Sealing assembly for a surgical access assembly and method of manufacturing the same

Abstract

The present invention relates to a seal assembly for a surgical access assembly and a method of manufacturing the same, and provides a method of manufacturing a seal assembly for a surgical access assembly, comprising forming a seal assembly having a unitary construction. The seal assembly comprises a support member, seal segments connected to the support member, bridges disposed between and interconnecting adjacent seal segments, and a plurality of abutments extending from each seal segment. The method further comprises placing the seal assembly into a processing bath, cutting the bridges, and folding the seal assembly.

Description

Technical Field

[0001] The disclosure generally relates to surgical access components for minimally invasive surgery. In particular, this disclosure relates to sealing components for surgical access components and their manufacture. Background Technology

[0002] Minimally invasive surgical procedures, including endoscopic and laparoscopic procedures, allow surgery on organs, tissues, and blood vessels at openings far from within the tissue. In laparoscopic procedures, a workspace must be created at the desired surgical site. A blow-in fluid, typically CO2, is introduced into the patient's abdomen to create an inflated state known as pneumoperitoneum. Surgical access assemblies are used to allow surgical instruments and endoscopes (or other visualization tools) to be introduced into the abdominal cavity to perform one or more surgical tasks. These surgical access assemblies maintain pneumoperitoneum pressure because they have one or more seals adapted for surgical instruments. Typically, in the absence of surgical instruments in the surgical access assembly, a "zero seal" seals the surgical access assembly, and an instrument seal seals around any surgical instruments that have been inserted through the surgical access assembly.

[0003] Today's market demands robust seals for surgical instruments that can accommodate and adjust to various sizes and withstand repeated insertions. Some surgical instruments may include sharp edges that could tear or otherwise damage the seal, and / or some seals (e.g., those with a solid inner diameter) withstand high insertion forces and are less durable to certain instruments (e.g., the seal may crack during insertion, leading to leakage or detachment into the patient's abdominal cavity). Therefore, surgical entry components with improved seal durability, along with easy and consistent manufacturing methods, would be beneficial. Summary of the Invention

[0004] In one aspect, this disclosure provides a method of manufacturing a sealing assembly for a surgical access component, comprising forming a sealing assembly having an integral construction. The sealing assembly includes a support member, sealing sections connected to the support member, bridges disposed between adjacent sealing sections and interconnecting the adjacent sealing sections, and a plurality of supports extending from each sealing section. The method further includes placing the sealing assembly into a processing bath, cutting the bridges, and folding the sealing assembly.

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

[0006] Placing the sealing assembly into the treatment bath may include placing the sealing assembly into a chlorination bath.

[0007] Placing sealing components into the treatment bath may include placing multiple sealing components into the treatment bath.

[0008] The method may additionally include removing the sealing assembly from the treatment bath before cutting the bridge.

[0009] The folded sealing assembly may include positioning sealing sections near a support member. Positioning the sealing sections may include overlapping the sealing sections in a sequential pattern.

[0010] On the other hand, this disclosure provides a sealing assembly for a surgical access device, comprising a support member, sealing sections connected to the support member, bridges disposed between adjacent sealing sections, and a plurality of supports extending from each of the sealing sections. The sealing assembly has an unfolded state in which the sealing sections extend radially outward from the support member in a substantially planar manner, and a folded state in which the sealing sections are positioned near the support member.

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

[0012] When the sealing assembly is in the folded state, each sealing segment can overlap with two adjacent sealing segments 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 edge of the sealing section may define an opening with a discontinuous sealing circumference. The opening of the sealing section may be concentric with the central opening of the support member. The inner edge of each sealing section may be substantially V-shaped.

[0014] Each sealing section can be connected to the support member via a connector portion. Each connector portion may include a movable hinge to allow the corresponding sealing section to be folded relative to the support member.

[0015] When the sealing assembly is in the unfolded state, the bridge can extend continuously between adjacent sealing sections, making the sealing sections interconnected, and when the sealing assembly is in the folded state, the bridge can be interrupted between adjacent sealing sections, making the sealing sections independent of each other.

[0016] Multiple supports may be localized areas of material, with a thickness greater than that of the supporting member, sealing section, and bridge. Multiple supports may extend from the side edges of each sealing section, and when the sealing assembly is in a folded state, multiple supports may be positioned at the outer terminal edges of the sealing assembly. Multiple supports may be positioned at the same locations on each sealing section.

