Devices for aiding insertion of minimally invasive medical instruments, and related systems and methods

Abstract

A device for insertion in a lumen of an entry guide device includes a tube portion sized to be received in the lumen and defining a passage extending from a proximal end to a distal end of the tube portion and configured to receive a medical instrument through the tube portion; a retention mechanism comprising one or more deflectable engagement features configured to releasably engage with one or more complementary engagement features, respectively, of the medical instrument entry guide device, wherein in an engaged state of the one or more engagement features with the one or more complementary engagement features, the device is retained in a fixed position relative to the medical instrument entry guide device, wherein the one or more engagement features are configured to deflect and disengage from the one or more complementary engagement features in response to sufficient force exerted on the one or more engagement features.

Description

PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304DEVICES FOR AIDING INSERTION OF MINIMALLY INVASIVE MEDICAL INSTRUMENTS, AND RELATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 729,552, filed December 9, 2024, the entirety of which is incorporated by reference herein.TECHNICAL FIELD

[0002] The present disclosure relates generally to devices for aiding in insertion of medical instruments during minimally invasive medical procedures, including those that at least in part utilize computer-assisted controls (sometimes referred to as “robotic” surgery). More particularly, the present disclosure relates to lumen insert devices that cooperate with entry guide devices to alter a configuration of a medical instrument insertion lumen of the entry guide device for insertion of medical instruments through an opening in the body. Related devices, systems, and methods are also described.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. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304 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 the same time. Use of such entry guide devices designed and sized to receive various medical instruments facilitates maintaining separation of the instruments so that during insertion in the body the instruments do not overlap or entangle.

[0007] The ability to provide a variety of use cases and accommodate various instrument configurations when using entry guide devices in medical procedures is desirable. Because different instruments may have different configurations and sizes (including transverse cross-sectional shapes and sizes), improvements are needed in the ability to utilize an entry guide device so as to allow for a variety of use cases and differing instrument configurations.SUMMARY

[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] Various embodiments contemplate a device for insertion in a lumen of an entry guide device includes a tube portion sized to be received in the lumen of the entry guide device, the tube portion defining a passage extending from a proximalPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 end of the tube portion to a distal end of the tube portion and configured to receive a medical instrument through the tube portion; a retention mechanism comprising one or more deflectable engagement features configured to releasably engage with one or more complementary engagement features, respectively, of the medical instrument entry guide device, wherein in an engaged state of the one or more engagement features with the one or more complementary engagement features, the device is retained in a fixed position relative to the medical instrument entry guide device, wherein the one or more engagement features are configured to deflect and disengage from the one or more complementary engagement features in response to sufficient force exerted on the one or more engagement features.

[0010] Various embodiments further contemplate a system for insertion of a medical instrument through an opening in a body that includes an entry guide device comprising a lumen configured to permit insertion of a medical instrument, and one or more complementary engagement features in the lumen. The system further includes a lumen insert device configured to be releasably installed in the entry guide device, which includes a tube portion sized to be received in the lumen of the entry guide device, the tube portion defining an passage extending from a proximal end of the tube portion to a distal end of the tube portion and configured to receive a medical instrument, and a retention mechanism comprising one or more deflectable engagement features configured to releasably engage with the one or more complementary engagement features of the entry guide device, wherein in an engaged state of the one or more deflectable engagement features with the one or more complementary engagement features of the entry guide device, the lumen insert device is retained in a fixed position relative to the entry guide device. The one or more deflectable engagement features are configured to be in the undeflected state on a condition of the one or more deflectable engagement features in an engaged state with the one or more complementary engagement features of the entry guide device, and the one or more deflectable engagement features are configured to deflect and disengage from the one or more complementary engagement features of the entry guide device in response to sufficient force exerted on the one or more deflectable engagement features so as to deflect the engagement features.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304

[0011] Yet additional embodiments contemplate a method of inserting a medical instrument through an opening in a body that includes positioning an entry guide device relative to an opening in a body, the entry guide device comprising one or more lumens configured to receive respective medical instruments for insertion into the opening of a body; inserting a tube portion of a lumen insert device into one of the one or more lumens of the entry guide device, wherein the tube portion defines a passage for insertion of a medical instrument; engaging one or more deflectable engagement features on the lumen insert device with one or more complementary engagement features in the lumen of the entry guide device; and inserting a medical instrument through the passage of the lumen insert device such that a shaft of the medical instrument is in a position to prevent deflection of the one or more deflectable engagement features and thereby retain the one or more deflectable engagement features and the one or more complementary engagement features in an engaged state.

[0012] 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.

[0013] 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 equivalent.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] 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.

[0015] FIG. 1 is a perspective view of an example surgical system in accordance with various embodiments.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304

[0016] FIGs. 2A and 2B are perspective views of embodiments of use of an entry guide device for insertions of medical instruments to perform a minimally invasive medical procedures.

[0017] FIG. 3 is an isometric view of an embodiment of an entry guide device.

[0018] FIG. 4 is a schematic illustration of an embodiment of a lumen configuration of an entry guide device.

[0019] FIG. 5 is a cross-sectional view of an embodiment of an entry guide device with a medical instrument inserted in one lumen and a lumen insert device in another lumen.

[0020] FIG. 6 is a perspective view of an embodiment of an entry guide device with a lumen insert device partially inserted.

[0021] FIG. 7 is a detailed cross-sectional view of portion 7-7 of FIG. 6 showing the lumen insert device installed and an instrument inserted in the lumen insert device.

[0022] FIG. 8 is a perspective view of another embodiment of a funnel portion of an entry guide device and a lumen insert device in an uninstalled state of the lumen insert device.

[0023] FIG. 9 is a detail cut-away, longitudinal cross-sectional side view of the funnel portion of the lumen insert device in an installed state of the entry guide device of FIG. 8.

[0024] FIG.10 is a perspective view of another embodiment of a lumen insert device.

[0025] FIG. 11 is a detailed perspective view of section 11-11 of FIG. 10.

[0026] FIG. 12 is a partial, detailed cross-sectional view of the lumen insert guide device of FIG. 10 in an installed position in an entry guide device with a medical instrument inserted through the lumen insert device.

[0027] FIG. 13 is a perspective view of yet another embodiment of a lumen insert device.

[0028] FIGs. 14A and 14B are longitudinal is a cross-sectional views of an embodiment of a lumen insert device in an installed position in an entry guide device without and with a medical instrument inserted through the lumen insert device.

[0029] FIG. 15 is an isometric view of another embodiment of a lumen insert device.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304

[0030] FIG. 16 is a detailed partial cutaway view of portion of a lumen insert device and sealing mechanism.

[0031] In the drawings, in many cases the last 2 digits in a three or four-digit reference numeral is used to represent like parts where possible. Those having ordinary skill in the art would understand, however, instances in which this is not the case from the context of the disclosure and drawings.DETAILED DESCRIPTION

[0032] 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, even though not specifically shown in the drawings or described in the text.

[0033] 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) at locations 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.

