Far-end limb perfusion cannula support and support cannula cover

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 obstructs a blood vessel. The device may include a tubular member and a first anchor configured to maintain a position of the tubular member relative to a blood vessel. The first anchor is configured to apposition an inner wall of a blood vessel. The second anchor may cooperate with the first anchor to maintain a position of the tubular member relative to the blood vessel.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 340,352, filed on May 10, 2023, and U.S. Provisional Application No. 63 / 444,529, filed on February 9, 2023, the contents of each of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure relates to methods, devices, and systems for preventing limb ischemia, such as that resulting from the use of a mechanical circulatory support device. Background Art

[0004] Limb ischemia is a rapid and sudden decrease in limb perfusion, often threatening the vitality of the limb. It may occur due to blood obstruction caused by indwelling sheaths and / or catheters, partial occlusions (e.g., atherosclerotic stenosis), and / or continuous occlusions caused by small vessels and / or large sheaths. It may also occur due to closure problems.

[0005] Limb ischemia is associated with mortality, and some literature suggests that the rate of limb ischemia may be high. Therefore, in addition to the negative impact on patients, it may also have a negative impact on ongoing clinical trials. Summary of the invention

[0006] In various aspects, a device may be provided. The device may include a tubular member configured to extend at least partially into a patient's blood vessel. 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 juxtaposed to an inner wall of the blood vessel.

[0007] The first anchor may include a delivery configuration and an expanded configuration. In the expanded configuration, the first anchor may have a diameter greater than the opening of the blood vessel through which the tubular member extends into the blood vessel. The first anchor may include a plurality of fingers. The first anchor may be attached at or near the distal end of the tubular member. The first anchor may include a base plate. The first anchor may include a nitinol braid and / or a polymer configured to open into an expanded 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 be atraumatically apposed to the inner wall of the blood vessel. When the first anchor is in the expanded configuration, the first anchor may be configured to be oriented perpendicular to the central axis of the tubular member.

[0008] The tubular member may include a cannula or a sheath.

[0009] The device may include a second tubular member disposed along the tubular member. The second tubular member may be operably coupled to the first anchor to move the first anchor from the delivery configuration to the deployed configuration.

[0010] The device may include a second anchor. The second anchor may be configured to be placed on an outer surface of a blood vessel. The first anchor and the second anchor may cooperate to hold the tubular member to 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.

[0011] The first anchor and the second anchor may clamp or grip the vessel to hold the tubular member to the vessel. The first anchor and the second anchor may include the same features. The first anchor and the second anchor may include different features.

[0012] 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 positioned 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 juxtaposed with an inner wall of the blood vessel.

[0013] The distal anchor portion may include one or more fingers. The distal anchor portion may include a base plate. The distal anchor portion may include one or more barbs. The proximal anchor may include one or more barbs. The one or more barbs of the proximal anchor may be sharper than the one or more barbs of the distal anchor. Each of the distal anchor and the proximal anchor may include an atraumatic disc.

[0014] In various aspects, a method may be provided. The method may include inserting a tubular member into a patient's blood vessel through an access site. The tubular member may extend at least partially into the blood vessel. The method may include maintaining the position of the tubular member to the blood vessel via a first anchor. The first anchor may be configured to juxtapose an inner wall of the blood vessel.

[0015] The method may include inserting the medical device into the patient via the tubular member. The method may include, prior to the holding step, inserting the first anchor into the vasculature in a delivery configuration. The method may include, prior to the holding step, moving the first anchor to an expanded configuration, wherein the diameter of the first anchor in the expanded configuration may be greater than the diameter of the opening through which the tubular member is inserted into the blood vessel.

[0016] The method may include returning the first anchor to the delivery configuration and removing the tubular member and the first anchor from the patient's vessel.

[0017] The holding step may include holding the position of the tubular member to the blood vessel via the first anchor and the second anchor. The second anchor may be positioned on the outside of the blood vessel. The first anchor and the second anchor may cooperate with each other to hold the position of the tubular member to the blood vessel.

[0018] The holding step may include clamping or clamping the blood vessel between the first anchor and the second anchor. The first anchor may include a distal anchor portion and a proximal anchor portion. The distal anchor portion may be configured to be juxtaposed with the inner wall of the blood vessel. The proximal anchor portion may be configured to engage with subcutaneous tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 is an image of a sheath with an arteriotomy locating feature and a hole for blood.

[0020] Figure 2 is a diagram of a dislocated (proximal) hole.

[0021] Figure 3 is a diagram of a dislocated (distal) hole.

[0022] Figure 4 is a picture of the retracted sheath window.

[0023] Figure 5 is a diagram of a device secured in an artery.

[0024] Figure 6 is a diagram of the soft distal tip showing its beginning (solid line) and ending (dashed line) expansion.

[0025] Figure 7 is a diagram of a device secured in an artery.

[0026] Figure 8 is a diagram of a sheath tube having a base plate.

