Medical device

Abstract

A medical device includes a shaft, a beam including a proximal end portion coupled to a distal end portion of the shaft. A body is coupled to the distal end portion of the beam and includes a fluid port. The medical device also includes a shield including a proximal end portion, a distal end portion, and an inner wall between the proximal end portion and the distal end portion of the shield. The distal end portion of the shield is coupled to the body, and the proximal end portion of the shield is located between the distal end portion of the shaft and the body. The inner wall of the shroud defines an interior volume in fluid communication with the fluid port such that fluid introduced into the fluid port flows through the interior volume of the shroud and is proximally directed toward the distal end portion of the shaft.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims the benefit of priority and filing date of U.S. Provisional Patent Application No. 63 / 447,379, filed on February 22, 2023, entitled “MEDICAL INSTRUMENT,” the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0002] Embodiments described herein relate to medical devices, and more particularly, to medical devices adapted for use with teleoperated surgical systems. More particularly, embodiments described herein relate to force-sensing medical devices that include structure that limits the range of motion of a force sensor beam to reduce force sensing artifacts that affect force feedback accuracy, and include cleaning fluid ports and fluid delivery structures adapted to support cleaning of such devices.

[0003] Minimally invasive surgery (MIS) employs medical instruments that can be controlled manually or via handheld or mechanically grounded remotely operated medical systems that operate at least in part with computer assistance ("telesurgical systems"). Many known MIS instruments include a therapeutic or diagnostic end effector (e.g., forceps, cutting tools, or cauterizing tools) mounted on an optional wrist mechanism at the distal end of an elongated shaft. During an MIS procedure, the end effector, optional wrist mechanism, and distal end of the shaft are typically inserted through a small incision or natural orifice to position the end effector at a surgical work site within the patient's body. The optional wrist mechanism can be used to change the position and orientation of the end effector relative to the shaft to perform the desired procedure at the work site. Medical instruments used with telesurgical systems typically include a proximal mechanical structure that is connected to the telesurgical system and receives mechanical force or torque input for driving the instrument wrist and end effector components.

[0004] Force sensing medical devices are known and, in conjunction with associated telesurgery systems, provide a force feedback sensation to a surgeon performing the procedure using these instruments during a MIS procedure. Force feedback increases the surgeon's sense of immersion, realism, and intuition when performing the procedure. Various force sensing instrument architectures are known. In one example architecture, a resiliently flexible beam is coupled between the distal end of an instrument shaft and an operable distal end member of the instrument. A sensor element (e.g., a strain sensor, such as a Wheatstone bridge circuit, a fiber Bragg grating, etc.) mounted on the beam senses an indication of strain in the beam as the beam deflects laterally due to instrument-tissue interaction, and the output from the sensor element serves as input to provide the force feedback sensation to the surgeon.

[0005] Mechanical hard stop structures can be used to limit the lateral deflection of the beam, thereby protecting the beam and sensor elements, as well as limiting the sensed strain used to generate force feedback to the surgeon. However, contact between the beam and the hard stop can cause undesirable strains within the beam. Due to these undesirable strains, the strain sensors on the beam indicate that the strain on the beam does not match the actual strain on the distal end of the instrument, and the force feedback given to the surgeon is incorrect. This situation is further described in U.S. Patent Publication No. 2021 / 0353373, filed on May 17, 2021, entitled "Hard Stop that Produces a Reactive Upon Engagement for Cantilevered-Based Force Sensing," the disclosure of which is incorporated herein by reference. Therefore, improved structures for limiting lateral force sensing beam deflection are desired. In addition, the stiffness of each of the various distal structures of the instrument as they interact is very important for providing effective force feedback to the surgeon.

[0006] Furthermore, reusable surgical instruments must be thoroughly cleaned and sterilized, both externally and internally. Force-sensing instruments present cleaning challenges due to the additional distal force-sensing structure. Similarly, proximal structures present challenges due to the need to limit the ingress of excess cleaning fluid when flushing the interior of the shaft. Therefore, improved structures for cleaning distal, proximal, and intermediate structures of teleoperated medical instruments are desirable. Summary of the Invention

[0007] This summary introduces some aspects of the embodiments described herein to provide a basic understanding. This summary is not an extensive overview of the inventive subject matter and is not intended to identify key or core elements or to delineate the scope of the inventive subject matter.

[0008] In some embodiments, a medical device includes an inner shaft, an outer shaft, and a beam. A proximal portion of the beam is coupled to a distal portion of the inner shaft. A body is coupled to the distal portion of the beam, and a strain sensor is coupled to the beam. A shield optionally includes a plurality of slits and has a distal portion coupled to the body. The distal portion of the outer shaft surrounds at least a portion of the distal portion of the inner shaft, at least a portion of the beam, and at least a portion of the shield. The plurality of slits is positioned in a contact region between the distal portion of the outer shaft and the shield. Contact between the shield and the distal portion of the outer shaft limits lateral deflection of the distal portion of the beam.

[0009] In some embodiments, each slit is curved. In some embodiments, each slit has a width of less than about 0.10 mm. In some embodiments, a longitudinal axis of the shield is defined between a proximal portion and a distal portion of the shield, and the shield is elastically deformable radially inwardly and elastically bendable along the longitudinal axis of the shield in the contact region.

[0010] In some embodiments, the medical device further comprises a bushing, wherein the bushing comprises a proximal portion and a distal portion. The proximal portion of the bushing is coupled to the distal portion of the inner shaft, and the distal portion of the bushing extends distally beyond the distal portion of the inner shaft and over at least a portion of the beam. The outer shaft extends over the bushing and is in sliding contact with the bushing.

[0011] In some embodiments, the shroud includes a tab, and the shroud is coupled to the body via the tab captured between the body and the distal portion of the beam. In some embodiments, the inner shaft translates within the outer shaft. In some embodiments, the inner shaft translates within a range of motion defined within the outer shaft between a proximal range of motion limit and a distal range of motion limit. The proximal portion of the shroud remains within the outer shaft within the range of motion of the inner shaft.

[0012] In some embodiments, a medical device includes a shaft, a beam, the shaft including a distal portion, the beam including a proximal portion and a distal portion, and the proximal portion of the beam is coupled to the distal portion of the shaft. A body is coupled to the distal portion of the beam and includes a fluid port. The medical device also includes a shroud, the shroud including a proximal portion, a distal portion, and an inner wall between the proximal and distal portions of the shroud. The distal portion of the shroud is coupled to the body, and the proximal portion of the shroud is located between the distal portion of the shaft and the body. The inner wall of the shroud defines an interior volume in fluid communication with the fluid port, such that fluid introduced into the fluid port flows through the interior volume of the shroud and is directed proximally toward the distal portion of the shaft.

[0013] In some embodiments, the medical device includes an end effector actuator element extending through a distal portion of the shaft and exiting the distal portion of the shaft at an exit location. Fluid introduced into the fluid port flows through the interior volume of the shield, is directed proximally along the actuator element, and is directed against the exit location.

[0014] In some embodiments, the medical device further comprises a hub having a proximal portion and a distal portion, wherein the proximal portion of the hub is coupled to the distal portion of the shaft and the distal portion of the hub is positioned between the distal portion of the shaft and the proximal portion of the shield.

[0015] In some embodiments, the bushing defines an interior volume between the distal end portion of the shaft and the distal end portion of the bushing, and fluid introduced into the fluid port flows through the interior volume of the shroud and proximally into the interior volume of the bushing.

[0016] In some embodiments, the medical device includes an end effector actuator element, and the bushing defines an interior volume between a distal portion of the shaft and the distal portion of the bushing. The end effector actuator element extends through the distal portion of the shaft, exits the distal portion of the shaft at an exit location, and extends through the interior volume of the bushing. Fluid introduced into the fluid port flows through the interior volume of the shroud, is directed proximally along the end effector actuator element, is directed into the interior volume of the bushing, and is directed against the exit location.

[0017] In some embodiments, the shaft is an inner shaft, and the medical device further comprises an outer shaft surrounding at least a portion of the inner shaft. The outer shaft comprises a distal end, and the shield optionally comprises a plurality of slits positioned in a contact region between a proximal portion of the shield and the distal end of the outer shaft. The contact between the proximal portion of the shield and the distal end of the outer shaft limits lateral deflection of the distal portion of the beam.

[0018] In some embodiments, a longitudinal axis of the shroud is defined between the proximal and distal portions of the shroud, and in the contact region, the shroud is elastically deformable radially inward and elastically bendable along the longitudinal axis of the shroud.

[0019] In some embodiments, each slit in the set of slits is shaped, sized, or both sized and configured to limit capture of a surgical suture. In some embodiments, the shaft is an inner shaft, and the medical device further comprises an outer shaft surrounding at least a portion of the inner shaft and surrounding a proximal portion of the shroud. The inner shaft translates within the outer shaft within a range of motion defined between a proximal range of motion limit and a distal range of motion limit. The proximal portion of the shroud remains within the outer shaft within the range of motion of the inner shaft.

