Seal assembly for surgical access assembly and method of making same - Patents.com

Abstract

To provide a seal assembly for a surgical access assembly, and a method of manufacturing the same.SOLUTION: A method of manufacturing a seal assembly for a surgical access assembly includes forming a seal assembly having a monolithic construction. The seal assembly includes a support member, seal sections connected to the support member, bridges disposed between adjacent seal sections and interconnecting the adjacent seal sections, and a plurality of standoffs extending from each seal section. The method also includes placing the seal assembly in a treatment bath, cutting the bridges, and folding the seal assembly.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present disclosure relates generally to surgical access assemblies for minimally invasive surgery. In particular, the present disclosure relates to a seal assembly for a surgical access assembly, and the manufacture thereof. [Background technology]

[0002] Minimally invasive surgical procedures, including endoscopic and laparoscopic procedures, allow surgery to be performed on organs, tissues, and vessels far removed from an opening in the tissue. Laparoscopic procedures require the creation of a working space at the intended surgical site. An insufflation fluid, typically CO2, is introduced into the patient's abdomen to create an inflated state called pneumoperitoneum. Surgical access assemblies allow the introduction of surgical instrumentation and an endoscope (or other visualization tool) into the abdominal cavity and are utilized to perform one or more surgical tasks. These surgical access assemblies have one or more seals that fit the surgical instrumentation and thus maintain the pneumoperitoneum pressure. Typically, a "zero seal" in a surgical access assembly seals the surgical access assembly when there is no surgical instrument in the surgical access assembly, and an instrument seal seals around a surgical instrument inserted through the surgical access assembly.

[0003] The wide range of surgical instrumentation on the market today requires robust seals that can accommodate and accommodate multiple sizes of surgical instrumentation and withstand multiple insertions of the surgical instrumentation. Some surgical instrumentation may include sharp edges that can tear or otherwise damage the seal, and / or some seals (e.g., seals with solid inner diameters) are subject to higher insertion forces and are less durable for certain surgical instrumentation (e.g., the seal may tear during insertion, causing leakage or dislodging of the seal into the patient's abdominal cavity). Therefore, it would be beneficial to have a surgical access assembly with improved seal durability and an easy and consistent method of manufacturing the same. Summary of the Invention [Means for solving the problem]

[0004] In one aspect, the present disclosure provides a method of manufacturing a seal assembly for a surgical access assembly, the method including forming a seal assembly having a monolithic structure. The seal assembly includes a support member, a seal segment connected to the support member, a bridge disposed between and interconnecting adjacent seal segments, and a plurality of standoffs extending from each seal segment. The method also includes placing the seal assembly in a processing bath, severing the bridge, and folding the seal assembly.

[0005] Forming the closure assembly may include molding the closure assembly from a common material.

[0006] Placing the closure assembly in a treatment bath may include placing the closure assembly in a chlorination bath.

[0007] Placing the closure assembly in the treatment bath may include placing a plurality of closure assemblies in the treatment bath.

[0008] The method may further include removing the encapsulation assembly from the treatment bath prior to severing the bridge.

[0009] Folding the closure assembly may include positioning the closure sections adjacent to the support member. Positioning the closure sections may include overlapping the closure sections in a continuous pattern.

[0010] In another aspect, the present disclosure provides a sealing assembly for a surgical access assembly including a support member, a sealing segment connected to the support member, a bridge disposed between adjacent sealing segments, and a plurality of standoffs extending from each of the sealing segments, The sealing assembly has a substantially planar, deployed state in which the sealing segments extend radially outward from the support member, and a folded state in which the plurality of sealing segments are positioned adjacent to the support member.

[0011] The sealing sections may include a first, second, third, fourth, fifth, and sixth sealing sections.The support member may be hexagonal.

[0012] When the seal assembly is in the folded state, each seal section may overlap two adjacent seal sections in each of the clockwise and counterclockwise directions.

[0013] The support member may define a central opening therethrough, and in the folded state, the inner edges of the sealing sections may define openings having a discontinuous sealing circumference. The openings of the sealing sections may be concentric with the central opening of the support member. The inner edges of each sealing section may be substantially V-shaped.

[0014] Each seal may be connected to the support member by a connector portion. Each connector portion may include a living hinge to enable folding of the respective seal section relative to the support member.

