Patent ID: 12256958

DETAILED DESCRIPTION

The present disclosure is now described with reference to exemplary medical access devices that may be used in accessing the interior of the body. However, it should be noted that reference to any particular procedure is provided only for convenience and not intended to limit the disclosure. A person of ordinary skill in the art would recognize that the concepts underlying the disclosed devices and application methods may be utilized in any suitable procedure, medical or otherwise. The present disclosure may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.

For ease of description, portions/regions/ends of a device and/or its components are referred to as proximal and distal ends/regions. It should be noted that the term “proximal,” is intended to refer to ends/regions closer to a user of the disclosed device (e.g., outside the body of the patient), and the term “distal,” used herein to refer to ends/regions farther away from the user of the disclosed device (e.g., inside the body of the patient). Similarly, extends “distally” indicates that a component extends in a distal direction, and extends “proximally” indicates that a component extends in a proximal direction. Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic.

Referring toFIGS.1A and1B, a medical device in the form of a medical access device10according to an embodiment is shown. Access device10may include a proximal ring12, a sleeve16attached to proximal ring12, and a guard assembly20at a distal end of sleeve16. A distal ring14may be disposed about and may move relative to sleeve16, proximal ring12, and guard assembly20. As shown inFIG.1B, guard assembly20may include a plurality of circumferentially arranged, longitudinally extending elongate guard members or petals30slidably received within a guard ring22and secured within a petal pockets portion40at a distal end of the sleeve16.

Distal ring14may be a flexible ring formed of a rubber, a resin, or the like. Distal ring14may be generally circular in cross-section and form a generally torus or O-ring shape, but the cross-section may take other shapes. A diameter of distal ring14may be approximately 50 mm to approximately 150 mm, but is not limited to this size. A tether18may be connected to distal ring14by a tether connection18a. Tether18may have a length sufficient to extend proximally from a body opening when distal ring14is disposed within the body, as will be described below. Tether18may be formed of any appropriate material.

Proximal ring12is shown in detail inFIGS.2A-2C. As shown inFIG.2A, proximal ring12may be solid and continuous about its circumference.FIG.2Bshows a cross-section of proximal ring12forming a generally “S” shape having a first end section12aangled radially outward from a central section12b, and a second end section12cextending radially inward from central section12b. Thus, the first end section12aand the second end section12bextend in opposite directions. Central section12cmay include a cross-section with parallel sides extending parallel to a longitudinal axis of the access device10. Proximal ring12may be formed in an alternative shape. Proximal ring12may be flexible and may be formed of any suitable material, including a medical grade polyurethane, rubber, resin, or similar flexible material to facilitate rolling of proximal ring12. Proximal ring12may be larger than guard ring22and larger than an opening in the body in which medical device10is inserted. For example, proximal ring12may be approximately 50 mm to approximately 150 mm, or approximately 100 mm. However, the diameter of proximal ring12is not limited thereto, and may be any size suitable for use assisting with the retraction of a body opening.

FIG.2Cillustrates sleeve16attached to proximal ring12in various alternative examples. As a first example, a proximal end of sleeve16may be fixedly attached to a radially outer surface of proximal ring12. According to another example, the proximal end of sleeve16may be fixedly attached to a radially inner surface of proximal ring12. According to yet another example, a channel17may be formed at a proximal end of sleeve16, and proximal ring12may be received and/or secured within channel17. In each example, proximal ring12may be rolled in the direction indicated by arrows H inFIG.2Cto cause sleeve16to wrap about proximal ring12and thus decrease a length or distance between proximal ring12and distal ring14, as will be described in more detail below.

With reference back toFIG.1A, sleeve16may be a continuous piece of material extending from proximal ring12to a distal end of guard assembly20. Sleeve16may be flexible and may conform to a shape and a size of a body opening100(see, e.g.,FIG.5A). For example, sleeve16may be a medical grade material, including a polyurethane film, a Kevlar or other cut or puncture resistant material, or the like. Sleeve16may be any length suitable for insertion into the body opening, with a remainder extending proximal from the body opening. For example, sleeve16may be approximately 100 mm to approximately 350 mm, or approximately 250 mm. However, the length of sleeve16may vary based on the medical procedure and/or the area of the body being accessed. As will be explained in more detail below, the distal end of sleeve16may form a portion of guard assembly20.

