Patent Description:
This document relates generally to medical devices, and more particularly, to medical devices for use in minimally invasive surgical procedures.

Surgical systems that operate at least in part with computer-assisted control ("telesurgical systems"), such as those employed for minimally invasive medical procedures, can include large and complex equipment to precisely control relatively small instruments. Such systems are sometimes referred to as robotic surgical systems or surgical robots. The da Vinci® Surgical Systems commercialized by Intuitive Surgical, Inc. are examples of telesurgical systems.

Various telesurgical system architectures exist. Some system architectures enable multiple (e.g., two, three, four, or more) surgical instruments to enter the body through a single body opening (surgical incision or natural orifice), and these systems are sometimes referred to as "single-port" systems (e.g., the da Vinci SP® Surgical System). Other system architectures enable multiple surgical instruments to enter the body individually at corresponding multiple locations, and these systems are sometimes referred to as "multi-port" systems (e.g., the da Vinci Xi® Surgical System). Persons of skill in the art will understand that multi-port systems may sometimes be configured during surgery to operate through a single natural body orifice, such as the mouth or anus, or through a single incision (e.g., Intuitive Surgical's Single Site® technology used with a da Vinci Xi® Surgical System). Persons of skill in the art will also understand that single- and multi-port configurations may be combined simultaneously in a single telesurgical system (e.g., two or more instruments inserted via one body opening, and one or more other instruments inserted via one or more corresponding other body openings).

Surgical instruments used during minimally invasive surgery typically include an endoscopic camera or therapeutic end effector mounted at the end of a long, slender instrument shaft. Since instrument end effectors are typically located deep within the body during surgery, telesurgical systems are designed to constrain rotation of the instrument at a point located on the instrument's shaft, often referred to as a remote center of motion. Either kinematic hardware structure or control system software design (or a combination of the two) may be used to impose this remote center of motion constraint. To minimize tissue trauma during surgery, the constrained remote center of motion is typically located at or near the body opening through which the instrument enters.

If a telesurgical system is to be used at or near the body opening, however, then several challenges exist. First, to provide sufficient distance between an instrument's constrained remote center of motion and its end effector, the constrained remote center of motion may need to be located proximally of the body opening, sometimes by several centimeters or more. Second, if part of the surgery is performed proximally of the ultimate surgical site (e.g., using the telesurgical system to perform dissection to reach the ultimate surgical site), there needs to be an easy way to relocate the constrained remote center of motion distally as the surgery progresses towards the deepest surgical site in the patient's body. A third challenge exists if insufflation is to be used in the body cavity in which the ultimate surgical site is located (e.g., the abdomen, the rectum). When the constrained remote center of motion is located at the patient's body wall, and when cannulas are used to introduce instruments past the body wall, seals in the cannulas are used to maintain insufflation gas pressure within the body cavity both when an instrument is inserted through the body wall via the cannula and when the instrument is removed from the cannula. But if the cannula is located proximal of the body opening, insufflation gas pressure must still be maintained.

Further, for a single-port system in which two or more instruments can be introduced into a patient and moved as a single instrument cluster, these challenges become more complex because the constrained remote centers of motion for the two or more instruments are located at the same point or close to one another. In addition, single-port system instruments may be designed with joints that allow them to be inserted close to one another, but then individually spread apart after passing beyond the body wall to provide triangulation to more effectively perform surgery. And, a further challenge exists during the use of a single-port system if an additional instrument (either a telesurgical system instrument or a manually operated instrument) is to be introduced to assist the surgery, because the cluster of single-port system instruments blocks some access locations of the additional instrument.

What is required, therefore, is a way to allow a single-port telesurgical system to be used with its constrained remote center of motion located proximally of the patient's body opening to perform surgery at or near the patient's body opening, to allow insufflation gas pressure to be maintained during this surgery, and also to allow an assist instrument to be introduced to any desired location in relation to the cluster of telesurgical system instruments during this surgery.

<CIT> discloses an access port for use in minimally invasive surgical procedures performed within a patient's abdominal cavity, which includes a body defining a bore configured to guide at least one surgical instrument into the abdominal, cavity, and concave and convex anchoring regions for securing the access port relative to the abdominal cavity.

<CIT> discloses a surgical apparatus for positioning within a tissue tract accessing an underlying body cavity that includes a seal anchor member including leading portion, a trailing portion, and an intermediate portion disposed between the leading and trailing portions. The leading portion of the seal anchor member is configured and adapted to ease insertion of the seal anchor member into the tissue tract. Subsequent to insertion of the seal anchor member, the leading portion of the seal anchor member is also configured and adapted to facilitate securing and/or anchoring of the seal anchor member within the tissue tract.

<CIT> discloses a medical device including a flexible tissue retractor and a releasable insert having multiple instrument openings. The insert can be in the form of an insert assembly including multiple components. A method of using the insert is also described.

The present invention provides an instrument entry guide as set out in the appended independent claim. Optional, but advantageous features are disclosed in the appended dependent claims. Examples according to this disclosure include a medical device that allows a multiple instrument entry guide to be located outside a patient's body and that simultaneously provides a sealed space between the entry guide and an opening in the patient's body wall to maintain insufflation. In this description, such a medical device is referred to as an "instrument access device". The instrument access device includes an envelope, and the envelope includes a distal opening at a distal end, a proximal opening at a proximal end, and an interior cavity between the distal and proximal openings. The envelope may have various shapes, such as a spheroid shape, ellipsoid shape, ovoid shape, barrel shape, lenticular shape, or bellows shape, for example.

At the distal end, the envelope can be coupled to a medical port device, such as a wound retractor, via a distal coupling component (e.g., a clamp) at the distal opening. At the proximal end, the envelope can be coupled, via a proximal coupling component, to a telesurgical system. The proximal coupling component is configured to accommodate multiple surgical instruments through a single opening and seal against insufflation gas escaping through the single opening.

The instrument access device is optionally configured to receive an insufflation gas and to maintain insufflation pressure within a cavity in the body of a patient and within the interior cavity of the envelope. The pressurized and sealed envelope cavity provides an operating space for shafts of multiple instruments of a telesurgical system to articulate outside the patient's body such that instrument end effectors are located at or near the surface of the body at the port device coupled to the instrument access device.

The proximal coupling component of the instrument access device is located at and is coupled to the proximal opening of the envelope. In some examples, the proximal coupling component includes a first port and a second port. The first port may be, for example, configured to receive an entry guide receptacle and, in the entry guide receptacle, an instrument entry guide (also simply "entry guide"), while the second port may be, for example, an assistant port. The assistant port may, for instance, support the introduction of a manuallyoperated instrument, items required for surgery, and removal of large and/or delicate specimens during a procedure. The proximal coupling component includes a center, and the first and second ports are located eccentrically on the proximal coupling component.

In an example, an entry guide receptacle is received in the first port of the instrument seal assembly. The entry guide receptacle works similarly to a cannula that would be received in the wound in cases where the end effectors are located deep inside the body. In some examples, the entry guide receptacle includes an instrument entry guide seal, which is configured to receive and seal an instrument entry guide. Compared with instrument entry guides received in a cannula in the wound, the instrument entry guide received, remote from the wound, in the entry guide receptacle within the first port may be shortened.

Instrument access devices in accordance with this disclosure optionally also include a mechanism configured to rotate the second (e.g., assistant) port around the first port without the envelope twisting about a central axis of the envelope. In some examples, the mechanism includes a gear train. In another example, the mechanism includes a linkage.

This Summary is intended to provide an overview of subject matter of the present patent application. The detailed description and accompanying drawings provide further information about various aspects of the inventive subject matter of the present patent application.

In the drawings, which are not necessarily to scale, like numerals describe similar components in different views. Like numerals having different letter suffixes represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in this document.

<FIG> are schematic cross-sectional views that illustrate aspects of various embodiments of an instrument access device <NUM> that is used together with a telesurgical system <NUM>. As shown in <FIG>, instrument access device <NUM> includes an envelope <NUM>, which has a proximal opening <NUM> and a distal opening <NUM>. The interior <NUM> of envelope <NUM> is empty so that one or more surgical instruments can be inserted through proximal opening <NUM> into the interior <NUM>, and the instruments can pass through and exit interior <NUM> through distal opening <NUM>. Envelope <NUM> may have various shapes as described in more detail below.

For reference, a center longitudinal axis <NUM> of instrument access device <NUM> and envelope <NUM> is defined extending through the proximal and distal openings <NUM>,<NUM>. As illustrated, in this specification, locations associated with the instrument access device are denoted as "proximal" or "distal". The term "distal" means a location closer to a surgical site. The term "proximal" means a location farther away from the surgical site and, thus, closer to the mechanical ground of the telesurgical system <NUM>. Similarly, as indicated by the arrows as shown, the-distal direction generally denotes the direction along the instrument access device away from the mechanical ground of telesurgical system <NUM> and towards a surgical site, and the proximal direction generally denotes the direction along the instrument access device away from the surgical site and towards the mechanical ground of telesurgical system <NUM>. And for still further reference, a world reference frame <NUM> is arbitrarily defined and is fixed in space. Typically, the instrument access device <NUM>, when in use, is oriented with its proximal opening <NUM> located above the distal opening <NUM> relative to the patient's body (i.e., the proximal opening being the "top opening", and the distal opening <NUM> being the "bottom opening"), as shown, such that surgery is performed from above. Note, however, that the instrument access device <NUM> can be used in any orientation.

Instrument access device <NUM> includes a distal coupling component <NUM> and a proximal coupling component <NUM>. Distal coupling component <NUM> is coupled, optionally removably or fixedly, to envelope <NUM> at distal opening <NUM>, and proximal coupling component <NUM> is coupled, optionally removably or fixedly, to envelope <NUM> at proximal opening <NUM>.

As shown, proximal coupling component <NUM> is removably coupled to mechanical ground at a coupling <NUM>. Any suitable coupling type may be used, and proximal coupling component <NUM> may be coupled, optionally, to mechanical ground via telesurgical system <NUM> (e.g., where telesurgical system <NUM> includes a proximal portion of coupling <NUM>), via another piece of operating room equipment (e.g., an operating table), or via any other suitable supporting structure that allows proximal coupling component <NUM> to be placed at a desired position and orientation in space (i.e., with reference to frame <NUM>; the combination of translational position and rotation orientation defining a unique pose of an object in three-dimensional space) and then be held stationary in that desired position and orientation during surgery performed with the use of telesurgical system <NUM>.

