Sealing assembly for surgical access components

Abstract

This invention relates to a sealing assembly for a surgical access component, and specifically provides an access component comprising an instrument valve housing and a valve assembly disposed within a cavity of the instrument valve housing. The valve assembly includes a protective assembly, a sealing assembly disposed adjacent to the protective assembly, and a centering mechanism for maintaining the sealing assembly and the protective assembly centered within the cavity of the instrument valve. The protective assembly includes a support ring and a plurality of protective sections disposed distal to the support ring. The sealing assembly includes a proximal sealing member, an intermediate sealing assembly, and a distal sealing member, the intermediate sealing assembly comprising a plurality of sealing sections arranged in a stacked configuration.

Description

[0001] Cross-reference to related applications

[0002] This application is a continuation-in-part of U.S. Patent Application No. 16 / 272,068, filed on February 11, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to an access assembly for minimally invasive surgery that includes a seal. More specifically, this disclosure relates to a seal for a surgical access assembly. Background Technology

[0004] To facilitate minimally invasive surgery, a working space must be created at the surgical site. Inhalation gas, typically CO2, is introduced into the patient's abdomen to create an inflated state known as pneumoperitoneum. Access components are used to allow the introduction of surgical instruments and endoscopes (or other visualization tools). These access components maintain pneumoperitoneum pressure because they have one or more seals suitable for surgical instruments. Typically, in the absence of surgical instruments in the access component, the "zero seal" seals the access component, and the instrument seal seals around the surgical instrument that has been inserted through the access component.

[0005] The wide variety of surgical instruments available today necessitates robust seals that can be adjusted to multiple sizes and withstand repeated insertions. Some instruments may contain sharp edges that can tear or otherwise damage the seal. Therefore, entry components with improved seal durability would be beneficial. Summary of the Invention

[0006] An entry assembly with improved sealing durability is provided. The entry assembly includes an instrument valve housing and a valve assembly. The instrument valve housing defines a cavity. The valve assembly is disposed within the cavity of the instrument valve housing. The valve assembly includes a protective assembly, a sealing assembly disposed adjacent to the protective assembly, and a centering mechanism for maintaining the sealing assembly and the protective assembly centered within the cavity of the instrument valve. The protective assembly includes a support ring and a plurality of protective sections disposed distal to the support ring. The sealing assembly includes a proximal sealing member, an intermediate sealing member, and a distal sealing member.

[0007] In one embodiment, the protective assembly includes six protective segments. Each of the plurality of protective segments may include a first side configured to receive overlapping portions of adjacent protective segments. The first side of each of the plurality of protective segments may be downwardly angled. Each of the plurality of protective segments may include a protective portion having a substantially kidney-shaped form. Each protective portion may include a notch and may be configured such that the notch forms an opening when the plurality of protective segments are assembled.

[0008] In some embodiments, at least one of the support ring and the plurality of protective sections includes a plurality of outwardly extending tabs for aligning the protective assembly with the centering mechanism. The proximal sealing member may include an annular flange and a sealing portion supported within the annular flange. The intermediate sealing assembly includes a plurality of sealing sections. The entry assembly may further include a retaining member having a plurality of pins. The centering mechanism may include an annular base defining channels for receiving the plurality of pins for maintaining the valve assembly in an assembled configuration.

[0009] Another inlet assembly with improved sealing durability includes an instrument valve housing and a valve assembly disposed within the instrument valve housing. More specifically, the instrument valve housing includes upper, lower, and inner housing sections and defines a cavity for receiving the valve assembly. The valve assembly includes a protective assembly, a sealing assembly disposed adjacent to the protective assembly, and a centering mechanism for maintaining the sealing assembly and the protective assembly in a centered position within the cavity of the instrument valve. The protective assembly includes multiple protective sections. The sealing assembly includes a proximal sealing member, an intermediate sealing assembly, and a distal sealing member. The intermediate sealing assembly includes multiple sealing sections in a stacked configuration; and

[0010] In one embodiment, the intermediate sealing assembly comprises six sealing segments. Each of the multiple sealing segments may have an airfoil shape. The inner edge of each of the multiple sealing segments may be straight. Alternatively, the inner portion of each of the multiple sealing segments may be tapered. At least one of the top and bottom surfaces of the inner portion may taper gradually. The intermediate sealing assembly may be hexagonal. The proximal sealing member may include an annular flange and a sealing portion supported within the annular flange. The proximal and distal sealing members may be used to support the intermediate sealing assembly. The entry assembly may further include a retainer assembly comprising upper and lower retainer members. At least one of the upper and lower retainer members may include a plurality of pins that are received through the protective assembly and the sealing assembly, the pins being used to retain the protective assembly and the sealing assembly relative to each other. Attached Figure Description

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

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

[0013] Figure 2 It was cut along section line 2-2. Figure 1 The side sectional view of the proximal region of the component shown;

[0014] Figure 3 This is an exploded perspective view of a valve assembly, which includes a centering mechanism, a protective assembly, a sealing assembly, and a retainer assembly.

