Insertion and access device for a surgical system

Abstract

Systems, devices, and / or methods related to surgical procedures, and more particularly, systems, devices, and / or methods for accessing an insufflated cavity of a patient during a surgical procedure and / or for positioning a surgical system or device in an insufflated cavity. Access and insertion devices configured to couple with sealing devices such as sealing sleeve devices and wound retractor devices. Access and insertion devices configured to provide a fluid seal around a portion of a surgical device during a surgical procedure.

Description

[Technical Field]

[0001] Various embodiments herein relate to systems, devices, and / or methods related to surgical procedures, and more particularly to systems, devices, and / or methods for accessing an insufflated cavity of a patient and / or positioning a surgical system or device in such a patient cavity. [Background technology]

[0002] Invasive surgical procedures are essential to address a variety of medical conditions, and where possible, minimally invasive procedures such as laparoscopy are preferred. However, known minimally invasive techniques, such as laparoscopy, are limited in scope and complexity due, in part, to (1) restricted mobility resulting from the use of rigid tools inserted through access ports and (2) limited visual feedback. Additionally, these techniques are limited by the difficulties associated with maintaining access to the surgical cavity while simultaneously maintaining insufflation within the body cavity. There is a need in the art for improved surgical methods, systems, and devices. Summary of the Invention

[0003] Various surgical access and insertion devices and methods are discussed herein. Some of the embodiments described herein are based on concepts described in U.S. Patent Application Publication No. 2021 / 0244439, the contents of which are incorporated by reference in relevant part.

[0004] In some embodiments of the present disclosure, a surgical insertion device includes a flexible canister defining a lumen, a top cap coupled to a proximal end of the canister, and an incision port removably coupled to a distal end of the canister, the incision port operably coupled to a first fluid seal member configured to maintain a fluid seal at the distal end of the canister. The canister is sized to accommodate a surgical device in the lumen of the canister. The top cap includes a lumen defined therein and a flexible seal having an opening formed therein, the lumen configured to accommodate a device body of a surgical device slidably disposed through the opening formed in the flexible seal. The flexible seal of the top cap may be formed from a silicone material and / or may include a wavy or sinusoidal cross-section to enable the flexible seal to conform to the exterior surface of the device body of the surgical device. This allows the flexible seal to include a second fluid seal member at the proximal end of the canister which forms a fluid seal around the device body while allowing relative slidable movement between the device body and the flexible seal.

[0005] In some embodiments, the first fluid seal member of the incision port can include a sealing sleeve device or a wound retractor seal device. In some embodiments, the first fluid seal member is a wound retractor seal configured to couple to the incision port by being flexibly disposed within at least two inwardly radially extending tabs formed on a distal portion of the incision port. In some embodiments, one or more of the inwardly radially extending tabs can include a rotatable latch. In some embodiments, the first fluid seal member is a wound retractor seal configured to couple to the incision port by being flexibly disposed around an outer portion of a plurality of barbs or tabs formed on the distal 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 flex or bend radially inward to allow a top ring portion of the wound retractor seal to couple to the outer portion of the plurality of barbs / tabs.

[0006] In some embodiments, a surgical insertion device according to the present disclosure may include an iris- or aperture-shaped seal at the top of the incision port. See, for example, https: / / www.sciencedirect.com / science / article / pii / S0015028204000135. This document describes a "wrap disk," i.e., an iris (or aperture or lens)-type seal mechanism and an opening that is actuated (e.g., opened or closed) by a rotary actuation mechanism. The iris seal mechanism may include, for example, a rotatable ratchet closure feature. In some embodiments, a surgical insertion device according to the present disclosure may include an insufflation port fluidly coupled to the incision port. In some cases, the insufflation port may couple with the incision port below (e.g., distally) the level of the iris seal and above (e.g., proximally) the level of the wound retractor.

[0007] In some embodiments, provided herein is an introducer for use in combination with a surgical access or insertion device. For example, the introducer may include a pair of downwardly extending introducer legs configured to be positioned within an opening in, for example, a top cap seal, and may be moved apart after being positioned within the opening in the top cap seal. In some embodiments of the present disclosure, a pair of relatively long introducer legs may be flexibly coupled to each other at their tops and configured to be biased toward a spread-apart configuration. Use may involve, for example, squeezing the legs together (e.g., by a surgeon or other medical professional) prior to insertion into the opening in the top cap. In some embodiments of the present disclosure, the pair of introducer legs may each include an individual component having a tab or protrusion formed on its top that engages with a slot or receptacle portion in a top ring of an insertion device, thereby, for example, holding the top cap opening in a more fully open position after the legs are positioned within the top cap opening. In yet other embodiments, a pair of introducer legs may be pivotally connected at a pivot joint with a handle associated with each introducer leg such that the legs and handles operate in a manner similar to scissors: that is, after positioning the introducer legs within the top cap opening, the introducer legs may be moved apart (e.g., radially outward) toward a spread-apart configuration, e.g., via movement of the handles toward each other ("squeezing" them together).

[0008] In some embodiments, rather than using a wound retractor device or a sealing sleeve device coupled to the incision port of the surgical insertion device, an alternative trocar-style wound attachment may instead be used at the patient's incision site. The alternative trocar-style wound attachment may be configured to couple to the lower portion of the flexible canister, for example, thereby forming an alternative surgical insertion device according to certain embodiments of the present disclosure.

[0009] In another embodiment of the present disclosure, a surgical insertion device includes a flexible canister defining a lumen, a top cap coupled to a proximal end of the canister, and an incision port removably coupled to a distal end of the canister, the incision port including a first fluid seal member configured to maintain a fluid seal at the distal end of the canister. The canister is sized to accommodate a surgical device in the lumen. The top cap includes at least one lumen defined therein, the at least one lumen configured to accommodate a device body of a surgical device slidably disposed therethrough. The at least one lumen of the top cap may include a second fluid seal member shaped to conform to an exterior surface of the device body, the second fluid seal member rotatably disposed within the top cap to enable rotation of the surgical device relative to the top cap while maintaining a fluid seal around the device body of the surgical device at the proximal end of the canister.

[0010] In some embodiments of the present disclosure, the flexible canister of the surgical insertion device has a conical shape. In some embodiments of the present disclosure, the flexible canister of the surgical insertion device facilitates tilting of the surgical device disposed therethrough in any direction. In some embodiments of the present disclosure, the distal end of the flexible canister is configured to be removably coupled to the incision port via an adapter clamp configured for one-handed operation. In some embodiments of the present disclosure, the adapter clamp further comprises a pressure relief valve.