[0015] When the sealing assembly is in an unfolded state, the bridge may extend continuously between adjacent sealing sections such that the sealing sections are interconnected, and when the sealing assembly is in a folded state, the bridge may be interrupted between adjacent sealing sections such that the sealing sections are independent of one another.

[0016] The standoffs may be localized regions of material that are thicker than the thickness of the support member, the sealing section, and the bridge. The standoffs may extend from a side edge of each sealing section, and the standoffs may be disposed on an outer edge of the sealing assembly when the sealing assembly is in the folded state. The standoffs may be disposed in the same location on each sealing section. The present invention provides, for example: (Item 1) 1. A method of manufacturing a closure assembly for a surgical access assembly, comprising: 2. Forming a encapsulation assembly having a monolithic structure, the encapsulation assembly comprising: A support member; a sealing section connected to the support member; a bridge disposed between adjacent sealing sections and interconnecting the adjacent sealing sections; a plurality of standoffs extending from each sealing section; placing the encapsulation assembly in a treatment bath; severing the bridge; and and folding the closure assembly. (Item 2) 13. The method of claim 12, wherein forming the closure assembly includes molding the closure assembly from a common material. (Item 3) 13. The method of any of the preceding claims, wherein placing the closure assembly in a treatment bath comprises placing the closure assembly in a chlorination bath. (Item 4) 13. The method of any of the preceding claims, wherein placing the closure assembly in the treatment bath comprises placing a plurality of closure assemblies in the treatment bath. (Item 5) 13. The method of any of the preceding claims, further comprising removing the encapsulation assembly from the treatment bath before severing the bridge. (Item 6) 13. The method of any of the preceding claims, wherein folding the closure assembly includes positioning the closure section adjacent to the support member. (Item 7) 13. The method of any of the preceding claims, wherein positioning the sealing sections includes overlapping the sealing sections in a continuous pattern. (Item 8) 1. A seal assembly for a surgical access assembly, comprising: A support member; a sealing section connected to the support member; a bridge disposed between adjacent sealing sections; a plurality of standoffs extending from each sealing section; The sealing assembly has a substantially planar, deployed state in which the sealing section extends radially outward from the support member, and a folded state in which the sealing section is positioned adjacent to the support member. (Item 9) 2. The sealing assembly of any of the preceding items, wherein the sealing sections include first, second, third, fourth, fifth, and sixth sealing sections. (Item 10) 13. The seal assembly of any of the preceding claims, wherein the support member is hexagonal. (Item 11) Item 11. The seal assembly of any of the preceding items, wherein in the folded state, each seal section overlaps two adjacent seal sections in each of a clockwise and counterclockwise direction. (Item 12) 13. A seal assembly as described in any of the preceding items, wherein the support member defines a central opening therethrough, and in the folded state, inner edges of the seal sections define an opening having a discontinuous seal circumference, the opening being concentric with the central opening of the support member. (Item 13) Item 11. The seal assembly of any of the preceding items, wherein the inner edge of each seal section is substantially V-shaped. (Item 14) 11. The seal assembly of claim 1, wherein each seal section is connected to the support member by a connector portion, each connector portion including a living hinge for enabling folding of the respective seal section relative to the support member. (Item 15) 11. The sealing assembly of claim 1, wherein when the sealing assembly is in the unfolded state, the bridge extends continuously between adjacent sealing sections such that the sealing sections are interconnected, and when the sealing assembly is in the folded state, the bridge is interrupted between the adjacent sealing sections such that the sealing sections are independent of one another. (Item 16) 13. The sealing assembly of claim 12, wherein the standoffs are localized regions of material that are thicker than a thickness of the support member, the sealing section, and the bridge. (Item 17) 11. The sealing assembly of claim 1, wherein the standoffs extend from a side edge of each sealing section, and the standoffs are disposed on an outer edge of the sealing assembly when the sealing assembly is in the folded state. (Item 18) Item 11. The sealing assembly of any of the preceding items, wherein the plurality of standoffs are disposed at the same position on each sealing section. (Summary) A method of manufacturing a seal assembly for a surgical access assembly includes forming a seal assembly having a monolithic structure including a support member, a seal segment connected to the support member, a bridge disposed between and interconnecting adjacent seal segments, and a plurality of standoffs extending from each seal segment. The method also includes placing the seal assembly in a processing bath, severing the bridge, and folding the seal assembly.