[0020] In some embodiments, a medical device includes a fluid delivery structure, a shaft extending within at least a portion of the fluid delivery structure, and a restrictor tube surrounding the shaft within the fluid delivery structure. A restrictor tube stopper is positioned proximally of the restrictor tube. Pressure from an introduced fluid against the restrictor tube causes the restrictor tube to translate proximally relative to the shaft until the restrictor tube contacts the restrictor tube stopper. Contact between the restrictor tube and the restrictor tube stopper limits fluid from traveling proximally past the restrictor tube stopper.

[0021] In some embodiments, the fluid delivery structure includes a flush port structure defining a flush port. Fluid introduced against the restrictor tube is introduced through the flush port and then delivered proximally along the outer surface of the shaft. In some embodiments, the restrictor tube is positioned to translate along the length of the shaft within the fluid delivery structure.

[0022] In some embodiments, the shaft is an inner shaft, and the medical device further comprises an outer shaft and a coupler. The outer shaft comprises a proximal portion coupled to the coupler. The coupler is coupled to the fluid delivery structure and comprises a port in fluid communication with a flush port of the fluid port structure. In some embodiments, fluid introduced against the restrictor tube is introduced through the flush port and is transferred distally through the port of the coupler and between the outer surface of the shaft and the inner surface of the outer shaft.

[0023] In some embodiments, the flush port is a first flush port, the medical device further comprises a proximal mechanical structure coupled to the fluid delivery structure, and the flush port structure comprises a second flush port. Fluid introduced into the second flush port is directed proximally to a location within the proximal mechanical structure. In some embodiments, the coupler comprises a proximal end, a longitudinal axis of the restrictor tube is defined between the proximal end of the restrictor tube and a distal end of the restrictor tube, and the restrictor tube is movable along the longitudinal axis of the restrictor tube between the proximal end of the coupler and a restrictor tube stop. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a plan view of a minimally invasive teleoperated surgical system for performing a medical procedure, such as surgery, according to an embodiment.

[0025] Figure 2 yes Figure 1 A perspective view of a user console for a minimally invasive teleoperated surgical system is shown.

[0026] Figure 3 yes Figure 1 A perspective view of an optional auxiliary unit of a minimally invasive teleoperated surgical system is shown.

[0027] Figure 4 yes Figure 1 A front view of a manipulator unit including a plurality of instruments of a minimally invasive teleoperated surgical system is shown.

[0028] Figure 5 is a schematic diagram of a medical device according to an embodiment.

[0029] Figure 6 is a schematic diagram of a medical device according to an embodiment.

[0030] Figure 7A is a schematic diagram illustrating a medical device with a restrictor tube in a first orientation according to an embodiment.

[0031] Figure 7B The diagram shows a flow restrictor tube in a second orientation. Figure 7A Schematic diagram of medical equipment.

[0032] Figure 8 is a perspective view of a medical device according to another embodiment.

[0033] Figure 9 yes Figure 8 An enlarged perspective view of a distal portion of a medical device.

[0034] Figure 10 yes Figure 8 A side view of a distal portion of a medical device, wherein the outer shaft is shown transparent for illustrative purposes.

[0035] Figure 11A yes Figure 8 A perspective view of a portion of a medical device with the outer shaft removed and the distal hub shown transparent for illustrative purposes.

[0036] Figure 11B yes Figure 8 FIG2 is a side view of a portion of a medical device with the outer shaft removed and the distal hub shown in transparency for illustrative purposes.

[0037] Figure 11C yes Figure 8 A perspective view of the end portion of a distal hub of a medical device.

[0038] Figure 12A yes Figure 8 A perspective view of a distal portion of a medical device with selected components removed for illustrative purposes.

[0039] Figure 12B yes Figure 8 A perspective view of a distal portion of a medical device with selected components removed for illustrative purposes.

[0040] Figure 13 is an exploded perspective view of a portion of the medical device of FIG. 12 .

[0041] Figure 14 yes Figure 8 A perspective view of a beam of a medical device with an outer mold.

[0042] Figure 15A yes Figure 8 A perspective view of a shield of a medical device.

[0043] Figure 15B yes Figure 8 A perspective view of a connecting rod of a medical device.

[0044] Figure 16 yes Figure 8 A perspective view of a proximal portion of a medical device with selected components of the proximal mechanism removed for illustrative purposes.

[0045] Figure 17 yes Figure 8Exploded view of a proximal portion of a medical device with selected components removed for illustrative purposes.

[0046] Figure 18 yes Figure 16 A cross-sectional view of a proximal portion of the medical device taken along line 18-18.

[0047] Figure 19 yes Figure 16 A cross-sectional view of the proximal portion of the medical device taken along line 19-19.

[0048] Figure 20 yes Figure 16 A cross-sectional view of a proximal portion of the medical device taken along line 20-20. DETAILED DESCRIPTION

[0049] The embodiments described herein can be advantageously used in various force sensing instrument applications (e.g., for grasping, cutting, and manipulation operations associated with minimally invasive surgery). The embodiments described herein can also be used in various non-medical applications, such as, for example, remotely operated systems for search and rescue, remotely controlled diving equipment, aviation equipment, and automobiles. The medical devices or apparatuses of the present application implement motion in three or more degrees of freedom (DOF). For example, in some embodiments, the end effector of a medical device can move in three mechanical DOFs relative to the body of the device, such as pitch, yaw, and roll (axial roll). The end effector itself may also have one or more mechanical DOFs, such as two jaws, each of which rotates relative to a clevis (two DOFs), and a distal clevis that rotates relative to a proximal clevis (one DOF). Thus, in some embodiments, the medical devices or apparatuses of the present application implement motion in six DOFs. The embodiments described herein can also be used to determine the force applied to (or by) the distal end portion of the instrument during use.

[0050] Embodiments described herein relate to force-sensing medical devices for determining forces applied to the medical device to control a surgical system (e.g., a minimally invasive, teleoperated surgical system). In some embodiments described herein, the medical device includes one or more irrigation ports at the distal end of the device, one or more irrigation ports at the proximal end of the device, or both. In some embodiments described herein, structure is provided at the distal portion of the device to limit the range of motion of the force sensor beam and reduce force artifacts that affect the accuracy of force feedback.

[0051] In some embodiments, a force-sensing medical device includes a force sensor system comprising a distal force sensor unit that can provide an indication of the force affecting the device. This force indication can be used by the system to transmit force feedback to a user control unit of the system. The distal force sensor unit can include a strain sensor coupled to an elastically deformable beam. The beam is configured to deform in response to a load affecting the distal portion of the device. The strain sensor includes one or more strain gauges that measure the resultant strain in the beam due to the deflection. In some embodiments, a sensor signal cable can be coupled to the distal force sensor unit, extend proximally, and couple to an electronic circuit board of the medical device. This electronic circuit board is described in detail in co-pending U.S. Provisional Patent Application No. 63 / 425,524, filed on November 15, 2022, the disclosure of which is incorporated herein by reference. The sensor signal cable transmits the strain signal to the electronic circuit board. Further details regarding the sensor signal cable are provided in co-pending U.S. Provisional Patent Application No. 63 / 425,520, filed on November 15, 2022, the disclosure of which is incorporated herein by reference.

[0052] In some embodiments, the medical device described herein includes a force sensor unit having a beam and one or more strain sensors on the beam. The medical device includes a shield surrounding at least a portion of the beam and coupled to the beam. The shield is formed from a superelastic shape memory material and optionally includes a plurality of slits along the shield's wall. The material and / or slits (when formed or otherwise included in the shield) allow the shield to elastically bend along the shield's longitudinal axis and elastically deform radially inward. An outer shaft surrounds at least a portion of the shield and has a distal portion positioned such that the slits in the shield are located in the contact region between the shield and the distal portion of the outer shaft. During use of the medical device, the contact between the shield and the distal portion of the outer shaft can limit lateral deflection of the distal portion of the beam while also limiting deformation to sense force. For example, because the shield is coupled to the beam, when the beam bends due to a force applied to the distal portion of the medical device, the shield will move with the beam until it contacts the outer shaft. The elasticity of the shield allows it to deform or bend when it contacts the external shaft and then return to its original linear shape. In other words, the shield has a biased linear shape and can bend or deform upon contact with the external shaft and return to its biased linear shape when no longer in contact with the external shaft. The deformation of the shield allows the deflection of the beam to be limited, while also limiting the deformation of the sensed force. Similarly, the slit creates a deformation region whose stiffness is much less than that of the beam, thereby limiting the deformation of the sensed force.

[0053] In some embodiments, described herein are medical devices that include a fluid flush port at a distal portion of the medical device. The distal flush port provides for a cleaning fluid to be introduced into the interior of the medical device to provide effective cleaning of internal components that might otherwise be blocked from access. A shield can be used to deflect or direct fluid proximally from the distal fluid port. In some embodiments, the distal flush port is located on a body component coupled to the distal portion of the shield. For example, the body can be a link or component of an end effector of a wrist assembly. The size and location of the distal flush port are selected to facilitate access and connection to a luer connector to connect a fluid source to the medical device.

