 28 may be comprised of two components that are mirror images of each other. FIG. 5 shows one of these components. The other component (not shown) is placed on top of the component shown, out of the page of FIG. 5, to define a cavity in which the ferrule 32 is seated. The two components of the rack 28 may be joined to fully or partially accommodate the ferrule 32. The components of the rack 28 may be joined by adhesive, ultrasonic welding, or any other means known in the art. The ferrule 32 may be fixedly coupled to the control wire 30 by crimping, adhesive, or other means known in the art. The control wire 30 extends from the distal end of the ferrule 32 through a channel 31 defined in the rack 28. The channel 31 extends from a cavity 29 to the distal end of the rack 28. The control wire 30 then extends through the handle body 18, the strain relief 20, the shaft of the device 10, and to the distal tip of the device 10. At the distal tip, the wire 30 is connected to the distal assembly in any suitable manner known in the art to actuate an end effector of the distal assembly.

[0033] The rack 24, pinion gear 26, and rack 28 interact such that the recesses 38 and extensions 36 engage with the extensions 40 and recesses 42 of the pinion gear 26 when the rack 24 moves in and out of the handle body 18, respectively, to move the pinion gear 26 clockwise and counterclockwise. The extensions 40 and recesses 42 of the pinion gear 26 also engage with the extensions 44 and recesses 46 of the rack 28, respectively, to raise and lower the rack 28 when the pinion gear 26 rotates clockwise or counterclockwise. As the rack 28 raises and lowers, the ferrule 32 and control wire 30 raise and lower accordingly. This movement correlates to actuation of the distal assembly / end effector. Minor adjustments, including the addition of more pinion gears and racks, can be made to enhance or change the desired movement. For example, by adding another pinion gear either between rack 24 and pinion gear 26 or between rack 28 and pinion gear 26, the opposite effect to that achieved by the configuration shown in Figure 5 can be achieved. Specifically, in Figure 5, pushing rack 24 distally moves rack 28 proximally, e.g., opening the end effector. Adding another gear as described above results in distal movement of rack 24 which causes distal movement of rack 28, e.g., closing the end effector.

[0034] FIG. 6 illustrates another cross-sectional view of the medical device 10 of FIGS. 2A and 2B, showing components within the handle body 18 not shown in FIG. 4. The components shown in FIG. 6 are used to articulate the distal end of a shaft (not shown) of the medical device. In FIG. 6, the knob 16 may be fixedly coupled to the pulley 54 by press fit, adhesive, or any method known in the art. The steering wires 56, 58 may be coupled to the pulley 54 such that when the knob 16 is rotated, one of the steering wires 56, 58 is pulled under tension. The steering wires 56, 58 are connected to a distal tip (e.g., a distal end of an articulation joint) such that when the steering wires 56, 58 are pulled under tension, the distal tip (not shown) articulates accordingly. For example, rotating knob 16 counterclockwise puts tension on steering wire 56 causing the distal tip to articulate in a first direction, and rotating knob 16 clockwise puts tension on steering wire 58 causing the distal tip to articulate in a second direction opposite the first direction. Steering wires 56, 58 may pass through tracks 60, 62. Tracks 60, 62 serve to confine the steering wires and prevent them from tangling with other components within the handle during use.

[0035] Aspects of the present disclosure include methods of using the device 10. To use the device 10, a user may first introduce the distal end of the device 10 into the GI tract through a natural orifice. The orifice may be, for example, the nose, mouth, or anus. Placement may be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement may also be in the GI tract, any other natural orifice or body tract, through a body incision, or in other body lumens or organs reachable through a delivery device, such as an endoscope or sheath. Once the desired site is accessed, the user may use only one hand (or two hands, if desired) to actuate one or more actuators, including knobs 14, 16 and actuator 12, to control articulation of the distal end of the medical device, actuation of the end effector, and / or rotation of the end effector relative to the shaft of the medical device 10.

[0036] 7A and 7B show an alternative embodiment of a medical device 110. The medical device 110 includes a handle 111 having a handle body 118 and three actuators: a lever 116, a knob 114, and a trigger 112. A strain relief 120 provides an interface between the handle 111 and a device sheath (not shown). The lever 116 may control the direction of articulation of the distal end 1030 illustrated in FIG. 1. For example, pushing the lever 116 away (or up as shown) may result in left articulation of the distal end, and pulling the lever 116 down may result in right articulation of the distal end. However, alternative actions are within the scope of this disclosure. For example, pushing the lever 116 away may result in right articulation of the distal end, and pulling the lever 116 down may result in left articulation of the distal end. The device may also be articulated up or down in a similar manner.