[0027] Fig. 9 is a diagram of features used to secure the sheath.

[0028] Fig.10 is a diagram of Nitinol with covered features.

[0029] Fig.11A and 11B is a diagram showing the state of the expansion feature used to locate the arteriotomy.

[0030] Fig.12 is a diagram showing the inner and outer axes of a changing characteristic shape.

[0031] Figures 13A-13C are photographs showing the braid / TPU in the middle of the shaft unexpanded (13A), expanded (13B), and near the hole (13C).

[0032] Figures 14A-14B are photographs showing the braid / TPU at the tip unexpanded (14A) and expanded (14B).

[0033] Fig.15A An embodiment having a distal anchor and a proximal anchor is shown.

[0034] Figures 15B-15D are outline diagrams of embodiments of different expansion feature configurations.

[0035] Fig.16A is a diagram of an embodiment of an expanded feature configuration.

[0036] Figure 16B-16P Various examples of double barb designs are shown (some in perspective and others in cross-sectional plan views).

[0037] Fig.17A and 17B A dual extrusion design is shown.

[0038] Fig.18A and Fig.18B are images showing additional embodiments of anchors.

[0039] Figures 19A-19C is a graphic depiction of an embodiment of a method for using a device having an anchor. DETAILED DESCRIPTION

[0040] As is well known, limb ischemia is a rapid and sudden decrease in perfusion to a patient's limb, which may occur due to blood obstruction caused by an indwelling sheath and / or catheter, partial occlusion (e.g., atherosclerotic stenosis), and / or continuous occlusion caused by a small vessel and / or large sheath. Limb ischemia may also occur due to closure problems. To overcome this condition of limb ischemia, clinicians may need to allow and / or create a path for flow through and / or around the sheath to deliver oxygenated blood to the patient's distal limb.

[0041] There are not many solutions on the market today to address distal limb ischemia, such as when a larger diameter catheter or introducer is used in an artery. For example, today's introducer systems typically do not allow for placement and removal of devices from the vasculature without requiring a significant solution to the bleeding at the arteriotomy site. Such solutions provide a way for physicians to place a larger bore device, such as an IMPELLA® heart pump, through an introducer and then pull the introducer back to allow blood flow to the distal limb while still sealing at the arteriotomy site.

[0042] Currently, physicians can pull back conventional introducer systems under fluoroscopy until only the tip is through the vessel wall, however, no anchor is in place. There is a significant risk of the sheath tip being pulled out of the vessel, resulting in bleeding and possible death. Many patients with IMPELLA® heart pumps or other devices may be sent from the catheterization lab to the ICU, where they may be supported for extended periods of time. In these settings, introducers may not be monitored, and their positional stability is important.

[0043] The inventors have recognized the benefits of a sheath (e.g., an introducer sheath) that does not occlude a blood vessel or can be substantially removed from a blood vessel while still remaining connected, such as via a fixation feature (e.g., an anchor). In some embodiments, the sheath can be configured to allow flow through and / or around the sheath to deliver oxygenated blood to a distal limb of a patient.

[0044] In view of the above, the disclosed solution can provide a means for allowing a clinician (e.g., a doctor) to position the distal tip of the sheath relative to the arteriotomy of a blood vessel, such as by an anchor. The disclosed solution can also provide a device such as fixing the sheath to the blood vessel via an anchor. It is understood that the anchor can include a delivery configuration (e.g., for inserting the sheath into the blood vessel) and an expanded configuration, in which the anchor fixes the sheath to the blood vessel. In some embodiments, the solution can allow the blood vessel to be fixed in place by clamping the blood vessel against the arterial wall from the inside and outside. In some embodiments, the anchor can include a nitinol braid, a balloon, and / or a base plate that can move between a delivery configuration and an expanded configuration.

[0045] In other embodiments, the solution described herein can provide a kind of mode that removes sheath at the end of operation without complete surgical cutting operation for clinicians.For example, the doctor can first remove the catheter from the introducer shaft, and the anchor can return to the delivery configuration afterwards, thereby allowing the introducer shaft (and the anchor to be taken out from the patient's body).In one embodiment, the anchor can be retracted so that the sheath can return to a roughly tubular shape.In an illustrative embodiment, the anchor can include a nitinol braid that can be restored to a tubular shape downwards, a balloon that can be contracted downwards to a tubular shape and / or a base plate that can be folded inwards, thereby allowing the doctor to pull the device from the anatomical structure.

[0046] In some embodiments, the anchor can be disposed at or near the distal tip of the introducer sheath through which a mechanical circulatory support device ("MCS"), such as a percutaneous blood pump, can be inserted. In other embodiments, the anchor can be included on an auxiliary sheath, such as a repositioning sheath, which can engage with the introducer sheath to secure the introducer sheath and the repositioning sheath to the vascular system. In such embodiments, the repositioning sheath can be placed inside the introducer sheath. In such embodiments, the repositioning sheath can help occlude the space between the MCS and the introducer sheath, which can prevent blood stagnation and clot formation in such a position.