FIGS.3A and3Billustrate a petal pockets portion40of guard assembly20formed by a distal end of sleeve16. The petal pocket portion40may include a plurality of petal pockets, channels or slots42formed at the distal end of sleeve16. As will be explained in more detail below, the petal pockets42may be sized to receive and secure petals30of guard assembly20. As shown inFIG.3A, in an unassembled configuration of access device10, the plurality of petal pockets42have an open distal end44and a closed proximal end46. The open distal end44of petal pocket portion40forms a distal-most end of sleeve16in the unassembled configuration. Petal pocket portion40may be formed by folding a length of sleeve16at the distal end of sleeve16back toward the proximal end of sleeve16. Then, the distal end of sleeve16is sealed with adhesive or laser welded to form each of the petal pockets42, with a final step of cutting the distal-most end of the sleeve16to form the open ends44of the petal pockets42. Alternatively, the petal pocket portion40could be formed by a separate sleeve portion sealed or welded to the distal end of the sleeve16to form the petal pocket portion40. The separate sleeve portion may be the same material or a different material as a material of sleeve16. Petal pockets42may have a length based, at least in part, on a size and shape of the opening in the body. For example, if a medical procedure is performed at an area having a small tissue T thickness and a large body cavity, the length of petal pockets42may be short enough such that petal pockets42do not contact guard ring22in such a way as to cause an obstruction. Petal pockets42may have a width approximately equal to or greater than a width of petals30contained therein. According to an example, there may be sixteen petal pockets42, corresponding to sixteen petals30. However, it will be understood that the number of petal pockets42and the number of petals30may change based on, e.g., a size of the sleeve or a width of petals30. As best shown inFIG.1B, in the assembled configuration of access device10, sleeve16may be inverted, or pulled through a central opening of guard assembly20. Thus, in this assembled configuration, the distal end of sleeve16includes the petal pocket portion40surrounding a portion of sleeve16, and the open ends44of petal pockets42are located proximal to the closed ends46. Further, the closed ends46of pockets42are at the distal-most end of sleeve16. As will be explained in more detail below, in this assembled configuration, the distal ring14may positioned between the inner surface of the petal pocket portion40and an outer portion of sleeve16at a distal-most end of sleeve16(FIG.9F). It will also be understood that petals30may be attached directly to sleeve16, e.g., via welding, such that petal pockets42are not necessary.

FIG.4illustrates an embodiment of guard assembly20with a portion of sleeve16omitted. As noted above, guard assembly20includes petals30and a guard ring22. Petals30may be elongate members having a generally rectangular cross-section. As shown inFIG.4, petals30may slide within guard ring22in the direction indicated by arrows A. For example, as shown in the embodiment ofFIGS.5A-5C, guard ring22may include a plurality of apertures or slots24radially disposed about guard ring22. Each aperture24may be sized to receive a single petal30. As petals30move relative to guard ring22, petals30may slide within apertures24. Apertures24may have a shape approximately equal to a cross-sectional shape of petals30. For example, apertures24may be rectangular in shape, and may be sized to have a height and width approximately equal to or greater than the thickness and width of each of petals30. According to an example, guard ring22may include sixteen apertures24, corresponding to sixteen petals30. However, it will be understood that the number of apertures24and the number of petals30may change based on, e.g., a size of the body opening or a width of petals30. In some examples, a protrusion23extends from an inner side of each aperture24toward a central axis of guard ring22. Protrusions23may be sloped from the inner side of each aperture24in a distal direction. Protrusions23may form a guide ramp for petals30and may reduce a stress on petals30as guard ring22moves relative to petals30.

A guard ring22′ according to another embodiment is shown inFIGS.6A-6C. Guard ring22′ includes apertures24′ distally arranged about guard ring22′. Adjacent apertures24′ may be offset in a proximal-distal direction. For example, a first aperture24′ may be arranged in guard ring22′ closer to a distal end of guard ring22′, and adjacent apertures24′ may be arranged in guard ring22′ closer to a proximal end of guard ring22′. The arrangement of apertures24′ may prevent petals30from bunching up as guard ring22′ moves relative to petals30. An inner surface26of each of apertures24′ may be sloped such that a radially outer surface of aperture24′ is more proximal than a radially inner surface of aperture24′, as shown by the cross-section of guard ring22′ inFIG.6C. This arrangement may guide petals30as petals30move relative to guard ring22′, similar to the guidance protrusions23provided in guard ring22.