[0017] The details of one or more embodiments of this disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the embodiments described in this disclosure will become apparent from the description and drawings, and from the claims. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a side perspective view of a surgical access assembly according to an aspect of the present disclosure. [Diagram 2] 2 is a side cross-sectional view of the surgical access assembly shown in FIG. 1 taken along section line 2-2. [Diagram 3] FIG. 1 is an exploded perspective view of a valve assembly with parts separated, including a centering mechanism, a guard assembly, a sealing assembly, and a retention assembly. [Figure 4]FIG. 4 is a top view of the closure assembly shown in FIG. 3 in an initial or pre-assembled state. [Diagram 5] FIG. 5 is a top perspective view of the closure assembly shown in FIG. 4 in a fully folded or assembled state. [Figure 6] FIG. 4 is a bottom perspective view of the valve assembly shown in FIG. 3 when assembled. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] The embodiments of the present disclosure are described below with reference to the accompanying drawings. However, it should be understood that the disclosed embodiments are merely examples of the present disclosure and may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limitations, but merely as a basis for claims and as a representative basis for teaching those skilled in the art to use the present disclosure in various ways in substantially any suitable detailed structure.

[0020] Like reference numbers refer to similar or identical elements throughout the description of the figures. Throughout this description, the term "proximal" refers to a portion of a structure, or component thereof, that is closer to the user, and the term "distal" refers to a portion of a structure, or component thereof, that is further from the user.

[0021] Surgical access assemblies having an obturator, known as a trocar assembly, are used during minimally invasive procedures, such as laparoscopic procedures, to provide insufflated, sealed access for surgical instruments to a body cavity, such as the abdominal cavity. The surgical access assembly of the present disclosure includes an instrument valve housing attached to a cannula. An obturator (not shown) is insertable through the instrument valve housing and cannula. The obturator can have a blunt distal end, or a bladed or non-bladed piercing distal end, and can be used to incise and / or separate tissue in the abdominal wall so that the surgical access assembly can be introduced into the abdomen. A handle of the obturator can engage or selectively lock to the instrument valve housing of the surgical access assembly.

[0022] Trocar assemblies are used to tunnel through an anatomical structure, e.g., the abdominal wall, by creating a new passageway through the anatomical structure or by passing through an existing opening through the anatomical structure. Once the surgical access assembly with the obturator has been tunneled through the anatomical structure, the obturator is removed, leaving the surgical access assembly in place. The instrument valve housing of the surgical access assembly contains a valve that prevents leakage of insufflation fluid from the body cavity while also allowing insertion of surgical instruments into the body cavity.

[0023] In various aspects, a bladeless optical trocar obturator may be provided that allows for the separation of tissue planes in a surgical procedure and visualization of body tissue fibers during separation, thereby allowing for a controlled traverse across the body wall. In other aspects, the trocar obturator may be bladeless, not optical, e.g., not providing simultaneous visualization through the distal tip of the trocar obturator. A bladeless trocar obturator may be provided for blunt dissection of the peritoneum during a surgical procedure.

[0024] A variety of trocar obturators suitable for use with the presently disclosed surgical access assemblies are known, including, for example, bladed, bladeless, blunt, optical, and non-optical. For a detailed description of the structure and function of an exemplary trocar assembly, including an exemplary trocar obturator and an exemplary cannula, see PCT Publication No. WO2016 / 186905 (the "'905 Publication"), the entire contents of which are incorporated herein by reference.

[0025] 1, a surgical access assembly according to an embodiment of the present disclosure is generally shown as surgical access assembly 100. Surgical access assembly 100 includes a cannula 102 and an instrument valve housing 110 secured to cannula 102. For a detailed description of an exemplary surgical access assembly, see the '905 Publication.

[0026] 2, the instrument valve housing 110 of the surgical access assembly 100 includes an upper housing segment 112, a lower housing segment 114, and an inner housing segment 116. The upper, lower, and inner housing segments 112, 114, 116 are configured to support a valve assembly 120 on a proximal end of the cannula 102. More specifically, the inner housing segment 116 is secured between the upper housing segment 112 and the lower housing segment 114, and the valve assembly 120 is received between the inner housing segment 116 and the lower housing segment 114. The upper housing segment 112 and the lower housing segment 114 of the instrument valve housing 110 may be selectively attachable to and removable from the inner housing segment 116. The lower housing segment 114 may be releasably or permanently attached to the cannula tube 104 (FIG. 1) of the cannula 102. In embodiments, either or both of the upper housing section 112 and the lower housing section 114 of the instrument valve housing 110 may include knots, notches, tabs, or otherwise be configured to facilitate engagement by the clinician.

