Patent Description:
Systems and methods for the surgical removal of tissue through body openings including small incision sites and/or body orifices are described. Where needed, a small incision is made in a patient to access surgically targeted tissue located inside a body cavity. Surgically targeted tissue may also be approached through a body orifice without an initial incision. Sometimes the targeted tissue is approached directly through the incision or body orifice. Other times, an access device system is placed and/or positioned into, across, at, and/or within the incision and/or body orifice to retract tissue, enlarge, reshape, and/or isolate the incision or body orifice. The access device system serves as a portal for accessing targeted tissue that is located in or adjacent to the body cavity or body orifice. The targeted tissue is detached from adjacent and surrounding tissue employing known surgical techniques and procedures. Once freed, the targeted tissue is ready for removal through the small incision or body orifice. If the targeted tissue is too large to be removed in whole, then it is reduced in size and removed in parts through the small incision. Ideally, the surgeon will "core" or "peel" the targeted tissue to keep it in one piece as much as possible. However, more likely than not, the targeted tissue will be reduced into multiple pieces.

Reducing the size of the targeted tissue is called morcellation. A morcellation procedure includes cutting the targeted tissue into smaller pieces manually with a scalpel or knife, for example, or employing a power morcellator to cut the targeted tissue so that it is removable through the small incision. Pieces of the targeted tissue are removed from the patient through the small incision. As the targeted tissue is being reduced in size in order to fit through the small incision, small pieces of tissue may be cut off and left behind in the patient. As such, morcellation is contraindicated in cases of malignancy or endometriosis. If cancer is morcellated, it can spread malignant tissue and upstage cancer and increase patient mortality.

A hysterectomy is an example of a surgical procedure that may involve morcellation. More than <NUM>,<NUM> hysterectomies are performed annually on women in the United States. Common reasons that a woman may have a hysterectomy are the presence of fibroids, cancer, endometriosis or prolapse. Of these hysterectomies, about <NUM>,<NUM> are performed laparoscopically. When the uterus is too large (><NUM>) to be removed through the vagina or if the cervix is still in place, the specimen must be reduced in size to be removed through an abdominal incision or through the vagina. During myomectomy (fibroid removal), large fibroids may also need to be extracted using a morcellation procedure. During morcellation, the targeted tissue (usually a uterus and sometimes adnexal structures) is brought to the abdominal wall surface such as with a tissue grasper and is reduced in size using a blade and removed through the incision from the pelvic cavity. In another variation, the targeted tissue is removed through a body orifice such as through the vagina. Fibroids, or uterine leiomyoma, account for about <NUM>-<NUM>% of hysterectomies. These are benign tumors of the uterus that can lead to heavy and painful bleeding. In the past there has been a mild concern that these tumors could be undetected cancer, or Leiomyosarcoma, and it was believed to affect about <NUM> in <NUM>,<NUM> women. More recent data has come out to support a much higher risk of undetected malignancy in these tumors, putting the range at <NUM>:<NUM> to <NUM>:<NUM>. Because of this elevated risk, many surgeons have begun changing their technique to try to enclose the specimen to do a closed morcellation process by morcellating in a bag to contain errant pieces and prevent dispersion and seeding of tumor cells, rather than morcellating without a bag in a process called open morcellation. Many GYN societies, including AAGL, ACOG, and SGO, have released statements warning of the potential danger of open morcellation. On April <NUM>th <NUM>, the FDA issued a statement discouraging the use of open power morcellation for hysterectomies and myomectomies for women undergoing these procedures for fibroids. The FDA also increased their estimated of malignant likelihood to <NUM> in <NUM>. For these reasons, systems and methods are needed to safely and effectively reduce tissue specimens. The present invention sets forth such safe systems for both manual morcellation and power morcellation performed in a closed system.

Examples of medical devices for maintaining (retracting) incisions through body tissue and/or for shielding incisions or body openings are disclosed in patent documents bearing publication numbers <CIT> and <CIT>.

According to the present invention there is provided a surgical shield as recited in claim <NUM>. Other embodiments are listed in the dependent claims.