[0034] 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 inPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 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 force transmission mechanism to the articulable mechanisms and / or moveable components of the end effector.

[0035] Those having ordinary skill in the art are generally familiar with a variety of medical instruments configured to perform minimally invasive medical procedures, 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.

[0036] It can be desirable to provide the ability during medical procedures that reduce the overall number of components needed while allowing for a wide variety of procedures and use cases to occur with such components. Throughout a minimally invasive medical procedure, it may be desirable to use various instruments which can have various configurations, including sizes and shapes. The ability to provide for a wide variety of use cases and differing sized instruments in the context of insertion of multiple medical instruments into a single opening using an entry guide device can pose challenges as the individual lumens of an entry guide device may be sized for particular instrument configurations.

[0037] To maximize efficiency, minimize incisions, and / or having to use multiple entry guide devices with differing lumen configurations (e.g., cross-sectional sizes and / or shapes) so as to provide the capability of accommodating instruments of differing configurations (e.g., lengths, cross-sectional sizes and / or cross-sectional shapes), therefore, it may be desirable to “repurpose” the lumen of an entry guide device designed to receive an instrument that has one configuration so that it is able to receive an instrument having a different configuration. By way of example, a lumen of an entry guide device may be relatively large in cross-sectional diameter and designed to receive an instrument with a relatively large shaft diameter. But, during a procedure, it may be desirable to use the lumen for insertion of an instrument having a relatively smaller shaft diameter. Because the lumen is sized to receive a larger instrument, the smaller instrument, while able to be inserted into the lumen, may not be held in place securely due to thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 discrepancy between the diameter of the instrument and the diameter of the lumen. As a result, the instrument may experience movement during use. This may cause a user to have less control over the instrument itself. Similar issues can arise if the lumen is designed for an instrument having a first cross-sectional shape and it is desirable during a procedure to insert an instrument having a second, different cross-sectional shape in the lumen.

[0038] Moreover, various medical procedures insert instruments from an environment of relatively lower pressure (ambient) to an environment of relatively higher pressure (e.g., insufflation medical gas pressure) within the body where the worksite is. To maintain such insufflation pressure, an entry guide device can have sealing mechanisms, such as septum seals, that seal against the instruments when inserted to prevent gas from escaping through the entry guide device. Accordingly, if an instrument is not sized to correspond to the lumen in the entry guide device, for example if it has a smaller shaft diameter and / or a different cross-sectional shape than the configuration of the entry guide device lumen, then sealing my not be properly effectuated.

[0039] The ability to utilize an entry guide device to accommodate a variety of instruments of differing configurations can be aided by providing the lumens of the entry guide device with differing cross-sectional sizes and / or shapes, including at least one lumen with a relatively larger cross-sectional size (e.g., diameter) to accept an instrument of relatively larger cross-sectional size. Further variation can be attained by selectively reducing the cross-sectional size of the lumen to a size corresponding to an instrument having a smaller cross-sectional size. Such a reduction may be temporary to allow the smaller instrument to be received therein as desired by a user while maintaining the ability to return the lumen to its original size. In addition, the cross-sectional size reduction of the lumen may allow the smaller instrument to be securely received within the reduced-sized lumen to minimize undesirable instrument movement during use and / or to ensure proper sealing against the instrument by a septum seal located in the lumen of the entry guide device.

[0040] Similarly, it may be desirable to selectively alter the cross-sectional shape of the lumen to provide the ability to accept instruments having different cross- sectional shapes.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304

[0041] The present disclosure contemplates the use of a lumen insert device that fits within a lumen of an entry guide device so as to selectively alter a configuration (e.g., cross-sectional size and / or shape) of the lumen, thereby permitting the lumen of the entry guide device to be configured for differing configurations of instruments. For example, a lumen insert device can be utilized so as to permit a lumen of an entry guide device to accept both an instrument having a first cross-sectional configuration (e.g., size and / or shape) and an instrument having a second cross-sectional configuration (e.g., size and / or shape), which differs from the first. A lumen insert device can also be referred to as a lumen reducer device, reducer, or permutations thereof.

[0042] Enabling removable installation of such a lumen insert device in an entry guide device in a relatively easy to use manner also is contemplated by various implementations herein. Further, in the installed state, lumen insert devices contemplated can be configured with retention mechanisms that provide for robust securing in use, while facilitating installation and removal.

[0043] Various embodiments of lumen insert devices used in conjunction with entry guide devices are contemplated by the present disclosure and are discussed with respect to exemplary implementations and figures below. Those of ordinary skill in the art would appreciate that the figures and descriptions thereof are nonlimiting and provided to aid in an understanding of principles of operation.

[0044] While entry guide devices and lumen insert devices in accordance with various embodiments can be used in a variety of medical procedures, as discussed above, including in manual laparoscopic medical procedures, 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. 1 is a perspective, diagrammatic view of one embodiment of a manipulator system 100 of such surgical system (a surgeon console and auxiliary equipment / control tower with which those having ordinary skill in the art are familiar with not depicted). Manipulator system 100 is implemented as a patient-side cart, and the medical procedure is in the abdomen of patent 102. However, the manipulator system 100 can be used for a wide variety of medical procedures by using various combinations of instruments. 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 supportsPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 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 a manipulator assembly 118 that couples with instruments 120 and is attached to an arm coupled to an entry guide device 126, for example, via connection with a cannula (not specifically labeled) in which the entry guide device can be inserted and coupled.

[0045] In one example, the manipulator support structure 106 includes a first setup link 110 and two passive rotation setup joints 112 and 114. Rotational setup joints allow manual positioning of the coupled setup links 111 and 113. Alternatively, some of these setup joints may be actively controlled, and more or fewer setup joints may be used in various configurations. Setup joints 112 and 114 and setup links 111 and 113 allow a person to place manipulator assembly 118 at various positions and orientations in Cartesian x, y, z space. A passive prismatic setup joint (not shown) between link 110 of manipulator support structure 106 and base 104 may be used for large vertical adjustments.

[0046] The manipulator system 100 may include multiple manipulatable links and joints that may be coupled together in various configurations to allow elements of the manipulator system 100 to move. Examples of such configurations and other details regarding manipulator system 100 are discussed U.S. Pat. App. Pub. No. US 2022 / 0401125, the content of which is incorporated by reference herein in its entirety.

[0047] As mentioned above, manipulator assembly 118 supports a plurality of medical instruments 124, with one or more such instruments coupled to the manipulator assembly 118 during a medical procedure. 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 124 are coupled (via their respective force transmission mechanisms at proximal ends (not illustrated in FIG. 1 ) to entry guide device manipulator assembly 118, the shafts of the instruments 124 are each aligned for insertion into one of the lumens in entry guide device 126. While the entry guide device 126 in FIG. 1 is depicted as located at a body wall of the patient P, it is to be understood that the manipulator system 100 can be used with entry guide devices located at a distance from thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 body wall, for example, using a pressurized, sealed envelope discussed below with reference to FIG. 2B.

