AU2009203017A1 - Surgical access port with locking latch mechanism - Google Patents

Description

P/00/011 Regulation 3.2 AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Surgical access port with locking latch mechanism The following statement is a full description of this invention, including the best method of performing it known to us: SURGICAL ACCESS PORT WITH LOCKING LATCH MECHANISM BACKGROUND The present invention relates in general to surgical devices and procedures, and more particularly to access devices. Surgical procedures are often used to treat and cure a wide range of diseases, conditions, and injuries. Surgery often requires access to internal tissue through open surgical procedures or endoscopic surgical procedures. The term endoscopicc" refers to all types of minimally invasive surgical procedures including laparoscopic and arthroscopic procedures. Endoscopic surgery has numerous advantages compared to traditional open surgical procedures, including reduced trauma, faster recovery, reduced risk of infection, and reduced scarring. Endoscopic surgery is often performed with an insufflatory fluid present within the body cavity, such as carbon dioxide or saline, to provide adequate space to perform the intended surgical procedures. The insufflated cavity is generally under pressure and is sometimes referred to as being in a state of pneumoperitoneum. Surgical access devices are often used to facilitate surgical manipulation of internal tissue while maintaining pneumoperitoneum. For example, trocars are often used to provide a port through which endoscopic surgical instruments are passed. Trocars generally have a sealing valve that prevent the insufflatory fluid from escaping while an instrument is positioned in the trocar. As a further example, hand access ports are also used during endoscopic surgery, sometimes referred to as hand assisted laparoscopic surgery ("HALS"). A hand access port will typically seal around a surgeon's hand or arm to prevent the insufflatory fluid from escaping while allowing the surgeon to manipulate tissue within the patient's body. Iris valves, gel pads, and inflatable balloons are some examples of seals used in HALS access ports. While surgical access devices are known, no one has previously made or used a surgical access device in accordance with the present invention. BRIEF DESCRIPTION OF DRAWINGS While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description taken in conjunction with the accompanying drawings illustrating some non-limiting 2 examples of the invention. Unless otherwise indicated, the figures are not necessarily drawn to scale, but rather to illustrate the principles of the invention. Fig. 1 depicts an exploded perspective view of an access port and a wound protector; Fig. 2 depicts a cross-sectional view of a deployed wound protector; Fig. 3 depicts a top plan view of a hinged latch in a closed and locked position; Fig. 4 depicts a top plan view of a hinged latch in an opened and unlocked position; and Fig. 5 depicts a perspective view of a hinged latch in a closed and locked position. DETAILED DESCRIPTION Fig.1 illustrates an example of a surgical access device. The device includes a wound protection (10) and a hand access port (20). The wound protector (10) in this example is a flexible variable length roll-up type of wound protector. Naturally, other types of wound protectors may also be used, including without limitation flexible fixed length wound protectors, flexible variable length pull-up types of wound protectors, rigid wound protectors, and the like. In this embodiment the distal ring (12) is circular ring with a circular cross-sectional geometry; however, non-circular rings and non-circular cross-sectional geometries are also possible. For instance, the distal ring could have an oval or elliptical in cross-sectional shape. In this embodiment the sleeve (14) is a single layered tube of material; however, a discontinuous sleeve or multi-layered sleeves are also possible. The sleeve (14) may be transparent, translucent, or opaque. As shown here, the sleeve (14) is fastened at its ends to the distal and proximal rings (12, 16) using an adhesive or heat sealing techniques; however, alternative techniques may also be employed. The length of the sleeve (14) can also vary. For instance, the sleeve may be between 2 cm and 14 cm in length; however, other lengths are also possible. The thickness of the sleeve (14) can also vary. In this embodiment the proximal ring (16) is a circular ring; however, non-circular rings are also possible. The proximal ring (16) can also vary in size, but is preferably sized to receive a surgeon's hand. Optionally, the ratio of the distal ring (12) and proximal ring (16) diameters is between 0.4 and 1.2. The proximal ring (16) can take a variety of different cross-sectional geometries. In this embodiment, the proximal ring (16) is formed from an extruded polymer with a cross-sectional geometry of has a generally figure eight shape. The extruded material is shaped 3 into a ring with metal wires inserted in the two annuli. Naturally, other geometries are also contemplated. Fig. 2 depicts an example of the wound protector (10) in a deployed position in a patient. In this example the wound protector in positioned in a patient's abdominal wall through an incision. To deploy the wound protector, the distal ring (12) is held in a collapsed position (e.g., in an oblong shape like an oval, a peanut, a figure eight, and the like) to reduce its size and then inserted through the incision. After insertion, the distal ring (12) is released and then expands to its ring-like shape. As shown here, the expanded distal ring (12) is larger than the incision and sits against the peritoneal surface of the abdominal wall. The proximal ring (16) includes a proximal face (16A), a distal face (16B), a medial face (16C), and a lateral face (16D). The medial and lateral faces (16C, 16D) each have a recessed valley about the circumference of the proximal ring (16). The proximal ring (16) is rollable to gather the flexible sleeve (14) around the proximal ring (16), and the distal face (16B) sits on the cutaneous surface of the abdominal wall (40). In the deployed position the proximal and distal rings (12, 16) are substantially aligned axially. The proximal ring (16) is rollable in the outward directions (as shown by the arrows) to shorten the sleeve (14) and in the inward direction to lengthen the sleeve (14), or vice versa. For the purposes of illustration, the sleeve (14) is depicted with an exaggerate thickness. Ordinarily in the deployed state the sleeve (14) would be wound many times around the proximal ring. The shortening of the sleeve (14) pulls the sleeve (14) taut against the incised wound defining an access passage. As one with ordinary skill in the art will 5 recognize, surgical procedures can be performed through the incision and the sleeve (14) protects the incised wound from infection and contamination. In addition, the taut sleeve (14) tends to pull the incised wound open thus functioning as a wound retractor. As demonstrated in this example, more retraction is possible by rolling the proximal ring (16) outward, while less retraction is possible by rolling the proximal ring (16) inward. 