Support structure for intravascular blood pump

Abstract

Improved systems for supporting (e.g., locating and / or positioning) intravascular devices described herein provide, for example, a multi-element configuration. Sets of struts optionally protrude from the intravascular device and contact the vessel wall. Localization and positioning of the pump can be provided by the struts and / or by the use of tethers that counteract the driving force to ensure localization.

Description

[Technical Field]

[0001] The field relates to localization and positioning structures and methods for intravascular blood pumps. [Background technology]

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 62 / 947,940, filed December 13, 2019, the entire contents of which are incorporated herein by reference in their entirety for all purposes. This application also claims priority to International Application No. PCT / US2020 / 062928, filed December 2, 2020, which claims priority to U.S. Provisional Patent Application No. 62 / 943,062, filed December 3, 2019, the entire contents of each of which are incorporated herein by reference in their entirety for all purposes. Any application for which a foreign or domestic priority claim is identified in an Application Data Sheet filed herewith is incorporated herein by reference under 37 CFR 1.57.

[0003] In the field of cardiac assist devices and mechanical circulatory support, blood pumps are used to assist the heart in circulating blood through the body. Some of these blood pumps are intravascular blood pumps, which are designed or adapted for use within blood vessels.

[0004] Some intravascular blood pumps have been described as including hooks for securing the intravascular pump to the interior wall of a blood vessel, which prevent translation of the device along the axis of the vessel and rotation of the device about the axis of the vessel through direct local contact. Summary of the Invention

[0005] There is a need for support or localization structures for pumps that can limit or prevent translation, limit or prevent rotation, help maintain the position of some parts of the pump relative to some anatomical structures, or any combination of these. Localization structures can be designed for acute, semi-acute, semi-chronic, or chronic use.

[0006] Blood is a harsh environment for devices, and intravascular clots, foreign bodies, or pathogens can have fatal consequences. Novel localization structures are needed that are biocompatible, non-thrombogenic, and non-hemolytic well beyond the expected lifespan of use. Furthermore, the function and removal of novel localization means should preferentially be consistent with any endothelialization that may occur during the expected lifespan of use.

[0007] Novel localization structures for intravascular devices preferably provide material and surface biocompatibility, design for hemodynamic compatibility (reduction or minimization of blood flow-mediated thrombogenicity and hemolysis and disruption of natural flow), reduction or minimization of trauma to the interior of blood vessels or other anatomical structures, sufficient localization and freedom of movement, and removability when the treatment provided by the localization device is complete.

[0008] Disclosed herein are localization and positioning systems and methods for medical devices, such as intravascular blood pumps or other intravascular devices. Various embodiments include one or more of the following elements: struts extending from the device to be localized, providing constant or intermittent contact with the vessel wall; tethers (e.g., power leads) to limit translation and aid in positioning; and propulsion to maintain localization.

[0009] In some embodiments, the localization and positioning system can be part of or include a support structure comprising struts, which are protrusions that extend distally and radially outward from the device to contact a vessel wall or other anatomical feature. Various illustrated embodiments show struts extending distally of the pump housing and impeller. However, it should be understood that any of the struts may instead extend proximal to the pump head (e.g., proximal to the motor housing). In such embodiments, one or more struts can extend proximally from the drive unit or shroud. In still other embodiments, one or more, e.g., a first plurality of struts, can extend distally of the pump housing and impeller, and one or more, e.g., a second plurality of struts, can extend proximal to the pump head (e.g., proximal to the motor housing). The struts can be shaped, formed, and treated such that for a given outward radial force in the expanded configuration, the radial force in the collapsed configuration and / or the force to move from the expanded configuration to the collapsed configuration is reduced (e.g., minimized).

[0010] The struts may be made of or otherwise formed from a biocompatible metal such as Nitinol, a shape memory alloy, or an alloy, and may be designed to have a specific shape and / or geometry. Through constant or intermittent contact with the inner wall of a vessel or some other anatomical feature, the struts can provide localization, positioning, or both. The device to be positioned can have multiple sets of struts, which can protrude from the device at one or more angles or at any angle. In some embodiments, the struts may have hook-like features. In other embodiments, the struts may have pads that interface with the surface of the vessel wall. For use with an intravascular device, the struts can have a collapsed configuration to fit within a sheath and an expanded configuration to provide localization and / or positioning. In some embodiments, the struts may have knees (or kinks or bends) to prevent the hooks or other features from contacting the inner wall of the sheath in the collapsed configuration. The struts may be shaped, formed, and treated such that for a given outward radial force in the expanded configuration, the radial force in the collapsed configuration and / or the force required to move from the expanded configuration to the collapsed configuration is reduced or minimized.

[0011] In some embodiments, the localization, stabilization, and positioning system (or support structure) can include one or more tethers that connect the device to be located and / or positioned to one or more anchors or contact points. The tethers can be flexible and can preferentially limit translation or rotation in one direction. In some embodiments, the tethers can have additional functionality. As one non-limiting example, the tethers can also include power leads that transmit power to the device being located or positioned.

[0012] In some embodiments, the localization, stabilization, and positioning system can include a propulsion means (e.g., a pump in various embodiments). When the device to be localized and / or positioned is an intravascular blood pump, in some embodiments, pumping blood is a key function of the device. The propulsive or reactive force generated by blood pumping can be used as part of the localization and positioning system.

[0013] In some embodiments, the localization and / or positioning system may comprise a combination of the above elements that together provide unique benefits or advantages.

[0014] The present description has outlined rather broadly various features of the present disclosure in order that the detailed description that follows may be better understood. Additional features and advantages of the present disclosure are described below.

[0015] In one embodiment, a blood flow assist system is disclosed. The blood flow assist system can include, or consist essentially of, an impeller disposed within a pump housing of a pump, the pump having a longitudinal axis, the impeller generating a thrust force as it operates within a blood vessel to pump blood, and a tether extending away from the pump housing, the tether configured to oppose loads applied in opposite directions at both ends of the tether. In some embodiments, a longitudinal component of the thrust force generated by the impeller directed along the longitudinal axis of the pump is opposed by the tether, the tether configured to maintain the position of the pump within the blood vessel without requiring contact between the pump and the vessel wall of the blood vessel.

