Surgical instrument clamp arm with adjustable coupling stability and

Abstract

A surgical instrument includes an end effector, a shaft assembly, a handle (5552), and a clamp arm alignment structure. The end effector includes an ultrasonic blade (5542) and a clamp arm pivotable relative to the ultrasonic blade between an open position and a closed position. The clamp arm includes an elongated coupling body (5560). The shaft assembly includes an outer sheath (5532) and an ultrasonic waveguide. A handle (5552) is attached to the clamp arm and can pivot the clamp arm between an open position and a closed position. The handle includes a clamp arm support (5570) that can receive the elongated coupling body of the clamp arm to assist in attaching the clamp arm to the handle. The clamp arm alignment structure facilitates alignment of the clamp arm relative to the ultrasonic blade in the closed position.

Description

Priority

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 514,011, filed July 17, 2023, entitled “Methods of End Effector Assembly and Related Arrangements for Surgical Instruments,” the entirety of which is hereby incorporated by reference herein. BACKGROUND

[0002] Various surgical instruments include an end effector having a knife element that vibrates at ultrasonic frequencies to cut and / or seal tissue (e.g., by denaturing the proteins in the tissue cells). These instruments include a piezoelectric element that converts electrical power into ultrasonic vibrations that are transmitted along an acoustic waveguide to the knife element. The precision of the cutting and coagulation can be controlled by the surgeon’s technique and adjustments to the power level, knife edge, tissue traction, and knife pressure.

[0003] Examples of ultrasonic surgical instruments include the HARMONIC ACE ® ultrasonic shears, HARMONIC WAVE ® ultrasonic shears, HARMONIC FOCUS ® ultrasonic shears, and HARMONIC SYNERGY ®Ultrasonic Shears, all of the above instruments are available from Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. Other examples of such devices, and related concepts, are disclosed in U.S. Pat. No. 5,322,055, entitled "Clamp Coagulator / Cutting System for Ultrasonic Surgical Instruments," issued June 21, 1994, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,873,873, entitled "Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism," issued February 23, 1999, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 5,980,510, entitled "Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Arm Pivot Mount," filed October 10, 1997, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,325,811, entitled "Blades with Functional Balance Asymmetries for use with Ultrasonic Surgical Instruments," issued December 4, 2001, the disclosure of which is incorporated by reference herein; U.S. Pat. No. 6,773,444, entitled "Blades with Functional Balance Asymmetries for Use with Ultrasonic Surgical Instruments," issued August 10, 2004, the disclosure of which is incorporated by reference herein; and U.S. Pat. No. 6,783,524, entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument," issued August 31, 2004, the disclosure of which is incorporated by reference herein.

[0004] Other examples of ultrasonic surgical instruments are disclosed in U.S. Pub. No. 2006 / 0079874, entitled "Tissue Pad for Use with an Ultrasonic Surgical Instrument," published April 13, 2006, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2007 / 0191713, entitled "Ultrasonic Device for Cutting and Coagulating," published August 16, 2007, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2007 / 0282333, entitled "Ultrasonic Waveguide and Blade," published December 6, 2007, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2008 / 0200940, entitled "Ultrasonic Device for Cutting and Coagulating," published August 21, 2008, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2009 / 0105750, entitled "Ergonomic Surgical Instruments," published April 23, 2009, the disclosure of which is incorporated by reference herein; U.S. Pub. No. 2010 / 0069940, entitled "Ultrasonic Device for Fingertip Control," published March 18, 2010, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2011 / 0015660, entitled "Rotating Transducer Mount for Ultrasonic Surgical Instruments," published January 20, 2011, the disclosure of which is incorporated by reference herein; and U.S. Pub. No. 2012 / 0029546, entitled "Ultrasonic Surgical Instrument Blades," published February 2, 2012, the disclosure of which is incorporated by reference herein.

[0005] Some ultrasound surgical instruments may include cordless transducers, such as those disclosed in the following documents: U.S. Publication No. 2012 / 0112687, entitled “Recharge System for Medical Devices,” published May 10, 2012, the disclosure of which is incorporated herein by reference; U.S. Publication No. 2012 / 0116265, entitled “Surgical Instrument with Charging Devices,” published May 10, 2012, the disclosure of which is incorporated herein by reference; and / or U.S. Patent Application No. 61 / 410,603, entitled “Energy-Based Surgical Instruments,” filed November 5, 2010, the disclosure of which is incorporated herein by reference.

[0006] Additionally, some ultrasonic surgical instruments may include joint motion axis segments. Examples of such ultrasonic surgical instruments are disclosed in the following patents: U.S. Publication No. 2014 / 0005701, entitled “Surgical Instruments with Articulating Shafts,” published January 2, 2014, the disclosure of which is incorporated herein by reference; and U.S. Publication No. 2014 / 0114334, entitled “Flexible Harmonic Waveguides / Blades for Surgical Instruments,” published April 24, 2014, the disclosure of which is incorporated herein by reference.

[0007] Although several surgical instruments and systems have been manufactured and used, it is believed that no one prior to the inventors had manufactured or used the invention described in the appended claims. Attached Figure Description

[0008] Although this specification provides for claims that specifically point out and expressly declare such technology, it is believed that such technology will be better understood from certain examples described below in conjunction with the accompanying drawings, wherein similar reference numerals indicate the same elements, and wherein: FIG. 1 A perspective view of an illustrative surgical instrument is depicted; FIG. 2 Depicting a closed configuration FIG. 1 A side front view of the end effector of the instrument; FIG. 3 Depicting the open configuration FIG. 2 A perspective view of the end effector; FIG. 4 Depicting a closed configuration FIG. 2a perspective view of an end effector of the surgical instrument; FIG. 5 depicts a perspective view of another illustrative surgical instrument; FIG. 6 depicts FIG. 5 an exploded perspective view of an end effector, a clamp arm assembly, and a shaft assembly of the surgical instrument; FIG. 7 depicts FIG. 6 a perspective view of a handle of the clamp arm assembly; FIG. 8 depicts a perspective view of a clamp arm initially attached to FIG. 7 a handle of the surgical instrument; FIG. 9 depicts FIG. 6 a perspective view of the assembled clamp arm and handle of the surgical instrument initially inserted over FIG. 8 a shaft assembly of the surgical instrument; FIG. 10 depicts FIG. 6 a perspective view of an assembled end effector of the surgical instrument; FIG. 11 depicts a perspective view of another illustrative surgical instrument; FIG. 12 depicts FIG. 11 an exploded perspective view of a distal end of a clamp arm assembly of the surgical instrument; FIG. 13 depicts FIG. 12 a perspective view of an underside of the distal end of the clamp arm assembly; FIG. 14 depicts FIG. 12 a perspective view of a distal end of a handle of the clamp arm assembly; FIG. 15 depicts FIG. 11 a cross-sectional view of an end effector of the surgical instrument; FIG. 16 depicts a cross-sectional view of a pivot mechanism that can be readily incorporated into the surgical instrument of FIG. 1 , FIG. 5 or FIG. 11 ; FIG. 17 depicts a cross-sectional view of a pivot mechanism that can be readily incorporated into the surgical instrument of FIG. 1 , FIG. 5 or FIG. 11 ; FIG. 18 depicts a cross-sectional view of a pivot mechanism that can be readily incorporated into the surgical instrument of FIG. 1 , FIG. 5 or FIG. 11 ; FIG. 19AA cross-sectional view of an illustrative pivot pin having a first shaft member and a second shaft member separated from one another is depicted; FIG. 19B A cross-sectional view of a pivot pin is depicted, wherein a first shaft member and a second shaft member are coupled to one another; FIG. 19A FIG. 20 A cross-sectional view of a pivot mechanism that can be readily incorporated into a surgical instrument of FIG. 1 , FIG. 5 or FIG. 11 is depicted; FIG. 21 A perspective view of a pivot mechanism including a pin, a clamping arm, and an outer sheath is depicted; FIG. 22 A cross-sectional view of a seventh pivot mechanism of FIG. 21 including a set screw having a pointed tip is depicted; FIG. 23 A cross-sectional view of a seventh pivot mechanism of FIG. 21 including a set screw having a cup is depicted; FIG. 24 Side views of a first clamping arm having various degrees of compliance are depicted; FIG. 25 A cross-sectional view of segment 25-25 of FIG. 24 is depicted; FIG. 26 Side views of a second clamping arm having various degrees of compliance are depicted; FIG. 27 A perspective view of a pivot mechanism is depicted; FIG. 28A A side view of a clamping arm is depicted; FIG. 28B A cross-sectional view of a portion of a clamping arm of FIG. 28A having a counterbore and a channel is depicted taken along line 28B-28B of FIG. 28A ; FIG. 29 A cross-sectional view of a fifth pivot mechanism of FIG. 28A having a clamping arm of FIG. 27 is depicted; FIG. 30 A cross-sectional view of a view of FIG. 29 having a mushroom-shaped pin is depicted; FIG. 31 A cross-sectional view of a pivot mechanism including an unflared pin, a clamping arm, and an outer sheath is depicted; FIG. 32 A cross-sectional view of a pivot mechanism of FIG. 31 including a flared pin, a clamping arm, and an outer sheath is depicted; FIG. 33 ​A side view of a clamping arm assembly including a clamping arm, a thumb grip, a handle, and a sleeve is depicted. FIG. 34 A side view of an ultrasonic surgical instrument with a handle assembly and another clamping arm assembly is depicted. FIG. 35 Depicting FIG. 34 An ultrasonic surgical instrument having a thumb grip ring and clamping arm that can be laser welded together, thermally riveted or pinned to form a joint. FIG. 36 Depicting FIG. 34 An ultrasonic surgical instrument having a thumb grip ring and a clamping arm, the thumb grip ring and clamping arm may include a pin along a longitudinal axis and having a modulus of construction to control the amount of deflection; FIG. 37 Depicting FIG. 34 An ultrasonic surgical instrument having a thumb grip ring that may include a rough ball and a clamping arm that may include a socket. FIG. 38 An exploded perspective view depicts an ultrasonic surgical instrument with a handle assembly and another clamping arm assembly. FIG. 39 Depicting FIG. 38 A perspective view of the distal tip of an ultrasound instrument; FIG. 40 Depicting FIG. 39 Bottom view of the distal tip of an ultrasound instrument; FIG. 41 Depicting FIG. 39 A bottom perspective view of the distal tip of an ultrasound instrument; FIG. 42 Depicting FIG. 39 A bottom perspective view of the wireframe at the distal tip of an ultrasound instrument; FIG. 43 Depicting FIG. 39 Top perspective view of the wireframe of the distal tip of an ultrasound instrument; FIG. 44 Depicting FIG. 39 A wireframe top view of the distal tip of an ultrasound instrument. FIG. 45 A clamping arm comprising a clamping tip and an adhesive clamping pad is depicted; FIG. 46 A perspective view of the clamping arm, including the clamping tip, clamping pad, and carrier, is depicted. FIG. 47 Depicting FIG. 46 Side view of the clamping arm; FIG. 48 Depicting FIG. 46 A perspective view of the clamping arm; and FIG. 49 depicted FIG. 46 perspective cross-sectional view of the clamping arm of

[0009] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the technology can be carried out in a variety of other ways, including those not necessarily depictured. The drawings are merely exemplary and are not intended to limit the scope or application of the technology. DETAILED DESCRIPTION

[0010] The description of certain examples of the technology below does not limit the scope or application of the technology. Other examples, features, aspects, embodiments, and advantages of the technology will become apparent to one of ordinary skill in the art from the descriptions and accompanying drawings. The description is presented for purposes of illustration and description, and is not intended to limit the scope of the technology.