[0048] The instrument mount interface(s) may be moved into position after attachment of the instrument(s). The plane in which the instrument mount interfaces are moved is generally perpendicular to the lengthwise axis of entry guide device 126, and the trajectories that instrument mount interfaces take in that plane may include straight and / or curved portions in various combinations. As a positioning element of a lateral motion mechanism moves along a trajectory, the instrument mount interface, and effectively a distal tip of a shaft of an instrument coupled to the instrument mount interface, moves along the same trajectory. Thus, motion of the positioning element causes the shaft to be moved to a location where the shaft is aligned with a lumen in entry guide device 126. The particular paths implemented in the positioning system depend at least in part on the types of medical instruments that can be mounted to the manipulator assembly 118 and / or the configuration of the lumens in entry guide device 126.

[0049] The ability to individually position an instrument, and thus its shaft, with respect to a lumen in an entry guide device by moving an instrument mount interface provides versatility to surgical system 100. For example, this ability allows entry guide devices with different lumen configurations to be used in system 100. In addition, the positioning system eliminates the need for medical procedure-specific instruments. In other words, the instrument manipulator positioning system allows use of a varied set of instruments. In view of this, the ability to use the same entry guide device without having to remove it during a medical procedure to accommodate this varied set of instruments is desirable.

[0050] Referring now to FIGs. 2A and 2B, 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 230 includes a proximal, generally funnel-shaped portion 232 with proximal end openings 233 (two of which, 233a and 233b, are labeled) that lead to respective individual isolated lumens in a main tube portion (not shown) extending distally from the funnel-shaped portion 232. Proximal and distal directions are indicated in FIGs. 2A and 2B, 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 groundPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 location at which the entry guide device 230 is fixed as indicated at G in FIG. 2A). The isolated lumens have distal end openings that open into a cannula 240 which is inserted into an opening between the two environments P1 and P2. In this way, medical instruments 224 (two of which 224a and 224b are labeled) can be inserted from environment P1 to environment P2 (end effectors of the instruments are shown but not labeled in the figures, while the proximal end force transmission mechanism is not shown).

[0051] The medical instruments 224 can be introduced through the respective openings 233 of the entry guide device 230 into the individual lumens in tube portion, and be advance out of the respective distal end openings and into cannula 240 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).

[0052] 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. 2B. FIG. 2B illustrates an entry guide device 230 used in conjunction with a sealed envelope 250 configured to maintain a pressurized environment P2 (e.g., pressurized with insufflation gas through a tube 251) 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 250 can be further assembled with a wound retractor 252 inserted into an opening in the body. As with the configuration of FIG. 2A, the entry guide device 230 can be coupled to a medical ground G located in the first environment P1 (which can be at ambient pressure).

[0053] 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. 2B) outside the body in circumstances where it may be desirable to utilize the instrument end effectors to perform parts of a medical procedure at the opening (e.g., incision site or natural orifice) in the body. The entry guide devices of FIGs. 2A and 2B 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 thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 second environment P2 can allow for the instruments 224 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 / 0401125, hereby incorporated by reference herein.

[0054] 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 233 and corresponding isolated lumen of the entry guide device, gas from environment P2 at the higher pressure is prevented from escaping through the opening 233 to environment P1 at the lower pressure; thereby allowing insufflation pressure to be maintained.

[0055] The funnel portion and sealing mechanism for providing sealing against instruments inserted in the lumens of an entry guide device can be an integrated unitary construction or alternatively can be provided as separated components assembled together to assist with placement (an replacement) of the sealing component used to provide the instrument sealing to prevent insufflation gas from escaping through the entry guide device when an instrument is in a lumen of the device as discussed above. FIG. 3 shows an isometric view of an embodiment of an entry guide device 330 comprising a main body portion with a funnel entry portion 332 and tube portion 331 , a sealing component 335, and an insertable funnel insert portion 332’ that provides the separated proximal end openings 333 that lead to the individual isolated lumens 334 of the tube portion 331 of the entry guide device 330.

[0056] So as to provide the capability to receive a wide variety of differing instrument configurations during a medical procedure, various implementations of entry guide devices are contemplated that combine multiple configurations of the lumens and the respective proximal end openings of the funnel portion leadingPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 thereto. FIGs. 4 depicts a non-limiting example of contemplated cross-sectional shapes and sizes of the lumen combinations that an entry guide device in accordance with the present disclosure may have so as to enable, when used in conjunction with a lumen insert device in accordance with implementations of the present disclosure, a wide variety of medical procedures and differing instruments to be used during a medical procedure without the need to remove the entry guide device, as will be explained in further detail below.

[0057] In the example of FIG. 4, the entry guide device lumen configuration includes four lumens, with two of the lumens 434a having a circular cross-section of the same size diameter, one of the lumens 434b having a circular cross-section of a larger size diameter than the lumens 434a, and another of the lumens 434c having an elliptical cross-section of relatively larger lateral dimensions. The lumen 434c can be designed to accept an endoscope, the lumens 434a to accept medical instruments of relatively smaller shaft diameters, and 434b to accept medical instruments of a relatively large shaft diameter. By way of non-limiting example only, it is contemplated that the lumens 434a can have a diameter sized to allow a 6 mm diameter shaft instrument, and the lumen 434b to accept a larger size diameter shaft instrument, such as 8 mm or 12 mm. These diameter sizes are exemplary only and various other diameter sizes are contemplated.

[0058] While the combination of lumen configurations depicted in FIG. 4 permits a variety of medical instruments to be used with the entry guide device, “repurposing” the lumen 434b to selectively allow it to accept smaller sized instruments would provide an even wider variety of medical instruments to be used during a medical procedure. To achieve such selective reconfiguration of the lumen, a lumen insert device can be used that can be selectively installed and removed in a lumen of an entry guide device, with consideration given to both providing a relatively easy installation and removal, but also a robust securing of the lumen insert device in the installed position, for example to withstand forces associated with instrument movement and reactive forces from interaction with the body wall from causing movement of the lumen insert device from its desired installed position in the entry guide device.

[0059] Referring now to FIG. 5, a longitudinal cross-sectional view of an entry guide device 530 including a plurality of instrument insertion lumens 534 is depicted in which two lumens are visible with one lumen 534a having a first cross-PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 sectional configuration that is circular with a diameter d1 and another lumen 534b having a second cross-sectional configuration differing from the first cross- sectional configuration. The cross-sectional configuration of lumen 534b is circular with a diameter d2 larger than d1 . For example, the lumen 534a and 534b may be similar to the lumens 434a and 434b, respectively, as described above in the embodiment of FIG. 4. Other portions of the entry guide device 530 can be similar to those described above with reference to entry guide devices 230 and 330.

