Insertion and access devices for surgical systems

Abstract

Systems, devices, and / or methods for providing access to an infused lumen of a patient and / or positioning a surgical system or device into the lumen during a surgical procedure, related to surgical procedures, and more particularly, to systems, devices, and / or methods for providing access to and / or positioning the surgical system or device into the lumen. The access and insertion device is configured to couple with sealing devices such as sealable sleeve devices and wound retractor devices. The access and insertion device is configured to provide a fluid seal around a portion of the surgical device during a surgical procedure.

Description

[0001] Related Applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 384,502, filed on November 21, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] Various embodiments herein relate to those related to surgery, and more particularly, systems, devices, and / or methods for accessing a insufflation cavity of a patient and / or positioning a surgical system or device into such a cavity of the patient. Background Art

[0004] Invasive surgery is essential for addressing various medical conditions. Where possible, minimally invasive surgery (such as laparoscopy) is preferred.

[0005] However, known minimally invasive techniques (such as laparoscopy) are limited in both scope and complexity, in part due to: (1) restricted movement due to the use of rigid tools inserted through access ports, and (2) limited visual feedback. Additionally, these techniques are limited due to the difficulties associated with maintaining access to the cavity while also maintaining insufflation of the surgical cavity. There is a need in the art for improved surgical methods, systems, and devices. Summary of the Invention

[0006] Various surgical access and insertion devices and methods are discussed herein. Some of the embodiments described herein build on the concepts disclosed in U.S. Published Patent No. 2021 / 0244439, the relevant portions of which are hereby incorporated by reference.

[0007] In some embodiments of the present disclosure, a surgical insertion device includes a flexible cannula that defines a cannula lumen; a top cap that is coupled to a proximal end of the cannula; and an incision port that is removably coupled to a distal end of the cannula, the incision port being operably coupled to a first fluid seal assembly configured to maintain a fluid seal at the distal end of the cannula. The cannula is sized to receive a surgical device within the lumen of the cannula. The top cap includes a lumen defined in the top cap and a flexible seal having an opening formed therein, wherein the lumen is configured to receive a device body of the surgical device that slidably passes through the opening formed in the flexible seal. The flexible seal of the top cap may be formed of a silicone material and / or may include a wavy or sinusoidal cross-section such that the flexible seal conforms to an outer surface of the device body of the surgical device. Thereby, the flexible seal may include a second fluid seal assembly that forms a fluid seal around the device body of the surgical device at the proximal end of the cannula while allowing relative slidable movement between the device body and the flexible seal.

[0008] In some embodiments, the first fluid seal assembly of the incision port may include a sealable sleeve device or a wound retractor seal device. In some embodiments, the first fluid seal assembly is a wound retractor seal configured to be coupled to the incision port by being flexibly disposed within at least two inwardly directed radial tabs formed in a distal portion of the incision port. In some embodiments, one or more of the inwardly directed radial tabs may include a rotatable latch. In some embodiments, the first fluid seal assembly is a wound retractor seal configured to be coupled to the incision port by being flexibly disposed around an outer portion of a plurality of barbs or tabs formed at an outer side portion of the incision port. In some embodiments, the plurality of barbs or tabs extend downwardly from a portion of the incision port and are configured to radially inwardly flex or bend such that an upper loop portion of the wound retractor seal is coupled to the outer portion of the barb / tab.

[0009] In some embodiments, a surgical insertion device according to the present disclosure may include an iris or port seal in an upper portion of the incision port. See, for example: https: / / www.sciencedirect.com / science / article / pii / S0015028204000135, which describes a "Lap Disk", an iris (or aperture or lens) type sealing mechanism and opening actuated (such as opened or closed) by a rotational actuation mechanism. For example, the iris sealing mechanism may include a rotatable ratchet closing function. In some embodiments, a surgical insertion device according to the present disclosure may include a insufflation port fluidly coupled to the incision port; in certain cases, the insufflation port may be coupled to the incision port below the level of the iris seal (e.g., distal to the iris seal) and above the level of the wound retractor (e.g., distal to the wound retractor).

[0010] In some embodiments, provided herein is a guide used in combination with a surgical access or insertion device. For example, the guide may include a pair of downwardly extending guide legs configured to be positioned within an opening, such as in a top cap seal, and may move apart after being positioned within the opening of the top cap seal. In some embodiments of the present disclosure, a pair of relatively long guide legs may be flexibly coupled together at an upper portion and biased toward a separated configuration; use thereof may involve, for example, pressing the legs together (by a surgeon or other healthcare practitioner) prior to insertion into the top cap opening. In some embodiments of the present disclosure, a pair of guide legs may include separate components, each having a tab or protrusion formed thereon such that the tab or protrusion is configured to engage within a slot or receiver portion of a top ring of the insertion device, thereby holding the top cap opening in a more fully opened position, e.g., after the legs have been placed within the top cap opening. In still other embodiments, a pair of guide legs may be pivotally coupled together at a pivot joint, with a handle portion associated with each guide leg such that the legs and the handle portion are operated in a manner similar to that of scissors. That is, after placing the guide legs within the top cap opening, the guide legs may be moved apart (e.g., radially outward) toward a separated configuration by, for example, moving the handle portions toward each other ( "squeezing" them together).

[0011] In some embodiments, a trocar-type alternative wound attachment may be alternatively employed at the incision site of a patient instead of using a wound retractor or a sealable sleeve device coupled to the incision port of a surgical insertion device. For example, the trocar-type alternative wound attachment may be configured to be coupled to a lower portion of a flexible cannula, such as to thereby form an alternative surgical insertion device according to certain embodiments of the present disclosure.

[0012] In another embodiment of the present disclosure, a surgical insertion device includes a flexible cannula that defines a cannula lumen; a top cap that is coupled to the proximal end of the cannula; and an incision port that is removably coupled to the distal end of the cannula, the incision port including a first fluid seal assembly configured to maintain a fluid seal at the distal end of the cannula. The cannula is sized to receive a surgical device within the lumen. The top cap includes at least one lumen defined in the top cap, wherein the at least one lumen is configured to receive a device body of a surgical device that is slidably disposed therethrough. The at least one lumen of the top cap may include a second fluid seal assembly shaped to conform to an outer surface of the device body, the second fluid seal assembly being rotatably disposed within the top cap such that the surgical device rotates relative to the top cap while maintaining a fluid seal around the device body of the surgical device at the proximal end of the cannula.

[0013] In some embodiments of the present disclosure, the flexible cannula of the surgical insertion device has a conical shape. In some embodiments of the present disclosure, the flexible cannula of the surgical insertion device facilitates tilting of the surgical device disposed within the flexible cannula in any direction. In some embodiments of the present disclosure, the distal end of the flexible cannula is configured to be removably coupled to the incision port by an adapter clamp configured for single-handed operation. In some embodiments of the present disclosure, the adapter clamp further includes a pressure relief valve.