[0037] The knob 114 is located on the front of the handle 111 and faces away from the user during operation. The plane about which the knob 114 rotates is perpendicular to the central axis of the device 110, which extends through the handle 118, the strain relief 120, and the device shaft. The knob 114 can control the rotational movement of the end effector 1025 illustrated in FIG. 1. For example, rotating the knob 114 to the left can translate to a rotation of the end effector in a counterclockwise motion relative to the device shaft, and rotating the knob 114 to the right can translate to a rotation of the end effector in a clockwise motion relative to the shaft. However, alternative movements are also within the scope of the present disclosure. For example, rotating the knob 114 to the right can translate to a rotation of the end effector in a counterclockwise motion, and rotating the knob 114 to the left can translate to a rotation of the end effector in a clockwise motion.

[0038] The trigger 112 may control the actuation (e.g., opening / closing motion) of the end effector 1025 illustrated in FIG. 1. For example, actuating the trigger 112 (pulling the trigger 112 into the handle body 118) may translate to an opening motion of the end effector (not shown), and releasing the trigger 112 (allowing or pushing the trigger 112 out of the body 118) may translate to a closing motion of the end effector. However, alternative motions are within the scope of this disclosure. For example, actuating the trigger 112 may open the end effector, and releasing the trigger 112 out of the handle 118 may close the end effector.

[0039] The handle 111 may include any combination of the trigger 112, the knob 114, and the lever 116. For example, the handle 111 may include only the knob 114 and the trigger 112, or any other combination. Also, each actuator is not limited to the above-mentioned operations. For example, the trigger 112 may control the articulation of the distal end 1030 (shown in FIG. 1), the knob 114 may control the opening / closing movement of the end effector 1025 (shown in FIG. 1), and the knob 116 may control the rotation of the distal tip (shown in FIG. 1). Also, any combination of these is possible.

[0040] 8 illustrates how a user 122 may grasp the medical device 110. The user 122 may control the lever 116 with his or her thumb. The user 122 may also control actuation (e.g., opening and closing) of the distal tip of the medical device 110 by fitting his or her middle finger within an opening (slot 113) in the trigger 112, and may control rotation of the knob 114 with his or her index finger. The user 122 may grasp the handle body 118 with the remaining fingers and palm of the hand. Thus, in use, the trigger 112 and knob 114 face away from the user 122, the lever 116 faces towards the user 122, and the knob 114 is located above the trigger 112. Additionally, the trigger 112, knob 114, and lever 116 reside in a common plane.

[0041] FIG. 9 shows a cross section of the handle 110 of FIGS. 7A and 7B. A knob 114 may control rotational movement of the distal tip relative to the shaft of the medical device. The knob 114 may be fixedly coupled to a pinion gear 148. A plurality of extensions and recesses of the pinion gear 148 may mesh with extensions and recesses of the pinion gear 150. The pinion gear 150 may be fixedly coupled to a proximal end of a shaft 164. The pinion gear 150 and the shaft 164 may be held in an upright position by an extension 151 of the handle body 118. The pinion gear 150 may sit on the extension 150 and the shaft 164 may pass through the extension 150. A pinion gear 166 may be fixedly coupled to a distal end of the shaft 164. The pinion gear 166 has multiple extensions and recesses that mesh with the extensions and recesses of the pinion gear 168. The pinion gear 168 may be fixedly coupled to the proximal end of the shaft 151. The ferrule 152 may be coupled to the distal end of the shaft 151 and may be fixedly connected to the control wire 130. The control wire 130 may be fixedly coupled to the ferrule 152 by adhesive, crimping, or any alternative coupling method known in the art. The distal end (not shown) of the wire 130 may be coupled to a distal assembly / end effector at the distal end of the device 110. When the knob 114 is rotated, the pinion gear 148 rotates. Thus, when the pinion gear 148 rotates, the pinion gear 150 rotates in the opposite direction due to the extensions and recesses of the pinion gear 148 meshing with the pinion gear 150. This motion can then rotate a pinion gear 166 coupled to the distal end of the shaft 164. Additionally, the extensions and recesses of the pinion gear 166 mesh with the pinion gear 168, causing the pinion gear 168 to rotate in the opposite direction when the pinion gear 166 rotates. Because the shaft 151 is coupled to the pinion gear 168, when the pinion gear 168 rotates, the shaft 151 and ferrule 152 can rotate accordingly. This motion translates to a rotation of the distal tip assembly / end effector relative to the shaft of the medical device 110.Also, due to the arrangement of parts within the handle body 118, clockwise rotation of the knob 114 results in clockwise rotation of the wire 30, and vice versa.

