Tissue containment system and method of use

Abstract

A tissue containment system comprises a flexible sleeve having a first opening, a second opening, and a body extending therebetween that defines an isolated interior for receiving excised tissue. The first opening is larger than the second opening, facilitating the passage of tissue through the first opening to the interior. The sleeve is configured to span a pelvic cavity, with the first opening positioned in a first cavity opening ( such as a vaginal opening or an abdominal incision) and the second opening positioned in a second cavity opening ( such as a vaginal opening or an abdominal incision), thereby isolating the contained tissue from the surrounding cavity.

Description

TISSUE CONTAINMENT SYSTEM AND METHOD OF USETECHNICAL FIELD

[0001] The present disclosure relates to the field of medical devices and particularly relates to tissue containment system for use in natural orifice surgery or minimally invasive surgery.BACKGROUND

[0002] Trans-vaginal surgical procedures such as hysterectomy or myomectomy have become common. In such procedures, the utems or myoma of the subject is dissected and retrieved through the vaginal canal. In some cases, if the dissected tissue is too big to be taken out, it is morcellated with a scalpel blade and retrieved through the vaginal canal. In this process of retrieval, the inner content of the tissue such as fluids, diseased pathologies, may get disseminated inside the abdominal cavity, which may lead to seeding and post-surgical complications. The disclosed herein is a system that can be used to contain or isolate the dissected tissue specimen prior to retrieval, thereby minimizing the chances of seeding and other complications.SUMMARY

[0003] Disclosed herein is a tissue containment system that can comprise a sleeve comprising a first opening, a second opening, and a sleeve body extending between the first opening and the second opening. The sleeve body defines an interior of the sleeve configured to receive tissue through at least the first opening. The sleeve can extend through a cavity of a subject with the first opening positioned in a first cavity opening and the second opening positioned in a second cavity opening. The first cavity opening can be a vagina or can be in an abdomen, and the second cavity opening can be the vagina or can be in the abdomen. The sleeve can be inserted into the cavity via the first cavity opening or the second cavity opening. The sleeve can be removed from the cavity via the first cavity opening or the second cavity opening.

[0004] Disclosed herein is a tissue containment system that can comprise: a sleeve comprising a first opening, a second opening, and a body extending between the first opening and the second opening, the body defining an interior configured to receive tissue through at least the first opening, the sleeve configured to extend through a pelvic cavity of a subject with the first opening positioned in a first cavity opening and the second opening positioned in a second cavity opening, wherein the first cavity opening is a vagina or is in an abdomen, and wherein the second cavity opening is the vagina or is in the abdomen; an envelope formed from at least a portion of the body, wherein the envelope extends around at least a portion of the first opening, and wherein the envelope comprises a first envelope opening and a second envelope opening; and a wire removably positioned within the envelope, wherein the wire is configured to resume a default shape spontaneously after deformation to cause the first opening to enlarge when the wire is positioned within the envelope, and wherein the wire is configured to be removed from the envelope via the first envelope opening or the second envelope opening. The first opening can be occluded to inhibit contentsof the interior of the sleeve from passing from the interior of the sleeve through the first opening. The first opening can be occluded pursuant to removal of the wire from the envelope.

[0005] In some implementations, the tissue containment system includes a sheath encasing at least a portion of the wire, wherein the sheath is configured to facilitate removing the wire from the envelope.

[0006] In some implementations, the sheath comprises one or more synthetic polymers.

[0007] In some implementations, the sheath comprises Teflon.

[0008] In some implementations, the body comprises an inner surface and an outer surface, wherein the inner surface comprises a first visual indicator, wherein the outer surface comprises a second visual indicator, wherein the first visual indicator is different from the second visual indicator to provide a visual distinction between the inner surface and the outer surface.

[0009] In some implementations, the sleeve comprises a first marking on the body adjacent to the first opening, wherein the sleeve comprises a second marking on the body adjacent to the second opening, wherein the first marking is different from the second marking to provide a visual distinction between the first opening and the second opening.

[0010] In some implementations, the first opening is larger than the second opening.

[0011] In some implementations, the sleeve comprises a cylindrical portion and a tapered portion, wherein the cylindrical portion is adjacent to the first opening or the second opening, wherein the tapered portion is adjacent to the cylindrical portion.

[0012] In some implementations, the first opening is configured to be tied pursuant to removal of the wire from the envelope to occlude the first opening to inhibit the contents of the interior of the sleeve from passing from the interior of the sleeve through the first opening.

[0013] In some implementations, the second opening is configured to be tied pursuant to removal of the wire from the envelope to occlude the second opening to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the second opening.

[0014] In some implementations, the body comprises an inner surface, wherein the inner surface comprises a cut-resistant material positioned adjacent to at least the second opening.

[0015] Disclosed herein is a tissue containment system that can comprise: a sleeve comprising a first opening, a second opening, and a body extending between the first opening and the second opening; and an introducer comprising: a distal section comprising: a first aperture configured to be at least partially inserted into a cavity of a subject; a second aperture; and a lumen extending between the first aperture and the second aperture, wherein the distal section is configured to hold at least the first opening of the sleeve within the lumen; and a proximal section removably connected to the second aperture of the distal section, wherein the proximal section is configured to hold at least the second opening of the sleeve when the proximal section is connected with the distal section, wherein the introducer is configured to deploy the first opening of the sleeve from the lumen of the distal section through the first aperture of the distal section into the cavity of the subject, wherein the proximal section of the introducer is configured to disconnect fromthe second aperture of the distal section to expose the second opening of the sleeve while at least a portion of the sleeve is deployed in the cavity of the subject, wherein the second opening of the sleeve is configured to be occluded to inhibit contents within the sleeve from passing through the second opening of the sleeve, wherein the second opening of the sleeve is configured to pass through the second aperture into the lumen of the distal section, and pass through the lumen of the distal section, and pass through the first aperture of the distal section and enter into the cavity of the subject.

[0016] In some implementations, the proximal section of the introducer comprises a handle.

[0017] In some implementations, the handle is removably connected with the proximal section of the introducer.

[0018] In some implementations, the proximal section is configured to mechanically connect responsive to force applied by a user to the proximal section and / or the distal section, and wherein the proximal section is configured to mechanically disconnect responsive to force applied by a user to the proximal section and / or the distal section.

[0019] In some implementations, the proximal section is configured to connect with the distal section via one or more threads, wherein the proximal section is configured to screw onto the distal section via the one or more threads.

[0020] In some implementations, the distal section includes threads proximate to the second aperture, wherein the threads are configured to mate with the proximal section of the introducer.

[0021] In some implementations, the second opening of the sleeve is configured to be occluded while the first aperture of the distal section is at least partially inserted into the cavity of the subject.

[0022] Disclosed herein is a tissue containment system that can comprise: a sleeve comprising a first opening, a second opening, and a sleeve body extending between the first opening and the second opening, the sleeve body defining an interior configured to receive tissue through at least the first opening, the first opening being larger than the second opening to facilitate receiving tissue through the first opening to the interior, the sleeve configured to extend through a pelvic cavity with the first opening positioned in a first cavity opening and the second opening positioned in a second cavity opening of a subject, wherein the first cavity opening is a vagina or is in an abdomen, and wherein the second cavity opening is the vagina or is in the abdomen; a wound guard comprising: a wound guard proximal end; a wound guard distal end configured for placement within the first cavity opening or the second cavity opening; a first side extending between the wound guard proximal end and the wound guard distal end; a second side extending between the wound guard proximal end and the wound guard distal end, the wound guard configured to deform responsive to force to cause a distance between the first side and the second side to change; an inner surface; and an outer surface configured to contact the sleeve and / or the first cavity opening or the second cavity opening, the wound guard configured to inhibit one or more surgical instruments from contacting a portion of the sleeve and / or a portion of the first cavity opening or a portion of the second cavity opening adjacent to the outer surface; and a tissue retractor comprising: a tissue retractor proximal end; a tissue retractor distal end configured for placement within the first cavity opening or the second cavity opening adjacent tothe wound guard; and a retractor body extending between the tissue retractor proximal end and the tissue retractor distal end, the retractor body defining a lumen configured to allow the one or more surgical instruments to pass therethrough, at least a portion of the retractor body contacting the inner surface of the wound guard, and the retractor body configured to fold to cause the tissue retractor proximal end to approach the tissue retractor distal end and create tension in the retractor body to apply outward radial force on the inner surface of the wound guard.

[0023] In some implementations, the sleeve comprises a cylindrical portion and a tapered portion, wherein the cylindrical portion is adjacent to the first opening or the second opening, wherein the tapered portion is adjacent to the cylindrical portion.

[0024] In some implementations, the sleeve comprises a first marking on the sleeve body adjacent to the first opening, wherein the sleeve comprises a second marking on the sleeve body adjacent to the second opening, wherein the first marking is different from the second marking to provide a visual distinction between the first opening and the second opening.

[0025] In some implementations, the sleeve body comprises an inner surface and an outer surface, wherein the inner surface comprises a first visual indicator, wherein the outer surface comprises a second visual indicator, wherein the first visual indicator is different from the second visual indicator to provide a visual distinction between the inner surface and the outer surface.

[0026] In some implementations, the wound guard comprises a cylindrical portion between the wound guard proximal end and the wound guard distal end.

[0027] In some implementations, the wound guard proximal end is semi-annular, wherein the wound guard distal end is semi-annular, wherein a diameter of the semi-annular wound guard proximal end is larger than a diameter of the semi-annular wound guard distal end.

[0028] In some implementations, the tissue containment system comprises: a wire removably coupled to the first opening, wherein the wire is configured to resume a shape spontaneously after deformation to cause the first opening to enlarge when the wire is coupled to the first opening.

[0029] In some implementations, the first opening is configured to be tied to inhibit the tissue from passing from the interior of the sleeve through the first opening, wherein the second opening is configured to be tied to inhibit the tissue from passing from the interior of the sleeve through the second opening.

[0030] In some implementations, the tissue containment system comprises: a clamp configured to close the first opening or the second opening to inhibit the tissue from passing from the interior of the sleeve through the first opening or the second opening.

[0031] Disclosed herein is a method of containing tissue that can comprise: deploying a first opening of a sleeve through a first abdominal opening into an abdominal cavity of a subject; manipulating the sleeve within the abdominal cavity of the subject to induce a tissue of the subject through the first opening into an interior of the sleeve; moving the first opening of the sleeve through the abdominal cavity toward a second abdominal opening of the abdominal cavity; removing the first opening of the sleeve fromthe abdominal cavity of the subject through the second abdominal opening of the subject; removing a flexible member from an envelope of the sleeve proximate to the first opening; wherein the flexible member is configured to spontaneously resume a default shape after deformation to cause the first opening to enlarge when the flexible member is positioned within the envelope; pursuant to removal of the flexible member from the envelope, occluding the first opening of the sleeve to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the first opening; and removing the sleeve from the abdominal cavity of the subject.

[0032] In some implementations, the method comprises occluding the first opening of the sleeve based on at least tying a knot in the sleeve.

[0033] In some implementations, the method comprises occluding the first opening of the sleeve based on at least applying a clamp to the sleeve.

[0034] In some implementations, the method comprises occluding the first opening of the sleeve based on at least folding the sleeve.

[0035] In some implementations, the method comprises occluding the second opening of the sleeve to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the second opening.