[0054] In some embodiments, described herein are medical devices that provide one or more flush ports at a proximal portion of the medical device. For example, a first flush port can allow a cleaning fluid to be introduced into the interior of the medical device at the proximal portion of the inner shaft, and the fluid can be directed distally along the outer surface of the shaft between the outer surface of the shaft and the inner surface of an outer shaft surrounding the inner shaft. When fluid is introduced into the medical device through the flush port, some of the fluid may be directed proximally. A restrictor tube and a restrictor tube stopper are used to limit the flow of fluid proximally past the restrictor tube stopper. The medical device can include a second flush port at the proximal portion that can be used to introduce a cleaning fluid into the medical device, which is then directed proximally to the interior of a proximal mechanical structure coupled to the proximal portion of the inner shaft.

[0055] As used herein, when used in conjunction with a reference numerical designation, the term "about" refers to the reference numerical designation plus or minus up to 10% of the reference numerical designation. For example, the expression "about 50" encompasses a range of 45 to 55. Similarly, the expression "about 5" encompasses a range of 4.5 to 5.5.

[0056] The term "flexible" in connection with a part (such as a mechanical structure, component, or assembly of components) should be interpreted broadly. Essentially, the term means that the part can be repeatedly bent and returned to its original shape without damage to the part. Some flexible components may also have elastic properties. For example, a component (such as a flexible member) is said to be elastic if it has the ability to absorb energy when it is elastically deformed and then release the stored energy (i.e., return to its original state) when unloaded. Many "rigid" objects have a slight inherent elastic "bend" due to material properties, although these objects are not considered "flexible" as the term is used in this article.

[0057] As used in this specification and the appended claims, the word "distal" refers to a direction toward a working site, and the word "proximal" refers to a direction away from a working site. Thus, for example, the end of a tool closest to the target tissue would be the distal end of the tool, and the end opposite the distal end (i.e., the end manipulated by a user or coupled to an actuation shaft) would be the proximal end of the tool.

[0058] In addition, the specific words selected to describe one or more embodiments and optional elements or features are not intended to limit the present invention. For example, as shown in the figures, spatial relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", etc., can be used to describe the relationship between one element or feature and another element or feature. In addition to the position and orientation shown in the figures, these spatial relative terms are intended to include different positions (i.e., translational placement) and orientations (i.e., rotational placement) of the device during use or operation. For example, if the device in the figure is flipped, the element described as "below" or "below" other elements or features will be "above" or "above" other elements or features. Therefore, the term "below" can include both the position and orientation of "above" and "below". The device can be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Likewise, descriptions of movement along (translation) and about (rotation) various axes include various spatial device positions and orientations.The combination of the position and orientation of a subject defines the subject's pose.

[0059] Similarly, unless the context indicates otherwise, geometric terms such as "parallel," "perpendicular," "circular," or "square" are not intended to require absolute mathematical precision. Instead, these geometric terms allow for variations due to manufacturing or functional equivalents. For example, if an element is described as "circular" or "substantially circular," components that are not exactly circular (e.g., components that are slightly rectangular or multi-sided polygonal) are still encompassed by the description.

[0060] In addition, unless the context indicates otherwise, the singular forms "a," "an," and "the" are intended to include the plural forms as well. The terms "comprises," "includes," "has," etc. specify the presence of stated features, steps, operations, elements, components, etc., but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, or groups.

[0061] Unless otherwise indicated, the terms device, medical equipment, apparatus and variations thereof are used interchangeably.

[0062] Aspects of the present invention are described with reference to a teleoperated surgical system. One example architecture of such a teleoperated surgical system is commercialized by Intuitive Surgical, Inc. of Sunnyvale, California. da Vinci ® surgical system. However, those skilled in the art will appreciate that the aspects of the invention disclosed herein can be embodied and implemented in a variety of ways, including computer-assisted, non-computer-assisted, and hybrid combinations of manual and computer-assisted embodiments and implementations. The implementations are presented merely as examples, and they should not be construed as limiting the scope of the aspects of the invention disclosed herein. Where applicable, aspects of the invention can be embodied and implemented in both relatively small, handheld, manual devices and relatively larger systems with additional mechanical support.

[0063] Figure 1The present invention is a plan view illustration of a remotely operated surgical system ("system") 1000 that operates at least in part with computer assistance ("telesurgical system"). Telesurgical system 1000 and its components are considered medical devices. Telesurgical system 1000 is a minimally invasive robotic surgery (MIRS) system used to perform minimally invasive diagnostic or surgical procedures on a patient P lying on an operating table 1010. The system may have any number of components (e.g., a user control unit 1100) for use by the system's operator (such as a surgeon or other specialized clinician S) during the procedure. MIRS system 1000 may also include a manipulator unit 1200 (commonly referred to as a surgical robot) and an optional auxiliary equipment unit 1150. Manipulator unit 1200 may include an arm assembly 1300 and a surgical instrument tool assembly removably coupled to the arm assembly. The manipulator unit 1200 can manipulate at least one removably coupled medical device (instrument) 1400 (e.g., a force-sensing medical device) through a minimally invasive incision or natural orifice in the body of the patient P, while the surgeon S observes the surgical site and controls the movement of the instruments 1400 via the control unit 1100. Images of the surgical site are obtained by an endoscope (not shown), such as a stereoscopic endoscope, which can be manipulated by the manipulator unit 1200 to orient the endoscope. The auxiliary equipment unit 1150 can be used to process the images of the surgical site for subsequent display to the surgeon S via the user control unit 1100. The number of instruments 1400 used at one time will generally depend on factors such as the diagnostic or surgical procedure and the space constraints within the operating room. If one or more of the instruments 1400 in use needs to be changed during the procedure, an assistant removes the instrument 1400 from the manipulator unit 1200 and replaces it with another instrument 1400 from the operating room tray 1020. Although shown in use with instrument 1400, any instrument described herein can be used with the system 1000.

[0064] Figure 2 1 is a perspective view of the user control unit 1100. The user control unit 1100 includes a left-eye display 1112 and a right-eye display 1114 for presenting a coordinated stereoscopic view of the surgical site to the surgeon S to achieve depth perception. The user control unit 1100 also includes one or more input control devices 1116 (input devices), which in turn cause the manipulator unit 1200 ( Figure 1The input devices 1116 provide at least the same degrees of freedom as their associated instruments 1400, providing the surgeon S with a sense of telepresence or integration of the input devices 1116 with (or direct connection to) the instruments 1400. In this manner, the user control unit 1100 provides the surgeon S with a strong sense of direct control over the instruments 1400. To this end, position, force, strain, or tactile feedback sensors (not shown), or any combination of these, are fed back from the instruments 1400 to one or both of the surgeon's hands via one or more input devices 1116.

[0065] The user control unit 1100 is Figure 1 11. The user control unit 1100 is shown as being in the same room as the patient, allowing the surgeon S to directly monitor the procedure (in person if necessary) and converse directly with the assistant, rather than over the phone or other communication medium. However, in other embodiments, the user control unit 1100 and the surgeon S may be in different rooms, an entirely different building, or other location remote from the patient, thereby allowing for remote surgical procedures.

[0066] Figure 3 is a perspective view of the auxiliary equipment unit 1150. The auxiliary equipment unit 1150 can be coupled to an endoscope (not shown) and can include one or more processors to process captured images for subsequent display (e.g., via the user control unit 1100, or on another suitable display located locally (e.g., on the unit 1150 itself as shown, on a wall-mounted display), and / or remotely). For example, in the case of a stereoscopic endoscope, the auxiliary equipment unit 1150 can process the captured images to present a coordinated stereoscopic image of the surgical site to the surgeon S via the left-eye display 1112 and the right-eye display 1114. Such coordination can include alignment between the opposing images and can include adjusting the stereo working distance of the stereoscopic endoscope. As another example, the image processing can include compensating for imaging errors (e.g., optical aberrations) of the image capture device using previously determined camera calibration parameters.

[0067] Figure 4A front perspective view of a manipulator unit 1200 is shown. Manipulator unit 1200 includes components for manipulating instrument 1400 (e.g., arms, linkages, motors, sensors, etc.) and an imaging device (not shown), such as a stereo endoscope, for capturing images of the procedural site. Specifically, instrument 1400 and the imaging device can be manipulated via a teleoperation mechanism having one or more mechanical joints. Furthermore, instrument 1400 and the imaging device are positioned and manipulated through an incision or natural orifice in a patient P by maintaining a center of motion, remote from the manipulator and generally located along the instrument axis, at the incision or orifice via kinematic mechanical or software constraints. In this manner, the incision size can be minimized.

[0068] Figure 5 is a schematic diagram of a medical device 2400 according to an embodiment. In some embodiments, medical device 2400 or any component thereof can optionally be part of a surgical system for performing surgical procedures and can include a manipulator unit, a series of kinematic linkages, a series of cannulas, and the like. Medical device 2400 (and any instruments described herein) can be used in any suitable surgical system, such as the MIRS system 1000 shown and described above. Medical device 2400 includes an inner shaft 2410, an outer shaft 2910, a beam 2810, a shroud 2900, and a body 2510. Inner shaft 2410 includes a distal portion 2412 coupled to a proximal portion 2811 of beam 2810. Body 2510 is coupled to distal portion 2812 of beam 2810. Shield 2900 includes a distal portion 2934 coupled to body 2510 and beam 2810, and a proximal portion 2933 extending proximally above beam 2810. In some embodiments, the shield 2900 includes tabs ( Figure 5 ), the tab is captured between the body 2510 and the distal portion 2812 of the beam 2810 to couple the shield 2900 to the body 2510 and the beam 2810.