Turning now to <FIG>, there is shown a surgical shield <NUM> in accordance with the present invention and, in the illustrated embodiment, this is adapted for placement within the vaginal canal. Although the shield <NUM> is adapted for vaginal placement, it may also be adapted for placement into other orifices and/or incision sites by making variations in size and shape. The shield <NUM> includes a guard portion <NUM> connected to a batten <NUM>.

Still referencing <FIG>, the guard portion <NUM> is substantially tubular in shape having an outer surface <NUM> and an inner surface <NUM> defining a lumen <NUM>. The lumen <NUM> may be any shape such as circular or oval. In one variation, the lumen <NUM> transitions from an oval shape at the proximal end opening to a circular shape in the middle and an oval shape at the distal end opening. The inner surface <NUM> conforms in shape to the outer surface <NUM> defining a thickness therebetween. The guard portion <NUM> is made of a flexible polymer that is cut-resistant. In another variation, the guard portion <NUM> is rigid. The leading distal end includes a bead <NUM> formed with the guard portion <NUM>. The bead <NUM> is located at the perimeter of the distal end opening. The bead <NUM> has a curved surface and an increased thickness relative to a side section of the guard portion <NUM>. The bead <NUM> increases the dimension at the distal end forming a hook-like feature or a protruding discontinuity at the outer surface <NUM>. In one variation, the bead <NUM> is only formed with respect to the outer surface <NUM> wherein the inner surface <NUM> is smooth and without a discontinuity at the bead location. The guard portion <NUM> also includes a proximal end opening. The guard portion <NUM> defines a length of the shield <NUM> between the proximal end opening and the distal end opening. The length of the shield <NUM> is configured such that when the shield <NUM> is placed inside the vagina, the bead <NUM> advantageously extends just past the pubic bone and the bead <NUM> engages the pubic bone of the patient to secure the shield <NUM> with respect to the anatomy and prevent it from being pulled proximally out of the vagina. Therefore, the bead <NUM> is larger or more prominent along the top of the guard portion <NUM> where it would engage the pubic bone relative to the bottom of the guard portion <NUM> at the distal end. In one variation, the bead <NUM> may be uniform in size and shape all the way around the distal end opening. The shield <NUM> need not anchor against the pubic bone and may contact the muscle wall of the vagina. In one variation, the proximal end opening at the proximal end does not include a bead and in another variation a proximal bead is provided to assist in anchoring the proximal end either to the anatomy or other device such as a retractor, containment bag or other access device such as a gel cap.

Turning now to <FIG>, the shape of the guard portion <NUM> will now be described in greater detail. The guard portion <NUM> is substantially shaped like an hourglass. In one variation, the hourglass shape includes an angled proximal opening and an angled distal opening as shown in <FIG>. In particular, the distal end opening is angled with respect to a horizontal plane at an angle <NUM> and the proximal end opening is angled with respect to the horizontal plane at an angle <NUM>. The horizontal plane <NUM> being substantially perpendicular to the longitudinal axis <NUM>. A lateral axis (not shown) extending into and out of the page is parallel to the planes containing the proximal and distal openings. In one variation, the angles <NUM>, <NUM> are substantially equal making the planes containing the proximal and distal openings substantially parallel to each other. In one variation, only the distal end is angled, meaning the plane containing the distal opening is angled with respect to the horizontal plane forming a less than <NUM>-degree angle <NUM> with the horizontal plane with the top end being forward-leaning such that it leads in an insertion orientation of the shield. The angled proximal end and distal end openings advantageously facilitate insertion of the shield <NUM> into the vaginal orifice creating a lower insertion profile which will be described in greater detail with respect to <FIG>. Still referencing <FIG>, the side section of the guard portion <NUM> is curved about a longitudinal axis <NUM> such that the outer surface <NUM> of the side section is concave and the inner surface <NUM> is conformingly convex. As can be seen in <FIG>, the side section is substantially hyperboloid in shape; however, the curves about the longitudinal axis <NUM> in the cross-section shown need not be hyperbolas. The cross-section of the guard portion <NUM> can generally be described as a C-shape that is revolved around the longitudinal axis <NUM> to create the lumen <NUM> and the tubular shape. <FIG> also illustrates the increased thickness of the bead <NUM> relative to the thickness of the side section as well as the decreased thickness of the bead <NUM> at the bottom relative to the top of the guard portion <NUM>. Also, the bottom of the guard portion <NUM> at the proximal end opening has a larger flange <NUM> that advantageously serves to drape over and protect the female anatomy surrounding the vaginal opening. The shield <NUM> in general and the guard portion <NUM> in particular serve as a protective surface that guards a containment bag, retractor and vaginal canal tissue at the insertion location. The shield <NUM> is made of hard, rigid, or semi-rigid, flexible, compliant, plastic or cut-resistant material or any material suitable according to one skilled in the art. The shield <NUM> provides a protective surface guarding the surrounding tissue and containment bag and/or retractor against sharp objects such as scalpels, blades or morcellators and the like that are used to cut and reduce targeted tissue for extraction. The shield <NUM> also provides an amount of retraction to maintain an effective working channel that remains open without collapsing.

