WO2016028931A1 - Systems, methods and devices for protecting organs during surgical procedures - Google Patents

Abstract

Device embodiments are directed to a surgical restraint system that may include a flexible sheet that may be disposed over a cross section of a body cavity in order to isolate and protect organs from a surgical site. Method embodiments may include tilting and returning a patient's body to and from a position such as the Trendelenburg position in addition to deploying and withdrawing the flexible sheet through a small incision in order to isolate and protect internal organs from disruption or injury during a surgical procedure. Such device and method embodiments may also be useful for providing greater access to an internal surgical site by displacing organs which are not involved with a given surgical procedure.

Description

SYSTEMS, METHODS AND DEVICES FOR PROTECTING ORGANS DURING

SURGICAL PROCEDURES

Related Patent Application(s)

This application claims priority under 35 U.S.C. section 1 19(e) from U.S. Provisional Patent Application No. 62/039,904, filed August 20, 2014, by A. Wittgrove et al., titled "Systems, Methods and Apparatus for Reducing the Risk of Intraoperative Collateral Injury to Organs", which is incorporated by reference herein in its entirety.

Background

In order to enhance the safety and efficacy of surgical procedures, there is a need for systems, methods and apparatus that minimize the risk of collateral injury to those tissues and organs that are not directly involved in the surgery. The need arises most acutely in surgeries to humans, but also in veterinary procedures and even in cadaver models used during education, research and development. In live surgeries involving colorectal, urinary, orthopedic and reproductive organs, for instance, there is a particular need to avoid unintentional injuries to the gastro-intestinal tract. It is well known, for example, that even a small, unintentional nick to the bowel during pelvic surgery could compromise the sterility of a surgical site, leading to infection, sepsis, and potentially death.

In the case of open surgical procedures, especially pelvic surgeries, relatively large abdominal incisions (e.g. 3" or more) are made to provide access to the surgical site. For these large incisions, the risk of collateral injury to the intestines may be mitigated by manually packing the bowel using gauss, sponges or surgical towels in order to protect the intestines. The packing materials may be held in place with retractors, clamps or even held in place by a surgical assistant. However, it has been recognized that open surgical procedures, involving large surgical incisions, may be problematic. More recently, advanced surgical equipment such as laparoscopes and endosurgical instruments have facilitated the development of closed surgical procedures. These closed operations, sometimes referred to as "keyhole" procedures, are performed with much smaller incisions or ports, speeding recovery time and reducing trauma to muscle and surrounding fascia. Inflating the abdominal cavity, usually with carbon dioxide gas, enhances access and maneuverability within the surgical site. Surgical robots, used to enhance dexterity in "keyhole" procedures are described by Madhani et. al in U.S. Patent No. 5,792,135, filed May 16, 1997, and titled "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity", which is incorporated by reference herein in its entirety. Unlike open procedures, in which blocking materials or members may be introduced through an incision, it is more difficult to isolate organs such as the intestines during closed procedures. In light of this difficulty, some laparoscopic or robotic surgeries are performed with the patient remaining in the Trendelenburg position throughout the surgery, relying on gravity to pull the intestines toward the upper torso, out of the way of the surgical site. However, leaving the patient in a head down position elevates the risk of significant injury. It is known, for example, that the Trendelenburg position can increase central venous pressure, elevate intra-ocular pressures, and possibly damage the retina, optic nerves and other delicate tissues. In laparoscopic and robotic surgeries, the suffusion of carbon dioxide gas into the torso may exacerbate these risks. Moreover, the risk of permanent injury increases with time, and in some cases closed surgical procedures may involve extended operating times. These long surgery times are particularly problematic with robotic surgeries, which can last several hours more when compared to equivalent open procedures. As such, there remains a need to manipulate and protect organs during closed surgical procedures.

Certain laparoscopic retractors have been used to lift and suspend more compact organs, pulling them out of an operative field, however, they may not be practical for protecting the intestines. Unlike more compact organs such as the uterus, liver or spleen, the intestines are more extensive, and span entire cross sections of the abdominal cavity and it is difficult to contain the intestines because the individual loops tend to spill out and slip past retractors, especially during Trendelenberg transitions. In summary, laparoscopic retractors may not be sufficient for keeping the intestines out of the operative field because they fail to span the entirety of a cross section of the torso. What has been needed are systems, methods and devices for keeping organs such as the intestines out of an operative field during surgical procedures such as laparoscopic and robotic surgical procedures. What have also been needed are such methods and devices that do not interfere with normal biological parameters such as blood flow and internal hydraulic pressures.

Summary

Some embodiments of an organ restraint device may include a flexible sheet that has a contact surface, a non-contact surface, high tensile strength, sufficient flexibility to be readily rolled into a tubular configuration, and a main body portion with an outer perimeter. The outer perimeter may include a shape profile that is configured to conform to an inside surface shape profile of a target body cavity. The organ restraint device may also include a plurality of optional elongate stiffener segments which are secured to the main body portion of the flexible sheet, which extend at least generally adjacent to the outer perimeter of the main body portion and which comprise a resilient, flexible elastic material. The restraint device embodiment may further include a plurality of anchor extensions which are secured relative to and extend outwardly from the outer perimeter of the main body portion of the flexible sheet and which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity such that the main body portion may resist displacement in a direction perpendicular to a contact surface of the flexible sheet.

Some embodiments of a method of organ restraint within a body cavity may include inserting an organ restraint device into the body cavity in a constrained state through an incision in a wall of the body cavity. Such an organ restraint device may include a flexible sheet including a contact surface, a non-contact surface, high tensile strength, sufficient flexibility to be readily rolled into a tubular configuration, and a main body portion with an outer perimeter. In some cases, the outer perimeter may include a shape profile that is configured to conform to an inside surface shape profile of a target body cavity. The organ restraint device may also include a plurality of optional elongate stiffener segments which are secured to the main body portion of the flexible sheet, which extend at least generally adjacent to the outer perimeter of the main body portion and which comprise a resilient, flexible elastic material; a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist displacement in a direction perpendicular to the flexible sheet. The method also includes identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity and withdrawing anchor extensions through respective incisions in the wall of the body cavity. Such withdrawal of the anchor extensions results in drawing the outer perimeter of the main body portion in proximity to an inner surface of the body cavity adjacent to each respective incision in the wall of the body cavity. The outer perimeter may be so withdrawn so as to span a cross section area of the body cavity with the flexible sheet. Finally, the method may include securing the anchor extensions relative to the wall of the body cavity.

Some embodiments of a method of organ restraint within a body cavity may include inserting an organ restraint device into the body cavity in a constrained state through an incision in a wall of the body cavity. The organ restraint device including a flexible sheet including a contact surface, a non-contact surface, high tensile strength, sufficient flexibility to be readily rolled into a tubular configuration, and a main body portion with an outer perimeter. The outer perimeter may be shaped to conform to an inside surface of a patient's abdominal cavity and include a ventral edge, a dorsal edge which is disposed opposite the ventral edge, a first lateral edge and a second lateral edge. The organ restraint device may also include a plurality of optional elongate stiffener segments which are secured to the main body portion of the flexible sheet, which extend at least generally adjacent to the outer perimeter of the main body portion and which comprise a resilient, flexible elastic material. The organ restraint device may further include a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist displacement in a direction perpendicular to the flexible sheet. The method may also include identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity and withdrawing anchor extensions through respective incisions in the wall of the body cavity and drawing the perimeter of the main body portion in proximity to an inner surface of the body cavity adjacent to each respective incision in the wall of the body cavity. The perimeter may be so drawn until the flexible sheet spans a cross section area of the body cavity. The method may further include withdrawing a pair of opposed anchor extensions which include the dorsal-most anchor extensions having respective longitudinal axes which are substantially collinear with each other such that the dorsal edge of the outer perimeter is tensioned to a position proximate the inner dorsal wall of the body cavity without applying excessive pressure to the patient's vasculature within or adjacent to the body cavity. Finally, the method may include securing the anchor extensions relative to the wall of the body cavity.

Some embodiments of a system for restraining organs from a surgical site within a cavity of a body may include a gas for inflating the cavity, a flexible sheet capable of being stretched to cover the cross section of the cavity and an access tube for inserting the flexible sheet into the cavity. The system may further include anchor extensions for attaching the flexible sheet within the cavity.

Some embodiments for a method for restraining organs from a surgical site within a cavity of a body may include inflating the cavity with a gas, inserting a flexible sheet through an access tube to the cavity and stretching the flexible sheet across a cross section of the cavity. The method may also include anchoring the flexible sheet within the cavity.

Some embodiments of an organ restraint device for restraining organs from a surgical site within an inflated cavity of a body may include a flexible sheet spanning a cross sectional area of the inflated cavity and a first anchor extension fixedly attached to a first portion of the flexible sheet to immobilize the first portion within the inflated cavity. The device may also include a second anchor fixedly attached to a second portion of the flexible sheet to immobilize the second portion within the inflated cavity. Some embodiments of an organ restraint device may include a flexible sheet having a contact surface, a non-contact surface, high tensile strength, sufficient flexibility to be readily rolled into a tubular configuration, and a main body portion with an outer perimeter, the outer perimeter including a shape profile that is configured to conform to an inside surface shape profile of a target body cavity. The organ restraint device may also include a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet. The anchor extensions may be configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist perpendicular displacement due to forces imposed on the main body portion. Such forces may be due to pressure from organs being restrained by the device in some cases. In addition, the anchor extensions and the main body portion of the flexible sheet may be formed from a continuous sheet of material with the anchor extensions being outward radial extensions of material of the flexible sheet.

Certain embodiments are described further in the following description, examples, claims and drawings. These features of embodiments will become more apparent from the following detailed description when taken in conjunction with the accompanying exemplary drawings.

Brief Description of the Drawings

The drawings illustrate embodiments of the technology and are not limiting. For clarity and ease of illustration, the drawings may not be made to scale and, in some instances, various aspects may be shown exaggerated or enlarged to facilitate an understanding of particular embodiments.

FIG. 1 illustrates components of a system for performing pelvic surgery including laparoscopic or robotic surgical instruments, a tilting operating table holding the body of a patient in the Trendelenburg position, and anchor extensions for holding a flexible sheet inside an inflated body cavity. FIG. 2 is a mid-sagittal cross section view showing the flexible sheet inserted and anchored between the intestines and reproductive organs with the body cavity in the Trendelenburg position.

FIG. 3 illustrates a method for reducing the risk of collateral injury to the intestines during laparoscopic and robotic surgeries involving the pelvis.

FIG. 4 is a mid-sagittal cross section view of the body cavity of the patient after it has undergone movement from the Trendelenburg position back to a horizontal position.

FIG. 5 is an axial cross section view of the body cavity in the Trendelenburg position showing the flexible sheet stretched across a cross section area of the body cavity.

FIG. 6 is an axial cross section view of the body cavity after undergoing motion from the Trendelenburg position to a horizontal position.

FIG. 7a illustrates an embodiment of a flexible sheet.

