Instrument entry guide

Abstract

Medical devices for surgical procedures are disclosed, particularly procedures involving manipulation of a surgical instrument end effector proximate a skin surface at an incision site. According to some embodiments, an instrument access device is configured to couple to a wound retractor at a distal end of the device and receive a multi-instrument entry guide in a port at a proximal end of the instrument access device, with an envelope between a distal end and a proximal end defining a sealed cavity for maintaining a gas pressure. Various embodiments provide means for rotating an auxiliary port in the envelope around a port receiving an instrument entry guide without twisting the envelope. Various envelope shapes are also disclosed. An instrument entry guide that aligns a surgical instrument shaft is also disclosed.

Description

[0001] CLAIM OF PRIORITY

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 908,531, filed September 30, 2019, the entirety of which is incorporated herein by reference. TECHNICAL FIELD

[0003] The present document relates generally to medical devices, and more particularly, to medical devices for use in minimally invasive surgical procedures. BACKGROUND

[0004] Surgical systems operated at least partially with computer-assisted control (‘‘teleoperated surgical systems’’) such as those used for minimally invasive medical procedures can include large, complex instruments for precise control of relatively small instruments. Such systems are sometimes referred to as robotic surgical systems or surgical robots. The da Vinci® surgical system commercialized by Intuitive Surgical, Inc. is an example of a teleoperated surgical system.

[0005] There are various teleoperated surgical system architectures. 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 separately at corresponding multiple locations, and these systems are sometimes referred to as “multi-port” systems (e.g., the da Vinci Xi® surgical system). Those skilled in the art will appreciate that multi-port systems can sometimes be configured to operate through a single natural body orifice (e.g., the mouth or anus) or through a single incision (e.g., Intuitive Surgical’s Single Site® technology used with the da Vinci Xi® surgical system) during surgery. Those skilled in the art will also appreciate that single-port and multi-port configurations can be combined simultaneously in a single teleoperated surgical 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).

[0006] Surgical instruments used during minimally invasive surgical procedures typically include an endoscopic camera or a therapeutic end effector mounted at the end of an elongated instrument shaft. Since the instrument end effector is typically located deep within the body during a surgical procedure, a teleoperated surgical system is designed to constrain rotation of the instrument at a point on the instrument shaft, often referred to as the remote center of motion. Either kinematic hardware structures or control system software design (or a combination of both) can be used to enforce this remote center of motion constraint. To minimize tissue trauma during a surgical procedure, the constrained remote center of motion is often located at or near the body opening through which the instrument is entered.

[0007] However, if a teleoperated surgical system is to be used at or near the body opening, there are several challenges. First, in order to provide sufficient distance between the constrained remote center of motion of the instrument and the end effector of the instrument, the constrained remote center of motion can need to be located proximal to the body opening, sometimes by several centimeters or more. Second, if part of the surgical procedure is performed proximal to the final surgical site (e.g., using the teleoperated surgical system to perform dissection to reach the final surgical site), a simple method is needed to reposition the constrained remote center of motion distally as the surgical procedure progresses to the deepest surgical site in the patient's body. A third challenge exists if insufflation is to be used in the body cavity (e.g., abdomen, rectum) in which the final surgical site is located. When the constrained remote center of motion is located at the body wall of the patient, and when a cannula is used to introduce the instrument through the body wall, a seal in the cannula is used to maintain the insufflation gas pressure within the body cavity when the 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 to the body opening, the insufflation gas pressure must still be maintained.

[0008] Furthermore, for single port systems in which two or more instruments can be introduced to the patient and moved as a single instrument cluster, these challenges become more complex as the constrained remote centers of motion of the two or more instruments are located at the same point or in close proximity to each other. Moreover, single port system instruments can be designed with joints that allow the single port system instruments to be inserted in close proximity to each other, but to expand apart separately after passing through the body wall to provide triangulation to perform the surgical procedure more effectively. And if additional instruments (teleoperated surgical system instruments or manually operated instruments) are to be introduced to assist in the surgical procedure, there are further challenges during the use of the single port system as the cluster of single port system instruments block some of the access locations for the additional instruments.

[0009] Accordingly, what is needed is a method to allow use of a single port teleoperated surgical system with a constrained remote center of motion of the single port teleoperated surgical system located proximal to a patient body opening to perform a surgical procedure at or near the patient body opening to allow maintenance of insufflation gas pressure during the surgical procedure and also to allow introduction of auxiliary instruments to any desired location relative to a cluster of teleoperated surgical system instruments during the surgical procedure. SUMMARY

[0010] Examples according to the present disclosure include a medical device that allows multiple instrument access guides to be located outside a patient body and simultaneously provides a sealed space between the access guides and an opening in the patient body wall to maintain insufflation. Such a medical device is referred to in this specification as an "instrument access device." The instrument access device includes an envelope that includes a distal opening at a distal end, a proximal opening at a proximal end, and an internal cavity between the distal opening and the proximal opening. The envelope can have various shapes, such as a spherical shape, an ellipsoidal shape, an ovoid shape, a barrel shape, a lens shape, or a bellows shape, for example.

[0011] 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 to a teleoperated surgical system via a proximal coupling component. The proximal coupling component is configured to accommodate multiple surgical instruments through a single opening and is sealed to prevent escape of insufflation gas through the single opening.

[0012] The instrument access device is optionally configured to receive insufflation gas and maintain insufflation pressure within a cavity of the patient body and within the internal cavity of the envelope. The pressurized and sealed envelope cavity provides operating space for shafts of multiple instruments of a teleoperated surgical system to articulate outside the patient body so that instrument end effectors are at or near a body surface at a port device coupled to the instrument access device.

[0013] The proximal coupling component of the instrument access device is located at and coupled to the proximal opening of the envelope. In some examples, the proximal coupling component includes a first port and a second port. For example, the first port can be configured to receive an access guide container, and an instrument access guide (also referred to simply as an "access guide") is received in the access guide container, while the second port can be, for example, an auxiliary port. The auxiliary port can support introduction of manually operated instruments, items needed for a surgical procedure, and removal of large and / or delicate samples during a procedure, for example. The proximal coupling component includes a center, and the first port and the second port are located eccentrically on the proximal coupling component.

[0014] In one example, the entry guide container is received in the first port of the instrument seal assembly. Where the end effector is located deep within the body, the entry guide container works similarly to a cannula that would be received in the wound. In some examples, the entry guide container includes an instrument entry guide seal configured to receive and seal an instrument entry guide. The instrument entry guide in the entry guide container received within the first port, away from the wound, can be shortened compared to the instrument entry guide received in the cannula in the wound.

[0015] The instrument access device according to the present disclosure optionally further includes a mechanism configured to rotate the second (e.g., secondary) port about the first port without the envelope twisting about the central axis of the envelope. In some examples, the mechanism includes a gear train. In another example, the mechanism includes a linkage.

[0016] This summary is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive treatment of the invention. The detailed description, and the accompanying figures, provide further information for illustrating various aspects of the subject matter of the present patent application. BRIEF DESCRIPTION OF DRAWINGS

[0017] In the drawings, which are not necessarily to scale, like numbers indicate like parts throughout the several views. Like numerals having different letter suffixes represent different instances of similar components. The drawings illustrate generally, by way of example, various embodiments discussed in the present document.

[0018] FIG. 1A is a schematic cross-sectional view of an instrument access device for use with a remote surgical system according to various embodiments.

[0019] FIG. 1B-1D is a schematic cross-sectional view of a distal end-to-port device coupling of an instrument access device according to various embodiments. FIG. 1A

[0020] FIG. 1E is a schematic cross-sectional view of a proximal element of an instrument access device according to various embodiments. FIG. 1A

[0021] FIG. 2 is a schematic top view illustrating operational features of the proximal coupling component 10.

[0022] FIG. 3 is a perspective view of an example remote surgical system according to various embodiments.

[0023] FIG. 4A is an exploded perspective view of an example instrument access device according to various embodiments. ​​

[0024] FIG. 4B is an exploded perspective view depicting additional details of the instrument access device of FIG. 4A .

[0025] FIG. 4C is a bottom plan view depicting a gear train for rotating one port within the instrument access device as depicted in FIG. 4A without twisting the enclosure of the device about the other port.

[0026] FIG. 4D and FIG. 4E are bottom plan views depicting the gear train of FIG. 4C at different rotational orientations.

[0027] FIG. 5A is a bottom perspective view depicting a gear train for rotating one port within the instrument access device as depicted in FIG. 4A without twisting the enclosure of the device about the other port, according to another embodiment.

[0028] FIG. 5B-5D are bottom plan views depicting the gear train of FIG. 5A at different rotational orientations.

[0029] FIG. 6A is a bottom perspective view depicting a gear train for rotating one port within the instrument access device as depicted in FIG. 4A without twisting the enclosure of the device about the other port, according to yet another embodiment.

[0030] FIG. 6B-6D are bottom plan views depicting the gear train of FIG. 6A at different rotational orientations.

[0031] FIG. 7A is a top perspective view of another example instrument access device according to various embodiments.

[0032] FIG. 7B is a top plan view depicting a linkage mechanism for rotating one port within the instrument access device as depicted in FIG. 7A without twisting the enclosure of the device about the other port, according to one embodiment.

[0033] FIG. 7C and FIG. 7D are top plan views depicting the linkage mechanism of FIG. 7B at different rotational orientations.

[0034] FIG. 8A is a perspective view of an example instrument access device including an ovoid enclosure, according to one embodiment.

[0035] FIG. 8B is a perspective view of an example instrument access device including a spherical envelope according to one embodiment.

[0036] FIG. 8C is a perspective view of an example instrument access device including a spheroid envelope according to one embodiment.

[0037] FIG. 8D is a perspective view of an example instrument access device including a bellows envelope according to one embodiment.

[0038] FIG. 8E is a perspective view of an example instrument access device including a lenticular envelope according to one embodiment.

[0039] FIG. 8F is a perspective view of an example instrument access device including a barrel envelope according to one embodiment.

[0040] FIG. 9A is a perspective view of an entry guide according to various embodiments.

[0041] FIG. 9B is a top view of a proximal end of an entry guide of FIG. 9A

[0042] FIG. 9C is an exploded perspective view depicting additional details of an entry guide of FIG. 9D

[0043] FIG. 9B is a cross-section taken along a longitudinal axis of an entry guide of FIG. 1A-1E DETAILED DESCRIPTION

[0044] FIG. 1A is a schematic cross-sectional view illustrating aspects of various embodiments of an instrument access device 1 for use with a remote surgical system 2. As shown, the instrument access device 1 includes an envelope 3 having a proximal opening 4 and a distal opening 5. The interior 6 of the envelope 3 is empty such that one or more surgical instruments can be inserted into the interior 6 through the proximal opening 4 and the instruments can pass through and exit the interior 6 through the distal opening 5. The envelope 3 can have various shapes as described in more detail below. FIG. 1B-1D

[0045] ​​​​For reference, a central longitudinal axis 7 of the instrument access device 1 and the enclosure 3 is defined as extending through the proximal opening 4 and the distal opening 5. As shown, in this specification, positions associated with the instrument access device are denoted as being "proximal" or "distal." The term "distal" refers to a position closer to the surgical site. The term "proximal" refers to a position further from the surgical site and thus closer to the mechanical floor of the teleoperated surgical system 2. Similarly, as indicated by the arrows shown, the distal direction generally denotes a direction along the instrument access device away from the mechanical floor of the teleoperated surgical system 2 and toward the surgical site, and the proximal direction generally denotes a direction along the instrument access device away from the surgical site and toward the mechanical floor of the teleoperated surgical system 2. And for further reference, a world reference coordinate frame 8 is arbitrarily defined and fixed in space. Typically, the instrument access device 1 is oriented in use with its proximal opening 4 above the distal opening 5 relative to the patient's body (i.e., the proximal opening is a "top opening" and the distal opening 5 is a "bottom opening"), as shown, so that the surgery is performed from above. Note, however, that the instrument access device 1 can be used in any orientation.