[0060] Lumens 534a and 534b of the entry guide device 530 are thus designed to accept medical instruments having differing configurations, such as a medical instrument with a relatively small instrument shaft (shown in dashed at 524) for insertion through lumen 534a and a medical instrument with a relatively larger instrument shaft for insertion through lumen 534b. The entry guide device 530 also includes a proximal instrument sealing structure 535 which provides for individual septum seals 535a, 535b in each of the lumens 534. Due to the size of the lumens and the respective instruments that can be received therein, the relatively small instrument shaft when inserted in lumen 534a and the relatively large instrument shaft when inserted in lumen 534b can friction fit with the septum seals 534a, 534b, respectively such that gas is prevented from escaping through a distal end of the lumens 534a, 534b and past the location where the seals 534a, 534b seal against the instrument shafts (see, e.g., seal 535a and shaft of instrument 524).

[0061] While in some portions of a medical procedure, it may be desirable to have the instrument with a relatively larger shaft diameter inserted through lumen 534b of the entry guide device 530, in the same procedure it may be desirable to withdraw that instrument and use another instrument inserted through the lumen 534b. If such instrument has a smaller shaft diameter, however, then the desirable tight fit in the lumen 534b and / or sealing against the septum seal 535b may not be achieved.

[0062] To address this issue and “repurpose” the lumen 534b, a lumen insert device 560 may be inserted into the lumen 534b, as illustrated in FIG. 5. The lumen insert device 560 has a shape that generally follows the contour of the entry guide device 530 funnel portion proximal end opening 533b and the lumen 534b of the tube portion 531 of the entry guide device. Thus, the lumen insert device 560 includes a proximal end funnel portion 562 defining a proximal endPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 opening 563 and a tube portion 561 extending distally from the proximal end funnel portion 562 and defining a passage 564 which opens at a distal end opening 566. The exterior dimensions of the lumen insert device 560 can be chosen so as to allow it to achieve a tight fit within the lumen 534b so as to control lateral play of the lumen insert device 560. Moreover, the exterior dimensions allow the lumen insert device 560 tube portion 561 to achieve sealing against the septum seal 535b of the entry guide device 530. In addition, a length of the lumen insert device 560 in the fully seated position in the lumen 534b is such that it is proximal to a distal lumen sealing structure 536 that is retained at a distal end portion of the entry guide device 530 to provide sealing of the distal openings of the lumens 534 of the entry guide device 530. In this manner, the lumen insert device 560 can remain in the inserted position illustrated without insertion of an instrument while sealing of the lumen 534b can be maintained due to the distal sealing structure 536 remaining in a closed, sealing configuration, thus preventing gas at a higher pressure (e.g., insufflation gas) in the environment of the distal portion of the entry guide device 530 from escaping through the lumen 534b and passage 565 of the lumen insert device 560. This further allows for instruments to be easily inserted and removed through the lumen insert device 560 without risk of the gas escaping.

[0063] The interior dimensions of the lumen insert device 560 allow for accepting an instrument having a shaft of relatively smaller diameter because the passage 564 has an interior diameter d3 that is smaller than the diameter d1 of the entry guide device lumen 534b. The passage 564 of the lumen insert device 560 can be provided with a seal 565, which can function similar to the individual instrument septum seals 535a, b, and seal against an instrument shaft when inserted through the lumen 564. In this way, insertion of the lumen insert device 560 achieves the repurposing of the lumen 534b, allowing the lumen 534b to be selectively used to accept either larger instruments or smaller instruments, while also maintaining sealing against the instruments inserted through the passage 564 of the lumen insert device 560.

[0064] As discussed above, it is desirable to be able to relatively easily and securely install a lumen insert device in accordance with various implementations to be able to promote efficiency and reliability during a medical procedure.Further, ensuring a secure and reliable installation is desirable to mitigate againstPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 any movement of the lumen insert device out of position because of a potential to break the seal against the lumen insert device and / or a seal with the instrument inserted in through the lumen of the lumen insert device. It also is desirable to ensure a secure and reliable installation of the lumen insert device that mitigates against movement of the lumen insert device because such motion can also impact instrument motion, causing undesirable or uncontrolled instrument motion. In some cases, however, it may be desirable to provide a relatively secure position of the lumen insert device, while allowing from a gentle rocking motion to accommodate instrument motion without risk of the lumen insert device becoming uninstalled. Finally, allowing for relatively easy removal of the lumen insert device also is desirable so that the lumen of the entry guide device in which it is installed can be reconfigured back to its initial state when it is desired to insert an instrument having a configuration for which the lumen is designed, e.g., a relatively larger diameter.

[0065] Various mechanisms to achieve the secure and reliable installation are discussed with reference to embodiments of illustrated in FIGs. 6-15 below.

[0066] With reference to FIGs. 6 and 7, an embodiment of a lumen insert device with a retention mechanism is illustrated. In FIGs. 6 and 7 a funnel portion 632 comprising proximal end openings 633 of an entry guide device 630 is depicted, which can be either an integrated funnel portion or the separate component assembled with the remaining parts of the entry guide device as discussed above with reference to FIG. 3. In FIG. 6, the proximal openings 633 lead to the individual isolated lumens of the entry device and a transition region 634’ where the funnel portion 632 meets the lumens 634 (two lumens 634a and 634b depicted and shown in dashed lines) is shown. The entry guide device 630 of FIGs. 6 and 7, includes four instrument insertion lumens 634 and corresponding proximal openings 633, but as in other embodiments more or fewer lumens and corresponding proximal openings 633 may be used. Similar to the embodiments of FIG. 4 and 5 discussed above, the lumens 634a, 634b and corresponding proximal openings 633 can have differing sizes, with lumen 634b being larger to accommodate an instrument of larger diameter. Thus, a lumen insert device 660 can be installed to selectively reduce the effective diameter of lumen 634b.

[0067] The lumen insert device 660 can have a general configuration similar to the lumen insert device 560, including a proximal funnel portion 662 defining aPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 proximal end opening 663 and a tube portion 661 defining a passage 664 having a distal end opening 666. The passage 664 can be sized to receive an instrument of relatively smaller diameter than what the lumen 634b is configured to receive, as described above with respect to FIGs. 4 and 5.

[0068] To promote a secure and relatively easy installation of the lumen insert device 660 in the entry guide device 630, lumen insert device 660 includes a releasable retention mechanism that includes a deflectable engagement feature configured to be selectively and releasably engaged with a complementary engagement feature on the entry guide device 630. When the engagement features are engaged, the lumen insert device 660 is retained in a fixed axial position and rotational orientation relative to the entry guide device 630. Removal of the lumen insert device 630 can occur, however, by applying sufficient force (e.g., proximally directed) on the insert lumen device 660 such that interaction of deflectable engagement feature with the entry guide device deflects the engagement feature and allows it to disengage from the complementary engagement feature.

[0069] As shown in FIGS. 6 and 7, in some implementations, the releasable retention mechanism includes a deflectable tab 667 protruding radially outward from an exterior of the tube portion 661 . The tab 667 can be located, for example, at the transition region 66T of the tube portion 661 close to where it meets the funnel portion 662. As shown in FIGs. 6 and 7, the tab 667 can be attached at a proximal region thereof with a cut out 668 in wall of the tube portion 661 provided around a perimeter of substantially the remaining portion of the tab 667 to allow the inward deflection of the tab 667.