[0047] Other ways of creating a flow path around a sheath to deliver oxygenated blood to a patient's distal limb are also disclosed herein. For example, in conventional systems, a sheath or other tubular member may be configured with a small window to facilitate placement of an aperture so that blood can flow from the tip of the sheath through the sheath body and out of the aperture to a distal artery. As will be appreciated in such an example, if the aperture is aligned too far proximally outside the artery, the patient may bleed into the subcutaneous tissue. If the aperture is aligned too far distally, it will abut against the vessel wall and blood will not be able to flow.

[0048] Differences in patient anatomy (vessel size, vessel depth) can make it difficult to design an integrated solution. The size of the window in which the hole must be located is such that the slightest misalignment by the physician or migration of the sheath over time due to patient movement or site maintenance (cleaning, flushing, etc.) can result in one of the above failure scenarios.

[0049] Turning now to the accompanying drawings, Figures 1 to 3 Shown is the challenge that may be experienced when trying to position the distal flow-enabling feature safely and reliably in a very small "window" to avoid serious bleeding complications with different patient anatomical exits. As shown in these views, the sheath 100 can be positioned in the patient's vascular system 102 (e.g., artery) with a feature 104 configured to position the arteriotomy and prevent further dislocation of the sheath. The distal end is a hole 106 that allows blood to enter the tip of the sheath from the proximal artery, pass through the sheath, and flow out of the hole, through the sheath to the distal artery. Window 105 shows the position of the hole 106 relative to the arteriotomy that allows effective use. It can be understood that in this case, even if properly installed in the vascular system, the sheath can completely block the blood vessel.

[0050] like Figure 2 As shown, in the case of a misplaced (proximal) hole 106, the hole slips out of the artery and blood can flow (see arrow) into the subcutaneous tissue, causing a hematoma instead of flowing to the distal artery. Figure 3As shown, in the case of a misplaced (distal) hole 106, the hole is advanced too far into the artery, against the vessel wall, and does not allow blood to flow (see arrow) into the sheath tip, through the sheath shaft, and out of the hole, thereby causing acute limb (e.g., leg, arm, etc.) ischemia.

[0051] As the inventors appreciate, trying to position the sheath tip just perfectly inside the vessel provides a small window of error. If the tip is too close, blood will seep from the arteriotomy into the subcutaneous tissue. If it is too far forward, the sheath tip will rest against the vessel wall, blocking blood flow and possibly causing vessel damage.

[0052] like Figure 4 As shown, the sheath 100 can be positioned to maintain access and hemostasis and allow blood to flow through the sheath (see left sheath). If the sheath 100 is retracted too far, it may lose access and cause blood to flow out of the arteriotomy and into the subcutaneous tissue, resulting in a hematoma (see middle sheath). If the sheath 100 is pushed forward too far, it may block blood flow (e.g., by contacting the wall of the vasculature), which can cause acute limb ischemia (see right sheath).

[0053] In view of the foregoing, the inventors have recognized the advantages of a device that can safely and securely position a sheath relative to an arteriotomy to facilitate distal limb perfusion.

[0054] In some embodiments, the device may include an anchor that may include one or more features, such as one or more mechanical features, to position the sheath relative to the arteriotomy and maintain the position of the sheath relative to the arteriotomy. In some embodiments, the anchor may provide user feedback to allow the user to know 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 in the lumen and a second is positioned outside the lumen. In such embodiments, these features can prevent acute limb ischemia by maintaining distal perfusion of peripheral devices.

[0055] First mechanical feature (inside the cavity)

[0056] The first mechanical feature, anchor 108, can be located on the shaft of sheath body 100 (e.g., at the distal end) and can be configured to position the arteriotomy by actuating the arteriotomy and retracting the sheath against the inner wall of the artery (see, e.g., Figure 5 ). It will be appreciated that in such embodiments, the anchor 108 can be configured to have a delivery configuration in which the anchor can pass through the arteriotomy and a deployed configuration in which the anchor has a cross-sectional area that exceeds the size of the arteriotomy so that retracting the sheath can apposition the anchor to the inner wall of the artery (positioning the sheath in its desired position).

[0057] In some embodiments, Figure 5 As shown, the anchor may include a single mechanical feature. In other embodiments, such as Figure 6 As shown, the anchor may include one or more fingers 110a, 110b that can move between a delivery configuration (solid lines) and an expanded configuration (dashed lines). It will be appreciated that once the sheath is in the vessel, the fingers of the anchor may be moved into the expanded configuration. In the expanded configuration, the fingers may be configured to be juxtaposed and provide resistance against the inner wall of the vessel.

