Asymmetrical shaft seal

Abstract

To provide an integrated seal system.SOLUTION: An integrated seal system comprises: a main body defining a center opening; a duck bill seal extending to a distal side from a bottom of the main body, and defining one or two or more division lines for separating facing seal flaps; and an asymmetric seal extending from the main body into the center opening in a radial direction, and including a diaphragm and an annular flange extending between the main body and the diaphragm. For equalizing total insertion resistance force and total removal resistance force generated by the integrated seal system, the diaphragm complements insertion resistance force and removal resistance force which is generated by the duck bill seal with respect to a shaft of a surgical tool extending through the duck bill seal.SELECTED DRAWING: Figure 3

Description

Background Art

[0001] During laparoscopic surgery, one or more small incisions are formed in the patient's skin, and a trocar assembly is inserted through the incisions to provide access to an internal body cavity such as the patient's abdomen. The trocar assembly operates as a pathway for introducing various surgical instruments and tools into the abdomen.

[0002] The trocar assembly generally includes a trocar and a seal assembly that is operably connected to a portion of the trocar or forms a portion of the trocar. The trocar includes a trocar housing and a cannula that extends distally from the trocar housing and provides a pathway into the patient's abdomen. The seal assembly includes one or more seals that help maintain insufflation into the penetrated body cavity and also help seal around a surgical tool that extends into the patient's abdomen through the trocar. In some applications, the seal assembly may include a seal cartridge that is at least partially received within the trocar housing.

[0003] The trocar seal assembly generally includes a "duckbill" seal that is normally closed until penetrated by the shaft of a surgical tool. When a surgical tool is introduced into the patient's abdomen, the duckbill seal receives and engages the outer periphery of the tool shaft when penetrated by the shaft. Due to its distally protruding design, the duckbill seal typically generates less resistance against the tool shaft during insertion of the surgical tool compared to the resistance generated while removing the surgical tool.

[0004] Hysteresis occurs due to the difference between insertion resistance and withdrawal resistance, because users (e.g., surgeons) typically or consciously do not anticipate that removing a surgical tool requires an additional force compared to the force required for insertion. In extreme cases, this can cause inadvertent damage or injury to the patient's tissue. In robotic surgery applications, the difference between insertion and withdrawal resistance necessitates separately programming and calibrating the robot for insertion and withdrawal movements to compensate for the differing resistances in each direction, resulting in further system complexity. [Brief explanation of the drawing]

[0005] The following figures are included to illustrate specific aspects of the disclosure, but should not be viewed as exclusive embodiments. The disclosed subject matter can be substantially modified, altered, combined, and equivalent in form and function without departing from the scope of the disclosure. [Figure 1] This is an isometric view of an exemplary trocar assembly that can incorporate the principles of this disclosure. [Figure 2] Figure 1 is a partially exploded view of the trocar assembly. [Figure 3] Figures 1 and 2 are enlarged cross-sectional side views of a portion of the trocar assembly. [Figure 4A] These are the isometric top and bottom views of the integrated sealing system shown in Figure 3, respectively. [Figure 4B] These are the isometric top and bottom views of the integrated sealing system shown in Figure 3, respectively. [Figure 5] This is a cross-sectional view of the integrated seal system, perpendicular to the dividing line of the integrated seal system. [Figure 6A] This is a progressive cross-sectional side view of an exemplary integrated seal system in operation. [Figure 6B] This is a progressive cross-sectional side view of an exemplary integrated seal system in operation. [Figure 6C] This is a progressive cross-sectional side view of an exemplary integrated seal system in operation. [Figure 6D] This is a progressive cross-sectional side view of an exemplary integrated seal system in operation. [Figure 6E] This is a progressive cross-sectional side view of an exemplary integrated seal system in operation. [Figure 7] This is an enlarged cross-sectional side view of another exemplary trocar assembly that may incorporate the principles of this disclosure. [Figure 8] This is an enlarged cross-sectional side view of another exemplary trocar assembly that may incorporate the principles of this disclosure. [Figure 9] This is an enlarged cross-sectional side view of another exemplary trocar assembly that may incorporate the principles of this disclosure. [Modes for carrying out the invention]

[0006] This disclosure relates to a trocar assembly, and more specifically, to an integrated sealing system designed to equalize the insertion and withdrawal forces acting on the shaft of a surgical tool.

[0007] Embodiments presented herein describe an integrated sealing system designed to equalize the insertion and withdrawal forces of a surgical tool. More specifically, the integrated sealing system may be included in a trocar assembly, which includes a trocar having a trocar housing and a cannula extending distally from the trocar housing. The integrated sealing system may be located in a central passage extending axially through the trocar and may be engageable with the shaft of a surgical tool extending through the central passage. The integrated sealing system may include an asymmetric seal and a duckbill seal positioned distal to the asymmetric seal. The asymmetric seal defines a diaphragm protruding proximally. The diaphragm operates to complement the insertion and withdrawal forces that the duckbill seal generates with respect to the shaft of the surgical tool, so as to equalize the total insertion and withdrawal forces generated by the integrated sealing system.

[0008] Figure 1 is an isometric view of an exemplary trocar assembly 100 into which the principles of the present disclosure can be incorporated. The illustrated trocar assembly 100 is only one embodiment of a trocar assembly into which the principles of the present disclosure can be suitably incorporated. Those skilled in the art will readily understand that many alternative designs and configurations of the trocar assembly 100 may be adopted or incorporated without departing from the scope of the present disclosure.

[0009] As shown in the figure, the trocar assembly 100 may include a trocar 102, a seal cartridge 104 releasably connected to the trocar 102, and a trocar bushing 106 that can be releasably connected to the proximal end of the seal cartridge 104. The trocar 102 includes a trocar housing 108 and a cannula 110 extending distally from the trocar housing 108. In some embodiments, the cannula 110 may include an integral extension of the trocar housing 108. In other embodiments, the trocar housing 108 and the cannula 110 may include two separate components that are mated to each other. The trocar 102 may be made of any rigid or semi-rigid material such as metal or plastic.