As shown, proximal coupling component <NUM> includes a first opening <NUM> and a second opening <NUM>. First opening <NUM> is sized to receive one or more telesurgical system instruments <NUM> of telesurgical system <NUM>. A cluster of three telesurgical system instruments <NUM> is shown-an endoscopic camera 14a and two therapeutic instruments 14b (e.g., grasping, cutting, or electrosurgical instruments, and the like). This instrument cluster is illustrative of various combinations of telesurgical system instruments <NUM> that may be received through first opening <NUM> into the interior <NUM> of envelope <NUM>. Second opening <NUM> is sized to receive one or more assist instruments <NUM> (e.g., grasping, cutting, electrosurgical, suction/irrigation, or stapling instruments, and the like). In some implementations the one or more assist instruments <NUM> are manually operated (illustrated by the hand symbol), and in other optional implementations the one or more assist instruments <NUM> are operated via telesurgical system <NUM> (illustrated in dashed line connection). Although a single second opening <NUM> is shown, proximal coupling component <NUM> may optionally include two, three, or more second openings to receive various combinations of additional manual or teleoperated assist instruments.

Distal coupling component <NUM> is removably coupled to patient <NUM> and surrounds a body opening <NUM>-either an incision or a natural orifice, such as the anus. During a surgical procedure, telesurgical system instruments <NUM> are received into envelope <NUM> and extend towards its distal opening <NUM>. In this way, telesurgical system instruments <NUM> may work at the patient's skin surface <NUM>, within the patient's body wall <NUM>, or at a surgical site <NUM> distal of the body wall <NUM>.

<FIG> are schematic cross-sectional views that illustrate in more detail the coupling of the distal end of instrument access device <NUM> to a port device <NUM> located at body opening <NUM> in a patient in various embodiments. Port device <NUM> retracts the patient's tissue and so keeps opening <NUM> open to allow surgical instruments to enter. As shown in <FIG>, port device <NUM> may have a generally fixed diameter and be adjustable in height as shown by the double-headed arrow so that it can be tightened against the patient's skin surface <NUM> and an interior surface <NUM> of body wall <NUM>. (An example of this type of port device <NUM> is commonly referred to as a wound retractor, or by similar terms. ) Alternatively, as shown in <FIG>, distal coupling component <NUM> may be removably or fixedly coupled to another type of port device 21a, which generally has a fixed diameter and a fixed height and is inserted into opening <NUM>. (An example of this type of port device 21a is an anal port used during transanal surgery. ) Alternatively, distal coupling component <NUM> may be removably or fixedly coupled to yet another type of port device 21b, which generally has a fixed diameter and a fixed height and is placed on the patient's skin surface, for example by adhesive or suction. If envelope <NUM> is sufficiently stiff, then a distally-directed force transmitted from proximal coupling component <NUM> (receiving, for example, a distally-directed force from telesurgical system <NUM>) through envelope <NUM> may be sufficient to maintain port device 21b in position. Alternatively, a structural support (not shown) may be coupled to port device 21b and used to keep port device 21b in position. This type of port device 21b allows the surgical instruments to work at or slightly below the patient's skin surface (e.g., to make an incision or to dissect tissue immediately under the skin surface). Other variations of port devices optionally may be used. If the distal coupling component <NUM> is removably coupled to a port device, then distal coupling component <NUM> may be optionally coupled to any of port devices <NUM>, 21a, or 21b, or to any other style of port device used during a surgical procedure. That is, a single instrument access device <NUM> may be used with any of two or more ports devices, depending on the surgery to be performed. Distal coupling component <NUM> optionally includes a clamp (not shown) or other suitable device that may be used to removably couple distal coupling component <NUM> to a port device. It should be noted that although gas pressure used to insufflate a body cavity for surgery can also be used to insufflate envelope <NUM>, the instrument access device and associated components optionally may be used in clinical situations in which patient insufflation gas is not used, in which case insufflation gas may be used solely to hold envelope <NUM> in its desired shape or to otherwise provide clinical benefits such as smoke evacuation from within envelope <NUM>.

<FIG> is a schematic cross-sectional view that illustrates proximal elements of instrument access device <NUM> in more detail. During surgery, teleoperated instruments <NUM> are inserted through first opening <NUM> along telesurgical instrument insertion axis <NUM>, and one or more assist instruments <NUM> are inserted through second opening <NUM> generally along assist instrument insertion axis <NUM>. If it becomes necessary to insert an assist instrument <NUM> into envelope <NUM> to a location <NUM> that is blocked by one or more telesurgical instruments <NUM>, then the position of second opening <NUM> must move with reference to the position of first opening <NUM> so that the assist instrument <NUM> can reach the desired location <NUM>. Therefore, since first opening <NUM> and its associated telesurgical instrument insertion axis <NUM> are stationary with reference to global frame <NUM>, second opening <NUM> and its associated assist instrument insertion axis <NUM> must orbit around first opening <NUM> (i.e., telesurgical instrument insertion axis <NUM>) until second opening <NUM> and its associated assist instrument insertion axis <NUM> are at a position from which assist instrument <NUM> can reach the location <NUM>. But, even though the distal coupling component <NUM> of envelope <NUM> is fixed with reference to frame <NUM> when coupled to a patient, envelope <NUM> should not twist around center axis <NUM> as second opening <NUM> and assist instrument insertion axis <NUM> orbit around first opening <NUM> and telesurgical instrument insertion axis <NUM>.

In one aspect, telesurgical instrument insertion axis <NUM> is offset from center axis <NUM>; in an alternate aspect, telesurgical instrument insertion axis <NUM> is coincident with center axis <NUM>; in yet another alternate aspect, alternate instrument insertion axis <NUM> is offset from center axis <NUM>; and in still another alternate aspect, alternate instrument insertion axis <NUM> is coincident with center axis <NUM>. Therefore it can be seen that if one of the center axis <NUM>, telesurgical instrument insertion axis <NUM>, or assist instrument insertion axis <NUM> is held stationary in space, the other two axes if offset from the stationary axis will orbit around the stationary axis without envelope <NUM> twisting. It can also be seen that if the center axis <NUM> is coincident with telesurgical instrument insertion axis <NUM> or assist instrument insertion axis <NUM>, then if the coincident axes are held stationary in space the remaining non-coincident axis will orbit around the coincident axes without envelope <NUM> twisting, and if the remaining non-coincident axis is held stationary in space, the coincident axes will orbit around the remaining non-coincident axis without envelope <NUM> twisting. Likewise, a similar relationship between fixed axes (single or coincident) and orbiting axes (single or coincident) exists for implementations in which two, three, or more optional second openings <NUM> are used. The following description concentrates on aspects in which the telesurgical instrument insertion axis is fixed in space and offset from center axis <NUM>, to avoid prolix description; skilled persons will understand that the described implementations can easily be modified to similarly describe other implementations in which the center axis <NUM> or assist instrument insertion axis <NUM> is fixed in space, and other implementations that include coincident axes.

<FIG> is a schematic top view that illustrates operating features of proximal coupling component <NUM>. Referring to <FIG> and <FIG> together, proximal coupling component <NUM> includes an inner stationary element 10a, an outer element 10b, and an orbital element 10c between stationary element 10a and outer element 10b. Stationary element 10a is coupled to mechanical ground (e.g., via coupling <NUM> as described above) so that, during a surgical procedure, element 10a remains stationary at a desired position and orientation with reference to reference frame <NUM> until a clinician moves stationary element 10a to a different (second) desired position and orientation if necessary. Outer element 10b is coupled to envelope <NUM> at proximal opening <NUM> and remains stationary relative to proximal opening <NUM>. Orbital element 10c is coupled to stationary element 10a and rotates around stationary element 10a at teleoperated instrument insertion axis <NUM>.

During use, when the distal opening <NUM> is fixed in space (e.g., when distal coupling component <NUM> is coupled to a port device), envelope <NUM> will undesirably twist if proximal opening <NUM> is rotated. Therefore, orbital element 10c includes a countermotion mechanism 10d that is coupled to outer element 10b, so that, as orbital element 10c rotates in a first direction around stationary element 10a by an angular amount θ, countermotion mechanism 10d rotates outer element 10b relative to orbital element 10c by an equal angular amount θ but in an opposite direction of rotation from orbital element 10c's direction of rotation around stationary element 10a (i.e., -θ). And since the two rotations are by equal angular amounts but in opposite directions, outer element 10b's orientation does not change with reference to frame <NUM>, and envelope <NUM> does not twist around center axis <NUM> when distal coupling component <NUM> is stationary with reference to frame <NUM>. That is, proximal opening <NUM>, distal opening <NUM>, stationary element 10a, outer element 10b and distal coupling component <NUM> all remain in the same relative orientation to one another as orbital element 10c rotates with reference to them. It can further be seen that since stationary element 10a is fixed in space, outer element 10b and orbital element 10c translate in position with reference to frame <NUM> (-x, y, as shown for orbital element 10c's rotation angle θ) as orbital element 10c orbits around stationary element 10a. But since envelope <NUM> is flexible or sufficiently movable with reference to distal opening <NUM> and distal coupling component <NUM>, its proximal opening <NUM> can translate with reference to its distal opening <NUM> without any accompanying twisting of envelope <NUM> around center axis <NUM>.

Referring to <FIG>, telesurgical instruments <NUM> are inserted through first opening <NUM> via an optional telesurgical instrument entry guide <NUM>. Non-limiting examples of telesurgical system entry guides <NUM> that accommodate two or more telesurgical instruments <NUM> are disclosed in <CIT>) (disclosing "Entry Guide for Multiple Instruments in a Single Port Surgical System") and <CIT>) (disclosing "Surgical System Entry Guide"), and also in International Patent Application Pubs. No. <CIT>) (disclosing "Surgical Instrument Guide") and <CIT>) (disclosing "Surgical Instrument Guide with Insufflation Channels").

In some implementations, entry guide <NUM> is inserted through an optional entry guide receptacle <NUM>, which is inserted through stationary element 10a and performs the function of an entry guide cannula. In other optional implementations, entry guide receptacle <NUM> is combined with or constitutes stationary element 10a, and entry guide <NUM> is inserted directly through stationary element 10a, which in this case performs the function of an entry guide cannula.