[0069] Beam 2810 is part of a force sensor system of medical device 2400 that includes at least one strain sensor 2830 positioned on beam 2810. Typically, during a medical procedure, a tool of medical device 2400 contacts anatomical tissue, which may result in x- and y-directed forces (which may be radial, transverse, or perpendicular to the long axis of the shaft) or z-directed forces (which may be axial or parallel to the long axis of the shaft (e.g., see FIG. 28). Figure 8 The beam 2810 is a device that is configured to measure the strain in the beam 2810 during operation of the medical device 2400. The strain sensor 2830 can measure the strain in the beam 2810 during operation of the medical device 2400. The measured beam strain can be used to determine the forces exerted on the tool in the x-axis and y-axis directions. These x-axis and y-axis forces are transverse (e.g., perpendicular) to the z-axis (which is parallel or collinear with the central axis of the beam).

[0070] In some embodiments, the body 2510 can be a link included within a wrist assembly having a plurality of articulated links. In some embodiments, an end effector comprising a tool (not shown) is coupled to the body 2510 (or wrist assembly) at a distal portion of the medical device. The tool can include, for example, an articulated jaw or another suitable surgical tool coupled to the body 2510. An end effector actuator element (not shown) can be coupled to the body 2510 and the tool and can be, for example, a cable, a strap, a rod, etc. The end effector actuator element can extend through the inner shaft 2410 and be coupled to a mechanical structure ( Figure 5 ). The mechanical structure may include components configured to actuate an end effector actuator element, which causes one or more components of the surgical instrument (such as, for example, a tool) to move. In some embodiments, the mechanical structure may be configured similar to or identical to the proximal mechanical structure 5700 described below.

[0071] In some embodiments, the shield 2900 optionally includes a plurality of slits 2935. Slits 2935 are merely an optional design feature that may provide certain improvements but are not required to be included in any embodiment described herein. The plurality of slits 2935 are defined by the wall of the shield 2900. In the depicted example, the slits 2935 have a wavy or curved shape and a width sized to prevent suture snagging in the slits 2935. This is particularly advantageous in applications where the end effector is a needle driver used for suturing during various procedures. This configuration of slits 2935 prevents any undesirable pinching or snagging of sutures, even during shield deformation. In some embodiments, the width of the slits 2935 is less than approximately 0.10 mm. The shield is positioned to cover and protect the strain sensor 2830 on the beam 2810, as well as actuating elements, cables, and the like that may be located at the distal end of the medical device 2400. The shield may also cover and protect actuator elements (such as a drive cable) or a cautery cable. Shield 2900 can be formed from a superelastic shape memory material, such as, for example, a nickel-titanium alloy (e.g., Nitinol), so that deformation or bending of shield 2900 is not permanent. In other words, shield 2900 can elastically deform radially inward and elastically bend radially inward during use of medical device 2400, as described in more detail below. Due to its flexibility, the superelastic material of shield 2900 provides greater tolerance for misalignment between shield 2900 and inner shaft 2410, which in turn provides a greater sensing range for the force sensor unit. Shield 2900 can also be formed with a thinner wall thickness to enhance sensing range. For example, in some embodiments, the wall thickness of shield 2900 can be 0.076 mm (0.003 inches), providing more clearance between inner shaft 2410 and shield 2900, enhancing sensing range, and providing more space for cleaning the medical device (described in more detail below). The shield 2900 may also deflect during cleaning to allow for better flow of fluid within the medical device 2400 .

[0072] The outer shaft 2910 extends distally over and around the distal portion 2412 of the inner shaft 2410, a portion of the beam 2810, and a portion of the shroud 2900, such that the distal portion 2912 of the outer shaft 2910 is positioned at a contact area 2930 between the distal portion 2912 of the outer shaft 2910 and the shroud 2900. Figure 5As shown, when the shield 2900 includes such slits 2935, the contact area 2930 is associated with the location of the plurality of slits 2935 (e.g., the contact area is at the same or substantially the same location as the slits 2935). The outer shaft 2910 extending partially over the slits 2935 also minimizes exposure of the slits 2935 to fluids and other body tissues during use. In some embodiments, the inner shaft 2410 translates within the outer shaft 2910 within a range of motion defined between a proximal range of motion limit and a distal range of motion limit. In such embodiments, the proximal end portion 2933 of the shield 2900 remains within the outer shaft 2910 within the range of motion of the inner shaft 2410.

[0073] During operation of the medical device, the contact between the shield 2900 and the distal portion 2912 of the outer shaft 2910 can limit lateral deflection of the distal portion of the beam. For example, during operation of the medical device 2400, if external forces applied to the distal portion of the medical device 2400 (e.g., on the body 2510) cause the beam 2810 to bend, the beam 2810 may bend radially outward. Because the shield 2900 is coupled to the beam 2800, when the beam 2800 bends due to these external forces, the shield 2900 will move with the beam 2810 until it contacts the outer shaft 2910. The material, thin wall thickness, and slits of the shield 2900 allow the shield 2900 to elastically deform and / or bend radially inward along the longitudinal axis of the shield 2900 when it contacts the outer shaft 2910. In doing so, lateral deflection of the beam 2810 is limited by the contact between the shield 2900 and the outer shaft 2910. As described above, the shroud 2900 can then return to its biased linear shape when no longer in contact with the outer shaft 2910 .

[0074] Figure 6 is a schematic diagram of a portion of a medical device 3400 according to another embodiment. In some embodiments, the medical device 3400, or any component thereof, is optionally part of a surgical system for performing a surgical procedure, and may include a manipulator unit, a series of kinematic linkages, a series of cannulas, etc. The medical device 3400 (and any instruments described herein) may be used in any suitable surgical system, such as the MIRS system 1000 shown and described above. The medical device 3400 includes a shaft 3410, a beam 3810, a shroud 3900, and a body 3510. The shaft 3410 includes a distal portion 3412 coupled to a proximal portion 3811 of the beam 3810. The body 3510 is coupled to the distal portion 3812 of the beam 3810. The shroud 3900 includes a distal portion 3934 coupled to the body 3510 and the beam 3810, and a proximal portion 3933 extending proximally above the beam 3810. In some embodiments, the shroud 3900 includes a tab ( Figure 6), the tab is captured between the body 3510 and the distal portion 3812 of the beam 3810 to couple the shield 3900 to the body 3510 and the beam 3810.

[0075] Beam 3810 is part of a force sensor system of medical device 3400, which includes at least one strain sensor ( Figure 6 As described above, during a medical procedure, the tools of the medical device 3400 contact anatomical tissue, which may result in x- and y-directed forces being exerted on the tools (which may be radial, transverse, or perpendicular to the long axis of the shaft) or z-directed forces (which may be axial or parallel to the long axis of the shaft (e.g., see Figure 8 The strain sensor can measure the strain in beam 3810 during operation of medical device 3400. The measured beam strain can be used to determine the forces exerted on the tool in the x-axis and y-axis directions. These x-axis and y-axis forces are transverse (e.g., perpendicular) to the z-axis (which is parallel or collinear with the central axis of the beam).

[0076] like Figure 6 As shown, the body 3510 includes a fluid port 3515 through which fluid can be introduced into the medical device 3400 to clean the internal components of the medical device 3400, as described in more detail herein. In some embodiments, the body 3510 is a link included within a wrist assembly having a plurality of articulated links. In some embodiments, an end effector comprising a tool (not shown) is coupled to the body 3510 at a distal portion of the medical device. The tool may include, for example, an articulated jaw or another suitable surgical tool coupled to the body 3510. An end effector actuator element (not shown) can be coupled to the body 3510 and the tool and can be, for example, a cable, a strap, a rod, etc. The end effector actuator element can extend through the shaft 3410 and exit the shaft 3410 at an exit location and be coupled to a mechanical structure ( Figure 6 ). The mechanical structure may include components configured to actuate an end effector actuator element, which causes one or more components of the surgical instrument (such as, for example, a tool) to move. In some embodiments, the mechanical structure may be configured similar to or identical to the proximal mechanical structure 5700 described below.

[0077] The shield 3900 has an inner wall 3936 between the proximal portion 3933 and the distal portion 3934 of the shield 3900. The inner wall 3936 of the shield 3900 defines an inner volume 3937 that is in fluid communication with the fluid port 3515 of the body 3510, such that fluid introduced into the fluid port 3515 flows through the inner volume 3937 of the shield 3900 and is Figure 63412 of the shaft 3410. In some embodiments, fluid introduced into the fluid port 3515 flows through the interior volume 3937 of the shroud 3900, is directed proximally along the end effector actuator element, and is directed against the exit location of the end effector actuator element. The ability to introduce fluid into the distal end of the medical device 2400 is important because fluid introduced from the proximal end of the medical device 2400 may be prevented from flowing distally toward the distal end of the medical device due to internal components that impede flow.

