Distal Limb Perfusion Cannula Stents and Stent Cannula Covers

Abstract

Devices and methods are provided for minimizing and / or preventing limb ischemia, such as when a medical device inserted into a patient's vasculature occludes a blood vessel. The device may include a tubular member and a first anchor configured to maintain the position of the tubular member relative to the blood vessel. The first anchor is configured to be apposed to an inner wall of the blood vessel. A second anchor may cooperate with the first anchor to maintain the position of the tubular member relative to the blood vessel.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 340,352, filed May 10, 2023, and U.S. Provisional Patent Application No. 63 / 444,529, filed February 9, 2023, the contents of each of which are incorporated by reference in their entirety into this specification.

[0002] Technical Field

[0002] The present disclosure relates to methods, devices, and systems used to prevent limb ischemia resulting from the use of mechanical circulatory assist devices. [Background technology]

[0003] background

[0003] Limb ischemia is a rapid and sudden reduction in limb perfusion that often threatens the viability of the limb. It can result from blockage of blood by indwelling sheaths and / or catheters, localized occlusion (e.g., atherosclerotic stenosis), and / or persistent occlusion due to small vessels and / or large sheaths. It can also result from closure problems.

[0004]

[0004] Limb ischemia is associated with mortality, and some literature suggests that the rates of limb ischemia may be high, which not only negatively impacts patients, but may also negatively impact ongoing clinical trials. Summary of the Invention [Means for solving the problem]

[0005] overview In various aspects, a device may be provided. The device may include a tubular member configured to extend at least partially into a blood vessel of a patient. The device may include a first anchor coupled to the tubular member and configured to maintain a position of the tubular member relative to the blood vessel. The first anchor may be configured to be apposed to an inner wall of the blood vessel.

[0006]

[0006] The first anchor may include a delivery configuration and a deployed configuration. In the deployed configuration, the first anchor may have a diameter larger than an opening of the vessel through which the tubular member extends into the vessel. The first anchor may include a plurality of fingers. The first anchor may be attached to or near a distal end of the tubular member. The first anchor may include a foot plate. The first anchor may include a nitinol braid and / or polymer configured to expand in the deployed configuration. The first anchor may include an inflatable balloon. The inflatable balloon may be operably coupled to a fluid source. The first anchor may be configured to atraumatically appose an inner wall of the vessel. When the first anchor is in the deployed configuration, the first anchor may be configured to be oriented perpendicular to a central axis of the tubular member.

[0007]

[0007] The tubular member may include a cannula or a sheath.

[0008]

[0008] The device can include a second tubular member disposed along the tubular member. The second tubular member can be operably coupled to the first anchor for moving the first anchor from the delivery configuration to the deployed configuration.

[0009]

[0009] The device may include a second anchor. The second anchor may be configured to be disposed on an exterior surface of a blood vessel. The first anchor and the second anchor may cooperate to hold the tubular member against the blood vessel. The second anchor may include a suture pad. The second anchor may include an expandable tip. The second anchor may include a nitinol braid or a polymer.

[0010]

[0010] The first and second anchors can clamp or sandwich the blood vessel to secure the tubular member to the blood vessel. The first and second anchors can include the same features. The first and second anchors can include different features.

[0011]

[0011] In various aspects, a device may be provided. The device may include an anchor configured to maintain a position of a tubular member relative to a blood vessel. The anchor may be positionable within the blood vessel. The anchor may include a proximal anchor portion configured to engage subcutaneous tissue. The anchor may include a distal anchor portion configured to be apposed to an inner wall of the blood vessel.

[0012]

[0012] The distal anchor portion may include one or more fingers. The distal anchor portion may include a foot plate. The distal anchor portion may include one or more barbs. The proximal anchor may include one or more barbs. The barb or barbs of the proximal anchor may be sharper than the barb or barbs of the distal anchor. Each of the distal and proximal anchors may include an atraumatic disc.

[0013] In various aspects, a method may be provided. The method may include inserting a tubular member into a blood vessel of a patient via an access site. The tubular member may extend at least partially into the blood vessel. The method may include retaining a position of the tubular member relative to the blood vessel with a first anchor. The first anchor may be configured to be apposed to an inner wall of the blood vessel.

[0014]

[0014] The method may include inserting a medical device into a patient through a tubular member. The method may include inserting a first anchor into a vascular system in a delivery configuration before a holding step. The method may include moving the first anchor into a deployed configuration before a holding step, where a diameter of the first anchor in the deployed configuration may exceed a diameter of an opening through which the tubular member is inserted into a blood vessel.

[0015]

[0015] The method may include returning the first anchor to a delivery configuration and removing the tubular member and the first anchor from the patient's blood vessel.

[0016]

[0016] The retaining step may include retaining the position of the tubular member relative to the blood vessel with a first anchor and a second anchor. The second anchor may be positioned outside the blood vessel. The first and second anchors may cooperate with each other to retain the position of the tubular member relative to the blood vessel.

