Circumferential Retractor System

Abstract

A circumferential retractor system is provided that includes a circumferential retractor and a flexible retainer that constricts and protects a body opening of a patient to provide access within the patient.

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63 / 154,227, filed February 26, 2021, and U.S. Provisional Patent Application Serial No. 63 / 154,290, filed February 26, 2021, which are incorporated by reference in their entireties.

[0002] FIELD OF THE DISCLOSURE This application relates generally to surgical access devices, and more particularly to circumferential protector and / or retractor systems and methods for surgical procedures that operate within a body cavity or through an opening or orifice. [Background technology]

[0003] Working space within a body cavity is always limited, especially when using surgical instruments and devices. Some procedures require placement of such instruments through very small incisions or openings in relatively small body cavities or surgical spaces, where visibility is often poor or limited. Small retractors can maintain or support small incisions or openings during procedures in such limited spaces, but also provide the user with less instrument triangulation than larger retractors, limiting their usefulness. Summary of the Invention [Means for solving the problem]

[0004] According to various embodiments, a circumferential protector / retractor is provided. According to various embodiments, a circumferential retractor system includes a circumferential protector / retractor and a retainer. In various embodiments, the circumferential retractor includes an outer ring having an outer diameter and configured to be positioned outside a body cavity, an inner ring having an outer diameter and configured to be positioned inside a body cavity, and a sheath. In various embodiments, the sheath includes an upper segment connected to the outer ring, the upper segment having a cylindrical shape with a proximal end having an inner diameter that matches or is smaller than the outer diameter of the inner ring and a distal end having an inner diameter that matches or is smaller than the outer diameter of the outer ring. In various embodiments, the sheath further includes a lower segment connected to the inner ring, the lower segment having a frustoconical shape with a proximal end having an inner diameter that matches or is smaller than the outer diameter of the inner ring and a distal end having an inner diameter that matches or is smaller than the outer diameter of the inner ring. The sheath defines an access channel extending from the outer ring to the inner ring. In various embodiments, the retainer is a monolithic, hourglass-shaped, flexible retainer disposed outside the access channel and configured to surround and contact a distal portion of the lower segment of the sheath.

[0005] In various embodiments, the upper and lower segments of the sheath are formed from the same material to form a monolithic structure. In various embodiments, the proximal end of the upper segment of the sheath is configured to be disposed outside the body cavity and the distal end of the upper segment of the sheath is configured to be disposed inside the body cavity. In various embodiments, the upper segment has a shape or profile that matches the outer profile of the outer ring and / or has an adjustable length configured to apply a radial force with adjustment of the length of the upper segment. In various embodiments, the length of the upper segment is adjustable by winding or rotating the outer ring while the lower segment remains unchanged to wrap a portion of the upper segment around the outer ring. In various embodiments, the outer ring is prevented from rotating and winding and / or adjusting beyond a predetermined stop position between the upper and lower segments of the sheath. In various embodiments, the sheath includes an indicator that marks a predetermined stop position between the upper and lower segments of the sheath of the outer ring or a predetermined position between the upper and lower segments of the sheath of the sheath.

[0006] In various embodiments, the upper segment is adjustable in length and the lower segment is non-adjustable in length, the lower segment connected to the inner ring is non-separable from the inner ring, and / or the upper segment connected to the outer ring is non-separable from the outer ring. In various embodiments, the sheath is compressible and / or made of a non-metallic material. In various embodiments, the inner ring is compressible from a circular to an oval shape and / or is biased back to a circular shape and / or the outer ring is not compressible. In various embodiments, the retainer has a length less than the full length of the sheath, is compressible, and / or has a non-adjustable length. In various embodiments, the lower segment of the sheath conforms to a shape, such as an hourglass shape, of the retainer.

[0007] In various embodiments, the retainer is configured to be disposed between the sheath and the tissue, and / or the lower segment of the sheath is configured to be disposed between the retainer and the insertion instrument. In various embodiments, the retainer is configured to surround only the lower segment of the sheath, and / or the outer surface of the lower segment of the sheath is disposed between the inner surface of the lower segment and the inner surface of the retainer. In various embodiments, the retainer is more flexible than the outer ring and / or the inner ring, and / or is less flexible than the sheath. In various embodiments, the retainer is disposed between the upper segment and the inner ring, and / or the sheath is configured to enlarge the central opening of the retainer. In various embodiments, the sheath is configured to straighten or flatten the retainer. In various embodiments, the sheath is configured to straighten or flatten a middle portion of the hourglass shape of the retainer. In various embodiments, the sheath is configured to change the shape of the retainer, such as an hourglass shape, to a different shape, such as a cylindrical shape. In various embodiments, the sheath is configured to straighten, flatten, and / or deform the retainer upon and / or due to shortening and / or adjusting the length of the upper segment of the sheath. In various embodiments, the retainer has a non-adjustable length and / or an upper inner diameter smaller than the inner diameter of the outer ring and / or an intermediate inner diameter smaller than the upper inner diameter and smaller than the inner diameter of the outer ring. In various embodiments, the retainer is temporarily deformable by a user and / or has an initial shape, is deformable, and is biased back to the initial shape.

[0008] In various embodiments, the outer ring includes a flexible ring having an internal lumen and a curved rod disposed within the internal lumen of the flexible ring, the curved rod being stiffer than the flexible ring. In various embodiments, the outer ring is rotatable about itself. In various embodiments, the length of the lower segment is greater than the length of the upper segment, the length of the upper segment is less than half the overall length of the sheath, and / or the length of the lower segment is greater than half the overall length of the sheath. In various embodiments, the lower segment has an upper diameter proximal to the upper segment and a lower diameter proximal to the inner ring, the lower diameter of the lower segment is smaller than the upper diameter of the lower segment, and / or the outer diameter of the outer ring is greater than the outer diameter of the inner ring.

[0009] In various embodiments, the distal portion of the retainer has a distal lip at its distal end to facilitate securing the distal portion inside the body cavity, and / or the proximal portion of the retainer has a proximal lip at its proximal end to facilitate securing the proximal portion outside the body cavity. In various embodiments, the distal portion of the retainer has an outer diameter larger than the outer diameter of the inner ring, and / or the proximal portion of the retainer has an inner diameter larger than the outer diameter of the inner ring, and / or the inner diameter of the retainer between the proximal and distal portions of the retainer is smaller than the inner diameter of the inner ring. In various embodiments, the sealing cap is configured to connect to the outer ring and / or a portion of the upper segment of the sheath. In various embodiments, the sealing cap seals the access channel and / or the connection between the sealing cap, the outer ring and / or a portion of the upper segment. In various embodiments, the inner ring has a tether attached thereto, and / or the tether has a length greater than the overall length of the sheath, and / or has a tether tag attached thereto.