[0027] The surgical access assembly 100 may also include features for stabilization of the surgical access assembly 100. For example, the distal end of the cannula tube 104 may carry a balloon anchor or another expandable member that engages the abdomen from the inside. See, for example, U.S. Patent No. 7,300,448, the entire contents of which are incorporated herein by reference. Features on the opposite side of the abdominal wall may be used to further stabilize the surgical access assembly 100, such as adhesive tabs or an adjustable foam collar.

[0028] The upper, lower, and inner housing sections 112, 114, 116 of the instrument valve housing 110 define a longitudinal passageway 111 for receiving a surgical instrument (not shown). A valve assembly 120 is supported within the instrument valve housing 110 to provide a sealed passageway of the surgical instrument (not shown) through the surgical access assembly 100.

[0029] 2 and 3, the valve assembly 120 supported within the instrument valve housing 110 includes a centering mechanism 130, a guard assembly 140, a sealing assembly 160, and a retaining assembly 180. The centering mechanism 130 of the valve assembly 120 allows radial movement of the valve assembly 120 relative to the instrument valve housing 110 when a surgical instrument is received therethrough, and returns the valve assembly 120 to a substantially centered position when the surgical instrument is withdrawn from within the instrument valve housing 110. The guard assembly 140 protects the sealing assembly 160 during insertion and withdrawal of the surgical instrument through the sealing assembly 160. The sealing assembly 160 provides a sealed passage of the surgical instrument through the instrument valve housing 110. The retaining assembly 180 maintains the centering mechanism 130, the guard assembly 140, and the sealing assembly 160 in an aligned relationship with one another.

[0030] 2 and 3, as discussed above, the centering mechanism 130 of the valve assembly 120 is configured to maintain the valve assembly 120 centered within the instrument valve housing 110 in the absence of a surgical instrument passing therethrough. In an embodiment, as shown, the centering mechanism 130 includes an outer annular ring 132, an inner annular ring 134, and a bellows 136 disposed between the outer annular ring 132 and the inner annular ring 134. The outer annular ring 132 is received between the inner housing section 116 and the lower housing section 114 to retain the centering mechanism 130 within the instrument valve housing 110. The inner annular ring 134 supports the guard assembly 140. For a detailed description of the structure and function of an exemplary centering mechanism, see U.S. Pat. No. 6,702,787, the contents of which are incorporated herein by reference in their entirety.

[0031] Although centering mechanism 130 is shown as having bellows 136, valve assembly 120 may include alternative centering mechanisms. For example, the centering mechanism may include an annular base and a number of spokes extending from the base, as described in U.S. Patent Application Publication No. 2015 / 0025477 (the "'477 Publication"), the entire contents of which are incorporated herein by reference. It is contemplated that the centering mechanism may include multiple sets of spokes, as disclosed in the '477 Publication.

[0032] 2 and 3, guard assembly 140 of valve assembly 120 is configured to protect sealing assembly 160 as a surgical instrument (not shown) passes through instrument valve housing 110. Guard assembly 140 includes a ring portion 142 and first, second, third, and fourth petals 144, 146, 148, 150. First, second, third, and fourth petals 144, 146, 148, 150 define openings 141 therebetween to facilitate sealed passage of a surgical instrument (not shown) through guard assembly 140. While shown as including four (4) petals, it is envisioned that guard assembly 140 may include any suitable number of petals, and that the petals may include flap portions of any size or configuration. For a detailed description of the structure and function of other exemplary guard assemblies, see U.S. Pat. Nos. 5,895,377 and 6,569,120, and U.S. patent application Ser. Nos. 16 / 394,043 and 16 / 238,823, the contents of each of which are incorporated by reference in their entirety herein.

[0033] Seal assembly 160 of valve assembly 120 is configured to provide a seal around an outer surface of a surgical instrument passing through instrument valve housing 110 (FIG. 1). In embodiments, and as shown, seal assembly 160 forms a flat seal. However, it is envisioned that embodiments of the present disclosure may be modified for use with a conical seal.

