Circumferential retractor / protector with walking seam

Abstract

A circumferential retractor / protector system is provided that includes a circumferential retractor / protector with a walking or angled seam and a cap or cover. The circumferential retractor / protector retracts and protects a patient's body opening and / or incision, providing access into a patient. The circumferential retractor / protector includes an angled or walking seam to minimize and limit sheath material buildup of the retractor / protector as its outer ring is rotated to adjust the length of the sheath of the retractor / protector.

Description

Docket No.: 10032-USP-PCTCircumferential Retractor / Protector with Walking SeamCross-Reference to Related Applications

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application Serial No. 63 / 721,427, filed on November 15, 2024, the disclosure of which is incorporated herein by reference in their entirety.Background

[0002] The present application is generally directed to surgical access systems and more particularly, surgical access systems including circumferential protect ors / retractors arranged to be partially positioned within a body cavity through an incision or body opening.

[0003] Surgical access devices are in surgery to facilitate the introduction of various surgical instruments into natural biological vessels, conduits, orifices, cavities, and other interior regions of the body. Some of these access devices are introduced into regions that include a fluid or gas under pressure. As such, it is often desirable to provide for the introduction of the surgical instrument into the cavity without permitting the escape of the pressurized fluid or gas. Additionally, surgeons are performing laparoscopic surgical procedures through a single or a limited number of access ports. The procedures may be performed through an incision, trans-vaginally. or trans-anally. What is needed is a surgical access system that can be deployed through an incision or a natural body orifice providing a system for insufflation, tissue protection, and / or a platform for the introduction of multiple surgical instruments of varying sizes, while maintaining sufficient stability for and / or sealing of the system.Summary

[0004] In accordance with various embodiments, a circumferential protector / retractor is provided. In accordance with various embodiments, a circumferential retractor system comprises a circumferential protector / retractor and a cap or cover. In various embodiments, the circumferential retractor comprises an outer ring having an outer diameter and arranged to be placed outside of a body cavity, an inner ring having an outer diameter and arranged to be placed inside of the body cavity, and a sheath. In various embodiments, the sheath has one end connected to the outer ring and an opposing end connected to the inner ring. The sheath delimits an access channel extending from the outer ring to the inner ring. The circumferential retractor / protectorDocket No.: 10032-USP-PCTretracts and / or protects a patient’s body opening and / or incision, providing access into a patient. The circumferential retractor / protector comprises an angled or walking seam to minimize and limit sheath material buildup of the retractor / protector as its outer ring is rotated to adjust the length of the sheath of the retractor / protector.

[0005] In various embodiments, a circumferential protector / retractor comprises an outer ring arranged to be place outside a patient, an inner ring arranged to be placed inside a patient, and / or a sheath being tubular and defining an access channel therethrough along a longitudinal axis and extending between the outer ring and the inner ring. In various embodiments, the sheath has a proximal end permanently connected to the outer ring and a distal end permanently connected to the inner ring and the outer ring is rotatable around an annular axis to adjust a length of the sheath between the outer ring and the inner ring. In various embodiments, the sheath comprises a sheath material, e.g., a film, having an angled seam, the angled seam being angled and not aligned with the longitudinal axis. In various embodiments, a cap is removably connected to the outer ring.

[0006] In various embodiment, the sheath has a tapered cylindrical shape or is a tapered cylinder. In various embodiments, the sheath material or film is formed from an asymmetrical unsealed film. In various embodiments, the asymmetrical unsealed film has a top non-straight edge, and a bottom non-straight edge connected to each other by straight side edges. In various embodiments, the asymmetrical unsealed film comprises a plurality of top straight edges and a plurality of bottom straight edges. In various embodiments, the plurality of top straight edges form a continuous top non-straight edge. In various embodiments, the plurality of bottom straight edges form a continuous bottom non-straight edge. In various embodiments, the plurality of top straight edges are connected to the plurality of bottom straight edges by two straight side edges. In various embodiments, the asymmetrical unsealed film comprises a first angled side portion and a second angled side portion in which the asymmetrical unsealed film is folded, and the first angled side portion and the second angled side portion overlap each other. In various embodiments, the first angled side portion is sealed to the second angled side portion to form the sheath with the tapered cylindrical shape. In various embodiments, an edge of the first angled side portion is aligned with an edge of the second angled side portion.

[0007] In various embodiments, the sheath has a straight cylindrical shape. In various embodiments, the film is formed from an unsealed film with a drop down tab. In various embodiments, the unsealed film has a top straight edge and a bottom straight by a straight sideDocket No.: 10032-USP-PCTedge. In various embodiments, the drop down tab has a width smaller than a width of the top straight edge and is angled relative to the top straight edge and the bottom straight edge. In various embodiments, the drop down tab forms the angled seam. In various embodiments, the unsealed film comprises a first side portion in which the asymmetrical unsealed film is folded and the first angled side portion and the drop down tab overlap each other. In various embodiments, the first side portion is sealed to the drop down tab to form the sheath with the straight cylindrical shape. In various embodiments, the angled seam comprises a first side portion and a second side portion permanently attached to each other and angled relative to each other. In various embodiments, the first side portion and the second side portion are angled relative to the longitudinal axis. In various embodiments, the film comprises a first portion along a first side edge overlapping a second portion of the film along a second side edge, the first portion of the film being permanently affixed to the second portion of the film and the first and second side edges angled relative to each other. In various embodiments, the first portion of the film has an upper surface and a bottom surface; and the second portion of the film has an upper surface and a bottom surface, the upper surface of the first portion of the film being permanently affixed to the upper surface of the second portion of the film.

[0008] In various embodiments, a cap comprises a gel pad affixed to a cap ring. In various embodiments, the cap ring has a movable lever and a lower ledge and the cap ring having a lower lip, the lower ledge of the lever being configured to be positioned under the outer ring and in contact with an edge of the outer ring facing the inner ring and the lower lip of the cap ring being configured to be positioned under the outer ring and in contact a second edge of the outer ring facing the inner ring.

[0009] In various embodiments, the angled seam is configured to minimize material buildup along an outer surface of the outer ring. In various embodiments, the angled seam is configured to have a predetermined height or thickness buildup on an outer surface of the outer ring. In various embodiments, the angled seam is configured to equal or not exceed a predetermined height or thickness of material buildup on an outer surface of the outer ring. In various embodiments, the angled seam is configured to spread out the film along an outer surface of the outer ring. In various embodiments, the angled seam has a spread length greater than a spread length of a straight seam.Docket No.: 10032-USP-PCT

[0010] Many of the attendant features of the present inventions will be more readily appreciated as the same becomes better understood by reference to the foregoing and following description and considered in connection with the accompanying drawings.Brief Description of the Drawings

[0011] FIG. 1 A is cross-sectional side view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0012] FIG. IB is a side view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0013] FIG. 1C is a perspective view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0014] FIG. ID is a top view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0015] FIG. IE is a bottom view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0016] FIG. 2 is a top view of a sheath of a circumferential protector / retractor with a straight seam.