[0014] Although multiple embodiments are disclosed, other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description and the accompanying drawings that illustrate and describe illustrative embodiments of the present disclosure. As will be recognized, the devices and / or methods described herein are capable of all modifications in various obvious aspects without departing from the nature and scope of the present disclosure. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a top perspective view of a system or device for positioning a surgical system or device into a body cavity of a patient according to some embodiments;

[0016] Figure 2A is a bottom perspective view of an incision port portion of a system or device for positioning a surgical system or device into a body cavity of a patient according to some embodiments;

[0017] Figure 2B and 2CBottom perspective view of an alternative incision port portion of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments;

[0018] Figure 3A Bottom perspective view of another alternative incision port portion of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments;

[0019] Figure 3B Is Figure 3A Partial cross-sectional perspective view of an incision port portion of;

[0020] Figure 4A Top perspective view of an incision port portion of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments;

[0021] Figure 4B Shows Figure 4A Partial cross-sectional view showing an exemplary arrangement of components of an incision port portion of;

[0022] Figure 5A Top perspective view of an incision port portion of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments, showing various aspects of a flexible seal arrangement;

[0023] Figure 5B Is according to some embodiments Figure 5A Side cross-sectional view of an incision port portion of, showing additional aspects of a flexible seal arrangement;

[0024] Figure 5C Is according to some embodiments Figure 5A And 5B Enlarged partial side cross-sectional view of an incision port portion of and, showing additional aspects of a flexible seal arrangement;

[0025] Figure 5D And 5E Top perspective view of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments of the present disclosure, showing views of a flexible seal arrangement in open and closed configurations, respectively;

[0026] Figure 6A Top perspective view of a system or device for positioning a surgical system or device into a body cavity of a patient, according to some embodiments of the present disclosure, showing views of a flexible seal arrangement in open and closed configurations, respectively;

[0027] Figure 6B Is Figure 6APartial cross-sectional side view of a system or device;

[0028] Figure 7A Is a top perspective view of a top cover portion and a top cover seal of an exemplary system or device for positioning a surgical system or device into a patient's body cavity according to some embodiments of the present disclosure;

[0029] Figure 7B Is Figure 7A Cross-sectional side view of the top cover and the top cover seal portion;

[0030] Figure 8A And 8B Is a top perspective view of an embodiment of a guide for facilitating the insertion of a surgical device through a top cover seal of a system or device according to some embodiments of the present disclosure;

[0031] Figure 9A And 9B Are top perspective and schematic cross-sectional views respectively showing alternative embodiments of a guide for facilitating the insertion of a surgical device through a top cover seal of a system or device according to some embodiments of the present disclosure;

[0032] Figure 10A And 10B Is a top perspective view of another alternative embodiment of a guide for facilitating the insertion of a surgical device through a top cover seal of a system or device according to some embodiments of the present disclosure;

[0033] Figure 11A Is a perspective view of an external pressurization system or device for positioning a surgical system or device into a patient's cavity according to some alternative embodiments;

[0034] Figure 11B Is according to Figure 11A Cross-sectional view of an external pressurization system or device according to an embodiment, the external pressurization system or device including an incision port containing a sealable sleeve device;

[0035] Figure 12A And 12B Is Figure 11A Perspective view of an external pressurization system or device, which shows the rotation of a surgical system or device within the external pressurization system or device from a first position to a second position;

[0036] Figure 13A Is a top view of a top cover according to an embodiment;

[0037] Figure 13B Is Figure 13A Perspective view of the top cover;

[0038] Figure 13C IsFigure 13A Cross-sectional view of the top cover of

[0039] Figure 14 is according to one embodiment Figure 11A Side view of an external pressurization system or device of , showing a surgical system or device tilted within the external pressurization system or device;

[0040] Figure 15A is according to one embodiment Figure 11A Partially exploded perspective view of the tank and adapter clamp of an external pressurization system or device of ;

[0041] Figure 15B is according to one embodiment Figure 11A Partially side cross-sectional view of the tank and adapter clamp of an external pressurization system or device of ;

[0042] Figure 15C is according to one embodiment Figure 11A Cross-sectional view of the tank and top cover of an external pressurization system or device of ;

[0043] Figure 16A is according to one embodiment Figure 11A Side view of an external pressurization system or device of ;

[0044] Figure 16B is according to one embodiment Figure 16A Enlarged side view of an external pressurization system or device of with a decompressed adapter clamp; and

[0045] Figure 17A and 17B are respectively a cross-sectional side view and an exploded side view of an alternative wound attachment assembly for use with the external pressurization system or device of the present disclosure according to an alternative embodiment. Detailed Description

[0046] The various embodiments described herein relate to systems, devices, and / or methods for accessing a patient's insufflation cavity and / or positioning a surgical system or device into such a cavity of the patient. This disclosure builds on the devices, methods, and systems described in U.S. Published Patent No. 2021 / 0244439, the relevant portions of which are hereby incorporated by reference.

[0047] Certain embodiments provide for inserting a surgical system / device into a patient's cavity while maintaining adequate insufflation of the body cavity. For example, some embodiments reduce the complexity of the access / insertion procedure and / or facilitate the steps required to perform the procedure. Other embodiments relate to devices having a minimal profile, minimal size, or generally minimal in both function and appearance to enhance the convenience of handling and use.

[0048] One exemplary embodiment of the present disclosure relates to an external pressurization system or device. For example, Figure 1 One embodiment of an external pressurization system or device 110 is depicted in. Device 110 includes a cannula 112 having a top cap 114 coupled to the top portion 113 of the cannula 112. In this embodiment, the device 110 includes an incision port 118 that is coupled to the cannula 112 at the base portion 115 of the cannula 112. The incision port 118 is configured to be positioned within an incision 158 formed in the patient's skin 122, thereby providing access to the patient's body cavity 124. As Figure 1 shown, the top cap 114 of the device 110 may include a top cap seal portion 130 and a top cap lumen or opening 134 formed therein. According to some embodiments, the top cap lumen 134 may be configured to receive a portion of a surgical device ( Figure 1 not shown in) to facilitate insertion of the surgical device through the device 110 and through the incision port 118 into the patient's body cavity 124.

[0049] Continuing to refer to Figure 1 , according to some embodiments, the external pressurization device 110 may be used to enable a surgical device (e.g., a robotic surgical device having one or more robotic arms coupled thereto) to enter and / or be positioned within the patient's body cavity 124 for use. For example, it may be desirable to position a robotic surgical device (see, for example Figure 11A , a robotic surgical device 26 having one or more end effectors 33 disposed at its distal end is shown in the figure, as depicted, for use with an alternative embodiment of the access and insertion device 10 of the present disclosure) within the patient's body cavity 124 (e.g., the peritoneum) in order to perform minimally invasive surgery within the body cavity 124. In such a procedure, it is typically desirable to insufflate the body cavity 124 with an insufflation gas such as carbon dioxide in order to create a working space within the body cavity 124. The insufflation gas may be provided to the body cavity 124 at a predetermined pressure to provide the desired amount of working space for the surgery, while taking care not to overpressurize the body cavity 124. It may be desirable to maintain the insufflation pressure within a certain range; thus, it may also be desirable to selectively seal and / or open the access to the body cavity 124 through the incision port 118 to maintain the desired insufflation pressure.