[0016] In some embodiments, the system includes a support structure coupled to or formed with the pump housing, the support structure configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed. In some embodiments, the support structure includes a plurality of elongated struts having a first end coupled to the pump housing and a second end opposite the first end, each elongated strut of the plurality of struts having an elongated body and extending between the first end and the second end. In some embodiments, the system includes a convex contact pad disposed on a distal portion of each of the plurality of struts, the convex contact pad configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed. In some embodiments, the plurality of struts includes a first plurality of struts and a second plurality of struts, and when the plurality of struts are in the expanded configuration, a first contact pad of the first plurality of struts is configured to engage the vessel wall at a first longitudinal position, and a second contact pad of the second plurality of struts is configured to engage the vessel wall at a second longitudinal position spaced from the first longitudinal position. In some embodiments, the contact pad is disposed distally and radially outward from the pump housing and configured to be reversibly deflectable to hold the pump housing within the vessel to hold the pump housing away from the vessel wall. In some embodiments, the contact pad comprises a convex periphery surrounding a convex vessel-engaging surface. In some embodiments, the contact pad comprises a convex profile in a cross-sectional plane disposed across the longitudinal axis of the pump. In some embodiments, the tether comprises a conductor configured to transmit electrical current from a source connectable to a proximal end of the tether to a motor operably coupled to the impeller. In some embodiments, the system further includes a motor housing coupled to a proximal portion of the pump housing, the motor being disposed within the motor housing. In some embodiments, the tether comprises a rotatable drive shaft connected to the motor disposed outside the patient's body.In some embodiments, the kit includes a blood flow assist system and a sheath sized and shaped to receive the pump housing, tether, and support structure.

[0017] In another embodiment, a blood flow assist system is disclosed that can include, or consist essentially of, an impeller disposed within a pump housing of a pump, the pump including a longitudinal axis, the impeller generating a thrust force as it operates within a blood vessel to pump blood, a tether extending away from the pump housing, the tether configured at opposite ends to resist loads applied in opposite directions, and a support structure.

[0018] In some embodiments, the support structure comprises a convex contact pad configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which it is disposed. In some embodiments, the system includes a motor operably coupled to the impeller. In some embodiments, the tether comprises a hollow elongate member surrounding a conductor disposed therein, the conductor configured to transmit current from a source connectable to a proximal end of the tether to the motor, the tether configured to resist loads applied in opposite directions at opposite ends thereof. In some embodiments, the system includes a plurality of elongate struts having a first end coupled to a second end of the pump and a second end opposite the first end, each elongate strut of the plurality of elongate struts comprising an elongate body extending between the first end and the second end, each strut of the plurality of elongate struts configured to store strain energy when a lateral load is applied. In some embodiments, the blood flow assist system includes a contact pad disposed on a second end of each elongate strut of the plurality of elongate struts, each contact pad having an enlarged width compared to the width of an immediately adjacent extent of a corresponding elongate strut of the plurality of elongate struts. In some embodiments, in use, a longitudinal component of a thrust force generated by the impeller directed along the longitudinal axis of the pump is opposed by the tension member of the tether.

[0019] In some embodiments, the contact pads comprise substantially circular pads having a diameter greater than the width of the adjacent extent of the corresponding elongate strut. In some embodiments, the elongate struts comprise at least one bend along their elongate bodies to facilitate folding of the struts into the lumen of the sheath. In some embodiments, each of the contact pads comprises a smooth surface without sharp edges or hooks. In some embodiments, each of the contact pads comprises a convex cross-sectional profile on the side facing the vessel. In some embodiments, each of the contact pads comprises a spherical portion. In some embodiments, the elongate struts are configured to apply a load to the aortic wall when deployed to locally radially expand the vessel wall tissue in which the contact pad is located. In some embodiments, the contact pads comprise holes configured to allow vessel wall tissue to be received therein. In some embodiments, each of the contact pads comprises one or more scalloped edges to allow vessel wall tissue to be received therein. In some embodiments, each of the contact pads comprises a dome-shaped portion. In some embodiments, the hollow elongate member is configured to receive a reinforcing member to facilitate introduction of the pump housing. In some embodiments, the pump further comprises a motor housing coupled to a proximal portion of the pump housing, the motor being disposed within the motor housing. In some embodiments, a lateral component of the thrust force directed in a direction transverse to the longitudinal axis of the pump is opposed by strain energy stored in at least one of the plurality of elongated struts upon deflection of one or more of the plurality of elongated struts. In some embodiments, the kit comprises a blood flow assist system and a sheath sized and shaped to receive the pump housing, the motor, the tether, and the plurality of elongated struts.

[0020] In some embodiments, the support structure comprises a plurality of elongated struts having a first end coupled to the second end of the pump and a second end opposite the first end, each elongated strut of the plurality of struts having an elongated body extending between the first end and the second end, and a convex contact pad disposed on a distal portion of each of the plurality of struts. In some embodiments, the plurality of struts includes a first plurality of struts and a second plurality of struts, and when the plurality of struts are in the expanded configuration, the first contact pad of the first plurality of struts is configured to engage the vessel wall at a first longitudinal position and the second contact pad of the second plurality of struts is configured to engage the vessel wall at a second longitudinal position spaced from the first longitudinal position. In some embodiments, when the struts are in the collapsed configuration, at least some of the struts have a major lateral dimension that is less than or equal to a major lateral dimension of the pump housing. In some embodiments, the contact pad is disposed distally and radially outwardly of the pump housing and is configured to be reversibly deflectable to retain the pump housing within the vessel to hold the pump housing away from the vessel wall. In some embodiments, the contact pad comprises a convex periphery surrounding a convex vessel-engaging surface. In some embodiments, the contact pad comprises a convex profile in a cross-sectional plane disposed across the longitudinal axis of the pump. In some embodiments, the tether comprises a conductor configured to transmit electrical current from a source connectable to a proximal end of the tether to a motor operably coupled to the impeller. In some embodiments, the pump further comprises a motor housing coupled to a proximal portion of the pump housing, the motor being disposed within the motor housing. In some embodiments, the tether comprises a rotatable drive shaft connected to a motor disposed outside the patient's body.

[0021] In another embodiment, a blood flow assist system is disclosed. The blood flow assist system can include, or consist essentially of, an impeller disposed within a pump housing of a pump; and a support structure coupled to or formed with the pump housing, the support structure including a plurality of struts, the support structure having an expanded configuration in which the plurality of struts extend outward relative to the pump housing and a collapsed configuration in which the pump is disposed within a sheath, wherein in the collapsed configuration, at least some of the struts have a major lateral dimension that is less than a major lateral dimension of the pump housing. In some embodiments, the blood flow assist system includes a motor housing and a motor disposed within the motor housing, the major lateral dimension of at least some of the struts being less than a major lateral dimension of the motor housing. In some embodiments, the blood flow assist system includes convex contact pads on distal portions of the struts, the convex contact pads configured to contact a vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed.

[0022] In another embodiment, a blood flow assist system is disclosed. The blood flow assist system can include, or consist essentially of, an impeller disposed within a pump housing of a pump; and a support structure coupled to or formed with the pump housing, the support structure including a plurality of struts, the support structure having an expanded configuration in which the plurality of struts extend outward relative to the pump housing and a collapsed configuration in which the pump is disposed within a sheath, the plurality of struts including a first plurality of struts and a second plurality of struts, wherein, when the plurality of struts are in the expanded configuration, first contact pads of the first plurality of struts are configured to engage the vessel wall at a first longitudinal position and second contact pads of the second plurality of struts are configured to engage the vessel wall at a second longitudinal position spaced from the first longitudinal position. In some embodiments, the blood flow assist system includes convex contact pads on distal portions of the plurality of struts, the convex contact pads configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed. In some embodiments, a major lateral dimension of at least a portion of the struts is smaller than a major lateral dimension of the pump housing. In some embodiments, the blood flow assist system includes a tether extending away from the pump housing, the tether configured to resist loads applied in opposite directions at opposite ends of the tether.