[0017] FIG. 3 is a top view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0018] FIG. 4 is side view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0019] FIG. 5 is top view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0020] FIG. 6 is top view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0021] FIG. 7A is side view of a flat and unfolded sheath of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0022] FIG. 7B-7E are conceptual views illustrating a geometrical design formation of the sheath of FIG. 7 A.

[0023] FIG. 8A is a side view of a sheath of a circumferential protector / retractor in accordance with various embodiments of the present invention.Docket No.: 10032-USP-PCT

[0024] FTG. 8B is a side view of a sheath of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0025] FIG. 9 is a side view of a sheath with a left-sided angled seam of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0026] FIG. 10 is a side view of a sheath with a right-sided angled seam of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0027] FIG. 11A is cross-sectional side view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0028] FIG. 1 IB is a perspective view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0029] FIG. 11C is a top view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0030] FIG. 11D is a bottom view of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0031] FIG. 12 is side view of a flat and unfolded sheath of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0032] FIG. 13 is a side view of a sheath with a left-sided angled seam of a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0033] FIG. 14A is a top view of a sealing cap configured to be attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0034] FIG. 14B is a perspective view of a cap configured to be attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0035] FIG. 14C is a side view of a cap configured to be attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0036] FIG. 14D is a bottom view of a cap configured to be attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0037] FIG. 15 A is a partial bottom view of a cap attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.

[0038] FIG. 15B is a partial side view of a cap attached to a circumferential protector / retractor in accordance with various embodiments of the present invention.Docket No.: 10032-USP-PCT

[0039] FTG. 16A is a partial bottom view of a cap attached to a circumferential protector / retractor with an outer ring rotated multiple times shortening a sheath of a protector / retractor in accordance with various embodiments of the present invention.

[0040] FIG. 16B is a partial side view of a cap attached to a circumferential protector / retractor with an outer ring rotated multiple times shortening a sheath of a protector / retractor in accordance with various embodiments of the present invention.

[0041] FIGS. 17A-F are views illustrating an interaction of cap with a sheath with a straight seam of a circumferential protector / retractor.

[0042] FIG. 18 is schematic view illustrating a sheath with a straight seam of a protector / retractor.

[0043] FIG. 19 is a schematic view illustrating a sheath with an angled seam of a protector / retractor in accordance with various embodiments of the present invention.

[0044] FIG. 20 is a graphical representation illustrating an exemplary comparison of a sheath with a straight seam to a sheath with an angled seam.

[0045] FIG. 21 is a side view of an outer ring of a protector / retractor in accordance with various embodiments of the present invention.

[0046] FIG. 22 is a top view of an outer ring of a protector / retractor in accordance with various embodiments of the present invention.Detailed Description

[0047] In accordance with various embodiments, surgical access systems and / or methods are provided, and various views of various embodiments of the surgical access systems and aspects thereof are shown in the figures, e.g., FIGS. 1-22. In various embodiments, the surgical access system provides self-retaining retraction and simultaneous insufflation of the vaginal canal or body cavity, while also allowing for instrument passage and manipulation. The surgical access system in accordance with various embodiments allows surgeons to perform various diagnostic and therapeutic procedures within the vaginal canal using endoscopic techniques. One exemplary procedure is an endoscopic colpotomy, which is an incision in the vaginal canal near or around the cervix created while using vaginal insufflation and laparoscopic instrumentation. Through a colpotomy, access into the peritoneal cavity can be gained. The surgical access system provides or allows for an endoscopic colpotomy by providing self-retaining retraction, insufflation, and scope / instrument access. In various embodiments, the system may be used for other proceduresDocket No.: 10032-USP-PCTthat require endoscopic access and / or endoscopic access with insufflation of the vaginal canal or body cavity.

[0048] In accordance with various embodiments, a surgical access system comprises a cap 50 and an adjustable circumferential protector / retractor 10 (hereinafter referred to as “retractor”) providing circumferential or 360 degrees of protection and / or retraction of an opening or orifice of a patient, providing unobstructed access into a patient’s body or cavity. In various embodiments, the circumferential protector / retractor comprises an outer or proximal ring 12, an inner or distal ring 16, and a sheath 14. The sheath 14, in various embodiments, is flexible and tubular defining a lumen or access channel therethrough and extending between the outer ring and the inner ring along a longitudinal axis. The sheath has a proximal end connected to the outer ring 12 and a distal end connected to the inner ring 16. The outer ring 12 is configured to be flipped or is rotatable around an annular axis 121 to adjust a length 141 of the sheath 14 between the outer ring and the inner ring. In various embodiments, a cap 50 is removably attached to the outer ring. In various embodiments, the cap 50 is a sealing cap and comprises a flexible material 52 arranged to seal against the outer ring 12 and the portion of the sheath 14 rolled or wound around the outer ring. In various embodiments, the cap 50 is a gel cap comprising a cap ring 52 and gel material or a gel pad 56 connected to the cap ring and the cap ring is arranged to be removably connected to the outer ring 12.

[0049] In various embodiments, a cap 50 may be attached to the retractor 10 and trocar sleeves and / or instrumentations may be inserted therethrough. In various embodiments, an insufflation stabilization bag system may be connected to the surgical access system to mitigate pulsing / billowing in the vaginal canal or body cavity. In accordance with various embodiments, the surgical access system provides the establishment of insufflation of the vaginal canal (pneumovagina) or body cavity, allowing for the passage of instruments for various diagnostic and therapeutic procedures (e.g., colpotomy creation using endoscopic techniques).

[0050] In various embodiments, a gel cap 50 is used to seal the opening between the body cavity and the area outside the body cavity while providing access into the body cavity from outside the body cavity. The gel cap includes a cap ring 52 that couples to the outer ring 12 of the retractor and a gel pad coupled to the cap ring. The gel pad 56 is made of a gel material and includes an access portion or passage through the gel for providing a passage from external the body to the body cavity. In various embodiments, the access portion may include a plurality ofDocket No.: 10032-USP-PCTintersecting dead-end slits. The access portion, in various embodiments, forms an instrument seal in the presence of an instrument inserted therethrough and a zero seal in the absence of an instrument inserted therethrough.

[0051] In various embodiments, the cap ring 52 includes a cylindrical ring having a proximal portion, a distal portion, and a longitudinal axis extending through or between the proximal and distal portions. A gel pad 56 is positioned at the proximal portion of the cap ring 52. The distal portion of the cap ring 52 is cylindrical and is configured to receive the outer ring of the retractor. In various embodiments, the distal portion of the cap ring 52 includes a lip 58 at the distal end thereof. The lip curves radially inwardly from a wall of the distal portion of the cap ring and extends around a portion of the circumference of the cap ring. In various embodiments, the lip extends around about 30° of the circumferences of the cap ring. The lip is configured to receive the distal-most end or portion of the outer ring such that the outer ring is positioned between the lip and the gel pad. In various embodiments, when the outer ring 12 of the retractor is received by the distal portion of the cap ring 52, the outer ring 12 of the retractor embeds into the gel pad at the distal portion of the cap ring and displaces the gel, thereby forming a seal between the gel pad and the outer ring and sheath of the retractor.