[0050] As described above, the incision port 118 can be placed in an incision 158 in the patient's skin 122 to form a seal in the area surrounding the incision 158 to fluid-tightly seal the patient's body cavity 124 relative to the ambient air outside the patient. For example, an incision 158 can be formed in the patient's skin 122 to provide access to the patient's body cavity 124, which in some embodiments can be the peritoneal cavity, but can also be any known body cavity. Once the incision 158 is formed, a fluid-sealing element (such as a wound retractor seal or a sealable sleeve device ( Figure 1 not shown in)) can be positioned in the incision 158. An example of a commercially available wound retractor seal that can work well with embodiments of the device 110 described herein is the SURGISLEEVE distributed by Medtronic, Inc. TM Wound Protector. Another example of a "standard" sealable sleeve device that can work well with certain embodiments described herein is a commercially available retractor port, such as the retractor available from Ethicon Endo-Surgery. The wound retractor or sealable sleeve device can be positioned through the incision 158, for example, by inserting the lower ring of the wound retractor seal through the incision such that the lower ring (or lower sleeve ring) is positioned within the patient's body cavity 124 and the upper ring (or upper sleeve ring) is positioned outside the patient, with the flexible sleeve portion extending through the incision 158. In some cases, the upper sleeve ring and / or lower sleeve ring of the wound retractor or sealable sleeve device is a flexible ring that can be deformed, for example, to facilitate insertion through the incision 158 and / or to facilitate attachment to the incision port 118.

[0051] Figure 2A A partial bottom perspective view of the access device 110 according to some embodiments is shown. In the depicted embodiment, the lower portion of the incision port 118 includes a number of shoulder or shelf portions 156 radially disposed around the periphery of the inner cavity formed within the incision port 118. Figure 2A The embodiment of shows three such shoulders 156 disposed around the inner cavity of the incision port 118; however, those of ordinary skill in the art will readily recognize that more or fewer shoulders 156 can be employed to achieve a similar effect. Each shoulder 156 extends downwardly and radially inwardly (e.g., from the lower ring 116 of the incision port 118) to form a "shelf" on or to which the upper sleeve ring 146A of the wound retractor can be located or attached. (Note: For clarity, Figure 2A–2C only shows the upper sleeve ring 146A of the wound retractor). For example, the upper sleeve ring 146A of the wound retractor can be flexed and / or bent as needed to position the upper part of the wound retractor in the shoulder 156 and thereby couple the wound retractor to the incision port 118 of the device 110.

[0052] Figure 2B and 2C shows Figure 2A a variation of the embodiment depicted in. In Figure 2B and 2C the depicted embodiment, one or more of the shoulders in the shoulder 156 are replaced by a pivotable latch 157 (as shown in Figure 2C that can be rotated to one side) to facilitate placing the upper ring 146A of the wound retractor in engagement with the inner portion of the incision port 118, and then the pivotable latch 157 can be rotated back into place (as shown in Figure 2B to hold the upper ring 146A in place (e.g., engaged with the incision port 118). In some embodiments, the pivotable latch 157 rotates about a pivot point formed in the lower ring 116 of the incision port 118. In some embodiments, it may be desirable to bias the pivotable latch 157 toward one position or the other, e.g., the pivotable latch 157 can be spring-biased toward the Figure 2B engagement position.

[0053] Figure 3A shows a partial bottom perspective view of the access device 110 according to some embodiments. In the depicted embodiment, the lower portion of the incision port 118 includes a plurality of barbs or tab portions 159 that are disposed around the periphery of the lumen formed within the incision port 118 and that extend downward from a portion of the incision port 118. In some embodiments, as shown in Figure 3B the plurality of tabs 159 can extend downward from a common ring 159A and can be either integrally formed with the common ring 159A or separately coupled to the common ring 159A. As indicated in Figure 3B a series of gaps or spaces 159B can be formed between adjacent tabs 159. In this way, the spacing of the adjacent tabs 159 can provide a degree of radial flexibility such that the upper ring 146A of the wound retractor can be coupled around the outer surface of the tabs 159 by radially inwardly flexing or bending one or more of the plurality of tabs 159, thereby positioning the upper ring 146A around the tabs 159. Once placed, the flexed tabs 159 (e.g., radially outward) are allowed to flex back to their normal / rest position such that the inner surface of the upper ring 146A lies on and / or is coupled to the outer surface of the plurality of tabs 159, substantially as shown in Figure 3B ).

[0054] Also as Figure 3A and 3B shown, the removal tab 140 is configured to facilitate removal of the wound retractor from the incision port 118. The removal tab 140 accomplishes this by pulling outwardly on the upper loop 146A of the wound retractor while simultaneously pushing inwardly on one or more of the tabs in tab 159. In some embodiments, for example, removal of the wound retractor from the incision port 118 can be further facilitated by tilting and / or pulling device 110 in a direction generally opposite to the direction of pushing and holding the removal tab. Figure 3A Also shown is a insufflation port 142 that can be included as part of the access device 110; the insufflation port 142 will be described in more detail below.

[0055] Figure 4A is an enlarged perspective view of a portion of an exemplary access device 110 having an insufflation port 142, the insufflation port being coupled to the incision port 118 of the device 110. Figure 4B A cross-sectional side view of the incision port 118 is provided, which shows the arrangement and / or placement of the insufflation port 142 relative to the components of the incision port 118. Figure 4A and 4B both show a valve 143 that is disposed on the insufflation port 142 to control, for example, the flow of air from an air source. In some cases, the valve 143 is a two-way stopcock valve 143 that is coupled to the outer end of the insufflation port 142. As Figure 4B detailed, the insufflation port 142 is configured to supply air or gas from a supply source (not shown) to the interior portion of the incision port 118. As shown, the insufflation port 142 is configured to fluidly couple an air supply (or other gas source) at a level in the incision port 118 that is above the level of the wound retractor or the sealable sleeve device. It should also be noted that the insufflation port 142 is configured to fluidly couple an air supply (or other gas source) at a level in the incision port 118 that is below the level of the "iris" seal mechanism disposed in the incision port 118. As Figure 4B seen, the insufflation port 142 is fluidly coupled to a lumen or cavity within the incision port 118 that is below the selectively sealable iris opening 148C. The iris seal mechanism includes a lower iris ring 148B and an upper iris ring 148A; the operation of the iris seal mechanism to selectively open and close the iris opening 148C will be described in more detail below.