[0017]

[0017] The retaining step may include clamping or sandwiching the blood vessel between a first and a second anchor. The first anchor may include a distal anchor portion and a proximal anchor portion. The distal anchor portion may be configured to appose an inner wall of the blood vessel. The proximal anchor portion may be configured to engage subcutaneous tissue. [Brief description of the drawings]

[0018] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1] FIG. 1 is a drawing of a sheath with an arteriotomy locating feature and blood holes. [Diagram 2]

[0019] 1 is a diagram of a mispositioned (proximal) hole. [Diagram 3]

[0020] 1 is a diagram of a mispositioned (distal) hole. [Figure 4]

[0021] 1 is a drawing of a retracted sheath window. [Diagram 5]

[0022] 1 is a diagram of a device secured within an artery. [Figure 6]

[0023] FIG. 1 is a drawing of a soft distal tip showing its beginning (solid line) and ending (dotted line) expansion. [Figure 7]

[0024] 1 is a diagram of a device secured to an artery. [Figure 8]

[0025] 1 is a drawing of a sheath with a footplate. [Figure 9]

[0026] 1 is a drawing of a feature for securing a sheath. [Figure 10]

[0027] 1 is a drawing of Nitinol with coating features. [Figure 11A]

[0028] 13A-13C are diagrams showing the state of the expansion feature for identifying the location of the arteriotomy. [Figure 11B]

[0028] FIG. 1 shows the state of an expansion feature that identifies the location of an arteriotomy. [Figure 12]

[0029] 13A-13C are diagrams showing inner and outer shafts with varying feature shapes. [Figure 13A]

[0030] Photograph showing braid / TPU disposed on a midshaft in an unexpanded state. [Figure 13B]

[0030] Photograph showing braid / TPU disposed on midshaft in expanded state. [Figure 13C]

[0030] Photograph showing braid / TPU placed on midshaft near hole. [Figure 14A]

[0031] Photograph showing the tip braid / TPU in an unexpanded state. [Figure 14B]

[0031] Photograph showing the tip braid / TPU in an expanded state. [Figure 15A]

[0032] 1 shows an embodiment having distal and proximal anchors. [Figure 15B]

[0033] FIG. 13 is a profile view of an embodiment of an extended feature configuration. [Figure 15C]

[0033] FIG. 11 is a profile diagram of an embodiment of an extended feature configuration. [Figure 15D]

[0033] FIG. 11 is a profile diagram of an embodiment of an extended feature configuration. [Figure 16A]

[0034] 1A-1C are diagrams of embodiments of extended feature configurations. [Figure 16B]

[0035] An example of a double-hook design is shown (see perspective and cross-sectional views in Figs. 16B-16P). [Figure 16C] An example of a double barb design is shown. [Figure 16D] An example of a double barb design is shown. [Figure 16E] An example of a double barb design is shown. [Figure 16F] An example of a double barb design is shown. [Figure 16G] An example of a double barb design is shown. [Figure 16H] An example of a double barb design is shown. [Figure 16I] An example of a double barb design is shown. [Figure 16J] An example of a double barb design is shown. [Figure 16K] An example of a double barb design is shown. [Figure 16L] An example of a double barb design is shown. [Figure 16M] An example of a double barb design is shown. [Figure 16N] An example of a double barb design is shown. [Figure 16O] An example of a double barb design is shown. [Figure 16P] An example of a double barb design is shown. [Figure 17A]

[0036] Shows a double crush design. [Figure 17B]

[0036] A double crush design is shown. [Figure 18A]

[0037] 13 is an image showing an additional embodiment of an anchor. [Figure 18B]

[0037] An image showing an additional embodiment of an anchor. [Figure 19A]

[0038] 1 illustrates an embodiment of a method of using the anchored device. [Figure 19B] 1 illustrates an embodiment of a method of using an anchored device. [Figure 19C] 1 illustrates an embodiment of a method of using an anchored device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Detailed Description

[0039] As is known, limb ischemia is a rapid and sudden decrease in a patient's limb perfusion, which may occur due to blockage of blood by an indwelling sheath and / or catheter, localized occlusion (e.g., atherosclerotic stenosis), and / or continuous occlusion due to small blood vessels and / or large sheaths. Limb ischemia may also occur as a result of closure problems. To overcome such instances of limb ischemia, clinicians may need to allow and / or create a pathway for flow through and / or around the sheath to deliver oxygenated blood to the patient's distal limb.

[0020]

[0040] Currently, there are few solutions on the market to address ischemia in the distal limb, such as when using larger diameter catheters or introducers in the arteries. For example, today's introducer systems typically do not allow for placement and removal of the device from the vasculature without the need for a significant solution to address bleeding at the arteriotomy site. Such a solution would provide a way for the physician to place a larger diameter device, such as the IMPELLA® heart pump, through the introducer and then pull back the introducer, allowing blood flow to reach the distal limb while the arteriotomy remains sealed.

[0021]

[0041] Currently, physicians can pull back conventional introducer systems under fluoroscopic guidance until only the tip penetrates the vessel wall, but because no anchor is in place, there is a significant risk that the sheath tip will withdraw from the vessel, causing bleeding and even death. Many patients receiving IMPELLA® heart pumps or other devices are transferred from the cath lab to the ICU where they may receive extended support. In this environment, the introducer may not be monitored and stability of its position is critical.

