AU781908B2 - Surgical access port - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 DIVISIONAL APPLICATION NAME OF APPLICANT(S): Smith Nephew, Inc. AND University of Massachusetts ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Little Collins Street Melbourne, 3000.

INVENTION TITLE: "Surgical access port" The following statement is a full description of this invention, including the best method of performing it known to us: QAOPER\CAE\2002UUNE\2543O8O DIV 169DOC 18/6/02 P. OPER 1S.,8U47.02 Isptdoc-2604

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SURGICAL ACCESS PORT Background of the Invention This invention relates to the field of surgical devices.

More particularly, the invention relates to apparatus for use during laparoscopic surgery comprising a tubular access port and a laparoscopic surgical method using a tubular access port, for accessing a patient's body cavity.

Abdominal surgery typically involves an incision in the abdominal wall large enough to accommodate a surgeon's hands, multiple instruments, and illumination of the body cavity.

While large incisions simplify access to the body cavity during *surgery, they also increase trauma, require extended recovery time, and can result in unsightly scars. In response to these S: drawbacks, minimally invasive surgical methods have been 15 developed.

In minimally invasive abdominal surgery, several smaller ••go incisions are made into the abdominal wall. One of the openings is used to inflate the abdominal cavity with gas, :which lifts the abdominal wall away from underlying organs and gee• 20 provides space to perform the desired surgery. This process is eeo referred to as insufflation of the body cavity. Additional •g openings can be used to accommodate instruments for o illuminating and viewing the cavity, as well as instruments involved in actually performing the surgery, instruments to manipulate, cut, or resect organs and tissue. While minimally invasive surgical methods overcome certain drawbacks of traditional methods, there are still various disadvantages.

In particular, there is limited tactile feedback from the manipulated tissue to the surgeon's hands. Also, tissue that is to be removed from the body cavity must be removed in pieces that are small enough to fit through one of the incisions.

P.AOPERM\SuU847-02 I sldoc-2&645 -2- Recently, new surgical methods have been developed that combine the advantages of the traditional and minimally invasive methods. In these new methods, small incisions are still used to inflate, illuminate, and view the body cavity, but in addition, an intermediate incision is made into the abdominal wall to accommodate the surgeon's hand. The intermediate incision must be properly retracted to provide a suitable-sized opening, and the perimeter of the opening is typically protected with a surgical drape to prevent bacterial infection. A sealing mechanism is also required to prevent the loss of insufflation gases while the eo ,surgeon's hand is either inserted into or removed from the body cavity through the retracted incision.

15 Summary of the Invention According to the present invention, there is provided an apparatus for use during laparoscopic surgery, the apparatus comprising a tubular access port defining a passageway for accessing a patient's body cavity through an 20 incision, the access port comprising an inflatable portion oo encircling the passageway and an iris valve configured to o adjustably seal the passageway. Preferably, the iris valve comprises a twistable membrane positioned along at least a portion of the passageway configured to adjustably constrict the passageway.

According to the present invention, there is provided a laparoscopic surgical method comprising, providing a tubular access port defining a passageway for accessing a patient's body cavity, the tubular access port having an inflatable portion encircling the passageway, inserting one end of the access port through an incision to the patient's body cavity P OPERuS.8847.2 IzpLd-266040 -3and twisting a membrane positioned along at least a portion of the passageway to constrict the passageway.

In general, the invention relates to a surgica1 access port that may allow a surgeon's hand or instrument to access a patient's body cavity through a sealable opening. The access port includes two parts, a wound retractor and an iris valve or twistable membrane. The wound retractor is designed to retract the edges of an incision made into a body cavity into an opening, and to seal around the edges of the opening, thereby forming a gas-tight connection between the body cavity and the interior of the access port. The iris valve or twistable membrane connects to the wound retractor external to the body cavity and provides a path for a surgeon to insert an instrument an/or his hand through S 15 the opening formed by the wound retractor. The iris valve Sor twistable membrane can seal around the instrument or :...surgeon's arm or glove, when the instrument or surgeon's hand is inserted into the body cavity, and can seal the opening when the instrument or surgeon's hand is removed from the access port. Thus, the port provides hand access to the body cavity, and prevents gases in the body cavity, such as insufflation gases, from escaping into the surroundings.

Preferably, the inflatable portion of the wound retractor is configured to secure the access port to the patient when one end of the tubular access port is inserted through the incision and the inflatable portion is inflated.

The inflatable portion may comprise an inflatable collar.

An inflation port is conveniently coupled to the inflatable portion.

PA\OPER'S. 4M847-02 I sp doc.-2&14DS -4- In one embodiment, the surgical access port further comprises a resistant lower ring encircling the passageway and configured to be inserted through the incision.