[0056] Figures 5A - 5C shows an exemplary arrangement of the various components of the incision port 118, including the components that can form the iris seal mechanism mentioned above. For example, Figure 5Ais a partial top perspective view of the access device 110, with certain portions of the access device depicted in transparent outline to show the ratchet ring 150 disposed within the incision port 118. The iris seal mechanism operates to selectively open and close the iris opening 148C by rotation of the upper iris ring 148A relative to the lower iris ring 148B. The ratchet mechanism of the ratchet ring 150 can operate to help prevent the accidental opening of the iris opening 148C; that is, rotation of the upper iris ring 148A relative to the lower iris ring 148B in one direction (e.g., clockwise) operates to close the iris opening 148C, while rotation in the opposite direction (e.g., counterclockwise) (if not prevented by the ratchet mechanism of the ratchet ring 150) would operate to open the iris opening 148C. For example, a slider mechanism 149 can be employed to provide a release of the "override" ratchet mechanism and thereby enable the opening of the iris opening 148C when the slider mechanism 149 is actuated simultaneously with counterclockwise rotation of the upper iris ring 148A and the lower iris ring 148B relative to each other.

[0057] Figure 5B is a cross-sectional side view of the elements of the iris seal mechanism described above. Figure 5C is an enlarged partial cross-sectional side view that shows additional details of the arrangement of components associated with the iris seal mechanism. For example, in Figure 5C , a flexible seal material 151 is shown, which is disposed on a portion of the upper iris ring 148A such that it opens and closes with the operation of the iris seal mechanism and forms a fluid seal when closed. The flexible seal material 151 is shown extending around the upper and lower surfaces of the upper iris ring 148 and is held in place by press-fit beads 152 that mechanically engage within channels formed in both the upper iris ring 148A and the lower iris ring 148B as shown.

[0058] Figure 5D and 5E is a top perspective view of the access device 110 with the iris seal mechanism, which shows what the iris opening 148C and the upper iris ring 148A would look like when the iris seal mechanism is in the open position ( Figure 5D ), and shows what the upper iris ring 148A might look like when the iris seal mechanism is in the closed position ( Figure 5E ).

[0059] Figure 6AIs a top perspective view of the access device 110 according to some embodiments of the present disclosure, the access device 110 including a top cap 114, a cannula 112, and an incision port 118. The top cap 114 is coupled to an upper portion of the cannula 112 and includes a top cap seal portion 130 disposed across an upper surface of the top cap 114. The top cap seal portion 130 has a top cap lumen or opening 134 formed therein. As previously described, the top cap lumen 134 can be configured to receive a portion of a surgical device ( Figure 6A not shown in) to facilitate insertion of the surgical device through the device 110 into a patient's body cavity, the surgical device being configured to pass through the top cap 114, through the cannula 112, and through the incision port 118 during a surgical procedure to, for example, gain access to the body cavity. The top cap seal portion 130 and the top cap opening 134 are formed to provide a fluid seal around a portion of the surgical device as the surgical device slidably moves through the top cap opening and / or as the surgical device is moved relative to the top cap seal portion 130.

[0060] Figure 6B Is Figure 6A A cross-sectional side view of the device 110 of, which shows details of an exemplary top cap seal portion 130 and opening 134 that can be used with the device 110 according to some embodiments. For example, in some embodiments, the cannula 112 can be formed from a TPU film stock. In some embodiments, the cannula 112 may have a relatively long length or height, which may be desirable to allow the cannula 112 to undergo a certain amount of rotation or torsion during movement and positioning of the surgical device inserted therein. In Figure 6B it is also noted that the wall material of the cannula 112 can be held in place at the upper and lower portions by, for example, a crimp bead formed in a lower portion of the top cap 114 and / or in a ring of the incision port 118.

[0061] Figure 7A And 7B Are enlarged views (top perspective view and cross-sectional side view, respectively) of the top cap 114 of the device 110, showing additional structural details that may be associated with the top cap seal 130 and / or the opening 134. For example, Figure 7BShows a cross-section of a top cover seal 130 having a wavy or sinusoidal shape between the outer perimeter of the seal 130 and the opening 134. The seal 130 can be formed of silicone; in some embodiments, the silicone will maintain a seal around the surgical device body even if the device body translates and / or rotates relative to the seal 130 and the seal opening 134. In some embodiments, the silicone of the seal 130 can comprise a molded silicone having a hardness of 00 - 50. In some additional embodiments, a parylene-C coating on the silicone of the seal 130 can provide a lubricious coating such that additional lubricant may not be required to maintain a slidable relationship between the seal 130 and the portion of the surgical device in which it is disposed. The wavy or sinusoidal cross-sectional shape and / or the silicone material may contribute to the ability of the seal 130 to maintain a fluid seal during such translational and / or rotational movement of the surgical device relative to the seal 130 and to maintain a fluid seal even when the surgical device does not have a matching circular or round cross-sectional shape. In some cases, the outer surface of the surgical device may, for example, comprise a D-shaped cross-section, but in some embodiments according to the present disclosure, the generally circular shape of the opening 134 will compress and conform to the surgical device body to maintain a fluid seal.

[0062] Figure 7B Also shown is that the shape of the lower top cover ring 160 is configured (e.g., recessed) to receive the outer portion of the top cover seal 130 disposed therein. The upper top cover ring 162 is disposed as Figure 7B shown to hold the positioning of the top cover seal 130 across the top cover 114. Additionally, in some embodiments, the lower top cover ring 160 can have a lower recess formed in its lower portion to facilitate placement and retention of the top portion of the cannister 112 by a press-fit bead 152 arrangement generally as Figure 7B shown.

[0063] One or more guide devices can be used in conjunction with the access and insertion device 110 of the present disclosure to facilitate placement of the surgical device into a slidable fluid-tight engagement with the top cover seal 130 of the top cover 114 of the device 110. Figure 8A and 8B An example of a guide for this purpose is shown. Figure 8A The guide 170 shown in is in a relaxed or expanded configuration and has a pair of legs 171 extending downwardly from a generally horizontal or flat top portion 173. Figure 8BIllustrated is a situation where the introducer 170 is prepared to keep the opening 134 of the seal 130 open. For example, a user can "pinch" a pair of legs 171 together and hold them while pushing them down into the opening 134. When sufficiently positioned within the opening 134, the user can release the legs 171, allowing them to expand outward to their normal configuration, thereby keeping the opening 134 open to facilitate placement and / or positioning of a portion of a surgical device through the opening. In some embodiments, a series of textures or ribs 172 can be disposed on the outer surface of the legs 171 to prevent the introducer from sliding upward and / or out of the opening 134 during use. Once the surgical device is properly placed within the opening 134 of the seal 130, the introducer 170 can be removed from the top cover opening 134 by pulling upward and / or outward on the flat top portion 173 of the introducer 170.