[0070] To provide the secure installation, the tab 667 is engageable with a complementary pocket engagement feature 637 located on the entry guide device 630. The exterior profile of the pocket engagement feature 637 is shown in FIG. 6 and the internal profile shown in the detailed view 7-7 in FIG. 7, which depicts a longitudinal cross-section of the entry guide device 630 with the lumen insert device 660 in the installed position and an instrument 624 received in the lumen insert device 660. More particularly, when the tab 667 engages with pocket engagement feature 637, the tab 667 is substantially surrounded by the internal surface of the pocket engagement feature 637, assisting in locking the lumen insert device 660 in a fixed axial position and rotational orientation relative to thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 lumen 634b of the entry guide device 630 in the absence of a force causing inward deflection of the tab 667.

[0071] During installation, the deflectable (e.g., elastically deflectable) nature of the tab 667 allows it to deflect radially inwardly when lumen insert device 660 is inserted into entry guide device 630 until it reaches the pocket 637, at which point tab 667 is able to return to its undeflected position and be received in the pocket feature 637, as shown in FIG. 7. The engagement of the tab 667 and pocket feature 637 thus provide a retention mechanism for the installed state of the lumen insert device 660 in the entry guide device 630, allowing the relative positioning thereof to be substantially fixed as described above.

[0072] With further reference to FIG. 7, the positioning of the tab 667 and corresponding pocket feature 637 further allow for interaction with an instrument when inserted through the lumen insert device 660 such that the instrument serves to prevent radial inward deflection of the tab 667 and consequent disengagement from the pocket feature 637. This ensures the lumen insert device 660 remains in the installed fixed axial position and orientation relative to the entry guide device 630 during a medical procedure when an instrument inserted and sized for the passage s664 of the lumen insert device 660 is in use.

[0073] While the tab 667 and pocket 637 can be located at respective transition regions where the respective funnel portions 632, 662 meet the respective lumen 634b and passage 664b, such locations are not so limited and the tab / pocket locations can be located elsewhere. Additionally, although the embodiment of FIGS. 6 and 7 show a single pair of tab / pocket engagement features, more than one such pair of complementary engagement features can be provided, such as in opposing positions diametrically across from each other for example. Further other shapes of complementary engagement features can be utilized. Attributes of the shape and structures of the embodiments of the tab 667 and pocket 637 engagement features are discussed further below.

[0074] Tab 667 and the corresponding portions of the pocket feature 637 that mates with it may have a generally triangular cross-section taken in the longitudinal cross-section, as depicted in FIG. 7. The cross-section of the tab 667 presents two angled surfaces 667’, 667” which extend radially outward from the exterior of the lumen insert device 660. More particularly, the angled surface 667’ extends from the tube portion 661 in a distal direction of the tube portion 661 andPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 the angled surface 667” extends from the tube portion 661 in a proximal direction of the tube portion 661 . The angled surfaces 667’, 667” meet at a tip. The angled surface 667’ can have an angle & relative to a centerline axis A of the lumen insert device 660 ranging from 20° to 60°' and the second angled surface can have an angle 0” relative to the axis A ranging from 20° to 60°. By way of nonlimiting example, 0’ can be 30° and O” can be 45°.

[0075] In the embodiment of FIGs. 6 and 7, the tab 667 is attached at its proximal end and the cut out 668 that allows for the radially inward deflection of the tab 667 extends around the distal end of the tab 667. The reverse arrangement is also contemplated by the present disclosure such that the tab 667 can be attached at its distal end with the cut out extending around the proximal end. The choice of the arrangement may depend on various factors, such as locations of other parts of the entry guide device and / or the lumen reducer device, and / or manufacturing, such as molding, considerations. For example, in the arrangement of FIGs. 6 and 7, the cutout is located above the septum sealing mechanism which allows for a relatively large inward deflection of the tab 667. If the reverse arrangement were used with the septum seal mechanism positioned at the transition area where the tube portion meets the funnel portion of the entry guide device, there may be interference with the sealing mechanism limiting deflection of the tab.

[0076] The overall length, size, and angles of the tab / pocket retention mechanisms described herein can be selected, in addition to achieving the ability to provide retention of the lumen insert device relative to the entry guide device, to provide audible and / or haptic feedback to a user of the tab moving into the pocket feature from the deflected state, with the feedback being sufficient so as to be perceptible to a user installing the lumen insert device in the entry guide device. Further, the various dimensions may be selected so that a user can feel when applying force to remove the lumen insert device that is securely retained (locked) in place, but nonetheless relatively easy to remove with a sufficient level force applied (force lifting the lumen insert device out of and away from the entry guide device in the absence of an instrument inserted through the lumen insert device.

[0077] Another embodiment of a lumen insert device with a latching mechanism comprising deflectable engagement features is illustrated in FIGs. 8 and 9. As shown in FIG. 8, lumen insert device 860 has portions similar to lumen insert device 660, including a funnel portion 862 and a tube portion 861 extendingPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 therefrom, with the tube portion 861 defining a passage 864 from the proximal openings of the funnel portion 862 to a distal end opening. The general structure of the lumen insert device 860 will not be repeated here and can be similar to that described above with reference to lumen insert device 660, with differences described here.

[0078] The lumen insert device 860 instead of a relative larger deflectable protrusion, includes deflectable engagement features comprising a plurality of deflectable tabs 869 formed on sides of the funnel portion 862. The deflectable tabs 867 are attached at their proximal end with a cutout 868 through a wall of the funnel portion 862 surrounding a distal end and substantially the remainder of the tab 867 so as to permit radial inward deflection of the tabs 867, in a manner similar to that described with respect to tab 667 of the embodiment of FIGs. 6 and 7. Rather than presenting a radially outwardly protruding profile, however, the tabs 867 have an exterior surface profile that lies substantially flush with the exterior surface of the remainder of the funnel portion 862.

[0079] As shown in FIG. 8, each of the tabs 867 has a small protrusion 869 integrally formed on an exterior surface at a distal portion thereof. One of the protrusions 869 is depicted in FIG. 8, with the other hidden from view, and both shown in the view of FIG. 9. The protrusions 869 are configured to engage in a snap-fit manner with a corresponding complementary recesses 839 provided in the funnel portion 832 of the entry guide device 830. More particularly, as shown in FIG. 8, an interior surface of the funnel portion 832 of the entry guide device 830 includes the complementary recesses 839.

[0080] Thus, when lumen insert device 830 is inserted into the entry guide device 860, the protrusions 869 abut against the interior surface of the proximal opening 833 of the funnel portion 832, causing the tabs 867 to deflect radially inwardly from their resting, non-deflected state. In a manner similar to tab 667 of the embodiment of FIGs. 6 and 7, as the lumen insert device 860 is advanced far enough into the entry guide device 830 and the protrusions 869 encounter the recesses 839, the tabs 867 return to their undeflected state with protrusions 869 engaging and mating with recesses 839, as shown in FIG. 9.

[0081] Thus, in the installed state, via its interior passage, lumen insert device 860, like the other embodiments of lumen insert devices 560, 660 can provide anPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 instrument insertion lumen of reduced size compared to the lumen of the entry guide device into which the lumen insert device 860 is installed.