[0017] Details of one or more aspects of this disclosure are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the aspects described in this disclosure will become apparent from the description, the drawings, and the claims. Attached Figure Description

[0018] Figure 1A side perspective view of the surgical entry component according to aspects of this disclosure;

[0019] Figure 2 For sections taken along section line 2-2 Figure 1 The surgical entry component is shown as a side cross-sectional view.

[0020] Figure 3 An exploded perspective view of the valve assembly with its parts separated, including the centering mechanism, the protective assembly, the sealing assembly, and the retainer assembly;

[0021] Figure 4 for Figure 3 The top plan view of the sealing assembly in its initial or pre-assembled state is shown.

[0022] Figure 5 for Figure 4 The top perspective view of the sealing assembly shown in its fully folded or assembled state; and

[0023] Figure 6 for Figure 3 The valve assembly shown is a bottom perspective view during assembly. Detailed Implementation

[0024] Various aspects of this disclosure are described below with reference to the accompanying drawings; however, it should be understood that the disclosed aspects are merely illustrative and may be embodied in various forms. Well-known functions or constructions have not been described in detail to avoid obscuring this disclosure with unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but are merely intended as the basis for the claims and as a representative basis for teaching those skilled in the art to apply this disclosure differently in practice with any appropriate detailed structure.

[0025] Similar reference numerals throughout the description of the accompanying drawings refer to similar or identical elements. Throughout this specification, the term "proximal" refers to a portion or component of the structure closer to the user, and the term "distal" refers to a portion or component of the structure farther from the user.

[0026] A surgical access assembly with an occluder (referred to as a cannula assembly) is used during minimally invasive surgery (e.g., laparoscopic surgery) and provides sealed access for surgical instruments into an inflated body cavity (such as the abdominal cavity). The surgical access assembly of this disclosure includes an instrument valve housing mounted on a cannula. An occluder (not shown) is inserted through the instrument valve housing and the cannula. The occluder may have a blunt distal end, or a bladed or bladeless penetrating distal end, and may be used to incise and / or dissect abdominal wall tissue, allowing the surgical access assembly to be introduced into the abdomen. The handle of the occluder may engage or selectively lock into the instrument valve housing of the surgical access assembly.

[0027] The cannula assembly is used to tunnel through anatomical structures, such as the abdominal wall, by forming a new channel through the structure or by passing through an existing opening in the structure. Once the surgical access assembly with an occluder has tunneled through the anatomical structure, the occluder is removed, leaving the surgical access assembly in place. The instrument valve housing of the surgical access assembly includes a valve that prevents the infused fluid from escaping from the body cavity while also allowing the insertion of surgical instruments into the body cavity.

[0028] In various aspects, bladeless optical trocar occluders can be provided, allowing for the separation of tissue planes during surgical procedures and visualization of somatic tissue fibers during dissection, thereby enabling control over the passage of somatic tissue fibers across the body wall. In other aspects, trocar occluders can be bladeless but not optical, for example, without simultaneous visualization through the distal tip of the occluder. Bladeless trocar occluders can be provided for blunt dissection of the peritoneum during surgical procedures.

[0029] Various cannula occluders suitable for the surgical access components of this disclosure are known, including, for example, bladed, bladeless, blunt, optical, and non-optical cannula occluders. For a detailed description of the structure and function of the exemplary cannula assembly including the exemplary cannula occluder and the exemplary cannula, please refer to PCT Publication WO 2016 / 186905 (“'905 Publication”), the contents of which are incorporated herein by reference in their entirety.

[0030] Now, let's refer to... Figure 1 The surgical access assembly according to an aspect of this disclosure is shown generally as surgical access assembly 100. Surgical access assembly 100 includes a cannula 102 and an instrument valve housing 110 attached to the cannula 102. For a detailed description of an exemplary surgical access assembly, please refer to the '905 disclosure.