[0064] Figure 9A and 9B Shows the design and use of another introducer embodiment that can be employed with the device 110. As Figure 9A and 9B shown, a pair of introducers 174 can be used to keep the opening 134 open for insertion of a surgical device. As Figure 9B shown, each introducer 174 has legs 175 that extend downward for placement in the opening 134, and tabs 176 that extend downward and are configured to mate with and / or be located within slots or notches 177 formed in the outer portion of the top cover 114 when the introducers 174 are sufficiently spread apart. Once the surgical device is properly placed within the opening 134 of the seal 130, the introducers 174 can be removed by pulling upward and / or outward on the top portions of the introducers 174.

[0065] Figure 10A and 10B Illustrates another alternative introducer embodiment that can be employed with the device 110 to position a surgical device in a sealed arrangement with the top cover 114 of the device 110. As Figure 10A shown, the scissor introducer 180 can include two similar halves 181 that are pivotally coupled to each other at a pivot joint 183. Each half 181 includes a leg portion 182 and a handle portion 184. In some embodiments, operating the two handle portions 184 (e.g., with one hand) causes the handle portions 184 to come together, causing the corresponding leg portions 182 to separate from each other. In use, as Figure 10AAs depicted, the legs 182 are positioned together, lowered into the opening 134, and then the actuating handle 184 is actuated to move the legs 182 outward and apart, thereby opening the opening 134 to a more fully opened position suitable for placing a surgical device within the opening 134 and / or passing it therethrough. In some embodiments, one or both handles may include a latch mechanism 185 to facilitate releasably latching or engaging the handle portions 184 together so that the opening 134 remains open during placement of the surgical device therein. Once the surgical device has been properly placed within the opening 134 of the seal 130, the guide 180 can be released and removed by disengaging the latch mechanism 185 (if used), moving the handle portions 184 apart from each other, and then pulling upward and / or outward on the guide 180 to remove the legs from the opening 134.

[0066] An alternative embodiment of the present disclosure relates to an external pressurization system or device. For example, Figure 11A and 11B One embodiment of an external pressurization system or device 10 is depicted. The device 10 has a canister 12 having a top cover 14 coupled to the top portion 13 of the canister 12. In this embodiment, the device 10 includes an incision port 18 coupled to the canister 12 at the base portion 15 of the canister 12. The incision port 18 is positioned within an incision 58 formed in the patient's skin 22, thereby providing access to the patient's body cavity 24. As Figure 11A and 11B shown, the device 10 can be configured to house a surgical device 26 such that the device 26 can be inserted into the patient cavity 24 through the device 10 and the port 18.

[0067] Continuing to refer to Figure 11A , according to some embodiments, the illustrated external pressurization device 10 can be used to enable a surgical device 26 to enter and / or be positioned within a patient's body cavity 24 for use. For example, it may be desirable to position a robotic surgical device 26 (e.g., having one or more end effectors 33 disposed at its distal end) within a patient's body cavity 24 (e.g., the peritoneum) in order to perform minimally invasive surgery within the body cavity 24. In such a procedure, it is generally desirable to insufflate the body cavity 24 with an insufflation gas such as carbon dioxide in order to create a working space within the body cavity 24. The insufflation gas can be provided to the body cavity 24 at a predetermined pressure to provide the desired amount of working space for the surgery while taking care not to over-pressurize the body cavity 24. It may be desirable to maintain the insufflation pressure within a certain range; thus, it may also be desirable to selectively seal and / or open the passageway into the body cavity 24 through the port 18 to maintain the desired insufflation pressure.

[0068] As described above, the incision port 18 can be placed in the incision 58 to form a seal in the area surrounding the incision 58 to fluid-tightly seal the patient's body cavity 24 relative to the ambient air outside the patient. For example, an incision 58 can be formed in the patient's skin 22 to provide access to the patient's body cavity 24, which in some embodiments can be the peritoneal cavity, but can also be any known cavity. Once the incision 58 is formed, the sealable sleeve device 46 (described below with reference to Figure 11B is positioned in the incision 58. An example of a "standard" sealable sleeve device 46 is a commercially available retractor port, such as the retractor available from Ethicon Endo-Surgery, Inc. The sealable sleeve device 46 can be positioned through the incision 58, for example, by inserting the lower sleeve ring 46B through the incision 58 such that the lower sleeve ring 46B is positioned within the patient's body cavity 24 and the upper sleeve ring 46A is positioned outside the patient, with the flexible sleeve 46C extending through the incision 58. According to one embodiment, the lower sleeve ring 46B of the sealable sleeve device 46 is a deformable flexible ring 46B such that it can be inserted through the incision 58.

[0069] In some embodiments, the adapter clamp 16 can be used to facilitate a relatively simple and / or quick coupling / connection between the base portion 15 of the cannula 12 and the incision port 18. Figure 11B is a cross-sectional view showing exemplary elements of the incision port 18 according to some embodiments. For example, Figure 11B shows a sealable sleeve device 46 positioned within the incision 58 and engaged with the adapter clamp 16 according to one embodiment. The upper sleeve ring 46A is shown engaged with one or more inwardly directed protrusions 56 formed on the inner portion of the adapter clamp 16. In some embodiments, according to some embodiments, there can be two or preferably three or more such protrusions or "shoulders" 56 against which and / or with which the upper sleeve rings 46A can lean and / or engage to couple the cannula 12 to the incision port 18. In some alternative embodiments, a continuous inwardly directed shoulder or shelf 56 (instead of a number of discrete protrusions) can be formed on the inner portion of the adapter clamp 16 against which the upper sleeve rings 46A can engage. Figure 11B The lower sleeve ring 46B positioned through the incision 58 and within the body cavity 24 is further shown, with the flexible sleeve 46C passing through the incision 58 to couple the upper sleeve ring 46A and the lower sleeve ring 46B together. Relative rotation of the upper sleeve ring 46A and the lower sleeve ring 46B with respect to each other can cause the flexible sleeve 46C to "tighten" and close the incision 58, and / or cause the upper sleeve ring 46A and the lower sleeve ring 46B to move closer to each other, thereby enhancing the sealing engagement of the clamp 16 with the surface of the patient's skin 22.

