Entry guide device sealing structures, and related devices, systems, and methods

Abstract

A sealing device includes a plurality of sealing flaps connected to and extending radially inwardly from a peripheral wall. In a closed configuration of each sealing flap, the free end portion of the sealing flap is located at a central region relative to the annular peripheral wall, and each of the plurality of sealing flaps is independently moveable relative to the other of the plurality of sealing flaps to move the sealing flap to an open configuration away from the central region. The sealing device can be used at a distal end portion of an entry guide device to independently seal each of a plurality of lumens of the entry guide device, while independently unsealing a lumen in response to an instrument inserted in the lumen and past the sealing flap.

Description

PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304ENTRY GUIDE DEVICE SEALING STRUCTURES, AND RELATED DEVICES, SYSTEMS, AND METHODSPRIORITY CLAIM

[0001] This application claims priority to U.S. Provisional Pat. App. No. 63 / 729,549, filed December 9, 2024, the contents of which are hereby incorporated by reference.TECHNICAL FIELD

[0002] The present disclosure relates generally to entry guide devices used for insertion of medical instruments in minimally invasive medical procedures, including those that at least in part utilize computer-assisted controls (sometimes referred to as “robotic” surgery). More specifically, the present disclosure relates to sealing used in conjunction with such entry guide devices to maintain insufflation during such medical procedures while various tools are inserted and removed during a procedure. Related systems, devices, and methods are also disclosed.INTRODUCTION

[0003] Medical systems that operate at least in part with computer-assisted control (sometimes referred to as “telesurgical systems” or “robotic surgical systems”), such as those employed for minimally invasive medical procedures, can include large and relatively complex equipment to precisely control relatively small instruments inserted into a body to access a remote worksite. The da Vinci® Surgical Systems commercialized by Intuitive Surgical, Inc. are examples of such telesurgical systems.

[0004] Various telesurgical system architectures exist, such as those that enable multiple medical instruments to enter a single opening in the body (sometimes referred to as “single-port” systems (an example being the da Vinci SP® Surgical System)), or those that enable multiple medical instruments to enter the body individually at corresponding multiple locations (sometimes referred to as “multiport” systems (an example being the da Vinci Xi® Surgical System)). Persons of ordinary skill in the art would understand that multi-port systems may sometimes be configured to operate through a single natural body orifice, such as the mouth or anus, or through a single incision (an example being Intuitive Surgical’s Single Site® technology used with a da Vinci xi® Surgical System). Persons of skill in thePCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 art would also understand that single- and multi-port architectures can be combined simultaneously in a single telesurgical system (e.g., two or more instruments inserted via one body opening and one or more other instruments inserted via one or more corresponding other body openings).

[0005] Generally, at least two medical instruments are in use at a time, including an endoscopic camera (the working end portion being a sensor or optics to capture images / provide observation of the worksite) and a manipulation medical instrument with an end effector that comprises a tool configured for manipulation at the worksite (such as, e.g., forceps, graspers, scissors, cutting devices, electrosurgical members, staplers, or a variety of other such mechanisms with which persons of ordinary skill in the art are familiar). In various cases, more than one such manipulation medical instrument may be utilized at a given time.

[0006] To introduce medical instruments into a single opening in the body, it can be useful to use an entry guide device that co-locates in a single device a plurality of separate and isolated guide lumens configured to receive and guide the insertion of a plurality of medical instruments at a time. Because such entry guide devices are used to introduce the medical instruments from an environment of relatively lower pressure (e.g., ambient environment) to an environment of relatively higher pressure (e.g., insufflation medical gas pressure), sealing is a consideration both while a medical instrument is inserted in a guide lumen of the entry guide device and while a medical instrument is not inserted in and / or being withdrawn from such a guide lumen. In either case, it is important to maintain sealing of the guide lumens so as to not permit insufflation gas to escape through the guide lumens due to the pressure differential between the two ends of the guide lumen (i.e. , proximal end opening to relatively lower pressure environment and distal end opening to relatively higher pressure environment).

[0007] The ability to provide a variety of use cases and accommodate various instrument configurations are factors that can pose issues for sealing of entry guide devices. A need exists to provide sealing in entry guide devices that allow for more robust and varied use cases, for example, allowing for a wider variety of instrument configurations to be used in conjunction with such entry guide devices.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304SUMMARY

[0008] Various embodiments of the present disclosure may solve one or more of the above-mentioned problems and / or may demonstrate one or more of the above-mentioned desirable features. Other features and / or advantages may become apparent from the description that follows.

[0009] In accordance with at least one aspect, one general aspect includes an apparatus for sealing an entry guide device for insertion of medical instruments through an opening in a body. The apparatus also includes a retention mechanism configured to be secured at a periphery of a distal end portion of the entry guide device. The apparatus also includes a sealing structure engaged with the retention mechanism. The sealing structure can include a plurality of sealing flaps independently moveable between an open configuration and a closed configuration. The apparatus also includes, where interaction of the retention mechanism with the plurality of sealing flaps exerts a preload force, biasing the respective sealing flaps in the closed configuration.

[0010] Implementations of the apparatus can include one or more of the following features. Each sealing flap of the plurality of sealing flaps can be moveable to the open configuration in a state of a medical instrument extending through the entry guide lumen and past the sealing flap. In the open configuration with a medical instrument extending past the sealing flap, each sealing flap abuts against the medical instrument. Each sealing flap can include a convex surface feature configured to abut against the medical instrument during passage of the medical instrument past the sealing flap. Each sealing flap can include one or more reinforcing ribs. The sealing structure further can include a flexure coupling each of the plurality of sealing flaps to a peripheral mouth of the sealing structure. The sealing structure can further include an annular collar surrounding the flexure and a flexure rib connecting the annular collar to the flexure. Each sealing flap can include two flexure ribs extending radially along the outer edges of each sealing flap. The retention mechanisms can include a retention cap configured to secure to the entry guide device and a retention collar held between the retention cap and the annular collar of the sealing structure so as to exert the preload force. The retention collar snap can fit to the retention cap. Each of the plurality of sealing flaps is shaped as a sector of a circle. At least one of the plurality of sealing flaps can differ in size from at least one other of the plurality of the plurality of sealingPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 flaps. Adjacent sealing flaps of the plurality of sealing flaps can be separated by slits. The sealing structure can be a monolithic structure. Each sealing flap can include a convex surface feature configured to be received in a distal end opening of a respective lumen of the entry guide device. In an open configuration of a sealing flap of the plurality of sealing flaps, the sealing structure can generate a hoop stress exerting a biasing force on the one sealing flap toward the closed configuration. In an open configuration of a sealing flap of the plurality of sealing flaps, the sealing structure can absorb a buckling energy to avoid buckling of the one sealing flap and deformation of the other of the plurality of sealing flaps.

[0011] At least another aspect includes an entry guide device for introducing medical instruments through an opening in a body. The entry guide device also includes a tube portion divided into a plurality of interior isolated lumens, each isolated lumen configured to receive a respective medical instrument. The device also includes an instrument sealing structure arranged and configured to seal against a medical instrument received in a respective lumen. The device also includes a lumen sealing structure coupled to a distal end portion of the tube portion. The device also includes a plurality of sealing flaps independently moveable relative to each other between an open configuration and a closed configuration. The device also includes, where in the closed configuration, each of the plurality of sealing flaps seals a distal end opening of a respective lumen of the plurality of isolated lumens. The device also includes, where in the open configuration, each of the plurality of sealing flaps is configured to permit passage of a medical instrument through the distal end opening of a respective lumen to extend past the sealing flap.

[0012] Implementations of the entry guide can include one or more of the following features. The entry guide device wherein at least one lumen of the plurality of interior isolated lumens is larger in diameter than the other lumens of the plurality of lumens. The at least one lumen having the larger diameter is configured to receive a reducer device defining a passage with a smaller diameter than the diameter of the at least one lumen and terminating at a location proximal the sealing flap of the plurality of sealing flaps sealing the at least one lumen. The at least one lumen having the larger diameter is also configured to receive a stapler instrument. The instrument sealing structure can include individual septum seals in the interior of each of the plurality of lumens configured to seal against anPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 instrument shaft of an instrument inserted in a respective lumen. The instrument sealing structure can include individual sealing members configured to seal against an exterior of each of the plurality of interior isolated lumens of the entry guide device. The instrument sealing structure is a monolithic structure. The entry guide device can include a funnel portion at a proximal end portion of the tube portion, the funnel portion defining a plurality of funnel sections respectively aligned with and opening to the plurality of interior isolated lumens. Interaction of the retention mechanism with the plurality of sealing flaps can exert a preload force biasing the respective sealing flaps in the closed configuration. The retention mechanism can include a retention cap configured to secure to the entry guide device and a retention collar held between the retention cap and the lumen sealing structure so as to exert the preload force. The retention collar can snap fit to the retention cap. Each sealing flap can include a convex surface feature configured to abut against the medical instrument during passage of the medical instrument past the sealing flap. The lumen sealing structure further can include a flexure coupling each of the plurality of sealing flaps to a peripheral mouth of the lumen sealing structure. The lumen sealing structure can further include an annular collar surrounding the flexure and a flexure rib connecting the annular collar to the flexure. Adjacent sealing flaps of the plurality of sealing flaps of the lumen sealing structure can be separated by slits. The sealing structure is a monolithic structure.

[0013] In yet another aspect, a method for providing access for insertion of medical instruments through an in a body includes inserting a medical device in a lumen of an entry guide device and past a first sealing structure located in an interior of the lumen. The method also includes sealing the lumen with a second sealing structure spaced from the first sealing structure such that gas is prevented from flowing through a distal end opening of the lumen.

[0014] Implementations of the method can include one or more of the following features. The method wherein the medical device is a reducer device defining an open passage, and sealing the lumen with the second sealing structure prevents gas from flowing into the passage. Inserting the reducer device past the first sealing structure can seal the space between the lumen and exterior surface of the reducer device. The medical device is a medical instrument and inserting the medical instrument can include inserting the medical instrument to an initialPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 position proximal to the second sealing structure. The first sealing structure can seal against the medical instrument to prevent gas from flowing through the distal end opening of the lumen proximally past the first sealing structure. The method can include positioning the entry guide device relative to a pressurized environment such that a pressure differential exists between the distal end opening and a proximal end opening of the lumen. The pressurized environment can include medical insufflation gas. The pressurized environment can be within an envelope over the opening in the body. The entry guide device can include a plurality of isolated lumens and a respective first sealing structure is in each lumen, and where the method further can include sealing each of the lumens with a respective second sealing structure separated from the respective first sealing structures. The respective first sealing structures can be part of a monolithic structure defining a plurality of sealing septa. The respective second sealing structures can be part of a monolithic structure defining a plurality of sealing flaps. The plurality of sealing flaps can move independently relative to each other between a closed sealing position against respective lumens of the entry guide device and an open position. Inserting an instrument past a sealing flap of the plurality of sealing flaps can move the sealing flap to the open position.