[0010] The seal cartridge 104 may be at least partially received within the trocar housing 108 and includes one or more operable latches 112 (one shown, one hidden) that releasably connect the seal cartridge 104 to the trocar housing 108. The trocar bushing 106 may include a bushing housing 114 that provides one or more operable latches 116 (one shown, one hidden) that releasably connect the trocar bushing 106 to the seal cartridge 104. However, in some embodiments, the trocar bushing 106 may be omitted from the trocar assembly 100 without departing from the scope of the present disclosure.

[0011] The trocar assembly 100 may also include an air valve 118 (e.g., a stopcock valve) that is operable to regulate the inflow of an air supply fluid (e.g., carbon dioxide) used to raise the inner wall of the patient's internal body cavity (e.g., the abdomen). In the illustrated embodiment, the air valve 118 is coupled to the seal cartridge 104 or otherwise forms part of it. However, in other embodiments, the air valve 118 may alternatively be coupled to the trocar housing 108 or form part of it.

[0012] Figure 2 is a partially exploded view of the trocar assembly 100 of Figure 1. More specifically, the trocar bushing 106 is shown separated from the seal cartridge 104. As shown, the trocar bushing 106 includes a reducer shaft 202 that extends distally from the bushing housing 114. To connect the trocar bushing 106 to the seal cartridge 104, the reducer shaft 202 can be extended into a central orifice 204 defined at the proximal end of the seal cartridge 104. The trocar bushing 106 may then be advanced distally so that the reducer shaft 202 extends through the seal cartridge 104 and the trocar housing 108, and finally into the interior of the trocar cannula 110. The trocar bushing 106 may be releasably connected to the seal cartridge 104 by receiving an operable latch 116 of the bushing housing 114 into a corresponding latch opening 206 defined on the proximal end of the seal cartridge 104.

[0013] The trocar bushing 106 and the corresponding reducer shaft 202 may operate to reduce the effective internal diameter of the trocar assembly 100, thereby allowing the trocar assembly 100 to accommodate and center a reduced-diameter surgical tool. For example, the trocar bushing 106 may be sized to accommodate a surgical tool with an outer diameter of 5 mm. If a larger diameter surgical tool is used, such as a surgical tool with an outer diameter of 8 mm or 12 mm, the trocar bushing 106 may be omitted, and such a larger diameter surgical tool may be introduced into the trocar assembly 100 via the central orifice 204.

[0014] Figure 3 is an enlarged cross-sectional side view of a portion of the assembled trocar assembly 100. As shown, the seal cartridge 104 may include one or more seals, namely a first or “proximal” seal 302 and a second or “distal” seal 304. The first seal 302 and the second seal 304 facilitate selective sealing of the trocar assembly 100 during operation. In the illustrated embodiment, the first seal 302 and the second seal 304 receive and engage with the outer surface of the reducer shaft 202 extending through the seal cartridge 104. During operation, the first seal 302 may be configured to seal-engage with the outer surface of the reducer shaft 202. Although two seals 302, 304 are shown in Figure 3, the seal cartridge 104 may alternatively include more than two or fewer seals without departing from the scope of the present disclosure.

[0015] In some embodiments, the first seal 302 may include an expandable open / close seal configured to receive a reducer shaft 202 extending through a seal cartridge 104 and to expand radially to seal against the reducer shaft 202. Alternatively, in embodiments where the trocar bushing 106 is omitted, the first seal 302 may seal around the outer surface of the shaft of a surgical tool (not shown). The second seal 304 may be configured to help maintain air supply when not penetrated, but may also seal against the outer circumference of the reducer shaft 202 if the trocar bushing 106 is used. In some embodiments, as shown, the second seal 304 may include a duckbill seal, which is generally known to those skilled in the art.

[0016] Seals 302 and 304 may be made of an elastic or flexible material. Suitable elastic or flexible materials include, but are not limited to, rubber (e.g., natural rubber, synthetic rubber, nitrile rubber, silicone rubber, urethane rubber, polyether rubber, chloroprene rubber, ethylene propylene diene monomer, styrene butadiene rubber, etc.), silicone, ethylene vinyl acetate, nylon, vinyl, spandex, polyurethane, polyethylene, polypropylene, polyisoprene, or any combination thereof.

[0017] According to an embodiment of the present disclosure, the trocar assembly 100 may further include a shaft seal, herein referred to as an integrated seal system 306, positioned within a central passage 308 that extends axially through the trocar assembly 100. The central passage 308 may include any elongated path that extends axially through the trocar assembly 100 and receives and guides the shaft of a surgical tool when the shaft of the surgical tool is inserted and removed. In the illustrated embodiment, for example, the central passage 308 is defined by a trocar bushing 106 that extends through the seal cartridge 104 and the trocar 102. More specifically, the central passage 308 is at least partially defined by the bushing housing 114 and the interior of the reducer shaft 202.

[0018] The integrated seal system 306 may be positioned within the central passage 308 or otherwise arranged to sealingly engage the outer surface of the shaft of a surgical tool that extends through the central passage 308. More specifically, when the shaft of a surgical tool (not shown) is introduced into the central passage 308, the integrated seal system 306 operates to seal around the outer peripheral surface of the shaft of the surgical tool. The integrated seal system 306 may be made of any of the elastic or flexible materials referred to herein with respect to seals 302, 304. In the illustrated embodiment, the integrated seal system 306 is disposed at the proximal end 310 of the reducer shaft 202 and, in some embodiments, may be held between the proximal end 310 of the reducer shaft 202 and a portion of the bushing housing 114 or otherwise sandwiched therebetween. However, in other embodiments, the integrated seal system 306 may be disposed at any position along the central passage 308 without departing from the scope of the present disclosure.