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

[0016] Figure 5 yes Figure 3 The sealing assembly shown is in an open configuration perspective view;

[0017] Figures 6 to 11 yes Figure 3 The perspective view of the sealing assembly shown in sequence, in partially folded and fully folded states;

[0018] Figure 12 yes Figure 3 Top perspective view of the valve assembly shown;

[0019] Figure 13 yes Figure 3 Bottom perspective view of the valve assembly shown;

[0020] Figure 14 This is a top view of a sealing assembly in an initial or folded configuration according to another embodiment of the present disclosure;

[0021] Figure 15 yes Figure 14 A perspective side view of a section of the sealing assembly shown;

[0022] Figure 16 It is along Figure 15 The section line 16-16 shown is the cut-off point. Figure 14 A side sectional view of a section of the sealing assembly shown;

[0023] Figure 17 yes Figure 14 The sealing assembly shown is in a top view of a folded configuration;

[0024] Figure 18 This is a perspective view of a valve assembly according to another embodiment of the present disclosure;

[0025] Figure 19 yes Figure 18 The exploded perspective view of the valve assembly shown includes a centering mechanism, a protective assembly, a sealing assembly, and a retainer assembly.

[0026] Figure 20 yes Figure 19 Top perspective view of the centering mechanism shown;

[0027] Figure 21 It is a section taken along line 21-21. Figure 20 A side sectional view of the centering mechanism shown in the diagram;

[0028] Figure 22 yes Figure 19 A top view of the protected section of the protective component shown;

[0029] Figure 23 It is a section taken along line 23-23. Figure 20 A sectional side view of the protective section shown;

[0030] Figures 24 to 29 yes Figure 19 A perspective view of the protective components shown in assembly order;

[0031] Figure 30 yes Figure 18 The side sectional view of the valve assembly shown;

[0032] Figure 31 This is a perspective view of a valve assembly according to yet another embodiment of the present disclosure;

[0033] Figure 32 yes Figure 31 The exploded perspective view of the valve assembly shown includes a centering mechanism, a protective assembly, a sealing assembly, and a retainer assembly.

[0034] Figure 33 yes Figure 32 Top perspective view of the sealing section of the sealing assembly shown;

[0035] Figure 34 yes Figure 33 A side view of the sealing section shown;

[0036] Figure 35 yes Figure 33 A top view of the sealing section of the sealing assembly shown;

[0037] Figure 36 It is a section taken from line 36-36. Figure 35 The side sectional view of the sealing section shown; and

[0038] Figures 37 to 42 yes Figure 33 The diagram shows a perspective view of the sealing sections in the assembly sequence. Detailed Implementation

[0039] Specific embodiments of this disclosure are described below with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely illustrative and may be embodied in various forms. Well-known functions or constructions are not 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 merely as the basis for the claims and as a representative basis for teaching those skilled in the art to use this disclosure with virtually any appropriately detailed construction. Throughout the description of the drawings, the same reference numerals refer to similar or identical elements.

[0040] As used herein, the term "far side" refers to the part of the instrument or its components that is further away from the user, while the term "proximal side" refers to the part of the instrument or its components that is closer to the user.

[0041] An access assembly with an occluder is used during minimally invasive procedures such as laparoscopic surgery, and the access assembly allows surgical instruments to be sealed into an inflatable cavity, such as the abdominal cavity. The access assembly of this disclosure includes an instrument valve housing mounted on a cannula body and includes an occluder (not shown) inserted through the valve housing and the cannula. The occluder may have a blunt distal end, or a penetrating distal end with or without a blade, and may be used to incise the abdominal wall so that the access assembly can be introduced into the abdomen. The handle of the occluder may engage or selectively lock into the instrument valve housing of the access assembly.

[0042] The access component is used to tunnel through anatomical structures, such as the abdominal wall, by forming a new channel through the anatomical structure or by passing through an existing opening in the anatomical structure. Once the cannula assembly with an occluder has tunneled through the anatomical structure, the occluder is removed, leaving the access component in place. The instrument valve housing of the access component contains a valve that prevents blown-in gas from escaping from the body cavity while also allowing surgical instruments to be inserted into the cavity.

[0043] In various embodiments, a bladeless optical cannula occluder may be provided, allowing for the separation of tissue planes during the procedure and visualization of somatic tissue fibers during dissection, thereby enabling controlled traversal across the body wall. In other embodiments, the cannula occluder may be bladeless but not optical, for example, without providing simultaneous visualization through the distal end of the occluder. A bladeless occluder may be provided for blunt dissection of the abdominal endothelium during the procedure.

[0044] Various trocar occluders suitable for use with the access components of this disclosure are known, including, for example, bladed, bladeless, blunt, optical, and non-optical trocar occluders. For a detailed description of the structure and function of an exemplary trocar assembly comprising an exemplary trocar occluder and an exemplary cannula, please refer to the commonly owned PCT Publication WO2016 / 186905 (“'905 Publication”), the contents of which are hereby incorporated herein by reference in their entirety.

[0045] Now, let's refer to... Figure 1 The access assembly according to an aspect of this disclosure is generally shown as access assembly 100. 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 access assembly, please refer to the '905 disclosure.

[0046] refer to Figure 2 The instrument valve housing 110 of the access assembly 100 includes an upper housing section 112, a lower housing section 114, and an inner housing section 116. The upper, lower, and inner housing sections 112, 114, and 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 and lower housing sections 112 and 114 of the instrument valve 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 access assembly 102. Figure 1 In an embodiment, either or both of the upper and lower housing sections 112, 114 of the instrument valve housing 110 may include protrusions, notches, tabs, or otherwise be configured to facilitate engagement by a clinician.

[0047] The entry assembly 100 may also include features for stabilizing the entry assembly 100. For example, the distal end of the cannula body 104 may carry a balloon anchor or another expandable member that engages the abdomen from the inside. See, for example, commonly owned U.S. Patent No. 7,300,448, the entire disclosure of which is hereby incorporated by reference. Features on opposite sides of the abdominal wall may be used to further stabilize the entry assembly, such as adhesive tabs or adjustable foam rings.