[0052] In various embodiments, the distal portion of the cap ring 52 comprises a swinging lever 54 that swings on a plane that is substantially perpendicular to the longitudinal axis of the cap ring. In various embodiments, the lever is positioned substantially opposite the lip on the distal portion of the cap ring. The outer surface of the cap ring 52 may include a lug to which the lever 54 is coupled. In various embodiments, the lug includes an aperture extending substantially parallel to the longitudinal axis of the cap ring and is adapted to receive a hinge pin portion of the lever. In various embodiments, the lever 54 includes a distal flat lip positioned at the distal end of the lever and lying in a plane that is positioned substantially perpendicular to the axis of the pin on the lever 54.

[0053] In a first, open state, the lever 54 is swung outwardly, away from the body of the cap ring 52 to provide clearance for inserting the outer ring 12 of the retractor into the cap. In a second, closed state, the lever is swung toward the cap ring such that the distal lip of the lever protrudes radially inwardly from the body of the lever and radially inwardly through the cap ring. With the lever in the first state, the cap is brought to the outer ring of the retractor at an angle with the lip portion of the cap ring toward the patient. The lip portion of the cap ring is slid under the outerDocket No.: 10032-USP-PCTring, between the outer ring and the patient, and then the remainder of the cap is swung onto the outer ring. The lever is swung closed into the second state. In the second state, the distal lip of the lever abuts the distal surface of the outer ring of the retractor and secures the cap to the retractor. Thus, the outer ring of the retractor is positioned between the lip portion of the cap ring and the distal lip of the lever at the distal end of the outer ring of the retractor and the gel pad at the proximal end of the outer ring of the retractor.

[0054] The cap ring 52 in various embodiments may be made of a polymer, such as polycarbonate and may be fabricated by methods including injection molding. The gel pad 56, in various embodiments, may be coupled to, attached to, formed, or integrated with the cap ring so that a gas-tight conduit is formed between the cap ring and the sheath 14. The gel pad covers and seals the entire opening in the cap ring. Additionally, the gel pad is adapted to cover substantially the entire opening and / or incision. In various embodiments, the gel material from which the gel pad is made or comprises is an elastomeric gel. The sheath 14 in various embodiments may comprises of other material instead of or in addition to film.

[0055] In various embodiments, the retractor 10 enables a surgeon to quickly retract and / or protectively line a surgical incision or natural body orifice, while easily accommodating variations in the body wall thicknesses between patients. In addition, embodiments of the retractor effectively seal around the interior and exterior of the incision or orifice, and allow a cap 50 to be coupled thereto, thereby effectively sealing the body cavity and enabling a surgical procedure to be performed. In various embodiments, the sheath 14 is configured to be disposed through an incision and line the incision and / or disposed through an opening in the patient. In various embodiments, the sheath 14 is adjustable to retract the incision and / or the opening in the patient.

[0056] In accordance with various embodiments, a retractor 10 is provided for the deployment into a patient’s cavity, e.g., the abdominal cavity for open or laparoscopic surgeries or the peritoneal cavity during transvaginal natural orifice transluminal endoscopic surgery (vNOTES). In various embodiments, the inner ring 16 of the retractor 10 is placed and deployed around the cervix and through a circumferential colpotomy . In various embodiments, the retractor is arranged to extend through a patient’s vaginal canal and / or into a colpotomy incision. In various embodiments, the length of the retractor is at least 7 inches. In various embodiments, the length of the retractor is equal or greater than the length of an averaged sized vaginal canal or, in various embodiments, the length of an averaged sized vaginal canal plus the length of a colpotomyDocket No.: 10032-USP-PCTincision. The overall width or diameter of the retractor is configured to provide retraction and / or visualization of the vaginal canal, while still being insertable into the colpotomy.

[0057] In various embodiments, the retractor 10 is inserted into an incision, such as an incision made in an abdominal wall, or a body orifice, such as the vagina, mouth, or anus. In various embodiments, the inner ring is configured to be disposed proximate an inner surface of the body wall of the patient and substantially surround the incision and / or opening. The inner ring, in various embodiments, is folded or compressed into an oval or other suitable shape and urged through the incision or body orifice into an associated body cavity. Once the inner ring is fully disposed within the associated body cavity, it is allowed to resume its original, relaxed shape. The inner ring is pulled upward against the inner surface of the body cavity, for example, by pulling the outer ring upward. When the inner ring 16 is in place, the outer ring is rotated, rolled about its annular axis. Rolling the outer ring rolls the sheath around the outer ring, reducing the distance between the inner ring and the outer ring and tensioning the sheath therebetween, thereby retracting the incision or body orifice.

[0058] In various embodiments, the sheath 14 may have a length to accommodate a particular surgical procedure and / or patient anatomy for placement of the retractor and that length may be significantly larger than diameter or width of the outer ring. A desired retraction level, in which the significantly larger sheath’s distance between the inner and outer ring is reduced or shorten, may also involve an increased number of rotations or flipping of the outer ring 12. In various embodiments, as the length of the sheath 14 increases relative to a cross-sectional diameter or width 122 of the outer ring 12, there is a corresponding increase in the number of rotations or flipping of the outer ring 12 utilized to provide a desired retraction level, stability, and / or shortening of the sheath to a desired operational length. For example, with a retractor having a sheath distance between the rings of about 5 inches, one rotation of the outer ring shortens the sheath distance to be less than 5 inches, e.g., by about a cross-sectional circumference or periphery of the other ring, to provide a desired retraction, stability, and / or operational length. However, with a retractor having a sheath distance between the rings of about 7 inches, multiple rotations, e.g., two or three, of the outer ring is utilized to shorten the sheath distance to be less than 5 inches to provide a desired retraction, stability, and / or operational length. A particular surgical procedure, e.g., vNOTES, and / or a patient’ s anatomy, may utilize or require such a long sheath, i.e., a retractor configured to have or be able to provide a sheath with a sheath distance that is sufficient toDocket No.: 10032-USP-PCTaccommodate a particular surgical procedure and / or patient anatomy, for the placement and operational use of the retractor.

[0059] In various embodiments, a sheath 14 of the retractor 10 is formed by a sheet of sheath material, e.g., a fdm, in which one end of the sheet is connected or joined to an opposing end of the sheet to form a straight cylinder or a tapered cylinder. In various embodiments, the sheet is provided, e.g., cut into a conical or fructo-conical shape, and one end of the sheet is connected or joined to an opposing end of the sheet to form a tapered cylinder, e.g., a first, proximal end, being larger in diameter than a second, distal end. With the cylindrical, tapered cylindrical shaped, and / or other shaped retractors similarly formed by connecting or joining opposing ends of a sheet of sheath material, an overlap of material, e.g., two layers of the sheath material, is formed at the connection or joining area of the sheet. The material overlap is two layers thick, i.e., has a thickness that is double the thickness of a single layer of sheath material. The material overlap in turn increases a thickness and / or height of a portion of the retractor where the outer ring 12 and / or inner ring 16 is attached to the material overlap. The material overlaps when aligned with the longitudinal axis of the sheath provides a straight seal / seam, e.g., a seal / seam aligned with the longitudinal axis of the sheath.