[0034] 4, the sealing assembly 160 is shown in an initial or pre-assembled state. The sealing assembly 160 includes a support member 162 and first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174, secured to the support member 162 by respective connector portions 164a, 166a, 168a, 170a, 172a, 174a. The connector portions 164a, 166a, 168a, 170a, 172a, 174a may include one or more living hinges as shown or may be otherwise configured to enable folding of the respective first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 relative to the support member 162.

[0035] In embodiments, the support member 162 and the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 of the sealing assembly 160 are formed of the same material, including, for example, polyurethane, polyisoprene, or a silicone elastomer (e.g., liquid silicone rubber). Alternatively, the support member 162 and the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 may be formed of different materials. In some embodiments, the support member 162 and / or the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 may include one or more fabric layers.

[0036] The support member 162 of the seal assembly 160 includes a hexagonal body or ring portion 162a, a seal portion 162b supported within the ring portion 162a. The ring portion 162a and the seal portion 162b may be formed of the same or different materials. The seal portion 162b defines a central opening 161. The support member 162a defines a plurality of openings 163 that correspond to a plurality of pins 186 (FIG. 3) extending from the upper retaining member 182 of the retaining assembly 180. The seal portion 162a provides additional support to the first, second, third, fourth, fifth and sixth seal sections 164, 166, 168, 170, 172, 174 when the seal assembly 160 is in the collapsed configuration.

[0037] In the embodiment, as shown, the ring portion 162a and the sealing portion 162b of the support member 162 are of unitary construction, i.e., monolithic, including first, second, third, fourth, fifth, and sixth sealing sections 164,166,168,170,172,174. Instead of including a ring portion for the sealing portion and separate ring portions for the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174, incorporating the ring portion 162a into the sealing portion 162b of the support member 162 of the sealing assembly 160 and forming the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 on the ring portion 162a of the support member 162 reduces the number of components in the sealing assembly 160, and ultimately the valve assembly 120. Incorporating the sealing portion 162b and the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 into the same ring portion 162 also reduces assembly time and reduces material costs.

[0038] When in a folded or assembled state (FIG. 5), the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 of the sealing assembly 160 define an opening 161a configured to receive a surgical instrument (not shown) inserted through the valve assembly 120 (FIG. 3) in a sealed manner. The first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 form a discontinuous or virtual seal circumference to reduce tearing during insertion, manipulation, and / or withdrawal of a surgical instrument (not shown) through the valve assembly 120.

[0039] Each of the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 of the sealing assembly 160 includes a wing-shaped body. When the sealing assembly 160 is in a folded configuration, each of the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 is configured such that two adjacent sealing segments partially overlap in each of the clockwise and counterclockwise directions. More specifically, the first sealing segment 164 is configured to overlap the sixth and fifth sealing segments 174, 172 in the clockwise direction and the second and third sealing segments 166, 168 in the counterclockwise direction, the second sealing segment 164 is configured to overlap the first and sixth sealing segments 164, 174 in the clockwise direction and the third and fourth sealing segments 164, 168 in the counterclockwise direction, and the third sealing segment 166 is configured to overlap the second and first sealing segments 166, 164 in the clockwise direction and the fourth and fifth sealing segments 170, 172 in the counterclockwise direction. the fourth sealing segment 170 is configured to overlap partially with the third and second sealing segments 168, 166 in the clockwise direction and the fifth and sixth sealing segments 172, 174 in the counterclockwise direction, the fifth sealing segment 172 is configured to overlap partially with the fourth and third sealing segments 170, 168 in the clockwise direction and the sixth and first sealing segments 174, 164 in the counterclockwise direction, and the sixth sealing segment 174 is configured to overlap partially with the fifth and fourth sealing segments 172, 170 in the clockwise direction and the first and second sealing segments 164, 166 in the counterclockwise direction.

[0040] In the embodiment, and as shown, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 are folded such that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 overlap in a continuous pattern in a counterclockwise direction. Alternatively, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 can be folded such that they overlap in a continuous clockwise direction. It is envisioned that the first, second, third, fourth, fifth, and sixth sealed sections 164, 166, 168, 170, 172, 174 may instead be folded in opposing pairs, e.g., the first and fourth sealed sections 164, 170 folded together, the second and fifth sealed sections 166, 172 folded together, the third and sixth sealed sections 168, 174 folded together, or may be folded in any other suitable manner.