[0036] In some implementations, the method comprises morcellating the tissue within the interior of the sleeve through the first abdominal opening or the second abdominal opening.

[0037] In some implementations, the method comprises removing the tissue from within the interior of the sleeve through the first opening of the sleeve or the second opening of the sleeve while at least a portion of the sleeve is within the abdominal cavity of the subject.

[0038] In some implementations, the method comprises removing the sleeve from the abdominal cavity of the subject through the first abdominal opening.

[0039] Disclosed herein is a method of containing tissue that can comprise: introducing a distal end of an introducer into a first cavity opening of a subject; deploying a first opening of a sleeve from the distal end of the introducer into a cavity of a subject; manipulating the sleeve within the cavity of the subject to induce a tissue of the subject through the first opening into an interior of the sleeve; moving the first opening of the sleeve through the cavity toward a second cavity opening of the subject; removing the first opening of the sleeve from the cavity of the subject through the second cavity opening of the subject; occluding a second opening of the sleeve while the distal end of the introducer is in the first cavity opening of the subject; passing the second opening of the sleeve through the distal end of the introducer into the cavity of the subject; and removing the sleeve and the tissue from the cavity of the subject.

[0040] In some implementations, the method comprises disconnecting a distal end of the introducer to expose the second opening of the sleeve.

[0041] Various combinations of the above and below recited features, embodiments, implementations, and aspects are also disclosed and contemplated by the present disclosure.

[0042] Additional implementations of the disclosure are described below in reference to the appended claims, which may serve as an additional summary of the disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Various implementations will be described hereinafter with reference to the accompanying drawings. These implementations are illustrated and described by example only and are not intended to limit the scope of the disclosure. In the drawings, similar elements may have similar reference numerals.

[0044] FIG. 1 A shows a tissue containment system comprising a sleeve, according to various implementations of the present disclosure.

[0045] FIG. IB shows the sleeve, according to various implementations of the present disclosure.

[0046] FIGS. 2A-2B show additional example sleeves, according to various implementations of the present disclosure.

[0047] FIG. 3 shows an example opening of a sleeve, according to various implementations of the present disclosure.

[0048] FIG. 4 shows an example sleeve with cut-resistant material, according to various implementations of the present disclosure.

[0049] FIG. 5A shows an example opening of a sleeve with a removable flexible member, according to various implementations of the present disclosure.

[0050] FIGS. 5B-5C are various views of the flexible member, according to various implementations of the present disclosure.

[0051] FIG. 6A shows an example opening of a sleeve with tabs, according to various implementations of the present disclosure.

[0052] FIGS. 6B-6C show another example opening of a sleeve with tabs, according to various implementations of the present disclosure.

[0053] FIGS. 7A-7C show an example sleeve with retractable cover, according to various implementations of the present disclosure.

[0054] FIGS. 8A-8E show an example introducer, according to various implementations of the present disclosure.

[0055] FIGS. 9A-9C show an example introducer with a distal section and proximal section, according to various implementations of the present disclosure.

[0056] FIG 10 shows an example wound guard, according to various implementations of the present disclosure.

[0057] FIG. 11 shows another example wound guard, according to various implementations of the present disclosure.

[0058] FIGS. 12A-12B show another example wound guard, according to various implementations of the present disclosure.

[0059] FIG. 13 shows another example wound guard, according to various implementations of the present disclosure.

[0060] FIG. 14 shows an example tissue retractor, according to various implementations of the present disclosure.

[0061] FIG. 15 shows another example tissue retractor, according to various implementations of the present disclosure.

[0062] FIG. 16 shows an example tissue retractor configured to guard against cuts, according to various implementations of the present disclosure.

[0063] FIGS. 17A to 17C show an example clamp configured to occlude an opening of a sleeve, according to various implementations of the present disclosure.

[0064] FIGS. 18A to 18B show another example clamp configured to occlude an opening of a sleeve, according to various implementations of the present disclosure.

[0065] FIGS. 19A-19H show a method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.

[0066] FIGS. 20A-20K show another method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.

[0067] FIGS. 21A-21K show another method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.

[0068] FIGS. 22A-22I show another method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.

[0069] FIGS. 23A-23H show another method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.

[0070] FIG 24A-24K show another method of implementing a tissue containment system within a cavity of a subject, according to various implementations of the present disclosure.DETAILED DESCRIPTION

[0071] The present disclosure will now be described with reference to the accompanying figures, wherein like numerals may refer to like elements throughout. The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. Furthermore, the devices, systems, and / or methods disclosed herein can include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the devices, systems, and / or methods disclosed herein. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components.

[0072] Some aspects and / or implementations have been described in connection with the accompanying drawings. The figures may be drawn to scale, but such scale is not limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosure. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and / or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, any methods described herein may be practiced using any device suitable for performing the recited steps. Various steps within a method may be executed in different order without altering the principles of the present disclosure.

[0073] FIG. 1 A shows a tissue containment system 150 (which may also be referred to herein as the “system”) comprising a sleeve 100. System 150 can contain tissue during natural orifice surgery or minimally invasive surgery. System 150 can optionally include one or more of an introducer 191, a wound guard 192, a tissue retractor 193, a locking clamp 194, and a locking thread 195.

[0074] FIG. IB is a side perspective view of sleeve 100. The sleeve 100 has a body 105, a first opening 101, and second opening 102. The body 105 can be made from a flexible, high strength, thin material such as TPU film, TPU coated Nylon fabric, polyethylene film, polypropylene film or any other material that is impermeable to liquids, tissue, biological material, microbes, etc.

[0075] The body 105 extends between the first opening 101 and the second opening 102. The body 105 has an outer surface 107 and an inner surface 109. The body 105 defines an interior 103 of the sleeve 100. The interior 103 extends between the first opening 101 and the second opening 102. The sleeve 100 can receive tissue, such as a utems, into the interior 103 via the first opening 101 or the second opening 102. The sleeve 100 can hold tissue in the interior 103. The first opening 101 is bigger than the second opening 102. For example, the first opening 101, when fully open, can have a larger cross-sectional area and / or diameter than the second opening 102, when the second opening 102 is fully open. Advantageously, a larger first opening 101 can facilitate inducing tissue to enter the interior 103 via the first opening 101.

[0076] The body 105 has a first cylindrical portion 110, a tapered portion 115, and a second cylindrical portion 120. The first cylindrical portion 110 is adjacent to the first opening 101. The second cylindrical portion 120 is adjacent to the second opening 102. The tapered portion 115 is adjacent to the first cylindrical portion 110 and / or the second cylindrical portion 120. The body 105 can have a circular and / or elliptical cross-section at any point along its length between the first opening 101 and the second opening 102. For example, the first cylindrical portion 110 and / or the second cylindrical portion 120 can have circular cross sections and / or elliptical cross sections. The body 105 can have a variable cross-sectional area and / or diameter along its length. For example, the first cylindrical portion 110 can have a larger cross- sectional area and / or diameter than the second cylindrical portion 120. The first cylindrical portion 110 can have a uniform cross-sectional area and / or diameter along its length from the first opening 101 to the tapered portion 115. The second cylindrical portion 120 can have a uniform cross-sectional area and / or diameteralong its length from the tapered portion 115 to the second opening 102. The tapered portion 115 can have a variable cross-sectional area and / or diameter along its length between the first cylindrical portion 110 and the second cylindrical portion 120. In some implementations, body 105 may have only one cylindrical portion such that tapered portion 115 may be adjacent to an opening, such as second opening 102. Sleeve 100 can include any of the structural and / or operational features of any of the other sleeves shown and / or described herein.

[0077] FIGS. 2A-2B illustrate additional example sleeves 200A-200C, according to various implementations. Sleeve 200A has body 205A extending between first opening 201 A and second opening 202A. In this example, body 205A has a uniform cross-sectional area and / or diameter along its length, such that the body 205A is substantially cylindrical (which may include elliptical cylindrical). Accordingly, the first opening 201A may be the same size as the second opening 202A (e.g., same cross-sectional area and / or diameter). The body 205A can have a circular or elliptical cross section at any point along its length.

[0078] Sleeve 200B has body 205B extending between first opening 20 IB and second opening 202B. In this example, body 205B has a variable cross-sectional area and / or diameter along its length, such that the body 205B is substantially conical (which may include elliptical conical). Accordingly, the first opening 201B may be larger than the second opening 202B (e.g., larger cross-sectional area and / or diameter). The body 205B can have a circular or elliptical cross section at any point along its length.

[0079] Sleeve 200C has body 205C extending between first opening 201 C and second opening 202C. In this example, body 205C has at least one cylindrical portion and a tapered portion.

[0080] FIG. 3 is a perspective view of an opening 301 of sleeve 300 which can include any of the structural and / or operational features of any of the other sleeves shown and / or described herein. The opening 301 can be at either end of sleeve 300. Opening 301 defines an opening to interior 303 of sleeve 300. Sleeve 300 has outer surface 307 and inner surface 309. Sleeve 300 has outer marking 306 on the outer surface 307. Sleeve 300 has inner marking 308 on inner surface 309. Advantageously, the outer marking 306 and / or the inner marking 308 can aid a user, such as a healthcare provider, in distinguishing the inner surface 309 from the outer surface 307. Thus, a user can facilitate introducing and / or containing tissue within the interior 303 of the sleeve 300.

[0081] In this example, outer marking 306 and inner marking 308 are proximate to opening 301 but separated from opening 301 by a distance. In some implementations, outer marking 306 and / or inner marking 308 may be at the end of outer surface 307 and inner surface 309 respectively, such that outer marking 306 and / or inner marking 308 are at the opening 301.

[0082] In various implementations, outer marking 306 can cover the entire outer surface 307, between 50% and 100% of the outer surface 307, between 50% and 75% of the outer surface 307, between 10% and 50% of the outer surface 307, between 5% and 25% of the outer surface 307, between 1% and 10% of the outer surface 307, or any value or range of values therebetween. Outer marking 306 can entirely or partially circumscribe the sleeve 300. Outer marking 306 can have various shapes, such as a band, a line, a zig zag, a cross-hatch, etc. Outer marking 306 can be visually and / or tactilely distinct from other portionsof the sleeve, 300 such as the inner marking 308, outer surface 307, and / or inner surface 309. For example, outer marking 306 can have a distinct color, pattern, shape, symbol, size, texture, material, alphanumeric, transparency, etc.

[0083] In various implementations, inner marking 308 can cover the entire inner surface 309, between 50% and 100% of the inner surface 309, between 50% and 75% of the inner surface 309, between 10% and 50% of the inner surface 309, between 5% and 25% of the inner surface 309, between 1% and 10% of the inner surface 309, or any value or range of values therebetween. Inner marking 308 can entirely or partially circumscribe the sleeve 300. Inner marking 308 can have various shapes, such as a band, a line, a zig zag, a cross-hatch, etc. Inner marking 308 can be visually and / or tactilely distinct from other portions of the sleeve, 300 such as the outer marking 306, outer surface 307, and / or inner surface 309. For example, inner marking 308 can have a distinct color, pattern, shape, symbol, size, texture, material, alphanumeric, transparency, etc. In this example, inner marking 308 has letters “XYZ” and in various implementation can have other alphanumeric characters to indicate various information such as brand name, inside of sleeve 300, opening of sleeve 300, direction, etc. In various implementations, outer marking 306 can have one or more alphanumeric characters.