[0046] The instrument access device 1 includes a distal coupling component 9 and a proximal coupling component 10. The distal coupling component 9 is optionally detachably or fixedly coupled to the enclosure 3 at the distal opening 5, and the proximal coupling component 10 is optionally detachably or fixedly coupled to the enclosure 3 at the proximal opening 4.

[0047] As shown, the proximal coupling component 10 is detachably coupled to the mechanical floor at a coupling 11. Any suitable coupling type can be used, and the proximal coupling component 10 can be optionally coupled to the mechanical floor via the teleoperated surgical system 2 (e.g., where the teleoperated surgical system 2 includes a proximal portion of the coupling 11), via another piece of operating room equipment (e.g., an operating table), or via any other suitable support structure that allows the proximal coupling component 10 to be placed in a desired orientation and orientation (i.e., a combination of translational orientation and rotational orientation that defines a unique pose of an object in three-dimensional space; reference coordinate frame 8) in space and then remain stationary in the desired orientation and orientation during a surgery performed using the teleoperated surgical system 2.

[0048] As shown, the proximal coupling component 10 includes a first opening 12 and a second opening 13. The first opening 12 is sized to receive one or more teleoperated surgical system instruments 14 of the teleoperated surgical system 2. A cluster of three teleoperated surgical system instruments 14 is shown - an endoscopic camera 14a and two therapeutic instruments 14b (e.g., grasping, cutting, or electrosurgical instruments, etc.). This instrument cluster illustrates the variety of combinations of teleoperated surgical system instruments 14 that can be received through the first opening 12 into the interior 6 of the enclosure 3. The second opening 13 is sized to receive one or more auxiliary instruments 15 (e.g., grasping, cutting, electrosurgical, suction / irrigation, or suturing instruments, etc.). In some embodiments, the one or more auxiliary instruments 15 are manually operated (illustrated by the hand symbol), while in other alternative embodiments, the one or more auxiliary instruments 15 are operated via the teleoperated surgical system 2 (illustrated with dashed-line connection). Although a single second opening 13 is shown, the proximal coupling component 10 can alternatively include two, three, or more second openings to receive various combinations of additional manual or teleoperated auxiliary instruments.

[0049] The distal coupling component 9 is detachably coupled to the patient 16 and surrounds a body opening 17 - an incision or natural orifice (e.g., the anus). During a surgical procedure, the teleoperated surgical system instruments 14 are received into the enclosure 3 and extend toward the distal opening 5 of the enclosure 3. In this way, the teleoperated surgical system instruments 14 can work at the patient's skin surface 18, within the patient's body wall 19, or at a surgical site 20 distal of the body wall 19.

[0050] FIG. 1B is a schematic cross-sectional view illustrating in more detail the coupling of the distal end of the instrument access device 1 to a port device 21 located at the body opening 17 in the patient's body in various embodiments. The port device 21 retracts the patient's tissue and thus keeps the opening 17 open to allow surgical instruments to enter. As shown, the port device 21 can have a substantially fixed diameter and be adjustable in height as shown by the double-headed arrow, such that it can be snug against the patient's skin surface 18 and the inner surface 22 of the body wall 19. (Examples of this type of port device 21 are commonly referred to as a wound retractor, or similar terminology.) Alternatively, as shown in FIG. 1C FIG. 1E ​As shown, the distal coupling component 9 can be detachably or fixedly coupled to another type of port device 21a, which typically has a fixed diameter and a fixed height and is inserted into the opening 17. (An example of this type of port device 21a is an anal port used during transanal surgery.) Alternatively, the distal coupling component 9 can be detachably or fixedly coupled to yet another type of port device 21b, which typically has a fixed diameter and a fixed height and is placed on the skin surface of the patient (e.g., by adhesive or suction). If the envelope 3 is sufficiently rigid, a distally directed force transmitted through the envelope 3 from the proximal coupling component 10 (e.g., receiving a distally directed force from the remote surgical system 2) can be sufficient to maintain the port device 21b in the proper orientation. Alternatively, a structural support (not shown) can be coupled to the port device 21b and used to hold the port device 21b in the proper orientation. This type of port device 21b allows the surgical instruments to work at or slightly below the skin surface of the patient (e.g., making an incision or dissecting tissue immediately beneath the skin surface). Other variations of port devices can optionally be used. If the distal coupling component 9 is detachably coupled to the port device, the distal coupling component 9 can optionally be coupled to any of the port devices 21, 21a or 21b, or to any other type of port device used during a surgical procedure. That is, depending on the surgery to be performed, a single instrument access device 1 can be used with any of two or more port devices. The distal coupling component 9 optionally includes a clamp (not shown) or other suitable device that can be used to detachably couple the distal coupling component 9 to the port device. It should be noted that, although the gas pressure used to insufflate the body cavity for the surgery can also be used to insufflate the envelope 3, the instrument access device and associated components can optionally be used in clinical situations that do not use patient insufflation gas, in which case the insufflation gas can only be used to maintain the envelope 3 in its desired shape, or otherwise provide a clinical benefit, such as evacuating smoke from within the envelope 3.

[0051] FIG. 2is a schematic cross-sectional view illustrating the proximal elements of the instrument access device 1 in more detail. During a surgical procedure, the teleoperated instrument 14 is inserted through the first opening 12 along a remote surgical instrument insertion axis 23, and one or more auxiliary instruments 15 are inserted through the second opening 13 along an auxiliary instrument insertion axis 24. If it is necessary to insert an auxiliary instrument 15 into a location 25 in the envelope 3 that is blocked by one or more teleoperated surgical instruments 14, the orientation of the second opening 13 must be moved relative to the orientation of the first opening 12 so that the auxiliary instrument 15 can reach the desired location 25. Thus, since the first opening 12 and its associated remote surgical instrument insertion axis 23 are stationary relative to the global coordinate system 8, the second opening 13 and its associated auxiliary instrument insertion axis 24 must orbit around the first opening 12 (i.e., the remote surgical instrument insertion axis 23) until the second opening 13 and its associated auxiliary instrument insertion axis 24 are at an orientation from which the auxiliary instrument 15 can reach the location 25. However, even though the distal coupling component 9 of the envelope 3 is fixed relative to the coordinate system 8 when coupled to the patient, the envelope 3 should not twist around the central axis 7 as the second opening 13 and auxiliary instrument insertion axis 24 orbit around the first opening 12 and remote surgical instrument insertion axis 23.

[0052] In one aspect, the remote surgical instrument insertion axis 23 is offset from the central axis 7; in an alternative aspect, the remote surgical instrument insertion axis 23 coincides with the central axis 7; in yet another alternative aspect, the alternative instrument insertion axis 24 is offset from the central axis 7; and in yet another alternative aspect, the alternative instrument insertion axis 24 coincides with the central axis 7. It can thus be seen that if one of the central axis 7, the remote surgical instrument insertion axis 23, or the auxiliary instrument insertion axis 24 remains stationary in space, the other two axes will orbit around the stationary axis if they are offset from the stationary axis, and the envelope 3 will not twist. It can also be seen that if the central axis 7 coincides with the remote surgical instrument insertion axis 23 or the auxiliary instrument insertion axis 24, then if the coinciding axis remains stationary in space, the remaining non-coinciding axis will orbit around the coinciding axis without the envelope 3 twisting, and if the remaining non-coinciding axis remains stationary in space, the coinciding axis will orbit around the remaining non-coinciding axis without the envelope 3 twisting. Likewise, for embodiments that use two, three, or more alternative second openings 13, there are similar relationships between the fixed axis (single or coinciding) and the orbiting axis (single or coinciding). The following description focuses on aspects in which the remote surgical instrument insertion axis is fixed in space and offset from the central axis 7 to avoid lengthy descriptions; one skilled in the art will understand that the described embodiments can be readily modified to similarly describe other embodiments in which the central axis 7 or the auxiliary instrument insertion axis 24 is fixed in space, as well as other embodiments that include coinciding axes.

[0053] FIG. 1E This is a schematic top view illustrating the operational features of the proximal coupling component 10. (See also: [link to related document]) FIG. 2 and θ The proximal coupling component 10 includes an inner stationary element 10a, an outer element 10b, and a track element 10c between the stationary element 10a and the outer element 10b. The stationary element 10a is coupled to the mechanical ground (e.g., via coupling element 11 as described above) such that during surgical procedures, element 10a remains stationary relative to the reference coordinate system 8 in the desired orientation and orientation until the clinician moves the stationary element 10a to a different (second) desired orientation and orientation (if necessary). The outer element 10b is coupled to the sleeve 3 at the proximal opening 4 and remains stationary relative to the proximal opening 4. The track element 10c is coupled to the stationary element 10a and rotates about the stationary element 10a at the remote control insertion axis 23.

[0054] During use, when the distal opening 5 is fixed in space (e.g., when the distal coupling component 9 is coupled to the port device), if the proximal opening 4 rotates, the sleeve 3 will undesirably twist. Therefore, the track element 10c includes a reverse motion mechanism 10d coupled to the external element 10b, such that when the track element 10c rotates about the stationary element 10a in a first direction at an angular distance... θ During rotation, the reverse motion mechanism 10d causes the external element 10b to move at an equal angle relative to the track element 10c. -θ However, it rotates around the stationary element 10a in a direction opposite to the rotation direction of the track element 10c (i.e., θ Furthermore, since the two rotational angles are equal but opposite in direction, the orientation of the outer element 10b relative to coordinate system 8 will not change, and the sleeve 3 will not twist about the central axis 7 when the distal coupling component 9 is stationary relative to coordinate system 8. That is, the proximal opening 4, the distal opening 5, the stationary element 10a, the outer element 10b, and the distal coupling component 9 all maintain the same relative orientation relative to each other when the track element 10c rotates relative to them. It can also be seen that since the stationary element 10a is fixed in space, the outer element 10b and the track element 10c, when the track element 10c runs along the track around the stationary element 10a, will remain relative to coordinate system 8. -x , y Such as the rotation angle of track element 10c FIG. 1E (As shown) it can be translated in orientation. However, since the envelope 3 is flexible or sufficiently movable relative to the distal opening 5 and the distal coupling member 9, the proximal opening 4 of the envelope 3 can be translated relative to its distal opening 5 without any accompanying torsion of the envelope 3 around the central axis 7.

[0055] refer toFIG. 1E The remote surgical instruments 14 are inserted through the first opening 12 via the optional remote surgical instrument entry guide 26. Non-limiting examples of remote surgical system entry guides 26 that accommodate two or more remote surgical instruments 14 are disclosed in U.S. Patent Nos. US 9,877,744 B2 (filed February 12, 2010) (disclosing “Entry Guide for Multiple Instruments in a Single Port Surgical System”) and US 9,757,149 B2 (filed June 16, 2014) (disclosing “Surgical System Entry Guide”), as well as in International Patent Application Publication Nos. WO 2018 / 013730 Al (filed July 12, 2017) (disclosing “Surgical Instrument Guide”) and WO 2018 / 013734 Al (filed July 12, 2017) (disclosing “Surgical Instrument Guide with Insufflation Channels”), all of which are incorporated herein by reference.

[0056] In some embodiments, the entry guide 26 is inserted through an optional entry guide receptacle 27 that is inserted through the stationary element 10a and performs the function of the entry guide cannula. In other optional embodiments, the entry guide receptacle 27 is combined with or constitutes the stationary element 10a, and the entry guide 26 is inserted directly through the stationary element 10a, in which case the stationary element 10a performs the function of the entry guide cannula.

[0057] To prevent the insufflation gas under pressure from leaking from the interior 6 of the enclosure 3 through the entry guide 26 with or without the remote surgical instruments 14 inserted through the entry guide 26, or through the receptacle 27 (or the stationary element 10a used as an entry guide receptacle) with or without the entry guide 26 inserted through the receptacle 27 (or the stationary element 10a used as an entry guide receptacle), various gas seal arrangements can be used. Non-limiting examples of entry guide seals 28 are disclosed in U.S. Patent Application Publication No. US 2014 / 0276464 Al (filed March 14, 2014) (disclosing “Sealing Multiple Surgical Instruments”), which is incorporated herein by reference.

