Sealing assembly for surgical access assembly

Abstract

The present invention relates to a seal assembly for a surgical access assembly. The surgical access assembly of the present invention includes an instrument valve housing and a valve assembly disposed within a cavity of the instrument valve housing. The valve assembly includes a guard assembly, a seal assembly disposed adjacent the guard assembly, and a centering mechanism for maintaining the seal assembly and the guard assembly centered within the instrument valve cavity. The seal assembly includes a multi-petal seal member and an upper support member and a lower support member. The upper support member and the lower support member sandwich the multi-petal seal member to reduce and / or eliminate leakage through the multi-petal seal member.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to surgical access assemblies for use in minimally invasive surgical procedures that include a seal. More particularly, the present disclosure relates to a seal for a surgical access assembly. BACKGROUND

[0002] To facilitate minimally invasive surgical procedures, a working space is created at the surgical site. An insufflation fluid, typically CO2, is introduced into the patient's abdomen to create an inflated condition known as pneumoperitoneum. Surgical access assemblies are used to allow the introduction of surgical instruments and endoscopes (or other visualization tools). These surgical access assemblies maintain the pneumoperitoneum pressure because they have one or more seals that accommodate the surgical instruments. Typically, a "zero seal" in the surgical access assembly seals the surgical access assembly in the absence of a surgical instrument in the surgical access assembly, and an instrument seal seals around a surgical instrument that has been inserted through the surgical access assembly.

[0003] Surgical instruments on the market today widely require a robust seal that can accommodate a variety of sizes and withstand multiple insertions of the surgical instrument. Certain instruments can include sharp edges that can tear or damage the seal. Accordingly, a surgical access assembly with improved seal durability would be beneficial. SUMMARY

[0004] A surgical access assembly with improved seal durability is provided. The surgical access assembly includes an instrument valve housing including an upper housing section, a lower housing section, and an inner housing section and defining a cavity, and a valve assembly disposed within the cavity of the instrument valve housing. The valve assembly includes a guard assembly including a plurality of guard portions, a seal assembly disposed adjacent the guard assembly, and a centering mechanism for maintaining the seal assembly and the guard assembly centered within the instrument valve cavity. The seal assembly includes a plurality of seal portions and an upper support member and a lower support member. The plurality of seal portions is movable from an expanded configuration to a folded configuration in which the seal assembly forms an octagonal member that defines an opening to facilitate the passage of a surgical instrument therethrough. The upper support member and the lower support member are respectively received proximal and distal to the plurality of seal portions and compressed about the plurality of seal portions to sandwich the plurality of seal portions therebetween.

[0005] In this embodiment, the upper and lower support members define an opening of about 0.30” to about 0.45”. The thickness of the upper and lower support members may be about 0.006 inches to about 0.015 inches. The plurality of seals may be formed of polyisoprene or liquid silicone rubber. Each of the plurality of seals may be connected to an adjacent seal in the plurality of seals via a connector portion. The connector portion may include a movable hinge. The upper support member may be connected to one seal in the plurality of seals via a connector portion, and the lower support member may be connected to another seal in the plurality of seals via another connector portion.

[0006] In some embodiments, the inner edge of each of the plurality of seals may be defined as V-shaped. The V-shape may include an angle of about 180 degrees to about 275 degrees. The plurality of seals may include a first seal, a second seal, a third seal, and a fourth seal, each of the first, second, third, and fourth seals overlapping an adjacent second, third, fourth, and first seal.

[0007] The surgical access assembly may further include a retainer assembly comprising an upper retainer member and a lower retainer member. At least one of the upper or lower retainer member may include a plurality of pins receivable through the protective assembly and the sealing assembly to retain the protective assembly and the sealing assembly relative to each other. A centering mechanism may include a bellows. The upper and lower support members may include hexagonal shapes. The upper and lower support members may include octagonal shapes.