[0022]

[0042] The inventors have recognized the advantages of a sheath (e.g., an introducer sheath) that does not occlude or can be substantially removed from a blood vessel while still maintaining a connection, such as via fixation features (e.g., anchors). In some embodiments, the sheath can be configured to permit flow through and / or around the sheath to deliver oxygenated blood to a distal limb of a patient.

[0023]

[0043] In view of the above, the disclosed solutions may provide a means to allow a clinician (e.g., physician) to position the distal tip of the sheath relative to a vascular arteriotomy, such as by an anchor. The disclosed solutions may also provide a means to secure the sheath to the vessel, such as via an anchor. As will be appreciated, the anchor may include a delivery configuration (e.g., for inserting the sheath into the vessel) and a deployed configuration in which the anchor secures the sheath to the vessel. In some embodiments, the solution may allow the vessel to be fixed in place by clamping against the arterial wall from the inside and outside. In some embodiments, the anchor may include a nitinol braid, a balloon, and / or a footplate that may move between a delivery configuration and a deployed configuration.

[0024]

[0044] In yet other embodiments, the solutions described herein may provide a way for the clinician to remove the sheath at the end of the procedure without requiring a full surgical cut procedure. For example, the physician may first remove the catheter from the introducer shaft, then return the anchor to the delivery configuration and allow the introducer shaft (and anchor) out of the patient. In embodiments, the anchor may be retracted to allow the sheath to return to a generally tubular shape. In an exemplary embodiment, the anchor may include a nitinol braid that may return to a tubular shape, a balloon that may return to a tubular shape, and / or a footplate that may be inwardly collapsible and allow the physician to withdraw the device from the anatomy.

[0025]

[0045] In some embodiments, the anchor may be located at or near the distal tip of an introducer sheath into which a mechanical circulatory assist device ("MCS"), such as a percutaneous blood pump, may be inserted. In other embodiments, the anchor may be included in an accessory sheath, such as a repositioning sheath, that engages the introducer sheath to secure the introducer sheath and repositioning sheath to the vasculature. In such embodiments, the repositioning sheath may be located within the introducer sheath. In such embodiments, the repositioning sheath may help occlude the space between the MCS and the introducer sheath, preventing blood stagnation and clot formation at such locations.

[0026]

[0046] Also disclosed herein are other aspects of forming a flow path around the sheath to deliver oxygenated blood to a patient's distal limb. For example, in conventional systems, a sheath or other tubular member may be configured with a small window to facilitate placement of a hole so that blood may flow from the tip of the sheath, through the sheath body, and through the hole to the distal artery. As will be appreciated in such instances, if the hole is aligned too proximally outside the artery, the patient may bleed into the subcutaneous tissue. If the hole is aligned too distally, blood will not flow against the vessel wall.

[0027]

[0047] Differences in patient anatomy (vessel size, vessel depth) can make it difficult to design an all-inclusive solution. The size of the window that the hole must be in creates conditions where slight misplacement by the physician or movement of the sheath over time due to patient movement or site maintenance (cleaning, flushing, etc.) can cause one of the failure conditions listed above.

[0028]

[0048] Turning now to the figures, Figures 1-3 illustrate the challenges that may be experienced when attempting to safely and reliably place features that allow distal flow within a very small "window" to avoid serious bleeding complications when patients have a variety of anatomical exits. As shown in these figures, a sheath 100 may be positioned within a patient's vasculature 102 (e.g., an artery) with features 104 configured to locate the arteriotomy and prevent the sheath from exiting further. Distal is a hole 106 that may allow blood coming from a proximal artery to enter the tip of the sheath, pass through the sheath, exit the hole, and flow into the distal artery. A window 105 indicates the location of the hole 106 relative to the arteriotomy that allows for effective use. As will be appreciated in these instances, the sheath may completely occlude the vessel even when properly placed in the vasculature.

[0029]

[0049] As seen in Figure 2, a mispositioned (proximal) hole 106 can cause the hole to exit the artery and blood to flow into the subcutaneous tissue (see arrows) instead of into the distal artery, potentially causing a hematoma. As seen in Figure 3, a mispositioned (distal) hole 106 can cause the hole to advance too far into the artery and against the vessel wall, preventing blood from flowing to the sheath tip, through the sheath shaft, and out the hole (see arrows), causing acute limb (e.g., leg, arm, etc.) ischemia.

[0030]

[0050] As understood by the inventors, there is a small window of error when attempting to perfectly position the sheath tip inside the vessel: if the tip is too proximal, blood will ooze from the arteriotomy into the subcutaneous tissue; if the tip is too forward, the sheath tip will be against the vessel wall, blocking blood flow and potentially causing vessel injury.