[0084] In some implementations, sleeve 300 can have a plurality of outer markings 306, such as identical outer marking 306 that repeat along the outer surface 307 and / or that are distinct from each other. In some implementations, sleeve 300 can have a first outer marking proximal to a first opening and a second outer marking proximal to a second opening, and the first and second outer marking can be distinct from each other to facilitate identifying the first opening and the second opening. In some implementations, sleeve 300 may not have outer marking 306 and / or inner marking 308.

[0085] FIG. 4 is a perspective view of a sleeve 400 with first opening 401, second opening 402, outer surface 407, inner surface 409, and lining 412. Sleeve 400 can include any of the structural and / or operational features of any of the other sleeves shown and / or described herein. Lining 412 can be a layer of material adjoined to inner surface 409 and / or may form a portion of inner surface 409. Lining 412 may be formed of a different material than other portions of sleeve 400, such as outer surface 407 and / or inner surface 409. Lining 412 canbe formed of a cut / tear-resistant material such as one or more of Kevlar, Spectra, Dyneema, or the like. Advantageously, lining 412 can inhibit sleeve 400 from being lacerated near the second opening 402, such as by surgical tools inserted through second opening 402. For example, a morcellator (e.g., a scalpel) can be inserted through second opening 402 to morcellate tissue within sleeve 400, and lining 412 can inhibit the morcellator from cutting the sleeve 400. Lining 412 may be flexible to allow forbending, folding, tying, etc. the sleeve 400 proximate to the second opening 402.

[0086] In this example, lining 412 is proximate to second opening 402 and separated from second opening 402 by a distance. In various implementations, lining 412 may not be separated from second opening 402 by a distance, such that lining 412 is directly adjacent to, and in contact, with opening 402. In some implementations, lining 412 can extend from proximate the second opening 402 to proximate the first opening 401. For example, lining 412 may be separated from first opening 401 by the same distance as it isseparated from second opening 402. In some implementations, sleeve 400 includes a first lining proximate to first opening 401 and a second lining proximate to second opening 402. In some implementations, lining 412 is proximate to only the first opening 401 or only the second opening 402. For example, the lining 412 may only be proximate to the second opening 402, which may be smaller than the first opening 401.

[0087] Lining 412 can be positioned on and / or can form between 5% and 15% of inner surface 409, between 5% and 25% of inner surface 409, between 15% and 25% of inner surface 409, between 10% and 50% of inner surface 409, between 25% and 50% of inner surface 409, between 50% and 75% of inner surface 409, between 50% and 90% of inner surface 409, or any value or range of values therebetween.

[0088] In various implementations, sleeve 400 can have inner markings and / or outer markings in combination with lining 412. For example, sleeve 400 can have inner markings superimposed on lining 412 and / or proximate to lining 412. In some implementations, inner markings can be positioned at least partially between lining 412 and opening 402.

[0089] FIG. 5 A is a perspective view of an opening 501 of a sleeve 500 of a tissue containment system 550 which can include any of the structural and / or operational features of any of the other tissue containment systems shown and / or described herein. The opening 501 can be at either end of the sleeve 500. Sleeve 500 includes body 505. Sleeve 500 includes envelope 518. Envelope 518 is formed from at least a portion of body 505. In this example, body 505 is folded and coupled to itself along attachment 521 to form envelope 515. Accordingly, in this example, envelope 518 is formed from the same material (e.g., body 505). In some implementations, envelope 518 can be formed form a plurality of materials. For example, a separate material (which can be the same material type as body 505) can be attached to body 505 to form an envelope. Body 505 can be attached to itself at attachment 521 via a heat weld wherein heat causes various portions of body 505 to melt and join together. In some implementations, attachment 521 can be formed from an adhesive, stitching, etc. to attach body 505 to itself.

[0090] In this example, envelope 518 is formed at opening 501 such that opening 501 is at least partially defined by envelope 518. For example, opening 501 can be defined as any portion of envelope 518 (e.g., any portion of body 505 extending beyond attachment 521). In some implementations, envelope 518 is positioned in proximity to opening 501 but separated from opening 501 by a distance. For example, in some cases, a portion of body 505 that does not form envelope 518 can extend between envelope 518 and opening 501. In some implementations, a plurality of envelopes can be positioned along sleeve 500.

[0091] Envelope 518 has at least one envelope opening 519 (e.g., first envelope opening 519A, second envelope opening 519B). Envelope 518 extends at least partially around opening 501. For example, as shown here, envelope forms a partial annulus around opening 501. In some implementations, envelope 518 forms a complete annulus around opening 501.

[0092] Tissue containment system 550 can include flexible member 522. Flexible member 522 can extend at least partially through envelope 518 such that envelope 518 houses at least a portion of flexible member 522. A portion of flexible member 522 can extend from the first envelope opening 519A and / or the second envelope opening 519B. As shown, flexible member 522 can be longer than envelope 518 suchthat a portion of flexible member 522 can extend from the first opening 519A at the same time that another portion of flexible member 522 extends from the second opening 519B. Flexible member 522 can be inserted into, and removed from, envelope 518 such as by a user. Accordingly, flexible member 522 can be removably coupled to sleeve 500. In some implementations, flexible member 522 can be permanently coupled to sleeve 500.

[0093] Flexible member 522 can comprise metal or a metal alloy, for example nickel and / or titanium. Flexible member 522 can comprise nitinol. Flexible member 522 can deform responsive to force. For example, force can cause flexible member 522 to change shape. Flexible member 522 can have elastic properties such that flexible member 522 can spontaneously resume a default shape after deformation. For example, if a user exerts force to cause the flexible member 522 to change from a default shape to a deformed shape, the flexible member 522 can automatically transition back to the default shape from the deformed shape when the user ceases to exert the force on the flexible member 522. Flexible member 522 is coupled to sleeve 500 at, or near, opening 501. Accordingly, flexible member 522 can cause opening 501 to change shape and / or size. Advantageously, a user can deform the flexible member 522 into a smaller profde to deploy opening 501 into a pelvic cavity and flexible member 522 can resume a default shape when opening 501 is deployed in the pelvic cavity. The default shape of the flexible member 522 can be circular or elliptical and can maximize the cross-sectional area of opening 501 to facilitate inducing tissue through opening 501.

[0094] Flexible member 522 can include one or more loops 524 (e.g., first loop 524A, second loop 524B). Flexible member 522 can pass through first loop 524A and / or second loop 524B, as shown and / or described in FIGS. 5B-5C, for example.

[0095] FIG. 5B shows an example implementation of flexible member 522. In this example, a portion of flexible member 522 is passed through loop 524B. For example, loop 524A can be passed through loop 524B, even when flexible member 522 is within envelope 518. A user can pass one of the loops 524 through the other when deploying sleeve 500 within a pelvic cavity. Loops 524 can advantageously secure flexible member 522 to itself to inhibit flexible member 522 from moving around within a pelvic cavity. When opening 501 of sleeve 500 is withdrawn from pelvic cavity, a user can remove flexible member 522 from outside of either loop 524 to withdraw flexible member from envelope 518.

[0096] FIG. 5C shows a cutaway view of an example implementation of flexible member 522. In this example, flexible member 522 includes wire 514 and sheath 516. Wire 514 can comprise metal or a metal alloy, for example nickel and / or titanium. Wire 514 can comprise nitinol. Sheath 516 can comprise one or more synthetic polymers, such as Teflon. Sheath 516 may have a lower coefficient of friction than wire 514. For example, sheath 516 can be smooth and / or slippery. Accordingly, sheath 516 can facilitate inserting and / or removing flexible member from envelope 518. Sheath 516 can encase at least a portion of wire 514. In some cases, one or more portions of wire 514 may be free from sheath 516 (e.g., not encased in sheath). For example, loop 524A and / or loop 524B may not be encased in sheath 516, and thus wire 514can be exposed in at least some portions of flexible member 522. In some implementations, flexible member 522 may not comprise sheath 516.

[0097] Flexible member 522 includes at least one crimp 526 (e.g., first crimp 526A, second crimp 526B). Wire 514 can terminate beneath crimps 526A, 526B. Thus, crimps 526A, 526B can secure the terminus of the wire 514 beneath respective crimps 526A, 526B and / or to sheath 516. Crimps 526A, 526B can encase at least a portion of wire 514 (e.g., terminus) and / or a portion of sheath 516. Crimps 526A, 526B can be formed of a metal such as stainless steel or plastic, synthetic, polymer, etc. Crimps 526 A, 526B can be heat shrunk around sheath 516 and / or wire 514. In various implementations, the crimps 526A, 526B and at least a portion of the sheath at either ends can be covered by a heat shrink cover.

[0098] FIG. 6 A is a perspective view of an opening 601 of a sleeve 600 of a tissue containment system 650 which can include any of the structural and / or operational features of any of the other tissue containment systems shown and / or described herein. The opening 601 can be at either end of the sleeve 600. Tissue containment system 650 can include one or more tabs 630. The tab(s) 630 can enable easy grasping and manipulation of opening 601 and / or sleeve 600. For example, a user can grasp tab(s) 630 (with a surgical tool for example) to move sleeve 600 within a pelvic cavity. The tab(s) 630 can be positioned at, or proximate to, opening 601. In this example, the tab(s) 630 extend beyond opening 601. The tab(s) 630 can be coupled to body 605. In various implementations, sleeve 600 can include an envelope and tab(s) 630 can be positioned on, and / or coupled to, said envelope. The tab(s) 630 can be loops. The tab(s) 630 can be made from material such as suture thread, Flat TPU films fused together, Ripstop Nylon fabric, etc.

[0099] FIG. 6B illustrates another example implementation of tissue containment system 650 that includes one or more tabs 630 coupled to sleeve 600. Tab(s) 630 can be formed of a different material than sleeve 600. For example, tab(s) 630 can comprise TPU coated nylon, TPU coated ripstop nylon, etc. A tab 630 can include a hole 631 that passes therethrough. The hole 631 can pass through the body 605. Accordingly, in this example, opening 601 may be substantially flush, whereas in the example shown in FIG. 6A, tab(s) 630 may protrude from opening 601.

[0100] FIG. 6C illustrates an example implementation of tissue containment system 650 with a surgical tool 633 passing through a hole 631 of a tab 630. Surgical tool 633 can be a grasper. Surgical tool 633 can pass through hole 631 of tab 630 to grasp another portion of the sleeve 600, such as another tab 630.

[0101] FIGS. 7A-7C shows a sleeve 700 which can include any of the structural and / or operational features of any of the other sleeves shown and / or described herein. Sleeve 700 has first opening 701, second opening 702, body 705 extending between first opening 701 and second opening 702, and retractable cover 734. Body 705 comprises a first cylindrical portion 710, a second cylindrical portion 720, and a tapered portion 715.

