Patent Description:
Access devices are commonly used in surgery to facilitate the introduction of various surgical instruments into natural biological vessels, conduits, orifices, cavities, and other interior regions of the body. These access devices include, for example, devices that facilitate the introduction of a needle into a vessel, and trocars that facilitate the introduction of laparoscopic instruments into the abdomen of the body.

Some of these access devices are introduced into regions that include a fluid or gas under pressure. In the case of a needle access device, the pressure may be from a liquid, such as blood. In the case of a trocar, the pressure may be from a gas, such as an insufflation gas. In either case, it is desirable to provide for the introduction of the surgical instrument into the cavity without permitting the escape of the pressurized fluid or gas.

In the case of trocars, a cannula at the distal end of the trocar is typically connected to a seal housing at the proximal end of the trocar. Together the cannula and housing form a working channel through which various instruments can be inserted to access the cavity. Seal mechanisms are commonly disposed in the housing and include a septum valve that seals the working channel when an instrument is in place, and a zero closure valve that seals the working channel when the instrument is removed.

Current surgical access ports allow for single instrument access through each port, or allow for multiple instrument access through a rigid cannula. Some devices, such as transanal endoscopic microsurgery (TEMS) units require that the device be attached to the surgical table to support the weight of the device, as well as to locate the position of the device respective to the patient. These devices do not provide flexibility to the surgeon in selecting instrument size, and they restrict instrument movement with their rigid cannulas. Additionally, surgeons are performing laparoscopic surgical procedures through a single or a limited number of access ports. The procedures may be performed through a single two (<NUM>) centimeter incision at the umbilicus, or in certain cases, trans-vaginally or trans-anally. What is needed is a system that meets the needs of these new procedures, facilitating more flexible movement of laparoscopic instruments through a single or limited number of ports while preventing the escape of pressured fluids or gasses and permitting large specimen removal. What is particularly needed is an access system that can be deployed into a natural body cavity, such as the vagina, providing a sealed system for insufflation and a platform for the introduction of multiple surgical instruments of varying sizes, while maintaining sufficient stability for anchoring the system within the cavity without damaging the body cavity wall. <CIT> and <CIT> disclose surgical access ports of the prior art.

According to the present invention there is provided a surgical access port system as claimed in Claim <NUM> of this specification.

Similar components have similar reference numbers throughout.

Surgical instrument access device system are useful, for example, for single incision, single port, and/or limited port laparoscopic surgical procedures, for example, abdominal (<FIG>), transvaginal (<FIG>), transoral (<FIG>), and transanal (<FIG>) procedures. Various surgical instrument access devices are described in <CIT>and <CIT>.

<FIG> shows an an access device system comprising a retractor <NUM>, an introducer <NUM> shown inserted into the retractor as if for placement in a body orifice, a cap <NUM>, one or more ports <NUM>, and an obturator <NUM>, which is useful in single port and/or limited port procedures. The retractor <NUM> is placed and/or positioned into, across, and/or through a surgical incision and/or body orifice to enlarge, reshape, and/or isolate the incision or body orifice. The cap <NUM> provides an artificial body wall through which instruments access the interior of a patient's body, for example, a body cavity, through ports <NUM>. The retractor <NUM> may be introduced into an orifice using the introducer <NUM>; ports <NUM> may be placed through the gel cap using obturator <NUM>. The components of the access device comprise any suitable biologically compatible materials.

With the gel cap <NUM> attached to the retractor <NUM>, the access device system allows the user to insufflate the orifice, such as the vaginal canal. The distention of the canal caused by the insufflation provides greater visualization of the anatomy (when compared, for example, to traditional vaginal hysterectomy) and removes the need for the use of rigid mechanical retractors which may cause damage to soft tissues. The gel cap may be detached at any point during the surgical procedure to allow for specimen removal.

The retractor <NUM> is made of a semi-pliable thermoplastic elastomer or thermoset polymer. For use in vaginal procedures, a length of approximately <NUM> to <NUM> and a diameter of approximately <NUM> to <NUM> will suit a range of anatomies. The retractor retracts and occludes the vagina. Suture ties <NUM> at proximal end <NUM> and/or a flange <NUM> along the tubular body may help prevent the retractor from dislodging once placed. The gel cap <NUM> may be attached with the aid of a lever <NUM> which locks under the proximal ring <NUM> of the retractor <NUM>. This creates a pressure resistant seal and insufflation is possible through insufflation ports <NUM> on the gel cap. Smoke evacuation is possible through the port not being used for insufflation. Instrument ports <NUM> may be placed in the gel cap <NUM> to allow for the use of various laparoscopic instruments. The gel cap may then be detached and specimens may be removed through the retractor <NUM>.