The top of the guard portion <NUM> includes a channel <NUM> that is sized and configured to receive the batten <NUM>. The channel <NUM> is clearly visible in <FIG>. The channel <NUM> includes a channel opening at the proximal end of the guard portion <NUM> for receiving the batten <NUM> and a closed distal end that is protected by the increased thickness of the bead <NUM>. The channel <NUM> is molded such that the batten <NUM> may be inserted into and removed from the channel <NUM>. For example, the batten <NUM> may be inserted into the channel <NUM> for the insertion of the shield <NUM> and then removed when the shield is placed in the anatomy. In another variation, the guard portion <NUM> is over molded onto the batten <NUM> such that it is not removable. The batten <NUM> may be secured with adhesive or other means such that the batten <NUM> is not removable in another variation. The guard portion <NUM> surrounding the channel <NUM> is thicker relative to the side section providing reinforcement to the guard and protection to the anatomy from the relatively more rigid batten <NUM>.

With particular reference to <FIG>, the batten <NUM> will now be described in greater detail. The batten <NUM> is substantially L-shaped having a curved lower leg <NUM> that conforms to the curvature of the channel <NUM> and the curved side section of the guard portion <NUM>. The upper leg <NUM> is substantially straight and sized and configured to be easily grasped by a surgeon's hand for insertion purposes. The batten <NUM> is made of a material that is relatively more rigid than the guard portion <NUM> so as to impart the guard portion <NUM> with rigidity and reinforcement properties that facilitate handling and insertion of the shield <NUM> as well as securement of the shield <NUM> to the anatomy. As such, the batten <NUM> can be made of rigid polymer, plastic or metal. The side section of the guard portion <NUM> has a softer durometer than the batten <NUM> such that the batten <NUM> serves to stiffen and reinforce the side section webbing to facilitate insertion of the shield <NUM>. The lower and upper legs <NUM>, <NUM> of the batten <NUM> have a width of approximately <NUM> (one inch). The lower leg <NUM> is curved to have an outer surface that is concave along its length and an outer surface that is convex along its width. The lower leg <NUM> is also curved to have an inner surface that is convex along its length and concave along its width so as to conform to the shape of the inner surface <NUM> and outer surface <NUM> of the guard portion <NUM>. The batten <NUM> may be located anywhere along the perimeter of the guard portion <NUM>. For example, the batten <NUM> with or without a channel <NUM> may be located at the bottom of the guard portion <NUM> such that the upper leg <NUM> of the batten <NUM> that serves as a handle portion angles downwardly toward the posterior side of the patient as morcellation would likely require protection porteriorly as shown in <FIG>. In another variation, the batten <NUM> is entirely omitted from the construction as shown in <FIG>.

Turning now to <FIG>, insertion of the shield <NUM> into the vagina or other orifice/incision will now be described. The batten <NUM> is inserted into the channel <NUM> that is sized and configured to receive the lower leg in a friction-fit or other type of engagement. As the batten <NUM> is retained in the channel <NUM>, the shield <NUM> is grasped by its upper leg <NUM> and angled with respect to the orifice such that the distal end of the lower leg <NUM> of the batten <NUM> and the rounded bead <NUM> at the distal end leads the insertion and serves as the leading end <NUM>. The movement of the shield <NUM> is pendulum-like about the proximal end of the upper leg to create an arc-like pathway of insertion. The shape of the guard portion <NUM> arising from the angled distal end opening creates a leading end <NUM> that increases in size in the proximal direction in a wedge-like manner forming an acute angle illustrated by the V-shaped dashed lines <NUM> in <FIG>. This wedge-like arrangement advantageously serves to retract tissue and facilitate insertion. The user advances the shield <NUM> with the leading end <NUM> retracting the tissue orifice along the way and then may rotate the shield <NUM> upwardly to hook the leading end <NUM> at the top portion of the bead <NUM> under the pubic bone or other tissue to anchor the shield <NUM> with respect to the anatomy. The user will manipulate the shield <NUM> rotating the shield <NUM> upwardly/anteriorly into position as can be seen in going from FIG. 189A to FIG.