[0058] Insufflation gas under pressure can be introduced into the interior 6 of the enclosure 3 via the static element 10a, or via the entry guide 26, or via the container 27, or via the seal 28, or by an arrangement of any of these four elements combined together to define a gas flow path. For example, if aspects of the static element 10a and the container 27 are combined into a single element and an entry guide seal 28 is used, insufflation gas can be introduced via these combined elements. As shown, insufflation gas from an insufflation gas source 29 travels along a gas flow path 30 into the interior 6 of the enclosure 3. As a result, an insufflation gas pressure 31, which is higher than the ambient atmospheric pressure outside of the enclosure 3, is maintained in the interior 6.

[0059] Alternatively, insufflation gas can be introduced into the interior 6 of the enclosure 3 via a gas flow path different from that illustrated by the gas flow path 30 (e.g., an instrument seal in the second opening 13 (as described below), or a dedicated insufflation port in the track element 10c, the enclosure 3, or the distal coupling component 9, for example). And optionally, one or more gas flow paths can be defined from the interior 6 to outside of the enclosure 3, illustrated by the opposite direction of the gas flow path 30. Such outward gas flow paths can be used for functions such as smoke evacuation if the remote instrument 14 or the auxiliary instrument 15 are not used to perform the smoke evacuation function.

[0060] The enclosure 3 can have various shapes and can be made of various materials. For example, the enclosure 3 can have a generally spherical shape, a generally ellipsoidal shape (i.e., flattened or elongated relative to the central axis 7), a generally ovoid shape (i.e., tapered at one end along the central axis 7), a generally cylindrical shape around the central axis 7, or other three-dimensional shapes that have clinical benefits (e.g., generally conical, generally prismatic, etc.).

[0061] The enclosure 3 can be made of a flexible plastic sheet that assumes the designed shape when there is sufficient insufflation gas pressure 31 within the interior 6 of the enclosure 3. Alternatively, the enclosure 3 can be made of a flexible, resilient material that maintains its shape without the need for internal gas pressure. In other options, structural elements (e.g., support ribs or similar structures) are used to help the enclosure 3 maintain its shape during use. And in other options, the enclosure is rigid.

[0062] The enclosure 3 can generally be transparent so that a clinician outside of the enclosure 3 can view the pose of the instruments 14, 15 within the enclosure 3. Alternatively, the enclosure 3 can be opaque, in which case images from an endoscope camera within the enclosure 3 can be used to determine the pose of the instruments 14, 15 within the enclosure 3. As another alternative, the enclosure 3 can be opaque with one or more transparent windows.

[0063] Still referring to FIG. 3The secondary instrument 15 is inserted through the second opening 13 via a secondary instrument seal 32. The instrument seal 32 serves to maintain the insufflation gas pressure within the enclosure 3 when the secondary instrument 15 is inserted or not inserted. Various suitable instrument seals are known and can be used, and non-limiting examples of instrument seals 32 are disclosed in U.S. Patent Application Publication No. 2017 / 0095269 Al (filed March 17, 2015) and International Patent Application No. PCT / US2019 / 031393 (filed May 8, 2019) (disclosing “Instrument Seal”), both of which are incorporated herein by reference.

[0064] Further aspects and details will now be described.

[0065] Remote surgical system

[0066] To illustrate the general background in which the instrument access apparatus as described above can be used, FIG. 3 A schematic perspective view illustrating aspects of a remote surgical system in accordance with various embodiments is provided. In general, for the purposes of this description, a remote surgical system includes three main components: an endoscopic imaging system, a user control system (master), and a manipulator system 210E (slave) (as shown in FIG. 3 All of these are interconnected by wired (electrical or optical) or wireless connections. One or more data processors (i.e., one or more logic units coupled to one or more memory systems) can be variously located in these main components to provide system functionality. Examples are disclosed in U.S. Patent No. US 9,060,678 (filed June 13, 2007) (disclosing “Minimally Invasive Surgical System”), which is incorporated herein by reference.

[0067] The imaging system performs image processing functions on, for example, captured endoscopic imaging data of a surgical site and / or preoperative or real-time image data from other imaging systems external to the patient. The imaging system outputs the processed image data (e.g., images of the surgical site, as well as related control and patient information) to the surgeon at the 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 can monitor the video; real-time feed video can be used for training, etc.).

[0068] The user control system includes multi-degree of freedom mechanical input devices that allow the surgeon to manipulate the instruments, entry guide(s), and imaging system devices under computer assistance. In certain aspects, these input devices can 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 so that the images on the display are generally focused at a distance corresponding to the surgeon's hands working behind / below the display screen.

[0069] Control during instrument insertion and use can be accomplished, for example, by the surgeon moving the instruments presented in the images with one or both of the input devices; the surgeon uses the input devices to translate and rotate the instruments in three-dimensional space. Similarly, one or more input devices can be used to translate and rotate the imaging system or associated surgical device assembly to steer the endoscope or instrument cluster toward a desired location on the output display and advance it within the patient.

[0070] The manipulator system 210E is illustrated in FIG. 3 In the depicted example, the manipulator system 210E is implemented as a patient side cart, and the surgery is in the abdomen of a patient 229. However, a surgical system including the manipulator system 210E can be used for a variety of surgeries by using a combination of various instruments.

[0071] The manipulator system 210E includes a base 201E that is shown mounted to the floor, or alternatively mounted to the ceiling or other mechanically grounded base (not shown). The base 201E can be movable or fixed (e.g., fixed to the floor, ceiling, wall, or other appliance such as a surgical table). The base 201E supports the remainder of the manipulator system, which includes generally passive, uncontrolled manipulator support structures 220E and actively controlled manipulator systems 230E (also referred to herein as entry guide manipulators 230E).

[0072] In one example, manipulator support structure 220E includes a first setup link 202E and two passive rotary setup joints 203E and 205E. Rotary setup joints 203E and 205E allow manual positioning of coupled setup links 204E and 206E. Alternatively, some of these setup joints can be actively controlled, and more or fewer setup joints can 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 azimuths and orientations in Cartesian x, y, z space. A passive prismatic setup joint (not shown) between link 202E and base 201E of manipulator support structure 220E can be used for large vertical adjustment 212E.

[0073] Entry guide manipulator 230E includes an entry guide manipulator assembly 231E that supports a plurality of surgical device assemblies, at least one of which is coupled to entry guide manipulator assembly 231E during a surgical procedure. Each surgical device assembly includes a teleoperated manipulator and a surgical instrument or camera instrument mounted on the manipulator. For example, in FIG. 3 one surgical device assembly includes an instrument 260E mounted to a manipulator 240E, which instrument 260E has a shaft 262E that extends through one of typically a plurality of passages in an entry guide 270E during a surgical procedure.

[0074] Entry guide manipulator assembly 231E includes an instrument manipulator positioning system (hereinafter simply "positioning system"). The positioning system moves an instrument mounting interface of one or more manipulators 240E within a plane so that when one or more instruments 260E are coupled to entry guide manipulator assembly 231E using the respective instrument mounting interface, the shafts of instruments 260E are each aligned for insertion into a passage in entry guide 270E. Although entry guide 270E is depicted as being located at a body wall of a patient, it will be appreciated that manipulator system 210E can also be used without modification where the entry guide is located at a distance from the body wall in an entry guide receptacle of an instrument access device as described herein.

[0075] The instrument mounting interface(s) can be moved into the proper orientation after attachment of the instrument(s). The plane in which the instrument mounting interface moves is generally perpendicular to the longitudinal axis of the entry guide 270E, and the trajectory of the instrument mounting interface in that plane can include straight and / or curved portions in various combinations. As the positioning element of the lateral motion mechanism of the positioning system moves along the trajectory, the instrument mounting interface, and effectively the distal tip of the shaft of the instrument coupled to the instrument mounting interface, moves along the same trajectory. Thus, motion of the positioning element causes the shaft to be moved into a position in which the shaft is aligned with the passage in the entry guide 270E. In that orientation, the shaft can enter and pass through the passage in the entry guide 270E without damaging the instrument and without impeding operation of the instrument. The particular path implemented in the positioning system depends at least in part on the type of surgical device assembly that can be mounted on the entry guide manipulator assembly 231E and / or the configuration of the passage in the entry guide 270E.

[0076] Different entry guides can be used in different surgical procedures. Entry guides that enter the body between the ribs can optionally have a different shape than entry guides that enter the body through an incision in the abdomen. Further, entry guides that enter the body are generally different, e.g., in length, than entry guides used outside the body, e.g., entry guides inserted through an entry guide receptacle at the proximal end of a sheath of an instrument access device as disclosed herein; entry guides used outside the body and at a distance from the body can be shortened relative to entry guides that enter the body. The different shapes of entry guides require different layouts of passages extending through the entry guides, i.e., different passage configurations. Further, for different instruments, the shape and / or size of the shaft of the instrument can be different. An entry guide is used that accommodates the shape and size of the shaft of the instrument used in a particular surgical procedure. The trajectory is designed to accommodate a set of entry guides that can be used with the manipulator system 210E.

[0077] The ability to position an instrument and thus its shaft individually relative to the passage in the entry guide by moving the instrument mounting interface provides versatility to the manipulator system 210E. For example, this ability allows entry guides with different passage configurations to be used in the system 210E. Further, the positioning system eliminates the need for instruments that are specific to a surgical procedure. In other words, the instrument manipulator positioning system allows a universal set of instruments to be used by moving the shaft of the instrument with a variety of entry guides, as described above.

[0078] The entry guide manipulator 230E includes a kinematic chain of links and joints that is movable by a motor or other actuator and that receives movement control signals associated with movement of the master arm at the user control system. Using the kinematic chain, the entry guide manipulator 230E can adjust the position and orientation of the positioning system of the entry guide manipulator assembly 231E and, by extension, the instrument. Generally, the entry guide manipulator 230E is configured and operated to constrain rotation of the instrument at a point on the shaft of the instrument, referred to herein as the remote center of motion.

[0079] Generally, the remote center of motion coincides with the position at which the instrument enters the patient, for example, at the umbilicus in abdominal surgery. However, in accordance with the present disclosure, in the case of an instrument access device that uses an instrument entry guide having an instrument entry guide located outside the body (in a port at the proximal end of the sheath of the instrument access device), the position of the remote center of motion likewise falls outside the body, for example, slightly above the body wall, and generally along the axis of the entry guide. A remote center of motion above the body wall allows the instrument to move radially outward from the extended axis of the entry guide proximal to the body wall of the patient, thereby gaining better triangulation access at or in the incision. A flexible instrument shaft, in combination with a flexible wound retractor, gives this flexibility in operating the instrument without risking trauma to the tissue.

[0080] The remote center of motion is the location at which the yaw axis, the pitch axis, and the roll axis intersect, i.e., the location at which the kinematic chain of the entry guide manipulator 230E remains effectively stationary as the joints move through their range of motion. As shown, the yaw joint 211E of the manipulator assembly is coupled between the end of the link 206E and the first end (e.g., proximal end) of the first manipulator link 213E. The yaw joint 211E allows the first manipulator link 213E to move relative to the link 206E in a motion that can be arbitrarily defined as "yaw" about a manipulator assembly yaw axis 223E. As shown, the yaw axis 223E of the joint 211E is aligned with the remote center of motion at or near the entry guide 270E. FIG. 3 The distal end of the first manipulator link 213E is coupled to the proximal end of the second manipulator link 215E by a first actively controlled revolute joint 214E. The distal end of the second manipulator link 215E is coupled to the proximal end of the third manipulator link 217E by a second actively controlled revolute joint 216E. The distal end of the third manipulator link 217E is coupled to the fourth manipulator link 219E by a third actively controlled revolute joint 218E; the fourth manipulator link 219E extends in two directions away from the revolute joint 218E, and thus has two distal ends relative to the position of the joint 218E.