[0019] One skilled in the art will readily understand that the central passageway 308 can be defined by other components of the trocar assembly 100 without departing from the scope of the present disclosure. As will be described hereinafter, for example, embodiments are contemplated herein where the trocar bushing 106 is omitted and the central passageway 308 is alternatively defined continuously through the seal cartridge 104 and the trocar 102. In such an embodiment, the integrated seal system 306 may be disposed, for example, within the seal cartridge 104 or at another location within the central passageway 308. In still other embodiments described herein, both the seal cartridge 104 and the trocar bushing 106 may be omitted from the trocar assembly 100, and it is contemplated that the central passageway 308 may alternatively be defined through the trocar housing 108 and the cannula 110. In such an embodiment, the integrated seal system 306 may be coupled and disposed at another location along the trocar housing 108 or the central passageway 308.

[0020] FIGS. 4A and 4B are, respectively, an isometric top view and a bottom view of an example of an integrated seal system 306 according to one or more embodiments. Referring first to FIG. 4A, the integrated seal system 306 may provide a generally circular body 402 that defines a central opening 404. In other embodiments, the body 402 may exhibit other cross-sectional shapes, such as polygonal or elliptical, without departing from the scope of the present disclosure. The asymmetric seal 406 may be defined by the body 402 and may extend radially within the central opening 404. As shown, the asymmetric seal 406 may include a diaphragm 408 and an annular flange 410 that extends between the body 402 and the diaphragm 408. As will be described hereinafter, the diaphragm 408 may engage the outer periphery of an object (e.g., the shaft of a surgical tool) that extends through the central opening 4 as well as through the integrated seal system 306 in another way and is configured to seal against the outer periphery.

[0021] In Figure 4B, the duckbill seal 412 (alternately called “check valves”) may be located on the bottom 414 of the body 402, or may extend distally from the bottom 414 in another manner. The duckbill seal 412 may define one or more dividing lines 416 (one is shown) that separate the opposing seal flaps 418. In its relaxed, non-penetrating state, the sealing flap 418 helps maintain air supply by remaining closed (sealed) along the dividing line(s) 416 and the duckbill seal 412. As an object (e.g., the shaft of a surgical tool) extends through the central opening 404, the duckbill seal 412 opens along the dividing line(s) 416 as the seal flap 418 separates, engaging with the outer circumference of the object and sealing against its outer circumference.

[0022] While the duckbill seal 412 is shown in a specific configuration and design, those skilled in the art will readily recognize that other configurations and designs may be adopted as alternatives without departing from the scope of this disclosure. For example, in some embodiments, the duckbill seal 412 may include two bisecting dividing lines (e.g., “double slits”) defining four or more seal flaps.

[0023] Figure 5 is a cross-sectional view of an integrated sealing system 306 perpendicular to the dividing line 416 in Figure 4B, according to one or more embodiments. As shown, the asymmetric seal 406 extends radially into the central opening 404 and terminates at the diaphragm 408, and the duckbill seal 412 extends distally from the bottom 414 of the body 402. In some embodiments, the integrated sealing system 306 may be molded as a single structure including both the asymmetric seal 406 and the duckbill seal 412. However, in other embodiments, the integrated sealing system 306 may include a multi-part structure. In such embodiments, the duckbill seal 306 may be overmolded onto the body 402, for example. Alternatively, the duckbill seal 306 may be attached to the body 402 using, for example, adhesive, ultrasonic welding, one or more mechanical fasteners, interlocking fits, snap-fits, or any combination thereof.

[0024] When an object such as the shaft of a surgical tool extends through the central opening 404, resistance is generated when the asymmetric seal 406 and the duckbill seal 412 engage independently with the outer circumference of the tool shaft. Depending on the distal extension and design of the duckbill seal 412, the insertion resistance and withdrawal resistance generated by the duckbill seal 412 on the tool shaft will differ. More specifically, the resistance generated by the sealing flap 418 engaging with the outer circumference of the tool shaft when the tool shaft is inserted (i.e., advancing distally) may be smaller (lower) than the resistance generated when the tool shaft is withdrawn (i.e., retracting proximal to the side).

[0025] Since the user (e.g., a surgeon) must actively adjust the insertion and withdrawal forces applied to the surgical tool during use, different insertion and withdrawal resistances can lead to hysteresis. Therefore, the user must mentally judge the amount of force required to insert or withdraw the surgical tool, which can negatively impact controllability and potentially cause injury or harm to the patient. In robotic surgical applications, the robot is powered by one or more motors capable of pushing and pulling the surgical tool. Different insertion and withdrawal resistances necessitate separately programming and calibrating the robot for opposite movements so that the same but opposite command input speeds for tool insertion and withdrawal result in equal and opposite physical movements of the tool.

[0026] The asymmetric seal 406 may be configured to compensate for the different insertion and withdrawal resistances generated by the duckbill seal 412, thereby providing an integrated sealing system 306 with a consistent (uniform) total resistance during tool insertion and withdrawal. To achieve this, the asymmetric seal 406 may be adjusted to generate greater resistance during tool insertion and less resistance during tool withdrawal, or may be otherwise optimized. When the resistance generated by the asymmetric seal 406 is combined with the resistance generated by the duckbill seal 412, the net resistance generated by the integrated sealing system 306 as a whole may be equal (or nearly equal) in both the tool insertion and tool withdrawal directions. As a result, the user's (e.g., surgeon's) operation of the surgical tool may be more consistent and reliable, and in robotic surgical applications, it may be unnecessary to calibrate or program different speeds for tool insertion and tool withdrawal.