Reference is now made toFIGS.7A-7C, which illustrate petals30and petal pocket portion40of guide assembly20. Petals30may be fixed within petal pockets42so that the petals30stay secured within pockets42during use of the access device10. As noted above, petals30may be generally rectangular in shape, having a longer length (from a proximal end32to a distal end34) than a width that is normal to the length. However, other shapes than rectangular may be used. Petals30may be flexible and/or bendable, and formed of a polyester material, a plastic material, or the like. As shown inFIG.7B, when the petals30are secured within petal pockets42, a majority of the petal30extends proximal of the petal pocket42. This also enables each petal30and corresponding petal pocket42to move freely relative to adjacent petals30based on a size and a shape of the opening in the body.

As shown inFIG.7A, petals30may each have a proximal end32which is wider than the distal end34of petals30. For example, proximal end32of petals30may have a width greater than a width of apertures24or24′. In this manner, as petals30slide relative to guard rings22or22′, the wider proximal end32may prevent guard rings22or22′ from sliding off petals30. Alternative embodiments of proximal end32of petal30are described with reference toFIGS.13A-13Cherein. Distal end34of petals30may include a grooved portion36having, for example, a pair of grooves which may be used to fasten petal30within petal pocket42. For example, distal end34of petal30may be inserted into petal pocket42in the direction indicated by arrow B inFIG.7A. Referring toFIG.7B, a connection portion44may be formed within one or more petal pockets42by melting, laser welding, or like method to deform sleeve16within the grooves of grooved portion36of to fix petals30within petal pockets42. Alternatively, connection portions44may be preformed within petal pockets42, e.g., using a raised piece of material. This may allow the petals30to be inserted into pockets42and past the connection portions44(with increased force and the tapered distal-most end of the petal30), yet make it difficult to remove the petals based on the connection portions and transversely extending ends of the grooves of grooved portion36. It will be understood that petals30may be fixed within petal pockets42in alternative manners, e.g., via direct adhesive, laser welding, or the like.

According to another embodiment,FIG.7Cillustrates a plurality of petals30′ disposed within respective petal pockets42. Petals30′ may be formed without an enlarged proximal end32and/or without distal end34. For example, each petal30′ may be a single rectangular piece of material fixed within respective petal pockets42via, e.g., laser welding, adhesive, or the like.

As described herein, proximal end32of petals30may be enlarged to prevent guard rings22or22′ from sliding off petals30. For example, as shown inFIG.13A, proximal end32of petal30may have a larger cross-section than a distal end of petal30, which may prevent petal30from sliding through slots24of guard ring22(or slots24′ of guard ring22′ shown inFIGS.6A-6C). According to another embodiment shown inFIGS.13B and13D, proximal end32may include a rivet32a(or other raised surface) which may increase a thickness proximal end32of petal30. A size of rivet32amay be larger than slot24of guard ring22(or slot24′ of guard ring22′ inFIGS.6A-6C) and may prevent petal30from sliding through slots24or24′. Yet another embodiment of proximal end32of petal30is shown inFIGS.13C and13E. A tab32a′ may be formed in proximal end32. Tab32a′ may extend downwards relative to petal30, as shown inFIGS.13C and13E, or upwards relative to petal30. Tab32a′ may contact a radially outer surface of guard ring22(or guard ring22′) and may prevent proximal end32of petal30from sliding through slots24or24′.

A method of inserting access device10will be described with reference toFIGS.9A-9F. Guard assembly20may be inserted into a body opening100as shown inFIG.9A. For example, the distal end of guard assembly20may be inserted through an incision in a tissue T of the body, a natural orifice, or any other body opening100in the direction indicated by arrow J. As guard assembly20is advanced distally into opening100, proximal end of sleeve16is maintained outside the body. A distal end of guard assembly20may be advanced distally into opening100such that guard ring22rests against an outer surface of tissue T surrounding opening100. While reference is made to guard ring22, it will be understood that guard ring22′ may be used in a similar manner as guard ring22.