[0031]

[0051] As seen in Figure 4, the sheath 100 can be positioned such that access and hemostasis are maintained and blood flows through the sheath (see left sheath). If the sheath 100 is retracted too far, access will be lost and blood may leak out of the arteriotomy into the subcutaneous tissue, causing a hematoma (see center sheath). If the sheath 100 is pushed too far forward, it may block blood flow (e.g., by contacting the wall of the vasculature) and cause acute limb ischemia (see right sheath).

[0032]

[0052] In view of the above, the inventors have recognized the advantage of a device that allows for stable and reliable placement of a sheath relative to an arteriotomy to enhance perfusion of the distal limb. In some embodiments, the device may include an anchor, which may include one or more features, such as one or more mechanical features for positioning the sheath relative to the arteriotomy and for holding the position of the sheath relative to the arteriotomy. In some embodiments, the anchor may provide user feedback so that the user knows the position of the sheath relative to the arteriotomy. In some embodiments, the anchor may include a set of mechanical features, one of which is positioned intraluminally and a second of which is positioned extraluminally. In such embodiments, the features may prevent acute limb ischemia by maintaining distal perfusion to the periphery.

[0033]

[0053] First Mechanical Feature (Intraluminal)

[0034]

[0054] A first mechanical feature, anchor 108, may be on the shaft of sheath body 100 (e.g., at the distal end) and may be configured to locate an arteriotomy by actuating it to draw the sheath against the inner wall of the artery (see, e.g., FIG. 5). As will be appreciated, in such an embodiment, anchor 108 may be configured to have a delivery configuration such that the anchor may pass through the arteriotomy, and a deployed configuration in which the anchor has a cross-sectional area that exceeds the size of the arteriotomy, such that retracting the sheath may position the anchor in line with the inner wall of the artery (positioning the sheath in its desired location).

[0035]

[0055] In some embodiments, such as shown in Figure 5, the anchor may include a single mechanical feature. In other embodiments, as shown in Figure 6, the anchor may include one or more fingers 110a, 110b that may move between a delivery configuration (solid lines) and a deployed configuration (dashed lines). As will be appreciated, the fingers of the anchor may move to a deployed configuration once the sheath enters the vessel. In the deployed configuration, the fingers are configured to appose against the inner wall of the vessel and provide resistance.

[0036]

[0056] In some embodiments (see, e.g., FIGS. 13A-13C), the anchor 108 may include a nitinol braid and polymer that is a tube when free during insertion (see, e.g., the delivery configuration in FIG. 13A) and expands to a desired shape (e.g., to a deployed position) when axially compressed after delivery into a vessel (see, e.g., FIG. 13B). In some embodiments, the nitinol braid and polymer are set to a desired shape (pre-set shape) when in the deployed configuration and are held under tension or present within the shaft during insertion (e.g., when in the delivery configuration). In this regard, in some embodiments, the anchor may be configured to automatically expand from the delivery position to the deployed position upon insertion into a vessel. In other embodiments, the clinician may need to selectively expand the anchor to the delivery position (e.g., by moving a first portion of the sheath relative to a second portion of the sheath or by moving the sheath in a direction opposite to the insertion direction).

[0037]

[0057] As will be appreciated, the expanded region may have a diameter that exceeds the diameter of the arteriotomy and is configured to be apposed to the inner wall of the vessel at the arteriotomy. Although not shown, it will be appreciated that when the sheath 102 of Figures 13A-13C is properly positioned, the anchor is configured to be apposed to the vessel wall at the anastomosis. As shown in Figure 13C, the sheath may include an opening 112 disposed distally relative to the adjustable feature to allow blood flow through the sheath.

[0038]

[0058] In some embodiments, a laser cut Nitinol stent-like tube may be used in place of the braid described above. As will be appreciated, the Nitinol braid and / or the laser cut Nitinol stent may have any suitable configuration.

[0039]

[0059] Figures 14A and 14B show another example anchor having an expandable Nitinol region. In such an embodiment, the expandable region (seen in its deployed configuration in Figure 14B) is configured to reside near the distal tip such that there is little or no sheath extending into the vasculature. In some embodiments, the anchor (adjustable feature) may include 72 ends, 1x1, 75 μm wire (C26) w / cilbond, and Carbothane PC-3575 0.080 mm laminate extrusion. The outer shaft used to force the shape change is constructed from Pebax.

[0040]

[0060] In Figures 11A and 11B the state of the expansion feature for locating the arteriotomy can be seen. The sheath shaft 102 and the mechanical feature of the anchor 108 in the delivery state (for insertion) are shown where it lies as a flat tube (Figure 11A). The sheath shaft 102 and the mechanical feature of the anchor 108 in the delivery state (for locating the arteriotomy) are shown in Figure 11B where its length is compressed and reduced and its diameter is bulged and expanded (bottom).

[0041]

[0061] In FIG. 12, the inner and outer shafts for varying feature shapes can be seen. An inner sheath shaft 102 and an outer sheath shaft 103 can be included, as well as an anchor 108 for locating the arteriotomy. The anchor can be secured to the inner shaft 102 at its distal end (right side). The anchor can be secured to the outer shaft 103 at its proximal end (left side) so that it can slide along the inner shaft. The assembly can be seen in a delivery position, where the anchor lies flat. The outer shaft can then be slid distally (see arrow), compressing the anchor to reduce its length and increase its diameter. As can be seen, the anchor can be positioned to appose the inner wall of the vessel. As can be further seen, the inner shaft can act as an actuator to actuate the expansion from the delivery configuration to the deployed configuration.