[0011] It should also be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. The description and examples are not mutually exclusive, and include combinations with each other as well as combinations with other, now known or later developed, teachings, expressions, embodiments, examples, etc. The teachings herein will thus include, where consistent, combinations of the teachings with other teachings, relating to other subjects, alone or in combination with other teachings. Other combinations and sub-combinations can be made based on such teachings.

[0012] For the sake of clarity, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of the surgical instrument. The term "proximal" refers to a position closer to the human or robotic operator of the surgical instrument and further from an element of the surgical end effector of the surgical instrument. The term "distal" refers to a position closer to the surgical end effector of the surgical instrument and further from the human or robotic operator of the surgical instrument.

[0013] I. Exemplary Ultrasonic Surgical Instruments FIGS. 1-4An exemplary ultrasonic surgical instrument (100) is illustrated. At least a portion of each instrument (100) may be constructed and operated in accordance with at least some of the teachings of the following patents: U.S. Patent No. 5,322,055, U.S. Patent No. 5,873,873, U.S. Patent No. 5,980,510, U.S. Patent No. 6,325,811, U.S. Patent No. 6,773,444, U.S. Patent No. 6,783,524, U.S. Publication No. 2006 / 0079874, U.S. Publication No. 2007 / 0191713, and U.S. Publication No. 2007 / 028233. U.S. Publication Nos. 3, 2008 / 0200940, 2009 / 0105750, 2010 / 0069940, 2011 / 0015660, 2012 / 0112687, 2012 / 0116265, 2014 / 0005701, 2014 / 0114334, U.S. Patent Application No. 61 / 410,603, and / or U.S. Patent Application No. 14 / 028,717. The disclosure of each of the foregoing patents, publications, and applications is incorporated herein by reference. As described herein and as will be described in more detail below, the device (100) is operable to substantially simultaneously cut tissue and seal or weld tissue (e.g., blood vessels, etc.). It should also be understood that the device (100) may have similar features to HARMONIC ACE. ® Ultrasonic scissors, Harmonic wave ® Ultrasonic scissors, HARMONIC FOCUS ® Ultrasonic scissors and / or harmonic synergy ® Various structural and functional similarities of ultrasonic scalpels. In addition, the device (100) may have various structural and functional similarities with the devices taught in any of the other references cited herein and incorporated herein by reference.

[0014] The teachings of the references cited in this article, HARMONIC ACE ® Ultrasonic scissors, Harmonic wave ® Ultrasonic scissors, HARMONIC FOCUS ® Ultrasonic scissors and / or harmonic synergy ® To the extent that there is some overlap between the teachings of the ultrasonic scalpel and the following teachings related to the instrument (100), it is not intended that any description herein be assumed to be accepted prior art. Some teachings herein will actually go beyond the teachings of the references cited herein and the HARMONIC ACE ®Harmonic Scalpel, Harmonic Wave ® Harmonic Scalpel, Harmonic Focus ® Harmonic Scalpel and Harmonic Synergy ® Harmonic Scalpel.

[0015] FIG. 1 An illustrative ultrasonic surgical instrument (100) configured for use in open surgery is illustrated. The instrument (100) of the present example includes a handle assembly (120), a shaft assembly (130), and an end effector (140). The handle assembly (120) includes a body (122) that includes a finger grip ring (124) and a pair of buttons (126). The instrument (100) also includes a clamp arm assembly (150) that is pivotable toward and away from the body (122). The clamp arm assembly (150) includes a handle (152) having a thumb grip ring (154). The thumb grip ring (154) and the finger grip ring (124) together provide a scissors grip type configuration. However, it will be appreciated that various other suitable configurations can be used, including but not limited to a pistol grip configuration.

[0016] The shaft assembly (130) includes an outer sheath (132) that extends distally from the body (122). A cap (134) is secured to the distal end of the sheath (132). As FIGS. 2-4 As best seen in FIG. 1, the end effector (140) includes an ultrasonic blade (142) and a clamp arm (144). The ultrasonic blade (142) extends distally from the cap (134). In the present example, the clamp arm (144) is an integral feature of the clamp arm assembly (150). The distal end of the handle (152) terminates in a pair of laterally opposed sidewalls (158), each of which extends distally into the clamp arm (144). The laterally opposed sidewalls (158) together define an opening (155) that receives a portion of the outer sheath (132).

[0017] The clamp arm (144) includes a clamp pad (146) that faces the ultrasonic blade (142). The clamp arm assembly 150 is pivotally coupled with the outer sheath 132 via a pin 156. The outer sheath (132) also includes a fin (136) that extends upwardly therefrom in the range of the laterally opposed sidewalls (158). The pin (156) extends through suitable portions of the laterally opposed sidewalls (158) and the fin (136) so as to pivotally couple the clamp arm assembly (150) with the outer sheath (132). The clamp arm (144) is positioned distal of the pin (156); while the handle (152) and the thumb grip ring (154) are positioned proximal of the pin (156). Thus, as FIGS. 3-4As shown, the clamp arm (144) is pivotable toward and away from the ultrasonic blade (142) based on the thumb grip ring (154) being pivoted toward and away from the body (122) of the handle assembly (120). Thus, it will be appreciated that the operator can squeeze the thumb grip ring (154) toward the body (122) to clamp tissue between the clamp pad (146) and the ultrasonic blade (142) to transect and / or seal the tissue. In some versions, one or more resilient members are used to bias the clamp arm (144) to the open position shown. By way of example only, such resilient members can include a leaf spring, a torsion spring, and / or any other suitable kind of resilient member. FIG. 3

[0018] Referring back to FIG. 1 , the ultrasonic transducer assembly (112) extends proximally from the body (122) of the handle assembly (120). The transducer assembly (112) is coupled with the generator (116) via a cable (114). The transducer assembly (112) receives power from the generator (116) and converts that power into ultrasonic vibrations through piezoelectric principles. The generator (116) can include a power source and control module that is configured to provide power to the transducer assembly (112) that is particularly suited for generating ultrasonic vibrations by the transducer assembly (112). By way of example only, the generator (116) can include a GEN 300 sold by Ethicon Endo-Surgery, Inc. (Cincinnati, Ohio). Additionally or alternatively, the generator (116) can be constructed in accordance with at least some of the teachings of U.S. Pub. No. 2011 / 0087212, entitled "Surgical Generator for Ultrasonic and Electrosurgical Devices," published April 14, 2011, the disclosure of which is incorporated by reference herein. It will also be appreciated that at least some of the functionality of the generator (116) can be integrated into the handle assembly (120), and the handle assembly (120) can even include a battery or other on-board power source, such that the cable (114) is eliminated. Other suitable forms that the generator (116) can take, as well as various features and operability that the generator (116) can provide, will be apparent to those of ordinary skill in the art in view of the teachings herein.

[0019] ​The ultrasonic vibrations generated by the transducer assembly (112) are transmitted along an acoustic waveguide (138) that extends through the shaft assembly (130) to the ultrasonic blade (142). The waveguide (138) is secured within the shaft assembly (130) via a pin (not shown) that passes through the waveguide (138) and the shaft assembly (130). Thus, the waveguide (138) is secured relative to the outer sheath (132). This pin is located at a position along the length of the waveguide 138 that corresponds to a node associated with the resonant ultrasonic vibrations transmitted through the waveguide 138. As noted above, when the ultrasonic blade (142) is in an actuated state (i.e., ultrasonic vibrations), the ultrasonic blade (142) is operable to effectively cut through and seal tissue, especially when the tissue is clamped between the clamp pad (146) and the ultrasonic blade (142). It will be appreciated that the waveguide (138) can be configured to amplify the mechanical vibrations transmitted through the waveguide (138). Moreover, the waveguide (138) can include features that are operable to control the gain of the longitudinal vibrations along the waveguide (138) and / or features to tune the waveguide (138) to the resonant frequency of the system.

[0020] In the present example, the distal end of the ultrasonic blade (142) is located at a position corresponding to an anti-node associated with the resonant ultrasonic vibrations transmitted through the waveguide (138) in order to tune the acoustic assembly to the preferred resonant frequency f o When the transducer assembly (112) is energized, the distal end of the ultrasonic blade (142) is configured to oscillate in a range of, for example, about 10 microns to 500 microns peak to peak, and in some cases in a range of about 20 microns to about 200 microns, at a predetermined vibration frequency f o The longitudinal movement. When the transducer assembly (112) of the present example is activated, these mechanical oscillations are transmitted through the waveguide to the ultrasonic blade (142), providing oscillation of the ultrasonic blade (142) at the resonant ultrasonic frequency. Thus, when tissue is clamped between the ultrasonic blade (142) and the clamp pad (146), the ultrasonic oscillations of the ultrasonic blade (142) can simultaneously cut the tissue and denature proteins in adjacent tissue cells, providing a coagulation effect with relatively little heat diffusion. In some versions, an electrical current can also be provided through the ultrasonic blade (142) and / or the clamp pad (146) to likewise seal the tissue.

[0021] An operator can actuate the buttons (126) to selectively actuate the transducer assembly (112) and thereby the ultrasonic blade (142). In the present example, two buttons (126) are provided: one button to activate the ultrasonic blade (142) at a low power level and another button to activate the ultrasonic blade (142) at a high power level. It will be appreciated, however, that any other suitable number of buttons and / or power levels can be provided. For example, a foot pedal can be provided to selectively actuate the transducer assembly (112). The buttons (126) of the present example are positioned so that an operator can easily operate the instrument (100) entirely with one hand. For example, the operator can position his thumb in the thumb grip ring (154), his ring finger in the finger grip ring (124), his middle finger around the body (122), and use his index finger to manipulate the buttons (126). Of course, the instrument (100) can be held and operated using any other suitable technique; and the buttons (126) can be located in any other suitable position.