[0027] To enable the asymmetric seal 406 to generate greater tool insertion resistance and less tool removal resistance, the diaphragm 408 may extend (protrude or project) proximally from the duckbill seal 412 or in any other way away from the duckbill seal 412. In other words, the diaphragm 408 may be configured to project proximally from or in the proximal direction from the flange 410 in its relaxed state. In some embodiments, as shown, the diaphragm 408 may have a bulbous or spherical cross-section. However, in other embodiments, the diaphragm 408 may have other cross-sectional shapes, such as, but not limited to, polygonal, pyramidal, conical, frustoconical, oval, or any combination thereof.

[0028] In the illustrated embodiment, the diaphragm 408 has a spherical or circular cross-section and exhibits a diameter D. The size of the diameter D, the circumferential connection position of the cross-section to the annular flange 310, and the size and range (e.g., thickness T) of the annular flange 310 can be varied to adjust the asymmetric seal 406 to generate insertion and removal forces such that the net total insertion force and total removal force of the integrated seal system 306 are equal when superimposed with the corresponding insertion and removal forces of the duckbill seal 412.

[0029] As used herein, the terms “equal” or “equalize” do not necessarily mean exactly equal or exactly equalized. As described herein, for example, the asymmetric seal 406 may operate to offset or complement the resistance generated by the duckbill seal 412, thereby making the net resistance as a whole generated by the integrated seal system 306 “equal” or “equalized.” This does not mean that the net insertion resistance and withdrawal resistance are exactly equal or exactly equalized, although this may certainly be the case. Rather, equalizing the net insertion resistance and withdrawal resistance means, through the operation of the asymmetric seal 406, bringing the magnitude of the total insertion resistance closer to the total withdrawal resistance, or vice versa.

[0030] Figures 6A to 6E are progressive cross-sectional side views of an exemplary integrated seal system 306 in operation according to one or more embodiments. More specifically, Figures 6A to 6D show the shaft 602 of an exemplary surgical tool in the process of being inserted into the integrated seal system 306 (i.e., advanced distally), and Figure 6E shows the shaft 602 being withdrawn from the integrated seal system 306 (i.e., retracted proximal to the other side). In Figure 6A, the shaft 602 advances distally toward the integrated seal system 306, as indicated by arrow A. Before the shaft 602 penetrates the integrated seal system 306, the diaphragm 408 protrudes proximal to the other side in its relaxed state. As described above, this allows the asymmetric seal 406 to have greater tool insertion resistance compared to the resistance generated during tool withdrawal. Furthermore, before the shaft 602 penetrates the integrated sealing system 306, the duckbill seal 412 remains closed at the dividing line(s) 416, which helps maintain air supply.

[0031] In Figure 6B, the shaft 602 advances a short distance distally A into the integrated seal system 306, and the diaphragm 408 engages with the outer surface 604 of the shaft 602. The engagement between the diaphragm 408 and the outer surface 604 provides a fluid seal that prevents the fluid (i.e., gas and liquid) from moving in any direction beyond its position. Furthermore, the friction that the diaphragm 408 generates against the shaft 602 causes the diaphragm 408 to bend distally, generating an insertion resistance force against the outer surface 604. At this point, as a result of the radial load on the diaphragm 408, which is partially transmitted to the duckbill seal 412, the duckbill seal 412 can also begin to open at the dividing line 416.

[0032] In Figure 6C, the shaft 602 advances further distally A into the integrated seal system 306, where it engages with the inner wall of the duckbill seal 412, more specifically, with the inner wall of the seal flap 418. The insertion resistance force generated by the diaphragm 408 against the outer surface 604 of the shaft 602 may remain constant as the shaft 602 continues its distal movement. Additional insertion resistance is generated as the shaft 602 advances through the duckbill seal 412 and the seal flap 418 engages with the outer surface 604 of the shaft 602. However, because the seal flap 418 is designed to protrude distally, the insertion resistance force generated by the duckbill seal 412 is smaller compared to the withdrawal resistance force when the shaft 602 is withdrawn proximal.

[0033] In Figure 6D, the shaft 602 advances distally A, completely penetrating the integrated seal system 306 and fully engaging with the inner wall of the seal flap 418. The insertion resistance forces generated by the diaphragm 408 and the seal flap 418 are combined here to provide the total insertion resistance force that the integrated seal system 306 generates against the shaft 602. The insertion resistance force that the diaphragm 408 and the seal flap 418 generate against the outer surface 604 of the shaft 602 may remain constant as the shaft 602 continues its distal movement.

[0034] Figure 6E shows the shaft 602 being withdrawn proximally from the integrated seal system 306, as indicated by arrow B. As the shaft 602 reverses direction, the friction generated by the diaphragm 408 against the shaft 602 causes the diaphragm 408 to bend proximally, generating an withdrawal resistance force against the outer surface 604. Because the diaphragm 408 naturally protrudes in the proximal direction B, the withdrawal resistance force generated by the asymmetric seal 406 may be less than its insertion resistance force. As the seal flap 418 continues to engage with the outer surface 604 of the shaft 602, the duckbill seal 412 generates an additional withdrawal resistance force. Because the seal flap 418 naturally extends distally, the withdrawal resistance force generated by the duckbill seal 412 may be greater than its insertion resistance force.

[0035] The withdrawal resistance forces generated by the diaphragm 408 and the seal flap 418, combined, provide the total withdrawal resistance force generated by the integrated seal system 306 against the shaft 602. Because the asymmetric seal 406 is designed to complement (cancel out) the insertion and withdrawal forces of the duckbill seal 412, the total insertion and withdrawal resistance forces of the integrated seal system 306 can be equalized, or otherwise made equal in both directions. Therefore, a user (e.g., a surgeon) or robot can insert or withdraw a surgical tool through the integrated seal system 306 by applying the same or equal amount of force to the shaft 602.