[0041] Inner edges 164b, 166b, 168b, 170b, 172b, 174b of first, second, third, fourth, fifth, and sixth seal sections 164, 166, 168, 170, 172, 174, respectively, of seal assembly 160 may define a V-shape, as shown, or may extend linearly. In embodiments, the V-shape defines an angle "α" of about one hundred eighty degrees (180°) to about two hundred seventy five degrees (275°). The V-shape of inner edges 164b, 166b, 168b, 170b, 172b, 164b facilitates receipt of a surgical instrument (not shown) through seal assembly 160.

[0042] Each of the first, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172, 174 defines a plurality of openings 165, 167, 169, 171, 173, 175 adjacent a respective connector portion 164a, 166a, 168a, 170a, 172a, 174a of each sealing section 164, 166, 168, 170, 172, 174, respectively. In the embodiment, and as shown, the plurality of openings 165, 167, 169, 171, 173, 175 are positioned such that each opening of the plurality of openings 163 in the support member 162 is aligned with an opening of the plurality of openings 165, 167, 169, 171, 173, 175 of a respective first, second, third, fourth, fifth, and sixth sealing section 164, 166, 168, 170, 172, 174, as well as an opening of the plurality of openings 165, 167, 169, 171, 173, 175 of two adjacent first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174. In this manner, each pin of the plurality of pins 186 ( FIG. 3 ) of the retention assembly 180 is received through the opening 163 of the support member 162 and through the openings 165, 167, 169, 171, 173, 175 in three of the six sealing segments 164, 166, 168, 170, 172, 174 when the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 are secured relative to one another in an assembled condition. This arrangement ensures the integrity of the sealing assembly 160 and, more specifically, the positioning of the first, second, third, fourth, fifth, and sixth sealing segments 164, 166, 168, 170, 172, 174 relative to one another and to the support member 162.

[0043] 4, the sealing assembly 160 includes a plurality of bridges 176a-f interconnecting the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174. The plurality of bridges 176a-f extend continuously between adjacent side edges 164c, 166c, 168c, 170c, 172c, 174c of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 such that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 are connected to one another and do not move independently of one another. More specifically, the first and second sealing sections 164, 166 are interconnected by bridge 176a, the second and third sealing sections 166, 168 are interconnected by bridge 176b, the third and fourth sealing sections 168, 170 are interconnected by bridge 176c, the fourth and fifth sealing sections 172, 174 are interconnected by bridge 176d, the fifth and sixth sealing sections 174, 176 are interconnected by bridge 176e, and the sixth and first sealing sections 176, 164 are interconnected by bridge 176f. The multiple bridges 176a-f are cut (e.g., made discontinuous) prior to folding the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 against the support member 162 so that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 can move independently of one another.

[0044] The sealing assembly 160 includes a plurality of standoffs 178a-c extending from each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174. The multiple standoffs 178a-c are localized regions of increased thickness of the sealing assembly 160, e.g., the standoffs 178a-c are thicker than the thickness of the support member 162, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174, and the multiple bridges 176a-f, such that when the multiple sealing assemblies 160 are arranged adjacent to one another (e.g., stacked together), the support member 162 and the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 of adjacent sealing assemblies 160 are spaced apart from one another. In an embodiment, the plurality of standoffs 178a-c are protrusions extending outwardly from each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174. Although the standoffs 178a-c are shown as having a circular shape, the shape of the standoffs 178a-c may vary, as described further below, so long as the standoffs 178a-c do not interfere with the function of the sealing assembly 160.

[0045] The plurality of standoffs 178a-c extend from side edges 164c, 166c, 168c, 170c, 172c, 174c of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 adjacent connector portions 164a, 166a, 168a, 170a, 172a, 174a and / or inner edges 164b, 166b, 168b, 170b, 172b, 174b. The plurality of standoffs 178a-c are disposed at the same location on each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174. In an embodiment, and as shown, each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 includes a standoff 178a, 178b on both of the side edges 164c, 166c, 168c, 170c, 172c, 174c adjacent the connector portions 164a, 166a, 168a, 170a, 172a, 174a, as well as a standoff 178c on one of the side edges 164c, 166c, 168c, 170c, 172c, 174c adjacent the inner edges 164b, 166b, 168b, 170b, 172b, 174b. The multiple standoffs 178a-c are positioned on each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 such that in the folded state (FIG. 5), the multiple standoffs 178a-c are disposed around the outer edge 160a of the sealing assembly 160, i.e., away from the functional area of ​​the sealing assembly 160.