[0022] The foregoing components and operability of the instrument (100) are merely illustrative. The instrument (100) can be constructed in numerous other ways in light of the teachings herein, as will be apparent to those of ordinary skill in the art. By way of example only, at least a portion of the instrument 100 can be constructed and / or operated in accordance with at least some of the teachings of any of the following patents, the disclosures of which are incorporated by reference herein: U.S. Patent No. 5,322,055; U.S. Patent No. 5,873,873; U.S. Patent No. 5,980,510; U.S. Patent No. 6,325,811; U.S. Patent No. 6,783,524; U.S. Pub. No. 2006 / 0079874; U.S. Pub. No. 2007 / 0191713; U.S. Pub. No. 2007 / 0282333; U.S. Pub. No. 2008 / 0200940; U.S. Pub. No. 2010 / 0069940; U.S. Pub. No. 2011 / 0015660; U.S. Pub. No. 2012 / 0112687; U.S. Pub. No. 2012 / 0116265; U.S. Pub. No. 2014 / 0005701; U.S. Pub. No. 2014 / 0114334; and / or U.S. Patent Application No. 14 / 031,665. Additional merely illustrative variations of the instrument (100) will be described in greater detail below. It will be appreciated that the variations described below can be readily applied to any of the instruments described above and / or mentioned in any of the references cited herein, etc.

[0023] II. Ultrasonic Surgical Instruments with Alignment Features for Ultrasonic Blades and Clamping Pads As mentioned above, the clamp arm (144) is in an open position (see FIG. 3) between an open position (see FIG. 4 ) to the ultrasonic blade (142) so as to properly grasp tissue between the clamp pad (146) and the ultrasonic blade (142), and then activate the ultrasonic blade (142) so as to transect and / or seal the grasped tissue. Also as noted above, in the current example, the clamp arm (144) is integrally formed with the handle (152) of the clamp arm assembly (150). In some instances, it can be desirable for the clamp arm (144) and the handle (152) to be formed of different materials. For example, during illustrative use, thermal energy can accumulate at the end effector (140) such that a metallic material can be more suitable for the clamp arm (144) to inhibit undesirable deformation in response to exposure to the accumulated thermal energy. However, it can be desirable to utilize a material having different properties for the handle (152), such as a lighter weight material (e.g., a suitable plastic). Of course, as will be apparent to those skilled in the art in light of the teachings herein, the clamp arm (144) and the handle (152) can be formed of any suitable first and second materials, respectively.

[0024] In some instances, when the clamp arm (144) and the handle (152) are formed from different materials and / or components, the clamp arm (144) and the handle (152) can need to be coupled together during assembly of the instrument (100). During assembly of the instrument (100), undesirable tolerance stack-ups can accumulate. For example, tolerance stack-ups can accumulate when the clamp arm (144) and the handle (152) are assembled together. As another example, tolerance stack-ups can accumulate when the handle (152) and the shaft assembly (130) are pivotally coupled together. Such tolerance stack-ups can undesirably affect the alignment between the clamp pad (146) and the ultrasonic blade (142) at the time of assembly, which can result in undesirable effects on the sealed and / or welded tissue. For example, in some instances, a user can desire to grasp tissue with only the distal tip of the ultrasonic blade (142) and the clamp pad (146), also referred to as a "tip pinch," to transect and / or seal a smaller portion of the tissue rather than a tissue segment that coincides along a majority of the length of the clamp pad (146) and / or the ultrasonic blade (142). Grasping tissue with the ultrasonic blade (142) and the clamp pad (146) via a tip pinch can allow a user to control the area of tissue that is transected and / or sealed with greater precision. However, in instances where the ultrasonic blade (142) and the clamp pad (146) fail to properly align, the longitudinal ends of the ultrasonic blade (142) and the clamp pad (146) can also fail to properly align with one another, which can undesirably affect the quality of tissue transection and / or sealing via a tip pinch. Thus, it can be desirable to have features that facilitate proper alignment between the ultrasonic blade (146) and the clamp arm (144) / clamp pad (146) when the end effector (140) is properly assembled and ready for illustrative use, especially in instances where the clamp arm (144) and the handle (152) are separate components that are coupled together during assembly of the instrument (100).

[0025] FIG. 5 An illustrative ultrasonic surgical instrument (5500) is shown that can be used in place of the ultrasonic surgical instrument (100) described above. Thus, the ultrasonic surgical instrument (5500) is substantially similar to the instrument (100) described above, but with the differences detailed herein. The instrument (5500) includes a handle assembly (5520), a shaft assembly (5530), an end effector (5540), and a clamp arm assembly (5550); they can be substantially similar to the handle (120), the shaft assembly (130), the end effector (140), and the clamp arm assembly (150), but with the differences detailed herein.

[0026] As will be described in greater detail below, the clamp arm (5544) of the end effector (5540) and the handle (5552) of the clamp arm assembly (5550) are separate components that are coupled together during assembly of the instrument (5500). As will be described in greater detail below, the clamp arm (5544) is configured to be directly pivotally coupled to the outer sheath (5532), thereby reducing cumulative tolerance stack-ups and further facilitating proper alignment (longitudinal and / or lateral) of the clamp arm (5554) / clamp pad (5546) with the ultrasonic blade (5542).

[0027] The handle assembly (5520) includes a body (5522), a finger grip ring (5524), and a button (5526); they can be substantially similar to the body (122), the finger grip ring (124), and the button (126) described above. While not shown, it will be appreciated that the body (5522) can be appropriately coupled to the ultrasonic transducer assembly (112) (similar to the body (122) described above) such that the ultrasonic transducer assembly (112) can appropriately transmit ultrasonic vibrations to the ultrasonic waveguide (5538) and the ultrasonic blade (5542) according to the descriptions above. The shaft assembly (5530) includes an outer sheath (5532), a cap (5534), and an ultrasonic waveguide (5538); they can be substantially similar to the sheath (132), the cap (134), and the ultrasonic waveguide (138) described above, but with the differences detailed below. The sheath (5532) of the present example includes a pivot coupling body (5536). Unlike the fins (136) of the sheath (132) described above, the pivot coupling body (5536) extends away from the outer sheath (5532) in a downward direction that extends away from a proximal portion of the handle (5552). As will be described in greater detail below, the location of the pivot coupling body (5536) allows the clamp arm (5544) to be directly pivotally coupled to the outer sheath (5532).

[0028] The clamp arm assembly (5550) includes a handle (5552) and a thumb ring grip (5554); they can be substantially similar to the handle (152) and the thumb ring grip (154) described above, but with the differences detailed herein. The handle (5552) and the thumb ring grip (5554) can be formed from a suitable material such as a plastic material. Turning to FIG. 6 The distal end of the handle (5552) includes a pair of laterally-opposed sidewalls (5558) that define a cavity (5555). The laterally-opposed sidewalls (5558) and the cavity (5555) can be substantially similar to the laterally-opposed sidewalls (158) and the cavity (155) described above, but with the differences detailed herein. Thus, when the instrument (5500) is assembled, the cavity (5555) is sized to appropriately house a portion of the outer sheath (5532).

[0029] At least one laterally opposing sidewall (5558) defines a clamp arm coupling aperture (5572) and a pivot aperture (5574). As will be described in greater detail below, the clamp arm coupling aperture (5572) is configured to receive a pin (5578) in order to properly attach the clamp arm (5544) with the handle (5552) such that pivotal driving of the handle (5552) relative to the outer sheath (5532) pivots the clamp arm (5544) relative to the ultrasonic blade (5542). As will also be described in greater detail below, the pivot aperture (5574) is sized to receive a pivot pin (5556) in order to allow the pivot pin (5556) to directly pivotally couple the clamp arm (5544) with the pivot coupling body (5536) of the outer sheath (5532) together via the sheath coupling aperture (5564) defined by the clamp arm (5544). Directly coupling the clamp arm (5544) with the outer sheath (5532) together can reduce undesirable tolerance stack-ups as compared to directly coupling the clamp arm (5544) to the handle (5552) which is then pivotally coupled to the outer sheath (5532). Reducing such undesirable tolerance stack-ups allows the clamp arm (5544), and thus the clamp pad (5546), to be better aligned with the ultrasonic blade (5542) once the instrument (5500) is assembled.

[0030] The distal end of the handle (5552) also includes a clamp arm support surface (5570) that extends between laterally-opposed sidewalls (5558) and also defines a portion of the cavity (5555). When the handle (5552) is pivotally coupled to the outer sheath (5532) in accordance with the description herein, the clamp arm support surface (5570) is positioned adjacent to an underside of the outer sheath (5532). In other words, the clamp arm support surface (5570) is positioned adjacent to a portion of the outer sheath (5532) that is associated with the pivotal coupling body (5536). The clamp arm support surface (5570) is sized to receive and support the elongated coupling body (5560) of the clamp arm (5544). Thus, the proximal end of the clamp arm (5544) can be brought into proper alignment with the clamp arm support surface (5570) and then inserted proximally into the extent of the clamp arm support surface (5570) until the through-holes (5572, 5574) defined by the at least one laterally-opposed sidewall (5558) are brought into proper alignment with the corresponding through-holes (5562, 5564) defined by the clamp arm (5544). In conjunction with the pins (5578), the clamp arm support surface (5570) can include complementary geometry that is suitably complementary to the corresponding portion of the elongated coupling body (5560) of the clamp arm (5544) so as to operatively retain the clamp arm (5544) relative to the handle (5552) so as to inhibit undesired relative movement between the clamp arm (5544) and the handle (5552) during illustrative use in accordance with the teachings herein.

[0031] The distal end of the handle portion (5552) also includes a clamp pad stop (5576). In the current example, the clamp arm (5544) is configured to selectively couple with the clamp pad (5546). Specifically, the clamp arm (5544) and the clamp pad (5546) can couple together via complementary geometry (e.g., a tongue and groove relationship) such that the clamp pad (5546) can slide distally along a predetermined path defined by the complementary mating features of the clamp arm (5544) and the clamp pad (5546) in order to initially couple with one another. Once the clamp pad (5546) is properly coupled to the clamp arm (554), and once the clamp arm (5544) is properly coupled to the handle portion (5554), the clamp pad stop (5576) is directly adjacent to the proximal surface (5545) of the clamp pad (5546). The clamp pad stop (5576) is configured to directly engage the proximal surface (5545) of the clamp pad (5546) in order to inhibit the clamp pad (5546) from sliding proximally relative to the clamp arm (5554) out of alignment. Thus, in accordance with the description herein, the clamp pad stop (5576) is configured to maintain the longitudinal alignment of the clamp pad (5546) relative to the clamp arm (5544) once the clamp arm (5544) and the clamp pad (5546) are properly coupled with the handle portion (5552).