[0081] The distal end of the first manipulator link 213E is coupled to the proximal end of the second manipulator link 215E by a first actively controlled revolute joint 214E. The distal end of the second manipulator link 215E is coupled to the proximal end of the third manipulator link 217E by a second actively controlled revolute joint 216E. The distal end of the third manipulator link 217E is coupled to the fourth manipulator link 219E by a third actively controlled revolute joint 218E; the fourth manipulator link 219E extends in two directions away from the revolute joint 218E, and thus has two distal ends relative to the position of the joint 218E.

[0082] 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 referred to as parallel link mechanisms when the input link motion and the output link motion remain parallel to each other). For example, if rotary joint 214E is actively rotated, then joints 216E and 218E are also actively rotated such that link 219E moves in a constant relationship to link 215E. Thus, it can be seen that the axes of rotation of joints 214E, 216E, and 218E are parallel. When these axes are perpendicular to the yaw axis 223E of joint 21 IE, links 215E, 217E, and 219E move relative to link 213E in a motion that can be arbitrarily defined as "pitch" about a manipulator assembly pitch axis. The manipulator pitch axis extends into and out of the page in Figure 2E at the remote center of motion of entry guide 270E or near the remote center of motion of entry guide 270E FIG. 4A Motion about the manipulator assembly pitch axis is indicated by arrow 221E. Since links 215E, 217E, and 219E move as a single assembly in this embodiment, the first manipulator link 213E can be considered an active proximal manipulator link, and the second through fourth manipulator links 215E, 217E, and 219E can collectively be considered an active distal manipulator link.

[0083] Entry guide manipulator assembly platform 232E is coupled to one of the distal ends of fourth manipulator link 219E. Entry guide manipulator assembly 231 is rotatably mounted on platform 232E. Entry guide manipulator assembly 231 can rotate a plurality of surgical device assemblies (e.g., 260E) as a group about axis 225E. In particular, entry guide manipulator assembly 231 rotates as a single unit relative to platform 232E in a motion that can be arbitrarily defined as "roll" about an entry guide manipulator assembly roll axis 225E.

[0084] In accordance with the present disclosure, all instruments (including camera instruments) access 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, cause the remote center of motion to be located distal of the entry guide manipulator assembly with sufficient distance to allow the entry guide manipulator assembly to move freely relative to the entry guide.

[0085] The entry guide container 275E can be removably coupled (directly or indirectly via a mount) to the distal end of the fourth manipulator link 219E opposite the distal end to which the entry guide manipulator assembly platform 232E is coupled. In one embodiment, the entry guide container 275E or the mount is coupled to the link 219E by a rotary joint that allows it to move between a stowed orientation adjacent the link 219E and an operating orientation that ensures the remote center of motion is located along the entry guide container 275E or the entry guide 270E received in the entry guide container 275E. According to one aspect, the entry guide container 275E is fixed in the proper orientation relative to the link 219E during operation. The entry guide container and the entry guide can be made of various materials, such as steel or extruded plastic. Plastic is less expensive than steel and can be suitable for single use per surgical procedure.

[0086] As the patient 229 is placed in different orientations on the movable table, various passive and active joints / links allow the positioning of the instruments and imaging systems in a wide range of motions. Certain passive and active joints and links in the manipulator support structure 210E and / or the entry guide manipulator 230E can be omitted to reduce the size and shape of the surgical system, or joints and links can be added to increase the degrees of freedom. It should be understood that the manipulator support structure 210E and the entry guide manipulator 230E can include various combinations of links, passive joints, and active joints (which can provide redundant degrees of freedom) to achieve the range of poses required for the surgery.

[0087] Instrument access device with counter motion mechanism

[0088] FIG. 4A is an exploded perspective view of an example instrument access device 400 according to various embodiments. In FIG. 3 the instrument access device 400 includes an entry guide container assembly 402 (including an entry guide container 426), a counter motion assembly 404, an envelope 406, and a clamp 408 (serving as a distal coupling component). In this embodiment, the entry guide container 426 and the counter motion assembly 404 together form a proximal coupling component.

[0089] The clamp 408 is received in the distal opening of the enclosure 406 and, in use, secures the instrument access device 400 to a wound retractor or similar port device at a body opening. The reverse motion assembly 404 is received in the proximal opening 418 of the enclosure 406 and includes a first port 410 that receives an entry guide container 426 and is also referred to as an "entry guide port" 410, and a second port 420 that can receive an auxiliary instrument and is also referred to as an "auxiliary port" 420. One or more instruments enter the instrument access device 400 at the proximal end, either through an entry guide received in the entry guide container 426 or through the auxiliary port 420. The enclosure 406 also includes an additional enclosure auxiliary port 422 through which other instruments can enter. Instruments, whether entered through the entry guide port 410 or the auxiliary port 420, 422, work within the enclosure 406 or exit the enclosure 406 through the distal opening to enter the patient's body. The auxiliary port 422 can optionally be configured to allow surgical implements (e.g., suture or mesh material, imaging probes, instrument accessories, etc.) to be introduced or removed from the interior of the enclosure 406, or to allow tissue to be removed from the interior of the enclosure 406.

[0090] The entry guide container assembly 402 includes an entry guide container 426 and a connector 416 that secures the instrument access device 400 to an arm of a teleoperated surgical system, such as described with reference to the system depicted and described above. FIG. 4B The entry guide container assembly 402 also includes gas lines 412 and 414 that carry insufflation gas through the lines and into the instrument access device 400, including into the enclosure 406. The insufflation lines 412, 414 can have standard flow luer fittings, or alternatively, other fittings that permit higher gas flow over time. The use of two gas lines 412, 414 serves to enable the insufflation source to be connected to either side of the entry guide port 410, which can accommodate space constraints in the surgical environment. Further, the two gas lines 412, 414 allow one line to be used for insufflation and the other line to be used for smoke evacuation, such as by venting the second line to the room or using an insufflator with a built-in smoke evacuator.

[0091] The reverse motion assembly 404 includes a track element 424 (as an example of element 10c) having openings defined therein for the access guide port 410 and the auxiliary port 420; an outer element 425 (as an example of element 10b) received in the proximal opening of the envelope 406; and a reverse motion mechanism that rotates the auxiliary port 420 about the access guide port 410 (and thus about the access guide container 426) without the envelope 406 twisting about the central axis of the envelope 406. In use, when the instrument access device is secured to a remote surgical system, the access guide container 426 remains stationary in space as the auxiliary port 420 rotates about it. (In this embodiment, the access guide container 426 functions as the stationary component 10a.)

[0092] FIG. 4B is an exploded perspective view depicting additional details of the instrument access device 400. In FIG. 4B the access guide container assembly 402 includes an access guide container 426, an instrument guide seal 428, a seal support 430, a cap 432, an access guide container O-ring 434, and an access guide container retention ring 436. The instrument guide seal 428 is received in the access guide container 426. The cap 432 is locked onto the access guide container 426, capturing (or “pinching”) the seal support 430 and the instrument guide seal 428 between the cap 432 and the access guide container 426. The access guide container O-ring 434 is received in the access guide port 410 and seals the outer surface of the inner lumen of the access guide container 426 in the port 410. The access guide container retention ring 436 couples the access guide container 426 into the access guide port 410, thereby connecting the access guide container assembly 402 to the reverse motion assembly 404.

[0093] In some examples, the access guide container assembly 402 is configured to receive an instrument access guide configured to receive and seal multiple instruments through a single port. In this case, the instrument guide seal 428 is configured to receive and seal the instrument access guide. In one example, the instrument guide seal 428 can include a cross-slit seal, a duckbill seal, a wiper seal, a diaphragm seal, or another type of seal suitable for receiving and sealing an instrument access guide according to the present disclosure. In one example, the instrument guide seal 428 includes a seal similar to the seal disclosed in International Application No. PCT / US2019 / 031393 (filed May 8, 2009) (disclosing “INSTRUMENT SEAL”), which is incorporated by reference herein in its entirety.

[0094] In FIG. 4CIn particular, the reverse motion assembly 404 includes a track element 424 that includes the entry guide port 410 and the auxiliary port 420. Further, the reverse motion assembly 404 includes an auxiliary port seal 438 and a boot O-ring 440. The auxiliary port seal 438 is received in and coupled to the auxiliary port 420. The auxiliary port seal 438 is configured to receive and seal a manually operated instrument, and can include various types of seals, including cross-slit, duckbill, wiper, or septum seals. In one example, the auxiliary port seal 438 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393. The boot O-ring 440 is received in a proximal opening 418 of the boot 406 and is configured to seal the exterior elements 425 of the reverse motion assembly 404 in the opening 418. The O-ring 440, along with the O-ring 434, is important to maintain insufflation while allowing the auxiliary port 420 to rotate about the entry guide port 410. The instrument access device 402 also includes a boot auxiliary port seal 442 received in a boot auxiliary port 422 of the boot 406. The boot auxiliary port seal 442 is configured to receive and seal a manually operated instrument, and can include various types of seals, including cross-slit, duckbill, wiper, or septum seals. In one example, the boot auxiliary port seal 442 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393.

[0095] FIG. 4C is a bottom plan view depicting a gear train 450 according to one embodiment. The gear train 450 is the mechanism by which the auxiliary port 420 is able to rotate about the entry guide container 426 and the entry guide port 410 without the boot 406 rotating about the central axis of the boot (or, in other words, without the boot 406 twisting). The gear train 450 includes a first gear 452, a second gear 454, an idler gear 456, and an intermediate gear 458. In FIG. 4C In particular, the first gear 452 and the second gear 454 are ring gears, with the gear teeth of the first gear 452 facing radially inward and the gear teeth of the second gear 454 facing radially outward. The intermediate gear 458 is a stepped spur gear, including a third spur gear 460 and a fourth spur gear 462 (hidden behind the third spur gear 460) that meshes with the idler gear 456 (partially hidden behind the third spur gear 460). The third spur gear 460 and the fourth spur gear 462 are coaxially coupled and rotate together.

[0096] The first gear 452 is positioned about the outer periphery of the track element 424 of the counter-motion assembly 404, and the first gear 452 is configured to be fixed to the outer element 425, which is coupled to the proximal opening 418 of the envelope 406. The second gear 454 is coupled to the outer periphery of the entry guide receptacle 426. Note that the first gear 452 and the second gear 454 are in different planes, with the second gear 454 above (i.e., below in a top-down view) the first gear 452, and they are not directly operably engaged with one another. The first gear 452 and the second gear 454 are coupled via an idler gear 456 and an intermediate gear 458 (all collectively forming the counter-motion mechanism 10d). More specifically, the idler gear 456 operably engages the second gear 454 and a fourth gear 462 of the intermediate gear 458. The fourth gear 462 is coupled to a third gear 460 of the intermediate gear 458, which in turn operably engages the first gear 452. The idler gear 456 reverses the direction of rotation between the first gear 452 and the second gear 454. In particular, from the perspective of the first gear 452, when the intermediate gear 458 (including the third gear 460 and the fourth gear 462) rotates clockwise, the idler gear 456 rotates counterclockwise. FIG. 4C

[0097] In the example of FIG. 4, the gear train 450 is depicted in a first orientation. To illustrate the motion of the gear train 450, and by extension the motion of the associated secondary port 420, the gear train 450 is depicted in two additional orientations. FIG. 4D FIG. 4E and FIG. 4C-4E Reference is made to FIG. 5, which illustrates the gear train 450 in a second orientation. In this orientation, the first gear 452 is rotated 90 degrees from the first orientation. The second gear 454 is also rotated 90 degrees from the first orientation, but in the opposite direction from the first gear 452. The idler gear 456 is rotated 90 degrees from the first orientation, but in the same direction as the first gear 452. The third gear 460 is rotated 90 degrees from the first orientation, but in the opposite direction from the first gear 452. The fourth gear 462 is rotated 90 degrees from the first orientation, but in the same direction as the first gear 452. FIG. 4A-4E ​​first gear 454 and the associated entry guide port 410 are translationally fixed in space and do not translate or rotate relative to the remote surgical system. (The entry guide container 426 is also translationally fixed in space, but rotates with the track element relative to the entry guide port 410.) The idler gear 456 is in operable engagement with and rotates about the second gear 454. As the idler gear 456 rotates as it translates about the second gear 454, the idler gear 456 rotates the fourth spur gear 462 of the intermediate gear 458, which in turn causes the third spur gear 460 of the intermediate gear 458 to rotate. As the third spur gear 460 rotates, it rotates and causes the first gear 452 to translate about the central axis of the entry guide port 410 without rotating about the central axis of the first gear 452. This is the manner in which the auxiliary port 420 is able to rotate about the entry guide port 410 and the entry guide container 426 without causing the envelope 406 (which is coupled to the first gear 452) to twist. Note that, along with the first gear 452 and the external elements 425 of the counter-motion mechanism, the proximal opening of the envelope 406 also translates and thereby changes its orientation relative to the distal opening of the envelope 406. This relative motion between the proximal and distal openings is accommodated by the flexible or movable nature of the envelope 406.