[0011] While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description and accompanying drawings, which show and describe illustrative embodiments. As will be understood, the devices and / or methods described herein are capable of modification in various obvious aspects without departing from the nature and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a top perspective view of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 2A] FIG. 1 is a bottom perspective view of an incision port portion of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 2B] FIG. 10 is a bottom perspective view of an alternative incision port of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 2C] FIG. 10 is a bottom perspective view of an alternative incision port of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 3A] FIG. 10 is a bottom perspective view of another alternative incision port of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 3B] 3B is a partial cross-sectional perspective view of the incision port portion of FIG. 3A. FIG. [Figure 4A] FIG. 1 is a top perspective view of an incision port portion of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments. [Figure 4B] 4B is a partial cross-sectional view illustrating an exemplary positioning of components of the incision port of FIG. 4A. [Figure 5A] 1 is a top perspective view of an incision port portion of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, illustrating aspects of a flexible seal arrangement according to some embodiments. FIG. [Figure 5B] 5B is a cross-sectional side view of the incision port portion of FIG. 5A showing further aspects of flexible seal arrangements according to some embodiments. [Figure 5C]5C is an enlarged, partial cross-sectional side view of the incision port portion of FIGS. 5A and 5B, showing further aspects of flexible seal arrangements according to some embodiments. [Figure 5D] FIG. 1 is a top perspective view of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, showing a view of the flexible seal arrangement in an open configuration, according to some embodiments of the present disclosure. [Figure 5E] FIG. 1 is a top perspective view of a system or apparatus for positioning a surgical system or device within a body cavity of a patient, showing a view of the flexible seal arrangement in a closed configuration, according to some embodiments of the present disclosure. [Figure 6A] 1A-1C are top perspective views of a system or apparatus for positioning a surgical system or device within a patient's body cavity, showing views of a flexible seal arrangement in open and closed configurations, respectively, according to some embodiments of the present disclosure; [Figure 6B] FIG. 6B is a partial cross-sectional side view of the system or device of FIG. 6A. [Figure 7A] FIG. 1 is a top perspective view of a top cap portion and a top cap seal of an exemplary system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some embodiments of the present disclosure. [Figure 7B] 7B is a side cross-sectional view of the top cap and top cap seal of FIG. 7A. [Figure 8A] FIG. 10 is a top perspective view showing an embodiment of an introducer for facilitating insertion of a surgical device through a top cap seal of a system or apparatus according to some embodiments of the present disclosure. [Figure 8B] FIG. 10 is a top perspective view showing an embodiment of an introducer for facilitating insertion of a surgical device through a top cap seal of a system or apparatus according to some embodiments of the present disclosure. [Figure 9A] FIG. 10 is a top perspective view illustrating an alternative embodiment of an introducer for facilitating insertion of a surgical device through a top cap seal of a system or apparatus according to some embodiments of the present disclosure. [Figure 9B]12A-12C are schematic cross-sectional views illustrating alternative embodiments of introducers for facilitating insertion of surgical devices through a top cap seal of a system or apparatus according to some embodiments of the present disclosure; [Figure 10A] FIG. 10 is a top perspective view illustrating another alternative embodiment of an introducer for facilitating insertion of a surgical device through a top cap seal of a system or apparatus according to some embodiments of the present disclosure. [Figure 10B] FIG. 10 is a top perspective view illustrating another alternative embodiment of an introducer for facilitating insertion of a surgical device through a top cap seal of a system or apparatus according to some embodiments of the present disclosure. [Figure 11A] 1 is a perspective view of an external pressure system or apparatus for positioning a surgical system or device within a body cavity of a patient, according to some alternative embodiments. [Figure 11B] 11B is a cross-sectional view of an external pressurized system or apparatus including a cutout port with a sealing sleeve device according to the embodiment of FIG. 11A. [Figure 12A] 11B is a perspective view of the external pressure system or apparatus of FIG. 11A showing the surgical system or device rotating from a first position to a second position within the external pressure system or apparatus. [Figure 12B] 11B is a perspective view of the external pressure system or apparatus of FIG. 11A showing the surgical system or device rotating from a first position to a second position within the external pressure system or apparatus. [Figure 13A] FIG. 10 is a top view of a top cap, according to one embodiment. [Figure 13B] FIG. 13B is a perspective view of the top cap of FIG. 13A. [Figure 13C] FIG. 13B is a cross-sectional view of the top cap of FIG. 13A. [Figure 14] FIG. 11B is a side view of the external pressure system or device of FIG. 11A showing the surgical system or device tilted within the external pressure system or device, according to one embodiment. [Figure 15A]FIG. 11B is a partially exploded perspective view of a canister and adapter clamp for the external pressurized system or device of FIG. 11A, according to one embodiment. [Figure 15B] FIG. 11B is a partial cross-sectional side view of a canister and adapter clamp for the external pressurized system or device of FIG. 11A, according to one embodiment. [Figure 15C] FIG. 11B is a cross-sectional view of a canister and top cap for the external pressurized system or device of FIG. 11A, according to one embodiment. [Figure 16A] FIG. 11B is a side view of the external pressurization system or device of FIG. 11A, according to one embodiment. [Figure 16B] FIG. 16B is an enlarged side view of an adapter clamp for the external pressurized system or device of FIG. 16A having a pressure relief device, according to one embodiment. [Figure 17A] FIG. 10 is a cross-sectional view of an alternative wound attachment assembly for use with an external pressure system or device of the present disclosure, according to an alternative embodiment. [Figure 17B] FIG. 10 is an exploded side view of an alternative wound attachment assembly for use with an external pressure system or device of the present disclosure, according to an alternative embodiment. [Figure 17C] 17B is a side cross-sectional view of the alternative wound attachment assembly of FIG. 17A that can be used with a canister and top cap to form an alternative access and / or insertion device. [Figure 17D] FIG. 10 is a top perspective view of an alternative access and / or insertion device. [Figure 17E] 10 is a schematic side view of an alternative access and / or insertion device. DETAILED DESCRIPTION OF THE INVENTION

[0013] Various embodiments described herein relate to systems, devices, and / or methods for accessing an insufflated cavity of a patient and / or positioning a surgical system or device in that cavity of a patient. This disclosure builds upon the devices, methods, and systems described in U.S. Patent Application Publication No. 2021 / 0244439, the contents of which are incorporated by reference in relevant part.