Other features and advantages of embodiments of this invention and of other embodiments of a surgical access port will be apparent from the following detailed description of the figures which are provided by way of example only.

Brief Description of the Drawings Fig. 1 is a cross-sectional view of a surgical access port.

Figs. 2A to 2E illustrate the steps in using the wound retractor portion of the access port of Fig. 1.

Fig. 3 is a cross-sectional view showing a variation of the surgical access port of Fig. 1.

15 Fig. 4 is a cross-sectional view of another embodiment of a surgical access port.

Fig. 5 is a schematic of a modular surgical access port.

i: Figs. 6A and 6B are schematic views of an iris valve in open and closed configurations, respectively.

oo Figs. 7A and 7B are cross-sectional views of another embodiment of a surgical access port.

Fig. 8 is a cross-sectional view of an embodiment of a wound retractor.

Fig. 9 is a cross-sectional view of another embodiment of a wound retractor.

Fig. 10 is a perspective view of an embodiment of the access port employing a glove.

Fig. 11 is a perspective view of another embodiment of the access port employing a glove.

Fig. 12 is a perspective view of a further embodiment of the access port employing a glove.

P .OPER\Sanf4847-2 Isp(doc.2&60,45 Fig. 13 is a schematic of a wound retractor having a light source for illuminating the body cavity.

Detailed Description The surgical access port is best described as having two parts, a wound retractor and a sealing sleeve.

The wound retractor includes a flexible tubular skirt having a first end reinforced with a stiff ring so that the first end is maintained in an open orientation, and a second end surrounded by one or more inflatable collars. The reinforced first end is inserted into the body cavity through an incision, providing a channel through the skirt from the outside to the inside of the body cavity. During use, the collars are inflated, thereby drawing out skirt within the incision and pulling the reinforced first end of the skirt tight against the inner wall of the patient's skin. As a result, the edges of the incision are retracted into an opening and the %e 0000 skirt seals around the perimeter of the opening along the inner abdominal wall to the outer surface of the skin.

A sealing sleeve is attached to the wound retractor portion above the inflatable collars. The sealing sleeve has an entry opening distal to the collars and extends the channel provided by the skirt. Within the sealing sleeve, a gas-tight seal is provided for conforming to the shape of an object a hand or instrument) inserted through the channel into the body cavity.

Alternatively, the sealing sleeve can include means for attaching a surgeons glove to the entry opening of the sleeve. In these cases, the exterior of the glove seals the channel while a surgeon's hand can be inserted 15 into the interior of the glove and access the body cavity.

SurQical Access Ports :As shown in Fig. 1, surgical access port 62 is a sleeve-like device having an entry opening 12 and an exit S 20 opening 18. During use, a surgeon inserts a hand into the entry opening 12 and accesses a patient's body cavity through exit opening 18, after the access port is oo inserted into the body cavity through an incision, and prevents gases used to insufflate the body cavity from 25 escaping through the incision. A flexible skirt 66 surrounds exit opening 18 and has a hem-like pocket 63 at its end proximal to exit opening 18. Pocket 63 encloses a ring 64 so that the skirt and exit: opening 18 are maintained in an open, substantially circular or elliptical orientation. Skirt 66 extends upward from exit opening 18 towards one or more inflatable collars 68 and 69 that surround skirt 66. The upper end of skirt 66 is connected to the upper-most collar 69, from the inner circumference of collar 69 to the top of collar 69. Each of the inflatable collars 68 and 69 respectively enclose an annular region. The annular regions may or may not be in fluid contact with one another, but they are isolated from the rest of the sleeve, body cavity, and surrounding. The collars 68 and 69 are inflated through one or more inlet ports 11. When collars 68 and 69 are in fluid communication with one another, only a single inlet port 11 is required.

An outer sleeve 10 is attached to the upper end of skirt 66 and extends upward towards entry opening 12.

Outer sleeve 10 encloses an upper chamber 16, which is in fluid contact with gases from the body cavity when exit opening 18 is inserted through an incision into the body cavity. Outer sleeve 10 is inverted at the entry opening 15 12 forming a flap valve 14, which seals upper chamber 16 from the surroundings external to entry opening 12.

The lower portion of access port 62, which Sncludes ring 64, skirt 66, and inflatable collars 68 and 69, form the wound retractor. During use, an incision 50, in the shape of a slit (Fig. 2A) is first made in the patient's abdominal wall 52. Ring 64 and the attached portion of skirt 66 are then inserted into the body cavity through incision 50 with collars 68 and 69 being uninflated and remaining external to incision 25 (Fig. 2B). If ring 64 is circular and has a diameter less than the length of ircision 50, it is inserted perpendicular to abdominal wall 52. Alternatively, if ring 64 is circular and its diameter is greater than the length of incision 50, ring 64 must be flexible enough to fit through incision 50 in a deformed state. Most preferably, ring 64 is rigid and has an elliptical shape with a maximum diameter longer than the length of incision 50 and a minimum diameter shorter than the length of incision 50. In this case, rigid ring 64 is 8 inserted into the body cavity by orienting its minimum diameter parallel to incision Once ring 64 is within the body cavity, it is oriented so that it is parallel to the abdominal wall 52 (Figs. 2C and 2D). Figs. and are cross-section views along the length and width, respectively, of incision 50, with collars 68 and 69 remaining uninflaced.