[0058] In some embodiments (see e.g. Figures 13A-13C ), the anchor 108 may include a nitinol braid and a polymer that is a tube when free during insertion (e.g., see Fig.13A delivery configuration) and expands upon axial compression after delivery into a vessel (e.g., in a deployed position) (see Fig. 13B ) to a desired shape. In some embodiments, the nitinol braid and polymer are set to a desired shape when in an expanded configuration (preset shape) and remain taut or reside within the shaft during insertion (e.g., in a delivery configuration). In this regard, in some embodiments, the anchor can be configured to automatically expand from a delivery position to an expanded position when inserted into a blood vessel. In other embodiments, the clinician may need to selectively expand the anchor to a 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).

[0059] It will be appreciated that the diameter of the expanded region may exceed the diameter of the arteriotomy and be configured to be juxtaposed to the inner wall of the blood vessel at the arteriotomy. Figures 13A-13C When the sheath 102 is properly positioned, the anchor is configured to be juxtaposed with the vessel wall at the anastomosis. Fig. 13C As shown, the sheath may include an opening 112 located distally relative to the adjustable feature to allow blood to flow through the sheath.

[0060] In some embodiments, a laser cut nitinol stent-like tube may be used to place the braid described above. It will be appreciated that the nitinol braid and / or the laser cut nitinol stent may have any suitable arrangement.

[0061] Fig.14A and Fig. 14B Another example of an anchor having an expandable nitinol region is shown. In such an embodiment, the expandable region (whose expanded configuration is as shown in FIG. Fig. 14BThe anchor (shown) is configured close to the distal tip so that little of the sheath extends into the vasculature. In some embodiments, the anchor (adjustable feature) can include a 72 end, 1x1, 75µm wire (C26) w / cilbond and Carbothane PC-3575 0.080 mm laminate extrusion. The outer shaft used to force the shape change is constructed of Pebax.

[0062] exist Fig.11A and 11B In FIG. 1 , the state of the expansion feature for positioning the arteriotomy can be seen. The sheath shaft 102 is shown in a delivery state (for insertion) and the mechanical features of the anchor 108, wherein the mechanical features of the anchor 108 are placed in a flat tubular shape ( Fig.11A ).exist Fig. 11B , the mechanical features of the sheath shaft 102 and anchor 108 are shown in a delivery state (for positioning an arteriotomy) in which their length has been compressed and reduced, and their diameter has been bulged and expanded (bottom).

[0063] exist Fig.12 In the figure, the inner shaft and outer shaft of the characteristic shape are seen to be changed. An inner sheath tube shaft 102 and an outer sheath tube shaft 103 and an anchor 108 for locating the arteriotomy can be included. The anchor can be fixed to the inner shaft 102 at its distal end (right side). The anchor can be fixed to the outer shaft 103 at its proximal end (left side) so that it can slide along the inner shaft. It can be seen that the assembly is in its delivery position, wherein the anchor is laid flat. Then, the outer shaft can slide distally (see arrow), compress the anchor and reduce its length and increase its diameter. It is understandable that the anchor can be positioned to be juxtaposed with the inner wall of the blood vessel. As will be further understood, the inner shaft can be operated as an actuator to actuate the expansion from the delivery configuration to the deployment configuration.

[0064] In some embodiments, the anchor (eg, an adjustable component) can be configured for atraumatic apposition with the inner surface of a blood vessel. In some embodiments, the anchor can be configured to conform to the diameter of the blood vessel.

[0065] In some embodiments, the anchor can be configured to be oriented perpendicular to the central axis of the inner sheath. In some embodiments, the anchor can be configured to be oriented at an angle of 30-60 degrees relative to the central axis of the inner sheath. In some embodiments, the anchor can be configured to be oriented at an angle of 45 degrees relative to the central axis of the inner sheath.

[0066] 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 no more than 0.4 mm when in a compressed state. In some embodiments, the anchor is fully reversible so as to be compressible to a diameter less than the inner diameter of the pump sheath and is configured to be removed through the pump sheath.

[0067] In some embodiments, the inner sheath may have a maximum outer diameter of no greater than 5.05 mm. In some embodiments, the inner sheath may have an inner diameter of 2.5-3.5 mm, such as 3.0 mm.

[0068] In some embodiments, the first mechanical feature (anchor 108) can include a shaped balloon that can expand to a desired shape (e.g., to a delivery configuration) when pressurized with a fluid. In such embodiments, the anchor can be fluidly coupled to a fluid source and can be positioned at or near the tip of the sheath 100. It will be appreciated that, as with other embodiments disclosed herein, the balloon can also be configured to be juxtaposed to the inner wall of the vasculature and have a diameter that exceeds the diameter of the access opening.

[0069] In other embodiments, the anchor may include a series of nitinol wires, which again may be movable between a delivery position and a deployed configuration, and which again may be configured for apposition with an inner wall of the patient's vasculature.