[0048] The upper, lower, and inner housing sections 112, 114, and 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 provide a sealed passage for the surgical instrument to pass through and enter the assembly 100.

[0049] For details, please refer to the following: Figure 2 and 3 Supported on 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 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 the 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 alignment with each other.

[0050] Continue to refer to Figure 2 and 3 As mentioned above, the centering mechanism 130 of the valve assembly 120 is configured to hold the valve assembly 120 within 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 housing section 116 and the lower housing section 114 to retain the centering mechanism 130 within the instrument valve housing 110. The 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 the commonly owned U.S. Patent No. 6,702,787 (“787 Patent”), the contents of which are incorporated herein by reference in their entirety.

[0051] Although shown as including a centering mechanism 130 with bellows 136, the valve assembly 120 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 commonly owned 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.

[0052] Still referencing Figure 2 and 3The protective assembly 140 of valve assembly 120 includes a ring portion 142 and first, second, third, and fourth flaps 144, 146, 148, and 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 flaps 144, 146, 148, and 150. Alternatively, the protective assembly 140 may be formed by molding or other techniques. It is envisioned that the protective assembly may include any number of flaps, and the flaps may include flap portions of any size or configuration. Exemplary protective assemblies and other aspects of access assemblies can be found, for example, in U.S. Patent Nos. 5,895,377 and 6,569,120 (“'377 and '120 Patents”) and PCT Publication WO91 / 12838, the entire disclosure of which is hereby incorporated by reference. For a detailed description of the structure and function of the exemplary protective components, please refer to the jointly owned U.S. Patent Applications Nos. 16 / 394,043 and 16 / 238,823, the contents of which are incorporated herein by reference in their entirety.

[0053] Now for specific reference Figures 4 to 11 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).

[0054] The sealing assembly 160 includes a first or folded configuration ( Figure 5 Move to folded configuration ( Figure 4 The first, second, third, fourth, fifth, and sixth segments or sections 162, 164, 166, 168, 170, and 172 of the sealing assembly 160. In a folded configuration, the sealing assembly 160 forms a substantially planar hexagonal member, wherein the first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 of the sealing assembly 160 define an opening 161 therebetween to allow a surgical instrument (not shown) to pass through the sealing assembly 160 in a sealed manner. In an embodiment, the diameter of the opening 161 is 0.025" to 0.100". By forming the opening 161 from the first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 of the sealing assembly 160, rather than forming it as a continuous solid opening through a single sealing member, the likelihood of the sealing assembly 160 tearing during the insertion, removal, and use of a surgical instrument passing through the sealing assembly is greatly reduced. Although shown to include six (6) sections, the sealing assembly 160 is envisioned to include as few as four (4) sections and as many as eight (8) sections.

[0055] The first, second, third, fourth, fifth, and sixth sections 162, 164, 166, 168, 170, and 172 of the sealing assembly 160 are formed of an elastic material, such as rubber, polyisoprene, or a silicone elastomer. In embodiments, the first, second, third, fourth, fifth, and sixth sections 162, 164, 166, 168, 170, and 172 may comprise one or more fabric layers.

[0056] For details, please refer to the following: Figure 5 The first and second sections 162, 164, the second and third sections 164, 166, the third and fourth sections 166, 168, the fourth and fifth sections 168, 170, and the fifth and sixth sections 170, 172 of the sealing assembly 160 are respectively connected to each other via connector portions 162a, 164a, 166a, 168a, 170a. In an embodiment, the connector portions 162a, 164a, 166a, 168a, 170a include movable hinges or are otherwise formed to facilitate folding of the sections.

[0057] The inner edges 162b, 164b, 166b, 168b, 170b, and 172b of the corresponding first, second, third, fourth, fifth, and sixth sections 162, 164, 166, 168, 170, and 172 of the sealing assembly 160 may be straight. Figure 14 ), or may be limited to V-shape ( Figure 5 In this embodiment, the V-shape defines an angle between 180° and 275°. The V-shape of the inner edges 162b, 164b, 166b, 168b, and 170b facilitates the reception of surgical instruments (not shown) passing through the sealing assembly 160.

[0058] Each of the first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 of the sealing assembly 160 includes an airfoil body configured to partially overlap with the corresponding connected second, third, fourth, fifth, and sixth segments 164, 166, 168, 170, and 172 when the sealing assembly 160 is in a folded configuration. The first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 are also configured to partially overlap with the corresponding adjacent third, fourth, fifth, sixth, first, and second segments 166, 168, 170, 172, 162, and 164, and with the corresponding adjacent sixth, first, second, third, fourth, and fifth segments 172, 162, 164, 166, and 168. For example, the first segment 162 overlaps with the connected second segment 164 and the adjacent third and sixth segments 166 and 172. In this way, a portion of each of the first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 overlaps with three segments.