[0042]

[0062] In some embodiments, the anchors (e.g., adjustable features) can be configured to atraumatically appose the inner surface of the vessel, hi some embodiments, the anchors can be configured to conform to the diameter of the vessel.

[0043]

[0063] In some embodiments, the anchors can be configured to be oriented perpendicular to the central axis of the inner sheath. In some embodiments, the anchors can be configured to be oriented at an angle of 30 to 60 degrees relative to the central axis of the inner sheath. In some embodiments, the anchors can be configured to be oriented at an angle of 45 degrees relative to the central axis of the inner sheath.

[0044]

[0064] In some embodiments, the anchor can be configured to expand to have an outer diameter of 8-10 mm. In some embodiments, the anchor can be configured to have a thickness of 0.4 mm or less when in a compressed state. In some embodiments, the anchor is fully reversible and compressible to a diameter less than the inner diameter of the pump sheath and configured to be removable through the pump sheath.

[0045]

[0065] In some embodiments, the inner sheath can have a maximum outer diameter of 5.05 mm or less, hi some embodiments, the inner sheath can have an inner diameter of 2.5 to 3.5 mm, for example 3.0 mm.

[0046]

[0066] In some embodiments, the first mechanical feature anchor 108 may include a shaped balloon that expands to a desired shape (e.g., to a delivery configuration) when pressurized with fluid. In such embodiments, the anchor may be fluidly coupled to a fluid source and positioned at or near the distal end of the sheath 100. As will be appreciated, as with other embodiments disclosed herein, the balloon may also be configured to appose an inner wall of the vasculature and may have a diameter that exceeds the diameter of the access opening.

[0047]

[0067] In yet other embodiments, the anchor may include a series of nitinol wires that may be movable again between a delivery location and a deployed configuration and configured to be apposed again to an inner wall of the patient's vasculature.

[0048]

[0068] In Figure 8, the device is shown being prevented from exiting the artery by a first anchor 108, which may include, for example, a foot plate having a cross-section larger than the arteriotomy. As will be appreciated, such a foot plate may include one or more mechanical features (e.g., fingers) that, once within the vessel, may be moved to a deployed configuration that may form a cross-section larger than the arteriotomy to hold the sheath against the arteriotomy. As will be appreciated, the foot plate may have any suitable shape.

[0049]

[0069] As will be appreciated, the first mechanical feature, anchor 108, can be located at various locations along the sheath. For example, the anchor can be at the tip of the sheath such that the sheath is substantially outside of the vessel while maintaining hemostasis and access. As will be appreciated, in some embodiments, this can allow for passage of a medical device (e.g., a mechanical circulatory assist device) into the patient while minimizing the amount of sheath that may extend into the vasculature (e.g., potentially causing an ischemic event). In other embodiments, the anchor can be mid-shaft of the sheath body, proximate to a distally adjacent hole (see, e.g., hole 112 in FIG. 13C) that allows blood to enter the sheath tip and flow through the hole to the distal artery.

[0050]

[0070] Second Mechanical Feature (Extraluminal)

[0051]

[0071] In some embodiments, the sheath body may include a second mechanical feature, i.e., a second lumen, that may be positioned extraluminally. In some embodiments, the second anchor may be configured to hold the sheath against the vessel. In some embodiments, the first and second anchors may cooperate to hold the sheath against the vessel at the arteriotomy. In this regard, the first and second anchors may have a press fit, snap fit, or other suitable engagement (e.g., an opening and a corresponding pin) to allow the first and second anchors to hold one another. As will be appreciated, the anchor need not include a second anchor as described above, but may instead be locked at the arteriotomy via only the first anchor.

[0052]

[0072] In some embodiments, the second mechanical feature may include a component, such as a suture pad, that is normally locked in place and that can be actively actuated (e.g., a button is pressed) to slide over the sheath body shaft and return to its normal locked-in-place configuration. In some embodiments, this component may be secured to the patient (e.g., via sutures).

[0053]

[0073] The second anchor may also include a tube with a soft, expandable tip that, when slid toward the first anchor and contacts the outer wall of the artery, widens / expands open to present the soft tip against the outer wall of the blood vessel.

[0054]

[0074] In yet another embodiment, the second anchor may comprise a nitinol braid and polymer that is a tube in its free state upon insertion and expands into the desired shape when axially compressed after being delivered extravascularly within the subcutaneous tissue.

[0055]

[0075] In some embodiments, the second anchor may include a nitinol braid and polymer that is set to a desired shape in its free state and held under tension during insertion.