[0036] Figure 7 is an enlarged cross-sectional side view of another trocar assembly 700 that may incorporate the principles of the present disclosure according to one or more embodiments. The trocar assembly 700 may be similar in some respects to the trocar assembly 100 of Figures 1 to 3, and can therefore be best understood by referring to the trocar assembly 100. In the figures, similar numbers again represent similar components that are not described in detail. Similar to the trocar assembly 100 of Figures 1 to 3, the trocar assembly 700 may include a trocar 102 and a seal cartridge 104 at least partially received within a trocar housing 108. However, unlike the trocar assembly 100 of Figures 1 to 3, the trocar bushing 106 (Figures 1 to 3) is omitted from the trocar assembly 700, as generally described above, and the first seal 302 of the seal cartridge 104 (Figure 3) is replaced by an integrated seal system 306.

[0037] The integrated seal system 306 is located within a central passage 704 that extends axially through the trocar assembly 700. Similar to the central passage 308 in Figure 3, the central passage 704 includes an elongated path that extends axially through the trocar assembly 700, providing a conduit for guiding and introducing surgical tools into the patient's internal body cavity. In the illustrated embodiment, the central passage 704 is continuously defined by the seal cartridge 104 and the trocar 102. The surgical tool can be introduced into the trocar 102 by extending through the central orifice 204 and continuously penetrating the integrated seal system 306 and the second seal 304, and can extend into the cannula 110. In such an embodiment, the asymmetric seal 406 may be designed and optimized to complement (cancel out) the insertion and withdrawal resistances generated by both the duckbill seal 412 and the second seal 304. Therefore, the asymmetric seal 406 may be configured to equalize the net resistance to the shaft of the surgical tool during insertion and removal.

[0038] Figure 8 is an enlarged cross-sectional side view of another trocar assembly 800 that may incorporate the principles of the present disclosure according to one or more embodiments. The trocar assembly 800 may be similar in some respects to the trocar assembly 700 of Figure 7, and is therefore best understood by reference to the trocar assembly 700. In the figure, similar numbers again represent similar components that are not described in detail. Similar to the trocar assembly 700 of Figure 7, the trocar assembly 800 may include a trocar 102 and a seal cartridge 104 at least partially received within a trocar housing 108.

[0039] However, unlike the trocar assembly 700 in Figure 7, the seal cartridge 104 may include a shaft seal referred to herein as an integrated seal system 802, which includes an asymmetric seal 804 axially separated from the duckbill seal 806. The asymmetric seal 804 and the duckbill seal 806 may be structurally and functionally similar to the asymmetric seal 406 and the duckbill seal 412 of the integrated seal system 306 in Figures 3, 4A-4B, and 5. However, the asymmetric seal 804 and the duckbill seal 806 in Figure 8 may include independent structures axially offset from each other or otherwise positioned in separate locations within the seal cartridge 104.

[0040] The integrated seal system 802 is located within a central passage 808 that extends axially through the trocar assembly 800. Similar to the central passage 308 in Figure 3, the central passage 808 includes an elongated path that extends axially through the trocar assembly 800, providing a conduit for guiding and introducing surgical tools into the patient's internal body cavity. In the illustrated embodiment, the central passage 808 is continuously defined by the seal cartridge 104 and the trocar 102. The surgical tool can be introduced into the trocar 102 by extending through the central orifice 204, passing through the integrated seal system 802, and more specifically by continuously passing through the asymmetric seal 804 and the duckbill seal 806, and then extending into the cannula 110. The integrated seal system 802 operates similarly to the integrated seal system 306 in Figures 3, 4A-4B, and 5, in that the asymmetric seal 804 can be designed and optimized to complement (cancel out) the insertion and withdrawal resistance generated by the duckbill seal 80. Thus, the asymmetric seal 804 can be configured to equalize the net resistance to the shaft of the surgical tool during insertion and withdrawal.

[0041] Figure 9 is an enlarged cross-sectional side view of another trocar assembly 900 that may incorporate the principles of the present disclosure according to one or more embodiments. The trocar assembly 900 may be similar in some respects to the trocar assembly 100 of Figures 1 to 3, and can therefore be best understood by referring to the trocar assembly 100. In the figures, similar numbers again represent similar components that are not described in detail. Similar to the trocar assembly 100 of Figures 1 to 3, the trocar assembly 900 may include a trocar 102. However, unlike the trocar assembly 100 of Figures 1 to 3, the trocar bushing 106 and seal cartridge 104 are omitted from the trocar assembly 900, and an integrated seal system 306, as generally described herein, may be operably coupled to the trocar housing 108. In the illustrated embodiment, the integrated seal system 306 is mounted at least partially outside the trocar housing 108. However, in other embodiments, as intended herein, the integrated sealing system 306 may be positioned entirely within the trocar housing 108, such as via a snap-fit ​​engagement with the inner wall of the trocar housing 108.

[0042] The integrated seal system 306 is located within a central passage 902 that extends axially through the trocar assembly 900. Similar to the central passage 308 in Figure 3, the central passage 902 includes an elongated path that extends axially through the trocar assembly 900, providing a conduit for guiding and introducing surgical tools into the patient's internal body cavity. In the illustrated embodiment, the central passage 902 is continuously defined by the trocar housing 108 and the cannula 110. The surgical tool can be introduced into the trocar 102 and extend into the cannula 110 by passing through the integrated seal system 306. As broadly described above, the asymmetric seal 406 can complement (cancel out) the insertion and withdrawal resistance generated by the duckbill seal 412, thereby equalizing the net resistance to the shaft of the surgical tool during insertion and withdrawal.