[0014] Certain embodiments provide for the insertion of a surgical system / device into a patient's body cavity while maintaining sufficient insufflation of the body cavity. For example, some embodiments reduce the complexity of the access / insertion procedure and / or facilitate the performance of the steps required for the procedure. Other embodiments relate to devices that have a minimal profile, minimal size, or generally minimal functionality and appearance to improve ease of handling and use.

[0015] Exemplary embodiments of the present disclosure relate to external pressurized systems or devices. For example, one implementation of an external pressurized system or device 110 is shown in FIG. 1. Device 110 comprises a canister 112 having a top cap 114 coupled to a top 113 of canister 112. In this embodiment, device 110 includes an incision port 118 coupled to canister 112 at a base 115 of canister 112. Incision port 118 is configured to be positioned within an incision 158 formed in a patient's skin 122, thereby providing access to a body cavity 124 of the patient. As shown in FIG. 1, top cap 114 of device 110 can include a top cap seal 130 having a top cap lumen or opening 134 formed therein. According to some embodiments, the top cap lumen 134 may be configured to accommodate a portion of a surgical device to facilitate insertion of the surgical device (not shown in FIG. 1 ) through the apparatus 110 and through the incision port 118 into the patient's body cavity 124.

[0016] With continued reference to FIG. 1 , an external pressurization device 110, according to some embodiments, may be used to enable a surgical device (e.g., a robotic surgical device having one or more robotic arms coupled thereto) to access and / or be positioned for use within a patient's body cavity 124. For example, it may be desirable to position a robotic surgical device (e.g., see FIG. 11A , which illustrates a robotic surgical device 26 having one or more end effectors 33 disposed at its distal end, as shown in use with an alternative embodiment of the presently disclosed access and insertion device 10) within a patient's body cavity 124, such as the peritoneum, to perform a minimally invasive surgical procedure within the body cavity 124. In such procedures, it is often desirable to insufflate the body cavity 124 with an insufflation gas, such as carbon dioxide, to create a working space within the body cavity 124. The insufflation gas may be supplied to the body cavity 124 at a predetermined pressure to provide a desired working space for the surgical procedure, taking care not to overpressurize the body cavity 124. It may be desirable to maintain the insufflation pressure within a predetermined range, and accordingly, it may likewise be desirable to selectively seal and / or open access to the body cavity 124 via the incision port 118 to maintain the desired insufflation pressure.

[0017] 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 that fluidly seals the patient's body cavity 124 from ambient air outside the patient. For example, the 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 may be the peritoneal cavity, but may also be any known body cavity. Once the incision 158 is formed, a fluid sealing member, such as a wound retractor seal or sealing sleeve device (not shown in FIG. 1 ), can be positioned in the incision 158. An example of a commercially available wound retractor seal that may work well with embodiments of the device 110 described herein is the SURGISLEEVE™ wound protector sold by Medtronic. Another example of a "standard" sealing sleeve device that may work well with certain embodiments described herein is a commercially available retractor port, such as the DEXTRUS® retractor available from Ethicon Endo-Surgery, Inc. The wound retractor or sealing sleeve device may be positioned by inserting the lower ring of the wound retractor seal through the incision 158, e.g., 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 and / or lower sleeve ring of the wound retractor or sealing sleeve device are flexible rings that are deformable, e.g., to facilitate insertion through the incision 158 and / or to facilitate connection to the incision port 118.

[0018] FIG. 2A shows a partial bottom perspective view of an access device 110 according to some embodiments. In the illustrated embodiment, the lower portion of the incision port 118 includes a plurality of ledges or shelves 156 arranged radially around the circumference of the lumen formed within the incision port 118. The embodiment of FIG. 2A shows three such ledges 156 arranged around the lumen of the incision port 118. However, one skilled in the art will readily recognize that more or fewer ledges 156 may be used to achieve a similar effect. Each ledge 156 extends downward and radially inward (e.g., from the lower ring 116 of the incision port 118) to form a “shelf” upon which the upper sleeve ring 146A of the wound retractor may rest or be coupled. (Note: For clarity, only the upper sleeve ring 146A of the wound retractor is shown in FIGS. 2A-2C.) For example, the upper sleeve ring 146 A of the wound retractor may be appropriately flexed and / or bent to seat the upper portion of the wound retractor against the ledge 156 , thereby coupling the wound retractor to the incision port 118 of the device 110 .

[0019] 2B and 2C show variations on the embodiment shown in FIG. 2A. In the embodiment shown in FIGS. 2B and 2C, one or more of the ledges 156 are replaced by a pivotal latch 157 that can be rotated out of the way to facilitate positioning the wound retractor's upper ring 146A into mating engagement with the interior portion of the incision port 118 (as shown in FIG. 2C), and then the pivotal latch 157 can be rotated back to its original position (as shown in FIG. 2B) to hold the upper ring 146A in place (e.g., engaged with the incision port 118). In some embodiments, the pivotal latch 157 rotates about a pivot point formed in the lower ring 116 of the incision port 118. In some implementations, it may be desirable for the pivotal latch 157 to be biased toward one position or the other; for example, the pivotal latch 157 may be spring biased toward the engaged position of FIG. 2B.

[0020] 3A is a partial bottom perspective view of an access device 110 according to some embodiments. In the illustrated embodiment, a lower portion of the incision port 118 includes a plurality of barbs or tabs 159 arranged around the circumference of a lumen formed within the incision port 118, the plurality of barbs or tabs 159 extending downwardly from a portion of the incision port 118. In some embodiments, the plurality of tabs 159 may extend downwardly from a common ring 159A, as shown in FIG. 3B, and may be integrally formed with or individually connected to the common ring 159A. As shown in FIG. 3B, a series of gaps or spaces 159B may be formed between adjacent tabs 159. Spacing adjacent tabs 159 in this manner allows the wound retractor's upper ring 146A to have some radial flexibility such that one or more of the tabs 159 are coupled to the outer surfaces of the plurality of tabs 159 by flexing or bending radially inward, thereby positioning the upper ring 146A about the tabs 159. Once positioned, the flexible tabs 159 are allowed to flex (e.g., radially outward) back to a normal / rest position such that the inner surface of the upper ring 146A seats and / or couples to the outer surfaces of the plurality of tabs 159, substantially as shown in FIG.