In this configuration, the diameter and stiffness of ring 64 are sufficient to prevent it from being pulled back through incision 50. The collars 68 and 69, which-have diameters equal to or greater than the length of incision are then inflated though inlet port 11. Collars 68 and 69 initially rest above abdominal wall 52 around incision 50. As collars 68 and 69 are inflated, they I 15 expand upward and their inner circumferences expand .radially outwardly (Figs. 2E). Since the upper end of skirt 66 is connected to the inner circumference of the upper-most collar 69, skirt 66 is also drawn upwards and radially outward, thereby drawing ring 64 tightly against 20 the inner surface of abdominal wall 52. As a result, the so* intermediate portion of skirt 66 is drawn tightly against *go the edges of incision 50, retracting the adjacent tissue and producing an opening into the body cavity and a gastight seal between the body cavity and the remainder ot goe• 25 access port 62. Fig. 2E illustrate a cross-sectional s"e view of incision 50 with collars 68 and 69 being inflated.

Once the wound retractor of access port 62 has provided a gas-tight seal around incision 50, the body cavity is inflated with gas. The gas also expands into upper chamber 16, inflating the upper portion of access port 62. The pressure within upper chamber 16 seals flap valve 14, which prevents gas from escaping through entry opening 12. The portion of flap valve 14 distal to entry opening 12 has a preferred flattened orientation formed 9 by heat sealing side portions 15a and 15b of flap valve 14 (Fig. As the flap valve extends upward towards entry opening 12, it opens into an approximately circular geometry. During use, the surgeon inserts his hand into upper chamber 16 through entry opening 12 and flap valv.

14. Insertion of the surgeon's hand momentarily breaks the seal between side portions 15a and 15b of flap valve 14, but thereafter the pressure within upper chamber seals flap valve 14 around the surgeon's arm. The loss of insufflation gases is thereby minimized during insertion and subsequent removal of the surgeon's hand.

Since these gas losses are small, they can be compensated for easily by known pumping means used for inflating and regulating pressure in the body cavity.

15 To prevent flap valve 14 from everting as a result of positive pressure in the upper chamber, the portion of the access port extending from the upper portion of outer S:sleeve 10 toward flap valve 14 along entry opening 12 can be reinforced with additional material to stiffen the access port in this region, and to maintain the preferred Sorientation, to prevent eversion.

In addition or alternatively, heat-sealed side .portions 15a and 15b can be provided with eyelet openings t'es 20a and 20b through which drawstring 22a and 22b are S. 25 attached (Fig. Drawstrings 22a and 22b extend in opposite directions such that tension placed upon them pulls the two walls of flap valve 14 into close approximation. The drawstrings pass through the walls of outer sleeve 10 via drawstring ports 24a and 24b.

Drawstring ports 24a and 24b form a friction fit around drawstrings 22a and 22b sealing upper chamber 16 from the surroundings and fixing the respective lengths of the drawstrings in upper chamber 16. Tension on drawstrings 22a and 22b can be increased by pulling on the drawstrings from the outside of outer sleeve 10, even as access port 62 is in use. In certain embodiments, drawstring ports 24a and 24b can further include one-way releasable locking mechanisms so that tension on the drawstrings can be increased and decreased from the outside of outer sleeve 10. The drawstrings prevent the inversion of flap valve 14 when upper chamber 16 is inflated and enhance the effectiveness of the flap valve seal, with and without insertion of a surgeon's hand.

In an alternative embodiment, drawstrings 22a and 22b are made of an elastic material and fixedly attached to the inner wall of outer sleeve 10. In this embodiment, the drawstrings do not extend outward through outer sleeve 10 and so the tension on them is not adjustable. Instead, the drawstrings are cut to a specific length to provide a preset tension on the flap valve opening when the upper chamber is fully expanded.

Fig. 4 shows another embodiment of hand access cert 62, which differs from the embodiments described previously in the following way. Flap valve 14 is 20 replaced with a flexible and expandable inner sleeve eoc that extends from entry opening 12 and attaches to skirt 66 near the upper-most collar. As a result, upper chamber 32 is completely isolated from the body cavity and the surroundings. Instead of being inflated by 25 insufflation gases from the body cavity, upper chamber 32 is inflated separately through inlet port 34.

