Single-port device access equipment

Abstract

This application discloses a medical device for surgical procedures, particularly relating to procedures for manipulating the end effector of a surgical instrument near the skin surface at an incision site. According to some embodiments, an instrument access device is configured to be coupled to a wound retractor at a distal end of the device and to receive multiple instrument entry guides in a port at a proximal end of the instrument access device, wherein a sash is located between a distal and proximal end defining a sealed cavity for maintaining inflated pressure. Various embodiments provide means for rotating an auxiliary port in the sash about the port receiving the instrument entry guide without twisting the sash. Various sash shapes are also disclosed. An instrument entry guide aligned with the axis of a surgical instrument is also disclosed.

Description

[0001] Priority requirements

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 908,501, filed September 30, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This document generally relates to medical devices, and more specifically, to medical devices used in minimally invasive surgical procedures. Background Technology

[0004] Surgical systems that utilize computer-aided control at least in part (“remote surgical systems”) (such as those used in 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. Intuitive Surgical, Inc. commercializes… A surgical system is an example of a remote surgical system.

[0005] Various remote surgical system architectures exist. Some architectures allow 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., da Vinci). Surgical systems). Other system architectures allow multiple surgical instruments to enter the body at multiple corresponding locations, and these systems are sometimes referred to as "multi-port" systems (e.g., da Vinci). Surgical systems). Those skilled in the art will understand that multi-port systems can sometimes be configured during surgery to operate through a single natural body opening (e.g., mouth or anus) or through a single incision (e.g., with da Vinci). The company's Single surgical system uses intuitive surgical manipulation techniques. (Technology) to operate. Those skilled in the art will also understand that single-port and multi-port configurations can be combined simultaneously in a single remote surgical system (e.g., two or more instruments inserted via a body opening, and one or more other instruments inserted via one or more corresponding other body openings).

[0006] Surgical instruments used during minimally invasive surgery typically include an endoscopic camera or treatment end effector mounted at the end of a slender instrument axis. Because the end effector is often located deep within the body during surgery, remote surgical systems are designed to constrain the rotation of the instrument at a point on the instrument axis (often called a remote center of motion). Kinematic hardware or control system software design (or a combination of both) can be used to implement this remote center of motion constraint. To minimize tissue trauma during surgery, the constrained remote center of motion is typically located at or near a body opening through which the instrument is inserted.

[0007] However, several challenges arise when using a telesurgical system at or near a body opening. First, to provide sufficient distance between the constrained telemotor and the instrument's end effector, the constrained telemotor may need to be located proximal to the body opening, sometimes by several centimeters or more. Second, if part of the surgery is performed proximal to the final surgical site (e.g., using a telesurgical system to perform anatomy to reach the final surgical site), a simple method is needed to reposition the constrained telemotor distally, as the surgery is performed towards the deepest part of the patient's body. A third challenge exists if insufflation is used within a body cavity containing the final surgical site (e.g., the abdomen, rectum). When the constrained telemotor is located at the patient's body wall, 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 as the instrument is inserted through the cannula and removed from the cannula. However, if the cannula is proximal to the body opening, the insufflation gas pressure must still be maintained.

[0008] Furthermore, these challenges become more complex for single-port systems where two or more instruments can be introduced into the patient and move as a single instrument cluster, because the constrained remote centers of motion of the two or more instruments are located at the same point or close to each other. Additionally, single-port system instruments can be designed with connectors that allow the instruments to be inserted close to each other, but then expand apart after passing through the body wall to provide triangulation for more efficient surgical procedures. Moreover, if additional instruments (teleoperative surgical system instruments or manually operated instruments) are to be introduced to assist in surgery, further challenges arise during the use of single-port systems, as the cluster of single-port system instruments obstructs some access points for additional instruments.

[0009] Therefore, what is needed is a method to allow the use of a single-port remote surgical system in which the constrained remote motion center of the single-port remote surgical system is located proximal to the patient's body opening to perform surgery at or near the patient's body opening, to allow maintenance of inflatable gas pressure during the surgery, and also to allow the introduction of auxiliary instruments to any desired location relative to the cluster of instruments of the remote surgical system during the surgery. Summary of the Invention

[0010] Examples of this disclosure include a medical device that allows a multi-instrument access guide to be located outside the patient's body and simultaneously provides a sealed space between the access guide and an opening in the patient's body wall to maintain inflatable insufflation. In this specification, such a medical device is referred to as a "device access device." The device access device includes a sheath comprising a distal opening at a distal end, a proximal opening at a proximal end, and an internal cavity located between the distal and proximal openings. For example, the sheath can have various shapes, such as a spherical shape, an ellipsoidal shape, an oval shape, a barrel shape, a lens shape, or a bellows shape.

[0011] At the distal end, the envelope can be coupled to a medical port device, such as a wound retractor, via a distal coupling member (e.g., a clamp) at a distal opening. At the proximal end, the envelope can be coupled to a remote surgical system via a proximal coupling member. The proximal coupling member is configured to contain multiple surgical instruments through a single opening and to seal against leakage of injection gas through that single opening.

[0012] The instrument access device is optionally configured to receive inflated gas and maintain inflated pressure within cavities in the patient's body and within the inner cavity of the envelope. The pressurized and sealed envelope cavity provides operating space for the axes of multiple instruments of the remote surgical system to make articulated connections outside the patient's body, such that the instrument end effector is located on or near the 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 may be configured to receive an access guide container and, within the access guide container, an instrument access guide (also simply referred to as an "access guide"), while the second port may be, for example, an auxiliary port. For example, the auxiliary port may support the introduction of manually operated instruments, surgical items, and the removal of large and / or fragile samples during procedures. The proximal coupling component includes a center, and the first and second ports are offset from the proximal coupling component.

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

[0015] The instrument access device according to this disclosure may optionally include a mechanism configured to rotate a second (e.g., auxiliary) port about a first port without the envelope twisting about its central axis. In some examples, the mechanism includes a gear train. In another example, the mechanism includes a linkage mechanism. Additionally, in examples, the mechanism may include a clutch (also referred to as a torque-limiting clutch or torque limiter) that disengages at least a portion of the mechanism in response to a threshold applied torque.

[0016] The present invention is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description and accompanying drawings provide further information regarding various aspects of the inventive subject matter of this patent application. Attached Figure Description

[0017] In the accompanying drawings, which are not necessarily to scale, the same numbers describe similar parts in different views. The same numbers with different letter suffixes represent different instances of similar parts. The accompanying drawings generally illustrate the various embodiments discussed in this document by way of example and not limitation.

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

[0019] Figures 1B-1D The illustrations are more detailed according to various embodiments. Figure 1A A schematic cross-sectional view of the coupling between the remote end of the instrument access device and the port device.

[0020] Figure 1E This is a schematic cross-sectional view illustrating the proximal elements of the instrument access device of FIG1 in more detail according to various embodiments.

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

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

[0023] Figure 4A This is an exploded perspective view of an example device access device according to various embodiments.

[0024] Figure 4B It is a description Figure 4A An exploded perspective view showing additional details of the instrument access device.

[0025] Figure 4C This is a bottom plan view depicting a gear train according to one embodiment, the gear train being used to rotate about another port as... Figure 4A The device described herein is connected to a port within the equipment without twisting the equipment's casing.

[0026] Figure 4D and Figure 4E It is a description Figure 4C Bottom plan view of the gear train in different rotational orientations.

[0027] Figure 5A This is a bottom perspective view depicting a gear train according to another embodiment, the gear train being used for rotation about another port. Figure 4A The device described herein is connected to a port within the equipment without twisting the equipment's casing.

[0028] Figures 5B-5D It is a description Figure 5A Bottom plan view of the gear train in different rotational orientations.

[0029] Figure 6A This is a bottom perspective view depicting a gear train according to yet another embodiment, the gear train being used to rotate about another port. Figure 4A The device described herein is connected to a port within the equipment without twisting the equipment's casing.

[0030] Figures 6B-6D It is a description Figure 6A Bottom plan view of the gear train in different rotational orientations.

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

[0032] Figure 7B This is a top plan view depicting a linkage mechanism according to one embodiment for rotation about another port. Figure 7A The device described herein is connected to a port within the equipment without twisting the equipment's casing.

[0033] Figure 7C and Figure 7D It is a description Figure 7B Top plan view of the linkage mechanism in different rotational orientations.

[0034] Figure 8AThis is a perspective view of an example device access device including an oval-shaped envelope according to one embodiment.

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

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

[0037] Figure 8D This is a perspective view of an example instrument access device including a corrugated tube-shaped envelope according to one embodiment.

[0038] Figure 8E This is a perspective view of an example device access device including a lens-shaped envelope according to one embodiment.

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

[0040] Figure 9A This is a perspective view of the entry guide according to various embodiments.

[0041] Figure 9B yes Figure 9A A top view of the proximal end of the entry guide.

[0042] Figure 9C It is a description Figure 9A An exploded perspective view showing additional details of the entry guide.

[0043] Figure 9D It is along Figure 9A The cross-section taken from the longitudinal axis of the entry guide.

[0044] Figures 10A-10C An example medical device including a clutch is depicted according to an example of this disclosure.

[0045] Figure 11A and Figure 11B An alternative clutch is depicted that can be used in an instrument access device according to an example of this disclosure. Detailed Implementation

[0046] Figures 1A-1E This is a schematic cross-sectional view illustrating various aspects of different embodiments of the instrument access device 1 used with the remote surgical system 2. (As shown...) Figure 1AAs shown, the instrument access device 1 includes a sleeve 3 having a proximal opening 4 and a distal opening 5. The interior 6 of the sleeve 3 is hollow, allowing one or more surgical instruments to be inserted into the interior 6 through the proximal opening 4, and for the instruments to pass through and exit the interior 6 through the distal opening 5. The sleeve 3 may have various shapes, as described in more detail below.

[0047] For reference, the central longitudinal axis 7 of the instrument access device 1 and the envelope 3 is defined to extend through the proximal opening 4 and the distal opening 5. As shown in this specification, the location associated with the instrument access device is referred to as "proximal" or "distal." The term "distal" refers to a location closer to the surgical site. The term "proximal" refers to a location farther from the surgical site and therefore closer to the mechanical surface of the remote surgical system 2. Similarly, as indicated by the arrows shown, the distal direction generally refers to the direction along the instrument access device away from the mechanical surface of the remote surgical system 2 and toward the surgical site, and the proximal direction generally refers to the direction along the instrument access device away from the surgical site and toward the mechanical surface of the remote surgical system 2. And for further reference, the world reference coordinate system 8 is arbitrarily defined and is fixed in space. Typically, the instrument access device 1 is oriented in use such that its proximal opening 4 is above the distal opening 5 relative to the patient's body (i.e., the proximal opening is the "top opening," and the distal opening 5 is the "bottom opening"), as shown, so that surgery can be performed from above. However, please note that the instrument access device 1 can be used in any orientation.

[0048] The device 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 cover 3 at the distal opening 5, and the proximal coupling component 10 is optionally detachably or fixedly coupled to the cover 3 at the proximal opening 4.

[0049] As shown, the proximal coupling component 10 is detachably coupled to the machine floor at coupling member 11. Any suitable coupling type can be used, and the proximal coupling component 10 can optionally be coupled to the machine floor via a remote surgical system 2 (e.g., where the remote surgical system 2 includes the proximal portion of coupling member 11), via another operating room fixture (e.g., an operating table), or via any other suitable support structure that allows the proximal coupling component 10 to be placed in the desired orientation and orientation in space (i.e., reference coordinate system 8; the combination of translational orientation and rotational orientation defines the unique pose of the object in three-dimensional space), and then remain stationary in the desired orientation and orientation during surgery performed using the remote surgical system 2.

[0050] As shown in the figure, 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 remote surgical system instruments 14 of the remote surgical system 2. A cluster of three remote surgical system instruments 14 is shown—an endoscope camera 14a and two treatment instruments 14b (e.g., grasping, cutting, or electrosurgical instruments, etc.). This instrument cluster illustrates various combinations of remote surgical system instruments 14 that can be received within the interior 6 of the envelope 3 through the first opening 12. The second opening 13 is sized to receive one or more auxiliary instruments 15 (e.g., grasping, cutting, electrosurgical, aspiration / irrigation, or suturing instruments, etc.). In some embodiments, one or more auxiliary instruments 15 are manually operated (illustrated by a hand symbol), while in other alternative embodiments, one or more auxiliary instruments 15 are operated via the remote surgical system 2 (illustrated by dashed lines). Although a single second opening 13 is shown, the proximal coupling component 10 may optionally include two, three, or more second openings to receive various combinations of additional manual or remote-controlled auxiliary instruments.

[0051] The distal coupling component 9 is detachably coupled to the patient 16 and surrounds the body opening 17—an incision or natural orifice (e.g., the anus). During the surgical procedure, the remote surgical system instrument 14 is received in the sheath 3 and extends toward the distal opening 5 of the sheath 3. Thus, the remote surgical system instrument 14 can operate at the patient's skin surface 18, within the patient's body wall 19, or at a surgical site 20 distal to the body wall 19.

