# Patent

## Title
Rotational coupling device for surgical instrument with flexible actuators

## Abstract

Rotational couplers for use with surgical devices that are actuated by semi-flexible actuators such as wires and the like. The couplers enable the actuators to apply various actuation motions to actuation features on the surgical device as well as other actuators to apply axial and rotational motions to the surgical device to manipulate the device into various orientations relative to an elongate shaft to which the device is movably attached.

## Background
FIELD OF THE INVENTION
The present invention generally relates to methods and devices for controlling movement of a working end of a surgical device.
BACKGROUND
In laparoscopic surgical procedures, a small incision is made in the body and an elongate shaft of a surgical device is inserted through the incision to position a distal end of the shaft at a surgical site. In endoscopic procedures, the elongate shaft of a surgical device is inserted through a natural orifice, such as the mouth or anus, and is advanced along a pathway to position a distal end of the device at a surgical site. Endoscopic procedures typically require the use of a flexible shaft to accommodate the tortuous pathway of the body lumen, whereas rigid shafts can be used in laparoscopic procedures. These tools can be used to engage and/or treat tissue in a number of ways to achieve a diagnostic or therapeutic effect.
Many current laparoscopic and endoscopic devices utilize articulating effectors to provide the user with more control over the orientation of the working end of the instrument. Integration of the controls for articulating, as well as actuating, a working end of a laparoscopic or endoscopic device tend to be complicated by the size constraints of the relatively small pathway through which it is inserted. The controls for an endoscopic device are further complicated by the flexibility of the shaft. Generally, the control motions are all transferred through the shaft as longitudinal translations, which can interfere with the flexibility of the shaft. There is also a desire to lower the force necessary to articulate and/or actuate the working end to a level that all or a great majority of surgeons can handle. One known solution to lower the force-to-fire is to use electrical motors. However, surgeons typically prefer to experience feedback from the working end to assure proper operation of the end effector. The user-feedback effects are not suitably realizable in present motor-driven devices.
U.S. Patent Application Publication No. US 2008/0147113 A1 to Rudolph H. Nobis et al., Ser. No. 11/610,803, filed Dec. 14, 2006, the disclosure of which is herein incorporated by reference in its entirety discloses various manually articulated surgical instruments that may be actuated by manipulating one or more actuation wires that extend from a handle through an elongate tube to an end effector operably coupled to the distal end of the tube. Various embodiments of those devices employ an end effector that may also be selectively rotated relative to a longitudinal axis of the device. When rotated, the actuation wire or wires also rotate to avoid malfunction thereof.
Accordingly, there remains a need for improved rotational coupling arrangement for surgical instruments that are actuated by flexible or semi-flexible members such as wires and the like.
The foregoing discussion is intended only to illustrate some of the shortcomings present in the field of the invention at the time, and should not be taken as a disavowal of claim scope.
BRIEF SUMMARY
Methods and devices are provided for controlling movement of a working end of a surgical device. In one embodiment, a surgical device is provided that has an elongate substantially hollow shaft that defines an elongate axis. An end effector may be operably coupled to a distal end of the elongate shaft for selective pivotal and rotational travel relative thereto. The end effector may have at least one actuation feature thereon that is actuatable upon application of axial actuation motions thereto. An articulation actuator may operably interface with the end effector for applying axial articulation motions thereto to cause the end effector to pivot relative to the distal end of the elongate shaft and selectively apply rotation motions thereto to cause the end effector to rotate relative to the distal end of the elongate shaft about the elongate axis. A first input actuator may be provided for transferring axial actuation motions. Various embodiments further include a rotational coupling that comprises a driving coupler that is movably supported within a portion of the elongate substantially hollow shaft and is also coupled to a distal end of the first input actuator for receiving the axial actuation motions therefrom. An idler coupler may be movably supported within a portion of the substantially elongate hollow shaft and may be rotatably coupled to the driving coupler for rotation relative thereto about the elongate axis. The idler coupler may be further configured for axial travel with the driving coupler along the actuation axis. At least one second input actuator may be coupled to the idler coupler and the actuation features on the end effector such that the second input actuator transfers the axial actuation motions from the rotational coupling to at least one actuation feature of the end effector. A proximal end of a three-bar linkage may be coupled to the distal end of the elongate shaft, and a distal end of the three-bar linkage may be coupled to an end effector. The end effector can be, for example, a grasper, a biopsy probe, a snare loop, forceps, scissors, a needle knife, a sphincterotome, etc. In use, the three-bar linkage is adapted to laterally articulate relative to a longitudinal axis of the elongate shaft to allow the end effector to be angularly oriented relative to the elongate shaft.
In accordance with other embodiments of the present invention, there is provided a surgical device that includes an elongate substantially hollow shaft that defines an elongate axis. An end effector is operably coupled to a distal end of the elongate shaft for selective pivotal and rotational travel relative thereto. The end effector may have at least one actuation feature thereon that is actuatable upon application of at least one axial actuation motion thereto. An articulation actuator may operably interface with the end effector to apply axial articulation motions thereto to cause the end effector to pivot relative to the distal end of the elongate shaft and to selectively apply rotation motions thereto to cause the end effector to rotate relative to the distal end of said elongate shaft about the elongate axis. A first input actuator may extend from the handle assembly to transfer at least one axial actuation motion. The embodiments may further comprise a rotational coupling that has a proximal tubular member that is rotatably supported within the hollow elongate shaft and is coupled to the first input actuator for receiving at least one axial actuation motion therefrom. A distal tubular member may be rotatably supported within the hollow elongate shaft and be coupled to the proximal tubular member for axial travel therewith such that the distal tubular member can rotate relative to the proximal tubular member. At least one second input actuator may be coupled to the distal tubular member and the actuation features on the end effector such that the second input actuator transfers the at least one axial actuation motion applied thereto to at least one actuation feature of the end effector.
In connection with other features of the present invention, there is provided various rotational couplings for surgical devices that are movably coupled to an elongate shaft wherein the surgical device has at least one actuation feature thereon that is actuatable upon application of at least one actuation motion from an actuator and which surgical device is articulatable and rotatable relative to the elongate shaft upon application of other actuation motions from another actuator. Various embodiments of the rotational coupling comprise a driver member that is coupled to the actuator for receiving at least one actuation motion therefrom. An idler member may be rotatably coupled to the driver member for selective rotation relative to the driver member about a longitudinal axis and is configured to axially move as a unit with the driver member. The driver member and the idler member may movably support a portion of the other actuator therein. An output member may be coupled to the idler member and the surgical device for transferring the at least one actuation motion from the idler member to the surgical device.