To prevent insufflation gas under pressure from leaking from interior <NUM> of envelope <NUM> through entry guide <NUM> with or without telesurgical instruments <NUM> inserted through entry guide <NUM>, or through receptacle <NUM> (or stationary element 10a functioning as an entry guide receptacle) either with or without an entry guide <NUM> inserted through receptacle <NUM> (or stationary element 10a functioning as an entry guide receptacle), various gas seal arrangements may be used. Non-limiting examples of entry guide seals <NUM> are disclosed in U. Patent Application Pub. No. <CIT>) (disclosing "Sealing Multiple Surgical Instruments").

Insufflation gas under pressure may be introduced into the interior <NUM> of envelope <NUM> via stationary element 10a, or via entry guide <NUM>, or via receptacle <NUM>, or via seal <NUM>, or by an arrangement of any of these four elements combined together to define a gas flow path. For example, if aspects of stationary element 10a and receptacle <NUM> are combined into a single element and an entry guide seal <NUM> is used, insufflation gas may be introduced via these combined elements. As illustrated, insufflation gas from an insufflation gas source <NUM> travels along a gas flow path <NUM> into interior <NUM> of envelope <NUM>. As a result, an insufflation gas pressure <NUM> higher than the ambient atmospheric pressure outside of envelope <NUM> is maintained in interior <NUM>.

Alternatively, insufflation gas may be introduced into the interior <NUM> of envelope <NUM> via gas flow paths other than illustrated by gas flow path <NUM>, such as an instrument seal in second opening <NUM> (described below), or such as a dedicated insufflation port in orbital element 10c, envelope <NUM>, or distal coupling component <NUM>. And optionally, one or more gas flow paths from interior <NUM> to outside envelope <NUM> may be defined, illustrated by the reverse direction of gas flow path <NUM>. Such an outward gas flow path may be used for functions such as smoke evacuation if a teleoperated instrument <NUM> or an assist instrument <NUM> is not used to perform a smoke evacuation function.

Envelope <NUM> may have various shapes and may be made of various materials. For example, envelope <NUM> may have a generally spheroid shape, a generally ellipsoid shape (i.e., flattened or elongated with reference to center axis <NUM>), a generally ovoid shape (i.e., tapered at one end along center axis <NUM>), a generally cylindrical shape around center axis <NUM>, or other three-dimensional shape of clinical benefit (e.g., generally conical, generally prism-shaped, and the like).

Envelope <NUM> may be made of flexible plastic sheeting that assumes the designed shape when sufficient insufflation gas pressure <NUM> exists within interior <NUM> of envelope <NUM>. Optionally, envelope <NUM> may be made of a flexible, resilient material that holds its shape without the need for interior gas pressure. In still other options, structural elements (e.g., support ribs or similar structures) are used to help envelope <NUM> hold its shape during use. And in still other options, envelope is rigid.

Envelope <NUM> may be generally transparent so that a clinician outside envelope <NUM> may view the pose of an instrument <NUM>, <NUM> within envelope <NUM>. Alternatively, envelope <NUM> may be opaque, in which case an image from an endoscopic camera within envelope <NUM> may be used to determine the pose of an instrument <NUM>, <NUM> within envelope <NUM>. As another alternative, envelope <NUM> may be opaque with one or more transparent windows.

Still referring to <FIG>, an assist instrument <NUM> is inserted through second opening <NUM> via an assist instrument seal <NUM>. Instrument seal <NUM> functions to maintain insufflation gas pressure within envelope <NUM> when an assist instrument <NUM> is either inserted or not inserted. Various suitable instrument seals are known and may be used, and non-limiting examples of an instrument seal <NUM> are disclosed in <CIT>) and in International Patent App. No. <CIT>) (disclosing "Instrument Seal").

Further aspects and details will now be described.

To illustrate the general context in which an instrument access device as described above may be used, <FIG> provides a schematic perspective view that illustrates aspects of a telesurgical system in accordance with various embodiments. In general, for the purposes of this description, a telesurgical system includes three main components: an endoscopic imaging system, a user control system (master), and a manipulator system 210E (slave) (shown in <FIG>), all interconnected by wired (electrical or optical) or wireless connections. One or more data processors (i.e., one or more logical units coupled to one or more memory systems) may be variously located in these main components to provide system functionality. Examples are disclosed in U. Patent No. <CIT>) (disclosing "Minimally Invasive Surgical System").

The imaging system performs image processing functions on, e.g., captured endoscopic imaging data of the surgical site and/or preoperative or realtime image data from other imaging systems external to the patient. The imaging system outputs processed image data (e.g., images of the surgical site, as well as relevant control and patient information) to a surgeon at user control system. In some aspects, the processed image data is output to an optional external monitor visible to other operating room personnel or to one or more locations remote from the operating room (e.g., a surgeon at another location may monitor the video; live feed video may be used for training; etc.).

The user control system includes multiple-degrees-of-freedom mechanical input devices that allow the surgeon to manipulate the instruments, entry guide(s), and imaging system devices, with computer assistance. These input devices may in some aspects provide haptic feedback from the instruments and surgical device assembly components to the surgeon. The user control system also includes a stereoscopic video output display positioned such that images on the display are generally focused at a distance that corresponds to the surgeon's hands working behind/below the display screen.

Control during insertion and use of the instruments may be accomplished, for example, by the surgeon moving the instruments presented in the image with one or two of the input devices; the surgeon uses the input devices to translate and rotate the instrument in three-dimensional space. Similarly, one or more input devices may be used to translate and rotate the imaging system or an associated surgical device assembly to steer an endoscope or instrument cluster towards a desired location on the output display and to advance inside the patient.

A manipulator system 210E is illustrated in <FIG>. In the depicted example, the manipulator system 210E is implemented as a patient-side cart, and the surgery is in the abdomen of patient <NUM>. However, the surgical system including manipulator system 210E can be used for a wide variety of surgeries by using various combinations of instruments.

Manipulator system 210E includes a floor-mounted base 201E as shown, or alternately a ceiling-mounted or other mechanically grounded base (not shown). Base 201E may be movable or fixed (e.g., to the floor, ceiling, wall, or other equipment such as an operating table). Base 201E supports the remainder of the manipulator system, which includes a usually passive, uncontrolled manipulator support structure 220E and an actively controlled manipulator system 230E, herein also referred to as entry guide manipulator 230E.

In one example, the manipulator support structure 220E includes a first setup link 202E and two passive rotational setup joints 203E and 205E. Rotational setup joints 203E and 205E allow manual positioning of the coupled setup links 204E and 206E. Alternatively, some of these setup joints may be actively controlled, and more or fewer setup joints may be used in various configurations. Setup joints 203E and 205E and setup links 204E and 206E allow a person to place entry guide manipulator 230E at various positions and orientations in Cartesian x, y, z space. A passive prismatic setup joint (not shown) between link 202E of manipulator support structure 220E and base 201E may be used for large vertical adjustments 212E.

Entry guide manipulator 230E includes an entry guide manipulator assembly 231E that supports a plurality of surgical device assemblies, at least one surgical device assembly being coupled to entry guide manipulator assembly 231E during a surgery. Each surgical device assembly includes a teleoperated manipulator and either a surgical instrument or a camera instrument mounted on the manipulator. For example, in <FIG>, one surgical device assembly includes, mounted to manipulator 240E, an instrument 260E with a shaft 262E that extends through one of typically multiple channels of entry guide 270E during a surgical procedure.

Entry guide manipulator assembly 231E includes an instrument manipulator positioning system (hereinafter simply "positioning system"). The positioning system moves instrument mount interfaces of one or more manipulators 240E in a plane so that, when one or more instruments 260E are coupled to entry guide manipulator assembly 231E using the respective instrument mount interfaces, the shafts of the instruments 260E are each aligned for insertion into one of the channels in entry guide 270E. While the entry guide 270E is depicted as located at a body wall of the patient, it is to be understood that the manipulator system 210E can also be used, without need for modifications, with entry guides located at a distance from the body wall in an entry guide receptacle of an instrument access device as herein described.

The instrument mount interface(s) may be moved into position after attachment of the instrument(s). The plane in which the instrument mount interfaces are moved is generally perpendicular to the lengthwise axis of entry guide 270E, and the trajectories that instrument mount interfaces take in that plane may include straight and/or curved portions in various combinations. As a positioning element of a lateral motion mechanism of the positioning system moves along a trajectory, the instrument mount interface, and effectively a distal tip of a shaft of an instrument coupled to the instrument mount interface, moves along the same trajectory. Thus, motion of the positioning element causes the shaft to be moved to a location where the shaft is aligned with a channel in entry guide 270E. In this position, the shaft can enter and pass through the channel in entry guide 270E without damaging the instrument and without inhibiting operation of the instrument. The particular paths implemented in the positioning system depend at least in part on the types of surgical device assemblies that can be mounted on the entry guide manipulator assembly 231E and/or the configuration of channels in entry guide 270E.

Different entry guides may be used in different surgical procedures. An entry guide that enters the body between the ribs may optionally have a different shape than an entry guide that enters the body through an incision in the abdomen. Further, entry guides that enter the body generally differ, e.g., in length, from entry guides used outside the body, such as entry guides inserted through an entry guide receptacle at a proximal end of an envelope of an instrument access device as disclosed herein; entry guides used outside of and at a distance from the body may be shortened relative to those entering the body. The different shapes of the entry guides require different layouts of the channels that extend through the entry guides, i.e., different channel configurations. Also, the shapes and/or sizes of the shafts of the instruments may be different for different instruments. An entry guide is used that accommodates the shapes and sizes of the shafts of the instruments used in a particular surgical procedure. The trajectories are designed to accommodate a set of entry guides that can be used with manipulator system 210E.

The ability to individually position an instrument, and hence its shaft, with respect to a channel in an entry guide by moving an instrument mount interface provides versatility to manipulator system 210E. For example, this ability allows entry guides with different channel configurations to be used in system 210E. In addition, the positioning system eliminates the need for surgical-procedure-specific instruments. In other words, the instrument manipulator positioning system allows use of a common set of instruments with a variety of entry guides by moving the instrument shafts around, as described above.

Entry guide manipulator 230E includes a kinematic chain of active joints and links that are movable by motors or other actuators and receive movement control signals that are associated with master arm movements at the user control system. Using this kinematic chain, the entry guide manipulator 230E can adjust the position and orientation of the positioning system of entry guide manipulator assembly 231E and, by extension, the instrument. Usually, the entry guide manipulator 230E is configured and operated to constrain rotation of an instrument at a point located on the instrument's shaft, herein referred to as a remote center of motion.