[0102] Retractable cover 734 can comprise the same material as body 705. In some implementations, retractable cover 734 can comprise a different material than body 705. Retractable cover 734 can be coupled (e.g., permanently) to body 705. Retractable cover 734 can be joined to body 705 viaone or more of a heat weld, adhesive, etc. In some implementations, retractable cover 734 and body 705 are manufactured as a single, unitary stmcture. Accordingly, retractable cover 734 and body 705 can be integrated with each other such that the connection between retractable cover 734 and body 705 is impermeable to biological substances, tissues, liquids, etc. In this example, retractable cover 734 is joined to the second cylindrical portion 720 proximate to second opening 702, which is smaller than the first opening 701. In some implementations, retractable cover can be joined to other portions of body 705 such as on first cylindrical portion 710 proximate to first opening 701, or to tapered portion 715. Retractable cover 734 can be joined to the second cylindrical portion 720 closer to the second opening 702 than to the tapered portion 715.

[0103] In this example, retractable 734 is shorter than the length of the body 705 from the first opening 701 to the second opening 702, and is also shorter than the length of the second cylindrical portion 720 from the tapered portion 715 to the second opening 702. In some implementations, retractable cover 734 is between 105% and 35% the length of the body 705, between 25% and 50% the length of the body 705, between 50% and 75% the length of the body 705, between 75% and 100% the length of the body 705, or any value or range of values therebetween.

[0104] As shown in FIG. 7 A, retractable cover 734 can envelope at least a portion of the body 705 (e.g., the second cylindrical portion 720) without enveloping the second opening 702 such that a portion of body 705 between the second opening 702 and the retractable cover 734 is exposed. As shown in FIG. 7B, retractable cover 734 can envelope the second opening 702 such that a portion of body 705 between the second opening 702 and the retractable cover 734 is also enveloped. The retractable cover 734 can envelope the second opening 702 without occluding the second opening 702 as shown in FIG. 7B. Thus, retractable cover 734 can transition between enveloping second opening 702 and not enveloping second opening 702. As shown in FIG. 7C, retractable cover734 can be occluded to occlude second opening 702. In this example, retractable cover 734 is tied in a knot 736 to occlude second opening 702 to inhibit biological substance from passing via second opening 702. In some implementations, retractable cover 734 can be occluded with one or more of clamp, a cinch, a fold, or the like.

[0105] Sleeve 700 can hold biological substance, such as a uterus, within the first cylindrical portion 710, tapered portion 715, and / or second cylindrical portion 720. A user can insert surgical instruments through second opening 702 to interact with said biological tissue. For example, a user can insert a morcellator through second opening 702 to morcellate a uterus. Advantageously, when retractable cover 734 envelopes the body 705 and exposes the second opening 702 (as shown in FIG. 7A, for example), such as state of the retractable cover 734 provides a shorter distance from the second opening 702 to wherever biological tissue may be held within the sleeve 700 (e.g., within the first cylindrical portion 710, thus rendering said biological substance more accessible to a user. Moreover, when retractable cover 734 envelopes the second opening 702 (as shown in FIG. 7B, for example), retractable cover 734 provides a greater length of material that can be sealed to occlude second opening 702 (as shown in FIG. 7C, for example).

[0106] Although various implementations of retractable cover 734 are shown and / or described with reference to the second opening 702, retractable cover 734 could in some cases transition between enveloping and not enveloping first opening 701. In some implementations, sleeve 700 includes a plurality of retractable covers (e.g., one near each opening).

[0107] FIGS. 8A-8B show an introducer 800 which can be included with any of the example tissue containment systems shown and / or described herein. The introducer 800 can introduce a sleeve into a cavity of a subject’s body, such as a pelvic cavity. Introducer 800 includes an outer tube 801 having a distal end 803 and a proximal end 804. The outer tube 801 can be rigid. For example, outer tube 801 can comprise one or more plastics such as polycarbonate, PC+ABS, ABS, etc., and / or one or more metals or metal alloys such as stainless steel.

[0108] Introducer 800 may include a handle 831 connected to distal end 803 of outer tube 801. In some implementations, introducer 800 may not include a handle. A user can hold handle 831 to manipulate the introducer 800. Introducer 800 can optionally include tip 841. The tip 841 can be removably attached to the distal end 803 of the outer tube 801. Accordingly, a user can attach the tip 841 to the distal end 803 of the introducer 800 for use during a procedure or can remove the tip 841 from the distal end 803, as desired or required for various procedures. In some implementations, the tip 841 can be permanently fixed to the introducer 800. The tip 841 can delineate the boundary between the uterine body and the vaginal canal during colpotomy procedure. The tip 841 can be provided in different sizes for compatibility with different subject anatomies. Colpotomy can also be performed without using the tip 841. The tip 841 can be made of non-conductive, heat-resistant material such as PTFE, PEEK, Silicone, etc.

[0109] In this example, introducer 800 includes expandable portion 861, which may be inflatable with air, such as a balloon. Expandable portion 861 is connected to distal end 803 of outer tube 801. Expandable portion 861 can expand to occlude a space between the outer tube 801 and subject tissue when its distal end 203 is passed into a body cavity. In some implementations, introducer 800 may not include expandable portion 861. Tube 862 is connected to expandable portion 861 and can provide air to expandable portion 861 to cause expandable portion 861 to expand. Valve 863 is connected to tube 862 and can control air flow into, and out of, tube 862. Valve 863 can be configured to allow one-way passage of air into tube 862 toward expandable portion 861 and to inhibit passage of air out of tube 862.

[0110] Introducer 800 includes an inner tube 811 which can be positioned within a lumen of outer tube 801. The inner tube 811 can be rigid. For example, inner tube 811 can comprise one or more plastics such as polycarbonate, PC+ABS, ABS, etc. and / or one or more metals or metal allows such as stainless steel. The inner tube 811 can be hollow and can allow passage of surgical instruments such as tenaculum, graspers, etc. through the inner tube 811 between the proximal end 804 and distal end 803. Introducer 800 includes end cap 821 which can connect inner tube 811 to outer tube 801 at the proximal end 804. End cap 821 can hold inner tube 811 in coaxial alignment with outer tube 801.

[0111] Sleeve 100 can be placed between outer tube 801 and inner tube 811. Introducer 800 can deploy sleeve 100 from within tube 801 into a cavity of a subject. In some implementations, a user can load sleeve 100 into the introducer 800.

[0112] Introducer 800 includes valve 851 and a reducer 852 which can seal the introducer 800 to inhibit gas leakage.

[0113] FIGS. 8C-8E illustrate introducer 800 deploying sleeve 100. Introducer 800 includes plunger 871 in this example, which passes through handle 831 into proximal end 804 of outer tube 801. A user can press plunger 871 to push plunger further within outer tube 801 as shown in FIGS. 8C-8E. As plunger 871 is pressed within outer tube 801, plunger 871 contacts sleeve 100 within tube 801 and causes sleeve 100 to deploy out of distal end 803 of outer tube 801. Sleeve 100 is deployed such that that the opening 101 of sleeve 100 deploys first. In some implementations, introducer 800 can include a screw in contact with the sleeve 100, wherein the screw can twist to push the sleeve 100 out through the distal end 803.

[0114] FIGS. 9A-9C illustrate tissue containment system 950 comprising introducer 900 and sleeve 100. Introducer 900 can include any of the structural and / or operational features of any of the other introducers shown and / or described herein, and vice versa. Introducer 900 includes distal section 913, proximal section 915, and handle 931. In some implementations, proximal section 915 is removably connected with handle 931. In some implementations, proximal section 915 comprises handle 931 such that proximal section 915 and handle 931 form a unitary stmcture. Proximal section 915 can removably connect with distal section 913.

[0115] Distal section 913 includes a first aperture 917, a second aperture 919, and a lumen 921 extending between the first aperture 917 and the second aperture 919. Proximal section 915 can connect to second aperture 919 and can disconnect from second aperture 919. A user can removably mechanically connect proximal section 915 to distal section 913 by applying force to proximal section 915 and / or distal section 913. Distal section 913 can include one or more threads 923 proximate to the second aperture 919. Proximal section 915 can connect to the distal section 913 via the one or more threads 923. For example, proximal section 915 can be screwed onto distal section 913 via the one or more threads 923. In some implementations, distal section 913 may not include threads. In some implementations, proximal section 915 can be pushed onto distal section 913. When proximal section 915 is connected with distal section 913, proximal section 915 can envelope the second aperture 919 of the distal section 913, such that the second aperture 919 is positioned with the proximal section 915.

[0116] Distal section 913 can hold at least a portion of the sleeve 100, such as the first opening 101, within the lumen 921. Introducer 900 can deploy the first opening 101 of the sleeve 100 from the lumen 921 of the distal section 913 into a cavity of a subject via the first aperture 917 of the distal section 913. Proximal section 915 can hold at least a portion of sleeve 100, such as the second opening 102, when proximal section 915 is connected to distal section 913. Proximal section 915 can hold the second opening 102 of the sleeve 100 while the sleeve 100 is loaded in the introducer 900, before the sleeve 100 is deployedfrom the introducer 900, while the first opening 101 is deployed into the cavity of the subject, and / or when the first opening 101 is removed from the cavity of the subject (for example when first aperture 9178 of distal section 915 is in the vagina and first opening 101 of sleeve 100 is pulled through an abdominal opening, or vice versa).

[0117] Proximal section 915 can disconnect from distal section 913 to expose the second opening 102 of the sleeve 100, such as while at least a portion of sleeve 100 is within the cavity of the subject (e.g., after the first opening 101 has been deployed into the cavity) and / or while the first aperture 917 of the introducer 900 is placed within a cavity opening (e.g., a vagina) of the subject. Exposing second opening 102 of the sleeve 100 by disconnecting proximal section 915 from the distal section 913 can allow the second opening 102 to be occluded (e.g., with a knot 936) while at least a portion of the sleeve 100 is within the lumen 921 of the distal section 913 of the introducer 900, while at least a portion of the sleeve 100 is within the cavity of the subject, and / or while the first aperture 917 of the introducer 900 is placed within a cavity opening (e.g., a vagina) of the subject. Thus, a user can occlude the second opening 102 of sleeve 100 after the first opening 101 of the sleeve 100 has been deployed into the cavity of the subject without having to remove the first aperture 917 of the introducer 900 from the cavity opening of the subject. Second opening 102 of the sleeve 100, even after it has been occluded, can pass through the second aperture 919, the lumen 921, and the first aperture 917 of the distal section 913, and can pass into the cavity of the subject.

[0118] FIG. 10 shows a wound guard 1000 which can protect a sleeve and / or a cavity opening (e.g., a vagina) of a subject, such as from surgical tools. The wound guard 1000 has a proximal end 10003, a distal end 1002, and a sidewall 1001 extending between the proximal end 1003 and the distal end 1002. The distal end 1002 can be placed with a cavity opening of a subject such as vagina or abdominal opening. The proximal end 1003 can be exposed outside of a cavity opening while the distal end 1002 is within the cavity opening. The wound guard 1000 includes a first side 1004 extending between the proximal end 1003 and the distal end 1002, and a second side 1005 extending between the proximal end 1003 and the distal end 1002. The first side 1004 and second side 1005 are both contiguous with the distal end 1002 and proximal end 1003. The first side 1004 and second side 1005 define a channel 1007 between the first side 1004 and second side 1005. The channel 1007 extends between the proximal end 1003 and the distal end 1002. A width of the channel 1007 defines a distance between the first side 1004 and the second side 1005. The channel 1007 can have a uniform width (e.g., distance between the first side 1004 and the second side 1005) along its length. The wound guard 1000 can be formed of a cut-resistant material. The wound guard 1000 can comprise one or more plastics, polymers, synthetics, such as polypropylene (PP), High-Density Polyethylene (HDPE), etc. The wound guard 1000 can comprise one or more fabrics or fabric-like materials such as Ultra-High Molecular Weight Polyethylene (UHMWPE), Kevlar, Reinforced composite, etc.

