Vascular sheath device and method of use

Abstract

A vascular sheath device comprising a tubular body with a proximal and a distal opening and a lumen therebetween, an anchor positioned at the distal end and configurable between an unexpanded and an expanded configuration, a flange surrounding the distal opening, and a backstop movably connected at the proximal end.

Description

VASCULAR SHEATH DEVICE AND METHOD OF USECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 710,692 filed on October 23, 2024, the contents of which are incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTION

[0002] Traditional vascular sheaths make it difficult or impossible to place wires, catheters, and / or dilators in both antegrade and retrograde directions from one access site. For procedures that require bidirectional access, this means repeating many of the steps to create multiple access sites increasing procedure complexity and time.

[0003] Thus, there is a need in the art for a novel vascular sheath device that enables bidirectional access to a vessel from a single access site.SUMMARY OF THE INVENTION

[0004] A vascular sheath device is described. The device includes a tubular body with a proximal and a distal opening and a lumen therebetween, an anchor positioned at the distal end and configurable between an unexpanded and an expanded configuration, a flange surrounding the distal opening, and a backstop movably connected at the proximal end.

[0005] In some examples, the anchor is a balloon configurable between an unexpanded and an expanded configuration. In some examples, the anchor comprises one or more structures extending radially from the outer diameter of the distal end of the tubular body when in the expanded configuration, wherein the one or more structures are configured to lie flat against the tubular body when in the unexpanded configuration. In some examples, moving the anchor fromthe unexpanded to the expanded configuration increases its diameter by 1 ,25x - 2x. Tn some examples, the anchor comprises an elastic, flexible, or distensible material. In some examples, the anchor comprises a rigid material. In some examples, the flange is configurable between an unexpanded and an expanded configuration. In some examples, the backstop is configured to move along the length of the tubular body. In some examples, the backstop is configured to move through a distance ranging between about 1 cm and 5 cm. In some examples, a compressive force is applied between the anchor and the backstop. In some examples, the compressive force ranges between 0 to 20 lbs.

[0006] In some examples, the tubular body is made of a material selected from the group consisting of: plastics, metals, metal alloys, polycarbonate, polyethylene, polylactic acid (PLA), and polyether ether ketone (PEEK). In some examples, the flange is made of a material selected from the group consisting of: silicone, rubber, and soft polymers. In some examples, the tubular body has an outer diameter ranging between about 0.1 mm and 5 mm. In some examples, the flange, in the expanded configuration, increases the inner diameter of the distal opening of the tubular body by about 0.1 mm and 5 mm. In some examples, the device further comprises one or more indicator elements positioned on the tubular body, wherein the one or more indicator elements are chosen from the group consisting of: radio-opaque markers, fluorescent markers, contrast agent markers, and any combinations thereof.

[0007] Also described is a method of utilizing a vascular sheath device, comprising providing a vascular sheath device, creating an opening within a tissue or vessel wall, inserting the tubular body into the opening while the anchor is in the unexpanded configuration, moving the anchor to the expanded configuration, moving the backstop in a distal direction to abut the opening, and inserting a medical instrument into the lumen of the tubular body. In some examples, a compressive force is applied between the anchor and the backstop. In some examples, the compressive force ranges between 0 to 20 lbs. In some examples, the medical instrument is a guide, a wire, a catheter, a balloon catheter, or a stent. In some examples, the method further comprises moving the anchor to the unexpanded configuration, moving the backstop in a proximal direction such that the compressive force on the tissue or vessel wall is removed, and removing the tubular body from the opening in the tissue or vessel wall, or adjusting the positioning of the tubular body.

[0008] Also described herein is a vascular sheath device, comprising a tubular body having distal and proximal openings, and an inner lumen therebetween, a first and second lateral opening positioned on a distal end of the body, wherein the first and second openings are diametrically opposite each other, and an anchor pivotally connected to a distal end of the inner lumen and configurable between a first orientation and a second orientation.

[0009] In some examples, the anchor has an elliptical and annular shape. Tn some examples, in the first orientation, the anchor diagonally spans the uppermost point of the edge of the first lateral opening and the lowermost point of the edge of the second lateral opening. In some examples, in the second orientation, the anchor is horizontal, with each end extending through each lateral opening. In some examples, the device further comprises a rod operably connected to the anchor and disposed within a groove within the wall of the tubular body. In some examples, the rod is slidable within the groove and configured such that sliding the rod in a first direction causes the anchor to move from the first orientation to the second orientation and sliding the rod in a second direction causes the anchor to move from the second orientation to the first orientation.BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:

[0011] Fig. 1 depicts a cross-sectional view of an exemplary vascular sheath device.

