Valve assemblies and retainers for surgical access assemblies

Abstract

To provide a valve assembly and a retainer for a surgical access assembly.SOLUTION: A surgical access assembly 100 includes a cannula 102, a valve housing 110 attached to the cannula, and a valve assembly positioned in the valve housing. The valve assembly includes a centering mechanism with a hoop and fingers, a ring with a flange at one end of the ring, a retainer having first and second discs, a guard having a frame and flaps attached to the frame, and a seal with petals attached to a support. The guard is at least partially disposed in the first disc, and the seal is at least partially disposed in the second disc.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to an assembly including a seal for minimally invasive surgery. More specifically, the present disclosure relates to a valve assembly and a retainer for a surgical access assembly.

Background Art

[0002] To facilitate minimally invasive surgery, a working space must be created at the surgical site. An infusion fluid, typically CO2, is introduced into the patient's abdomen to create an inflated state called pneumoperitoneum. A surgical access assembly is utilized to enable the introduction of surgical instruments and an endoscope (or other visualization tool). These surgical access assemblies maintain the pressure of the pneumoperitoneum because they have one or more seals that conform to the surgical instruments. Typically, the "zero seal" in a surgical access assembly seals the surgical access assembly when no surgical instrument is within the surgical access assembly, and the instrument seal seals around a surgical instrument inserted through the surgical access assembly.

[0003] Today, the range of surgical instruments on the market requires a robust seal that can be adjusted to multiple sizes and withstand multiple insertions and extractions of surgical instruments. Some surgical instruments may include sharp edges that can tear or otherwise damage the seal.

[0004] In addition to instrument seals, valve assemblies also include guards and centering mechanisms. Guards help minimize damage to instrument seals during insertion and withdrawal of surgical instruments through the valve assembly. Retainers are commonly used to maintain the position and alignment of the various components used in valve assemblies. Retainers may have multiple components that connect them using posts and holes. Because these posts must penetrate various components of the valve assembly, they can also increase the assembly time of the valve assembly. Retainers without posts and corresponding holes would be beneficial. [Overview of the Initiative] [Means for solving the problem]

[0005] In the embodiment, the surgical access assembly includes a cannula, a valve housing coupled to the proximal end of the cannula, and a valve assembly disposed within the valve housing. The valve assembly includes a centering mechanism, a ring, a retainer, a guard, and a seal. The centering mechanism includes a hoop having fingers extending radially outward from the outer surface of the hoop. Each finger is flexibly connected to the outer surface and biased to move away from the outer surface. The ring has an outer diameter and a flange located at one end of the ring. The other end of the ring abuts against one end of the hoop. The retainer has a first disc disposed within the ring and a second disc disposed within the hoop. The first disc is attachable to the second disc regardless of the direction of rotation of the first disc relative to the second disc. The guard includes a frame and a flap flexibly coupled thereto. The guard is partially disposed within the first disc. The seal includes petals flexibly coupled to a support, and the seal is partially disposed within the second disc.

[0006] The first disk may include a channel adapted to receive a portion of the frame, and the second disk may include a groove adapted to receive a portion of the support. The second disk may also include a receptacle configured to receive a projection of the plate.

[0007] One of the first or second disks may include a ridge surrounding its central opening, and the other of the first or second disk may include a slot surrounding its central opening. The ridge may be fitted to mate into the slot to join the first and second disks together.

[0008] The first disk may be fixed to the second disk. The first disk may be welded to the second disk.

[0009] In embodiments, a valve assembly used in a surgical access assembly includes a guard, a seal, a centering mechanism, and a retainer. The guard includes a frame and a flap flexibly coupled thereto. The seal includes a support and a petal flexibly coupled thereto. The centering mechanism includes a hoop and fingers. The fingers have first and second ends. The first end of the finger is flexibly coupled to the outer surface of the hoop, and the second end of the finger is biased away from the outer surface. The retainer has first and second discs. The first disc has a ridge, and the second disc has a slot configured to receive the ridge. Either the first or second disc is positionable within the passage defined by the hoop.

[0010] The valve assembly may be positioned within the housing of the surgical access assembly.

[0011] The first disc of the retainer may be fixed to the second disc of the retainer regardless of the orientation of their relative angles.

[0012] The valve assembly may include a plate positioned between the seal and the second disc.

[0013] The plate may include protrusions, and the second disk may include receptacles that receive the protrusions of the plate.

[0014] The guard and seal may be positioned between the first and second discs of the retainer.

[0015] The valve assembly may include a ring that contacts the hoop, and the ring may be configured to receive the other of the first or second disk therein.