[0023] In another embodiment, a blood flow assist system is disclosed. The blood flow assist system can include, or consist essentially of, an impeller disposed within a pump housing of a pump, the pump including a longitudinal axis, the impeller generating a thrust force as the impeller operates within a blood vessel to pump blood; a tether coupled to a first end of the pump; and a support structure including contact pads that can be elastically deflected toward and away from the longitudinal axis of the pump, the contact pads having a free state spaced from the longitudinal axis of the pump by a distance greater than the half-width of the blood vessel in which the pump housing is deployed, the contact pads applying sufficient force to the wall of the blood vessel to press a portion of the contact pad into the wall such that a peripheral portion of the blood vessel wall is radially inward from the contact surface of the contact pad. In some embodiments, the contact pads are configured to engage the wall of the blood vessel when applied without snagging. In some embodiments, the contact pads include an elongated member and an enlarged blood vessel wall contact surface disposed at an end of the elongated member. In some embodiments, the tether comprises a conductor configured to transmit electrical current from a source connectable to a proximal end of the tether to a motor operably coupled to the impeller.

[0024] In another embodiment, a blood flow assist system is disclosed. The blood flow assist system can include, or consist essentially of, a pump comprising: an impeller disposed within a pump housing; a strut having a first end disposed on or coupled to the pump housing, a second end opposite the first end, and an inflection zone disposed between the first and second ends, the second end being resiliently deflectable toward and away from the longitudinal axis of the pump, the strut's free state spacing the second end away from the longitudinal axis of the pump, and the second end of the strut configured to engage a wall of a blood vessel. The system can include, or consist essentially of, a sheath disposed over the pump and having an inner wall configured to deflect the strut between its first and second ends, the inflection zone configured such that the second end of the strut is spaced apart from the inner wall of the sheath when the strut is deflected by the inner wall of the sheath. In some embodiments, the second end of the strut comprises a hook. In some embodiments, the inflection zone comprises an S-shaped connection between a first span of the strut and a second span of the strut, the first span and the second span being arranged along parallel trajectories. In some embodiments, the blood flow assist system includes a tether coupled to a first end of the pump, the tether comprising an electrical transport portion comprising a conductor configured to carry electrical current to or from a source connectable to a proximal end of the electrical transport portion.

[0025] In another embodiment, a method of operating a blood flow assist system can include, or consist essentially of, providing a pump to a treatment location within a patient's blood vessel, the pump including a pump housing disposed within a sheath, an impeller disposed within the pump housing, and a plurality of elongated struts extending from the pump housing in a collapsed configuration, each elongated strut including a convex contact pad at a distal end thereof; providing relative motion between the sheath and the pump to remove the pump from the sheath, the plurality of elongated struts radially self-expanding to an expanded configuration in which at least one convex contact pad at least intermittently contacts a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall; and rotating the impeller to pump blood. In some embodiments, the method includes carrying electrical current to a motor through a tether comprising a conductor, the motor operably coupled to the impeller, the tether coupled to the pump, wherein rotating the impeller generates a thrust force, the tether opposing the thrust force. In some embodiments, the method includes percutaneously delivering a sheath to a treatment location and then delivering a pump to the treatment location. In some embodiments, the method includes forcing a portion of the contact pad into a vessel wall. In some embodiments, the method includes removing the pump from the patient.

[0026] In another embodiment, a method of operating a blood flow assist system is disclosed. The method can include, or consist essentially of, providing a pump to a treatment location within a patient's blood vessel, the pump including a pump housing disposed within a sheath, an impeller disposed within the pump housing, and a plurality of elongated struts extending distally from the pump housing in a collapsed configuration; providing relative motion between the sheath and the pump to remove the pump from the sheath, the plurality of elongated struts radially self-expanding to an expanded configuration in which at least one contact pad on an end of at least one of the plurality of elongated struts at least intermittently contacts a vessel wall of the blood vessel to maintain spacing of the pump from the vessel wall, the at least one contact pad applying sufficient force to press a portion of the contact pad against the vessel wall of the blood vessel such that a peripheral portion of the vessel wall is radially inward from the contact pad; and rotating the impeller to pump blood. In some embodiments, the method includes percutaneously delivering a sheath to the treatment location and then delivering the pump to the treatment location. In some embodiments, the method includes removing the pump from the patient. In some embodiments, the method includes carrying current to the motor by a tether comprising a conductor, the motor operably coupled to the impeller and the tether coupled to the pump.

[0027] In another embodiment, a method of manufacturing a blood flow assist system is disclosed. The method can include, or consist essentially of, providing an impeller within a pump housing of a pump, the pump being disposed along a longitudinal axis, the impeller generating a thrust force when operating within a blood vessel to pump blood; coupling a tether to a first end of the pump; and coupling a support structure to a second end of the pump, the support structure including a convex contact pad configured to at least intermittently contact a vessel wall to maintain spacing of the pump housing from the vessel wall within which the pump housing is disposed. In some embodiments, the method includes providing a motor within a motor housing of the pump, the motor housing being disposed distal to the pump housing. In some embodiments, the support structure comprises a plurality of elongated struts having a first end coupled to the second end of the pump and a second end opposite the first end, each elongated strut of the plurality of struts having an elongated body extending between the first end and the second end, each strut of the plurality of elongated struts configured to store strain energy when a lateral load is applied to the second end of the strut of the plurality of elongated struts. In some embodiments, the method includes patterning the plurality of elongated struts. In some embodiments, the patterning includes laser cutting the plurality of elongated struts from a sheet of material.

[0028] In another embodiment, a method of operating a blood flow assist system is disclosed that can include, or consist essentially of, providing a pump to a treatment location within a patient's blood vessel, the pump including a pump housing disposed within a sheath, an impeller disposed within the pump housing, and a tether extending proximally from the pump housing to an exterior of the patient, the tether configured to oppose oppositely applied loads at opposite ends of the tether; providing relative motion between the sheath and the pump to remove the pump from the sheath; and rotating the impeller to pump blood and generate a thrust force, wherein a longitudinal component of the thrust force generated by the impeller directed along a longitudinal axis of the pump is opposed by the tether, the tether configured to maintain the position of the pump within the blood vessel without requiring contact between the pump and a vessel wall of the blood vessel. In some embodiments, the pump includes a plurality of elongated struts extending distally from the pump housing in a collapsed configuration, each elongated strut of the plurality of struts including a convex contact pad at a distal end thereof, and providing relative motion includes radially self-expanding the plurality of elongated struts to an expanded configuration in which at least one convex contact pad is in at least intermittent contact with a vascular wall of the blood vessel to maintain spacing of the pump from the vascular wall. [Brief explanation of the drawings]

[0029] These and other features, aspects, and advantages are described below with reference to the drawings, which are for illustrative purposes only and should not be construed as limiting the scope of the embodiments in any way. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure. In the drawings, like reference numerals indicate corresponding features consistently throughout like embodiments. Each of the figures will now be briefly described.