[0060] As shown for example, in FIGS. 2 and 18, when the outer ring of the retractor is flipped or rotated to adjust the retractor to provide a desired retraction, stability, and / or sheath length, the material overlap, e.g., the straight seal / seam 30, remains aligned with the longitudinal axis 15 of the sheath 14 gathering at a single area or portion on the outer ring 12 with each flip or rotation of the outer ring. The sheath material buildup or seam in one location (and non-movement or travel of the material buildup or seam 30, represented by circle 34) when rotating the outer ring can cause difficulties in attaching a cap 50 to the outer ring 12 and portions of the sheath, e.g., the sheath material buildup, and / or the cap remaining attached to the outer ring and portions of the sheath once the cap is initially or seemingly attached. Additionally, a spread length of a straight seam is fixed and / or limited as also represented by circle 34.

[0061] For example, as shown in FIGS. 17A-17F, the sheath material buildup may not allow the cap to properly sit and / or seal against the outer ring and a portion of the sheath. The sheath material buildup may also cause the latch of the cap to not properly engage with the outer ring, e.g., the lever will not completely close or will partially remain open and / or the lip or lever will not remain positioned sufficiently under the outer ring. Additional forces may also be employedDocket No.: 10032-USP-PCTto forcibly attach the cap to the outer ring and portions of the sheath to overcome the sheath material buildup that may result in sheath and / or cap to not operate as intended. Furthermore, the cap may not stay attached to the outer ring and a portion of the sheath and with insufflation or a pressurized condition being introduced. Sealing and / or protection between the sheath the patient’s opening, incision or body wall may also be compromised and / or provide a leak path or unintended opening or path into the patient due to the sheath material buildup. Additionally, the positioning of the outer ring relative to the patient’s opening, incision, or body wall may also provide a leak or unintended opening or path due to the sheath material buildup. The difficulties can be more pronounced based on the thickness of the sheath and / or with an increased number of flips in which the sheath material buildup increases and / or becomes more prominent.

[0062] In various embodiments, a sheath 14 comprises an angled seal, seam or overlap 40. In various embodiments, the angled seam comprises a sheath material overlap with an edge that is angled relative to a longitudinal axis. In various embodiments, the angled seal / seam 40 is provided by a sheet of sheath material, e.g., a film, in which one end or edge of the sheet is angled and connected or joined to an opposing angled end or edge of the sheet to form a straight cylinder and / or a tapered cylinder. In various embodiments, with the straight cylindrical, tapered cylindrical shaped, and / or other shaped retractors are similarly formed by connecting or joining opposing angled edges or edge portions of a sheet of sheath material, an overlap of material, e.g., two layers of the sheath material, formed at the connection or joining area of the sheet that is not aligned with or angled relative to the longitudinal axis of the sheath. The material overlap is angled relative to the longitudinal axis of the sheath and provides an angled seam, e.g., a seam not aligned or angled with respective the longitudinal axis of the sheath. In various embodiments, the angled seam is an angled film-to-film seal. The angled film-to-film seal has a length greater than the length of the sheath, a width smaller than the width of the sheath, and / or a thickness being as thick as two layers of the sheath. The angled film-to-film seal is formed by welding or sealing, e.g., via heat, opposing angled portions or ends of a sheet of film to form a straight cylinder or a tapered cylinder.

[0063] The angled seam 40 is configured to maintain a predetermined number of layers or buildup of sheath material on the outer ring and / or to distribute the buildup of sheath material across the outer ring as the outer ring is flipped or rotated. For example, when the outer ring of the retractor is flipped to adjust the sheath to provide a desired retraction, stability, and / or sheathDocket No.: 10032-USP-PCTlength to accommodate a patient’s anatomy and / or surgical procedure, the angled seam, e g., the flap or overlapping portion of the sheath material, is arranged to move or “walk” around and along the outer ring (e.g., in the direction represented by arrow 44) with each flip or rotation of the outer ring, as shown for example in FIGS. 3, 6 and 19. The angled seal / seam or overlap material 40 as such will be distributed along the outer ring with each flip of the outer ring which reduces and / or prevents the material buildup at a singular point or area on the outer ring. Additionally, the angled seam has a spread length greater than a spread length of a straight seam as seen for example in comparison to FIGS. 2 and 3.

[0064] As such, as shown for example in FIGS. 16A-16B, the angled seal / seam 40 provides the distributed sheath material buildup and / or reduced and a preventive sheath material buildup in one location or area when flipping the outer ring which allows or removes the difficulties in attaching a cap to the outer ring and portions of the sheath and / or the cap remaining attached to the outer ring and portions of the sheath once the cap is initially attached. In various embodiments, the angled seal / seam allows the latch of the cap to be closed over the walking angled seal / seam or anywhere on the outer ring.

[0065] In various embodiments, the sheath material buildup distributed and limited or restricted in the amount it can build up or increase does not interfere with the cap attachment, facilitating or allowing the cap to properly sit and / or seal against the outer ring and a portion of the sheath as well as facilitating or allowing the latch, lip, or lever of the cap to properly engage with the outer ring and / or remain positioned sufficiently under the outer ring. Additional forces are also not needed or used to attach the cap to the outer ring and portions of the sheath and the cap may stay attached to the outer ring and a portion of the sheath and with insufflation or a pressurized condition being introduced. The difficulties are also not more pronounced based on the thickness of the sheath and / or with an increased number of flips as the sheath material buildup plateaus or remains substantially constant or not increasing, as shown graphically in FIG. 20.

[0066] Additionally, as shown graphically in FIG. 20, referring to measurement B shown in FIG. 22 and can be similarly shown referring to measurement A shown in FIG. 21, in comparison to a straight seal / seam 30, the sheath material buildup is about three layers of material thick per flip and with each successive flip, the material buildup increases, while the sheath material buildup with the walking / angled seal / seam 40 for an initial flip is about three layers of material thick, while subsequent flips the sheath material buildup doesn’t increase or remains constant. In variousDocket No.: 10032-USP-PCTembodiments, the angled seal / seam 40 provides the same and ultimately less of a buildup of material at a single location along the outer ring in comparison to a straight seal / seam. In various embodiments, the angled seal / seam ensures that the sheath material buildup does not exceed a predetermined material height, diameter, or thickness relative to the outer ring’s height, diameter, or thickness. The angled seam ensures that the height, diameter, and / or thickness of the sheath material build up reaches and maintains a constant level or amount after a predetermined number of flips or rotations of the outer ring. Likewise, the angled seam ensures that the height, diameter, and / or thickness of a portion or outer surface of the outer ring in which the angled seam is positioned increases then reaches and maintains or remains at a constant level or amount after a predetermined number of flips or rotations of the outer ring. Similarly, the overall width, diameter or footprint of the outer ring increases then reaches and maintains or remains at a constant level or amount after a predetermined number of flips or rotations of the outer ring. In various embodiments, the constant level or amount is predetermined and / or is equal to or less than an overall width, diameter or footprint of a cap ring arranged to be removably connectable to the outer ring.