[0031] refer to Figure 2 The instrument valve housing 110 of the surgical access assembly 100 includes an upper housing section 112, a lower housing section 114, and an inner housing section 116. The upper housing section 112, lower housing section 114, and inner housing section 116 are configured to support the valve assembly 120 on the proximal end of the cannula 102. More specifically, the inner housing section 116 is secured between the upper housing section 112 and the lower housing section 114, and the valve assembly 120 is received between the inner housing section 116 and the lower housing section 114. The upper housing section 112 and lower housing section 114 of the instrument valve housing 110 are selectively attached to and detached from the inner housing section 116. The lower housing section 114 can be releasably or permanently attached to the cannula body 104 of the cannula 102. Figure 1In various aspects, one or both of the upper housing section 112 and the lower housing section 114 of the instrument valve housing 110 may include knurling, dents, tabs, or be otherwise configured to facilitate engagement by a clinician.

[0032] The surgical access assembly 100 may also include features for stabilizing the surgical access assembly 100. For example, the distal end of the cannula 104 may carry a balloon anchor or other inflatable member for medial engagement of the abdomen. For example, see U.S. Patent No. 7,300,448, the contents of which are incorporated herein by reference in their entirety. Features on opposite sides of the abdominal wall may be used for additional stabilization of the surgical access assembly 100, such as adhesive tabs or adjustable foam collars.

[0033] The upper housing section 112, lower housing section 114, and inner housing section 116 of the instrument valve housing 110 define a longitudinal passage 111 for receiving a surgical instrument (not shown). The valve assembly 120 is supported within the instrument valve housing 110 to provide a sealed passage for the surgical instrument (not shown) to pass through the surgical access assembly 100.

[0034] For details, please refer to the following: Figure 2 and 3 The valve assembly 120, supported within the instrument valve housing 110, includes a centering mechanism 130, a protective assembly 140, a sealing assembly 160, and a retainer assembly 180. When a surgical instrument is received through the valve assembly 120, the centering mechanism 130 allows the valve assembly 120 to move radially relative to the instrument valve housing 110, and once the surgical instrument is withdrawn from the instrument valve housing 110, the centering mechanism returns the valve assembly 120 to a substantially centered position. The protective 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 for the surgical instrument through the instrument valve housing 110. The retainer assembly 180 maintains the centering mechanism 130, the protective assembly 140, and the sealing assembly 160 in an aligned relationship with each other.

[0035] Continue to refer to Figure 2 and 3As described above, the centering mechanism 130 of the valve assembly 120 is configured to maintain the valve assembly 120 at the center of the instrument valve housing 110 without any surgical instruments passing through it. In various aspects, and as shown, the centering mechanism 130 includes an outer annular washer 132, an inner annular washer 134, and a bellows 136 disposed between the outer annular washer 132 and the inner annular washer 134. The outer annular washer 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 washer 134 supports the protective assembly 140. For a detailed description of the structure and function of the exemplary centering mechanism, please refer to U.S. Patent No. 6,702,787, the contents of which are incorporated herein by reference in their entirety.

[0036] Although the centering mechanism 130 is shown as having a bellows 136, the valve assembly 120 may include an alternative centering mechanism. For example, the centering mechanism may include an annular base and a plurality of spokes extending from the base, as described in U.S. Patent Application Publication No. 2015 / 0025477 (“'477 Publication”), the contents of which are incorporated herein by reference in their entirety. It is contemplated that the centering mechanism may include multiple sets of spokes, as disclosed in '477 Publication.

[0037] Continue to refer to Figure 2 and 3 When a surgical instrument (not shown) passes through the instrument valve housing 110, the protective assembly 140 of the valve assembly 120 is configured to protect the sealing assembly 160. The protective assembly 140 includes a gasket portion 142 and a first flap 144, a second flap 146, a third flap 148, and a fourth flap 150. The first flap 144, second flap 146, third flap 148, and fourth flap 150 define an opening 141 between them to facilitate the passage of the surgical instrument (not shown) through the sealed channel of the protective assembly 140. Although shown as including four (4) flaps, it is contemplated that the protective assembly 140 may include any suitable number of flaps, and the flaps may include flap portions of any size or configuration. For a detailed description of the structure and function of other exemplary protective components, please refer to U.S. Patent Nos. 5,895,377 and 6,569,120 and U.S. Patent Application Nos. 16 / 394,043 and 16 / 238,823, the contents of which are incorporated herein by reference in their entirety.

[0038] The sealing assembly 160 of the valve assembly 120 is configured to surround the instrument valve housing 110. Figure 1 The outer surface of the surgical instrument provides a seal. In various aspects, and as shown, the sealing assembly 160 forms a flat sealing body; however, it is conceivable that aspects of this disclosure can be modified for use with a conical sealing body.