[0098] This oscillatory translation of the first gear 452 (and the associated envelope 406) about the entry guide port 410 is achieved at least in part by the gear ratios of the various gears of the gear train 450: the gear ratios are selected such that the rotation remains synchronized in that a rotation of the first gear 452 by an angle in one direction relative to the idler gear 456 is accompanied by a rotation of the second gear 454 by the same angle in the opposite direction relative to the idler gear 452. In particular, the gear ratio of the third spur gear 460 to the fourth spur gear 462 is equal to the gear ratio of the first gear 452 to the second gear 454. The motion of the first gear 452 can be tracked in FIG. 5A space by reference to index marks 464 on the external elements 425 and the gear 452. Note that, while the index marks 464 translate relative to the entry guide container 426 and the entry guide port 410, the marks 464 and thus the first gear 452 do not rotate. Or, in other words, the first gear remains in a fixed rotational orientation relative to the entry guide container 426 and the entry guide port 410.

[0099] FIG. 5Ais a bottom perspective view depicting a gear train 550 according to another embodiment. The gear train 550 is another mechanism by which the auxiliary port 420 can be rotated about the entry guide container 426 and the entry guide port 410 without the envelope 406 rotating about the central axis of the envelope (or in other words, the envelope 406 does not twist). The gear train 550 includes a first gear 552, a second gear 554, and an intermediate gear 556. In FIG. 4A the first gear 552 and the second gear 554 are ring gears, where the gear teeth of the first gear 552 and the second gear 554 face radially inward. Further, the intermediate gear 556 is a stepped spur gear including a third spur gear 560 and a fourth spur gear 562, such that the gears 560 and 562 are coaxially coupled and rotate together.

[0100] The first gear 552 is positioned about the outer periphery of the track element 424 of the counter-motion assembly 404, and along with the outer element 425 is configured to be positioned in and coupled to the proximal opening 418 of the envelope 406 (see FIG. 4B and FIG. 5B ). The second gear 554 is positioned about the outer periphery of the entry guide container 426. The intermediate gear 556 is positioned between the first gear 552 and the second gear 554. The third spur gear 560 of the intermediate gear 556 operably engages the first gear 552. The fourth spur gear 562 of the intermediate gear 556 operably engages the second gear 554.

[0101] FIG. 5B is a bottom plan view depicting the gear train 550. In FIG. 5C the first gear 552 and the second gear 554 are ring gears, where the gear teeth of the first gear 552 and the second gear 554 face radially inward. Further, the intermediate gear 556 is a stepped spur gear including a third spur gear 560 and a fourth spur gear 562, such that the gears 560 and 562 are coaxially coupled and rotate together. FIG. 5D and FIG. 5B-5D the first gear 552 and the second gear 554 are ring gears, where the gear teeth of the first gear 552 and the second gear 554 face radially inward. Further, the intermediate gear 556 is a stepped spur gear including a third spur gear 560 and a fourth spur gear 562, such that the gears 560 and 562 are coaxially coupled and rotate together. FIG. 5B-5D Referring first to , it is noted that the second gear 554 and by association the entry guide container 426 remain fixed in space and do not translate or rotate relative to other components. The fourth spur gear 562 of the intermediate gear 556 rotates about and operably engages the second gear 554. As the fourth spur gear 562 rotates about the second gear 554, the third spur gear 560 of the intermediate gear 556 engages and turns the first gear 552, which causes the first gear 452 to translate about the central axis of the entry guide port 410 without rotating relative to the central axis of the first gear 552. This is the manner in which the auxiliary port 420 can be rotated about the entry guide port 410 and the entry guide container 426 without causing the envelope 406, which is coupled to the first gear 552, to twist.

[0102] This oscillatory translation of the first gear 552 (and, by association, the envelope 406) about the entry guide port 410 is at least partially achieved through the gear ratios of the individual gears of the gear train 550. Specifically, the gear ratio of the third spur gear 560 to the fourth spur gear 562 is equal to the gear ratio of the first gear 552 to the second gear 554. Movement of the first gear 552 can be tracked in FIG. 6A reference to the external element 425 and the index mark 564 on the gear 552. Note that while the index mark 564 translates relative to the entry guide container 426 and the entry guide port 410, the mark 564 and thus the first gear 552 do not rotate. In other words, the first gear remains in a fixed rotational orientation relative to the entry guide container 426 and the entry guide port 410.

[0103] FIG. 6A is a bottom perspective view depicting a gear train 650 according to yet another embodiment. The gear train 650 is another mechanism by which the auxiliary port 420 can rotate about the entry guide container 426 and the entry guide port 410 without the envelope 406 rotating about the central axis of the envelope (or, in other words, without the envelope 406 twisting). The gear train 650 includes a first gear 652, a second gear 654, and an intermediate gear 656, and the gear train 650 operates in a similar manner to the gear train 550, except as FIG. 4A shown, the first gear 652 and the second gear 654 are ring gears, with the gear teeth of the first gear 652 and the second gear 654 facing radially outward, and the intermediate gear 656 is a stepped spur gear, which includes a third spur gear 660 and a fourth spur gear 662 that are located outside of the first ring gear 652 and the second ring gear 654.

[0104] The first gear 652 is positioned about the outer periphery of the track element 424 of the counter-motion assembly 404, and, along with the external element 425, is configured to be positioned in and coupled to the proximal opening 418 of the envelope 406 (see FIG. 4B and FIG. 6B). The second gear 654 is positioned around the outer perimeter of the entry guide container 426. The intermediate gear 656 is positioned between the first gear 652 and the second gear 654. In this example, the outer member 425 includes three outwardly projecting optional tabs 666, and the intermediate gear 656, including the third spur gear 660 and the fourth spur gear 662, is seated within one of the three tabs 666. The tabs 666 can serve multiple functions, including housing the intermediate gear 656 and providing finger grips to manipulate the counter-motion assembly 404 to rotate the auxiliary port 420. The third spur gear 660 of the intermediate gear 656 operably engages the first gear 652. The fourth spur gear 662 of the intermediate gear 656 operably engages the second gear 654.

[0105] FIG. 6B is a bottom plan view depicting the gear train 650 according to the present disclosure. In FIG. 6C , the gear train 650 is depicted in a first orientation. To illustrate the motion of the gear train 650, and by extension the motion of the associated track member 424 and the auxiliary port 420, the gear train 650 is depicted in FIG. 6D and FIG. 6B-6D two additional orientations. Reference is made to FIG. 6B-6D , it is first noted that the second gear 654 and by extension the associated entry guide container 426 remain fixed in space and do not translate or rotate relative to the other components. The fourth spur gear 662 of the intermediate gear 656 rotates around the second gear 654 and operably engages the second gear 654. As the fourth spur gear 662 rotates around the second gear 654, the third spur gear 660 of the intermediate gear 656 engages and turns the first gear 652, which causes the first gear 652 to translate around the central axis of the entry guide port 410 without rotating about the central axis of the first gear 652. This is the manner in which the auxiliary port 420 is able to rotate around the entry guide port 410 and the entry guide container 426 without causing the envelope 406, which is coupled to the first gear 652, to twist.

[0106] This oscillating translation of the first gear 652 (and by extension the envelope 406) around the entry guide port 410 is achieved at least in part by the gear ratio of the various gears of the gear train 650. Specifically, the gear ratio of the third spur gear 660 to the fourth spur gear 662 is equal to the gear ratio of the first gear 652 to the second gear 654. The motion of the first gear 652 can be tracked in FIG. 7A with reference to the index marks 664 on the outer member 425 and the gear 652. Note that while the index marks 664 translate relative to the entry guide container 426 and the entry guide port 410, the marks 664, and thus the first gear 652, do not rotate. In other words, the first gear remains in a fixed rotational orientation relative to the entry guide container 426 and the entry guide port 410.

[0107] FIG. 4A is a top perspective view of a proximal coupling component 700 of another instrument access device according to various embodiments. The proximal coupling component 700 includes an entry guide receptacle assembly 702 and a reverse motion assembly 704. The sheath of the instrument access device (coupled to the proximal coupling component) and the clamp (disposed in and coupled to a distal opening of the sheath) are not shown. The sheath and the clamp are the same or similar to those depicted in FIG. 4B and FIG. 3 for the instrument access device 400.

[0108] The reverse motion assembly 704 includes an inner hub 706, an outer rim 708, and a crank arm 710. The inner hub 706 includes an entry guide port 712 and an auxiliary port 714. The entry guide port 712 and the auxiliary port 714 are eccentrically positioned on the inner hub 706. The outer rim 708 is coupled to the sheath. The inner hub 706 is rotatable relative to the outer rim 708 about a central axis of the outer rim 708. The entry guide receptacle assembly 702, including an entry guide receptacle 716 and a connector 718, is received in the entry guide port 712. The crank arm 710 is pivotably connected to the outer rim 708. The connector 718 secures the instrument access device 700 to an arm of a teleoperated surgical system (e.g., the systems depicted and described with reference to FIG. 7A ).

[0109] The inner hub 706, the outer rim 708, the crank arm 710, and the entry guide receptacle assembly 702 are connected to one another to form a linkage mechanism. The linkage mechanism is configured to rotate the auxiliary port 714 about the entry guide receptacle 716 without rotating the sheath coupled to the outer rim 708 about a central axis of the sheath. Thus, the linkage mechanism allows the auxiliary port 714 to rotate about the entry guide receptacle 716 without twisting the sheath.

[0110] In the example of FIG. 7A , the inner hub 706, the outer rim 708, the crank arm 710, and the entry guide receptacle assembly 702 are connected to one another to form a 4-bar linkage mechanism 724, more specifically, a parallel 4-bar linkage mechanism. The entry guide receptacle assembly 702 is a ground link of the 4-bar linkage mechanism, and the crank arm 710 is an input link of the linkage mechanism. The inner hub 706 and the outer rim 708 are each a coupled link of the parallel 4-bar linkage mechanism formed by the inner hub 706, the outer rim 708, the crank arm 710, and the entry guide receptacle assembly 702. The four rotational axes associated with the joints of the linkage mechanism 724 are in FIG. 7Adashed line, where pairs of adjacent links are coupled. At the first axis 730, the crank arm 710 is coupled to the entry guide container assembly 702 (at or near the connector 718 of the entry guide container assembly 702). The second axis 732 through the center of the entry guide port corresponds to the joint that couples the entry guide container assembly 702 to the inner hub 706. The third axis 734 through the common center of the rim 708 and hub 706 corresponds to the joint that couples the hub 706 to the outer rim 708. The fourth axis 736, which is the pivot axis of the crank arm 710, couples the rim 708 to the crank arm 710. The distance between the axes 730, 736 (the length of the crank arm link) is equal to the distance between the axes 732, 734 (the distance between the center of the rim and the entry guide port), and the distance between the axes 730, 732 is equal to the distance between the axes 734, 736, such that the axes 730, 732, 734, 736 form a parallelogram.