[0032] As mentioned above, the clamp arm (5544) includes an elongated coupling body (5560) that defines a handle coupling through-hole (5562) and a sheath coupling through-hole (5564). The clamp arm (5544) can be formed from a suitable second material such as a metallic material. Thus, in some cases, the handle portion (5552) can be formed from a first material (e.g., a plastic material) having desired properties for the handle portion (5552), while the clamp arm (5544) can be formed from a second material (e.g., a metallic material) having desired properties for the clamp arm (5544). Once the elongated coupling body (5560) of the clamp arm (5544) is properly inserted into the clamp arm support surface (5570), the handle coupling through-hole (5562) is sized to align with the clamp arm coupling through-hole (5572) of the handle portion (5552). Once the through-holes (5562, 5572) are aligned, a pin (5578) is inserted into both through-holes (5562, 5572) in order to properly couple the clamp arm (5544) with the handle portion (5552) in accordance with the description herein.

[0033] The sleeve connection through-hole (5564) is sized to align with the pivot through-hole (5574) of the handle (5552) once the elongated connecting body (5560) of the clamping arm (5544) is properly inserted into the clamping arm support surface (5570). As mentioned above, the pivot pin (5556) is configured to pivotally connect the outer sleeve (5532) directly to the clamping arm (5544) via the pivot connecting body (5536) and the sleeve connection through-hole (5564) to reduce accumulated tolerances during the assembly of the instrument (5500), thereby promoting proper alignment between the clamping arm (5544) / clamping pad (5546) and the ultrasonic scalpel (5542) during illustrative use of the instrument (5500) as described herein. Therefore, the sheath connection through hole (5564), pivot pin (5556) and pivot connection body (5536) serve as a clamping arm alignment structure that promotes proper alignment of the clamping arm (5544) / clamping pad (5545) with the ultrasonic scalpel (5542) when the clamping arm (5544) is in the closed position.

[0034] FIGS. 8-10 An exemplary assembly of the clamping arm (5540), the handle (5552), and the shaft assembly (5530) is shown. First, as FIG. 8 As shown, the clamping arm (5544) can be initially inserted into the cavity (5555) such that the elongated connecting body (5560) of the clamping arm (5544) is properly accommodated within the clamping arm support surface (5570) of the handle (5552). Once properly inserted, the through holes (5562, 5564) of the elongated connecting body (5560) are properly aligned with the corresponding through holes (5572, 5574) of the handle (5552). Once the through holes (5562, 5572) are properly aligned, the pin (5578) is inserted into the two through holes (5562, 5572), thereby attaching the clamping arm (5540) to the handle (5542), such that movement of the handle (5552) drives corresponding movement of the clamping arm (5540). It should also be understood that, when the clamping pad stop (5576) is used, the clamping pad (5546) is prevented from disengaging from the clamping arm (5546) by engaging with the clamping pad stop (5576) and the proximal surface (5548) of the clamping arm (5544).

[0035] Next, as FIG. 9As shown, the ultrasonic blade (5542) can be inserted through the cavity (5555) defined by the laterally opposing side walls (5558) and the clamp arm support surface (5570) until both the sheath coupling through hole (5564) of the clamp arm (5552) and the pivot through hole (5574) of the handle (5552) are aligned with the pivot coupling body (5536) of the outer sheath (5532). Next, in accordance with the description herein, the pivot pin (5556) is inserted through the pivot through hole (5574) of the handle (5552), the sheath coupling through hole (5564) of the clamp arm (5544), and the pivot coupling body (5536) of the sheath (5532) so as to pivotally couple the handle (5552) and the clamp arm (5552) with the outer sheath (5532). Once pivotally coupled, the handle (5552) and the clamp arm (5544) can pivot relative to the sheath (5532) and the ultrasonic blade (5542) so as to properly grasp tissue, in accordance with the description herein. It will be appreciated that the pin (5556) is sized to properly engage the sheath coupling through hole (5564) of the clamp arm (5544) and the pivot coupling body (5536) of the outer sheath (5532), thereby facilitating alignment between the clamp arm (5544) and the ultrasonic blade (5542) by reducing cumulative tolerance stack-up during assembly of the instrument (5500). The location of the pivot coupling body (5536) allows the clamp arm (5544) to be directly pivotally coupled with the outer sheath (5532) without having to further modify the clamp arm (5544).

[0036] FIG. 11 An exemplary ultrasonic surgical instrument (5600) that can be used in place of the ultrasonic surgical instrument (100) described above is shown. Thus, the ultrasonic surgical instrument (5600) is substantially similar to the instrument (100) described above, but for the differences detailed herein. The instrument (5600) includes a handle assembly (5620), a shaft assembly (5630), an end effector (5640), and a clamp arm assembly (5650); which can be substantially similar to the handle (120), the shaft assembly (130), the end effector (140), and the clamp arm assembly (150), but for the differences detailed herein.

[0037] As will be described in more detail below, the clamping arm (5644) of the end effector (5640) and the shank (5652) of the clamping arm assembly (5650) are separate components joined together during the assembly of the instrument (5600). As will be described in more detail below, the clamping arm (5644) is configured to be adjustable relative to the shank (5652) before attachment relative to the shank (5652), thereby allowing the clamping arm (5644) to be properly aligned with the ultrasonic scalpel (5642) after the shank (5652) is pivotally coupled to the outer sheath (5632) of the shaft assembly (5630). After the handle (5652) is pivotally coupled to the shaft assembly (5630), the customizable adjustability of the clamping arm (5644) relative to the handle (5652) reduces the cumulative tolerance stack-up and further facilitates the alignment (longitudinal and / or lateral) of the clamping arm (5644) / clamping pad (5646) with the ultrasonic scalpel (5642).

[0038] The handle assembly (5620) includes a body (5622), a finger grip ring (5624), and a button (5626); these may be substantially similar to the body (122), finger grip ring (124), and button (126) described above. Although not shown, it should be understood that the body (5622) may be suitably coupled to the ultrasonic transducer assembly (112) (similar to the body (122) described above) such that the ultrasonic transducer assembly (112) may suitably transmit ultrasonic vibrations to the ultrasonic waveguide (5638) and ultrasonic scalpel (5642) as described above. The shaft assembly (5630) includes an outer sheath (5632), a cover (5634), and an ultrasonic waveguide (5638); these may be substantially similar to the sheath (132), cover (134), and ultrasonic waveguide (138) described above, but with differences detailed below. The sheath (5632) of the current example includes a pivoting member (not shown) that can be substantially similar to the pivoting member body (5536) described above. Thus, unlike the fins (136) of the sheath (132) described above, the pivoting member (not shown) extends in a downward direction away from the outer sheath (5632) in a proximal portion away from the shank (5652).

[0039] The gripping arm assembly (5650) includes a handle (5652) and a thumb ring grip (5654); they may be substantially similar to the handle (152) and thumb ring grip (154) described above, but with the differences detailed herein. The handle (5652) and thumb ring grip (5654) may be formed from a suitable material such as plastic. [Go to...] FIG. 12The distal end of the handle (5652) includes a pair of laterally-opposed sidewalls (5658) that define a cavity (5655). The laterally-opposed sidewalls (5658) and the cavity (5655) can be substantially similar to the laterally-opposed sidewalls (158) and the cavity (155) described above, but with the differences detailed herein. Thus, when the instrument (5600) is assembled, the cavity (5655) is sized to properly house a portion of the outer sheath (5632). At least one of the sidewalls (5558) defines a through-hole (5674) that is sized to receive the pivot pin (5656) to pivotally couple the handle (5652) to the outer sheath (5632).

[0040] The clamp arm (5644) includes an elongated coupling body (5660). The clamp arm (5644) can be formed of a suitable second material, such as a metallic material. Thus, in some instances, the handle (5652) can be formed of a first material (e.g., a plastic material) having desired properties for the handle (5652), while the clamp arm (5644) can be formed of a second material (e.g., a metallic material) having desired properties for the clamp arm (5644). As will be described in greater detail below, the clamp arm coupling body (5660) is sized to fit within a clamp arm cavity (5686) defined by a clamp arm mounting support (570) of the handle (5652).

[0041] The distal end of the handle (5652) further includes a clamp arm mounting support (5670) that extends between the laterally-opposed sidewalls (5658) and also defines a portion of the cavity (5655). When the handle (5652) is pivotally coupled to the outer sheath (5632) in accordance with the description herein, the clamp arm mounting support (5670) is positioned adjacent to an underside of the outer sheath (5632). In other words, the clamp arm mounting support (5670) is positioned adjacent to a portion of the outer sheath (5632) associated with the pivot coupling (not shown).

[0042] The clamp arm mounting support (5670) includes a base (5680) and a weld plate (5682). In some instances, the weld plate (5682) can be secured and fastened to the base (5680), such as via an overmolding process. Turning to FIG. 15The weld plate (5682) defines a pivot opening (5685) sized to receive the pivot pin (5656). Thus, the weld plate (5782) is configured to be directly pivotably coupled to the outer sheath (5632). The base (5680) can be formed of the same material as the handle (5652). Thus, in the current example, the base (5680) is formed of a plastic material. The weld plate (5682) is formed of a suitable material (such as a metallic material) configured to be fastened to the elongated coupling body (5660) of the clamp arm (5644) via welding.

[0043] The clamp arm mounting support (5670) defines a clamp arm cavity (5686) sized to receive the elongated coupling body (5660) of the clamp arm (5644). As FIGS. 13-15 As best shown, the weld plate (5682) and the base (5680) define a weld window (5684). When the elongated coupling body (5660) of the clamp arm (5644) is properly inserted into the clamp arm cavity (5685), a portion of the elongated coupling body (5660) can enter via the weld window (5684).

[0044] The clamp arm mounting support (5670) is sized to receive and support the elongated coupling body (5660) of the clamp arm (5644). During assembly, the proximal end of the clamp arm (5644) can be properly aligned with the clamp arm mounting support (5670) and then inserted proximally into the range of the clamp arm cavity (5686). Prior to welding to the weld plate (5682) in accordance with the description herein, the elongated coupling body (5660) can be adjusted within the clamp arm cavity (5686) relative to the clamp arm mounting support (5670) so that the clamp arm (5644) can be positioned in proper alignment with the ultrasonic blade (5642). Prior to welding the clamp arm (5644) to the weld plate (5682), the clamp arm (5644) can be positioned relative to the clamp arm mounting support (5670) via rotation about one or more suitable axes, translation along one or more suitable paths, and / or a combination of rotation and translation along any suitable path, which will be apparent to those of skill in the art in view of the teachings herein. Once the clamp arm (5644) is positioned in proper alignment with the ultrasonic blade (5642), the elongated coupling body (5560) is then permanently fastened (e.g., via welding) relative to the clamp arm support (5670). It will be appreciated that the weld window (5684) provides access for securing the elongated coupling body (5560) to the clamp arm support (5670).