[0078] In some embodiments, as described above for shield 2900, shield 3900 can be formed from a superelastic shape memory material (such as, for example, Nitinol). Because the flexibility of shield 3900 provides a greater sensing range, the superelastic material of shield 3900 provides greater tolerance for misalignment between shield 3900 and shaft 3410. Shield 3900 can also be formed with a thinner wall thickness to enhance the sensing range. For example, in some embodiments, the wall thickness of shield 3900 can be 0.076 mm (0.003 inches), providing more clearance between shaft 3410 and shield 3900, enhancing the sensing range, and more space for cleaning medical devices (described in more detail below). It can also deflect during cleaning to improve fluid flow within medical device 3400. The shape memory aspect of Nitinol material of shield 3900 provides shield 3900 with a lower elastic modulus than, for example, stainless steel, which allows shield 3900 to avoid permanent deformation under high strain conditions.

[0079] In some embodiments, the medical device 3400 may optionally include a sleeve ( Figure 6 3900 ). The sleeve has a proximal portion coupled to the distal portion 3412 of the shaft 3410 and a distal portion located between the distal portion 3412 of the shaft 3410 and the proximal portion 3933 of the shroud 3900. The sleeve may define an internal volume between the distal portion 3412 of the shaft 3410 and the distal portion of the sleeve, and fluid introduced into the fluid port 3515 of the body 3510 flows through the internal volume 3937 of the shroud 3900 and flows proximally into the internal volume of the sleeve. In some embodiments, the medical device 3400 includes an end effector actuator element ( Figure 6 34), which extends through the shaft 3410, exits the distal end portion 3412 of the shaft 3410 at an exit location, and extends through the interior volume of the bushing. In some embodiments, fluid introduced into the fluid port 3515 flows through the interior volume 3937 of the shroud 3900, is directed proximally along the end effector actuator element, is directed into the interior volume of the bushing, and is directed against the exit location.

[0080] In some embodiments, the medical device 3400 includes at least a portion of an outer shaft (e.g., a sleeve) surrounding a distal portion 3412 of the shaft 3410, at least a portion of the shield 3900, and at least a portion of the sleeve. Figure 6 (not shown). In some embodiments, the proximal portion 3933 of the shroud 3900 is positioned proximal to the distal portion of the outer shaft such that fluid introduced through the flush port 3515 is directed proximally through the interior volume 3937 of the shroud 3900, and the shroud 3900 helps direct the fluid proximally into the interior volume of the hub. Thus, the outer shaft surrounds the proximal portion 3933 of the shroud 3900 such that the fluid is directed to the distal portion of the distal hub.

[0081] Figure 7A and Figure 7B is a schematic diagram of a portion of a medical device 4400 according to another embodiment. In some embodiments, medical device 4400 or any component thereof may optionally be part of a surgical system for performing a surgical procedure and may include a manipulator unit, a series of kinematic linkages, a series of cannulas, and the like. Medical device 4400 (and any instruments described herein) may be used in any suitable surgical system, such as the MIRS system 1000 shown and described above. Medical device 4400 includes a shaft 4410, a fluid delivery structure 4919, a restrictor tube 4920, and a restrictor tube stopper 4922. Shaft 4410 extends within at least a portion of fluid delivery structure 4919, and restrictor tube 4920 surrounds a portion of shaft 4410 within restrictor structure 4919. Restrictor tube stopper 4922 is positioned proximal to restrictor tube 4920. Fluid delivery structure 4919 allows fluid to be introduced into medical device 4400 for cleaning internal components of medical device 4400. When fluid is introduced into the fluid delivery structure 4919 at a location distal to the restrictor tube 4920, pressure F from the fluid against the restrictor tube 4920 causes the restrictor tube 4920 to translate proximally relative to the shaft 4410 until the restrictor tube 4920 contacts the restrictor tube stop 4922, which limits the travel of the restrictor tube 49 / 20. Figure 7A As shown, in the first orientation, the restrictor tube 4920 is spaced apart from the restrictor tube stop 4922 by a distance D. Figure 7B As shown, when fluid pressure F is introduced against the distal end of the restrictor tube 4920, the restrictor tube 4920 translates proximally along the length of the shaft 4410 (see arrow T) until it contacts the restrictor tube stop 4922. The restrictor tube stop 4922 is sized and shaped to limit the proximal travel of fluid past the restrictor tube stop 4922. In this manner, the fluid is forced to travel distally, producing the desired cleaning effect as desired.

[0082] The inner diameter of the restrictor tube 4920 is sized to have a small clearance from the outer surface of the shaft 4410 so that the shaft 4410 is Figure 9 ) (i.e., proximally and distally). When no fluid pressure is present, the restrictor tube 4920 has a tight fit with the shaft 4410 but is free to float, while the restrictor stop 4922 has a large clearance from the outer surface of the shaft 4410 and is in a fixed orientation and does not move. When fluid pressure is present against the restrictor tube 4920, the restrictor tube 4920 closes the gap between the restrictor tube 4920 and the restrictor stop 4922. Because the clearance between the restrictor tube 4920 and the shaft 4410 is so small, there is no path for fluid to flow (e.g., as described above, the fluid is forced to travel distally).

[0083] In some embodiments, the fluid delivery structure 4919 includes a flush port structure ( Figure 7A and Figure 7B ), and the fluid flushing port structure may include one or more fluid ports through which fluid may be introduced and directed proximally along the exterior of the shaft 4410 and directed proximally against the distal end of the restrictor tube 4920. In some embodiments, the medical device 4400 further includes an outer shaft having a proximal end portion coupled to a coupler ( Figure 7A and Figure 7B (neither is shown in the figure). The coupler is coupled to the fluid delivery structure 4919 and includes a fluid port in fluid communication with the flush port of the fluid port structure. Fluid introduced against the restrictor tube 4920 is introduced through the flush port of the fluid port structure and delivered distally through the port of the coupler and between the outer surface of the shaft and the inner surface of the outer shaft. In some embodiments, the longitudinal axis of the restrictor tube 4920 is defined between the proximal end of the restrictor tube 4920 and the distal end of the restrictor tube 4920, and the restrictor tube 4920 is movable along the longitudinal axis of the restrictor tube 4920 between the proximal end of the coupler and a restrictor tube stopper 4922.

[0084] In some embodiments, the fluid delivery structure 4919 includes a flush port structure that includes a first flush port and a second flush port. Fluid introduced into the first flush port is directed proximally toward the restrictor tube 4920 and distally between the outer surface of the shaft and the inner surface of the outer shaft. Fluid introduced into the second flush port is directed proximally to a location within a mechanical structure coupled to the fluid delivery structure 4919. Thus, the first flush port and the second flush port are not in fluid communication with each other.

[0085] Figure 8-Figure 20A medical device 5400 is shown according to another embodiment. The medical device 5400 includes various components as described above with respect to the previous embodiments, which provide improved accuracy in force sensing and fluid flushing capabilities. In some embodiments, the medical device 5400 or any component thereof is optionally part of a surgical system for performing a surgical procedure, and may include a manipulator unit, one or more kinematic linkages, one or more cannulas, etc. The medical device 5400 (and any instruments described herein) may be used in any suitable surgical system, such as the MIRS system 1000 shown and described above. Figure 8-Figure 1 5, the medical device 5400 includes an outer shaft 5910 (e.g., see Figure 10 ), proximal mechanical structure 5700, fluid delivery structure 5919, distal force sensor unit 5800 (which includes beam 5810 (see Figure 13 ) ), distal bushing 5924, shield 5900, inner shaft 5410, wrist assembly 5500 and end effector 5460 at the distal end portion of medical device 5400. Fluid delivery structure 5919 includes the following Figures 16-20 Fluid transfer components at the proximal portion of medical device 5400 are depicted.

[0086] For example, Figure 9 As shown, the medical device 5400 also includes one or more end effector actuation elements 5420 (also referred to herein as "actuation elements") that couple the proximal mechanical structure 5700 to the wrist assembly 5500 and the end effector 5460. The actuation elements 5420 can be, for example, cables, straps, rods, etc. The medical device 5400 is configured such that selective movement of the actuation elements 5420 produces rotation of the wrist assembly 5500 about a first rotational axis A1 (see FIG. Figure 9 ) (i.e., pitch rotation) (which serves as the pitch axis; the term Pitch is arbitrary), the end effector 5460 rotates around the second axis of rotation A2 (see Figure 9 ) (which serves as the yaw axis; the term yaw The present invention also provides a method for adjusting the pitch or yaw of the instrument 5400, wherein the tool member of the end effector 5460 is rotated in a yaw direction (which is arbitrary), a cutting or grasping rotation of the tool member of the end effector 5460 about the second rotational axis A2, or any combination of these movements. Changing the pitch or yaw of the instrument 5400 can be performed by manipulating the actuating element 5420 in a manner similar to that described in, for example, U.S. Patent No. 8,821,480 B2, entitled "Four-Cable Wrist with Solid Surface Cable Channels" (filed on July 16, 2008), which is incorporated herein by reference in its entirety. Therefore, the specific movements of each drive element to achieve the desired motion will not be described below.