[0119] The sidewall 1001 defines a lumen 1006 extending between the proximal end 1003 and the distal end 1002. The sidewall 1001 can have a semi-annular cross section (with a gap at the channel 1007) at any point along the lumen 1006. For example, the proximal end 1003 and / or the distal end 1002can be semi-annular. The proximal end 1003 can be larger (e.g., greater diameter) than the distal end 1002 which can advantageously facilitate the introduction of surgical tools into the lumen 1006 via the proximal end 1003. The lumen 1006 can have a variable diameter along its length between the proximal end 1003 and the distal end 1002. At least a portion of the sidewall 1001 can be cylindrical, such as near the distal end 1002. At least a portion of the sidewall 1001 can be flared, such as a portion near the proximal end 1003. Surgical tools, such as a scalpel, morcellator, grasper, etc. can be inserted into and / or through the lumen 1006. Sidewall 1001 can inhibit surgical tools within the lumen 1006 from interacting with subject tissue and / or a sleeve.

[0120] The wound guard 1000 can deform responsive to force, which can cause the first side 1004 and the second side 1005 to approach or separate from each other, the channel 1007 width to change, and / or a cross-section of the lumen 1006 to change. For example, a user can squeeze the sidewall 1001 to cause the channel 1007 width to decrease and / or to cause the lumen 1006 cross section to decrease. Advantageously, deforming the wound guard 1000 can facilitate inserting the wound guard 1000 into, and / or removing the wound guard 1000 from a cavity opening of a subject. The wound guard 1000 can have elastic properties such that the wound guard 1000 can spontaneously resume a default shape after deformation. The wound guard 1000 can have anisotropic flexibility such that the wound guard 1000 is more flexible in certain directions than in others. For example, the wound guard 1000 may deform responsive to radial force around the sidewall 1001 more easily than to forces in other directions, such as compressive forces between the proximal end 1003 and the distal end 1002.

[0121] The sidewall 1001 of the wound guard 1000 has an inner surface 1008 and an outer surface 1009. In some implementations, the outer surface 1009 can contact subject tissue of a cavity opening and / or a sleeve inserted into a cavity opening. In some implementations, a tissue retractor can be inserted into lumen 1006 such that said tissue retractor can contact the inner surface 1008.

[0122] FIG. 11 is another example wound guard 1100 which can include any of the structural and / or operational features of any of the other wound guards shown and / or described herein. The wound guard 1100 has a proximal end 1103, a distal end 1102, a first sidewall 1101 A extending between the proximal end 1103 and the distal end 1102, a second sidewall 1101B extending between the proximal end 1103 and the distal end 1102, a first channel 1107 A, and a second channel 1107B.

[0123] The first channel 1107A extends between the proximal end 1103 and the distal end 1102, whereas the second channel 1107B extends only partially between the proximal end 1103 and the distal end 1102. Thus, the first channel 1107A is longer than the second channel 1107B. The first channel 1107A defines a distance between the first sidewall 1101A and the second sidewall 110 IB. The second channel 1107B defines another distance between the first sidewall 1101A and the second sidewall 1101B. The first sidewall 1101 A is connected to the second sidewall 110 IB along the proximal end 1103 where the second channel 1107B terminates. In various implementations, the wound guard 1100 can include more than two sidewalls spaced apart from each other by more than two channels.

[0124] The wound guard 1100 can deform responsive to force, which can cause the first channel 1107A and / or the second channel 1107B to change widths. For example, a user can squeeze the first sidewall 1101 A and the second sidewall 110 IB to decrease the cross-sectional area of the distal end 1102 and / or proximal end 1103. Deforming the wound guard 1100 can facilitate inserting the wound guard 1100 into, and / or removing the wound guard 1100 from a cavity opening of a subject. Advantageously, a plurality of channels can allow the wound guard 1100 to experience greater deformation than a single channel.

[0125] FIG. 12A is a top view of another example wound guard 1200 that comprises a lumen 1206, a sidewall 1201, a channel 1207, and a slot 1220. The channel 1207 provides access through the sidewall 1201 to the lumen 1206.

[0126] FIG. 12B is a sideview of the wound guard 1200 positioned within opening 102 of sleeve 100. In various implementations, a tissue retractor can be positioned between the wound guard 1200 and sleeve 100 and / or between the sleeve 100 and the subject’s body. In this example, tissue 1210 is being morcellated within wound guard 1200. A grasper 1230 can grasp the tissue 1210. A scalpel 1240 can morcellate the tissue 1210. The scalpel 1240 can pass through the slot 1220 to morcellate the tissue 1210 within the wound guard 1200. The slot 1220 can advantageously guide the scalpel 1240 to inhibit the scalpel 1240 from contacting the sleeve 100 and / or the subject’s body thereby minimizing chances of damage and / or injury.

[0127] FIG. 13 is a sideview of an example wound guard 1300 comprising a first sidewall 1301A and second sidewall 1301B. In this example, tissue 1310 is being morcellated within wound guard 1300. Grasper 1330 can grasp the tissue 1310 to facilitate morcellation. Scalpel 1340 can morcellate the tissue 1310 within the wound guard 1300. Wound guard 1300 has connector 1311 that can connect to scalpel 1340. Connector 1311, when connected to scalpel 1340, can cause the scalpel 1340 to align such that the blade of the scalpel 1340 would only interact with the first sidewall 1301A or the second sidewall 1301B when the scalpel 1340 is moved. For example, connector 1311 can act like a hinge allowing the scalpel 1340 to rotate about the connector 1311. Thus, connector 1311 can restrict the range of motion of the scalpel 1340 to cause the blade of the scalpel 1340 to only interact with the first sidewall 1301 A or the second sidewall 1301B and to inhibit the blade of the scalpel 1340 from interacting with the cavity opening of the subject, the sleeve, and / or the tissue retractor.

[0128] FIG. 14 shows an example tissue retractor 1400 that has a proximal opening 1403, a distal opening 1402, a body 1401 extending between the proximal opening 1403 and the distal opening 1402, a proximal ring 1413, and a distal ring 1412. The body 1401 defines a lumen 1406. The body 1401 has inner surface 1408 and outer surface 1409. The tissue retractor 1400 can be formed of one or more materials such as Thermoplastic Polyurethane (TPU), polyethylene (PE), and / or polypropylene (PP), TPU coated Nylon, Ultra-High Molecular Weight Polyethylene (UHMWPE), Kevlar, etc.

[0129] The proximal ring 1413 is positioned adjacent to, and / or at the proximal opening 1403. The proximal ring 1413 is flexible. The distal ring 1412 is positioned adjacent to, and / or at the distal opening1402. The distal ring 1412 is semi-rigid, for example, less flexible than the proximal ring 1413. The distal opening 1402 and / or distal ring 1412 can pass into a cavity of a subject. The proximal opening 1403 and / or proximal ring 1413 can be exposed outside of a subject cavity while the distal opening 1402 and / or distal ring 1412 is inserted within the cavity of the subject.

[0130] The proximal ring 1413 can be furled around itself to cause the proximal ring 1413 to approach the distal ring 1412 and to cause tension in the body 1401 to facilitate opening a cavity opening of a subject such as a vagina or abdominal incision.

[0131] In some implementations, tissue retractor 1400 can be placed within the lumen of a wound guard such that the outer surface 1409 of the tissue retractor 1400 contacts said wound guard. In such cases, the tissue retractor 1400 can advantageously apply force to the wound guard to cause the wound guard to expand (in cases where the wound guard is deformable) to provide a clear access into the cavity of the subject. Surgical instruments can pass through the lumen 1406 of the tissue retractor 1400. In some implementations, a wound guard can be placed within the lumen 1406 of the tissue retractor 1400 such that the wound guard contacts the inner surface 1408 of the tissue retractor 1400.

[0132] FIG. 15 shows an example tissue retractor 1500 that has a proximal opening 1503, a distal opening 1502, a body 1501 extending between the proximal opening 1503 and the distal opening 1502, a proximal ring 1513, and a distal ring 1512. The body 1501 defines a lumen 1506. The body 1501 has inner surface 1508 and outer surface 1509. The tissue retractor 1500 can be formed at least partially of one or more materials such as Thermoplastic Polyurethane (TPU), polyethylene (PE), and / or polypropylene (PP), TPU coated Nylon, Ultra-High Molecular Weight Polyethylene (UHMWPE), Kevlar, etc.

[0133] In this example, at least a portion 1520 of the body 1501 is formed of a cut resistant material such as Spectra, Dyneema, Kevlar, Ripstop Nylon, a reinforced fabric, or the like. The portion 1520 can be positioned on and / or form part of the inner surface 1508 and / or the outer surface 1509. The portion 1520 can extend around an entire or partial circumference of the body 1501. The portion 1520 may only extend partially between the proximal opening 1403 and the distal opening 1502. The portion 1520 of the body 1501 can protect the cavity opening of the subject and / or the sleeve from accidental damage from surgical tools passing through the lumen 1506 of the tissue retractor 1500. In some implementations, the tissue retractor 1500 can be used without a separate wound guard at least because the portion 1520 of the body can provide the protection that a wound guard would.

[0134] FIG. 16 shows an example tissue retractor 1600 with scalpel 1640 and grasper 1630 inserted within tissue retractor 1600 to morcellate and / or grasp tissue 1610. Tissue retractor 1600 can be placed within a cavity opening of a subject such as a vagina or abdominal incision. Tissue retractor 1600 includes one or more petals 1601 (such as petal 1601 A and petal 160 IB) which can protect the subject and / or sleeve from scalpel 1640 and / or grasper 1630, or other surgical instruments. Petals 1601 can be placed on anterior and posterior side of the cavity opening. Tissue retractor 1600 includes adjuster 1613 that is operably connected with petals 1601. Adjuster 1613 can cause petals 1601 to move, for example to move apart from each other to increase the size of the opening of the cavity of the subject. The adjuster1613 can lock / hold the petals 1601 in place. Thus, tissue retractor 1600 can retract the subject opening as well as protect against damage from surgical instruments.

[0135] FIGS. 17A-17C show example implementations of a clamp 1700. Clamp 1700 can be placed around sleeve 100 to occlude an opening of the sleeve 100. In this example, clamp 1700 is placed proximate to opening 101. In some implementations, clamp 1700 can be placed proximate to opening 102. FIG. 17C shows the clamp 1700 in an open configuration. FIG. 17B shows the clamp 1700 in a closed configuration. The clamp 1700 can be rigid or flexible. The clamp 1700 can be formed from one or more materials such as plastic, Nylon, Acrylonitrile Butadiene Styrene (ABS), polypropylene, high density polyethylene, Silicone, Thermoplastic Polymethane (TPU), elastomer, or the like.

[0136] In various implementations, either opening of sleeve 100 can be occluded without clamp such as by tying sleeve 100 into a knot near either opening, by folding the sleeve 100 at the opening 101 to and tying a suture thread to further squeeze the sleeve material and prevent any leak, by folding the sleeve 100 at the opening 101 and applying a clamp (such as clamp 1700 or clamp 1800) around the fold. In various implementations, both openings of sleeve can be occluded (with the same or different technique). In various implementations only one opening of sleeve may be occluded.