[0059] Each of the first, second, third, fourth, fifth, and sixth segments 162, 164, 166, 168, 170, and 172 defines a plurality of openings 163, 165, 167, 169, 171, and 173 along the outer periphery of each segment 162, 164, 166, 168, 170, and 172. In an embodiment, and as shown, the plurality of openings 163, 165, 167, 169, 171, and 173 are arranged such that the first two openings and the last two openings of each plurality of openings 163, 165, 167, 169, 171, and 173 are aligned with the last two openings and the first two openings of the adjacent segment. For example, as described above, the first segment 162 overlaps with the connected second segment 164 and the adjacent third and sixth segments 166 and 172. In this manner, when the sealing assembly 160 is in a folded configuration, the first two openings 163a of the plurality of openings 163 are aligned with the last two openings 167b of the plurality of openings 167 in the third section 166, and the second two openings 163b of the plurality of openings 163 in the first section 162 are aligned with the first two openings 173a of the plurality of openings 173 in the sixth section.

[0060] Multiple openings 163, 165, 167, 169, 171, and 173 are configured to receive pin 186 of the retainer assembly 180. Figure 3 This is to maintain the sealing assembly 160 in a folded state and to secure the sealing assembly 160 relative to the protective assembly 140 and the centering mechanism 130.

[0061] Now refer to Figures 6 to 11Describes the method for folded seal assembly 160. First, refer to... Figure 6 As indicated by arrow "A", the first segment 162 of the sealing assembly 160 is folded relative to the second segment 164 at the hinge portion 162a between the first and second segments 162, 164, such that a portion of the first segment 162 adjacent to the hinge portion 162a is aligned with a portion of the second segment 164 of the sealing assembly 160 adjacent to the hinge portion 162a. In this manner, a plurality of openings 163 in the portion of the first segment 162 adjacent to the hinge portion 162a are aligned with a plurality of openings 165 in the overlapping portion of the second segment 164 of the sealing assembly 260 adjacent to the hinge portion 162a.

[0062] Turning Figure 7 As indicated by arrow "B", the second segment 164 of the sealing assembly 160 is folded relative to the third segment 166 at the hinge portion 164a between the second and third segments 164, 166, such that a portion of the second segment 164 adjacent to the hinge portion 164a overlaps in length with a portion of the third segment 166 of the sealing assembly 160 adjacent to the hinge portion 164a. In this manner, a plurality of openings 165 in the portion of the second segment 164 adjacent to the hinge portion 164a are aligned with a plurality of openings 167 in the overlapping portion of the third segment 166 of the sealing assembly 160 adjacent to the hinge portion 164a.

[0063] refer to Figure 8 As indicated by arrow "C", the third segment 166 of the sealing assembly 160 is folded relative to the fourth segment 168 of the sealing assembly 160 at the hinge portion 166a between the third and fourth segments 166, 168, such that a portion of the third segment 166 adjacent to the hinge portion 166a overlaps with a portion of the fourth segment 168 of the sealing assembly 260 adjacent to the hinge portion 166a. In this manner, a plurality of openings 167 in the portion of the third segment 166 adjacent to the hinge portion 166a are aligned with a plurality of openings 169 in the overlapping portion of the fourth segment 168 of the sealing assembly 160 adjacent to the hinge portion 166a.

[0064] refer to Figure 9 As indicated by arrow "D", the fourth segment 168 of the sealing assembly 160 is folded relative to the fifth segment 170 of the sealing assembly 160 at the hinge portion 168a between the fourth and fifth segments 168, 170, such that a portion of the fourth segment 168 adjacent to the hinge portion 168a overlaps with a portion of the fifth segment 170 of the sealing assembly 160 adjacent to the hinge portion 168a. In this manner, a plurality of openings 169 in the portion of the fourth segment 168 adjacent to the hinge portion 168a are aligned with a plurality of openings 171 in the overlapping portion of the fifth segment 170 adjacent to the hinge portion 168a.

[0065] Turning Figure 10 As indicated by arrow "E", the fifth segment 170 of the sealing assembly 160 is folded relative to the sixth segment 172 at the hinge portion 170a between the fifth and sixth segments 170, 172, such that a portion of the fifth segment 170 adjacent to the hinge portion 170a overlaps with a portion of the sixth segment 172 of the sealing assembly 260 adjacent to the hinge portion 170a. In this manner, a plurality of openings 171 in the portion of the fifth segment 170 adjacent to the hinge portion 170a are aligned with a plurality of openings 173 in the overlapping portion of the sixth segment 170 of the sealing assembly 160 adjacent to the hinge portion 170a.

[0066] Figure 11 The seal assembly 160 is shown in a fully folded configuration. In one embodiment, a portion of the sixth segment 172 of the seal assembly 160 is inserted beneath the first segment 162 of the seal assembly 160, such that the first and sixth segments 162, 172 interweave. This interweaving increases the integrity of the seal assembly 160.

[0067] Return to reference Figure 2 and 3 The retainer assembly 180 of the valve assembly 120 is configured to fix the protective assembly 140 relative to the sealing assembly 160 and to fix the protective and sealing assemblies 140, 160 to the centering mechanism 130. The retainer assembly 180 includes an upper retainer member 182 and a lower retainer member 184.

[0068] 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 received in a locking manner in a plurality of openings 185 of the lower retainer member 184. Figure 3 In an embodiment, 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 secure 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). Either or both of the upper and lower retainer members 182, 184 may include locking features (not shown) for engaging the plurality of pins and securing the upper retainer member 182 to the lower retainer member 184.

[0069] For details, please refer to the following: Figure 2The multiple pins 186 of the upper retainer member 182 extend through the ring portion 142 of the protective assembly 140, through the sealing assembly 160, through the inner ring 134 of the centering mechanism 130, and into the multiple openings 185 in the lower retainer member 184.