Turning to <FIG>, the outer ring <NUM> is proximal a funnel section <NUM> and the outer ring <NUM> has a substantially circular footprint. The outer ring <NUM> can be sized and configured to sealingly couple to a cap or other access device thereon. One or more suture points <NUM> can be disposed on the retractor <NUM> adjacent the outer ring <NUM>. Two suture points <NUM> are generally diametrically opposed relative to the generally circular profile of the outer ring <NUM>. The retractor can include more or fewer than two suture points disposed of various locations relative to the outer ring <NUM>.

With continued reference to <FIG>, the tubular body <NUM> has a generally circular profile defining a generally cylindrical passage <NUM>. The generally cylindrical passage is desirably large enough to accommodate more than one laparoscopic instrument there through such that a single natural orifice access device can be used to provide access for multiple surgical instruments in a body cavity. Moreover, generally cylindrical passage is desirably large enough such that multiple surgical instruments positioned there through can be translated or pivoted relative to one another, allowing a surgeon to manipulate the instruments as desired during a surgical procedure. The generally cylindrical passage extends between a proximal end <NUM> of the retractor <NUM> adjacent the outer ring <NUM> to a distal end <NUM> of the retractor <NUM> adjacent the flange <NUM>. In <FIG> and <FIG>, the tubular body <NUM> has a circular cross-section. The tubular body <NUM> may though have another shape, for example, an oval cross section, an octagonal cross-section, or other shapes as may be appropriate for the natural orifice of interest. The tubular body <NUM> may also comprise one or more coatings that provide additional functionality, for example, an anti-microbial coating.

The funnel segment <NUM> provides a diametric reduction between the relatively large diameter of the outer ring <NUM>, which is sized and configured to be removably coupled to an access device such as a cap, and the relatively smaller diameter of the passage <NUM>, which is sized to fit within a natural orifice with minimal distention of the orifice. The funnel segment <NUM> has an inner surface which can provide a bearing surface for an obturator or introducer used to advance to the retractor <NUM> into a body cavity. Alternatively, the funnel segment can have a substantially linear taper between the relatively large diameter and the relatively smaller diameter such that the inner surface is a frustoconical segment, or the funnel segment <NUM> can have a curved profile between the relatively large diameter and the relatively smaller diameter. In a further alternative, there may be no funnel section at all, as where the tubular body connects directly to the outer ring.

It can be desirable that the outer ring <NUM> is relatively stiff compared with the relatively flexible tubular body <NUM> of the retractor <NUM> so that the outer ring <NUM> can sealingly engage an access device such as a cap. With reference to <FIG>, a perspective view of the retractor is illustrated with a partial cutaway of the outer ring <NUM>. The outer ring <NUM> includes an annular groove <NUM> formed therein in which a reinforcing member <NUM> is disposed. The reinforcing member <NUM> can comprise a metallic member such as a wire formed into a ring shape. For example, in the reinforcing member <NUM> can comprise a stainless steel ring positioned within the groove <NUM> during manufacture of the retractor <NUM> or the reinforcing number <NUM> can comprise an injectable nonmetallic member. For example, a glass filled polymer or polycarbonate material can be injected into the groove <NUM> during manufacture of the retractor <NUM>.

While the illustrated retractor <NUM> includes a reinforcing member to enhance the rigidity of the outer ring <NUM>, the retractor <NUM> could be formed in a multiple-shot molding process. For example, an inner segment of the retractor defined by the tubular body <NUM> and the flange <NUM> may be formed in one molding operation from a flexible material, and an outer segment of the retractor <NUM> defined by the funnel segment <NUM> and the outer ring <NUM>, formed in another molding operation from a relatively rigid material such as a polycarbonate material or other suitable material.

With continued reference to <FIG>, the retractor <NUM> includes a continuous generally annular groove. In other arrangements, a plurality of noncontiguous recesses can each receive one of a plurality of reinforcing members. Moreover, the outer ring can include two or more concentric generally annular grooves, which each receive a corresponding reinforcing member.