[0010] According to various embodiments, the circumferential protector / retractor includes a sheath including an upper segment having a first shape and a lower segment having a second shape different from the first shape of the upper segment, hi various embodiments, the retainer has a third shape different from the first shape of the upper segment and the second shape of the lower segment.

[0011] In various embodiments, the retainer has a length greater than the length of the upper segment, less than the entire length of the sheath, and / or has a non-adjustable length. In various embodiments, the retainer is compressible, configured to be disposed between the sheath and the tissue, and / or configured to surround only the lower segment of the sheath. In various embodiments, an outer surface of the lower segment of the sheath is disposed between an inner surface of the lower segment and an inner surface of the retainer, and / or the sheath is configured to enlarge a central opening of the retainer. In various embodiments, the sheath is configured to straighten or flatten the retainer. In various embodiments, the sheath is configured to change the shape of the retainer to a different shape. In various embodiments, the sheath is configured to straighten, flatten, and / or deform the retainer upon and / or due to shortening and / or adjusting the length of the upper segment of the sheath. In various embodiments, the retainer is less flexible than the sheath, is less adjustable, has a non-adjustable length, is elastic, is temporarily deformable by a user, is deformable to a fourth shape different from the third shape, is biased to return to the third shape, and / or is more rigid than the sheath.

[0012] In various embodiments, a circumferential retractor system includes a circumferential protector / retractor including a sheath including an upper segment having a first shape and a lower segment having a second shape different from the first shape of the upper segment. In various embodiments, the upper and lower segments of the sheath are formed from the same material and / or form a monolithic structure. In various embodiments, a proximal portion of the upper segment of the sheath is configured to be positioned outside the body wall and / or a distal portion of the upper segment of the sheath is configured to be positioned inside the body wall.

[0013] In various embodiments, the length of the lower segment is greater than the length of the upper segment, the length of the upper segment is less than half the total length of the sheath, and / or the length of the lower segment is less than half the total length of the sheath. In various embodiments, the length of the upper segment is adjustable, and / or the length of the lower segment is non-adjustable. In various embodiments, the sheath is compressible, formed of a non-metallic material, multi-layered, or any combination thereof. In various embodiments, an outer ring is connected to the upper segment of the sheath, and / or an inner ring is connected to the lower segment of the sheath. In various embodiments, a first shape of the upper segment corresponds to and / or has an outer shape that corresponds to an outer shape of the outer ring connected to the upper segment. In various embodiments, the upper segment is configured to apply a radial force as the upper segment shortens, has an adjustable length configured to apply a radial force as the length of the upper segment is adjusted, and / or is adjustable by gathering and / or wrapping the upper segment around the outer ring while the lower segment and / or its length remain unchanged and the outer ring is rolled, rotated and / or adjusted. In various embodiments, the upper segment is configured to apply a radial force as the upper segment shortens by wrapping a portion of the upper segment around the outer ring while the length of the lower segment remains unchanged and the outer ring is rotated around itself.

[0014] In various embodiments, the outer ring is prevented from rotating and / or adjusting beyond a predetermined position on the sheath, the upper or lower segment, the distal end of the upper segment, and / or the proximal end of the lower segment. In various embodiments, the outer ring has a fixed, non-adjustable diameter. In various embodiments, the outer ring includes multiple rings, a first ring stacked on a second ring, a flexible ring, and a rigid ring that is less flexible than the flexible ring, and / or a flexible ring with an internal lumen and a curved rigid rod, hoop, or bar disposed within the internal lumen of the flexible ring.

[0015] In various embodiments, the outer ring includes an inner rigid ring encased in an outer flexible ring, the inner rigid ring being harder than the outer flexible ring. In various embodiments, the inner rigid ring is made of metal and / or the outer flexible ring is made of plastic. In various embodiments, the inner rigid ring is formed of a harder material than the material of the outer flexible ring. In various embodiments, the outer ring is rotatable about itself. In various embodiments, the outer ring has a fixed, predetermined diameter, a fixed thickness that is about one-sixth (1 / 6) or less of the total length of the upper segment, and / or a fixed height that is about one-sixth (1 / 6) or less of the total length of the upper segment.

[0016] In various embodiments, the inner ring includes slits to facilitate folding of the inner ring, is ovally compressible, is deformable and placeable with inner portions of the inner ring in contact with one another, and is capable of returning to an initial shape and / or is biased to return to an initial shape. In various embodiments, the inner ring has a fixed circumference that cannot be expanded. In various embodiments, the inner ring is deformable and / or the outer ring is non-deformable. In various embodiments, the inner ring is the distal-most portion of the circumferential retractor. In various embodiments, the sealing cap is configured to connect to a tether attached to the outer ring and / or a portion of the upper segment of the sheath and / or the inner ring. In various embodiments, the tether has a length greater than the entire length of the sheath and / or has a tether tag attached to the tether.

[0017] In various embodiments, the distal end of the lower segment of the sheath is connected to an inner portion of the inner ring. In various embodiments, the distal end of the lower segment of the sheath is connected to an outer portion of the inner ring. In various embodiments, the lower segment of the sheath is tapered. In various embodiments, the second shape of the lower segment of the sheath is a frusto-cone tapered from the distal end of the upper segment to the inner ring. In various embodiments, the lower segment has a diameter that tapers from the proximal end of the lower segment to the distal end of the lower segment. In various embodiments, the lower segment has a diameter that tapers at a constant rate from the proximal end of the lower segment to the distal end of the lower segment. In various embodiments, the lower segment has a curved sidewall. In various embodiments, the lower segment has a symmetrical sidewall. In various embodiments, the lower segment has a curved symmetrical sidewall.

[0018] In various embodiments, the upper segment has a constant outer diameter and a constant inner diameter extending from the proximal end of the upper segment to the distal end of the upper segment. In various embodiments, the constant outer and / or inner diameter of the upper segment reduces sheath tension by maintaining a sheath diameter that matches the diameter of the outer ring with each inversion, rotation, or adjustment of the outer ring. In various embodiments, the upper segment has a lower or less sheath tension than the lower segment. In various embodiments, the lower segment has a higher sheath tension than the upper segment. In various embodiments, the upper segment is configured to be wrapped, wrapped, and / or rotated a predetermined number of times around the outer ring. In various embodiments, the predetermined number is at least 6 times, and / or about 6 times, and / or less.

[0019] In various embodiments, the lower segment has a sidewall that extends transversely, vertically, and / or horizontally relative to the longitudinal axis of the sheath. In various embodiments, the upper segment has a sidewall that extends in a direction parallel to the longitudinal axis of the sheath. In various embodiments, a portion of the lower segment is angled relative to the upper segment. In various embodiments, the shape, such as the third shape, of the retainer has a proximal funnel and / or an opposing distal funnel. In various embodiments, the retainer has a proximal funnel or tapered portion and / or an opposing distal funnel or tapered portion. In various embodiments, the proximal funnel portion has a diameter that gradually decreases from its proximal end to its distal end. In various embodiments, the distal funnel portion has a diameter that gradually increases from its proximal end to its distal end. In various embodiments, the retainer has an hourglass shape.

