Patent Description:
In order to facilitate minimally invasive surgery, a working space must be created at the desired surgical site. An insufflation fluid, typically CO<NUM>, is introduced into the abdomen of the patient to create an inflated state called a pneumoperitoneum. Access assemblies are utilized to allow the introduction of surgical instrumentation and endoscopes (or other visualization tools). These access assemblies maintain the pressure for the pneumoperitoneum, as they have one or more seals that adapt to the surgical instrumentation. Typically, a "zero-seal" in the access assembly seals the access assembly in the absence of a surgical instrument in the access assembly, and an instrument seal seals around a surgical instrument that has been inserted through the access assembly.

The breadth of surgical instrumentation on the market today requires a robust seal capable of adjusting to multiple sizes and withstanding multiple insertions of surgical instrumentation. Some of the instrumentation can include sharp edges that can tear or otherwise damage seals. Therefore, it would be beneficial to have an access assembly with improved seal durability.

Patents <CIT> <CIT>, <CIT>, <CIT> are all examples of known prior art in the field of valve and seal assemblies.

An access assembly includes an instrument valve housing including upper, lower, and inner housing sections and defining a cavity. A valve assembly is disposed within the cavity of the instrument valve housing. The valve assembly includes a guard assembly, and a seal assembly disposed distally of the guard assembly. The seal assembly includes a support member and a plurality of seal sections connected to the support member. The support member includes a ring portion and a seal portion disposed within the ring portion. The support member and the plurality of seal sections are integrally formed.

In embodiments, the seal assembly includes first, second, third, fourth seal, fifth, and sixth seal sections. The ring portion may be hexagonal. Each seal section of the plurality of seal sections may include a substantially wing shape. An inner edge of each seal section of the plurality of seal sections may be tapered.

In some embodiments, each seal section of the plurality of seal sections is connected to the ring portion by a living hinge. Each seal section of the plurality of seal sections may overlap two adjacent seal sections of the plurality of seal sections in a clockwise direction. Each seal section of the plurality of seal sections may overlap two adjacent seal sections of the plurality of seal sections in a counter-clockwise direction.

The access assembly may further include a retainer assembly including an upper retainer member, a lower retainer member, and a plurality of pins extending from one of the upper or lower retainer members. Each pin of the plurality of pins may be received through an opening in three seal sections of the plurality seal sections and through an opening in the ring portion of the support member.

Also provided is a valve assembly including a guard assembly, and a seal assembly disposed distal of the guard assembly. The seal assembly includes a support member and a plurality of seal sections connected to the support member. The support member includes a ring portion and a seal portion disposed within the ring portion. The support member and the plurality of seal sections are integrally formed.

In addition, provided is a seal assembly including a support member having a ring portion and a seal portion disposed within the ring portion, and a plurality of seal sections extending from the ring portion of the support member. The support member and the plurality of seal sections are integrally formed.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with a general description of the disclosure given above, and the detailed description of the embodiments given below, serve to explain the principles of the disclosure, wherein:.

Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Like reference numerals refer to similar or identical elements throughout the description of the figures.

As used herein, the term "distal" refers to that portion of the instrument, or component thereof which is farther from the user while the term "proximal" refers to that portion of the instrument or component thereof which is closer to the user. As used herein, the term "about" means that the numerical value is approximate and small variations would not significantly affect the practice of the disclosed embodiments. Where a numerical limitation is used, unless indicated otherwise by the context, "about" means the numerical value can vary by ±<NUM>% and remain within the scope of the disclosed embodiments.

Surgical access assemblies with obturators are employed during minimally invasive surgery, e.g., laparoscopic surgery, and provide for the sealed access of surgical instruments into an insufflated body cavity, such as the abdominal cavity. The surgical access assemblies of the present disclosure include an instrument valve housing mounted on a cannula tube, and include an obturator (not shown) inserted through the valve housing and cannula. The obturator can have a blunt distal end, or a bladed or non-bladed penetrating distal end and can be used to incise the abdominal wall so that the surgical access assembly can be introduced into the abdomen. The handle of the obturator can engage or selectively lock into the instrument valve housing of the surgical access assembly.

Surgical access assemblies are employed to tunnel through an anatomical structure, e.g., the abdominal wall, either by making a new passage through the anatomical structure or by passing through an existing opening through the anatomical structure. Once the surgical access assembly with the obturator has 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 includes valves that prevent the escape of insufflation fluid from the body cavity, while also allowing surgical instruments to be inserted into the body cavity.