The interior of inner sleeve 30 provides a channel from entry opening 12 to the wound retractor. When upper chamber 32 is inflated, the positive pressure in upper chamber 32 collapses together the walls of expandable inner sleeve 30, thereby sealing the channel, or alternatively, sealing inner sleeve 30 around the arm cf a surgeon.

Inner sleeve 30 includes a central portion having a flattened orientation formed by heat sealing side 11 portions 38a and 38b. Hence, the circumference of inner sleeve 30 begins substantially circular near entry opening 12, becomes elongate in the vicinity of side portions 38a and 38b, and becomes substantially circular again in the vicinity of collars 68 and 69. As described previously, the access port can also include eyelet openings 40a and 40b in side portions 38a and 38b, through which drawstrings 42a and 42b are attached, respectively. The drawstrings extend outwardly through drawstring ports 44a and 44b. When upper chamber 32 is inflated to a pressure greater than the pressure in the body cavity and the surroundings, the positive pressure collapses together the walls of inner sleeve 30 between side portions 38a and 38b, sealing the body cavity from 15 entry opening 12. As a result of drawstrings 42a and 42b, this seal is enhanced.

During use of this embodiment, the wound retractor portion of access port 62 is implemented as described previously (and shown in Figs. 2A-2E). Upper chamber 32 20 is then inflated, sealing the body cavity from the surroundings. Following this step, the body cavity is insufflated. If the pressure in the body cavity is greater than pressure in upper chamber 32, the seal will leak insufflation gas to the surroundings, otherwise the 25 seal will be maintained. In this way, the isolated upper Schamber 32 insures that the insufflation pressure in the body cavity will remain below the pressure in the upper chamber. As the surgeon inserts his hand through access port 62 and into the body cavity, the positive pressure from upper chamber 32 will force inner sleeve 30 to conform to the shape of the surgeon's arm, thereby maintaining the seal. As mentioned before, any loss of insufflation gas during the insertion and removal of the surgeon's hand can be compensated for by the insufflation pump.

12 Access port 62 may further include a one-way relief valve 46, such as a duck-billed relief valve, between upper chamber 32 and a region within inner sleeve proximal to inflatable collars 68 and 69. A duckbilled relief valve is a one-way valve that opens when there is a sufficient pressure differential between opposite sides of the valve. In this embodiment, relief valve 46 would begin to leak if the pressure in upper chamber 32 became too large. For example, when the surgeon's arm is within inner sleeve 30, the volume of upper chamber 32 becomes compressed, thereby increasing the pressure within upper chamber 32 and against the surgeon's arm. This may be uncomfortable for the i surgeon. Advantageously, relief valve 46 would optimize the effectiveness of the seal around the surgeon's arm and the comfort of the surgeon by releasing gas from ,upper chamber 32 to the body cavity. The insufflation pump used to inflate upper chamber 32 could compensate for any loss of gas from upper chamber 32 that may be 20 required to maintain an effective seal once the surgeon removes his hand.

Relief valve 46 also allows the body cavity to be insufflated with the same pump used to inflate upper :o chamber 32. Once the pressure in upper chamber 32 25 reaches a preset value, gas will leak through relief valve 46 insufflating the body cavity. The seal between the entry opening and the body cavity will be maintained since the pressure in upper chamber will remain larger than the pre7sure in the body cavity. In a further embodiment, the access port includes a second one-way relief valve extending from inflatable collars 68 and 69 to the upper chamber. Thus, a single pumping means could be used to first inflate collars 68 and 69, then inflate upper chamber 32, and finally inflate the body cavity.

The relief valves would require that the pressure in P:%OPERaAn8847-02 13collars 68 and 69 is greater than the pressure in upper chamber 32, which is greater than the pressure in the body cavity.

A relief valve may also be positioned between upper chamber 32 and a region of inner sleeve 30 proximal to entry opening 12. In this case gas will leak from the upper chamber into the surroundings.

Access Port Variations In another embodiment, the access port described above having an inner and outer sleeve can also include a second pair of drawstrings for imparting a second region of the inner

V.

sleeve with a preferred flattened geometry. Thus, when the seal formed by the first flattened region is broken during the insertion or removal of a surgeon's hand, pressure from the inflated upper chamber provides a second seal at the second flattened region, or vice-versa.

eoee Alternatively, for any of the embodiments described S.previously, a flap valve can be connected to the skirt and ooo extend into the wound retractor, thereby providing a second eeee 20 seal on the surgeon's arm. Thus, when the surgeon's hand oo ,breaks either seal, the remaining seal prevents the escape of o insufflation gases.