FIG. 7b illustrates the flexible sheet embodiment of FIG. 7a with tension applied. FIG. 8 illustrates an embodiment of a flexible sheet.

FIG. 9 illustrates an embodiment of a flexible sheet.

FIG. 10 illustrates an embodiment of anchoring extensions.

FIG. 1 1 illustrates an embodiment of a flexible sheet.

FIG. 12 is a perspective view of an organ restraint device embodiment.

FIG. 13 is an elevation view of the embodiment of the organ restraint device embodiment of FIG. 12.

FIG. 14 is a transverse cross section view of the organ restraint device embodiment of FIG. 13, taken along lines 14-14 of FIG. 13.

FIG. 15 is an elevation view of the contact side of the organ restraint embodiment of FIG. 12 showing the lettered visual indicators which distinctly identify each anchor extension of the device embodiment.

FIG. 16 is an enlarged view of the material of the flexible sheet of the organ restraint device embodiment of FIG. 15 indicated by the encircled portion 16 in FIG. 15.

FIG. 17 illustrates another embodiment of the material of the flexible sheet of the organ restraint device embodiment of FIG. 15 indicated by the encircled portion 16 in FIG. 15. FIG. 17A illustrates another embodiment of the material of the flexible sheet of the organ restraint device embodiment of FIG. 15 indicated by the encircled portion 16 in FIG. 15, the material having a continuous surface without any significant pore structure.

FIG. 18 is a perspective view of an access tube embodiment showing an

embodiment of an organ restraint device in a constrained state disposed within an inner lumen of the access tube.

FIG. 19 shows the access tube of FIG. 18 with the organ restraint device

embodiment extended distally therefrom and beginning to self-expand.

FIG. 20 is an elevation view of a patient lying supine on a surgical table that may be controllably tilted, the surgical table being disposed adjacent to a robotic surgical device embodiment.

FIG. 21 shows the surgical table of FIG. 20 with the patient and surgical table tilted head down in the Trendelenburg position indicated by angle Θ which is measured between the plane of the bottom of the table and a horizontal line.

FIG. 22 shows the patient and surgical table of FIG. 21 with surgical access tools in communication with an interior volume of the patient's abdominal body cavity.

FIG. 23 shows the patient of FIG. 22 with a partially cut away view illustrating the abdominal cavity of the patient with the patient's intestines pushed towards the top of the body cavity by force of gravity due to the patient's head down tilted position and creating an open space between the intestines and reproductive organs.

FIG. 24 is a transverse cross section view of the patient's abdomen taken along lines 24-24 of FIG. 23 showing the access tube with the distal tip thereof in communication with the interior volume of the body cavity.

FIG. 25 shows an organ restraint device embodiment being deployed from the distal port of the access tube.

FIG. 26 is an enlarged view of an anchor extension of an embodiment of an organ restraint device being retracted by a surgical grasper through an incision and inner lumen of an optional access grommet in a wall of the patient's abdomen.

FIG. 26A is an elevation view in partial section of an anchor extension secured and wrapped around a clamp end of a hemostat. FIG. 27 is a transverse cross section view of the patient's abdomen with the patient lying in a horizontal position and illustrating the organ restraint device of FIG. 12 deployed across the abdominal body cavity with an outer perimeter of the main body portion of the flexible sheet in approximation with the inner surface of the body cavity.

FIG. 28 is an enlarged elevation view of a ramp stop embodiment of an anchor extension of the organ restraint device of FIG. 12 being pulled through an incision in the wall of the patient's abdomen with one ramp stop shown in a compressed state within the incision and two freed ramp stops outside the incision in an expanded state.

FIG. 29 is an elevation view of the patient with a partially cut away view of the patient's abdominal cavity with the organ restraint device embodiment deployed.

FIG. 30 is an elevation view with the patient of FIG. 29 returned to a horizontal position with the organ restraint embodiment deployed.

FIG. 31 is an elevation view of the patient of FIG. 30 in a horizontal position with the deployed organ restraint device shown in a partially cut away view of the patient's abdomen.

FIG. 32 is a perspective view of the organ restraint device embodiment of FIG. 31 (with all other structures removed for clarity of illustration) in a deployed bulged out state due to deformation due to pressure from the intestines being constrained by the device.

FIG. 33 is a lateral view of the deployed organ restraint device embodiment of FIG. 2.

FIG. 34 is a transverse cross section view of the deployed organ restraint device embodiment of FIG. 31 with the patient in a horizontal position and illustrating the shift of cross section shape of the patient's abdominal cavity with a dashed line indicating a profile of the outer surface of the patient's abdomen when in the tilted Trendelenburg position (as shown in FIG. 29).

FIG. 35 is an elevation view of a robotic surgical procedure being performed on the patient in a horizontal position with the organ restraint device embodiment deployed within the patient's body cavity.

FIG. 36 is an elevation view of the patient after the surgical procedure shown in FIG. 35 returned to the tilted head down Trendelenburg position for removal of the organ restraint device embodiment. FIG. 37 is a transverse cross section view of the patient's abdominal cavity with the organ restraint device embodiment being retracted through an access tube which is disposed through an incision in the wall of the patient's abdomen.

FIG. 38 is a perspective view of an embodiment of an organ restraint device that includes curtain tethers that have a distal end secured to a dorsal stiffener disposed along a dorsal edge of the outer perimeter of the main body portion of the flexible sheet of the organ restraint device embodiment.

FIG. 39 is an elevation view of the organ restraint device embodiment of FIG. 38.

FIG. 40 is an enlarged view in transverse section of a curtain tether embodiment passing in an alternating fashion through pores a portion of a flexible sheet of the organ restraint device embodiment of FIG. 39 taken along lines 40-40 of FIG. 39.

FIG. 41 is a perspective view of an embodiment of an organ restraint device that includes stiffener radial rib embodiments.

FIG. 42 is an enlarged view in section of a directional anchor extension constraint grommet embodiment.

FIG. 43 shows the directional anchor extension constraint grommet of FIG. 42 with an anchor extension of an organ restraint device embodiment disposed and secured within an inner lumen of the grommet.

FIG. 44 is an enlarged view in section of an anchor extension constraint grommet embodiment.

FIG. 45 shows the anchor extension constraint grommet of FIG. 44 with an anchor extension of an organ restraint device embodiment secured within an inner lumen of the grommet by a tapered plug disposed within the inner lumen. Detailed Description

Some embodiments discussed herein include systems, methods and devices for holding back and restraining those organs not intended for surgery. The systems, methods and devices may be used to effectively isolate a surgical site in order to avoid collateral damage to organs which are not the target of a surgical procedure as well as providing increased access to those that are. In some cases, the systems may include a variety of devices and equipment that may optionally be used in conjunction with any of the device embodiments discussed herein and for use with any of the method

embodiments. In some cases, the systems may include any suitable combination of organ restraint devices including flexible sheets in addition to surgical tables, including tilting surgical tables, imaging systems such as endoscopes, fluoroscopy devices, laparoscopes and the like, surgical equipment including hemostats, surgical grippers and surgical robots. It should also be noted that although the discussion of the devices and methods herein is generally focused on the treatment of a living human patient, any of the device or method embodiments discussed herein may be used or adapted for use in any other suitable indication such as use in animals, any portions of humans or animals, and in vitro use in human or animal models or cadavers. One benefit of such methods and devices may include reduced patient time in the Trendelenburg position. In some cases, the methods include techniques known in the art for performing "keyhole" surgery.

Specifically, for such a procedure, a body cavity may be inflated, preferably with a gas such as carbon dioxide. For the purposes of the discussion herein, the body cavity may be understood to contain both organs intended for surgery (e.g. colorectal, orthopedic, urinary or reproductive organs within the pelvis) as well as other organs (e.g. the

intestines) not intended for surgery. In addition, the organs not intended for surgery may be shifted away from the surgical site by first moving the patient, or a body cavity

generally, to the Trendelenburg position. Examples of some systems and methods for restraining organs may be found in U.S. Patent Application Serial No. 13/844,425 filed March 15, 2013, by A. Wittgrove, titled "System and Method for Restricting Bowel During Laparoscopic Surgery", which is incorporated by reference herein in its entirety.

With the patient moved to the Trendelenburg position, the intestines may be allowed to move toward the patient's head, separating them from the surgical site. A flexible sheet made from a material such as a fabric mesh or polymer may be rolled or compressed into a narrow shape for insertion into the inflated body cavity through an access tube. The flexible sheet may be fed all the way through an inner lumen of the access tube to an exit location within the body cavity. Once inserted inside the body cavity, the flexible sheet may be unrolled or uncompressed and situated between the surgical site and organs intended to be isolated. The perimeter of the flexible sheet may then be anchored to an interior surface of the walls of the inflated body cavity in a manner that spans the cross section of the abdominal cavity, using small incisions and grabbing strings to tie off the flexible sheet for example, thereby isolating the intestines from the surgical site. In some cases, the flexible sheet may be anchored to the walls of the inflated body cavity walls in a manner that spans the cross section of the abdomen, using small incisions and grabbing anchor extensions or perimeter portions of the flexible sheet. The patient, or body cavity generally, may then be moved from the Trendelenburg position back to a horizontal position or a more horizontal position than the Trendelenburg position. The flexible sheet, held in place by the anchor points, holds back the intestines, isolating them from the surgical site, thereby reducing the risk of collateral injury to the intestines during surgery. When the surgery is complete, the patient or body cavity may be returned to the Trendelenburg position, the anchor extensions may be removed, and the flexible sheet may be re-rolled or compressed and removed through a surgical port in the patient's abdomen.

For some embodiments, when the flexible sheet may be anchored inside the inflated body cavity with at least a portion of the flexible sheet being held under a state of tension in a manner that retains coverage of the cross sectional area of the body cavity, even as that cross sectional area may shift in shape. Such shifts in cross section area shape could result, for example, from gas absorption, leakage, and forcible contact during surgery, patient motion, gravitational effects during transitions between Trendelenburg and horizontal body positions or the like. There may be, in some cases, a specific need to provide systems, methods and devices with sufficient coverage to span an entire of torso cross sections without gaps or other possible avenues for slippage of portions of the intestines, while also avoiding compression of the major blood vessels of the abdomen.

Some embodiments may include deploying a flexible sheet that once released from tension in the body self-expand to fully deploy the fabric. Other embodiments may include features of the flexible sheet that may be pulled on or tensioned to thereby deploy stiffeners that cause the flexible sheet to expand. For some embodiments, anchor extensions may include strings that pass through abdominal incisions to be tied off somewhere on the outside of the patient's body, or more specifically, outside of the body cavity being treated. Other anchor extensions may be deployed through the patient's skin internally to create actual holding force. These anchor extension embodiments may include, for example, a hook passing through the patient's skin that prevents the holding feature from moving. Other embodiments may use features that may be passed through incisions or other passages of the patient's skin and tightened with structures such as those used on tie wraps using parts on the outside of the body to prevent pull-through. As discussed above, embodiments of the flexible sheet may include a mesh material. Some embodiments include more rigid sheets such as a heavy gauge woven cloth or woven polymers and may also include solid or semi-solid unwoven materials without any significant pore structure such as continuous sheet of material such as a flexible sheet of PVC, PTFE, polyurethane or similar polymers as discussed in more detail below.