[0052] Figures 1B-1D This 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 a body opening 17 within the patient's body in various embodiments. The port device 21 retracts into the patient's tissue and thus keeps the opening 17 open to allow surgical instruments to enter. Figure 1B As shown, the port device 21 can have a generally fixed diameter and is height-adjustable as indicated by the double-headed arrows, allowing it to fit snugly 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 wound retractors, or similar terms.) Alternatively, as... Figure 1CAs shown, the distal coupling member 9 can be detachably or fixedly coupled to another type of port device 21a, which typically has a fixed diameter and 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 member 9 can be detachably or fixedly coupled to yet another type of port device 21b, which typically has a fixed diameter and fixed height and is placed on the patient's skin surface (e.g., by adhesive or suction). If the sheath 3 is sufficiently rigid, the distal force transmitted from the proximal coupling member 10 through the sheath 3 (e.g., receiving a distal force from the remote surgical system 2) may be sufficient to hold 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 surgical instruments to operate at or slightly below the surface of the patient's skin (e.g., to form incisions or anatomical tissue immediately below the skin surface). Other variations of the port device may optionally be used. If the distal coupling member 9 is detachably coupled to the port device, the distal coupling member 9 may optionally be coupled to any one of port devices 21, 21a, or 21b, or to any other type of port device used during the surgical procedure. That is, depending on the surgical procedure to be performed, a single instrument access device 1 may be used with any one of two or more port devices. The distal coupling member 9 may optionally include a clamp (not shown) or other suitable device for detachably coupling the distal coupling member 9 to the port device. It should be noted that although the gas pressure used for injecting gas into the body cavity for surgical procedures can also be used to inject gas into the envelope 3, the instrument access device and associated components may optionally be used in clinical situations where patient-injected gas is not used, in which case the injection gas may be used only to hold the envelope 3 in its desired shape or to otherwise provide clinical benefit, such as venting smoke from within the envelope 3.

[0053] Figure 1EThis is a schematic cross-sectional view illustrating the proximal elements of the instrument access device 1 in more detail. During surgery, a remotely operated instrument 14 is inserted through a first opening 12 along a remote surgical instrument insertion axis 23, and one or more auxiliary instruments 15 are typically inserted through a second opening 13 along an auxiliary instrument insertion axis 24. If an auxiliary instrument 15 must be inserted into a position 25 in the envelope 3 that is blocked by one or more remote 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 position 25. Therefore, 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 travel along a track 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 in an orientation from which the auxiliary instrument 15 can reach position 25. However, even if 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 when the second opening 13 and the auxiliary instrument insertion axis 24 are running along the track around the first opening 12 and the remote surgical instrument insertion axis 23.

[0054] In one aspect, the remote surgical instrument insertion axis 23 deviates from the central axis 7; in another aspect, the remote surgical instrument insertion axis 23 coincides with the central axis 7; in yet another aspect, the alternative instrument insertion axis 24 deviates from the central axis 7; and in yet another aspect, the alternative instrument insertion axis 24 coincides with the central axis 7. Therefore, it can 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, then the other two axes, if deviating from the stationary axis, will move along a track around 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 coincident axis remains stationary in space, the remaining non-coincident axes will move along a track around the coincident axis, and the envelope 3 will not twist; and if the remaining non-coincident axes remain stationary in space, the coincident axis will move along a track around the remaining non-coincident axes, and the envelope 3 will not twist. Similarly, for embodiments using two, three, or more optional second openings 13, a similar relationship exists between the fixed axis (single or coincident) and the track axis (single or coincident). The following description focuses on the aspect in which the remote surgical instrument insertion axis is fixed in space and offset from the central axis 7 to avoid a lengthy description; those 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 including coincident axes.

[0055] Figure 2 This is a schematic top view illustrating the operational features of the proximal coupling component 10. (See also: [link to related document]) Figure 1E and Figure 2 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 a mechanical ground (e.g., via coupling element 11 as described above) such that during surgical procedures, element 10a remains stationary relative to 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.

[0056] During use, when the distal opening 5 is fixed in space (e.g., when the distal coupling member 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 by an angle θ, the reverse motion mechanism 10d causes the external element 10b to rotate relative to the track element 10c by an equal angle θ but in a direction opposite to the rotation direction of the track element 10c (i.e., -θ) around the stationary element 10a. And because the two rotational angles are equal but opposite in direction, the orientation of the external element 10b relative to the coordinate system 8 does not change, and when the distal coupling member 9 is stationary relative to the coordinate system 8, the sleeve 3 will not twist about the central axis 7. That is, the proximal opening 4, the distal opening 5, the stationary element 10a, the external element 10b, and the distal coupling member 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 external element 10b and the track element 10c translate in orientation relative to the coordinate system 8 (-x, y, as indicated by the rotation angle θ of the track element 10c) as the track element 10c moves along the track about the stationary element 10a. 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 translate relative to its distal opening 5 without any accompanying torsion of the envelope 3 about the central axis 7.

[0057] refer to Figure 1EThe remote surgical instrument 14 is 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 include two or more remote surgical instruments 14 are disclosed in U.S. Patent Nos. 9,877,744 B2 (filed February 12, 2010) (publishing "Entry Guide for Multiple Instruments in a Single Port Surgical System") and 9,757,149 B2 (filed June 16, 2014) (publishing "Surgical System Entry Guide"), as well as in International Patent Application Publication Nos. WO 2018 / 013730A1 (filed July 12, 2017) (publishing "Surgical Instrument Guide") and WO 2018 / 013734 A1 (filed July 12, 2017) (publishing "Surgical Instrument Guide with Insufflation Channels"), all of which are incorporated herein by reference.

[0058] In some embodiments, the access guide 26 is inserted via an optional access guide container 27, which is inserted through the stationary element 10a and performs the function of an access guide cannula. In other alternative embodiments, the access guide container 27 is combined with or constitutes the stationary element 10a, and the access guide 26 is directly inserted through the stationary element 10a, in which case the stationary element 10a performs the function of an access guide cannula.

[0059] To prevent pressurized gas from leaking from the interior 6 of the sleeve 3 through the access guide 26 with or without insertion of the remote surgical instrument 14, or through the container 27 (or the stationary element 10a serving as the access guide container) with or without insertion of the access guide 26, various gas sealing arrangements may be used. A non-limiting example of the access guide seal 28 is disclosed in U.S. Patent Application Publication No. 2014 / 0276464 A1 (filed March 14, 2014) (publishing “Sealing Multiple Surgical Instruments”), which is incorporated herein by reference.

[0060] The pressurized injection gas can be introduced into the interior 6 of the envelope 3 via the stationary element 10a, or via the inlet guide 26, or via the container 27, or via the seal 28, or by any of these four elements arranged together to define the gas flow path. For example, if multiple aspects of the stationary element 10a and the container 27 are combined into a single element and the inlet guide seal 28 is used, the injection gas can be introduced via these combined elements. As shown, the injection gas from the injection gas source 29 travels along the gas flow path 30 into the interior 6 of the envelope 3. As a result, the injection gas pressure 31, which is higher than the ambient atmospheric pressure outside the envelope 3, is maintained in the interior 6.

[0061] Alternatively, the injection gas can be introduced into the interior 6 of the sleeve 3 via a different gas flow path than that illustrated by gas flow path 30 (e.g., the instrument seal in the second opening 13 (described below), or a dedicated injection port in the track element 10c, sleeve 3, or distal coupling component 9, for example). And optionally, one or more gas flow paths can be defined from the interior 6 to the exterior of the sleeve 3, illustrated by the opposite direction of gas flow path 30. Such outward gas flow paths can be used for functions such as smoke extraction if the remote control instrument 14 or auxiliary instrument 15 is not used to perform a smoke extraction function.

[0062] The envelope 3 can have various shapes and can be made of various materials. For example, the envelope 3 can have a generally spherical shape, a generally ellipsoidal shape (i.e., flattened or elongated relative to the central axis 7), a generally oval shape (i.e., tapering 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.).

[0063] The envelope 3 can be made of a flexible plastic sheet that takes on a designed shape when there is sufficient inflation gas pressure 31 inside the envelope 3's interior 6. Alternatively, the envelope 3 can be made of a flexible, resilient material that maintains its shape without requiring internal gas pressure. In other options, structural elements (e.g., support ribs or similar structures) are used to help the envelope 3 maintain its shape during use. And in other options, the envelope is rigid.

[0064] The cover 3 can typically be transparent, allowing a clinician outside the cover 3 to view the orientation of the instruments 14, 15 within the cover 3. Alternatively, the cover 3 can be opaque, in which case images from an endoscope camera inside the cover 3 can be used to determine the orientation of the instruments 14, 15 within the cover 3. As another alternative, the cover 3 can be opaque but have one or more transparent windows.

[0065] Still referencing Figure 1EThe auxiliary instrument 15 is inserted through the second opening 13 via the auxiliary instrument seal 32. The instrument seal 32 is used to maintain the inflation gas pressure within the sleeve 3 whether the auxiliary instrument 15 is inserted or not. Various suitable instrument seals are known and can be used, and non-limiting examples of the instrument seal 32 are disclosed in U.S. Patent Application Publication No. 2017 / 0095269A1 (filed March 17, 2015) and International Patent Application No. PCT / US2019 / 031393 (filed May 8, 2019) (published as “Instrument Seal”), both of which are incorporated herein by reference.

[0066] Further aspects and details will now be described.

[0067] Remote surgical system

[0068] To illustrate the general background in which the aforementioned instruments can be used to access devices, Figure 3 Schematic perspective views illustrating various aspects of a remote surgical system according to various embodiments are provided. Generally, for the purposes of this specification, the remote surgical system includes three main components: an endoscopic imaging system, a user control system (master), and a manipulator system 210E (slave) (e.g. Figure 3 (As shown), all of these are interconnected via wired (electrical or optical) or wireless connections. One or more data processors (i.e., one or more logical units coupled to one or more memory systems) may be located differently in these main components to provide system functionality. An example is disclosed in U.S. Patent No. 9,060,678 (filed June 13, 2007) (disclosing "Minimally Invasive Surgical System"), which is incorporated herein by reference.

[0069] The imaging system performs image processing functions on, for example, endoscopic imaging data of the surgical site captured and / or preoperative or real-time image data from other imaging systems outside the patient. The imaging system outputs the processed image data (e.g., an image of the surgical site, along with associated 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., where the surgeon at another location can monitor the video; real-time video feeds can be used for training, etc.).

[0070] The user control system includes multi-degree-of-freedom (DOF) mechanical input devices that allow the surgeon to manipulate instruments, access guides, and imaging system devices with computer assistance. In some respects, these input devices can provide tactile feedback from instruments and surgical equipment components to the surgeon. The user control system also includes a stereoscopic video output display positioned such that the image on the display is typically focused at a distance corresponding to the distance of the surgeon's hands working behind / below the display screen.

[0071] Control during instrument insertion and use can be accomplished, for example, by the surgeon using one or two input devices to move the instruments presented in the image; 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 components to steer the endoscope or cluster of instruments toward the desired location on the output display and advance it inside the patient.

[0072] The 210E control system is in Figure 3 The illustration shows that in the depicted example, the manipulator system 210E is implemented as a patient-side trolley, and the surgery is performed in the abdomen of the patient 229. However, surgical systems including the manipulator system 210E can be used for a variety of surgical procedures by using various combinations of instruments.

[0073] Manipulator system 210E includes a base 201E mounted on the floor as shown, or alternatively mounted on the ceiling or other mechanically grounded base (not shown). Base 201E may be movable or fixed (e.g., fixed to a floor, ceiling, wall, or other fixture (e.g., a surgical table)). Base 201E supports the remainder of the manipulator system, which includes a generally passive, uncontrolled manipulator support structure 220E and an actively controlled manipulator system 230E (also referred to herein as access guide manipulator 230E).

[0074] In one example, the manipulator support structure 220E includes a first setting link 202E and two passive rotary setting joints 203E and 205E. Rotary setting joints 203E and 205E allow manual positioning of the coupled setting links 204E and 206E. Alternatively, some of these setting joints can be actively controlled, and more or fewer setting joints can be used in various configurations. Setting joints 203E and 205E, as well as setting links 204E and 206E, allow a person to position the access guide manipulator 230E at various orientations and orientations in Cartesian x, y, z space. A passive prismatic setting joint (not shown) between link 202E and base 201E of the manipulator support structure 220E can be used for large vertical adjustments 212E.

[0075] The access guide manipulator 230E includes an access guide manipulator assembly 231E supporting multiple surgical device assemblies, at least one of which is coupled to the access guide manipulator assembly 231E during surgery. Each surgical device assembly includes a remote manipulator and surgical instruments or camera instruments mounted on the manipulator. For example, in Figure 3 In this context, a surgical device assembly includes an instrument 260E mounted to a manipulator 240E, the instrument 260E having a shaft 262E that extends through one of a plurality of channels typically accessing a guide 270E during a surgical procedure.

[0076] The access guide manipulator assembly 231E includes an instrument manipulator positioning system (hereinafter referred to as the "positioning system"). The positioning system moves in a plane the instrument mounting interfaces of one or more manipulators 240E such that when one or more instruments 260E are coupled to the access guide manipulator assembly 231E using their respective instrument mounting interfaces, the axes of each instrument 260E are aligned for insertion into a channel in the access guide 270E. Although the access guide 270E is depicted as being located at the patient's body wall, it should be understood that the manipulator system 210E can also be used without modification, wherein the access guide is located at a distance from the body wall within the access guide container of the instrument access device as described herein.

[0077] One or more instrument mounting interfaces can be moved to an appropriate orientation after the attachment of one or more instruments. The plane in which the instrument mounting interface moves is generally perpendicular to the longitudinal axis of the access guide 270E, and the trajectory of the instrument mounting interface in this plane can include various combinations of straight and / or curved portions. As the positioning element of the lateral movement mechanism of the positioning system moves along the trajectory, the distal tip of the shaft of the instrument mounting interface and the instrument effectively coupled to the instrument mounting interface moves along the same trajectory. Thus, the movement of the positioning element causes the shaft to be moved to a position where the shaft is aligned with the channel in the access guide 270E. In this orientation, the shaft can enter and pass through the channel in the access guide 270E without damaging the instrument or hindering its operation. The specific path implemented in the positioning system depends at least in part on the type of surgical device assembly that can be mounted on the access guide manipulator assembly 231E and / or the configuration of the channel in the access guide 270E.