BRIEF DESCRIPTION OF THE FIGURES
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
FIG. 1 is a side view of an end effector and portion of elongate shaft with which various rotational coupling embodiments of the present invention may be employed;
FIG. 2 is a cross-sectional view of the end effector and elongate shaft of FIG. 1 with the end effector shown in an articulated position;
FIG. 2A is an enlarged cross-sectional view of a portion of the end effector of FIG. 2;
FIG. 3 is a perspective view of a handle assembly embodiment that may be employed in connection with various embodiments of the present invention;
FIG. 4 is an exploded assembly view of the handle assembly of FIG. 3;
FIG. 5 is a partial assembly view of a portion of the handle assembly of FIGS. 3 and 4;
FIG. 6 is another partial assembly view of a portion of the handle assembly of FIGS. 3-5; and
FIG. 7 is a cross-sectional view of another end effector and elongate shaft employing another rotational coupling embodiment of the present invention.



DETAILED DESCRIPTION
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
The present invention generally provides methods and devices for controlling movement of a working end of a surgical device and, in particular, for performing various surgical procedures using an instrument having an end effector that can be articulated relative to an elongate shaft of the device by means of flexible or semi-flexible actuation members such as, for example, wires. As will described in further detail below, various embodiments are provided with a unique and novel coupling arrangement that permits the end effector to be rotated without adversely affecting the actuation wire or wires. Articulation and rotation of the end effector will allow the end effector to be positioned at various locations during a surgical procedure, thereby providing the user with precise control over the end effector. A person skilled in the art will appreciate that the present invention has application in endoscopic procedures, laparoscopic procedures, and in conventional open surgical procedures, including robotic-assisted surgery.
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating the handle portion of the surgical instrument. The term “proximal” referring to the portion closest to the clinician and the term “distal” referring to the portion located away from the clinician. It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical”, “horizontal”, “up” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
FIGS. 1 and 2 illustrate one exemplary embodiment of an insertion portion 10 of a manually articulatable surgical device. The insertion portion 10 is preferably configured to be inserted into a patient's body, and it can be rigid for laparoscopic applications, flexible for endoscopic applications, or it can have rigid and flexible portions as may be desired. As shown, the insertion portion 10 may include a substantially hollow elongate shaft 12 that has a working end or end effector 14 coupled to a distal end 12b thereof by a three-bar linkage 16. See FIG. 2. While the end effector 14 can have various configurations, as will be discussed in more detail below, in the illustrated embodiment the end effector 14 is in the form of a grasper having “actuation features” such as, for example, opposed jaws 18a, 18b that are pivotally coupled to one another. As used herein, the term “actuation features” refers to movable or otherwise actuatable member(s), device(s), instrument(s), portion(s) of the end effector that are manipulatable or otherwise perform a desired function upon application of one or more actuation motions thereto. Such actuation features may include, but are not limited to, grasper jaws, biopsy forceps, tissue-penetrating spikes, snare loops, scissors, needle knives, sphincterotomes, etc. As the present Detailed Description proceeds, the person of ordinary skill in the art will readily appreciate that the various embodiments of the present invention may be effectively and advantageously employed with a variety of different end effector configurations. Accordingly, the protection afforded to the various embodiments of the present invention should not be limited to a specific end effector that employs a specific actuation feature.
The three-bar linkage 16 allows the end effector 14 to be oriented at an angle relative to a longitudinal axis L-L of the elongate shaft 12. The device can also optionally be configured to allow the end effector 14 to rotate relative to and about the longitudinal axis L-L of the elongate shaft 12. In the illustrated embodiment, the three-bar linkage 16 is rotatably coupled to the distal end 12b of the elongate shaft 12, and thus the three-bar linkage 16, as well as the end effector 14 coupled thereto, can be positioned in various axial orientations. The location of the rotation joint R proximal of the articulation joint A is particularly advantageous in that rotation of the end effector 14 can change the location of the plane within which the end effector 14 articulates.
The three-bar linkage 16 can have a variety of configurations, but in an exemplary embodiment, as shown in more detail in FIG. 2, it includes three links 20, 22, 24 that are movably coupled to one another. Each link can have a variety of configurations, but in an exemplary embodiment, the first and second links 20, 22 each have a generally hollow elongate shape and the third link 24 is in the form of an elongate rod or bar. The first link 20 can have a proximal end 20a that is coupled to a distal end 12b of the elongate shaft 12 via first and second rotation couplings 26 and 28 which will be discussed in more detail below. The distal end 20b of the first link 20 can be movably coupled to a proximal end 22a of the second link 22, e.g., by a pivot joint. The distal end 22b of the second link 22 can in turn be coupled to the end effector 14 for manipulation thereof by the three-bar linkage 16. The third link 24 can extend at least partially through the first and second links 20, 22, and it can have a distal end 24b that is pivotally coupled to the second link 22, e.g., by a pivot pin, to form the three-bar linkage 16. The particular location at which the third link 24 mates to the second link 22 can vary, but it is preferably pivotally mated at a location that will allow the third link 24 to apply a force to the second link 22 to cause the second link 22 to articulate relative to the first link 20. The proximal end of the third link 24 can be coupled to an articulation coupling 34 that is coupled to an articulation actuator 30 that extends through the elongate shaft 12 and at least partially through the first link 20.