[0021] 3A and 3B also show a removal tab 140 configured to facilitate removal of the wound retractor from the incision port 118. The removal tab 140 accomplishes this by simultaneously pulling the wound retractor's top ring 146A outward and pressing one or more tab portions 159 inward. In some embodiments, removal of the wound retractor from the incision port 118 can be further facilitated by, for example, tilting and / or pulling the device 110 in a direction generally opposite the direction in which the removal tab is pressed and held. FIG. 3A also shows an insufflation port 142 that may be included as part of the access device 110. The insufflation port 142 is described in more detail below.

[0022] FIG. 4A is an enlarged perspective view of a portion of an exemplary access device 110 having an insufflation port 142 coupled to the insufflation port 118 of the device 110. FIG. 4B provides a side cross-sectional view of the insufflation port 118, illustrating the placement and / or location of the insufflation port 142 relative to various components of the insufflation port 118. Both FIGS. 4A and 4B show a valve 143 disposed in the insufflation port 142 to control the flow of air from, for example, an air source. In some cases, the valve 143 is a two-way stopcock 143 coupled to the outer end of the insufflation port 142. As detailed in FIG. 4B, the insufflation port 142 is configured to supply air or gas from a source (not shown) to the interior of the insufflation port 118. As shown, the insufflation port 142 is configured to fluidly connect an air source (or other gas source) to the insufflation port 118 at a level within the insufflation port 118 above a wound retractor or sealing sleeve device. It should also be noted that insufflation port 142 is configured to fluidly communicate an air supply (or other gas source) at a level within insufflation port 118 that is below the level of an "iris" sealing mechanism disposed within insufflation port 118. As can be seen in FIG. 4B, insufflation port 142 is in fluid communication with a lumen or cavity within insufflation port 118 that is below a selectively sealable iris opening 148C. The iris sealing mechanism includes a lower iris ring 148B and an upper iris ring 148A, the operation of which to selectively open and close iris opening 148C is described in more detail below.

[0023] 5A-5C illustrate an exemplary arrangement of various components of the incision port 118, including components that can form the iris seal mechanism described above. For example, FIG. 5A is a partial top perspective view of the access device 110, with certain portions 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 through relative rotation of the upper and lower iris rings 148A, 148B. The ratchet mechanism of the ratchet ring 150 may operate to help prevent the inadvertent 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, and rotation in the opposite direction (e.g., counterclockwise) operates to open the iris opening 148C unless prevented by the ratchet mechanism of the ratchet ring 150. The slider mechanism 149 can be used to provide a release to "override" the ratchet mechanism, thereby allowing the iris opening 148C to be opened, for example, by simultaneous actuation of the slider mechanism 149 and counterclockwise rotation of the upper iris ring 148A and the lower iris ring 148B relative to one another.

[0024] Figure 5B is a side cross-sectional view of the elements described above with respect to the iris seal mechanism. Figure 5C is an enlarged partial side cross-sectional view showing additional details of the arrangement of components associated with the iris seal mechanism. For example, in Figure 5C, flexible sealant 151 is shown disposed on a portion of upper iris ring 148A so as to open and close with operation of the iris seal mechanism and form a fluid seal when closed. Flexible sealant 151 is shown extending around the periphery of the upper and lower surfaces of upper iris ring 148A and is held in place via press-fit beads 152 that mechanically engage channels formed in both upper iris ring 148A and lower iris ring 148B as shown.

[0025] Figures 5D and 5E are top perspective views of an access device 110 having an iris seal mechanism, showing the iris opening 148C and upper iris ring 148A that may be visible when the iris seal mechanism is in the open position (Figure 5D), and the upper iris ring 148A that may be visible when the iris seal mechanism is in the closed position (Figure 5E).

[0026] 6A is a top perspective view of an access device 110 according to some embodiments of the present disclosure, the access device 110 including a top cap 114, a canister 112, and an incision port 118. The top cap 114 is coupled to the top of the canister 112 and includes a top seal 130 disposed across an upper surface of the top cap 114. The top cap seal 130 has a top cap lumen or opening 134 formed therein. As described above, the top cap lumen 134 may be configured to accommodate a portion of a surgical device (not shown in FIG. 6A ) to facilitate insertion of the surgical device through the apparatus 110 into a patient's body cavity, for example, to gain access to the body cavity during a surgical procedure, the surgical device being configured to pass through the top cap 114, through the canister 112, and through the incision port 118. Top cap seal 130 and top cap opening 134 are configured to provide a fluid seal for a portion of a surgical device while slidably moving the surgical device through the top cap opening and / or while moving the surgical device relative to top cap seal 130.

[0027] FIG. 6B is a side cross-sectional view of the device 110 of FIG. 6A, showing details of an exemplary top cap seal 130 and opening 134 that can be used with the device 110 according to some embodiments. In some embodiments, the canister 112 may be formed from, for example, a TPU film stock. In some embodiments, the canister 112 may have a relatively long length or height, which may be desirable to allow for some rotation or twisting of the canister 112 during movement and positioning of a surgical device inserted therein. Note that in FIG. 6B, the wall material of the canister 112 may be held in place at either or both the top and bottom via, for example, a press-fit bead arrangement formed on the bottom of the top cap 114 and / or the ring of the cut port 118.

[0028] 7A and 7B are enlarged views (top perspective and side cross-sectional views, respectively) of the top cap 114 of device 110, showing additional structural details that may be associated with the top cap seal 130 and / or opening 134. FIG. 7B shows a cross-section of the top cap seal 130, for example, having a wavy or sinusoidal shape between the outer periphery of the seal 130 and opening 134. The seal 130 may be formed from silicone, and in some embodiments, the silicone maintains a seal around the surgical device body even while the surgical device body translates and / or rotates relative to the seal 130 and seal opening 134. In some embodiments, the silicone of the seal 130 may comprise molded silicone having a 00-50 durometer. In some further embodiments, a Parylene-C coating on the silicone of the seal 130 may provide a lubricious coating so that no additional lubricant is required to maintain a slidable relationship between the seal 130 and a portion of a surgical device disposed therethrough. The wavy or sinusoidal cross-sectional shape and / or silicone material may contribute to the ability of seal 130 to maintain a fluid seal during such translational and / or rotational movement of a surgical device relative to seal 130, even when the surgical device does not have a matching round or circular cross-sectional shape. In some cases, the exterior surface of the surgical device may include, for example, a D-shaped cross-section, but the generally circular shape of opening 134 is compressed and conformed around the surgical device body to maintain a fluid seal in accordance with some embodiments of the present disclosure.