[0016] In the embodiment, the surgical access assembly includes a valve housing, a cannula extending from the valve housing, and a valve assembly disposed within the valve housing. The valve assembly has a retainer including a centering mechanism, a guard with a frame and a flap coupled to the frame, a seal with a support and a petal coupled to the support, and first and second discs. The centering mechanism has a hoop and fingers extending radially from the hoop. The guard is located on the first side of the centering mechanism, and the seal is located on the second side of the centering mechanism. The guard is coupled to the first disc in a fixed orientation, and the seal is coupled to the second disc in a fixed orientation. The first disc is mountable to the second disc regardless of the orientation of rotation of the first disc relative to the second disc.

[0017] The first disk may include a ridge, and the second disk may include a slot for receiving the ridge. The first and second disks may be fixed to each other. The first and second disks may be welded together.

[0018] The first disk may include a channel adapted to receive a portion of the frame, and the second disk may include a groove adapted to receive a portion of the support. The present invention provides, for example, the following: (Item 1) A surgical access assembly, Cannula and, A valve housing connected to the proximal end of the cannula, The valve assembly is disposed within the valve housing, and the valve assembly is A centering mechanism including a hoop having fingers extending radially outward from the outer surface of the hoop, wherein each finger is flexibly connected to the outer surface and biased to move away from the outer surface; A ring having an outer diameter and a flange positioned at one end of the ring, the other end of the ring abutting against one end of the hoop, A retainer having a first disk disposed in the ring and a second disk disposed in the hoop, wherein the first disk can be attached to the second disk regardless of the direction of rotation of the first disk relative to the second disk, A guard comprising a frame and a flap flexibly coupled thereto, the guard being partially located within the first disk, A surgical access assembly comprising a seal, which includes petals flexibly bonded to a support, and which is partially disposed within the second disk. (Item 2) The surgical access assembly described above, wherein the first disk includes a channel adapted to receive a portion of the frame. (Item 3) A surgical access assembly according to any of the above items, wherein the second disk includes a groove adapted to receive a portion of the support. (Item 4) A surgical access assembly according to any of the above items, wherein the first disk includes a channel adapted to receive a portion of the frame, and the second disk includes a groove adapted to receive a portion of the frame and a receptacle configured to receive a projection of a plate. (Item 5) One of the first or second disks includes a ridge surrounding its central opening, the other of the first or second disks includes a slot surrounding its central opening, the ridge is adapted to fit within the slot, thereby coupling the first and second disks, the surgical access assembly according to any of the above items. (Item 6) The surgical access assembly according to any of the above items, wherein the first disk is fixed to the second disk. (Item 7) The surgical access assembly according to any of the above items, wherein the first disk is welded to the second disk. (Item 8) A valve assembly for use in a surgical access assembly, A guard including a frame and a flap flexibly coupled thereto, A seal including a support and petals flexibly coupled thereto, A centering mechanism including a hoop and fingers, the fingers having first and second ends, the first end of the fingers being flexibly coupled to the outer surface of the hoop, the second end of the fingers being biased away from the outer surface, the centering mechanism. A retainer having first and second disks, the first disk having a ridge, the second disk having a slot configured to receive the ridge therein, one of the first or second disks being positionable within a passage defined by the hoop, a retainer, comprising a valve assembly. (Item 9) The valve assembly according to any of the above items, wherein the valve assembly is positionable within a housing of a surgical access assembly. (Item 10) The valve assembly according to any of the above items, wherein the first disk of the retainer is fixable to the second disk of the retainer regardless of their relative angular orientation. (Item 11) The valve assembly according to any of the above items, further comprising a plate disposed between the seal and the second disk. (Item 12) The valve assembly according to any of the above items, wherein the plate includes a protrusion and the second disk includes a receptacle for receiving the protrusion of the plate. (Item 13) The valve assembly according to any of the above items, wherein the guard and the seal are located between the first disk and the second disk of the retainer. (Item 14) The valve assembly according to any of the above items, further comprising a ring that abuts the hoop, the ring being configured to receive the other of the first or second disks therein. (Item 15) A surgical access assembly, a valve housing, a cannula extending from the valve housing, and a valve assembly disposed within the valve housing, the valve assembly including a centering mechanism having a hoop and fingers extending radially from the hoop, a guard having a frame and a flap coupled to the frame, the guard being disposed on a first side of the centering mechanism, a seal having a support and a flap coupled to the support, the seal being disposed on a second side of the centering mechanism, and a retainer including first and second disks, the guard being coupled to the first disk in a fixed orientation, the seal being coupled to the second disk in a fixed orientation, and the first disk being attachable to the second disk regardless of the direction of rotation of the first disk relative to the second disk. (Item 16) A surgical access assembly according to any of the above items, wherein the first disk includes a ridge and the second disk includes a slot for receiving the ridge. (Item 17) A surgical access assembly according to any of the above items, wherein the first and second disks are fixed to each other. (Item 18) A surgical access assembly according to any of the above items, wherein the first and second discs are welded together. (Item 19) A surgical access assembly according to any of the above items, wherein the first disk includes a channel adapted to receive a portion of the frame. (Item 20) A surgical access assembly according to any of the above items, wherein the second disk includes a groove adapted to receive a portion of the support. (Summary) The surgical access assembly includes a cannula, a valve housing attached to the cannula, and a valve assembly positioned within the valve housing. The valve assembly includes a centering mechanism with a hoop and fingers, a ring with a flange at one end of the ring, a retainer having first and second discs, a guard with a frame and a flap attached to the frame, and a seal with petals attached to a support. The guard is at least partially located within the first disc, and the seal is at least partially located within the second disc. [Brief explanation of the drawing]