For some embodiments, access and introduction of the flexible sheet into the body cavity through the wall of the abdomen may be accomplished using a trocar or similar feature on the tube to enter the cavity or could use an optional surgical instrument.

Additionally the entry and exit locations, that is, the surgical incisions for passage of the anchor extensions from the body cavity may have grommets disposed therein to both support and verify the position of the device.

FIGS. 1 and 2 illustrate component of a system embodiment for reducing the risk of collateral injury to the intestines during laparoscopic and robotic surgeries involving the pelvis. An operating table 10 is capable of tilting the patient 20, or the patient's body cavity generally, in a Trendelenburg position at an angle Θ. The system also includes robotic surgery instruments 30. As shown in Figure 1 , the body cavity 40 containing both the intestines and the pelvic surgery site has been suffused with a gas; providing access. The system also includes a flexible sheet 60 and anchors 50 for attaching the flexible sheet to the inflated body cavity. The flexibility of the flexible sheet 60 may include the properties of suppleness and pliability, while still maintaining a high level of tensile strength. Exemplary materials for the flexible sheet 60 such as Nylon mesh, Nylon fabrics, expanded

polytetrafluoroethylene sheets (PTFE) or the like may include such pliable, supple, flexible properties while maintaining good tensile strength in response to tension in the plane of the flexible sheet 60. FIG. 2 provides a midsagittal cross sectional view of the inside of the body cavity 40 in the Trendelenburg position. The flexible sheet 60 is shown inserted between the intestines 70 and the reproductive organs 80. The flexible sheet is attached to the walls of the body cavity 40 using anchors 50.

FIG. 3 illustrates a method for reducing the risk of collateral injury to the intestines during laparoscopic and robotic surgeries involving the pelvis. The method comprises a sequence indicated by blocks with arrows 12. The method includes inflating a body cavity as indicated in block 15 by suffusing it with a gas such as carbon dioxide. In some instances, the body cavity may be understood to include both organs intended for surgery (e.g. reproductive organs within the pelvis) as well as other organs (e.g. the intestines) not intended for surgery. The method also includes moving the patient to the Trendelenburg position as indicated by block 25 so that the intestines or other organs are allowed to move toward the patient's head, separating them from the surgical site. The flexible sheet 60 such as a fabric mesh or polymer may be rolled or compressed into a narrow tube shape as indicated in block 35 for insertion into the inflated body cavity through a small incision or access port. Once inserted inside the body cavity, the flexible sheet 60 may be unrolled or uncompressed and situated between the surgical site and organs intended to be isolated as indicated in block 45. The flexible sheet 60 may then be anchored to the walls of the inflated body cavity walls in a manner that spans the cross section of the abdomen, as indicated by block 55, thereby isolating the intestines from the surgical site. The patient may then be moved, as indicated in block 65, from the Trendelenburg position to a horizontal position. The flexible sheet, held in place by the anchors, holds back the intestines, isolating them from the surgical site, thereby reducing the risk of collateral injury during surgery. Laparoscopic or Robotic surgery may then be performed as indicated in block 75. When the surgery is complete, the patient is returned from the Trendelenburg position as indicated in block 85. The anchors may then be removed as indicated by block 95, and the flexible sheet is re-rolled or compressed as indicated in block 105 and removed through a surgical port as indicated in block 1 15. Finally, the patient may be returned to the horizontal position for recovery as indicated by block 125.

FIG. 4 is a mid-sagittal cross sectional view of the body cavity 40 after it has been moved from the Trendelenburg position to a horizontal position. In response to the horizontal positioning, the body cavity 40 is shown in a representative new shape, which is illustrated in reference to a dotted line 90 representing the former contour of the body cavity from when it was in the Trendelenburg position. In addition, the flexible sheet 60, while still being anchored, may assume a distorted convex shape in response to the force exerted by the intestines once the body has been returned to the horizontal position. In some cases, the flexible sheet may be in a state of tension when distorted as illustrated in FIG. 4.

FIG. 5 shows an axial cross section of the inflated body cavity 40 taken along the cross sectional line 5-5 shown in FIG. 1 while in the Trendelenburg position. Anchors 50 are shown around the perimeter of the flexible sheet 60, fixedly attaching the flexible sheet to the walls of the body cavity 40. The flexible sheet 60 is pulled in tension between at least a pair of anchors in order to conform to the cross sectional profile 1 10 of the body cavity. In some cases, the flexible sheet 60 may be configured for avoiding pressure to the vena cava and aortic blood vessels 100. For some such embodiments, a U-shaped cutout portion 120 of the flexible sheet 60 may be used for this purpose. Methods for avoiding pressure may further include first attaching the flexible sheet 60 to the back of the body cavity, adjacent to the blood vessels 100 and then tensioning the flexible sheet 60 by pulling it upward, away from the back wall of the abdomen.

FIG. 6 shows an axial cross section of the inflated body cavity 40 taken along the cross sectional line 6-6 shown in FIG. 4 after it has been moved from the Trendelenburg position to a horizontal position as per the process indicated in block 65. In response to the horizontal positioning, the body cavity 40 is shown in a representative new shape, which is illustrated in reference to a dotted line 90 representing the former contour of the body cavity from when it was in the Trendelenburg position. In addition, the flexible sheet 60, while still being anchored, may assume a distorted convex shape, represented by curved lines 130 in response to the force exerted by the intestines. In some instances, the flexible sheet 60 remains pulled in tension between at least a pair of anchors in order to conform to the cross sectional profile 1 10 of the body cavity 40.

FIGS. 7a-1 1 illustrate embodiments for reducing the risk of collateral injury to the intestines during laparoscopic and robotic surgeries involving the pelvis. FIG. 7a shows an embodiment in which the flexible sheet 60 is formed from a stretchable mesh or polymer allowing it to conform with variable cross sections as illustrated in FIG. 5 and FIG. 6. In particular the flexible sheet 60 with anchors 50 is shown in FIG. 7b with the flexible sheet 60 in a stretched state of tension between specific anchors 51 and 52. FIG. 8 shows an alternative embodiment in which the anchors 50 of the flexible sheet are formed from contiguous extensions of the same material used for the flexible sheet 60. Figure 9 shows an alternative embodiment in which the anchors are formed from springs or other stretchable materials such as polymers allowing the flexible sheet 60 to conform with variable cross sections as illustrated in FIG. 5 and FIG. 6. FIG. 10 shows an embodiment for anchoring flexible sheet 60. Anchor 50, which is fixedly attached to flexible sheet 60 is pulled through a clamping fixture 53 inserted into an incision in the body cavity 40. FIG. 1 1 shows an embodiment in which the flexible sheet 60 is wound around a spring-loaded roller 56 with spring anchors 55. The flexible sheet 60 may be deployable by pulling on the anchors 50 and unrolling in a manner similar to a window shade in accordance with the process indicated by block 45. When the process is complete, anchors 50 can be released and the roller 56 is allowed to return the flexible sheet 60 to a rolled up configuration in accordance the process indicated by block 105.

Some organ restraint device embodiments may include may include features such as a flexible sheet configuration that may be placed inside of an inflated body cavity to provide coverage of an entire or nearly entire cross sectional area of the body cavity thereby isolating organs such as the intestines from an operative field. In some cases, the flexible sheet may have an overlay of flexible resilient elongate stiffeners to enhance the controllability and resilience of the flexible sheet to facilitate self-opening of the flexible sheet during deployment. A sufficient number of anchor extensions may be provided to sufficiently and temporarily secure the outer perimeter of the main body portion of the flexible sheet against or in near proximity to the entire inner surface perimeter of the body cavity so as prevent passage of the organs, such as intestines, being restrained. For some embodiments, the anchor extensions may be contiguous extensions formed from the same piece of material used for the flexible sheet, in order to strengthen the device, simplify manufacturing and provide a design that may more uniformly distribute perimeter forces during use. In addition, in some cases, the anchor extensions may be labeled with visual identifiers such as letters, numbers, colors or other identifiers such as radiopaque markers in order to facilitate identification of each anchor extension and discernment of which anchor extension is secured at which specific location. It may also be desirable in some instances to provide an organ restraint device configuration that provides sufficient approximation of the outer perimeter of the device to an inside surface of the body cavity to prevent passage of organs being restrained without the need for any incisions through a patients back muscles or the application of excessive compression on vital vessels or nerves disposed within a patient's abdomen or other body cavity being treated.

The organ restraint device embodiment 200 shown in FIGS. 12-17A includes a flexible sheet 202 having a main body portion 204 with a contact surface 206, a non- contact surface 208, high tensile strength for loads oriented generally in the plane of the flexible sheet and sufficient flexibility to be readily rolled into a tubular or otherwise constrained configuration. The main body portion 204 of the flexible sheet 202 may include an outer perimeter 210 which has a shape profile that is configured to conform to an inside surface shape profile of a target body cavity. In some cases, the outer perimeter 210 of the main body portion 204 may generally have a rectangular shape with a major transverse dimension, indicated by arrow 205, of about 25 cm to about 45 cm and a minor transverse dimension, indicated by arrow 207, of about 12 cm to about 22 cm. However, the outer perimeter 210 of the main body portion 204 of the flexible sheet 202 may have any suitable shape profile, such as a shape profile that is generally rectangular shape (as per the embodiment in FIG. 13), generally trapezoidal shape, generally kidney shaped (as shown in the embodiment of FIG. 5) generally round shaped or any other suitable shape that conforms to the shape of an inside surface of a body cavity to be treated.

As discussed above, the flexibility of such flexible sheet embodiments 202 may include the properties of suppleness and pliability, while still maintaining a high level of tensile strength in a direction generally in the plane of the flexible sheet. Exemplary materials for the flexible sheet such as Nylon mesh, Nylon fabrics, expanded

polytetrafluoroethylene sheets (PTFE) or the like may include such pliable, supple, flexible properties while maintaining good tensile strength in response to tension in the plane of the flexible sheet 202.

In some cases, the flexible sheet 202 may include a mesh structure made from high strength biocompatible filaments which may include elongate filaments 212 having an outer transverse dimension of about 0.2 mm to about 0.8 mm. For some embodiments, the polymer material of the high strength biocompatible filaments may include materials such as Nylon®, polytetrafluoroethylene (PTFE), high density polyethylene (HDPE) and the like.

In some cases, the flexible sheet 202, and particularly mesh embodiments of the flexible sheet, may be configured to avoid localized pressure points that might occlude or partially occlude the vasculature of the organ being restrained. In some cases, the flexible sheet 202 may be fabricated from a mesh material having weave and hole spacing sufficiently small to avoid micro-occlusions of the blood vessels of organs coming into contact with the mesh. Such a mesh structure may also include regularly spaced pores 214 that extend through the sheet 202 from the contact surface to the non-contact surface, the pores having an inner transverse dimension of about 1 mm to about 10 mm in some cases. Additionally, in some cases, the mesh may be treated or composed of materials such as polytetrafluoroethylene (PTFE) or GoreTex ® that may avoid or reduce the incidence of tissue adhesions to the flexible sheet embodiments 202.