[0015] In yet another aspect, a sealing device includes an annular peripheral wall, a plurality of sealing flaps connected to and extending radially inwardly from the annular peripheral wall with each of the plurality of sealing flaps terminating in a free end portion. In a closed configuration of each sealing flap, the free end portion of the sealing flap is located at a central region relative to the annular peripheral wall. Each of the plurality of sealing flaps is independently moveable relative to the other of the plurality of sealing flaps to move the sealing flap to an open configuration away from the central region. The device also can include a flexure coupling each of the plurality of sealing flaps to the peripheral wall.

[0016] Implementations of the sealing device can include one or more of the following features. The sealing device can include an annular collar surrounding the flexure. The sealing device can include a flexure rib connecting the annular collar to the flexure. Each sealing flap can include two flexure ribs extending radially along the outer edges of each sealing flap. Each sealing flap can include a convex surface feature located on a sealing surface of each sealing flap. The convex surface feature is asymmetrical and can include an apex located towardPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 the free end portion. The convex surface feature can have a surface finish differing from a surface finish of a portion of the sealing flap surrounding the convex surface feature. In an open configuration of a respective sealing flap, a hoop stress can act on the sealing flap to prevent buckling of the sealing flap. In an open configuration of a respective sealing flap, a hoop stress can act on the sealing flap causing a biasing force on the sealing flap toward the closed configuration. Radial slits can separate adjacent sealing flaps of the plurality of sealing flaps. The radial slits can extend at least partially vertically, relative to the radial extending direction, the peripheral wall.

[0017] Additional objects, features, and / or advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure and / or claims. At least some of these objects and advantages may be realized and attained by the elements and combinations particularly pointed out in the appended claims.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claims; rather the claims should be entitled to their full breadth of scope, including equivalents.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure can be understood from the following detailed description, either alone or together with the accompanying drawings. The drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate one or more exemplary embodiments of the present teachings and, together with the description, explain certain principles and operation. In the drawings,

[0020] FIGs. 1 A and 1 B are perspective views of embodiments of an entry guide device that co-locates a plurality of isolated lumens to insert medical instruments from a first environment to a second environment;

[0021] FIG. 2A is a perspective view of an embodiment of a funnel-shaped portion of an entry guide device and sealing mechanism;

[0022] FIG. 2B is a partial cut-away view of the funnel-shaped portion and sealing mechanism of FIG. 2A and a portion of a tube portion of the entry guide device;PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304

[0023] FIG. 3 is a perspective view of an embodiment of a lumen reducer device;

[0024] FIGs. 4A and 4B illustrate a partial cut-away view of the entry guide device of FIGs. 2A and 2B with a medical instrument having a relatively shorter length end effector in a partially inserted position and a medical instrument having a relatively longer length end effector in a partially inserted position, respectively;

[0025] FIG. 5 is a partial cut-away, schematic view of an embodiment of an entry guide device comprising a distally located lumen sealing structure;

[0026] FIG. 6A is a side view of an embodiment of an entry guide device lumen sealing structure;

[0027] FIG. 6B is a plan view of a sealing side of the entry guide device lumen sealing structure of FIG. 6A;

[0028] FIG. 6C is a plan view of the side of the entry guide device lumen sealing structure opposite the sealing side of FIG. 6B;

[0029] FIG. 7A is a side view of another embodiment of an entry guide device lumen sealing structure;

[0030] FIG. 7B is a side view of the entry guide device lumen sealing structure rotated 90° from the view of FIG. 7A;

[0031] FIG. 7C is a cross-sectional view of the entry guide device lumen sealing structure taken through section C-C of FIG. 7A;

[0032] FIG. 7D is a cross-sectional view of the entry guide device lumen sealing structure taken through section D-D of FIG. 7B;

[0033] FIG. 7E is a perspective view of the entry guide device lumen sealing structure of FIGs. 7A-7D;

[0034] FIG. 7F is a partial cut-away view the entry guide device lumen sealing structure of FIG. 7E;

[0035] FIG. 7G is a plan view of a sealing side of the entry guide device lumen sealing structure of FIG. 7E;

[0036] FIG. 7H is a plan view of the entry guide device lumen sealing structure of FIG. 7E taken from the opposite side as FIG. 7G;

[0037] FIG. 8 is a partial cut-away view of an embodiment of a distal end portion of a tube portion of an entry guide device with a retainer mechanism securing an entry guide device lumen sealing structure to the entry guide device;

[0038] FIG. 9A is a perspective isometric view of an embodiment of an entry guide device lumen sealing structure and retainer mechanism;PCT APPLICATION ATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304

[0039] FIG. 9B is a partial sectional assembly view of an embodiment of an entry guide device lumen sealing structure and retainer mechanism;

[0040] FIG. 9C is a partial sectional assembly view of an embodiment of an entry guide device lumen sealing structure and retainer mechanism;

[0041] FIG. 10A is a partial cut-away view of the entry guide device lumen sealing structure and retainer mechanism of FIGs. 9A-9C secured to a distal end portion of a tube portion of an entry guide device;

[0042] FIG. 10B is an isolated, top view of a sealing flap of the entry guide device lumen sealing structure of FIGs. 9A-9C;

[0043] FIG. 10C is an isolated, bottom view of the sealing flap of the entry guide device lumen sealing structure of FIGs. 9A-9C;

[0044] FIG. 11 is a partial view of an embodiment of a sealing flap convex surface feature interacting with an instrument shaft;

[0045] FIG. 12A is a perspective view of an embodiment of an entry guide device instrument sealing structure taken from the proximal-facing side of the sealing structure;

[0046] FIG. 12B is a perspective view of the entry guide instrument sealing structure taken from the distal-facing side of the sealing structure.

[0047] FIG. 12C is a partial interior cross-sectional view showing the instrument sealing structure of FIG. 12A in place relative to lumens of an entry guide device;

[0048] FIG. 13A illustrates a partial cut-away view of an embodiment of an entry guide device comprising a lumen sealing structure and instrument sealing structure with a medical instrument having a relatively longer length end effector in a partially inserted position;

[0049] FIG. 13B illustrates a partial cut-away view of the entry guide device of FIG. 13A with a lumen reducer device in an inserted position;

[0050] FIG. 14 is a perspective isometric view of an embodiment of an assembly that utilizes an entry guide device and an envelope utilized for providing access to an opening in a body through which the medical instruments can be further inserted to access a worksite; and

[0051] FIG. 15 is a diagrammatic view of an embodiment of a computer-assisted, single-port manipulator system.DETAILED DESCRIPTIONPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304

[0052] All examples and illustrative references are non-limiting and should not be used to limit the claims to specific implementations and embodiments described herein and their equivalents. Any headings are solely for formatting and should not be used to limit the subject matter in any way, because text under one heading may cross reference or apply to text under one or more headings. Finally, in view of this disclosure, particular features described in relation to one aspect or embodiment may be applied to other disclosed aspects or embodiments of the invention, even though not specifically shown in the drawings or described in the text.

[0053] Medical instruments used during minimally invasive medical procedures typically include a proximal end portion that remains outside the body, a distal working end portion that is inserted inside the body to access the remote site, and a shaft (that may be flexible or rigid and comprise one or more joints to allow controlled steering (bending) between the proximal end portion and the distal working end portion). Generally, at least two medical instruments are in use at a time, including an endoscopic camera (the working end portion being a sensor or optics to capture images / provide observation of the worksite) and a manipulating medical instrument with an end effector that comprises a tool configured for manipulation of an object (e.g., tissue, etc.) at the worksite (such as, e.g., forceps, graspers, scissors, cutting devices, electrosurgical members, staplers, of a variety of other such mechanisms with which persons of ordinary skill in the art are familiar). In various cases, more than one such manipulating medical instrument may be utilized at a given time.

[0054] The proximal end portion of such medical instruments can comprise a force transmission mechanism configured to transmit actuation forces to move articulable mechanisms and / or moveable components of the end effector. The force transmission mechanism can include various drive members operable in response to manual inputs or teleoperated inputs through a manipulator system with which the instruments can be coupled. Actuation members (such as cables, rods, and the like) can transmit force from the drive members of the proximal end portion to the articulable mechanisms and / or moveable components of the end effector.

[0055] Those having ordinary skill in the art are generally familiar with a variety of medical instruments configured to perform minimally invasive medical procedures,PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 whether laparoscopically via manual manipulation or via computer-assisted (e.g., robotic) technology. As noted above, in some medical procedures it is desirable to utilize a single opening (single port) and an entry guide device to assist with insertion and removal of multiple medical instruments throughout a medical procedure. With reference to FIGs. 1 A and 1 B, perspective views of embodiments of an entry guide device that co-locates a plurality of isolated lumens to insert medical instruments from a first environment to a second environment for use in a medical procedure are shown. The entry guide device 10 includes a proximal, generally funnel-shaped portion 12 with proximal end openings 13 (two of which, 13a and 13b, are labeled) that lead to respective individual isolated lumens in a main tube portion (not shown) extending distally from the funnel-shaped portion 12. Proximal and distal directions are indicated in FIGs. 1 A and 1 B, with the distal direction being generally more toward the worksite (e.g., surgical site), and the proximal direction generally away from the worksite (e.g., toward a ground location at which the entry guide device 10 is fixed as indicated at G in FIG. 1 A). The isolated lumens have distal end openings that open into a cannula 30 which is inserted into an opening between the two environments P1 and P2. In this way, medical instruments 20 (two of which 20a and 20b are labeled) can be inserted from environment P1 to environment P2. The medical instruments 20 can be introduced through the respective openings 13 of the entry guide device 10 into the individual lumens in tube portion 11 , and be advanced out of the respective distal end openings 14 and into cannula 30 so as to be able to insert the medical instruments from the first environment P1 (e.g., outside the body) to the second environment P2 (e.g., inside the body containing the worksite).