[0046] In a method of manufacturing the closure assembly 160, the closure assembly 160 is molded from a single or common material (e.g., polyisoprene or liquid silicone rubber) such that the closure assembly 160 is monolithically formed, as seen in FIG. 4. The closure assembly 160 is then placed in a treatment bath (e.g., a chlorination bath) to reduce the tackiness of the closure assembly 160 and to lower the coefficient of friction of the material forming the closure assembly 160. This process aids, in part, in the handling and assembly of the closure assembly 160 and aids, in part, in the function of the closure assembly 160.

[0047] In an embodiment, multiple sealing assemblies 160 are placed in a treatment bath (e.g., the sealing assemblies 160 are stacked together). The multiple bridges 176a-f of each of the sealing assemblies 160 prevent the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 from separating from each other and coupling with the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174 of other sealing assemblies 160 during the treatment process. The multiple standoffs 178a-c of each of the sealing assemblies 160 prevent the sealing assemblies 160 from sticking to each other by maintaining a space between their surfaces. In this manner, the multiple bridges 176a-f and the multiple standoffs 178a-c ensure that the entire sealing assembly 160 is treated (e.g., exposed to chlorination).

[0048] After the closure assembly 160 has been processed and, if necessary, further processed (eg, sterilized), the plurality of bridges 176a-f of the closure assembly 160 are cut and the closure assembly 160 is folded.

[0049] To fold the seal assembly 160, each of the first, second, third, fourth, fifth, and sixth seal sections 164, 166, 168, 170, 172, 174 is folded at the respective connector portion 164a, 166a, 168a, 170a, 172a, 174a against the support member 162. The first, second, third, fourth, fifth, and sixth seal sections 164, 166, 168, 170, 172, 174 may be folded simultaneously such that adjacent seal sections overlap one another. More specifically, the second seal section 166 overlaps the first seal section 164, the third seal section 168 overlaps the second seal section 166, and so on until the first seal section 164 overlaps the sixth seal section 174. This overlapping or interweaving pattern increases the integrity of the seal assembly 160, i.e., reduces the likelihood that the seal assembly 160 will leak when a surgical instrument is received therethrough. As noted above, alternatively, the seal sections may be folded in any manner, including opposing seal sections folded together.

[0050] In the folded state, the first, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172, 174 are disposed adjacent to the sealing portion 162b of the support member 162, and a number of standoffs 178a-c are positioned around the outer edge 160a of the folded sealing assembly 160.

[0051] FIG. 6 illustrates a bottom view of the assembled valve assembly 120. The sealing assembly 160 is secured relative to the centering mechanism 130 and the guard assembly 140 (FIG. 3) by the retention assembly 180. More specifically, a plurality of pins 186 extending from an upper retention member 182 (FIG. 3) of the retention assembly 180 extend through the guard assembly 140, the centering mechanism 130, and the sealing assembly 160 and are secured within openings 185 of the lower retention member 184. In an embodiment, the plurality of pins 186 are welded, glued, adhered, bonded, or otherwise secured within a plurality of openings 185 in the lower retention member 184 to secure the upper retention member 182 and the lower retention member 184 together. The lower retention member 184 may alternatively or additionally include a plurality of pins (not shown), with the upper retention member 182 defining a plurality of corresponding openings (not shown). Either or both of the upper and lower retaining members 182 , 184 may include locking features (not shown) for engaging a plurality of pins 186 and securing the upper retaining member 182 to the lower retaining member 184 .

[0052] Although several aspects of the present disclosure are shown in the drawings, it is intended that the present disclosure is not limited to these aspects, as it is believed that the present disclosure should be taken as broad as the art permits, and that the specification should be read in the same manner. Therefore, it is understood that the present disclosure is not limited to the exact aspects described, and that various other changes and modifications can be made by those skilled in the art without departing from the scope or spirit of the present disclosure. Therefore, the above description should not be interpreted as limiting, but merely as an illustration of the aspects of the present disclosure. Therefore, the scope of the present disclosure should be determined by the appended claims and their legal equivalents, rather than by the examples given.