The articulation actuator 30 can have a variety of configurations, but in an exemplary embodiment, the articulation actuator 30 comprises a “semi-flexible” member or wire fabricated from, for example, stainless steel, Nickel-Titanium alloy (Nitinol®), etc. As used herein, the term “semi-flexible” means components that are able to exhibit adequate flexibility within the desired strain with pit permanent deformation yet deliver acceptable stiffness for the desired load transmission. As can be seen in FIG. 2, articulation coupling 34 may comprise a tubular member that is attached to the articulation actuator 30 and is pivotally attached to the third link 24. In various embodiments, for example, the articulation actuator 30 may be attached to the articulation coupling 34 by, for example, welding, gluing, swaging, coining, crimping, etc.
In use, proximal movement of the articulation actuator 30 relative to and along the longitudinal axis L-L of the elongate shaft 12 will apply a proximally-directed force to the third link 24. The third link 24 will thus apply a proximally-directed force to the second link 22, causing the second link 22 to pivot laterally relative to the longitudinal axis L-L of the elongate shaft 12. As a result, the second link 22, with the end effector 14 coupled thereto, will move laterally in a single plane to allow the end effector 14 to extend at an angle relative the longitudinal axis L-L of the elongate shaft 12, as shown in FIG. 2. The end effector 14 can be returned to the original, longitudinally-aligned position, shown in FIG. 1 by moving the articulation actuator 30 distally relative to the elongate shaft 12.
As previously indicated, in addition to articulating movement, the end effector 14 can also be configured to rotate relative to the elongate shaft 12, thus allowing the end effector 14 to be positioned in multiple angular orientations. The particular location of the rotation joint R can vary, and it can be located proximal to the three-bar linkage 16, at a mid-portion of the three-bar linkage 16, or distal to the three-bar linkage 16. In an exemplary embodiment, the rotation joint R is located proximal to the three-bar linkage 16, and more preferably proximal to the articulation joint A formed between the first and second links 20, 22. As shown in FIGS. 2 and 2A, the first link 20 can be rotatably coupled to the distal end 12b of the elongate shaft 12 by one or more rotation couplings.
The illustrated embodiment includes first and second rotation couplings 26, 28. Second rotation coupling 28 may be affixed to (e.g., welded, glued, etc.) to a coupling sleeve 490. The first rotation coupling 26 has a generally elongate hollow shape with a proximal end 26a that is fixedly mated to the elongate shaft 12 and a distal end 26b that has deflectable tabs 26c formed therearound. The tabs 26c can be formed by longitudinally-extending cut-outs formed in and spaced radially around the distal end 26b of the first rotation coupling 26. Each tab 26c can include an annular flange or lip formed on an inner surface thereof. The second rotation coupling 28 can be rotatably supported on the coupling sleeve 490 by advancing the tabs 26c over a retention flange 492 on the coupling sleeve 490. The tabs 26c will deflect until the annular flange or lip on the tabs 26c extends into and engages a groove 494 formed in the coupling sleeve 490. The elongate shaft 12 may be affixed to the first rotation coupling 26 by welding, adhesive, etc. Such arrangement permits the first rotation coupling 26 and the elongate shaft 12 to rotate about the coupling sleeve 490.
As can also be seen in FIGS. 2 and 2A, the proximal end 20a of the of first link 20 extends onto the distal end 28b of the second rotation coupling 28, to enable the first link 20 to rotate relative thereto. Rotation of articulation actuator 30 relative to and about the longitudinal axis L-L of the elongate shaft 12 will rotate the articulation coupling 34 and the third link 24, which is coupled to the second link 22, which in turn is coupled to the end effector 14 and the first link 20. As a result, the entire three-bar linkage 16 will rotate with the end effector 14 relative to and about the longitudinal axis L-L of the elongate shaft 12. Rotation can also be done while the end effector 14 is articulated, thereby changing the plane within which the end effector 14 articulates.
Various embodiments of the subject invention may further include a third rotation coupling 500. The third rotation coupling 500 may include a driving coupler 510 that is axially and rotatably movable within the elongate shaft 12 and a portion of the coupling sleeve 490. An idler coupler 520 may be rotatably coupled to a distal end 510a of the driving coupler 510 in the manner depicted in FIGS. 2 and 2A such that the driving coupler 510 and the idler coupler 520 may rotate relative to each other, yet move axially as a unit within the elongate shaft 12. The driving coupler 510 has an axial hole 512 extending therethrough through which a portion of the articulation actuator 30 movably and rotationally extends. Likewise, the idler coupler 520 has an axial hole 522 through which a portion of the articulation actuator 30 movably and rotationally extends. Thus, actuation of the articulation actuator 30 is not impeded by the coupling 500.