[0030] [Figure 1A] 1 is a schematic perspective, partially exploded view of a blood flow assist system according to various embodiments.

[0031] [Figure 1B] 1B is a schematic perspective view of a pump in the distal portion of the blood flow assist system of FIG. 1A.

[0032] [Figure 1C] FIG. 1C is a schematic perspective, partially exploded view of the pump of FIG. 1B.

[0033] [Figure 1D] 1 is a schematic cross-sectional side view of a motor housing according to various embodiments.

[0034] [Figure 1E] FIG. 2 is a schematic perspective view of a motor and a motor mounting support.

[0035] [Figure 1F] 1 is a schematic perspective view of a distal end of a power lead having a lumen shaped to receive a conductor configured to supply power to a motor. FIG.

[0036] [Figure 1G] FIG. 2 is a schematic perspective view of a proximal end portion of a power lead.

[0037] [Figure 1H] FIG. 1 is a schematic side view of a pump disposed in a collapsed configuration within a delivery sheath.

[0038] [Figure 1I] FIG. 10 is a schematic perspective view of a retrieval mechanism used to remove a pump, according to some embodiments.

[0039] [Figure 1J] FIG. 10 is a cross-sectional view of an alternative embodiment in which the drive shaft is coupled to a motor configured to be located external to the patient when the pump is in use.

[0040] [Figure 2A] 1 is an image showing a front perspective view of a location system, according to one embodiment.

[0041] [Figure 2B] FIG. 2B is a schematic side view of the location system of FIG. 2A.

[0042] [Figure 2C] FIG. 2C is a schematic plan view of a laser cutting pattern for the location system of FIG. 2B.

[0043] [Figure 2D] FIG. 1 is a schematic side view of a support post having a dome-shaped or spherical contact pad.

[0044] [Figure 2E] FIG. 1 is a schematic perspective view of a contact pad for driving into a vessel wall, according to some embodiments.

[0045] [Figure 2F] 2E is a schematic cross-sectional front view of the contact pad shown in FIG. 2E.

[0046] [Figure 2G] 2F is a schematic cross-sectional side view of the contact pad shown in FIG. 2E.

[0047] [Figure 3A] 1 is an image of a front perspective view of a location system according to another embodiment.

[0048] [Figure 3B] 3B is an image of a side view of the location system of FIG. 3A.

[0049] [Figure 3C] FIG. 3C is a schematic side view of the location system of FIGS. 3A-3B.

[0050] [Figure 3D] FIG. 4 is a schematic enlarged view of a second end of the support pillar of FIGS. 3A to 3C.

[0051] [Figure 3E] FIG. 1 is a schematic plan view of a localization system in a laser cut pattern before assembly. [Figure 3F] FIG. 1 is a schematic plan view of a localization system in a laser cut pattern before assembly.

[0052] [Figure 3G] 3E shows a plan view of the distal end of the strut of FIG. 3D.

[0053] [Figure 4A] 1 illustrates a method for delivering and deploying a localization and positioning system incorporating a strut with contact pads, a tether, and propulsion. [Figure 4B] 1 illustrates a method for delivering and deploying a localization and positioning system incorporating a strut with contact pads, a tether, and propulsion. [Figure 4C] 1 illustrates a method for delivering and deploying a localization and positioning system incorporating a strut with contact pads, a tether, and propulsion. [Figure 4D] 1 illustrates a method for delivering and deploying a localization and positioning system incorporating a strut with contact pads, a tether, and propulsion. [Figure 4E] 1 illustrates a method for delivering and deploying a localization and positioning system incorporating a strut with contact pads, a tether, and propulsion.

[0054] [Figure 5A] FIG. 10 is a schematic perspective view of a location system in a folded configuration according to another embodiment.

[0055] [Figure 5B] FIG. 5B is a schematic plan view of a laser cutting design for the system of FIG. 5A.

[0056] [Figure 6] 1 is a schematic side view of a plurality of struts according to various embodiments. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0057] Referring now to the drawings, illustrated elements are not necessarily shown to scale and like or similar elements are designated by the same reference numerals throughout the several views.

[0058] Referring generally to the drawings, it will be understood that the illustrations are for purposes of illustrating particular embodiments of the present disclosure and are not intended to be limiting thereof. It should be understood that while most of the terms used herein will be recognizable to those skilled in the art, unless expressly defined, terms should be construed to adopt the meaning currently accepted by those skilled in the art.

[0059] I. Overview of the Blood Flow Support System Various embodiments disclosed herein relate to a blood flow assist system 1 configured to provide circulatory support to a patient, as shown in FIGS. 1A-1I. The system 1 can be sized for intravascular delivery to a treatment location within the patient's circulatory system, e.g., a location within the patient's descending aorta. As shown in FIG. 1A, the system 1 can have a proximal end 21 having a connector 23 configured to connect to an external control system, e.g., a console (not shown). The connector 23 can provide electrical communication between the control system and a power lead 20 extending distally from the connector 23 and the proximal end 21 along a longitudinal axis L. The power lead 20 can include an elongate body that electrically and mechanically connects to a pump 2 at or near a distal end 22 of the blood flow assist system 1, the distal end 22 being spaced apart from the proximal end 21 along the longitudinal axis L. As described herein, the power lead 20 can also function as a flexible tether configured to resist loads applied in opposite directions at opposite ends of the power lead 20.

[0060] The pump 2 can include a pump head 50 including a pump housing 35 connected to a drive unit 9 including a motor housing 29. A retrieval mechanism 48 can be provided at a proximal end portion of the pump 2. In some embodiments, the retrieval mechanism can be coupled to the distal end of the power lead 20 between the power lead 20 and the motor housing 29. After a procedure, a clinician can remove the pump 2 from the patient by engaging a tool (e.g., a snare, clamp, hook, etc.) with the retrieval mechanism 48 and withdrawing the pump 2 from the patient. For example, the retrieval mechanism 48 can include a neck portion 49 (e.g., a reduced diameter portion) at the proximal curved portion 51 c of the motor housing 29 and an enlarged diameter portion disposed proximal to the neck portion 49. The enlarged diameter portion can include a first curved portion 51 a and a second curved portion 51 b, as shown in FIGS. 1B, 1C, and 1I. The first and second curved portions 51 a, 51 b can include convex surfaces, e.g., convex ball portions. The first and second curved portions 51 a, 51 b can have different radii of curvature. For example, as shown in FIG. 1I, the first curved portion 51 a can have a larger radius of curvature than the second curved portion 51 b. In some embodiments, the first curved portion 51 a can be disposed on either side of the retrieval mechanism 48. The second curved portion 51 b can be disposed around the first curved portion 51 a and can have a radially outward facing surface and a proximally facing convex surface coupled to the distal end of the power lead 20. The neck portion 49 can have a first depth at a first circumferential position of the retrieval mechanism 48 and a second depth at a second circumferential position of the retrieval mechanism 48 spaced from the first circumferential position that is smaller than the first depth.