0 The hand access port (20) includes a resilient pad (22) supported in a rigid circumferential frame (24). The pad (22) has a central aperture (26). In use the aperture (26) will stretch open to receive and seal against a surgeon's arm. A surgeon's hand will typically be lubricated to facilitate ingress and egress. The aperture (26) can take a variety of different shapes and forms, but in the present example comprise two axially offset normal slits. The aperture (26) 5 in this example is self-closing in the absence of a surgeon's arm. The latch (28) allows the hand 4 access port (20) to be selectively attachable and detachable from the proximal ring (16) of the wound protector (10). Naturally, a wide variety of other attaching mechanisms could also be used. The pad (22) is this embodiment is formed from a closed-cell foam, made with neoprene, polyethylene, or the like. The pad (22) could also be formed from an open-cell foam encapsulated in a substantially gas impermeable membrane such as silicone, polyisoprene, polyurethane, or the like. In an alternative embodiment, the pad (22) can be made from a gel material. Gel materials are known in the art have typically have a low durometer, high elongation, and good tear strength. In one example, a gel material may have an ultimate elongation less than about 1000 percent and a durometer not less than about 5 Shore A. In another example, the gel material may have an ultimate elongation greater than about 1000 percent and a durometer less than about 5 Shore A, which is sometimes referred to as an "ultragel." In an alternative embodiment, the hand access port (20) takes the form of an iris valve. A latch (30) is used to attach the hand access port (20) to the wound protector (10). The latch (30) is connected to the frame (24) with a hinge (32) about which the latch (30) pivots between opened and closed positions. In this embodiment the pivot axis is generally parallel with the axis of the aperture (26). To attach the hand access port (20) to the wound protector (10), the latch (30) is placed in its opened position while the frame is positioned laterally about the proximal ring (16) while deployed in a patient. The latch (30) is then pivoted to its closed position. The medial portion (34) of the latch (30) engages the distal face (16B) thus securing the hand access port (20) to the proximal ring (16). A lock (36) is connected to the frame (24) to keep the latch (30) in its closed position. The lock (36) may be selectively engaged or disengaged from the latch (30). In this embodiment a spring biases a tab to mate with a corresponding recess feature in the latch (36) to engage the lock (36). In this embodiment, the lock (36) includes a tab oriented generally circumferentially with the frame (24); however, alterative orientations are also contemplated. A finger operated release compresses the spring and withdraws the tab, thus disengaging the lock (36) and allowing the latch (30) to be pivoted to its opened position. The tab/recess could be reversed such that the tab portion is located on the latch (30) while the recess portion is located on the lock (36). 5 Figs. 3 and 4 illustrates an alternative embodiment. The latch (40) is connected to the frame (24) with a hinge (42) about which the latch (40) pivots between a closed position (Fig. 3) and an open position (Fig. 4). To attach the hand access port (20) to the wound protector (10), the latch (40) is placed in its opened position while the frame is positioned laterally about the proximal ring (16) while deployed in a patient. The latch (40) is then pivoted to its closed position. The medial portion (44) of the latch (40) engages the distal face (16B) thus securing the hand access port (20) to the proximal ring (16). A lock (46) is connected to the frame (24) to keep the latch (40) in its closed position. The lock (46) may be selectively engaged or disengaged. In this embodiment the lock comprises a pivoting hook-shaped portion that interfaces with a mating feature in the latch (40). A tortional spring may be used to bias the lock (46) to engage the latch (40). Optionally, the lock/latch (46/40) interface may include an interference snap fit. Fig. 5 illustrates an alternative embodiment. The latch (50) is connected to the frame (24) with a hinge (52) about which the latch (50) pivots between a closed position and an open position. A lock (56) is connected to the frame (24) to keep the latch (50) in its closed position. The lock (56) may be selectively engaged or disengaged. In this embodiment the lock comprises a pivoting arm that interfaces with a mating feature in the latch (50). When the lock is in its engaged state, the mating feature of the latch (50) is interposed between the pivoting arm and the frame (24). Optionally, the lock/latch (56/50) interface may include an interference snap fit. Preferably, the devices described above will be processed before surgery. First, a new or used device is obtained and if necessary cleaned. The device can then be sterilized. In one sterilization technique the access device is placed in a closed and sealed container, such as a plastic or TYVEK bag. Optionally, the device can be bundled in the container as a kit with other components, including one or more of the following: a wound protector, hand access port, a mounting ring for the wound protector, a tube of lubricant, a marker, an incision template or scale, an instruction sheet, and the like. The container and device, as well as any other components, are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in the sterile container. The sealed container keeps the device sterile until it is opened in the medical facility. 6 Having shown and described various embodiments and examples of the present invention, further adaptations of the methods and devices described herein can be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the specific materials, dimensions, and the scale of drawings will be understood to be non-limiting examples. In addition, the foregoing teachings could be implemented for non-HALS procedures, such as reducing the scale to seal against instruments in traditional laparoscopic procedures. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure, materials, or acts shown and described in the specification and drawings. 7