[0012] Fig. 2A depicts a front view of an exemplary balloon anchor in the deflated configuration. Fig. 2B depicts a front view of an exemplary balloon anchor in the inflated configuration.

[0013] Fig. 3 A depicts a cross-sectional view of an exemplary balloon anchor in the deflated configuration. Fig. 3B depicts a cross-sectional view of an exemplary balloon anchor in the inflated configuration.

[0014] Fig. 4A depicts a cross-sectional view of an exemplary vascular sheath device in the deflated configuration. Fig. 4B depicts a cross-sectional view of an exemplary vascular sheath device in the inflated configuration.

[0015] Fig. 5 depicts a cross-sectional view of an exemplary vascular sheath device, highlighting the compressive force on the tissue.

[0016] Fig. 6A depicts an exemplary undeployed anchor. Fig. 6B depicts the exemplary anchor of Fig. 6A in the deployed configuration.

[0017] Fig. 7A depicts an exemplary undeployed anchor. Fig. 7B depicts the exemplary anchor of Fig. 7A in the deployed configuration.

[0018] Fig. 8A depicts an exemplary undeployed anchor. Fig. 8B depicts the exemplary anchor of Fig. 8 A in the deployed configuration.

[0019] Fig. 9A depicts an exemplary undeployed anchor. Fig. 9B depicts the exemplary anchor of Fig. 9A in the deployed configuration.

[0020] Fig. 10 depicts a perspective view of an exemplary vascular sheath device inserted within a vessel showing the anchor in the undeployed configuration.

[0021] Fig. 11 depicts a perspective view of an exemplary vascular sheath device showing the anchor in the deployed configuration.

[0022] Fig. 12 depicts a cross-sectional view of an exemplary vascular sheath device inserted within a vessel.

[0023] Fig. 13 depicts a cross-sectional view of an exemplary vascular sheath device inserted within a vessel showing the anchor in the undeployed configuration.

[0024] Fig. 14 depicts a cross-sectional view of an exemplary vascular sheath device showing the anchor in the deployed configuration.

[0025] Fig. 15 depicts a ghosted view of an exemplary vascular sheath device with the anchor in the undeployed configuration.

[0026] Fig. 16 depicts a ghosted view of an exemplary vascular sheath device with the anchor in the deployed configuration.

[0027] Fig. 17 depicts a side view of an exemplary vascular sheath device.DETAILED DESCRIPTION

[0028] The following discussion omits or only briefly describes conventional features of vascular sheath devices that are apparent to those skilled in the art. Those of ordinary skill in the pertinent arts may thus recognize that other elements may be desirable and / or necessary to implement the devices, systems, and / or methods described herein. It is noted that various examples are described in detail with reference to the drawings. Reference to these various examples does not limit the scope of the claims attached hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible implementations for the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations. As such, it is understood that this detailed description is exemplary and explanatory only and is not restrictive of the broad inventive concepts upon which the examples disclosed herein are based.

[0029] Unless otherwise specifically defined herein, all terms are to be given their broadest reasonable interpretation. This includes meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc.

[0030] It is noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified. The terms “includes” and / or “including,” when used in this specification, specify the presence of stated features,elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0031] Relative terms such as “horizontal,” “vertical,” “up,” “down,” “top,” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then-described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation in actuality. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The phrases “operatively” or “operably connected” indicates such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship.

[0032] Reference throughout the specification to “exemplary”, “one example”, “an example” or “some examples” means that a particular feature, structure, or characteristic described in connection with at least one example of the subject matter disclosed. Thus, the appearance of the phrases “in one example”, “in an example” or “in some examples” in various places throughout the specification is not necessarily referring to the same example. Further, the particular features, structures or characteristics of “one example”, “an example” or “some examples” may be combined in any suitable manner with each other to form additional examples of such combinations. It is intended that examples of the disclosed subject matter cover modifications and variations thereof. Terms such as “first,” “second,” “third,” etc., merely identify one of a number of portions, components, steps, operations, functions, and / or points of reference as disclosed herein, and likewise do not necessarily limit embodiments of the present disclosure to any particular configuration or orientation.