Conventionally, the remote center of motion coincides generally with the position at which an instrument enters the patient (e.g., at the umbilicus for abdominal surgery). In accordance with this disclosure, however, where an instrument access device with an instrument entry guide located outside the body (in a port at the proximal end of the envelope of the instrument access device) is used, the position of the remote center of motion likewise falls outside the body, e.g., slightly above the body wall, and generally along the axis of the entry guide. A remote center of motion above the body wall allows for instruments to be moved radially outward from the entry guide's extended axis proximally of the patient's body wall and so get better triangulation access at or in the incision. Flexible instrument shafts in conjunction with a flexible wound retractor render such flexibility in operating the instruments possible without risking trauma to tissue.

The remote center of motion is the location at which yaw, pitch, and roll axes intersect, i.e., the location at which the kinematic chain of entry guide manipulator 230E remains effectively stationary while joints move through their range of motion. As shown in <FIG>, a manipulator assembly yaw joint 211E is coupled between an end of setup link 206E and a first end, e.g., a proximal end, of a first manipulator link 213E. Yaw joint 211E allows first manipulator link 213E to move with reference to link 206E in a motion that may be arbitrarily defined as "yaw" around a manipulator assembly yaw axis 223E. As shown, yaw axis 223E of joint 211E is aligned with a remote center of motion located at or near the entry guide 270E.

A distal end of first manipulator link 213E is coupled to a proximal end of a second manipulator link 215E by a first actively controlled rotational joint 214E. A distal end of second manipulator link 215E is coupled to a proximal end of a third manipulator link 217E by a second actively controlled rotational joint 216E. A distal end of third manipulator link 217E is coupled to a fourth manipulator link 219E by a third actively controlled rotational joint 218E; the fourth manipulator link 219E extends in both directions away from the rotational joint 218E and, thus, has two distal ends relative to the location of the j oint 218E.

In one embodiment, links 215E, 217E, and 219E are coupled together to act as a coupled motion mechanism. Coupled motion mechanisms are well known (e.g., such mechanisms are known as parallel motion linkages when input and output link motions are kept parallel to each other). For example, if rotational joint 214E is actively rotated, then joints 216E and 218E are also actively rotated so that link 219E moves with a constant relationship to link 215E. Therefore, it can be seen that the rotational axes of joints 214E, 216E, and 218E are parallel. When these axes are perpendicular to yaw axis 223E of joint 211E, links 215E, 217E, and 219E move with reference to link 213E in a motion that may be arbitrarily defined as "pitch" around a manipulator assembly pitch axis. The manipulator pitch axis extends into and out of the page in <FIG> at remote center of motion at or near the entry guide 270E. The motion around the manipulator assembly pitch axis is represented by arrow 221E. Since links 215E, 217E, and 219E move as a single assembly in this embodiment, first manipulator link 213E may be considered an active proximal manipulator link, and second through fourth manipulator links 215E, 217E, and 219E may be considered collectively an active distal manipulator link.

An entry guide manipulator assembly platform 232E is coupled to one of the distal ends of fourth manipulator link 219E. Entry guide manipulator assembly <NUM> is rotatably mounted on platform 232E. Entry guide manipulator assembly <NUM> can rotate a plurality of surgical device assemblies (e.g., 260E) as a group around axis 225E. Specifically, entry guide manipulator assembly <NUM> rotates as a single unit with reference to platform 232E in a motion that may be arbitrarily defined as "roll" around an entry guide manipulator assembly roll axis 225E.

In accordance with the present disclosure, all the instruments (including a camera instrument) enter the instrument access device via a single port, which is generally stationary relative to the remote center of motion imposed by entry guide manipulator 230E (and defined by the intersection of manipulator assembly yaw axis 223E, manipulator assembly pitch axis 221E, and manipulator roll axis 225E). The configuration of links 215E, 217E, and 219E, and the configuration of joints 214E, 216E, and 218E are such that remote center of motion is located distal of entry guide manipulator assembly, with sufficient distance to allow entry guide manipulator assembly to move freely with respect to the entry guide.

An entry guide receptacle 275E may be removably coupled (directly or indirectly via a mount) to the distal end of fourth manipulator link 219E opposite the distal end to which entry guide manipulator assembly platform 232E is coupled. In one implementation, the entry guide receptacle 275E or mount is coupled to link 219E by a rotational joint that allows it to move between a stowed position adjacent link 219E and an operational position that ensures that the remote center of motion is located along the entry guide receptacle 275E or the entry guide 270E received therein. During operation, the entry guide receptacle 275E is fixed in position relative to link 219E according to one aspect. Entry guide receptacles and entry guides may be made of various materials, e.g., steel or extruded plastic. Plastic, which is less expensive than steel, may be suitable for one-time use per surgical procedure.

The various passive setup joints/links and active joints/links allow positioning of the instruments and imaging system with a large range of motion when a patient <NUM> is placed in various positions on a movable table. Certain setup and active joints and links in the manipulator support structure 210E and/or entry guide manipulator 230E may be omitted to reduce the surgical system's size and shape, or joints and links may be added to increase degrees of freedom. It should be understood that the manipulator support structure 210E and entry guide manipulator 230E may include various combinations of links, passive joints, and active joints (redundant degrees of freedom may be provided) to achieve a necessary range of poses for surgery.

<FIG> is an exploded perspective view of an example instrument access device <NUM> in accordance with various embodiments. In <FIG>, instrument access device <NUM> includes entry guide receptacle assembly <NUM> (including entry guide receptacle <NUM>), countermotion assembly <NUM>, envelope <NUM>, and clamp <NUM> (serving as distal coupling component). The entry guide receptacle <NUM> and countermotion assembly <NUM> together form the proximal coupling component in this embodiment. Clamp <NUM> is received in a distal opening of envelope <NUM>, and, in use, affixes instrument access device <NUM> to a wound retractor or similar port device at a body opening. Countermotion assembly <NUM> is received in a proximal opening <NUM> of envelope <NUM>, and it includes a first port <NUM> that receives the entry guide receptacle <NUM> and is therefore also referred to as the "entry guide port" <NUM>, and a second port <NUM> that can receive assist instruments and is therefore also referred to as the "assistant port" <NUM>. One or more instruments enter instrument access device <NUM> at the proximal end through an entry guide received in entry guide receptacle <NUM> or through the assistant port <NUM>. Envelope <NUM> also includes an additional envelope assistant port <NUM> through which further instruments can enter. The instruments (whether entering through the entry guide port <NUM> or either of the assistant ports <NUM>, <NUM>) either work within envelope <NUM> or leave it through the distal opening to enter the patient's body. The assistant port <NUM> may optionally be configured to allow surgical equipment (e.g., suture or mesh material, imaging probes, instrument accessories, and the like) to be introduced or removed from the interior of envelope <NUM>, or to allow tissue to be removed from the interior of envelope <NUM>.

Entry guide receptacle assembly <NUM> includes entry guide receptacle <NUM> as well as a connector <NUM> that affixes instrument access device <NUM> to an arm of a teleoperated surgical system, such as the system depicted and described with reference to <FIG>. Further, entry guide receptacle assembly <NUM> includes gas lines <NUM> and <NUM>, which carry insufflation gas through the lines and into instrument access device <NUM>, including into envelope <NUM>. The insufflation lines <NUM>, <NUM> may have standard flow Luer fittings or, alternatively, other fittings that permit a higher gas flow volume over time. The use of two gas lines <NUM>, <NUM> serves to enable connecting an insufflation source to either side of the entry guide port <NUM>, which can accommodate spatial constraints in surgical setting. Further, the two gas lines <NUM>, <NUM> allow one line to be used for insufflation and the other line to be used for smoke evacuation, e.g., by venting the second line to the room or using an insufflator with built-in smoke evacuator.

Countermotion assembly <NUM> includes an orbital element <NUM> (as an example of element 10c) in which the openings of the entry guide port <NUM> and the assistant port <NUM> are defined, an outer element <NUM> (as an example of element 10b) received in the proximal opening of the envelope <NUM>, and a countermotion mechanism that rotates assistant port <NUM> around entry guide port <NUM> (and, thus, entry guide receptacle <NUM>) without envelope <NUM> twisting about a central axis of the envelope <NUM>. In use, when the instrument access device is affixed to a telesurgical system, entry guide receptacle <NUM> remains stationary in space as assistant port <NUM> rotates around it. (In this embodiment, entry guide receptacle <NUM> serves the function of the stationary component 10a.

<FIG> is an exploded perspective view depicting additional details of instrument access device <NUM>. In <FIG>, entry guide receptacle assembly <NUM> includes entry guide receptacle <NUM>, instrument guide seal <NUM>, seal support <NUM>, cover <NUM>, entry guide receptacle O-ring <NUM>, and entry guide receptacle retaining ring <NUM>. Instrument guide seal <NUM> is received in entry guide receptacle <NUM>. Cover <NUM> locks onto entry guide receptacle <NUM>, capturing (or "sandwiching") seal support <NUM> and instrument guide seal <NUM> between the cover <NUM> and entry guide receptacle <NUM>. Entry guide receptacle O-ring <NUM> is received in entry guide port <NUM> and seals the outer surface of the lumen of entry guide receptacle <NUM> in port <NUM>. Entry guide receptacle retaining ring <NUM> couples entry guide receptacle <NUM> into entry guide port <NUM> and thereby connects entry guide receptacle assembly <NUM> to countermotion assembly <NUM>.

In some examples, entry guide receptacle assembly <NUM> is configured to receive an instrument entry guide, which is configured to receive and seal multiple instruments through a single port. In such cases, instrument guide seal <NUM> is configured to receive and seal the instrument entry guide. In an example, instrument guide seal <NUM> can include a cross-slit seal, duckbill seal, wiper seal, septum seal, or another type of seal appropriate for receiving and sealing an instrument entry guide in accordance with this disclosure. In an example, instrument guide seal <NUM> includes a seal similar to that disclosed in International Application No. <CIT>) (disclosing an "INSTRUMENT SEAL").