[0111] The reverse motion assembly 704 also includes a locking mechanism for locking the linkage 724 from moving, and thus for locking the auxiliary port 714 in an orientation relative to the entry guide container 716 and the entry guide port 712. In FIG. 7B the locking arm 720 can be deflected relative to the outer rim 708 and includes a catch on the underside of the locking arm 720. The outer rim 708 includes a ratchet tooth 722. The locking arm 720 is resilient and configured to lock into the ratchet tooth 722. The locking arm 720 can be deflected to lift the locking arm out of engagement with the ratchet tooth 722, and thus to unlock the linkage formed by the inner hub 706, the outer rim 708, the entry guide container assembly 702, and the crank arm 710, which in turn allows the auxiliary port 714 to rotate relative to and about the entry guide container 716 and the entry guide port 712.

[0112] FIG. 7B is a plan view depicting the linkage 724 formed by the inner hub 706, the outer rim 708, the entry guide container assembly 702, and the crank arm 710. In FIG. 7C the example shown, the linkage 724 is depicted in a first orientation. To illustrate the motion of the linkage 724, and thus the motion of the associated auxiliary port 714, the linkage 724 is depicted in FIG. 7D and FIG. 7B-7D two additional orientations. In these plan views, the rotation axes 730, 732, 734, 736 are indicated by black dots. Reference is made to FIG. 4A-7Dfirst note that the entry guide container 716 remains fixed in space and does not translate or rotate relative to other components. The crank arm 710 can pivot relative to the inner hub 706 and the outer rim 708. Pivoting the crank arm 710 causes the inner hub 706 to rotate relative to the outer rim 708. Further, pivoting the crank arm 710 causes the outer rim 708, to which the envelope is connected, to translate without rotating about the central axis of the outer rim 708. This is the manner in which the auxiliary port 714 can rotate about the entry guide container 716 and the entry guide port 712 without causing the envelope, which is coupled to the outer rim 708, to twist.

[0113] envelope

[0114] As described above, examples in accordance with the present 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 opening and the proximal opening. The distal end of the envelope is coupled to a distal coupling component, which can be or include, for example, a clamp. The clamp or other distal coupling component, in turn, can be coupled to a wound retractor or other port device. The proximal end of the envelope is coupled to a proximal coupling component, for example, a proximal coupling component that includes a reverse motion assembly as described above. The instrument access device is configured to receive insufflation gas and to maintain insufflation pressure within the cavity in the patient’s body and to maintain insufflation pressure within the cavity of the envelope. The pressurized and sealed envelope cavity provides operating space for shafts of multiple instruments of a teleoperated surgical system to articulate outside the body so that instrument end effectors can be located at or near the body surface at the incision site of a wound retractor coupled to the instrument access device.

[0115] In examples in accordance with the present disclosure, the pressurized envelope is configured to allow triangulation of shafts of multiple instruments of a teleoperated surgical system within the cavity of the envelope. Accordingly, the envelope needs to provide sufficient space to allow manipulation of multiple instruments within the cavity of the envelope and to allow a surgeon to triangulate the instruments to perform various procedures at or near the body surface at the incision site of a wound retractor coupled to the instrument access device. U.S. Patent No. US 9,060,678 B2 (filed June 13, 2007) discloses aspects of instrument triangulation in a single port surgical system and is incorporated herein by reference.

[0116] The pressurized envelope can, but need not, be manufactured from a transparent material, including, for example, a transparent polymer. It is beneficial for the envelope to be transparent to provide visualization for a clinician to view 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 reverse motion assembly described above with reference to FIG. 1) that is coupled to a wound retractor or other port device. The transparent envelope provides a clear view of the incision site to which the envelope is connected. FIG. 8A-8FThe proximal coupling component can receive medical instruments via one or more ports (e.g., a primary entry guide port and an auxiliary port) and the envelope can provide visualization of instruments introduced via these ports to a clinician. When an opaque material is used for the envelope, visualization can be provided by an endoscopic camera inserted through one of the ports into the instrument access device, or alternatively through one or more transparent windows in the envelope.

[0117] In various embodiments, the envelope of the instrument access device extends radially outward beyond the proximal and distal openings in the envelope (and thus beyond portions of the proximal and distal coupling components received in the respective openings) when pressurized with insufflation gas or when configured with sufficient rigidity. Example shapes and configurations of the envelope are described with reference to FIG. 8A

[0118] FIG. 8A is a perspective view depicting an example instrument access device 800 according to various embodiments. In FIG. 4A-7D the instrument access device 800 includes an envelope 802, a distal coupling component 804, an entry guide receptacle assembly 806, and a counter-motion assembly 808. The entry guide receptacle assembly 806 and the counter-motion assembly 808 can be similar to the entry guide receptacle assemblies and counter-motion assemblies described above with reference to FIG. 8A For example, the entry guide receptacle assembly 806 includes an entry guide receptacle 810 and the counter-motion assembly 808 includes a track element 812 having an entry guide port 814 and an auxiliary port 816, the track element 812 being surrounded by an outer element 813.

[0119] The envelope 802 includes a distal opening 818 and a proximal opening 820. The distal opening 818 of the envelope 802 is coupled to and receives the clamp (or other distal coupling component) 804, which is configured to connect to a port device, such as a wound retractor assembly, at a cut site. The proximal opening 820 of the envelope 802 is coupled to and receives the counter-motion assembly 808. The distal opening 818 of the envelope 802 can be coupled to the clamp 804 by a variety of means, including using adhesive or heat sealing the envelope 802 to the clamp 804. Similarly, the proximal opening 820 of the envelope 802 can be coupled to the counter-motion assembly 808 by a variety of means, including using adhesive or heat sealing the envelope 802 to the counter-motion assembly 808 at the outer element 813.

[0120] As will be described in greater detail below, the envelope 802 can be a variety of shapes and sizes. Generally, however, the envelope 802 extends radially outward beyond the clamp 804 and the counter-motion assembly 808 when the envelope 802 is pressurized with insufflation gas or if sufficiently rigid. As FIG. 8A ​As shown by the example, the envelope 802 includes a proximal section 822 and a distal section 824. The proximal section 822 of the envelope 802 is coupled to the distal section 824 at a junction 826. The proximal section 822 can be coupled to the distal section 824 by a variety of means, including using an adhesive, or heat sealing the proximal section 822 to the distal section 824. The proximal section 822 and the distal section 824 can each be a single continuous piece, or alternatively formed from multiple pieces. In a multiple piece section 822, 824, the proximal opening 820 can be formed in a first piece included in the proximal section 822, and the distal opening 818 can be formed in a second piece included in the distal section 824.

[0121] The proximal section 822 of the envelope 802 can be a first convex section. The distal section 824 of the envelope 804 can be a second convex section generally opposite the proximal convex section 822. The combination of the proximal section 822 and the distal section 824 can form an ovoid shape as shown (e.g., characterized by two convex portions of generally different heights meeting at a common maximum diameter). As will be described in detail below, other shapes are possible. In the depicted example, the maximum diameter of the envelope 802 is at the junction 826 connecting the proximal section 822 to the distal section 824. In one example, the maximum diameter of the envelope 802 is optionally greater than the longitudinal height of the envelope 802. Additionally, the junction 826 can be located below a transverse plane of the envelope 802 longitudinally (in a direction along a central axis defined through the distal opening 818 and the proximal opening 820 of the envelope). In other words, since the proximal section 822 of the envelope 802 extends a first distance along the central axis and the distal section 824 of the envelope 802 extends a second distance along the central axis, the second distance can be less than the first distance. Positioning the junction 826 below the longitudinal midpoint of the envelope 802 can improve visualization for the clinician by providing a greater field of view through the proximal section 822 unobstructed by the junction 826.

[0122] The envelope 802 includes an optional additional auxiliary port 828. The envelope auxiliary port 828 includes a seal 830 received in the port 828 of the envelope 802. The envelope auxiliary port seal 830 is configured to receive and seal a manually operated instrument and can include various types of seals, including cross-slit, duckbill, wiper, and / or septum seals. In FIG. 8B-8F In one example, the envelope auxiliary port seal 830 includes a cross-slit seal. In another example, the envelope auxiliary port seal 830 includes a seal similar to the seal disclosed in International Application No. PCT / US2019 / 031393 (filed May 8, 2019), which is incorporated by reference herein.

[0123] Enclosure 802 (and other envelopes according to this disclosure) can be made of a variety of materials, including a variety of transparent polymers. In one example, envelope 802 is made of acetate, polyester, vinyl, or polyurethane (e.g., thermoplastic polyurethane (TPU)). Enclosure 802 can be manufactured in a variety of ways, including vacuum forming. In another example, envelope 802 is made of a flat sheet having multiple seams that are joined together to form the final shape of envelope 802.

[0124] FIG. 8B-8F This is a perspective view depicting an additional example cover according to this disclosure. The same materials listed above may also be used. FIG. 8B The envelope. FIG. 4A-7D In this device access device 832, a sleeve 834, a clamp 836, an access guide container assembly 838, and a reverse motion assembly 840 are included. The access guide container assembly 838 and the reverse motion assembly 840 can be similar to those described above. FIG. 8B The described entry guide container assembly and instrument sealing assembly.

[0125] The envelope 834 includes a distal opening 850 and a proximal opening 851. The distal opening 850 of the envelope 834 is coupled to and receives a clamp 836, which is configured to connect to a port device, such as a wound retractor assembly at an incision site. The proximal opening 851 of the envelope 834 is coupled to and receives a reverse motion assembly 840. The distal opening 850 of the envelope 834 can be coupled to the clamp 836 by various means, including using an adhesive or heat-sealing the envelope 834 to the clamp 836. Similarly, the proximal opening 851 of the envelope 834 can be coupled to the reverse motion assembly 840 by various means, including using an adhesive or heat-sealing the envelope 834 to the reverse motion assembly 840 at an external element.

[0126] exist FIG. 8B In the example, the envelope 834 has a substantially spherical shape (allowing for some deviation from a perfect sphere, for example, to accommodate proximal and distal openings). Although not in FIG. 8A As depicted in the text, but in the example, the spherical envelope 834 may be formed by two or more hemispherical segments joined together at seams or other joints.

[0127] The envelope 834 optionally includes an additional auxiliary port 852. The envelope auxiliary port 852 includes a seal 853 received in port 852 of the envelope 834. The envelope auxiliary port seal 853 is configured to receive and seal manually operated instruments and may include various types of seals, including cross slits, duckbill seals, scraper seals, and / or diaphragm seals. FIG. 8CIn an example, the enclosure auxiliary port seal 853 includes a cross-slit seal. In another example, the enclosure auxiliary port seal 853 includes a seal similar to the seal disclosed in International Application No. PCT / US2019 / 031393.

[0128] The enclosure 834 can be manufactured in a variety of ways, including vacuum forming. In another example, the enclosure 834 is manufactured from a flat sheet having a plurality of seams that are joined to one another to form the final shape of the enclosure 834.

[0129] Referring now to FIG. 4A-7D , the instrument access device 854 includes an enclosure 855, a clamp 856, an entry guide receptacle assembly 857, and a counter-motion assembly 858. The entry guide receptacle assembly 857 and the counter-motion assembly 858 can be similar to the entry guide receptacle assembly and the instrument seal assembly described above with reference to FIG. 8C .

[0130] The enclosure 855 includes a distal opening 862 and a proximal opening 863. The distal opening 862 of the enclosure 855 is coupled to and receives the clamp 856, which is configured to connect to a port device, such as a wound retractor assembly at an incision site. The proximal opening 863 of the enclosure 855 is coupled to and receives the counter-motion assembly 858. The distal end 862 of the enclosure 855 can be coupled to the clamp 856 by a variety of means, including using an adhesive or heat sealing the enclosure 855 to the clamp 856. Similarly, the proximal end 863 of the enclosure 855 can be coupled to the counter-motion assembly 858 by a variety of means, including using an adhesive or heat sealing the enclosure 855 to the counter-motion assembly 858 at an external element.