[0082] In the engaged state of the protrusions 869 and recesses 839, the complementary features provide a retention mechanism that fixes the axial position and rotational orientation of the lumen insert device 860 relative to the entry guide device 830. Upon a sufficient force acting proximally on the lumen insert device 860 to lift it out of and away from the entry guide device, the interaction of the tabs 867 with the funnel portion 832 of the entry guide device can cause the tabs 867 to again deflect radially inwardly, allowing the protrusions 869 to be dislodged from recesses 839 and the lumen insert device 860 removed from the entry guide device 830.

[0083] As with the embodiment deflectable tab 667, the deflectable tabs 867 can be designed to provide a tactile and / or audible feedback to a user to signal installation of the lumen insert device 860 in the entry guide device 830 via the snap-fit engagement of the protrusions 869 in the recesses 839.

[0084] In the embodiment of FIGs. 8 and 9, there are engagement features (e.g., two deflectable tabs 867 with protrusions 869) similarly formed and disposed diametrically opposite one another, with corresponding complementary engagement features in the form of recesses 839 on the funnel portion 832 of the entry guide device. However, such number and arrangement is not limiting and one or more than two such engagement features and complementary engagement features could be provided.

[0085] With reference now to FIGs. 10 and 11 , in various embodiments, a retention mechanism for a lumen insert device installed in an entry guide device can include complementary engagement features located toward a distal end portion of the lumen insert device. As will be explained further below, positioning the retention mechanism more distally can provide a robust engagement in a state of a medical instrument inserted through the lumen insert device based on the forces exerted by the instrument during medical procedures. In view of space considerations toward the distal portion of the lumen insert device, however, the engagement features used on both the lumen insert device and the entry guide device may generally have a smaller profile than features that can be used when located more proximally near the funnel portion of the devices, where there is generally more space.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304

[0086] As shown in the perspective view of a lumen insert device in FIG. 10 and the detailed view 1 1-11 of FIG. 10 shown in FIG. 1 1 , a distal portion of the tube portion 961 of the lumen insert device 960 includes a ledge 970 that extends at least partially circumferentially around the tube portion 961. The ledge 970 is relatively small in profile and extends radially outward from tube portion 961 , defining a proximally facing shoulder surface 971 . The ledge 970 tapers in the distal direction so that a smooth profile occurs distally of the shoulder surface 971 where the ledge 970 meets the remainder of the tube portion 961 .

[0087] A complementary engagement feature can be provided on the interior surface of the lumen of the entry guide device that mates with the shoulder surface 971 of the ledge 970 of the lumen insert device 960. FIG. 12 shows a detailed view of an embodiment of the complementary engagement feature comprising an undercut in the interior surface of the lumen 934 of the entry guide device, with the undercut forming a shoulder surface 981 complementary to and having a reverse orientation of the ledge 970 and shoulder surface 971. Stated differently, the shoulder surface 981 faces in a distal direction. The arrangement of the ledge 970 and undercut 980 allows for the lumen insert device 960 to be inserted past the undercut 980. Then, upon insertion of an instrument 924 through the passage of the lumen insert device 960 as shown in FIG. 12, the instrument shaft can provide a force against the lumen insert device 960, allowing the shoulder surfaces 971 , 981 to abut each other and catch to provide resistance against movement of the lumen insert device 960 relative to the entry guide device 930. In other words, the engagement of the shoulder surfaces 971 , 981 serves as a hook and catch type of retention mechanism to retain the lumen insert device 960 in a fixed axial position and rotational orientation relative to the entry guide device 930.

[0088] In some implementations, the distally located retention mechanism (e.g., the ledge and undercut complementary engagement features of the embodiment of FIGs. 10-12) can be used in conjunction with the proximally located retention mechanism of a lumen insert device described above, such as the deflectable tab embodiments of FIGS. 6-9, to provide an additional retention mechanism of the lumen insert device when in the installed position in the entry guide device lumen. FIG. 13 depicts an embodiment of a lumen insert device 1360 that includes a combination of the proximally located retention mechanism comprising the tabsPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304868 with protrusions 869 of the embodiment of FIGs. 8 and 9, with the distally located retention mechanism comprising the ledge 970 of the lumen insert device of the embodiment of FIGs. 10-12. Likewise, and as explained in further detail with reference to FIG. 14, a lumen insert device having proximally located retention mechanism features similar to those described with the embodiment of FIGs. 6 and 7 can have a distally located retention mechanism features similar to the ledge engagement feature described in the embodiment of FIGs. 10-12.

[0089] Providing the combination of the proximally located and distally located engagement features can enhance the retention of the lumen insert device in the installed position in the entry guide device.

[0090] In various embodiments, a side wall opening in the tube portion of the lumen insert device can be useful to allow some desired lateral movement of medical instruments inserted through the lumen insert device. A sidewall opening 863 in the tube portion 861 is depicted in the embodiment of FIG. 8, but can also be provided in the side wall of the tube portions of any of the lumen insert guide devices disclosed here. Such an opening can be useful to allow some lateral movement of the instrument.

[0091] FIGs. 14A and 14B depict embodiments of a lumen insert device 1060 having a configuration generally similar to the configuration of lumen insert device 660, but additionally including a sidewall opening 1063 in the tube portion 1061 and a distally located retention feature comprising a ledge1070, having a structure similar to ledge 970. The ledge 1070 is disposed generally opposite the opening 1063 on the circumference of the tube portion 1061 . The arrangement of the deflectable tab 1067, the ledge 1070, and the side wall opening 1063 of the lumen insert device 1060 enables engagement with the complementary pocket and undercut features 1037, 1080 of the entry guide device 1030 in robust manner in an inserted state of an instrument in the lumen insert device 1060 so as to provide a self-locking engagement of the complementary engagement features to hold the lumen insert device 1060 in a fixed axial position and rotational orientation relative to the entry guide device 1030. Further, the side wall opening 1063 allows some lateral movement of the instrument 1024.

[0092] In the longitudinal cross-sectional view of FIG. 14A, the lumen insert device 1060 is shown in the installed state in one of the lumens 1034b of the entry guide device 1030 (a second lumen 1034a also depicted) and without an instrumentPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 inserted through the passage 1064 of the lumen insert device 1060. As illustrated, sealing is effected to prevent gas (e.g., insufflation gas) escaping through the distal opening of the lumen 1034b in this state and past or through the passage 1064 of the lumen insert device 1060 due to the instrument sealing structure 1035 comprising the septum sealing structure 1035b located in the lumen 1034b sealing against the external surface of the lumen insert device 1060 and due to the distal sealing structure 1036 with individual sealing flaps 1036a, 1036b respectively sealing the distal openings of the lumens 1034 of the entry guide device 1060.