[0137] FIGS. 18A-18B show another example clamp 1800 that can occlude an opening of a sleeve. For example, clamp 1800 can be positioned around a loop of a sleeve near an opening to occlude the opening. FIG. 18A shows the clamp 1800 in an open configuration. FIG. 18B shows the clamp 1800 in a closed configuration.

[0138] Various example methods of using a tissue containment system in a laparoscopically assisted vaginal hysterectomy are shown and / or described herein. Any of the tissue containment systems shown and / or described herein, or aspects thereof, such as a sleeve, wound guard, tissue retractor, etc. can be implemented in any combination in any of the example methods shown and / or described. These methods are not intended to limit the present disclosure and should not be considered exhaustive. There may be other ways in which aspects of the present disclosure (e.g., tissue containment system) can be used that can be beneficial for the subject. Although the methods presented herein may be in the context of laparoscopically assisted vaginal surgery, the tissue containment systems of the present disclosure can be used in other procedures such as laparoscopic, endoscopic or other natural orifice procedures for isolating and retrieving dissected tissue or organs.

[0139] As illustrated in FIGS. 19A-19H, 20A-20K, 21A-21K, 22A-20I, and 23A-20H a user (such as a healthcare provider) can laparoscopically separate tissue 1910 (such as a uterus or other biological organ or structure) from the subject’s body 1911 within the abdominal cavity 1915 (which may also be referred to as a pelvic cavity, cavity, or the like). Surrounding organs such as the bladder 1914 and the rectum 1916 are shown as reference landmarks. The user can place a laparoscope 1975 with trocar 1976 into the abdominal cavity 1915 through first laparoscopic port 1971, which may also be referred to as an optical port, laparoscopic incision, abdominal opening, pelvic opening, cavity opening, or the like. The user can place a laparoscopic grasper 1973 into the abdominal cavity 1915 through a second laparoscopic port1972, which may also be referred to as a laparoscopic incision, abdominal opening, pelvic opening, cavity opening, or the like. The user can manipulate the sleeve 1900 within the abdominal cavity 1915 with the laparoscopic grasper 1973.

[0140] FIGS. 19A-19H illustrate an example implementation of a tissue containment system 1950 comprising at least a sleeve 1900. The user can pass the first opening 1901 of the sleeve 1900 through the vagina 1917 into the abdominal cavity 1915. The user can occlude the vagina 1917 to prevent loss of pneumoperitoneum, such as using a gauze piece. The user can move the first opening 1901 with the laparoscopic grasper 1973 to place the tissue 1910 through the first opening 1901 within the sleeve 1900. With the tissue 1910 within the sleeve 1900, the user can continue to move the first opening 1901 with the laparoscopic grasper 1973 through the abdominal cavity 1915 to the exterior of the subject’s body 1911 through an abdominal opening, such as the first laparoscopic port 1971 or in some cases the second laparoscopic port 1972. Sleeve 1900 can extend through the abdominal cavity 1915 with the first opening 1901 and the second opening 1902 passing through different abdominal openings, such as the first laparoscopic port 1971 and the vagina 1917. The tissue 1910 is thus contained within the sleeve 1900.

[0141] The first opening 1901 can be occluded to inhibit biological substances, liquids, tissue 1910, etc. from passing through the first opening 1901. The first opening 1901 can be occluded with occlusion member 1990, which can include one or more of a clamp, suture, or knot of the sleeve 1900 tied on itself. In some cases, sleeve 1900 canbe folded on itself with the occlusion member 1990 applied on the fold. The first opening 1901 canbe occluded while the second opening 1902 is exterior to the body 1911.

[0142] The tissue 1910 can be extracted from the abdominal cavity 1915 through the second opening 1902. In some cases, the tissue 1910 canbe morcellated for example if the tissue 1910 is too large for removal via the vagina 1917. During extraction, the tissue 1910 can be held using grasper 1930 which may be a tenaculum, artery forceps, or similar instrument. The vagina 1917 can be dilated such as with a speculum 1920. The user can morcellate the tissue 1910 with a scalpel 1940. In this case, the speculum 1920 protects the vagina 1917 and / or the sleeve 1900 from accidental cutting by the scalpel 1940.

[0143] The sleeve 1900 can be pulled out through the vagina 1917. Occlusion member 1990 at the first opening 1901 ensures that the contents within the sleeve 1900 do not spill out through the first opening 1901 when the sleeve is being removed from the subject’s body 1911.

[0144] As illustrated in FIGS. 20A-20K, 21A-21K, 22A-20I, and 23A-20H, the introducer 1980 can introduce the sleeve 1900 into the abdominal cavity 1915 of the subject’s body 1911. The user can load the sleeve 1900 into the introducer 1980 or the sleeve 1900 can be pre-loaded into the introducer 1980. The distal end 1943 of the introducer 1980 is inserted into the abdominal cavity 1915 via the vagina 1917. Introducer 1980 can include expandable portion 1961 at or near distal end 1943 which can be expanded to inhibit gas leakage through from abdominal cavity 1915 through vagina 1917. The expandable portion 1961 may be a balloon that canbe inflated with air, such as with a syringe. In some implementations, distal end 1943 can include a tip configured for laparoscopic colpotomy to delineate the cutting area. Colpotomy can also be performed without using a distal tip of the introducer 1980.

[0145] FIGS. 20A-20K illustrate an example implementation of a tissue containment system 2050 comprising at least a sleeve 1900, introducer 1980, wound guard 2010, and tissue retractor 2020. Introducer 1980 can introduce at least the first opening 1901 of the sleeve 1900 into the abdominal cavity 1915. In some implementations, the sleeve 1900 includes a wire, such as a nitinol memory wire, at or near the first opening 1901. The wire can cause the first opening 1901 to spontaneously open by itself once deployed from the introducer 1980 within the abdominal cavity 1915.

[0146] The user can pass a grasper 1930 through the introducer 1980 to grasp the tissue 1910. The tissue 1910 can be held in place and / or pulled toward the vagina 1917 with the grasper 1930. The user can move the first opening 1901 with the laparoscopic graspers 1973 from the introducer 1980 through the abdominal cavity 1915, including over the tissue 1910 to place the tissue 1910 with the sleeve 1900. The user can move the first opening 1901 through first laparoscopic port 1971, or other abdominal opening, which can be done at the same time as removing laparoscope 1975 from the first laparoscopic port 1971.

[0147] In implementations with a “memory” wire, the user can remove the wire from the first opening 1901 while the first opening 1901 is exposed through the first laparoscopic port 1971 and the second opening is exposed through the vagina 1917. After the memory wire is removed, the user can occlude the first opening 1901 with occluding member 1990 to inhibit leakage through first opening 1901. The first opening 1901 can be occluded before, during, or after morcellation (if morcellation occurs) and / or before, during, or after, the tissue 1910 is removed from the abdominal cavity 1915.

[0148] If the tissue 1910 is small, it can be directly removed with the grasper 1930 through the second opening 1902 while the second opening 1902 is in the vagina 1917. If the tissue 1910 is too large, it can be morcellated. For morcellation, the wound guard 2010 is placed within sleeve 1900 via the second opening 1902. Thus, wound guard 2010 is placed at least partially within vagina 1917. Tissue retractor 2020 can be placed within wound guard 2010 with the distal ring 2022 of the tissue retractor 2020 placed within the vagina 1917 and the proximal ring 2023 exposed to a user outside of the vagina 1917. A user can furl the proximal ring 2023 to create tension within the tissue retractor 2020 to cause the tissue retractor 2020 to exert radial force on the wound guard 2010 and the vagina 1917 to dilate the wound guard 2010 and the vagina 1917 to facilitate morcellation and / or extraction. In some implementations, wound guard 2010 is positioned within tissue retractor 2020 such that tension within tissue retractor 2020 retracts an abdominal opening without retracting wound guard 2010.

[0149] The user can morcellate the tissue 1910 with scalpel 1940 as the user extracts the tissue 1910 with grasper 1930. The wound guard 2010 and tissue retractor 2020 are removed following tissue 1910 extraction. The sleeve 1900 with any tissue residue and fluids is then taken out by pulling the second opening 1902 through the vagina 1917 causing first opening 1901 to re-enterthe abdominal cavity 1915 via the first laparoscopic port 1971 and pass through the abdominal cavity 1915 to vagina 1917 where it exits the body 1911.

[0150] FIGS. 21A-21K illustrate an example implementation of a tissue containment system 2150 comprising at least a sleeve 1900, introducer 1980, wound guard 2010, and tissue retractor 2020.Introducer 1980 can introduce at least the first opening 1901 of the sleeve 1900 into the abdominal cavity 1915 through the vagina 1917. User can pull the first opening 1901 through the abdominal cavity 1915 to envelop tissue 1910 within the sleeve 1900 and can pull first opening 1901 out of abdominal cavity 1915 through an abdominal opening such as first laparoscopic port 1971 while the second opening 1902 remains at the vagina 1917. In some implementations, the sleeve 1900 includes a wire, such as a nitinol memory wire, at or near the first opening 1901 which can cause the first opening 1901 to spontaneously open once deployed within the abdominal cavity 1915. User can grasp and / or move the uterus with one or more graspers 1930 which can be inserted into the abdominal cavity 1915 through one or more abdominal openings, such as first laparoscopic port 1971 and vagina 1917.

[0151] The tissue 1910 can be morcellated through first laparoscopic port 1971. The wound guard 2010 is placed within sleeve 1900 via the first opening 1901. Thus, wound guard 2010 is placed at least partially within the first laparoscopic port 1971. Tissue retractor 2020 is placed within wound guard 2010 with the distal ring 2022 of the tissue retractor 2020 placed within the first laparoscopic port 1971 and the proximal ring 2023 exposed to a user outside of the first laparoscopic port 1971. A user can furl the proximal ring 2023 to create tension within the tissue retractor 2020 to cause the tissue retractor 2020 to exert radial force on the wound guard 2010 and the first laparoscopic port 1971 to dilate the wound guard 2010 and the first laparoscopic port 1971 to facilitate morcellation and / or extraction.

[0152] The user can morcellate the tissue 1910 with scalpel 1940 as the user extracts the tissue 1910 with grasper 1930. The wound guard 2010 and tissue retractor 2020 are removed following tissue 1910 extraction. In implementations with a “memory” wire, the user can remove the wire from the first opening 1901 while the first opening 1901 is exposed through the first laparoscopic port 1971 and the second opening is exposed through the vagina 1917. After the memory wire is removed, the user can occlude the first opening 1901 with occluding member 1990 to inhibit leakage through first opening 1901. In this example, because the tissue 1910 is morcellated and / or extracted through the first opening 1901, the first opening 1901 is occluded after morcellation (if morcellation occurs) and / or after the tissue 1910 is removed from the abdominal cavity 1915 through the first opening 1901. Thus, the tissue 1910 can be morcellated and / or removed through the same opening of the sleeve 1900 that is occluded (e.g., the first opening 1901 in this example).