[0067] In various embodiments, the angled seal / seam is angled at a predetermined angle Al. In various embodiments, the predetermined angle is about 10 to 15 degrees relative to the longitudinal axis 15 of the sheath 14. In various embodiments, the greater the angle relative to the longitudinal axis of the sheath, the greater the step of the angled seal / seam for each flip and the more walking or distribution of the angled seal / seam along the outer ring.

[0068] In various embodiments, as shown for example in FIG. 7A, an unsealed, unfolded, or preconfigured sheath material, e.g., film, fabric, and / or membrane, with an asymmetric shape is provided to provide the angled seam 40 for a tapered cylindrical sheath, e.g., as shown in FIG. 8. In various embodiments, the asymmetrical unsealed film includes a lack of balanced proportions and / or a lopsided or uneven arrangement in accordance with various embodiments. In various embodiments, the asymmetrical unsealed film is configured to be folded upon itself in that the side edges align with each other and the side edges connected to form the tapered cylindrical sheath. However, the asymmetrical unsealed film cannot be folded in half such that one half has a shape that matches with the shape of the other half. As shown in the illustrated embodiment, the asymmetrical unsealed film comprises a plurality of top straight edges having varying lengths, e g., lengths XI, X2, X3 and X4 and a plurality of bottom straight edges having varying lengths,Docket No.: 10032-USP-PCTe.g., lengths XI and X5. The plurality of top straight edges are connected to the plurality of bottom straight edges by two opposing straight side edges. A top left straight edge and a bottom left straight edge adjacent to a first or left straight side edge have the same or equal lengths, e.g., length XI. This top left straight edge, first / left straight side edge, and bottom left straight edge form or delimit a first or left side seam portion. Similarly, a top right straight edge and a bottom right straight edge adjacent to a second or right straight side edge have the same or equal lengths, e.g., length XI . The top right straight edge is parallel to the bottom right straight and the top left straight edge is parallel to bottom left straight edge. The top right straight edge, second / right straight side edge and bottom right straight edge form or delimit a second or right side seam portion. The asymmetrical unsealed film is configured such that when folded the second / right seam portion overlaps the first / left seam portion in which edges of the first seam portion overlaps and is aligned with edges of the second seam portion. In various embodiments, the first and second seam portions have the same or equal lengths and widths to provide an attachment area, e.g., a seal, adhesion, or weld area, to connect or join the first and seam portions together to delimit and / or form the angled seam. The size and / or shape of the first and second seam portions are configured to ease connection, e.g., heat sealing, of the portions to each other. In various embodiments, the size and / or shape of the first and second seam portions delimit and / or define a material overlap or buildup of the angled seam.

[0069] In various embodiments, a bottom first straight edge adjacent to the bottom left straight edge has a length that is the same or equals an overall diameter of the inner ring, e g., a diameter extending between the inner and / or outer periphery of the inner ring. In various embodiments, a bottom second straight edge adjacent to the bottom right straight edge has a length that is the same or equals an overall diameter of the inner ring, e.g., a diameter extending between the inner and / or outer periphery of the inner ring. In various embodiments, the bottom first straight edge and the bottom second straight edge have the same or equal lengths, e.g., length X5. In various embodiments, the bottom first straight edge is parallel to a top first straight edge adjacent to the top left straight edge with the top first straight edge having a length shorter or less than a length of the bottom first straight edge. In various embodiments, the bottom second straight edge is parallel to a top second straight edge adjacent to the top first straight edge with the top second straight edge having a length longer or greater than a length of the bottom second straight edge. In various embodiments, the top first straight edge has a length shorter or less than the length of the topDocket No.: 10032-USP-PCTsecond straight edge. In various embodiments, the top second straight edge is angled down or away from the top first straight edge and towards the bottom second straight edge. In various embodiments, a top third straight edge adjacent to the top right straight edge is angled down or away from the top second straight edge and towards the bottom second straight edge. In various embodiments, the top second straight edge has a length greater or longer than the length of the top third straight edge. In various embodiments, the top third straight edge has a length shorter or less than the length of the top second straight edge or the top first straight edge. In various embodiments, the top right straight edge adjacent to the top third straight edge is angled down or away from the top third straight edge and towards the bottom right straight edge. In various embodiments, a length or distance between the top first straight edge to the bottom left straight edge delimits a maximum length or distance between the inner and outer rings and / or between the proximal end or connection of the sheath to the outer ring and the distal end or connection of the sheath to the inner ring. In various embodiments, a length or distance between the top second straight edge to the bottom right straight edge delimits a maximum length or distance between the inner and outer rings and / or between the proximal end or connection of the sheath to the outer ring and the distal end or connection of the sheath to the inner ring. In various embodiments, the top left straight edge, the top first straight edge, the top second straight edge, the top third straight edge and the top right straight edge are or form a continuous top non-straight edge of the asymmetrical unsealed film. In various embodiments, the bottom left straight edge, the bottom first straight edge, the bottom second straight edge, and the bottom right straight edge are or form a continuous bottom non-straight edge of the asymmetrical unsealed film. In various embodiments, the top left straight edge, the top right straight edge, the bottom left straight edge, and the bottom right edge have the same or equal length. In various embodiments, the top left straight edge, the top right straight edge, the bottom left straight edge, and the bottom right edge have a length shorter or less than the top first, second and / or third straight edges, or the bottom first and / or second straight edges.

[0070] In various embodiments, the shape of the asymmetrical unsealed film is provided by a sheath material or film cutout, such that the cut film would not be symmetric. In reference to the geometrical conceptual design formation to provide the asymmetrical shape from a rectangular sheet of film, a triangle of film 141 is geometrically "removed" from the left side of the cut film shape, as shown in FIG. 7B. Prior to the “re-insertion” of the triangle an alignment tab 142 isDocket No.: 10032-USP-PCTcreated. The width of the alignment tab is removed from the bottom right side, as shown in FIG.7C. In various embodiments, if the sheath is straight / cylindrical, the width is removed from the top and the bottom. The removed triangle of fdm 141 is geometrically "added" to the right side of the cut fdm, as shown in FIG. 7D. The resulting edges are modified to be equivalent lengths. In various embodiments, an alignment tab 143 is provided as shown in FIG. 7E to assist in forming the sheath. The operations can also be reversed from right to left, i.e., a right-sided angled seam or a left-sided angled seam relative to the longitudinal axis as shown for example in FIGS. 9 and 10. As shown in FIG. 8, the tapered cylindrical sheath has a width or diameter at the proximal end of the sheath, e.g., width X6, being greater than a width or diameter at the distal end of the sheath, e.g., width X5. In various embodiments, the width or diameter at the proximal end of the sheath matches or equals the diameter between the inner and / or outer periphery of the outer ring and the width or diameter at the distal end of the sheath matches or equals the diameter or width between the inner and / or outer periphery of the inner ring. In various embodiments, the length or distance between the inner or outer ring, e.g., length Y2, is equal or less than the maximum or length of the asymmetrical unsealed film. In various embodiments, the angle of the angled seam, e.g., angle Al, as shown in FIGS. 9 and 10, are defined by the length of asymmetrical unsealed film or distance between the top and bottom edges and / or the angles between the left straight side edge and the top and / or bottom straight edge. In various embodiments, the angle of the angled seam is defined by the length of asymmetrical unsealed film or distance between the top and bottom edges in which a reduction or lessening of the distance increases the steepness of the angle and thereby the amount of material overlap of the angled seam with a rotation of the outer ring. In various embodiments, the angle of the angled seam is defined by the angle between the left straight side edge and the top and / or bottom straight edge in which an increase in one or both angle sizes increases the steepness of the angle of the angled seam and thereby the amount of material overlap of the angled seam with a rotation of the outer ring.