In various embodiments, a bladeless optical trocar obturator may be provided that permits separation of tissue planes in a surgical procedure and visualization of body tissue fibers as they are being separated, thereby permitting a controlled traversal across a body wall. In other embodiments, the trocar obturator may be bladeless without being optical, e.g., without providing contemporaneous visualization thereof through the distal tip of an obturator. The bladeless obturator may be provided for the blunt dissection of the abdominal lining during a surgical procedure.

Various trocar obturators suitable for use with the surgical access assembly of the present disclosure are known and include, for example, bladed, bladeless, blunt, optical, and non-optical. For a detailed description of the structure and function of exemplary trocar assemblies, including exemplar trocar obturators and exemplar cannulas, please refer to <CIT> ("the '<NUM> publication").

With initial reference now to <FIG>, a surgical access assembly according to aspects of the present disclosure is shown generally as surgical access assembly <NUM>. The surgical access assembly <NUM> includes a cannula <NUM> and an instrument valve housing <NUM> secured to the cannula <NUM>. For a detailed description of an exemplary surgical access assembly, please refer to the '<NUM> publication.

With reference to <FIG>, the instrument valve housing <NUM> of the surgical access assembly <NUM> includes an upper housing section <NUM>, a lower housing section <NUM>, and an inner housing section <NUM>. The upper, lower, and inner housing sections <NUM>, <NUM>, <NUM> are configured to support a valve assembly <NUM> on a proximal end of the cannula <NUM>. More particularly, the inner housing section <NUM> is secured between the upper and lower housing sections <NUM>, <NUM>, and the valve assembly <NUM> is received between the inner and lower housing sections <NUM>, <NUM>. The upper and lower housing sections <NUM>, <NUM> of the instrument valve housing <NUM> may be selectively attachable to, and detachable from, the inner housing section <NUM>. The lower housing section <NUM> may be releasably or permanently attached to a cannula tube <NUM> (<FIG>) of the cannula <NUM>. In embodiments, either or both of the upper and lower housing sections <NUM>, <NUM> of the instrument valve housing <NUM> may include knurls, indentations, tabs, or be otherwise configured to facilitate engagement by a clinician.

The surgical access assembly <NUM> may also include features for the stabilization of the surgical access assembly. For example, the distal end of the cannula tube <NUM> may carry a balloon anchor or another expandable member that engages the abdomen from the interior side. For example, see <CIT>. A feature on the opposite side of the abdominal wall may be used to further stabilize the surgical access assembly, such as adhesive tabs or adjustable foam collars.

The upper, lower, and inner housing sections <NUM>, <NUM>, <NUM> of the instrument valve housing <NUM> define a longitudinal passage <NUM> for receipt of a surgical instrument (not shown). The valve assembly <NUM> is supported within the instrument valve housing <NUM> to provide sealed passage of the surgical instrument (not shown) through the surgical access assembly <NUM>.

With particular reference to <FIG> and <FIG>, the valve assembly <NUM> supported in the instrument valve housing <NUM> (<FIG>) includes a centering mechanism <NUM>, a guard assembly <NUM>, a seal assembly <NUM>, and a retainer assembly <NUM>. The centering mechanism <NUM> of the valve assembly <NUM> permits radial movement of the valve assembly <NUM> relative to the instrument valve housing <NUM> when a surgical instrument is received through the valve assembly <NUM>, and returns the valve assembly <NUM> to a generally centered position once the surgical instrument is withdrawn from within the instrument valve housing <NUM>. The guard assembly <NUM> protects the seal assembly <NUM> during insertion and withdrawal of a surgical instrument through the seal assembly <NUM>. The seal assembly <NUM> provides sealed passage of the surgical instrument through the instrument valve housing <NUM>. The retainer assembly <NUM> maintains the centering mechanism <NUM>, the guard assembly <NUM>, and the seal assembly <NUM> in an aligned relationship with one another.

With continued reference to <FIG> and <FIG>, as noted above, the centering mechanism <NUM> of the valve assembly <NUM> is configured to maintain the valve assembly <NUM> centered within the instrument valve housing <NUM> (<FIG>) in the absence of a surgical instrument passing through the valve assembly <NUM>. In embodiments, and as shown, the centering mechanism <NUM> includes an outer annular ring <NUM>, an inner annular ring <NUM>, and a bellows <NUM> disposed between the outer annular ring <NUM> and the inner annular ring <NUM>. As shown in <FIG>, the outer annular ring <NUM> is received between the inner housing section <NUM> and the lower housing section <NUM> to retain the centering mechanism <NUM> within the instrument valve housing <NUM>. The inner annular ring <NUM> supports the guard assembly <NUM>. For a detailed description of the structure and function of an exemplary centering mechanism, please refer to <CIT>.