oo In a further embodiment, the surgical access port can be modular as shown in Fig. 5, comprising a wound retractor 200 (as described above) and a sealing sleeve 202. Depending on the particular embodiment, the sealing sleeve could, for example, include an outer sleeve having a flap valve seal within an entry opening the embodiment shown in Fig. 1) or an inflatable chamber formed between an inner and outer sleeve the embodiment shown in Fig. For surgical procedures that do not require insufflation of the body cavity, the wound retractor can be used on its own for retracting an 14 incision to make an opening into the body cavity. When insufflation of the body cavity is necessary, the sealing sleeve is attached to the wound retractor using a reusable gas-tight attachment means 204, such as a ziplock seal. Alternatively, for example, the attachment means can include a compression or threaded fit between a pair of semi-rigid collars attached to the sealing sleeve and wound retractor, respectively. Otherwise, the surgical access port is structured and function.s similarly to the embodiments described above.

In other embodiments, the wound retractors described herein can be used with other types of sealing sleeves. In particular, rather than sealing means based on inflation, mechanical sealing means well known in the 15 art can be provided. For example, as shown in Figs. 6A and 6B, the sealing sleeve can include an iris valve 76 attached to the upper end of the skirt above the inflatable collars. The iris valve is formed from two stiff rings 70 and 72 attached to opposite ends of a tubular piece 74 of elastic material (Fig. 6A). In this configuration, iris valve 76 is open. To seal the opening, or alternatively, to seal around a surgeon's arm inserted through the opening, the upper ring 72 is rotated relative to the lower ring 70, as a result 25 tubular piece of elastic material 74 becomes twisted and the opening through the tubular piece contracts (Fig.

6B). To lock the relative positions of the upper and lower rings, the rings are attached to one another using a clasping mechanism 78 and 80, a latch.

Alternatively, for example, the lower ring can be provided with upright pegs evenly spaced around its circumference. The upright pegs fit into corresponding openings in the upper ring, so that when the upper ring is placed on the lower ring the rotational position of the rings relative to one another is fixed.

15 Another embodiment of a sealing sleeve 101 is shown in Figs. 7A and 7B. The top end 108 of sleeve is maintained in an open configuration by its connection to a rigid ring 110. Just below rigid ring 110, the inner wall of sleeve 100 is connected to an inflatable cuff 112, which is made out of an expanding, elastomeric material rubber). Surrounding inflatable cuff 112 on the outside of sleeve 10 is a stiff backing 100 of a close-fitting non-expanding material a nylon weave). Since backing 100 is non-expanding, cuff 112 will expand inward when inflated, thereby sealing around a surgeon's arm when the surgeon's hand is inserted through the channel formed by wound retractor 106.

Furthermore, since there is a region of flexible material 15 between cuff 112 and wound retractor 106, the surgeon can easily alter the angle of his arm and the penetration depth of his hand, without jeopardizing the seal formed by cuff 112. When the surgeon's hand is removed from the access port, cuff 112 can be inflated further to 20 completely seal the channel.

Alternatively, to seal the channel when the -surgeon's hand is removed, rigid ring 110 can receive a snap-on cap 114 (Fig. 7B), which covers the opening at the top end 108 of sleeve 100. The cap is made of a 25 semi-flexible material, which includes, for example, hard rubber, polyvinyl chloride (PVC), and foam. Cap 114 includes a groove 117, above a lower inner lip 116. that mates with rigid ring 110. The mechanical pressure created by a slight undersizing of the diameter of groove 117 above inner lip 116 relative to the diameter of rigid ring 110 forms a tight seal. Cap 114 can also include instrument ports 118 and 120, which provide gas-tight sealable openings into the body cavity for surgical instruments trocars, cannulas, and endoscopes).

16 In another embodiment, shown in Fig. 8, the wound retractor described previously can further include a rigid ring 210 surrounding the outer perimeter of inflatable collars 68 and 69. For example, skirt 66 can Sextend over, and connect to, the outer perieter o inflatable collars 68 and 69, enclosing rigid ring 210 between these collars. Alternatively, for example, one of the inflatable collars can include additional material for enclosing rigid ring 210 around the outer perimeter of that collar. Rigid ring 210 will help prevent collars 68 and 69 from deforming in response to forces from the retracted opening when inflated, and will provide structure to the top part of a wound retractor 212 when collars 68 and 69 are uninflated. Furthermore, rigid ring 210 allows snap-on cap 114 to directly cover the channel provided by wound retractor 212. Cap 114 is mounted onto ring 210 by a compression fit. The diameter of rigid ring 210 is slightly larger than the diameter of groove 117 above lower lip 116, thereby forming a tight 20 seal.