In <FIG>, countermotion assembly <NUM> includes orbital element <NUM>, which includes entry guide port <NUM> and assistant port <NUM>. In addition, countermotion assembly <NUM> includes assistant port seal <NUM> and envelope O-ring <NUM>. Assistant port seal <NUM> is received in and is coupled to assistant port <NUM>. Assistant port seal <NUM> is configured to receive and seal a manually operated instrument and can include a variety of types of seals, including a cross-slit, duckbill, wiper, or septum seal. In an example, assistant port seal <NUM> includes a seal similar to that disclosed in International Application No. <CIT>. Envelope O-ring <NUM> is received in proximal opening <NUM> of envelope <NUM> and is configured to seal outer element <NUM> of countermotion assembly <NUM> in opening <NUM>. Together with O-ring <NUM>, O-ring <NUM> is important for holding insufflation while allowing the assistant port <NUM> to rotate about the entry guide port <NUM>. The instrument access device <NUM> also includes an envelope assistant port seal <NUM>, which is received in envelope assistant port <NUM> of envelope <NUM>. Envelope assistant port seal <NUM> is configured to receive and seal a manually operated instrument and can include a variety of types of seals, including a cross-slit, duckbill, wiper, or septum seal. In an example, envelope assistant port seal <NUM> includes a seal similar to that disclosed in International Application No. <CIT>.

<FIG> is a bottom plan view depicting gear train <NUM> in accordance with one embodiment. Gear train <NUM> is a mechanism by which assistant port <NUM> is able to rotate around entry guide receptacle <NUM> and entry guide port <NUM> without envelope <NUM> rotating about a central axis of the envelope, or, in other words, without envelope <NUM> twisting. Gear train <NUM> includes first gear <NUM>, second gear <NUM>, idler gear <NUM>, and intermediate gear <NUM>. In <FIG>, first gear <NUM> and second gear <NUM> are ring gears, with the gear teeth of first gear <NUM> facing radially inward and the gear teeth of second gear <NUM> facing radially outward. Intermediate gear <NUM> is a step spur gear including third spur gear <NUM> and fourth spur gear <NUM> (hidden behind third spur gear <NUM>) engaged with idler gear <NUM> (partially hidden behind third spur gear <NUM>). Third and fourth spur gears <NUM>, <NUM> are coaxially coupled and rotate together.

First gear <NUM> is positioned around the outer periphery of orbital element <NUM> of countermotion assembly <NUM>, and it is configured to be affixed to outer element <NUM>, which is coupled to proximal opening <NUM> of envelope <NUM>. Second gear <NUM> is coupled to the outer periphery of entry guide receptacle <NUM>. Note that the first and second gears <NUM>, <NUM> are located in different planes, second gear <NUM> being above (that is, in the bottom-up view, below) first gear <NUM>, and they do not directly operatively engage each other. The first and second gears <NUM>, <NUM> are coupled via idler gear <NUM> and intermediate gear <NUM> (all collectively forming countermotion mechanism 10d). More specifically, idler gear <NUM> operatively engages second gear <NUM> and fourth gear <NUM> of intermediate gear <NUM>. Fourth gear <NUM> is coupled to third gear <NUM> of intermediate gear <NUM>, which, in turn, operatively engages first gear <NUM>. Idler gear <NUM> reverses the direction of rotation between first gear <NUM> and second gear <NUM>. In particular, from the perspective of the view of <FIG>, idler gear <NUM> rotates counter-clockwise when intermediate gear <NUM> (including third and fourth gears <NUM> and <NUM>) rotates clockwise.

In the example of <FIG>, gear train <NUM> is depicted in a first position. To illustrate motion of the gear train <NUM>, and by association assistant port <NUM>, gear train <NUM> is depicted in two additional positions in <FIG> and <FIG>. Referring to <FIG>, note first that second gear <NUM> and, by association, entry guide receptacle <NUM> stay fixed in space and do not either translate or rotate relative to the telesurgical system. (Entry guide port <NUM> is likewise translationally fixed in space but rotates along with the orbital element relative to the entry guide receptacle. ) Idler gear <NUM> is operatively engaged with and rotates around second gear <NUM>. As idler gear <NUM> turns as it translates around second gear <NUM>, idler gear <NUM> turns fourth spur gear <NUM> of intermediate gear <NUM>, which, in turn causes third spur gear <NUM> of intermediate gear <NUM> to turn. As third spur gear <NUM> turns, it rotates first gear <NUM> and causes first gear <NUM> to translate around a central axis of entry guide port <NUM> without rotating about the central axis of first gear <NUM>. This is the manner in which assistant port <NUM> is able rotate around entry guide port <NUM> and entry guide receptacle <NUM> without causing envelope <NUM> (which is coupled to first gear <NUM>) to twist. Note that, along with first gear <NUM> and the outer element <NUM> of the countermotion mechanism, the proximal opening of the envelope <NUM> translates as well and thereby changes its position relative to the distal opening of the envelope <NUM>. This relative motion between the proximal and distal openings is accommodated by the flexible or movable nature of the envelope <NUM>.

This swinging translation of first gear <NUM> (and by association envelope <NUM>) about entry guide port <NUM> is enabled, at least in part, by the gear ratios of the various gears of gear train <NUM>: the gear ratios are chosen such that the rotations remain synchronized in that a rotation of the first gear <NUM> relative to the idler gear <NUM> by a certain angle in one direction is accompanied by a rotation of the second gear <NUM> relative to the idler gear <NUM> by the same angle in the opposite direction. In particular, a gear ratio of the third spur gear <NUM> to the fourth spur gear <NUM> is equal to a gear ratio of first gear <NUM> to second gear <NUM>. The motion of first gear <NUM> can be tracked in <FIG> by reference to index mark <NUM> on the outer element <NUM> and gear <NUM>. Note that while index mark <NUM> translates relative to entry guide receptacle <NUM> and entry guide port <NUM>, the mark <NUM> and therefore first gear <NUM> do not rotate. Or in other words, the first gear stays in a fixed rotational orientation relative to entry guide receptacle <NUM> and entry guide port <NUM>.

<FIG> is a bottom perspective view depicting gear train <NUM> in accordance with another embodiment. Gear train <NUM> is another mechanism by which assistant port <NUM> is able to rotate around entry guide receptacle <NUM> and entry guide port <NUM> without envelope <NUM> rotating about a central axis of the envelope, or in other words without envelope <NUM> twisting. Gear train <NUM> includes first gear <NUM>, second gear <NUM>, and intermediate gear <NUM>. In <FIG>, first gear <NUM> and second gear <NUM> are ring gears with the gear teeth of first gear <NUM> and second gear <NUM> facing radially inward. Additionally, intermediate gear <NUM> is a step spur gear including third spur gear <NUM> and fourth spur gear <NUM>, so that gears <NUM> and <NUM> are coaxially coupled and rotate together.

First gear <NUM> is positioned around the outer periphery of orbital element <NUM> of countermotion assembly <NUM> and is configured, along with outer element <NUM>, to be positioned in and coupled to proximal opening <NUM> of envelope <NUM> (see <FIG> and <FIG>). Second gear <NUM> is positioned around the outer periphery of entry guide receptacle <NUM>. Intermediate gear <NUM> is positioned between first gear <NUM> and second gear <NUM>. Third spur gear <NUM> of intermediate gear <NUM> operatively engages first gear <NUM>. Fourth spur gear <NUM> of intermediate gear <NUM> operatively engages second gear <NUM>.

<FIG> is a bottom plan view depicting gear train <NUM>. In the example of <FIG>, gear train <NUM> is depicted in a first position. To illustrate motion of the gear train <NUM>, and by association orbital element <NUM>, which includes assistant port <NUM>, gear train <NUM> is depicted in two additional positions in <FIG> and <FIG>. Referring to <FIG>, note first that second gear <NUM>, and by association entry guide receptacle <NUM>, stay fixed in space and do not either translate or rotate relative to other components. Fourth spur gear <NUM> of intermediate gear <NUM> rotates around and is operatively engaged to second gear <NUM>. As fourth spur gear <NUM> rotates around second gear <NUM>, third spur gear <NUM> of intermediate gear <NUM> engages and turns first gear <NUM>, which causes first gear <NUM> to translate around a central axis of entry guide port <NUM> without rotating relative to the central axis of first gear <NUM>. This is the manner in which assistant port <NUM> is able to rotate around entry guide port <NUM> and entry guide receptacle <NUM> without causing envelope <NUM> (which is coupled to first gear <NUM>) to twist.

This swinging translation of first gear <NUM> (and by association envelope <NUM>) about entry guide port <NUM> is enabled, at least in part, by the gear ratios of the various gears of gear train <NUM>. In particular, a gear ratio of the third spur gear <NUM> to the fourth spur gear <NUM> is equal to a gear ratio of first gear <NUM> to second gear <NUM>. The motion of first gear <NUM> can be tracked in <FIG> by reference to index mark <NUM> on the outer element <NUM> and gear <NUM>. Note that while index mark <NUM> translates relative to entry guide receptacle <NUM> and entry guide port <NUM>, the mark <NUM>, and therefore first gear <NUM> do not rotate. In other words, the first gear stays in a fixed rotational orientation relative to entry guide receptacle <NUM> and entry guide port <NUM>.

<FIG> is a bottom perspective view depicting gear train <NUM> in accordance with yet another embodiment. Gear train <NUM> is another mechanism by which assistant port <NUM> is able to rotate around entry guide receptacle <NUM> and entry guide port <NUM> without envelope <NUM> rotating about a central axis of the envelope, or in other words without envelope <NUM> twisting. Gear train <NUM> includes first gear <NUM>, second gear <NUM>, and intermediate gear <NUM>, and it operates in a manner similar to gear train <NUM> with the differences that, as shown in <FIG>, first gear <NUM> and second gear <NUM> are ring gears with the gear teeth of first gear <NUM> and second gear <NUM> facing radially outward, and intermediate gear <NUM> is a step spur gear including third spur gear <NUM> and fourth spur gear <NUM> located outside the first and second ring gears <NUM>, <NUM>.

First gear <NUM> is positioned around the outer periphery of orbital element <NUM> of countermotion assembly <NUM> and is configured, along with the outer element <NUM>, to be positioned in and coupled to proximal opening <NUM> of envelope <NUM> (see <FIG> and <FIG>). Second gear <NUM> is positioned around the outer periphery of entry guide receptacle <NUM>. Intermediate gear <NUM> is positioned between first gear <NUM> and second gear <NUM>. In this example, the outer element <NUM> includes three outward-protruding optional tabs <NUM>, and intermediate gear <NUM>, which includes third and fourth spur gears <NUM>, <NUM>, is arranged within one of the three tabs <NUM>. Tabs <NUM> can serve multiple functions, including housing intermediate gear <NUM> and providing finger grips to manipulate countermotion assembly <NUM> to rotate assistant port <NUM>. Third spur gear <NUM> of intermediate gear <NUM> operatively engages first gear <NUM>. Fourth spur gear <NUM> of intermediate gear <NUM> operatively engages second gear <NUM>.