[0056] In other applications, the second environment P2 can be a sealed environment at least partially outside the body but over the opening in the body and providing access of the instrument thereto, as will be explained with reference to FIG. 1 B. FIG. 1 B illustrates an entry guide device 10 used in conjunction with a sealed envelope 40 configured to maintain a pressurized environment P2 (e.g., pressurized with insufflation gas through a tube 41 ) and provide access to an opening in a body through which the medical instruments can be further inserted to access a worksite. For example, the sealed envelope 40 can be further assembled with a wound retractor 42 inserted into an opening in the body. FIG.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.003041 B shows an isometric view of the sealed envelope 40 with the wound retractor 42. As with the configuration of FIG. 1A, the entry guide device 10 can be coupled to a medical ground G located in the first environment P1 (which can be at ambient pressure).

[0057] Use of such a sealed, pressurized envelope can be useful to allow medical instruments to deploy (e.g., bend so as to orient the instrument end effectors as shown in FIG. 1 B) outside the body in circumstances where it may be desirable to utilize the instrument end effectors to perform aspects of a medical procedure at the opening (e.g., incision site or natural orifice) in the body. The entry guide devices of FIGs. 1 A and 1 B may otherwise be similar in their general configurations, with tube portions of the entry guide device extending from the funnel-shaped portions coming in a variety of differing lengths selectable based on the particular medical procedures of interest. As can be appreciated, the different locations of the second environment P2 can allow for the instruments 20 to exit into the second environment P2 at different locations relative to the opening in the body so as to attain different centers of motion. For additional details as to the use of a sealed, pressurized envelope for access to an opening in a body in a single port computer-assisted surgical application, reference is made to U.S. App. Pub. No. US 2022 / 0401 125, hereby incorporated by reference herein.

[0058] As discussed above, the first environment P1 and the second environment P2 can be maintained at different pressures. For example, in various medical procedures, the second environment P2 is a pressurized environment filled with medical insufflation gas and thus at a higher pressure than the first environment P1 (which is typically at ambient pressure). Because of this pressure differential between the first and second environments P1 , P2, an entry guide device can include a sealing mechanism that seals the entry guide device such that in the absence of a medical instrument inserted through an opening 13 and corresponding isolated lumen of the entry guide device, gas from environment P2 at the higher pressure is prevented from escaping through the opening 13 to environment P1 at the lower pressure; thereby allowing insufflation pressure to be maintained.

[0059] With reference now to FIGs. 2A and 2B, which show respectively a perspective view of an embodiment of the funnel-shaped portion 212 of an entry guide device 210 and a partial cut-away view of the funnel-shaped portion 212PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 and tube portion 211 , a sealing mechanism can include a co-located instrument and lumen sealing mechanism located proximate where the end of the funnel- shaped portion 212 meets the tube portion 211 in where the individual isolated lumens extend respectively from the openings 213. The sealing mechanism includes an instrument sealing structure 245 providing individual septum seals 246 (with two such septum seals 246a, 246b labeled) for the openings 213 of the funnel-shaped portion 212 of the entry guide device 210 that lead to the individual isolated lumens of the tube portion 211 . Such an instrument sealing structure with the individual septum seals 246 allows for sealing against each instrument individually when inserted in the entry guide device through the openings 213 and into the isolated lumens of the tube portion 211 .

[0060] In addition to the instrument sealing structure 245 and so as to ensure a seal when an instrument is not inserted through an opening and corresponding lumen of the entry guide device, a plurality of lumen sealing doors 247 (two such sealing doors 247a, 247b labeled) are also used. The sealing doors 247 are rigid doors hingedly connected to the funnel-shaped portion 212 to open away from the center line in response to a medical instrument inserted through the septum seal 246 and into a respective lumen of the tube portion 211 . FIG. 2B illustrates the sealing door 247b in the closed state sealed against the septum seal 247b, while sealing door 247a is in the open state to allow an instrument (not shown) to be inserted into the tube portion 211. In FIG. 2A, both depicted sealing doors 247a, 247b are shown in the closed state.

[0061] Thus, when an instrument is not inserted through a respective opening 213 and lumen of the tube portion 211 , the seal is maintained by cooperation of the lumen sealing doors 247 and the instrument septum seals 246 (i.e., the closure of the sealing door 247 against the septum seal 256), preventing gas from escaping through the lumens of the tube portion 21 1 from the environment P2 to P1 . When an instrument is inserted through a respective opening 213 and lumen of the tube portion 211 , the instrument can push the respective sealing door 247 open, and the corresponding septum seal 246 seals against the instrument exterior to provide the sealing between environments P2 and P1 . The sealing doors 247 can be biased so as to move back to the closed position once the instrument is removed. Manual actuation levers to open and close the doors also can optionally be provided. The separately openable / closeable sealing doors 247 allow forPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 individual and independent insertion and removal of instruments, for example, during a procedure, without gas escaping through the entry device and consequent loss of insufflation pressure. Reference is made to U.S. App. Pub. No. US 2022 / 0401125, incorporated by reference herein, for further details relating to a sealing mechanism such as that depicted in FIGs. 2A and 2B.

[0062] In various applications, it may be desirable to accommodate instruments of differing sizes for a particular opening in the funnel-shaped portion of an entry guide device and corresponding isolated lumen in the tube portion of the entry guide device. For example, it may be desirable to allow for a relative larger diameter instrument (e.g., a stapler instrument) as well as a relatively smaller diameter instrument (e.g., a grasper instrument) through a respective funnelshape opening / lumen pairing of the entry guide device. To allow for such flexibility, the opening and corresponding lumen can be sized to accommodate a first, relatively larger diameter instrument and an entry guide device lumen reducer device can be used to allow for a relatively smaller instrument to be inserted. The lumen reducer device is a hollow tube fitting with an open passage and which can be inserted in a fit and sealed manner within the relatively larger lumen of the entry guide device so as to reduce the size of the inner diameter to accommodate a relatively smaller instrument.

[0063] 0ne nonlimiting embodiment of a lumen reducer device 300 which can be inserted into a respective opening / lumen of an entry guide device is depicted in FIG. 3. The reducer device 300 can have a funnel-shaped portion that can be received in a fit manner in a proximal opening (e.g., 13, 213) of the funnel-shaped portion of the entry guide device (e.g., 10, 210) and a tube portion 302 that can be inserted to reduce the diameter of an individual lumen of a tube portion of the entry guide device. As can be appreciated, however, inserting a reducer device such as reducer device 300 into an entry guide device with an instrument and lumen sealing mechanism such as that described above with reference to FIG. 2 would present issues with maintaining the pressure differential between environment P2 and environment P1 . That is, the insertion of the reducer device 300 would open the sealing door 247 and, while a seal may be maintained around the exterior of the tube portion of the reducer device 300 by virtue of fitting against a septum seal 247, due to the hollow, open passage extending through thePCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 reducer device 300, gas can escape through the passage of the reducer device between the environments P2 and P1 .

[0064] In addition to accommodating instruments having different size (diameter) shafts as discussed above, it may be desirable to accommodate instruments having different lengths of end effectors (i.e., the portion of the instrument coupled to the shaft and that provides the operable tool for manipulation during a procedure). In some cases, an instrument can have both a relatively larger shaft diameter and longer length end effector, but some instruments may have one or the other.

[0065] For example, the stapler end effector of a stapler instrument is generally longer than the length of various other end effectors (such as, for example, graspers, scissors, electrocautery end effectors, etc.), and additionally the shaft of the stapler instrument can be relatively larger than other instruments. However, this is a nonlimiting example, and instruments may have a variety of shaft diameters and end effector lengths and entry guide devices and / or reducer devices in accordance with the present disclosure can be used with a variety of such instruments.

[0066] In some use cases, it is desirable to insert the instruments partially into the entry guide device to ready them for use in a procedure prior to actually inserting them fully for use. FIGs. 4A and 4B illustrate such a case in which an instrument 420a having a relatively shorter length end effector is in a partially inserted position (FIG. 4A) in entry guide device 210 and an instrument 420b having a relatively longer length end effector is in a partially inserted position (FIG. 4B) in entry guide device 210. As shown, the partially inserted position of the instrument 420b having a relatively longer length end effector in FIG. 4B results in the end effector portion of the instrument extending past the septum seal and opening of the sealing door 247b, while the end effector portion instrument 420a is positioned above the septum seal and sealing door 247b in FIG. 4A. And because it is the end effector (which may be oddly shaped, sized differently from the shaft of the instrument, and have gaps that are not in contact with the septum seal) that is positioned where the septum seal 246b, the seal may not be sufficiently closed and gas may leak through between the environments P2 and P1 .

[0067] To accommodate a reducer device, and thus the ability to utilize an entry guide device for insertions of relatively larger and smaller instruments, the presentPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 disclosure contemplates a sealing mechanism that includes a lumen sealing structure which can be located at a distal end portion of an entry guide device. For example, such a lumen sealing structure can be placed at a location distal to where a lumen reducer device would interact and open the sealing structure when positioned in the entry guide device to accommodate insertion of a relatively smaller instrument. Such a sealing structure can have sealing members that are independently openable and closable against the individual lumens of the entry guide in response to individual instruments being inserted through the respective lumens of the entry guide device. The sealing members can additionally be biased toward a closed position such that removal of the instrument allows the sealing member to return to a closed position. To reduce the number of parts and facilitate manufacture, however, the sealing members can be part of a monolithic (e.g., molded) sealing structure, similar to a duckbill valve. The sealing mechanism of entry guide devices in accordance with embodiments of the present disclosure can further include an instrument sealing structure at a proximal portion of the entry guide device to allow for individual septum sealing against the exterior surface of the respective instrument shafts (including a lumen reducer device) inserted through a proximal opening and corresponding lumen of the entry guide device.

[0068] In accordance with various embodiments, the present disclosure contemplates a sealing mechanism that separates the locations of an instrument sealing structure from a lumen sealing structure used to provide a seal between environments at different pressures (e.g. P1 and P2) when an entry guide device is used to provide access for insertion of instruments between the two environments, but in the absence of an instrument inserted through a given proximal opening / lumen in the entry guide device. Likewise, separating the locations of the instrument sealing structure from the lumen sealing structure used to provide a seal between environments at different pressures (e.g., P1 and P2) can allow for an instrument to be partially inserted in the entry guide device such that it extends through the septum seal but not through the more distal seal structure.