As shown in Fig. 9, wound retractor 224 can further include an inflatable cuff 220 attached directly to skirt 66 of the wound retractor adjacent to the inner perimeter of inflatable collars 68 and 69. In this case, wound retractor 224 includes a sealing means for the channel into the body cavity cuff 220) and a sealing sleeve is unnecessary. Cuff 220 is made of an expandable, elastomeric material and will expand inward when inflated, sealing around a surgeons arm that is inserted through the channel formed by wound retractor 224. When the surgeon's arm is removed, cuff 220 can either be inflated to completely seal the channel, or alternatively, cuff 220 can receive a sealing plug 230.

After plug 230 is inserted into wound retractor 224, inflated cuff 220, when inflated, fits securely within 17 recessed groove 232, thereby sealing the channel. As with cap 114, sealing plug 230 can include one or more sealable instrument ports 234 for inserting instruments into the body cavity through wound retractor 224.

Access Port Variations using a Glove In another series of embodiments shown in Figs.

10-12, a seal is made between the cuff of a glove worn by the surgeon and the opening of the sealing sleeve.

A

wound retractor 300 of an access port 302 provides an opening through an abdominal wall 304 into a body cavity 306. A flexible tubular sleeve 310 is attached to wound retractor 300 external to body cavity 306, extending the channel formed by wound retractor 300 to an entry opening 312 of sleeve 310. A sealing collar 3.14 is connected to 15 sleeve 310 surrounding entry opening 312. Sealing collar 314 is for mating to an enlarged cuff 317 of a glove 316 worn by a surgeon, thereby sealing the channel from the surroundings.

Sleeve 310 can be provided with a means for 20 closing the channel along an intermediate portion 318 of sleeve 310 to seal the opening to body cavity 306. For example, along a circumference 322 of intermediate portion 318, sleeve 310 can attach to a drawstring 320, which can be drawn up external to sleeve 310 (Fig. 25 When drawstring 320 is drawn up, carcumference 322 contracts until the channel into body cavity 306 is completely covered by sleeve 310. in another embodiment, shown in Fig. 11, intermediate portion 318 can be closed by a "bear-trap" clamp 330 comprising two hinged arcuate bands 332 and 334 connected to the base of sleeve 310.

When bands 332 and 334 extend away from one another, they surround the base of sleeve 310 and the channel remains open. As bands 332 and 334 are brought together above wound retractor 300, they force together opposite inner 18 surfaces of sleeve 310, thereby closing the channel and sealing the opening to body cavity 306.

In a further embodiment, shown in Fig. 12, inner surfaces of intermediate portion 318 of sleeve 310 include a zip-lock seal 340 for sealing the opening to body cavity 306. In other embodiments, a separate mechanical clamp can be used to hold inner surfaces of intermediate portion 318 together, thereby closing the channel.

During use, the closing means is used to seal the opening into body cavity 306 formed by wound retractor 300. Body cavity 306 is then insufflated, with the closing means preventing the escape of insufflation gases into the surroundings. Cuff 317 of surgeon's glove 316 15 is then mated with sealing collar 314 and the closing means is released so that the surgeon's gloved hand can access body cavity 306. The open end of sleeve 310 is sealed to enlarged cuff 317, preventing the escape of insufflation gases even though the closing means 20 surrounding intermediate portion 318 is not in use. The length of flexible sleeve 310 provides the surgeon's arm with a sufficient movement range. When the surgeon brings his gloved hand above intermediate portion 318, *the closing means can be reset, thereby resealing the 25 opening to body cavity 306. Thereafter, enlarged cuff 317 is detached from sealing collar 314 and the surgeon's gloved hand is removed from access port 302.

In one embodiment, enlarged cuff 317 includes a radially-outwardly extending flange 350 that mates with an inner groove 352 within sealing collar 314. Flange 350 is made of a semi-rigid material plastic or rubber) that is sufficiently deformable for flange 350 to be inserted into sealing collar 314 and mate with groove 352 (Fig. 10). In the above embodiment, glove 316 can be a standard surgical glove and flange 350 can be formed 19 by placing a bracelet over the surgeon's gloved hand and mounting the bracelet to the wrist portion of the glove using an adhesive material. In order to seal the channel, the bracelet is designed to mate with groove 352.

Alternatively, a bracelet 360 can be worn underneath glove 316 (Figs. 11-12). Again, glove 31f; is a standard surgical glove, which is typically made of a flexible and semi-elastic material latex, natural rubber, or polymeric materials). In this case, the surgeon places a bracelet 360 around his wrist and then pulls glove 316 over his hand and the bracelet. Glove 316 conforms to the shape of bracelet 360, thereby forming enlarged cuff 317, which completely surrounds the 15 wrist of the surgeon and can mate with sealing collar 314.

:314: In these embodiments, bracelet 360 is made of a substantially rigid or semi-rigid material an oring made of hard rubber) and has a fixed diameter.