[0033] Moreover, throughout this disclosure, various aspects can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the disclosure.Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, 6, and any whole and partial increments there between. This applies regardless of the breadth of the range. As used herein, the term “about” in reference to a measurable value, such as an amount, a temporal duration, and the like, is meant to encompass variations of plus or minus 20%, plus or minus 10%, plus or minus 5%, plus or minus 1%, and plus or minus 0.1% of the specified value, as such variations are appropriate.

[0034] The terms “proximal,” “distal,” “anterior,” “posterior,” “medial,” “lateral,” “superior,” and “inferior” are defined by their standard usage indicating a directional term of reference. For example, “proximal” refers to a position that is situated nearer to the center of a body or point of attachment or interest, while “distal” refers to a position that is situated away from the center of the body or point of attachment or interest. In another example, “anterior” refers to the front of a body or structure, while “posterior” refers to the rear of a body or structure, in relation to a relative viewpoint. In another example, “medial” refers to the direction towards the midline of a body or structure, and “lateral” refers to the direction away from the midline of a body or structure. In some examples, “lateral” or “laterally” may refer to any sideways direction. In another example, “superior” refers to the top of a body or structure, while “inferior” refers to the bottom of a body or structure. It should be understood, however, that the directional term of reference may be interpreted within the context of a specific body or structure, such that a directional term referring to a location in the context of the reference body or structure may remain consistent as the orientation of the body or structure changes.

[0035] The terms “patient,” “subject,” “individual,” and the like are used interchangeably herein, and refer to any human, animal, or other living organism, amenable to the systems, devices and methods described herein.

[0036] Described herein is a vascular sheath device configured to be inserted through a vessel wall and to provide bidirectional access to the vessel. It should be noted that while describedherein as a vascular sheath device, the device of this disclosure may be used to provide access to any bodily vessel, tube, organ, or body cavity through a tissue wall.

[0037] Referring now to Fig. 1 shown is a front view of a vascular sheath device 100 (hereinafter “device 100”). Device 100 generally comprises a tubular body 102 with a distal end 104 and a proximal end 106. The distal and proximal ends 104 and 106 comprise distal and proximal openings at the respective ends, forming a lumen 108 therebetween. The tubular body may have a length 110 ranging between about 10 mm and about 130 cm, an outer diameter ranging between about 0.1 mm and about 10 mm, and an inner diameter ranging between about 0.1 mm and about 10 mm. In some examples, the inner and / or outer diameters of the tubular body 102 may vary along its length. The tubular body 102 may be made of any suitable rigid material including, but not limited to, plastics, metals, metal alloys, polycarbonate, polyethylene, polylactic acid (PLA), polyether ether ketone (PEEK), and any suitable organic or non-organic polymer. The distal end 104 of the tubular body 104 may be configured to be inserted at least partially within an opening of the vessel wall 10, or at least partially within the vessel 20. The proximal end 106 of the tubular body 102 may be configured to remain external to the vessel 20 and / or vessel wall 10.

[0038] Referring now to Fig. 2A and Fig. 2B, shown is a front-view of the distal end of the tubular body. The tubular body 102 further comprises an anchor 112 surrounding the outer diameter of the distal end 104, configurable between at least a first and a second configuration. In some examples, and as depicted in Figs. 2A - 2B, the anchor 112 is a balloon having at least an inflated and deflated configuration. Fig. 2A depicts the anchor 112 in the deflated configuration and Fig. 2B depicts the anchor 112 in the inflated configuration. In the deflated configuration, the balloon anchor 112 may be configured to lie flat around the outer diameter of the tubular body 102. In the inflated configuration, the balloon anchor 112 may be configured to increase the outer diameter of the distal end of tubular body 102, thereby anchoring the device 100 in the vessel 20. In some examples, and in the inflated configuration, the balloon has a diameter of 1 ,25x - 2x the diameter of the balloon in the deflated configuration. In some examples, the inflated balloon 112 may have a diameter ranging between 1 mm and 2 cm. The balloon anchor 112 may be formed of any suitable flexible, elastic or distensible material including, but not limited to nylon, polyethylene terephthalate, polyurethane, polyether blocamide, silicone polymers, elastomeric polymers, thermoplastic elastomers, composites, and the like.