Also in various embodiments, a “first” input actuator 530 is attached to the driving coupler 510. The input actuator 530 may comprise, for example, a “semi-flexible” member or wire that may be manufactured from stainless steel, Nickel-Titanium alloy (Nitinol®), etc. Likewise, an output actuator 540 that may comprise, for example, a “semi-flexible” member or wire that may be manufactured from stainless steel, Nickel-Titanium alloy (Nitinol®), etc. is attached to the idler coupler 520 and an actuation pusher 44 in the end effector 14.
As indicated above, the end effector 14 of the device can have various configurations but in the embodiment shown in FIGS. 1 and 2, the end effector 14 is in the form of a grasper having opposed jaws 18a, 18b. Jaw 18a includes a distal portion 36b that may have a series of teeth 37 formed thereon for grasping tissue, and a proximal portion 36a, that pivotally mates to an actuation link 40. See FIG. 1. Jaw 18b includes a distal portion 38b that may have a series of teeth 39 formed thereon for grasping tissue, and a proximal portion 38a that pivotally mates to an actuation link 42. The jaws 18a, 18b may be pivotally mated to one another at a pivot point P located between the proximal and distal portions 36a, 38a, 36b, 38b. The proximal end of each actuation link 40, 42 may be pivotally mated to an actuation pusher 44 that may be slidably disposed within and between opposed slots formed in a distal portion of the second link 22. Such a configuration will prevent independent rotation of the actuation pusher 44 relative to the second link 22. As can also be seen in FIG. 2, the distal end 24b of the second link 24 is pivotally coupled to (pinned) to the link 22.
In use, proximal movement of the input actuator 530 relative to the elongate shaft 12 will pull the driving coupler 510 and idler coupler 520 in the proximal direction “PD” within the coupling sleeve 490. Movement of the idler coupler 520 in the proximal direction “PD” also causes the actuation pusher 44 to move within the slots formed in the second link 22. The actuation links 40, 42 will thus be pulled in the proximal direction “PD”, bringing the proximal and distal portions 36a, 38a, 36b, 38b of each jaw 18a, 18b toward each other to thereby close the jaws 18a, 18b. Conversely, distal movement of the input actuator 530 causes the driving coupler 510 and idler coupler 520 to move distally and cause the actuation pusher 44 to also move distally within the slots formed in the second link 22. Such movement will cause the links 40, 42 and the proximal and distal portions 36a, 38a, 36b, 38b of the jaws 18a, 18b to pivot laterally outward, thereby opening the jaws 18a, 18b. 
As previously indicated, the device can also include a handle assembly 50 coupled to the proximal end of the elongate shaft 12 and have various controls formed thereon for controlling and manipulating the device. A person skilled in the art will appreciate that the particular configuration of the handle can vary, and that various techniques known in the art can be used for effecting movement of various portions on the device. FIGS. 3-5 illustrate one exemplary embodiment of a handle 50 for use with the insertion portion 10 of the device shown in FIGS. 1 and 2. As shown, the handle 50 has a generally elongate cylindrical configuration to facilitate grasping thereof. The handle housing 52 can have an integral or unitary configuration, or it can be formed from two housing halves 52a, 52b that mate together to enclose various components therein. The housing halves 52a, 52b are shown in FIG. 4 and may be removably attached together by bolts 53 and nuts 55. The various components disposed within the handle housing 52 can also vary, but in an exemplary embodiment, the handle assembly 50 includes an articulation knob 54 for articulating and rotating the end effector 14, and an actuation knob 56 for actuating the end effector 14.
The articulation knob 54 may have a generally cylindrical configuration. The knob 54 can have an integral or unitary configuration, or it can be formed from two halves 54a, 54b that may be coupled together by bolts 57 and nuts 59, as shown. While various techniques can be used to affix the articulation actuator 30 to the articulation knob 54, in an exemplary embodiment the articulation knob 54 includes an axle 58 fixedly disposed therein and engaged between the knob halves 54a, 54b. The articulation actuator 30 extends through an inner lumen of the axle 58 and is affixed thereto. Various fastening techniques can be used to affix the articulation actuator 30 to the axle 58 including, for example, an interference or compression fit, an adhesive, or other mechanical or chemical mating techniques known in the art. The proximal end 30a of the articulation actuator 30 can mate to the knob 54 such that rotation and translation of the knob 54 will cause corresponding rotation and translation of the articulation actuator 30, thereby rotating and articulating the end effector 14, as previously described.
In various embodiments, the handle housing 52 can include an elongate cavity 52c formed therein that is configured to slidably and rotatably receive a portion of the knob 54 therein. The handle housing 52 can also include one or more cut-outs 60 formed therein for allowing a user to access the knob. FIG. 3 illustrates opposed cut-outs 52d, 52e formed in the handle housing 52. The articulation knob 54 can also include features to facilitate movement thereof. For example, the articulation knob 54 can include one or more surface features formed on an external surface thereof for allowing the user to more easily grasp the knob. In the illustrated embodiment, the knob 54 includes a series of longitudinally-oriented teeth 54t formed on a portion thereof. In various embodiments, the articulation knob 54 may have two axially spaced annular grooves 62 and 64 formed therein as shown. In particular, when the articulation knob 54 has been moved to its distal-most position, the annular groove 62 is positioned to selectively receive a locking screw 70 therein. Likewise, when the articulation knob 54 is in its proximal-most position, the annular groove 64 is positioned to selectively receive the locking screw 70 therein. Thus, by use of the locking screw 70, the surgeon may lock the device in a desired articulated position.