[0070] During the surgical procedure utilizing the access component 100, a surgical instrument (not shown) is introduced into the instrument valve housing 110 through longitudinal channels 111 in the upper, lower, and inner housing sections 112, 114, 116. As described in '377 and '120 patents, the distal end of the surgical instrument engages with flaps 144, 146, 148, 150 of the protective assembly 140. Figure 3 The corresponding flaps 144, 146, 148, and 150 are bent downwards to contact the sealing assembly 160, thereby opening the central opening 163 of the sealing assembly 160 to accommodate the passage of a surgical instrument through the sealing assembly 160. The protective assembly 130 minimizes damage to the sealing assembly 160 during insertion of the instrument through the valve assembly 120. The protective assembly 130 protects the sealing assembly 160 from tearing or other damage when the surgical instrument is received through and withdrawn from the sealing assembly 160. As described above, the multi-flap configuration of the sealing assembly 160 reduces the likelihood of tearing of the sealing assembly 160 during insertion and / or removal of the surgical instrument through it.

[0071] Now for reference Figures 14 to 17 A sealing assembly according to another embodiment of this disclosure is generally shown as sealing assembly 260. Sealing assembly 260 is substantially similar to sealing assembly 160 described above. Figures 4 to 11 ), and will only describe the differences between the two in detail.

[0072] The sealing assembly 260 is configured to pass through the instrument valve housing 110 ( Figure 2 The sealing assembly 260 provides a seal around the outer surface of the surgical instrument (not shown). The seal assembly 260 includes components that can be opened from either the first or folded configuration (…). Figure 14 Fold to Fold Configuration ( Figure 17 The first, second, third, fourth, fifth, and sixth lobes or segments 262, 264, 266, 268, 270, and 272 of the sealing assembly 260. In the folded configuration, the sealing assembly 260 forms a substantially planar hexagonal member, wherein the first, second, third, fourth, fifth, and sixth segments 262, 264, 266, 268, 270, and 272 of the sealing assembly 260 define an opening 261 therebetween to allow a surgical instrument (not shown) to pass through the sealing assembly 260 in a sealed manner.

[0073] The inner edges 262b, 264b, 266b, 268b, 270b, and 272b of the corresponding first, second, third, fourth, fifth, and sixth sections 262, 264, 266, 268, 270, and 272 of the sealing assembly 160 are tapered. The tapered inner edges 262b, 266b, and 270b of the first, third, and fifth sections 262, 266, and 270 are respectively disposed on the first surfaces 262', 266', and 270' of the corresponding first, third, and fifth sections 262, 266, and 270. Figure 17 The tapered inner edges 264b, 268b, and 272b of the second, fourth, and sixth sections 264, 268, and 272 are respectively disposed on the second surfaces 264", 268", and 272" of the corresponding first, third, and fifth sections 262, 266, and 270. The tapered inner edges 262b, 264b, 266b, 268b, 270b, and 272b of the corresponding first, second, third, fourth, fifth, and sixth sections 262, 264, 266, 268, 270, and 272 facilitate the sealed reception of surgical instruments through the opening 261 in the sealing assembly 260.

[0074] Seal assembly 260 is used in conjunction with the aforementioned seal assembly 160 ( Figure 3 A similar method is used to fix it to the instrument valve housing 110. Figure 2 Inside. The sealing assembly 260 operates in a manner similar to that of the sealing assembly 160.

[0075] Figure 18 and 19 A valve assembly according to another embodiment of the present disclosure is shown, generally represented as valve assembly 320. Valve assembly 320 is configured to be supported on an instrument valve housing (e.g., instrument valve housing 110). Figure 2 The valve assembly 320 includes a centering mechanism 330, a protective assembly 340, a sealing assembly 360, and a retainer member 380. When a surgical instrument is received through the valve assembly 320, the centering mechanism 330 allows the valve assembly 320 to move radially relative to the instrument valve housing 310, and once the surgical instrument is withdrawn from the instrument valve housing 310, the centering mechanism returns the valve assembly 320 to a substantially centered position. The protective assembly 340 protects the sealing assembly 360 during the insertion and withdrawal of the surgical instrument through the sealing assembly 360. The sealing assembly 360 allows the surgical instrument to pass through the instrument valve housing 110 in a sealed manner. The retainer member 380 maintains the centering mechanism 330, the protective assembly 340, and the sealing assembly 360 in alignment with each other.

[0076] refer to Figure 20 and 21The centering mechanism 330 of the valve assembly 320 is configured to hold the valve assembly 320 in the instrument valve housing 110. Figure 2 Centered within. In an embodiment, and as shown, the centering mechanism 330 includes an annular base 332 and a plurality of spokes 334 extending from the annular base 332. The annular base 332 defines a channel 333. The channel 333 is configured to receive a plurality of pins 386 extending from the retainer ring 382 of the retainer member 380. The plurality of pins 386 of the retainer member 380 may be frictionally secured within the annular base 332. Alternatively, the plurality of pins 386 may be secured within the channel 333 of the annular base by adhesive, welding, mechanical fasteners, or any other suitable means.

[0077] Continue to refer to Figure 20 and 21 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, a plurality of spokes 334 extending from the annular base 332 of the centering mechanism 330 act as springs that bias the annular base 332 toward a central position within the instrument valve housing 110. It is envisioned that the centering mechanism 330 may comprise multiple sets of spokes, as disclosed in '477 Publication.