Optionally, some flexible sheet embodiments 202 may include a thin continuous layer of flexible polymer or the like that does not have any significant pore structure as shown in the exemplary embodiment of FIG. 17A. Such a thin continuous layer may include or be made from materials such as Nylon®, PVC, polyurethane, PTFE or the like. For some embodiments, the flexible sheet 202 may also optionally include elastic stretchable materials that may elastically distend upon the exertion of pressure from restrained organs. Such elastic materials for the flexible sheet 202 may include latex or latex-like synthetic polymers.

The organ restraint device 200 shown has a plurality of optional elongate stiffener segments 216 which may be secured at least to the main body portion 204 of the flexible sheet 202, typically on the non-contact surface 208. For the embodiment shown, the elongate stiffeners 214 extend at least generally adjacent to the outer perimeter of the main body portion 204 and are made from a resilient, flexible elastic material. The elongate stiffeners 214 may include perimeter reinforcements that serve to enhance the shape-holding properties of the organ restraint device 200. The non-contact surface 208 is the surface of the flexible sheet 202 that is disposed away from the organs being restrained when the device is deployed and in use. In this way, a generally smooth uninterrupted surface of the flexible sheet 202 may be disposed towards and in contact with the organs 218 being restrained (as shown in FIG. 23) in order to minimize contact of any ridges or edges of the elongate stiffener 216 with the organs. The elongate stiffener structures may provide a variety of benefits. In some cases, the flexible elongate stiffeners 216 may give the organ restraint device 200 resilient and elastic self-expanding or self- unfurling properties when being deployed within a patient's body cavity 220 (see FIG. 23). During minimally invasive procedures where the procedure is being visualized through an endoscope 222 (see FIG. 24) or the like, this self-expanding property may be particularly useful for providing access and the ability to identify the various components of the device 200 during deployment and delivery through a constrained access tube 224 or the like as shown in FIG. 18. In some cases, the organ restraint device embodiments 200 shown will generally self-expand after being ejected from the distal end 226 of the access tube 224 in an amount sufficient to separate some or all of the anchor extensions 228 from each other to allow the operator to identify most or all of the anchor extensions 228 which facilitates any necessary repositioning of the device 200 and accurate retraction of the anchor extensions 228 through the proper respective incisions 230 in the abdominal wall 232 as shown in FIG. 24. In some cases, the access tube 224 may have a length of about 10 cm to about 30 cm, more specifically, about 15 cm to about 25 cm. Some access tube embodiments 224 may have an inner lumen with an inner transverse dimension or diameter of about 0.5 cm to about 1 .5 cm, more specifically, about 0.8 cm to about 1 .2 cm.

For the embodiment 200 shown, the elongate stiffeners 216 form an optional continuous network 234 of interconnected stiffener segments 216 that include a dorsal edge segment 236, a ventral edge segment 238, and two lateral edge segments 240 and 242 of a perimeter segment such as segments 236, 238, 240 and 242. The continuous network 234 of also includes a first optional reinforcement segment 244 adjacent and parallel to the dorsal edge segment 236 and a second optional reinforcement segment 246 adjacent and parallel to the first reinforcement segment 244. The optional reinforcement segments 244 and 246 extend across the main body portion 204 from the first lateral edge segment 240 to the second lateral edge segment 242.

Such flexible resilient elongate stiffener elements 216 may be applied to the mesh of the flexible sheet 202 by methods such as silk screening, inkjet application, over- molding or any other suitable method. For some such embodiments, the material of the elongate stiffener elements 216 may encapsulate filaments of mesh embodiments of the flexible sheet 202 to provide a mechanical bond between the elongate stiffener elements 216 and the flexible sheet 202. In other cases, the stiffener elements 216 may be bonded to the flexible sheet 202 by any suitable method such as adhesive bonding, welding or the like. The network 234 of elongate stiffener segments 216 may also include anchor extension reinforcements 248 to enhance the tensile strength of the anchor extensions 228 and also to promote unfolding of the anchor extensions 228 inside of the body cavity 220 of the torso 250 shown in FIG. 20.

In some instances, the elongate stiffeners 216 may be made from materials such as a resilient elastic polymer including one or more thermoplastic elastomers (TPE), acrylonitrile butadiene styrene (ABS) plastics, silicones, other polymeric adaptations and the like. The resilient elastic polymer material of some elongate stiffener embodiments 216 including some or all of the elongate stiffener segments 216 of the continuous network 234 of stiffener segments 216 may have a shore hardness of about 30A to about 50A, a thickness 252 of about 0.5 mm to about 4 mm and an outer transverse dimension 254 of about 1 mm to about 10 mm, as indicated by the arrows in FIG. 14, in some cases.

A plurality of anchor extensions 228 are typically disposed in fixed relation to the outer perimeter 210 of the main body portion 204 of the flexible sheet 202, allowing the sheet 202 to be firmly secured to the inside perimeter 256 of an inflated body cavity 220 such as in the area of a patient's torso 250 shown in FIG. 24. The anchor extensions 228 shown in the embodiment 200 of FIGS. 12-17A are formed as contiguous extensions of the same and continuous piece of mesh material used for the main body portion 204 of flexible sheet 202 as shown. Optionally, the anchor extensions 228 may be made from separate components and secured to the nominal outer perimeter 210 of the main body portion 204 of the flexible sheet 202. The plurality of anchor extensions 228 are secured relative to and extend outwardly from the outer perimeter 210 of the main body portion 204 of the flexible sheet 202. The anchor extensions 228 are configured to transmit outward radial tension to the outer perimeter 210 of the main body portion 204 of the flexible sheet 202 such that the outer perimeter 210 of the main body portion 204 of the flexible sheet 202 may substantially conform to an interior surface 256 of a body cavity 220. The anchor extensions 228 may be sufficiently secured to a wall 232 of the body cavity 220 such that the main body portion 204 may resist perpendicular displacement in response to pressure from organs 218 being restrained as shown and discussed below with regard to FIGS. 31 - 33. For some organ restraint embodiments 200, the number of anchor extensions 228 may be 5 or more, in some cases, 6 anchor extensions 228 or more, and in still further examples, 7 anchor extensions 228 or more. Some embodiments of an organ restraint device 200 may have about 6 anchor extensions 228 to about 9 anchor extensions 228.

For such embodiments where the anchor extensions 228 and the main body portion 204 of the flexible sheet 202 are at least partially formed from a continuous sheet of material and the anchor extensions 228 include outward radial extensions of material of the flexible sheet 202, an outer profile of each anchor extension may transition smoothly with a rounded filleted transition 258 relative to the nominal outer perimeter 210 of the main body portion 204 of the flexible sheet 202 as shown in FIG. 13. Such a rounded filleted transition 258 may have a radius of curvature as indicated by arrow R in FIG. 13 of about 1 cm to about 5 cm in some cases.

The aspect ratio of a tapered configuration of contiguous anchor extension embodiments 228 may be chosen to more uniformly distribute perimeter forces on the perimeter 210 of the main body portion 204 of the flexible sheet 202 in order to reduce gaps and the associated risk of slippage. In some cases, a flexible sheet portion that is an extension of the material of the main body portion 204 of some or all of the anchor extensions 228 may have an outer profile that tapers transversely from an inside end 260 to an outside end 262 of each anchor extension 228. In some cases, the outer profile of such anchor extensions 228 may have an outer taper angle as indicated by arrow 264 in FIG. 13 of about 20 degrees to about 30 degrees. Such a taper profile may be useful for both spreading tension evenly at the perimeter 210 of the main body portion 204 while keeping a thickness and bulk of the anchor extensions at a value that allows easy passage through incisions 230 in the wall 232. In addition, the anchor extensions 228 of any of the organ restraint device embodiments discussed herein may have an axial length measured from a nominal surface of the outer perimeter 210 of the main body portion 204 to an outer end 262 of the anchor extensions 228 indicated by arrow 266 of at least about 5 cm, more specifically, about 5 cm to about 12 cm, and even more specifically, about 7 cm to about 10 cm. In some cases, labels such as visual identifiers 268, as shown in FIG. 15, may be printed or cut out directly into the material of the anchor extensions 228. For such embodiments, each of the plurality of anchor extensions 228 may include a unique identifier to distinguish each anchor extension 228 from other anchor extensions 228 to facilitate identification of each respective anchor extension 228 and deployment of the device 200 within a body cavity 220 as shown in FIG. 15. The unique identifiers 268 may include any suitable type of identifier such as a radio identifier including RFID type identifiers and the like that may be identified by use of a radio signal or radiopaque identifiers such as identifiers made from gold, platinum, tantalum, bismuth or the like that may be visualized by x-ray or fluoroscopy type imaging systems. However, for the embodiment 200 shown in FIGS. 12-17A, the unique identifiers 268 include visual identifiers wherein a unique number, letter, color or other unique distinguishing symbol is marked on each anchor extension that is unique from those marked on all other anchor extensions 228. Such visual identifiers 268 may be viewed with the naked eye or with an optical instrument such as an endoscope 222 or the like. In some cases, it may also be desirable to mark some of the anchor extensions 228 with the same identifier so as to form a pattern that may still be useful for facilitating efficient and timely deployment of the device 220. For example, for some embodiments, all of the anchor extensions 228 on the first lateral edge 240 may share a common identifier 268, all of the anchor extensions 228 on the ventral edge 238 may share a common identifier 268 that is unique from the identifier 268 of the anchor extensions 228 on the first lateral edge 240, and the anchor extensions 228 of the second lateral edge 242 may have a third unique identifier 268.

As discussed above, the anchor extensions 228 may also include at least one elongate stiffener segment 216 extending at least along an axial length of the respective anchor extension 228. Such an elongate stiffener segment 216 may optionally be part of the continuous network 234 of stiffeners 216 of the main body portion 204 as shown in the organ restraint device embodiment 200 of FIG. 12. Each elongate stiffener segment 216 of some or all of the anchor extensions 228 may include at least one resilient ramp stop 270 that extends from and is secured to the elongate stiffener 216 extending the axial length thereof. Such a resilient ramp stop 270 may have elements which are suitable and configured for lateral compression and corresponding ramp stop retraction during passage of the anchor extensions through a constraining lumen, such as an incision 230 in a wall 232 of a patient's abdomen 250 or the like. Such lateral compression may take place as a respective anchor extension 228 that includes at least one ramp stop 270 is being pulled in an outward radial direction through a constraining lumen 230 during deployment of the organ restraint device 200. Once the ramp stop 270 has exited the constraining lumen 230, the elements configured for lateral compression may then undergo lateral extension as indicated by arrow 272 of upon release of the outer radial constraint of the constraining lumen 230 as shown in detail in FIG. 28. The elements of the ramp stop 270 configured for compression and lateral extension may include resilient angled extensions 274, such as the resilient angled extensions 274 shown in FIG. 13 and in more detail in FIG. 28. The resilient angled extensions 274 give the ramp stop embodiments 270 shown an "arrow head" type shape or configuration. The anchor extensions 228 of the organ restraint embodiment 200 shown include a plurality of resilient ramp stops 270 disposed at spaced intervals along the elongate stiffener 216 of each respective anchor extension 228 which extends the axial length of each respective anchor extension 228. For some such embodiments, the plurality of ramp stops 270 for each anchor extension 228 may be disposed at spaced intervals of about 2 cm to about 5 cm between each ramp stop 270. Some such anchor extension embodiments 228 may include about 2 to about 5 resilient ramp stops 270.