[0070] exist Figure 8 , the device is shown as being prevented from leaving the artery by a first anchor 108, which includes, for example, a base plate having a cross-section larger than the arteriotomy. It will be appreciated that such a base plate may include one or more mechanical features (e.g., fingers) that may be moved into an expanded configuration that, once in the vessel, may create a cross-section larger than the arteriotomy to retain the sheath relative to the arteriotomy. It will be appreciated that the base plate may have any suitable shape.

[0071] It will be appreciated that, in view of the above, the first mechanical feature (anchor 108) can be located at various locations along the sheath. For example, the anchor can reside at the tip of the sheath such that the sheath is substantially outside the vessel while maintaining hemostasis and access. It will be appreciated that in some embodiments, this can minimize the amount of sheath that can extend into the vasculature (e.g., potentially causing an ischemic event) while still allowing a medical device (e.g., a mechanical circulatory support device) to enter the patient. In other embodiments, the anchor can reside in the mid-axis of the sheath body, proximal to a distally adjacent hole (see, e.g., FIG. 1 ). Fig. 13C A hole 112 in the sheath allows blood to enter the sheath tip and pass through the hole to the distal artery.

[0072] Second mechanical feature (outside the cavity)

[0073] In some embodiments, the sheath body may include a second mechanical feature or a second lumen that may be positioned outside the cavity. In some embodiments, the second anchor may be configured to hold the sheath to a blood vessel. In some embodiments, the first anchor and the second anchor may work in unison to hold the sheath to a blood vessel at an arteriotomy. In this regard, the first anchor and the second anchor may have a press fit, a snap fit or other suitable engagements (e.g., an opening and corresponding pins) to allow the first anchor and the second anchor to hold each other. As will be appreciated, the anchor does not need to include this second anchor as described above, and may alternatively only be locked at the arteriotomy via the first anchor.

[0074] In some embodiments, the second mechanical feature can include a component, such as a suture pad, that can be normally locked in place and can slide on the sheath body shaft when actively activated (e.g., a button is pressed) and can return to its normal locked position configuration. In some embodiments, the component can be secured to the patient (e.g., by sutures).

[0075] The second anchor may also include a tube with a soft, expandable tip, which, when slid toward the first anchor and in contact with the outer wall of the artery, opens / expands and positions the soft tip against the outer wall of the vessel.

[0076] In yet another embodiment, the second anchor may include a nitinol braid and a polymer that is tubular in a free state during insertion and expands to a desired shape when axially compressed after delivery to the exterior of a blood vessel within the subcutaneous tissue.

[0077] In some embodiments, the second anchor may include a nitinol braid and a polymer that sets to a desired shape when in a free state and remains taut during insertion.

[0078] In some other embodiments, a laser cut nitinol stent-like tube can be used for the second mechanical feature. A shaped balloon can be used as the second mechanical feature, which can expand to a desired shape when pressurized with a fluid after delivery within the subcutaneous tissue to the outside of the blood vessel. Like the first mechanical feature, the second mechanical feature can also be configured to move between a delivery configuration and an expanded configuration.

[0079] It will be appreciated that the second anchor may be positioned in a variety of locations. For example, in some embodiments, the second mechanical feature may be on the sheath body shaft and may have the purpose of securing the sheath in place by providing back tension with the first mechanical feature. In some embodiments, the second mechanical feature may also be positioned proximal to the first mechanical feature and secure the sheath in place by "clamping" the vessel between the first and second mechanical features.

[0080] In other embodiments, the second mechanical feature may be positioned proximal to the first mechanical feature and secure the sheath in place by "pinching" the skin / subcutaneous tissue / vessel between the first and second mechanical features.

[0081] As will be appreciated, in some embodiments, the first mechanical feature and the second mechanical feature may have the same features and / or arrangement (e.g., similar to those presented above with respect to the first mechanical feature), but the first mechanical feature and the second mechanical feature may be different. As will be further appreciated, in some embodiments, the first mechanical feature and the second mechanical feature may also include a first anchor and a second anchor (where each anchor includes one or more mechanical features).

[0082] like Figure 5 As shown, the device (such as Figure 3 The device of claim 1 is inserted into an artery, wherein an embodiment of the first mechanical feature 108 is circular and conforms to the diameter of the artery. It can be secured in place by a second mechanical 114 feature, which can include a tube with a soft, expandable tip that conforms to the outer surface of the artery. In this regard, the device can be secured in place by "sandwiching" the artery between the first anchor and the second anchor.

[0083] exist Figure 7 , the device is seen to be secured by inner and outer elements of the sheath (e.g., first and second anchors) that clamp the artery to secure it in place. As shown in this view, the first and second anchors may have similar Figure 6 , wherein the inner and outer fingers engage one another to, for example, retain the sheath relative to a vessel.

[0084] exist Fig. 9 , an embodiment of an anchor for securing the sheaths can be seen. In this embodiment, a first mechanical feature 108 having a tip of the inner sheath shaft (sheath A) and a second mechanical feature 114 having a tip of the outer sheath shaft (sheath B) can be seen. When each sheath shaft is retracted proximally and the mechanical elements are exposed, they can be deformed into a preset shape.