[0070] AsFigure 12A and 12B As shown in 12B , in some embodiments of the present disclosure, the surgical device 26 is configured to be positioned through the external pressurization device 10 (e.g., through the lumen formed in the top cap 14, through the length of the cannula 12, and through the patient's incision 58 and into the body cavity 24). In some embodiments, the external pressurization device 10 includes a rotatable seal assembly (such as the rotatable assembly 30 depicted in Figure 13A and 13B ) disposed within the top cap 14 that enables the surgical device 26 to rotate within the top cap 14 and / or the cannula 12 and relative to the top cap and / or the cannula. For example, the surgical device 26 in Figure 12A can be rotated counterclockwise by approximately 90 degrees (as shown in Figure 12B ) so as to cause the same amount of rotation or orientation change at the distal end of the surgical device 26 (e.g., at the end effector 33 disposed in the body cavity 24). Figure 13A and 13B For example, the surgical device 26 in Figure 12A can be rotated counterclockwise by approximately 90 degrees (as shown in Figure 12B ) so as to cause the same amount of rotation or orientation change at the distal end of the surgical device 26 (e.g., at the end effector 33 disposed in the body cavity 24). Figure 12A in Figure 12A Figure 12B as shown in Figure 12B

[0071] Figure 13A and 13B 13B shows an exemplary top cap 14 having a seal assembly (or "rotatable seal") 30 rotatably disposed within an inner portion of the top cap 14. For example, the seal assembly 30 can have a generally circular outer profile that is complementary and / or mating with the generally circular inner surface of the top cap 14. As is known in the art, the seal assembly 30 can be rotatably disposed within the top cap 14 by a ball bearing design. Alternatively, the rotatable seal 30 can be rotatably coupled to the top cap 14 by any known mechanism, device, or method. The seal assembly 30 has a generally flat upper surface in which a shaped lumen 34 is disposed. For example, in some embodiments, the shape of the shaped lumen 34 can be conformable to the outer surface of a portion of the surgical device 26 (e.g., the device body 27 of the robotic surgical device 26 according to some embodiments), thereby forming a seal around the aforementioned portion of the surgical device 26. More specifically, the shaped lumen 34 is substantially "D"-shaped, as best shown in Figure 13A (and as discussed in further detail below), such that the lumen 34 matches the outer cross-sectional circumferential shape of the body 27 of the surgical device 26 that can be positioned therethrough, thereby establishing a fluid seal between the device body 27 and the seal 30. Figure 13A as best shown in Figure 13A

[0072] Now referring to Figure 13C , a side cross-sectional view of the exemplary top cap 14 is shown, in which the seal assembly 30 is rotatably disposed therein by a ball bearing arrangement 31 formed in the inner surface of the top cap 14. In the specific embodiment shown, the seal assembly 30 can include a generally annular vertically extending portion 32 and a generally flat or horizontal portion 33, in which the shaped lumen 34 is formed. In Figure 13CIn the exemplary embodiment shown, the horizontal portion 33 is disposed at the upper end of the vertically extending portion 32; however, this orientation can be changed; that is, the horizontal portion 33 can be disposed at the lower end or the middle portion of the vertically extending portion 32, with a similar effect.

[0073] The seal assembly 30 is configured to rotate as the surgical device 26 rotates, thereby maintaining a conformal seal around the outer surface of the surgical device 26. In certain embodiments, this is due to the complementary shapes of the inner cavity 34 and a portion of the outer surface of the surgical device 26. For example, in Figure 13A and 13B , the inner cavity 34 is a generally "D"-shaped opening in the seal assembly 30 that corresponds to the generally "D"-shaped outer surface of the device body 27 of the surgical device 26. Of course, other suitable complementary shapes can also be selected based on the particular surgical device 26 being used. Thus, in use, when the surgical device 26 rotates about the longitudinal axis of the device body 27, the rotatable seal 30 rotates with the body 27.

[0074] In some embodiments, the seal formed by the shaped inner cavity 34 around the surgical device 26 can allow for a certain amount of slidable relative displacement of the device 26 relative to the seal 30. For example, the surgical device 26 may be able to slide vertically relative to the shaped inner cavity 34 such that the surgical device 26 can be positioned within the body cavity 24 while maintaining the seal formed by the seal assembly 30 around the surgical device 26. In some embodiments, the seal assembly 30 can further include actuation features whereby a user can selectively engage and / or disengage the seal. For example, in some embodiments, an actuator (e.g., a button or latch, not shown) can be disposed on or near the top cover 14 such that the user can operate the seal with one hand (e.g., engage and / or disengage). For example, such an actuator can act, for example, by temporarily releasing the circumferentially or radially oriented tension that exists in the seal assembly 30 during normal operation.

[0075] In some embodiments, the canister 12 of the external pressurization device 10 can be formed of a flexible material, which can thereby facilitate the positioning and / or manipulation of the surgical device 26 relative to the patient's body cavity 24, as Figure 14 shown in the exemplary embodiment depicted. For example, the canister 12 can be formed of a flexible material such as polyethylene plastic, latex, nylon, or silicone rubber. Thus, in terms of the shape of the canister 12, the canister 12 can be manipulated and is configurable, and can further be configured to be longitudinally compressed such that the height of the canister 12 can be reduced during insertion of the robotic surgical device 26 into the patient's cavity 24.

[0076] Figure 14The embodiments herein illustrate that the shape of the flexible cannula 12 can be generally conical. According to one embodiment, during compression, the conical cannula 12 can be configured to collapse or compress itself or otherwise allow the top cap 14 to move towards the incision port 18. In some embodiments, the flexibility of the material selected for the cannula 12 and / or the length or height of the cannula 12 can be such that the cannula body 12 can be tilted or bent to a certain extent in different directions to facilitate the positioning and use of the surgical device 26 passing through the cannula 12. For example, in some embodiments, the shape of the cannula 12 can be generally conical and can be formed such that the surgical device 26 passing through it can be bent or angled away from a generally vertical orientation by up to 45 degrees or more in any direction. As Figure 14 shown in the embodiments shown in

[0077] Figure 15A and 15B This may help the surgical device 26 to have greater positioning flexibility within the patient's body cavity 24. Figure 11B The embodiments shown in show an external pressurization device 10 that includes an adapter clamp 16 configured to facilitate a quick and / or easy connection / linkage between the base portion 15 of the cannula 12 and an incision port (such as

[0078] the incision port 18) of the incision 58 placed in the patient's skin 22 as shown in Figure 15A As described above, the incision port 18 can include a sealable sleeve device or a retractor port, such as a commercially available

[0079] retractor port. Figure 15A and 15B As described above, according to some embodiments, the adapter clamp 16 can include one or more inwardly directed protrusions 56 formed on the inner portion of the adapter clamp 16. Alternatively, according to some embodiments, the adapter clamp 16 can include a substantially continuous inwardly directed shoulder or shelf 56 formed on the inner portion of the adapter clamp 16. The protrusion or shelf 56 can form a mating surface on which a portion (e.g., the upper sleeve ring 46A) of the sealable sleeve device 46 is configured to be located and / or engage. In Figure 15A the embodiments shown in Figure 15BShows an enlarged cross-sectional view of the connection between the clamp 16 and the base portion 15 of the can 12. For example, the threads 54 of the clamp 16 can engage the corresponding threads of the lower sealing ring 17, as Figure 15B shown, the two threads together being configured to compress or "clamp" the outwardly extending portion of the base portion 15 of the can 12 between the upper portion of the clamp 16 and the inner portion of the lower sealing ring 17 to effect a secure engagement.