[0008] A valve assembly is provided, including a sealing assembly with improved durability. The valve assembly includes: a protective assembly comprising a plurality of protective portions; a sealing assembly disposed adjacent to the protective assembly; and a centering mechanism for holding the sealing assembly and the protective assembly centrally within an instrument valve cavity. The sealing assembly includes a plurality of sealing portions, an upper support member, and a lower support member. The plurality of sealing portions are movable from an unfolded configuration to a folded configuration, in which the sealing assembly forms an octagonal member defining an opening to facilitate the sealed passage of surgical instruments. The upper and lower support members are respectively disposed proximal and distal to the plurality of sealing portions and are compressed around the plurality of sealing portions to clamp the plurality of sealing portions therebetween.

[0009] In one embodiment, the valve assembly further includes a retainer assembly having an upper retainer member and a lower retainer member. At least one of the upper and lower retainer members may include a plurality of pins receivable through the protective assembly and the sealing assembly for retaining the protective assembly and the sealing assembly relative to each other. The upper support member may be connected to a seal among a plurality of seals via a connector portion, and the lower support member may be connected to another seal among a plurality of seals via another connector portion.

[0010] A sealing assembly with improved durability is provided. The sealing assembly includes a plurality of sealing portions movable from an unfolded configuration to a folded configuration, in which the sealing assembly forms an octagonal member defining an opening to allow for the sealed passage of surgical instruments. The sealing assembly also includes an upper support member disposed proximal to the plurality of sealing portions and a lower support member disposed distal to the plurality of sealing portions. The upper and lower support members are compressed around the plurality of sealing portions to clamp them therebetween. Attached Figure Description

[0011] Embodiments of the present disclosure are illustrated in conjunction with the accompanying drawings, which are incorporated in and form part of this specification, and are used together with the general description of the disclosure given above and the detailed description of the embodiments given below to illustrate the principles of the disclosure, wherein:

[0012] Figure 1 This is a side perspective view of a surgical access component according to an embodiment of the present disclosure;

[0013] Figure 2 yes Figure 1 The surgical entry component shown is a side view section taken along section line 2-2;

[0014] Figure 3 yes Figure 2 The diagram shows a three-dimensional view of the valve assembly with its components separated, including the centering mechanism, the protective assembly, the sealing assembly, and the retainer assembly.

[0015] Figure 4 yes Figure 3 Top perspective view of the sealing assembly shown;

[0016] Figure 5 yes Figure 3 The bottom perspective view of the sealing assembly shown;

[0017] Figure 6 yes Figure 3 A perspective view of the support member of the sealing assembly shown;

[0018] Figure 7 yes Figure 4 The sealing assembly shown is a side cross-sectional view taken along section line 7-7;

[0019] Figure 8 This is a perspective view of a sealing assembly according to another embodiment of the present disclosure;

[0020] Figure 9 yes Figure 8 A top view of the sealing assembly in its unfolded state;

[0021] Figures 10-14 yesFigure 8 A perspective view of the sealing assembly in a continuously partially folded state; and

[0022] Figure 15 yes Figure 8 The diagram shows a three-dimensional view of the sealing assembly in a fully folded state. Detailed Implementation

[0023] Specific embodiments of the surgical access component are described below with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely exemplary embodiments of this disclosure and may be embodied in various forms. To avoid obscuring this disclosure with unnecessary detail, well-known functions or constructions have not been described in detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis for the claims and as a representative basis for teaching those skilled in the art to use the invention differently with virtually any suitable detailed construction. Throughout the description with reference to the drawings, the same reference numerals denote similar or identical elements.

[0024] As used herein, the term "distal" refers to the portion of the device or its components further away from the user, while the term "proximal" refers to the portion of the device or its components closer to the user. As used herein, the term "about" means that the value is approximate and that small variations will not significantly affect the practice of the disclosed embodiments. When using numerical limits, unless the context otherwise indicates, "about" means that the value can vary by ±10% and remain within the range of the disclosed embodiments.