[0039] The balloon anchor 112 may have any suitable shape when inflated and is configured to increase the outer diameter of the distal end 104, thereby preventing the removal of the device 100 from the vessel 20 and / or vessel wall 10. For example, the balloon anchor 112 may have a spherical, ovular, cylindrical, conical, annular, toroidal, or irregular shape. It should be appreciated that the balloon may comprise pleats, folds, seams, recesses, indents or the like, configured to allow the balloon to fold and / or lay flat against the tubular body 102. Further, it should be appreciated that the balloon anchor 112 must be at least partially deflated when the device 100 is inserted or removed from the vessel 20 and / or the vessel wall 10 to prevent tissue / vessel damage. In some examples, the balloon anchor 112 may be inflated through the introduction of air / gas or fluid within the balloon. In some examples, the balloon anchor 112 may be inflated via a saline solution, a contrast solution, or any other solution or fluid known to one of skill in the art. In some examples, the balloon anchor 112 may comprise an opening into the tubular body 102, through which gas / fluid may be introduced for the inflation of the balloon. In some examples, the tubular body 102 may comprise a second lumen configured to connect the balloon to a source of fluid / gas.

[0040] It should be appreciated that the anchor 112 may be formed of any other suitable rigid or flexible material and in any suitable shape configured to deploy at the distal tip of the device 100, thereby increasing the outer diameter of the distal opening of tubular body 102. In some examples, the deployed diameter of the anchor is about 1.2x - 2x the diameter of the undeployed anchor. In some examples, the anchor 112 may comprise one or more structures configured to extend radially from the outer diameter of the distal end 104 of tubular body 102 when in the expanded configuration. The one or more structures may be configured to lie flat against the tubular body 102 when in the unexpanded configuration. Such alternative configurations are depicted in Figs. 6 -9, showing exemplary anchors 112 in the deployed and undeployed configurations. In other examples, the anchor 112 may be formed of an elastomeric material (for example nitinol) and configured such that the anchor 112 is biased towards the deployed state and is able to be compressed while the device 100 is inserted into or removed from the opening of the vessel wall.

[0041] Referring now to Fig. 3 A and Fig. 3B, shown is a cross-sectional view of the distal end 104 of the tubular body 102, with Fig. 3A depicting the anchor 112 in the deflated configuration and Fig. 3B depicting the anchor 112 in the inflated configuration. In some examples, the distal tip of tubular body 102 further comprises a flange 114 surrounding the distal tip of the tubular body 102. The flange 114 may be flexible and formed from a soft or semi-rigid material including, but not limited to, plastics, silicone, rubber, polylactic acid (PLA), polyether ether ketone (PEEK), polyethylene, soft polymers and any other semi-rigid material known to one of skill in the art. In some examples, the flange 114 may be a distal extension of the tubular body 102, and connected to the distal tip of tubular tip 102. In some examples, the flange 114 is generally circular and curves concavely, thereby providing a smooth edge at the distal opening of the tubular body 102. The smooth edge may prevent the kinking or snagging of any medical instrument (for example, wires, guides, catheters and the like) being inserted into or removed from the vascular sheath device. The flange 112 may further increase the inner diameter of the distal opening of the device 100. In some examples, the outer diameter may be increased by 0.1 to 15 mm.

[0042] In some examples, the flange 114 may be configured to be moved between a deployed and an undeployed configuration. That is, the flange 114 may be undeployed when device 100 is inserted into the body vessel and may be deployed once the device 100 is in place within the vessel wall. Fig. 3 A depicts the flange 114 in the undeployed state and Fig. 3B depicts the flange 114 in the deployed state. In some examples, the anchor 112 and the flange 114 may be operably coupled such that the inflation / deployment of the anchor 112 and the deployment of flange 114 occurs simultaneously. In other examples, the anchor 112 and the flange 114 may be positioned or operably connected such that the inflation of the anchor 112 causes the deployment of flange 114 and the deflation of the anchor 112 causes the flange 114 to be undeployed, or vice versa. In some examples, one or more inflation lumens 118 may be disposed within the wall of tubular body 102, and fluidly connected to the balloon anchor 112. The inflation lumens 118 may be configured to direct fluids / gases to the balloon anchor 112 to inflate the balloon anchor 112, or may be connected to suction pumps to deflate the balloon anchor 112.