[0080] Figure 15C is a cross-sectional side view of an exemplary engagement between the top cover 14 and the top portion 13 of the can 12, showing a similar arrangement as described above with respect to the clamp 16. For example, as Figure 15C shown, complementary threads 55 formed on the outer lower surface of the top cover 14 and the inner surface of the upper sealing ring 11 can be used to fasten and thereby compress or "clamp" the outwardly extending portion of the top portion 13 of the can 12 between the lower portion of the top cover 14 and the inner lower portion of the upper sealing ring 11 to effect a secure engagement.

[0081] In some embodiments, the adapter clamp 16 can further include a pressure relief valve 62, as Figure 16A and 16B shown in the embodiments depicted. For example, the pressure relief valve 62 can be configured to release pressure that may accumulate within the can 12 and / or the body cavity 24. In some embodiments, the pressure relief valve 62 can be enabled or actuated to release the pressure generated during the advancement (e.g., downward movement) of the surgical device 26 into the external pressurizing device 10 and into the body cavity 24. During such advancement of the surgical device 26, the can 12 of the device 10 can slightly compress and / or collapse on its own, resulting in a decrease in volume and simultaneously an increase in pressure within the can 12 and / or the body cavity 24. For example, the excess pressure can be released by actuating the pressure relief valve 62 when a certain predetermined pressure relief set point is reached to avoid such an undesirable pressure increase (which may be harmful to the patient). In one embodiment, the pressure relief valve 62 can include a resilient valve that deforms to release pressure when the pressure reaches and / or exceeds a certain amount. Other forms of the pressure relief valve 62 that are considered suitable by those of ordinary skill in the art can also be used.

[0082] In use, according to one embodiment, an external pressurization device according to any embodiment herein can be positioned in a manner to perform a surgical procedure. First, in some implementations, an incision port (such as port 18) is first positioned in the incision to establish a fluid seal between the patient cavity and the external ambient air. In one embodiment, the insertion device 10 is coupled to port 18 before positioning the incision port 18 in the incision. Alternatively, port 18 is first positioned in the incision and then the insertion device 10 is coupled to port 18. In any case, once the incision port 18 and the insertion device 10 are positioned, the patient's cavity can be insufflated. In certain implementations, since a fluid communication can be created between the cavity and the interior of the insertion device 10 through the incision port 18, the entire interior of the insertion device 10 will be under the same pressure as the cavity.

[0083] According to one embodiment, once the insertion device 10 is properly positioned, the process of inserting the robotic device 26 into the insufflated cavity 24 of the patient can be performed as follows. Initially, at the start, the two arms of the robotic device 26 are parallel and perpendicular to the incision, as best shown in Figure 12A and 12B . Then, the robot 26 descends through the inner cavity 34 in the top cap 14 and through the opening created by the incision port 18. According to one embodiment, when the robotic device 26 descends such that the arms enter the patient cavity, the flexible bladder 12 of the insertion device 10 can contract in height by allowing the flexible material portion of the bladder 12 to "wrinkle" or begin to form folds, such that the top cap 14 moves closer to the incision port 18.

[0084] Figure 17A and 17B depict alternative wound attachment assemblies. For example, Figure 17A is a cross-sectional side view of an alternative wound attachment assembly 190 that can be used with any of the external pressurization access or insertion devices 110 or 10 described above to facilitate entry and / or insertion of a surgical device and / or robotic device 26 into the patient's body cavity 24 or 124. Figure 17B provides Figure 17A an exploded side view of the alternative wound attachment assembly 190. Figure 17A and 17B The device 190 depicted in will provide a seal at the patient's incision in place of the function of the incision port and / or wound retractor device discussed above. Figure 17BShows the components of this embodiment, which may include a trocar-style access device 192, a valve / seal device 194 (e.g., a duckbill or similar-style valve or seal), and an attachment ring 196 for engaging with the base portion of the access and insertion device 10 / 110 of the present disclosure. It is noted that this embodiment does not relate to a sealable sleeve device or a wound retractor seal that is part of an incision port.

[0085] Figure 17C is Figure 17A A cross-sectional side view of an alternative wound attachment assembly 190, which can be used in combination with the cannister 112 and the top cap 114 to form an alternative access and / or insertion device 210. As shown, the attachment ring 196 of the wound attachment assembly 190 is coupled to the lower portion of the cannister 112. The remainder of the cannister 112 and the top cap 114 is substantially the same as described above with reference to the access device 110. Figure 17D A top perspective view of the alternative access and / or insertion device 210 is provided, while Figure 17E is a schematic side view of the alternative access and / or insertion device 210, showing its placement through an incision 158 formed in the skin 122 so that a surgical device can access and be inserted into the patient's body cavity 124 while performing a surgical procedure therein.

[0086] It should be understood that for all the various embodiments described herein, the medical device inserted into the patient is any known medical or surgical device for performing a surgical procedure within the patient's cavity. In certain embodiments, it should be understood that the medical device is a robotic surgical device having one or two arms. In various alternatives, the robotic surgical device or system may have or use three or more arms. In additional alternatives, the device (or additional devices) may be a camera or a camera system. Still other alternatives include using "assistive" tools that can be inserted along with one or more medical devices or robotic devices.

[0087] Although the invention has been described with reference to the preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the present disclosure.

Claims

1. A surgical insertion device, comprising: (a) A flexible cannula that defines a cannula lumen, the flexible cannula being sized to receive a surgical device within the cannula lumen; (b) A top cap that is coupled to a proximal end of the flexible cannula, the top cap including a top cap housing and a top cap lumen defined within the top cap housing, wherein at least one top cap lumen is configured to receive a portion of the surgical device that is slidably disposed through at least a portion of the at least one top cap lumen; and (c) An incision port that is coupled to a distal end of the flexible cannula, the incision port including at least one downwardly extending shoulder, the at least one downwardly extending shoulder being configured to facilitate coupling an upper ring portion of a fluid seal assembly to the incision port, the fluid seal assembly being configured to provide a fluid seal at the incision port.

2. The surgical insertion device according to claim 1, wherein the at least one downwardly extending shoulder includes an inwardly facing shelf portion that is configured to support the upper ring portion of the fluid seal assembly that is located on the inwardly facing shelf portion.

3. The surgical insertion device according to claim 2, comprising at least two downwardly extending shoulders and inwardly facing shelf portions disposed around a lumen of the incision port.

4. The surgical insertion device according to claim 3, comprising three downwardly extending shoulders and inwardly facing shelf portions, the three downwardly extending shoulders and inwardly facing shelf portions being evenly spaced around the lumen of the incision port and being configured to receive the upper ring portion of the fluid seal assembly when the upper ring portion of the fluid seal assembly is flexibly positioned within the downwardly extending shoulders and inwardly facing shelf portions.