Although shown including the centering mechanism <NUM> having bellows <NUM>, the valve assembly <NUM> may include alternative centering mechanisms. For example, the centering mechanism may include an annular base and a plurality of spokes extending from the base, as described in <CIT> ("the '<NUM> publication"). It is envisioned that the centering mechanism may include multiple sets of spokes, as disclosed in the '<NUM> publication.

With continued reference to <FIG> and <FIG>, the guard assembly <NUM> of the valve assembly <NUM> is configured to protect the seal assembly <NUM> as a surgical instrument (not shown) passes through the instrument valve housing <NUM> (<FIG>). The guard assembly <NUM> includes a ring portion <NUM> and first, second, third, and fourth petals <NUM>, <NUM>, <NUM>, <NUM>. The first, second, third, and fourth petals <NUM>, <NUM>, <NUM>, <NUM> define an opening <NUM> therebetween to facilitate sealed passage of a surgical instrument (not shown) through the guard assembly <NUM>. Although shown including four (<NUM>) petals, it is envisioned that the guard assembly may include any suitable number of petals, and the petals may include flap portions of any size or configuration. For detailed description of the structure and function of other exemplary guard assemblies, please refer to <CIT> and <CIT> ("the '<NUM> and '<NUM> patents") and <CIT>and <CIT>.

Referring to <FIG>, the seal assembly <NUM> of the valve assembly <NUM> is configured to provide a seal around an outer surface of a surgical instrument passing through the instrument valve housing <NUM> (<FIG>). In embodiments, and as shown, the seal assembly <NUM> forms a flat seal body; however, it is envisioned that the aspects of the present disclosure may be modified for use with a conical seal body.

The seal assembly <NUM> includes a support member <NUM>, and first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> secured to the support member <NUM> 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 be otherwise configured to permit folding of the respective first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> relative to the support member <NUM>.

In embodiments, the support member <NUM> and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> are formed of the same material, including, for example, polyurethane, polyisoprenes, or silicone elastomers. Alternatively, the support member <NUM>, and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be formed of different materials. In embodiments, the support member <NUM> and/or the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may include one or more fabric layers.

As noted above, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> define a planar configuration when the seal assembly <NUM> is in the folded condition (<FIG>). However, the seal assembly <NUM> may define a conical seal.

The support member <NUM> of the seal assembly <NUM> includes a hexagonal body or ring portion 162a and a seal portion 162b supported within the support member 162a. The ring portion 162a and the seal portions 162b may be formed of the same or different materials. The seal portion 162b defines a central opening <NUM>. The support member 162a defines a plurality of openings <NUM> corresponding to a plurality of pins <NUM> (<FIG>) extending from an upper retainer member <NUM> of the retainer assembly <NUM>. The seal portion 162a provides additional support to the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> when the seal assembly <NUM> is in the folded configuration.

In embodiments, and as shown, the ring portion 162a and the seal portion 162b of the support member <NUM> are of unitary construction, i.e., monolithic, with the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. By incorporating the ring portion 162a with the seal portion 162b of the support member <NUM> of the seal assembly <NUM> and forming the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> on the ring portion 162a of the support member <NUM>, instead of including a ring portion for the seal portion and a separate ring portion for the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, the number of components in the seal assembly <NUM>, and ultimately, the valve assembly <NUM>, is reduced. The incorporation of the seal portion 162b and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> with the same ring portion <NUM> also reduces assembly time and reduces material costs.

When in the folded condition (<FIG>), the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> define an opening 161a configured to receive a surgical instrument (not shown) inserted through the valve assembly <NUM> in a sealed manner. The first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> form a non-continuous or virtual seal circumference to reduce tearing during insertion, manipulation, and/or withdrawal of a surgical instrument (not shown) through the valve assembly <NUM>.