<FIG> is a bottom plan view depicting gear train <NUM> in accordance with this disclosure. In the example of <FIG>, gear train <NUM> is depicted in a first position. To illustrate motion of the gear train <NUM>, and by association orbital element <NUM> and assistant port <NUM>, gear train <NUM> is depicted in two additional positions in <FIG> and <FIG>. Referring to <FIG>, note first that second gear <NUM> and by association entry guide receptacle <NUM> stay fixed in space and do not either translate or rotate relative to other components. Fourth spur gear <NUM> of intermediate gear <NUM> rotates around and is operatively engaged to second gear <NUM>. As fourth spur gear <NUM> rotates around second gear <NUM>, third spur gear <NUM> of intermediate gear <NUM> engages and turns first gear <NUM>, which causes first gear <NUM> to translate around a central axis of entry guide port <NUM> without rotating about the central axis of first gear <NUM>. This is the manner in which assistant port <NUM> is able rotate around entry guide port <NUM> and entry guide receptacle <NUM> without causing envelope <NUM> (which is coupled to first gear <NUM>) to twist.

This swinging translation of first gear <NUM> (and by association envelope <NUM>) about entry guide port <NUM> is enabled, at least in part, by the gear ratios of the various gears of gear train <NUM>. In particular, a gear ratio of the third spur gear <NUM> to the fourth spur gear <NUM> is equal to a gear ratio of first gear <NUM> to second gear <NUM>. The motion of first gear <NUM> can be tracked in <FIG> by reference to index mark <NUM> on the outer element <NUM> and gear <NUM>. Note that while index mark <NUM> translates relative to entry guide receptacle <NUM> and entry guide port <NUM>, the mark <NUM> and therefore first gear <NUM> do not rotate. In other words, the first gear stays in a fixed rotational orientation relative to entry guide receptacle <NUM> and entry guide port <NUM>.

<FIG> is a top perspective view of proximal coupling component <NUM> of another instrument access device in accordance with various embodiments. The proximal coupling component <NUM> includes entry guide receptacle assembly <NUM> and countermotion assembly <NUM>. The envelope (coupled to proximal coupling component) and clamp (disposed in and coupled to the distal opening of the envelope) of the instrument access device are not shown. The envelope and clamp are the same or similar to those depicted in <FIG> and <FIG> for instrument access device <NUM>.

Countermotion assembly <NUM> includes inner hub <NUM>, outer rim <NUM>, and crank arm <NUM>. Inner hub <NUM> includes entry guide port <NUM> and assistant port <NUM>. Entry guide port <NUM> and assistant port <NUM> are positioned eccentrically on inner hub <NUM>. Outer rim <NUM> is coupled to the envelope. Inner hub <NUM> is rotatable relative to outer rim <NUM> about a central axis of outer rim <NUM>. Entry guide receptacle assembly <NUM>, which includes entry guide receptacle <NUM> and connector <NUM>, is received in entry guide port <NUM>. Crank arm <NUM> is pivotally connected to outer rim <NUM>. Connector <NUM> affixes instrument access device <NUM> to an arm of a teleoperated surgical system, such as the system depicted and described with reference to <FIG>.

Inner hub <NUM>, outer rim <NUM>, crank arm <NUM>, and entry guide receptacle assembly <NUM> are connected to one another to form a linkage. The linkage is configured to rotate assistant port <NUM> around entry guide receptacle <NUM> without the envelope connected to outer rim <NUM> rotating about a central axis of the envelope. Thus, the linkage allows assistant port <NUM> to rotate around entry guide receptacle <NUM> without twisting the envelope.

In the example of <FIG>, inner hub <NUM>, outer rim <NUM>, crank arm <NUM>, and entry guide receptacle assembly <NUM> are connected to one another to form a <NUM>-bar linkage <NUM>, more specifically, a parallel <NUM>-bar linkage. Entry guide receptacle assembly <NUM> is the ground link of the <NUM>-bar linkage, and crank arm <NUM> is the input link of the linkage. Inner hub <NUM> and outer rim <NUM> are each coupler links of the <NUM>-bar parallel linkage formed by inner hub <NUM>, outer rim <NUM>, crank arm <NUM>, and entry guide receptacle assembly <NUM>. The four axes of rotation associated with the joints of the linkage <NUM>, where pairs of adjacent links are coupled, are depicted with dashed lines in <FIG>. At the first axis <NUM>, the crank arm <NUM> is coupled to the entry guide receptacle assembly <NUM> (at or near the connector <NUM> of the entry guide receptacle assembly <NUM>). The second axis <NUM>, which goes through the center of the entry guide port, corresponds to the joint that couples the entry guide receptacle assembly <NUM> to the inner hub <NUM>. The third axis <NUM>, which goes through the common center of the rim <NUM> and hub <NUM>, corresponds to the joint that couples the hub <NUM> to the outer rim <NUM>. The fourth axis <NUM>, which is the pivot axis of the crank arm <NUM>, couples the rim <NUM> to the crank arm <NUM>. The distance between axes <NUM>, <NUM> (the length of the crank-arm link) is equal to the distance between axes <NUM>, <NUM> (the distance between the centers of the rim and the entry guide port), and the distance between axes <NUM>, <NUM> is equal to the distance between axes <NUM>, <NUM>, such that the axes <NUM>, <NUM>, <NUM>, <NUM> form a parallelogram.

Countermotion assembly <NUM> also includes a locking mechanism for locking linkage <NUM> from moving and thereby for locking assistant port <NUM> in a position relative to entry guide receptacle <NUM> and entry guide port <NUM>. In <FIG>, lock arm <NUM> is deflectable relative to outer rim <NUM> and includes a catch on an underside of lock arm <NUM>. Outer rim <NUM> includes ratchet teeth <NUM>. Lock arm <NUM> is resilient and configured to lock into ratchet teeth <NUM>. Lock arm <NUM> can be deflected to raise the lock arm out of engagement with ratchet teeth <NUM> and thereby unlock the linkage formed by inner hub <NUM>, outer rim <NUM>, entry guide receptacle assembly <NUM>, and crank arm <NUM>, which in turn allows assistant port <NUM> to rotate relative to and about entry guide receptacle <NUM> and entry guide port <NUM>.

<FIG> is a plan view depicting linkage <NUM> formed by inner hub <NUM>, outer rim <NUM>, entry guide receptacle assembly <NUM>, and crank arm <NUM>. In the example of <FIG>, linkage <NUM> is depicted in a first position. To illustrate motion of linkage <NUM>, and by association assistant port <NUM>, linkage <NUM> is depicted in two additional positions in <FIG> and <FIG>. The axes of rotation <NUM>, <NUM>, <NUM>, <NUM> are indicated by black dots in these plan views. Referring to <FIG>, note first that entry guide receptacle <NUM> stays fixed in space and does not either translate or rotate relative to other components. Crank arm <NUM> is pivotable relative to inner hub <NUM> and outer rim <NUM>. Pivoting crank arm <NUM> causes inner hub <NUM> to rotate relative to outer rim <NUM>. Additionally, pivoting crank arm <NUM> causes outer rim <NUM>, which is connected to the envelope, to translate without rotating about a central axis of outer rim <NUM>. This is the manner in which assistant port <NUM> is able to rotate around entry guide receptacle <NUM> and entry guide port <NUM> without causing the envelope (which is coupled to outer rim <NUM>) to twist.

As noted above, examples according to this disclosure include an instrument access device that includes an envelope, and the envelope includes a distal opening at a distal end, a proximal opening at a proximal end, and a cavity between the distal and proximal ends and openings. The distal end of the envelope is coupled to a distal coupling component, which may be or include, e.g., a clamp. The clamp or other distal coupling component can, in turn, be coupled to a wound retractor or other port device. The proximal end of the envelope is coupled to a proximal coupling component, e.g., one including a countermotion assembly as described above. The instrument access device is configured to receive an insufflation gas and to maintain insufflation pressure within a cavity in the body of a patient and to maintain insufflation pressure within the cavity of the envelope. The pressurized and sealed envelope cavity provides an operating space for shafts of multiple instruments of a teleoperated surgical system to articulate outside the body such that instrument end effectors can be located at or near the surface of the body at the incision site of the wound retractor coupled to the instrument access device.

In examples according to this disclosure, the pressurized envelope is configured to allow shafts of multiple instruments of a teleoperated surgical system to triangulate within the cavity of the envelope. Thus, the envelope needs to provide enough space to allow multiple instruments to be manipulated within the cavity of the envelope and to allow a surgeon to triangulate the instruments to perform various procedures at or near the surface of the body at the incision site of the wound retractor coupled to the instrument access device. Patent No. <CIT>) discloses aspects of instrument triangulation in a single-port surgical system.

The pressurized envelope may be (but need not be) manufactured from a transparent material, including, for example, a transparent polymer. Beneficially, a transparent envelope provides visualization for a clinician to see the incision site to which the envelope is connected. In use of the instrument access device, the envelope is connected to a proximal coupling component (similar to the examples described above with reference to <FIG>) that can receive medical instruments via one or more ports (e.g., a primary entry guide port and an assistant port), and the envelope can provide visualization for the clinician for instruments introduced via these ports. When an opaque material is used for the envelope, visualization can be provided by an endoscopic camera inserted into the instrument access device via one of the ports, or optionally by one or more transparent windows in the envelope.

In various embodiments, the envelope of the instrument access device, when pressurized with insufflation gas or when constructed with sufficient rigidity, extends radially outward beyond the proximal and distal openings in the envelope (and thus beyond the portions of the proximal and distal coupling components received in the respective openings). Example shapes and configurations of the envelope are described with respect to <FIG>.

<FIG> is a perspective view depicting example instrument access device <NUM> according to various embodiments. In <FIG>, instrument access device <NUM> includes envelope <NUM>, distal coupling component <NUM>, entry guide receptacle assembly <NUM>, and countermotion assembly <NUM>. Entry guide receptacle assembly <NUM> and countermotion assembly <NUM> can be similar to the entry guide receptacle assemblies and countermotion assemblies described above with reference to <FIG>. For example, entry guide receptacle assembly <NUM> includes entry guide receptacle <NUM> and countermotion assembly <NUM> includes orbital element <NUM> having entry guide port <NUM> and assistant port <NUM>, surrounded by outer element <NUM>.