Turning now to <FIG>, the shield <NUM>, with or without a batten <NUM>, having a guard portion <NUM> that is made of flexible material is manipulated for insertion by folding the guard portion <NUM> into the lumen <NUM> from an undeflected state shown in <FIG> to a deflected state having a reduced size at the distal end as shown in <FIG>. The bottom end of the shield <NUM> is flexed upwardly in the direction shown by the arrow in <FIG>. Fingers inserted inside the lumen <NUM> of the shield <NUM> can easily grasp the guard portion <NUM> to scrunch the guard portion <NUM> into a deflected configuration or fold the guard into a U-like shape having a reduced distal end suitable for insertion as shown in <FIG>. Once in position, the fingers may release the guard portion <NUM> and because of the flexible material of the guard portion <NUM>, the guard portion <NUM> will spring toward its undeflected state advantageously anchored inside the vagina. In another variation shown in <FIG>, an introducer <NUM> is employed to facilitate insertion of the shield <NUM> into the orifice.

The shield <NUM> may also be employed in combination with a retractor The retractor may include a first ring and a second ring interconnected by a flexible sidewall. The sidewall of the retractor defines a central opening extending along the longitudinal axis of the retractor. The second ring can be compressed and inserted through the vaginal canal where it expands to create a securement against inside the vagina. The first ring resides above the entrance to the vagina outside the patient where it can be rolled down to retract and enlarge the vaginal canal. The shield <NUM> is inserted into the central opening of the retractor following placement of the retractor. The bead <NUM> at the distal end of the shield <NUM> is configured to connect to the second ring of the retractor and the proximal end of the guard portion <NUM> such as the flange <NUM> is configured to connect to the first ring to secure the shield <NUM> to the retractor. The proximal end and the distal end of the shield <NUM> may snap under or over the first and second rings of the retractor, respectively. Alternatively, the retractor may be provided with a channel <NUM> and a batten <NUM> inserted into the channel <NUM> to help place and stiffen the retractor. The batten <NUM> may be removed to roll down the first ring of the retractor and then the batten <NUM> may be reinserted into the channel <NUM> or not.

In a hysterectomy, myomectomy or other procedure, the uterus is detached from the body via instruments inserted through the vagina or through one or more abdominal ports. After the uterus has been detached, the shield <NUM> may be inserted directly into the vagina as described above employing the batten <NUM> and manipulating the leading end <NUM> to lead the insertion and anchoring the bead <NUM> such as under the pubic bone or against the vagina. The proximal flange <NUM> resides near the entrance to the vagina. The detached uterus would be gasped and pulled into the lumen <NUM> of the shield <NUM> against which it may be safely morcellated with a blade permitting the uterus to be cut into smaller pieces and completely removed through the vagina.

In another variation, a containment bag is placed inside the abdominal cavity either through an abdominal port or through the vaginal canal. The removed uterus is placed into the containment bag. The bag includes a tether and a proximal flexible ring. The tether of the containment bag is pulled through the vagina. The proximal ring of the containment bag is compressed into a low-profile configuration to facilitate pulling the proximal end of the containment bag through the vagina. The ring of the containment bag is pulled outside the body and allowed to expand into an open configuration, thereby, opening the mouth of the containment bag. The ring of the containment bag resides outside the entrance to the vagina. The ring of the containment bag may be rolled-down to roll the sidewall of the bag onto the ring of the containment bag. This action brings the removed uterus inside the bag closer to the vaginal opening. The shield <NUM> is then inserted into the mouth of the containment bag and into the vaginal canal. The proximal flange <NUM> resides at or near the entrance to the vagina. In one variation, the proximal flange <NUM> of the shield <NUM> is snapped under or over the ring of the containment bag. In such an embodiment, the proximal flange <NUM> may include a bead-like reinforcement for snapping to the bag or other device such as a gel cap. The removed uterus is gasped with a grasper and pulled into the lumen <NUM> of the shield <NUM> where morcellation can commence.