[0078] Different access guides can be used in different surgical procedures. Access guides that enter the body between multiple ribs may optionally have a different shape than those that enter the body through an abdominal incision. Furthermore, access guides that enter the body are generally different in length, for example, from those used outside the body, such as those inserted through an access guide container at the proximal end of the sheath of an instrument access device as disclosed herein; access guides used outside the body and at a distance from the body may be shorter than those used inside the body. Different shapes of access guides require different layouts of the channel extending through the access guide, i.e., different channel configurations. Furthermore, the shape and / or size of the instrument's shaft may differ for different instruments. Access guides with shaft shapes and sizes that accommodate instruments used in specific surgical procedures are used. The track is designed to accommodate a set of access guides that can be used with the manipulator system 210E.

[0079] The ability to individually position an instrument relative to a channel in the access guide via a movable instrument mounting interface, and thus to position its axis, provides versatility to the manipulator system 210E. For example, this capability allows the use of access guides with different channel configurations within the system 210E. Furthermore, the positioning system eliminates the need for instruments specific to surgical procedures. In other words, the instrument manipulator positioning system allows the use of a universal instrument set with multiple access guides, as described above, by moving the instrument axis.

[0080] The entry guide manipulator 230E includes a kinematic chain of movable joints and links, which can be moved by a motor or other actuator and receive movement control signals associated with the movement of the main arm at the user control system. Using this kinematic chain, the entry guide manipulator 230E can adjust the orientation and orientation of the positioning system of the entry guide manipulator assembly 231E, and adjust the instrument by extension. Typically, the entry guide manipulator 230E is configured and operated to constrain the rotation of the instrument at a point located on the axis of the instrument (referred to herein as the remote center of motion).

[0081] Typically, the orientation of the telemotion center coincides with the location of instrument entry into the patient (e.g., at the umbilicus in abdominal surgery). However, according to this disclosure, in the case of an instrument access device with an instrument entry guide located outside the body (in a port at the proximal end of the instrument access device's sheath), the orientation of the telemotion center also falls outside the body, for example, slightly above the body wall, and generally along the axis of the entry guide. The telemotion center above the body wall allows the instrument to move radially outward from the extension axis of the entry guide proximal to the patient's body wall, thereby achieving better triangulation access at or near the incision site. The flexible instrument axis, combined with a flexible wound retractor, provides this flexibility when manipulating the instrument without risking tissue trauma.

[0082] The remote motion center is the location where the yaw axis, pitch axis, and roll axis intersect; that is, the position where the motion chain entering the guide manipulator 230E remains effectively stationary as the joint moves through the joint's range of motion. For example... Figure 3 As shown, the controller assembly yaw connector 211E is coupled between one end of the setting link 206E and a first end (e.g., the proximal end) of the first controller link 213E. The yaw connector 211E allows the first controller link 213E to move relative to the link 206E in a manner that can be arbitrarily defined as “yawing” about the controller assembly yaw axis 223E. As shown, the yaw axis 223E of the connector 211E is aligned with a remote center of motion located at or near the entry guide 270E.

[0083] The distal end of the first actuator link 213E is coupled to the proximal end of the second actuator link 215E via a first active control rotary joint 214E. The distal end of the second actuator link 215E is coupled to the proximal end of the third actuator link 217E via a second active control rotary joint 216E. The distal end of the third actuator link 217E is coupled to the fourth actuator link 219E via a third active control rotary joint 218E; the fourth actuator link 219E extends in two directions away from the rotary joint 218E and therefore has two distal ends relative to the joint 218E.

[0084] 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., a mechanism is called a parallel motion linkage when the input and output link movements remain parallel to each other). For example, if rotary joint 214E rotates actively, joints 216E and 218E also rotate actively, causing link 219E to move in a constant relationship with 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 211E, links 215E, 217E, and 219E relative to link 213E can be arbitrarily defined as a "pitch" motion about the pitch axis of the actuator assembly. The actuator pitch axis extends in and out at or near the remote center of motion of the entry guide 270E. Figure 3 The movement about the pitch axis of the manipulator assembly is indicated by arrow 221E. Since links 215E, 217E, and 219E move as a single component in this embodiment, the first manipulator link 213E can be considered as the active proximal manipulator link, and the second to fourth manipulator links 215E, 217E, and 219E can be collectively considered as the active distal manipulator links.

[0085] The access guide manipulator assembly platform 232E is coupled to one of the distal ends of the fourth manipulator link 219E. The access guide manipulator assembly 231 is rotatably mounted on the platform 232E. The access guide manipulator assembly 231 can rotate multiple surgical device assemblies (e.g., 260E) as a group about axis 225E. Specifically, the access guide manipulator assembly 231 rotates as a single unit relative to the platform 232E with a motion that can be arbitrarily defined as “rolling” about the access guide manipulator assembly roll axis 225E.

[0086] According to this disclosure, all instruments (including camera instruments) enter the instrument access device via a single port, which is generally stationary relative to the remote center of motion applied by the entry guide manipulator 230E (and is defined by the intersection of the manipulator assembly yaw axis 223E, the manipulator assembly pitch axis 221E, and the manipulator roll axis 225E). The configuration of links 215E, 217E, and 219E, and the configuration of joints 214E, 216E, and 218E, such that the remote center of motion is located distal to the entry guide manipulator assembly, with sufficient distance to allow the entry guide manipulator assembly to move freely relative to the entry guide.

[0087] The access guide container 275E can be detachably coupled (directly or indirectly via a mounting) to the distal end of the fourth manipulator link 219E, which is opposite to the distal end of the access guide manipulator assembly platform 232E to which it is coupled. In one embodiment, the access guide container 275E or the mounting is coupled to the link 219E via a rotary joint that allows it to move between a retracted position and an operational position adjacent to the link 219E, the operational position ensuring that the remote center of motion is located along the access guide container 275E or received in the access guide 270E. According to one aspect, during operation, the access guide container 275E is fixed in the appropriate orientation relative to the link 219E. The access guide container and the access guide can be made of various materials, such as steel or extruded plastic. Plastic is cheaper than steel and is suitable for single-use per surgical procedure.

[0088] When the patient 229 is positioned in different orientations on the movable stage, various passive and active joints / links allow for a wide range of motion in positioning instruments and imaging systems. Certain joints and links in the manipulator support structure 210E and / or the access 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 degrees of freedom. It should be understood that the manipulator support structure 210E and the access guide manipulator 230E can include various combinations of links, passive joints, and active joints (which can provide redundant degrees of freedom) to achieve the required range of postures for the surgical procedure.

[0089] Instrument access equipment with reverse motion mechanism

[0090] Figure 4A This is an exploded perspective view of an example device access device 400 according to various embodiments. Figure 4A In this embodiment, the instrument access device 400 includes an access guide container assembly 402 (including an access guide container 426), a reverse motion assembly 404, a sleeve 406, and a clamp 408 (serving as a distal coupling component). In this embodiment, the access guide container 426 and the reverse motion assembly 404 together form a proximal coupling component.

[0091] A clamp 408 is received in the distal opening of the sleeve 406 and, in use, secures the instrument access device 400 to a wound retractor or similar port device at the body opening. A reverse motion assembly 404 is received in the proximal opening 418 of the sleeve 406 and includes a first port 410 for receiving an entry guide container 426 and thus referred to as an "entry guide port" 410, and a second port 420 for receiving an auxiliary instrument and thus referred to as an "auxiliary port" 420. One or more instruments enter the instrument access device 400 proximally via an entry guide received in the entry guide container 426 or via the auxiliary port 420. The sleeve 406 also includes an additional sleeve auxiliary port 422 through which other instruments may enter. Instruments (whether entering via the entry guide port 410 or auxiliary ports 420, 422) operate within the sleeve 406 or exit the sleeve 406 through the distal opening to enter the patient's body. The auxiliary port 422 may optionally be configured to allow surgical instruments (e.g., sutures or mesh material, imaging probes, instrument accessories, etc.) to be introduced or removed from inside the envelope 406, or to allow tissue to be removed from inside the envelope 406.

[0092] Access guide container assembly 402 includes access guide container 426 and connector 416, which secures instrument access device 400 to the arm of a remote surgical system, such as Reference 402. Figure 3 The system is described and illustrated. Furthermore, the access guide container assembly 402 includes gas lines 412 and 414 that carry injection gas through the lines and into the instrument access device 400, including the access sleeve 406. The injection lines 412, 414 may have standard flow Luer fittings, or alternatively, other fittings that allow higher gas flow rates over time. The use of two gas lines 412, 414 allows for the connection of an injection source to either side of the access guide port 410, which can accommodate space constraints in a surgical environment. Furthermore, the two gas lines 412, 414 allow one line to be used for injection while the other is used for fume extraction, for example, by venting a second line into the room or using an injector with a built-in fume extractor.

[0093] The reverse motion assembly 404 includes a track element 424 (as an example of element 10c) defining openings in the entry guide port 410 and the auxiliary port 420; an outer element 425 (as an example of element 10b) received in a proximal opening of the sleeve 406; and a reverse motion mechanism that allows the auxiliary port 420 to rotate about the entry guide port 410 (and thus about the entry guide container 426) without the sleeve 406 twisting about its central axis. In use, when the instrument access device is secured to a remote surgical system, the entry guide container 426 remains stationary in space as the auxiliary port 420 rotates about it. (In this embodiment, the entry guide container 426 functions as the stationary component 10a.)

[0094] Figure 4B This is an exploded perspective view depicting additional details of the instrument access device 400. Figure 4B In this assembly, the access guide container assembly 402 includes an access guide container 426, an instrument guide seal 428, a sealing support 430, a cap 432, an access guide container O-ring 434, and an access guide container retaining ring 436. The instrument guide seal 428 is received within the access guide container 426. The cap 432 locks onto the access guide container 426, capturing (or “clamping”) the sealing 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 cavity of the access guide container 426 in the port 410. The access guide container retaining ring 436 couples the access guide container 426 to the access guide port 410, thereby connecting the access guide container assembly 402 to the reverse motion assembly 404.

[0095] In some examples, the inlet guide container assembly 402 is configured to receive an instrument inlet guide that is 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 inlet guide. In one example, the instrument guide seal 428 may include a cross-slit seal, a duckbill seal, a scraper seal, a diaphragm seal, or another type of seal suitable for receiving and sealing an instrument inlet guide according to this disclosure. In one example, the instrument guide seal 428 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393 (filed May 8, 2009) (disclosing “INSTRUMENT SEAL”), the entire contents of which are incorporated herein by reference.

[0096] exist Figure 4BIn this embodiment, the reverse motion assembly 404 includes a track element 424, which includes an inlet guide port 410 and an auxiliary port 420. Furthermore, the reverse motion assembly 404 includes an auxiliary port seal 438 and a sleeve 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 may include various types of seals, including cross slits, duckbill, scraper, or diaphragm seals. In one example, the auxiliary port seal 438 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393. The sleeve O-ring 440 is received in a proximal opening 418 of the sleeve 406 and is configured to seal the outer element 425 of the reverse motion assembly 404 in the opening 418. O-ring 440, together with O-ring 434, is important for maintaining inflation while allowing the auxiliary port 420 to rotate about the access guide port 410. The instrument access device 402 also includes a sleeve auxiliary port seal 442 received in the sleeve auxiliary port 422 of the sleeve 406. The sleeve auxiliary port seal 442 is configured to receive and seal manually operated instruments and may include various types of seals, including cross-slit, duckbill, scraper, or diaphragm seals. In one example, the sleeve auxiliary port seal 442 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393.

[0097] Figure 4C This is a bottom plan view depicting a gear train 450 according to one embodiment. The gear train 450 is a mechanism through which the auxiliary port 420 can rotate about the entry guide container 426 and the entry guide port 410 without the sleeve 406 rotating about its central axis (or in other words, the sleeve 406 not twisting). The gear train 450 includes a first gear 452, a second gear 454, an idler gear 456, and an intermediate gear 458. Figure 4C In this configuration, the first gear 452 and the second gear 454 are ring gears, with the tooth surfaces of the first gear 452 facing radially inward and the tooth surfaces of the second gear 454 facing radially outward. The intermediate gear 458 is a stepped spur gear, comprising a third spur gear 460 and a fourth spur gear 462 (hidden behind the third spur gear 460) that meshes with an 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.

[0098] The first gear 452 is positioned around the outer periphery of the track element 424 of the reverse motion assembly 404, and is configured to be fixed to an external element 425, which is coupled to a proximal opening 418 of the sleeve 406. The second gear 454 is coupled to the outer periphery of the guide container 426. Note that the first gear 452 and the second gear 454 are in different planes, with the second gear 454 above the first gear 452 (i.e., below in a bottom-up view), and they are not directly operably meshed with each other. The first gear 452 and the second gear 454 are coupled via an idler gear 456 and an intermediate gear 458 (all together forming the reverse motion mechanism 10d). More specifically, the idler gear 456 operably meshes with the second gear 454 and the fourth gear 462 of the intermediate gear 458. The fourth gear 462 is coupled to the third gear 460 of the intermediate gear 458, which in turn operably meshes with the first gear 452. The idler gear 456 reverses the rotational direction between the first gear 452 and the second gear 454. Specifically, from... Figure 4C From the perspective of rotation, when the intermediate gear 458 (including the third gear 460 and the fourth gear 462) rotates clockwise, the idler gear 456 rotates counterclockwise.