[0069] Referring to FIG. 5, a partial cut-away, schematic view of an entry guide device with a proximally located instrument sealing structure 550 and a distally located lumen sealing structure 560 in accordance with various embodiments ofPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 the present disclosure is depicted. The entry guide device 510 includes a funnel- shaped proximal portion 512 and a tube portion 511 extending distally from the funnel-shaped proximal portion 512. Openings 513 in the funnel-shaped proximal portion 512 (two such openings 513a, 513b depicted) lead to isolated lumens 514 of the tube portion 511 (two such lumens 514a, 514b depicted). Located at a proximal portion of the tube portion 511 is an instrument sealing structure 550 that provides for individual sealing against shafts of instruments inserted in the lumens 514a, 514b (one such instrument 520 shown in FIG. 5). Distal end openings of the lumens 514a, 514b are sealed by an entry guide device lumen sealing structure560 secured to the tube portion 511. The lumen sealing structure 560 comprises a plurality of sealing members 561 configured as flaps (two such sealing members 561 a, 561 b depicted) which are independently moveable in response to an instrument being inserted through a lumen 514a or 514b, such that one of the sealing flaps 561 can be opened via a resilient movement without the other sealing flap opening with it, as shown by the dotted line, sealing structure 561 a in the open position, while 561 b remains closed to seal the lumen 515b. The individual sealing flaps 561 are part of a monolithic structure, which can be similar to a duckbill valve structure but still allowing independent movement of the sealing flaps 561 between the open and closed positions relative to the individual lumens 514a, 514b of the entry guide device, thereby permitting independent sealing and unsealing of those lumens. Upon removal of an instrument exerting a force to resiliently deform and open a sealing flap 561 , the sealing flaps 561 are configured to be biased to move back to the closed, sealing position. For example, the formation of the sealing structure 560 can provide hoop stress similar to a duckbill valve but that works to prevent buckling while the individual sealing flaps561 are moved to the open position. In other words, the deformation of the individual sealing flaps 561 is controlled to allow opening while not creating stress on other portions of the sealing structure such that other sealing flaps would deform and potentially open. The hoop stress additionally provides a biasing force tending to return the individual sealing flaps 561 to their respective closed states when the force of the instrument acting against the valve is removed (e.g., the instrument is withdrawn).

[0070] As can be appreciated, the sealing structure 560 positioned at the distal end portion of the tube portion 511 can allow a medical device, such as a medicalPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 instrument 520 with a relatively long end effector to be partially inserted or a lumen reducer device to be inserted, as described above, in a position that does not open the sealing flaps (e.g., sealing flap 561a in the schematic of FIG. 5).

[0071] FIGs. 6A-6C depict an embodiment of an entry guide device lumen sealing structure in accordance with the present disclosure, with FIG. 6A showing a perspective view, and FIGs. 6B and 6C showing opposite plan views (FIG. 6B showing the sealing side of the sealing structure that abuts against the lumens of an entry guide device as will be shown and described further below). An entry guide device lumen sealing structure 660 can be used as any of the entry guide device lumen sealing structures herein. Entry guide device lumen sealing structure 660 has a generally shallow funnel shape with a peripheral wall defining a wide mouth portion 665 and a plurality of individual sealing flaps 661 (four such sealing flaps 661 a-661 d) extending radially inwardly and downwardly from the mouth portion 665. The mouth portion 665 can be sized to fit around the distal end portion of the tube portion of the entry guide device. The sealing flaps 661 a-661 d have a generally sector shape and together complete an overall circular-shaped structure reflected in the plan view of FIGS. 6B and 6C. Stated differently, the sealing flaps 661 a-661 d can generally be shaped similar to slices of a pie. The sealing flaps 661 a-661 d are secured at their respective outer circumferential regions to the common peripheral portion defined by the funnel shaped-portion and taper to a termination end portion 663a-663d at a common central region, the termination end portion being a free end of the sealing flap. The termination end portions 663a-663d can be rounded or blunt and thus the sealing flaps 661 a-661 d do not necessarily terminate in a pointed tip, although such an embodiment is contemplated. The individual sealing flaps 661 a-661 d thus are part of an integral (e.g., monolithic) body.

[0072] Radial slits 664a-664d are provided between adjacent sealing flaps 661 a- 661 d. The slits 664a-664d can extend radially outward from the termination ends including extending at least partially vertically along the sidewall that connects the sealing flaps 661 a-661 d to the wide mouth portion 665 (not visible in the views of FIGs. 6A-6C but shown further below with reference to slits 764 depicted in FIGs. 7C-7F). The termination ends of the flaps 661a-661 d can also be separated from each other at the central region by a gap G. The slits 664a-664d and gap G allow for the sealing flaps 661 a-661 d to move to an open configuration via resilientPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 movement of the termination ends radially away from the central region, for example, in response to force exerted by a medical instrument moving past the sealing flaps 661 a-661 d, as will be described further below.

[0073] Thus, by fitting the wide mouth portion 665 around the distal end of the tube portion of an entry guide device and retaining the sealing structure 660 at the distal end of the tube portion of an entry guide device, as depicted in FIG. 5, for example, the individual sealing flaps 661 a-661 d can individually seal respective lumens of the entry guide device. As described above, the individual sealing flaps 661 a-661 d can be opened separately from the other sealing flaps so as to individually allow passage of a medical instrument through the lumen and past the sealing flap sealing the lumen, while the other sealing flaps can maintain their seals with the other respective lumens.

[0074] Various mechanisms can be used to retain the lumen sealing structure 660 on the tube portion of an entry guide device, one embodiment of which is discussed in further detail below, with additional retention mechanisms including, but not limited to, bonding with adhesive, overmolding the sealing structure to the tube portion to create a permanent sealing structure, anchoring the sealing structure via complementary threading provided on the seal structure and tube portion of the entry guide device, heat staking, welding, snap fit retention using complementary snap-fit features on the tube portion of the entry guide device and seal structure, and a variety of other mechanism which those having ordinary skill in the art would be familiar with.

[0075] Additional aspects and features in accordance with additional embodiments of an entry guide device lumen sealing structure will now be described with reference to FIGs. 7A-8. The embodiments of FIGs. 7A-8 include various elements in common with those described above with respect to the embodiments of FIGs. 5-6C and therefore are not necessarily repeated again below in an effort to reduce redundancy. Similar elements are labeled with the second two digits _XX in common as those in FIGs. 5-6C, except with 700 or 800 series for the beginning digit.

[0076] Various features may optionally be utilized so as to enable forming an entry guide device lumen sealing structure as an integral unitary (e.g., monolithic) body that allows each of the sealing flaps to individually, independently, resiliently, and repeatedly open to permit passage of a medical instrument and move back to thePCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 closed, sealing position against a lumen of the entry guide device. In other words, the entry guide device lumen sealing structure will be able to withstand multiple uses with resilient opening and closing of individual sealing flaps. For example, with reference to FIGs. 7A-7H, a first side view and a second side view from 90 degrees apart (FIGs. 7A and 7B); the respective cross-sections indicated in those views (FIGs. 7C and 7D); a perspective view (FIG. 7E); a partial cut-away perspective view (FIG. 7F); a plan view from the sealing side (FIG. 7G); and a plan view from the opposite side of the sealing side (FIG. 7H) of an embodiment of an entry guide device lumen sealing structure 760 is illustrated.

[0077] To assist with promoting the resilient opening and biased closing of the plurality of sealing flaps 761 , the sealing flaps 761 and peripheral wall defining the wide mouth portion 765 of the sealing structure 760 join at a flexure 762 (see FIGs. 7C, 7D, and 7F) where the material is relatively thin. The flexure 762 joining the wide mouth portion 765 and sealing flaps 761 provides a buckling element that stores energy when the sealing flaps 761 are moved to the open position and springs back to the original position, allowing the sealing flaps 761 to independently and resiliently bend to open and return to the closed position as depicted by the double-headed arrow in FIG. 7F. The sealing structure thus behaves similar to a duckbill valve whereby the hoop stress of the flexure region 762 allows for controlled deformation without buckling to allow the sealing flaps 761 to individually open but prevent buckling that would deform (and potentially open) the other sealing flaps and also to prevent over-deformation of an open sealing flap. In addition, the hoop stress allows the sealing flaps 761 to return to their closed state (termination ends positioned in the central region) once the force opening a sealing flap is removed.

[0078] To further aid in the ability to ensure the sealing flaps 761 return to the closed configuration and sufficiently seal against the entry guide device lumens, the flexure 762 can be formed as part of an overall living hinge type of structure with an auxiliary flexure structure comprising an annular collar 768 spaced from and surrounding the flexure 762 and radially extending flexure ribs 767. As will be described further below, in various embodiments, the annular collar 768 can interact with a retention mechanism that fits with the sealing structure 760 and retains it on an entry guide device. The flexure 762, flexure ribs 767, and annular collar 768 can allow individual movement of the sealing flaps 761 about thePCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 flexure 762 to the open position, while the hoop stress discussed above prevents buckling to a degree that would cause opening of another flap while also enhancing the bias and return toward the closed position. To further assist with biasing of a sealing flap 761 toward a closed position, a force applied to the annular collar 768 as illustrated by the arrow F1 in FIG. 7F can create a force F2 at the termination end portion 763 of a sealing flap 761 (see FIG. 7F), thereby ensuring closure against and sealing of the distal end opening of the lumen of the entry guide device. In addition, as also illustrated in FIG. 7F, a force F3 on the annular collar 768 can also assist with keeping the sealing flaps 761 in a closed sealing position in the absence of a force tending to open the sealing flaps 761 . The forces F1 and F3 acting on the annular collar 768 can be applied using a retention mechanism that can sit around the wide mouth portion 765 and exert forces on the annular collar 768, various embodiments of which are described below with reference to FIGs. 8-10.

[0079] The flexure ribs 767 can be provided on an underside of the sealing flaps 761 (i.e., the side facing away from the entry guide device lumen when the sealing structure 760 is retained on the entry guide device as shown best perhaps in FIG. 7H) and extend along the radially extending edges of each sealing flap adjacent to the slits 764. Accordingly, each sealing flap 761 can have at least two flexure ribs 767 to assist in providing a passive closure loading of the sealing flaps 761 (a biased closed position) when interacting with a retainer structure applying the force F1 as explained further below, while still allowing for sufficient flexibility to resiliently flex the flaps 761 about the flexure region 762.