[0029] Figure 7B also shows a lower top cap ring 160 that is shaped (e.g., recessed) to accommodate an outer portion of the top cap seal 130 disposed therein. An upper top cap ring 162 is disposed as shown in Figure 7B to hold the positioning of the top cap seal 130 over the top cap 114. Additionally, in some embodiments, the lower top cap ring 160 may have a lower recess formed in its lower portion to facilitate positioning and retention of the top of the canister 112 via placement of the press-fit bead 152, as shown schematically in Figure 7B.

[0030] One or more introducer devices may be used with the presently disclosed access and insertion device 110 to facilitate placement of a surgical device into slidable, fluid-sealed engagement with the top cap seal 130 of the top cap 114 of the device 110. One example of an introducer for this purpose is shown in FIGS. 8A and 8B. The introducer 170 is shown in a relaxed or expanded configuration in FIG. 8A, having a pair of legs 171 extending downwardly from a generally horizontal or flat top 173. FIG. 8B shows the introducer 170 primed for use in holding open the opening 134 in the seal 130. For example, a user can "pinch" the pair of legs 171 together while pushing them down the opening 134. Once sufficiently positioned within opening 134, the user may release legs 171, causing legs 171 to spread outward to a normal configuration, thereby holding opening 134 open and allowing for easier placement and / or positioning of a portion of a surgical device therethrough. In some embodiments, a series of textures or ribs 172 may be disposed on the exterior surface of legs 171 to help keep the introducer from sliding up and / or out of opening 134 during use. Once the surgical device is properly positioned within opening 134 of seal 130, introducer 170 may be removed from top cap opening 134 by pulling flat top 173 of introducer 170 upward and / or outward.

[0031] 9A and 9B illustrate the design and use of another introducer embodiment that can be used with device 110. A pair of introducers 174, as shown in FIGS. 9A and 9B, can be used to hold opening 134 open for insertion of a surgical device. Each introducer 174 has downwardly extending legs 175 for placement in opening 134 and downwardly extending tabs 176 configured to mate with and / or seat within slots or notches 177 formed in the exterior of top cap 114 when introducers 174 are sufficiently separated, as shown in FIG. 9B. Once a surgical device is properly positioned within opening 134 in seal 130, introducers 174 can be removed by pulling the tops of introducers 174 upward and / or outward.

[0032] 10A and 10B illustrate another alternative introducer embodiment that may be used with device 110 to position a surgical device in sealed arrangement with top cap 114 of device 110. As shown in FIG. 10A , scissor-type introducer 180 may include two similar halves 181 pivotally connected to one another at pivot joint 183. Each half 181 includes legs 182 and a handle 184. In some embodiments, manipulation of the two handles 184 to bring them together (e.g., one-handed) causes the corresponding legs 182 to spread apart. In use, the legs 182 are positioned together as shown in FIG. 10A and positioned downwardly into opening 134, and then the handles 184 are actuated to spread the legs 182 outward, thereby opening opening 134 to a more fully opened position suitable for placing a surgical device into and / or through opening 134. In some embodiments, one or both handle portions may include a latching mechanism 185 to facilitate releasable latching or engagement of the handle portions 184 together to hold the opening 134 open while positioning a surgical device therein. Once the surgical device is properly positioned within the opening 134 of the seal 130, the introducer 180 may be released and removed by releasing the latching mechanism 185 (if used), moving the handle portions 184 apart, and then pulling the introducer 180 upward and / or outward to remove the legs from the opening 134.

[0033] Alternative embodiments of the present disclosure relate to external pressurized systems or devices. For example, one implementation of an external pressurized system or device 10 is shown in FIGS. 11A and 11B. Device 10 includes a canister 12 with a top cap 14 coupled to the top 13 of canister 12. In this embodiment, device 10 includes an incision port 18 coupled to canister 12 at the base 15 of canister 12. Incision port 18 is positioned within an incision 58 formed in a patient's skin 22, thereby providing access to a patient's body cavity 24. As shown in FIGS. 11A and 11B, device 10 can be configured to receive a surgical device 26, thereby allowing the device 26 to be inserted through device 10 and port 18 into the patient's body cavity 24.

[0034] With continued reference to FIG. 11A , an external pressurization device 10 as illustrated may be used, according to some embodiments, to enable a surgical device 26 to access and / or be positioned for use within a patient's body cavity 24. For example, it may be desirable to position a robotic surgical device 26 having one or more end effectors 33 disposed at a distal end within a patient's body cavity 24, such as the peritoneum, to perform a minimally invasive surgical procedure within the body cavity 24. In such procedures, it is often desirable to insufflate the body cavity 24 with an insufflation gas, such as carbon dioxide, to create a working space within the body cavity 24. The insufflation gas may be supplied to the body cavity 24 at a predetermined pressure to provide a desired working space for the surgical procedure, taking care not to over-pressurize the body cavity 24. It may also be desirable to maintain the insufflation pressure within a predetermined range. Therefore, it may also be desirable to selectively seal and / or open access to the body cavity 24 via the port 18 to maintain the desired insufflation pressure.

[0035] 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 that fluidly seals the patient's body cavity 24 from ambient air outside the patient. For example, the 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 body cavity. Once the incision 58 is made, a sealing sleeve device 46 (described below with reference to FIG. 11B ) can be positioned in the incision 58. An example of a “standard” sealing sleeve device 46 is a retractor port, such as the DEXTRUS® retractor available from Ethicon Endo-Surgery. The sealing sleeve device 46 may 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 located within the patient's body cavity 24, the upper sleeve ring 46A is located outside the patient, and the flexible sleeve 46C extends through the incision 58. According to one embodiment, the lower sleeve ring 46B of the sealing sleeve device 46 is a flexible ring 46B that is deformable so that it can be inserted through the incision 58.