An embodiment of a natural orifice surgical access port system in accordance with the present invention, configured to provide retraction and access without using insufflation gases, is shown in <FIG>. In some natural orifices, for example, the vagina, pressure from a standard insufflator can be insufficient to maintain a visible, stable surgical working space due to leaks and billowing created by surges from the insufflator. In this embodiment, the retractor <NUM> has a proximal ring <NUM> and a tubular body <NUM>, with the tubular body adapted to engage a retaining sleeve <NUM>. The retaining sleeve includes a lip <NUM> at the proximal end and at least two retracting arms <NUM> at the distal end. The retracting arms are connected to the retaining sleeve with an articulating hinge <NUM> that allows the arms to move between a closed position (<FIG>), in which the distal ends of the arms in proximity, and an open position (<FIG>), in which the distal ends of the arms are moved away from each other. Optionally, the retracting arms may include an angled lead <NUM> near the hinge <NUM>.

In the embodiment of <FIG>, the tubular body includes an external thread <NUM> wrapped around the exterior of the tubular body, adapted to engage an internal thread <NUM> disposed around the surface of the interior lumen of the retaining sleeve <NUM>.

In an alternative embodiment, a ratcheting mechanism comprising teeth <NUM> and a series of pawls <NUM> may be used instead of internal and external threads (see <FIG>). The ratchet mechanism allows the retractor to advance through the lumen of the retaining sleeve with relative ease while resisting backwards movement until the sides of the tubular body of the retractor are manually depressed to release the ratchet mechanism.

In use, the tubular body <NUM> of the retractor <NUM> is advanced forward through the lumen of the retaining sleeve <NUM> until contact is made with the retracting arms <NUM>. The angled lead <NUM> on the retracting arm allows for the opening to occur at an incremental rate to accommodate a variety of anatomies. The lip <NUM> on the retaining sleeve ensures that the proximal end of the lumen will not enter the orifice and provides a holding point during the advancement of the retractor. As seen in <FIG>, the fully advanced channel presses on the retracting arms, causing them to flare out and hold open the vaginal canal. With the tissue of the vaginal canal retracted, direct access is available to the cervix and surrounding tissue. In <FIG>, the retractor is drawn back; the retracting arms are disengaged and are able to fold together. This state facilitates insertion and removal from the orifice.

A natural orifice access system can include a retractor <NUM> and an optional obturator <NUM> (<FIG>). The obturator can have a proximal bearing surface <NUM> sized and configured to bear against the inner surface <NUM> of the funnel segment <NUM> and a distal dilation surface <NUM> sized and configured to expand a natural orifice for passage of the retractor <NUM>. Thus, during insertion of the retractor <NUM> into a natural orifice, the dilation surface <NUM> expands a pathway to a surgical site in a body cavity while the obturator bears on the inner surface <NUM> of the funnel segment <NUM> to advance the retractor <NUM> into position in the surgical site. Furthermore, the obturator can have a handle <NUM> at a proximal end thereof adapted to facilitate selective twisting or rotation of the obturator about a longitudinal axis thereof during insertion.

As shown in the alternative arrangement of <FIG>, the obturator <NUM> may include a straight shaft piece <NUM> between the distal dilation surface <NUM> and the proximal bearing surface <NUM> that facilitates dilation of the natural orifice prior to inserting the retractor. It can then be combined with the retractor <NUM> to help ease insertion, as shown in <FIG>.

In arrangements having an inflatable member on the retractor, the optional obturator <NUM> may be modified with an indent <NUM> to provide clearance for the inflation port, as shown in <FIG>.

Claim 1:
A surgical access port system adapted for performing surgical procedures at a natural orifice of the patient comprising:
an outer ring (<NUM>), wherein the outer ring (<NUM>) is configured to be disposed proximate the natural orifice of the patient;
a tubular body (<NUM>) having a longitudinal axis, a proximal end and a distal end, wherein the proximal end of the tubular body (<NUM>) is coupled to the outer ring (<NUM>);
a retaining sleeve (<NUM>), the retaining sleeve (<NUM>) comprising a longitudinal axis, a proximal end, a distal end, and a lumen, wherein the tubular body (<NUM>) is disposed within the lumen and adapted to move parallel along the longitudinal axis of the retaining sleeve (<NUM>); and
at least two arms (<NUM>), the surgical access port system being characterized by:
each of the at least two arms (<NUM>) being connected to the distal end of the retaining sleeve (<NUM>) by an articulating hinge (<NUM>) configured to facilitate movement of the at least two arms (<NUM>) between a closed position and an open position, and
each of the at least two arms (<NUM>) being movable from the closed position to the open position by the distal end of the tubular body (<NUM>) engaging with the at least two arms (<NUM>).