[0080] With reference to FIG. 8, a sealing structure 860 (which can have a configuration similar to sealing structure 760) can be retained around the distal end portion of a tube portion 811 of an entry guide device 810 (only the distal end tube portion which is depicted) using a retention mechanism 870. The retention mechanism 870 is a generally annular flange that can be made of a material having more rigidity than the sealing structure 860. The retention mechanism 870 can create a tight fit around a wide mouth portion 865 of the sealing structure 860 and be affixed to the distal end portion of the tube portion 811 of the entry guide device 810 using any of a variety of securing mechanisms (e.g., fasteners, snap-fit engagement, friction fit engagement, complementary threading, etc.) A radially inwardly extending ledge 871 can be positioned to sit between the wide mouthPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 portion 865 of the sealing structure and the annular collar 868 so as to provide a downward force F1 on the annular collar 868 as described above with reference to FIG. 7F. As further described above, the force F1 contributes to a preload force F2 biasing the sealing flaps 861 (two sealing flaps 861 a, 861 b depicted) in the closed, sealing position against the lumens 814 (two lumens 814a, 814b depicted). In addition, interaction between the retention mechanism 870 and the annular collar 868 can exert a force F3 further contributing to the preload force F2 and biasing the sealing flaps 861 to the closed, sealing position. Because there is an inherent interference creating the preload force F2, the annular collar 868 tends to bulge outward and relax the flap so as to reduce the preload F2. The reaction force F3 maintains the structural support for the annular collar so as to maintain the preload force F2.

[0081] 0ther embodiments of retention mechanisms that can interact with the entry guide device lumen sealing structures described herein can be utilized to achieve the same effects as described above and the embodiments herein are non-limiting. For example, a two-piece retention structure can be used, which can provide ease in assembly and fitting of a sealing structure relative to an entry guide device. FIGs. 9A-9D depict another embodiment of a retention mechanism 970 that is a two-piece structure including a retention collar 971 that fits between an annular collar 968 and a wide mouth portion 965 of a sealing structure 960 (which can have a configuration similar to the sealing structures 660, 760, 860 described above). FIG. 9A is an isometric view and FIGs. 9B and 9C are partial, sectional assembly views.

[0082] The retention collar 971 provides a structure similar to the ledge 871 to exert the preload force F1 on the annular collar 968, as described above with reference to FIGs. 7A-8. The retention mechanism 970 further includes a retention cap 972 that can be secured to the distal end portion of the tube portion of an entry guide device using any of a variety of fasteners as described above. The retention collar 971 can engage with the retention cap 972 in a snap-fit manner so as to facilitate assembly of the sealing structure 960 and the entry guide device. For example, as shown in FIGs. 9B and 9C, an inner, lower annular edge 971 L of the retention collar 971 can sit underneath the wide mouth portion 965 in a space between the wide mouth portion 965 and the upper part of the annular collar 968. An outer, upper annular edge 971 U of the retention collar 971 can provide a snap-PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 fit engagement with the retention cap 972 via a complementary flange feature 974 provided on an inner circumference of a lower portion of the retention cap 972.

[0083] To further assist with assembly of the retention mechanism 970 with the sealing structure 960, complementary locating features can be provided on the retention cap 972 and the sealing structure 960. For example, complementary male and female locating features can be provided on the retention cap and sealing structure. As illustrated in FIGs. 9A-9C, the retention cap 972 includes a cut-out region 979 that mates with a complementary boss 980 on the sealing structure 960. By providing the boss 980 with a height that resides above the remaining portion of the sealing structure 960, the boss can provide a datum for not only rotationally orienting the retention cap 972 relative to the sealing structure 960 but also for positioning the retention cap 972 along the height dimension of the sealing structure 960 (axial z-dimension) so that it interacts with the remaining portions of the sealing structure 960 as desired, as further described herein. While in the embodiment of FIGs. 9A-9C, the complementary locating features are shown as a female feature on the retention cap and a male feature on the sealing structure, those of ordinary skill in the art would appreciate that the locations could be reversed. Similarly, differing shapes and / or locations of such locating features could be altered.

[0084] The engagement of the retention collar 971 and retention cap 972 and the fixing of the assembly to the entry guide device can provide a secure means of attaching and protecting the lumen sealing structure 960 while also providing the preload force to bias the sealing flaps 961 to a closed position.

[0085] FIG. 10A depicts a partial cut-away view of the entry guide device lumen sealing structure 960 and retention mechanism 970 secured to the distal end portion of the tube portion 911 of an entry guide device 910. In the view of FIG. 10A, the underside of sealing structure 960 is shown with a view of the flexure ribs 967 from that perspective. FIG. 10B depicts an isolated view of one of the sealing flaps 961 of the entry guide device lumen sealing structure 960, showing the top of sealing structure 960 with a detailed view of a surface feature 969. FIG. 10C depicts an isolated view of the sealing flap 961 of FIG. 10B, showing the underside of sealing structure 960 such that a reinforcement rib 966 is shown in detail.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304

[0086] The flexure ribs 767, 867, 967 provide additional stiffness without adding too much weight so as to avoid “weighing down” and causing a force that tends to open and unseal the sealing flaps 761 , 861 , 961 against the entry guide device lumens. To further assist with rigidity of the sealing flaps without adding too much weight, reinforcement ribs can be provided in more central regions of the underside (side opposite the sealing side) of each of the sealing flaps. Such reinforcement ribs 766, 966 can be best seen in FIGs. 7A, 7B, 7H, and 10B. The reinforcing ribs 766, 966 can also assist with preventing inversion of the sealing flaps 761 , 961 as they move, particularly during retraction of an entry guide lumen device. More particularly, the reinforcing ribs 766, 966 may aid in preventing inversion of the sealing flaps 761 , 961 due to creation of a vacuum by air trapped between the device lumen sealing structure 960 and the instrument, with such vacuum creating a low-pressure area adjacent the sealing flaps 761 when the instrument is removed. The reinforcing ribs 766, 966 may thus increase the rigidity of the sealing flaps 761 to help prevent such inversion. In addition, or in the alternative, a leak may be added to the sealing flaps 761 to prevent creation of a vacuum. In some examples, as shown in FIG. 10C, the reinforcing ribs 766, 966 may extend along substantially a full length of the sealing flaps 761 , 861 , 961 .

[0087] The reinforcing ribs 766, 966 may further protect against permanent deformation of the sealing flaps 761 , 961 when they are placed in an open configuration. The reinforcing ribs 766, 966 depicted represent one embodiment of such reinforcing ribs and should be understood to be one non-limiting configurations, with various other shapes, sizes and placements of such reinforcing ribs contemplated and can be selected based on the principles of operation and intended purposes described herein.

[0088] Another optional feature of an entry guide device lumen sealing structure that can be provided are surface features that can assist with functionality of the sealing structure in moving to the open configuration and achieving a good seal with the distal end openings of the entry guide device lumens. With reference to the embodiments of the sealing structures illustrated in FIGs. 7-10, sealing flaps 761 , 861 , 961 are provided with convex surface features (e.g., bumps) 769, 869, 969 (see FIGs. 7G, 8, 9A-9B, 10B), situated generally in a central region of the sealing flap and on the sealing side (lumen-facing side when secured to the entry guide device). The location and profile of the convex surface feature 769, 869,PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304969 on each respective sealing flap 761 , 861 , 961 can be sized and positioned to at least partially protrude into the distal end openings of the respective lumens of the entry guide device. This arrangement can assist with ensuring a good seal between the distal end of the lumen with the region of a sealing flap around the surface feature.

[0089] In addition, the convex surface feature 769, 869, 969 provides a surface that can interact with (slide against) a medical instrument shaft as it passes through the lumen of the entry guide device and past the sealing flap 761 . In various embodiments, the convex surface feature 769, 869, 969 may be positioned such that it contacts and slides against the outer lateral surface of the instrument shaft. Such interaction is illustrated in FIG. 11 , showing the convex surface feature 769, 869, 969 on a sealing flap 761 , 861 , 961 resting against the outer surface of an instrument shaft 1120. This can reduce the contact surface area between the instrument shaft 1120 and the sealing flap 761 , 861 , 961 to assist with reducing friction and facilitate the ability of the instrument to open and move past the sealing flap 761 , 861 , 961. Further, the interaction of the instrument shaft and the convex surface feature 769, 869, 969 can help to prop the sealing flap 761 , 861 , 961 open and away from a tip of the instrument 1120 (tip not shown in FIG. 11 ), thereby avoiding the instrument tip catching on the flap 761 , 861 , 961 as it is moved away from the lumen of the entry guide device to the open position and as the instrument is retracted back out of the distal opening of the entry guide lumen during withdrawal from entry guide.

[0090] T o assist with avoiding the instrument tip catching on the flap 761 , 861 , 961 , the convex surface features 769, 869, 969 can have an asymmetric surface profile with an apex that is closer to the termination end of a sealing flap 761 , 861 , 961 , as best shown in FIGs. 8 and 11 . Such a profile, as depicted in FIG. 11 , can assist in causing the sealing flap 761 , 861 , 961 to be positioned sufficiently far from the instrument tip as the instrument is withdrawn due to the interaction between the lateral surface of the instrument and the convex surface profile 769, 869, 969.

[0091] I n some embodiments, a surface finish of the convex surface features 769, 869, 969 can differ from the rest of the sealing flap 761 , 861 , 961 so as to further reduce friction and enhance the ability of the instrument shaft to slide along the convex surface feature 769, 869, 969 as it opens and as the instrument shaftPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 moves past the sealing flap 761 ,861 , 961 . In some examples, the surface finish may include a lubricating surface finish to reduce friction, further reducing the likelihood of inversion of the sealing flap 761 , 861 , 961 as the instrument shaft retracts from the sealing flap 761 , 861 . 961 . In other embodiments to reduce friction, the convex surface feature 769, 869, 969 can be overmolded with other portions of the sealing flap 761 , 861 , 961 and made of a material having a hardness that is higher than the portions of the sealing flap 769, 869, 969 surrounding the convex surface feature 761 , 861 , 961 . For example, the convex surface feature 761 , 861 , 961 can be made of relatively hard plastic to reduce friction. While the convex surface feature 769, 869, 969 can be relatively hard plastic, the remaining portions surrounding the convex surface feature can be elastomeric or other materials to provide the flexibility and sealing properties contemplated herein.

[0092] In some embodiments, portions of the sealing flap 761 , 861 , 961 may have geometrical changes to further reduce friction and prevent inversion of the sealing flap 761 , 861 , 961 . For example, an edge 963 of the sealing flap 761 , 861 , 961 may be rounded to reduce friction between the instrument shaft and the sealing flap 761 , 861 , 961 , as shown in FIG. 10B. One or more portion(s) of the sealing flap 761 , 861 , 961 which may contact the instrument shaft may also be provided with an alternative surface texture ST to modify the surface roughness of portion(s) of the sealing flap 761 , 861 , 961 , as shown in FIG. 9C. For example, the surface texture ST can increase the surface roughness compared to not having the surface texture. In particular for elastomeric materials, increasing the surface roughness can help to reduce friction between the instrument shaft and the sealing flap so as to reduce the potential for inversion of the sealing flap during withdrawal / retraction of an instrument.