[0045] Accordingly, during assembly, the weld windows (5684), the weld plates (5682), and the elongate coupling body (5660) are configured to reduce the cumulative tolerance stack-up during assembly of the instrument (5600) to facilitate proper alignment between the clamp arm (5644) / clamp pad (5646) and the ultrasonic blade (5642) during exemplary use of the instrument (5600) according to the description herein. The weld windows (5684), the weld plates (5682), and the elongate coupling body (5666) act as a clamp arm alignment structure to facilitate proper alignment of the clamp arm (5644) / clamp pad (5645) and the ultrasonic blade (5642) when the clamp arm (5644) is in the closed position.

[0046] III. Clamping Arms for Surgical Instruments with Adjustable Coupling Stability and Related Methods It can be beneficial to include an adjustable compression pivot mechanism between the clamp arm assembly (150) and the shaft assembly (130) to achieve a selectable amount of friction at the pivot point of the pin (156). By increasing the compression, the frictional resistance of the pivoting clamp arm assembly (150) relative to the shaft assembly (130) at the pivot point of the pin (156) can be increased. By decreasing the compression, the frictional resistance of the pivoting clamp arm assembly (150) relative to the shaft assembly (130) at the pivot point of the pin (156) can be decreased. A manufacturer-set compression allows for custom adjustment of each assembly to a particular compression with a coefficient of friction regardless of the tolerance combination on the clamp arm and pivot shaft. Controlling the pivot frictional resistance between the clamp arm assembly (150) and the shaft assembly (130) can provide the user with real-time mechanical feedback during exemplary use of the instrument (100), which improves the perception of the device. Examples of such pivot mechanisms are detailed below, which can be incorporated in whole or in part into one or more of the surgical instruments described herein, such as the surgical instrument (100).

[0047] FIG. 16 A cross-sectional view of a pivot mechanism (4100) that can be readily incorporated into the instruments (100, 5500, 5600) described above is depicted. The pivot mechanism (4100) includes a handle (4152), an outer sheath (4132) having a fin (4136), and a pin (4156); they can be readily incorporated into the instrument (100) to replace the handle (152), the outer sheath (132), the fin (136), and the pin (156) described above, respectively. Accordingly, the handle (4252), the outer sheath (4232), the fin (4236), and the pin (4256) can be substantially similar to the handle (152), the outer sheath (132), the fin (136), and the pin (156) described above, respectively, but with the differences detailed herein.

[0048] Pin (4156) pivotally couples handle (4152) with outer sheath (4132). Pin (4156) includes a shoulder (4161) that is configured to compress against a side surface of either handle (4152) or fin (4136) of outer sheath (4132). Pivot mechanism (4100) further includes a bushing (4157) that is configured to be inserted over an end of pin (4156) opposite first shoulder (4161) during assembly. Specifically, bushing (4157) is configured to be inserted over pin (4156) toward shoulder (4161) such that bushing (4157) engages a side surface of either handle (4152) or fin (4136) that is not engaged by shoulder (4161) of pin (4156) when handle (4152) and outer sheath (4132) have been pivotally coupled via pin (4156). In other words, bushing (4157) is inserted over pin (4156) such that bushing (4157) and shoulder (4161) compress the surfaces of fin (4136) and handle (4152) toward each other, thereby customizing the frictional resistance to pivoting handle (4152) relative to outer sheath (4132).

[0049] Once a suitable frictional resistance is created based on the spacing of bushing (4157) relative to pin (4156), bushing (4157) can be welded to pin (4156) in order to control the pivot frictional resistance between handle (4152) and outer sheath (4132). Additionally, the size / placement of bushing (4157) can be selected in order to properly align clamp pad (146) with ultrasonic blade (142) during assembly in accordance with the teachings herein. In other words, the outer radius of bushing (4157) and / or the radial position of bushing (4157) relative to pin (4156) can be selected in order to properly space handle (4152) relative to outer sheath (4132) such that clamp pad (146), which is attached to handle (4152), and ultrasonic blade (142), which is properly attached to outer sheath (4132), are properly aligned.

[0050] FIG. 17A cross-sectional view of another pivot mechanism (4200) that can be readily incorporated into the instruments (100, 5500, 5600) described above is depicted. The pivot mechanism (4200) includes a handle (4252), an outer sheath (4232) having fins (4236), and a pin (4256); they can be readily incorporated into the instrument (100) to replace the handle (152), the outer sheath (132), the fins (136), and the pin (156) described above, respectively. Thus, the handle (4252), the outer sheath (4232), the fins (4236), and the pin (4256) can be substantially similar to the handle (152), the outer sheath (132), the fins (136), and the pin (156) described above, respectively, but with the differences detailed herein.

[0051] The pivot mechanism (4200) in the current example includes two bushings (4257) on opposite ends of the pin (4156). The bushings (4257) together function in a substantially similar manner as the shoulder (4161) and the bushing (4157) described above. Thus, after the handle (4252) and the outer sheath (4232) are pivotally coupled via the pin (4156), each bushing (4257) can be advanced along the opposite end of the pin (4256) in order to compress portions of the outer sheath (4232) and the handle (4252) toward one another, thereby customizing the frictional resistance to pivoting the handle (4252) relative to the outer sheath (4232). Once a suitable frictional resistance is generated based on the spacing of the bushings (4257) relative to the pin (4256), the handle (4252), and the outer sheath (4232), the bushings (4257) can be welded to the pin (4256) in order to control the pivot frictional resistance between the handle (4252) and the outer sheath (4232). Additionally, the size / placement of the bushings (4257) can be selected in order to properly align the clamp pad (146) with the ultrasonic blade (142) during assembly in accordance with the teachings herein. In other words, the outer radius of the bushings (4257) and / or the radial position of the bushings (4257) relative to the pin (4256) can be selected in order to properly space the handle (4252) relative to the outer sheath (4232) such that the clamp pad (146), which is attached to the handle (4252), and the ultrasonic blade (142), which is properly attached to the outer sheath (4232), are properly aligned.

[0052] FIG. 18Another pivot mechanism (4000) is depicted that can be readily incorporated into the instruments (100, 5500, 5600) described above. The pivot mechanism (4000) includes a handle (4052) having lateral walls (4058), a clamp arm (4044), an outer sheath (4032) having fins (4036), and a pin (4056); they can be readily incorporated into the instrument (100) to replace the handle (152), lateral walls (158), clamp arm (144), outer sheath (132), fins (136), and pin (156), respectively, described above. Thus, the handle (4052), clamp arm (4044), outer sheath (4032), fins (4036), and pin (4056) can be substantially similar to the handle (152), clamp arm (144), outer sheath (132), fins (136), and pin (156), respectively, described above, but with the differences detailed herein.

[0053] The handle (4052) is configured to pivot relative to the outer sheath (4032). The laterally-opposed lateral walls (4058) include inner surfaces (4015) that are directly adjacent to the respective lateral walls of the outer sheath (4032). The outer sheath (4032) and the laterally-opposed lateral walls (4058) can be different materials having different wear characteristics, such as metal and plastic, respectively. The outer sheath (4032) can be configured to fit within the extent of the laterally-opposed lateral walls (4058) such that there is an interference fit along the contact surfaces (4015) of the laterally-opposed lateral walls (4058) and the respective lateral walls of the outer sheath (4032). The interference fit can be a "low level" such that the handle (4052) can still pivot relative to the outer sheath (4032). Because the outer sheath (4032) and the opposed lateral walls (4058) are made of materials having different wear characteristics, the frictional resistance created by the "low level" interference between the laterally-opposed lateral walls (4058) and the outer sheath (4032) can slightly remove portions of the opposed lateral walls (5058) in response to repeatedly and rapidly pivoting the handle (4052) relative to the outer sheath (4032). Removing portions of the opposed lateral walls (5058) can then reduce the frictional resistance of pivoting the handle (4052) relative to the outer sheath (4032), effectively adjusting (e.g., controlling the level of) the frictional resistance of pivoting the handle (4052) relative to the outer sheath (4032).

[0054] The interference fit can remove any lateral clearance between the opposed lateral walls (4058) and the outer sheath (4032) such that there can be no lateral movement between the two components, causing increased alignment between the clamp pad (146) and the ultrasonic blade (142).

[0055] Additional mechanisms for adjustment include forming voids on the inner side of the contact surface (4015) in addition to small radial extrusion ribs (not shown), or measuring and sorting various outer shrouds (4032) relative to the plastic component.

[0056] FIG. 20 A cross-sectional view of another pivot mechanism (4300) that can be readily incorporated into the instruments (100, 5500, 5600) described above is depicted, FIGS. 19A-19B A cross-sectional view of the pin (4356) of the pivot mechanism (4300) is depicted. The pivot mechanism (4300) includes a handle (4352), an outer shroud with a fin (4336), and a pin (4356); they can be readily incorporated into the instrument (100) to replace the handle (152), the outer shroud (132), the fin (136), and the pin (156) described above, respectively. Thus, the handle (4352), the fin (4336), and the pin (4356) can be substantially similar to the handle (152), the fin (136), and the pin (156) described above, respectively, but with the differences detailed herein.

[0057] As FIGS. 19A-19B As best shown, the pin (4356) includes complementary shafts (4370, 4380) configured to mate with one another to adjust the overall length of the pin (4356). The first shaft (4370) includes an inner elongated member (4374) sized to fit within a complementary opening (4286) defined by an outer elongated member (4384) of the second shaft (4380). The inner elongated member (4374) can be suitably positioned within the range of the complementary opening (4286) such that the inner elongated member (4374) and the outer elongated member (4384) cooperatively allow the overall length of the pin (4356) to be adjusted (prior to being secured together according to the description herein). Each shaft (4370, 4380) also includes a flange (4374, 4384). The flanges (4374, 4384) exert a compressive force on the fin (4336) and the handle (4352) such that adjustment of the length of the pin (4356) can suitably adjust the frictional resistance of the pivoting handle (4352) relative to the fin (4336) of the outer shroud.