[0019] Embodiments of instrument seals are disclosed herein with reference to the drawings.

[0020] [Figure 1] This is a perspective view of a surgical access assembly according to an embodiment of the present disclosure. [Figure 2] This is a cross-sectional view of the surgical access assembly shown in Figure 1, cut along the cutting line 2-2 in Figure 1. [Figure 3] This is a magnified view of the detailed specified area in Figure 2. [Figure 4] This is a top perspective view of a valve assembly according to an embodiment of the present disclosure. [Figure 5] Figure 4 is a bottom perspective view of the valve assembly. [Figure 6] Figure 4 is an exploded view of the valve assembly with its components separated, including the centering mechanism, ring, guard, seal, plate, and retainer. [Figure 7] Figure 6 shows a bottom perspective view of the upper disc of the retainer and a top perspective view of the lower disc of the retainer. [Figure 8] Figure 6 is a top perspective view of the seal located inside the bottom disc of the retainer, and the bottom disc is located inside the hoop of the centering mechanism shown in Figure 6. [Figure 9] This is a bottom perspective view of the guard in Figure 6, which is positioned inside the upper disc of the retainer in Figure 6, and the upper disc is positioned inside the ring in Figure 6. [Figure 10] Figure 6 is a top perspective view of the unfolded seal. [Figure 11] Figure 10 is a top view of the seal. [Figure 12] This is a cross-sectional view of the end of a seal petal, cut along the cross-sectional line 12-12 in Figure 11. [Figure 13] Figure 10 is a top view of the sticker showing the order in which the petals are folded. [Figure 14] This is a top view of the seal in Figure 10 in its fully folded configuration. [Figure 15] This is a top view of the guard in the deployed configuration shown in Figure 6. [Figure 16] This is an end cross-sectional view of the guard flap cut along the cutting line 16-16 in Figure 15. [Figure 17] Figure 15 is a top view of the guard, showing the folding order of the flaps. [Figure 18] Figure 15 is a top view of the guard in its fully folded configuration. [Modes for carrying out the invention]

[0021] Embodiments of instrument seals for surgical access assemblies of the present disclosure are described in detail below with reference to the drawings, in which similar reference numerals refer to the same or corresponding elements in each of several figures. As is common in the art, the term “proximal” refers to a part or component closer to the user or operator, e.g., a surgeon or clinician, and the term “distal” refers to a part or component further away from the user.

[0022] A surgical access assembly is used during minimally invasive surgery, such as laparoscopic surgery, to provide sealed access to a body cavity, such as the abdominal cavity, with gas injected. The surgical access assembly of this disclosure includes a valve housing attached to a cannula tube and an embolizer (not shown) inserted through the valve housing and the cannula tube. The embolizer may have a blunt distal end or a bladed or unbladed perforating distal end and may be used to incise the abdominal wall to allow the surgical access assembly to be introduced into the abdomen. The handle of the embolizer may be engaged or selectively locked within the valve housing of the surgical access assembly.

[0023] A surgical access assembly equipped with a trocar embolus is used to advance through anatomical structures, such as the abdominal wall, either by creating a new passage through the structure or by passing through an existing opening in the anatomical structure. Once the surgical access assembly with the trocar has advanced through the anatomical structure, the trocar embolus is removed and the surgical access assembly is left in place. The valve housing of the surgical access assembly includes a valve that prevents leakage of the injectable fluid from the body cavity, allows insertion of surgical instruments into the body cavity, and minimizes leakage of the injectable fluid.

[0024] In various embodiments, bladeless optical trocar embolizers may be provided that allow for the separation of tissue surfaces in surgical procedures and the visualization of body tissue fibers when they are separated, thereby enabling controlled transverses across the body wall. In other embodiments, the trocar embolizer may be non-optical, for example, bladeless, and not provide simultaneous visualization through the distal tip of the embolizer. Bladeless embolizers may be provided for blunt incision of the peritoneum during surgical procedures.