5. The surgical insertion device according to claim 3, further comprising a pivotable shoulder portion that extends from a lower portion of the incision port, wherein the pivotable shoulder portion is configured to pivot between a first insertion position for facilitating positioning of the upper ring portion of the fluid seal assembly within the lower portion of the incision port and a second engagement position for securing the upper ring portion of the fluid seal assembly to the lower portion of the incision port.

6. The surgical insertion device according to claim 5, wherein the pivotable shoulder portion is spring biased toward the second engagement position.

7. The surgical insertion device according to claim 1, wherein the at least one downwardly extending shoulder includes a plurality of circumferentially spaced tabs that are configured to support the upper ring portion of the fluid seal assembly, the upper ring portion being flexibly coupled to an outer portion of the circumferentially spaced tabs.

8. The surgical insertion device according to claim 7, wherein one or more of the circumferentially spaced tabs are configured to flex radially inwardly such that the upper ring portion of the fluid seal assembly can be positioned around the outer portion of the circumferentially spaced tabs.

9. The surgical insertion device according to claim 8, wherein the incision port further comprises at least one removal tab extending outwardly from the incision port, the at least one removal tab being configured to enable removal of the fluid seal assembly from the incision port upon actuation of the removal tab.

10. The surgical insertion device according to claim 9, wherein actuation of the removal tab comprises moving the removal tab outwardly or downwardly relative to the incision port, and wherein actuation of the removal tab pulls the upper ring portion of the fluid seal assembly away from the circumferentially spaced tabs.

11. The surgical insertion device according to claim 1, wherein the fluid seal assembly is a sealable sleeve device or a wound retractor seal device.

12. A surgical insertion device comprising: (a) a flexible cannula defining a cannula lumen, the flexible cannula sized to receive a surgical device within the cannula lumen; (b) a top cap coupled to the proximal end of the flexible cannula, the top cap including a top cap housing and a top cap lumen defined within the top cap housing, wherein at least one top cap lumen is configured to receive a portion of the surgical device slidably disposed therethrough; and (c) an incision port coupled to the distal end of the flexible cannula, the incision port including an iris seal mechanism disposed therein, the iris seal mechanism configured to selectively open and close a passage through the lumen of the incision port upon relative rotation of an upper iris assembly and a lower iris assembly.

13. The surgical insertion device according to claim 12, wherein the incision port further comprises a ratchet mechanism associated with the iris seal mechanism, the ratchet mechanism configured to allow relative rotation of the upper iris assembly and the lower iris assembly in a first direction toward closure of the iris seal mechanism.

14. The surgical insertion device according to claim 13, wherein the incision port further comprises a release mechanism associated with the iris seal mechanism, the release mechanism configured to disable the ratchet mechanism upon actuation to allow relative rotation of the upper iris assembly and the lower iris assembly in a second direction toward opening of the iris seal mechanism.

15. The surgical insertion device according to claim 12, wherein the incision port further comprises a insufflation port configured to deliver a gas supply to the lumen of the incision port.

16. The surgical insertion device according to claim 15, wherein the insufflation port is configured to deliver gas to the lumen of the incision port below the iris sealing mechanism.

17. The surgical insertion device according to claim 15, wherein the insufflation port includes a valve to selectively allow or restrict the flow of gas to the lumen of the incision port.

18. The surgical insertion device according to claim 12, wherein the top cap further includes a top cap sealing portion disposed across an upper portion of the top cap lumen, the top cap sealing portion having a top cap opening formed therein, and the top cap sealing portion having a wavy cross-sectional shape to provide flexibility.

19. The surgical insertion device according to claim 18, wherein the top cap sealing portion is formed of molded silicone having a durometer value in the range of 00 to 50.

20. The surgical insertion device according to claim 18, wherein the top cap sealing portion is formed of molded silicone and has a Parylene-C coating.

21. A guide system for a surgical insertion device, the guide system comprising: a pair of downwardly extending guide legs; and an actuating mechanism for holding the guide legs apart after inserting the guide legs into a top cap opening formed in a top cap sealing portion of a surgical insertion device, wherein the downwardly extending guide legs are configured to be removed from the top cap opening after positioning a surgical instrument through the top cap opening.

22. The guide system according to claim 21, wherein the pair of downwardly extending guide legs are flexibly coupled to each other at their upper portions and are biased to move apart when placed within the top cap opening of the top cap sealing portion.

23. The guide system according to claim 21, wherein the pair of downwardly extending guide legs further includes tabs configured to be located within a pair of corresponding slots formed in an outer portion of the top cap of the surgical insertion device.

24. The guide system according to claim 21, wherein the pair of downwardly extending guide legs are rotatably coupled together about a pivot joint, each of the guide legs having a corresponding handle portion coupled thereto, the handle portions being configured to move the guide legs apart when the handle portions are moved together after placing the guide legs within the top cap opening of the top cap sealing portion.

25. A surgical insertion device, comprising: (a) a flexible cannula defining a cannula lumen, the flexible cannula sized to receive a surgical device within the cannula lumen; (b) a top cap coupled to a proximal end of the flexible cannula, the top cap including a top cap housing and a top cap lumen defined in the top cap housing, wherein at least one top cap lumen is configured to receive a portion of the surgical device slidably disposed therethrough; and (c) A trocar wound attachment assembly, the trocar wound attachment assembly being coupled to the distal end of the flexible cannister, the trocar wound attachment assembly including a trocar entry portion, a seal portion disposed in an upper portion of the trocar entry portion, and an attachment ring for coupling the trocar wound attachment assembly to the flexible cannister of the surgical insertion device.

26. A surgical insertion device comprising: (a) A flexible cannister that defines a cannister lumen, the flexible cannister sized to receive a surgical device within the cannister lumen; (b) A top cap coupled to the proximal end of the flexible cannister, the top cap including a top cap housing and at least one top cap lumen defined in the top cap housing, wherein the at least one top cap lumen is configured to receive a portion of the surgical device slidably disposed therethrough; and (c) An incision port releasably coupled to the distal end of the flexible cannister, wherein the incision port includes a first fluid seal assembly configured to provide a fluid seal at the distal end of the flexible cannister, and wherein the at least one top cap lumen includes a second fluid seal assembly shaped to conform to an outer surface of the portion of the surgical device disposed through the top cap lumen, the second fluid seal assembly rotatably disposed within the top cap housing such that the surgical device is capable of rotating relative to the top cap housing while maintaining a fluid seal around the surgical device at the proximal end of the flexible cannister.

27. The surgical insertion device of claim 26, wherein the flexible cannister of the surgical insertion device has a conical shape.

28. The surgical insertion device of claim 26, wherein the flexible cannister of the surgical insertion device facilitates tilting of the surgical device disposed therethrough from a generally vertical orientation.

29. The surgical insertion device of claim 26, wherein the distal end of the flexible cannister is configured to be releasably coupled to the incision port by an adapter clamp configured for single-handed operation.

30. The surgical insertion device of claim 29, wherein the adapter clamp further includes a pressure relief valve.

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