[0042] 9, the lever 116 includes a cam 154. The control wires 156, 158 are coupled to the cam 154 such that when the lever 116 is pushed up, the cam 154 rotates counterclockwise creating tension in the steering wire 156. When the lever 116 is pulled down, the cam 154 rotates clockwise creating tension in the steering wire 158. Because the wire 156 is coupled to the distal tip (e.g., an articulation joint), tension in the steering wires 156, 158 is translated into articulation motion at the distal tip. The control blocks 128, 160, 162, 163 of the handle body 118 control the position of the steering wires 156, 158 within the handle and help guide the wires 156, 158 within the handle body 118 as the wires 156, 158 translate.

[0043] The trigger 112 includes a slot 113 that allows a user to use a finger to actuate the trigger 112. The slot 113 can take on various shapes and sizes to allow a user to actuate the trigger 112. For example, the slot can have a circular shape, oval shape, rectangular shape, as shown in FIG. 9, or any shape that allows a user to use a finger to actuate the trigger 112. A rack 124 is fixedly coupled to the trigger 112. When the trigger 112 is actuated (pulled into the handle body 118 via a slot in the handle body 118), the rack 124 translates longitudinally within the handle and toward the user. The extensions and recesses of the rack 124 mesh with the recesses and extensions of the pinion gear 126. As the rack 124 translates longitudinally within the handle, the pinion gear 126 rotates clockwise. This rotation of the pinion gear 126 causes the rack 163 to move sideways (up and down; proximally and distally). For example, when the pinion gear 126 rotates clockwise, the rack 163 rises (moves proximally). Similarly, when the pinion gear 126 rotates counterclockwise, the rack 163 falls (moves distally). The rack 163 may be fixedly coupled to the shaft 165 by adhesive, welding, or any other means known in the art. The shaft 165 is coupled to the proximal end of the pinion gear 168. As described above, the pinion gear 168 is coupled to the shaft 151 and the ferrule 152 such that when the pinion gear 168 rises or falls, the shaft 151 and the ferrule 152 move accordingly. This motion is translated into actuation (e.g., an opening and closing movement) of the distal tip / end effector of the medical device 110.

[0044] The device of FIGS. 7A and 7B is used similarly to the device 10 of FIGS. 2A and 2B. To use the device 10, a user may first introduce the distal end of the device 110 into the GI tract through a natural orifice. The orifice may be, for example, the nose, mouth, or anus. Placement may be in any portion of the GI tract, including the esophagus, stomach, duodenum, large intestine, or small intestine. Delivery and placement may also be in the GI tract, any other natural orifice or body tract, through a body incision, or in other body lumens or organs reachable through a delivery device, such as an endoscope or sheath. Once the desired site is accessed, the user may use only one hand (or two hands, if desired) to actuate one or more actuators, including the knob 114, lever 116, and trigger 112, to control articulation of the distal end of the medical device 110, actuation of the end effector, and / or rotation of the end effector relative to the shaft of the medical device 110.

[0045] 10 illustrates an alternative embodiment of a medical device 210. As shown in FIG. 11 shows a medical device 210 including a handle 211, an actuator base 205, an actuator assembly 216, a shaft 212, an articulating section 217, and an end effector 215 at a distal end 214. The actuator assembly 216 may include a knob, a joystick, or any actuator known in the art. The end effector 215 may consist of any end effector known in the art, such as a grasper, basket, brush, scissors, forceps, knife, etc. The end effector 215 is coupled to the distal-most end of the articulating section 217, which allows the device 210 to move in multiple directions by mechanisms that will be described further herein. The proximal end of the articulating section 217 is coupled to the distal end of the shaft 212. A strain relief 213 is coupled to the proximal end of the shaft 212. The strain relief 213 serves as the interface between the shaft 212 and the actuator base 205.