Claims (14)

1. A surgical device, comprising: a) a roll-up wound protector comprising a distal ring, a proximal ring, and a flexible sleeve having a length extending between the proximal and distal rings, the proximal ring having proximal and distal surfaces and being rollable to gather the flexible sleeve around the proximal ring and shorten the length of the flexible sleeve; b) a hand access port comprising a gel pad with a central aperture and a rigid circumferential frame, the aperture being aligned with the proximal and distal rings and being adapted to receive and seal against a surgeon's arm; c) a latch connected to the frame with a hinge, the latch pivoting about the hinge between opened and closed positions to selectively attach and detach the hand access port to the proximal ring; and d) a lock connected to the frame, the lock being selectively engaged and disengaged with the latch to prevent the latch from pivoting from its closed position to its opened position.

2. A surgical device, comprising: a) a roll-up wound protector comprising a distal ring, a proximal ring, and a flexible sleeve having a length extending between the proximal and distal rings, the proximal ring having a proximal and distal surfaces and being rollable to gather the flexible sleeve around the proximal ring and shorten the length of the flexible sleeve; and b) a hand access port with an aperture aligned with the proximal and distal rings, the aperture being adapted to receive and seal against a surgeon's arm, the access port comprising a resilient pad and a frame; and c) a latch connected to the frame, the latch having a closed position where the frame is fastened to the proximal ring; d) a lock selectively engageable with latch to keep the latch in its closed position. 8

3. A surgical device, comprising: a) a wound protector comprising a distal ring, a proximal ring, and a flexible sleeve having a length extending between the proximal and distal rings; and b) a hand access port comprising a central aperture, the aperture being aligned with the proximal and distal rings and being adapted to receive and seal against a surgeon's arm; and c) a latch connected to the hand access port for selectively attaching and detaching the hand access port to the wound protector; d) a lock connected to the hand access port for selectively engaging and disengaging the latch.

4. The surgical device of claim 3, wherein the proximal ring is rollable to gather the flexible sleeve around the proximal ring to shorten the sleeve.

5. The surgical device of claim 3, wherein the wound protector is a fixed length.

6. The surgical device of claim 3, wherein the hand access port is a pad.

7. The surgical device of claim 6, wherein the pad comprises a closed cell foam. 5

8. The surgical device of claim 6, wherein the pad comprise an open cell foam.

9. The surgical device of claim 6, wherein the pad comprises a gel material.

10. The surgical device of claim 9, wherein the gel material is an ultragel material. 0

11. The surgical device of claim 3, wherein latch pivots between an opened position and a closed position.

12. The surgical device of claim 11, wherein the lock prevents the latch from pivoting to its 35 opened position. 9

13. The surgical device of claim 3, wherein the lock is biased to engage the latch.

14. The surgical device of claim 3, wherein the lock engages the latch with an interference snap fit. 10