[0071] In accordance with various embodiments, an angle of the angled seam relative to the bottom edge of a tapered cylindrical sheath, e.g., angle H, is defined or set by a plurality of angles, e.g., angles of an asymmetrical unsealed or preconfigured sheath. For example, as shown in FIG.8B, the bottom, a left sided angle, e.g., angle F, is taken with respect to the bottom left edge and a right sided angle, e.g., angle G, with respect to the bottom right edge are used. At the top, an imaginary horizontal line is placed from a pivot point as circled. The left and right-side anglesDocket No.: 10032-USP-PCTrelative to the top edge, e g., angles B, are used. Continuing the right side, a drop angles with respect to each other, e.g., angles C and D, are used. The summation of these angles divided by 2 is the angle, e.g., angle H, for the angled seam of the tapered cylindrical sheath.

[0072] An exemplary an unsealed, unfolded, or preconfigured sheath material, e.g., film, fabric, and / or membrane, with a drop down tab for a straight cylindrical sheath with an angled seam 40 is also shown for example in FIGS. 12-13. In various embodiments, the drop down tab unsealed film is configured to be folded upon itself in that the side edges align with each other and the side edges are connected to form the straight cylindrical sheath. As shown in the illustrated embodiment, the drop down tab unsealed film comprises a plurality of top straight edges having varying lengths, e.g., lengths XI 1 and length (X21-X11) and a plurality of bottom straight edges having varying lengths, e.g., lengths XI 1 and length (X31-X11). The plurality of top straight edges are connected to the plurality of bottom straight edges by two opposing straight side edges. A top left straight edge and a bottom left straight edge adjacent to a first or left straight side edge have the same or equal lengths, e.g., length XI 1. This top left straight edge, first / left straight side edge, and bottom left straight edge form or delimit a first or left side seam portion. Similarly, a top right straight edge and a bottom right straight edge adjacent to a second or right straight side edge have the same or equal lengths, e.g., length XI 1. The top right straight edge is parallel to the bottom right straight and the top left straight edge is parallel to bottom left straight edge. The top right straight edge, second / right straight side edge and bottom right straight edge form or delimit a second or right side seam portion. The drop down tab unsealed film is configured such that when folded the second / right seam portion overlaps the first / left seam portion in which edges of the first seam portion overlaps and is aligned with edges of the second seam portion. In various embodiments, the first and second seam portions have the same or equal lengths and widths to provide an attachment area, e.g., a seal, adhesion, or weld area, to connect or join the first and seam portions together to delimit and / or form the angled seam. The size and / or shape of the first and second seam portions are configured to ease connection, e.g., heat sealing, of the portions to each other. In various embodiments, the size and / or shape of the first and second seam portions delimit and / or define a material overlap or buildup of the angled seam.

[0073] In various embodiments, a bottom straight edge adjacent to the bottom left straight edge and / or bottom right straight edge has a length that is the same or equals to two times an overall diameter of the inner ring, e.g., a diameter extending between the inner and / or outer periphery ofDocket No.: 10032-USP-PCTthe inner ring. Tn various embodiments, the bottom straight edge is parallel to a top straight edge adjacent to the top left straight edge. In various embodiments, the top straight edge adjacent to the top left straight edge and / or top right straight edge has a length that is the same or equals to two times an overall diameter of the outer ring, e.g., a diameter extending between the inner and / or outer periphery of the outer ring. In various embodiments, the bottom straight edge has equal to or slightly greater than a length of the top straight edge. In various embodiments, the top right straight edge is angled, e.g., angle A4, down or away from the top straight edge and towards the bottom straight edge. In various embodiments, the bottom right straight edge is angled down or away from the bottom straight edge and away from the top straight edge. In various embodiments, the top right straight edge, the second side edge and the bottom right straight edge form a drop down tab of the unsealed fdm.

[0074] In various embodiments, a length or distance between the top straight edge to the bottom straight edge delimits a maximum length or distance between the inner and outer rings and / or between the proximal end or connection of the sheath to the outer ring and the distal end or connection of the sheath to the inner ring. In various embodiments, the top left straight edge, the top straight edge, and the top right straight edge are or form a continuous top non-straight edge of the drop down tab unsealed film. In various embodiments, the bottom left straight edge, the bottom straight edge, and the bottom right straight edge are or form a continuous bottom non-straight edge of the drop down tab unsealed film. In various embodiments, the top left straight edge, the top right straight edge, the bottom left straight edge, and the bottom right edge have the same or equal length. In various embodiments, the top left straight edge, the top right straight edge, the bottom left straight edge, and the bottom right edge have a length shorter or less than the top straight edge and / or the bottom straight edge.

[0075] As shown in FIG. 13, the straight cylindrical sheath has a width or diameter at the proximal end of the sheath, e.g., width X41, being equal to a width or diameter at the distal end of the sheath. In various embodiments, the width or diameter at the proximal end of the sheath matches or equals the diameter between the inner and / or outer periphery of the outer ring and the width or diameter at the distal end of the sheath matches or equals the diameter or width between the inner and / or outer periphery of the inner ring. In various embodiments, the length or distance between the inner or outer ring, e.g., length Y21, is equal or less than the maximum or length of the asymmetrical unsealed film. In various embodiments, the angle of the angled seam, e.g., angleDocket No.: 10032-USP-PCTA 1 , as shown in FIG. 13, are defined by the length of drop down unsealed film or distance between the top and bottom straight edges, e.g., length Y21, and / or the angles between the left straight side edge and the top and / or bottom straight edge, e.g., angles A2 and / or A3. In various embodiments, the angle of the angled seam is defined by the length of drop down tab unsealed film or distance between the top and bottom edges in which a reduction or lessening of the distance increases the steepness of the angle and thereby the amount of material overlap of the angled seam with a rotation of the outer ring. In various embodiments, the angle of the angled seam is defined by the angle between the left straight side edge and the top and / or bottom straight edge in which an increase in one or both angle sizes increases the steepness of the angle of the angled seam and thereby the amount of material overlap of the angled seam with a rotation of the outer ring. In accordance with various embodiments, an angle of the angled seam relative to the bottom edge of a straight cylindrical sheath is defined the angle relative to the bottom edge of the unsealed or preconfigured drop down tab film.