[0025] Various trocar embolizers are known that are suitable for use with the surgical access assemblies of this disclosure, including, for example, bladed, bladeless, blunt, optical, and non-optical types. For a detailed description of the structure and function of exemplary trocar assemblies, including exemplary trocar embolizers and exemplary cannulas, see PCT Publication WO2016 / 186905 ("Published '905"), the contents of which are incorporated herein by reference in their entirety.

[0026] Referring first to Figure 1, a surgical access assembly according to an aspect of this disclosure is generally shown as a surgical access assembly 100. The surgical access assembly 100 includes a cannula 102 with a cannula tube 104 extending therefrom, and a valve housing 110 fixed to the cannula tube 104. For a detailed description of an exemplary surgical access assembly, see Publication '905.

[0027] Referring further to Figure 2, the valve housing 110 of the surgical access assembly 100 includes an upper housing section 112, a lower housing section 114, and an inner housing section 116. The upper housing section 112, the lower housing section 114, and the inner housing section 116 are configured to support the valve assembly 120 on the proximal end of the cannula 102. More specifically, the inner housing section 116 is fixed between the upper housing section 112 and the lower housing section 114, and the valve assembly 120 is received between the inner housing section 116 and the lower housing section 114. The upper housing section 112 and the lower housing section 114 of the valve housing 110 may be selectively attachable to and detachable from the inner housing section 116. The lower housing section 114 may be releasable or permanently attached to the cannula tube 104 of the cannula assembly 102. In the embodiment, either or both of the upper housing section 112 and the lower housing section 114 of the valve housing 110 may include knots, notches, tabs, or be otherwise configured to facilitate engagement by a clinician.

[0028] The surgical access assembly 100 may also include features for stabilizing the surgical access assembly. For example, the distal end of the cannula tube 104 may carry a balloon anchor or another expandable member that engages with the abdomen from the internal side. See, for example, U.S. Patent No. 7,300,448, the full disclosure of which is incorporated herein by reference. Features on the opposite side of the abdominal wall may be used to further stabilize the surgical access assembly, such as an adhesive tab or an adjustable foam collar.

[0029] The upper housing section 112, the lower housing section 114, and the inner housing section 116 of the valve housing 110 define a longitudinal passage 111 for receiving surgical instruments (not shown). The valve assembly 120 is supported within the valve housing 110 and provides a sealed passage for surgical instruments through the surgical access assembly 100. A duckbill or zero-closure seal 150 is located within the valve housing 110. The zero-closure seal 150 is configured to prevent fluid from passing proximal through the valve housing 110 from the cannula tube 104 when no surgical instruments are located within the valve housing 110.

[0030] Referring here to Figure 3, the various components of the valve assembly 120 are shown in their assembled configuration. The valve assembly 120 includes the ring 122, the centering mechanism 130, the guard 140, the seal 160, and the first and second discs 180, 190 of the retainer 200 (Figure 6).

[0031] Referring further to Figure 6, the ring 122 has a flange 124 and is located in the proximal region of the valve assembly 120. The flange 124 extends proximal to the ring 122 at an angle to the ring 122 such that the proximal end of the ring 122 has a diameter greater than the diameter of the distal end of the ring 122. The rim 126 extends from the distal end of the wall 121 of the ring 122 toward the central opening 128 (i.e., the inside) of the ring 122 and defines the ledge. The rim 126 is in contact with the hoop 132 of the centering mechanism 130.

[0032] Referring again to Figures 1-3 and Figure 6, the centering mechanism 130 includes a hoop 132 and fingers 134 that are flexibly and elastically attached to the outer surface of the hoop 132. The fingers 134 extend radially from the outer surface of the hoop 132 and are biased to move away from the outer surface of the hoop 132. When the centering mechanism 130 is positioned in the valve housing 110, the distal portions of the fingers 134 contact the inner surface of the lower housing section 114. The fingers 134 are configured to help maintain the coaxial alignment of the center of the hoop 132 with the longitudinal central axis XX of the valve housing 110. Because all of the fingers 134 are slightly compressed toward the outer surface of the hoop 132, the hoop 132 is subjected to a spring load when positioned in the valve housing 110. Because the fingers 134 are equally compressed, the hoop 132 is in equilibrium, and its center is coaxially aligned with the longitudinal central axis XX of the valve housing 110. When the hoop 132 is moved radially away from the longitudinal central axis XX of the valve housing 110, some of the fingers 134 are compressed more, while some of the fingers 134 are under less compression (i.e., relaxed). This can occur when a surgical instrument is inserted through the hoop 132 and moved radially relative to the longitudinal central axis XX of the valve housing 110. When the surgical instrument is removed, the fingers 134 under greater compression prompt the hoop 132 to return towards the longitudinal central axis XX and towards equilibrium. Furthermore, the hoop 132 includes a rim 136 that extends from the proximal end of the wall of the hoop 132 toward the opening 138 of the hoop 132 (i.e., inward) and defines a ledge. The rim 136 of the hoop 132 is in contact with the rim 126 of the ring 122. The rim 136 of hoop 132 and the rim 126 of ring 122 both extend inward by the same distance.