In use, the articulation knob 54 can be grasped by a user and rotated about its longitudinal axis (i.e., about the longitudinal axis L-L of the shaft 12 and handle 50). Rotation of the knob 54 will cause corresponding rotation of the axle 58 and the articulation actuator 30. The articulation actuator 30 is not coupled to the articulation knob 54 and therefore is not affected by its actuation. As previously explained, rotation of the articulation actuator 30 will cause corresponding rotation of the three-bar linkage 16 and the end effector 14. The articulation knob 54 can also be moved or translated longitudinally along the longitudinal axis L-L, and within the elongate cavity 52c formed in the handle housing 52. Proximal movement of the articulation knob 54 within the handle housing 52 will pull the articulation actuator 30 in the proximal direction “PD”, thereby articulating the end effector 14, as previously explained. Distal movement of the articulation knob 54 within the handle housing 52 will in turn move the articulation actuator 30 distally, thereby returning the end effector 14 to its original longitudinally-aligned position.
As indicated above, the device can also include an actuation knob 56 for actuating the actuation features on the end effector 14 (i.e. for firing, opening and closing, energizing, etc.). The actuation knob 56 can have a variety of configurations, but in the illustrated embodiment the knob 56 has a bar-bell shape. The knob 56 can have an integral or unitary configuration, or it can be formed from two halves 56a, 56b that mate together, as shown in FIG. 4. The proximal end 530a of the input actuator 530 can be affixed to the actuation knob 56 such that translation of the knob 56 will cause corresponding translation of the input actuator 530, thereby actuating the end effector 14 as previously described. In the illustrated embodiment, the proximal end 530a of the input actuator 530 may have a bend 532 formed therein for mating with the actuation knob 56 as described, for example, in U.S. Patent Publication No. U.S. 2008/0147113 A1, which has been herein incorporated by reference in its entirety. The proximal end 530a may be slidably supported within a support member 534 that is slidably received within a slot 538 formed in a shaft portion 62 of the handle 60. The input actuator 530 also passes through the axle 58 such that it may axially slide therein and axle 58 may be freely rotated therearound.
Actuation knob 56 is slidably disposed around an elongate shaft portion 62 of the handle housing 52. In use, the knob 56 can be grasped by a user and translated along the shaft portion 62 of the handle housing 52. Proximal movement of the actuation knob 56 along the shaft portion 62 will pull the input actuator 530 proximally, thereby opening the jaws 18a, 18b of the end effector 12 as previously explained. Distal movement of the actuation knob 56 along the shaft portion 62 will in turn move the input actuator 530 distally, thereby moving the jaws 18a, 18b to the closed position. Those of ordinary skill in the art will appreciate that the unique and novel third rotational coupler 500 of the present invention enables the actuators 30, 530, 540 to be independently operated while avoiding aberrant twisting/jamming of the actuators when the end effector is to be articulated, rotated and/or actuated.
Another rotational coupler embodiment 600 of the present invention is depicted in FIG. 7. As can be seen in that Figure, the rotational coupler 600 may include a coupler housing 610 that is supported in an outer sheath 620 which is supported in the hollow elongate shaft 12. The coupling housing 610 may be fabricated from, for example, stainless steel, etc. and be provided in two mating pieces that may be coupled together by welding, gluing, swaging, coining, crimping, etc. The outer sheath 620 may be fabricated from, for example, stainless steel, etc. In various embodiments, the coupling housing 610 has a centrally disposed cylindrical opening 612 formed therein and an axial passage 614 extending therethrough. A proximal tubular member 630 that has a flanged end 632 is mounted within the coupling housing 610 as shown. Likewise, a distal tubular member 640 that has a flanged end 642 is also mounted within the coupling housing 610 as shown. Tubular members 630, 640 may be fabricated from, for example, stainless steel, etc. Tubular members 630, 640 are sized to axially rotate about axis L-L relative to the coupling housing 610 as will be discussed in further detail below.
As can be further seen in FIG. 7, the proximal tubular member 630 has an axial passage 634 therethrough and the distal tubular member 640 has a passage 644 therethrough. When mounted within the coupling housing 610, the passages 634 and 644 are coaxially aligned to form a passage 650 through the coupler for operably receiving an actuator member 570 therethrough such that the actuation member 570 can freely move axially and rotate within the passage 650. The actuation member 570 may comprise, for example, stainless steel, Nickel-Titanium alloy (Nitinol®), etc. The device may have a handle member of the type described above such that the proximal end of the actuation member 570 is coupled to the actuation knob 56 in the manners described above. The distal end 570b of the actuation member 570 may be coupled to the actuation pusher 44 in the above-described manner. In use, proximal movement of the actuation member 570 relative to the elongate shaft 12 will pull the actuation pusher 44 in the proximal direction “PD” within the slots formed in the second link 22. The actuation links 40, 42 will thus be pulled proximally “PD”, bringing the proximal and distal portions 36a, 38a, 36b, 38b of each jaw 18a, 18b toward each other to thereby close the jaws 18a, 18b. Conversely, distal movement of the actuation member 570 causes the actuation pusher 44 to also move distally within the slots formed in the second link 22, which will cause the links 40, 42 and the proximal and distal portions 36a, 38a, 36b, 38b of the jaws 18a, 18b to pivot laterally outward, thereby opening the jaws 18a, 18b. 