Once guard assembly20is positioned within opening100, distal ring14may be moved distally along the outside of sleeve16, as shown by arrows K inFIG.9B. As shown inFIGS.9B and9C, distal ring14may continue to be moved distally in the direction indicated by arrows K. Distal ring14may be pinched or otherwise deformed and moved into body opening100via the space created by the inverted portion of sleeve16and the inner surface of petal pocket portion40. As distal ring14continues to move into the body, distal ring14pulls a portion of sleeve16into the body opening (see arrow M, as shown inFIG.9D), such that a portion of sleeve16is distal of guard assembly20(seeFIG.9E). Once the distal ring is distally beyond the opening100, the distal ring may expand to an approximately circular shape, and in doing so, causing the distal end of guard assembly20, including the distal end34of petals30, to move radially outward within the body, as shown inFIG.9E.

Once distal ring14is expanded within the body, the user may pull proximal ring12in the proximal direction, as indicated by arrows P inFIG.9F. Movement of sleeve16in the direction indicated by arrows P urges distal ring14in the proximal direction, as indicated by arrows N, and against tissue T within the body. With reference toFIGS.10A-10E, the user may subsequently roll proximal ring12in the direction indicated by arrows H. Rolling proximal ring12may cause the sleeve16disposed outside the body to gather around proximal ring12, as shown inFIGS.10C-10E. As the user continues to roll proximal ring12in the direction indicated by arrows H, the excess material of sleeve16gathers around proximal ring12and proximal ring12approaches body opening100. As further shown inFIG.10B, continued rolling of proximal ring12urges the distal ring14against the distal surface of tissue T, effectively seating, anchoring or “locking” guard assembly20within opening100. Continued rolling of proximal ring12shortens the amount of sleeve16between the proximal ring12and distal ring14, thereby causing the sleeve16to exert a generally radial force G on opening100to enlarge the opening100. This shortening of the distance between the proximal ring12and distal ring14also urges guard ring22against a proximal surface of tissue T, and causes proximal ends32of petals30to slide radially outward from guard ring22. The continued rolling of proximal ring12, and in particular the radial force G from sleeve16, causes the distal end of petals30that are disposed within opening100and in petal pocket portion40, to press radially expand against tissue T. Due to the shortening of the distance between the proximal ring12and distal ring14, the petals slide proximally through guard ring22so that less of the distal end of the petals30is located within opening100. Further the radial expansion of opening100causes the petals30to move circumferentially so that there is less circumferential overlap of the petals30. Finally, since the proximal end32of petals30extend outside the body, radial expansion of guard assembly20may be assisted by an operator pulling on individual petals30of the guard assembly20.

The movement of the petals is shown inFIGS.8A-8C, which illustrate movement of petals30within guard ring22. In a first state, proximal ends32of petals22may be adjacent and/or may rest against guard ring22. Petals30may significantly overlap with each other at the distal end. A guard aperture46may be formed at the confluence of the distal ends of petals30, as shown inFIG.8A. When proximal ring is rolled to shorten the distance of the sleeve16between proximal ring12and distal ring14, petals30may be urged against a tissue of the body opening100(FIG.9A). As the sleeve16further urges petals30against the tissue (indicated by arrow G.FIGS.8B and8C), the tissue and petals30are urged radially outward, increasing a diameter of guard aperture46. As petals30are capable of sliding within and relative to guard ring22, proximal ends32of petals30move radially outward in the direction indicated by arrow F. Guard aperture46may provide access to a body cavity via the body opening, while providing protection to the tissue of the body opening. The radially expansion of the guard aperture46, and the associated radial expansion of the distal end of sleeve16within the opening, provide a protected access opening through which tools, devices, and other medical instruments may be inserted into opening100. Further, since petals30still cover all or generally all of the opening100in the radially expanded configuration, petals30may provide substantially full circumferential protection to tissue T from being cut by sharp instruments, friction forces causes by inserting or removing medical instruments via opening100, or other trauma that may be caused by inserting and/or removing medical devices via opening100. Once medical device10is disposed within opening100, medical instruments or other devices may be inserted and/or removed via opening100to perform medical procedures.