[0036] In some embodiments, an adapter clamp 16 may be used to facilitate a relatively easy and / or quick coupling / connection between the base 15 of the canister 12 and the incision port 18. FIG. 11B is a cross-sectional view illustrating exemplary elements of the incision port 18 according to some embodiments. For example, FIG. 11B illustrates a sealing sleeve device 46 positioned within an incision 58 and engaged with the adapter clamp 16 according to one embodiment. The upper sleeve ring 46A is shown engaging one or more inward protrusions 56 formed on the interior of the adapter clamp 16. In some embodiments, there may be two, or preferably three or more, such protrusions or "ledges" 56 upon which the upper sleeve ring 46A can rest and / or engage to couple the canister 12 to the incision port 18, according to some embodiments. In some alternative embodiments, a continuous inward ledge or shelf 56 (rather than multiple individual protrusions) may be formed on the interior of the adapter clamp 16 upon which the upper sleeve ring 46A may engage. 11B further shows the lower sleeve ring 46B positioned within the body cavity 24 through the incision 58, with the flexible sleeve 46C connecting the upper and lower sleeve rings 46A, 46B through the incision 58. Rotation of the upper and lower sleeve rings 46A, 46B relative to one another can cause the flexible sleeve 46C to "bundle," sealing the incision 58 and / or urging the upper and lower sleeve rings 46A, 46B toward one another, thereby improving the sealing engagement of the clamp 16 with the surface of the patient's skin 22.

[0037] 12A and 12B, in some embodiments of the present disclosure, the surgical device 26 is configured to be disposed through the external pressure device 10 (e.g., extending through a lumen formed in the top cap 14, through the length of the canister 12, through the patient's incision 58, and into the body cavity 24). In some embodiments, the external pressure device 10 includes a rotatable seal member (such as rotatable member 30 shown in FIGS. 13A and 13B) disposed within the top cap 14, which allows the surgical device 26 to rotate within the top cap 14 and / or relative to the canister 12. For example, the surgical device 26 of FIG. 12A can be rotated approximately 90 degrees counterclockwise (as shown in FIG. 12B) to produce the same amount of rotation or change in orientation at the distal end of the surgical device 26, e.g., at the end effector 33 disposed within the body cavity 24.

[0038] 13A and 13B illustrate an exemplary top cap 14 having a seal member (or "rotatable seal") 30 rotatably disposed within the top cap 14. For example, the seal member 30 can have a generally circular outer shape that complements and / or mates with the generally circular interior surface of the top cap 14. The seal member 30 can be rotatably disposed within the top cap 14 by a ball-bearing design, as known in the art. Alternatively, the rotatable seal 30 can be rotatably coupled to the top cap 14 by any known mechanism, device, or method. The seal member 30 has a generally flat upper surface with a shaped lumen 34 disposed therein. In some embodiments, for example, the shaped lumen 34 can have a shape that conforms to the exterior surface of a portion of a surgical device 26 (such as the device body 27 of a robotic surgical device 26, according to some embodiments) to form a seal around the portion. More specifically, the shaped lumen 34 is substantially "D" shaped, as best shown in FIG. 13A (discussed in more detail below), and the lumen 34 conforms to the outer cross-sectional circumferential shape of the body 27 of the surgical device 26 that can be positioned therethrough, thereby establishing a fluid-tight seal between the device body 27 and the seal 30.

[0039] 13C, a cross-sectional side view of an exemplary top cap 14 is shown having a seal member 30 rotatably disposed therein via a ball bearing arrangement 31 formed on the interior surface of the top cap 14. In the particular embodiment shown, the seal member 30 may have a generally annular vertically extending portion 32 and a generally flat or horizontal portion 33, with the formed lumen 34 formed in the horizontal portion 33. In the exemplary embodiment shown in FIG. 13C, 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 could be disposed at the lower end or in the middle of the vertically extending portion 32, with similar effect.

[0040] The seal member 30 is configured to rotate in conjunction with the rotation of the surgical device 26 to maintain a conforming seal about the exterior surface of the surgical device 26. In certain embodiments, this is due to the complementary shape of the lumen 34 and a portion of the exterior surface of the surgical device 26. For example, in FIGS. 13A and 13B, the lumen 34 is a generally "D" shaped opening in the seal member 30 that corresponds to the generally "D" shaped exterior surface of the device body 27 of the surgical device 26. Of course, other appropriate complementary shapes can be selected based on the particular surgical device 26 being used. Thus, in use, as the surgical device 26 is rotated about the longitudinal axis of the device body 27, the rotatable seal 30 rotates with the body 27.

[0041] In some embodiments, the seal formed by the shaped lumen 34 around the surgical device 26 can allow for a degree of slidable relative displacement of the device 26 with respect to the seal 30. For example, the surgical device 26 may be slidable vertically relative to the shaped lumen 34 to allow positioning of the surgical device 26 within the body cavity 24 while maintaining the seal formed by the seal member 30 around the surgical device 26. In some embodiments, the seal member 30 may further include an actuation feature that allows a user to selectively engage and / or disengage the seal. For example, in some embodiments, an actuator (e.g., a button or latch, not shown) may be disposed on or near the top cap 14 to allow a user to one-handedly operate (e.g., engage and / or disengage) the seal. Such an actuator can function, for example, by temporarily releasing circumferential or radial tension on the seal member 30 that exists during normal operation.

[0042] In some embodiments, the canister 12 of the external pressurization device 10 can be formed from a flexible material, which may facilitate positioning and / or manipulation of the surgical device 26 relative to the patient's body cavity 24, as shown in the exemplary embodiment depicted in FIG. 14. For example, the canister 12 may be formed from a flexible material such as polyethylene plastic, latex, nylon, or silicone rubber. In this manner, the canister 12 may be manipulated and configurable with respect to the shape of the canister 12 and may even be configured to be compressed longitudinally, thereby allowing the height of the canister 12 to be reduced during insertion of the robotic surgical device 26 into the patient's body cavity 24.

[0043] The embodiment of FIG. 14 illustrates a generally conical flexible canister 12. According to one embodiment, during compression, the conical canister 12 may be configured to collapse, compress, or otherwise allow the top cap 14 to move toward the incision port 18. In some embodiments, the flexibility of the material selected for the canister 12 and / or the length or height of the canister 12 may allow the canister 12 to tilt or bend in various directions to facilitate positioning and use of a surgical device 26 disposed therethrough. For example, in some embodiments, the canister 12 may be generally conical and formed such that a surgical device 26 disposed therethrough may be bent or angled 45 degrees or more in any direction from a generally vertical orientation. This may allow for greater flexibility in positioning the surgical device 26 within the patient's body cavity 24, as suggested by the embodiment illustrated in FIG. 14.