In some cases, the main body portion 204 of the flexible sheet 202 may have an outer perimeter 210 that is shaped to conform to an inside surface 256 of a an abdominal cavity 220, the outer perimeter 210 including a ventral edge 278, a dorsal edge 280 which is disposed opposite the ventral edge 278, a first lateral edge 282 and a second lateral edge 284 and there optionally being no anchor extensions 228 disposed along the dorsal edge 280 of the outer perimeter 210 of the main body portion 204. Notwithstanding organ restraint device embodiments 200 that do not have any anchor extensions 228 extending from the dorsal edge 280, the anchor extensions may generally be evenly distributed about the edges of the main body portion 204 that do include anchor extensions 228. Anchor extensions may also be disposed extending from corners of the generally rectangular configuration of the flexible sheet 202 such as at the junctions between the various edges 278, 280, 282, and 284. For example, for the embodiment 200 shown, there is one anchor extension 228 extending outwardly from the junction and corner of the main body portion between the dorsal edge 280 and the first lateral edge 282, one anchor extension 228 extending from the corner and junction between the first lateral edge 282 and the ventral edge 278, one anchor extension 228 extending from the corner and junction between the ventral edge 278 and the second lateral edge 284, and one anchor extension 228 extending from the corner and junction between the second lateral edge 284 and the dorsal edge 280. In addition, there are three more anchor extensions 228 which are evenly distributed along and extending from the ventral edge 278 for a total of 7 anchor extensions 228 for the organ restraint embodiment 200.

The outer perimeter 210 of some organ restraint devices 200 may include a ventral edge 278 that is generally arcuate in shape, generally coinciding with the shape of an inner surface 256 of a patient's torso 250 across the inner ventral surface 276 of the patient's abdomen 250 as shown in FIG. 24. The outer perimeter 210 may also include a dorsal edge 280 with an arcuate shaped relief or cutout 286 which may be substantially centered along the dorsal edge 280, allowing relief space in the flexible sheet 202 for the patient's aorta 288 and vena cava 290 when the organ restraint device 200 is deployed in the patient's abdomen 250.

For the embodiment 200 shown, such an effect may be enhanced by a pair of opposed anchor extensions 228 which include the dorsal-most anchor extensions 228, including a first dorsal-most anchor extension 291 and a second dorsal-most anchor extension 293. Each dorsal-most anchor extension 291 and 293 has a respective longitudinal axis 292 which is substantially collinear with the other as shown by the dashed line 292 in FIG. 13. Each of these respective longitudinal axes of the dorsal-most anchor extensions 228 may also be aligned with, substantially aligned with or disposed adjacent a peak 294 of the arcuate shaped relief or cutout 286 of the dorsal edge 280 of the device 200. Appropriate tensioning at the anchor extensions 228 may be used in order to enhance coverage of the cross section area of the body cavity 220 while avoiding blood vessel and nerve compression, particularly in the dorsal area including such vessels as the aorta 288 and vena cava 290 as shown in FIG. 27 and discussed more below. That is, tensioning of the flexible sheet 202 by the anchor extensions 228 may be controlled in a manner that avoids compression of the major blood vessels within the torso, including the aorta 288 and vena cava 290, while still providing coverage of an entire cross section of the torso. In some cases, the arcuate shaped relief 286 in the dorsal edge 280 may be centered or substantially centered along the length of the dorsal edge 280 and may have a radius of curvature as indicated by arrow 295 of about 5 cm to about 40 cm, more specifically about 20 cm to about 40 cm, and a depth from a nominal profile of the dorsal edge 280, as indicated by arrow 296 in FIG. 13, of about 0.5 cm to about 5 cm, more specifically of about 2 cm to about 4 cm.

Regarding the organ restraint device embodiments discussed above and any other suitable organ restraint device embodiments, a method of organ restraint within a body cavity 220 of a patient may include a series of procedures that are used to safely isolate and restrain organs 218 that are not involved with the subject surgical procedure.

Although in some circumstances the organ restraint device embodiments discussed herein may be deployed without body cavity inflation with a fluid or tilting of the patient's body 250, or a body cavity 220 generally, in many cases it may be advantageous to do so. Thus, a procedure may begin by placing the patient or body cavity generally on a tilting surgical table 298 in the horizontal position as shown in FIG. 20 and then optionally inflating the target body cavity 220 with an inflation fluid 300 and then tilting the patient or body cavity 220 into a head down angled position, such as the Trendelenburg position as shown in FIG. 21 . The inflation of the interior volume of the body cavity 220 may be carried out with low pressure pressurization by infusion of a fluid 300 such as a gas including air, nitrogen, CO2 or the like prior to inserting the organ restraint device 200 into the body cavity 220.

For some procedures, the body cavity 220 may be inflated with a gas 300 to a pressure of about 10 mm Hg to about 20 mm Hg. The body cavity 200 may also be inflated with a transparent fluid in the form of a liquid such as water in some cases.

Regarding tilting of the patient or body cavity generally in a head down type position, this particular position may be useful in order to use gravity to displace the intestines or other organs being restrained 218 within the abdominal cavity 220 towards the patient's head 302 or upper end of the body cavity generally and away from the organs in the pelvis 304 that may be subject to the desired surgical procedure. When combined with inflation of the body cavity 220, a physical separation may take place leaving a gap 306 between the intestines 218 and the pelvic area or organs thereof 304 as seen in the cut away view of FIG. 23. This gap 306 may be used to more freely deploy the organ restraint device 200 and reduce the time for deployment. In some cases for the purpose of deploying the organ restraint devices discussed herein, the patient may be subject to the head down

Trendelenburg position for a small amount of time compared to the time that would be necessary to perform the desired surgical procedure in the head down position. In some circumstances, deployment of the organ restraint device may take only about 5 minutes to about 20 minutes after which the patient may be returned to the horizontal position or a position which is more horizontal than the Trendelenburg position. It should be noted that for any of the method embodiments discussed herein, the step of returning the patient from a Trendelenburg position to a horizontal position may also include returning the patient to a position that is more horizontal that the Trendelenburg position as many surgical procedures are carried out at a position that is not completely horizontal. For some such procedures, the patient, or any portion of the patient including the body cavity 220, may be tilted into a head down position having a table angle Θ of about 15 degrees to about 45 degrees with respect to horizontal.

With the patient or body cavity generally in the head down tilted position and body cavity 220 inflated, a series of appropriately placed incisions 230 may be made in the wall 232 surrounding the body cavity 220 with a tool such as a trocar 308, as shown in FIGS. 22 and 23. For minimally invasive laparoscopic type procedures, the entire surgery may be performed without the need for any large cut down type incisions in the wall 232. As such, in some cases, all of the incisions 230 made in the wall 232 may be small puncture type incisions 230. Once the appropriately located incisions 230 have been made in the abdominal wall 232, the organ restraint device 200 may be inserted into the inflated body cavity 220 in a constrained state through the incision 230 in the wall 232 of the body cavity 220. In some cases, inserting the organ restraint device 200 into the body cavity 220 in a constrained state may include inserting the access tube 224 into the body cavity 220 from a position outside the body cavity 220 such that the distal end 226 of the access tube 224 is disposed within the body cavity 220 as shown in FIG. 24. Thereafter, the organ restraint device 200 may be ejected from an inner lumen 310 of the access tube 224 through a distal port of the access tube 224 into the body cavity 220 as shown in FIG. 25. The organ restraint device 200 may be preloaded into the inner lumen 310 of the access tube 224 in some instances prior to insertion of the access tube 224 into the body cavity 220 as shown in FIG. 19 or in some cases the access tube 224 may be inserted such that it is in communication with the interior volume of the body cavity 220 prior to insertion of the organ restraint device 200 into the inner lumen 310 of the access tube 224. The organ restraint device 200 may be pushed from the inner lumen 310 of the access tube 224 with any suitable instrument such as a pushrod (not shown).

Once the organ restraint device 200 has been pushed into the body cavity 220 from the distal port of the access tube 224, the operator may begin identifying and accessing the anchor extensions 228 of the organ restraint device 200. The organ restraint device embodiment 200 of FIGS. 12-17A is configured to self-expand or partially self-expand due to the elastic resilience of the network 234 of stiffener segments 216 disposed on the device 200. As such, the various features of the organ restraint device 200 may be visualized with a visualization device such as an endoscope 222 disposed through an incision 230 in the wall 232 of the body cavity 220 as shown in FIG. 25. Once the anchor extensions 228 of the organ restraint device 220 can be seen, they can then be accessed and gripped with a device such as a surgical gripper 312, such as a 3mm or 5 mm surgical gripper 312, through each respective incision 230 in the wall 232 of the body cavity 220 as shown in FIGS. 25- 27. Although not always necessary or desirable, the plurality of incisions 230 in the wall 232 of the body cavity 220 through which the anchor extensions 228 will pass may generally lie in the same plane with each other so that when the device 200 is deployed the outer perimeter 210 of the main body portion 204 will also lie generally in a plane that may be transverse to the body cavity 220. In some cases the plane of the incisions 230 may be substantially perpendicular to a longitudinal axis of the abdominal body cavity 220.

For the organ restraint device embodiment 200 shown, each of the plurality of anchor extensions 228 includes a unique visual identifier 268 such as the letters marked on each anchor extension 228 as shown in FIG. 15. In this way, as the operator views the self-expanded or partially self-expanded organ restraint device 200 through the endoscope 222, the operator will be able to distinguish each anchor extension 228 from other anchor extensions 228 to determine which extension 228 to grasp and pull through each respective incision 230 of the wall 232 of the body cavity 220 as shown in FIGS. 26-28. Once a proper anchor extension 228 has been identified with regard to the incision 230 in which the surgical grasper 312 is disposed, the proper anchor extension 228 may be grasped and the anchor extension 228 may be pulled through the incision 230 with the surgical grasper 312. For some embodiments, an optional access grommet 314 having an inner lumen 316 may be disposed in the incision 230 in the wall 232 of the patient's abdomen 250 as shown in FIG. 26. In such cases, the surgical gripper 312 may access the body cavity 220 through the inner lumen 316 of the grommet 314 and the respective anchor extension 228 may be pulled through the same lumen 316. This process may be continued for all of the anchor extensions 228 of the organ restraint device 200 whereby all of the anchor extensions 228 are withdrawn through respective incisions 230 in the wall 232 of the body cavity 220. As a result, the perimeter 210 of the main body portion 204 may be drawn in proximity to an inner surface 256 of the body cavity 220 adjacent to each respective incision 230 in the wall 232 of the body cavity 220 so as to span a cross section area of the body cavity 220 with the flexible sheet 202 as shown in FIG. 27. Once in position within the grommets 314 or bare incisions 230 of the wall 232 of the body cavity 220, the anchor extensions 228 must be sufficiently secured in order for the main body portion 204 of the organ restraint device 200 to resist pressure thereon from the organs 218 being restrained. In some cases, securing the anchor extensions 228 to the wall 232 of the body cavity 220 comprises securing the anchor extensions 228 outside the wall 232 of the body cavity 220 with a hemostat device 318. In such cases, a portion of each anchor extension 228 that extends from each incision 230 may be gripped and twisted about a surgical device such as the hemostat 318 shown in FIG. 26A. The grip and twisting action of the hemostat 318 prevents the respective anchor extension 228 from being pulled back through the incision 230 or inner lumen 316 of the grommet 314.