[0093] In various embodiments, it is contemplated that the entry guide device lumen sealing structures are made of rubber and formed as a single monolithic structure, such as via molding or other additive manufacturing processes. For example, the lumen sealing structures in accordance with various embodiments can be made of rubber, such as for example, polyisoprene rubber, silicone, or other suitable material. The sealing structures can be made of a material having a durometer ranging from 30 Shore A to 70 Shore A, for example. The entry guide device lumen sealing structures also may be surface treated, such as, forPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 example, via chlorination (e.g., for polyisoprene rubber), parylene, or UV treated (e.g., for silicone rubber). Surface finish can also be modified to either reduce friction (e.g., rougher surface on the bumps) or to improve sealing (e.g., polished finish on the flaps). Various other materials and process techniques may be used for the lumen sealing structure, including but not limited to, using a material made of elastomer formed via transfer molding, compression molding, or liquid silicone rubber molding (LSR); casted urethane; and / or manufactured by additive manufacturing.

[0094] Sealing flaps of the various entry guide device lumen sealing structures in accordance with the disclosure can have a variety of sizes and each can differ from the other, be the same, or two or more can have the same size while differing from others. In other words, various combinations of sizes of the sealing flaps are contemplated but are selected so as to be able to cover and seal the distal end opening of a respective corresponding lumen of an entry guide device when the sealing flap is in the closed configuration. Likewise, any number of sealing flaps can be formed in the entry guide device lumen sealing structures depending on the number of lumens provided in the entry guide device. Thus, while four sealing flaps, with two larger and two smaller, are depicted in various embodiments, such configurations are nonlimiting and other numbers and shapes / sizes of sealing flaps are contemplated as within the scope of the disclosure to be selected based on shapes and size of the lumens of an entry guide device. Additionally, while various embodiments depict an overall funnel- shaped configuration of entry guide device lumen sealing structures, flatter configurations are contemplated and again may be selected based on the profile of the entry guide device lumen distal ends against which the sealing flaps will abut and seal.

[0095] As discussed above, entry guide device lumen sealing structures such as those discussed with reference to FIGs. 5-10, can be used in conjunction with a more proximally located instrument sealing structure located in an interior of each of the individual lumens of an entry guide device. Such an instrument sealing structure can be provided as unitary (e.g., monolithic) structure that provides a plurality of individual septum seals for the individual lumens of an entry guide device, such as an instrument sealing structure similar to the instrument sealing structure described above with reference to FIG. 2.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304

[0096] Another embodiment of an instrument sealing structure in accordance with various embodiments is illustrated in FIGs. 12A-12C, with FIG. 12A showing the proximal-facing side of the instrument sealing structure, FIG. 12B showing the distal-facing side of the instrument sealing structure, and FIG. 12C showing a partial interior cross-sectional view of the sealing structure in place relative to lumens of an entry guide device. The instrument sealing structure 1250 depicted in FIGs. 12A-12C can be a unitary, integral body (e.g., monolithic) and define a plurality of individual openings, the peripheral edges of which define septum or O- ring type seals 1251 (with four such seals 1251 a-1251 d depicted in FIGs. 12A and 12B). Instruments sized to pass through the openings can fit with the peripheral edges in a tight fit manner so as to provide sealing of the seals 1251 a-1251 d against respective inserted instruments.

[0097] In the embodiment of FIGs. 12A-12C, the openings have a variety of sizes intended to accommodate and seal against a variety of differing cross-sectional sizes and shapes of instruments. The instrument sealing structure 1250 is configured to be seated at a location close to where a funnel-shaped portion of an entry guide device meets the tube portion proximate the proximal end openings of each lumen of the tube portion, for example, as shown with reference to FIGs. 13A-13B discussed further below. In this way, each of the individual seals 1251 a- 1251 d can be seated in a corresponding lumen of the entry guide device. It should be appreciated that the number and size of openings, and thus individual seals, of the entry guide device lumen sealing structure 1250 depicted is one non-limiting example, and any number of openings and corresponding seals can be used with various permutations of shapes and sizes depending on the particular entry guide device lumen structure and instruments to be utilized.

[0098] An instrument sealing structure in accordance with various embodiments can further optionally include locating features configured to interact (e.g., mate) with complementary features (not shown) on an entry guide device so as to help orient and seat the instrument sealing structure. Exemplary locating features 1253 are depicted in the embodiment of FIGs. 12A-12C.

[0099] As also shown in FIG. 12A, a lubricant receptacle 1254 can optionally be formed in a surface of the instrument sealing structure 1250. The lubricant receptacle 1254 may be located so as to abut each of the seals 1251 a-1251 d and side walls of the lubricant receptacle 1254 can be provided with small channelsPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.003041254’ that provide respective fluid communication between the lubricant receptacle 1254 and the individual seals 1251 a-1251 d. Thus, the lubricant receptacle 1254 can be filled with lubricant which can pass through the channels 1254’ to keep the individual septum seals 1251 a-1251 d lubricated as an instrument shaft slides in and out past the individual septa (i.e., the sealing structure 1250 is self-lubricating).

[0100] Referring to FIG. 12B, seal members 1252a-1252b are also included on the distal face of the sealing structure 1250. These seal members provide sealing around the outside of the individual lumens of the entry guide device so as to prevent gas from leaking through a lumen that has an instrument inserted past the distally located lumen sealing structure (not shown) and into a lumen that does not have an instrument inserted. Stated differently, the seals 1252 at the distal face can prevent “cross-talk” (gas escape) from one lumen to an adjacent lumen.

[0101] FIG. 12C shows a partial sectional view of the instrument sealing structure 1250 positioned in an entry guide device so as to show the placement relative to lumens 1214 (two shown in FIG. 12C). As can be seen, the openings 1251 are positioned proximally facing and are sized to seal around an instrument shaft of an instrument 1220 (one instrument depicted in FIG. 12C) inserted through a lumen 1214. In addition, the distal sealing members (e.g., O-rings) 1252 (1252a-1252d shown in FIG. 12B) of the sealing structure 1250 seal around the outside of the individual lumens 1214 of the entry guide device. Those distal sealing members prevent gas from leaking through one lumen 1214 that has an instrument 1220 inserted past the distally located lumen sealing structure (not shown) and into another lumen 1214 that does not have an instrument inserted, as shown by the arrow in FIG. 12C (the arrow representing the potential gas path escape in the absence of the sealing members 1252).

[0102] In various embodiments, it is contemplated that an instrument sealing structure is made of rubber and formed as a single monolithic structure, such as via molding or other additive manufacturing processes. For example, the sealing structures in accordance with various embodiments can be made of rubber, such as for example, polyisoprene rubber, having a durometer ranging from, for example, 30 Shore A to 70 Shore A. The instrument sealing structures can also surface treated, such as, for example, via chlorination (e.g., for polyisoprene rubber), parylene, or UV treated (e.g., for silicone rubber). VariousPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 other materials and process techniques may be used for the lumen sealing structure, including but not limited to, using a material made of elastomer formed via transfer molding, compression molding, or liquid silicone rubber molding (LSR); casted urethane; and / or manufactured by additive manufacturing.

[0103] With reference to FIGs. 13A and 13B, an embodiment of an entry guide device 1310 (which can have a configuration similar to the entry guide devices 10, 210, 510 as described herein) that includes both an instrument sealing structure 1350 (such as, e.g., instrument sealing structure 1250) and a lumen sealing structure 1360 (such as, e.g., lumen sealing structure 560, 660, 760, 860, 960), with the latter secured to the entry guide device 1310 by a two- piece retention mechanism 1370 including a retention collar 1371 and retention cap 1372 (which can be similar to that described above with reference to the retention mechanism 970 of FIGs. 9 and 10), is illustrated. In FIG. 13A, a medical instrument 1320 having a relatively longer end effector (e.g., a stapler instrument) is inserted in one of the lumens of the entry guide device in a position similar to that described with reference to FIG. 4B above). In FIG. 13B, a lumen reducer device 1300 is inserted similar to that described above with reference to FIG. 3. As can be seen, because of the location of the lumen sealing structure 1360, the entry guide device lumens 1314 can remain sealed so as to isolate an environment P2 in which the distal end opening of the lumens 1314 of the entry guide device 1310 are located from an environment P1 in which the proximal end openings are located. Stated differently, while the medical instrument 1320 or the reducer device 1300 may be inserted partially into a lumen 1314 of the entry guide device and past the septum seal of 1351 of the instrument sealing structure 1350, the sealing flap 1361 of the entry guide device lumen sealing structure 1360 can remain in its respective closed position against the distal end opening of the lumen 1314 to maintain the sealing of the lumen 1314 (and, for example, prevention of insufflation gas from escaping through the lumen).

[0104] When the instrument 1320 of FIG. 13A is ready for use, its advancement can break the seal of the sealing flap 1361 against the lumen 1314 by exerting a force on the sealing flap 1361 to resiliently move it to an open position as discussed above, while such advancement further places the shaft 1320’ of the medical instrument 1320 in sealed engagement with the septum seal 1351 so as to maintain sealing between the two environments P1 and P2 withPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 which the lumen 1314 is in fluid communication (not shown in FIG. 13A, but similar to the arrangement depicted in FIG. 5).

[0105] Similarly, with respect to FIG. 13B, when a medical instrument (not shown) sized to be used with the lumen reducer device 1300 is ready for use, it can be inserted through the lumen reducer device 1300 and past the sealing flap 1361. The lumen reducer device 1300 can be fitted with its own septum seal 1303 internally to create a seal like a seal of 1351 of the instrument sealing structure 1350, and seal against the medical instrument in the reducer device 1300. This sealing, in addition to the sealing of the seal 1351 against the exterior surface of the lumen reducer device 1300, maintains sealing between the two environments P1 and P2 with which the lumen 1314 is in fluid communication.