[0044] 15A and 15B illustrate an embodiment of an external pressurization device 10 including an adapter clamp 16 configured to facilitate quick and / or easy connection / coupling between a base 15 of a canister 12 and an incision port, such as the incision port 18 of FIG. 11B, which is shown disposed at an incision 58 in a patient's skin 22. As noted above, the incision port 18 may comprise a sealing sleeve device or a retractor port, such as, for example, the commercially available DEXTRUS® retractor port.

[0045] As noted above, the adapter clamp 16, according to some embodiments, may include one or more inwardly facing protrusions 56 formed therein. Alternatively, the adapter clamp 16, according to some embodiments, may include a substantially continuous inwardly facing ledge or shelf 56 formed therein. The protrusion or shelf 56 may form an engagement surface configured to seat and / or engage a portion of the sealing sleeve device 46 (e.g., the upper sleeve ring 46A). In the embodiment shown in FIG. 15A, the clamp 16, according to some embodiments, may further include a fastening latch 52 to facilitate forming a compressive engagement about the upper sleeve ring 46A of the sealing sleeve device 46.

[0046] 15A and 15B, further details of adapter clamp 16 are shown. For example, in FIG. 15A, threads 54 are formed on the exterior top of clamp 16 to facilitate connection of device 10 to canister 12. FIG. 15B shows an enlarged cross-sectional view of the connection between clamp 16 and base 15 of canister 12. For example, threads 54 on clamp 16 may engage corresponding threads on lower seal ring 17, which are configured to compress or "sandwich" the outward extension of base 15 of canister 12 between the top of clamp 16 and the interior of lower seal ring 17 in a secure engagement, as shown in FIG. 15B.

[0047] 15C is a side cross-sectional view of an exemplary connection between top cap 14 and top 13 of canister 12, showing an arrangement similar to that described above with respect to clamp 16. For example, complementary threads 55 formed on the outer lower surface of top cap 14 and the inner surface of upper sealing ring 11 can be used to clamp, and thereby compress or "sandwich," an outward extension of top 13 of canister 12 between the lower portion of top cap 14 and the inner lower portion of upper sealing ring 11, as shown in FIG.

[0048] 16A and 16B. The pressure relief valve 62 may be configured to relieve pressure that may build up inside the canister 12 and / or the body cavity 24, for example. In some embodiments, the pressure relief valve 62 may be activated or allow relief of pressure that occurs during advancement (e.g., downward movement) of the surgical device 26 into the external pressurized device 10 and into the body cavity 24. During such advancement of the surgical device 26, the canister 12 of the device 10 may compress or collapse somewhat on itself, resulting in a decrease in volume and a concomitant increase in pressure within the canister 12 or the body cavity 24. This undesirable increase in pressure (which may be harmful to the patient) may be avoided, for example, by activating the pressure relief valve 62 to relieve excess pressure when a predetermined pressure relief set point is reached. In one embodiment, the pressure relief valve 62 may comprise an elastic valve that deforms to release pressure when the pressure reaches and / or exceeds a certain amount. Other forms of the pressure relief valve 62 may be utilized as deemed appropriate by one skilled in the art.

[0049] In use, according to one embodiment, an external pressurization device according to any embodiment herein can be positioned for a surgical procedure in the following manner. First, in some implementations, an incision port (such as port 18) is first positioned within the incision to establish a fluid seal between the patient's body cavity and the outside atmosphere. In one embodiment, the insertion device 10 is coupled to the incision port 18 before positioning the port 18 within the incision. Alternatively, the port 18 is first positioned within the incision, and then the insertion device 10 is coupled to the port 18. In either case, once the incision port 18 and insertion device 10 are positioned, the patient's body cavity can be insufflated. In certain implementations, the fluid communication between the body cavity and the interior of the insertion device 10, which can be established by the incision port 18, places the entire interior of the insertion device 10 under the same pressure as the body cavity.

[0050] According to one embodiment, once the insertion device 10 is correctly positioned, the process of inserting the robotic device 26 into the patient's insufflation cavity 24 can be performed as follows. Initially, the robotic device 26 starts with both arms parallel and perpendicular to the incision, as best shown in FIGS. 12A and 12B . The robot 26 then descends through the lumen 34 of the top cap 14 and through the opening formed by the incision port 18. According to one embodiment, as the robotic device 26 is lowered so that its arms enter the patient's body cavity, the flexible canister 12 of the insertion device 10 can contract in height by allowing a portion of the flexible material of the canister 12 to begin to "collapse" or form folds as the top cap 14 approaches the incision port 18.

[0051] An alternative wound attachment assembly is shown in FIGS. 17A and 17B. For example, FIG. 17A is a side cross-sectional view of an alternative wound attachment assembly 190 that may be used with any of the external pressurized access or insertion devices 110 or 10 described above to facilitate access and / or insertion of a surgical and / or robotic device 26 into a patient's body cavity 24 or 124. FIG. 17B provides an exploded side view of the alternative wound attachment assembly 190 of FIG. 17A. The device 190 illustrated in FIGS. 17A and 17B would function in place of the incision port and / or wound retractor device described above to provide a seal at the patient's incision. FIG. 17B shows components of this embodiment, which may include, for example, a trocar-style access device 192, a valve / seal device 194 (e.g., a duckbill or equivalent style valve or seal), and an attachment ring 196 for engaging the base of the presently disclosed access and insertion device 10 / 110. Notably, this embodiment does not involve the use of a sealing sleeve device or wound retractor seal as part of the incision port.

[0052] Figure 17C is a side cross-sectional view of the alternative wound attachment assembly 190 of Figure 17A that can be used with the canister 112 and 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 mates with the lower portion of the canister 112. The remainder of the canister 112 and top cap 114 are substantially as described above with reference to the access device 110. Figure 17D is a top perspective view of the alternative access and / or insertion device 210, while Figure 17E is a schematic side view of the alternative access and / or insertion device 210, showing placement through an incision 158 formed in the skin 122 to allow access and insertion of a surgical device into a patient's body cavity 124 in connection with performing a surgical procedure therein.