In other instances, the withdrawn anchor extensions 228 may be secured in other ways. For example, the anchor extensions 228 may each include an elongate stiffener segment 216 extending along an axial length thereof and at least one resilient ramp stop 270 that extends from and is secured to the elongate stiffener 216 extending the axial length of the anchor extension 228. Such a ramp stop 270 may be suitable for lateral compression and corresponding ramp stop 270 retraction during passage of the anchor extensions 228 in an outward radial direction through a constraining lumen, such as an incision 230 in the wall 232 of the body cavity 220, as shown in FIG. 28. The ramp stops 270 may undergo lateral extension and expansion upon release of the outer radial constraint of the constraining lumen 230. The lateral extension and expansion may serve to secure the anchor extensions 228 to the wall 232 of the body cavity 220. As such, securing the anchor extensions 228 to the wall 232 of the body cavity 220 may include pulling one or more of the ramp stops 270 of the anchor extensions 228 through incisions 230 in the wall 232 of the body cavity 220 and allowing one or more of the ramp stops 270 to extend laterally outside the body cavity 220 also as shown in FIG. 28. Or in other words, as discussed above, once the ramp stop 270 has exited the constraining lumen 230, the elements configured for lateral compression may then undergo lateral extension of the ramp stop 270 or elements thereof upon release of the outer radial constraint of the constraining lumen 230 as shown in detail in FIG. 28. The elements configured for compression and lateral extension may include resilient angled extensions 274, such as the resilient angled extensions 274 shown in FIG. 13 and in more detail in FIG. 28 that give the ramp stop embodiments 270 shown an "arrow head" type shape or configuration. An outer end 322 of each engaged resilient angled extension 274 may be disposed against an outer surface 324 of the patient's abdomen 250 adjacent the respective incision 230 creating a mechanical stop to prevent the anchor extension 228 from pulling back into the body cavity 220 due to force on the main body portion 204 of the organ restraint device 220. In some cases, at least some of the anchor extensions 228 may include a plurality of resilient ramp stops 270 at spaced intervals along the elongate stiffener 216 extending the axial length of the respective anchor extensions 228. For such embodiments, securing the anchor extensions 228 to the wall 232 of the body cavity 220 may include pulling the sequential ramp stops 270 of each such anchor extension 228 through respective incisions 230 in the wall 232 of the body cavity 220 and allowing one of the plurality of sequential ramp stops 270 to extend laterally outside the body cavity 220 at a desired amount of retraction of the anchor extension 228. It has also been found that in some instances, the elongate stiffener segment 216 and ramp stop structure 270 of the resilient compressible materials discussed above may also serve to seal the incision 230 in the wall 232 of the body cavity 220 from leakage of the pressurized gas 300 in the body cavity 220 as well as secure the anchor extensions 228.

For some embodiments of the organ restraint device 200, the main body portion 204 of the flexible sheet 202 may have an outer perimeter 210 that is shaped to conform to an inside surface 256 of a patient's abdominal cavity 220 including a ventral edge 278, a dorsal edge 280 which is disposed opposite the ventral edge 278, a first lateral edge 282 and a second lateral edge 284. As discussed above, the pair or dorsal-most anchor extensions 228 may have respective longitudinal axes 292 which are substantially collinear with each other and substantially aligned with the apex or peak 294 of the relief cut out 286 of the dorsal edge 280 of the main body portion 204 as shown in FIG. 27. In addition, for some embodiments, there are optionally no anchor extensions 228 disposed along the dorsal edge 280 of the outer perimeter 210 of the main body portion 204. Such an embodiment may be useful in order to avoid the need for creating incisions 230 through the patient's back muscles or near critical nerve paths. For such embodiments,

withdrawing the anchor extensions 228 through respective incisions 230 in the wall 232 of the body cavity 220 may include withdrawing a pair of dorsal-most opposed anchor extensions 228 in some cases such that the cut out relief portion 286 is tensioned to a lateral position proximate the spine, aorta 288, and vena cava 290 of the patient FIG. 27. During deployment, this pair of opposed anchor extensions 228 may be tensioned such that the dorsal edge 280 of the outer perimeter 210 is tensioned to a position proximate the inner dorsal wall surface 326 of the body cavity 220 at the position of the patient's spinal structures and vasculature 328 as shown in FIG. 27. Such tensioning may be carried out without applying excessive pressure to the patient's vasculature 328 such as the aorta 288 and vena cava 290 within or adjacent to the body cavity 220 as also shown in FIG. 27. For this procedure, it may also be desirable in some cases to create the dorsal-most opposed incisions 230 through the wall 232 of the patient's abdomen 250 along an imaginary line that passes up to about 1 cm or so of the ventral surface of the patient's spinal structures 328 as indicated by the dashed lines 292 and arrows 330 in FIG. 27. Such a location of dorsal-most opposed incisions may serve to create a tension line 292 across the main body portion 204 that is sufficiently proximate to the inner dorsal surface of the body cavity 232 to prevent passage of organs being restrained 218 but still leave sufficient clearance between the dorsal edge of the main body portion and the spinal structures to prevent adverse affects to the patient being treated.

Once the organ restraint device 200 has been properly deployed as shown in the partially cut away view of FIG. 29, the patient may be returned to a substantially horizontal position as shown in FIG. 30 from the Trendelenburg position. A desired surgical procedure, such as a minimally invasive robotic surgical procedure may then be performed using a robotic surgical instrument 332 as shown in FIG. 35. While in the horizontal position with the organ restraint device 200 properly deployed, the main body portion 204 of the flexible sheet 202 of the device 200 may be distended or otherwise bulge outward during the procedure due to the pressure of the organs 218 being restrained on the contact side 206 of the flexible sheet 202, in this case intestines 218, as shown in FIGS. 31 -33. It is also the case, in some circumstances, that the outer profile of the patient's abdomen 250 will change shape and outer when tilted back to the horizontal position from the tilted Trendelenburg position or the like. FIG. 34 illustrates a cross section view of the patient's abdomen 250 in a horizontal position with the organ restraint device 200 deployed. A dashed line 334 indicates the profile of the outer surface 324 of the patient's abdomen 250 when the patient was in the tilted position. This change of body cavity profile may also contribute to the distention or bulging of the main body portion 204 of the flexible sheet 202 due to pressure from the organs 218 being restrained as the reduction in cross section of the body cavity 220 can produce additional looseness or slack in the main body portion 204when in the horizontal position.

Once the desired surgical procedure is completed with the patient in the horizontal position as shown in FIG. 35, the patient may then be tilted back into a head down position such as the Trendelenburg position as again shown in FIG. 36. The anchor extensions 228 or portions of the flexible sheet 202 adjacent thereto may then be accessed from within the body cavity 220 and pulled back through the incisions 230 and from the wall 232 of the body cavity 220. Once all of the anchor extensions 228 have been pulled through the wall 232 of the body cavity 220, the organ restraint device 200 may be withdrawn through an incision 230 in the wall 232 of the body cavity 220 as shown in FIG. 37. In some cases, the organ restraint device 200 may be constrained once again and withdrawn through the inner lumen 310 of the access tube 224 or a similar device. In other cases, the organ restraint device 200 may be withdrawn directly through an incision 230 in the wall 232 of the body cavity 220. Once the organ restraint device 200 has been withdrawn, the patient may be once again tilted back to a substantially horizontal position as shown in FIG. 20 and the inflation fluid 300 deflated from the body cavity 220. In some cases, the inflation fluid 300 may be deflated from the body cavity 220 prior to tilting the patient back to a substantially horizontal position.

FIGS. 38-40 illustrate an organ restraint device embodiment 340 which includes features configured specifically to prevent compression of important organs 218, such as a patient's nerves and vasculature, during deployment and while in a deployed state. The organ restraint device embodiment 340 shown includes a flexible sheet 342 having additional auxiliary curtain tethers 344, fixedly attached to a stiffener element 346 disposed along a relief 348 at the dorsal edge 350 of the flexible sheet 342. The relief 348 may have an inwardly disposed radius shape as discussed above with regard to the organ restraint device embodiment 200 of FIG. 12. For some embodiments, the curtain tethers 344 may be slidably attached via loose threading among a fabric or mesh of the flexible sheet 342 as detailed in FIG. 40. Also, for some embodiments, the curtain tethers 344 may be co-linear with one or more of the ventral anchor extensions 352 and pass through the same respective incisions 230 in the wall 232 of the patient's abdomen 250. However, the original ventral anchor extensions 352 are pulled to attach the outer perimeter 354 of the flexible sheet 342 to the boundary of the inside of the torso, the curtain tethers 344 may be tensioned separately to more effectively form the cutout relief 348, pulling a portion of the dorsal edge 350 at the outer perimeter 354 away from the aorta 288 and vena cava 290 as shown by arrows 356 in FIG. 39. The organ restraint device 340 of FIGS. 38-40 may generally have the same features, dimensions, and materials as those of the organ restraining device embodiment 200 discussed above.

Figure 41 illustrates an organ restraint device embodiment 360 that includes a flexible sheet 362 in which the fabric has been overlaid with elongate stiffeners 364 to selectively impart advantageous properties to the flexible sheet 362. The elongate stiffeners 364 of the organ restraint device embodiment 360 of FIG. 41 may include some or all of the features, dimensions or materials of the elongate stiffener embodiments 216 discussed above. The elongate stiffener configuration 364 of the main body portion 366 of the flexible sheet 362 of the device 360 may include optional sheet ribs 368 which extend generally from the dorsal side 370 of the flexible sheet 362 to the ventral side 372 along a line which may be substantially collinear with a longitudinal axis 374 of a respective anchor extension 376. In this way, such sheet ribs 368 may be configured to provide resilient properties to the flexible sheet 362 across the entire span from the dorsal edge 370 to the ventral edge 372 and across the anchor extensions 376 as well. Such sheet ribs 368 may also provide enhanced tensile strength to the flexible sheet 362 along the length of the sheet ribs 368 from the dorsal edge 370 to the outer ends 378 of the respective anchor extensions 376 that optionally include sheet rib extensions 368. In some cases, the sheet ribs 368 may also be useful to promote or facilitate unfolding and unfurling of the main body 366 of the flexible sheet 362 once released from the outer constraint of the access tube 224 or the like. The elongate stiffener segment configuration 364 that includes sheet ribs 368 may be used for any suitable flexible sheet embodiment discussed herein.