Insertion of medical device10into another body opening, e.g., a vaginal opening, is shown inFIGS.23A-23C. For example, guard assembly20may be inserted into a vaginal opening and distal ring14may be subsequently inserted into the vaginal opening as shown inFIG.23A. With reference toFIG.23B, distal ring14may be seated within a body cavity against the tissue surrounding the vaginal opening. Guard assembly20may expand as proximal12is rolled toward the vaginal opening. As shown inFIG.23C, a cap (such as cap1000inFIG.18A, or any cap described herein) may be attached to proximal ring12. The cap may facilitate insertion of medical tools and/or may aid in performing medical procedures. Additionally, or alternatively, the cap may facilitate insufflation and/or desufflation of the body cavity, e.g., by preventing or releasing gas from the cavity during a medical procedure.

Alternatively, or additionally, one or more devices may be inserted through opening100prior to inserting medical device10. For example, as shown inFIG.12, a tissue containment bag200may be inserted into opening100prior to inserting medical device10. Containment bag200may be used for any medical procedure, e.g., a morcellation procedure on a tissue sample210. After containment bag200is inserted via opening100and tissue sample210is disposed within containment bag200, medical device10may be inserted into opening100in the manner described herein. In this manner, when guard assembly20is “locked” within opening100, petals30may protect both tissue T within opening100and containment bag200extending through opening100, as shown inFIG.12. Thus, in the event a morcellation, such as a manual morcellation using a sharp instrument, or any other procedure is performed, petals30may protect containment bag200and/or tissue T within opening100from being cut or otherwise compromised.

Once the medical procedure is complete, medical device10may be removed from opening100as shown inFIGS.11A-11C. For example, a user may grasp tether18and move tether18in the proximal direction, indicated by arrow O. Such movement causes distal ring14, which is attached to tether18at tether connection18a(seeFIG.1A), to fold or deform and move proximally through opening100. Once distal ring14is pulled proximally through opening100, the access device10can be easily pulled out from body opening100. In this manner, movement of tether18in the proximal direction removes medical device10from opening100. In the event another medical device (e.g., containment bag200) was inserted prior to medical device10, the other medical device may then be removed through opening100.

Access device10may thus provide a single device for both retraction and protection of a body opening100. Further the overlapping petals30of guard assembly20allow for retraction and protection over a plurality of different retracted sizes of opening100. In some instances, this may provide improved protection for small, vulnerable incisions, which may increase the protection of these vulnerable access openings. Access device10provides for ease of use by providing simultaneous insertion and removal of the retraction sleeve16and guard assembly20, and simultaneous retraction of opening100and expansion of the guard assembly20. Access device10may also provide protection for various body openings100, e.g., different tissue (e.g., abdominal wall) thicknesses and different incision or orifice shapes and sizes since access device10is self-adjusting. Further, access device10may provide protection to the tissue surround a body opening100inside and outside the body, as well as the walls or tissue within the opening. In addition, distal ring14may anchor access device10and may provide additional protection to a bag or other device inserted through the body opening by, for example, providing an additional securement of the bag or device, and/or urging the bag or device farther away from the body opening100.

According to an example, manual morcellation in containment bag200may be desired for certain types of tissues, e.g., tissues that may be exposed to cancers, benign growths, and/or other pathogens. Performing these procedures in containment bag200may prevent the spread of the pathogens through a body as the tissue is morcelated. However, using a scalpel and/or forceps during morcellation may damage containment bag200such as at a location near the opening in the body (e.g., incision, natural orifice, etc.) through which containment bag200is extended. Damaging containment bag200may be a critical failure in the procedure, as it may allow pathogens to spread throughout the body. In another example, inserting medical instruments or tools, e.g., a knife, grasping mechanism, or the like, may damage tissue at a location near the opening in the body (e.g., incision, natural orifice, etc.). Medical device10may provide a barrier between (1) the medical instruments or tools and (2) containment bag200and/or tissue at the opening of the body through which the medical instruments or tools are inserted.

An access device300according to another embodiment is shown inFIGS.14A-14E. Access device300may include a guard300including guard ring310with one or more guard elements320extending therefrom. Guard ring310may be an annular device having an opening312. Guard elements320may be attached at a first end to guard ring310via a hinge, an area having a reduced amount of material, or other mechanism for hingedly connecting guard elements320to guard ring310. Guard elements320may be curved along their length, as shown inFIGS.14A and14B, or may be straight (not shown). Guard elements320may also be tapered from the end connected to guard ring310to an opposite end. This may enable guard elements320to approach and/or contact each other in an insertion configuration, shown inFIG.14B.