Also in various embodiments, an input articulation member 730 is non-movably affixed to the proximal end of the proximal tubular member 630. The input articulation member 730 may comprise, for example, stainless steel, Nickel-Titanium alloy (Nitinol®), etc. and be non-movably affixed to the proximal tubular member 630 by, for example, welding, gluing, swaging, coining, crimping, etc. The proximal end of the input articulation member 730 may be coupled to the articulation knob 54 in the manners described above. Thus, the input articulation member 730 may be axially and rotatably moved within the elongate shaft 12 by manipulation of the articulation knob 54.
Also in various embodiments, an output articulation member 740 is non-movably attached to the distal tubular member 640 and the articulation coupling 34. The output articulation member 740 may comprise, for example, stainless steel, Nickel-Titanium alloy (Nitinol®), etc. and be attached to the distal tubular member 640 by, for example, welding, gluing, swaging, coining, crimping, etc. In use, movement of the input articulation member 730 in the proximal direction “PD” relative to and along the longitudinal axis L-L of the elongate shaft 12 will pull the proximal tubular member 630 as well as the entire rotational coupler 600 in the proximal direction “PD” and will apply a proximally-directed force to the third link 24. The third link 24 will thus apply a proximally-directed force to the second link 22, causing the second link 22 to pivot laterally relative to the longitudinal axis L-L of the elongate shaft 12. As a result, the second link 22, with the end effector 14 coupled thereto, will move laterally in a single plane to allow the end effector 14 to extend at an angle relative the longitudinal axis L-L of the elongate shaft 12. The end effector 14 can be returned to the original, longitudinally-aligned position, shown in FIG. 1 by moving the input articulation member 730 distally relative to the elongate shaft 12.
Rotation of input articulation member 730 relative to and about the longitudinal axis L-L of the elongate shaft 12 will rotate the articulation coupling 34 and the third link 24, which is coupled to the second link 22, which in turn is coupled to the end effector 14 and the first link 20. As a result, the entire three-bar linkage 16 will rotate with the end effector 14 relative to and about the longitudinal axis L-L of the elongate shaft 12. Rotation can also be accomplished while the end effector 14 is articulated, thereby changing the plane within which the end effector 14 articulates. Again such unique and novel rotational coupler arrangement enable the actuators 30, 530, 540 to be independently operated while avoiding aberrant twisting/jamming of the actuators when the end effector is to be articulated, rotated and/or actuated.
While the rotational couplers discussed above are described and shown in connection with an end effector that employs actuation features such as grasper jaws, the various coupler embodiments of the present invention may be effectively employed in connection with a variety of other end effectors for performing various surgical procedures. Examples of such end effector arrangements may comprise those end effector arrangements described in U.S. Patent Application Publication No. U.S. 2008/0147113, such as, for example, biopsy forceps, tissue-penetrating spikes, snare loops, scissors, needle knives and sphincterotomes. A person skilled in the art will appreciate that the rotation coupler embodiments of the present invention may be used in connection with a variety of other end effectors other than those described and illustrated herein and in the aforementioned published application which has been herein incorporated by reference in its entirety.
As indicated above, the various devices disclosed herein for controlling movement of a working end of a surgical device can be used in a variety of surgical procedures, including endoscopic procedures, laparoscopic procedures, and in conventional open surgical procedures, including robotic-assisted surgery. In one exemplary endoscopic procedure, an elongate shaft of a surgical device, such as one previously disclosed herein, can be inserted through a natural orifice and a body lumen to position an end effector located at a distal end of the elongate shaft adjacent to tissue to be treated. An articulation actuator can be translated along a longitudinal axis of the elongate shaft to cause a three-bar linkage to laterally articulate the end effector in a direction substantially perpendicular to a longitudinal axis of the elongate shaft to allow the end effector to be angularly oriented relative to the elongate shaft. This can be achieved by actuating one or more actuation mechanisms formed on a handle of the device. The method can also include rotating the end effector relative to the elongate shaft. In one embodiment, the three-bar linkage can rotate with the end effector relative to the elongate shaft. For example, the articulation actuator can be rotated relative to the elongate shaft to rotate both the three-bar linkage and the end effector. In another embodiment, the end effector can rotate relative to the three-bar linkage. For example, an actuation wire coupled to the end effector and extending through the elongate shaft and the three-bar linkage can be rotated.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.
It is preferred that device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
The invention which is intended to be protected is not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such equivalents, variations and changes which fall within the spirit and scope of the present invention as defined in the claims be embraced thereby.