[0025] A surgical access component is used during minimally invasive surgical procedures such as laparoscopic surgery to allow surgical instruments to be sealed into an inflated body cavity, such as the abdominal cavity. The surgical access component of this disclosure includes: an instrument housing mounted on a cannula body, and a stopper (not shown) inserted through the valve housing and the cannula. The stopper may have a blunt distal end, or a bladed or bladeless penetrating distal end, and may be used to incise the abdominal wall to allow the surgical access component to be introduced into the abdomen. The handle of the stopper may engage or selectively lock onto the instrument housing of the surgical access component.

[0026] The surgical access component can be used to tunnel through anatomical structures by creating a new channel through an anatomical structure (such as the abdominal wall) or by using an existing opening through the anatomical structure. Once the cannula assembly has tunneled through the anatomical structure, the cannula occluder is removed, leaving the cannula assembly in place. The instrument housing of the cannula 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.

[0027] In various embodiments, a bladeless optical cannula occluder may be provided, allowing for the separation of tissue planes during surgical procedures and visualization of tissue fibers during dissection, thereby allowing control over the passage of tissue fibers through the body wall. In other embodiments, the cannula occluder may be bladeless but not optical, for example, providing visualization without passing through the distal tip of the occluder. A bladeless occluder may be provided for blunt dissection of the abdominal wall during surgical procedures.

[0028] Various cannula needle occluders suitable for the cannulas of this disclosure are known, including, for example, bladed, bladeless, blunt, optical, and non-optical cannula needle occluders. For a detailed description of the structure and function of exemplary cannula needle assemblies including exemplary cannula needle occluders and exemplary cannulas, please refer to PCT Publication No. WO 2016 / 186905 (“905 Publication”), the contents of which are incorporated herein by reference in their entirety.

[0029] Now, first refer to Figure 1 The surgical access assembly according to aspects of this disclosure is shown as a cannula assembly 100. Cannula assembly 100 includes a cannula 102 and an instrument housing 110 secured to the cannula 102. For a detailed discussion of the exemplary cannula assembly, please refer to the '905 disclosure.

[0030] Reference Figure 2 The instrument housing 110 of the cannula 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 proximally to 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 housing 110 are selectively attached to and detachable from the inner housing section 116. The lower housing section 114 may be releasably or permanently attached to the cannula body 104 of the cannula assembly 102. In an embodiment, one or both of the upper shell section 112 and the lower shell section 114 of the instrument valve housing 110 may include knurling, dents, tabs, or be otherwise configured to facilitate engagement by a clinician.

[0031] The cannula assembly 100 may also include features for stabilizing the surgical access assembly. For example, the distal end of the cannula body 104 may carry a balloon anchor or other inflatable member for medial engagement with the abdomen. See, for example, U.S. Patent No. 7,300,448, the entire disclosure of which is incorporated herein by reference. Features on opposite sides of the abdominal wall may be used to further stabilize the surgical access assembly, such as adhesive tabs or adjustable foam collars.

[0032] The upper shell section 112, lower shell section 114, and inner shell section 116 of the instrument valve housing 110 define a longitudinal channel 111 for receiving a surgical instrument (not shown). The valve assembly 120 is supported within the instrument valve housing 110 to allow the surgical instrument to seal through the cannula assembly 100.

[0033] Specific reference Figure 2 and 3 Supported in the instrument valve housing 110 ( Figure 2 The valve assembly 120 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 housing 110 and additionally holds the valve assembly 120 in a substantially centered position within the instrument housing 110. 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 allows the surgical instrument to pass through the instrument housing 110 in a sealed manner. The retainer assembly 180 holds the centering mechanism 130, the protective assembly 140, and the sealing assembly 160 in alignment with each other.

[0034] Continue to refer to Figure 2 and Figure 3 As mentioned above, the centering mechanism 130 of the valve assembly 120 is configured to hold the valve assembly 120 in the instrument valve housing 110. Figure 2 Centered within. In an embodiment, and as shown, the centering mechanism 130 includes an outer ring 132, an inner ring 134, and a bellows 136 disposed between the outer ring 132 and the inner ring 134. Figure 2 As shown, an outer ring 132 is received between the inner shell section 116 and the lower shell section 114 to retain the centering mechanism 130 within the instrument valve housing 110. An inner ring 134 supports the sealing assembly 160. 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 entire contents of which are incorporated herein by reference.