Envelope <NUM> includes distal opening <NUM> and proximal opening <NUM>. Distal opening <NUM> of envelope <NUM> is coupled to and receives clamp (or other distal coupling component) <NUM>, which is configured to be connected to a port device, such as a wound retractor assembly, at an incision site. Proximal opening <NUM> of envelope <NUM> is coupled to and receives countermotion assembly <NUM>. Distal opening <NUM> of envelope <NUM> can be coupled to clamp <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to clamp <NUM>. Similarly, proximal opening <NUM> of envelope <NUM> can be coupled to countermotion assembly <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to countermotion assembly <NUM> at the outer element <NUM>.

As will be described in greater detail below, envelope <NUM> can be of a variety of shapes and sizes. In general, however, envelope <NUM>, on condition that envelope <NUM> is pressurized with insufflation gas or if sufficiently rigid, extends radially outward beyond clamp <NUM> and countermotion assembly <NUM>. In the example of <FIG>, envelope <NUM> includes proximal section <NUM> and distal section <NUM>. Proximal section <NUM> of envelope <NUM> is coupled to distal section <NUM> at junction <NUM>. Proximal section <NUM> can be coupled to distal section <NUM> by a variety of means, including using an adhesive, or heat-sealing proximal section <NUM> to distal section <NUM>. Proximal section <NUM> and distal section <NUM> may each be a single contiguous piece, or be alternatively formed of multiple pieces. In multi-piece sections <NUM>, <NUM>, the proximal opening <NUM> may be formed in a first piece included in the proximal section <NUM>, and the distal opening <NUM> may be formed in a second piece included in the distal section <NUM>.

Proximal section <NUM> of envelope <NUM> can be a first convex section. Distal section <NUM> of envelope <NUM> can be a second convex section generally opposed to proximal convex section <NUM>. The combination of proximal section <NUM> and distal section <NUM> can form an ovoid shape as shown (e.g., as characterized by two convex portions that meet at a common maximum diameter, but generally differ in height). As will be described in detail below, other shapes are also possible. In the depicted example, the maximum diameter of envelope <NUM> is located at junction <NUM> connecting proximal section <NUM> to distal section <NUM>. In an example, the maximum diameter of envelope <NUM> is optionally larger than the longitudinal height of envelope <NUM>. Additionally, junction <NUM> can be located below a transverse plane that bisects envelope <NUM> longitudinally (in a direction along a center axis defined through the distal and proximal openings <NUM> and <NUM> of the envelope). In other words, with proximal section <NUM> of the envelope <NUM> extending a first distance along the center axis and the distal section <NUM> of the envelope <NUM> extending along a second distance along the center axis, the second distance can be less than the first distance. Locating junction <NUM> below the longitudinal midpoint of envelope <NUM> can improve visualization for a clinician by providing a larger field of view through proximal section <NUM> that is unobstructed by junction <NUM>.

Envelope <NUM> includes an optional additional assistant port <NUM>. Envelope assistant port <NUM> includes seal <NUM>, which is received in port <NUM> of envelope <NUM>. Envelope assistant port seal <NUM> is configured to receive and seal a manually operated instrument and can include a variety of types of seals, including a cross-slit, duckbill, wiper, and/or septum seal. In the example of <FIG>, envelope assistant port seal <NUM> includes a cross-slit seal. In another example, envelope assistant port seal <NUM> includes a seal similar to the seals disclosed in International Application No. <CIT>).

Envelope <NUM> (and other envelopes in accordance with this disclosure) can be manufactured from a variety of materials, including a variety of transparent polymers. In an example, envelope <NUM> is manufactured from acetates, polyester, vinyl, or urethanes (e.g., thermoplastic polyurethane (TPU)). Envelope <NUM> can be manufactured in a variety of ways, including vacuum forming. In another example, envelope <NUM> is manufactured from a flat panel with multiple seams, which are joined to one another to form the final shape of envelope <NUM>.

<FIG> are perspective views depicting additional example envelopes in accordance with this disclosure. The same materials as listed above may be used for the envelopes of <FIG> as well. In <FIG>, instrument access device <NUM> includes envelope <NUM>, clamp <NUM>, entry guide receptacle assembly <NUM>, and countermotion assembly <NUM>. Entry guide receptacle assembly <NUM> and countermotion assembly <NUM> can be similar to the entry guide receptacle assemblies and instrument seal assemblies described above with reference to <FIG>.

Envelope <NUM> includes distal opening <NUM> and proximal opening <NUM>. Distal opening <NUM> of envelope <NUM> is coupled to and receives clamp <NUM>, which is configured to be connected to a port device, such as a wound retractor assembly at an incision site. Proximal opening <NUM> of envelope <NUM> is coupled to and receives countermotion assembly <NUM>. Distal opening <NUM> of envelope <NUM> can be coupled to clamp <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to clamp <NUM>. Similarly, proximal opening <NUM> of envelope <NUM> can be coupled to countermotion assembly <NUM> by a variety of means, including using an adhesive or heat-sealing envelope <NUM> to countermotion assembly <NUM> at the outer element.

In the example of <FIG>, envelope <NUM> has a substantially spherical shape (allowing for some deviations from perfect spherical shape, e.g., to accommodate for the proximal and distal openings). Although not depicted in <FIG>, in examples, spherical envelope <NUM> may be formed from two or more semi-spherical sections joined together at a seam or other junction.

Envelope <NUM> includes, optionally, an additional assistant port <NUM>. Envelope assistant port <NUM> includes seal <NUM>, which is received in port <NUM> of envelope <NUM>. Envelope assistant port seal <NUM> is configured to receive and seal a manually operated instrument and can include a variety of types of seals, including a cross-slit, duckbill, wiper, and/or septum seal. In the example of <FIG>, envelope assistant port seal <NUM> includes a cross-slit seal. In another example, envelope assistant port seal <NUM> includes a seal similar to seals disclosed in International Application No. <CIT>.

Envelope <NUM> can be manufactured in a variety of ways, including vacuum forming. In another example, envelope <NUM> is manufactured from a flat panel with multiple seams, which are joined to one another to form the final shape of envelope <NUM>.

Referring now to <FIG>, instrument access device <NUM> includes envelope <NUM>, clamp <NUM>, entry guide receptacle assembly <NUM>, and countermotion assembly <NUM>. Entry guide receptacle assembly <NUM> and countermotion assembly <NUM> can be similar to the entry guide receptacle assemblies and instrument seal assemblies described above with reference to <FIG>.

Envelope <NUM> includes distal opening <NUM> and proximal opening <NUM>. Distal opening <NUM> of envelope <NUM> is coupled to and receives clamp <NUM>, which is configured to be connected to a port device, such as a wound retractor assembly at an incision site. Proximal opening <NUM> of envelope <NUM> is coupled to and receives countermotion assembly <NUM>. Distal end <NUM> of envelope <NUM> can be coupled to clamp <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to clamp <NUM>. Similarly, proximal end <NUM> of envelope <NUM> can be coupled to countermotion assembly <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to countermotion assembly <NUM> at the outer element.

In the example of <FIG>, envelope <NUM> has an oblate spheroid shape. Although not depicted in <FIG>, in examples, oblate spheroid envelope <NUM> may be formed from two or more semi-spheroid sections which are joined together at a seam or other junction. Although not depicted in <FIG>, envelope <NUM> can optionally include an additional assistant port having an assistant port seal as described above.

In <FIG>, instrument access device <NUM> includes envelope <NUM>, clamp <NUM>, entry guide receptacle assembly <NUM>, and countermotion assembly <NUM>. Entry guide receptacle assembly <NUM> and countermotion assembly <NUM> can be similar to the entry guide receptacle assemblies and instrument seal assemblies described above with reference to <FIG>.

In the example of <FIG>, envelope <NUM> has a generally cylindrical shape, and more specifically a cylindrical bellows shape. Although not depicted in <FIG>, in examples, bellows-shaped envelope <NUM> may be formed from two or more sections joined together at seam(s) or other junction(s). Additionally, although not depicted in <FIG>, envelope <NUM> can optionally include an additional assistant port having an assistant port seal.

Envelope <NUM> includes distal opening <NUM> and proximal opening <NUM>. Distal opening <NUM> of envelope <NUM> is coupled to and receives clamp <NUM>, which is configured to be connected to a port device, such as a wound retractor assembly at an incision site. Proximal opening <NUM> of envelope <NUM> is coupled to and receives countermotion assembly <NUM>. Distal end <NUM> of envelope <NUM> can be coupled to clamp <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to clamp <NUM>. Similarly, proximal opening <NUM> of envelope <NUM> can be coupled to countermotion assembly <NUM> by a variety of means, including using an adhesive, or heat-sealing envelope <NUM> to countermotion assembly <NUM>.

In the example of <FIG>, envelope <NUM> has a lenticular shape. The lenticular-shaped envelope <NUM> includes first and second convex sections <NUM>, <NUM> sharing a common maximum diameter. The two convex sections <NUM>, <NUM> are positioned opposite one another, and they are joined in an equatorial region <NUM>, where the common maximum diameters of the two sections <NUM>, <NUM> meet. In the example of <FIG>, the envelope <NUM> includes rib <NUM> at the equatorial region <NUM>, and rib <NUM> extends radially outward from first convex section <NUM> and second convex section <NUM>. Rib <NUM> provides structural support around the perimeter of equatorial region <NUM> to prevent, for example, inward buckling of the lenticular shape at the equatorial region <NUM> under insufflation pressure.

The two sections <NUM>, <NUM> of lenticular-shaped envelope <NUM> may be symmetrical as shown, or they may be of different sizes. For example, proximal convex section <NUM> may have a larger longitudinal height than distal convex section <NUM> to provide enhanced visibility inside the envelope as described above. The proximal and convex sections may be joined together at seam(s) or other junction(s). Additionally, although not depicted in <FIG>, envelope <NUM> can optionally include an additional assistant port having an assistant port seal as described above.