[0033] Referring here to Figures 3, 7, 11, and 15, the first disk 180 and the second disk 190 of the retainer 200 are fixed to each other. The first or upper disk 180 has a central opening 188 and a ridge 186 surrounding the central opening 188. A recess 183 extends below the bottom surface of the first disk 180. Although shown as a hexagonal recess 183, the recess 183 may have different configurations with fewer (e.g., 4) or more (e.g., 8) sides to match the configuration of the guard 140. Continuing with the hexagonal configuration, each side of the recess 183 includes a channel 182 configured to receive a portion of the frame 148 of the guard 140. In particular, the frame 148 includes a complementary number of sides 144a-f, each side 144a-f being insertable into one of the channels 182. This arrangement fixes the orientation between the first disk 180 and the guard 140 such that the guard 140 remains rotatably fixed to the first disk 180 when the sides 144a-f of the frame 148 are at least partially inserted into the channels 182 of the recess 183. The second or bottom disk 190 has a slot 196 configured to receive the ridge 186 of the first disk 180. The second disk 190 also includes a hexagonal recess 193 extending below the upper surface of the second disk 190. Similar to the first disk 180, the second disk 190 may have a configuration with fewer or more sides, which does not have to match the configuration of the first disk 180 but matches the configuration of the support 170 of the seal 160. Continuing with the hexagonal configuration, each side of the recess 193 includes a groove 192 configured to receive a portion of the support 170 of the seal 160. In particular, the support 170 includes a complementary number of sides 172a to f, each side 172a to f being insertable into one of the grooves 192. This arrangement fixes the orientation between the second disk 190 and the seal 160 such that the seal 160 remains rotatably fixed to the second disk 190 when the sides 172a to f of the support 170 are at least partially inserted into the grooves 192 of the recess 193. Furthermore, the recess 193 includes a receptacle 194 configured to receive a projection 156 of the plate 152 (Figure 6).The engagement between the projection 156 on plate 152 and the receptacle 194 on the second disc 190 connects plate 152 to the second disc 190 and maintains a fixed orientation between them. By using the projection 156 on plate 152 and the receptacle 194 on the second disc 190, the orientation between plate 152 and the second disc 190 is restricted to a certain number of orientations. Plate 152 helps to support the seal 160 and restricts the bending of the petals 162a-f of the seal 160 toward the cannula tube 104 when a surgical instrument (not shown) is inserted through the angle of the seal.

[0034] Referring here to Figures 3, 4, 6, and 15, the guard 140 includes a frame 148 having six sides 144a-f. As described above, the frame 148 may include fewer sides (e.g., four) or more sides (e.g., eight), provided that the number of sides 144 corresponds to the number of channels 182 in the first disk 180. Each side 144a-f is generally rectangular and includes bars 145a-f that extend along most of the length of the corresponding flaps 142a-f. Each block 146a-f extends from one end of the bars 145a-f of the corresponding side 144a-f. Each block 146a-f is positioned midway between the top and bottom surfaces of the bars 145a-f and extends parallel to the top and bottom surfaces of the bars 145a-f. Each bar 145a-f is configured to be received within the corresponding channel 182 of the recess 183 of the first disk 180, thereby fixing the relative orientation of the guard 140 with respect to the first disk 180. When assembled, the bottom surfaces of the bars 145a-f are substantially flush with the bottom surface of the first disk 180. Furthermore, with the guard 140 positioned within the recess 183 of the first disk 180, the first disk 180 is positioned within the central opening 128 of the ring 122.

[0035] Referring further to Figures 8 and 11, the seal 160 is shown with a support 170 having six sides 172a-f. As described above, the support 170 may have fewer sides (e.g., four) or more sides (e.g., eight), provided that the number of sides 172 corresponds to the number of grooves 192 in the second disc 190. Each side 172a-f is generally rectangular and includes beams 175a-f that extend along most of the length of the corresponding petals 162a-f. Wedges 176 extend from the opposing ends of each beam 175a-f. Each wedge 176 is positioned midway between the top and bottom surfaces of the beams 175a-f and extends parallel to the top and bottom surfaces of the beams 175a-f. The wedges 176 are joined to form a living hinge 178, as will be described in more detail below. Each beam 175a-f is received in the corresponding groove 192 of the recess 193 of the second disc 190, thereby fixing the relative orientation of the seal 160 with respect to the second disc 190. When assembled, the upper surfaces of the beams 175a-f are substantially flush with the upper surface of the second disc 190. Furthermore, with the seal 160 positioned in the recess 193 of the second disc 190, the second disc 190 is positioned within the opening 138 of the hoop 132.