[0043] Referring back to Fig. 1, device 100 may further comprise a movable backstop 116. In some examples, the backstop 116 may be configured to be moved along the length 110 of theproximal end 106 of the tubular body 102. Fig. 4A depicts the backstop in a proximal position, while Fig. 4B depicts the backstop moved to a distal position such that it is in contact with the vessel wall 10. In some examples, the backstop 116 is configured to provide an adjustable compressive force on the tissue between the anchor 112 and the backstop 116, as depicted in Fig.5. The compressive force provided on the tissue may range between 0 to 20 lbs. In some examples, the compressive force applied to the tissue or vessel wall may be adjusted by moving the backstop 116 in the distal or proximal direction to respectively increase or decrease the compressive force. The compressive force enables a more robust connection of the vascular sheath device to the vessel, thereby preventing any undesirable motion or removal of the device while it is in use. In some examples, the backstop 116 may be formed of any rigid material suitable for exerting a compressive force. The material may be the same as that of the tubular body 102 or may be a different material. For example, plastics, metals, metal alloys, polycarbonate, polyethylene, polylactic acid (PLA), polyether ether ketone (PEEK), and the like may be used.

[0044] In some examples, the backstop 116 may have an outer diameter or width larger than that of the outer diameter of tubular body 102. In some examples, the outer diameter of the backstop 116 may range between 0.1 mm and 60 mm. The backstop 116 may be formed in any suitable shape such that a force may be applied to the vessel wall 10 without damaging the tissue. For example, the movable backstop 116 may be formed in a cubical, cuboidal, conical or pyramidal shape configured to surround the outer diameter of tubular body 102. The backstop 116 may be movably connected to the tubular body 102 using any suitable movable or slidable mechanisms known to one of skill in the art. Suitable mechanisms could include a ratcheting mechanism, a friction fit, threads, slides, a button release, a latch, a twisting cam action or the like. In some examples, a mechanical pushing or pulling force may be required to move the backstop 116. In other examples, a separate tool may be utilized to move the backstop 116. In some examples, the tubular body 102 may further comprise stops to limit the range of motion of the backstop 116. In some examples, the backstop may be moved through a length ranging between 5 mm and 45 mm. In some examples, the distance between the backstop 116 and the anchor may be adjustable, and may range between about 10 mm and about 100 mm.

[0045] Device 100 may further comprise one or more indicator elements. In some examples, the one or more indicator elements may be radio opaque markers, fluorescent markers, contrast agent markers and the like. The one or more indicator elements may be positioned at any location on the device 100 such as on the tubular body 102, on the anchor 112, the flange 114, or the backstop 116. The one or more indicator elements may be configured to be detected by any imaging mode known to one of skill in the art, including but not limited to, ultrasound, x-rays, CT, MRI, PET, and the like. The indicator elements may be utilized to visualize and position the device 100 when placed in a subject’s vessel and to aid in the insertion or removal of a medical instrument in a vessel using the device. In some examples, the device 100 may further comprise a side port fluidly connected to the lumen 108 at one end. The side port may be connected to a fluid pump at the other end via a tube or a conduit and may be configured to allow the return of blood, thereby allowing a surgeon to confirm that the device 100 is positioned at an appropriate depth within the vessel prior to the deployment of the balloon anchor 112.

[0046] In some examples, and as depicted in Figs. 6A - 9B, the anchor 112 may have any alternative configuration. In some examples, the anchor 112 may comprise expandable structures, radially extendable structures, hinged structures, collapsible or buckling structures, and the like. The anchor 112 generally has an undeployed configuration, wherein the anchor lies flat against the tubular body 102 or is contained within the tubular body 102, and a deployed configuration wherein the anchor 112 increases the diameter of the distal end of the device 100 such that the device 100 is securely retained within a vessel or graft. The anchor 112 may be operably connected to an external actuator to move the anchor 112 between the undeployed and deployed configurations. It should be appreciated that the anchor 112 may be formed from any material known to one of skill in the art but must be sufficiently rigid so as to securely retain the device 100 within the vessel / graft.

[0047] In some examples, the device 100 may be configured to provide bidirectional access for any medical instrument configured to be inserted into a vessel. The medical instrument may be inserted into the lumen 108 of the tubular body 102 when the device 100 is secured to the vessel wall. Examples of medical instruments may include wires, guides, catheters, balloon catheters, stents, and the like. In some examples, the anchor may be deflated such the sheath may bemanipulated for bidirectional access, or for removal of the device 100 from the tissue or vessel wall.