[0043] The embodiments disclosed herein include the following: A. A trocar assembly comprising a trocar including a trocar housing and a cannula extending distally from the trocar housing, and an integrated sealing system positioned in a central passage extending axially through the trocar and engaging with the shaft of a surgical tool extending through the central passage, wherein the integrated sealing system comprises an asymmetric seal and a duckbill seal positioned distal to the asymmetric seal, the asymmetric seal defining a diaphragm that complements the insertion and withdrawal forces generated by the duckbill seal with respect to the shaft of a surgical tool, such that the total insertion and withdrawal forces generated by the integrated sealing system are equalized. B. A method comprising positioning a trocar assembly adjacent to a patient, wherein the trocar assembly comprises a trocar having a trocar housing and a cannula extending distally from the trocar housing, and an integrated sealing system positioned in a central passage extending axially through the trocar, the integrated sealing system comprising an asymmetric seal having a diaphragm and a duckbill seal positioned distal to the asymmetric seal. The method further includes inserting the shaft of a surgical tool into a central passage, thereby penetrating an integrated seal system; generating a first insertion resistance force when the diaphragm engages with the shaft of the surgical tool; generating a second insertion resistance force when the duckbill seal engages with the shaft of the surgical tool; and withdrawing the shaft of the surgical tool from the central passage, thereby generating a first withdrawal resistance force by the diaphragm and a section withdrawal resistance force by the duckbill seal, wherein the first insertion resistance force complements the second insertion resistance force and the first withdrawal resistance force complements the second withdrawal resistance force, so as to equalize the total insertion resistance force and total withdrawal resistance force generated by the integrated seal system. C. An integrated seal system comprising: a body defining a central opening; a duckbill seal extending distally from the bottom of the body and defining one or more dividing lines separating opposing seal flaps; and an asymmetric seal defined by the body and extending radially into the central opening, the asymmetric seal comprising a diaphragm and an annular flange extending between the body and the diaphragm, wherein the diaphragm complements the insertion and extraction resistance generated by the duckbill seal on the shaft of a surgical tool extending through the duckbill seal, such that the total insertion and extraction resistance generated by the integrated seal system is equalized.

[0044] Each of embodiments A, B, and C may have one or more of the following additional elements in any combination: Element 1: Further comprising a seal cartridge releasably connected to a trocar, and a trocar bushing releasably connected to the seal cartridge and having a reducer shaft extending through the seal cartridge into the cannula, wherein a central passage is defined by the trocar bushing. Element 2: An integrated seal system is located at the proximal end of the reducer shaft. Element 3: Further comprising a seal cartridge releasably connected to a trocar, wherein a central passage is continuously defined by the seal cartridge and the trocar, and a diaphragm complements the insertion and withdrawal resistances generated by the duckbill seal and an additional seal located within the seal cartridge, thereby equalizing the total insertion and withdrawal resistances generated by the integrated seal system and the additional seal. Element 4: Further includes a seal cartridge releasably connected to a trocar, wherein a central passage is continuously defined by the seal cartridge and the trocar, and the asymmetric seal and duckbill seal are independent structures axially offset from each other within the central passage. Element 5: The integrated seal system is mounted on the trocar housing. Element 6: The integrated seal system includes a body defining a central opening, the asymmetric seal being defined by the body and extending radially within the central opening, and the duckbill seal extending distally from the bottom of the body. Element 7: An annular flange extends between the body and the diaphragm. Element 8: The asymmetric seal generates greater resistance during tool insertion and less resistance during tool removal, and the duckbill seal generates less resistance during tool insertion and greater resistance during tool removal. Element 9: The diaphragm has a cross-sectional shape selected from the group consisting of bulbous, spherical, polygonal, pyramidal, conical, frustoconical, oval, and any combination or combination thereof. Element 10: The diaphragm protrudes proximally to the duckbill seal.

[0045] Element 11: The trocar assembly further includes a seal cartridge releasably connected to the trocar, and a trocar bushing releasably connected to the seal cartridge and having a reducer shaft extending through the seal cartridge into the cannula, wherein a central passage is defined by the trocar bushing. Element 12: The trocar assembly further includes a seal cartridge releasably connected to the trocar, wherein a central passage is continuously defined by the seal cartridge and the trocar, and the method further includes generating a third insertion resistance force when an additional seal located within the seal cartridge engages with the shaft of a surgical tool, generating a third withdrawal resistance force by the additional seal when the surgical tool is withdrawn, and complementing the second and third insertion resistance forces with a first insertion resistance force and the second and third withdrawal resistance forces with a first withdrawal resistance force so that the total insertion resistance force and total withdrawal resistance force generated by the integrated seal system and the additional seal are equalized. Element 13: The trocar assembly further includes a seal cartridge releasably connected to the trocar, a central passage continuously defined by the seal cartridge and the trocar, and an asymmetric seal and a duckbill seal, which are independent structures axially offset from each other within the central passage. Element 14: An integrated seal system is mounted on the trocar housing.

[0046] Element 15: The asymmetric seal is engageable with the shaft of the surgical tool and generates greater resistance during tool insertion and less resistance during tool removal, while the duckbill seal generates less resistance during tool insertion and greater resistance during tool removal. Element 16: The diaphragm has a cross-sectional shape selected from the group consisting of bulbous, spherical, polygonal, pyramidal, conical, frustoconical, oval, and any combination or combination thereof. Element 17: The body is made of an elastic or flexible material selected from the group consisting of rubber, silicone, ethylene vinyl acetate, nylon, vinyl, spandex, polyurethane, polyethylene, polypropylene, polyisoprene, and any combination thereof.

[0047] As a non-restrictive example, exemplary combinations applicable to A, B, and C include element 1 with element 2, and element 6 with element 7.