[0020] According to various embodiments, a circumferential retractor system is provided that includes a first circumferential retractor, a retainer, and / or a second circumferential retractor. In various embodiments, the first circumferential retractor includes a sheath that includes an upper segment having a first shape and a lower segment having a second shape different from the first shape of the upper segment. In various embodiments, the retainer is disposed between the first circumferential retractor and the second circumferential retractor. In various embodiments, the retainer is stiffer than the upper and lower segments of the sheath. In various embodiments, the upper segment has an adjustable length, the retainer has a fixed, non-adjustable length, and / or the lower segment has a fixed, non-adjustable length.

[0021] In various embodiments, the inner ring is connected to the lower segment of the first circumferential retractor and / or is inseparable from the lower segment and / or is configured to be inserted through a central opening of the retainer. In various embodiments, the inner ring is configured to be disposed distally and / or disposed near a distal end of the retainer. In various embodiments, the outer ring is connected to the upper segment and / or is inseparable from the upper segment. In various embodiments, the outer ring has a first position distal to a proximal end of the retainer and a second position proximal to the proximal end of the retainer, and in various embodiments, the outer ring is rotatable to move the outer ring from the first position to the second position. In various embodiments, the sheath is configured to secure the retainer between the lower segment of the sheath and the inner ring. In various embodiments, the upper segment has an adjustable length configured to secure the retainer between the lower segment of the sheath and the inner ring. In various embodiments, the sheath includes a protrusion configured to secure the retainer between the protrusion and the inner ring.

[0022] In various embodiments, the second circumferential retractor includes and / or is a containment bag. In various embodiments, the second circumferential retractor includes a sheath having a cylindrical shape, a containment bag, and / or a frusto-conical shape. In various embodiments, the second circumferential retractor has a portion, such as a distal portion, configured to be inserted through and positioned within a body wall, a retainer is configured to be inserted through and positioned within the body wall over the portion, such as the distal portion, of the second circumferential retractor, and / or a lower segment of the first circumferential retractor is configured to be inserted through and positioned within the body wall over the retainer.

[0023] In various embodiments, the sheath is configured to secure the retainer between a lower segment of the sheath and the inner ring. In various embodiments, the upper segment has an adjustable length configured to secure the retainer between the lower segment of the sheath and the inner ring. In various embodiments, the sheath includes a protrusion configured to secure the retainer between the protrusion and the inner ring. In various embodiments, the protrusion extends fully or partially circumferentially around the sheath. In various embodiments, the protrusion has a width or height less than a width or height of the inner ring. In various embodiments, the circumferential retractor includes a containment bag. In various embodiments, the sheath has a cylindrical shape, a containment bag, and / or a frusto-conical shape.

[0024] Many of the attendant features of the present invention will become more readily appreciated as the same becomes better understood by reference to the above and following descriptions when considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1A] 1 is a perspective view of a protector / retractor according to various embodiments of the present invention; [Figure 1B] 1 is a perspective view of a protector / retractor according to various embodiments of the present invention; [Figure 2A] FIG. 2 is a side view of a protector / retractor according to various embodiments of the present invention. [Figure 2B] FIG. 2 is a side view of a protector / retractor according to various embodiments of the present invention. [Figure 3A] 1A-1D are top views of a protector / retractor according to various embodiments of the present invention. [Figure 3B] 1A-1D are top views of a protector / retractor according to various embodiments of the present invention. [Figure 4A] 1A-1C are bottom views of protector / retractors according to various embodiments of the present invention. [Figure 4B] 1A-1C are bottom views of protector / retractors according to various embodiments of the present invention. [Diagram 5] 1A-1D are top views of a deployed protector / retractor according to various embodiments of the present invention. [Figure 6] FIG. 2 is a side view of a protector / retractor according to various embodiments of the present invention. [Figure 7] 1A-1C are perspective views of channels or retainers according to various embodiments of the present invention. [Figure 8] 1A-1C are top views of channels or retainers according to various embodiments of the present invention. [Figure 9] 1A-1C are side views of channels or retainers according to various embodiments of the present invention. [Figure 10] 1A-1C are cross-sectional side views of channels or retainers according to various embodiments of the present invention. [Figure 11A] 1A-1D are various views of a channel or retainer according to various embodiments of the present invention. [Figure 11B] 1A-1D are various views of a channel or retainer according to various embodiments of the present invention. [Figure 11C] 1A-1D are various views of a channel or retainer according to various embodiments of the present invention. [Figure 12] 1A-1C are side views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 13] 1A-1C are cross-sectional side views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 14] 1A-1C are bottom views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 15] 1A-1C are perspective views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 16] 1A-1C are perspective views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 17] 1A-1C are side views of a protector / retractor and a channel or retainer according to various embodiments of the present invention. [Figure 18]1A-1C are perspective views of a deployed protector / retractor and a channel or retainer according to various embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] According to various embodiments, protector / retainer devices, systems and / or methods are provided, and various views of exemplary protector / retainer devices, systems and various embodiments of these aspects are illustrated in FIGS.

[0027] In various embodiments, the retractor system includes a circumferential protector / retractor (hereinafter referred to as a "retractor") and / or a self-retaining retainer or channel. In various embodiments, the system provides self-retaining retraction and simultaneous insufflation of the vaginal canal or body cavity while also allowing the passage and manipulation of instruments. The retractor system according to various embodiments allows the surgeon to perform various diagnostic and therapeutic procedures in the vaginal canal using endoscopic techniques. One exemplary procedure is an endoscopic colpotomy, in which the vaginal canal is incised near or around the formed cervix while using vaginal insufflation and laparoscopic instruments. Access to the abdominal cavity can be achieved through the vaginal incision. The retractor system provides or enables the endoscopic colpotomy by providing self-retaining retraction, insufflation, and scope / instrument access. In various embodiments, the system can also be used for other procedures requiring endoscopic access and / or endoscopic access with insufflation of the vaginal canal or body cavity. In various embodiments, the retractor can be fitted with a sealing cap through which a trocar sleeve and / or instruments can be inserted. In various embodiments, an air insufflation stabilizing bag system can be connected to the retractor system to reduce pulsation / billowing of the vaginal canal or body cavity. According to various embodiments, the retractor system establishes air insufflation into the vaginal canal (pneumovagina) or body cavity to allow passage of instruments for various diagnostic and therapeutic procedures (e.g., vaginal incision creation using endoscopic techniques).