[0039] Now go to Figure 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, and 174 secured to the support member 162 via corresponding connector portions 164a, 166a, 168a, 170a, 172a, and 174a. As shown, the connector portions 164a, 166a, 168a, 170a, 172a, and 174a may include one or more movable hinges, or be otherwise configured to allow folding of the corresponding first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 relative to the support member 162.

[0040] In various aspects, the support member 162 and the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 of the sealing assembly 160 are formed of the same material, including, for example, polyurethane, polyisoprene, or silicone elastomers (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, and 174 may be formed of different materials. In some aspects, the support member 162 and / or the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 may include one or more fabric layers.

[0041] The support member 162 of the sealing assembly 160 includes a hexagonal body or washer portion 162a and a sealing portion 162b supported within the washer portion 162a. The washer portion 162a and the sealing portion 162b may be formed of the same or different materials. The sealing portion 162b defines a central opening 161. The support member 162a defines a plurality of pins 186 extending from the upper retainer member 182 of the retainer assembly 180. Figure 3 The sealing assembly 160 has multiple corresponding openings 163. When the sealing assembly 160 is in a folded configuration, the sealing portion 162a provides additional support for the first, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172 and 174.

[0042] In all aspects, and as shown in the figures, the gasket portion 162a and the sealing portion 162b of the support member 162 have an integral construction with the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174, i.e., an integral construction. By combining the gasket portion 162a of the support member 162 of the sealing assembly 160 with the sealing portion 162b and forming the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 on the gasket portion 162a of the support member 162, instead of including a gasket portion for the sealing section and separate gasket portions for the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174, the number of components in the sealing assembly 160 is reduced, and ultimately the number of components in the valve assembly 120 is reduced. The combination of sealing portion 162b and the first, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172 and 174 with the same gasket portion 162 also reduces assembly time and lowers material costs.

[0043] When in a folded or assembled state ( Figure 5 The first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 of the sealing assembly 160 define an opening 161a, which is configured to receive a sealably inserted through the valve assembly 120. Figure 3 Surgical instruments (not shown). First, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172, 174 form discontinuous or virtual sealing circumferences to reduce tearing during insertion, manipulation and / or withdrawal of surgical instruments (not shown) through valve assembly 120.

[0044] Each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 of the sealing assembly 160 includes an airfoil body. When the sealing assembly 160 is in a folded configuration, each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 is configured to partially overlap with two adjacent sealing sections in both clockwise and counterclockwise directions. More specifically, the first sealing section 164 is configured to partially overlap with the sixth and fifth sealing sections 174, 172 in a clockwise direction and with the second and third sealing sections 166, 168 in a counterclockwise direction; the second sealing section 164 is configured to partially overlap with the first and sixth sealing sections 164, 174 in a clockwise direction and with the third and fourth sealing sections 164, 168 in a counterclockwise direction; and the third sealing section 166 is configured to partially overlap with the second and first sealing sections 166, 164 in a clockwise direction and with the fourth and fifth sealing sections 170, 172 in a counterclockwise direction. The fourth sealing section 170 is configured to partially overlap with the third and second sealing sections 168 and 166 in a clockwise direction and with the fifth and sixth sealing sections 172 and 174 in a counterclockwise direction. The fifth sealing section 172 is configured to partially overlap with the fourth and third sealing sections 170 and 168 in a clockwise direction and with the sixth and first sealing sections 174 and 164 in a counterclockwise direction. The sixth sealing section 174 is configured to partially overlap with the fifth and fourth sealing sections 172 and 170 in a clockwise direction and with the first and second sealing sections 164 and 166 in a counterclockwise direction.

[0045] In all aspects, and as shown in the figure, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 are folded such that they overlap in a sequential pattern in a counterclockwise direction. Alternatively, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 can be folded to overlap in a sequential clockwise direction. It is conceivable that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 could instead be folded in opposite pairs, for example, the first and fourth sealing sections 164 and 170 folded together, the second and fifth sealing sections 166 and 172 folded together, and the third and sixth sealing sections 168 and 174 folded together, or folded in any other suitable manner.