[0087] The inner shaft 5410 includes a proximal portion 5411 coupled to the fluid delivery structure 5919 and a distal portion 5412 coupled to the beam 5810 of the distal force sensor unit 5800 (see FIG. Figure 11A and Figure 11B ). The beam 5810 may include or have one or more strain sensors 5830 coupled thereto (see Figure 13 ) to measure the forces applied to surgical instruments in the x and y directions during surgical procedures. The proximal end portion 5411 of the inner shaft 5410 is coupled to the proximal mechanical structure 5700 in a manner that allows the inner shaft 5410 to translate relative to the proximal mechanical structure 5700 along the z-axis direction. The inner shaft 5410 also defines an internal lumen (not shown) and / or a plurality of channels through which the actuating element 5420 and other components (e.g., electrical wiring, grounding wires, etc.) can be conveyed from the proximal mechanical structure 5700 to the wrist assembly 5500.

[0088] The wrist assembly 5500 includes a proximal first link 5510 and a distal second link 5610. The first link 5510 is coupled to the second link 5610 so that the second link 5610 can rotate about a first rotation axis A1 (which serves as a pitch axis, termed Pitch The proximal first link 5510 includes a proximal portion coupled to a distal portion 5812 of the beam 5810. The distal second link 5610 is coupled to the end effector 5460 so that the end effector 5460 can rotate about a second rotation axis A2 (see FIG. Figure 9 ). In this embodiment, the end effector 5460 includes a first tool member 5462 and a second tool member 5482 forming jaws for engaging, grasping, and / or manipulating tissue during a surgical procedure. The end effector 5460 is operably coupled to the proximal mechanical structure 5700 so that the tool members 5462 and 5482 rotate relative to the inner shaft 5410 about a first rotational axis A1. Although the end effector 5460 includes tool members 5462, 5482 as jaws or clamps (e.g., which can be used as a needle driver), in alternative embodiments, the end effector 5460 can include other types of tools, such as a cutter, an energized tool member for cauterization or electrosurgical procedures, etc.

[0089] During a medical procedure, the tools 5462, 5482 of the end effector 5460 may contact anatomical tissue, which may result in forces in the x, y, or z directions (e.g., see Figure 9The beam 5810 is applied to the tools 5422, 5482 in the x-, y-, and z-axis directions shown in FIG. The strain sensor 5830 can measure the strain in the beam 5810 during operation of the medical device 5400. The measured beam strain can be used to determine the forces applied to the tools 5462, 5482 in the x-axis and y-axis directions. These x-axis and y-axis forces are transverse (e.g., perpendicular) to the z-axis (which is parallel or collinear with the central axis of the beam).

[0090] The proximal mechanism 5700 includes a chassis that supports or contains components configured to actuate the actuation element 5420, which causes movement of one or more components of the surgical instrument, such as, for example, the wrist assembly 5500 or the tools 5462, 5482. The actuation element 5420 extends from the proximal mechanism 5700 to the drive pulleys 5467, 5487 of the wrist assembly 5500 and the tool members 5462, 5482 of the end effector 5460 (see FIG. Figure 9 ).like Figure 8 As shown, the proximal mechanical structure 5700 also includes an instrument support structure including a base 5770. In other embodiments, various support structures may alternatively be used, such as a chassis, a frame, a bed, a unitary peripheral housing of the proximal mechanical structure, and the like.

[0091] The outer shaft 5910 can be any suitable elongated shaft that can be disposed over the inner shaft 5410 and includes a distal portion 5912 and a proximal portion 5911 coupled to a fluid delivery structure 5919. The outer shaft 5910 defines a lumen between the proximal portion 5911 and the distal portion 5912. The inner shaft 5410 extends within the lumen of the outer shaft 5910 and can move relative to the outer shaft 5910. For example, the inner shaft 5410 can translate longitudinally in a direction parallel to the central axis of the inner shaft 5410.

[0092] For example, as in Figure 12A 、 Figure 12B and Figure 13 As shown in FIG, an overmold component 5820 is provided on the beam 5810 to protect the beam 5810 and the strain sensor 5830 from damage and exposure to body fluids and body tissue. The beam 5810 also includes an anchor 5825 at the proximal end of the beam 5810 to which the overmold component 5820 is coupled. For illustrative purposes, Figure 12B The beam 5810 is shown without the overmolded component 5820. Anchor 5825 is coupled to the distal portion 5412 of the inner shaft 5410. The anchor 5825 includes an opening 5821 (e.g., see Figure 14) and a shoulder 5828 through which the actuating element 5420 and other wires can be routed, the shoulder 5828 being coupled to a distal bushing 5924 described below. The distal end portion 5812 of the beam 5810 includes a connector 5813 that includes an opening 5821 for routing the actuating element 5420 and other wires. The connector 5813 also defines a cutout 5823. The connector 5813 is used to couple the beam 5810 to the shield 5900 and the first link 5510, as described in more detail below. The overmolded component 5820 also provides a seal 5822 for the actuating element 5420 extending through the opening 5821 to prevent fluid and other materials from passing proximally through the opening 5821.

[0093] The shield 5900 includes a distal portion 5934 coupled to the first link 5510 and the beam 5810, and a proximal portion 5933 extending proximally above the beam 5810 (and the overmold component 5820). Figure 13 、 Figure 15A and Figure 15B As shown, the shield 5900 includes a pair of tabs 5940 and an opening 5941. The tabs 5940 couple the shield 5900 to the connector 5813 of the beam 5810 and the first link 5510. More specifically, the tabs 5940 are captured or clamped between the first link 5510 and the connector 5813 so that the tabs 5940 abut the distal cable transmission structure 5511 within the first link 5510 (see FIG. Figure 15B ) and a portion of the connector 5813, thereby securing the shield 5900 to the distal portion 5812 of the beam 5810 and the first link 5510. This eliminates the need for additional attachment mechanisms (such as, for example, welding for securing the shield 5900).

[0094] like Figure 15A As best shown in FIG, the shield 5900 is tubular and defines an interior volume 5937. The shield 5900 also optionally defines a plurality of slits 5935 through a wall 5936 of the shield 5900. As described above, although the medical device 5400 is Figure 8-Figure 205935, but the slits 5935 are merely an optional design feature and are not required to be included. In any embodiments as described herein, the shield 5900 may or may not define or include a plurality of slits 5935. The slits 5935 have a wavy or curved shape and have a width sized to prevent the suture from snagging in the slits 5935. This is particularly advantageous in applications where the end effector is a needle driver for suturing during various procedures. With this configuration of the slits 5935, the shield 5900 can avoid any undesirable clamping or snagging of the suture even during deformation of the shield. The slits 5935 provide enhanced flexibility and bendability of the shield 5900. In some embodiments, the width of the slits 5935 is less than about 0.10 mm. The shield 5900 is positioned to cover and protect the strain sensor 5830, the actuator 5420, the wires, etc. on the beam 5810, which may be located at the distal portion of the medical device 5400. The shield 5900 can be formed of a superelastic shape memory material (such as, for example, Nitinol alloy). Thus, the shield 5900 can bend or deform and return to a biased linear configuration, for example, as Figure 9 、 Figure 10 、 Figure 11A 、 Figure 12A and Figure 15A . For example, shield 5900 can elastically deform radially inward and elastically bend radially inward during use of medical device 5400, as described in more detail below. Due to its flexibility, the superelastic material of shield 5900 provides greater tolerance for misalignment between shield 5900 and inner shaft 5410, which also provides a greater sensing range for force sensor unit 5800. Shield 5900 can also be formed with a relatively thin wall thickness to enhance the sensing range and provide more clearance for other components used for cleaning medical device 5400, as described in more detail below. For example, in some embodiments, the wall thickness of shield 5900 can be approximately 0.076 mm (0.003 inches). The superelastic material, thin wall thickness, and slits provide shield 5900 with greater flexibility, allowing shield 5900 to deflect or deform during cleaning to improve the flow of cleaning fluid within medical device 5400.

[0095] refer to Figure 10 、 Figures 11A-11C , the outer shaft 5910 extends distally and surrounds the distal end portion 5412 of the inner shaft 5410, a portion of the beam 5810 (and the overmolded component 5820), and a portion of the shield 5900. For example, as in Figure 10As shown in FIG, the distal end portion 5912 of the outer shaft 5910 is positioned at a contact area 5930 between the distal end portion 5612 of the outer shaft 3910 and the shroud 5900, and the contact area 5930 is associated with the location of the plurality of slits 5935 (e.g., the contact area is at the same or substantially the same location as the slits). The outer shaft 5910 extending partially over the slits 5935 also minimizes exposure of the slits 5935 to fluid and other body tissue during use. As described above, the inner shaft 5410, coupled to the anchor 5825 at the proximal end portion 5811 of the beam 5810, can translate within the outer shaft 5910 within a range of motion defined between a proximal range of motion limit and a distal range of motion limit, and the proximal end portion 5933 of the shroud 5900 remains within or surrounded by the outer shaft 5910 within this range of motion of the inner shaft 5410. In other words, as the inner shaft 5410 , beam 5810 , shroud 5900 , and first link 5510 translate proximally and distally relative to the outer shaft 5910 , the proximal end portion 5933 of the shroud 5900 remains surrounded by the outer shaft 5910 .