[0028] According to various embodiments, a retractor 3 is provided that is deployed within a body cavity of a patient, for example, within the abdominal cavity in open or laparoscopic surgery, or within the peritoneal cavity during transvaginal natural orifice transluminal endoscopic surgery (vNOTES). The retractor according to various embodiments includes an outer or upper portion that includes an outer support or outer ring connected to a sheath having an upper portion or segment. The upper segment 91 of the sheath according to various embodiments has a shape that matches the outer profile or footprint of the outer support. In various embodiments, the upper segment 91 has a circular or cylindrical shape. According to various embodiments, the outer or upper portion of the retractor facilitates external atraumatic placement and manipulation of the retractor, as well as attachment of additional surgical devices such as sealing caps, lighting and / or air delivery units. The outer or upper portion may also provide high contractibility and triangulation. According to various embodiments, the retractor includes an inner or lower portion including an inner support or ring connected to a sheath having a lower portion or segment. The lower segment 93 of the sheath according to various embodiments has a shape that matches the outer profile or footprint of the outer support or outer ring at one end and the inner profile or footprint of the inner support or inner ring at an opposite end. In various embodiments, the lower segment has a conical, frusto-conical, or frusto-conical shape. According to various embodiments, the inner or lower portion or segment facilitates atraumatic placement and fixation of the retractor within the patient's cavity.

[0029] In various embodiments, the retractor 3 protects and / or constricts the patient's opening or hole circumferentially or 360 degrees to provide unhindered access to the patient's body or cavity. The retractor includes an outer ring or support 5 and an inner ring or support 7. The upper or outer ring 5 is configured to be placed or secured to the outside of the patient for ease of access, adjustment of the retraction force, and / or placement of the retractor. In various embodiments, the outer or outer ring 5 of the retractor can be fitted with an instrument port, seal, or gel cap. The lower or inner ring 7 can be inserted through an opening in the patient, such as an incision or natural orifice, to secure the retractor within the patient. The inner ring 7 is smaller than the outer ring 5. In various embodiments, the outer ring 5 has a larger diameter than the inner ring 7.

[0030] The inner and outer rings are connected by a film, fabric, membrane or sheath 9. In various embodiments, the retractor is length adjustable, such as by wrapping a sheath 9 around the outer ring 5 to shorten the distance between the rings, which can apply a contracting or radial force to constrict or enlarge the patient's opening. In various embodiments, the retractor is length adjustable or otherwise adjustable to accommodate different patient body types or body wall thicknesses.

[0031] The retractor is sufficiently flexible so as to be atraumatic when deployed or otherwise disposed through a patient opening and into the patient opening. In various embodiments, the sheath 9 is formed of an elastomeric or non-metallic material so as to be atraumatic when the retractor is in operation or deployment or otherwise disposed through a patient opening and into the patient opening, and / or has no or only minimal thermal conductivity. In various embodiments, the sheath 9 is formed of one or more layers of material, and in various embodiments is anisotropic, e.g., stretchable or extensible in the longitudinal direction but no or only minimally stretchable in the radial direction, and is formed of or includes one or more layers of fabric or similar material having such anisotropic properties.

[0032] According to various embodiments, the sheath 9 includes an upper segment 91 and a lower segment 93. The upper segment 91 has a proximal end attached to the outer ring 5 and a distal end attached to and / or extending from the lower segment 93. In various embodiments, the upper segment 91 has a circular or cylindrical shape. The lower segment 93 has a distal end attached to the inner ring 7 and a proximal end attached to and / or extending from the upper segment 91. According to various embodiments, the lower segment 93 of the sheath 9 has a frusto-conical shape tapered from the distal or lower end of the upper segment 91 towards the inner ring 7. In various embodiments, the upper segment 91 has an outer diameter that matches or closely matches the outer diameter of the outer ring 5. The upper segment 91 has a constant outer diameter extending from its proximal end to its distal end. Since the difficulty of everting or rolling the outer ring 5 is primarily driven by the increased film tension with each eversion, the constant diameter of the upper segment 91 of the sheath 9 allows the outer ring 5 to be everted, rotated or rolled a predetermined or pre-determined number of times with minimal effort to gather or shorten the proximal portion of the upper segment 91 as the upper segment is wrapped, wrapped or wound around the outer surface of the outer ring 5 with less or no increase in the film or material tension of the sheath 9. While a rigid outer ring, such as an outer ring having a rigid hoop or segment on the inside or outside, may be useful because it is sufficiently rigid to connect and seal to a sealing cap or laparoscopic port, the use of such an outer ring may increase the above difficulties. This may also be difficult for the user as more force must be applied to achieve a high amount of retraction. Additionally, applying excessive force to evert the outer ring may compromise the integrity of the film near the outer ring as the film tension increases with each eversion. Additionally, excessive tension on the film near the outer ring can pull the film inward, narrowing the access channel or instrument path and making it more susceptible to damage from sharp instruments.Thus, according to various embodiments, the retractor achieves a higher amount of retraction compared to a non-uniform or non-constant diameter sheath or sheath upper segment, such as a full conical sheath, while still maintaining the integrity of the sheath film or material. According to various embodiments, a cylindrical or constant diameter upper segment helps reduce film tension by maintaining a sheath diameter that matches the outer ring diameter with each inversion.

[0033] In various embodiments, the outer diameter of the distal end of the lower segment 93 matches or closely matches the outer diameter of the inner ring 7. In various embodiments, the outer diameter of the proximal end of the lower segment 93 matches or closely matches the outer diameter of the outer ring 5 and / or the outer diameter of the upper segment 91. The lower segment 93 is curved, angled, or tapered to have a larger upper diameter relative to a smaller lower diameter. In various embodiments, the lower segment 93 has an angular or linear taper extending from its proximal end to its distal end. In various embodiments, the lower segment, such as the lower segment 95, has a curved or arcuate taper extending from its proximal end to its distal end. The tapered lower sheath segment allows the sheath 9 to be attached to a smaller diameter inner ring compared to a larger diameter outer ring or upper segment and used within similarly small or similarly sized incisions, openings, holes, and / or anatomical entrances, channels, or spaces. According to various embodiments, the angle of the tapered or gradually decreasing diameter lower segment 93 is constant and symmetrical to ensure constant tension around the entire circumference of the sheath 9. This maximizes contraction while the body cavity or anatomical space is being insufflated to maintain or maximize an airtight seal against the patient's body or body wall and / or sealing cap or laparoscopic port.