[0056]

[0076] In yet other embodiments, a laser cut Nitinol stent-like tube may be used for the second mechanical feature. A shaped balloon may be used as the second mechanical feature, which can expand into a desired shape when pressurized with fluid after being delivered outside the blood vessel in the subcutaneous tissue. Similar to the first mechanical feature, the second mechanical feature may also be configured to move between a delivery configuration and a deployed configuration.

[0057]

[0077] As will be appreciated, the second anchor can be positioned in a variety of locations. For example, in some embodiments, the second mechanical feature can be on the sheath body shaft and have the purpose of fixing the sheath in place by providing a counter tension with the first mechanical feature. In some embodiments, the second mechanical feature can also be positioned proximally relative to the first mechanical feature and fix the sheath in place by "sandwiching" the vessel between the first and second mechanical features.

[0058]

[0078] In yet other embodiments, the second mechanical feature can be positioned proximally relative to the first mechanical feature, locking the sheath in place by "sandwiching" the skin / subcutaneous tissue / vessel between the first and second mechanical features. It will be appreciated that in some embodiments, the first and second mechanical features may have the same features and / or configurations (e.g., similar to those set forth above with respect to the first mechanical feature), although the first and second mechanical features may be different. It will be further appreciated that in some embodiments, the first and second mechanical features may also include first and second anchors (each including one or more mechanical features).

[0059]

[0079] As seen in Figure 5, a device such as that of Figure 3 may be shown inserted into an artery, where an embodiment of a first mechanical feature 108 is rounded to conform to the diameter of the artery. This may be secured in place by a second mechanical feature 114, which may include a tube with a soft expandable tip that conforms to the exterior surface of the artery. At this point, the device may be secured in place by "sandwiching" the artery between the first and second anchors.

[0060]

[0080] In Figure 7, the device is seen secured by inner and outer elements of the sheath (e.g., first and second anchors) that sandwich the artery to secure the device in place. As shown in this figure, the first and second anchors can have a configuration similar to the fingers shown in Figure 6 (e.g., fingers 110a, 110b of first anchor 108 and fingers 116a, 116b of second anchor 114), where the inner and outer fingers engage each other to hold the sheath against, for example, the blood vessel.

[0061]

[0081] In Figure 9, an embodiment of an anchor for securing the sheaths can be seen. In this embodiment, a first mechanical feature 108 with the distal end of the inner sheath shaft (Sheath A) and a second mechanical feature 114 with the distal end of the outer sheath shaft (Sheath B) can be seen. When each sheath shaft is retracted proximally, exposing the mechanical elements, they can deform into a preset shape.

[0062]

[0082] 10, an anchor having Nitinol with covering features is shown, where first mechanical feature 108 and second mechanical feature 114 are sheaths that sandwich the vessel wall and may include a pre-set flared Nitinol braid with a frame covering (e.g., ePTFE).

[0063]

[0083] Subcutaneous Anchor Design

[0064]

[0084] In some embodiments, as shown in FIG. 15A, the sheath 100 may be configured to include a proximal anchor 118 and a distal anchor 120. In such embodiments, the proximal anchor may be configured to engage subcutaneous tissue while the distal anchor is configured to appose the inner wall of the vessel to provide resistance. In this regard, the distal anchor 120 may include one or more of the configurations described above with respect to the first anchor 108. As will also be appreciated in view of the above, the proximal and distal anchors may also enable the anchors to maintain the position of the sheath 100 relative to the vessel throughout. In some embodiments, the proximal and distal anchors may enable the sheath to maintain a desired angle θ of the sheath relative to the patient. In some embodiments, the angle may be between 30° and 60°, for example, an angle of 45°.

[0065]

[0085] As can be seen from the views of Figures 15B, 15C, and 15D, the proximal and distal anchors can have a variety of different configurations. As can be seen, one or both of the anchors can have a similar design as described above with respect to the first and second anchors. For example, in 15B, the anchors can include a disk-barb design, where the distal anchor is configured to be atraumatic and has a shape set to conform to the vessel. The proximal anchor is an atraumatic bump. In some embodiments, the atraumatic bump can include an inflatable balloon. This shape can be retracted by passing another sheath over it, and the pulling force of various embodiments can be about 5N for retraction of the distal barb.

[0066]

[0086] In Figure 15B, a dual collapse design can be seen. In such an embodiment, both the distal and proximal anchors can include both atraumatic discs.

[0067]

[0087] In Figure 15C, the anchors may include a stent-disc design. For example, the distal anchor may include stent-like struts shaped to seat along the inner diameter of the vessel. The proximal anchor may include an atraumatic disc (which in other embodiments may be an expansion section).

[0068]

[0088] 16A-P show various examples of anchors 124 having proximal and distal anchor portions 126, 128, also referred to herein as a double anchor or dual barb design (some in perspective views and others in cross-sectional plan views). In some embodiments, the distal anchor (e.g., the distal barb) may be configured to be atraumatic and have a shape set to conform to the vessel. In some embodiments, the distal anchor may have multiple fingers movable between a delivery configuration and a deployed configuration. In some embodiments, the fingers may include elongated members that extend substantially parallel to the longitudinal axis of the anchor when in the delivery configuration. As will be appreciated, the fingers may all have the same configuration (e.g., length and shape), but the configuration of the fingers may vary from finger to finger. In some embodiments, the fingers may splay outwardly, away from the longitudinal axis of the anchor. In some embodiments, the first and second anchors may be integrally formed with one another, but may be joined in any suitable manner.