[0078] Briefly return to the reference Figure 19 The protective assembly 340 of valve assembly 320 includes a support ring 342 and a plurality of protective sections 344. Although only a single support ring 342 is shown positioned proximally to the plurality of protective sections 344, it is contemplated that the protective assembly may include support rings 342 positioned proximally and distally to the plurality of protective sections 344. The support ring 342 defines a plurality of openings 341 for receiving a plurality of pins 386 extending from the retainer ring 382 of retainer member 380. The support ring 342 includes a plurality of radially outwardly extending tabs 342a. The plurality of tabs 342a facilitate positioning of the protective assembly 340 within centering mechanism 330. As shown, the plurality of protective sections 344 includes six protective sections 346a to 346f. It is contemplated that the protective assembly 340 may include more or fewer than six protective sections 346a to 346f.

[0079] refer to Figure 22 and 23 The six protective sections 346a to 346f are substantially similar, and will be described in detail only with respect to the exemplary protective section 346. Protective section 346 includes a base portion 348 and a protective portion 350 extending from the base portion 348. The base portion 348 of protective section 346 defines a first opening 347a and a second opening 347b, thereby forming a plurality of openings 347 for receiving a retainer member 380. Figure 19The retainer section 346 comprises multiple pins 386. Although shown as having three openings 347, it is contemplated that the retainer section 346 may contain any number of openings corresponding in number and location to the multiple pins 386 of the retainer member 380. At least one tab 348a extends radially outward from the base portion 348. As shown, the retainer section 346 includes a pair of tabs 348a. The tabs 348a facilitate positioning of the retainer assembly 340 within the centering mechanism 330.

[0080] The protective section 346 of the protective assembly 340 defines at least one longitudinal slot 349 disposed between the base portion 348 and the protective portion 350. As shown, the protective section 346 defines a pair of longitudinal slots 349. The longitudinal slots 349 facilitate bending of the protective portion 350 relative to the base portion 348. The protective portion 350 of the protective section 346 defines a substantially kidney-shaped portion including a notch 351 along an inner edge 352. When multiple protective sections 346a to 346f are assembled ( Figure 29 An opening 353 for receiving surgical instruments (not shown) is formed in the recess 351 along the inner edge 352 of the protective portion 350. Figure 29 ).

[0081] refer to Figure 23 The first side 354 of the protective section 346 slopes downward relative to the rest of the protective section 346. The edge 354a of the first side 354 of the protective section 346 is spaced apart from the horizontal plane "h" defined by the surface of the rest of the protective section 346 by a distance "δ". When assembling the plurality of protective sections 344 of the protective assembly 340 ( Figure 29 The downward inclination of the first side 354 of the protective section 346 accommodates the overlapping portions of adjacent protective sections 346a to 346f, such that the multiple protective sections 344 are arranged in a substantially planar manner.

[0082] Now for reference Figures 24 to 29 This will describe a method for assembling multiple protection sections 344. First, refer to... Figure 24 The first protective section 346a is positioned such that the first side 354 of the protective portion 350 of the first protective section 346a is tilted downward.

[0083] Turning Figure 25 The second protective section 346b is positioned such that the protective portion 350 of the second protective section 346b overlaps with the first side 354 of the first protective section 346a, wherein the first side 354 of the protective portion 350 of the second protective section 346b is inclined downward and away from the first protective section 346a. Consequently, the first opening 347a of the second protective section 346b overlaps with the second opening 347b of the first protective section 346a.

[0084] refer to Figure 26 The third protective section 346c is positioned such that the protective portion 350 of the third protective section 346c is adjacent to the first side 354 of the second protective section 346a. Figure 25 The second protective section 346b overlaps with the third protective section 346c, where the first side 354 of the protective portion 350 is inclined downwards and away from the second protective section 346b. As a result, the first opening 347a of the third protective section 346c overlaps with the second opening 347b of the second protective section 346b.

[0085] refer to Figures 27 to 29 The fourth, fifth, and sixth protective sections 346d, 346e, and 346f are similarly positioned, except that the first side (not shown) of the protective portion 350 of the sixth protective section 346f is positioned below the protective portion 350 of the first protective section 346a to complete the assembly of the multiple protective sections 344 of the protective assembly 340.

[0086] As described in further detail below, the multiple protective sections 344 of the protective assembly 340 are maintained in the assembled configuration by the retainer assembly 380.

[0087] Return to reference Figure 19 And refer to other Figure 30 The valve assembly 320's sealing assembly 360 includes a proximal sealing member 362, an intermediate sealing assembly 364, and a distal sealing member 368. The proximal sealing member 362 includes an annular flange 370 and a sealing portion 372 supported within the annular flange 370. The sealing portion 372 is formed of an elastic material, such as rubber, and defines a central opening 371. The annular flange 370 is configured to guide a surgical instrument (not shown) through the central opening 371 in the sealing portion 372. The intermediate sealing assembly 364 is substantially similar to the sealing assemblies 160 and 260 described above. The distal sealing member 366 corresponds in shape to the intermediate sealing assembly 364. The distal sealing member 366 is formed of an elastic material, such as rubber, and defines a central opening 365.

[0088] For details, please refer to the following: Figure 30 The proximal sealing member 362 and the distal sealing member 366 of the sealing assembly 370 together provide support for the intermediate sealing assembly 364. More specifically, the intermediate sealing assembly 364 is sandwiched between the sealing portion 372 of the proximal sealing member 362 and the distal sealing member 366. When a surgical instrument (not shown) is received through the sealing assembly 360, the distal sealing member 366 supports the intermediate sealing assembly 364. Similarly, when the surgical instrument is withdrawn from the sealing assembly 360, the proximal sealing member 362 supports the intermediate sealing assembly 364.