[0034] The smaller inner ring allows or facilitates insertion of the inner ring and / or portions of the lower segment 93 of the sheath 9 through similarly smaller or similarly sized incisions, openings, holes and / or anatomical entrances, channels or spaces. In various embodiments, the outer ring 5, the upper segment 91 of the sheath 9, and / or the proximal end of the lower segment 93 of the sheath 9 have a diameter of about 4-5 inches (10.16 cm-12.7 cm), and in various embodiments, the outer ring 5, the upper segment 91 of the sheath 9, and / or the proximal end of the lower segment 93 of the sheath 9 have a diameter of about 4.4 inches (11.176 cm). In various embodiments, the diameter of the outer ring matches the diameter of the upper segment to ensure or enable the upper segment 91 of the sheath 9 to be welded to the outer ring 5. According to various embodiments, the outer ring 5, the upper segment 91 of the sheath 9, the proximal end of the lower segment 93 of the sheath 9, or a combination thereof have approximately the same diameter. In various embodiments, the inner ring 7 and / or the distal end of the lower segment 93 of the sheath 9 have a diameter of about 2-3 inches, and in various embodiments, the distal end of the inner ring 7 and / or the lower segment 93 of the sheath 9 have a diameter of about 2.8 inches. In various embodiments, the outer ring 5, the upper segment 91 of the sheath 9, and / or the proximal end of the lower segment 93 of the sheath 9 have a diameter larger than the inner ring diameter and / or the diameter of the distal end of the lower segment 93 of the sheath 9, and in various embodiments, about 1-2 inches larger. In various embodiments, the larger outer ring diameter compared to the inner ring diameter increases contractibility and / or provides a wider platform for a sealing cap or laparoscopic port, thus unhindering or enhancing triangulation of instruments. According to various embodiments, the inner ring diameter and / or the diameter of the distal end of the lower segment 93 of the sheath 9 is predetermined or limited by the predetermined or limited size of the incision, internal anatomy, and / or surgical application. In various embodiments, the inner ring 7 and / or the diameter of the distal end of the lower segment 93 of the sheath 9 are sized and configured to fit through a linear colpotomy.In various embodiments, the diameter of the inner ring and the diameter of the distal end of the lower segment 93 of the sheath 9 are approximately the same. In various embodiments, the inner ring 7 is more flexible or less rigid than the outer ring 5. In various embodiments, the inner ring 7 has one or more detents, apertures, slits, or the like to facilitate collapse or folding of the inner ring 7 to facilitate insertion and / or fixation of the inner ring 7. In various embodiments, the inner ring 7 is deformable, compressible, or collapsible, e.g., deforms from a generally circular shape to a generally oval or folded shape, and is biased or resilient, e.g., such that an inner portion of the inner ring 7 moves near or contacts an opposing inner portion of the inner ring 7, and / or returns or reverts to an original or initial undeformed or compressed shape. In various embodiments, a tether 21 and tether tag 23 are attached to the inner ring 7 and / or the distal portion of the lower segment 93 of the sheath 9 to facilitate positioning and / or removal of the inner ring 7.

[0035] In various embodiments, the outer ring 5 is stiffer than the inner ring 7. In various embodiments, the outer ring 5 comprises one or more first rings, hoops or segments attached to or embedded within one or more second rings, hoops or segments that are more flexible or less rigid than the first rings, hoops or segments. In various embodiments, the outer ring 5 is a flexible ring having an internal lumen with rigid hoops or rods extending within the lumen of the flexible ring, the flexible ring being more flexible than the rigid hoops or rods.

[0036] According to various embodiments, the length of the upper segment 91 is pre-determined or predetermined based on the expected number of inversions the outer ring 5 will evert or roll to achieve or maximize contraction. In various embodiments, the pre-determined number of inversions is about 4-6, and in various embodiments, about 5. Thus, in various embodiments, the length of the upper segment 91 is about 5 times or 4-6 times the height or length of the outer ring 5. In various embodiments, the length of the upper segment 91 is at least about 2 times greater than the height or length of the outer ring 5. According to various embodiments, the outer ring 5 is prevented or limited from everting or rolling beyond the distal end of the upper segment 91 and / or into the lower segment 93 of the sheath 9 by one or more barriers, such as protrusions, bumps, or raised or different materials disposed between the upper and lower segments to maintain ease of use. In various embodiments, the protrusions, bumps, or raised or different materials extend circumferentially, fully or partially, around the sheath. In various embodiments, the same protrusion is configured to secure the channel or retainer 31 between the protrusion and the inner ring. In various embodiments, the sheath includes another protrusion, bump, or raised or different material configured to secure the channel or retainer 31 between the protrusion and the inner ring. In various embodiments, the protrusion, bump, or raised or different material extends circumferentially, fully or partially, around the sheath. In various embodiments, the protrusion, bump, or raised or different material has a width or height that is less than the width or height of the inner ring. In various embodiments, one or more markings or similar identifiers are provided that indicate or delineate the upper segment 91 from the lower segment 93 to further facilitate ease of use of the retractor. In various embodiments, the outer ring is prevented from rotating, rolling and / or adjusting beyond a predetermined stop between the upper and lower segments of the sheath. In various embodiments, the sheath includes an indicator that marks a predetermined stop position of the outer ring between the upper and lower segments of the sheath or a predetermined position between the upper and lower segments of the sheath.In various embodiments, the length of the upper segment 91 is sufficient to provide enough slack for insertion of a retractor. In various embodiments, the length of the upper segment 91 is minimized to avoid excessive eversion or rolling up of the outer ring 5, which can cause undesirable operational issues.

[0037] In various embodiments, the length of the lower segment 93 is pre-determined or predetermined based on the surgical application. In various embodiments, the length of the lower segment 93 is an expected or pre-determined final length between the inner and outer rings when the retractor is deployed and fully retracted. In various embodiments, the length of the lower segment 93 is approximately the length of the vaginal canal, the thickness of the abdominal wall, and / or any combination therebetween. In various embodiments, the length of the lower segment 93 is longer than the length of the upper segment 91. In various embodiments, the length of the upper segment 91 is less than the entire length or half of the entire length of the sheath 9.

[0038] In various embodiments, the outer ring 5 and inner ring 7 are formed of the same material and the sheath 9 is formed of a different material. In various embodiments, the outer ring 5 is more rigid or less flexible than the sheath 9 and the sheath 9 is more flexible or less rigid than the inner ring 7. In various embodiments, the upper and lower segments of the sheath 9 are formed of the same material and in various embodiments are monolithic or formed to provide a unitary, integral or monolithic structure. In various embodiments, the upper segment 91 is formed of a more flexible material than the lower segment 93 and / or the lower segment 93 is reinforced or formed of a different or more durable / puncture resistant material compared to the material of the upper segment 91.

[0039] In various embodiments, another or second sheath, membrane or film is disposed between the channel or retainer 31 and the patient's tissue, and thus the retainer is disposed between the another or second sheath and sheath 9. In various embodiments, the other or second sheath is attached to the sheath 9 or outer ring, or is attached to another or different retractor.