[0048] Accordingly, the systems and methods disclosed are well-adapted to achieve the results and benefits mentioned, as well as the inherent results and benefits therein. The teachings of this disclosure can be modified and implemented in equivalent ways that are evident to those skilled in the art who are interested in the teachings herein, although different; therefore, the specific embodiments disclosed above are merely illustrative. Furthermore, it is not intended to limit the details of the structures or designs shown herein other than those described in the following claims. Accordingly, the specific exemplary embodiments disclosed above may be modified, combined, or altered, and all such variations are considered to be within the scope of this disclosure. The systems and methods illustrated herein can be adequately implemented in the absence of any elements not specifically disclosed herein and / or any optional elements disclosed herein. Compositions and methods are described using the terms “comprising,” “containing,” or “including” various components and processes, but compositions and methods may also “consist essentially of” or “consist of” various components and processes. All numbers and ranges disclosed above may differ to some extent. Whenever a numerical range with lower and upper limits is disclosed, any number and any range that falls within that range is specifically disclosed. In particular, all ranges of values ​​(of form) disclosed herein ("about a to about b," or equivalently "about a to b (from approximately a to b)," or equivalently "about a to b (from approximately ab)") should be understood to describe all numbers and ranges that fall within a broad range of values. Furthermore, terms in the claims have plain and ordinary meanings unless explicitly and clearly defined otherwise by the patentee. In addition, when used in claims, the indefinite article "a" or "an" is defined herein to mean one or more of the elements it introduces.In the event of any inconsistency in the use of a word or term in this Specified Patent or other document that may be incorporated herein by reference, the definition consistent with this Specified Patent or other Patent or other Document should be adopted.

[0049] The terms “proximal” and “distal” are defined herein in relation to a surgeon or a robotic surgical system having an interface configured to mechanically and electrically connect a surgical tool to a robotic manipulator. The term “proximal” refers to the location of an element closer to the surgeon or robotic manipulator, and the term “distal” refers to the location of an element further away from the surgeon or robotic manipulator. Furthermore, the use of directional terms such as up, down, superior, downward, upward, downward, left, right, etc., is used in relation to representative embodiments as shown in the figures, where upward or upward direction is toward the top of the corresponding figure, and downward or downward direction is toward the bottom of the corresponding figure.

[0050] As used herein, the phrase “at least one of” preceding a set of items is accompanied by the terms “and” or “or” to separate any of the items, but modifies the list as a whole, rather than each individual component of the list (i.e., each item). The phrase “at least one of” allows for meanings that include at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” mean A only, B only, or C only, any combination of A, B, and C, and / or at least one of each of A, B, and C, respectively.

[0051] [Implementation Method] (1) A trocar assembly, A trocar comprising a trocar housing and a cannula extending distally from the trocar housing, An integrated seal system comprising an integrated seal system located in a central passage extending axially through the trocar and engaged with the shaft of a surgical tool extending through the central passage, wherein the integrated seal system comprises an asymmetric seal and a duckbill seal positioned distal to the asymmetric seal, A trocar assembly in which the asymmetrical seal defines a diaphragm that complements the insertion and extraction resistance generated by the duckbill seal on the shaft of the surgical tool, such that the total insertion and extraction resistance generated by the integrated sealing system is equalized. (2) A seal cartridge releasably connected to the trocar, The trocar assembly according to Embodiment 1, further comprising a trocar bushing having a reducer shaft releasably connected to the seal cartridge and extending through the seal cartridge into the cannula, wherein the central passage is defined by the trocar bushing. (3) The trocar assembly according to Embodiment 2, wherein the integrated seal system is located at the proximal end of the reducer shaft. (4) The trocar assembly according to Embodiment 1, further comprising a seal cartridge releasably connected to the trocar, wherein the central passage is continuously defined by the seal cartridge and the trocar, and the diaphragm complements the insertion and withdrawal resistances generated by the duckbill seal and an additional seal disposed within the seal cartridge, thereby equalizing the total insertion and withdrawal resistances generated by the integrated seal system and the additional seal. (5) The trocar assembly according to Embodiment 1, further comprising a seal cartridge releasably connected to the trocar, wherein the central passage is continuously defined by the seal cartridge and the trocar, and the asymmetric seal and the duckbill seal are independent structures offset axially from each other within the central passage.

[0052] (6) The trocar assembly according to Embodiment 1, wherein the integrated sealing system is mounted on the trocar housing. (7) The trocar assembly according to Embodiment 1, wherein the integrated sealing system includes a body defining a central opening, the asymmetric seal being defined by the body and extending radially within the central opening, and the duckbill seal extending distally from the bottom of the body. (8) The trocar assembly according to embodiment 7, wherein an annular flange extends between the main body and the diaphragm. (9) The trocar assembly according to Embodiment 1, wherein the asymmetric seal generates greater resistance during tool insertion and less resistance during tool removal, and the duckbill seal generates less resistance during tool insertion and greater resistance during tool removal. (10) The trocar assembly according to Embodiment 1, wherein the diaphragm has a cross-sectional shape selected from the group consisting of bulbous, spherical, polygonal, pyramidal, conical, frustoconical, oval, and any combination or a combination thereof.