[0089] Although the reference seal assembly 360 is shown and described, it is contemplated that the valve assembly 320 may contain any suitable seal assembly.

[0090] As described above, the retainer ring 382 of the retainer member 380 includes a plurality of pins 386, which pass through a plurality of openings 342, 347 in the support ring 342 and a plurality of protective sections 344 of the protective assembly 340 and are received through the sealing assembly 360. The plurality of retaining pins 386 are secured within channels 333 of the annular base 332 of the centering mechanism 330 to maintain the protective assembly 340 and the sealing assembly 360 in the assembled configuration.

[0091] Figure 31 and 32 A valve assembly according to another embodiment of the present disclosure is shown, generally represented as valve assembly 420. Valve assembly 420 is configured to be supported on an instrument valve housing (e.g., instrument valve housing 110). Figure 2 It includes a centering mechanism 430, a protective component 440, a sealing component 460, and a retainer component 480.

[0092] When the surgical instrument is received through the valve assembly 420, the centering mechanism 430 of the valve assembly 420 allows the valve assembly 420 to be positioned relative to the instrument valve housing 110. Figure 2 The valve assembly 420 moves radially, and once the surgical instrument is withdrawn from the instrument valve housing 410, the centering mechanism returns the valve assembly 420 to a substantially centered position. As shown, the centering mechanism 430 is substantially similar to the centering mechanism 330 described above. It is contemplated that the valve assembly 420 may include alternative centering mechanisms, such as the centering mechanism 130 described above.

[0093] The protective component 440 of valve assembly 420 protects the sealing assembly 460 during the insertion and withdrawal of surgical instruments through the sealing assembly 460. As shown, the protective component 440 is substantially similar to the protective component 440 described above. It is contemplated that valve assembly 420 may include alternative protective components, such as the protective component 140 described above. The sealing assembly 460 allows the surgical instrument to pass through the instrument valve housing 110 in a sealed manner. The retainer component 480 maintains the centering mechanism 430, the protective component 440, and the sealing assembly 460 in alignment with each other.

[0094] Continue to refer to Figure 31 and 32 And refer to other Figure 33 and 34The sealing assembly 460 of valve assembly 420 includes a proximal sealing member 462, an intermediate sealing assembly 464, and a distal sealing member 466. The proximal sealing member 462 is substantially similar to the proximal sealing member 362 described above and includes an annular flange 462a and a sealing portion 462b supported within the annular flange 462a. The intermediate sealing assembly 464 is similar to the sealing assemblies 160 and 260 described above and will be further described in detail below. The distal sealing member 366 corresponds in size and shape to the sealing portion 462b of the proximal sealing member 462. The proximal sealing member 462 and the distal sealing member 466 of sealing assembly 470 together provide support to the intermediate sealing assembly 464.

[0095] The intermediate sealing assembly 464 of the sealing assembly 460 includes a plurality of sealing segments 470 (first, second, third, fourth, fifth, and sixth sealing segments 472a to 472f) arranged in an overlapping or stacked configuration. In the overlapping configuration, the intermediate sealing assembly 464 forms a substantially planar hexagonal member, wherein the first, second, third, fourth, fifth, and sixth sealing segments 472a to 472f of the sealing assembly 464 define an opening 463 (…). Figure 32 This allows surgical instruments (not shown) to pass through the sealing assembly 460 in a sealed manner. Although the sealing sections 472a to 472f of the sealing assembly 464 are shown and described as forming separate components, it is contemplated that the sealing sections may be integrally formed with or otherwise fixed to the central portion. In this way, the sealing sections are folded over the central portion to form an overlapping or interlaced configuration.

[0096] In the embodiment, the diameter of the opening 463 of the intermediate sealing assembly 464 is 0.025" to 0.100". By forming the opening 463 from the first, second, third, fourth, fifth, and sixth sealing sections 472a to 472f of the sealing assembly 460, rather than forming a continuous solid opening through a single sealing member, the likelihood of the sealing assembly 460 tearing during the insertion, removal, and manipulation of surgical instruments passing through the sealing assembly is greatly reduced. Although shown to include six (6) sealing sections, it is contemplated that the sealing assembly 460 may include as few as four (4) sealing sections and as many as eight (8) sealing sections.

[0097] The first, second, third, fourth, fifth, and sixth sealing sections 472a to 472f of the sealing assembly 460 are formed of an elastic material, such as rubber, polyisoprene, or a silicone elastomer. In embodiments, the first, second, third, fourth, fifth, and sixth sealing sections 472a to 472f may comprise one or more fabric layers.

[0098] Now for reference Figure 35 and 36 The first, second, third, fourth, fifth, and sixth sealing sections 472a to 472f are substantially the same, and will be described in detail only with respect to the exemplary sealing section 472. The exemplary sealing section 472 is substantially similar to the sealing sections of the sealing assemblies 160, 260 described above. More specifically, the sealing section 472 includes an airfoil body configured to partially overlap with adjacent sealing sections. The inner or edge portion 476 of the sealing section 472 may be straight (…). Figure 14 Alternatively, a V-shape may be defined, as shown. In an embodiment, the V-shape is defined as an angle "β" between approximately 180° and approximately 275°. The V-shape of the inner portion 474 facilitates the reception of surgical instruments (not shown) passing through the sealing assembly 460.