[0040] In various embodiments, the sheath 9 is configured to secure the channel or retainer 31 between the lower segment 93 of the sheath and the inner ring 7. In various embodiments, the upper segment 91 has an adjustable length configured to secure the retainer 31 between the lower segment 93 of the sheath and the inner ring 7. In various embodiments, the sheath includes a protrusion configured to secure the retainer 31 between the protrusion and the inner ring 7. In various embodiments, the protrusion extends fully or partially circumferentially around the sheath. In various embodiments, the protrusion has a width or height less than the width or height of the inner ring 7. In various embodiments, the circumferential retractor includes a containment bag. In various embodiments, the sheath has a cylindrical shape, a containment bag, and / or a frusto-conical shape.

[0041] According to various embodiments, the opening, hole, or incision at the surgical site is contracted by compressing the inner ring 7 through the opening so that the ring is secured under or within the desired tissue. In various embodiments, the inner ring 7 is configured to be flexible and / or compressible to fit through the opening, yet rigid and / or biased to return to its original shape and retain its shape when deployed to provide an anchor for the retractor. The outer ring 5 everts or rolls around itself downward or toward the inner ring 7 to bring the upper segments 91 of the retractor together to contract the opening, i.e., to increase the diameter of the opening in the patient, thereby providing an access channel through the sheath 9 and the opening. Everting or rolling the outer ring 5 downward increases tension on the sheath 9, exerting a circumferential outward pressure on the opening, contracting the opening and / or the body wall.

[0042] In various embodiments, a sealing cap or gel cap or port is attached to the outer ring 5 and / or to the patient's body cavity or surgical site being insufflated. Instruments can be inserted through the cap, port, or sleeve located or provided within the cap to access the internal anatomy or surgical site during insufflation.

[0043] In various embodiments, the outer diameter or circumference of the retractor during operation and / or deployment is determined by or is no larger than the outer diameter of the outer ring 5. In various embodiments, the upper and lower segment sheaths allow surgery through a relatively large instrument port or entry point providing optimal or maximized instrument triangulation and through a relatively small incision without sacrificing the range and amount of retraction or ease of use. In various embodiments, the retractor provides a retracted diameter of about 25 mm. In various embodiments, the retractor provides a retracted diameter that is larger than the retracted diameter of a similarly sized retractor having a fully cylindrical sheath and / or a fully tapered sheath with a similarly sized inner ring. In various embodiments, the retractor provides an access or channel or passageway into the patient's body cavity. In various embodiments, the length of the retractor is adjustable to accommodate 360 ​​degree hands-free protection and / or retraction of different patient anatomy and / or patient orifices. In various embodiments, the retractor can not include an outer ring 5, an inner ring 7, or both. In various embodiments, the retractor includes a containment bag. In various embodiments, the retractor can be used in open and laparoscopic surgery. According to various embodiments, the retractor is positioned to provide variable, atraumatic, circumferential retraction of the surgical site. Circumferential retraction of the surgical site enhances visibility and access to the target tissue while protecting the opening, channel, or wound margin.

[0044] In various embodiments, the sheath 3 is formed by die cutting two flat sheets of film, each providing a square or rectangular cross section and a trapezoidal cross section. The two cut sheets are connected, e.g., welded at their side edges to each other, to form an upper cylindrical segment 91 and a lower frustoconical segment 93. According to various embodiments, the sheath is made of thermoplastic polyurethane (TPU). In various embodiments, the inner ring and / or the outer ring are made of TPU, and in various embodiments, the outer ring 5 includes one or more rigid hoops or segments, e.g., made of stainless steel, polycarbonate, or GRIVORY, and is connected to, embedded in, or otherwise attached to such rigid hoops or segments. The inner ring 7, which is placed through the opening or incision or into the patient, is smaller than the outer ring 5, which remains outside the opening or incision or outside the patient.

[0045] According to various embodiments, a channel or retainer 31 is provided and inserted into a patient's body opening, such as an incision and / or a natural orifice. In various embodiments, the channel or retainer 31 has a proximal funnel or tapered portion and an opposing distal funnel or tapered portion. In various embodiments, the proximal funnel portion has a gradually decreasing diameter from its proximal end to its distal end. In various embodiments, the distal funnel portion has a gradually increasing diameter from its proximal end to its distal end. In various embodiments, the channel or retainer 31 has an hourglass shape, and in various embodiments, the channel or retainer defines a lumen or access channel or pathway from its proximal end to its distal end. Upon insertion, the distal portion of the channel or retainer 31 is disposed internally or within a surgical space or body cavity, such as the vaginal canal, while the proximal portion remains external or outside the surgical space or body cavity.

[0046] In various embodiments, the channel or retainer 31 is axially symmetric. In various embodiments, the symmetry of the channel or retainer 31 allows for non-directional placement, which increases the convenience of the user. In various embodiments, the proximal and distal portions have the same curvature or share the same curve. In various embodiments, the proximal portion has a proximal diameter equal to the distal diameter of the distal portion. In various embodiments, the proximal portion has a distal diameter equal to the proximal diameter of the distal portion. In various embodiments, the proximal portion has a proximal lip or flange at its proximal end for easily or further securing the proximal portion to an outer or external portion of the patient's body, and / or the distal portion has a distal lip or flange at its distal end for easily or further securing the distal portion to an inner or internal portion of the patient's body.

[0047] In various embodiments, the proximal portion and / or lip has a larger diameter, footprint, or profile than the distal portion and / or lip. In various embodiments, a larger proximal portion compared to the distal portion facilitates sealing outside the patient's body. In various embodiments, the distal portion and / or lip has a larger diameter, footprint, or profile than the proximal portion and / or lip. In various embodiments, a larger distal portion compared to the proximal portion facilitates or enhances fixation of the channel or retainer 31 within the body, such as within the vaginal introitus. However, in various embodiments, a larger distal portion compared to the proximal portion may be difficult to insert into and / or through a patient's opening.

[0048] In various embodiments, the outermost diameter of the channel or retainer 31 is sized to be placed within a patient's opening, incision or hole to provide an initial constriction of the opening. According to various embodiments, the outermost diameter of the channel or retainer 31 is sized to be placed within a vaginal introitus or vaginal canal opening. In various embodiments, the outermost diameter of the channel or retainer 31 is about 45-75 mm, and in various embodiments, the innermost diameter is about 20-50 mm.

[0049] In various embodiments, the innermost diameter of the channel or retainer 31 can affect the user's ability to insert the inner ring of the retractor and ultimately the ability to insert and manipulate instruments for the intended procedure. In various embodiments, due to anatomical variations, multiple sizes of channels can be provided to be used at the surgeon's discretion. In various embodiments, channels of different depths are provided while the inner and outer diameters remain the same.