[0036] Referring here to Figures 3, 8, and 9, a first disc 180, in which a guard 140 is installed, is positioned within the ring 122, and a second disc 190, in which a seal 160 is installed, is positioned within the hoop 132. As seen in Figures 3 and 7, the first disc 180 has a notch 187 at its distal end that surrounds the first disc 180. The notch 187 complements the rim 126 of the ring 122 and is configured to support the first disc 180 within the opening 128 of the ring 122. The rim 126 provides a limit stop as the first disc 180 moves distally through the ring 122. The outer diameter of the first disc 180 and the inner diameter of the ring 122 may be sized such that the first disc 180 is held within the opening 128 of the ring 122 by frictional engagement between the outer surface of the first disc 180 and the inner surface of the ring 122. Similarly, the second disk 190 also includes a notch 197 at its proximal end that surrounds the second disk 190. The notch 197 complements the ledge 136 of the hoop 132 and is configured to restrict the proximal movement of the second disk 190 through the hoop 132. The outer diameter of the second disk 190 and the inner diameter of the hoop 132 may be sized such that the second disk 190 is held within the hoop 132 by frictional engagement between the outer surface of the second disk 190 and the inner surface of the hoop 132. When the ring 122 and the hoop 132 are positioned in contact with each other, with the first disk 180 fully sealed within the ring 122 and the second disk 190 fully sealed within the hoop 132, the bottom surface of the first disk 180 rests on the top surface of the second disk 190. Furthermore, a ridge 186 extending from the bottom surface of the first disk 180 enters a slot 196 extending from the top surface of the second disk 190, thereby joining the first disk 180 and the second disk 190, as well as the ring 122 and the hoop 132.

[0037] Since the ridge 186 of the first disc 180 and the slot 196 of the second disc 190 extend continuously around the central openings 188 and 198 of the first and second discs 180 and 190 respectively, the first disc 180 can be mounted on the second disc 190 in a number of orientations, rather than a discrete number of orientations defined by the complementary arrangement of the post and receptacle, as seen in the fixed arrangement of the plate 152 and the second disc 190. Furthermore, by using the arrangement of the ridge 186 and slot 196 between the first disc 180 and the second disc 190, the orientation between the guard 140 and the seal 160 can be easily adjusted before the first and second discs 180 and 190 are fixed together. This simplifies the assembly of the valve assembly 120 and assists in the orientation of the guard 140 and the seal 160 before the first and second discs 180 and 190 are fixed together. Once the desired orientation between the guard 140 and the seal 160 is achieved, the first disc 180 is welded to the second disc 190. Welding the first and second discs 180, 190 together provides a fluid seal between the first disc 180 and the second disc 190. The first and second discs 180, 190 are intended to be able to be fixed to each other using adhesive. The first disc 180 may include slots, and the second disc 190 may also include ridges.

[0038] Referring here to Figures 10-14, a series of steps are shown to convert the seal 160 from an unfolded configuration (Figure 10) to a folded configuration (Figure 14). First, as seen in Figures 10 and 11, the seal 160 is in the unfolded configuration. Each beam 175a-f is connected to an adjacent beam 175a-f, with one exception. As shown in Figure 11, one of the wedges 176 of the first petal 162a is spaced apart from one of the wedges of the sixth petal 162f, and the remaining wedges 176 are connected to one another. A living hinge 178 is formed where the wedges 176 are connected to one another. Furthermore, as seen in Figure 12, each petal 162a-f is angled with respect to the top and bottom surfaces of the corresponding beams 175a-f. As will be discussed below, this angled arrangement, associated with the gap between the wedges 176 of the first and sixth petals 162a, 162f, facilitates the folding and unfolding of the seal 160. Each petal 162a-f is connected to the corresponding beams 175a-f of the support 170 along the first or connecting side 161a-f. Each petal 162a-f also includes angled second and third sides 163a-f, 165a-f, which spread out from the corresponding connecting side 161a-f. The fourth and fifth sides 167a-f, 169a-f of each petal 162a-f are interconnected with the angled second and third sides 163a-f, 165a-f. The fourth and fifth sides 167a-f, 169a-f of petals 162a-f are of equal length and are angled toward the corresponding connecting side 161a-f so that they intersect at a point that bisects the connecting side 161a-f. The fourth and fifth sides are oriented so that they define an angle of 150°. The fourth and fifth sides may define an angle of approximately 120° to approximately 165°. The first and second extenders 162a-f, 164a-f are attached to the fourth and fifth sides 167a-f, 169a-f. The first and second extenders 162a-f, 164a-f are of equal length and intersect at a taper 173a-f which is also located at a point that bisects the corresponding connecting side 161a-f.