[0076] The surgical access system comprise a cap, cover, or lid coupled to the outer ring of the retractor, which seals the retractor, for example, for maintaining pneumoperitoneum. In some embodiments, cap is removable, for example to provide access into the body cavity. Some embodiments of the cap comprise a transparent or translucent portion, thereby allowing a user to view into the body cavity without removing the cap. In various embodiment, a cap removably attached to the outer ring is configured to substantially surround the incision and / or opening. In various embodiments, a plurality of sealing valves and / or gas / fluid inlet and / or outlet ports are operatively attached to or incorporated in the cap. In various embodiments, at least a portion of the inner ring has a non-circular cross section and / or a notch that facilitates folding and / or insertion of the inner ring. In various embodiments, the outer ring comprises lock points as the outer ring is rotated. As the sheath rolls-up around the outer ring when rotating the outer ring, the lock points reduce or prevent the outer ring from rotating backwards, thus prevent the sheath from unraveling or unrolling from the outer ring. These lock points also provide incremental rotational positions for the outer ring, thereby providing incremental retraction. The lock points, in various embodiments, also help keep the outer ring from tilting as a result of forces encountered during retraction.

[0077] In various embodiments, the cap 50 is arranged to maintain pneumoperitoneum during multiple instrument exchanges and to substantially prevent unintentional loss ofDocket No.: 10032-USP-PCTpneumoperitoneum. In various embodiments, the cap provides substantially continuous access and visibility during surgery. In various embodiments, the cap has a small profde for use in procedures with limited surgical space. In various embodiments, a distal portion of the cap ring 52 is substantially cylindrical and is dimensioned and configured to receive the outer ring of the retractor. The cap ring comprises a latch mechanism that removably couples the cap ring to the outer ring. When the outer ring 12 of the retractor is received in the distal portion of the cap ring, the outer ring of the wound retractor contacts and embeds within a portion of a flexible seal, e.g., a gel pad, disposed at the distal portion of the cap ring, thereby displacing a portion of the gel, and forming a seal between the gel pad, and the outer ring and sheath of the wound retractor. Thus, the distal portion of the gel pad is in juxtaposition with the incision or body orifice.

[0078] In some embodiments, the gel pad 56 is coupled to, attached to, formed with, or integrated with the cap ring to provide a gas-tight seal between the cap ring and the sheath. The gel pad covers and seals the entire opening in the cap ring, as well as covering substantially the entire wound or orifice opening. The gel pad provides a gas tight seal around a variety of shapes and sizes of instruments inserted therethrough.

[0079] In various embodiments, a surgical access system is provided for performing laparoscopic surgical procedures at a single access site wherein an incision is made in the abdominal wall of a patient and the abdominal cavity is pressurized with an insufflation gas. In various embodiments, the surgical access system is adapted to provide access to the abdominal cavity for surgical procedures while maintaining insufflation pressure in the abdominal cavity. In various embodiments, a surgical access system is provided for performing a surgical procedure at an access site wherein a body cavity of a patient is pressurized with an insufflation gas. In various embodiments, the surgical access system is adapted to provide access to the body cavity for surgical procedures while maintaining insufflation pressure in the body cavity.

[0080] In various embodiments, a tether 22 is attached to the inner ring 16. In various embodiments, a tether has a distal end attached to the inner ring and a proximal end of the tether extends through the sheath and the outer ring and, in various embodiments, is connected to a tether tag 24. Pulling the tether tag and / or the proximal end of the tether draws the inner ring towards the outer ring 12. Further pulling the tether causes the inner ring to contact the outer ring, thereby deforming the inner ring as it passes through the outer ring. In various embodiments, a proximal portion of the tether and the tether tag 24 remain outside of the body. In accordance with variousDocket No.: 10032-USP-PCTembodiments, the proximal portion of the tether and tether tag provide outside user access, i.e., not within the body cavity, to assist in removal of the retractor from the patient.

[0081] In various embodiments, the sheath 14 comprises a film, fabric, or membrane. In various embodiments, the outer ring 12 is configured to be placed outside of the patient for ease of accessibility, adjustment of the retraction force and / or placement of the retractor. In various embodiments, a sealing or gel cap 50 may be attached to the outer ring 12 of the retractor 10. The retractor 10, in various embodiments, is sufficiently flexible to be atraumatic when the retractor is deployed or otherwise placed through and disposed in the opening of the patient. In various embodiments, the outer diameter or periphery of the retractor in operation and / or, as deployed, is delimited or is no larger than the outer diameter of the inner and / or outer rings. In various embodiment, the sheath 14 is made of an elastomeric or non-metallic material to be atraumatic and / or not or minimally thermally conductive when the retractor 10 is in operation or deployed or otherwise placed through and disposed in the opening of the patient. In various embodiments, the sheath 14 is made of one or more layers of material and in various embodiments is anisotropic, e.g., stretchable, or extendable longitudinally but not or minimally radially, being made of or including one or more layers of a fabric or similar materials with such anisotropic characteristics. In various embodiments, the sheath 14 is cylindrical in shape or is tapered having a larger upper diameter relative to a smaller lower diameter. In various embodiments, the outer ring 12 has a diameter greater than the inner ring 16.

[0082] Additionally, as shown, for example, in FIGS. 3, 19, and 20, the angled seam, in accordance with various embodiments, is configured to minimize material buildup along an outer surface of the outer ring, have a predetermined height or thickness buildup on an outer surface of the outer ring, be to equal or not exceed a predetermined height or thickness of material buildup on an outer surface of the outer ring, spread out the film along an outer surface of the outer ring, and / or have a spread length greater than a spread length of a straight seam.

[0083] In various embodiments, the retractor / protector comprises a plurality of angled or walking seams. In various embodiments, the plurality of angled seams are configured to limit or maintain (or not exceed) a predetermined material buildup (a thickness and / or cross-sectional width or diameter of the outer ring) as the outer ring is rotated. In various embodiments, the plurality of angled seams increases the overall width or diameter of the outer ring between the inner and / or outer periphery of the outer ring but is configured to limit or maintain (or not exceed)Docket No.: 10032-USP-PCTa predetermined material buildup (and the overall width or diameter of the outer ring) as the outer ring is rotated.

[0084] In various embodiments, the retractor or surgical access system provides access or a channel or pathway into a patient’s body cavity and / or in various embodiments may be flexible being able to bend and / or allow tissue or the like to deform or compress portions thereof. In various embodiments, the retractor is adjustable in length to accommodate different patient anatomies and / or 360 degrees of hands-free protection and / or retraction of the opening in the patient. In various embodiments, the retractor may not include an inner ring.

[0085] The above description is provided to enable any person skilled in the art to make and use the devices or systems and perform the methods described herein and sets forth the best modes contemplated by the inventors of carrying out their inventions. Various modifications, however, will remain apparent to those skilled in the art. It is contemplated that these modifications are 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, it should be noted that although shown or described separately each embodiment and aspects thereof may be combined with one or more of the other embodiments and aspects thereof unless expressly stated otherwise. It is merely for easing readability of the specification that each combination is not expressly set forth.