[0050] In various embodiments, the depth of the channel or retainer 31 is sufficient to grasp or otherwise engage tissue structures at a patient's opening, such as the vaginal introitus, and in various embodiments serves as an anchor for placement of the inner ring. In various embodiments, the depth of the channel or retainer 31 is about 20-40 mm, and in various embodiments, about 30 mm. In various embodiments, the depth of the channel or retainer 31 is sized and configured to expand the thickness of the body wall or introitus, such as the vaginal introitus. In various embodiments, the curvature and / or depth of the channel or retainer 31 facilitates secure placement at the body wall or introitus, such as the vaginal introitus.

[0051] According to various embodiments, the channel or retainer 31 is formed of a semi-rigid polymeric material, such as KRATON. In various embodiments, the channel or retainer 31 is substantially flexible to allow manual compression and manipulation to manually place it through a body orifice into a body orifice, such as a vaginal introitus. In various embodiments, the channel or retainer 31 is flexible and resilient to recover to its original or initial shape or un-crushed or un-deformed state after being released from compression or manual manipulation. In various embodiments, the channel or retainer 31 is configured or formed of a material that promotes or provides optimal atraumatic friction with the target contact anatomy to further aid in self-anchoring of the channel or retainer 31 within the anatomy and / or to the sheath. In various embodiments, the channel or retainer 31 is made of silicone rubber.

[0052] In various embodiments, the proximal and distal lips are formed of the same material and the remainder of the channel or retainer is formed of a different material. In various embodiments, the proximal lip is stiffer or less flexible than the remainder of the channel or retainer and in various embodiments, the distal lip is stiffer or less flexible than the remainder of the channel or retainer. In various embodiments, the proximal lip is stiffer or less flexible than the distal lip. In various embodiments, the proximal and distal portions, with or without the proximal and / or distal lips, are formed of the same material and in various embodiments are monolithic or monolithically formed to provide a unitary, integral or monolithic structure. In various embodiments, the proximal portion is formed of a softer material than the distal portion and / or the distal portion is reinforced or formed of a different or more durable / puncture resistant material compared to the material of the proximal portion.

[0053] According to various embodiments, the channel or retainer 31 provides an initial contraction of a body cavity, such as the vaginal canal, after initial insertion into the body cavity or through a body opening, such as the vaginal introitus. In various embodiments, the inner ring of the sheath is compressed or otherwise deformed and inserted through the channel or retainer 31. In various embodiments, lifting or pulling a proximal portion of the sheath or outer ring facilitates seating or positioning of the inner ring and / or an upper surface of the inner ring against the channel or retainer 31 and / or an underside of the channel or retainer 31, which serves as an anchor point for the sheath to remain in place or to be further secured or attached within the body cavity, such as the vaginal canal.

[0054] In various embodiments, the outer ring is inverted, rotated, or rolled to bring the sheath, such as the upper segment of the sheath, together and together. In various embodiments, the outer ring is inverted or rolled to bring the sheath, such as the upper segment of the sheath, together and together, contracts the channel or retainer 31 or expands the innermost diameter or central opening of the channel or retainer 31 and / or constricts the body opening, such as the vaginal introitus, and / or collapses or compresses the curved or parabolic cross-section of the channel or retainer 31 at the patient's opening, such as the vaginal introitus. The parabolic or curved "pinching-effect" of the channel or retainer 31 facilitates or provides a self-retaining contraction and enhanced sealing capability during insufflation into the surgical space. In various embodiments, the sheath is configured to straighten or flatten the retainer. In various embodiments, the sheath is configured to straighten or flatten the hourglass-shaped central portion of the retainer. In various embodiments, the sheath is configured to change the shape of the retainer, such as an hourglass shape, to a different shape, such as a cylinder. In various embodiments, the sheath is configured to straighten, flatten, and / or change the shape of the retainer when shortening and / or adjusting the length of the upper segment of the sheath and / or when and / or when and / or when the upper segment of the sheath is brought together around the rotated outer ring. In various embodiments, the channel or retainer 31 does not provide a sealing capability or function against an instrument inserted through the lumen of the channel or retainer 31, i.e., is unable to seal against such an instrument. In various embodiments, the channel or retainer 31 is configured with a lumen size or shape, overall size or shape, or any combination thereof, such as, for example, a material or coating that prevents a sealing capability or function against an instrument inserted through the lumen of the channel or retainer 31, i.e., is unable to seal against such an instrument. In various embodiments, the retractor does not provide a sealing capability or function against an instrument inserted through the lumen or access channel through the retractor, i.e., is unable to seal against such an instrument.In various embodiments, the retractor and the channel or retainer together effect contraction of a body opening, such as the vaginal introitus. In various embodiments, contraction or expansion of an entire body cavity, such as the vaginal canal, is achieved through insufflation, and the retractor and / or the channel or retainer facilitate or enhance the seal.

[0055] In various embodiments, the inner ring 7 of the retractor 3 and / or the inner flange or distal portion of the channel or retainer is positioned and deployed around the cervix through a circumferential vaginal incision. In various embodiments, the lower segment of the retractor and / or the distal portion of the channel or retainer is configured to extend through the patient's vaginal canal and / or into the vaginal incision. In various embodiments, the length of the lower segment of the retractor and / or the distal portion of the channel or retainer is at least 3 inches (7.5 centimeters). In various embodiments, the length of the lower segment of the retractor and / or the distal portion of the channel or retainer is equal to or greater than the length of an average-sized vaginal canal, or in various embodiments, equal to or greater than the length of an average-sized vaginal canal plus the length of the vaginal incision. The overall width or diameter of the retractor and / or the channel or retainer is configured to provide contraction and / or visualization of the vaginal canal while still being insertable into a vaginal incision.

[0056] According to various embodiments, a circumferential retractor system is provided that includes a first circumferential retractor, a channel or retainer 31, and / or a second circumferential retractor. In various embodiments, the channel or retainer 31 is disposed between the first circumferential retractor and the second circumferential retractor. In various embodiments, the second circumferential retractor is identical to the first circumferential retractor. In various embodiments, the second circumferential retractor includes a sheath having a cylindrical and / or frusto-conical shape. In various embodiments, only the second circumferential retractor has a cylindrical and / or frusto-conical shape. In various embodiments, the second circumferential retractor includes and / or is a containment bag. In various embodiments, the second circumferential retractor has a portion, such as a distal portion, configured to be inserted through the body wall and positioned within the body wall, the retainer 31 is configured to be inserted through the body wall and positioned within the body wall over a portion, such as the distal portion, of the second circumferential retractor, and / or the lower segment 93 of the first circumferential retractor is configured to be inserted through the body wall and positioned within the body wall over the retainer 31.