[0099] exist Figure 4C In the example, gear train 450 is depicted in a first position. To illustrate the movement of gear train 450, and its movement via the associated auxiliary port 420, gear train 450 in... Figure 4D and Figure 4E It is depicted in two additional orientations. (Reference) Figures 4C-4EFirst, note that the second gear 454 and the associated access guide container 426 remain fixed in space and do not translate or rotate relative to the remote surgical system. (The access guide port 410 is also translated and fixed in space, but rotates relative to the access guide container along with the track element.) The idler gear 456 is operatively engaged with and rotates about the second gear 454. As the idler gear 456 rotates and translates about the second gear 454, it 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 causes the first gear 452 to rotate and cause the first gear 452 to translate about the central axis of the access guide port 410 without rotating about the central axis of the first gear 452. This is how the auxiliary port 420 can rotate about the access guide port 410 and the access guide container 426 without causing the sleeve 406 (which is coupled to the first gear 452) to twist. Note that, together with the first gear 452 and the external element 425 of the reverse motion mechanism, the proximal opening of the sleeve 406 also translates, thereby changing its orientation relative to the distal opening of the sleeve 406. This relative movement between the proximal and distal openings is accommodated by the flexible or movable characteristics of the sleeve 406.

[0100] This oscillating translation of the first gear 452 (and via the associated sleeve 406) about the guide port 410 is achieved at least in part by the gear ratios of the individual gears in the gear train 450: the gear ratios are chosen such that the rotation remains synchronized because the rotation of the first gear 452 relative to the idler gear 456 at a certain angle in one direction is accompanied by the rotation of the second gear 454 relative to the idler gear 452 at the same angle in the opposite direction. Specifically, 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 movement of the first gear 452 can... Figures 4A-4E The first gear 452 is tracked by reference to the indexing mark 464 on the external element 425 and the gear 452. Note that although the indexing mark 464 is translated relative to the entry guide container 426 and the entry guide port 410, the mark 464 and therefore 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.

[0101] Figure 5AThis is a bottom perspective view depicting a gear train 550 according to another embodiment. The gear train 550 is another mechanism through which the auxiliary port 420 can rotate about the entry guide container 426 and the entry guide port 410 without the sleeve 406 rotating about its central axis (or in other words, the sleeve 406 not twisting). The gear train 550 includes a first gear 552, a second gear 554, and an intermediate gear 556. Figure 5A In this configuration, the first gear 552 and the second gear 554 are ring gears, wherein the gear teeth of the first gear 552 and the second gear 554 face radially inward. Furthermore, the intermediate gear 556 is a stepped spur gear comprising a third spur gear 560 and a fourth spur gear 562, such that gears 560 and 562 are coaxially coupled and rotate together.

[0102] The first gear 552 is positioned around the outer periphery of the track element 424 of the reverse motion assembly 404, and together with the outer element 425, is configured to be positioned in and coupled to the proximal opening 418 of the sleeve 406 (see [link]). Figure 4A and Figure 4B The second gear 554 is positioned around the outer periphery of the guide container 426. An intermediate gear 556 is positioned between the first gear 552 and the second gear 554. A third spur gear 560 of the intermediate gear 556 operably meshes with the first gear 552. A fourth spur gear 562 of the intermediate gear 556 operably meshes with the second gear 554.

[0103] Figure 5B This is a bottom plan view depicting gear train 550. Figure 5B In the example, gear train 550 is depicted in a first position. To illustrate the movement of gear train 550, and the movement via the associated track element 424 including auxiliary port 420, gear train 550 in... Figure 5C and Figure 5D It is depicted in two additional orientations. (Reference) Figures 5B-5D First, note that the second gear 554 and the associated 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 the second gear 554 and operably engages with 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 rotates the first gear 552, causing 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 how the auxiliary port 420 can rotate about the entry guide port 410 and the entry guide container 426 without causing the sleeve 406 (which is coupled to the first gear 552) to twist.

[0104] This oscillating translation of the first gear 552 (and via the associated sleeve 406) about the guide port 410 is achieved at least in part by the gear ratios of the individual gears in 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. The movement of the first gear 552 can be... Figures 5B-5D The first gear 552 is tracked by reference to the external element 425 and the indexing mark 564 on the gear 552. Note that although the indexing mark 564 is translated relative to the entry guide container 426 and the entry guide port 410, the mark 564 and therefore 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.

[0105] Figure 6A This is a bottom perspective view depicting a gear train 650 according to yet another embodiment. The gear train 650 is another mechanism through which the auxiliary port 420 can rotate about the entry guide container 426 and the entry guide port 410 without the sleeve 406 rotating about its central axis (or in other words, the sleeve 406 not twisting). The gear train 650 includes a first gear 652, a second gear 654, and an intermediate gear 656, and operates in a manner similar to gear train 550, except that, as Figure 6A As shown, the first gear 652 and the second gear 654 are ring gears, wherein the gear teeth of the first gear 652 and the second gear 654 face 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 located outside the first ring gear 652 and the second ring gear 654.

[0106] The first gear 652 is positioned around the outer periphery of the track element 424 of the reverse motion assembly 404, and together with the outer element 425 is configured to be positioned in and coupled to the proximal opening 418 of the sleeve 406 (see...). Figure 4A and Figure 4BThe second gear 654 is positioned around the outer periphery of the guide container 426. An intermediate gear 656 is positioned between the first gear 652 and the second gear 654. In this example, the external element 425 includes three outwardly projecting optional tabs 666, and the intermediate gear 656, including a third spur gear 660 and a fourth spur gear 662, is housed within one of the three tabs 666. The tabs 666 can serve various functions, including receiving the intermediate gear 656 and providing a grip for manipulating the reverse motion assembly 404 to rotate the auxiliary port 420. The third spur gear 660 of the intermediate gear 656 operatively meshes with the first gear 652. The fourth spur gear 662 of the intermediate gear 656 operatively meshes with the second gear 654.

[0107] Figure 6B This is a bottom plan view depicting the gear train 650 according to this disclosure. Figure 6B In the example, gear train 650 is depicted in a first position. To illustrate the movement of gear train 650, and the movement via associated track element 424 and auxiliary port 420, gear train 650 in... Figure 6C and Figure 6D It is depicted in two additional orientations. (Reference) Figures 6B-6D First, note that the second gear 654 and the associated entry guide container 426 remain fixed in space and do not translate or rotate relative to other components. The fourth spur gear 662 of the intermediate gear 656 rotates about the second gear 654 and operatively engages with the second gear 654. As the fourth spur gear 662 rotates about the second gear 654, the third spur gear 660 of the intermediate gear 656 engages and rotates the first gear 652, causing the first gear 652 to translate about the central axis of the entry guide port 410 without rotating about the central axis of the first gear 652. This is how the auxiliary port 420 can rotate about the entry guide port 410 and the entry guide container 426 without causing the sleeve 406 (which is coupled to the first gear 652) to twist.

[0108] This oscillating translation of the first gear 652 (and via the associated sleeve 406) about the guide port 410 is achieved at least in part by the gear ratios of the individual gears in 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 movement of the first gear 652 can be... Figures 6B-6D The indexing mark 664 on the reference external element 425 and gear 652 is tracked. Note that although the indexing mark 664 is translated relative to the entry guide container 426 and the entry guide port 410, the mark 664, and therefore the first gear 652, does 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.

[0109] Figure 7A This is a top perspective view of the proximal coupling component 700 of another device access device according to various embodiments. The proximal coupling component 700 includes an access guide container assembly 702 and a reverse motion assembly 704. The device access device's sheath (coupled to the proximal coupling component) and clamp (arranged in and coupled to the distal opening of the sheath) are not shown. The sheath and clamp are... Figure 4A and Figure 4B Those that are the same or similar to those described in the description for use in the instrument access device 400.

[0110] The reverse motion assembly 704 includes an inner hub 706, an outer edge 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 edge 708 is coupled to a sleeve. The inner hub 706 is rotatable relative to the outer edge 708 about its central axis. An entry guide container assembly 702, including an entry guide container 716 and a connector 718, is received in the entry guide port 712. The crank arm 710 is pivotally connected to the outer edge 708. The connector 718 secures the instrument access device 700 to a remote surgical system (e.g., reference 708). Figure 3 The arm of the system (depicting and describing).

[0111] The inner hub 706, outer edge 708, crank arm 710, and inlet guide container assembly 702 are connected to each other to form a linkage mechanism. This linkage mechanism is configured to rotate an auxiliary port 714 about the inlet guide container 716, while the sleeve connected to the outer edge 708 does not rotate about the central axis of the sleeve. Therefore, this linkage mechanism allows the auxiliary port 714 to rotate about the inlet guide container 716 without twisting the sleeve.

[0112] exist Figure 7A In the example, the inner hub 706, outer edge 708, crank arm 710, and entry guide container assembly 702 are connected to each other to form a four-bar linkage 724, more specifically, a parallel four-bar linkage. The entry guide container assembly 702 is the ground link of the four-bar linkage, and the crank arm 710 is the input link of the linkage. The inner hub 706 and outer edge 708 are each coupling links of the parallel four-bar linkage formed by the inner hub 706, outer edge 708, crank arm 710, and entry guide container assembly 702. The four axes of rotation associated with the joint of the linkage 724 are... Figure 7ADepicted in dashed lines, pairs of adjacent connecting rods are coupled here. 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, passing 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, passing through the common center of the edge 708 and the hub 706, corresponds to the joint that couples the hub 706 to the outer edge 708. The fourth axis 736, serving as the pivot axis of the crank arm 710, couples the edge 708 to the crank arm 710. The distance between axes 730 and 736 (the length of the crank arm connecting rod) is equal to the distance between axes 732 and 734 (the distance between the center of the edge and the entry guide port), and the distance between axes 730 and 732 is equal to the distance between axes 734 and 736, such that axes 730, 732, 734, and 736 form a parallelogram.

[0113] The reverse motion assembly 704 also includes a locking mechanism for locking the linkage mechanism 724 in place, thereby locking the auxiliary port 714 in an orientation relative to the entry guide container 716 and the entry guide port 712. Figure 7A In the locking arm 720, the locking arm 720 is deflectable relative to the outer edge 708 and includes a latch on the underside of the locking arm 720. The outer edge 708 includes ratchet teeth 722. The locking arm 720 is resilient and configured to lock into the ratchet teeth 722. The locking arm 720 can be deflected to raise the locking arm and disengage it from the ratchet teeth 722, thereby unlocking the linkage mechanism formed by the inner hub 706, the outer edge 708, the entry guide container assembly 702, and the crank arm 710. This, in turn, allows the auxiliary port 714 to rotate relative to and about the entry guide container 716 and the entry guide port 712.

[0114] Figure 7B This is a plan view depicting the linkage mechanism 724 formed by the inner hub 706, outer edge 708, entry guide container assembly 702, and crank arm 710. Figure 7B In the example, linkage 724 is depicted in a first position. To illustrate the movement of linkage 724, and the movement via the associated auxiliary port 714, linkage 724 is... Figure 7C and Figure 7D The figures are depicted in two additional orientations. In these plan views, the axes of rotation 730, 732, 734, and 736 are indicated by black dots. (Reference) Figures 7B-7DFirst, note that the inlet guide container 716 remains fixed in space and does not translate or rotate relative to other components. The crank arm 710 is pivotable relative to the inner hub 706 and the outer edge 708. Pivoting the crank arm 710 causes the inner hub 706 to rotate relative to the outer edge 708. Furthermore, pivoting the crank arm 710 causes the outer edge 708, which is attached to the sleeve, to translate without rotating about the central axis of the outer edge 708. This is how the auxiliary port 714 can rotate about the inlet guide container 716 and the inlet guide port 712 without causing the sleeve (which is coupled to the outer edge 708) to twist.

[0115] envelope

[0116] As described above, examples according to this disclosure include an instrument access device comprising a sheath, and the sheath including a distal opening at a distal end, a proximal opening at a proximal end, and a cavity between the distal and proximal openings. The distal end of the sheath is coupled to a distal coupling member, which may be, for example, a clamp. The clamp or other distal coupling member may then be coupled to a wound retractor or other port device. The proximal end of the sheath is coupled to a proximal coupling member, for example, a proximal coupling member including the reverse motion assembly as described above. The instrument access device is configured to receive inflated gas and maintain inflated pressure within a cavity in the patient's body and to maintain inflated pressure within the cavity of the sheath. The pressurized and sealed sheath cavity provides operating space for the axes of multiple instruments of a remotely operated surgical system to allow for articulation outside the body, such that an instrument end effector can be located at or near the body surface at the incision site of the wound retractor coupled to the instrument access device.

[0117] In the examples according to this disclosure, the pressure envelope is configured to allow triangulation of the axes of multiple instruments of a remotely controlled surgical system within the envelope's cavity. Therefore, the envelope needs to provide sufficient space to allow manipulation of multiple instruments within the envelope's cavity and to allow the surgeon to triangulate the instruments to perform various procedures at or near the incision site of a wound retractor coupled to an instrument access device. U.S. Patent No. 9,060,678 B2 (filed June 13, 2007) discloses several aspects of instrument triangulation in a single-port surgical system and is incorporated herein by reference.

[0118] The pressure occluder can (but must) be made of a transparent material, including, for example, a transparent polymer. Advantageously, a transparent occluder provides clinicians with visualization of the incision site to which it is attached. In the use of instrument access devices, the occluder is attached to a proximal coupling component (similar to the one mentioned above). Figures 4A-7D(As described in the example), the proximal coupling component can receive a medical device via one or more ports (e.g., a primary access guide port and an auxiliary port), and the envelope can provide the clinician with visualization of the device introduced via these ports. When an opaque material is used for the envelope, visualization can be provided via an endoscopic camera inserted into the device access device via one of the ports, or optionally via one or more transparent windows in the envelope.

[0119] In various embodiments, the sheath of the instrument access device extends radially outward beyond the proximal and distal openings in the sheath, either when pressurized with injection gas or when constructed with sufficient rigidity (and thus beyond multiple portions of the proximal and distal coupling components received in the respective openings). Example shapes and configurations of the sheath are referenced. Figures 8A-8F describe.