An insert330may be inserted into opening312and may urge or move guard elements320radially outward from the insertion configuration ofFIG.14Bto a protection configuration shown inFIG.14C. In the protection configuration, guard elements320may be urged radially outward by (1) insert330, (2) a material of guard elements320(e.g., a shape memory material), and/or a spring or biasing mechanism (not shown) attached to guard elements320and guard ring310. Guard elements320may secure access device300in an insertion opening (e.g., an incision or a natural orifice). Insert330may have an outer wall defining an opening332. Opening332may allow instruments, body tissue, and/or other materials or tools to pass from an outside of the body into the body cavity during a medical procedure. Insert330may be formed of a material that is tear resistant and may protect tissue surrounding the insertion opening and/or a bag inserted into the insertion opening from being cut, torn, or otherwise breached by a medical tool during a medical procedure.

A method of inserting access device300will now be described. Guard ring310may be inserted into an opening in a body such that guard elements320extend into the body and guard ring310is positioned against an outer surface of the body, as shown inFIG.14D. The opening may be an incision or any natural orifice (e.g., anus, vagina, etc.). Once access device300is properly positioned in the opening, insert330may be inserted into opening312of guard ring310and moved toward a body cavity. This may cause guard elements320to move radially outward, as shown in FIG.14E. Guard elements320may contact tissue along the opening in the body and/or on an inner surface of a body cavity. This may secure access device300in the opening. Medical tools may be inserted through opening332to access a target site and perform a medical procedure. Once a medical procedure is complete, insert330may be removed from opening312. Removing insert330may cause guard elements320to move radially inward. Distal ring310may then be pulled outward away from the opening, such that guard elements320may be pulled from the opening.

An access device400according to another embodiment is shown inFIG.15A-15D. Access device400may include a proximal ring410, a distal ring420, and a plurality of straps430connecting proximal ring410to distal ring420. Straps430may be connected at a first end to distal ring420in a fixed manner. For example, straps430may extend into openings in distal ring420, or straps430may be looped around distal ring420to connect thereto.

Straps430may include ridges432(e.g., protrusions) along one side of each strap430, as shown inFIG.15B. Straps430may extend from distal ring420through corresponding slots412in proximal ring410. Each slot in proximal ring410may include a protrusion412awhich may engage ridges432of straps430. For example, protrusion412amay be disposed between two adjacent ridges432. To move strap430relative to proximal ring410, a force may be applied to strap430sufficient to overcome a force supplied by protrusion412aand ridges432to maintain a position of strap430to proximal ring410. For example, this may provide a friction lock or may be a ratchet-type device. Pulling straps430in the direction indicated by arrow Q inFIGS.15A and15Band/or pushing proximal ring in the direction indicated by arrow R in FIG.15C may cause a distance between proximal ring410and distal ring420to be reduced. To increase the distance between distal ring420and proximal410, proximal ring410may be moved away from distal ring420. In some instances, a strap ring434may be attached to an end of each strap430opposite distal ring420(FIG.15D). Strap ring434may enable a user to move all straps430at a same time. While four straps430are shown in the drawings, it will be understood that any number of straps430may be provided, for example, two, three, five, or more.

In some instances, straps430may be used to protect tissue of an opening through which a medical procedure may be performed. Alternatively, or additionally, a guard (such as those devices used with medical access devices10and/or insert330ofFIG.14A) may be used with access device400. For example, a guard device may be inserted into an opening formed in proximal ring410and distal ring420and may protect tissue as described herein. For example, access device400may be inserted into an opening and straps430may be adjusted to position proximal ring410and distal ring adjacent tissue defining the opening. In some instances, a bag may be positioned in the body opening, and access device may be positioned within the bag, such that the bag is positioned between access device400and the tissue defining the body opening. An insert, such as insert330, may be positioned within an opening defined by proximal ring410and an opening defined by distal ring420. Insert330may prevent instrument from damaging the tissue wall and/or a bag positioned radially outward of access device400during a medical procedure. Alternatively, a guard may be positioned within the body opening, and access device400may be positioned within an opening of the guard. Tightening straps430may maintain a position of the guard within the body opening.