## Claims

1. A surgical device, comprising:
an elongate substantially hollow shaft defining an elongate axis;
an end effector operably coupled to a distal end of said elongate shaft for selective pivotal and rotational travel relative thereto, said end effector having at least one actuation feature thereon that is actuatable upon application of at least one axial actuation motion thereto;
an articulation actuator operably interfacing with said end effector for applying at least one axial motion thereto to cause said end effector to pivot relative to said distal end of said elongate shaft and for selectively applying at least one rotation motion thereto to cause said end effector to rotate relative to said distal end of said elongate shaft about said elongate axis;
a rotational coupling, comprising:
a driving coupler movably supported within a portion of said elongate substantially hollow shaft; and
an idler coupler movably supported within said portion of said substantially elongate hollow shaft and rotatably coupled to said driving coupler for rotation relative thereto about said elongate axis and axial travel with said driving coupler along said actuation axis;

an input actuator for applying said at least one axial actuation motion, said input actuator coupled at a distal end to the driving coupler, wherein said at least one axial actuation motion is transmitted to said driving coupler, and wherein said driving coupler transmits said at least one axial actuation motion to said idler coupler; and
at least one output actuator coupled at a proximal end to said idler coupler and at a distal end to said actuation features on said end effector such that said output actuator transfers said at least one axial actuation motion from said rotational coupling to said at least one actuation feature of said end effector.