The distal end of the shield <NUM> is angled as described above which advantageously helps to move the detached uterus into the shield <NUM>. The uterus is morcellated with a blade while it is at least partially resident within the shield <NUM> before being completely removed in whole or in parts. The shield <NUM> advantageously protects the surrounding tissues as well as the containment bag from the sharp blade helping to maintain the integrity of the containment bag and the closed morcellation system while expanding and increasing the space of the working channel.

In another variation, the same procedure is carried out as in the previous paragraph but a retractor is inserted into the mouth of the containment bag after the uterus has been placed into the containment bag and after the ring of the containment bag is pulled to outside the body. The second ring of the retractor is compressed for easy insertion into the mouth of the containment bag and then allowed to expand into an open configuration inside the containment bag in a location distal to the vaginal canal inside the abdominal cavity. The first ring of the retractor that is resident outside the body is rolled about itself to roll the sidewall of the retractor onto the first ring. This action retracts not only the vaginal canal but also retracts the containment bag out of the way clearing the vaginal canal for insertion of the shield <NUM>. The containment bag is captured between the retractor and the vaginal canal keeping it in place and preventing its migration into or out of the vaginal canal. The shield <NUM> is then inserted into the central lumen of the retractor that is residing inside the containment bag. The shield <NUM> may be attached to the retractor or containment bag by snapping one or more of the proximal end and distal end to first ring or second ring of the retractor or ring of the containment bag. The uterus can then be grasped with a surgical instrument and pulled from the unprotected pouch of the containment bag into the central lumen <NUM> of the shield <NUM> where the uterus is morcellated with a blade while it is at least partially resident within the shield <NUM> before being completely removed in whole or in parts. The shield <NUM> advantageously protects the surrounding vaginal canal as well as the containment bag and retractor from the sharp blade helping to maintain the integrity of the containment bag and the closed morcellation system while providing the surgeon with a mechanism to perform morcellation safely and quickly.

In another variation, the same procedure is carried out in the same way as in the previous paragraph except that the retractor is placed into the vaginal canal before the containment bag and the specimen inside is pulled through the vaginal canal. In this variation, the removed uterus is placed inside the containment bag located inside the abdominal cavity and the tether attached to the proximal end of the containment bag is pulled with a grasper through the central lumen of the retractor bringing the proximal ring and mouth of the containment bag to the outside of the patient. The ring of the containment bag may then be rolled down to bring the detached uterus closer to the opening. Afterwards, the shield <NUM> is inserted. It retracts the containment bag creating a working channel though the central lumen <NUM> of the shield <NUM> for moving and morcellating the detached uterus. The proximal flange <NUM> of the shield <NUM> may be snapped under the ring of the containment bag or the proximal first ring of the retractor. The containment bag is captured between the retractor and the shield <NUM> keeping it from slipping proximally or distally during the procedure. The flange <NUM> of the shield <NUM> may also serve as a cut-resistant surface protecting against sharp blades used to cut the uterus for removal. For all of the above procedures, a containment bag and retractor combination may be used in lieu of one or more of the containment bag and retractor.

Claim 1:
A surgical shield (<NUM>) for insertion into and protection of an orifice of a patient; the surgical shield comprising:
a guard portion (<NUM>) being made of cut-resistant material and having a generally tubular shape defining a lumen (<NUM>) extending along a longitudinal axis (<NUM>) between a proximal opening at a proximal end and a distal opening at a distal end; the guard portion (<NUM>) having a lateral axis perpendicular to the longitudinal axis;
characterized in that the distal opening lies in a distal plane that is angled with respect to the longitudinal axis to facilitate insertion of the distal end of the shield into an orifice of the patient; the surgical shield comprising a leading distal insertion angle (<NUM>) that is defined by a projection of the distal plane and the guard portion onto a plane perpendicular to the lateral axis.