[0046] The handle 211 includes a proximal extension 218, a slot 222, a U-shaped extension 252, and an extension 200. The handle 211 may be constructed of any rigid material. The extension 200 includes an opening for receiving and coupling the handle base 205, either permanently or temporarily, by any means known in the art, including press-fit, adhesive, snap-fit, and the like. The handle 211 may be coupled to the actuator base 205 such that when the handle 211 is rotated about its longitudinal axis, the medical device 210 rotates in the same or similar manner. The actuator assembly 216 is internally constrained within the actuator base 205 and includes a ball-and-socket joint, as described further herein. Additionally, the connection of the handle 211 to the actuator base 205 creates a gap 254 between the handle 211 and the actuator assembly 216. This gap 254 allows a user to comfortably grip the actuator assembly 216 without interference with the handle 211. An extension 218 extends from the proximal end of the U-shaped extension 252. The extension 218 may have a length sufficient to allow a user to fully grasp the extension with one hand. The extension 218 may take on a variety of shapes and sizes. For example, the extension 218 may have a tapered shape toward the proximal end for a more comfortable grip (as shown) and may have a circular or rectangular shape in cross section. The slot 222 is disposed on or adjacent the distal end of the extension 218 and may have a variety of shapes and sizes to allow a user to insert one or more fingers through the slot 222. For example, the slot 222 may have an oval shape, a circle, a square, a rectangle, etc. as shown.

[0047] The handles are configured so that a user (not shown) can grasp the handle with one hand in a variety of ways. For example, a user may grasp the actuator assembly 216 with one or two fingers and a thumb (or only two fingers, not including the thumb) of one hand. The remaining fingers can wrap around the extension and grasp the extension 218 by holding the extension in the palm of the one hand. One or more fingers of a single handle can be inserted through the slots 222. The handle 211 can then be rotated so that the handle is in a more neutral or natural position for the user relative to the actuator assembly 216. For example, the handle 211 can be held so that the U-shaped extension is below the actuator assembly 216 as shown, or on either side of the actuator assembly 216.

[0048] FIG. 12 is a cross-sectional view of the strain relief 213, the actuator base 205, and the actuator assembly 216, and FIG. 13 shows an enlarged perspective view of the actuator assembly 216 and a distal portion of the handle 211 of the medical device 210. The actuator assembly 216 includes an actuator 219 and a ball 224. An extension 228 extends from a proximal portion of the actuator 219 along a central axis through the ball 224. The extension 228 is movable within the ball 224 along the longitudinal axis of the extension, as described further herein. The ball 224 is constrained by a socket 238 such that the ball 224 is movable relative to the actuator base 205 (is rotatable about its center) without being removed from the actuator base 205 when the actuator 219 is moved in any orientation (e.g., left, right, up, down, or any combination of these movements).

[0049] 12 , control wire 236 extends through shaft 212 and strain relief 213 and is fixedly coupled to a distal end of block 242. Spring 230 or other flexible connector extends from a proximal end of block 242 along a central axis and from a distal end of block 244 along a central axis. Block 244 is fixedly coupled to extension 228 along the central axis of extension 228 via, for example, a threaded connection, press fit, welding, adhesive, etc. Extension 228 passes through the central axis of ball 224. Steering wires 232, 236 extend through shaft 212 from distal articulation section 217 of shaft 212 and may be fixedly coupled to ball 224 on either side of ball 224. The medical device 210 is not limited to including two steering wires 232, 236 (as shown), but may include one or several steering wires depending on the desired articulation of the distal tip. For example, two steering wires may control the articulation direction in two directions (e.g., left, right), while four steering wires may control the articulation direction of the distal tip in four directions (e.g., left, right, up, down).

[0050] FIG. 14 shows a partial cross-sectional view of device 210 during articulation. Actuator assembly 216 can move in any direction (as described above) to tension one or more steering wires, such as steering wires 232, 234. During rotation of ball 224, spring 230 deflects as shown in FIG. 14. This rotation of ball 224 translates to articulation motion at distal tip 214. For example, as actuator assembly 216 moves upward, steering wire 234 is tensioned. This tension results in downward movement of articulation 217. Similarly, as actuator assembly 216 moves downward, steering wire 236 is tensioned resulting in upward movement of distal tip 214.

[0051] 15A and 15B show cross-sectional views of the handle 210 when the distal tip 214 is actuated, e.g., opened or closed. When the end effector of the distal tip 214 is open, the distal end of the actuator 219 is pressed against the proximal wall of the ball 224. The extension 228 extends from the distal wall of the actuator 219 through the central axis of the ball 224. The actuator 219 is configured to be pulled away from the proximal surface of the ball 224 when the end effector of the distal tip 214 is closed. The extension 228 can be pulled along the central axis of the ball 224. This action pulls the spring 230, the block 242, and the control wire 236 along the central axis of the ball 224. This action translates into a closing action of the end effector of the distal tip 214. By pushing the actuator 219 back into the ball 224, the end effector of the distal tip 214 may be actuated or opened. The actuator 219 may also be configured such that as the actuator 219 is rotated relative to the ball 224, the end effector of the distal tip 214 may be rotated relative to the shaft 212. For example, when the actuator 219 is rotated in a clockwise direction, the distal tip 214 is correspondingly rotated clockwise, and vice versa.