[0085] exist Fig.10 , an anchor having nitinol with a covering feature is shown. There, the first mechanical feature 108 and the second mechanical feature 114 are sheaths that grip the vessel wall and may include a pre-expanded nitinol braid with a framework covering (e.g., ePTFE).

[0086] Subcutaneous anchor design

[0087] In some embodiments, Fig.15A As shown, the sheath 100 can be configured to include a proximal anchor 118 and a distal anchor 120. In such embodiments, the proximal anchor can be configured to engage with subcutaneous tissue, while the distal anchor is configured to be juxtaposed with the inner wall of the blood vessel and provide resistance to the inner wall of the blood vessel. In this regard, the distal anchor 120 can include one or more of the above-mentioned structures regarding the first anchor 108. As can also be understood in the above views, the proximal anchor and the distal anchor can also enable the anchors to maintain the position of the sheath 100 relative to the blood vessel passed through. In some embodiments, the proximal anchor and the distal anchor can allow the sheath to maintain the desired angle θ of the sheath relative to the patient. In some embodiments, the angle can be between 30° and 60°, for example an angle of 45°.

[0088] If in view of Fig. 15B , Fig. 15C and Fig.15D As will be appreciated from the drawings shown in FIG, the proximal and distal anchors may have a variety of different arrangements. It will be appreciated that one or both of the anchors may have a design similar to the first and second anchors described above. For example, in Fig. 15B In some embodiments, the anchor may include a disc-barb design, wherein the distal anchor is configured to be atraumatic and has a shape that is configured to conform to the blood vessel. The proximal anchor is an atraumatic bump. In some embodiments, the atraumatic bump may include an expandable balloon. The shape may be retracted by passing another sheath thereover, and for various embodiments, the pull force for retraction of the distal barb may be ~5N.

[0089] exist Fig. 15B In the embodiment shown in Figure 1, a dual extrusion design can be seen. In such an embodiment, both the distal anchor and the proximal anchor can include an atraumatic disk.

[0090] exist Fig. 15C In some embodiments, the anchor may include a stent-disc design. For example, the distal anchor may have stent-like struts that are shaped to sit along the inner diameter of the vessel. The proximal anchor may include an atraumatic disc (in other embodiments, it may be a protrusion).

[0091] Fig.16A-P shows various examples of anchors 124 having a proximal anchoring portion 126 and a distal anchoring portion 128, also referred to herein as dual anchors or dual barb designs (some shown in perspective views and others shown in cross-sectional plan views). In some embodiments, the distal anchor (e.g., distal barbs) can be configured to be atraumatic and have a shape set to conform to a blood vessel. In some embodiments, the distal anchor can have a plurality of fingers that can move between a delivery configuration and an expanded configuration. In some embodiments, the fingers can include an elongated member that extends substantially parallel to the longitudinal axis of the anchor when in the delivery configuration. It is understood that the fingers can all have the same configuration (e.g., length and shape), but the configuration of the fingers can vary from finger to finger. In some embodiments, the fingers can splay outward and away from the longitudinal axis of the anchor. In some embodiments, the first anchor and the second anchor can be formed integrally with each other, but they can be joined in any suitable manner.

[0092] As described above, in the deployed configuration, the distal anchor can be juxtaposed with the vessel wall. In contrast, the proximal barb can be sharper and can be configured to engage (e.g., pierce) subcutaneous tissue, for example. The distal and proximal anchoring portions can have any suitable arrangement. In some embodiments, the anchors shown in these views can be used as the first anchor and / or second anchor disclosed herein.

[0093] It will be appreciated that the anchor may be attached at various locations along the sheath, such as at or near the distal tip, and / or at a portion of the sheath proximal to an opening through which blood may flow.

[0094] Fig.17A and 17B A dual extrusion design is also shown. For example, as shown in this view, both the distal anchor and the proximal anchor include an atraumatic section. Fig.17A and Fig. 17B As shown, each of the anchors can be moved between a compressed delivery position and an expanded deployed position.

[0095] Fig.18A Additional embodiments of anchors are also shown. Fig.18A As shown, in some embodiments, the anchor can include a stent-like base plate that can be disposed at the distal end of the sheath. In some embodiments, the anchor can be used not only to hold the sheath on the vessel (see #1 and #2, for example, to allow distal perfusion), but the anchor can also remain in the vessel after the sheath is removed for closure (see #3). In this regard, the base plate can include a membrane. It can also include a collagen agent, for example, to promote closure.

[0096] Fig.18AAn example of a rotational deployment of an anchor is illustrated. As shown in this view, the anchor can have a coiled arrangement. It can also have one or more expandable portions.