[0035] 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 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.

[0036] Still referencing Figure 2 and Figure 3 The protective assembly 140 of valve assembly 120 includes a ring portion 142 and a first flap 144, a second flap 146, a third flap 148, and a fourth flap 150. The protective assembly 140 may be formed from a sheet of plastic / polymer material by stamping with a tool used to form the ring portion 142 and the flaps 144, 146, 148, and 150. Alternatively, the protective assembly 140 may be formed by molding or other techniques. It is contemplated that the protective assembly may include any number of flaps, and the flaps may include flap portions of any size or configuration. For exemplary protective assemblies and other aspects of surgical access assemblies, please refer to U.S. Patent Nos. 5,895,377 and 6,569,120, the entire disclosure of which is incorporated herein by reference. For a detailed description of the structure and function of other exemplary protective components, please refer to publicly available U.S. Patent Nos. 16 / 394,043 and 16 / 238,823 (Atty. Case Nos. C00019509.USU1 (203-12169), A0000135US01 (203-12267) and C00017498US01 (203-12319)), the entire contents of which are incorporated herein by reference.

[0037] Now continue with the reference. Figure 2 and Figure 3 The sealing assembly 160 of the valve assembly 120 is configured to pass through the instrument valve housing 110 ( Figure 2 A seal is provided around the outer surface of the surgical instrument (not shown).

[0038] The sealing assembly 160 includes a multi-lobed or multi-segment sealing member 162, an upper support member 164, and a lower support member 166. As shown, the multi-lobed sealing member 162 includes six lobes or six segments forming a hexagonal body and defining an opening 161. Although shown as including six (6) segments, it is contemplated that the sealing assembly 160 may include any suitable number of segments, for example, as few as four (4) segments or as many as eight (8) segments. By forming the opening 161 of the multi-lobed sealing member 162 from multiple lobes, rather than forming it as a continuous solid opening through a single sealing member, the likelihood of the multi-lobed sealing member 162 tearing during its insertion, removal, and use is greatly reduced. Although shown with overlapping wing-shaped lobes 162a, it is contemplated that aspects of this disclosure may be modified for use with sealing members having lobes with alternative constructions and arrangements. Exemplary multi-lobe sealing members are shown and described in U.S. Patent No. 16 / 272,068, filed February 11, 2019, the entire contents of which are incorporated herein by reference.

[0039] Special Reference Figure 6 The upper support member 164 and lower support member 166 of the sealing assembly 160 each comprise a hexagonal shape corresponding to the shape of the multi-lobed sealing member 162, and each has openings 163 and 165. Although shown as having hexagonal bodies, the upper support member 164 and lower support member 166 may have bodies corresponding in size and shape to any multi-lobed sealing member (e.g., multi-lobed sealing member 162). The openings 163 and 165 are sized to allow proper coverage of the multi-lobed sealing member 162 while still allowing reception of larger surgical instruments (not shown) through the sealing assembly 160 with minimal impact on force. In embodiments, the diameters of the openings 163 and 165 may range from about 0.300 to about 0.450".

[0040] The upper support member 164 and the lower support member 166 may be formed of polybutadiene, liquid silicone rubber, or any other material with sufficient tensile properties. In the embodiments, the thickness of the upper support member 164 and the lower support member 166 is between 0.006 inches and 0.015 inches. As will be described in further detail below, the upper support member 164 and the lower support member 166 form a sandwich structure around the multi-lobed sealing member 162 to mitigate the effects of leakage paths within the multi-lobed sealing member 162.