[0052] Figures 16A, 16B, and 16C show alternative embodiments of handles and how a user may grip them. These handles may be used with the actuator assembly 216 of Figures 11-15B. Also, these handles may be coupled to the actuator assembly 216 in the same manner as described above. Only the differences in the handles are described below.

[0053] 16A, the handle 311 includes a handle extension 318 having a slot 322. A U-shaped side extension 352 is pivotally attached to the distal end of the extension 318. A gap 354 is defined between the actuator assembly 216 and the U-shaped extension 352. A pivot pin 356 is located between the proximal end of the U-shaped extension 352 and the distal end of the handle extension 318. In the state of FIG. 16A, the handle extension 318 and the handle slot 322 are located in the same plane as the U-shaped extension 352. The user 322 can grasp the actuator assembly 216 using the index finger and thumb. The remaining fingers of the user 322 can grasp the handle extension 318 or extend through the finger slot 322.

[0054] 16B shows the handle 311 in a pivoted state. In this state, the handle 318 is perpendicular to the U-shaped handle extension 352. The user 322 may use their index finger and thumb to grasp the actuator assembly 216. The remaining fingers of the user 322 may grasp the handle extension 318 and / or extend through the finger slots 322. This pivoted state of the handle 311 may allow the user to hold the handle in a more neutral grip.

[0055] 16C illustrates another embodiment of the handle 411. The handle 411 includes inwardly curved extensions 458, 460 that lie in a plane perpendicular or nearly perpendicular to the longitudinal axis of the medical device and extend upward from the proximal end of the handle extension 451. The extensions 458, 460 are curved and have a space between the tops of the extensions 458, 460 to allow insertion of a user's wrist into the space defined between the extensions 458, 460. The handle extension 452 extends from the distal end of the handle extension 451 and is fixedly coupled (or integral) to the handle extension 406. The handle extension 406 extends downward from the handle base 405. The handle extensions 406, 452, 451 are configured in a U-shape to form a gap 454 between the actuator assembly 216 and the handle 411. The gap 454 allows the user to grip the actuator assembly 216 without interfering with the handle 411. The user can grip the actuator 216 in the same or similar arrangement as described in the above-mentioned embodiments. For example, the user may grip the actuator assembly 216 using the index finger and thumb. The remaining fingers of the user may be positioned in any orientation that is comfortable for the user. The user may insert their hand through the extensions 458, 460 or insert their wrist / arm through the top gap between the ends of the extensions 458, 460 so that the extension rests on the distal portion of the user's wrist or arm and position the wrist / arm within the circular space between the extensions 458, 460. The slot 452 may be for decorative purposes.

[0056] Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

[0057] As can be seen, various aspects described herein can help improve the effectiveness of a treatment, e.g., a procedure for treating a treatment site. Various aspects described herein can help reduce and / or minimize the duration of a treatment, can help reduce the risk of inadvertent manipulation by a user, and / or can help reduce the risk of inadvertent contact with tissue or other materials during delivery, repositioning, or use of a medical device in a treatment.

[0058] Although the principles of the present disclosure have been described herein with reference to exemplary embodiments for various applications, the present disclosure is not limited thereto. Those skilled in the art and those who utilize the teachings provided herein may recognize additional modifications, applications, embodiments, and equivalent replacements that all fall within the scope of the embodiments described herein. Thus, the present disclosure should not be considered as limited by the above description.

Claims

1. 1. A medical device, comprising: a handle having at least one actuator; a shaft having a proximal end connected to the handle and a distal end; a distal assembly connected to the distal end of the shaft and including an end effector; Equipped with The handle is configured to enable a user to manipulate the at least one actuator with one hand to (1) actuate the end effector, (2) rotate the end effector relative to the shaft, and (3) articulate a distal portion of the shaft.

2. 2. The medical device of claim 1, wherein the at least one actuator includes a first actuator, a second actuator, and a third actuator, the first actuator rotates the end effector relative to the shaft, the second actuator actuates the end effector, and the third actuator articulates the distal portion of the shaft.