[0061] Beneficially, as shown in FIG. 1I, one or more first planes P1 extending parallel to the longitudinal axis L and intersecting the first curved portion 51a can have a first angle or taper between the proximal curved portion 51c of the motor housing 29 and the first curved portion 51a. One or more second planes P2 extending parallel to the longitudinal axis L and intersecting the second curved portion 51b can have a second angle or taper (different from the first angle or taper) between the proximal curved portion 51c of the motor housing 29 and the second curved portion 51b. The first angle or taper can provide a gradual, continuous (almost monotonically decreasing) geometric transition between the proximal curved portion 51c of the motor housing 29 and the power lead 20, which can provide smooth blood flow and reduce the risk of thrombosis. The second curved portion 51b can function as a lobe extending radially outward, e.g., radially outward from the first curved portion 51a. The second curved portion 51b can be used to engage a retrieval device or snare to remove the pump 2 from the anatomy. Some cross sections through the longitudinal axis of the retrieval mechanism 48 can include a substantial neck (e.g., a local minimum in the radius of curvature measured along its central axis), while other cross sections through the longitudinal axis of the retrieval mechanism 48 can include a non-substantial local minimum or no local minimum. In the illustrated embodiment, there are two first curved portions 51a that can function as a dual-lobe retrieval mechanism. In other embodiments, more or fewer lobes can be provided to enable pump retrieval while ensuring a smooth flow transition between the motor housing 29 and the power lead 20.

[0062] As shown in FIGS. 1B-1C, 1E, and 1I, the neck portion 49 can be disposed between the curved portions 51a, 51b and the proximal convex surface 51c of the motor housing 29. In the illustrated embodiment, the retrieval mechanism 48 can be coupled to or integrally formed with the motor housing 29. In other arrangements, the retrieval mechanism 48 can be disposed at other locations on the pump 2. As shown, the retrieval mechanism 48 can be symmetrically and continuously disposed about the longitudinal axis L. In other configurations, the retrieval mechanism 48 can include multiple distinct surfaces spaced circumferentially and / or longitudinally. In the illustrated embodiment, the motor housing 29 (and motor) can be part of the pump 2 and can be disposed inside the patient's vasculature during use. However, in other embodiments, the motor housing 29 (and motor) can be disposed outside the patient, and a drive cable can be connected to the impeller 6.

[0063] As shown in FIGS. 1A-1C, the drive unit 9 can be configured to impart rotation to the impeller assembly 4 disposed within the pump housing 35 of the pump head 50. As described herein, the drive unit 9 can include a drive magnet 17 (see FIG. 1D) and a motor 30 (see FIGS. 1D-1E) disposed within a motor housing 29 covered by a distal drive unit cover 11. The motor 30 is shown schematically in FIG. 1D. The drive unit cover 11 can be formed by or coupled to a drive bearing 18. The drive magnet 17 can be magnetically coupled to a corresponding driven or rotor magnet (not shown) of the impeller assembly 4 disposed proximal to the impeller 6 within the shroud 16. A power lead 20 can extend from the treatment location outside the patient's body and can provide power (e.g., current) and / or control to the motor 30. Thus, in some embodiments, the rotary drive shaft does not extend outside the patient's body. As described herein, the power lead 20 can energize the motor 30, thereby rotating the drive magnet 17 about the longitudinal axis L, which can serve as, be aligned with, or correspond to the axis of rotation. Rotation of the drive magnet 17 can impart rotation of the primary or first impeller 6 of the rotor magnet and impeller assembly 4 about the longitudinal axis L. For example, as described herein, the rotor magnet (which can be mechanically fixed to the impeller shaft 5) can rotate the impeller shaft 5 (which can serve as a flow conduit) and the first impeller 6 to pump blood. In other embodiments, the drive unit 9 can include a stator or other fixed magnetic device. The stator or other magnetic device can be energized, for example, with alternating current, to impart rotation to the rotor magnet. In the illustrated embodiment, the impeller 6 can have one or more blades 40 extending radially outward along a radial axis R that is radially transverse to the longitudinal axis L.For example, the first impeller 6 may have multiple (e.g., two) longitudinally aligned blades 40 extending radially outward from a common hub and having a common length along the longitudinal axis L. The curvature and / or overall profile may be selected to improve flow rate and reduce shear stress. Those skilled in the art will understand that other designs for the first impeller 5 may be suitable.

[0064] As shown in FIGS. 1A-1C, the impeller assembly 4 can be disposed within a shroud 16. The impeller shaft 5 can be supported at a distal end by a sleeve bearing 15 connected to a distal portion of the shroud 16. A support structure, such as a position identification system 100 (described further below), can include a base 36 coupled to the sleeve bearing 15 and / or the shroud 16. In some embodiments, the base 36, the sleeve bearing 15, and / or the shroud 16 can be welded to one another. In other embodiments, the sleeve bearing 15 and / or the shroud 16 can be formed as a single piece. As shown in FIGS. 1A and 1C, the base 36, the sleeve bearing 15, and the shroud 16 of the support structure or position identification system 100 (which can be part of or function as the support structure) can cooperate to at least partially define a pump housing 35. The localization system 100 can include a plurality of self-expanding struts 19 having convex contact pads 24 configured to contact the vessel wall to maintain spacing of the pump housing 35 from the vessel wall in which the pump housing 35 is located. In FIGS. 1A-1C , the struts 19 of the localization system 100 are shown in an expanded, deployed configuration, with the contact pads 24 extending radially outward to a position where the contact pads 24 contact the vessel wall in which the pump 2 is located, at least partially controlling the position and / or orientation of the pump head 50 relative to the vessel wall during operation of the system 100, e.g., to anchor the pump 2.