[0120] Figure 8A This is a perspective view depicting an example device access device 800 according to various embodiments. Figure 8A In this context, the instrument access device 800 includes a sleeve 802, a distal coupling component 804, an access guide container assembly 806, and a reverse motion assembly 808. The access guide container assembly 806 and the reverse motion assembly 808 can be similar to those described above. Figures 4A-7D The description includes an entry guide container assembly and a reverse motion assembly. For example, the entry guide container assembly 806 includes an entry guide container 810, and the reverse 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.

[0121] 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 a clamp (or other distal coupling component) 804, which is configured to connect to a port device, such as a wound retractor assembly, at the incision site. The proximal opening 820 of the envelope 802 is coupled to and receives a reverse motion assembly 808. The distal opening 818 of the envelope 802 can be coupled to the clamp 804 by various means, including using adhesives or heat-sealing the envelope 802 onto the clamp 804. Similarly, the proximal opening 820 of the envelope 802 can be coupled to the reverse motion assembly 808 by various means, including using adhesives or heat-sealing the envelope 802 onto the reverse motion assembly 808 at the external element 813.

[0122] As will be described in more detail below, the envelope 802 can be of various shapes and sizes. However, generally, when the envelope 802 is pressurized with gas or, if sufficiently rigid, the envelope 802 extends radially outward beyond the clamp 804 and the reverse motion assembly 808. Figure 8AAs shown in the example, the envelope 802 includes a proximal segment 822 and a distal segment 824. The proximal segment 822 of the envelope 802 is coupled to the distal segment 824 at a mating point 826. The proximal segment 822 can be coupled to the distal segment 824 by various means, including using an adhesive or heat-sealing the proximal segment 822 to the distal segment 824. The proximal segment 822 and the distal segment 824 can each be a single continuous piece, or alternatively formed by multiple pieces. In the multiple segments 822, 824, a proximal opening 820 can be formed in a first piece included in the proximal segment 822, and a distal opening 818 can be formed in a second piece included in the distal segment 824.

[0123] The proximal segment 822 of the envelope 802 may be a first convex segment. The distal segment 824 of the envelope 804 may be a second convex segment generally opposite to the proximal convex segment 822. The combination of the proximal segment 822 and the distal segment 824 may form an oval shape as shown (e.g., characterized by two convex portions that meet at a common maximum diameter but are generally at different heights). Other shapes are also possible, as will be described in detail below. In the depicted example, the maximum diameter of the envelope 802 is located at the junction 826 where the proximal segment 822 connects to the distal segment 824. In one example, the maximum diameter of the envelope 802 may optionally be greater than the longitudinal height of the envelope 802. Additionally, the junction 826 may be located longitudinally (in the direction along the central axis defined by the distal opening 818 and the proximal opening 820 of the envelope) below the transverse plane that bisectes the envelope 802. In other words, since the proximal segment 822 of the envelope 802 extends along the central axis by a first distance and the distal segment 824 of the envelope 802 extends along the central axis by a second distance, the second distance can be smaller than the first distance. Positioning the junction 826 below the longitudinal midpoint of the envelope 802 can improve visualization for clinicians by providing a larger field of view through the proximal segment 822 without obstruction by the junction 826.

[0124] Enclosure 802 includes an optional additional auxiliary port 828. Enclosure auxiliary port 828 includes a seal 830 received within port 828 of envelope 802. Enclosure auxiliary port seal 830 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. Figure 8A 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 that disclosed in International Application No. PCT / US2019 / 031393 (filed May 8, 2019), which is incorporated herein by reference.

[0125] 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.

[0126] Figures 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. Figures 8B-8F The envelope. Figure 8B 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. Figures 4A-7D The described entry guide container assembly and instrument sealing assembly.

[0127] 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.

[0128] exist Figure 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 Figure 8B 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.

[0129] 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. Figure 8AIn one example, the envelope auxiliary port seal 853 includes a cross slit seal. In another example, the envelope auxiliary port seal 853 includes a seal similar to that disclosed in International Application No. PCT / US2019 / 031393.

[0130] Envelope 834 can be manufactured in a variety of ways, including vacuum forming. In another example, envelope 834 is manufactured from a flat plate with multiple seams that are connected to each other to form the final shape of envelope 834.

[0131] Now for reference Figure 8C The instrument access device 854 includes a sleeve 855, a clamp 856, an access guide container assembly 857, and a reverse motion assembly 858. The access guide container assembly 857 and the reverse motion assembly 858 can be similar to those described above. Figures 4A-7D The described entry guide container assembly and instrument sealing assembly.

[0132] The envelope 855 includes a distal opening 862 and a proximal opening 863. The distal opening 862 of the envelope 855 is coupled to and receives a 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 envelope 855 is coupled to and receives a reverse motion assembly 858. The distal end 862 of the envelope 855 can be coupled to the clamp 856 by various means, including using adhesives or heat-sealing the envelope 855 to the clamp 856. Similarly, the proximal end 863 of the envelope 855 can be coupled to the reverse motion assembly 858 by various means, including using adhesives or heat-sealing the envelope 855 to an external component.

[0133] exist Figure 8C In the example, envelope 855 has an oblate spheroid shape. Although not in... Figure 8C As depicted in the text, but in the example, the oblate spheroidal envelope 855 can be formed from two or more hemispherical segments joined together at seams or other joints. Although not described in the text... Figure 8C As depicted, but envelope 855 may optionally include an additional auxiliary port having an auxiliary port seal as described above.

[0134] exist Figure 8D In this context, the instrument access device 864 includes a sleeve 865, a clamp 866, an access guide container assembly 867, and a reverse motion assembly 868. The access guide container assembly 867 and the reverse motion assembly 868 can be similar to those described above. Figures 4A-7D The described entry guide container assembly and instrument sealing assembly.

[0135] The envelope 865 includes a distal opening 872 and a proximal opening 873. The distal opening 872 of the envelope 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 an incision site. The proximal opening 873 of the envelope 865 is coupled to and receives a reverse motion assembly 868. The distal end 872 of the envelope 865 can be coupled to the clamp 866 by various means, including using adhesives or heat-sealing the envelope 865 to the clamp 866. Similarly, the proximal end 873 of the envelope 865 can be coupled to the reverse motion assembly 868 by various means, including using adhesives or heat-sealing the envelope 865 to an external element.

[0136] exist Figure 8D In the example, envelope 865 has a generally cylindrical shape, and more specifically, a cylindrical bellows shape. Although not in Figure 8D As depicted, but in the example, the bellows-shaped sleeve 865 can be formed from two or more sections joined together at one or more seams or other joints. Furthermore, although not described in... Figure 8D As depicted, envelope 865 may optionally include an additional auxiliary port with an auxiliary port seal.

[0137] exist Figure 8E In this context, the instrument access device 874 includes a sleeve 875, a clamp 876, an access guide container assembly 877, and a reverse motion assembly 878. The access guide container assembly 877 and the reverse motion assembly 878 can be similar to those described above. Figures 4A-7D The described entry guide container assembly and instrument sealing assembly.

[0138] The envelope 875 includes a distal opening 882 and a proximal opening 883. The distal opening 882 of the envelope 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 an incision site. The proximal opening 883 of the envelope 875 is coupled to and receives a reverse motion assembly 878. The distal end 882 of the envelope 875 can be coupled to the clamp 876 by various means, including using adhesives or heat-sealing the envelope 875 to the clamp 876. Similarly, the proximal opening 883 of the envelope 875 can be coupled to the reverse motion assembly 878 by various means, including using adhesives or heat-sealing the envelope 875 to the reverse motion assembly 878.

[0139] exist Figure 8EIn the example, the envelope 875 has a lens shape. The lens-shaped envelope 875 includes a first convex segment 884 and a second convex segment 885, which share a common maximum diameter. The two convex segments 884 and 885 are positioned opposite each other and are connected in an equatorial region 886, where the common maximum diameter of the two segments 884 and 885 intersects. Figure 8E In the example, 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 perimeter of the equatorial region 886 to prevent, for example, the lens shape from buckling inward at the equatorial region 886 under inflation pressure.

[0140] The two sections 884, 885 of the lens-shaped envelope 875 can be symmetrical as shown, or they can be of different dimensions. For example, the proximal convex section 884 may have a greater longitudinal height than the distal convex section 885 to provide enhanced visibility within the envelope as described above. The proximal and convex sections may be joined together at one or more seams or other joints. Furthermore, although not in Figure 8E As depicted, but envelope 865 may optionally include an additional auxiliary port having an auxiliary port seal as described above.

[0141] exist Figure 8F In this context, the device access device 888 includes a cover 889. The device access device 888 can connect to... Figure 8E The device access device 874 is substantially similar, except that the envelope 889 of the device access device 888 is not lenticular like that of the envelope 875, but instead includes an elongated vertical section 892 between two (e.g., convex) top sections 890 and a bottom section 891. Therefore, the envelope 889 generally has a barrel shape (e.g., bulging outward at the center, or alternatively, substantially cylindrical) defined at the top and bottom by convex surfaces or, alternatively, flat or substantially flat surfaces. When pressurized with 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 may include auxiliary ports and seals (not shown) as described above.

[0142] Enter guide

[0143] As described above, various device access devices according to this disclosure (e.g., devices 400, 700, 800, 832, 854, 864, 874, 888) are configured to receive a device access guide in an access guide container located in the access guide port of the device access device. Examples of such access guides are described in the following disclosure.

[0144] Figure 9A This is a perspective view of an instrument entry guide 900 according to various embodiments. The entry guide 900 includes a funnel portion 902 at its proximal end and a shaft portion 904 connected to the distal end of the funnel portion 902. A plurality of instrument channels are defined in the entry guide 900, and each instrument channel includes an optional proximal tapered inlet 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 may include two, three, or more instrument channels. Each instrument channel is configured to receive and guide an instrument through the entry guide to emerge from the distal end of the lumen 908. The cross-sections of the instrument channels may all have the same size and shape, or they may vary in size and / or shape to guide different instruments through the entry guide.

[0145] Figure 9B This is a top view of the guide 900, showing... Figure 9A The funnel portion 902 and the tapered inlet portion 906 at the proximal end of the entry guide 900. Figure 9B An instrument channel (inlet portion 906 and lumen 908) with different cross-sectional shapes and sizes is illustrated according to one embodiment. One lumen 910 has a relatively larger circular cross-section than the circular cross-section of lumen 912. In an alternative embodiment, lumen 910 is designed to receive an instrument containing an instrument shaft having a diameter of 14 mm or less, for example, a diameter in the range of 10-14 mm. Two lumens 912 have relatively smaller circular cross-sections than lumen 910. These lumens 912 are optionally designed to each receive an instrument with an instrument shaft having a diameter of 7 mm or less, for example, a diameter of approximately 6.5 mm. A fourth lumen 914 has an elliptical cross-section and is suitable for accommodating, for example, a camera instrument. The relative dimensions and cross-sectional shapes of lumens 910, 912, and 914 illustrate various combinations of lumen sizes and cross-sectional shapes that can be used in embodiments of the access guide 900.

[0146] Figure 9CThis is an exploded perspective view illustrating further details of the entry guide 900. 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 that is held 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 manufacturing, the instrument seal 924 can be placed in the lower portion 922, and then the upper portion 924 can be snapped into the lower portion 922, wherein an O-ring 926 seals the two portions along their edges. The instrument seal 924 includes a sealing opening 928 aligned with the instrument channel 906 and the lumen 908, and the sealing opening 928 is sized and shaped to accommodate the associated instrument outer diameter. The entry guide 900 also includes pivot sealing gates 930, each sealing gate 930 aligned with one of the sealing openings 928 and the associated instrument channel 906. In some embodiments, the access guide also includes a lever 932 to manually operate the door 930. (Some, but not all, of the pivot doors 930 and levers 932 are shown disassembled to the side.)

[0147] Door 930 may be spring-loaded and biased to a closed state. In its closed state, each door engages with and seals against instrument seal 924, wherein the sealing portion of the door seals one of the sealing openings 928. When an instrument is inserted through the inlet portion 906 of the funnel portion 902 and into the corresponding lumen in the shaft 904, the door 930 associated with the lumen is pushed open. When door 930 is in the open state, the lip of the corresponding sealing opening 928 seals against the shaft of the instrument extending through the corresponding instrument channel. Instrument seal 924, engaged with sealing door 930, prevents injection gas from escaping through the instrument channel when no instrument is inserted and prevents injection gas from escaping between the inner wall of the channel and the instrument shaft when an instrument is inserted. Further details regarding the entry guide and associated sealing are described in U.S. Patent No. 9,629,681B2 (filed March 14, 2014) (disclosed as “Sealing Multiple Surgical Instruments”), which is incorporated herein by reference.

[0148] Figure 9DThis is a cross-sectional view of the entry guide 900 taken along its longitudinal axis (i.e., along the direction of axis 904). Unlike existing entry guides, the entry guide 900 is configured to slightly bend the axis 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 axes, although entering the instrument channels in the funnel portion 902 from substantially 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 axis 904. In existing entry guides, this substantially parallel reorientation of the instrument axes is achieved by slightly bending the distal end of lumen 908 radially outward to compensate for the residual orientation deviation of the instrument axes caused by the radially inward component of the orientation of the instrument axes entering the instrument channels. However, when the length of the shaft 904 entering the guide 900 is shortened (e.g., to minimize the space occupied by the shaft 904 within the envelope of the instrument access device according to this disclosure), this straightening effect is insufficient to keep the instrument shafts parallel as they exit the lumen 908. Therefore, if the enter guide shaft 904 is shortened without further compensation for the inward directional bias of the resiliently bendable instrument shafts entering the proximal end of the enter guide, the instrument shafts will cross or collide after they exit the enter guide lumen 908.