FIGS. 42 and 43 show an enlarged view in section of an optional directional anchor extension constraint grommet embodiment 380. The inner lumen 382 of the constraint grommet 380 has an inner surface 384 with directional ridges 386 having sharp edges that may serve to allow easy passage of an anchor extension 228 in an outward direction during deployment of an organ restraint device 200 while resisting inward movement of the anchor extension 228. Such a constraint grommet 380 may be used in lieu of or in conjunction with the methods and devices of securing the anchor extensions discussed above. FIG. 43 shows the directional anchor extension constraint grommet 380 of FIG. 42 with an anchor extension 228 of an organ restraint device embodiment 200 disposed and secured within an inner lumen of the grommet 380.

FIG. 44 is an enlarged view in section of an anchor extension constraint grommet embodiment 390 that has a substantially smooth bore 392 which is configured for use with a tapered plug 394 in order to secure an anchor extension 228 thereto. FIG. 45 shows the anchor extension constraint grommet 390 of FIG. 44 with an anchor extension 228 of an organ restraint device embodiment 200 disposed within an inner lumen 392 of the constraint grommet 390 and secured within the inner lumen 392 of the grommet 390 due to frictional force created by the tapered plug 394 which has been forcibly pushed into the inner lumen 392 of the grommet 390 and remaining disposed within the inner lumen 392 so as to squeeze the anchor extension 228 between an outside surface of the tapered plug 394 and an inside surface of the bore 392 of the constraint grommet 390. Each of these constraint grommets 380 and 390 of FIGS. 42-45 may optionally be used for any of the deployment methods discussed above.

With regard to the above detailed description, like reference numerals used therein may refer to like elements that may have the same or similar dimensions, materials and configurations. While particular forms of embodiments have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the embodiments of the invention. Accordingly, it is not intended that the invention be limited by the forgoing detailed description.

The entirety of each patent, patent application, publication and document referenced herein is hereby incorporated by reference. Citation of the above patents, patent applications, publications and documents is not an admission that any of the foregoing is pertinent prior art, nor does it constitute any admission as to the contents or date of these documents.

Modifications may be made to the foregoing embodiments without departing from the basic aspects of the technology. Although the technology may have been described in substantial detail with reference to one or more specific embodiments, changes may be made to the embodiments specifically disclosed in this application, yet these modifications and improvements are within the scope and spirit of the technology. The technology illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms "comprising," "consisting essentially of," and "consisting of may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible within the scope of the technology claimed. The term "a" or "an" may refer to one of or a plurality of the elements it modifies (e.g., "a reagent" can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described. Although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be made, and such modifications and variations may be considered within the scope of this technology. Certain embodiments of the technology are set forth in the claim(s) that follow(s).

Claims

What is claimed is:

1 . An organ restraint device, comprising:

a flexible sheet including a contact surface, a non-contact surface, and a main body portion with an outer perimeter, the outer perimeter including a shape profile that is configured to conform to an inside surface shape profile of a target body cavity; and

a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist perpendicular displacement.

2. The device of claim 1 further comprising a plurality of elongate stiffener segments which are secured to the main body portion of the flexible sheet, which extend at least generally adjacent to the outer perimeter of the main body portion and which comprise a resilient, flexible elastic material.

3. The device of claim 1 wherein the flexible sheet comprises a mesh structure including high strength biocompatible filaments.

4. The device of claim 3 wherein the mesh structure comprises elongate polymer filaments having an outer transverse dimension of about 0.2 mm to about 0.8 mm.

5. The device of claim 3 wherein the mesh structure comprises pores, the pores having an inner transverse dimension of about 1 mm to about 10 mm.

6. The device of claim 3 wherein high strength biocompatible filaments of the mesh structure comprises a polymer material.

7. The device of claim 6 wherein the polymer material of the high strength biocompatible filaments comprises a material selected from the group consisting of Nylon®, PTFE and HDPE.

8. The device of claim 1 wherein the flexible sheet comprises a thin flexible continuous layer without any significant pore structure.

9. The device of claim 8 wherein the thin continuous layer comprises a material selected from the group consisting of Nylon®, PVC, polyurethane, and PTFE.

10. The device of claim 2 wherein the elongate stiffener segments comprise a continuous network of interconnected segments.

1 1 . The device of claim 10 wherein the elongate stiffener segments comprise a resilient elastic polymer.

12. The device of claim 1 1 wherein the resilient elastic polymer comprises a polymer selected from the group consisting of TPE, ABS plastic, and silicone.

13. The device of claim 1 1 wherein the resilient elastic polymer comprises a shore hardness of about 30A to about 50A.

14. The device of claim 1 wherein the anchor extensions and the main body portion of the flexible sheet are at least partially formed from a continuous sheet of material and the anchor extensions comprise outward radial extensions of material of the flexible sheet.

15. The device of claim 14 wherein the flexible sheet portion of the anchor extensions have an outer profile that tapers transversely from an inside end to an outside end of each anchor extension.

16. The device of claim 15 wherein an outer profile of each anchor extension transitions smoothly with a rounded filleted transition to the nominal outer perimeter of the main body portion of the flexible sheet.

17. The device of claim 1 wherein the anchor extensions comprise an elongate stiffener extending along an axial length thereof.

18. The device of claim 15 wherein at least some of the anchor extensions comprise at least one resilient ramp stop that extends from and is secured to an elongate stiffener segment extending the axial length thereof and that is suitable for lateral compression and corresponding ramp stop retraction during passage of the anchor extensions in an outward radial direction through a constraining lumen and lateral extension of the ramp stop upon release of the outer radial constraint of the constraining lumen.

19. The device of claim 18 wherein at least some of the anchor extensions comprise a plurality of resilient ramp stops at spaced intervals along elongate stiffener segments extending the axial length of the respective anchor

extensions.

20. The device of claim 19 wherein the plurality of ramp stops are disposed at spaced intervals of about 2 cm to about 5 cm.

21 . The device of claim 19 wherein at least some of the anchor extensions comprise about 2 to about 5 resilient ramp stops.

22. The device of claim 1 1 wherein the elongate stiffener segments have a thickness of about 0.5 mm to about 4 mm and an outer transverse dimension of about 1 mm to about 10 mm.

23. The device of claim 1 wherein the outer perimeter of the main body portion has a generally rectangular shape with a major transverse dimension of about 25 cm to about 45 cm and a minor transverse dimension of about 12 cm to about 22 cm.

24. The device of claim 1 wherein the device includes at least 6 anchor extensions.

25. The device of claim 1 wherein the main body portion of the flexible sheet has an outer perimeter that is shaped to conform to an inside surface of a patient's abdominal cavity including a ventral edge, a dorsal edge which is disposed opposite the ventral edge, a first lateral edge and a second lateral edge and there are no anchor extensions disposed along the dorsal edge of the outer perimeter of the main body portion.

26. The device of claim 25 wherein a pair of opposed anchor extensions which comprise the dorsal-most anchor extensions include respective longitudinal axes which are substantially collinear with each other.

27. The device of claim 25 wherein the dorsal edge comprises a cut out relief portion in the outer perimeter configured to avoid contact with abdominal vasculature including the aorta and vena cava.

28. The device of claim 1 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of at least about 5 cm.

29. The device of claim 28 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of about 5 cm to about 12 cm.

30. The device of claim 29 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of about 7 cm to about 10 cm.

31 . The device of claim 1 wherein the outer perimeter of the main body portion of the flexible sheet comprises a shape profile selected from the group consisting of generally rectangular shape, generally trapezoidal shape, generally kidney shaped and generally round shaped.

32. The device of claim 1 wherein each of the plurality of anchor extensions comprise a unique identifier to distinguish each anchor extension from other anchor extensions to facilitate identification of each respective anchor extension and deployment of the device within the body cavity.

33. The device of claim 32 wherein the unique identifiers comprise visual identifiers.

34. The device of claim 33 wherein the unique visual identifiers comprise a number marked on each anchor extension that is unique from numbers marked on all other anchor extensions.

35. The device of claim 33 wherein the unique visual identifiers comprise a letter marked on each anchor extension that is unique from letters marked on all other anchor extensions.

36. The device of claim 33 wherein the unique visual identifiers comprise a color marked on each anchor extension that is unique from colors marked on all other anchor extensions.

37. A method of organ restraint within a body cavity, comprising: inserting an organ restraint device into the body cavity in a constrained state through an incision in a wall of the body cavity, the organ restraint device comprising:

a flexible sheet including a contact surface, a non-contact surface, and a main body portion with an outer perimeter, the outer perimeter including a shape profile that is configured to conform to an inside surface shape profile of a target body cavity, and

a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist displacement in a direction perpendicular;

identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity;

withdrawing anchor extensions through respective incisions in the wall of the body cavity and drawing the perimeter of the main body portion in proximity to an inner surface of the body cavity adjacent to each respective incision in the wall of the body cavity so as to span a cross section area of the body cavity with the flexible sheet; and

securing the anchor extensions relative to the wall of the body cavity.

38. The method of claim 37 wherein inserting the organ restraint device within the body cavity in a constrained state comprises inserting an access tube into the body cavity from a position outside the body cavity such that a distal end of the access tube is disposed within the body cavity and ejecting the organ restraint device from an inner lumen of the access tube through distal port of the access tube into the body cavity.

39. The method of claim 37 further comprising visualizing the organ restraint device within the body cavity with a visualization device and wherein identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity comprises visualizing the anchor extensions with the visualization device.

40. The method of claim 39 wherein visualizing the anchor extensions with the visualization device comprises visualizing the anchor extensions with an endoscope.

41 . The method of claim 39 wherein each of the plurality of anchor extensions comprise a unique visual identifier to distinguish each anchor extension from other anchor extensions and wherein identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity comprises visualizing the unique visual identifiers.

42. The method of claim 37 wherein securing the anchor extensions to the wall of the body cavity comprises securing the anchor extensions outside the wall of the body cavity with a hemostat device.

43. The method of claim 37 wherein the anchor extensions comprise an elongate stiffener segment extending along an axial length thereof and at least one resilient ramp stop that extends from and is secured to the elongate stiffener segment extending the axial length thereof and that is suitable for lateral compression and corresponding ramp stop retraction during passage of the anchor extensions in an outward radial direction through a constraining lumen and lateral extension of the ramp stop upon release of the outer radial constraint of the constraining lumen and securing the anchor extensions to the wall of the body cavity comprises pulling ramp stops of the anchor extensions through incisions in the wall of the body cavity and allowing the ramp stops to extend laterally outside the body cavity.