A method of inserting access device400will now be described. Distal ring420may be inserted into an opening, e.g., an incision or a natural orifice (anus, vagina, etc.), such that the distal ring420is seated within a body cavity. Straps430may subsequently pulled outward from the body, e.g., in a proximal direction. In some instances, proximal ring410may be simultaneously moved toward the opening in the body, e.g., in a distal direction indicated by arrow R inFIG.15C. This movement may cause straps430to move within corresponding slots412such that ridges432move past protrusions412a. In some cases, strap ring434may be moved proximally, which may cause all straps430to move simultaneously.

Once proximal ring410is seated against an outer surface of the body, a user may insert tools through an opening in proximal ring410and distal ring420to access a target site with in the body. In some instances, a guard (such as those guards used with access device10) may be inserted into the opening to provide additional protection against tools during the medical procedure. Once the procedure is complete, access device400may be removed from the opening. In some instances, proximal movement of access device400may cause distal ring420to be moved outside the opening. Alternatively, proximal ring410may be moved proximally relative to straps430to provide slack between proximal ring410and distal ring420. Once a sufficient slack in straps430is achieved, distal ring420may be pulled from the opening.

FIGS.16A-Jillustrate various embodiments of designs for a distal ring, such as distal ring14inFIG.1. With reference toFIG.16A, distal ring14may include a single annular ring with a circular cross-section. It will be understood that the cross-section is not limited thereto, and may be ovular, rectangular, or the like.

FIG.16Billustrates another example of a distal ring114. Distal ring114may include two distal rings114a,114bstacked one on top of the other, e.g., stacking two distal rings14, connected together via a piece of material114c. In some instances, distal rings114a,114bmay be formed as a unitary piece, e.g., via extrusion.FIG.16Cillustrates another example of a distal ring214in which three distal rings214a,214b,214care stacked together. Adjacent distal rings214a,214b,214cmay be connected via material214d. As with distal ring114, distal ring214may be formed as a unitary piece.

FIG.16Dillustrates an example of a distal ring314including a plurality of stacked rings314a. Adjacent rings314amay include diameters different from each other such that distal ring314may be funnel-shaped. As with distal rings14and114, adjacent rings314amay be connected via material between each adjacent ring314aand/or distal ring314may be formed as a unitary member. The funnel-shaped design of distal ring314may allow the shape of distal ring314to be selected by a physician based, e.g., based on the type of procedure being performed, the size of the opening, and/or a patient-specific anatomy. In some instances, the physician may cut distal ring314at one or more locations to select the size of distal ring314.

FIG.16Eillustrates a distal ring414having an ovular cross-section, which may increase a stability and a sealing surface of an access device within the body. As another example,FIG.16Fillustrates a distal ring514having a C-shaped cross section, which may improve the stability and/or the grip of distal ring514within the opening. This may provide a better seal between the access device and the opening, e.g., by seating the access device against the opening.

A distal ring614having an elongated outer surface with a V-shaped region near its center is shown inFIG.16G. Distal ring614may be compressed and/or may expand via the V-shaped region to provide improved sealing between the opening and the access device.

FIG.16Hillustrates a distal ring714, which may expand from a generally circular shape to a generally ovular shape, as shown by arrows Z. This configuration may allow distal ring714to have a reduced cross-sectional area during insertion to the body, which may allow distal ring714to fit through smaller body openings. Once inserted into the body, distal ring714may expand to provide a larger cross-sectional area which may provide increased rigidity to an access device during a procedure.

FIGS.16H and16Iillustrate distal rings814and914, respectively, which may have an inflation portion. Distal ring814has a generally circular cross-section, similar to that of distal ring14. A radially outer surface814aof distal ring814include an inflatable member814b, which may be inflated or deflated to provide additional sealing and support between the access device and the body. Distal ring914may be V-shaped, e.g., similar to distal ring614, and may include an inflatable member914apositioned generally in the V-shaped region. Similar to inflatable member814a, inflatable member914amay be inflated or deflated and may provide improved sealing or support to an access device.

FIGS.17A and17Billustrate examples of distal rings positioned within a body opening.FIG.17Aillustrates a distal ring, e.g., distal ring14, positioned within a natural orifice of the patient, with an access device, e.g., access device10, protruding through the opening.FIG.17Billustrates a distal ring, e.g., distal ring214or distal ring314, which has may have been sized to fit the patient-specific anatomy. An access, device, e.g., access device10, may protrude from the natural opening. The various shapes, sizes, and functionalities (e.g., inflation, deflation) of the distal rings may provide improved sealing and/or positioning of an access device within the body.