[0099] like Figure 36 As shown, the inner portion 474 of the sealing section 472 is tapered; for example, the thickness of the inner portion 474 decreases by distances "a" and "b" from the proximal and distal surfaces, respectively. Although shown as a symmetrical taper, for example, with the same distances "a" and "b", it is contemplated that the inner portion 474 of the sealing section 472 may taper only on one of the proximal and distal surfaces, or that the distances "a" and "b" may be different. The tapered configuration of the inner portion 474 facilitates the insertion and withdrawal of surgical instruments through the sealing assembly 460. The tapered configuration of the inner portion 474 of the sealing section 472 also provides an improved seal around surgical instruments received through the sealing assembly 470.

[0100] Figures 37 to 42 The diagram illustrates the assembly of the intermediate sealing assembly 464. More specifically, the diagram shows a stacked and overlapping configuration of multiple sealing segments 470. The multiple sealing segments 470 of the intermediate sealing assembly 464 are connected by a retainer assembly 480 ( Figure 32 The retainer assembly 480 is maintained in its assembled configuration. More specifically, the multiple pins 486 of the upper retainer member 482 of the retainer assembly 480 ( Figure 32 The seal is received through multiple openings 473 in the sealing section 472. The retainer assembly 480 further retains the sealing assembly 460 relative to the centering mechanism 430 and the protective assembly 440. Multiple pins 486 of the retainer assembly 480 are secured to the lower retainer member 484 of the retainer assembly 480. Figure 32 More specifically, multiple pins 486 are secured in the channel 485 of the lower retainer member 484 by any suitable means, including, for example, friction fit, welding or adhesive.

[0101] 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 invention is limited only by the spirit and scope of the appended claims.

Claims

1. An entry component comprising: Instrument valve housing, with its defined cavity; as well as A valve assembly disposed within the cavity of the instrument valve housing, the valve assembly comprising: A protective assembly comprising a support ring and a plurality of protective sections disposed distal to the support ring; A sealing assembly, disposed adjacent to the protective assembly, the sealing assembly comprising a proximal sealing member, an intermediate sealing assembly, and a distal sealing member; and A centering mechanism for maintaining the sealing assembly and the protective assembly centered within the cavity of the instrument valve. Each of the plurality of protection sections includes a first side that slopes downward relative to the remainder of the protection section to accommodate overlapping portions of adjacent protection sections, such that when the valve assembly is in the assembled state, the plurality of protection sections are arranged in a substantially planar manner. Each of the plurality of protective sections includes a base portion and a protective portion extending from the base portion, and the first side of each of the plurality of protective sections includes a portion of the base portion and a portion of the protective portion.

2. The entry component according to claim 1, wherein the protection component comprises six protection sections.

3. The access component of claim 1, wherein the protective portion has a substantially kidney-shaped configuration.

4. The access component of claim 3, wherein each protective portion includes a notch and is configured such that the notch forms an opening when the plurality of protective sections are assembled.

5. The entry assembly of claim 1, wherein the support ring and at least one of the plurality of protective sections include a plurality of outwardly extending tabs for aligning the protective assembly with the centering mechanism.

6. The entry assembly of claim 1, wherein the proximal sealing member comprises an annular flange and a sealing portion supported within the annular flange.

7. The entry assembly of claim 1, wherein the intermediate sealing assembly comprises a plurality of sealing sections.

8. The entry assembly of claim 1, further comprising a retaining member having a plurality of pins, wherein the centering mechanism comprises an annular base defining a channel for receiving the plurality of pins for maintaining the valve assembly in an assembled configuration.

9. An entry component comprising: An instrument valve housing, comprising an upper, lower, and 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 component comprises multiple protective sections; A sealing assembly disposed adjacent to the protective assembly, the sealing assembly comprising a proximal sealing member, an intermediate sealing assembly and a distal sealing member, the intermediate sealing assembly comprising a plurality of sealing segments in a stacked configuration; as well as A centering mechanism for maintaining the sealing assembly and the protective assembly centered within the cavity of the instrument valve. Each of the plurality of protection sections includes a first side that slopes downward relative to the remainder of the protection section to accommodate overlapping portions of adjacent protection sections, such that when the valve assembly is in the assembled state, the plurality of protection sections are arranged in a substantially planar manner. Each of the plurality of protective sections includes a base portion and a protective portion extending from the base portion, and the first side of each of the plurality of protective sections includes a portion of the base portion and a portion of the protective portion.

10. The entry assembly of claim 9, wherein the intermediate sealing assembly comprises six sealing sections.

11. The entry assembly of claim 9, wherein each of the plurality of sealing segments comprises an airfoil shape.

12. The entry assembly of claim 9, wherein the inner edge of each of the plurality of sealing segments is straight.

13. The entry assembly of claim 9, wherein the inner portion of each of the plurality of sealing segments is tapered.

14. The entry component of claim 13, wherein at least one of the top surface and the bottom surface of the inner portion gradually narrows.

15. The entry assembly of claim 9, wherein the intermediate sealing assembly is hexagonal.

16. The entry assembly of claim 9, wherein the proximal sealing member comprises an annular flange and a sealing portion supported within the annular flange.

17. The entry assembly of claim 16, wherein the proximal and distal sealing members are used to support the intermediate sealing assembly.

18. The entry assembly of claim 17, further comprising a retainer assembly including upper and lower retainer members, wherein at least one of the upper and lower retainer members includes a plurality of pins that can be received through the protective assembly and the sealing assembly, the plurality of pins being used to retain the protective assembly and the sealing assembly relative to each other.

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