[0058] During assembly, the shafts (4370, 4380) are inserted into aligned pin openings (4335) defined by the fins (4336) of the outer sheath and the handle (4352) at opposite ends such that the inner elongated member (4374) is properly housed within the outer elongated member (4384). The overall length of the pin (4356) is adjusted so that the flanges (4374, 4384) exert a desired amount of compressive force between the fins (4336) and the handle (4352), thereby creating a desired amount of frictional pivot resistance. Once the desired amount of compressive force is generated, the shafts (4370, 4380) are welded together, thereby fixing the distance between the shafts (4370, 4380). In some cases, a bearing washer (4360) is interposed between the flanges (4374, 4384) and the handle (4352) to ensure that an appropriate amount of frictional pivot resistance is generated.

[0059] FIGS. 21-22 Another pivot mechanism (4600) that can be readily incorporated into the instruments (100, 5500, 5600) described above is depicted, including a pin (4656), a handle (4644), and an outer sheath (4632). The pivot mechanism (4600) includes a handle (4644), an outer sheath (4632), and a pin (4656); they can be readily incorporated into the instrument (100) to replace the handle (152), the outer sheath (132), and the pin (156) described above, respectively. Thus, the handle (4652), the outer sheath (4632), and the pin (656) can be substantially similar to the handle (152), the outer sheath (132), and the pin (156) described above, respectively, but with the differences detailed herein.

[0060] The outer sheath (4632) includes a threaded opening (4765) in communication with the pin (4656). The pin (4656) can be fastened (such as welded or adhered) to the handle (4644) at opposite ends. As FIG. 22As shown, a set screw (4680) can be threaded into the threaded opening (4675) to thereby exert a force on the pin (4656). The force exerted on the pin (4656) by the set screw (4680) can exert a frictional force on the pin (4656). The force exerted by the set screw (4680) can be selectively adjusted by advancing or retracting the set screw (4680) within the threaded opening (4765). With the set screw (44680) threadably attached to the outer sheath (4632 via the threaded opening (4675) and the pin (4656) secured to the handle (4644), the frictional force generated by the engagement between the set screw (4680) and the pin (4656) adjusts the frictional resistance to pivoting the handle (4644) relative to the outer sheath (4632). Thus, the frictional resistance to pivoting the handle (4644) relative to the outer sheath (4632) can be adjusted to a desired amount. The set screw (4680) can include a tip (4682) of a different material than the rest of the set screw (4680). The tip (4682) can include nylon.

[0061] FIG. 23 An alternative set screw (4780) is depicted having a cup shape proximate the pin (4656) that is configured to exert a frictional force on the pin (4656).

[0062] FIG. 24 An alternative clamp arm assembly (4844) is depicted that can be readily incorporated into the instruments (100, 5500, 5600) described above in place of the clamp arm assemblies (150, 5550, 5650). Thus, the clamp arm assembly (4844) can be substantially similar to the clamp arm assemblies (150, 5550, 5650) described above, but with the differences detailed herein. In particular, the clamp arm assembly (4844) has a compliance variation along the length of the handle (4852). In other words, some longitudinal sections of the handle (4852) can be stiffer (i.e., less easily elastically deflected in response to grasping tissue in accordance with the teachings herein), while other longitudinal sections can be more compliant (i.e., more easily elastically deflected in response to grasping tissue in accordance with the teachings herein). Controlling the compliance variation along the length of the handle (4852) can allow for a controlled deflection profile during illustrative use in accordance with the description herein.

[0063] The clamp arm assembly (4844) can include a thumb grip ring (4854), a clamp tip (4846), a handle (4852), and a pin aperture (4856). To achieve variable compliance along the handle (4852) when an operator exerts a force on the thumb grip ring (4854), the handle (4852) can include regions of varying compliance. FIG. 25depicts a cross-sectional view of segment A-A of FIG. 24 Region (4890) without reinforcing ribs can be a high compliance region, region (4892) with closely packed ribs can be a low compliance region, and region (4894) with spaced apart ribs can be a medium compliance region relative to regions (4890, 4892).

[0064] FIG. 26 depicts a side view of a second clamping arm assembly (4944) substantially similar to the clamping arm assembly (4844) described above, but with differences detailed herein. The clamping arm (4944) includes a thumb grip ring (4954), a handle (4952), and a pin hole (4956), which can be substantially similar to the thumb grip ring (5854), handle (4852), and pin hole (4856) described above, but with differences detailed below. Specifically, the handle (4952) is porous along a desired longitudinal segment, such that more porous regions can be more compliant compared to less porous regions, rather than having ribs dictate a level of compliance with varying degrees of compliance. The porosity can vary along the handle (4952).

[0065] FIG. 27 depicts a perspective view of a fifth pivot mechanism (4400) including an outer sheath (4432) with a pin (4456). The pin (4456) can be integral with the outer sheath (4432) at initial production of the outer sheath (4432), or can be included later, and can include a radius between a sidewall of the outer sheath (4432) and the pin (4456). FIG. 28A depicts a side view of a clamping arm (4444), and FIG. 28B depicts a cross-sectional view (section A) of a portion of the clamping arm (4444) having a counterbore (4480) and a channel (4482). The channel (4482) can be configured to allow the pin (4456) to be turned during assembly toward a direction in axial alignment with the counterbore (4480). Once the pin (4456) and the counterbore (4480) are in axial alignment, as FIG. 29 shown, a lateral end of the pin (4456) can be heated or pressed, thereby forming a mushroom in a counterbore portion of the counterbore (4480), as FIG. 30 shown.

[0066] FIGS. 31-32 depicts a cross-sectional view of a sixth pivot mechanism (4500) including a pin (4556), a clamping arm (4544), and an outer sheath (4532). As FIG. 31As shown, the pin (4556) can have opposing tapered mandrels (4580) pointing into the hole of the pin (4556) to flare the ends of the pin (4556). With the flared ends of the pin (4556), the pin (4556) can be fastened to the clamp arm (4544). The pin (4556) can also be press fit into the outer sheath (4532) to provide a friction fit between the outer sheath (4532) and the clamp arm (4544). The tapered mandrels (4580) can be hollow and can be positioned into the hollow hole of the pin (4556) as shown by the arrows. FIG. 32 A pin (4556) in a flared configuration is depicted.

[0067] In an alternative embodiment (not shown), a partially slotted pin can be included in place of the pin (4556). The tapered mandrels (4580) can be changed to wedges instead of tapers to flare the ends of the pin.

[0068] In another alternative embodiment (not shown), a hollow tube geometry or a slotted pin geometry can be present on one side of a flanged pin.

[0069] FIG. 33 A side view of a clamp arm assembly (5050) including a clamp arm (5044), a thumb grip (5054), a handle (5052), and a sleeve (5080) is depicted. The clamp arm (5044) and the thumb grip (5054) can be made of different materials and processes. The sleeve (5052) can be used to couple the clamp arm (5044) and the thumb grip (5054) along the handle (5052). The sleeve (5052) can be a cylindrical tube that will be hardened and / or shrunk around the clamp arm (5044) and the thumb grip (5054) to couple the two. The sleeve (5052) can also be made of metal and adhered to the thumb grip (5054) and the clamp arm (5044) to couple the two.

[0070] FIG. 34 A side view of an ultrasonic surgical instrument (5100) with a handle assembly (5120) and another clamp arm assembly (5150) is depicted. The handle assembly (5120) can include an outer sheath (5132) and an ultrasonic blade (5142). The clamp arm assembly (5150) can include a clamp arm (5144), a thumb grip ring (5154), a pin (5156), and a joint (5180). The joint (5180) can be adjustable to change the angle (Θ) between the thumb grip ring (5154) and the handle assembly (5120).

[0071] As FIG. 35As shown, the thumb grip ring (5154) and the clamping arm (5144) can be laser welded together, heat-riveted, or pinned to form a joint (5180). FIG. 36 As shown, the thumb grip ring (5154) and the clamping arm (5144) may include a pin (5182) along the longitudinal axis and having a modulus of construction, thereby controlling the amount of deflection between the thumb grip ring (5154) and the clamping arm (5144). FIG. 37 As shown, the thumb grip ring (5154) may include a rough ball, and the clamping arm (5144) may include a recess. A metal ring (5184) may be welded to either or both of the thumb grip ring (5154) and the clamping arm (5144).

[0072] FIG. 38 An exploded perspective view of an ultrasonic surgical instrument (5200) having a handle assembly (5220) and another clamping arm assembly (5250) is depicted. The handle assembly (5220) may include an outer sheath (5232) and an ultrasonic scalpel (5242). The clamping arm assembly (5250) may include a clamping arm (5244), a thumb grip (5254), and a pin (5256). The pin (5256) may be a track rivet configured to apply frictional force to the clamping arm (5244) and the outer sheath (5232). The clamping arm (5244) may be metal injection molded (MIM) and may be assembled or overmolded to the thumb grip (5254). The clamping tip (5246) may be a MIM, which may be a secondary MIM with a constant radius keyway configured to engage a clamping pad.

[0073] like FIGS. 38-44 As shown, the clamping tip (5246) can be attached to the clamping arm (5244) by sliding the proximal end of the clamping tip (5246) into the cavity of the clamping arm (5244). During assembly, the ultrasonic scalpel (5242) can be aligned with the clamping tip (5246), and then the cap (5290) can be welded to the clamping arm (5244) to secure / lock the clamping tip (5246) in place for consistent alignment.

[0074] FIG. 45 A clamping arm (5344) comprising a clamping tip (5346) and a clamping pad (5348) is depicted. The clamping tip (5346) may be metal, such as stainless steel, and the clamping pad (5348) may be bonded to the clamping tip (5346) using a PTFE pretreatment and an adhesive. A pretreatment may be applied, and the adhesive may be applied within an application window after an appropriate curing time. The pretreatment may include sodium ammonia etching, plasma etching, and a PTFE primer.

[0075] FIGS. 46-49A clamp arm (5444) is shown that includes a clamp tip (5446), a clamp pad (5448), and a carrier (5480). The clamp tip (5446) can include a T-shaped slot configured to receive the clamp pad (5448). The carrier (5480) can be stamped metal and can include a spring configured to lock the clamp pad (5448) into the clamp tip (5446), thereby preventing the clamp pad (5448) from exiting. The carrier (5480) can also be welded to the clamp tip (5446), thereby preventing the clamp pad (5448) from exiting.