FIGS.18A and18Billustrate a cap1000which may be clipped onto a proximal ring of an access device, e.g., proximal ring12of access device10ofFIG.1. Cap1000may include an annular member1010extending from a first surface1000aof cap1000. Annular member1010may include an outer annular wall1012and an inner annular wall1014. An annular lumen1016may be defined between outer annular wall1012and inner annular wall1014. One or both of outer annular wall1012and inner annular wall1014may be capable of bending or being deformed. An opening1018may be formed between outer annular wall1012and inner annular wall1014when outer annular wall1012and inner annular wall1014are deformed, which may allow access to annular lumen1016. This may allow cap1000to be clipped or otherwise attached to proximal ring12. For example, as shown inFIG.18A, proximal ring12may fit within annular lumen1016such that cap1000may be secured to access device10. In some examples, cap1000may include one or more ports through which medical instruments, air, water, or other items may be introduced or removed during a medical procedure. It will be understood that the one or more ports may be attached to a port device1020, as shown inFIG.18B, and may be attached to cap1000via a screw fit, clip, snap fit, or the like.

A cap1100according to another example is shown inFIG.19. Cap1100may have an outer annular wall1112and one or more levers1114hingedly attached to cap1100via one or more pivot points1116. Levers1114may pivot between an open position and a closed position (the closed position shown inFIG.19). Outer annular wall1112may be placed such that it is radially outward from proximal ring12. Levers1114may be moved from the open position to the closed position, where a portion of levers1114contact proximal ring12. In some instances, levers1114may push or urge proximal ring12against an inner surface of outer annular wall1112. In an example, levers1114may be biased via a biasing member (e.g., a spring) in the closed position. To remove cap1100, levers1114may be pivoted about pivot point1116to the open position, and cap1100may be removed from proximal ring12.

A cap1200according to another example is shown inFIGS.20A and20B. Cap1200may include an annular wall portion1210extending form cap1200and may include an inflatable member1220, e.g., a balloon, attached to an end of annular wall portion1210. An inflation mechanism1230, e.g., a pump device or tube configured to attach to an air supply, may be attached to cap1200. Annular wall portion1210may be inserted into an opening defined by proximal ring12. Inflatable member1220may then be inflated via inflation mechanism1230. Inflatable member1220may inflate and secure cap1200to an inner surface of proximal ring12. To remove cap1200, air may be released from inflatable member1220and cap1200may be removed from the opening of proximal ring12.

A cap1300according to an example is shown inFIG.21. A sleeve1310may extend from sleeve16in a proximal direction, e.g., away from a body opening, at a location where proximal ring12is attached to sleeve16. Sleeve1310may include a proximal ring1320which may be flexible. Cap1300may fit within an opening of proximal ring1320. Sleeve1310may move proximally and distally as proximal ring12is rolled or unrolled.

A cap1400according to an example is shown inFIGS.22A,22B, and22C. Cap1400may include an elastic sleeve having a plurality of ports1410at a first end and an opening1420at an opposite end as shown inFIGS.22A and22B. The material of cap1400at opening1420may stretch or expand as indicated by arrows X inFIGS.22A and22B. Opening1420may be placed over proximal ring12and the material may contract or be released to contact proximal ring12as shown inFIG.22C. This may allow cap1400to be sealed to proximal ring12of an access device (e.g., access device10inFIGS.1A and1B). Ports1410may allow access to medical instruments, while maintaining a fluid seal e.g., to prevent bodily materials and/or fluids from escaping through an opening in the access device.

It will be understood that, unless specifically set forth herein, any material known in the art may be used for the various elements. For example, features may include a medical grade plastic or rubber, a ceramic, a metal, or a combination thereof.

It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. For example, the configuration of petals arranged radially about the guard may change in size and number, based on a size of an opening in the body to be accessed. In other examples, the distal ring may be fixedly attached to a portion of the sleeve or the guard20. Various components of the medical access device may be changed based on the size and/or location of the body opening, and/or the medical procedure to be performed via the body opening. Further, embodiments allow different auxiliary medical devices to access the body via the body opening, while protecting tissue of the body opening and/or the auxiliary medical devices at least at the body opening. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.