[0046] As shown in the figure, the inner edges 164b, 166b, 168b, 170b, 172b, and 174b of the corresponding first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 of the sealing assembly 160 may define a V-shape or may extend straight. In each respect, the V-shape defines an angle "α" from about 180 degrees to about 275 degrees (275 degrees). The V-shape of the inner edges 164b, 166b, 168b, 170b, and 172b facilitates the reception of surgical instruments (not shown) through the sealing assembly 160.

[0047] Each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 defines a plurality of openings 165, 167, 169, 171, 173, and 175, which are adjacent to the corresponding connector portions 164a, 166a, 168a, 170a, 172a, and 174a of each sealing section 164, 166, 168, 170, 172, and 174, respectively. In all respects, and as shown in the figures, a plurality of openings 165, 167, 169, 171, 173, 175 are arranged such that each opening of a plurality of openings 163 in the support member 162 is aligned with the openings of a plurality of openings 165, 167, 169, 171, 173, 175 of the corresponding first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, 174, and is aligned with the openings of a 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 way, when the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 are fixed relative to each other in the assembled state, the plurality of pins 186 of the retainer assembly 180 ( Figure 3 Each pin in the sealing assembly 160 passes through an opening 163 in the support member 162 and is received through openings 165, 167, 169, 171, 173, and 175 in three of the six sealing sections 164, 166, 168, 170, 172, and 174. This arrangement ensures the integrity of the sealing assembly 160 and, more specifically, ensures that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 are positioned relative to each other and to the support member 162.

[0048] Continue to refer to Figure 4The sealing assembly 160 includes a plurality of bridges 176a-f that interconnect the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174. The plurality of bridges 176a-f extend continuously between adjacent side edges 164c, 166c, 168c, 170c, 172c, and 174c of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174, such that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 are connected together and do not move independently of each other. More specifically, the first and second sealing sections 164 and 166 are interconnected by bridge 176a, the second and third sealing sections 166 and 168 are interconnected by bridge 176b, the third and fourth sealing sections 168 and 170 are interconnected by bridge 176c, the fourth and fifth sealing sections 172 and 174 are interconnected by bridge 176d, the fifth and sixth sealing sections 174 and 176 are interconnected by bridge 176e, and the sixth and first sealing sections 176 and 164 are interconnected by bridge 176f. Before folding the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 against the support member 162, the bridges 176a-f are cut (e.g., discontinuously) so that the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 can move independently of each other.

[0049] The sealing assembly 160 includes a plurality of supports 178a-c extending from each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174. The plurality of supports 178a-c are localized areas where the thickness of the sealing assembly 160 increases; for example, the thickness of the supports 178a-c is greater than the thickness of the support member 162, the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174, and the plurality of bridges 176a-f, such that when the plurality of sealing assemblies 160 are arranged adjacent to each other (e.g., stacked together), the support member 162 and the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 of the adjacent sealing assemblies 160 are spaced apart from each other. In each aspect, the plurality of supports 178a-c are protrusions extending outward from each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174. Although supports 178a-c are shown as having a circular shape, the shape of supports 178a-c may vary as long as supports 178a-c do not interfere with the function of sealing assembly 160, as further described below.

[0050] Multiple supports 178a-c extend from the side edges 164c, 166c, 168c, 170c, 172c, and 174c of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 adjacent to the connector portions 164a, 166a, 168b, 170b, 172c, and 174b. The multiple supports 178a-c are disposed in the same positions on each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174. In all respects, and as shown in the figures, each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 includes supports 178a and 178b on the two side edges 164c, 166c, 168c, 170c, 172c, and 174c adjacent to the connector portions 164a, 166a, 168a, 170a, 172a, and 174a, and a support 178c on one of the side edges 164c, 166c, 168c, 170c, 172c, and 174c adjacent to the inner edges 164b, 166b, 168b, 170b, 172b, and 174b. Multiple supports 178a-c are positioned on each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174, such that in the folded state ( Figure 5 Multiple supports 178a-c are disposed around the outer terminal edge 160a of the sealing assembly 160, i.e., away from the functional area of ​​the sealing assembly 160.