Each of the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> includes a wing-shaped body. When the seal assembly <NUM> is in the folded configuration, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are configured to partially overlap two adjacent seal sections in each of the clockwise and the counter-clockwise directions. More particularly, the first seal section <NUM> is configured to partially overlap, the sixth and fifth seal sections <NUM>, <NUM> in the clockwise direction and the second and third seal section <NUM>, <NUM> in the counter-clockwise direction, the second seal section <NUM> is configured to partially overlap the first and sixth seal sections <NUM>, <NUM> in the clockwise direction and the third and fourth seal sections <NUM>, <NUM> in the counter-clockwise direction, the third seal section <NUM> is configured to partially overlap the second and first seal sections <NUM>, <NUM> in the clockwise direction and the fourth and fifth seal section <NUM>, <NUM> in the counter-clockwise direction, the fourth seal section <NUM> is configured to partially overlap the third and second seal sections <NUM>, <NUM> in the clockwise direction and the fifth and sixth seal sections <NUM>, <NUM> in the counter-clockwise direction, the fifth seal section <NUM> is configured to partially overlap the fourth and third seal sections <NUM>, <NUM> in the clockwise direction and the sixth and first seal sections <NUM>, <NUM> in the counter-clockwise direction, and the sixth seal section <NUM> is configured to partially overlap the fifth and fourth seal sections <NUM>, <NUM> in the clockwise direction and the first and second seal sections <NUM>, <NUM> in the counter clockwise direction.

In embodiments, and as shown, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are folded such that the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> overlap in a sequential pattern in counter-clockwise direction. Alternatively, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may folded to overlap in a sequential clockwise direction. It is envisioned that the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may instead be folded in opposed pairs, i.e., first and fourth seal sections <NUM>, <NUM> folded together, second and fifth seal sections, <NUM>, <NUM> folded together, and third and sixth seal sections <NUM>, <NUM> folded together, or in any other suitable manner.

An inner edge 164b, 166b, 168b, 170b, 172b, 174b of the respective first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> may define a V-shape, as shown, or may extend straight across. In embodiments, the V-shape defines an angle "α" from about one-hundred eighty degrees (<NUM>°) to about two-hundred seventy-five degrees (<NUM>°)(<FIG>). The V-shape of the inner edges 164b, 166b, 168b, 170b, 172b 164b facilitates reception of a surgical instrument (not shown) through the seal assembly <NUM>.

Each of the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> defines a plurality of openings <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> (<FIG>) adjacent the respective connector portions 164a, 166a, 168a, 170a, 172a, 174a of each seal section <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, respectively. In embodiments, and as shown, the plurality of openings <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are arranged such each opening of the plurality of openings <NUM> in the support member <NUM> is aligned with an opening of the plurality of openings <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the respective first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and an opening of the plurality of openings <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the two adjacent first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. In this manner, each pin of the plurality of pins <NUM> (<FIG>) of the retainer assembly <NUM> is received through an opening <NUM> in the support member <NUM> and through an opening <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> in three of the six seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> when the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are secured relative to each other in the assembled configuration. This arrangement ensures the integrity of the seal assembly <NUM>, and more particularly, ensures the positioning of the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> relative to each other and the support member <NUM>.

<FIG> and <FIG> illustrate the method of folding the seal assembly <NUM>. As shown in <FIG>, each of the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are folded relative to the support member <NUM> at the respective connector portion 164a, 166a, 168a, 170a, 172a, 174a, as indicated by arrows "A", "B", "C", "D", "E", and "F" respectively. As shown, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are folded simultaneously, with adjacent seal sections overlapping one another. More particularly, the second seal section <NUM>, overlaps the first seal section <NUM>, the third seal section <NUM> overlaps the second seal section <NUM>, and so on until the first seal section <NUM> overlaps the sixth seal section <NUM>. This overlapping or interweaving pattern increases the integrity of the seal assembly <NUM>, i.e., reduces the likelihood of the seal assembly <NUM> leaking when a surgical instrument is received therethrough. As noted above, alternatively, the seal sections may be folded in any manner, including, with opposed seal sections folded together.

<FIG> and <FIG> illustrate the seal assembly <NUM> in the folded condition. In the folded configuration, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are disposed adjacent the seal portion 162b of the support member <NUM>.

<FIG> illustrates a bottom view of the assembled valve assembly <NUM>. The seal assembly <NUM> is secured relative to the centering mechanism <NUM> and the guard assembly <NUM> (<FIG>) by retainer assembly <NUM>. More particularly, the plurality of pins <NUM> extending from the upper retainer member <NUM> (<FIG>) of the retainer assembly <NUM> extend through the guard assembly <NUM>, the centering mechanism <NUM>, and the seal assembly <NUM>, and are secured within openings <NUM> of the lower retainer member <NUM>. In embodiments, the plurality of pins <NUM> is welded, glued, adhered, bonded or otherwise secured within the plurality of openings <NUM> in the lower retainer member <NUM> to secure the upper retainer member <NUM> and the lower retainer member <NUM> together. The lower retainer member <NUM> may instead, or additionally, include a plurality of pins (not shown) with the upper retainer member <NUM> defining a plurality corresponding openings (not shown). Either or both of the upper and lower retainer members <NUM>, <NUM> may include locking features (not shown) for engaging the plurality of pins <NUM> and securing the upper retainer member <NUM> to the lower retainer member <NUM>.