[0039] The wedges 176 of the first to fifth beams 175a to e are connected to the wedges 176 of the second to sixth beams 175b to f, which define five living hinges 178 with a gap between the first beam 175a and the sixth beam 175f. The wedge 176 of the first beam 175a is not connected to the wedge 176 of the sixth beam 175f, so that the first beam 175a and the first petal 162a can be repositioned without disturbing the positions of the sixth beam 175f and the sixth petal 162f. The first petal 162a is folded by pivoting the first beam 175a and the first petal 162a around a point defined by the living hinge 178 located between the first beam 175a and the second beam 175b. Therefore, the first petal 162a partially overlaps with the second petal 162b. Subsequently, the first and second petals 162a and 162b are rotated by rotating the second beam 175b around a living hinge 178 formed between the second beam 175b and the third beam 175c, so that the second petal 162b partially overlaps with the third petal 162c. Next, the first, second, and third petals 162a-c are rotated by rotating the third beam 175c around a living hinge 175 formed between the third beam 175c and the fourth beam 175d, so that the third petal 162c partially overlaps with the fourth petal 162d. Next, the first, second, third, and fourth petals 162a-d are rotated by pivoting the fourth beam 175d around a living hinge 178 formed between the fourth beam 175d and the fifth beam 175e, such that the fourth petal 162d partially overlaps with the fifth petal 162e. The first, second, third, fourth, and fifth petals 162a-e are rotated by pivoting the fifth beam 175e around a living hinge 178 formed between the fifth petal 175e and the sixth petal 175f, such that the fifth petal 162e partially overlaps with the sixth petal 162f, and the sixth petal 162f partially overlaps with the first petal 162a. The fully folded seal 160 is shown in Figure 14.

[0040] After all the petals 162a-f are folded, the central orifice 166 is defined and configured to engage with the outer surface of the surgical instrument inserted through the seal 160, so that the central orifice 166 surrounds the surgical instrument in a sealing manner, preventing the passage of the injected fluid and defining a fluid sealing barrier. The petals 162a-f of the seal are combined so that each petal 162a-f overlaps at least partially with the first adjacent petal 162 and at least partially with the second adjacent petal 162. This combined arrangement of the petals 162a-f facilitates the seal 160 to maintain its shape during the insertion and withdrawal of the surgical instrument through the central orifice 166. For example, referring further to Figures 2 and 3, when a surgical instrument is inserted through the valve housing 110 of the surgical access assembly 100, the shaft of the surgical instrument passes through the central opening 188 of the first disc 188, the central bore 141 of the guard 140, the central orifice 166 of the seal 160, and the central opening 198 of the second disc 190. As the shaft of the surgical instrument passes through the central orifice 166 of the seal 160 during insertion, the petals 162a-f of the seal 160 surrounding the outer surface of the shaft of the surgical instrument toward the second disc 190 provide a fluid sealing barrier between the petals 162a-f of the seal 160 and the shaft of the surgical instrument. During withdrawal of the surgical instrument, the petals 162a-f of the seal 160 bend toward the proximal portion of the valve housing 110 in response to the proximal movement of the shaft of the surgical instrument. When the shaft of the surgical instrument is removed from the central orifice 166 of the seal 160, the petals 162a-f of the seal 160 elastically return to their initial or stationary configuration (Figure 3). Because the petals 162a-f are combined, they return to their initial configuration. If the petals 162a-f have slightly different moving speeds, the combined arrangement of petals 162a-f acts as a governor, resulting in the slowest moving petal 162, which limits the moving speed of the remaining petals 162. This tends to maintain contact between the petals 162a-f and the outer surface of the shaft of the surgical instrument, thereby maintaining the fluid sealing boundary of the seal 160 against the surgical instrument during the movement of the shaft against the seal 160.

[0041] Referring here to Figures 15-18, the guard 140 of the valve assembly 120 is shown. The guard 140 helps protect the seal 160 during the insertion and withdrawal of surgical instruments through the valve assembly 120. The central opening 141 of the guard 140 has a diameter larger than the outer diameter of the shaft of the surgical instrument. During the insertion of a surgical instrument through the valve assembly 120, the shaft of the surgical instrument passes through the central opening 141 of the guard 140. Because the diameter of the central opening 141 is larger than the diameter of the shaft of the surgical instrument, the shaft may pass through the central opening 141 without contacting the flaps 142a-f of the guard 140. If the shaft is off-axis from the longitudinal central axis of the guard 140, or if the shaft is inserted at an angle to the longitudinal central axis, the tip of the shaft will contact one or more flaps 142a-f of the guard 140 in order for the shaft to move through the central opening 141 of the guard 140. The longitudinal central axis of the guard 140 is coaxially aligned with the longitudinal central axis XX of the valve housing 110 (Figure 2). One or more flaps 142a-f of the guard 140 act to reduce the impact force from the tip of the shaft transmitted to the seal 160. This helps maintain the integrity and lifespan of the seal 160 so that it can withstand multiple insertions of surgical instruments without damage from the surgical instruments.