Claims

1. 1. A method of manufacturing a closure assembly for a surgical access assembly, the method comprising: forming a encapsulation assembly having a monolithic structure, the encapsulation assembly including a support member, a plurality of encapsulation sections connected to the support member, a bridge disposed between adjacent encapsulation sections interconnecting the adjacent encapsulation sections, and a plurality of standoffs extending from each encapsulation section; placing the seal assembly in a treatment bath to reduce tackiness of the seal assembly and to lower a coefficient of friction of a material forming the seal assembly; severing the bridge; and folding the closure assembly; Including, the plurality of sealing segments include a first sealing segment, a second sealing segment, a third sealing segment, a fourth sealing segment, a fifth sealing segment, and a sixth sealing segment, and when the sealing assembly is stacked with another sealing assembly, the support member and the first sealing segment, the second sealing segment, the third sealing segment, the fourth sealing segment, the fifth sealing segment, and the sixth sealing segment of the sealing assembly are spaced from the support member and the first sealing segment, the second sealing segment, the third sealing segment, the fourth sealing segment, the fifth sealing segment, and the sixth sealing segment of the other sealing assembly by the plurality of standoffs; The support member defines a central opening therethrough, and in a folded state, inner edges of the sealing segments define an opening having a discontinuous sealing circumference, the opening being concentric with the central opening of the support member.

2. The method of claim 1 , wherein forming the closure assembly comprises molding the closure assembly from a common material.

3. The method of claim 1 , wherein placing the closure assembly in the treatment bath comprises placing the closure assembly in a chlorination bath.

4. The method of claim 1 , wherein placing the closure assembly in the treatment bath comprises placing a plurality of closure assemblies in the treatment bath.

5. The method of claim 1, further comprising removing the sealing assembly from the treatment bath before cutting the bridge.

6. The method of claim 1 , wherein folding the closure assembly includes positioning the plurality of closure sections adjacent to the support member across a thickness of the support member.

7. The method of claim 6 , wherein positioning the plurality of sealing sections comprises overlapping the plurality of sealing sections with one another.

8. 1. A closure assembly for a surgical access assembly, the closure assembly comprising: A support member; a plurality of sealing sections connected to the support member; a bridge disposed between adjacent sealing sections; a plurality of standoffs extending from each sealing section; Equipped with the sealing assembly has an unfolded state and a folded state, in which the plurality of sealing segments extend radially outward from the support member and are planar, and in which the plurality of sealing segments are positioned adjacent to the support member in a thickness direction of the support member in the folded state, the sealing assembly being in the folded state after the bridges disposed between adjacent sealing segments are severed; the plurality of sealing segments include a first sealing segment, a second sealing segment, a third sealing segment, a fourth sealing segment, a fifth sealing segment, and a sixth sealing segment, and when the sealing assembly is stacked with another sealing assembly, the support member and the first sealing segment, the second sealing segment, the third sealing segment, the fourth sealing segment, the fifth sealing segment, and the sixth sealing segment of the sealing assembly are spaced from the support member and the first sealing segment, the second sealing segment, the third sealing segment, the fourth sealing segment, the fifth sealing segment, and the sixth sealing segment of the other sealing assembly by the plurality of standoffs; A seal assembly, wherein the support member defines a central opening therethrough, and in the folded state, inner edges of the seal segments define an opening having a discontinuous seal circumference, the opening being concentric with the central opening of the support member.

9. The seal assembly of claim 8 , wherein the support member is hexagonal.

10. 9. The seal assembly of claim 8, wherein in the folded state, each seal segment overlaps one adjacent seal segment in a clockwise direction and overlaps one adjacent seal segment in a counterclockwise direction.

11. The seal assembly of claim 8 , wherein an inner edge of each seal section is V-shaped.

12. The seal assembly of claim 8 , wherein each seal section is connected to the support member by a connector portion, each connector portion including a living hinge for permitting folding of the respective seal section relative to the support member.

13. 9. The sealing assembly of claim 8, wherein when the sealing assembly is in the unfolded state, the bridge extends continuously between adjacent sealing sections such that the plurality of sealing sections are interconnected, and when the bridge is cut between the adjacent sealing sections such that the plurality of sealing sections are independent of one another, the sealing assembly is in the folded state.

14. The encapsulation assembly of claim 8 , wherein the standoffs are localized areas of material that are thicker than a thickness of the support member and the sealing sections and the bridge.

15. 9. The seal assembly of claim 8, wherein the plurality of standoffs extend from a side edge of each seal section, and wherein the plurality of standoffs are disposed on an outer edge of the seal assembly when the seal assembly is in the folded state.

16. The encapsulation assembly of claim 15 , wherein the standoffs are disposed at the same location on each encapsulation section.

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