Referring to <FIG>, a seal assembly according to another aspect of the disclosure is shown generally as seal assembly <NUM>. The seal assembly <NUM> is substantially similar to the seal assembly <NUM> described hereinabove, and will only be described in detail with regards to the differences therebetween. The seal assembly <NUM> is configured to be received within the instrument valve housing <NUM> (<FIG>) and provide a seal around an outer surface of a surgical instrument passing through the instrument valve housing <NUM>. As shown, the seal assembly <NUM> forms a flat seal body; however, it is envisioned that the aspects of the disclosure may be modified for use with a conical seal body.

The seal assembly <NUM> includes a support member <NUM>, and first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> secured to the support member <NUM>. In some aspects of the disclosure, the support member <NUM> and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> are formed of the same material, including, for example, polyurethane, polyisoprenes, or silicone elastomers. Alternatively, the support member <NUM>, and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are formed of different materials. In other aspects, the support member <NUM> and/or the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may include one or more fabric layers.

As noted above, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> define a planar configuration when the seal assembly <NUM> is in the folded condition (<FIG>). However, the seal assembly <NUM> may define a conical seal when in the folded condition.

The support member <NUM> of the seal assembly <NUM> includes a hexagonal body or ring portion 262a and a seal portion 262b supported within the support member 262a. The ring portion 262a and the seal portions 262b may be formed of the same or different materials. The seal portion 262b defines a central opening <NUM>. The support member 262a defines a plurality of openings <NUM> (<FIG>) corresponding to the plurality of pins <NUM> (<FIG>) extending from the upper retainer member <NUM> of the retainer assembly <NUM>. The seal portion 262a provides additional support to the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> when the seal assembly <NUM> is in the folded configuration (<FIG>).

As shown, the ring portion 262a and the seal portion 262b of the support member <NUM> are of unitary construction, i.e., monolithic, with the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. By incorporating the ring portion 262a with the seal portion 262b of the support member <NUM> of the seal assembly <NUM> and forming the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> on the ring portion 262a of the support member <NUM>, instead of including a ring portion for the seal portion and a separate ring portion for the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, the number of components in the seal assembly <NUM>, and ultimately, the valve assembly <NUM>, is reduced (<FIG>). The incorporation of the seal portion 262b and the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> with the same ring portion <NUM> also reduces assembly time and reduces material costs.

The first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> are identical to each other in structure and function, and will be described in detail with reference to first seal section <NUM> shown in <FIG>. The first seal section <NUM> includes a wing-shaped body secured to the support member <NUM> by a connector portion 264a. The connector portion 264a may include a single living hinge, as shown, or a plurality of living hinges (<FIG>), or may be otherwise configured to permit folding of the first seal section <NUM> relative to the support member <NUM>. The first seal section <NUM> and the support member <NUM> may define a notch 263a on either side of the connector portion 264a to facilitate folding of the first seal section <NUM> relative to the support member <NUM>. The notches 263a may include a triangular configuration, as shown, or may be otherwise configured to facilitate folding of the first seal section <NUM> relative to the support member <NUM>.

Inner edge 264b of the first seal section <NUM> of the seal assembly <NUM> may define a V-shape, as shown, or may extend straight across. In embodiments, the V-shape defines an angle "α" from about one-hundred eighty degrees (<NUM>°) to about two-hundred seventy-five degrees (<NUM>°). The V-shape of the inner edge 264b facilitates reception of a surgical instrument (not shown) through the seal assembly <NUM>. Each inner edge 264b may be tapered to further facilitate reception of the surgical instrument through the seal assembly <NUM> in a sealed manner.

The first seal section <NUM> defines a plurality of openings 265a adjacent the connector portion 264a between the first seal section <NUM> and the support member <NUM>, and an opening 265b along each lateral edge 264c of the first seal section <NUM> adjacent the inner edge 264b of the first seal section <NUM>. The lateral edges 264c of the first seal section <NUM> each defines a semi-circular cutout 265c between each of the openings 265b and the plurality of openings 265a. The cutouts 265c reduce the amount of material forming the first seal section <NUM>. The cutouts 265c may allow for additional flexing of the first seal section <NUM>.