[0065] The first fluid port 27 can be provided distal to the impeller assembly 4 at the distal end of the pump housing 35. The shroud 16 can include a proximal ring 26 coupled to the motor housing 29 and a plurality of second fluid ports 25 formed in a proximal portion of the shroud 16 adjacent (e.g., immediately distal to) the proximal ring 26. As shown in FIG. 1C , the second fluid ports 25 can include openings formed between axially extending members 60 (also referred to as pillars) extending along the longitudinal axis L (which can also serve as the longitudinal axis of the pump head 2 and / or pump housing 35) between the proximal ring 26 and the cylindrical section 59 of the shroud 16. In some embodiments, the axially extending members 60 can be shaped or otherwise configured to function as vanes that can shape or direct the flow of blood through the second fluid ports 25. For example, in various embodiments, the axially extending member 60 can be angled, tapered, or curved (e.g., in a spiral pattern) to match the profile of the impeller blades 40 and / or to accelerate blood flow through the pump 2. In other embodiments, the axially extending member 60 may not be angled to match the blades 40. In some embodiments, the first fluid port 27 can comprise an inlet port through which blood enters. In such embodiments, the impeller assembly 4 can draw blood into the first fluid port 27 and expel blood from the pump 2 through the second fluid port 25, which can function as an outlet port. However, in other embodiments, the direction of blood flow can be reversed, in which case the second fluid port 25 can function as a fluid inlet and the first fluid port 27 can function as a fluid outlet.

[0066] As shown in FIGS. 1A-1D, system 1 includes a drive unit 9 having a motor 30 that can be enclosed within a motor housing 29. A drive magnet 17 can be rotatable by motor 30 via a motor shaft 51. Motor 30 can be electrically connected to power lead 20. Power lead 20 can function as a flexible tether comprising an elongated tensile member configured to resist loads applied in opposite directions at both ends of power lead 20. In one embodiment, power lead 20 is hollow, as described further below. As shown in FIGS. 1D and 1F, power lead 20 can include an insulator having a central lumen 55 and multiple (e.g., three) outer lumens 56A-56C extending along the length of power lead 20. One or more conductors can be disposed within hollow elongated power lead 20 and configured to transmit electrical current from a source, such as an external control system, to motor 30. For example, in some embodiments, the outer lumens 56A-56C can be sized and shaped to receive corresponding electrodes or wires (not shown) for powering the motor 30. For example, the lumens 56A-56C can receive wires configured to provide ground and drive voltages to corresponding windings on the motor. The electrodes can extend through corresponding openings 57A-57C in the motor mounting support 54, which is configured to support the motor 30. The central lumen 55 can be sized and shaped to receive an elongated stiffening member or guidewire (not shown). The stiffening member or guidewire can be inserted into the central lumen 55 through an opening 65 in the proximal end 21 (see FIG. 1G) during delivery to guide the pump 2 to a treatment location or to help maintain the pump 2 in a given position. The stiffening member or guidewire can be easily inserted and removed during delivery. As shown in FIG. 1G, connector 23 near proximal end 21 of system 1 can have electrical contacts 58A-58C electrically connected to wires or conductors within corresponding outer lumens 56A-56C.Contacts 58A-58C may comprise rings spaced apart by insulating material and may be configured to electrically connect to corresponding electrical components within a control system or console (not shown).

[0067] Beneficially, the blood flow assist system 1 can be delivered percutaneously to a treatment location on a patient. FIG. 1H shows the pump 2 disposed within an elongate sheath 28. As shown, the struts 19 are held in a collapsed configuration by the inner wall of the sheath 28. As discussed further below, the struts 19 can be configured to collapse in a controlled manner, e.g., such that at least a portion of the struts is biased outward from the inner wall of the sheath 28 when disposed within the sheath. As shown, the struts 19 can include a knee 102 that can help space the distal end of the struts 19 (e.g., at or near the contact pads 24 or hooks) from the inner wall of the sheath 28 such that, in the collapsed configuration within the sheath 28, a space 46 exists between the contact pads 24 or hooks and the inner wall of the sheath 28.

[0068] The knees 102, in one embodiment, can be the same configuration for each of the struts 19. In such an embodiment, the struts 19 may all fold or fold in the same manner within the sheath 28. In another embodiment, the knees 102 of one or more struts 19 can be distinct from the knees 102 of one or more other struts 19 such that the struts fold or fold in different manners. As described herein, in various embodiments, the struts may be longitudinally aligned, longitudinally offset, or staggered. For example, a pair of opposing struts 19 (e.g., positioned radially opposite one another) can have knees 102 that cause the pair of opposing struts to fold before the other struts 19 of the pump 2 fold. In one example, the pump 2 has four struts 19. Two opposing struts 19 are configured to bend at their knees 102 before the knees of the other struts 19 bend. In this manner, two opposing struts 19 can be folded into a position between the other two struts to provide a compact arrangement. The knee 102 can be configured so that some struts undergo a greater degree of bending or folding. Thus, the space 46 between the contact pad 26 and the inner wall of the sheath 28 can be two to six times (possibly three to four times) larger for one or more, e.g., another pair of struts 19, than for one or more, e.g., a pair of struts, which can be provided to avoid strut entanglement. Thus, in various embodiments, some struts can be structured to initially fold upon engagement with the sheath 28, with the remaining struts able to fold as the sheath 28 induces the initial strut to fold.

[0069] In some embodiments, one or more struts include knees 102 that can control the order in which the struts collapse. For example, one or more struts can have a knee 102 that is more proximally positioned relative to the position of the knee 102 of one or more other struts. In one example, two opposing struts 19 can have a knee 102 that is more proximally positioned than the knee 102 of another strut 19. In one example, a first set of opposing struts 19 has a knee 102 that is more proximally positioned than a second set of struts 19 that are positioned approximately 90 degrees offset from the first set of struts 19. This can allow distal advancement of the sheath 28 to more fully collapse the first set of struts 19 before more fully collapsing the second set of struts 19. In further variations, the knees 102 can be longitudinally spaced on adjacent struts 19 so that adjacent struts collapse at different times or speeds. While the illustrated embodiment includes a knee 102, in other embodiments, a knee may not be provided. For example, the struts 19 can be retracted at different rates by hinges and / or by varying the thickness or properties of material within or along the length of one or more struts 19 to control the timing or speed of collapse as the sheath 28 is advanced. Living hinge structures can be formed along the length of one or more struts 19 to control the timing, speed, and / or sequence of retraction of the struts 19. In one example, a region of reduced thickness across the length of the strut 19 causes the strut to collapse or bend as the sheath is advanced across the region of reduced thickness. By offsetting the longitudinal position of the reduced thickness region within the strut 19, the sequence of retraction can be controlled.