[0106] As discussed above with reference to FIG. 1 B, in various embodiments, the present disclosure contemplates the use of an entry guide device having a separated and independently operable instrument sealing structure and lumen sealing structure in conjunction with a sealed envelope configured to maintain a pressurized environment and thus provide the ability to deploy instruments outside the body. FIG. 14 is an isometric, perspective view of an embodiment of an assembly that utilizes an entry guide device and an envelope that can be utilized for providing access to an opening in a body through which the medical instruments can be further inserted to access a worksite. In FIG. 14, an assembly 1400 includes an entry guide device main body 1410 that includes a funnel-shaped portion 1412 and a tube portion 141 1 defining a plurality of isolated lumens (not shown). An instrument sealing structure 1450 can be seated in the main entry guide device body at the end of the funnel shaped portion 1412 where the funnel-shaped portion meets the tube portion 1411. The instrument sealing structure 1450 can be configured as, for example, any of the instrument sealing structures 1250, 1350 discussed above. To assist removal, replacement, and maintenance, the instrument sealing structure 1450 can be provided as a separate component and thus a separate funnel insert 1412’ can be utilized and positioned in the funnel-shaped portion 1412 of the main entry guide device body 1410 once the sealing structure 1450 is in position. The funnel insert 1412’ can provide separated proximal openings 1413 to guide individual instruments (not shown) to respective lumens of the tube portion 1411.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304

[0107] The assembly 1400 further includes the envelope 1440 fitted with a cannula 1443 and insufflation tubing 1441 to provide insufflation gas to the envelope 1440. Various other seals and port entries are also included (not labeled) for insertion of various medical devices as may be used for a procedure. The tube portion 1411 of the entry guide device main body 1410 fits within the cannula 1443 such that its distal end is positioned within the sealed environment P2 created by the envelope 1440 and the proximal end (funnel-shaped portion with the funnel insert) is outside the envelope in environment P1. The assembly can be completed by securing the entry guide device lumen sealing structure 1460 to the distal end portion of the tube portion 1411 using a retention mechanism, such as a two-piece retention mechanism including a retention collar 1471 and retention cap 1472 similar to that described above with reference to the retention mechanism 970 of FIGs. 9 and 10. However, other retention mechanism configurations can be used as discussed herein. The lumen sealing structure 1460 can be configured as, for example, any of the lumen sealing structures 560, 660, 760, 860, 960. Moreover, providing the lumen sealing structure 1460 as a separate component that can be easily mounted and removed from the entry guide device can assist with assembly, removal, replacement, and maintenance.

[0108] As further depicted in FIG. 14, a lumen reducer device 1500, which can be configured similar to lumen reducer devices 300, 1300, can also be included as part of the assembly, and can be inserted in the entry guide device 1410 so as to reduce a size of one of the lumens as described above. The reducer device 1500 can comprise separate parts assembled together or can be of unitary construction.

[0109] Further, while not shown in FIG. 14, the assembly 1400 can be used with a wound retractor as described above with reference to FIG. 1 B.

[0110] For additional details as to the use and configuration of a sealed, pressurized envelope for access to an opening in a body in a single port computer-assisted surgical application, reference is made to U.S. App. Pub. No. US 2022 / 0401125, incorporated by reference herein.

[0111] Use of an entry guide device with separate proximal instrument sealing structures and distal lumen sealing structures in accordance with various embodiments is not limited to use with the assembly depicted in FIG. 14 and various other uses of the same are contemplated as discussed above.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304

[0112] While entry guide devices with sealing structure(s) in accordance with various embodiments can be used in a variety of medical procedures, as discussed above, various implementations contemplate their use as part of a computer-assisted teleoperated surgical system to guide medical instruments into a single opening (port) in a body. FIG. 15 is a perspective isometric view of one embodiment of a manipulator system 100 of such a surgical system (a surgeon console and auxiliary equipment / control tower not depicted). The manipulator system 100 includes a base 104 that may be movable or fixed (e.g., to the floor, ceiling, wall, or other equipment such as an operating table). Base 104 supports the remainder of the manipulator system 100, which includes a usually passive, uncontrolled manipulator support structure 106 and an actively controlled manipulator 108, which can include the entry guide device manipulator 108 as it connects with an entry guide device 110, for example, via connection with a cannula in which the entry guide device can be inserted and coupled, for example as described above with reference to FIGs. 1A and 14.

[0113] Entry guide device manipulator 108 includes an entry guide device manipulator assembly 118 that supports a plurality of medical instruments 120, with one or more such instruments coupled to entry guide device manipulator assembly 118 during a surgery.

[0114] Entry guide device manipulator assembly 118 includes an instrument manipulator positioning system (“positioning system”). The positioning system moves instrument mount interfaces of one or more instrument manipulators 122 in a plane so that, when one or more instruments 120 are coupled to entry guide device manipulator assembly 118, the shafts of the instruments 120 are each aligned for insertion into one of the lumens in entry guide device 110. While the entry guide device 110 is depicted as located at a body wall of the patient P, it is to be understood that the surgical system 100 can be used, without need for modifications, with entry guide devices located at a distance from the body wall, for example, using a pressurized, sealed envelope as discussed above.

[0115] The surgical system 100 may include multiple manipulatable links and joints that may be coupled together in various configurations to allow elements of the surgical system 100 to move. Examples of such configurationsPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 and other details regarding surgical system 100 are discussed U.S. Pat. App. Pub. No. US 2022 / 0401 125, the contents of which are incorporated by reference.

[0116] This description and the accompanying drawings that illustrate various aspects and embodiments should not be taken as limiting — the claims define the scope of protection. Various mechanical, compositional, structural, electrical, and operational changes can be made without departing from the spirit and scope of this description and the claims. In some instances, well-known structures, components, and techniques have not been shown or described in detail in order not to obscure the present disclosure. Like numbers in two or more figures that end in the same two digits but begin with a different series, such as 8xx, 10xx, etc. are utilized as best as possible to represent the same or similar elements and should be understood from the context in which they are used.

[0117] Embodiments described above illustrate but do not limit the disclosure. It should also be understood that numerous modifications and variations are possible in accordance with the principles of the present disclosure. For example, in many aspects the devices described herein are used as singleport devices; i.e., all components necessary to complete a surgical procedure enter the body via a single-entry port. In some aspects, however, multiple devices and ports may be used.

[0118] Various embodiments described herein can be well suited for use in medical applications. In particular, some embodiments are suitable for use in, for example, surgical, teleoperated surgical, diagnostic, therapeutic, and / or biopsy procedures. Such procedures could be performed, for example, on human patients, animal patients, human cadavers, animal cadavers, and portions or human or animal anatomy. Some embodiments can also be suitable for use in, for example, for non-surgical diagnosis, cosmetic procedures, imaging of human or animal anatomy, gathering data from human or animal anatomy, training medical or non-medical personnel, and procedures on tissue removed from human or animal anatomies (without return to the human or animal anatomy). Even if suitable for use in such medical procedures, the embodiments can also be used for benchtop procedures on non-living material and forms that are not part of a human or animal anatomy. Moreover, some embodiments are also suitable for use in non-medical applications, such as industrial robotic uses. In non-limiting embodiments, the techniques, methods, and devices described herein can bePCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304 used in, or can be part of, a computer-assisted surgical system employing robotic technology such as the da Vinci® Surgical Systems commercialized by Intuitive Surgical, Inc., of Sunnyvale, California. Those ordinarily skilled in the art will understand, however, that aspects disclosed herein can be embodied and implemented in various ways and systems, including manually operated instruments and computer-assisted, teleoperated systems, in both medical and non-medical applications. Reference to the daVinci® Surgical Systems are illustrative and not to be considered as limiting the scope of the disclosure herein.

[0119] As used herein and / or in the claims, terms such as computer- assisted or teleoperable in referencing manipulator systems, or the like should be understood to refer broadly to any system comprising one or more controllable kinematic structures (“manipulators”, “manipulator support structures”, and permutations thereof) that are movable and controllable at least in part through the aid of an electronic controller (with or without human inputs). Such systems can occasionally be referred to in the art and in common usage as robotically assisted systems or robotic systems. Such systems include systems that are controlled by a user (for example through teleoperation), by a computer automatically (so-called autonomous control), or by some combination of these. In examples in which a user controls at least some of the operations of the manipulator, an electronic controller (e.g., a computer) can facilitate or assist in the operation. The term “computer” as used in “computer-assisted manipulator systems” refers broadly to any electronic control device for controlling, or assisting a user in controlling, operations of the manipulator, and is not intended to be limited to things formally defined as or colloquially referred to as “computers.” For example, the electronic control device in a computer-assisted manipulator system could range from a traditional “computer” (e.g., a general-purpose processor plus memory storing instructions for the processor to execute) to a low-level dedicated hardware device (analog or digital) such as a discrete logic circuit or application specific integrated circuit (ASIC), or anything in between. Further, manipulator systems can be implemented in a variety of contexts to perform a variety of procedures, both medical and non-medical. Thus, although some examples described in greater detail herein can be focused on a medical context, the devices and principles described herein are also applicable to other contexts, such as industrial manipulator systems.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.00304

[0120] Elements and their associated aspects that are described in detail with reference to one embodiment can, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element can nevertheless be claimed as included in the second embodiment.

[0121] As used herein, “first”, “second”, ’’third”, etc. are adjectives used to distinguish between different components or elements. Thus, “first”, “second”, and “third” are not intended to imply any ordering of the components or elements, or to imply any total number of components or elements.

[0122] Further, this description’s terminology is not intended to be limiting. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — can be used to describe one element’s or feature’s relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e. , locations) and orientations (i.e., rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. A device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes includes various special device positions and orientations. In addition, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. And, the terms “comprises”, “comprising”, “includes”, and the like specify the presence of stated features, steps, operations, elements, and / or components but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups.

[0123] Components described as coupled can be electrically or mechanically directly coupled, or they can be indirectly coupled via one or more intermediate components. Mathematical and geometric terms are not necessarily intended to be used in accordance with their strict definitions unless the context ofPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 the description indicates otherwise, because a person having ordinary skill in the art would understand that, for example, a substantially similar element that functions in a substantially similar way could easily fall within the scope of a descriptive term even though the term also has a strict definition.

[0124] Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and figures, and practice of the embodiments disclosed herein. It is intended that the specification and embodiments be considered as illustrative only, with the following claims being entitled to their fullest breadth, including equivalents, under the applicable law.

Claims

PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304CLAIMSWHAT IS CLAIMED IS:1 . An apparatus for sealing an entry guide device for insertion of medical instruments through an opening in a body, the apparatus comprising: a retention mechanism configured to be secured at a periphery of a distal end portion of the entry guide device; and a sealing structure engaged with the retention mechanism, the sealing structure comprising a plurality of sealing flaps independently moveable between an open configuration and a closed configuration, wherein interaction of the retention mechanism with the plurality of sealing flaps exerts a preload force biasing the respective sealing flaps in the closed configuration.