[0096] like Figure 9 、 Figure 10 and Figures 11A-11C As shown, the proximal portion 5927 of the distal bushing 5924 is coupled to the distal portion 5412 of the inner shaft 5410, and the distal portion 5928 extends distally above the proximal portion 5811 of the beam 5810. The distal bushing 5924 includes an interior volume 5925 and a circumferential interior protrusion 5926 (see FIG. Figure 11C ). The internal protrusion 5926 is Figure 11B The position L1 is anchored by the shoulder 5828 of the anchor 5825 (see Figure 14 ) is captured, the shoulder 5828 is coupled to the distal portion 5412 of the inner shaft 5410. The proximal portion 5927 of the distal bushing 5924 is captured by, for example Figure 11B The weld at the mid-position L2 is coupled to the distal portion 5412 of the inner shaft 5410. The distal bushing 5924 provides support to the distal portion 5912 of the outer shaft 5910, provides a low friction bearing surface for relative motion between the inner and outer shafts 5410, 5910, creates an air-filled barrier to prevent air from escaping the surgical space, and is used during cleaning of the medical device, as described below.

[0097] During operation of the medical device, beam 5810 may bend or deflect due to external forces exerted on the distal portion of medical device 5400 (e.g., wrist assembly 5500 or end effector 5460). For example, beam 5810 may bend radially outward. Because shield 5900 is coupled to beam 5800, when beam 5800 bends due to these external forces, shield 5900 will move with beam 5810 until it contacts distal portion 5912 of outer shaft 5910, for example, at contact area 5930. The material, thin wall thickness, and / or slits of shield 5900 allow shield 5900 to elastically deform and / or bend radially inward along the longitudinal axis of shield 5900 when it contacts outer shaft 5910. In doing so, lateral deflection of beam 5810 is limited by the contact between shield 5900 and outer shaft 5910. As described above, when the shroud 5900 is no longer in contact with the outer shaft 5910, the shroud 5900 can then return to its biased linear shape.

[0098] The components of the medical device 5400 also provide access to the distal portion of the medical device 5400 for cleaning purposes. Figure 9 、 Figure 10 、 Figure 12A 、 Figure 12B and Figure 13 As shown, the proximal first link 5510 includes a fluid port 5515 through which fluid can be introduced into the distal portion of the medical device 5400 to clean the internal components of the medical device 5400. The fluid port 5515 is in fluid communication with the opening 5941 of the shield 5900 and the cutout 5823 of the connector 5813 of the beam 5810. Figure 10 As shown by arrows FF, when fluid is introduced through fluid port 5515, the fluid flows proximally through opening 5941 and cutout 5823 into the interior volume of shroud 5900, where it is directed by shroud 5900 into interior volume 5925 of distal bushing 5924. The fluid is prevented from flowing through the distal end of anchor 5825 and distal bushing 5924 and is conveyed distally back to an exit location at the distal end of medical device 5400, as shown by arrows BF. For example, most of the fluid will flow back distally in the gap between the outer surface of shroud 5900 and inner surface 5917 of outer shaft 5910, and some fluid may flow back into the interior volume of shroud 5900 and distally toward the distal end of medical device 5400.

[0099] Thus, fluid can flow within the medical device 5400, along the overmolded portion 5820 of the beam 5810 and along the actuating element 5420. The outer shaft 5910 is positioned to help contain the fluid within the medical device 5400 as it flows between the proximal portion 5933 of the shield 5900 and the distal end 5928 of the distal hub 5924. The fluid port 5515 is positioned on the first link 5510 at a location where it can be easily accessed and connected to a fluid source. In some embodiments, the fluid port 5515 can be configured as a luer connector coupled to a fluid source. In some embodiments, an adapter can be used to couple the fluid source to the fluid port 5515.

[0100] Figures 16-20 A fluid delivery structure 5919 and components at the proximal portion of the medical device 5400 are shown to provide access for cleaning internal components at the proximal portion of the medical device 5400. For example, Figure 17 As shown in the exploded view of FIG, the fluid delivery structure 5919 includes a flush port structure 5945, a flow restriction tube 5920, and a flow restriction tube stopper 5922. The fluid delivery structure 5919 also includes a coupler 5923 located inside the fluid delivery structure 5619 (see FIG. Figures 18-20 ). The flush port structure 5945 includes a first component 5946 coupled to a second component 5947. The first component 5946 includes a first flush port 5948, a second flush port 5949, a channel 5351 in fluid communication with the first flush port 5948, and a first flush channel 5952. The second component 5947 includes an extension tube 5953 received in the channel 5951 (see Figure 18 ), and defines a second flushing channel 5954. The second component 5947 further defines an interior region 5955. When the first component 5946 is coupled to the second component 5947, the first flushing port 5948 is in fluid communication with the second flushing channel 5954 (eg, Figure 18 ), and the second flush port 5949 and the first flush channel 5952 are in fluid communication with the interior region 5955 (as shown Figure 20 shown).

[0101] like Figures 18-20As shown, the inner shaft 5410 extends within at least a portion of the fluid delivery structure 5919, and the restrictor tube 5920 and the restrictor tube stopper 5922 each surround a portion of the inner shaft 5410 within the restrictor structure 5919. The restrictor tube stopper 5922 is fixedly positioned proximal to the restrictor tube 5920. As described above with respect to the medical device 4400, the restrictor tube 5920 can translate proximally and distally relative to the inner shaft 5410. When the restrictor tube 5920 translates proximally, the restrictor tube stopper 5922 limits translation of the restrictor tube 5920 in the proximal direction. In other words, the restrictor tube 5920 can move from a first orientation and a second orientation, in which the proximal portion 5931 of the restrictor tube 5920 is spaced apart (not shown in FIG. 18020) from the distal end 5929 of the restrictor tube stopper 5922 (see, for example, FIG. 18020). Figure 7A In the second position, the proximal end 5931 of the flow limiting tube 5920 contacts the distal end 5929 of the flow limiting tube stopper 5922, as shown in FIG. Figures 18-20 shown.

[0102] The fluid delivery structure 5919 allows fluid to be introduced into the medical device 5400 to clean the internal components of the medical device 5400. The fluid can be introduced through the first fluid port 5948, the second fluid port 5949, or both. When the fluid is introduced through the first fluid port 5948, the fluid will flow through the first flushing channel 5954, through the opening 5921 of the coupler 5923, and can be Figure 18 and Figure 19 The fluid flowing distally can flow in the gap between the outer surface 5413 of the inner shaft 5410 and the inner surface 5917 of the outer shaft 5910. The fluid can flow along the outer surface 5413 of the inner shaft 5410 in the gap (as shown by the arrows FF in FIG. Figure 10 FD in the figure) to the distal portion of the medical device 5400 where the fluid can exit the medical device 5400. For example, at the distal portion 5412 of the shaft 5410, the fluid can exit the medical device 5400 through one or more return openings 5416 (e.g., see FIG. Figure 10 、 Figure 11A and Figure 11B 5416) exiting or entering and flowing in the opposite or reverse direction (proximally) within the interior volume of the shaft 5410 (as shown in FIG. Figure 10 and Figure 18 The fluid flowing in the proximal direction can exert a fluid pressure F on the distal end 5933 of the flow restrictor tube 5920 (see FIG. Figure 19), and causes the restrictor tube 5920 to translate proximally until the proximal end 5931 of the restrictor tube 5920 contacts the distal end 5929 of the restrictor tube stop 5922. Fluid can flow around the outer surface of the restrictor tube 5920 but is prevented from traveling in the proximal direction beyond the restrictor tube stop 5922. Figure 20 As shown, when fluid is introduced through the second fluid port 5949 , the fluid flows through the first flush channel 5952 , into the interior region 5955 , and proximally into the proximal mechanism 5700 (eg, to clean additional portions of the medical device 5400 ).

[0103] While various embodiments have been described above, it should be understood that these have been presented by way of example only and not limitation. Where the above methods and / or schematics indicate specific events and / or flow patterns occurring in a particular order, the ordering of the specific events and / or operations may be modified. While embodiments have been particularly shown and described, it should be understood that various changes in form and detail may be made.

[0104] For example, any of the instruments described herein (and components thereof) are optional parts of a telesurgery system for performing minimally invasive surgical procedures, and may include a manipulator unit, a series of kinematic linkages, a series of cannulas, and the like. Thus, any of the instruments described herein may be used in any suitable surgical system, such as the MIRS system 1000 shown and described above. In addition, any of the instruments shown and described herein may be used to manipulate target tissue during a surgical procedure. Such target tissue may be cancer cells, tumor cells, lesions, vascular occlusions, thrombosis, stones, uterine fibroids, bone metastases, adenomyosis, or any other body tissue. The examples of target tissues presented are not an exhaustive list. In addition, target structures may also include artificial substances (or non-tissues) within or associated with the body, such as, for example, stents, portions of artificial tubes, fasteners within the body, and the like.

[0105] For example, any component of the surgical instruments described herein can be constructed from any material, such as medical grade stainless steel, nickel alloys, titanium alloys, and the like. Furthermore, any of the connecting rods, tool members, beams, shafts, connectors, cables, or other components described herein can be constructed from multiple components that are later connected together. For example, in some embodiments, a connecting rod can be constructed by connecting separately constructed components together. However, in other embodiments, any of the connecting rods, tool members, beams, shafts, connectors, cables, or components described herein can be constructed as a single unit.