[0041] Special Reference Figure 7The overlapping layers of multiple petals of the multi-petal sealing member 162 of the sealing assembly 160 provide a path for blown-in fluid to leak through the valve assembly 120. The upper support member 164 and the lower support member 166 of the sealing assembly 160 are configured to reduce the likelihood of blown-in fluid leakage through the multi-petal sealing member 162. More specifically, the upper support member 164 and the lower support member 166 are arranged proximally and distally to the multi-petal sealing member 162, respectively, and are configured to be compressed around the multi-petal sealing member 162. By compressing the multi-petal sealing member 162 between the upper support member 164 and the lower support member 166, leakage between the layers of the multi-petal sealing member 162 can be significantly reduced and / or eliminated. The upper support member 164 and the lower support member 166 also help prevent or reduce damage to the multi-petal sealing member 162 during the insertion, manipulation, and removal of surgical instruments.

[0042] Each of the multi-lobed sealing member 162, the upper support member 164, and the lower support member 166 defines a plurality of openings 161a, 163a, and 165a for receiving a leg 186 extending from the upper retainer member 182 of the retainer assembly 180.

[0043] Continue to refer to Figure 7 The upper support member 164 of the sealing assembly 160 is arranged between the inner ring 134 of the protective assembly 140 and the centering mechanism 130. A multi-lobed sealing member 162 is arranged on the opposite side of the inner ring 134, and the lower support member 164 of the sealing assembly 160 is disposed adjacent to the multi-lobed sealing member 162. A plurality of legs 186 of the retainer assembly 180 are received by each of the centering mechanism 130, the protective assembly 140, and the sealing assembly 160, the sealing assembly including the multi-lobed seal 162, the upper support member 164, and the lower support member 166.

[0044] The upper retainer member 182 and the lower retainer member 184 of the retainer assembly 180 are configured to compress the upper support member 164 and the lower support member 166, with the sealing assembly 160 sandwiched therebetween. In this way, any leakage between the petals 162a of the multi-petal sealing member 162 is reduced or eliminated in size.

[0045] Valve assembly 120 retainer assembly 180 ( Figure 3 The retainer assembly 180 is configured to fix the protective assembly 140 relative to the sealing assembly 160 and to secure the protective assembly 140 and the sealing assembly 160 to the centering mechanism 130. The retainer assembly 180 includes an upper retainer member 182 and a lower retainer member 184. As described above, the upper retainer member 182 includes a plurality of pins 186. The plurality of pins 186 extend from the bottom surface of the upper retainer member 182. Each of the plurality of pins 186 is configured to be lockably received in a plurality of openings 185 in the lower retainer member 184. Figure 3The upper retainer member 182 and the lower retainer member 184 are fastened together within an opening in the upper retainer member 182. In embodiments, a plurality of pins 186 are welded, glued, bonded, adhesively bonded, or otherwise secured within a plurality of openings 185 in the lower retainer member 184 to fasten the upper retainer member 182 and the lower retainer member 184 together. Alternatively, 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). Any one 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 and fastening the upper retainer member 182 to the lower retainer member 184.

[0046] Multiple pins 186 of the upper retainer member 182 extend through the ring portion 142 of the protective assembly 140, through openings 163a, 165a, 167a in the various multi-lobed sealing members 162 and the upper support member 164 and lower support member 166 of the sealing assembly 160, through the inner ring 134 of the centering mechanism 130, and into the opening 185 in the lower retainer member 184.

[0047] During surgical procedures using the cannula assembly 100, a surgical instrument (not shown) is introduced into the instrument housing 110 through longitudinal channels 113 in the upper housing section 112, lower housing section 114, and inner housing section 116. As described above, the distal end of the surgical instrument engages with the protective assembly 140, causing the flap portion of the protective assembly 140 to bend downwards to contact the multi-lobed sealing member 162 of the sealing assembly 160, thereby causing the central opening 163 of the multi-lobed sealing member 162 to open to accommodate the passage of the surgical instrument through the sealing assembly 160. Leakage through the multi-lobed sealing member 162 is reduced and / or eliminated by compressing the upper support member 164 and lower support member 166 of the sealing assembly 160 in a sandwich manner around the multi-lobed sealing member 162.