[0042] In particular, the guard 140 includes flaps 142a-f attached to a frame 148 having multiple sides. As shown in Figure 15, the guard 140 includes a frame 148 having six sides with six flaps 142a-f, each flap 142a-f being flexibly and elastically attached to one side 145a-f of the frame 148. The frame 148 may include fewer sides 145 (e.g., four) or more sides 145 (e.g., eight), provided that the number of sides 145 corresponds to the number of channels 182 present in the recesses 183 of the first disk 180. Each side 145a-f of the frame 148 is generally trapezoidal. Similar to the support 170 of the seal 160, the sides 145a-f of the frame 148 are coupled to each other, except for two sides 145a, 145f (Figure 15). Each side 145a-f of the frame 148 has blocks 146a-f at one end of sides 14a-f. The blocks 146a-e of the first to fifth sides 145a-e are connected to the second to sixth sides 145b-f, which define five living hinges 149. Since the block 146a of the first side 145a is not connected to the sixth side 145f, the first side 145a and the first flap 142a can be repositioned without disturbing the position of the sixth side 145f and the sixth flap 142f. This makes it possible to fold the guard 140, as will be described below. Furthermore, as can be seen in Figure 16, each flap 142a-f is angled with respect to the top and bottom surfaces of the corresponding sides 145a-f. This angled arrangement, related to the gap between the first side 145a and the sixth side 145f, facilitates the folding and unfolding of the guard 140, as will be discussed below.

[0043] With the guard 140 in its initial deployed configuration (Figure 15), the first flap 142a is folded by pivoting the first side 145a and the first flap 142a around a point defined by a living hinge 149 located between the first side 145a and the second side 145b. Thus, the first flap 142a partially overlaps the second flap 142b. Subsequently, the first and second flaps 142a and 142b are pivoted by pivoting the second side 145b around a living hinge 149 formed between the block 146b of the second side 145b and the third side 145c, so that the second flap 142b partially overlaps the third flap 142c. Next, the first, second, and third flaps 142a-c are rotated by pivoting the third side 145c around a living hinge 149 formed between the block 146c of the third side 145c and the fourth side 145d, such that the third flap 142c partially overlaps with the fourth flap 142d. Subsequently, the first, second, third, and fourth flaps 142a-d are rotated by pivoting the fourth side 145d around a living hinge 149 formed between the block 149d of the fourth side 145d and the fifth side 145e, such that the fourth flap 142d partially overlaps with the fifth flap 142e. The first, second, third, fourth, and fifth flaps 142a-e are pivoted by pivoting the fifth side 145e around a living hinge 149 formed between the block 146e of the fifth side 145e and the sixth side 145f, such that the fifth flap 142e partially overlaps with the sixth flap 142f, and the sixth flap 142f partially overlaps with the first flap 142a. The fully folded guard 140 is shown in Figure 18.

[0044] It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as an example of specific embodiments. Those skilled in the art will anticipate other modifications within the scope and spirit of the claims appended herein.

Claims

1. A valve assembly used in a surgical access assembly, wherein the valve assembly is A guard including a frame and a plurality of flaps flexibly coupled to the frame, A seal comprising a support and a plurality of petals flexibly bonded to the support, A centering mechanism comprising a hoop and a plurality of fingers, wherein the plurality of fingers have a first end and a second end, the first end of the plurality of fingers is flexibly coupled to the outer surface of the hoop, and the second end of the plurality of fingers is biased to move away from the outer surface; A retainer having a first disk and a second disk, wherein the first disk has a ridge and a central opening, and the second disk has a slot and a central opening, the slot being configured to receive the ridge into the slot, and either the first disk or the second disk being positionable within a passage defined by the hoop, the ridge extending continuously around the central opening of the first disk, and the slot extending continuously around the central opening of the second disk, and A valve assembly comprising:

2. The valve assembly according to claim 1, wherein the valve assembly is positionable within the housing of a surgical access assembly.

3. The valve assembly according to claim 1, wherein the first disc of the retainer is fixable to the second disc of the retainer regardless of the angle of the first disc relative to the second disc.

4. The valve assembly according to claim 1, further comprising a plate positioned between the seal and the second disk, the plate being configured to support the seal and to restrict the bending of the plurality of petals.

5. The valve assembly according to claim 4, wherein the plate includes a plurality of protrusions, and the second disc includes a plurality of receptacles for receiving the plurality of protrusions of the plate.

6. The valve assembly according to claim 1, wherein the guard and the seal are positioned between the first disc of the retainer and the second disc of the retainer.

7. The valve assembly according to claim 1, further comprising a ring in contact with the hoop, the ring configured to receive the other of the first disk or the second disk.

Images