[0149] To remedy this problem and maintain instrument axis parallelism at the exit of the shortened entry guide lumen 908, one or more of the lumens 908 are modified to include a small protrusion 940 at their distal ends. The protrusion 940 extends radially inward into the lumen 908 such that the instrument axis extending through the lumen is radially deflected outward from the centerline of the lumen and the central axis of the entry guide. The protrusion 940 in the lumen can be positioned at a central junction between multiple lumens such that it points away from the central axis of the entry guide shaft 904. The protrusion 940 is designed to be sized and shaped to deflect and orient the instrument axis parallel to the longitudinal axis of the entry guide shaft 904. The size and shape of the protrusion 940 can, for example, depend on the flexibility of the instrument axis of the instrument intended to be received in the respective lumen 908. Some instruments extending through the instrument channel in the entry guide 900 can have sufficiently rigid axes such that the protrusion 940 is not required at the distal end of the respective instrument channel of these instruments. Thus, for example, Figure 9B The access guide 900 depicted herein may have protrusions at the ends of the three lumens 910, 912 intended for receiving surgical instruments, while the lumen 914 for a camera may lack such protrusions because the camera shaft is sufficiently rigid. However, in general, the access guide according to this document may include inward protrusions 940 in any one or more (including all) lumens.

[0150] In some embodiments, a protrusion 940 at the distal end of the lumen 908 forms a ramp that defines a lumen diameter that decreases from the proximal end of the ramp to the distal end of the ramp, and the ramp is positioned toward the center of the axis 904 at the junction between the lumens 908.

[0151] According to another aspect, the access guide 900 may optionally include a relief portion defining a hole in the outer periphery of the access guide shaft 904 in an orientation opposite to the protrusion or ramp. This hole extends outwardly into the diameter of the lumen 908 and thus allows for additional bending of the instrument shaft. That is, the hole provides additional space for the instrument shaft to bend outward, which would otherwise result in the shaft contacting the outer wall of the lumen. While the protrusion, as described above, reorients the instrument shaft to a generally parallel configuration after it has left the distal end of the access guide, in alternative embodiments, the protrusion in the lumen 108 is configured to intentionally laterally extend the instrument to either a laterally converging or laterally diverging orientation. In a laterally converging orientation, the protrusion still sufficiently extends the instrument shaft to prevent collisions during normal operation. In a laterally diverging orientation, the protrusion extends the instrument shaft to provide additional spacing between instruments.

[0152] Torque limiting clutch

[0153] Figures 10A-10C An example medical device including a clutch is depicted according to an example of this disclosure. Figure 10A This is a partial cross-sectional view of an example instrument access device 1000, including the access guide container assembly 1002 and the reverse motion assembly 1004. Although not shown in... Figure 10A As depicted in the reference, but in this example, the device access device 1000 may include components similar to those in the reference reference. Figures 4A-4E The example described is substantially similar to the suffix and wound retractor clamp (used as a distal coupling component). The reverse motion assembly 1004 includes a track element 1024 defining openings in the access guide port and the auxiliary port; an outer element 1025 received in the proximal opening of the suffix; and a reverse motion mechanism that rotates the auxiliary port about the access guide port without twisting the suffix about its central axis. Regarding the reverse motion mechanism of the instrument access device 1000, Figures 10A-10C The examples are basically similar in function, operation, and structure. Figures 4A-4E Examples. However, the reverse motion mechanism of the reverse motion assembly 1004 includes a torque limiting clutch configured to disengage from the reverse rotation of the reverse motion mechanism in response to a torque applied at a threshold.

[0154] It has been found that, in certain situations, clinicians or other users may operate the device access device according to this disclosure in a manner that applies a load to components of the reverse motion assembly / mechanism, which can damage or otherwise cause malfunction of one or more components of the reverse motion assembly / mechanism. In some applications, for example, while rotating the auxiliary port around the entry guide container and entry guide port, the user of the device access device may grasp the envelope or a portion thereof and hold the envelope fixed to an external element of the reverse rotation assembly of the access device. When the user grasps the envelope in this manner, the envelope is essentially forced to rotate with the rotation of the auxiliary port around the entry guide container and entry guide port. In these situations, the envelope is pulled against the reverse rotational action of the reverse motion assembly / mechanism and a relatively high load is placed on the components of the device, which can lead to wear or malfunction of such components.

[0155] refer to Figures 10A-10C The reverse motion assembly 1004 includes a gear train 1050, which is a mechanism through which the auxiliary port can rotate about the inlet guide container and the inlet guide port while the sleeve does not rotate about the central axis of the sleeve (or in other words, does not twist the sleeve). The gear train 1050 includes a first gear 1052, a second gear 1054, an idler gear 1056, and an intermediate gear 1058. The intermediate gear 1058 is a stepped spur gear, including a third spur gear 1060 and a fourth spur gear 1062 meshing with the idler gear 1056. Figure 10B and Figure 10C The depicted third spur gear 1060 includes a first end-face gear 1064, and the fourth spur gear 1062 includes a second end-face gear 1066. As... Figure 10B and Figure 10C As illustrated in the examples, a face gear (sometimes called a crown gear) is a gear having teeth that project at right angles to the face of a cylindrical gear component (typically projecting parallel to the face compared to the teeth of a spur gear 1060 or 1062). Face gears or crown gears are also defined as a type of bevel gear with a pitch cone angle of 90 degrees.

[0156] In the example of the instrument access device 1000, the first end face gear 1064 of the third spur gear 1060 is biased by a section of the track element 1024 to mesh with the second end face gear 1066 of the fourth spur gear 1062. For example... Figure 10AAs depicted, track element 1024 includes a protrusion 1068 extending distally from the proximal end of track element 1024 to abut a fourth spur gear 1062. During operation under load / torque below a threshold level, the third spur gear 1060 and the fourth spur gear 1062 are biased to mesh with each other via the protrusion 1068 of track element 1024, and the third spur gear 1060 and the fourth spur gear 1062 rotate together.

[0157] However, in response to a load / torque exceeding a threshold level, the load applied by the user to the reverse motion assembly 1004 overcomes the inherent spring force of the track element 1024, causing the first end face gear 1064 to slide relative to the second end face gear 1066 and thereby disengaging the third spur gear 1060 from the fourth spur gear 1062. When the third spur gear 1060 disengages from the fourth spur gear 1062, the reverse rotation of the gear train 1050, which prevents sleeve torsion, is disengaged, and the outer element 1025, track element 1024, and sleeve rotate together in the same direction around the entry guide port. The elasticity of the track element 1024, applied to the fourth spur gear 1062 via the protrusion 1068, serves to automatically re-engage the third spur gear 1060 and the fourth spur gear 1062, and thus re-engage the reverse rotation of the gear train 1050 when the load / torque applied by the user is removed or reduced.

[0158] The instrument access device according to this disclosure may include a clutch or torque limiter, the clutch or torque limiter functioning similarly to but structurally different from the example clutch comprising a first end face gear 1064 (third spur gear 1060), a second end face gear 1066 (fourth spur gear 1062), and an elastic section of the track element 1024. For example, the third spur gear 1060 and the fourth spur gear 1062 may be biased to mesh with each other by springs arranged in the cavity of the reverse motion assembly 1004. As another example, Figure 11A Figure 11C depicts an alternative clutch that can be used in the instrument access device 1000 to disengage the reverse rotation of the reverse motion assembly 1004 (particularly the gear train 1050) in response to a torque applied at a threshold.

[0159] Figure 11A and Figure 11B An alternative torque limiting clutch is described, which is configured to disengage the reverse rotation of the reverse motion assembly of the instrument access device according to the present disclosure. Figure 11A and Figure 11B The clutch can be implemented at the engagement point / coupling point between the second gear 1054 of the gear train 1050 and the outer periphery of the entry guide container of the instrument access device 1000. Figure 11A An example second gear 1054 with elastic fingers 1100 is depicted, and Figure 11BA second gear 1054 is schematically depicted on the outer periphery of the inlet guide container 1026, the second gear 1054 including protrusions 1102 on both sides where the paired fingers 1100 are disposed.

[0160] When operating under load / torque levels below a threshold, the second gear 1054 is configured to be fixedly coupled to the inlet guide container 1026 such that the second gear 1054 does not rotate about the periphery of the inlet guide container. The second gear 1054 includes a plurality of resilient fingers 1100 circumferentially distributed on its inner surface to engage a plurality of protrusions 1102 circumferentially distributed on the outer surface of the inlet guide container 1026. The fingers 1100 and protrusions 1100 are circumferentially distributed such that pairs of resilient fingers 1100 are arranged on opposite sides of each of the protrusions 1102 to retain the second gear 1054 from rotating in response to applied torque ranges below a threshold.

[0161] However, in response to a load / torque exceeding a threshold level, the load applied by the user overcomes the inherent spring force of the finger 1100, causing the finger to deflect radially outward and disengage from the protrusion 1102. In this situation, the second gear 1054 is released to rotate relative to the guide container 1026, which in turn causes a reverse rotation of the gear train to align with the above reference. Figure 10A and Figure 10B Disengagement is similar to that described. In order to re-engage the coupling between the second gear 1054 and the outer periphery of the guide container 1026, the second gear 1054 only needs to be rotated by a load / torque at least less than a threshold value, which is sufficient to re-engage the paired fingers 1100 with each of the protrusions 1102.

[0162] Example:

[0163] The following numbered examples are illustrative embodiments:

[0164] 1. A medical device comprising: a sheath including a proximal opening; and a proximal coupling member in the proximal opening of the sheath; the proximal coupling member comprising: an external element coupled to the sheath, a track element including a first opening and a second opening, an access guide container received in the first opening, and a gear train coupling the access guide container to the external element; the gear train comprising: a first gear fixedly positioned in the proximal opening of the sheath, a second gear fixedly coupled to the periphery of the access guide container, and one or more intermediate gears meshing with the first gear and the second gear, the first gear being rotatable relative to the second gear without rotating about a central axis of the first gear, and the one or more intermediate gears being rotatable and translatable relative to the first gear and the second gear.

[0165] 2. The medical device according to Example 1, wherein: the track element includes a center; and the first opening and the second opening are eccentrically positioned on the track element.

[0166] 3. The medical device according to Example 1 or Example 2, wherein: the movement of a plurality of gears causes the track element and the second port to rotate about the first port and the inlet guide container.

[0167] 4. The medical device according to any one of Examples 1-3, wherein one or more intermediate gears comprise: an idler gear; and an intermediate gear; the idler gear meshes with a second gear and an intermediate gear; and the intermediate gear meshes with the idler gear and a first gear.

[0168] 5. The medical device according to Example 4, wherein: the intermediate gear includes a stepped gear, the stepped gear including a third gear and a fourth gear coupled to the third gear; the third gear meshes with a first gear; and the fourth gear meshes with an idler gear.

[0169] 6. The medical device according to Example 5, wherein: the transmission ratio of the third gear to the fourth gear is equal to the transmission ratio of the first gear to the second gear.

[0170] 7. The medical device according to Example 5 or Example 6, wherein: the first gear and the second gear are ring gears; and the idler gear and the intermediate gear are spur gears.

[0171] 8. The medical device according to any one of Examples 1-3, wherein: one or more intermediate gears include a stepped gear, the stepped gear including a third gear and a fourth gear coupled to the third gear; the third gear meshes with a first gear; and the fourth gear meshes with a second gear.

[0172] 9. The medical device according to Example 8, wherein: the transmission ratio of the third gear to the fourth gear is equal to the transmission ratio of the first gear to the second gear.

[0173] 10. The medical device according to Example 8, wherein: the first gear and the second gear are ring gears; and the third gear and the fourth gear are spur gears.

[0174] 11. The medical device according to any one of Examples 1-10, wherein: the envelope pressurized with injection gas comprises a sphere.

[0175] 12. The medical device according to any one of Examples 1-10, wherein: the envelope pressurized with gas comprises a flattened spherical shape.

[0176] 13. The medical device according to any one of Examples 1-10, wherein: the envelope pressurized with injection gas comprises a lens shape.

[0177] 14. The medical device according to any one of Examples 1-10, wherein: the envelope pressurized with injection gas comprises a barrel shape.

[0178] 15. The medical device according to any one of Examples 1-10, wherein: the sheath pressurized with injection gas comprises a bellows shape.

[0179] 16. The medical device according to any one of Examples 1-10, wherein: the envelope pressurized with gas comprises an oval shape.

[0180] 17. The medical device according to any one of Examples 1-16 further comprises: a distal coupling member coupled to a distal opening of the envelope.

[0181] 18. The medical device according to Example 17, wherein: the distal coupling component is configured to be coupled to the wound retractor assembly.

[0182] 19. The medical device according to any one of Examples 1-18 further comprises: receiving a multi-instrument access guide in an access guide container.

[0183] 20. The medical device according to Example 19 further includes: an access guide seal received in an access guide container; wherein multiple instrument access guides are received in and sealed by the access guide seal.

[0184] 21. The medical device according to any one of Examples 1-20 further comprises: an instrument seal received in a second port.

[0185] 22. The medical device according to any one of Examples 1-21 further comprises: a third port in the envelope between the proximal opening and the distal opening of the envelope.

[0186] 23. The medical device according to Example 22 further includes: an instrument seal received in a third port.

[0187] 24. A medical device comprising: a sheath including a proximal opening; and a proximal coupling member in the proximal opening of the sheath; the proximal coupling member comprising: an inner hub including a first opening and a second opening; an outer edge coupled to the sheath and surrounding the inner hub; an access guide container received in the first opening; and a crank arm pivotally connected to the outer edge and the access guide container, the inner hub being rotatable relative to the outer edge; the inner hub, the outer edge, the access guide container and the crank arm being connected to each other to define a linkage mechanism, and movement of the linkage mechanism causing the inner hub and the second opening to rotate about the first opening and the access guide container.