[0070] In the collapsed configuration, the struts 19 can be compressed to a diameter or major transverse dimension at one or more locations that is approximately the same as (or slightly smaller than) the diameter of the shroud 16. Thus, as shown in the collapsed configuration of FIG. 1H, at least a portion of the struts 19 is compressed to a diameter or major transverse dimension that is smaller than the major transverse dimension or diameter of the pump housing 35, shroud 16, and / or drive unit 9. In some embodiments, at least a portion of the struts have a major transverse dimension that is equal to or smaller than the major transverse dimension of the pump housing 35. In some embodiments, at least a portion of the struts have a major transverse dimension that is smaller than the major transverse dimension of the pump housing 35 and / or motor housing 29. The patient can be prepared for the procedure in a catheterization lab in standard fashion, and the femoral artery can be accessed via percutaneous or surgical techniques. The sheath 28 (or a dilator structure within the sheath 28) can be passed over a guidewire and positioned at a treatment location, for example, in the descending aorta. After the sheath 28 is positioned (and the dilator removed), the pump 2 can be advanced into the sheath 28, and the pump 2 can be positioned in the mid-thoracic aorta approximately 4 cm below the takeoff of the left subclavian artery. In other embodiments, the pump 2 and sheath 28 can be advanced together to the treatment location. Positioning the pump 2 in this location can beneficially allow for sufficient cardiac support as well as increased perfusion of other organs, such as the kidneys. Once in the treatment location, relative motion can be provided between the sheath 28 and the pump 2 (e.g., the sheath 28 can be retracted relative to the pump 2, or the pump 2 can be advanced from the sheath 28). The struts 19 of the localization system can self-expand radially outward along the radial axis R due to stored strain energy to the deployed and expanded configuration shown in FIGS. 1A-1C. In some embodiments, such as those in which the vasculature is accessed by the femoral artery, the struts 19 can extend distally, e.g., distally beyond the distal end of the shroud 16 and / or impeller 6. In other embodiments, the pump 2 can be delivered percutaneously through the subclavian artery, as described herein.In such embodiments, the struts 19 may extend proximally, e.g., proximal to the pump housing 35 and / or motor housing 29. In yet other embodiments, multiple struts may extend proximally and distally relative to the pump 2. The convex contact pads 24 may engage the vessel wall to stabilize (e.g., help anchor) the pump 2 within the patient's vasculature. Once in position for treatment, the clinician can engage the control system to activate the motor 30, which rotates the impeller assembly 4 to pump blood.

[0071] Thus, in some embodiments, the pump 2 can be inserted into the femoral artery and advanced to a desired treatment location within the descending aorta. In such a configuration, the pump 2 can be positioned such that the distal end 22 is upstream of the impeller 6, e.g., the distally located first fluid port 27 is upstream of the second fluid port 25. For example, in embodiments in which the treatment location is accessed surgically or percutaneously via the femoral artery, the first fluid port 27 can serve as an inlet for the pump 2, and the second port 25 can serve as an outlet for the pump 2. The strut 19 can extend distally beyond the distal end of the pump housing 35. However, in other embodiments, the pump 2 can be inserted percutaneously through the left subclavian artery and advanced to a desired treatment location within the descending aorta. In such a configuration, the pump 2 can be positioned such that the distal end 22 of the system 1 is downstream of the impeller 6, e.g., the distally located first fluid port 27 is downstream of the second fluid port 25. In embodiments where the treatment location is accessed via the left subclavian artery, the second fluid port 25 can serve as an inlet to the pump 2 and the first port 27 can serve as an outlet for the pump 2.

[0072] Once the procedure is complete, the pump 2 can be removed from the patient. For example, in some embodiments, the pump can be withdrawn proximally (and / or the sheath 28 can be advanced distally) so that the distal edge of the sheath 28 engages the radially outwardly facing surface 43 of the strut 19. In some embodiments, the distal edge of the sheath 28 can engage the knee 102 of the strut (see, e.g., FIGS. 2A-3C ). The distal edge of the sheath 28 can exert a radially inward force on the radially outwardly facing surface 43 (e.g., approximately at the knee 102) to collapse the strut 19 and retract it into the sheath 28. To collapse the strut 19 into the sheath 28 in the collapsed configuration, a relative motion opposite to that used to deploy the pump 2 can be provided between the sheath 28 and the pump 2 (e.g., between the sheath 28 and the impeller assembly 4 and pump housing 35). In some embodiments, the pump 2 can be withdrawn from the sheath 28, with the sheath 28 inside the patient's body, and the sheath 28 can then be used for another procedure or removed. In other embodiments, the sheath 28 and pump 2 can be removed from the patient's body together.

[0073] The above description includes an embodiment in which the proximal end of the drive shaft 51 is disposed within the drive unit 9. The proximal end of the drive shaft 51 and the motor 30 are disposed within the body during use. FIG. 1J illustrates another embodiment in which the motor 30A is disposed outside the body during use. An elongated, flexible shaft 51′ is coupled at its distal end to the drive magnet 17. The shaft 51′ extends through the elongated body 20′ and is, or can be, coupled at its proximal end to the motor 30A. The motor 30A can be larger than the motor 30 because it does not need to be disposed within the profile of the sheath 28. The elongated body 20′ can have one or more lumens. The shaft 51′ may extend through a central lumen 55. One or more outer lumens 56a can be provided to channel fluid within the system to lubricate and / or cool the shaft 51′. Rotation of the proximal end of shaft 51' by motor 30a results in rotation of the entire length of shaft 51' through elongated body 20', which in turn results in rotation of drive magnet 17. Rotation of drive magnet 17 causes rotation of one or more magnets within impeller 6, creating flow through pump 2 via magnetic attraction of these magnets across the distal drive unit cover. In other embodiments, shaft 51' can be mechanically coupled directly to impeller 6 so that rotation does not rely on magnetic coupling. One or more shaft rotation supports 54A can be provided within distal housing 29A to support a distal portion of shaft 51'. Elongated body 20' and / or shaft 51' can include tethers to control or assist pump position, for example, to oppose the thrust force of impeller 6 to reduce or minimize movement of pump 2 during operation.

[0074] Further details of pump 2 and associated components shown in Figures 1A-1H can be found throughout International Patent Application No. PCT / US2020 / 062928, filed December 2, 2020, the entire contents of which are incorporated herein by reference in their entirety for all purposes.

[0075] II. Strut As described herein, the support structure or localization system 100 may include a plurality of struts 19. The struts 19 may have a first fixed end 38 at a base 36 coupled to or formed with the shroud 16 and a second free end 39 opposite the first end 38. The struts 19 may extend from a housing of a device, such as an intravascular device (e.g., a pump housing 35), and may include protrusions extending radially and distally outward to provide constant or intermittent contact with a vessel wall 37 (see FIGS. 4A-4B) of the patient's vasculature. As noted above, in other embodiments, the struts 19 may extend proximally relative to the pump housing 35 and / or the motor housing 29. For example, as shown in FIGS. 1A-1C, the struts 19 may extend along a longitudinal axis L distal to the first fluid port 27 and the impeller 6. In embodiments where the vasculature is accessed through the femoral artery, the struts 19 can extend distally and upstream of the first fluid port 27 and the impeller 6. In embodiments where the vasculature is accessed through the subclavian artery, the struts 19 can extend downstream of the fluid port 27. The struts 19 can extend to and at least partially define the distal-most end of the blood flow assist system 1. In some embodiments, no portion of the blood flow assist system 1 is located distal to the distal end of the struts 19. In some embodiments, the struts 19 can be made from a flexible, shape-setting metal or alloy, such as Nitinol. A support structure 100 including multiple struts 19 can be used to provide localization of an intravascular device, such as the pump 2. Using multiple struts 19 allows each of the struts 19 to act against one another, thereby transmitting a radial force to the area of the struts 19 in contact with the vessel wall 37. The multiple struts 19 can also be effective in positioning an intravascular device (such as pump 2) or a portion of an intravascular device relative to the vessel wall 37. For example, multiple struts 19 surrounding a first fluid port 27 (e.g., in some embodiments, an inlet port) of intravascular pump 2 effectively positions inlet port 27 of pump 2 approximately in the center of the vessel 37.The struts 19 for positioning the intravascular device can have a collapsed configuration for travel through a sheath 28 (see FIG. 1H) for deployment or retrieval, and an expanded configuration for providing positioning.