[0153] The sleeve 1900 with any tissue residue and fluids is then taken out by pulling the second opening 1902 through the vagina 1917 causing first opening 1901 to re-enter the abdominal cavity 1915 via the first laparoscopic port 1971 and pass through the abdominal cavity 1915 to vagina 1917 where it exits the body 1911. Thus, the tissue 1910 can be removed from the abdominal cavity 1915 via a different opening (e.g., the first laparoscopic port 1971) than an opening through which the sleeve 1900 is removed (e.g., the vagina 1917). Moreover, as shown and / or discussed the tissue 1910 can be removed from abdominal cavity 1915 via a different opening (e.g., the first laparoscopic port 1971) than an opening through which the sleeve 1900 was introduced into the abdominal cavity 1915 (e.g., via the vagina 1917).

[0154] In some implementations, the sleeve 1900 can be removed through the first laparoscopic port 1971. In such cases, the second opening 1902 can be occluded (in addition to, or in place of, the first opening 1901 being occluded). Thus, the tissue 1910 can be morcellated and / or extracted through an abdominal opening (e.g., the first laparoscopic port 1971) and the sleeve 1900 can also be removed through the same abdominal opening. Thus, the sleeve 1900 can be removed through a different opening (e.g., first laparoscopic port 1971) than the opening through which it was introduced into the abdominal cavity 1915 (e.g., the vagina 1917).

[0155] FIGS. 22A-22I illustrate an example implementation of a tissue containment system 2250 comprising at least a sleeve 1900 and introducer 1980, which can be used during laparoscopically assisted Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). As shown, once sleeve 1900 is deployed within abdominal cavity 1915 and tissue 1910 is placed within sleeve 1900, a port 1993 with at least one sealed opening and at least one connection with a stopcock is positioned within the second opening 1902 of the sleeve 1900. In some implementations, the port 1993 can be positioned within a tissue retractor such as attached to proximal ring of the tissue retractor within the second opening 1902. The sleeve 1900 containing the tissue is insufflated with air passed via the port 1993. Laparoscope 1975 can be passed into one of the openings on the port 1993 to visualize the tissue 1910. The tissue 1910 can be morcellated using a power morcellator 1994 which can be passed into one of the openings on the port 1993. The morcellated tissue 1910 is pulled out via the second opening 1902. The first opening 1901 is occluded. The sleeve 1900 is removed through the vagina 1917.

[0156] FIGS. 23A-23H illustrate an example implementation of a tissue containment system 2350 comprising at least a sleeve 1900 and introducer 1980. The introducer 1980 can introduce the sleeve 1900 into the abdominal cavity 1915 via the vagina 1917. In some implementations, the sleeve 1900 can include a wire that can spontaneously resume a shape after deformation to cause the first opening 1901 to open when deployed within the abdominal cavity 1915. The first opening 1901 can be pulled through an abdominal opening, such as the first laparoscopic port 1971 which can be done while the second opening is within the introducer 1980 and / or vagina 1917.

[0157] The second opening 1902 can be pulled from the introducer 1980 and / or vagina 1917, through the abdominal cavity 1915, such as with grasper 1973, through another abdominal opening, such as second laparoscopic port 1972. Thus, both the first opening 1901 and the second opening 1902 can be exposed through two different abdominal openings (which may not include the vagina 1917) at the same time while the sleeve 1900 extends between the abdominal openings through the abdominal cavity 1915 and while the tissue 1910 is within the sleeve 1900.

[0158] The sleeve 1900 can be insufflated to facilitate power morcellation. A trocar 1976 is connected with insufflation is passed into the second opening 1902 of the sleeve 1900 to insufflate the sleeve 1900. A laparoscope 1975 is passed through the trocar 1976 and the inside of the sleeve 1900 with the tissue is visualized. A power morcellator 1994 is then passed through the first opening 1901 of the sleeve 1900 and morcellation of the tissue is performed. Thereafter, all instruments are removed, the sleeve 1900is deflated and the second opening 1902 of the sleeve 1900 is occluded. The sleeve 1900 is remove from the abdominal cavity 1915 by pulling on the first opening 1901.

[0159] FIGS. 24A-24K illustrate an example implementation of a tissue containment system 2450 comprising at least a sleeve 1900, introducer 1980, wound guard 2010, and tissue retractor 2020. Introducer 1980 can introduce at least the first opening 1901 of the sleeve 1900 into the abdominal cavity 1915 through the vagina 1917. User can pull the first opening 1901 through the abdominal cavity 1915 to envelop tissue 1910 within the sleeve 1900 and can pull first opening 1901 out of abdominal cavity 1915 through an abdominal opening such as first laparoscopic port 1971 while the second opening 1902 remains at the vagina 1917. In some implementations, the sleeve 1900 includes a wire, such as a nitinol memory wire, at or near the first opening 1901 which can cause the first opening 1901 to spontaneously open once deployed within the abdominal cavity 1915. User can grasp and / or move the utems with one or more graspers 1930 which can be inserted into the abdominal cavity 1915 through one or more abdominal openings, such as first laparoscopic port 1971 and vagina 1917.

[0160] The tissue 1910 can be morcellated through first laparoscopic port 1971. The wound guard 2010 is placed within sleeve 1900 via the first opening 1901. Thus, wound guard 2010 is placed at least partially within the first laparoscopic port 1971. Tissue retractor 2020 can be placed within wound guard 2010 with the distal ring 2022 of the tissue retractor 2020 placed within the first laparoscopic port 1971 and the proximal ring 2023 exposed to a user outside of the first laparoscopic port 1971. A user can furl the proximal ring 2023 to create tension within the tissue retractor 2020 to cause the tissue retractor 2020 to exert radial force on the wound guard 2010 and the first laparoscopic port 1971 to dilate the wound guard 2010 and the first laparoscopic port 1971 to facilitate morcellation and / or extraction.

[0161] The user can morcellate the tissue 1910 with scalpel 1940 as the user extracts the tissue 1910 with grasper 1930. The wound guard 2010 and tissue retractor 2020 are removed following tissue 1910 extraction. The user can occlude the second opening 1902 with occluding member 1990 to inhibit leakage through second opening 1902. The second opening 1902 can be occluded before, during, or after morcellation (if morcellation occurs) and / or before, during, or after the tissue 1910 is removed from the abdominal cavity 1915 through the first opening 1901. Thus, the tissue 1910 can be morcellated and / or removed through a different opening of the sleeve 1900 that is occluded.

[0162] The sleeve 1900 with any tissue residue and fluids is then taken out by pulling the first opening 1901 through the first laparoscopic port 1971 causing second opening 1902 to enter the abdominal cavity 1915 via the vagina 1917 and pass through the abdominal cavity 1915 to first laparoscopic port 1971 where it exits the body 1911. Thus, the tissue 1910 can be morcellated and / or removed from the abdominal cavity 1915 via the same opening (e.g., the first laparoscopic port 1971) through which the sleeve 1900 is removed. Moreover, as shown and / or discussed the tissue 1910 and / or sleeve 1900 can be removed from abdominal cavity 1915 via a different opening (e.g., the first laparoscopic port 1971) than an opening through which the sleeve 1900 was introduced into the abdominal cavity 1915 (e.g., via the vagina 1917).Additional Considerations

[0163] Certain categories of persons, such as caregivers, clinicians, doctors, nurses, users, may be used interchangeably to describe a person providing care to a subject. Moreover, the term “subject” may refer to a person, a subject, an animal, etc. Although certain implementations and examples have been described herein, it will be understood by those skilled in the art that many aspects of the systems and devices shown and described in the present disclosure may be differently combined and / or modified to form still further implementations or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable. The various features and processes described herein may be used independently of one another, or may be combined in various ways. For example, elements may be added to, removed from, or rearranged compared to the disclosed example implementations. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure.

[0164] Any methods and processes described herein are not limited to any particular sequence, and the blocks or states relating thereto can be performed in other sequences that are appropriate. For example, described blocks or states may be performed in an order other than that specifically disclosed, or multiple blocks or states may be combined in a single block or state, or certain method or process blocks may be omitted, or certain blocks or states may be performed in a reverse order from what is shown and / or described. The example blocks or states may be performed in serial, in parallel, or in some other manner. Blocks or states may be added to or removed from the disclosed example implementations.

[0165] The methods disclosed herein may include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication.

[0166] The methods and tasks described herein may be performed and fully automated by a computer system. The computer system may, in some cases, include multiple distinct computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in a memory or other non-transitory computer-readable storage medium or device (e.g., solid state storage devices, disk drives, etc.). The various functions disclosed herein may be embodied in such program instructions, and / or may be implemented in application-specific circuitry (e.g., ASICs or FPGAs) of the computer system. Where the computer system includes multiple computing devices, these devices may, but need not, be co-located. The results of the disclosed methods and tasks may be persistently stored by transforming physical storage devices, such as solid state memory chips and / or magnetic disks, into a different state. The computer system may be a cloud-based computing system whose processing resources are shared by multiple distinct entities or other users. The systems and modules may also be transmitted as generated data signals (for example, as part of a carrier wave or other analog or digital propagated signal)on a variety of computer-readable transmission mediums, including wireless-based and wired / cable-based mediums, and may take a variety of forms (for example, as part of a single or multiplexed analog signal, or as multiple discrete digital packets or frames).

[0167] Many other variations than those described herein will be apparent from this disclosure.For example, depending on the implementation, certain acts, events, or functions of any of the algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (for example, not all described acts or events are necessary for the practice of the algorithms). Moreover, in certain implementations, acts or events can be performed concurrently, for example, through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, different tasks or processes can be performed by different machines and / or computing systems that can function together.

[0168] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain features, elements, and / or steps are optional. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements, and / or steps are included or are to be always performed. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Further, the term "each," as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term "each" is applied.

[0169] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0170] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 10 degrees, 5 degrees, 3 degrees, or 1 degree. As another example, in certain embodiments, the terms “generally perpendicular” and “substantially perpendicular” refer to avalue, amount, or characteristic that departs from exactly perpendicular by less than or equal to 10 degrees, 5 degrees, 3 degrees, or 1 degree.

[0171] As used herein, “real-time” or “substantial real-time” may refer to events (e.g., receiving, processing, transmitting, displaying etc.) that occur at a same time as each other, during a same time as each other, or overlap in time with each other. “Real-time” may refer to events that occur at distinct or non-overlapping times the difference between which is imperceptible and / or inconsequential to humans such as delays arising from electrical conduction or transmission. A human may perceive real-time events as occurring simultaneously, regardless of whether the real-time events occur at an exact same time. As a non-limiting example, “real-time” may refer to events that occur within a time frame of each other that is on the order of milliseconds, seconds, tens of seconds, or minutes. For example, “real-time” may refer to events that occur within a time frame of less than 1 minute, less than 30 seconds, less than 10 seconds, less than 1 second, less than 0.05 seconds, less than 0.01 seconds, less than 0.005 seconds, less than 0.001 seconds, etc.

[0172] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0173] As used herein, “system,” “instrument,” “apparatus,” and “device” generally encompass both the hardware (for example, mechanical and electronic) and, in some implementations, associated software (for example, specialized computer programs for operational control) components.

[0174] It should be emphasized that many variations and modifications may be made to the herein-described implementations, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Any section headings used herein are merely provided to enhance readability and are not intended to limit the scope of the implementations disclosed in a particular section to the features or elements disclosed in that section. The foregoing description details certain implementations. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems and methods can be practiced in many ways. As is also stated herein, it should be noted that the use of particular terminology when describing certain features or aspects of the systems and methods should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the systems and methods with which that terminology is associated.