[0076] IV. Exemplary Combinations The following embodiments relate to various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that neither the following embodiments nor the aspects or features thereof are exhaustive of the coverage or spirit of any claims that can be filed in the future. No disclaimer is intended. The following embodiments are provided only as examples of how the teachings herein can be combined or applied. It should be understood that various teachings herein can be combined in many different ways to yield additional embodiments. Also, additional embodiments can be obtained by making reasonable variations to the embodiments provided herein. Thus, the following embodiments are not intended to be exhaustive, but rather are intended to be representative of the various ways in which the teachings herein can be applied. Any additional claims that can be filed later that contain additional features or aspects not expressly mentioned in the following embodiments are not intended to be disclaimed. The following embodiments are provided only as examples of how the teachings herein can be combined or applied.

[0077] Example 1 A surgical instrument comprising: (a) an end effector comprising: (i) an ultrasonic blade, and (ii) a clamp arm configured to pivot relative to the ultrasonic blade between an open position and a closed position, wherein the clamp arm comprises an elongate coupling body; (b) a shaft assembly comprising: (i) an outer sheath, and (ii) an ultrasonic waveguide secured relative to the outer sheath, wherein the ultrasonic waveguide is at least partially housed within the outer sheath; (c) a handle attached to the clamp arm, wherein the handle is configured to pivot relative to the shaft assembly to drive the clamp arm between the open position and the closed position, wherein the handle comprises a clamp arm support configured to receive the elongate coupling body of the clamp arm to assist in attaching the clamp arm to the handle; and (d) a clamp arm alignment structure configured to facilitate alignment of the clamp arm relative to the ultrasonic blade in the closed position.

[0078] Example 2 The surgical instrument of Example 1, wherein the clamp arm alignment structure comprises: (a) a pivot coupling body located on the outer sheath; (b) a through hole defined by the elongate coupling body of the clamp arm; and (c) a pin configured to pivotally couple the clamp arm and the outer sheath together directly via the pivot coupling body of the outer sheath and the through hole defined by the elongate coupling body.

[0079] Example 3 The surgical instrument of Example 2, wherein the handle extends proximally away from the end effector along a first side of the outer sheath, wherein the pivot coupling body is located on a second side of the outer sheath.

[0080] Example 4 The surgical instrument of Example 3, wherein the first side and the second side face away from each other.

[0081] Example 5 The surgical instrument of any one or more of Examples 2-4, wherein the handle is attached to the clamp arm via a second pin that extends through a second through hole defined by the elongate coupling body to the clamp arm and through a sidewall of the handle.

[0082] Example 6 The surgical instrument of Example 5, wherein the end effector further comprises a clamp pad coupled to the clamp arm.

[0083] Example 7 The surgical instrument of Example 6, wherein the handle further comprises a clamp pad lock configured to inhibit actuation of the clamp pad in a proximal direction relative to the clamp arm when the clamp arm is attached to the handle.

[0084] Example 8 The surgical instrument of Example 1, wherein the clamp arm alignment structure comprises a weld plate associated with the clamp arm support of the handle.

[0085] Example 9 The surgical instrument of Example 8, wherein the weld plate is configured to receive the elongate coupling body of the clamp arm.

[0086] Example 10 The surgical instrument of Example 9, wherein the weld plate defines a weld window such that the elongate coupling body of the clamp arm is configured to be fastened to the weld plate after initial insertion into the clamp arm support.

[0087] Example 11 The surgical instrument of Example 10, wherein the elongate coupling body is configured to be adjusted relative to the weld plate prior to fastening to the weld plate.

[0088] Example 12 The surgical instrument of Example 11, wherein the weld plate is directly pivotally coupled to the outer sheath via a pin.

[0089] Example 13 The surgical instrument of any one or more of Examples 1-12, further comprising a handle assembly, wherein the shaft assembly extends distally from the handle assembly.

[0090] Example 14 The surgical instrument of Example 13, wherein the handle assembly comprises a transducer assembly.

[0091] Example 15 The surgical instrument of Example 14, wherein the handle assembly comprises a button configured to activate the transducer.

[0092] Example 16 A surgical instrument comprising: (a) an acoustic waveguide; (b) an end effector comprising: (i) an ultrasonic blade in acoustic communication with the acoustic waveguide, (ii) a clamp arm, (iii) an outer sheath; and (iv) a hinge configured to pivotably couple the clamp arm to the outer sheath; the hinge configured to selectively resist pivoting.

[0093] Example 17 The surgical instrument of Example 16, the hinge configured to apply a frictional force to thereby selectively resist pivoting.

[0094] Example 18 The surgical instrument of Example 16, the hinge comprising a first shaft and a second shaft, the first shaft comprising a flange, the second shaft comprising a flange, a portion of the first shaft configured to fit inside a portion of the second shaft to secure the clamp arm to the outer sheath.

[0095] Example 19 The surgical instrument of Example 16, the hinge comprising a pin and a set screw configured to apply a frictional force to the pin.

[0096] Example 20 A surgical instrument comprising: (a) an acoustic waveguide; (b) an end effector comprising: (i) an ultrasonic blade in acoustic communication with the acoustic waveguide, (ii) a clamp arm comprising a shaft comprising variable compliance along a length, (iii) an outer sheath; and (iv) a hinge configured to pivotably couple the clamp arm to the outer sheath.

[0097] Example 21 A surgical instrument comprising: (a) an acoustic waveguide; (b) an end effector comprising: (i) an ultrasonic blade in acoustic communication with the acoustic waveguide, (ii) a clamp arm, (iii) an outer sheath; and (iv) a hinge configured to pivotably couple the clamp arm to the outer sheath; the hinge configured to selectively resist pivoting.

[0098] Example 22 The surgical instrument of Example 21, the hinge configured to apply a frictional force to selectively resist pivoting.

[0099] Example 23 The surgical instrument of any one or more of Examples 21-22, the hinge comprising a pin and a bushing, the pin configured to couple to the bushing to secure the clamp arm to the outer sheath.

[0100] Example 24 The surgical instrument of any one or more of Examples 21-23, the pin comprising a flange configured to contact a sidewall of the clamp arm and a shoulder configured to contact a sidewall of the outer sheath.

[0101] Example 25 The surgical instrument of any one or more of embodiments 21-24, the bushing comprising a first bushing, the hinge further comprising a second bushing, the first and second bushings positioned on respective opposite ends of the pin.

[0102] Example 26 The surgical instrument of any one or more of embodiments 21-25, the first and second bushings secured to the pin via a weld.

[0103] Example 27 The surgical instrument of any one or more of embodiments 21-26, the hinge comprising a first shaft and a second shaft, the first shaft comprising a flange, the second shaft comprising a flange, a portion of the first shaft configured to fit inside a portion of the second shaft, thereby securing the clamp arm to the outer sheath.

[0104] Example 28 The surgical instrument of any one or more of embodiments 21-27, the hinge comprising a splay portion configured to secure the clamp arm to the outer sheath.

[0105] Example 29 The surgical instrument of any one or more of embodiments 21-28, the hinge comprising a pin and a set screw configured to apply a frictional force to the pin.

[0106] Example 30 A surgical instrument comprising: (a) an acoustic waveguide; (b) an end effector comprising: (i) an ultrasonic blade in acoustic communication with the acoustic waveguide, (ii) a clamp arm comprising a shaft comprising variable compliance along a length, (iii) an outer sheath; and (iv) a hinge configured to pivotably couple the clamp arm to the outer sheath.

[0107] Example 31 The surgical instrument of embodiment 30, the shaft comprising a hollow portion.

[0108] Example 32 The surgical instrument of any one or more of embodiments 30-31, the shaft comprising a strut through the hollow portion.

[0109] Example 33 The surgical instrument of any one or more of embodiments 30-32, the struts are unevenly distributed throughout the hollow portion, thereby varying the compliance along the length.

[0110] Example 34 The surgical instrument of any one or more of embodiments 30-33, the shaft has a variable porosity, thereby varying the compliance along the length.

[0111] Example 35 The surgical instrument of any one or more of embodiments 30-34, the shaft includes a sleeve configured to vary the compliance of the shaft along the length.

[0112] Example 36 The surgical instrument of any one or more of embodiments 30-35, the shaft includes a joint configured to vary an angle of use between the clamp arm and the outer sheath.

[0113] Example 37 The surgical instrument of any one or more of embodiments 30-36, the joint includes a ball and socket configured to vary the angle of use.

[0114] Example 38 A surgical instrument comprising: (a) an acoustic waveguide; (b) an end effector comprising: (i) an ultrasonic blade in acoustic communication with the acoustic waveguide, (ii) a clamp arm comprising a clamp tip comprising a clamp pad affixed to the clamp tip by one of an adhesive or a spring clip, (iii) an outer sheath; and (iv) a hinge configured to pivotably couple the clamp arm to the outer sheath.

[0115] Example 39 The surgical instrument of embodiment 38, the clamp pad is affixed to the clamp tip by the adhesive.

[0116] Example 40 The surgical instrument of any one or more of embodiments 38-39, the clamp pad is affixed to the clamp tip by the spring clip.

[0117] Example 41 The surgical instrument of any one or more of embodiments 38-40, the spring clip is configured to press against a dimple of the clamp tip to thereby attach the clamp pad to the clamp tip.

[0118] Example 42 A surgical instrument comprising: (a) a shaft assembly comprising: (i) an outer sheath, and (ii) an ultrasonic waveguide secured relative to the outer sheath, wherein the ultrasonic waveguide is at least partially housed within the outer sheath; (b) an end effector comprising: (i) an ultrasonic blade attached to and extending distally from the ultrasonic waveguide, and (ii) a clamp arm configured to pivot relative to the ultrasonic blade between an open position and a closed position, wherein the clamp arm comprises an elongate coupling body defining a handle coupling aperture; (c) a handle comprising a clamp arm support sized to receive the elongate coupling body of the clamp arm to assist in attaching the clamp arm to the handle, wherein the handle defines a clamp arm coupling aperture; (d) a first coupling pin extending through the handle coupling aperture of the clamp arm and the clamp arm coupling aperture of the handle, wherein the handle and the first coupling pin are configured to pivot relative to the shaft assembly to drive the clamp arm between the open position and the closed position; and (e) a clamp arm alignment structure configured to facilitate alignment of the clamp arm relative to the ultrasonic blade in the closed position, wherein the clamp arm alignment structure comprises: (i) a pivot coupling body located on the outer sheath, wherein the pivot coupling body extends away from the outer sheath in a direction away from the handle, (ii) a shaft coupling aperture defined by the elongate coupling body of the clamp arm, and (ii) a second coupling pin configured to pivotally couple the clamp arm and the outer sheath together directly via the pivot coupling body of the outer sheath and the shaft coupling aperture defined by the elongate coupling body.

[0119] V. Miscellaneous It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. The above-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable methods, features, components, and / or functions described herein can be implemented in conformance with the teachings contained in this document. Such modifications and variations are intended to be included within the scope of any claims. Though described in the context of particular embodiments, the methods and procedures described herein can be implemented in conformance with other embodiments and the claims.