In <FIG>, instrument access device <NUM> includes envelope <NUM>. Instrument access device <NUM> can be substantially similar to instrument access device <NUM> of <FIG>, except that its envelope <NUM>, instead of being lenticular-shaped like envelope <NUM>, includes an elongated vertical section <NUM> between the two (e.g., convex) top and bottom sections <NUM>, <NUM>. Thus, envelope <NUM> generally has the shape of a barrel (e.g., bulging outward in the center, or, alternatively, being substantially cylindrical) bounded at the top and bottom by convex or, alternatively, flat or generally flat surfaces. Envelope <NUM>, when pressurized with insufflation gas, extends radially outward beyond a clamp or other distal coupling component as well as beyond the countermotion assembly of a proximal coupling component. Envelope <NUM> may include an assistant port and seal (not shown) as described above.

As explained above, various instrument access devices in accordance with this disclosure (e.g., devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) are configured to receive an instrument entry guide in an entry guide receptacle located in an entry guide port of the instrument access device. An example such entry guide is described in the following disclosure.

<FIG> is a perspective view of an instrument entry guide <NUM> in accordance with the invention. The entry guide <NUM> includes a funnel portion <NUM> at the proximal end and, connected to the distal end of the funnel portion <NUM>, a shaft portion <NUM>. Multiple instrument channels are defined in entry guide <NUM>, and each instrument channel includes an optional proximal tapered lead-in portion <NUM> in funnel portion <NUM> and a distal lumen <NUM> in shaft portion <NUM>. Four instrument channels are shown, and other optional implementations may include two, three, or more instrument channels. Each instrument channel is configured to receive and guide an instrument through the entry guide to emerge from the distal end of the lumen <NUM>. The cross sections of the instrument channels may all have the same size and shape, or they may vary in size and/or shape to guide different instruments through the entry guide.

<FIG> is a top view of entry guide <NUM>, showing the funnel portions <NUM> and its tapered lead-in portions <NUM> at the proximal end of the entry guide <NUM> of <FIG>. <FIG> illustrates instrument channels (lead-in portions <NUM> and lumens <NUM>) of different cross-sectional shapes and sizes in accordance with one embodiment. One lumen <NUM> has a relatively larger round cross section than round cross section lumens <NUM>. In one optional implementation, lumen <NUM> is sized to receive an instrument comprising an instrument shaft with a diameter of <NUM> millimeters or less, such as diameters in the range of <NUM>-<NUM> millimeters. Two lumens <NUM> have relatively smaller round cross sections than lumen <NUM>. These lumens <NUM> are optionally sized to each receive an instrument with an instrument shaft having a diameter of <NUM> millimeters or less, such as diameters that are approximately <NUM> millimeters. The cross section of the fourth lumen <NUM> is oval in shape, and it is suitable to accommodate, e.g., a camera instrument. The relative sizes and cross-sectional shapes of the lumens <NUM>, <NUM>, <NUM> illustrate that various combinations of lumen sizes and cross section shapes may be used in implementations of entry guide <NUM>.

<FIG> is an exploded perspective view of the entry guide <NUM> that illustrates further detail. As shown, the funnel portion <NUM> may be formed of two parts: an upper part <NUM> and a lower part <NUM>. The lower part <NUM> optionally may be integrally formed with the shaft <NUM>. The entry guide <NUM> further includes an instrument seal <NUM> captured between the upper and lower parts <NUM>, <NUM> of the funnel portion <NUM>. The seal may be made, e.g., of silicone. During manufacturing, the instrument seal <NUM> can be seated in the lower part <NUM>, and the upper part <NUM> can then be snapped into the lower part <NUM>, with an O-ring <NUM> sealing the two parts along their rims. The instrument seal <NUM> includes seal openings <NUM> aligned with the instrument channels <NUM> and lumens <NUM>, and the seal openings <NUM> are sized and shaped to accommodate an associated instrument outer diameter. The entry guide <NUM> further includes pivoting seal doors <NUM> each aligned with one of the seal openings <NUM> and the associated instrument channel <NUM>. In some embodiments, the entry guide also includes levers <NUM> to manually operate the doors <NUM>. (Some, but not all, of the pivoting doors <NUM> and levers <NUM> are shown exploded off to the side.

The doors <NUM> may be spring-loaded and biased to the closed state. In its closed state, each door engages with and seals against the instrument seal <NUM>, with a sealing portion of the door sealing one of the seal openings <NUM>. When an instrument is inserted through a lead-in portion <NUM> of the funnel portion <NUM> and into a corresponding lumen in the shaft <NUM>, the door <NUM> associated with the lumen is pushed open. When a door <NUM> is in an open state, the lip of corresponding seal opening <NUM> seals against the shaft of the instrument extending through the corresponding instrument channel. The instrument seal <NUM> in conjunction with the sealing door <NUM> prevents insufflation gas from escaping through an instrument channel when no instrument is inserted and from escaping between the inner wall of the channel and the instrument shaft when an instrument is inserted. Further details of entry guides and associated sealing aspects are described in <CIT>)(disclosing "Sealing Multiple Surgical Instruments").

<FIG> is a cross-sectional view of the entry guide <NUM>, taken along a longitudinal axis of the entry guide <NUM> (i.e., along the direction of the shaft <NUM>). Unlike prior entry guides, entry guide <NUM> is configured to slightly bend the shafts of one or more of the inserted instruments. In prior entry guide configurations, the instrument channels in an entry guide are configured so that instrument shafts, despite entering the instrument channels in the funnel portion <NUM> from generally different directions, exit the lumens <NUM> of the shaft <NUM> substantially parallel to each other and to the longitudinal axis of the entry guide <NUM> (e.g., deviating from the longitudinal axis by no more than <NUM> degree). In prior entry guides, this reorientation of the instrument shafts to be generally parallel is achieved by curving the distal ends of the lumens <NUM> slightly radially outward, compensating for the remaining orientational bias of the instrument shafts that results from the radially inward component of their orientation where they enter the instrument channels. But this straightening effect is insufficient to keep the instrument shafts parallel upon exiting the lumens <NUM> when the length of the shaft <NUM> of the entry guide <NUM> is shortened, e.g., to minimize the space the shaft <NUM> takes up inside the envelope of an instrument access device in accordance with the present disclosure. Thus, if the entry guide shaft <NUM> is shortened without further compensating for the inward orientational bias of resiliently bendable instrument shafts entering the proximal end of the entry guide, the instrument shafts will cross or collide after they exit the entry guide lumens <NUM>.

To remedy this problem and keep the instrument shafts parallel at the exit of the lumens <NUM> of a shortened entry guide, one or more of the lumens <NUM> are modified to include a small projection <NUM> at their distal ends. Projection <NUM> extends radially inward into to the lumen <NUM> to deflect the instrument shaft extending through the lumen radially outward from the lumen's centerline and the entry guide's central axis. The projection <NUM> in a lumen may be positioned on the central junction between the multiple lumens such that it points away from the central axis of the entry guide shaft <NUM>. The projection <NUM> is sized and shaped to deflect and orient a shaft of an instrument parallel to the longitudinal axis of the entry guide shaft <NUM>. The size and shape of the projection <NUM> may, for instance, depend on the flexibility of the instrument shaft of the instrument intended to be received in the respective lumen <NUM>. Some instruments extending through instrument channels in entry guide <NUM> may have shafts that are sufficiently rigid that no projection <NUM> is required at the distal end of these instruments' corresponding instrument channel. And so, for example, an entry guide <NUM> as depicted in <FIG> may have projections at the ends of the three lumens <NUM>, <NUM> intended to receive surgical instruments, whereas the lumen <NUM> for the camera may lack such a projection because the camera shaft is sufficiently rigid. In general however, an entry guide in accordance herewith may include inward projections <NUM> in any one or more, including all, lumens.

The projection <NUM> at the distal end of lumen <NUM> forms a ramp that defines a lumen diameter that decreases from a proximal end of the ramp to a distal end of the ramp, and the ramp is positioned toward a center of the shaft <NUM> at the junction between the lumens <NUM>.

In accordance with a further aspect, entry guide <NUM> may optionally include a relief that defines an aperture in the outer periphery of the entry guide shaft <NUM> at a position opposite to the projection or ramp. This aperture extends the diameter of the lumen <NUM> outward and so allows for the extra bend in the instrument shaft. That is, the aperture provides extra room for the instrument shaft to bend outward, where the shaft would otherwise contact the outer wall of the lumen. Although the projections as described above reorient the instrument shafts into a generally parallel configuration after exiting the distal end of the entry guide, in optional alternate embodiments the projections in the lumens <NUM> are configured to deliberately spread the instruments laterally to a laterally converging orientation or to a laterally diverging orientation. In the laterally converging orientation, the projections still spread the instrument shafts sufficiently to prevent the instruments from colliding during normal operation. In the laterally diverging orientation, the projections spread the instrument shafts to provide additional spacing between the instruments.

Persons of skill in the art will understand that any of the features described above may be combined with any of the other example features, as long as the features are not mutually exclusive. All possible combinations of features are contemplated, depending on clinical or other design requirements.

The examples (e.g. methods, systems, or devices) described herein may be applicable to surgical procedures, non-surgical medical procedures, diagnostic procedures, cosmetic procedures, and non-medical procedures or applications. The examples may also be applicable for training, or for obtaining information, such as imaging procedures. The examples may be applicable to handling of tissue that has been removed from human or animal anatomies and will not be returned to a human or animal, or for use with human or animal cadavers.

The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. " Such examples may include elements in addition to those shown or described. But, the present inventors also contemplate examples in which only those elements shown or described are provided.

Geometric terms, such as "parallel", "perpendicular", "round", or "square", are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as "round" or "generally round", a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description. Coordinate systems or reference frames are provided for aiding explanation, and implantations may use other reference frames or coordinate systems other than those described herein.

Claim 1:
An instrument entry guide (<NUM>) comprising:
a shaft (<NUM>) comprising a proximal end, a distal end, a plurality of instrument lumens (<NUM>) between the proximal and distal ends of the shaft, and a central axis through the proximal and distal ends and between the plurality of instrument lumens;
wherein the plurality of lumens are parallel to one another within the shaft;
wherein at least a first one of the plurality of lumens comprises a projection (<NUM>) at the distal end of the shaft; and
wherein:
the projection extends radially inward into the first one of the plurality of lumens in a direction radially away from the central axis;
characterised in that the projection defines an inner diameter of the first one of the plurality of lumens that decreases from a proximal end of the projection to a distal end of the projection; and
the projection comprises a ramp.