[0048] Now for reference Figures 8 to 15 According to another embodiment of the invention, the sealing assembly is generally shown as sealing assembly 260. Sealing assembly 260 is interchangeable with sealing assembly 160 described above herein, and only the differences between them will be described in detail.

[0049] Special Reference Figure 9 The sealing assembly 260 includes a plurality of sealing portions 262, an upper support member 264, and a lower support member 266. The plurality of sealing portions 262, the upper support member 264, and the lower support member 266 are fixed to each other. In an embodiment, and as shown, the sealing assembly 260 is integrally formed, i.e., a one-piece or monolithic design. The sealing assembly 260 may be stamped, molded, or otherwise formed.

[0050] The sealing assembly 260 comprises a plurality of sealing portions 262 including a first portion 262a, a second portion 262b, a third portion 262c, and a fourth portion 262d. Although only four (4) portions are shown, it is contemplated that the sealing assembly 260 may include up to eight (8) portions. The plurality of sealing portions 262 of the sealing assembly 260, as well as the upper support member 264 and the lower support member 266, may be formed of the same or different materials. In an embodiment, at least a plurality of sealing portions 262 are formed of an elastic material, such as rubber, polyisoprene, or a silicone elastomer. In an embodiment, the first portion 262a, the second portion 262b, the third portion 262c, and the fourth portion 262d may include one or more fabric layers.

[0051] Each of the first portion 262a, second portion 262b, third portion 262c, and fourth portion 262d of the multi-lobed sealing member 262 of the sealing assembly 260, as well as the upper support member 264 and lower support member 266, comprises an octagonal shape, although other shapes are contemplated. The inner edges 268a, 268b, 268c, and 268d of the respective first portion 262a, second portion 262b, third portion 262c, and fourth portion 262d of the sealing assembly 260 may be straight (not shown) or may be defined as V-shaped or cut-away as shown. In an embodiment, the V-shape is defined at an angle between forty-five degrees (45°) and one hundred and eighty degrees (180°). In an embodiment, the V-shape is defined at an angle of ninety degrees (90°). The V-shape of the inner edges 268a, 268b, 268c, and 268d of the corresponding first portion 262a, second portion 262b, third portion 262c, and fourth portion 262d of the sealing assembly 260 facilitates the reception of surgical instruments (not shown) through the sealing assembly 260. The first portion 262a, second portion 262b, third portion 262c, and fourth portion 262d of the multi-leaf sealing member 262 can form a flat seal (as shown) or a conical seal.

[0052] Continue to refer to Figure 9As shown, the upper support member 264 and the first portion 262a of the sealing assembly 260 are connected to each other via connector portion 263a; the first portion 262a and the second portion 262b of the sealing assembly 260 are connected to each other via connector portion 263b; the second portion 262b and the third portion 262c of the sealing assembly 260 are connected to each other via connector portion 263c; the third portion 262c and the fourth portion of the sealing assembly 260 are connected to each other via connector portion 263d; and the fourth portion 262d of the sealing assembly 260 and the lower support member 266 are connected to each other via connector portion 263e. In an embodiment, the connector portions 263a, 263b, 263c, 263d, and 263e of the sealing assembly 260 include movable hinges or are otherwise formed to facilitate folding of the portions and support members.

[0053] Each of the first portion 262a, the second portion 262b, the third portion 262c, and the fourth portion 262d, as well as the upper support member 264 and the lower support member 266, defines a plurality of openings 265a, 265b, 265c, and 265d along the outer periphery of each portion 262a, 262b, 262c, and 262d, respectively, and defines a plurality of openings 265e and 265f along the outer periphery of the upper support member 264 and the lower support member 266. The plurality of openings 265a, 265b, 265c, 265d, 265e, and 265f are configured to receive the pin 186 of the retainer assembly 180. Figure 7 This is to keep the sealing assembly 260 in a folded state and to secure the sealing assembly 260 relative to the protective assembly 140 and the centering mechanism 130.