[0093] As discussed above with reference to the embodiment of FIG. 5, the configuration of the lumen insert device 1060 permits full insertion into the lumen 1034b of the entry guide device 1030 without an instrument inserted while maintaining the ability to prevent the escape of insufflation gas due to the sealing flap 1036b remaining in the closed configuration. This in turn allows for instruments to be removed and inserted through the lumen insert device without the need to remove the lumen insert device each time an instrument is removed. In other words, the lumen insert device 1060 can remain in place in the entry guide device 1030 throughout a medical procedure and regardless of whether an instrument is currently inserted through it or not without compromising the sealing of the lumen 1034b due to the distal sealing structure flap 1036b remaining in its closed configuration.

[0094] FIG. 14B, the lumen insert device 1060 is shown in the installed state in the lumen 1034b of the entry guide device 1030 with an instrument 1024 inserted in the passage 1064 of the lumen insert device 1060 (the shaft of the instrument 1024 visible, but the end effector and proximal end force transmission mechanism not shown). As discussed above with reference to FIG. 7, the instrument 1024 prevents radially inward deflection of the deflectable tab 1067, thereby retaining the engagement of the tab 1067 in the pocket 1037 of the entry guide device 1030. Additionally, when body wall forces are exerted on the instrument 1024, it can create a reactive force that is directed radially outward at the distal end portion of the tube portion 1061 of the lumen insert device 1060 proximate the location of the ledge 1070 thereby aligning the shoulder surfaces 1071 , 1081 of the ledge 1070 and undercut 1080 so as to further prevent potential ejection of the lumen insert device 1060 from the entry guide device 1030. It should bePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 appreciated that a similar result can occur when the ledge / undercut arrangement is provided in conjunction with the tab / protrusion / recess arrangement of the embodiments of FIGs. 8 and 9.

[0095] Removal of the instrument 1020 allows for the ledge 1070 and undercut 1080 to disengage as the shoulder surfaces 1071 ,1081 move out of alignment. Further, a withdrawal (proximally directed) force on the lumen insert device 1060 can allow for the deflectable tab 1067 to deflect inwardly due to interaction with the surface of the entry guide device 1030 and disengage from the pocket 1037, allowing the lumen insert device 1060 to be removed from the installed position and the entry guide device 1030.

[0096] As discussed above with reference to FIGs. 5, 14A, and 14B, it is contemplated that the various lumen insert devices described can include an internal septum seal such as seals 565, 1065 within the passage defined by the tube portion of the lumen insert devices (e.g., within tube portions 661 , 861 , 961 , 1061 ) which can help retain a medical instrument inserted through the lumen insert device and also create a seal for insufflation gas in a state of a medical instrument inserted through the lumen insert device and being advanced past, and thereby opening, a respective sealing flap of the distal sealing device. With reference to FIG. 14B, for example, with an instrument 1024 inserted in the lumen insert device 1060 and past the distal opening of the lumen 1034b and the distal sealing flap 1036B, gas (e.g., insufflation gas) that is able to enter lumen 1034b due to opening of the sealing flap 1036b and unsealing the distal opening of the lumen 1034b is prevented from escaping as a result of the sealing mechanism 1065 sealing around the instrument 1024. Further, the septum seal 1035b continues to maintain a seal between the lumen 1034 and the insert guide device 1060. In addition, the sealing structure 1035 as a whole can prevent gas from escaping between the lumens, for example from lumen 1034b to neighboring lumen 1034a which may be open to the ambient environment.

[0097] In one embodiment, a multiple piece construction can be used for a lumen insert guide device. Such a construction can permit the seal to be replaceable and / or can facilitate manufacturing. As can be seen in FIGs. 15 and 16 (which shows the detail 16-16 in FIG. 5), a lumen insert device 1 160 can have a multipiece construction in which the funnel portion 1162 is provided with an insertable stem portion 1162’ that can be inserted into a distal tube portion 1161’ to form thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 entirety of the tube portion 1161 of the lumen insert device 1060. A sealing mechanism 1 165 (which can serve as seal 565, 1065) can fit between the two components 1 161 ’, 1 162’ as depicted in FIG. 16 and comprise an outer circumferentially extending portion 1165’ and an inner portion 1 165” that is positioned in the passage 1164 defined by the tube portion 1161 forming the septum seal that interacts with the instrument when an instrument is inserted through the passage 1164 of the lumen inert device. The portion 1 165” of seal 1 165 provides an interference fit and seals the region between the stem portion 1 162 and the distal tube portion 116T.

[0098] While various embodiments illustrated and described above with respect to the figures relate to lumen insert devices that reduce a diameter of an instrument insertion lumen of an entry guide device, it is further contemplated that lumen insert devices could be used to alter a cross-sectional shape of the instrument insertion lumen of an entry guide device as well. For example, a lumen insert guide device with a passage having a one cross-sectional shape (e.g., circular) could be fit in an entry guide device to selectively alter the configuration of the lumen of the entry guide device, which lumen may have another cross-sectional shape (e.g., elliptical) differing from the that of the passage.

[0099] The above description and the accompanying drawings that illustrate aspects and embodiments of the present inventions should not be taken as limiting — the claims define the protected inventions. Various mechanical, compositional, structural, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known structures and techniques have not been shown or described in detail to avoid obscuring the embodiments and disclosure.

[0100] 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.

[0101] Further, this description’s terminology is not intended to limit the invention. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — may 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 encompassPCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.00304 different positions (i.e., locations) and orientations (i.e. , rotational placements) of the device in use or operation in addition to the position and orientation shown in the figures. For example, if the device in the figures were 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. The device may 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 include various special device positions and orientations.

[0102] The singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context indicates otherwise. 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. Components described as coupled may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components.

[0103] 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.

[0104] 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 medical procedure enter the body via a single entry port. In some aspects, however, multiple devices and ports may be used.

Claims

PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERNATE DOCKET NO. : 1084.0248.00304CLAIMSWHAT IS CLAIMED IS:1 . A device for insertion in a lumen of an entry guide device, the device comprising: a tube portion sized to be received in the lumen of the entry guide device, the tube portion defining a passage extending from a proximal end of the tube portion to a distal end of the tube portion and configured to receive a medical instrument through the tube portion; a retention mechanism comprising one or more deflectable engagement features configured to releasably engage with one or more complementary engagement features, respectively, of the medical instrument entry guide device, wherein in an engaged state of the one or more engagement features with the one or more complementary engagement features, the device is retained in a fixed position relative to the medical instrument entry guide device, wherein the one or more engagement features are configured to be in the undeflected state on a condition of the one or more engagement feature in an engaged state with the one or more complementary engagement features, and wherein the one or more engagement features are configured to deflect and disengage from the one or more complementary engagement features in response to sufficient force exerted on the one or more engagement features.

2. The device of claim 1 , further comprising a septum seal in the passage.

3. The device of claim 1 , further comprising a funnel portion at a proximal end portion of the device, wherein the tube portion extends distally from the funnel portion.

4. The device of any of claims 1-3, wherein the one or more deflectable engagement features comprise a pair of deflectable engagement features disposed diametrically opposite each other and configured to engage a pair of complementary engagement features of the medical instrument entry guide device.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.003045. The device of claim 4, wherein each of the pair of deflectable engagement features comprise a deflectable tab comprising a protrusion on a free end of the tab.