2. The surgical device of claim 1 wherein said actuation feature is selected from the group of actuation features consisting of grasper jaws, a biopsy probe, a snare loop, forceps, scissors, a needle knife, and a sphincterotome.

3. The surgical device of claim 1 wherein said articulation actuator comprises a semi-flexible wire that is axially and rotatably movable relative thereto.

4. The surgical device of claim 1 wherein said input actuator comprises a first semi-flexible wire and wherein said output actuator comprises a second semi-flexible wire.

5. The surgical device of claim 1 wherein said end effector is operably coupled to said distal end of said substantially hollow elongate shaft by a multiple-bar linkage.

6. The surgical device of claim 5 wherein said multiple-bar linkage comprises:
a first substantially hollow link rotatably coupled at a proximal end to said distal end of said substantially hollow elongate shaft and such that said first link may rotate about said elongate axis, wherein said rotation causes said end effector to rotate about said elongate axis, and wherein the first substantially hollow link is pivotably coupled to said end effector such that said end effector may pivot relative thereto about a pivot axis;
a second link coupled to said articulation actuator and movably supported within said first link for axial travel relative thereto in response to said axial articulation motions applied thereto from said articulation actuator; and
a third link pivotally coupled to said first link and to said second link and coupled to said end effector such that the application of said axial articulation motions to said second link by said articulation actuator causes said end effector to pivot about said pivot axis.

7. The surgical device of claim 1 further comprising a handle assembly coupled to a proximal end of said substantially hollow elongate shaft.

8. The surgical device of claim 7 wherein said articulation actuator is operably coupled to an articulation knob that is rotatably and axially movably supported on said handle assembly and wherein said input actuator is operably coupled to an actuation knob that is axially movably supported on said handle assembly.

9. The surgical device of claim 1 wherein the end effector is operably coupled to said distal end of said elongate shaft by a second rotation coupling, wherein said second rotation coupling includes a first portion that is fixedly coupled at a proximal end to said elongate shaft and includes a second portion that is fixedly coupled at a distal end to said end effector, and wherein a proximal end of the second portion is rotatably coupled to a distal end of the first portion for rotation thereto.

10. The surgical device of claim 9 wherein said articulation actuator passes through an opening in said first rotational coupling and an opening in said second rotation coupling.

11. The surgical device of claim 9 wherein said end effector is operably coupled to said distal end of said second portion of said second rotation coupling by a multiple-bar linkage comprising:
a first substantially hollow link rotatably coupled at a proximal end to said distal end of said second portion of said second rotation coupling such that said first link may rotate about said elongate axis, wherein rotation causes said end effector to rotate about said elongate axis, and wherein the first substantially hollow link is pivotably coupled to said end effector such that said end effector may pivot relative thereto about a pivot axis;
a second link coupled to said articulation actuator and movably supported within said first link for axial travel relative thereto in response to said axial articulation motions applied thereto from said articulation actuator; and
a third link pivotably coupled to said first link and to said second link and coupled to said end effector such that application of said axial articulation motions to said second link by said articulation actuator causes said end effector to pivot about said pivot axis.

12. A surgical device, comprising:
an elongate substantially hollow shaft defining an elongate axis;
an end effector operably coupled to a distal end of said elongate shaft for selective pivoting relative to the elongate axis and rotating about the elongate axis, said end effector having at least one actuation feature thereon that is actuatable upon application of at least one axial actuation motion thereto;
an articulation actuator operably interfacing with said end effector and configured to move along the elongate axis and to rotate about the elongate axis, wherein motion of the articulation actuator along the elongate axis causes said end effector to pivot relative to the elongate axis, and wherein rotation of the articulation actuator about the elongate axis causes the end effector to rotate about the elongate axis;
an input actuator coupled to the articulation actuator, wherein the input actuator transmits force to the articulation actuator in a direction along the elongate axis and transmits torque to the articulation actuator about the elongate axis; and
a rotational coupling comprising:
a driving coupler arranged within a portion of the elongate substantially hollow shaft, wherein the driving coupler is movable along the elongate axis within the portion of the elongate substantially hollow shaft, and wherein the driver coupler is fixed relative to the elongate axis;
an idler coupler arranged within the portion of the elongate substantially hollow shaft and rotatably coupled to the driving coupler, wherein the idler coupler is movable along the elongate axis and with the driving coupler, and wherein the idler coupler rotates about the elongate axis; and
an output actuator coupled at a proximal end to the idler coupler and at a distal end to the end effector, the output actuator applying the at least one axial actuation motion to the at least one actuation feature of the end effector when the driving coupler and the idler coupler move along the elongate axis.