[0054] Now refer to Figures 10 to 15 The method for describing the folded sealing assembly 260 is described first. Refer to [reference needed]. Figure 10 At the connector portion 263a between the upper support member 264 and the first portion 262a, the upper support member 264 is folded relative to the first portion 262a of the plurality of seals 262, as indicated by arrow "A," such that the upper support member 264 overlaps with the first portion 262a. In this way, the plurality of openings 265e are aligned with the plurality of openings 265a in the overlapping portion of the first portion 262a of the sealing assembly 260.

[0055] Go to Figure 11 The first portion 262a of the sealing assembly 260 is folded relative to the second portion 262a of the sealing assembly 260 at the connector portion 263b between the first portion 262a and the second portion 262b, as indicated by arrow "B", such that the first portion 262a overlaps with the second portion 262b of the sealing assembly 260. In this way, a plurality of openings 265a of the first portion 262a are aligned with a plurality of openings 265b in the overlapping portion of the second portion 262b of the sealing assembly 260.

[0056] refer to Figure 12 As shown, the second portion 262a of the sealing assembly 260 is folded relative to the third portion 262b at the connector portion 263c between the second portion 262a and the third portion 262b, as indicated by arrow "C," such that the second portion 262b overlaps with the third portion 262c of the sealing assembly 260. In this way, the plurality of openings 265b of the second portion 262b are aligned with the plurality of openings 265c in the overlapping portion of the third portion 262c of the sealing assembly 260.

[0057] refer to Figure 13 As shown, the third portion 262c of the sealing assembly 260 is folded relative to the fourth portion 262d of the sealing assembly 260 at the connector portion 263d between the third portion 262c and the fourth portion 262d, as indicated by arrow "D," such that the third portion 262c overlaps with the fourth portion 262d of the sealing assembly 260. In this way, the plurality of openings 265c of the third portion 262c are aligned with the plurality of openings 265d in the overlapping portion of the fourth portion 168 of the sealing assembly 160.

[0058] refer to Figure 14 The fourth portion 262d of the sealing assembly 260 is folded relative to the lower support member 266 of the sealing assembly 260 at the connector portion 163e between the fourth portion 262d and the lower support member 266, as indicated by arrow "E", such that the fourth portion 262d overlaps with the lower support member 266. In this way, the plurality of openings 265d of the fourth portion 262d are aligned with the plurality of openings 265f in the overlapping portion of the lower support member 266.

[0059] Sealing assembly 260 is fixed to instrument valve housing 110 in a manner similar to that of sealing assembly 160 described above. Figure 2 Inside. Sealing assembly 260 operates in a manner similar to sealing assembly 160.

[0060] Although various embodiments of the present disclosure have been shown and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many variations, modifications, and substitutions will now occur to those skilled in the art without departing from the present disclosure. Therefore, the present disclosure is limited only by the spirit and scope of the appended claims.

Claims

1. Surgical access components, including: An instrument valve housing, comprising an upper housing section, a lower housing section, and an inner housing section, and defining a cavity; as well as A valve assembly, disposed within the cavity of the instrument valve housing, the valve assembly comprising: The protective assembly includes multiple protective parts. A sealing assembly, arranged adjacent to the protective assembly, includes a plurality of sealing portions, an upper support member, and a lower support member. The plurality of sealing portions are movable from an unfolded configuration to a folded configuration, in which the sealing assembly forms an octagonal member defining an opening to allow for the sealed passage of surgical instruments. The upper support member and the lower support member are respectively arranged proximal and distal to the plurality of sealing portions and are compressed around the plurality of sealing portions to clamp the plurality of sealing portions therebetween. and A centering mechanism for holding the sealing assembly and the protective assembly centered within the cavity of the instrument valve housing. Each of the plurality of sealing portions is connected to an adjacent sealing portion of the plurality of sealing portions via a connector portion. The connector portion includes a movable hinge. The upper support member is connected to one of the plurality of sealing parts via a connector portion, and the lower support member is connected to another of the plurality of sealing parts via another connector portion. The upper support member and the sealing part, adjacent sealing parts, and the sealing part and the lower support member are all connected sequentially through only one connector part to form a linear connection structure.