[0051] In the method of manufacturing the sealing assembly 160, the sealing assembly 160 is molded from a single or general-purpose material (e.g., polyisoprene or liquid silicone rubber) such that the sealing assembly 160 is integrally formed, as... Figure 4 As seen. The sealing assembly 160 is then placed in a treatment bath (e.g., a chlorination bath) to reduce the stickiness of the sealing assembly 160 and decrease the coefficient of friction of the materials forming the sealing assembly 160. This process contributes in part to the disposal and assembly of the sealing assembly 160 and in part to the function of the sealing assembly 160.

[0052] In various aspects, multiple sealing assemblies 160 are placed in a treatment bath (e.g., sealing assemblies 160 are stacked together). 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 interlocking 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. Multiple supports 178a-c of each of the sealing assemblies 160 prevent the sealing assemblies 160 from adhering to each other by maintaining space between the surfaces of the sealing assemblies 160. In this way, the multiple bridges 176a-f and the multiple supports 178a-c ensure that the entire sealing assembly 160 is treated (e.g., exposed to chlorination).

[0053] After processing the sealing assembly 160 and further processing as needed (e.g., sterilization), the plurality of bridges 176a-f of the sealing assembly 160 are cut, and the sealing assembly 160 is folded.

[0054] To fold the sealing assembly 160, each of the first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 folds relative to the support member 162 at the corresponding connector portions 164a, 166a, 168a, 170a, 172a, and 174a. The first, second, third, fourth, fifth, and sixth sealing sections 164, 166, 168, 170, 172, and 174 can fold simultaneously, with adjacent sealing sections overlapping each other. More specifically, the second sealing section 166 overlaps with the first sealing section 164, the third sealing section 168 overlaps with the second sealing section 166, and so on, until the first sealing section 164 overlaps with the sixth sealing section 174. This overlapping or interlacing pattern increases the integrity of the sealing assembly 160, i.e., reduces the likelihood of leakage when passing through its receiving surgical instruments. As mentioned above, alternatively, the sealing sections can be folded in any way, including folding opposite sealing sections together.

[0055] In the folded state, the first, second, third, fourth, fifth and sixth sealing sections 164, 166, 168, 170, 172 and 174 are located near the sealing portion 162b of the support member 162, and a plurality of supports 178a-c are positioned around the outer terminal edge 160a of the folded sealing assembly 160.

[0056] Figure 6 This illustration shows a bottom view of the assembled valve assembly 120. The sealing assembly 160 is positioned relative to the centering mechanism 130 and the protective assembly 140 via the retainer assembly 180. Figure 3) Fixed. More specifically, from the upper retainer member 182 of the retainer assembly 180 ( Figure 3 A plurality of extending pins 186 extend through the protective assembly 140, the centering mechanism 130, and the sealing assembly 160, and are secured within openings 185 of the lower retainer member 184. In various aspects, the plurality of pins 186 are welded, glued, bonded, adhesively bonded, or otherwise secured within the plurality of openings 185 in the lower retainer member 184 to secure the upper retainer member 182 and the lower retainer member 184 together. The lower retainer member 184 may alternatively or additionally include a plurality of pins (not shown), wherein the upper retainer member 182 defines a plurality of corresponding openings (not shown). Either or both of the upper retainer member 182 and the lower retainer member 184 may include locking features (not shown) for engaging the plurality of pins 186 and securing the upper retainer member 182 to the lower retainer member 184.

[0057] While various aspects of this disclosure have been shown in the drawings, they are not intended to be limited thereto, as this disclosure is intended to be as broad as permitted in the art and should be read in the same manner. Therefore, it should be understood that this disclosure is not limited to the precise 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 this disclosure. Consequently, the foregoing description should not be construed as limiting, but merely as illustrative of aspects of this disclosure. Therefore, the scope of this disclosure should be determined by the appended claims and their legal equivalents, and not by the examples given.

Claims

1. A method of manufacturing a sealing assembly for a surgical access component, comprising: A sealing assembly with an integral structure is formed, the sealing assembly comprising: Supporting components; A sealed section connected to the support member; A bridge is provided between adjacent sealing sections and interconnects the adjacent sealing sections; and Multiple supports extending from each sealing section; Place the sealing assembly in the treatment bath; Cut the bridge; and Fold the sealing assembly.

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

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

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

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

6. The method of claim 1, wherein folding the sealing assembly includes positioning the sealing section near the support member.

7. The method of claim 6, wherein positioning the sealing section comprises overlapping the sealing sections in a sequential pattern.

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