[0057] The above description is provided to enable those skilled in the art to make and use the devices or systems and to practice the methods described herein, and describes the best mode contemplated by the inventors for carrying out the invention. However, various modifications may still be apparent to those skilled in the art. These modifications are intended to be within the scope of the present disclosure. Different embodiments or aspects of such embodiments may be shown in various figures and described throughout the specification. However, each embodiment and aspect thereof shown or described alone may also be combined with one or more of the other embodiments and aspects thereof, unless expressly stated otherwise. The lack of explicit description of each combination is merely for ease of reading the specification.

[0058] Although the present application discloses several embodiments, aspects and examples, those skilled in the art will appreciate that the present invention extends not only to the specifically disclosed embodiments, aspects and examples, but also to other alternative embodiments and / or uses of the present invention, as well as obvious modifications and equivalents thereof. Moreover, the various features of the invention may be used alone or in combination with other features of the invention other than those explicitly described above. Thus, it should be understood that the present invention may be practiced other than as specifically described, including various changes in size, shape and material, without departing from the scope of the invention. Thus, the embodiments of the present invention should be considered in all respects as illustrative and not restrictive. Thus, the scope of the invention disclosed herein should not be limited by the specific disclosed embodiments described above, but should be determined only by a fair reading of the following claims. [Explanation of symbols]

[0059] 3 Retractor 5 Outer Ring 7 Inner Ring 9. Sheath 21 Tether 23 Tether Tag 91 Upper Segment 93 Lower Segment

Claims

1. A circumferential retractor system, Circumferential retractor, A monolithic hourglass-shaped flexible retainer, The circumferential retractor is equipped with, An outer ring that is rotatable, has an outer diameter, and is configured to be positioned outside the body cavity, An inner ring having an outer diameter and configured to be positioned inside the body cavity, Sheath and, The sheath includes, The upper segment connected to the outer ring, The lower segment connected to the inner ring, Includes, The upper segment has a cylindrical shape including a proximal end having an inner diameter matching the outer diameter of the outer ring and a distal end having an inner diameter matching the outer diameter of the outer ring, and the outer ring is inseparable from the upper segment. The lower segment has a frustoconical shape including a proximal end having an inner diameter matching the outer diameter of the outer ring and a distal end having an inner diameter smaller than the outer diameter of the inner ring and smaller than the outer diameter of the outer ring, the sheath defines an access channel extending from the outer ring to the inner ring, the upper segment and the lower segment are formed as a monolithic structure and have different lengths, the length of the upper segment is adjustable, The retainer is positioned outside the access channel and is configured to surround and contact the distal portion of the lower segment of the sheath, and is positioned between the upper segment and the inner ring. The sheath is configured such that the lower segment of the sheath is positioned within the central opening of the retainer and within the hourglass-shaped intermediate portion of the retainer, and the outer ring rotates to bring together the upper segment of the sheath, shorten the length of the upper segment of the sheath, expand the central opening of the retainer, and flatten the hourglass-shaped intermediate portion of the retainer, thereby enlarging the central opening of the retainer and straightening the hourglass-shaped intermediate portion of the retainer. A system characterized by the following features.

2. The retainer is configured to surround only the lower segment of the sheath. The system according to claim 1.

3. The outer surface of the lower segment of the sheath is positioned between the inner surface of the lower segment and the inner surface of the retainer. The system according to claim 1.

4. The length of the lower segment is not adjustable, and the lower segment connected to the inner ring is not separable from the inner ring. The system according to claim 3.

5. The proximal end of the upper segment of the sheath is configured to be positioned outside the body cavity, and the distal end of the upper segment of the sheath is configured to be positioned inside the body cavity. The system according to claim 4.

6. The retainer has a length shorter than the total length of the sheath, the retainer is compressible and has an inadjustable length, and the retainer is configured to be positioned between the sheath and the tissue. The system according to claim 5.

7. The retainer is more flexible than the outer ring and the inner ring. The system according to claim 3.

8. The retainer has an upper inner diameter and an intermediate inner diameter, wherein the upper inner diameter of the retainer is smaller than the inner diameter of the outer ring, and the intermediate inner diameter of the retainer is smaller than both the upper inner diameter and the inner diameter of the outer ring. The system according to claim 7.

9. The retainer is temporarily deformable by the user, and is deformable from the hourglass shape and biased to return to the hourglass shape. The system according to claim 8.

10. The length of the lower segment is longer than the length of the upper segment, the length of the upper segment is less than half the total length of the sheath, and the length of the lower segment is greater than half the total length of the sheath. The system according to claim 8.

11. The lower segment has an upper inner diameter proximal to the upper segment and a lower inner diameter proximal to the inner ring, wherein the lower inner diameter of the lower segment is smaller than the upper inner diameter of the lower segment, and the outer diameter of the outer ring is larger than the outer diameter of the inner ring. The system according to claim 10.

12. The retainer has a proximal portion and a distal portion, and the distal portion has a distal lip at the distal end of the retainer to facilitate fixation of the distal portion to the inside of the body cavity. The system according to claim 11.

13. The distal portion of the retainer has an outer diameter larger than the outer diameter of the inner ring, the proximal portion of the retainer has an inner diameter larger than the outer diameter of the inner ring, and the inner diameter of the retainer between the proximal and distal portions is smaller than the inner diameter of the inner ring. The system according to claim 12.

14. The inner ring is deformable, the outer ring is not deformable, and the inner ring is the most distal part of the circumferential retractor. The system according to claim 13.

15. The inner ring is configured to be inserted through the central opening of the retainer and positioned near the distal end of the retainer, and the sheath is configured to secure the retainer between the lower segment of the sheath and the inner ring. The system according to any one of claims 1 to 14.

16. The outer ring includes a flexible ring having a lumen and a curved rod disposed within the lumen of the flexible ring, wherein the curved rod is harder than the flexible ring. The system according to any one of claims 1 to 14.

17. The system further comprises a sealing cap configured to connect the outer ring and the proximal portion of the upper segment of the sheath, a tether attached to the inner ring, and a tether tag attached to the tether, wherein the tether has a length longer than the total length of the sheath, and the tether is configured to move the inner ring away from the distal end of the retainer toward the central opening of the retainer as it moves toward the proximal side. The system according to claim 16.

18. The containment bag further includes a distal portion configured to be inserted through the body wall and positioned within the body cavity, the retainer configured to be inserted through the body wall and positioned on the containment bag, and the lower segment of the circumferential retractor configured to be inserted through the body wall and positioned on the retainer. The system according to claim 16.

19. The device further comprises a second circumferential retractor, the second circumferential retractor having a distal portion configured to be inserted through the body wall and positioned within the body cavity, and the retainer configured to be inserted through the body wall and positioned on the second circumferential retractor. The system according to claim 16.

20. The lower segment of the circumferential retractor is configured to be inserted through the body wall and positioned on the retainer. The system according to claim 19.

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