2. The surgical access component according to claim 1, wherein, The upper support member and the lower support member define an opening of 0.30” to 0.45”.

3. The surgical access component according to claim 1, wherein, The thickness of the upper and lower support members is 0.006 inches to 0.015 inches.

4. The surgical access component according to claim 1, wherein, The plurality of sealing parts are formed of polyisoprene or liquid silicone rubber.

5. The surgical access component according to claim 1, wherein, The inner edge of each of the plurality of sealing portions is defined as V-shaped.

6. The surgical access component according to claim 5, wherein, The V-shape includes an angle of 180 to 275 degrees.

7. The surgical access component according to claim 1, wherein, The plurality of sealing portions includes a first sealing portion, a second sealing portion, a third sealing portion, and a fourth sealing portion, each of the first sealing portion, the second sealing portion, the third sealing portion, and the fourth sealing portion overlapping the adjacent second sealing portion, the third sealing portion, the fourth sealing portion, and the first sealing portion.

8. The surgical access assembly of claim 1, further comprising a retainer assembly, the retainer assembly including an upper retainer member and a lower retainer member.

9. The surgical access component according to claim 8, wherein, At least one of the upper retainer member and the lower retainer member includes a plurality of pins receivable through the protective assembly and the sealing assembly to retain the protective assembly and the sealing assembly relative to each other.

10. The surgical access component according to claim 1, wherein, The centering mechanism includes a bellows.

11. The surgical access component according to claim 1, wherein, The upper support member and the lower support member are octagonal in shape.

12. A valve assembly comprising: The protective components include multiple protective parts. A sealing assembly, arranged adjacent to the protective assembly, includes a plurality of sealing portions, an upper support member, and a lower support member. The plurality of sealing portions are movable from an unfolded configuration to a folded configuration, in which the sealing assembly forms an octagonal member defining an opening to allow for the sealed passage of surgical instruments. The upper and lower support members are respectively arranged proximal and distal to the plurality of sealing portions and are compressed around the plurality of sealing portions to clamp them therebetween. A centering mechanism for holding the sealing assembly and the protective assembly centered within the cavity of the surgical entry assembly. Each of the plurality of sealing portions is connected to an adjacent sealing portion of the plurality of sealing portions via a connector portion. The connector portion includes a movable hinge. The upper support member is connected to one of the plurality of sealing parts via a connector portion, and the lower support member is connected to another of the plurality of sealing parts via another connector portion. The upper support member and the sealing part, adjacent sealing parts, and the sealing part and the lower support member are all connected sequentially through only one connector part to form a linear connection structure.

13. The valve assembly of claim 12, further comprising a retainer assembly having an upper retainer member and a lower retainer member, wherein, At least one of the upper retainer member and the lower retainer member includes a plurality of pins receivable through the protective assembly and the sealing assembly to retain the protective assembly and the sealing assembly relative to each other.

14. A sealing assembly, comprising: Multiple sealing portions, which can be moved from an unfolded configuration to a folded configuration, in which the sealing assembly forms an octagonal member that defines an opening to allow surgical instruments to pass through in a sealed manner; An upper support member is arranged near the plurality of sealing portions; and A lower support member is disposed distal to the plurality of sealing portions, and the upper support member and the lower support member are compressed around the plurality of sealing portions to clamp the plurality of sealing portions therebetween. Each of the plurality of sealing portions is connected to an adjacent sealing portion of the plurality of sealing portions via a connector portion. The connector portion includes a movable hinge. The upper support member is connected to one of the plurality of sealing parts via a connector portion, and the lower support member is connected to another of the plurality of sealing parts via another connector portion. The upper support member and the sealing part, adjacent sealing parts, and the sealing part and the lower support member are all connected sequentially through only one connector part to form a linear connection structure.

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