[0131] In FIG. 8C an example, the enclosure 855 has a spheroid shape. Although not depicted in FIG. 8C , in an example, the spheroid enclosure 855 can be formed from two or more hemispherical segments that are joined together at seams or other junctions. Although not depicted in FIG. 8D , the enclosure 855 can optionally include additional auxiliary ports having auxiliary port seals as described above.

[0132] In FIG. 4A-7D , the instrument access device 864 includes an enclosure 865, a clamp 866, an entry guide receptacle assembly 867, and a counter-motion assembly 868. The entry guide receptacle assembly 867 and the counter-motion assembly 868 can be similar to the entry guide receptacle assembly and the instrument seal assembly described above with reference to FIG. 8D .

[0133] The enclosure 865 includes a distal opening 872 and a proximal opening 873. The distal opening 872 of the enclosure 865 is coupled to and receives a clamp 866, which is configured to connect to a port device, such as a wound retractor assembly at a surgical incision site. The proximal opening 873 of the enclosure 865 is coupled to and receives a counter-motion assembly 868. The distal end 872 of the enclosure 865 can be coupled to the clamp 866 by a variety of means, including using an adhesive or heat sealing the enclosure 865 to the clamp 866. Similarly, the proximal end 873 of the enclosure 865 can be coupled to the counter-motion assembly 868 by a variety of means, including using an adhesive or heat sealing the enclosure 865 to the counter-motion assembly 868 at the exterior element.

[0134] In FIG. 8D examples, the enclosure 865 has a generally cylindrical shape, and more particularly, a cylindrical bellows shape. Although not depicted in FIG. 8D , in examples, the bellows-shaped enclosure 865 can be formed from two or more segments joined together at a seam(s) or other joint(s). Further, although not depicted in FIG. 8E , the enclosure 865 can optionally include an additional auxiliary port with an auxiliary port seal.

[0135] In FIG. 4A-7D , the instrument access device 874 includes an enclosure 875, a clamp 876, an entry guide container assembly 877, and a counter-motion assembly 878. The entry guide container assembly 877 and the counter-motion assembly 878 can be similar to the entry guide container assembly and the instrument seal assembly described above with reference to FIG. 8E .

[0136] The enclosure 875 includes a distal opening 882 and a proximal opening 883. The distal opening 882 of the enclosure 875 is coupled to and receives a clamp 876, which is configured to connect to a port device, such as a wound retractor assembly at a surgical incision site. The proximal opening 883 of the enclosure 875 is coupled to and receives a counter-motion assembly 878. The distal end 882 of the enclosure 875 can be coupled to the clamp 876 by a variety of means, including using an adhesive or heat sealing the enclosure 875 to the clamp 876. Similarly, the proximal opening 883 of the enclosure 875 can be coupled to the counter-motion assembly 878 by a variety of means, including using an adhesive or heat sealing the enclosure 875 to the counter-motion assembly 878.

[0137] In FIG. 8EIn the example of FIG. 9, the envelope 875 has a lens shape. The lens-shaped envelope 875 includes a first convex segment 884 and a second convex segment 885 that share a common maximum diameter. The two convex segments 884, 885 are positioned opposite one another, and they join in an equatorial region 886 at which the common maximum diameter of the two segments 884, 885 converges. In FIG. 8E In the example of FIG. 9, the envelope 875 includes a rib 887 at the equatorial region 886, and the rib 887 extends radially outward from the first convex segment 885 and the second convex segment 886. The rib 887 provides structural support around the circumference of the equatorial region 886 to prevent inward flexing of the lens shape at the equatorial region 886, for example, under gas injection pressure.

[0138] The two segments 884, 885 of the lens-shaped envelope 875 can be symmetrical as shown, or they can be different sizes. For example, the proximal convex segment 884 can have a greater longitudinal height than the distal convex segment 885 to provide enhanced visibility within the envelope as described above. The proximal and convex segments can be joined together at a seam(s) or other joint(s). Further, although not depicted in FIG. 9, the envelope 865 can optionally include additional auxiliary ports with auxiliary port seals as described above. FIG. 8F

[0139] In the example of FIG. 10, the instrument access device 888 includes an envelope 889. The instrument access device 888 can be substantially similar to the instrument access device 874 of FIG. 9, except that the envelope 889 of the instrument access device 888 is not lens-shaped as is the envelope 875, but instead includes an elongated vertical segment 892 between two (e.g., convex) top and bottom segments 890, 891. Thus, the envelope 889 generally has a barrel shape (e.g., outwardly convex at the center, or alternatively substantially cylindrical) bounded at the top and bottom by convex, or alternatively flat or substantially flat, surfaces. When pressurized with gas injection gas, the envelope 889 extends radially outward beyond the clamp or other distal coupling component and beyond the reverse motion assembly of the proximal coupling component. The envelope 889 can include auxiliary ports and seals (not shown) as described above. FIG. 8E FIG. 9A In the example of FIG. 10, the instrument access device 888 includes an envelope 889. The instrument access device 888 can be substantially similar to the instrument access device 874 of FIG. 9, except that the envelope 889 of the instrument access device 888 is not lens-shaped as is the envelope 875, but instead includes an elongated vertical segment 892 between two (e.g., convex) top and bottom segments 890, 891. Thus, the envelope 889 generally has a barrel shape (e.g., outwardly convex at the center, or alternatively substantially cylindrical) bounded at the top and bottom by convex, or alternatively flat or substantially flat, surfaces. When pressurized with gas injection gas, the envelope 889 extends radially outward beyond the clamp or other distal coupling component and beyond the reverse motion assembly of the proximal coupling component. The envelope 889 can include auxiliary ports and seals (not shown) as described above.

[0140] Entry guide

[0141] As described above, various instrument access devices according to the present disclosure (e.g., devices 400, 700, 800, 832, 854, 864, 874, 888) are configured to receive an instrument entry guide in an entry guide receptacle located in an entry guide port of the instrument access device. Examples of such entry guides are described in the following disclosure.​​

[0142] FIG. 9B is a perspective view of an instrument access guide 900 according to various embodiments. The access guide 900 includes a funnel portion 902 at a proximal end, and a shaft portion 904 connected to a distal end of the funnel portion 902. A plurality of instrument channels are defined in the access guide 900, and each instrument channel includes an optional proximal tapered lead-in portion 906 in the funnel portion 902 and a distal lumen 908 in the shaft portion 904. Four instrument channels are shown, and other alternative embodiments can include two, three, or more instrument channels. Each instrument channel is configured to receive and guide an instrument through the access guide to emerge from a distal end of the lumen 908. The cross-sections of the instrument channels can all be the same size and shape, or they can vary in size and / or shape to guide different instruments through the access guide.

[0143] FIG. 9A is a top view of the access guide 900, showing FIG. 9B the funnel portion 902 at the proximal end of the access guide 900 of FIG. 9C is shown with instrument channels (lead-in portions 906 and lumens 908) of different cross-sectional shapes and sizes according to one embodiment. One lumen 910 has a relatively larger circular cross-section than a circular cross-section lumen 912. In one alternative embodiment, the lumen 910 is sized to receive an instrument including an instrument shaft having a diameter of 14 millimeters or less, such as a diameter in the range of 10-14 millimeters. Two lumens 912 have relatively smaller circular cross-sections than the lumen 910. These lumens 912 are optionally sized to each receive an instrument having an instrument shaft with a diameter of 7 millimeters or less, such as a diameter of approximately 6.5 millimeters. A fourth lumen 914 has an elliptical cross-section and is suitable for containing, for example, a camera instrument. The relative sizes and cross-sectional shapes of the lumens 910, 912, 914 illustrate that various combinations of lumen sizes and cross-sectional shapes can be used in embodiments of the access guide 900.

[0144] FIG. 9Dis an exploded perspective view of the entry guide 900 illustrating further details. As shown, the funnel portion 902 can be formed of two parts: an upper portion 920 and a lower portion 922. The lower portion 922 can optionally be integrally formed with the shaft 904. The entry guide 900 also includes an instrument seal 924 captured between the upper portion 920 and the lower portion 922 of the funnel portion 902. The seal can be made of, for example, silicone. During manufacture, the instrument seal 924 can be seated in the lower portion 922 and then the upper portion 924 can be snapped into the lower portion 922 with O-rings 926 sealing the two portions along their edges. The instrument seal 924 includes seal openings 928 aligned with the instrument channels 906 and the lumens 908 and are sized and shaped to accommodate the associated instrument outer diameters. The entry guide 900 also includes pivot seal doors 930, each aligned with one of the seal openings 928 and the associated instrument channel 906. In some embodiments, the entry guide also includes levers 932 to manually operate the doors 930. (Some, but not all, of the pivot doors 930 and levers 932 are shown exploded to the side.)

[0145] The doors 930 can be spring loaded and biased to a closed state. In their closed state, each door engages and seals against the instrument seal 924 with the sealing portion of the door sealing one of the seal openings 928. When an instrument is inserted through the funnel portion 902's lead-in portion 906 and into the corresponding lumen in the shaft 904, the door 930 associated with the lumen is pushed open. When the door 930 is in the open state, the lip of the corresponding seal opening 928 seals against the shaft of the instrument extending through the corresponding instrument channel. The instrument seal 924 in combination with the seal doors 930 prevents insufflation gas from escaping through the instrument channels when no instrument is inserted and prevents insufflation gas from escaping between the inner walls of the channels and the instrument shaft when an instrument is inserted. Further details of the entry guide and associated sealing aspects are described in U.S. Patent No. 9,629,681 B2 (filed March 14, 2014) (disclosing "Sealing Multiple Surgical Instruments"), which is incorporated herein by reference.

[0146] FIG. 9Bis a cross-sectional view of the entry guide 900 taken along the longitudinal axis of the entry guide 900 (i.e., along the direction of the shaft 904). Unlike existing entry guides, the entry guide 900 is configured to slightly curve the shafts of one or more of the inserted instruments. In existing entry guide configurations, the instrument channels in the entry guide are configured such that the instrument shafts, despite entering the instrument channels in the funnel portion 902 from generally different directions, are substantially parallel to each other and parallel to the longitudinal axis of the entry guide 900 (e.g., deviating from the longitudinal axis by no more than 1 degree) as they exit the lumen 908 of the shaft 904. In existing entry guides, this re-orientation of the instrument shafts to be generally parallel is achieved by slightly curving the distal end of the lumen 908 radially outward, to compensate for the residual directional bias of the instrument shafts resulting from the radially inward component of the orientation of the instrument shafts entering the instrument channels. But when the length of the shaft 904 of the entry guide 900 is shortened (e.g., to minimize the space occupied by the shaft 904 within the sheath of an instrument access device according to the present disclosure), this straightening effect is insufficient to maintain the instrument shafts parallel as they exit the lumen 908. Thus, if the entry guide shaft 904 is shortened without further compensation for the inward directional bias of the elastically bendable instrument shafts entering the proximal end of the entry guide, the instrument shafts will cross or collide after they exit the entry guide lumen 908.

[0147] To remedy this problem and maintain the instrument shafts parallel at the exit of the lumen 908 of a shortened entry guide, one or more of the lumens 908 are modified to include a small protrusion 940 at their distal end. The protrusion 940 extends radially inward into the lumen 908 to deflect the instrument shafts extending through the lumen radially outward from the centerline of the lumen and the central axis of the entry guide. The protrusion 940 in a lumen can be positioned on a central junction between multiple lumens, such that it is pointed away from the central axis of the entry guide shaft 904. The protrusion 940 is sized and shaped to deflect and orient the shaft of an instrument parallel to the longitudinal axis of the entry guide shaft 904. The size and shape of the protrusion 940 can depend, for example, on the flexibility of the instrument shaft of the instrument intended to be received in the corresponding lumen 908. Some instruments extending through the instrument channels in the entry guide 900 can have shafts sufficiently rigid that no protrusion 940 is needed at the distal end of the corresponding instrument channel. Thus, for example, ​ The entry guide 900 depicted in FIG. 9A can have protrusions at the ends of the three lumens 910, 912 intended to receive surgical instruments, while the lumen 914 for the camera can lack such protrusions, as the camera shaft is sufficiently rigid. In general, however, an entry guide according to the present disclosure can include inward protrusions 940 in any one or more (including all) of the lumens.