[0053] (11) The trocar assembly according to Embodiment 1, wherein the diaphragm protrudes proximally to the duckbill seal. (12) A method, Positioning the trocar assembly adjacent to the patient, the trocar assembly is A trocar having a trocar housing and a cannula extending distally from the trocar housing, An integrated seal system located in a central passage extending axially through the trocar, the integrated seal system comprising an asymmetric seal having a diaphragm and a duckbill seal positioned distal to the asymmetric seal, and the integrated seal system comprising an integrated seal system comprising an asymmetric seal having a diaphragm and a duckbill seal positioned distal to the asymmetric seal, The shaft of the surgical tool is inserted into the central passage, thereby passing through the integrated seal system. The diaphragm generates a first insertion resistance force when it engages with the shaft of the surgical tool, The duckbill seal generates a second insertion resistance force when it engages with the shaft of the surgical tool, This includes removing the shaft of the surgical tool from the central passage, thereby generating a first withdrawal resistance force by the diaphragm and a section withdrawal resistance force by the duckbill seal, A method in which the first insertion resistance complements the second insertion resistance and the first removal resistance complements the second removal resistance so that the total insertion resistance and total removal resistance generated by the integrated sealing system are equalized. (13) The method according to Embodiment 12, wherein the trocar assembly further comprises a seal cartridge releasably connected to the trocar, and a trocar bushing having a reducer shaft releasably connected to the seal cartridge and extending through the seal cartridge into the cannula, the central passage being defined by the trocar bushing. (14) The trocar assembly further includes a seal cartridge releasably connected to the trocar, the central passage being continuously defined by the seal cartridge and the trocar, and the method is When the additional seal placed within the seal cartridge engages with the shaft of the surgical tool, a third insertion resistance force is generated. When the surgical tool is removed, the additional seal generates a third resistance to removal, The method according to Embodiment 12, further comprising: supplementing the second and third insertion resistances with the first insertion resistance, and supplementing the second and third removal resistances with the first removal resistance, so that the total insertion resistance and total removal resistance generated by the integrated seal system and the additional seals are equalized. (15) The method according to Embodiment 12, wherein the trocar assembly further includes a seal cartridge releasably connected to the trocar, the central passage being continuously defined by the seal cartridge and the trocar, and the asymmetric seal and the duckbill seal being independent structures axially offset from each other within the central passage.

[0054] (16) The method according to embodiment 12, wherein the integrated sealing system is mounted on the trocar housing. (17) An integrated sealing system, The main body defines the central opening, A duckbill seal extending distally from the bottom of the main body and defining one or more dividing lines separating opposing seal flaps, An asymmetric seal defined by the body and extending radially within the central opening, comprising a diaphragm and an annular flange extending between the body and the diaphragm, An integrated sealing system in which the diaphragm complements the insertion and withdrawal resistance generated by the duckbill seal on the shaft of a surgical tool extending through the duckbill seal, so as to equalize the total insertion and withdrawal resistance generated by the integrated sealing system. (18) The integrated seal system according to Embodiment 17, wherein the asymmetric seal is engageable with the shaft of the surgical tool and generates greater resistance during tool insertion and less resistance during tool removal, and the duckbill seal generates less resistance during tool insertion and greater resistance during tool removal. (19) The integrated seal system according to Embodiment 17, wherein the diaphragm has a cross-sectional shape selected from the group consisting of bulbous, spherical, polygonal, pyramidal, conical, frustoconical, oval, and any combination or a combination thereof. (20) The integral seal system according to Embodiment 17, wherein the main body is made of an elastic or flexible material selected from the group consisting of rubber, silicone, ethylene vinyl acetate, nylon, vinyl, spandex, polyurethane, polyethylene, polypropylene, polyisoprene, and any combination thereof.

Claims

1. It is an integrated sealing system, The main body defines the central opening, A duckbill seal extending distally from the bottom of the main body and defining one or more dividing lines separating opposing seal flaps, An asymmetric seal extending radially from the main body into the central opening, comprising a diaphragm and an annular flange extending between the main body and the diaphragm, The main body has an outer end and an inner end, and the duckbill seal extends distally from the bottom of the main body at the inner end. The aforementioned main body is The first annular portion extending distally from the bottom of the main body at the outer end, The inner end includes a second annular portion extending proximal to the top of the main body, When the diaphragm is in a relaxed state, a portion of the diaphragm protrudes proximally to the annular flange, and the second annular portion is configured to protrude proximally to the diaphragm. The diaphragm complements the insertion and withdrawal resistance generated by the duckbill seal on the shaft of the surgical tool extending through the duckbill seal, so that the total insertion and withdrawal resistance generated by the integrated sealing system are equalized. An integrated sealing system in which the asymmetric seal is engageable with the shaft of the surgical tool and generates greater resistance during tool insertion and less resistance during tool removal, and the duckbill seal generates less resistance during tool insertion and greater resistance during tool removal.

2. The integrated seal system according to claim 1, wherein the diaphragm has a cross-sectional shape selected from the group consisting of bulbous, spherical, polygonal, pyramidal, conical, frustoconical, oval, and any combination or a combination thereof.

3. The integrated seal system according to claim 1, wherein the main body is made of an elastic or flexible material selected from the group consisting of rubber, silicone, ethylene vinyl acetate, nylon, vinyl, spandex, polyurethane, polyethylene, polypropylene, polyisoprene, and any combination thereof.

4. The integrated seal system according to claim 1, wherein the diaphragm has a cross-sectional thickness greater than the cross-sectional thickness of the annular flange.

5. The integrated seal system according to claim 4, wherein the duckbill seal has a first surface facing proximal direction and a second surface facing distal direction, and the first surface includes a flat portion extending parallel to the second surface and a convex portion extending between the flat portion and the dividing line.

6. Trocar assembly, A trocar comprising a trocar housing and a cannula extending distally from the trocar housing, A trocar assembly comprising an integrated seal system according to claim 1, the integrated seal system being located in a central passage extending axially through the trocar.

7. The trocar assembly according to claim 6, further comprising a seal cartridge releasably connected to the trocar, wherein the central passage is continuously defined by the seal cartridge and the trocar.

8. A seal cartridge releasably connected to the trocar, The trocar assembly according to claim 6, further comprising a trocar bushing having a reducer shaft releasably connected to the seal cartridge and extending through the seal cartridge into the cannula, wherein the central passage is defined by the trocar bushing.

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