[0175] Those of skill in the art would understand that information, messages, and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughoutthe above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0176] While the above detailed description has shown, described, and pointed out novel features, it can be understood that various omissions, substitutions, and changes in the form and details of the devices or algorithms illustrated can be made without departing from the spirit of the disclosure. As can be recognized, certain portions of the description herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others. The scope of certain embodiments disclosed herein is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

WHAT IS CLAIMED IS:

1. A tissue containment system, comprising: a sleeve comprising a first opening, a second opening, and a body extending between the first opening and the second opening, the body defining an interior configmed to receive tissue through at least the first opening, the sleeve configmed to extend through a pelvic cavity of a subject with the first opening positioned in a first cavity opening and the second opening positioned in a second cavity opening, wherein the first cavity opening is a vagina or is in an abdomen, and wherein the second cavity opening is the vagina or is in the abdomen; an envelope formed from at least a portion of the body, wherein the envelope extends around at least a portion of the first opening, and wherein the envelope comprises a first envelope opening and a second envelope opening; and a wire removably positioned within the envelope, wherein the wire is configmed to resume a default shape spontaneously after deformation to cause the first opening to enlarge when the wire is positioned within the envelope, and wherein the wire is configmed to be removed from the envelope via the first envelope opening or the second envelope opening, wherein the first opening is configmed to be occluded to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the first opening, and wherein the first opening is configured to be occluded pursuant to removal of the wire from the envelope.

2. The tissue containment system of claim 1 further comprising a sheath encasing at least a portion of the wire, wherein the sheath is configured to facilitate removing the wire from the envelope.

3. The tissue containment system of claim 2, wherein the sheath comprises one or more synthetic polymers.

4. The tissue containment system of claim 2, wherein the sheath comprises Teflon.

5. The tissue containment system of claim 1 , wherein the body comprises an inner surface and an outer surface, wherein the inner surface comprises a first visual indicator, wherein the outer surface comprises a second visual indicator, wherein the first visual indicator is different from the second visual indicator to provide a visual distinction between the inner surface and the outer surface.

6. The tissue containment system of claim 1, wherein the sleeve comprises a first marking on the body adjacent to the first opening, wherein the sleeve comprises a second marking on the body adjacent to the second opening, wherein the first marking is different from the second marking to provide a visual distinction between the first opening and the second opening.

7. The tissue containment system of claim 1, wherein the first opening is larger than the second opening.

8. The tissue containment system of claim 1, wherein the sleeve comprises a cylindrical portion and a tapered portion, wherein the cylindrical portion is adjacent to the first opening or the second opening, wherein the tapered portion is adjacent to the cylindrical portion.

9. The tissue containment system of claim 1 , wherein the first opening is configured to be tied pursuant to removal of the wire from the envelope to occlude the first opening to inhibit the contents of the interior of the sleeve from passing from the interior of the sleeve through the first opening.

10. The tissue containment system of claim 1, wherein the second opening is configured to be tied pursuant to removal of the wire from the envelope to occlude the second opening to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the second opening.

11. The tissue containment system of claim 1, wherein the body comprises an inner surface, wherein the inner surface comprises a cut-resistant material positioned adjacent to at least the second opening.

12. A tissue containment system, comprising: a sleeve comprising a first opening, a second opening, and a body extending between the first opening and the second opening; and an introducer comprising: a distal section comprising: a first aperture configmed to be at least partially inserted into a cavity of a subject; a second aperture; and a lumen extending between the first aperture and the second aperture, wherein the distal section is configured to hold at least the first opening of the sleeve within the lumen; and a proximal section removably connected to the second aperture of the distal section, wherein the proximal section is configured to hold at least the second opening of the sleeve when the proximal section is connected with the distal section, wherein the introducer is configmed to deploy the first opening of the sleeve from the lumen of the distal section through the first aperture of the distal section into the cavity of the subject, wherein the proximal section of the introducer is configured to disconnect from the second aperture of the distal section to expose the second opening of the sleeve while at least a portion of the sleeve is deployed in the cavity of the subject, wherein the second opening of the sleeve is configured to be occluded to inhibit contents within the sleeve from passing through the second opening of the sleeve,wherein the second opening of the sleeve is configured to pass through the second aperture into the lumen of the distal section, and pass through the lumen of the distal section, and pass through the first aperture of the distal section and enter into the cavity of the subject.

13. The tissue containment system of claim 12, wherein the proximal section of the introducer comprises a handle.

14. The tissue containment system of claim 13, wherein the handle is removably connected with the proximal section of the introducer.

15. The tissue containment system of claim 12, wherein the proximal section is configured to mechanically connect responsive to force applied by a user to the proximal section and / or the distal section, and wherein the proximal section is configured to mechanically disconnect responsive to force applied by a user to the proximal section and / or the distal section.

16. The tissue containment system of claim 12, wherein the proximal section is configured to connect with the distal section via one or more threads, wherein the proximal section is configured to screw onto the distal section via the one or more threads.

17. The tissue containment system of claim 12, wherein the distal section includes threads proximate to the second aperture, wherein the threads are configured to mate with the proximal section of the introducer.

18. The tissue containment system of claim 12, wherein the second opening of the sleeve is configured to be occluded while the first aperture of the distal section is at least partially inserted into the cavity of the subject.

19. A tissue containment system, comprising: a sleeve comprising a first opening, a second opening, and a sleeve body extending between the first opening and the second opening, the sleeve body defining an interior configured to receive tissue through at least the first opening, the first opening being larger than the second opening to facilitate receiving tissue through the first opening to the interior, the sleeve configured to extend through a pelvic cavity with the first opening positioned in a first cavity opening and the second opening positioned in a second cavity opening of a subject, wherein the first cavity opening is a vagina or is in an abdomen, and wherein the second cavity opening is the vagina or is in the abdomen; a wound guard comprising: a wound guard proximal end;a wound guard distal end configured for placement within the first cavity opening or the second cavity opening; a first side extending between the wound guard proximal end and the wound guard distal end; a second side extending between the wound guard proximal end and the wound guard distal end, the wound guard configured to deform responsive to force to cause a distance between the first side and the second side to change; an inner surface; and an outer surface configured to contact the sleeve and / or the first cavity opening or the second cavity opening, the wound guard configured to inhibit one or more surgical instruments from contacting a portion of the sleeve and / or a portion of the first cavity opening or a portion of the second cavity opening adjacent to the outer surface; and a tissue retractor comprising: a tissue retractor proximal end; a tissue retractor distal end configured for placement within the first cavity opening or the second cavity opening adjacent to the wound guard; and a retractor body extending between the tissue retractor proximal end and the tissue retractor distal end, the retractor body defining a lumen configured to allow the one or more surgical instruments to pass therethrough, at least a portion of the retractor body contacting the inner surface of the wound guard, and the retractor body configured to fold to cause the tissue retractor proximal end to approach the tissue retractor distal end and create tension in the retractor body to apply outward radial force on the inner surface of the wound guard.

20. The tissue containment system of claim 19, wherein the sleeve comprises a cylindrical portion and a tapered portion, wherein the cylindrical portion is adjacent to the first opening or the second opening, wherein the tapered portion is adjacent to the cylindrical portion.

21. The tissue containment system of claim 19, wherein the sleeve comprises a first marking on the sleeve body adjacent to the first opening, wherein the sleeve comprises a second marking on the sleeve body adjacent to the second opening, wherein the first marking is different from the second marking to provide a visual distinction between the first opening and the second opening.

22. The tissue containment system of claim 19, wherein the sleeve body comprises an inner surface and an outer surface, wherein the inner surface comprises a first visual indicator, wherein the outer surface comprises a second visual indicator, wherein the first visual indicator is different from the second visual indicator to provide a visual distinction between the inner surface and the outer surface.

23. The tissue containment system of claim 19, wherein the wound guard comprises a cylindrical portion between the wound guard proximal end and the wound guard distal end.

24. The tissue containment system of claim 19, wherein the wound guard proximal end is semiannular, wherein the wound guard distal end is semi-annular, wherein a diameter of the semi-annular wound guard proximal end is larger than a diameter of the semi-annular wound guard distal end.

25. The tissue containment system of claim 19 further comprising: a wire removably coupled to the first opening, wherein the wire is configured to resume a shape spontaneously after deformation to cause the first opening to enlarge when the wire is coupled to the first opening.

26. The tissue containment system of claim 19, wherein the first opening is configured to be tied to inhibit the tissue from passing from the interior of the sleeve through the first opening, wherein the second opening is configured to be tied to inhibit the tissue from passing from the interior of the sleeve through the second opening.

27. The tissue containment system of claim 19 further comprising: a clamp configured to close the first opening or the second opening to inhibit the tissue from passing from the interior of the sleeve through the first opening or the second opening.

28. A method of containing tissue, comprising: deploying a first opening of a sleeve through a first abdominal opening into an abdominal cavity of a subject; manipulating the sleeve within the abdominal cavity of the subject to induce a tissue of the subject through the first opening into an interior of the sleeve; moving the first opening of the sleeve through the abdominal cavity toward a second abdominal opening of the abdominal cavity; removing the first opening of the sleeve from the abdominal cavity of the subject through the second abdominal opening of the subject; removing a flexible member from an envelope of the sleeve proximate to the first opening; wherein the flexible member is configmed to spontaneously resume a default shape after deformation to cause the first opening to enlarge when the flexible member is positioned within the envelope; pursuant to removal of the flexible member from the envelope, occluding the first opening of the sleeve to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the first opening; and removing the sleeve from the abdominal cavity of the subject.

29. The method of claim 28 further comprising occluding the first opening of the sleeve based on at least tying a knot in the sleeve.

30. The method of claim 28 further comprising occluding the first opening of the sleeve based on at least applying a clamp to the sleeve.

31. The method of claim 28 further comprising occluding the first opening of the sleeve based on at least folding the sleeve.

32. The method of claim 28 further comprising occluding the second opening of the sleeve to inhibit contents of the interior of the sleeve from passing from the interior of the sleeve through the second opening.

33. The method of claim 28 further comprising morcellating the tissue within the interior of the sleeve through the first abdominal opening or the second abdominal opening.

34. The method of claim 28 further comprising removing the tissue from within the interior of the sleeve through the first opening of the sleeve or the second opening of the sleeve while at least a portion of the sleeve is within the abdominal cavity of the subject.

35. The method of claim 28 further comprising removing the sleeve from the abdominal cavity of the subject through the first abdominal opening.

36. A method of containing tissue, comprising: introducing a distal end of an introducer into a first cavity opening of a subject; deploying a first opening of a sleeve from the distal end of the introducer into a cavity of a subject; manipulating the sleeve within the cavity of the subject to induce a tissue of the subject through the first opening into an interior of the sleeve; moving the first opening of the sleeve through the cavity toward a second cavity opening of the subject; removing the first opening of the sleeve from the cavity of the subject through the second cavity opening of the subject; occluding a second opening of the sleeve while the distal end of the introducer is in the first cavity opening of the subject; passing the second opening of the sleeve through the distal end of the introducer into the cavity of the subject; and removing the sleeve and the tissue from the cavity of the subject.

37. The method of claim 36, further comprising disconnecting a distal end of the introducer to expose the second opening of the sleeve.

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