[0148] In some embodiments, the protrusion 940 at the distal end of the lumens 908 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 the center of the shaft 904 at the junction between the lumens 908.

[0149] According to another aspect, the entry guide 900 can optionally include a relief that defines a hole in the outer periphery of the entry guide shaft 904 at an orientation opposite the protrusion or ramp. The hole extends the diameter of the lumens 908 outward, and thus allows for additional bending of the instrument shafts. That is, the hole provides additional space for the instrument shafts to bend outward, which would otherwise contact the outer wall of the lumens. While the protrusion as described above reorients the instrument shafts to a generally parallel configuration after the instrument shafts exit the distal end of the entry guide, in an optional alternative embodiment, the protrusion in the lumens 108 is configured to intentionally spread the instruments laterally to a laterally converging orientation or a laterally diverging orientation. In the laterally converging orientation, the protrusion still spreads the instrument shafts sufficiently to prevent the instruments from colliding during normal operation. In the laterally diverging orientation, the protrusion spreads the instrument shafts to provide additional spacing between the instruments.

[0150] The following numbered examples are illustrative embodiments:

[0151] 1. An instrument entry guide, comprising: a shaft comprising a proximal end, a distal end, and a plurality of instrument lumens between the proximal end and the distal end of the shaft; wherein the plurality of lumens are parallel to each other within the shaft; wherein at least a first lumen of the plurality of lumens comprises a protrusion at the distal end of the shaft; and wherein the protrusion extends radially inward into the first lumen of the plurality of lumens to reduce an inner diameter of the first lumen of the plurality of lumens.

[0152] 2. The instrument entry guide of example 1, wherein the protrusion is sized and shaped to position the instrument shafts to be parallel to a longitudinal axis of one or more of the plurality of lumens distal of the distal end of the shaft of the instrument entry guide.

[0153] 3. The instrument entry guide of example 1 or example 2, wherein: the plurality of lumens comprises four lumens; and three of the four lumens comprise a protrusion at the distal end of the shaft.

[0154] 4. The instrument entry guide of example 3, wherein the four lumens comprise: two lumens configured to receive an instrument comprising an instrument shaft having a diameter of 6 millimeters or less; and one lumen configured to receive an instrument comprising an instrument shaft having a diameter of 14 millimeters or less.

[0155] 5. The instrument entry guide of any of examples 1-4, wherein the protrusion comprises a ramp that defines a lumen diameter that decreases from a proximal end of the ramp to a distal end of the ramp.

[0156] 6. The instrument access guide of example 5, wherein the ramp is positioned toward the center of the shaft at a junction between the plurality of lumens.

[0157] 7. The instrument access guide of any of examples 1-6, wherein at least a first lumen of the plurality of lumens includes a relief that defines a bore in the shaft positioned opposite the protrusion.

[0158] 8. The instrument access guide of any of examples 1-7, wherein: a second lumen of the plurality of lumens includes a second protrusion at a distal end of the shaft; the second protrusion extends radially inward into the second lumen of the plurality of lumens to reduce an inner diameter of the second lumen of the plurality of lumens; a central axis of the shaft is defined between the proximal end and the distal end of the shaft; the first protrusion extends in a first radial direction relative to the central axis; and the second protrusion extends in a second radial direction relative to the shaft that is different than the first radial direction.

[0159] 9. An instrument access guide, comprising: means for guiding a first shaft of a first instrument through a first instrument channel and a second shaft of a second instrument through a second instrument channel; and means for deflecting the first shaft of the first instrument at a distal end of the means for guiding; the means for deflecting the first shaft is sized and shaped to deflect the first shaft to be parallel to a longitudinal axis of the means for guiding.

[0160] 10. The instrument access guide of example 9, further comprising: means for deflecting the second shaft of the second instrument at the distal end of the means for guiding; the means for deflecting the second shaft is sized and shaped to deflect the second shaft to be parallel to the longitudinal axis of the means for guiding.

[0161] 11. The instrument access guide of example 9 or example 10, further comprising: means for allowing the first shaft of the first instrument to deflect beyond an outer perimeter of the means for guiding at the distal end of the means for guiding.

[0162] 12. The instrument access guide of example 9 or example 10, further comprising: means for allowing the first shaft of the first instrument and the second shaft of the second instrument to deflect beyond an outer perimeter of the means for guiding at the distal end of the means for guiding.

[0163] 13. A medical device, comprising: an instrument guide comprising a proximal end, a distal end, a plurality of instrument channels open between the proximal end and the distal end, and a longitudinal axis through the proximal end and the distal end and between the plurality of instrument channels; and a first protrusion on an inner wall of a first instrument channel of the plurality of instrument channels at a distal end of the shaft, the protrusion oriented in a first direction radially away from the central longitudinal axis.

[0164] 14. The instrument access guide of example 13, further comprising a second protrusion on an inner wall of a second instrument channel of the plurality of instrument channels at the distal end of the shaft, the second protrusion oriented in a second direction radially away from the longitudinal axis, the second direction being different than the first direction.

[0165] Those skilled in the art will appreciate that any of the above features can be combined with any other example feature, so long as the features are not mutually exclusive. All possible combinations of features are contemplated, depending on the clinical or other design requirements.

[0166] Examples described herein (e.g., methods, systems, or devices) can be applicable to surgical procedures, non-surgical medical procedures, diagnostic procedures, cosmetic procedures, and non-medical procedures or applications. Examples can also be applicable to training, or for obtaining information, such as imaging procedures. Examples can be applicable to handling tissue that has been removed from a human or animal anatomy and will not be returned to the human or animal, or for use with a human or animal cadaver.

[0167] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the application can be practiced. These embodiments are also referred to as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0168] In the event of inconsistent usages between this document and any document so incorporated by reference, the use in this document controls.

[0169] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “comprising” are used as the plain English equivalents of the respective terms “including” and “comprising.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such terms in the claim are still deemed to fall within the scope of such claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0170] Geometric terms, such as "parallel," "perpendicular," "circular," or "square," are not intended to require absolute mathematical precision, unless otherwise indicated by context. Rather, such geometric terms allow for variations due to manufacturing or equivalent function. For example, if an element is described as "circular" or "approximately circular," a component that is not a perfect circle (e.g., a component that is slightly oval or polygonal) is still encompassed by this description. Coordinate systems or frames of reference are provided to assist in explanation, and implantation can use other frames of reference or coordinate systems than those described herein.

[0171] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be utilized, such as would be apparent to one of ordinary skill in the art, upon reading the above description. The Abstract is provided to allow a quick determination of the disclosure's purpose. The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or the meaning of the claims. Also, in the above Detailed Description, various features can be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This should not be interpreted as intending that an unclaimed disclosure cannot be claimed or is indispensable to any claim. Rather, inventive subject matter can reside in less than all features of a single disclosed embodiment. The following claims are hereby expressly incorporated by reference as examples or embodiments of the present subject matter, wherein each claim can stand on its own as a separate embodiment, and the scope of the present subject matter is not to be construed as being limited only to the expressly claimed subject matter.

Claims

1. An instrument access guide, comprising: a shaft comprising a proximal end, a distal end, a plurality of instrument lumens between the proximal and distal ends of the shaft, and a central shaft axis through the proximal and distal ends and between the plurality of instrument lumens, wherein the plurality of instrument lumens are parallel to each other within the shaft; at least a first lumen of the plurality of instrument lumens comprises a first protrusion at the distal end of the shaft; the first protrusion extends radially inward into the first lumen of the plurality of instrument lumens in a direction radially away from the central shaft axis; the first protrusion reduces an inner diameter of the first lumen of the plurality of instrument lumens; the first protrusion is sized and shaped to orient an instrument shaft inserted through the first lumen of the plurality of instrument lumens parallel to the central shaft axis of the shaft; and the first protrusion comprises a ramp defining a lumen diameter of the first lumen of the plurality of instrument lumens that decreases from a proximal end of the ramp to a distal end of the ramp.

2. The instrument access guide of claim 1, wherein the first protrusion is sized and shaped to position the instrument shaft parallel to the central shaft axis distal to the distal end of the shaft of the instrument access guide.

3. The instrument access guide of claim 1, wherein: the plurality of instrument lumens comprises four lumens; and three of the four lumens comprise the first protrusion at the distal end of the shaft.

4. The instrument access guide of claim 3, wherein the four lumens comprise two lumens configured to receive an instrument comprising an instrument shaft having a diameter of 8 millimeters or less, and one lumen configured to receive an instrument comprising an instrument shaft having a diameter of 14 millimeters or less.

5. The instrument access guide of claim 1, wherein the ramp is positioned toward a center of the shaft at a junction between the plurality of instrument lumens.

6. The instrument access guide of any of claims 1-4, wherein at least the first lumen of the plurality of instrument lumens comprises a relief defining a hole in the shaft positioned opposite the first protrusion.

7. The instrument access guide of claim 1, wherein: a second lumen of the plurality of instrument lumens comprises a second protrusion at the distal end of the shaft; the second protrusion extends radially inward into the second lumen of the plurality of instrument lumens in a direction radially away from the central shaft axis to reduce an inner diameter of the second lumen of the plurality of instrument lumens; the first protrusion extends in a first radial direction relative to the central shaft axis; and the second protrusion extends in a second radial direction relative to the shaft different from the first radial direction.

8. An instrument access guide, comprising: a guide for guiding a first shaft of a first instrument through a first instrument channel and a second shaft of a second instrument through a second instrument channel, the guide having an axis extending along the length of and between the first instrument channel and the second instrument channel; and a deflection device for deflecting the first shaft of the first instrument at a distal end of the guide device; 9. The instrument access guide of claim 8, wherein: the deflection device comprises a first deflection lumen in the shaft of the guide device; and the first deflection lumen is configured to receive the first shaft of the first instrument. the deflection device for deflecting the second shaft of the second instrument extends into the second instrument channel in a second direction radially away from the axis and is sized and shaped to deflect the second shaft to be parallel to the axis of the guide device.

9. The instrument access guide of claim 8, further comprising: a deflection device for deflecting the second shaft of the second instrument at a distal end of the guide device; the deflection device for deflecting the second shaft extends into the second instrument channel in a second direction radially away from the axis and is sized and shaped to deflect the second shaft to be parallel to the axis of the guide device.

10. The instrument access guide of claim 8 or 9, further comprising: a device for allowing the first shaft of the first instrument to be deflected beyond an outer perimeter of the guide device at the distal end of the guide device.

11. The instrument access guide of claim 8 or 9, further comprising: a device for allowing the first shaft of the first instrument and the second shaft of the second instrument to be deflected beyond an outer perimeter of the guide device at the distal end of the guide device.

12. A medical device, comprising: an instrument guide comprising a proximal end, a distal end, a plurality of instrument channels opening between the proximal end and the distal end, and a longitudinal axis passing through the proximal end and the distal end and between the plurality of instrument channels; and a first protrusion on an inner wall of a first instrument channel of the plurality of instrument channels at the distal end of the instrument guide, the first protrusion extending into the first instrument channel of the plurality of instrument channels in a first direction radially away from the longitudinal axis and defining a channel diameter that decreases from a proximal end of the first protrusion to a distal end of the first protrusion, wherein the first protrusion is sized and shaped to orient an instrument shaft inserted through the first instrument channel of the plurality of instrument channels to be parallel to a central axis of the shaft, and wherein the first protrusion comprises a ramp that defines the channel diameter of the first instrument channel of the plurality of instrument channels that decreases from a proximal end of the ramp to a distal end of the ramp.

13. The medical device of claim 12, further comprising: a second protrusion on an inner wall of a second instrument channel of the plurality of instrument channels at the distal end of the shaft, the second protrusion oriented to extend into the first instrument channel of the plurality of instrument channels in a second direction radially away from the longitudinal axis, the second direction being different than the first direction. ​

Images