[0188] 25. The medical device according to Example 24, wherein: the inner hub includes a center; and the first opening and the second opening are eccentrically positioned on the inner hub.

[0189] 26. The medical device according to Example 24 or Example 25, wherein: the linkage mechanism is a four-bar linkage mechanism.

[0190] 27. The medical device according to Example 26, wherein: the ground link of the four-bar linkage includes an entry guide container.

[0191] 28. The medical device according to Example 26 or Example 27, wherein: the coupling link of the four-bar linkage includes an outer edge.

[0192] 29. The medical device according to any one of Examples 26-28, wherein: the coupling link of the four-bar linkage includes an inner hub.

[0193] 30. The medical device according to any one of Examples 26-29, wherein: the input link of the four-bar linkage includes a crank arm.

[0194] 31. The medical device according to any one of Examples 26-30, wherein: the linkage mechanism comprises a parallel linkage mechanism.

[0195] 32. The medical device according to any one of Examples 24-31, wherein: the pivoting of the crank arm causes the inner hub to rotate relative to the outer edge.

[0196] 33. The medical device according to Example 32, wherein: the pivoting of the crank arm causes the outer edge to translate without rotating about the central axis of the outer edge.

[0197] 34. A medical device comprising: means for closing a cavity, the means for closing including a proximal opening and a central longitudinal axis defined by the proximal opening; means for receiving one or more instruments, the means for receiving being fixed in the proximal opening of the means for closing, and the means for receiving including a first port and a second port; and means for rotating the second port about the first port without twisting the means for closing about the central longitudinal axis.

[0198] 35. The medical device according to Example 34, wherein: the means for closure includes a distal opening; and the central longitudinal axis is defined by the distal opening.

[0199] 36. The instrument and medical access device according to Example 34 or Example 35, wherein: the means for rotation includes a gear train; and movement of the gear train causes the second port to rotate about the first port without twisting the means for closure about a central longitudinal axis.

[0200] 37. The medical device according to Example 34 or Example 35, wherein: the means for rotation includes a linkage mechanism; and movement of the linkage mechanism causes the second port to rotate about the first port without twisting the means for closure about the central longitudinal axis.

[0201] 38. The medical device according to Example 34, wherein: the receiving means comprises: a track element fixedly coupled to the closing means, the track element comprising a first port and a second port, and an entry guide container for receiving in the first port; and the rotating means comprises: a gear train connecting the track element to the entry guide container, wherein movement of the gear train causes the track element and the second port to rotate about the first port and the entry guide container.

[0202] 39. The medical device according to Example 34, wherein: the receiving means comprises: an inner hub including a first port and a second port, coupled to an outer edge of a means for closing, the outer edge surrounding the inner hub, receiving an entry guide container in the first port, and a crank arm pivotally connected to the inner hub and the outer edge; and the rotating means comprises: a linkage mechanism defined by the inner hub, the outer edge, the entry guide container and the crank arm, wherein movement of the linkage mechanism causes the inner hub and the second port to rotate about the first port and the entry guide container.

[0203] 40. A medical device comprising: a sheath including a proximal opening; means for reverse movement, comprising: an outer element fixedly coupled to the sheath at the proximal opening; a track element surrounded by the outer element; a first instrument port in the track element; a second instrument port in the track element; means for fixing the first instrument port at a fixed position in space; and means for rotating the outer element in the reverse direction about the track element with a first angular displacement in a first direction when the second instrument port rotates about the first instrument port in a second direction with a second angular displacement, the second angular displacement being equal to the first angular displacement, and the second direction being opposite to the first direction.

[0204] 41. The medical device according to Example 40, wherein: the envelope includes a distal opening opposite to the proximal opening; the medical device further includes means for clamping the port device; and the means for clamping is fixedly coupled to the envelope at the distal opening.

[0205] 42. The medical device according to Example 40 or Example 41, wherein: the means for reverse rotation comprises a gear mechanism.

[0206] 43. The medical device according to Example 40 or Example 41, wherein: the means for reverse rotation includes a linkage mechanism.

[0207] 44. A medical device comprising: a sheath including a proximal opening; and a proximal coupling member in the proximal opening of the sheath, wherein the proximal coupling member comprises: an external element coupled to the sheath; a track element surrounded by the external element and including a first opening and a second opening; a receiving instrument entry guide container in the first opening; and a mechanism for coupling the entry guide container to the external element, wherein the mechanism comprises a clutch, wherein under a first torque below a threshold torque causing the track element to rotate in a first direction, the mechanism causes the track element and the second opening to rotate about the first opening in the first direction and causes the external element and the sheath to rotate in a reverse direction about the track element in a second direction opposite to the first direction; and wherein under a second torque above a threshold torque causing the track element to rotate in the first direction, the mechanism causes the track element and the second opening to rotate about the first opening in the first direction, and the clutch disengages from the reverse rotation of the external element and the sheath in the second direction.

[0208] 45. The medical device of claim 44, wherein: the mechanism includes a gear train that couples the inlet guide container to an external element.

[0209] 46. ​​The medical device of claim 45, wherein: the gear train comprises: a first gear fixedly positioned in a proximal opening of the envelope; a second gear coupled to the periphery of the guide container; and one or more intermediate gears meshing with the first gear and the second gear, the first gear being rotatable relative to the second gear without rotating about the central axis of the first gear, and the one or more intermediate gears being rotatable and translatable relative to the first gear and the second gear.

[0210] 47. The medical device of claim 46, wherein: one or more intermediate gears include a clutch; and the clutch is configured to disengage one or more intermediate gears from the first gear in response to a second torque.

[0211] 48. The medical device of claim 47, wherein: one or more intermediate gears comprise stepped spur gears, the stepped spur gears comprising a third gear and a fourth gear; the clutch comprises a first end face gear biased by an elastic member to mesh with a second end face gear, the first end face gear being on the third gear of the stepped spur gear, and the second end face gear being on the fourth gear of the stepped spur gear; and under the condition that a first torque causes the track element to rotate in a first direction, the spring force of the elastic member biases the first end face gear to mesh with the second end face gear and causes the third gear and the fourth gear to rotate synchronously; and under the condition that a second torque causes the track element to rotate in the first direction, the spring force of the elastic member is overcome, and the first end face gear slides relative to the second end face gear.

[0212] 49. The medical device of claim 48, wherein: the proximal coupling member includes a cavity, and a stepped spur gear is in the cavity; the track element defines a proximal wall of the cavity; and the resilient member includes a portion of the track element responsive to a second torque deflection.

[0213] 50. The medical device of claim 46, wherein: the clutch couples the second gear to the periphery of the inlet guide container; and the clutch is configured to disengage the mechanism from reverse rotation in response to a second torque by disengaging the second gear from the periphery of the inlet guide container, causing the second gear to rotate relative to the inlet guide container.

[0214] 51. The medical device of claim 50, wherein the clutch comprises: a protrusion on an outer surface of an access guide container; at least one resilient finger on an inner surface of a second gear, wherein, under a first torque causing the track element to rotate in a first direction, the at least one resilient finger engages the protrusion to prevent the second gear from rotating relative to the access guide container, and wherein, under a second torque causing the track element to rotate in the first direction, the at least one resilient finger deflects out of engagement with the protrusion and the second gear rotates relative to the access guide container.

[0215] 52. The medical device of claim 51, wherein: at least one resilient finger comprises a first resilient finger and a second resilient finger; the protrusion comprises a first side and a second side opposite to the first side; the first resilient finger is on the first side of the protrusion; and the second resilient finger is on the second side of the protrusion; under the condition that a first torque causes the track element to rotate in a first direction, the first resilient finger and the second resilient finger engage the protrusion to prevent the second gear from rotating relative to the inlet guide container; and under the condition that a second torque causes the track element to rotate in the first direction, the first resilient finger and the second resilient finger deflect away from the protrusion, and the second gear rotates relative to the inlet guide container.

[0216] 53. The medical device of claim 46, wherein: one or more intermediate gears comprise a stepped spur gear; the stepped spur gear comprises a third gear and a fourth gear coupled to the third gear; the third gear meshes with a first gear; and the fourth gear meshes with a second gear.

[0217] 54. The medical device according to claim 53, wherein: the transmission ratio between the third gear and the fourth gear is equal to the transmission ratio between the first gear and the second gear.

[0218] 55. The medical device according to claim 53, wherein: the first gear and the second gear are ring gears; and the third gear and the fourth gear are spur gears.

[0219] 56. The medical device according to any one of claims 44-55, wherein: the track element comprises a center; and the first opening and the second opening are eccentrically positioned on the track element.

[0220] 57. The medical device according to any one of claims 44-55, wherein: the envelope includes a distal opening; and the medical device further includes a distal coupling member coupled to the distal opening of the envelope.

[0221] 58. The medical device of claim 57, wherein: the distal coupling component is configured to be coupled to the wound retractor assembly.

[0222] 59. The medical device according to any one of claims 44-55, further comprising: receiving a multi-instrument access guide in an access guide container.

[0223] 60. The medical device of claim 59, further comprising: an access guide seal received in an access guide container; wherein multiple instrument access guides are received in and sealed by the access guide seal.

[0224] 61. The medical device according to any one of claims 46-55, further comprising: an instrument port in the sleeve between the proximal opening and the distal opening of the sleeve.

[0225] 62. A medical device comprising: means for closing a cavity, the means for closing including a proximal opening and a central longitudinal axis defined by the proximal opening; means for receiving one or more instruments, the means for receiving being in the proximal opening of the means for closing, and the means for receiving including a first port and a second port; means for rotating the second port about the first port without twisting the means for closing about the central longitudinal axis; and means for disengaging at least a portion of the means for rotating in response to a torque applied in response to a threshold.

[0226] 63. The medical device of claim 62, wherein: the second port rotates about the first port and the means for closing twists about the central longitudinal axis, provided that at least a portion of the means for rotation disengages in response to a threshold applied torque.

[0227] 64. The medical device of claim 62, wherein: the receiving means comprises a center; a longitudinal axis of the center intersects the center; and a first opening and a second opening are eccentrically positioned on the receiving means.

[0228] 65. The medical device according to any one of claims 62-64, wherein: the means for rotation comprises a gear train, and the gear train comprises a stepped spur gear, the stepped spur gear comprising a third gear and a fourth gear; the means for disengagement comprises a first end face gear, a second end face gear, and an elastic member biasing the first end face gear to mesh with the second end face gear; the first end face gear is on the third gear of the stepped spur gear, and the second end face gear is on the fourth gear of the stepped spur gear; and under the condition that at least a portion of the means for rotation disengages in response to a threshold applied torque, the spring force of the elastic member is overcome, and the first end face gear slides relative to the second end face gear.

[0229] 66. The medical device according to any one of claims 62-64, wherein: the means for rotation comprises a gear train, and the gear train comprises a gear fixedly coupled to the periphery of the instrument container in the first port; and the means for disengagement comprises a protrusion on the periphery of the instrument container and at least one resilient finger on the inner surface of the gear and engaging with the protrusion to prevent the gear from rotating relative to the instrument container; and under the condition that at least a portion of the means for rotation disengages in response to a threshold applied torque, the resilient finger disengages from the protrusion and the gear rotates relative to the instrument container.

[0230] Those skilled in the art will understand that any of the features described above can be combined with any other example features, provided that these features are not mutually exclusive. All possible combinations of features have been considered, depending on clinical or other design requirements.

[0231] The examples described herein (e.g., methods, systems, or devices) are applicable to surgical procedures, non-surgical medical procedures, diagnostic procedures, cosmetic procedures, and non-medical procedures or applications. The examples may also be applicable to training or for acquiring information, such as imaging procedures. The examples may be applicable to handling tissues that have been removed from human or animal anatomy and will not be returned to the human or animal, or to human or animal carcasses.

[0232] The above detailed description includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those shown or described. However, the inventors also contemplate examples where only those elements shown or described are provided. Furthermore, the inventors contemplate examples using any combination or arrangement of those elements (or one or more aspects thereof) shown or described, whether relative to a particular example (or one or more aspects thereof) or relative to other examples (or one or more aspects thereof) shown or described herein.

[0233] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0234] In this document, as is common in patent documents, the terms “a” or “one” are used to include one or more, independent of any other instances or uses of “at least one” or “one or more.” In this document, the term “or” is used to indicate a non-exclusive “or,” so “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “comprising” and “wherein” are used as simple English equivalents to the corresponding terms “including” and “in.” Furthermore, in the following claims, the terms “comprising” and “including” are open-ended, meaning that any system, device, article, composition, formulation, or process that includes elements other than those listed after such terms is still considered to fall within the scope of that claim. Additionally, 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.

[0235] Geometric terms such as “parallel,” “perpendicular,” “circular,” or “square” are not intended to require absolute mathematical precision unless the context indicates otherwise. Instead, such geometric terms allow for variations due to manufacturing or equivalent functions. For example, if an element is described as “circular” or “approximately circular,” parts that are not precisely circular (e.g., slightly elliptical or polygonal parts) are still included in this description. Coordinate systems or frames of reference are provided to aid interpretation, and other frames of reference or coordinate systems besides those described herein may be used.

[0236] The above description is intended to be illustrative and not restrictive. For example, the examples (or one or more aspects thereof) described above may be used in combination with each other. Other embodiments may be used, for example, by those skilled in the art after reading the above description. An abstract is provided to allow the reader to quickly determine the nature of the technical disclosure. The submission of the abstract is to be understood that it is not intended to interpret or limit the scope or meaning of the claims. Furthermore, in the above detailed description, various features may be combined together to simplify this disclosure. This should not be construed as meaning that any unclaimed disclosed feature is essential to any claim. Rather, the subject matter of the invention may not be limited to all features of a particular disclosed embodiment. Therefore, the following claims are incorporated herein by way of example or embodiment, wherein each claim exists independently as a separate embodiment, and these embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined with reference to the appended claims and the full scope of their equivalents.