6. The device of claim 5, wherein the complementary engagement features are recesses and the protrusions are configured to engage respectively with the recesses.

7. The device of claim 6, wherein the protrusions snap fit with the recesses.

8. The device of claim 5, further comprising: a funnel portion at a proximal end portion of the device, wherein the tube portion extends distally from the funnel portion, and wherein the deflectable tabs are formed in an outer surface of the funnel portion.

9. The device of claim 5, further comprising a ledge defining a shoulder on an outer surface of the tube portion at a distal end portion of the tube portion, wherein the shoulder of the ledge is configured to engage with a complementary shoulder of an undercut feature on an interior surface of the lumen of the medical instrument entry guide device.

10. The device of any of claims 1-3, further comprising a ledge defining a shoulder on an outer surface of the tube portion at a distal end portion of the tube portion, wherein the shoulder of the ledge is configured to engage with a complementary shoulder of an undercut feature on an interior surface of the lumen of the medical instrument entry guide device.1 1 . The device of any of claims 1 -3, wherein the passage of the tube portion is configured to receive a medical instrument in a position so as to prevent deflection of the one or more deflectable engagement features by an amount sufficient to disengage with the one or more complementary engagement feature.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.0030412. The device of claim 11 , wherein the one or more deflectable engagement features are deflectable radially inward.

13. The device of any of claims 1-3, wherein the one or more deflectable engagement features is one or more deflectable tabs protruding radially outward relative to the tube portion.

14. The device of claim 13, wherein the one or more deflectable tabs have a triangular cross-section in a cross-section taken longitudinally through the device.

15. The device of claim 13, further comprising: a funnel portion at a proximal end portion of the device, wherein the tube portion extends distally from the funnel portion, and wherein the one or more deflectable tabs are at a location where the tube portion meets the funnel portion.

16. The device of claim 15, wherein a cut out at least partially surrounds each of the one or more deflectable tabs.

17. The device of claim 15, wherein in a longitudinal cross-section the one or more deflectable tabs have two angled surfaces extending radially outward from the device and meeting at a rounded tip.

18. The device of claim 17, wherein: a first angled surface of the two angled surfaces extends from the tube portion toward a proximal end of the tube portion, and a second angled surface of the two angled surfaces extends from the tube portion toward a distal end of the tube portion.

19. The device of claim 18, wherein: the first angled surface is angled in a range of about 20 degrees to about 60 degrees relative to a longitudinal axis of the tube portion, and the second angled surface is angled in a range of about 20 degrees to about 60 degrees relative to the longitudinal axis of the tube portion.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WOALTERN TE DOCKET NO. : 1084.0248.0030420. The device of claim 13, wherein the one or more complementary engagement features comprise one or more pockets configured to receive and mate with the one or more deflectable tabs.21 . A system for insertion of a medical instrument through an opening in a body, the system comprising: an entry guide device comprising: a lumen configured to permit insertion of a medical instrument, and one or more complementary engagement features in the lumen; and a lumen insert device configured to be releasably installed in the entry guide device, the lumen insert device comprising: a tube portion sized to be received in the lumen of the entry guide device, the tube portion defining an passage extending from a proximal end of the tube portion to a distal end of the tube portion and configured to receive a medical instrument; a retention mechanism comprising one or more deflectable engagement features configured to releasably engage with the one or more complementary engagement features of the entry guide device, wherein in an engaged state of the one or more deflectable engagement features with the one or more complementary engagement features of the entry guide device, the lumen insert device is retained in a fixed position relative to the entry guide device, wherein the one or more deflectable engagement features are configured to be in the undeflected state on a condition of the one or more deflectable engagement features in an engaged state with the one or more complementary engagement features of the entry guide device, and wherein the one or more deflectable engagement features are configured to deflect and disengage from the one or more complementary engagement features of the entry guide device in response to sufficient force exerted on the one or more deflectable engagement features so as to deflect the engagement features.PCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.0030422. The system of claim 21 , wherein the deflectable engagement features are configured to provide one or both of an audible or a tactile feedback in response from moving from a deflected state to an undeflected state into engagement with the complementary engagement features of the entry guide device.

23. The system of claim 21 , wherein, in the engaged state of the deflectable engagement features and the complementary engagement features, the sufficient force to deflect the engagement features is above a threshold level providing feedback to a user of secure engagement of the lumen insert device with the entry guide device.

24. A system for insertion of a medical instrument through an opening in a body, the system comprising: an entry guide device comprising: a lumen configured to permit insertion of a medical instrument, and one or more complementary engagement features in the lumen; and a device according to any of claims 1-20.

25. A method of inserting a medical instrument through an opening in a body, the method comprising: positioning an entry guide device relative to an opening in a body, the entry guide device comprising one or more lumens configured to receive respective medical instruments for insertion into the opening of a body; inserting a tube portion of a lumen insert device into one of the one or more lumens of the entry guide device, wherein the tube portion defines a passage for insertion of a medical instrument; engaging one or more deflectable engagement features on the lumen insert device with one or more complementary engagement features in the lumen of the entry guide device; and inserting a medical instrument through the passage of the lumen insert device such that a shaft of the medical instrument is in a position to prevent deflection of the one or more deflectable engagement features and thereby retain thePCT APPLICATIONATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304 one or more deflectable engagement features and the one or more complementary engagement features in an engaged state.

26. The method of claim 25, wherein engagement of the one or more deflectable engagement features and the complementary engagement features is sufficient to resist movement of the lumen insert device relative to the lumen of the entry guide device in response to force exerted by movement of the medical instrument.

27. The method of claim 25 or 26, further comprising engaging a shoulder of a ledge on an external surface of the tube portion of the lumen insert device with a complementary shoulder of an undercut on an internal surface of the lumen of the entry guide device.

28. The method of claim 27, wherein the ledge and the undercut are provided at distal portions of the tube portion of the lumen insert device and lumen of the entry guide device, respectively.

29. The method of claim 28, wherein the engaging of the shoulder and the complementary shoulder prevents withdrawal of the lumen insert device from the entry guide device in response to force caused by movement of the medical instrument.

30. The method of claim 25 or 26, inserting the medical instrument through the passage of the tube portion comprises engaging an outer surface of the shaft of the medical instrument with a septum seal located in the tube portion.31 . The method of claim 25 or 26, wherein engaging one or more deflectable engagement features on the lumen insert device with one or more complementary engagement features in the lumen of the entry guide device comprises engaging one or more protruding tabs on the lumen insert device with one or more pockets on the entry guide device.

32. The method of claim 25 or 26, wherein engaging one or more deflectable engagement features on the lumen insert device with one or more complementaryPCT APPLICATION ATTORNEY DOCKET NO. : P06814-WO ALTERN TE DOCKET NO. : 1084.0248.00304 engagement features in the lumen of the entry guide device comprises engaging one or more protrusions on a deflectable tab of the lumen insert device with one or more recesses on the entry guide device.

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