3. 3. The medical device of claim 2, wherein at least the first actuator is a trigger, the second actuator is a knob, and the third actuator is a knob, and the handle is configured to allow the user to simultaneously place the index finger of one hand on the trigger, the thumb of one hand on the first knob, the middle finger of one hand on the second knob, and the palm of one hand on the handle.

4. 4. The medical device of claim 3, wherein the handle is configured such that, in use, the first knob faces away from the user, the second knob is located on the left side of the handle body relative to the user, and the trigger is located at the top of the handle.

5. The medical device of any one of claims 1 to 4, wherein the mechanism for controlling actuation of the end effector includes a first rack, a pinion gear that meshes with the first rack, and a second rack that meshes with the pinion gear and is coupled to a control wire.

6. 6. The medical device of claim 5, wherein when the first rack moves into and out of a handle body of the handle, the pinion gear rotates clockwise and counterclockwise, respectively, causing the second rack and the control wire to move proximally and distally, respectively.

7. 6. The medical device of claim 5, wherein the mechanism for controlling rotation of the end effector relative to the shaft includes a first pinion gear and a second pinion gear that meshes with the first pinion gear, the control wire being positioned within the second pinion gear such that when the first pinion gear rotates clockwise and counterclockwise, the second pinion gear rotates counterclockwise and clockwise, respectively, thereby rotating the control wire.

8. The medical device of any one of claims 1 to 4, wherein the mechanism for controlling articulation of the distal portion of the shaft includes a first control wire and a second control wire coupled to a pulley, the first control wire and the second control wire coupled to the pulley such that the first control wire is pulled under tension when the pulley rotates clockwise and the second control wire is pulled under tension when the pulley rotates counterclockwise.

9. 3. The medical device of claim 2, wherein the first actuator is a knob, the second actuator is a trigger, and the third actuator is a lever, and the knob, trigger, and lever are configured such that the user can simultaneously place the index finger of one hand on the knob, the thumb of one hand on the lever, the middle finger of one hand on the trigger, and the palm of one hand on the handle.

10. 10. The medical device of claim 9, wherein the handle is configured such that, in use, the knob faces away from the user, the lever faces towards the user, and the trigger faces away from the user.

11. The medical device of any one of claims 1, 2, 9, and 10, wherein the mechanism for controlling actuation of the end effector includes a first rack, a pinion gear that meshes with the first rack, and a second rack that meshes with the pinion gear and is coupled to a control wire.

12. 12. The medical device of claim 11, wherein the pinion gear rotates clockwise and counterclockwise when the first rack moves into and out of a handle body of the handle, respectively, thereby moving the second rack and the control wire proximally and distally, respectively.

13. 11. The medical device of claim 1, wherein the mechanism for controlling rotation of the end effector relative to the shaft includes a first pinion gear, a second pinion gear that meshes with the first pinion gear and is fixedly coupled to a proximal end of the shaft, a third pinion gear that is fixedly coupled to a distal end of the shaft, and a fourth pinion gear that meshes with the third pinion gear, wherein a control wire is positioned within the fourth pinion gear, and wherein when the first pinion gear rotates clockwise and counterclockwise, the fourth pinion gear rotates, thereby rotating the control wire.

14. 11. The medical device of claim 1, 2, 9, or 10, wherein the mechanism for controlling articulation of the distal portion of the shaft includes a first control wire and a second control wire coupled to a cam, the first control wire and the second control wire coupled to the cam such that the first control wire is pulled under tension when the cam rotates clockwise and the second control wire is pulled under tension when the cam rotates counterclockwise.

15. the at least one actuator is an actuator, the actuator being a knob, the knob being coupled to the base of the handle by a ball at a distal end of the knob and a socket at a proximal end of the base of the handle, the knob comprising: a first mechanism for controlling actuation of the end effector, the first mechanism including a control wire coupled to a distal end of the knob and translating the control wire in response to proximal retraction and distal pushing of the knob; a second mechanism for controlling rotation of the end effector relative to the shaft, the second mechanism including the control wire coupled to a distal end of the knob, the second mechanism rotating the control wire clockwise and counterclockwise when the knob is rotated clockwise and counterclockwise, respectively; 10. The medical device of claim 1, comprising: a third mechanism for controlling articulation of the distal portion of the shaft, the third mechanism comprising a first articulation wire and a second articulation wire coupled to the ball, the third mechanism configured such that the first articulation wire is pulled under tension when the knob is moved in a first direction and the second articulation wire is pulled under tension when the knob is moved in a second direction opposite the first direction.

Images