[0069]

[0089] As above, in the deployed configuration, the distal anchor may appose to the vessel wall. In contrast, the proximal barbs may be sharper and configured to engage (e.g., pierce) subcutaneous tissue, for example. The distal and proximal anchor portions may have any suitable configuration. In some embodiments, the anchors shown in these figures may be used as any of the first and / or second anchors disclosed herein.

[0070]

[0090] As will be appreciated, the anchors may be attached at different locations along the sheath, for example at or near the distal tip and / or in portions of the sheath near openings through which blood may flow.

[0071]

[0091] 17A and 17B also illustrate a dual collapse design. For example, as shown in this figure, both the distal and proximal anchors include an atraumatic section. As shown in FIGs. 17A and 17B, each of the anchors can be movable between a compressed delivery position and an expanded deployed position.

[0072]

[0092] FIG. 18A also shows additional embodiments of anchors. As shown in these FIG. 18A, in some embodiments, the anchors may include a stent-like footplate that may be placed at the distal end of the sheath. In some embodiments, the anchors may not only be used to hold the sheath against the vessel (see #1 and #2), but may also remain in the vessel after the sheath is removed for closure, e.g., to allow distal perfusion (see #3). In this regard, the footplate may include a membrane. It may also include a dose of collagen, e.g., to facilitate closure.

[0073]

[0093] 18A shows an example of rotational deployment of an anchor. As shown in this figure, the anchor can have a coiled configuration. It can also have one or more expandable sections.

[0074]

[0094] In the illustrated example (see FIGS. 19A-19C), to utilize some embodiments disclosed herein, a sheath may first be inserted over the dilator and the dilator removed. In such embodiments, the sheath straightens tortuous anatomical structures and / or bypasses calcification sites. Optionally, a medical device, such as a mechanical circulatory assist device (e.g., a percutaneous pump), may be inserted through the sheath and positioned in the appropriate location (e.g., within the ventricle). Once the sheath (and optional medical device) is in place, an anchor may be deployed. If the sheath can be retracted, it may be retracted at this point. The anchor may be apposed to the vessel. A second anchor may then be deployed to pinch the vessel and / or a subcutaneous barb may be deployed to lock the anchor in place. In some embodiments, a Touhy butterfly may then be advanced to secure the anchor with compression from the skin. In some embodiments, if the sheath is a distal perfusion sheath, the sheath may be oriented perpendicular to the centerline of the vessel or perpendicular to the skin surface. In some embodiments, the sheath can be oriented perpendicular to the centerline of the vessel or ±10 degrees from perpendicular to the surface of the skin.

[0075]

[0095] In another illustrated example, the device can include an introducer sheath that can be configured to have a first state that can be used, for example, for insertion of a sheath with a corresponding dilator to deliver a pump (e.g., an Impella® blood pump) through calcifications, tortuous sections, or other patient anatomy that would not otherwise allow passage of the pump.

[0076]

[0096] The first mechanical feature may be a nitinol braid concentrically disposed around the inner sheath body and at the distal tip. It may be fixed to the inner sheath body at its most distal portion. The proximal end of the mechanical feature may be fixed to an outer sheath shaft that may slide along the inner sheath shaft. The inner sheath shaft may have a liner (e.g., a PTFE liner) that may be coil reinforced and may have an outer jacket. It may be attached at its proximal end to a sheath hub that includes a hemostasis valve and a flushing side arm. The outer sheath shaft may be attached at its proximal end to a molded hub that is lockable in two positions. In the first state, it may be located in a proximal position adjacent to the distal side of the sheath hub of the inner shaft.

[0077]

[0097] The second mechanical feature may be a catheter lock including a housing, a spring-loaded button, a locking tube, and a suture pad. It may be concentrically disposed between the proximal and distal ends of the outer shaft. In the first state, the button is not depressed so that the spring exerts a compressive force on the locking tube, securing the second mechanical feature to the outer sheath shaft. The second mechanical feature may be located proximally adjacent to the distal side of the molded hub of the outer sheath shaft. The introducer sheath occupies most or all of the cross-sectional area of ​​the lumen, allowing little or no flow through the sheath.

[0078]

[0098] The device may be configured to have a second state, which may be used, for example, to position a pump and initiate therapy. The sheath may be partially retracted from the artery with the distal tip still within the arterial lumen. The first mechanical feature may be actuated to pull the sheath under tension, such that the mechanical feature faces the vessel wall without being withdrawn. The second mechanical feature may be actuated and slid downward to press against the skin with a force, and may be deactuated to lock into place on the shaft, providing a counterforce against the first mechanical feature to lock the sheath in place. The shaped hub of the outer shaft may be moved forward to a second position where it is locked in place. The first feature may be shortened in length and enlarged in diameter. The introducer sheath occupies a limited luminal cross-sectional area, and sufficient distal perfusion passes through the sheath.