[0120] It should be understood that any patents, patent publications, or other publications referred to herein are incorporated by reference to the extent that the incorporated material is not inconsistent with existing definitions, statements, or other disclosure material set forth in the present disclosure. However, in the event that any conflict is deemed to exist between the material being incorporated by reference and that set forth in the present disclosure, then in favour of the material specifically set forth in the present disclosure. Any material, or portion thereof, that is said to be incorporated by reference herein, but which contradicts existing definitions, statements, or other disclosure material set forth in the present disclosure is only incorporated to the extent that the material is not contradictory.

[0121] Versions of the devices described above can have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures. By way of example only, various teachings herein can be readily incorporated into a robotic surgical system such as the DAVINCI® system by Intuitive Surgical, Inc., of Sunnyvale, California. ™System. Similarly, those of ordinary skill in the art will recognize that the various teachings herein can be readily incorporated into any of the following patents: U.S. Patent No. 5,792,135, entitled "Articulated Surgical Instrument For Performing Minimally Invasive Surgery With Enhanced Dexterity and Sensitivity," issued August 11, 1998, the disclosure of which is incorporated by reference herein; U.S. Patent No. 5,817,084, entitled "Remote Center Positioning Device with Flexible Drive," issued October 6, 1998, the disclosure of which is incorporated by reference herein; U.S. Patent No. 5,878,193, entitled "Automated Endoscope System for Optimal Positioning," issued March 2, 1999, the disclosure of which is incorporated by reference herein; U.S. Patent No. 6,231,565, entitled "Robotic Arm DLUS for Performing Surgical Tasks," issued May 15, 2001, the disclosure of which is incorporated by reference herein; U.S. Patent No. 6,783,524, entitled "Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument," issued August 31, 2004, the disclosure of which is incorporated by reference herein; U.S. Patent No. 6,364,888, entitled "Alignment of Master and Slave in a Minimally Invasive Surgical Apparatus," issued April 2, 2002, the disclosure of which is incorporated by reference herein; U.S. Patent No. 7,524,320, entitled "Mechanical Actuator Interface System for Robotic Surgical Tools," issued April 28, 2009, the disclosure of which is incorporated by reference herein;U.S. Patent No. 7,691,098, entitled "Platform Link Wrist Mechanism," issued April 6, 2010, the disclosure of which is incorporated by reference herein; U.S. Patent No. 7,806,891, entitled "Repositioning and Reorientation of Master / Slave Relationship in Minimally Invasive Telesurgery," issued October 5, 2010, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,844,789, entitled "Automated End Effector Component Reloading System for Use with a Robotic System," issued September 30, 2014, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,820,605, entitled "Robotically-Controlled Surgical Instruments," issued September 2, 2014, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,616,431, entitled "Shiftable Drive Interface for Robotically-Controlled Surgical Tool," issued December 31, 2013, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,573,461, entitled "Surgical Stapling Instruments with Cam-Driven Staple Deployment Arrangements," issued November 5, 2013, the disclosure of which is incorporated by reference herein;U.S. Patent No. 8,602,288, entitled "Robotically-Controlled Motorized Surgical End Effector System with Rotary Actuated Closure Systems Having Variable Actuation Speeds," issued December 10, 2013, the disclosure of which is incorporated by reference herein; U.S. Patent No. 9,301,759, entitled "Robotically-Controlled Surgical Instrument with Selectively Articulatable End Effector," issued April 5, 2016, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,783,541, entitled "Robotically-Controlled Surgical End Effector System," issued July 22, 2014, the disclosure of which is incorporated by reference herein; U.S. Patent No. 8,479,969, entitled "Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a Robot," issued July 9, 2013; U.S. Patent Publication No. 8,800,838, entitled "Robotically-Controlled Cable-Based Surgical End Effectors," issued August 12, 2014, the disclosures of which are incorporated by reference herein; and / or U.S. Patent No. 8,573,465, entitled "Robotically-Controlled Surgical End Effector System with Rotary Actuated Closure Systems," issued November 5, 2013, the disclosure of which is incorporated by reference herein.

[0122] Devices of the type described above can be designed to be disposed of after a single use, or they can be designed to be used multiple times. Devices may, in either case or both, 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 and / or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device can be disassembled, and certain identified pieces can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular pieces, some versions of the device can be reassembled for subsequent use either at a reconditioning facility, or by a clinical operator immediately prior to a 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.

[0123] By way of example only, versions described herein can be sterilized prior to, and / or following, a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in the sterile container for later use. A device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0124] Having shown and described various embodiments of the present application, further adaptations and modifications can be made thereto by those of ordinary skill in the art without departing from the scope of the application. Several of such possible modifications have already been mentioned, and others will be apparent to those skilled in the art. For instance, the example embodiments, implementations, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative only and are not intended to be limiting. Accordingly, the scope of the present application should be considered limited only by the following claims.

Claims

1. A surgical instrument, said surgical instrument comprising: (a) An end effector, the end effector comprising: (i) Ultrasonic scalpel, and (ii) A clamping arm configured to pivot relative to the ultrasonic scalpel between an open position and a closed position, wherein the clamping arm includes an elongated connecting body; (b) A shaft assembly, the shaft assembly comprising: (i) outer sheath, and (ii) An ultrasonic conductor, the ultrasonic conductor being secured relative to an outer sheath, wherein the ultrasonic conductor is at least partially contained within the outer sheath. (c) A handle attached to the clamping arm, wherein the handle is configured to pivot relative to the shaft assembly to drive the clamping arm between the open position and the closed position, wherein the handle includes a clamping arm support configured to receive the elongated connecting body of the clamping arm to assist in attaching the clamping arm to the handle; and (d) Clamping arm alignment structure, the clamping arm alignment structure being configured to facilitate alignment of the clamping arm relative to the ultrasonic scalpel in the closed position.

2. The surgical instrument according to claim 1, wherein, The clamping arm alignment structure includes: (a) A pivoting coupling body located on the outer sheath. (b) A through-hole, defined by the elongated connecting body of the clamping arm, and (c) A pin configured to directly pivotally connect the clamping arm to the outer sheath via the pivoting coupling body of the outer sheath and the through hole defined by the elongated coupling body.

3. The surgical instrument according to claim 2, wherein, The handle extends proximally away from the end effector along a first side of the outer sheath, wherein the pivot coupling body is located on a second side of the outer sheath.

4. The surgical instrument according to claim 3, wherein, The first side and the second side are opposite to each other.

5. The surgical instrument according to claim 2, wherein, The handle is attached to the clamping arm via a second pin, which extends through a second through-hole defined by the elongated connecting body to the clamping arm and through the sidewall of the handle.

6. The surgical instrument according to claim 5, wherein, The end effector also includes a clamping pad connected to the clamping arm.

7. The surgical instrument according to claim 6, wherein, The handle also includes a clamping pad lock configured to suppress the clamping pad from actuating in the proximal direction relative to the clamping arm when the clamping arm is attached to the handle.

8. The surgical instrument according to claim 1, wherein, The clamping arm alignment structure includes a welded plate associated with the clamping arm support of the handle.

9. The surgical instrument according to claim 8, wherein, The welding plate is configured to receive the elongated connecting body of the clamping arm.

10. The surgical instrument according to claim 9, wherein, The welding plate defines a welding window such that the elongated connecting body of the clamping arm is configured to be fastened to the welding plate after initial insertion into the clamping arm support.

11. The surgical instrument according to claim 10, wherein, The elongated connecting body is configured to be adjustable relative to the welding plate before being fastened to it.

12. The surgical instrument according to claim 11, wherein, The welding plate is directly pivotally connected to the outer sheath via a pin.

13. The surgical instrument of claim 1, further comprising a handle assembly, wherein, The shaft assembly extends distally from the handle assembly.

14. The surgical instrument according to claim 13, wherein, The handle assembly includes a transducer assembly.

15. The surgical instrument according to claim 14, wherein, The handle assembly includes a button configured to activate the transducer.

16. A surgical instrument, said surgical instrument comprising: (a) Acoustic waveguide; (b) An end effector, the end effector comprising: (i) An ultrasonic scalpel, wherein the ultrasonic scalpel is acoustically connected to the acoustic waveguide. (ii) Clamping arm, (iii) Outer sheath; and (iv) A hinge configured to pivotally connect the clamping arm to the outer sheath, the hinge being configured to selectively resist pivoting.

17. The surgical instrument of claim 16, wherein the hinge is configured to apply frictional forces to selectively resist pivoting.

18. The surgical instrument of claim 16, wherein the hinge includes a first shaft and a second shaft, the first shaft including a flange, the second shaft including a flange, and a portion of the first shaft being configured to engage within a portion of the second shaft to secure the clamping arm to the outer sheath.

19. The surgical instrument of claim 16, wherein the hinge comprises a pin and a retaining screw, the retaining screw being configured to apply a frictional force to the pin.

20. A surgical instrument, said surgical instrument comprising: (a) A shaft assembly, the shaft assembly comprising: (i) outer sheath, and (ii) An ultrasonic conductor, the ultrasonic conductor being secured relative to an outer sheath, wherein the ultrasonic conductor is at least partially contained within the outer sheath. (b) An end effector, the end effector comprising: (i) An ultrasonic scalpel, said ultrasonic scalpel being attached to and extending distally from the ultrasonic conductor, and (ii) A clamping arm configured to pivot relative to the ultrasonic scalpel between an open position and a closed position, wherein the clamping arm includes an elongated connecting body defining a shank connecting through hole; (c) A handle, the handle including a clamping arm support, the clamping arm support being sized to receive the elongated connecting body of the clamping arm to assist in attaching the clamping arm to the handle, wherein the handle defines a clamping arm connecting through hole. (d) A first coupling pin extending through the shank coupling through-hole of the clamping arm and the clamping arm coupling through-hole of the shank, wherein the shank and the first coupling pin are configured to pivot relative to the shaft assembly to drive the clamping arm between the open position and the closed position; and (e) A clamping arm alignment structure configured to facilitate alignment of the clamping arm relative to the ultrasonic scalpel in the closed position, wherein the clamping arm alignment structure includes: (i) A pivoting coupling body located on the outer sheath, wherein the pivoting coupling body extends away from the outer sheath in a direction opposite to the handle. (ii) A shaft connection through-hole, said shaft connection through-hole being defined by the elongated connecting body of the clamping arm, and (ii) A second connecting pin configured to directly pivotally connect the clamping arm to the outer sheath via the pivoting connecting body of the outer sheath and the shaft connecting through hole defined by the elongated connecting body.

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