[0048] Also described herein is a method of utilizing the vascular sheath device, comprising providing a vascular sheath device 100, creating an opening within a tissue or vessel wall, inserting the tubular body 102 into the opening while the anchor 112 and / or the flange 114 are in the deflated / undeployed configuration, deploying the anchor 112 and the flange 114, moving the backstop 116 in a distal direction to abut the opening, and inserting a medical instrument into the lumen 108 of the tubular body 102, such that the medical instrument is inserted into the vessel. In some examples, a compressive force is applied between the anchor and the backstop, which may range between 0 to 20 lbs. In some examples, the medical instrument may be a guide, a wire, a catheter, a balloon catheter, or a stent. The method may further comprise removing the medical instrument from the tubular body 102, moving the anchor 112 and the flange 114 into the deflated / undeployed configuration, moving the backstop 116 in the proximal direction thereby removing the compressive force, and removing or adjusting the positioning of the vascular sheath device.

[0049] In some examples, the device 100 may be configured to occlude a vessel or graft, thereby prohibiting flow within the vessel to allow for interventions within the vessel. For example, a diameter of the ballon anchor 112 may be at least equal to the inner diameter of the vessel 20 and may be positioned so as to fully occlude the vessel 20. In some examples, the balloon anchor 112 may be oriented and deployed within the vessel 20 such that the diameter of the balloon 112 is anchored between the walls of the vessel 20, thereby prohibiting flow within the vessel 20. The tubular body 102 may be at least partially flexible such that the tubular body 102 is bendable at angles ranging between 0° and 90° relative to the longitudinal axis of the tubular body 102. In some examples, the tubular body 102 may be at least partially formed from sufficiently flexible materials to allow the tubular body 102 to bend within the vessel 20. In some examples, the tubular body 102 may comprise one or more flexible regions, e.g. corrugated regions, to allow the tubular body 102 to bend within the vessel 20. The backstop 116 may then be advanced to abut the access site, thereby securing the tubular body 102 within the access site. Surgical instruments may then be advanced through the lumen 108 of the tubular body 102 for diagnostic or therapeutic procedures within the occluded vessel 20. Occluding the vessel may help toprevent complications in the opposing direction of the vessel, such as by preventing embolization when removing a blood clot, or may allow for better tracking of the device 100 within the body.

[0050] Also described herein is a method of using the vascular sheath device 100. The method generally comprises the steps of: providing a vascular sheath device, which may be any vascular sheath device described herein, creating an opening within a vessel 20, inserting the tubular body 102 into the opening while the anchor 112 is an unexpanded configuration, moving the anchor 112 to the expanded configuration, wherein in a first position, the expanded anchor 112 abuts the opening within the vessel thereby securing the device 100 within the vessel 20 while allowing flow within the vessel, and in a second position, the diameter of the expanded anchor 112 is anchored between the walls of the vessel 20 thereby prohibiting flow within the vessel 20, moving the backstop 116 such that it abuts the opening in the vessel on the exterior side, and inserting a medical instrument into the lumen 108 of the tubular body 102 such that the medical instrument is inserted into the vessel 20.

[0051] Referring now to Fig. 10, shown is a perspective view of an exemplary vascular sheath device 200 positioned within a vessel 30. Device 200 generally comprises a tubular body 202 having a distal end 204 and a proximal end 206, each end comprising openings forming an inner lumen 208 therebetween, and an anchor 210 pivotally connected to the inner wall of the body 202 within the inner lumen 208, and configurable between an undeployed configuration and a deployed configuration.

[0052] In some examples, the tubular body 202 may have a length ranging between about 10 mm and about 130 cm, an outer diameter ranging between about 0.1 mm and about 10 mm, and an inner diameter ranging between about 0.1 mm and about 10 mm. In some examples, the inner and / or outer diameters of the tubular body 202 may vary along its length. The tubular body 202 may be made of any suitable rigid material including, but not limited to, plastics, metals, metal alloys, polycarbonate, polyethylene, polylactic acid (PLA), polyether ether ketone (PEEK), and any suitable organic or non-organic polymer. In some examples, the distal end 204 of the tubular body 202 may be configured to be inserted at least partially within an opening in a vessel 30, or at least partially within the vessel 30. The proximal end 206 of the tubular body 202 may be configured to remain external to the vessel 30. Referring now to Fig. 11, the distal end of thebody 202 further comprises first and second lateral openings 212a and 212b configured to provide antegrade and retrograde access to the vessel 30 via the inner lumen 208. In some examples, the first and second lateral openings 212a and 212b are positioned diametrically opposite each other. In some examples, the first and second lateral openings 212a and 212b have an oval or elliptical shape and have smooth rounded edges. Fig. 12 depicts a cross-sectional view of the device 200.