44. The method of claim 43 wherein at least some of the anchor extensions comprise a plurality of resilient ramp stops at spaced intervals along the elongate stiffener segment extending the axial length of the respective anchor extensions and securing the anchor extensions to the wall of the body cavity comprises pulling ramp stops of the anchor extensions through incisions in the wall of the body cavity and allowing one of the plurality of the ramp stops to extend laterally outside the body cavity at a desired amount of retraction of the anchor extension.

45. The method of claim 37 wherein the main body portion of the flexible sheet has an outer perimeter that is shaped to conform to an inside surface of an abdominal cavity including a ventral edge, a dorsal edge which is disposed opposite the ventral edge, a first lateral edge and a second lateral edge and there are no anchor extensions disposed along the dorsal edge of the outer perimeter of the main body portion and wherein withdrawing anchor extensions through respective incisions in the wall of the body cavity comprises withdrawing a pair of opposed anchor extensions which comprise the dorsal-most anchor extensions including respective longitudinal axes which are substantially collinear with each other such that the dorsal edge of the outer perimeter is tensioned to a position proximate the inner dorsal wall of the body cavity without applying excessive pressure to the patient's vasculature within or adjacent to the body cavity.

46. The method of claim 45 wherein the dorsal edge comprises a cut out relief portion in the outer perimeter and wherein withdrawing the pair of opposed anchor extensions comprises withdrawing the pair of opposed anchor extensions such that the cut out relief portion is tensioned to a position proximate the spine, aorta, or vena cava.

47. The method of claim 37 further comprising inflating the body cavity with an inflation fluid and tilting the body cavity into a Trendelenburg position prior to inserting the organ restraint device into the body cavity.

48. The method of claim 47 wherein inflating the body cavity with a fluid comprises inflating the body cavity with a gas selected from the group consisting of air, nitrogen and CO2.

49. The method of claim 47 wherein inflating the body cavity with a fluid and tilting the patient into a Trendelenburg position comprises tilting the body cavity into a head down position having a table angle of about 15 degrees to about 45 degrees with respect to horizontal.

50. The method of claim 47 further comprising returning the body cavity to a substantially horizontal position from the Trendelenburg position then performing a surgical procedure.

51 . The method of claim 50 wherein performing a surgical procedure comprises performing a minimally invasive robotic surgical procedure.

52. The method of claim 50 further comprising tilting the body cavity back into a head down Trendelenburg position, pulling the anchor extensions from the wall of the body cavity and withdrawing the organ restraint device through an incision in the wall of the body cavity.

53. The method of claim 52 further comprising tilting the body cavity back to a substantially horizontal position and deflating the inflation fluid from the body cavity.

54. The method of claim 53 wherein the inflation fluid is deflated from the body cavity prior to tilting the patient back to a substantially horizontal position.

55. The method of claim 37 wherein withdrawing the anchor extensions through respective incisions in the wall of the body cavity and drawing the perimeter of the main body portion in proximity to an inner surface of the body cavity comprises withdrawing the anchor extensions with a surgical grasper.

56. A method of organ restraint within a body cavity, comprising:

inserting an organ restraint device into the body cavity in a constrained state through an incision in a wall of the body cavity, the organ restraint device comprising:

a flexible sheet including a contact surface, a non-contact surface, and a main body portion with an outer perimeter, the outer perimeter being shaped to conform to an inside surface of an abdominal cavity and including a ventral edge, a dorsal edge which is disposed opposite the ventral edge, a first lateral edge and a second lateral edge, and

a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist displacement in a direction perpendicular to the flexible sheet;

identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity;

withdrawing anchor extensions through respective incisions in the wall of the body cavity and drawing the perimeter of the main body portion in proximity to an inner surface of the body cavity adjacent to each respective incision in the wall of the body cavity so as to span a cross section area of the body cavity with the flexible sheet and further comprising withdrawing a pair of opposed anchor extensions which comprise the dorsal-most anchor extensions including respective longitudinal axes which are substantially collinear with each other such that the dorsal edge of the outer perimeter is tensioned to a position proximate the inner dorsal wall of the body cavity without applying excessive pressure to the vasculature within or adjacent to the body cavity; and

securing the anchor extensions relative to the wall of the body cavity.

57. The method of claim 56 wherein the dorsal edge comprises a cut out relief portion in the outer perimeter and wherein withdrawing the pair of opposed anchor extensions comprises withdrawing the pair of opposed anchor extensions such that the cut out relief portion is tensioned to a position proximate the spine, aorta, or vena cava.

58. The method of claim 56 wherein inserting the organ restraint device within the body cavity in a constrained state comprises inserting an access tube into the body cavity from a position outside the body cavity such that a distal end of the access tube is disposed within the body cavity and ejecting the organ restraint device from an inner lumen of the access tube through distal port of the access tube into the body cavity.

59. The method of claim 56 further comprising visualizing the organ restraint device within the body cavity with a visualization device and wherein identifying and accessing the anchor extensions through respective incisions in the wall of the body cavity comprises visualizing the anchor extensions with the visualization device.

60. The method of claim 56 further comprising inflating the body cavity with an inflation fluid and tilting the body cavity into a Trendelenburg position prior to inserting the organ restraint device into the body cavity.

61 . The method of claim 60 wherein inflating the body cavity with a fluid comprises inflating the body cavity with a gas selected from the group consisting of air, nitrogen and CO₂.

62. The method of claim 60 wherein inflating the body cavity with a fluid and tilting the patient into a Trendelenburg position comprises tilting the body cavity into a head down position having a table angle of about 15 degrees to about 45 degrees with respect to horizontal.

63. The method of claim 60 further comprising returning the body cavity to a substantially horizontal position from the Trendelenburg position then performing a surgical procedure.

64. The method of claim 63 wherein performing a surgical procedure comprises performing a minimally invasive robotic surgical procedure.

65. The method of claim 63 further comprising tilting the body cavity back into a head down Trendelenburg position, pulling the anchor extensions from the wall of the body cavity and withdrawing the organ restraint device through an incision in the wall of the body cavity.

66. The method of claim 65 further comprising tilting the body cavity back to a substantially horizontal position and deflating the inflation fluid from the body cavity.

67. The method of claim 66 wherein the inflation fluid is deflated from the body cavity prior to tilting the body cavity back to a substantially horizontal position.

68. A system for restraining organs from a surgical site within a cavity of a body which comprises:

a gas for inflating the cavity;

a flexible sheet capable of being stretched to cover the cross section of the cavity;

an access tube for inserting the flexible sheet into the cavity; and anchor extensions for attaching the flexible sheet within the cavity.

69. The system of claim 68 wherein the cross section is situated between said organs and said surgical site.

70. The system of claim 69 wherein the cross section is an axial cross section.

71 . The system of claim 70 further comprising a tilting table to controllably tilt the body between a horizontal position and a Trendelenburg position.

72. The system of claim 71 further comprising a surgical robot.

73. The system of claim 68 wherein the flexible sheet comprises a fabric mesh.

74. The system of claim 68 wherein the flexible sheet comprises a polymer.

75. The system of claim 68 wherein the surgical site comprises a pelvis.

76. The system of claim 68 wherein the organs include intestines.

77. A method for restraining organs from a surgical site within a cavity of a body comprising:

insufflating the cavity with a gas;

inserting a flexible sheet through an access tube to the cavity;

stretching the flexible sheet across a cross section of the cavity; and anchoring the flexible sheet within the cavity.

78. The method of claim 77 wherein stretching the flexible sheet across a cross section of the cavity comprises stretching the flexible sheet across a cross section that is situated between the organs and the surgical site.

79. The method of claim 78 wherein stretching the flexible sheet across a cross section of the cavity comprises stretching the flexible sheet across a cross section comprises an axial cross section.

80. The method of claim 79 further comprising transitioning the body between a Trendelenburg position and a horizontal position.

81 . The method of claim 80 further comprising performing laparoscopic surgery on the body.

82. The method of claim 80 further comprising performing robotic surgery on the body.

83. An organ restraint device for restraining organs from a surgical site within an inflated cavity of a body, comprising:

a flexible sheet spanning a cross sectional area of the inflated cavity;

a first anchor fixedly attached to a first portion of the flexible sheet to immobilize the first portion within the inflated cavity; and

a second anchor fixedly attached to a second portion of the flexible sheet to immobilize the second portion within the inflated cavity.

84. The device of claim 83 wherein a portion of the flexible sheet is tensioned to conform to a portion of the cross sectional area.

85. The device of claim 83 wherein a portion of the flexible sheet is tensioned between the first anchor and the second anchor.

86. The device of claim 83 wherein said flexible sheet comprises a fabric mesh.

87. The device of claim 83 wherein said flexible sheet comprises a polymer.

88. An organ restraint device, comprising:

a flexible sheet including a contact surface, a non-contact surface, and a main body portion with an outer perimeter, the outer perimeter including a shape profile that is configured to conform to an inside surface shape profile of a target body cavity; and

a plurality of anchor extensions which extend outwardly from the outer perimeter of the main body portion of the flexible sheet, which are configured to transmit outward radial tension to the outer perimeter of the main body portion of the flexible sheet such that the outer perimeter of the main body portion of the flexible sheet may substantially conform to an interior surface of a body cavity and the main body portion may resist perpendicular displacement, and wherein the anchor extensions and the main body portion of the flexible sheet are formed from a continuous sheet of material and the anchor extensions comprise outward radial extensions of material of the flexible sheet.

89. The device of claim 88 wherein the flexible sheet portion of the anchor extensions have an outer profile that tapers transversely from an inside end to an outside end of each anchor extension.

90. The device of claim 89 wherein an outer profile of each anchor extension transitions smoothly with a rounded filleted transition to the nominal outer perimeter of the main body portion of the flexible sheet.

91 . The device of claim 88 wherein the outer perimeter of the main body portion has a generally rectangular shape with a major transverse dimension of about 25 cm to about 45 cm and a minor transverse dimension of about 12 cm to about 22 cm.

92. The device of claim 88 wherein the device includes at least 6 anchor extensions.

93. The device of claim 88 wherein the main body portion of the flexible sheet has an outer perimeter that is shaped to conform to an inside surface of a patient's abdominal cavity including a ventral edge, a dorsal edge which is disposed opposite the ventral edge, a first lateral edge and a second lateral edge and there are no anchor extensions disposed along the dorsal edge of the outer perimeter of the main body portion.

94. The device of claim 93 wherein a pair of opposed anchor extensions which comprise the dorsal-most anchor extensions include respective longitudinal axes which are substantially collinear with each other.

95. The device of claim 93 wherein the dorsal edge comprises a cut out relief portion in the outer perimeter configured to avoid contact with abdominal vasculature including the aorta and vena cava.

96. The device of claim 88 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of at least about 5 cm.

97. The device of claim 96 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of about 5 cm to about 12 cm.

98. The device of claim 97 wherein the anchor extensions have an axial length measured from a nominal surface of the outer perimeter to an outer end of the anchor extensions of about 7 cm to about 10 cm.