[0097] In the example shown (see FIG. 19A to FIG. 19C ), in order to utilize some embodiments disclosed herein, a sheath sleeve may first be inserted over the dilator, and the dilator may be removed. In such embodiments, the sheath straightens and bends the anatomical structure and / or bypasses calcification. Optionally, a medical device such as a mechanical circulatory support device (e.g., a percutaneous pump) may be inserted via the sheath and placed in an appropriate position (e.g., in the ventricle). Once the sheath (and optional medical device) is in place, the anchor may be deployed. If the sheath may be retracted, retraction may occur at this time. The anchor may be juxtaposed with the vessel. A second anchor may then be deployed to clamp the vessel and / or a subcutaneous barb may be deployed to lock the anchor in place. In some embodiments, the Touhy butterfly may then be advanced to secure the anchor using compression from the skin. In some embodiments, where the sheath is a distal perfusion sheath, the sheath may be oriented perpendicular to the centerline of the vessel or perpendicular to the surface of the skin. In some embodiments, the sheath may be oriented to ±10 degrees perpendicular to the centerline of the vessel or perpendicular to the surface of the skin.

[0098] In another illustrated example, the device can include an introducer sheath. The device can be configured to have a first state that can be used, for example, to insert a sheath with a corresponding dilator and to deliver a pump (e.g., an Impella® blood pump) through calcified, tortuous, or otherwise impassable patient anatomy.

[0099] The first mechanical feature can be a nitinol braid, which is concentrically located around and at the distal tip of the inner sheath body. The distal-most portion can be fixed to the inner sheath body. The proximal end of the mechanical feature can be fixed to an outer sheath shaft, which can slide along the inner sheath shaft. The inner sheath shaft can have a liner (e.g., a PTFE liner), which can be coil-enhanced and can have a coat. It can be attached to a sheath hub at its proximal end, and the sheath hub includes a hemostatic valve and a side arm for flushing. The outer sheath shaft can be attached to a molded hub at its proximal end, and the molded hub can be locked in two positions. In the first state, it can be located at a proximal position of the distal side of the sheath hub close to the inner shaft.

[0100] The second mechanical feature can be a catheter lock, which includes a housing, a button with a spring, a locking tube and a suture pad. It can be concentrically located between the proximal and distal ends of the outer shaft. In the first state, the button is not pressed, so the spring produces a compressive force on the locking tube, fixing the second mechanical feature to the outer sheath shaft. The second mechanical feature can be in a proximal position of a molded hub adjacent to the outer sheath shaft on the distal side. The introducer sheath can occupy a large or complete lumen cross-sectional area with almost no fluid passing through the sheath.

[0101] The device can be configured to have a second state that can be used, for example, to place a pump and start treatment. The sheath can be partially retracted from the artery with the distal tip still within the lumen of the artery. The first mechanical feature can be activated and the sheath can be tightened so that the mechanical feature is against the vessel wall and is not pulled out. The second mechanical feature can be activated, slid down to press against the skin with force, and deactivated to fix in place on the shaft, thereby providing a reaction force to the first mechanical feature to fix the sheath in place. The molded hub of the outer shaft can be moved forward to a second position, where it locks in place. The length of the first feature can be reduced and the diameter can be increased. The introducer sheath occupies a limited lumen cross-sectional area, with sufficient distal perfusion passing through the sheath.

[0102] The device can be configured to have a third state that can be used, for example, when treatment is complete and the user removes the pump from the sheath. A wire for maintaining access can be inserted into the sheath. The first mechanical feature can be returned to an unexpanded state and the sheath can be removed. The arteriotomy is closed with conventional techniques (manual pressure, vascular closure device, etc.). The hub of the outer shaft can be moved in a distal direction to its first position where it is locked in place. The length of the first feature can be increased back to its original length, and the diameter is substantially returned to its original diameter.

[0103] Although embodiments are shown and described in which (one or more) anchors and / or the 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 alternatively be formed on another accessory, such as a reduction sheath, which is configured to engage with the introducer sheath.

[0104] In some embodiments, Fig.19A As shown, in the pre-deployment stage, the self-expandable preformed anchor can be positioned at the tip of the inner sheath (e.g., a repositioning sheath). The inner sheath can include an anchor protection sleeve placed around the anchor and optionally around a portion of the inner sheath. It is understood that the anchor protection sleeve may not slide into the hub and slide into the introducer (e.g., pump) sheath.

[0105] During the expansion, Fig.19BAs shown, the resetting sheath can be pushed into the pump sheath. The anchor protective sleeve will bridge the anchor through the hemostatic valve of the pump sheath, but the anchor protective sleeve will not enter the pump sheath body. Once the anchor is pushed through the tip of the pump sheath, the anchor will automatically deploy. The resetting sheath can then be pulled back slightly (in the proximal direction) to ensure that the anchor is tightened relative to the tip of the pump sheath. Then, once the anchor is deployed, the resetting sheath position can be locked by locking the feature at the pump sheath hub. The pump sheath can then be retracted until resistance is felt, indicating that the anchor is juxtaposed with the inner wall of the blood vessel. In some embodiments, the adjustable butterfly can be pushed forward to press against the skin and then sutured in place to hold the pump sheath in place.