[0053] In some examples, the anchor 210 has a generally elliptical and annular shape having a middle opening to prevent the anchor 210 from occluding the device 200 or the vessel 30. In some examples, the length of the anchor 210 (i.e. the length of its major axis) is greater than the outer diameter of the body 202, such that in a horizontal orientation, the ends of the anchor 210 may protrude through the lateral openings 212a and 212b. In some examples, the width of the anchor 210 (i.e. the length of its minor axis) has a length less than or equal to the inner diameter of the body 202.

[0054] Referring now to Fig. 13, the first and second lateral openings 212a and 212b are each defined respectively by edges 214a and 214b formed by the wall of the tubular body 102. In some examples, and in the first orientation, the anchor 210 is configured to diagonally span between an uppermost point of the edge 214a of first lateral opening 212a and the lowermost point of the edge 214b of second lateral opening 212b. In some examples, the edges 214a and 214b may comprise stops at the positions where the anchor 210 interfaces with each edge, configured to securely retain the anchor 210 in the diagonal orientation. In other examples, the anchor 210 may be securely held between the edges of the lateral openings 212a and 212b via a tension force. Referring now to Fig. 14, the anchor 210 may be rotated to a second orientation wherein the anchor 210 is perpendicular to the length of the body 202 and each end of the anchor 212 protrudes from each lateral window 212a and 212b, thereby providing an anchoring surface configured to securely retain the device 200 within the vessel 30. It should be appreciated that in either orientation, the anchor 210 allows for fluid connection within the vessel and between the device 100 and the vessel due to the annular shape of the anchor 210.

[0055] Referring now to Fig. 15, the anchor 210 is securely attached to the body 202 within the inner lumen 208 via a first attachment 216. The first attachment 216 may comprise a pivot or ahinge mechanism configured to allow the anchor 210 to rotate between the diagonal and horizontal orientations. In some examples, the first attachment 216 may be positioned within a first groove 220a in the body 202. In some examples, the first attachment 216 is configured to be slidable within the groove 220, such that the first attachment 216 allows the anchor 210 to rotate into the horizontal orientation, and slide in a proximal direction to contact the vessel wall. In some examples, a rod 218 may be operably coupled to the anchor 210 via a second attachment. The rod 218 may be disposed within a second groove 220b of the inner surface of the body 202, such that the first attachment 216 and the second attachment are diametrically opposite each other and define a pivot axis for the anchor 210. The rod 218 may be configured to be slidable within the groove 220. The rod 218 may be configured such that sliding the rod 218 towards the proximal end 206 causes the anchor 210 to be oriented in the horizontal orientation, and sliding the rod 218 toward the distal end 204 causes the anchor 210 to be oriented in the diagonal orientation. In some examples, the rod 218 and the grooves 220 extend through the length of the body 202 and the rod 218 may extend out of the proximal end 206 of the body (as depicted in Fig. 17) such that the rod may be manipulated externally to actuate the anchor 210.

[0056] In some examples, the anchor 210 may be formed from rigid or at least partially rigid materials including, but not limited to, polytetrafluoroethylene (PTFE), polyurethane, silicone, nylon, nitinol, braided stainless steel, polycarbonate, and the like. In some embodiments, the anchor 210 may be formed from the same material as the body 202 or may be formed from different materials. In some examples, the anchor 210 may have a length ranging between 1 mm and 2 cm. In some examples, the anchor 210 may have a width ranging between 0.5 mm and 2 cm. In some examples, the rotation of the anchor 210 may utilize any other actuation mechanism known to one of skill in the art. In some examples, the device 200 may further comprise a backstop configured such that the vessel wall may be compressed between the anchor 210 and the backstop to more securely retain the device 200 within the vessel 20.

[0057] In some examples, the devices and methods disclosed herein may be utilized to provide bidirectional access to a body vessel (i.e. both antegrade and retrograde access) via a single access site. For example, the disclosed devices and methods may be utilized for access into a blood vessel, an artery, a vein, a graft, a fistula, and the like. In some examples, the disclosed device and method allows for the use of a single access site for hemodialysis procedures. Thisminimizes the risk of pseudoaneurysm development, aneurysm development, thrombosis, bleeding, or stenosis that may lead to failure of access in the future. The devices and methods disclosed herein may also be utilized to occlude a vessel at a desired location for diagnostic or therapeutic interventions within the vessel, while preventing complications in other areas of the vessel.