[0086] Although this application discloses certain embodiments, aspects, and examples, it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments, aspects, and examples to other alternative embodiments and / or uses of the invention and obvious modifications and equivalents thereof. Further, the various features of these inventions can be used alone, or in combination with other features of these inventions other than as expressly described above. It is therefore to be understood that the present invention may be practiced otherwise than specifically described, including various changes in the size, shape, and materials, without departing from the scope of the present invention. Thus, embodiments of the present invention should be considered in all respects as illustrative and not restrictive. Hence, it is intended that the scope of the present inventions herein disclosed should not be limited by the particular disclosed embodiments described above but should be determined only by a fair reading of the claims which follow.

Claims

Docket No.: 10032-USP-PCTClaims:

1. A circumferential protector / retractor system comprising:a circumferential protector / retractor comprising:an outer ring arranged to be place outside a patient;an inner ring arranged to be placed inside a patient;a sheath being tubular and defining an access channel therethrough along a longitudinal axis and extending between the outer ring and the inner ring, the sheath having a proximal end permanently connected to the outer ring and a distal end permanently connected to the inner ring and the outer ring being rotatable around an annular axis to adjust a length of the sheath between the outer ring and the inner ring, and the sheath comprising a film having an angled seam, the angled seam being angled and not aligned with the longitudinal axis; and a cap removably connected to the outer ring.

2. The system of claim 1, wherein the sheath has a tapered cylindrical shape.

3. The system of any one of the previous claims, wherein the film is formed from an asymmetrical unsealed film.

4. The system of claim 3, wherein the asymmetrical unsealed film has a top non-straight edge, and a bottom non-straight edge connected to each other by straight side edges.

5. The system of claim 3, wherein the asymmetrical unsealed film comprises a plurality of top straight edges and a plurality of bottom straight edges.

6. The system of claim 5, where the plurality of top straight edges form a continuous top non-straight edge.

7. The system of claim 5 or 6, wherein the plurality of bottom straight edges form a continuous bottom non-straight edge.Docket No.: 10032-USP-PCT8. The system of any one of claims 5 to 7, wherein the plurality of top straight edges are connected to the plurality of bottom straight edges by two straight side edges.

9. The system of claim 8, wherein the asymmetrical unsealed film comprises a first angled side portion and a second angled side portion in which the asymmetrical unsealed film is folded and the first angled side portion and the second angled side portion overlap each other.

10. The system of claim 9, wherein the first angled side portion is sealed to the second angled side portion to form the sheath with the tapered cylindrical shape.

11. The system of claim 9 or 10, wherein an edge of the first angled side portion is aligned with an edge of the second angled side portion.

12. The system of claim 1, wherein the sheath has a straight cylindrical shape.

13. The system of claim 12, wherein the film is formed from an unsealed film with a drop down tab.

14. The system of claim 13, wherein the unsealed film has a top straight edge and a bottom straight by a straight side edge.

15. The system of claim 13 or 14, wherein the drop down tab has a width smaller than a width of the top straight edge and is angled relative to the top straight edge and the bottom straight edge.

16. The system of claims 13 to 15, wherein the drop down tab forms the angled seam.

17. The system of claims 13 to 16, wherein the unsealed film comprises a first side portion in which the unsealed film is folded and the first angled side portion and the drop down tab overlap each other.Docket No.: 10032-USP-PCT18. The system of claim 17, wherein the first side portion is sealed to the drop down tab to form the sheath with the straight cylindrical shape.

19. The system of any one of the previous claims wherein the angled seam comprises a first side portion and a second side portion permanently attached to each other and angled relative to each other.

20. The system of any one of the previous claims, wherein the first side portion and the second side portion are angled relative to the longitudinal axis.

21. The system of any one of the previous claims, wherein the film comprises a first portion along a first side edge overlapping a second portion of the film along a second side edge, the first portion of the film being permanently affixed to the second portion of the film and the first and second side edges angled relative to each other.

22. The system of claim 21, wherein the first portion of the film has an upper surface and a bottom surface; and the second portion of the film has an upper surface and a bottom surface, the upper surface of the first portion of the film being permanently affixed to the upper surface of the second portion of the film.

23. The system of any one of the previous claims, wherein the cap comprises a gel pad affixed to a cap ring.

24. The system of claim 23, wherein the cap ring has a movable lever and a lower ledge and the cap ring having a lower lip, the lower ledge of the lever being configured to be positioned under the outer ring and in contact with an edge of the outer ring facing the inner ring and the lower lip of the cap ring being configured to be positioned under the outer ring and in contact a second edge of the outer ring facing the inner ring.

25. The system of any one of the previous claims, wherein the angled seam is configured to minimize material buildup along an outer surface of the outer ring.Docket No.: 10032-USP-PCT26. The system of any one of the previous claims, wherein the angled seam is configured to have a predetermined height or thickness buildup on an outer surface of the outer ring.

27. The system of any one of the previous claims, wherein the angled seam is configured to equal or not exceed a predetermined height or thickness of material buildup on an outer surface of the outer ring.

28. The system of any one of the previous claims, wherein the angled seam is configured to spread out the film along an outer surface of the outer ring.

29. The system of claim 28, wherein the angled seam has a spread length greater than a spread length of a straight seam.

30. A circumferential protector / retractor comprising:an outer ring arranged to be place outside a patient;an inner ring arranged to be placed inside a patient;a sheath being tubular and defining an access channel therethrough along a longitudinal axis and extending between the outer ring and the inner ring, the sheath having a proximal end permanently connected to the outer ring and a distal end permanently connected to the inner ring and the outer ring being rotatable around an annular axis to adjust a length of the sheath between the outer ring and the inner ring, and the sheath comprising a film having an angled seam, the angled seam being angled and not aligned with the longitudinal axis.

31. The system of claim 30, wherein the sheath has a tapered cylindrical shape.

32. The system of claim 31, wherein the film is formed from an asymmetrical unsealed film.

33. The system of claim 32, wherein the asymmetrical unsealed film comprises a first angled side portion and a second angled side portion in which the asymmetrical unsealed film is foldedDocket No.: 10032-USP-PCTand the first angled side portion and the second angled side portion overlap each other to form the sheath.

34. The system of claim 30, wherein the sheath has a straight cylindrical shape.

35. The system of claim 34, wherein the film is formed from an unsealed film with a drop down tab.

36. The system of claims 35, wherein the drop down tab forms the angled seam and the unsealed film comprises a first side portion in which the unsealed film is folded and the first angled side portion and the drop down tab overlap each other and sealed together to form the sheath with the straight cylindrical shape.

37. The system of any one of claims 31 to 36 wherein the angled seam comprises a first side portion and a second side portion permanently attached to each other and angled relative to each other.

38. The system of any one of claims 31 to 37, wherein the angled seam is configured to minimize material buildup along an outer surface of the outer ring.

39. The system of any one of claims 31 to 38, wherein the angled seam is configured to have a predetermined height or thickness buildup on an outer surface of the outer ring.

40. The system of any one of claims 31 to 39, wherein the angled seam is configured to equal or not exceed a predetermined height or thickness of material buildup on an outer surface of the outer ring.

41. The system of any one of claims 31 to 40, wherein the angled seam is configured to spread out the film along an outer surface of the outer ring.

Images