20 Sealing collar 314 can comprise an inflatable bladder 364 for expanding against and mating with enlarged cuff 317 (Fig. 11). Sealing collar 314 can also be made of a semi-compressible material foam or a gel-filled bladder), which provides an interference fit with 0: 25 enlarged cuff 317. Alternatively, bracelet 360 can have *o a cross-sectional shape designed to fit with an inner groove 370 of sealing collar 314 (Fig. 12). Glove material pressed between fitted collar 314 and bracelet 360 functions as a gasket, enhancing the effectiveness of the seal.

In any of the embodiments using the bracelet and glove, the seal is maintained without constricting the surgeons arm, which can be a source of discomfort. The surgeon's arm is not constricted because bracelet 360 has a fixed diameter and need only fit loosely around the 20 surgeon's arm. However, by mating with sealing collar 314, bracelet 360 securely attaches glove 316 to entry opening 312 of sleeve 300, sealing the opening to the body cavity, and allowing access to the body cavity via glove 316.

Preventing the constriction of a surgeon's arm can be further achieved by an embodiment in which the crosssectional diameter of bracelet 360 along the lengt:h of the surgeons arm is slightly larger than the corresponding dimension of groove 370. Hence, an interference fit between the mating components is provided along a direction parallel to the surgeon's arm, and bracelet 360 is not compressed along a direction that S004 will constrict a surgeon's arm.

15 In some embodiments, it is desirable for the diameter of bracelet 360, and the glove itself, to be large enough that the surgeon can remove his hand from glove 316 without detaching glove 316 from sleeve 310.

In this case, access port 300, glove 316 and bracelet 360 20 combine to form a detachable glove box, in which, during use, the surgeon can insert and remove his hand from the body cavity at will (via glove 316) with no loss of Insufflation gas, and when the procedure is completed, glove 316 can be detached from access port 300.

25 It is worth pointing out, however, that the diameter of bracelet 360 should not be too large to prevent a surgeon's range of movement. In particular, the diameter of enlarged cuff 317 formed by bracelet 360 should be smaller than the diameter of the retracted incision. As a result, the surgeon can completely insert his gloved hand and arm, including enlarged cuff 317, through the retracted opening into the body cavity.

Alternatively, the glove and cuff can be designed such that the glove extends up to, for example, a surgeon's elbow, and the cuff fits around the surgeon's upper 21 forearm or elbow to provide the surgeon a sufficient reach inside the body cavity.

In other embodiments, a separate mechanical or elastic clamp can be used to attach glove 316 to the entry opening 312 of sleeve 310. Furthermore, in any of the above embodiments, additional mechanical or elastic, clamping or tightening means elastic bands, drawstrings, or incremental tightening rings) can be used to enhance the seal provided by the connection of enlarged cuff 317 to sealing collar 314.

Inclusion of a Light Source In further embodiments, any of the embodiments described previously can include a light source connected to a portion of the wound retractor inserted into and facing the body cavity. For example, referring to Fig.

13, a wound retractor 130 includes inflatable collar 132 surrounding an entry opening 133 external to a patient's abdominal wall 135, a skirt 134 extending from uppermost collar 132 through an incision into a body cavity 138, and a ring 136 reinforcing the substantially circular O0Q opening of the end of skirt 134 distal to uppermost collar 132. Encased within skirt 134 is a plurality of optical fibers 142 extending along the length of skirt 134 toward ring 136. The optical fibers can also be adhered to the inner or outer walls of skirt 134. The ends of fiber optic cables 142 face into the body cavity and extend around the perimeter of exit opening 140 adjacent to ring 136. The optical fibers 142 pass through skirt 134 to the outer perimeter of entry opening 133 where they are bundled together and connected to an external light source 144.

Other light sources can also be used. For example the ring could be luminescent and the skirt pocket transparent. In particular, the ring could be 22 electroluminescent, so that when a current or a voltage is applied, the ring emits light. Wire used to pass current or voltage into the ring could be encased in the skirt as was described above for fiber optic cables. In another embodiment, the ring material is phosphorescent and is "charged-up" by it exposing it to light, e.g., ultraviolet light, prior to use. In a further embodiment, the ring could enclose chemiluminescent material. In this case, a seal within the ring is ruptured immediately prior to use, thereby mixing a plurality of materials that react with one another and emit light from the ring.

Materials and Manufacture In the above embodiments, a gas-tight, flexible, 15 and partially elastic material, such as a plastic or a rubber, is used for the skirt, collars, and the inner and cuter sleeves. For example, polyethylene, polypropylene, urethane, natural rubber, or latex can be used. The .material for the ring provides stiffness to the lower end 20 of the skirt. In particular, the ring should be stiff enough that it will not pass through the incision when it is initially parallel to the inner wall of a patient's skin and a force is drawing it tight against the inner wall. The ring can be made of, metals, polyvinyi 25 chloride (PVC), hard rubber, and foam. Alternatively.

the hem-shaped pocket could be gas-tight and the ring pneumatic, with the pocket being filled with a gas, liquid, or gel. During use, the pocket is filled prior to, or after, the insertion of the exit opening into the body cavity. Methods of molding or heating-sealing together flexible plastic materials into prescribed medically-approved objects are well known in the art and can be carried out by commercial entities Dielectrics Industries, Chicopee, MA).