2. The apparatus of claim 1 , wherein each sealing flap of the plurality of sealing flaps is moveable to the open configuration in a state of a medical instrument extending through the entry guide device and past the sealing flap.

3. The apparatus of claim 2, wherein in the open configuration with a medical instrument extending past the sealing flap, each sealing flap abuts against the medical instrument.

4. The apparatus of claim 3, wherein each sealing flap comprises a convex surface feature configured to abut against the medical instrument during passage of the medical instrument past the sealing flap.

5. The apparatus of any of claims 1 -4, wherein each sealing flap comprises one or more reinforcing ribs.

6. The apparatus of any of claims 1 -4, wherein the sealing structure further comprises a flexure coupling each of the plurality of sealing flaps to a peripheral mouth of the sealing structure.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.003047. The apparatus of claim 6, wherein the sealing structure further comprises an annular collar surrounding the flexure and a flexure rib connecting the annular collar to the flexure.

8. The apparatus of claim 7, wherein each sealing flap comprises two flexure ribs extending radially along outer edges of each sealing flap.

9. The apparatus of claim 7, wherein the retention mechanisms comprises a retention cap configured to secure to the entry guide device and a retention collar held between the retention cap and the annular collar of the sealing structure so as to exert the preload force.

10. The apparatus of claim 9, wherein the retention collar snap fits to the retention cap.1 1 . The apparatus of any of claims 1 -4, wherein each of the plurality of sealing flaps is shaped as a sector of a circle.

12. The apparatus of claim 11 , wherein at least one of the plurality of sealing flaps differs in size from at least one other of the plurality of the plurality of sealing flaps.

13. The apparatus of claim 1 , wherein adjacent sealing flaps of the plurality of sealing flaps are separated by slits.

14. The apparatus of any of claims 1 -4, wherein the sealing structure is a monolithic structure.

15. The apparatus of any of claims 1-4, wherein each sealing flap comprises a convex surface feature configured to be received in a distal end opening of a respective lumen of the entry guide device.

16. The apparatus of any of claims 1-4, wherein, in an open configuration of a sealing flap of the plurality of sealing flaps, the sealing structure generates a hoopPCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.00304 stress exerting a biasing force on the one sealing flap toward the closed configuration.

17. The apparatus of any of claims 1-4, wherein, in an open configuration of one sealing flap of the plurality of sealing flaps, the sealing structure absorbs a buckling energy to avoid buckling of the one sealing flap and deformation of the other of the plurality of sealing flaps.

18. An entry guide device for introducing medical instruments through an opening in a body, the entry guide device comprising: a tube portion divided into a plurality of interior isolated lumens, each lumen extending configured to receive a medical instrument; an instrument sealing structure arranged and configured to seal against a medical instrument received in a respective lumen; and a lumen sealing structure coupled to a distal end portion of the tube portion, the sealing structure comprising: a plurality of sealing flaps independently moveable relative to each other between an open configuration and a closed configuration, wherein in the closed configuration, each of the plurality of sealing flaps seals a distal end opening of a respective lumen of the plurality of isolated lumens, and wherein in the open configuration, each of the plurality of sealing flaps is configured to permit passage of a medical instrument through the distal end opening of the respective lumens and extending past the sealing flap.

19. The entry guide device of claim 18, wherein at least one lumen of the plurality of lumens is larger in diameter than the other lumens of the plurality of lumens.

20. The entry guide device of claim 19, wherein the at least one lumen that is larger in diameter is configured to receive a reducer device defining a passage smaller than the at least one lumen and terminating at a location proximal the sealing flap of the plurality of sealing flaps sealing the at least one lumen.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERNATE DOCKET NO. : 1084.0247.0030421. The entry guide device of claim 19, wherein the at least one lumen that is larger in diameter is configured to receive a stapler instrument.

22. The entry guide device of any of claims 18-21 , wherein the instrument sealing structure comprises individual septum seals in the interior of each of the plurality of lumens configured to seal against an instrument shaft of an instrument inserted in a respective lumen.

23. The entry guide device of any of claims 18-21 , wherein the instrument sealing structure comprises individual sealing members configured to seal against an exterior of each of the plurality of lumens of the entry guide device.

24. The entry guide device of any of claims 18-21 , wherein the instrument sealing structure is a monolithic structure.

25. The entry guide device of claim 24, further comprising a funnel portion at a proximal end portion of the tube portion, the funnel portion defining a plurality of funnel sections respectively aligned with and opening to the plurality of interior isolated lumens.

26. The entry guide device of any of claims 18-21 , further comprising: a retention mechanism configured to be secured at a periphery of a distal end portion of the entry guide device, wherein interaction of the retention mechanism with the plurality of sealing flaps exerts a preload force biasing the respective sealing flaps in the closed configuration.

27. The entry guide device of claim 26, wherein the retention mechanism comprises a retention cap configured to secure to the entry guide device and a retention collar held between the retention cap and the lumen sealing structure so as to exert the preload force.

28. The entry guide device of claim 27, wherein the retention collar snap fits to the retention cap.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERN TE DOCKET NO. : 1084.0247.0030429. The entry guide device of any of claims 18-21 , wherein each sealing flap comprises a convex surface feature configured to abut against the medical instrument during passage of the medical instrument past the sealing flap.

30. The entry guide device of claim 18, wherein the lumen sealing structure further comprises a flexure coupling each of the plurality of sealing flaps to a peripheral mouth of the lumen sealing structure.

31. The entry guide device of claim 30, wherein the lumen sealing structure further comprises an annular collar surrounding the flexure and a flexure rib connecting the annular collar to the flexure.

32. The entry guide device of any of claims 18-21 , wherein adjacent sealing flaps of the plurality of sealing flaps of the lumen sealing structure are separated by slits.

33. The entry guide device of any of claims 18-21 , wherein the sealing structure is a monolithic structure.

34. A method for providing access for insertion of medical instruments through an opening in a body, the method comprising: inserting a medical device in a lumen of an entry guide device and past a first sealing structure located in an interior of the lumen; and sealing the lumen with a second sealing structure spaced from the first sealing structure such that gas is prevented from flowing through a distal end opening of the lumen.

35. The method of claim 34, wherein the medical device is a reducer device defining an open passage, and sealing the lumen with the second sealing structure prevents gas from flowing into the passage.

36. The method of claim 35, wherein inserting the reducer device past the first sealing structure seals the space between the lumen and exterior surface of the reducer device.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.0030437. The method of any of claims 34-36, wherein the medical device is a medical instrument and inserting the medical instrument comprises inserting the medical instrument to an initial position proximal to the second sealing structure.

38. The method of claim 37, further comprising: inserting the medical instrument through the lumen to a subsequent position past the second sealing structure, wherein the first sealing structure seals against the medical instrument to prevent gas from flowing through the distal end opening of the lumen proximally past the first sealing structure.

39. The method of any of claims 34-36, further comprising positioning the entry guide device relative to a pressurized environment such that a pressure differential exists between the distal end opening and a proximal end opening of the lumen.

40. The method of claim 39, wherein the pressurized environment comprises medical insufflation gas.

41. The method of claim 39, wherein the pressurized environment is within an envelope over the opening in the body.

42. The method of any of claims 34-36, wherein the entry guide device comprises a plurality of isolated lumens and a respective first sealing structure is in each lumen, and wherein the method further comprises sealing each of the lumens with a respective second sealing structure separated from the respective first sealing structures.

43. The method of claim 42, wherein the respective first sealing structures are part of a monolithic structure defining a plurality of sealing septa.

44. The method of claim 42, wherein the respective second sealing structures are part of a monolithic structure defining a plurality of sealing flaps.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WOALTERN TE DOCKET NO. : 1084.0247.0030445. The method of claim 44, wherein the plurality of sealing flaps are independently moveable relative to each other between a closed sealing position against respective lumens of the entry guide device and an open position.

46. The method of claim 45, wherein inserting an instrument past a sealing flap of the plurality of sealing flaps moves the sealing flap to the open position.

47. A sealing device comprising: an annular peripheral wall; a plurality of sealing flaps connected to and extending radially inwardly from the annular peripheral wall, wherein each of the plurality of sealing flaps terminates in a free end portion, wherein, in a closed configuration of each sealing flap, the free end portion of the sealing flap is located at a central region relative to the annular peripheral wall, and wherein each of the plurality of sealing flaps is independently moveable relative to the other of the plurality of sealing flaps to move the sealing flap to an open configuration away from the central region.

48. The sealing device of claim 47, further comprising a flexure coupling each of the plurality of sealing flaps to the peripheral wall.

49. The sealing device of claim 47, further comprising an annular collar surrounding the flexure.

50. The sealing device of claim 49, further comprising a flexure rib connecting the annular collar to the flexure.

51. The sealing of claim 50, wherein each sealing flap comprises two flexure ribs extending radially along outer edges of each sealing flap.

52. The sealing device of any of claim 47-51 , wherein each sealing flap comprises a convex surface feature located on a sealing surface of each sealing flap.PCT APPLICATIONATTORNEY DOCKET NO. : P06813-WO ALTERNATE DOCKET NO. : 1084.0247.0030453. The sealing device of claim 52, wherein the convex surface feature is asymmetrical and comprises an apex located toward the free end portion.

54. The sealing device of claim 53, wherein the convex surface feature has a surface finish differing from a surface finish of a portion of the sealing flap surrounding the convex surface feature.

55. The sealing device of claim 53, wherein the convex surface feature is overmolded of a plastic material exhibiting a hardness higher than a portion of the sealing flap surrounding the convex surface feature.

56. The sealing device of any of claims 47-51 , wherein in an open configuration of a respective sealing flap, a hoop stress acts on the sealing flap to prevent buckling of the sealing flap.

57. The sealing device of any of claims 47-51 , wherein in an open configuration of a respective sealing flap, a hoop stress acts on the sealing flap causing a biasing force on the sealing flap toward the closed configuration.

58. The sealing device of any of claims 47-51 , wherein radial slits separate adjacent sealing flaps of the plurality of sealing flaps.

59. The sealing device of claim 58, wherein the radial slits extend at least partially vertically, relative to the radially inwardly extending direction, along the peripheral wall.

59. The sealing device of any of claims 47-51 , wherein each sealing flap has one or more portions having a modified surface texture.

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