[0058] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

CLAIMSWhat is claimed is:

1. A vascular sheath device comprising:a tubular body with a proximal and a distal opening and a lumen therebetween; an anchor positioned at the distal end and configurable between an unexpanded and an expanded configuration;a flange surrounding the distal opening; anda backstop movably connected at the proximal end.

2. The device of claim 1, wherein the anchor is a balloon configurable between an unexpanded and an expanded configuration.

3. The device of claim 1, wherein the anchor comprises one or more structures extending radially from the outer diameter of the distal end of the tubular body when in the expanded configuration, wherein the one or more structures are configured to lie flat against the tubular body when in the unexpanded configuration.

4. The device of claim 1 , wherein moving the anchor from the unexpanded to the expanded configuration increases its diameter by 1.25x - 2x.

5. The device of claim 1, wherein the anchor comprises an elastic, flexible or distensible material.

6. The device of claim 1, wherein the anchor comprises a rigid material.

7. The device of claim 1, wherein the flange is configurable between an unexpanded and an expanded configuration.

8. The device of claim 1, wherein the backstop is configured to move along the length of the tubular body.

9. The device of claim 8, wherein the backstop is configured to move through a distance ranging between about 1 cm and 5 cm.

10. The device of claim 1, wherein a compressive force is applied between the anchor and the backstop.

11. The device of claim 10, wherein the compressive force ranges between 0 to 20 lbs.

12. The device of claim 1, wherein the tubular body is made of a material selected from the group consisting of plastics, metals, metal alloys, polycarbonate, polyethylene, polylactic acid (PLA), and polyether ether ketone (PEEK).

13. The device of claim 1, wherein the flange is made of a material selected from the group consisting of: silicone, rubber, and soft polymers.

14. The device of claim 1, wherein the tubular body has an outer diameter ranging between about 0.1 mm and 5 mm.

15. The device of claim 7, wherein the flange, in the expanded configuration, increases the inner diameter of the distal opening of the tubular body by about 0.1 mm and 5 mm.

16. The device of claim 1, further comprising one or more indicator elements positioned on the tubular body, wherein the one or more indicator elements are chosen from thegroup consisting of: radio-opaque markers, fluorescent markers, contrast agent markers, and any combinations thereof.

17. A method of utilizing a vascular sheath device, comprising: providing the vascular sheath device of claim 1;creating an opening within a tissue or vessel wall;inserting the tubular body into the opening while the anchor is in the unexpanded configuration;moving the anchor to the expanded configuration;moving the backstop in a distal direction to abut the opening; and inserting a medical instrument into the lumen of the tubular body.

18. The method of claim 17, wherein a compressive force is applied between the anchor and the backstop.

19. The method of claim 18, wherein the compressive force ranges between 0 to 20 lbs.

20. The method of claim 17, wherein the medical instrument is a guide, a wire, a catheter, a balloon catheter, or a stent.

21. The method of claim 18, further comprising:moving the anchor to the unexpanded configuration;moving the backstop in a proximal direction such that the compressive force on the tissue or vessel wall is removed; andremoving the tubular body from the opening in the tissue or vessel wall or adjusting the positioning of the tubular body.

22. A vascular sheath device, comprising:a tubular body having distal and proximal openings, and an inner lumen therebetween;a first and second lateral opening positioned on a distal end of the body, wherein the first and second openings are diametrically opposite each other; andan anchor pivotally connected to a distal end of the inner lumen and configurable between a first orientation and a second orientation.

23. The device of claim 22, wherein the anchor has an elliptical and annular shape.

24. The device of claim 22, wherein in the first orientation, the anchor diagonally spans the uppermost point of the edge of the first lateral opening and the lowermost point of the edge of the second lateral opening.

25. The device of claim 22, wherein in the second orientation, the anchor is horizontal, with each end extending through each lateral opening.

26. The device of claim 22, further comprising a rod operably connected to the anchor and disposed within a groove within the wall of the tubular body.

27. The device of claim 26, wherein the rod is slidable within the groove and configured such that sliding the rod in a first direction causes the anchor to move from the first orientation to the second orientation and sliding the rod in a second direction causes the anchor to move from the second orientation to the first orientation.

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