[0053] For all of the various embodiments described herein, the medical device inserted into the patient is understood to be a known medical or surgical device for performing a procedure within a patient's body cavity. In certain embodiments, the medical device is understood to be a robotic surgical device having one or two arms. In various options, the robotic surgical device or system can have or use three or more arms. As yet another option, the device (or additional device) can be a camera or camera system. Still other options include the use of a "helper" tool that can be inserted along with one or more medical or robotic devices.

[0054] Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the scope of the disclosure.

Claims

1. 1. A surgical insertion device comprising: (a) a flexible canister defining a canister lumen and sized to receive a surgical device within said canister lumen; (b) a top cap coupled to a proximal end of the flexible canister, the top cap comprising: a top cap housing; and a top cap lumen defined within the top cap housing, the at least one top cap lumen configured to accommodate a portion of the surgical device slidably disposed therethrough; (c) a slit port coupled to a distal end of the flexible canister, the slit port including at least one downwardly extending ledge configured to facilitate coupling an upper ring portion of a fluid seal member to the slit port, the fluid seal member configured to provide a fluid seal at the slit port; and A surgical insertion device comprising:

2. The surgical insertion device of claim 1 , wherein the at least one downwardly extending ledge comprises an inwardly facing shelf configured to support the upper ring portion of the fluid seal member seated thereon.

3. The surgical insertion device of claim 2 , comprising at least two downwardly extending ledges and inward shelves disposed around the lumen of the incision port.

4. 4. The surgical insertion device of claim 3, comprising three downwardly extending ledges and inward shelves equally spaced around the lumen of the incision port, the incision port configured to receive the upper ring portion of the fluid seal member when the upper ring portion is flexibly positioned within the downwardly extending ledges and inward shelves.

5. 4. The surgical insertion device of claim 3, further comprising a pivotable ledge extending from a lower portion of the incision port, the pivotable ledge configured to pivot between a first insertion position to facilitate positioning the upper ring portion of the fluid seal member into the lower portion of the incision port and a second engagement position to secure the upper ring portion of the fluid seal member to the lower portion of the incision port.

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

7. 2. The surgical insertion device of claim 1, wherein the at least one downwardly extending ledge comprises a plurality of circumferentially spaced tabs configured to support the upper ring portion of the fluid seal member flexibly coupled to outer portions of the circumferentially spaced tabs.

8. 8. The surgical insertion device of claim 7, wherein one or more of the circumferential spacing tabs are configured to flex radially inward to allow positioning of the upper ring portion of the fluid seal member about an outer portion of the circumferential spacing tab.

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

10. 10. The surgical insertion device of claim 9, wherein actuation of the detachment tab comprises outward or downward movement of the detachment tab relative to the incision port, and actuation of the detachment tab pulls the upper ring portion of the fluid seal member away from the circumferential spacing tabs.

11. The surgical insertion device of claim 1 , wherein the fluid seal member is a sealing sleeve device or a wound retractor seal device.

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

13. 13. The surgical insertion device of 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 and lower iris members in a first direction toward closure of the iris seal mechanism.

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

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

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

17. The surgical insertion device of claim 15, wherein the insufflation port comprises a valve that selectively allows or restricts the flow of gas into the lumen of the incision port.

18. 13. The surgical insertion device of claim 12, wherein the top cap further comprises a top cap seal disposed over an upper portion of the top cap lumen, the top cap seal having a top cap opening formed therein, the top cap seal having a wavy cross-sectional shape to provide flexibility.

19. The surgical insertion device of claim 18, wherein the top cap seal is formed from molded silicone having a durometer value in the range of 00-50.

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

21. 1. An introducer system for a surgical insertion device, comprising: a pair of downwardly extending introducer legs; a mechanism operable to hold the introducer legs apart after insertion of the introducer legs into a top cap opening formed in a top cap seal of a surgical insertion device; Equipped with An introducer system, wherein the downwardly extending introducer legs are configured to be removed from the top cap opening after positioning a surgical instrument therein.

22. 22. The introducer system of claim 21, wherein the pair of downwardly extending introducer legs are flexibly connected to one another at their tops and biased to move apart upon placement of the top cap seal portion into the top cap opening.

23. 22. The introducer system of claim 21, wherein the pair of downwardly extending introducer legs further comprise tabs configured to seat within a pair of corresponding slots formed in an exterior portion of the top cap of the surgical insertion device.

24. 22. The introducer system of claim 21, wherein the pair of downwardly extending introducer legs are rotatably coupled together about a pivot joint, each of the introducer legs having a corresponding handle portion coupled thereto, the handle portions configured to move the introducer legs apart when the handle portions are moved together after placement of the introducer legs into the top cap opening of the top cap seal portion.

25. 1. A surgical insertion device comprising: (a) a flexible canister defining a canister lumen and sized to receive a surgical device within said canister lumen; (b) a top cap coupled to a proximal end of the flexible canister, the top cap comprising: a top cap housing; and a top cap lumen defined within the top cap housing, the at least one top cap lumen configured to accommodate a portion of a surgical device slidably disposed therethrough; (c) a trocar wound attachment assembly coupled to a distal end of the flexible canister, the trocar wound attachment assembly including a trocar access portion, a seal portion disposed on a top of the trocar access portion, and an attachment ring for coupling the trocar wound attachment assembly to the flexible canister of the surgical insertion device; A surgical insertion device comprising:

26. 1. A surgical insertion device comprising: (a) a flexible canister defining a canister lumen and sized to receive a surgical device within said canister lumen; (b) a top cap coupled to a proximal end of the flexible canister, the top cap comprising: a top cap housing; and at least one top cap lumen defined within the top cap housing, the at least one top cap lumen configured to accommodate a portion of a surgical device slidably disposed therein; (c) a slit port releasably coupled to a distal end of the flexible canister; the incision port comprising a first fluid seal member configured to provide a fluid seal at the distal end of the flexible canister; the at least one top cap lumen includes a second fluid seal member shaped to conform to an exterior surface of the portion of the surgical device disposed through the top cap lumen, the second fluid seal member being rotatably disposed within the top cap housing to permit rotation of the surgical device relative to the top cap housing while maintaining a fluid seal around the surgical device at the proximal end of the flexible canister.

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

28. 27. The surgical insertion device of claim 26, wherein the flexible canister 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 canister is configured to be releasably coupled to the incision port via an adapter clamp configured for one-handed operation.

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

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