[0106] While instruments are generally shown as having a tool member rotational axis (e.g., axis A2) that is perpendicular to the wrist member rotational axis (e.g., axis A1), in other embodiments, any instrument described herein may include a tool member rotational axis that is offset from the wrist assembly rotational axis by any suitable angle. While various embodiments have been described as having particular features and / or component combinations, other embodiments may have any combination of features and / or components from any of the embodiments discussed above. Various aspects have been described in the general context of medical devices (and more specifically, surgical instruments), but various aspects of the invention are not necessarily limited to use in medical devices.

Claims

1. A medical device comprising: a shaft including a distal portion; a beam comprising a proximal portion and a distal portion, the proximal portion of the beam coupled to the distal portion of the shaft; a body coupled to the distal portion of the beam, the body including a fluid port; and a shield comprising a proximal portion, a distal portion, and an inner wall between the proximal and distal portions of the shield; wherein the distal portion of the shield is coupled to the body; wherein the proximal portion of the shield is located between the distal portion of the shaft and the body; and wherein the inner wall of the shroud defines an interior volume in fluid communication with the fluid port such that fluid introduced into the fluid port flows through the interior volume of the shroud and is directed proximally toward the distal end portion of the shaft.

2. The medical device according to claim 1, wherein: The medical device includes an end effector actuator element; the end effector actuator element extending through the distal portion of the shaft and exiting the distal portion of the shaft at an exit location; and Fluid introduced into the fluid port flows through the interior volume of the shroud, is directed proximally along the end effector actuator element, and is directed against the exit location.

3. The medical device of claim 1 , wherein: The medical device further includes a sleeve; The bushing includes a proximal portion and a distal portion; the proximal portion of the bushing coupled to the distal portion of the shaft; and The distal portion of the bushing is located between the distal portion of the shaft and the proximal portion of the shroud.

4. The medical device according to claim 3, wherein: the bushing defining an interior volume between the distal end portion of the shaft and the distal end portion of the bushing; and Fluid introduced into the fluid port flows through the interior volume of the shroud and proximally into the interior volume of the bushing.

5. The medical device of claim 3, wherein: The medical device includes an end effector actuator element; the bushing defining an interior volume between the distal portion of the shaft and the distal portion of the bushing; the end effector actuator element extending through the distal portion of the shaft, exiting the distal portion of the shaft at an exit location, and extending through the interior volume of the bushing; and Fluid introduced into the fluid port flows through the interior volume of the shroud, is directed proximally along the end effector actuator element, into the interior volume of the bushing, and against the exit location.

6. The medical device according to any one of claims 1 to 5, wherein: The shaft is an inner shaft; The medical device further includes an outer shaft surrounding at least a portion of the inner shaft; The outer shaft includes a distal end; the shroud comprising a plurality of slits positioned at a contact area between the shroud and the distal end of the outer shaft; and Contact between the shroud and the distal end of the outer shaft limits lateral deflection of the distal portion of the beam.

7. The medical device of claim 6, wherein: a longitudinal axis of the shroud defined between the proximal portion and the distal portion of the shroud; and At the contact area, the shield is elastically deformable radially inwardly and elastically bendable along the longitudinal axis of the shield.

8. The medical device of claim 6, wherein: Each of the plurality of slits is shaped, sized, or shaped and sized to limit capture of a surgical suture.

9. The medical device according to any one of claims 1 to 5, wherein: The shaft is an inner shaft; The medical device further includes an outer shaft surrounding at least a portion of the inner shaft and surrounding the proximal portion of the shield; the inner shaft translates within the outer shaft within a range of motion defined between a proximal range of motion limit and a distal range of motion limit; and The proximal portion of the shield is retained within the outer shaft within the range of motion of the inner shaft.

10. A medical device comprising: fluid delivery structure; a shaft extending within at least a portion of the fluid conveying structure; a restrictor tube surrounding the shaft within the fluid transfer structure; and a restrictor tube stopper located proximal to the restrictor tube; wherein pressure from fluid introduced against the restrictor tube causes the restrictor tube to translate proximally about the axial direction until the restrictor tube contacts the restrictor tube stop; and wherein contact between the restrictor tube and the restrictor tube stop limits the fluid from traveling proximally past the restrictor tube stop.

11. The medical device of claim 10, wherein: The shaft includes an outer surface; The fluid delivery structure includes a flush port structure; defining a flush port in the flush port structure; and The fluid is introduced through the flush port, then passed proximally along the outer surface of the shaft, and then introduced against the restrictor tube.

12. The medical device of claim 10, wherein: The restrictor tube is positioned to translate within the fluid delivery structure along the length of the shaft.

13. The medical device of claim 11, wherein: The shaft is an inner shaft; The medical device further includes an outer shaft and a coupler; The outer shaft includes a proximal portion coupled to the coupler; the coupler being coupled to the fluid transfer structure; and The coupler includes a port in fluid communication with the flush port of the flush port structure.

14. The medical device of claim 13, wherein: The outer shaft includes an inner surface; and The fluid is introduced through the flush port and then passes distally through the port of the coupler and between the outer surface of the shaft and the inner surface of the outer shaft.

15. The medical device of claim 11, wherein: The flushing port is a first flushing port; The medical device further includes a proximal mechanical structure coupled to the fluid delivery structure; The flush port structure includes a second flush port; and Fluid introduced into the second flush port is directed proximally to a location within the proximal mechanism.

16. The medical device of claim 13, wherein: The restrictor tube includes a proximal end and a distal end, and a longitudinal axis of the restrictor tube is defined between the proximal end and the distal end of the restrictor tube; The coupler includes a proximal end; and The restrictor tube is movable along the longitudinal axis of the restrictor tube between a proximal end of the coupler and the restrictor tube stopper.

17. A medical device comprising: a shaft including a distal portion; a beam comprising a proximal portion and a distal portion, the proximal portion of the beam coupled to the distal portion of the shaft; a body coupled to the distal portion of the beam; a shield comprising a proximal portion, a distal portion, and an inner wall between the proximal and distal portions of the shield; and a bushing comprising a proximal portion and a distal portion, the proximal portion of the bushing being coupled to the distal portion of the shaft, and The distal portion of the bushing is located between the distal portion of the shaft and the proximal portion of the shroud, wherein the distal portion of the shield is coupled to the body; wherein the proximal portion of the shield is located between the distal portion of the shaft and the body; and Wherein the inner wall of the shroud defines an interior volume configured to receive a fluid that flows through the interior volume of the shroud and is directed proximally toward the distal end portion of the shaft.

18. The medical device of claim 17, wherein: the bushing defining an interior volume between the distal end portion of the shaft and the distal end portion of the bushing; and Fluid introduced into the fluid port flows through the interior volume of the shroud and proximally into the interior volume of the bushing.

19. The medical device of claim 17, wherein: The medical device includes an end effector actuator element; the bushing defining an interior volume between the distal portion of the shaft and the distal portion of the bushing; the end effector actuator element extending through the distal portion of the shaft, exiting the distal portion of the shaft at an exit location, and extending through the interior volume of the bushing; and Fluid introduced into the interior volume of the shroud is directed proximally along the end effector actuator element, into the interior volume of the bushing, and against the exit location.

20. A medical device comprising: an inner shaft including a distal portion; a beam comprising a proximal portion and a distal portion, the proximal portion of the beam coupled to the distal portion of the inner shaft; a body coupled to the distal portion of the beam; a strain sensor coupled to the beam; a shield comprising a proximal portion, a distal portion, and a plurality of slits; and an outer shaft including a distal portion; wherein the distal portion of the shield is coupled to the body; wherein the distal portion of the outer shaft surrounds at least a portion of the distal portion of the inner shaft, at least a portion of the beam, and at least a portion of the shroud; wherein the plurality of slits are positioned at a contact area between the shield and the distal portion of the outer shaft; and wherein contact between the shroud and the distal portion of the outer shaft limits lateral deflection of the distal portion of the beam.

21. The medical device of claim 20, wherein: Each of the plurality of slits is curved.

22. The medical device of claim 20, wherein: Each of the plurality of slits is shaped, sized, or shaped and sized to limit capture of a surgical suture.

23. The medical device of claim 20, wherein: a longitudinal axis of the shroud defined between the proximal portion and the distal portion of the shroud; and In the contact region, the shield is elastically deformable radially inwardly and elastically bendable along the longitudinal axis of the shield.

24. The medical device of claim 20, wherein: The medical device further includes a sleeve; The bushing includes a proximal portion and a distal portion; the proximal portion of the bushing coupled to the distal portion of the inner shaft; the distal portion of the bushing extending distally beyond the distal portion of the inner shaft and covering at least a portion of the beam; and The outer shaft extends over the bushing and is in sliding contact with the bushing.

25. The medical device of claim 20, wherein: The shroud includes a tab; and The shroud is coupled to the body with the tab captured between the body and the distal portion of the beam.

26. The medical device according to any one of claims 20 to 25, wherein: The inner shaft translates within the outer shaft.

27. The medical device according to any one of claims 20 to 25, wherein: the inner shaft translates within the outer shaft within a range of motion defined between a proximal range of motion limit and a distal range of motion limit; and The proximal portion of the shield is retained within the outer shaft within the range of motion of the inner shaft.

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