[0106] The anchor can be undeployed by retracting the positioning sheath.

[0107] Embodiments of the present disclosure are described in detail with reference to the accompanying drawings, wherein the same 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 implemented in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be interpreted as restrictive, but only as the basis for the claims, and as a representative basis for teaching those skilled in the art to adopt the present disclosure differently with almost any appropriately detailed structure.

Claims

1. A device comprising: a tubular member configured to extend at least partially into a blood vessel of a patient; and A first anchor is coupled to the tubular member and is configured to maintain a position of the tubular member relative to the blood vessel, wherein the first anchor is configured to be apposed to an inner wall of the blood vessel.

2. The device according to claim 1, wherein: The first anchor comprises a delivery configuration and a deployed configuration, wherein, in the deployed configuration, the first anchor has a diameter larger than an 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 at or near the distal end of the tubular member.

5. The device according to claim 1, wherein: The first anchor includes a base plate.

6. The device according to claim 1, wherein: The first anchor includes a nitinol braid and / or a polymer configured to expand to a deployed configuration.

7. The device according to claim 1, wherein: The first anchor includes an expandable balloon.

8. The device of claim 7, wherein the inflatable balloon is operably coupled to a fluid source.

9. The device of claim 1, further comprising a second tubular member disposed along the tubular member, wherein the second tubular member is operably coupled to the first anchor to move the first anchor from a delivery configuration to a deployed configuration.

10. The device according to claim 1, wherein: The first anchor is configured for atraumatic apposition to an inner wall of the blood vessel.

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

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

13. The device of claim 1, further comprising a second anchor configured to be placed on an outer surface of the blood vessel, wherein The first anchor and the second anchor cooperate to retain the tubular member to the blood vessel.

14. The device according to claim 13, wherein: The second anchor includes a suture pad.

15. The device according to claim 13, wherein: The second anchor includes an expandable tip.

16. The device according to claim 13, wherein: The second anchor comprises a nitinol braid or a polymer.

17. The device according to claim 13, wherein: The first anchor and the second anchor clamp or grip the blood vessel to retain the tubular member to the blood vessel.

18. The device of claim 13, wherein the first anchor and the second anchor include the same features.

19. The device of claim 13, wherein the first anchor and the second anchor comprise different features.

20. An apparatus comprising: An anchor configured to maintain a position of a tubular member relative to a blood vessel, the anchor being positionable within the blood vessel, wherein the anchor comprises: a proximal anchoring portion configured to engage subcutaneous tissue; and A distal anchoring portion is configured to be juxtaposed with an inner wall of the blood vessel.

21. The device according to claim 20, wherein: The distal anchoring portion includes one or more fingers.

22. The device according to claim 20, wherein: The distal anchor includes a base plate.

23. The device according to claim 20, wherein: The distal anchor includes one or more barbs.

24. The device according to claim 23, wherein: The proximal anchor includes one or more barbs, wherein the one or more barbs of the proximal anchor are more pointed than the one or more barbs of the distal anchor.

25. The device according to claim 20, wherein: Each of the distal anchor and the proximal anchor includes an atraumatic disc.

26. A method comprising: inserting a tubular member through the access site into a blood vessel of a patient, the tubular member extending at least partially into the blood vessel; and The position of the tubular member is maintained to the blood vessel via a first anchor configured to be apposed to an inner wall of the blood vessel.

27. The method of claim 26, further comprising inserting a medical device into the patient via the tubular member.

28. The method of claim 26, further comprising: Prior to the maintaining step, the first anchor is inserted into the vasculature in a delivery configuration.

29. The method of claim 27, further comprising: Prior to the maintaining step, the first anchor is moved to the expanded configuration, wherein a diameter of the first anchor in the expanded configuration is larger than a diameter of the opening through which the tubular member is inserted into the blood vessel.

30. The method of claim 29, further comprising: The first anchor is returned to the delivery configuration, and the tubular member and the first anchor are removed from the patient's vessel.

31. The method of claim 26, wherein: The retaining step includes maintaining the position of the tubular member to the blood vessel via a first anchor and a second anchor, the second anchor being positioned outside of the blood vessel.

32. The method according to claim 31, wherein: The first anchor and the second anchor cooperate with each other to maintain the position of the tubular member to the blood vessel.

33. The method according to claim 31, wherein: The holding step includes clamping or sandwiching the blood vessel between the first anchor and the second anchor.

34. The method of claim 26, wherein: The first anchor includes a distal anchor portion and a proximal anchor portion, wherein the distal anchor portion is configured to be juxtaposed with an inner wall of the blood vessel, and wherein the proximal anchor portion is configured to engage subcutaneous tissue.

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