23 Other Embodiments It is to be understood that while the invention has been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the invention, which is defined by the scope of the appended claims. For example, the surgical access port can also be used and adapted for insertion of a surgical tool rather than, or in addition to, a surgeon's hand.

Moreover, the sealing sleeve can be provided with a plurality of access openings to simultaneously accommodate a plurality of hands and/or instruments that Sare be inserted into the body cavity. Also, the rings, collars and entry and exit openings, are not limited to 15 substantially circular shapes, instead they could, for example, have an elliptical shape to better accommodate the inserted object and provide the desired retraction of i" the incision. Furthermore, the length of the sealed side portions in the sealing sleeve can also be optimized to 20 more effectively seal the inserted object.

S: The retractor and sealing sleeve are not limited to surgical applications. They can be used in any application in which the edges of an incision into a surface is retracted into an opening, and where 25 appropriate, a seal is used to prevent the escape of gases through the opening.

P 'OPERCAE'-24l'OOd" c.n'do,. IN/'O' 24- Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

Other aspects, advantages, and modifications are within the scope of the following claims.

*e o• o o*

Claims (19)

1. Apparatus for use during laparoscopic surgery, the apparatus comprising a tubular access port defining a passageway for accessing a patient's body cavity through an incision, the access port comprising an inflatable portion encircling the passageway and an iris valve configured to adjustably seal the passageway.

2. The apparatus of claim 1, wherein the inflatable portion is configured to secure the access port to the patient when one end of the tubular access port is inserted through the incision and the inflatable portion is inflated. 15

3. The apparatus of claim 1 or 2, wherein the passageway defined by the tubular access port is sized to pass a surgeon's hand.

4. The apparatus of any one of claims 1 to 3, wherein the iris valve comprises a twistable membrane positioned along at least a portion of the passageway configured to adjustably constrict the passageway.

The apparatus of claim 4 when dependent on claim 3, wherein the twistable membrane is configured to adjustably constrict around a surgeon's arm inserted through the passageway.

6. The apparatus of claim 4 or 5, wherein the twistable membrane is configured to adjustably constrict around an instrument inserted through the passageway. P: OPERM\S4U7.-02 I sp do.26M4/05 -26-

7. The apparatus of any one of claims 4 to 6, wherein the twistable membrane is configured to adjustably close the passageway in the absence of any object inserted through the passageway.

8. The apparatus of any one of the preceding claims, wherein the inflatable portion encircling the passageway comprises an inflatable collar.

9. The apparatus of any one of the preceding claims, wherein the access port further comprises a resilient lower ring encircling the passageway and configured to be inserted o: through the incision.

10. The apparatus of any one of the preceding claims, wherein the access port further comprises an inflation port coupled to the inflatable portion.

11. A laparoscopic surgical method comprising: 20 providing a tubular access port defining a passageway :for accessing a patient's body cavity, the tubular access port having an inflatable portion encircling the passageway; inserting one end of the access port through an incision to the patient's body cavity; and twisting a membrane positioned along at least a portion of the passageway to constrict the passageway.

12. The method of claim 11, further comprising inserting a surgeon's hand through the passageway to access the patient's body cavity. P:\OPERSan48847 2 Isp.doc-2N -27-

13. The method of claim 11, further comprising inserting an instrument through the passageway to access the patient's body cavity.

14. The method of any one of claims 11 to 13, further comprising securing the access port to the patient by inflating the inflatable portion.

The method of any one of claims 11 to 14, wherein the inflatable portion encircling the passageway comprises an inflatable collar.

16. The method of any one of claims 11 to 15, wherein the access port further comprises a resilient lower ring 15 encircling the passageway which is inserted through the incision.

17. The method of claim any one of claims 11 to 16, wherein the access port further comprises an inflation port coupled 20 to the inflatable portion.

18. The method of any one of claims 11 to 17, further comprising sealing the passageway by twisting the membrane.

19. The apparatus of claim 1 and substantially as hereinbefore described with reference to the accompanying drawings. p'OPER&Sa48472 lsp~d=c.2&V.4ff5 -28- The laparoscopic surgical method of claim 11 and substantially as hereinbefore described with reference to the accompanying drawings. this 26th day of April, 2005 University of Massachuesetts Smith Nephew, Inc. By DAVIES COLLISON CAVE Patent Attorneys for the Applicant