<FIG> illustrates the method of folding the seal assembly <NUM>. Each of the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> is folded relative to the support member <NUM>, as indicated by arrows "G", "H", "I", "J", "K", and "L" respectively. As shown, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are folded simultaneously, with adjacent seal sections overlapping one another. More particularly, the second seal section <NUM>, overlaps the first seal section <NUM>, the third seal section <NUM> overlaps the second seal section <NUM>, and so on until the first seal section <NUM> overlaps the sixth seal section <NUM>. This overlapping or interweaving pattern increases the integrity of the seal assembly <NUM>, i.e., reduces the likelihood of the seal assembly <NUM> leaking when a surgical instrument is received therethrough. As noted above, alternatively, the seal sections may be folded in any manner, including, with opposed seal sections folded together.

In some aspects of the disclosure, and as shown, the plurality of openings 265a and the openings 265b of the first seal section <NUM> are arranged such that, when the seal assembly <NUM> is in the folded condition (<FIG>), each opening of the plurality of openings <NUM> in the support member <NUM> is aligned with an opening of the plurality of openings 265a of the first seal section <NUM>, with two openings of each of the adjacent second and sixth seal sections <NUM><NUM>, and with one opening of each of the third and fifth seal sections <NUM>, <NUM>. This arrangement ensures the integrity of the seal assembly <NUM>, and more particularly, ensures the positioning of the first, second, third, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM> relative to each other and the support member <NUM>.

<FIG> illustrates the seal assembly <NUM> in the folded condition. In the folded condition, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the seal assembly <NUM> define an opening 261a configured to receive a surgical instrument (not shown) inserted through the valve assembly <NUM> in a sealed manner. The first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> form a non-continuous or virtual seal circumference to reduce tearing during insertion, manipulation, and/or withdrawal of a surgical instrument (not shown) through the valve assembly <NUM> (<FIG>).

When the seal assembly <NUM> is in the folded configuration, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are configured to partially overlap two adjacent seal sections in each of the clockwise and the counter-clockwise directions. More particularly, the first seal section <NUM> is configured to partially overlap, the sixth and fifth seal sections <NUM>, <NUM> in the clockwise direction and the second and third seal section <NUM>, <NUM> in the counter-clockwise direction, the second seal section <NUM> is configured to partially overlap the first and sixth seal sections <NUM>, <NUM> in the clockwise direction and the third and fourth seal sections <NUM>, <NUM> in the counter-clockwise direction, the third seal section <NUM> is configured to partially overlap the second and first seal sections <NUM>, <NUM> in the clockwise direction and the fourth and fifth seal section <NUM>, <NUM> in the counter-clockwise direction, the fourth seal section <NUM> is configured to partially overlap the third and second seal sections <NUM>, <NUM> in the clockwise direction and the fifth and sixth seal sections <NUM>, <NUM> in the counter-clockwise direction, the fifth seal section <NUM> is configured to partially overlap the fourth and third seal sections <NUM>, <NUM> in the clockwise direction and the sixth and first seal sections <NUM>, <NUM> in the counter-clockwise direction, and the sixth seal section <NUM> is configured to partially overlap the fifth and fourth seal sections <NUM>, <NUM> in the clockwise direction and the first and second seal sections <NUM>, <NUM> in the counter clockwise direction.

In some aspects of the disclosure, and as shown, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are folded such that the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> overlap in a sequential pattern in counter-clockwise direction. Alternatively, the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may folded to overlap in a sequential clockwise direction. It is envisioned that the first, second, third, fourth, fifth, and sixth seal sections <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may instead be folded in opposed pairs, i.e., first and fourth seal sections <NUM>, <NUM> folded together, second and fifth seal sections, <NUM>, <NUM> folded together, and third and sixth seal sections <NUM>, <NUM> folded together, or in any other suitable manner.

Claim 1:
A seal assembly (<NUM>, <NUM>) comprising:
a support member (<NUM>, <NUM>); and
a plurality of seal sections (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) connected to the support member, characterised in that
the support member including a ring portion (162a, 262a) and a seal portion (162b, 262b) disposed within the ring portion, the seal portion supporting the plurality of seal sections when the plurality of seal sections is in a folded position, the seal portion and the plurality of seal sections, when in said folded position, defining an opening (161a, 261a) configured to receive a surgical instrument in a sealed manner, wherein the ring portion, seal portion and the plurality of seal sections are integrally formed.