Claims

1. A medical device comprising: A cover including a proximal opening; and The proximal coupling component in the proximal opening of the envelope; The proximal coupling component includes: External components coupled to the envelope A track element comprising a first opening and a second opening. Receives the inlet guide container in the first opening, and The gear train that couples the inlet guide container to the external component; The gear train includes: The first gear is fixedly positioned in the proximal opening of the envelope. The second gear, which is fixedly coupled to the periphery of the entry guide container, and One or more intermediate gears meshing with the first gear and the second gear. The first gear is capable of rotating relative to the second gear without rotating about the central axis of the first gear, and The one or more intermediate gears are capable of rotation and translation relative to the first gear and the second gear.

2. The medical device according to claim 1, wherein: The track element includes a center; and The first opening and the second opening are eccentrically positioned on the track element.

3. The medical device according to claim 1, wherein: The movement of the first gear, the second gear, and the one or more intermediate gears causes the track element and the second opening to rotate around the first opening and the entry guide container.

4. The medical device of claim 1, wherein the one or more intermediate gears comprise: idler wheel; and intermediate gear; The idler gear meshes with the second gear and the intermediate gear; and The intermediate gear meshes with the idler gear and the first gear.

5. The medical device according to claim 4, wherein: The intermediate gear includes a stepped gear, which includes a third gear and a fourth gear coupled to the third gear; The third gear meshes with the first gear; and The fourth gear meshes with the idler gear.

6. The medical device according to claim 5, wherein: The transmission ratio between the third gear and the fourth gear is equal to the transmission ratio between the first gear and the second gear.

7. The medical device according to claim 5, wherein: The first gear and the second gear are ring gears; and The idler gear and the intermediate gear are spur gears.

8. The medical device according to claim 1, wherein: The one or more intermediate gears include a stepped gear, the stepped gear including a third gear and a fourth gear coupled to the third gear; The third gear meshes with the first gear; and The fourth gear meshes with the second gear.

9. The medical device according to claim 8, wherein: The transmission ratio between the third gear and the fourth gear is equal to the transmission ratio between the first gear and the second gear.

10. The medical device according to claim 8, wherein: The first gear and the second gear are ring gears; and The third gear and the fourth gear are spur gears.

11. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with injection gas, comprises a spherical shape.

12. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with injected gas, comprises a flattened spherical shape.

13. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with injected gas, comprises a lens shape.

14. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with injected gas, comprises a barrel shape.

15. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with injected gas, comprises a bellows shape.

16. The medical device according to any one of claims 1-10, wherein: The envelope, pressurized with gas, comprises an oval shape.

17. The medical device according to any one of claims 1-10, further comprising: A distal coupling component, which is coupled to the distal opening of the envelope.

18. The medical device according to claim 17, wherein: The distal coupling component is configured to be coupled to the wound retractor assembly.

19. The medical device according to any one of claims 1-10, further comprising: Receives multiple instruments into the inlet guide container.

20. The medical device of claim 19, further comprising: Receives the entry guide seal in the entry guide container; The multi-instrument access guide is received in the access guide seal and sealed by the access guide seal.

21. The medical device according to any one of claims 1-10, further comprising: The instrument seal is received in the second opening.

22. The medical device according to any one of claims 1-10, further comprising: A third opening in the envelope, between the proximal opening and the distal opening.

23. The medical device according to claim 22, further comprising: The instrument seal is received in the third opening.

24. A medical device comprising: A cover including a proximal opening; and The proximal coupling component in the proximal opening of the envelope; The proximal coupling component includes: The inner hub includes a first opening and a second opening. Coupled to the sleeve and surrounding the outer edge of the inner hub. Receives the inlet guide container in the first opening, and Pivotibly connected to the outer edge and the crank arm of the entry guide container, The inner hub can rotate relative to the outer edge. The inner hub, the outer edge, the entry guide container, and the crank arm are connected to each other to define the linkage mechanism, and The movement of the linkage mechanism causes the inner hub and the second opening to rotate around the first opening and the entry guide container.

25. The medical device according to claim 24, wherein: The inner hub includes a center; and The first opening and the second opening are eccentrically positioned on the inner hub.

26. The medical device according to claim 24, wherein: The linkage mechanism is a 4-bar linkage.

27. The medical device according to claim 26, wherein: The ground link of the four-bar linkage includes the entry guide container.

28. The medical device according to claim 26, wherein: The coupling link of the four-bar linkage includes the outer edge.

29. The medical device according to claim 26, wherein: The coupling link of the four-bar linkage includes the inner hub.

30. The medical device according to claim 26, wherein: The input link of the four-bar linkage includes the crank arm.

31. The medical device according to claim 26, wherein: The linkage mechanism includes a parallel linkage mechanism.

32. The medical device according to any one of claims 24-31, wherein: The pivoting of the crank arm causes the inner hub to rotate relative to the outer edge.

33. The medical device according to claim 32, wherein: The pivoting of the crank arm causes the outer edge to translate without rotating about the central axis of the outer edge.

34. A medical device comprising: A device for sealing, used to seal a cavity, the device for sealing comprising a proximal opening and a central longitudinal axis defined by the proximal opening; A receiving device for receiving one or more instruments, the receiving device being secured in the proximal opening of the device for closing, and the receiving device comprising: First port and second port; as well as A track element comprising the first port and the second port and fixedly coupled to the means for closure; Receive the inbound boot container in the first port; as well as The device for rotation, which causes the second port to rotate about the first port without twisting the device for closure about the central longitudinal axis, includes a gear train connecting the track element to the inlet guide container. The movement of the gear train causes the track element and the second port to rotate about the first port and the entry guide container.

35. The medical device according to claim 34, wherein: The device for closure includes a distal opening; and The central longitudinal axis is defined by the distal opening.

36. A medical device comprising: A cover including a proximal opening; A device for reverse motion, comprising: An external element is fixedly coupled to the sleeve at the proximal opening. The track element surrounded by the external elements, The first instrument port in the track element. The second instrument port in the track element. A device for fixing the first instrument port in a fixed position in space, and A means for rotating an external element in the opposite direction about a track element by a first angular displacement in a first direction when the second instrument port rotates about the first instrument port in a second direction by a second angular displacement, the second angular displacement being equal to the first angular displacement, and the second direction being opposite to the first direction.

37. The medical device according to claim 36, wherein: The envelope includes a distal opening opposite the proximal opening; The medical device also includes means for clamping the port device; and The clamping device is fixedly coupled to the sleeve at the distal opening.

38. The medical device according to claim 36 or 37, wherein: The device for reverse rotation includes a gear mechanism.

39. The medical device according to claim 36 or 37, wherein: The device for reverse rotation includes a linkage mechanism.

40. A medical device comprising: A cover including a proximal opening; and The proximal coupling component in the proximal opening of the envelope. The proximal coupling component includes: External components coupled to the envelope; A track element surrounded by the external element and comprising a first opening and a second opening; The instrument in the first opening is received into the guide container; as well as The mechanism that couples the inlet guide container to the external component. The mechanism mentioned above includes a clutch. Wherein, under the condition that a first torque below a threshold torque causes the track element to rotate in a first direction, the mechanism causes the track element and the second opening to rotate about the first opening in the first direction and causes the outer element and the cover to rotate about the track element in a second direction opposite to the first direction; and Wherein, under the condition that a second torque higher than the threshold torque causes the track element to rotate in the first direction, the mechanism causes the track element and the second opening to rotate about the first opening in the first direction, and the clutch disengages from the external element and the sleeve in the reverse rotation in the second direction.

41. The medical device according to claim 40, wherein: The mechanism includes a gear train that couples the entry guide container to the external element.

42. The medical device according to claim 41, wherein: The gear train includes: A first gear fixedly positioned in the proximal opening of the envelope; A second gear coupled to the periphery of the entry guide container; and One or more intermediate gears meshing with the first gear and the second gear. The first gear can rotate relative to the second gear but not about the central axis of the first gear, and The one or more intermediate gears can rotate and translate relative to the first gear and the second gear.

43. The medical device according to claim 42, wherein: The one or more intermediate gears include the clutch; and The clutch is configured to disengage the one or more intermediate gears from the first gear in response to the second torque.

44. The medical device according to claim 43, wherein: The one or more intermediate gears include a stepped spur gear, the stepped spur gear including a third gear and a fourth gear; and The clutch includes a first end face gear biased by an elastic member to mesh with a second end face gear, the first end face gear being on the third gear of the stepped spur gear, and the second end face gear being on the fourth gear of the stepped spur gear. Under the condition that the first torque causes the track element to rotate in the first direction, the spring force of the elastic member biases the first end face gear to mesh with the second end face gear, and causes the third gear and the fourth gear to rotate synchronously. and Under the condition that the second torque causes the track element to rotate in the first direction, the spring force of the elastic member is overcome, and the first end face gear slides relative to the second end face gear.

45. The medical device according to claim 44, wherein: The proximal coupling component includes a cavity, and the stepped spur gear is located within the cavity; The track element defines the proximal sidewall of the cavity; and The elastic member includes a portion of the track element that responds to the second torque deflection.

46. ​​The medical device according to claim 42, wherein: The clutch couples the second gear to the periphery of the inlet guide container; and The clutch is configured to disengage from the reverse rotation of the mechanism in response to the second torque by disengaging the second gear from the periphery of the inlet guide container, causing the second gear to rotate relative to the inlet guide container.

47. The medical device of claim 46, wherein the clutch comprises: The protrusion on the outer surface of the entry guide container; and At least one elastic finger on the inner surface of the second gear, Wherein, under the condition that the first torque causes the track element to rotate in the first direction, the at least one elastic finger engages the protrusion to prevent the second gear from rotating relative to the inlet guide container, and When the second torque causes the track element to rotate in the first direction, the at least one elastic finger deflects out of engagement with the protrusion and the second gear rotates relative to the inlet guide container.

48. The medical device according to claim 47, wherein: The at least one elastic finger includes a first elastic finger and a second elastic finger; The protrusion includes a first side and a second side opposite to the first side; The first elastic finger is on the first side of the protrusion, and the second elastic finger is on the second side of the protrusion; Under the condition that the first torque causes the track element to rotate in the first direction, the first elastic finger and the second elastic finger engage the protrusion to prevent the second gear from rotating relative to the inlet guide container; and Under the condition that the second torque causes the track element to rotate in the first direction, the first and second elastic fingers deflect out of engagement with the protrusion, and the second gear rotates relative to the inlet guide container.

49. The medical device according to claim 42, wherein: The one or more intermediate gears include stepped spur gears; The stepped spur gear includes a third gear and a fourth gear coupled to the third gear; The third gear meshes with the first gear; and The fourth gear meshes with the second gear.

50. The medical device according to claim 49, wherein: The transmission ratio between the third gear and the fourth gear is equal to the transmission ratio between the first gear and the second gear.

51. The medical device according to claim 49, wherein: The first gear and the second gear are ring gears; and The third gear and the fourth gear are spur gears.

52. The medical device according to any one of claims 40-51, wherein: The track element includes a center; and The first opening and the second opening are eccentrically positioned on the track element.

53. The medical device according to any one of claims 40-51, wherein: The envelope includes a distal opening; and The medical device further includes a distal coupling component coupled to the distal opening of the envelope.

54. The medical device according to claim 53, wherein: The distal coupling component is configured to be coupled to the wound retractor assembly.

55. The medical device according to any one of claims 40-51, further comprising: Receives multiple instruments into the inlet guide container.

56. The medical device of claim 55, further comprising: Receive the entry guide seal in the entry guide container. The multi-instrument access guide is received in the access guide seal and sealed by the access guide seal.

57. The medical device according to any one of claims 42-51, further comprising: The instrument port in the envelope between the proximal opening and the distal opening of the envelope.

58. A medical device comprising: A device for sealing, used to seal a cavity, the device for sealing comprising a proximal opening and a central longitudinal axis defined by the proximal opening; A receiving device for receiving one or more instruments, the receiving device being in the proximal opening of the device for closure, and the receiving device including a first port and a second port; A device for rotation, which causes the second port to rotate about the first port without twisting the device for closure about the central longitudinal axis; as well as A disengagement device that disengages from at least a portion of the rotation device in response to a torque applied at a threshold.

59. The medical device according to claim 58, wherein: Under the condition that at least a portion of the device for rotation disengages in response to the applied torque of the threshold, the second port rotates about the first port and the device for closure twists about the central longitudinal axis.

60. The medical device according to claim 58, wherein: The receiving device includes a center; The central longitudinal axis intersects the center; and The first port and the second port are eccentrically positioned on the receiving device.

61. The medical device according to any one of claims 58-60, wherein: The device for rotation includes a gear train, and the gear train includes a stepped spur gear, which includes a third gear and a fourth gear; The disengagement device includes a first end face gear, a second end face gear, and an elastic member that biases the first end face gear to mesh with the second end face gear. The first end face gear is on the third gear of the stepped spur gear, and the second end face gear is on the fourth gear of the stepped spur gear; and When at least a portion of the device for rotation disengages in response to the applied torque at the threshold, the spring force of the elastic member is overcome, and the first end face gear slides relative to the second end face gear.

62. The medical device according to any one of claims 58-60, wherein: The device for rotation includes a gear train, and the gear train includes gears fixedly coupled to the periphery of the instrument container in the first port; The disengagement device includes a protrusion on the periphery of the instrument container and at least one resilient finger on the inner surface of the gear and engaging with the protrusion to prevent the gear from rotating relative to the instrument container. and When at least a portion of the device for rotation disengages in response to a torque applied to the threshold, the resilient finger disengages from the protrusion and the gear rotates relative to the instrument container.

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