[0079]

[0099] The device may be configured to have a third state, which may be used, for example, when treatment is completed and the user removes the pump from the sheath. A wire to maintain access may be inserted into the sheath. The first mechanical feature may be returned to an unexpanded state and the sheath may be removed. The arteriotomy is closed with standard procedures (manual compression, vascular closure device, etc.). The hub of the outer shaft may be moved distally to a first position where it is locked in place. The length of the first feature may return to its original length and the diameter may return to substantially its original diameter.

[0080]

[0100] Although embodiments are shown and described in which the anchor and / or first and second mechanical features may be included on an introducer (e.g., an introducer sheath for inserting a medical device), in some embodiments the anchor may instead be formed on another accessory, such as a repositioning sheath configured to engage with the introducer sheath.

[0081]

[0101] In some embodiments, as shown in FIG. 19A during a pre-deployment stage, a self-expandable pre-formed anchor can be positioned at the distal end of an inner sheath (e.g., a repositioning sheath). The inner sheath can include an anchor protector sleeve disposed around the anchor and optionally a portion of the inner sheath. As will be appreciated, the anchor protector sleeve may not be slidable within the hub and introducer (e.g., pump) sheath.

[0082]

[0102] During deployment, the repositioning sheath can be pushed into the pump sheath as shown in FIG. 19B. The anchor protector sleeve bridges the anchor through the pump sheath's hemostatic valve, but the anchor protector sleeve does not enter the pump sheath body. The anchor self-deploys as it is pushed out of the pump sheath tip. The repositioning sheath is then pulled back slightly (proximally) to ensure that the anchor is held taut against the pump sheath tip. Once the anchor is deployed, the repositioning sheath position can be locked by locking features at the pump sheath hub. The pump sheath can then be retracted until resistance is felt indicating that the anchor is apposed to the inner vessel wall. In some embodiments, the adjustable butterfly can be pushed forward against the skin and then sutured in place to hold the pump sheath in place.

[0083]

[0103] The anchors can be de-deployed by retracting the repositioning sheath.

[0084]

[0104] The embodiments of the present disclosure will be described in detail with reference to the figures in which like reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. Well-known functions or structures are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for claims and as a representative basis for teaching those skilled in the art to employ the present disclosure in various ways in substantially any appropriately detailed structure.

Claims

1. A tubular member configured to extend at least partially into the patient's blood vessels, A first anchor, which is connected to the tubular member and configured to maintain the position of the tubular member relative to the blood vessel, wherein the first anchor is configured to be positioned alongside the inner wall of the blood vessel. A device that includes this.

2. The device according to claim 1, wherein the first anchor includes a delivery configuration and a deployment configuration, and in the deployment configuration, the first anchor has a diameter larger than the opening of the blood vessel through which the tubular member extends into the blood vessel.

3. The device according to claim 1, wherein the first anchor includes a plurality of fingers.

4. The device according to claim 1, wherein the first anchor is attached to the distal end of the tubular member or near thereto.

5. The device according to claim 1, wherein the first anchor comprises (i) a footplate, (ii) a nitinol braid and / or polymer configured to spread out into a deployable configuration, or (iii) an inflatable balloon.

6. The device according to claim 1, further comprising a second tubular member arranged along the tubular member, the second tubular member being operably coupled to the first anchor in order to move the first anchor from a delivery configuration to a deployment configuration.

7. The device according to claim 1, wherein the first anchor is configured to be placed alongside the inner wall of the blood vessel in a non-traumatic manner.

8. The device according to claim 1, wherein when the first anchor is in a deployed configuration, the first anchor is configured to be oriented perpendicular to the central axis of the tubular member.

9. The device according to claim 1, wherein the tubular member includes a cannula or a sheath.

10. The device according to claim 1, further comprising a second anchor configured to be positioned on the outer surface of the blood vessel, wherein the first anchor and the second anchor cooperate to hold the tubular member with respect to the blood vessel.

11. The device according to claim 10, wherein the second anchor comprises (i) a suture pad, (ii) an expandable tip, or (iii) a nitinol braid or polymer.

12. The device according to claim 10, wherein the first anchor and the second anchor clamp or hold the blood vessel in order to hold the tubular member with respect to the blood vessel.

13. The device according to claim 10, wherein the first anchor and the second anchor include the same feature portion.

14. The device according to claim 10, wherein the first anchor and the second anchor include different feature portions.

15. A device comprising an anchor configured to hold the position of a tubular member relative to a blood vessel, wherein the anchor is positionable within the blood vessel, A proximal anchor portion configured to engage with subcutaneous tissue, A distal anchor portion configured to be positioned alongside the inner wall of the aforementioned blood vessel, A device that includes this.

16. The procedure involves inserting a tubular member into a patient's blood vessel through an access site, wherein the tubular member extends at least partially into the blood vessel. The position of the tubular member relative to the blood vessel is maintained by a first anchor, wherein the first anchor is configured to be positioned alongside the inner wall of the blood vessel. A method that includes this.

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