[0076] FIG. 2A is an image showing a front perspective view of a location-locating system 100A, according to one embodiment. FIG. 2B is a schematic side view of the location-locating system 100A of FIG. 2A. FIG. 2C is a schematic plan view of a laser cutting pattern for the location-locating system 100A. FIG. 2D is a schematic side view of a strut 19A having a dome-shaped or spherical contact pad 24A. Unless otherwise noted, components in FIGS. 2A-2D may be the same or substantially similar to like-numbered components in FIGS. 1A-1H, and some reference numbers are appended with the letter "A." For example, as shown in FIGS. 2A-2D, each strut 19A may include an elongated body extending between a first end 38 and a second end 39. Each strut 19A may include a material (e.g., a shape memory alloy) configured to store strain energy when a lateral compressive load is applied, e.g., compressively, along a radial axis R. The stored strain energy can be used, as described herein, to locate and / or maintain positioning relative to the vessel wall 37. For example, the stored strain energy can result in an outward radial force being exerted against the vessel wall 37. The outward radial force can serve, at least in part, to locate, stabilize, and / or position the pump 2 relative to the vessel wall 37.

[0077] In some embodiments, the portion of the strut 19A that contacts the vessel wall 37 can have a desired shape to aid in localization and / or positioning. In some embodiments, a portion of the strut 19A, such as the second end 39 of the strut 19A, can include a contact element 104 configured to be shaped as a substantially flat contact pad 24A. In the illustrated embodiment, the contact pad 24A is shown as being generally round or dome-shaped. Other shaped ends, such as oval ends, may be appropriate. In some embodiments, a contact pad 24 shape that avoids sharp corners and / or edges may be preferred. When deployed, the contact pad 24A can be pressed against the vessel wall 37 by a radial force transmitted by the strut 19A. As the pad 24A presses against the vessel wall 37, the vessel wall 37 can "pillow" around the edge of the pad 24A or form a depression in which the pad sits. The elongate struts can be configured to apply a load to a vessel wall 37 (e.g., an aortic wall) when the contact pads 24A are deployed to locally radially expand the apposed vessel wall tissue. For example, the contact pads 24 can be resiliently deflectable toward and away from the longitudinal axis L of the pump housing 35. The contact pads 24 can have a free state spaced apart from the longitudinal axis L of the pump housing 35 by a distance greater than the half-width of the vessel 37 in which the pump housing 35 is deployed.

[0078] The contact pad 24 can apply sufficient force to the wall of the blood vessel 37 to push or lift a portion of the contact pad 24 into the wall. The contact pad 24 can be configured to engage the wall of the blood vessel 37 without catching on it during application. In some configurations, the struts 19A can flex with vessel wall movement (e.g., with the expansion and contraction of the vessel wall) so that the struts 19A can maintain contact with the vessel 37 as the vessel 37 expands or contracts. This flexing can enhance the ability of the struts 19A and pad 24A to locate an intravascular device (e.g., pump 2) by resisting sliding motion of the pad 24A. The amount of flexing of the pad 24A into the vessel wall 37 (and therefore the amount of flexing) can be controlled by adjusting the radial force that the struts 19A transmit to the contact pad 24A. The pad 24A may have holes or irregular edges to enhance the flexing effect.

[0079] As shown in FIGS. 2E-2G, the struts 19A′ can include contact pads 24B having “slide runner” edges 66 that flare or slope away from the vessel wall 37 to prevent sharp edges from being pressed into the vessel wall 37. As shown in FIGS. 2E-2G, the contact pads 24B can include contact surfaces 67 that engage and press into the vessel wall 37 such that a peripheral portion of the wall 37 extends radially inward relative to at least a portion (e.g., contact surface 67) of the contact pads 24B that engage the wall 37. The profile of the pads 24B in FIGS. 2E-2G, including the edges 66, contact surfaces 67, and elongated members of the struts 19A, can define a convex profile or shape. In the illustrated configuration, the contact surfaces 67 can include a generally planar or flat shape, and the edges 66 can extend at an obtuse angle relative to the contact surfaces 67. In some embodiments, the contact surfaces 67 can include a curved surface, such as a convex spherical or domed surface. Such a design can reduce or minimize the possibility of traumatic damage to the vessel wall 37, de-endothelializing and aiding in removal without damaging the vessel. With sufficient radial force and thrust, such a design can provide stable positioning of the strut contact pads 24A.

[0080] As shown in FIGS. 2A-2B, the struts 19A can include knees 102 that can help keep the struts 19A away from the inner wall of the sheath 28 when the struts 19A are collapsed within the sheath 28, as shown above in FIG. 1H. The sheath 28 can include an inflection where the curvature of the radially outward-facing surface of the struts 19A changes. As shown in FIG. 2B, for example, the struts 19A can include multiple integrally formed and interconnected segments 103a-103d. The first segment 103a can extend distally and radially outward from the base 36A at an angle A relative to the longitudinal axis L. The second segment 103b can extend distally and radially inward from the distal end of the first segment 103a at an angle B relative to the longitudinal axis L. The third segment 103c can extend distally and radially outward from the distal end of the second segment 103b at an angle C relative to the longitudinal axis L. The fourth segment 103d can extend distally and radially inward from the distal end of the third segment 103c at an angle D relative to the longitudinal axis L.

[0081] 2B, the strut 19A can have multiple curvatures and / or angular variations along its length. In various embodiments, angle A can be in the range of 30° to 70°, 40° to 60°, or 45° to 55° relative to the longitudinal axis L. Angle B can be in the range of 10° to 30°, 15° to 25°, or 18° to 24° relative to the longitudinal axis L. Angle C can be in the range of 20° to 60°, 30° to 50°, or 35° to 45° relative to the longitudinal axis L. Angle D can be in the range of 20° to 45°, or 25° to 35° relative to the longitudinal axis L. The base 36A can have a first height H1 in the range of 0.1 inches to 0.3 inches. In the expanded configuration, the radial separation along the radial axis R between the ends of the struts 19A can have a second height H2 in the range of 1 inch to 2 inches, or in the range of 1.2 inches to 1.6 inches.

[0082] Beneficially, using multiple angles and curvatures for the struts 19A can enable the struts 19A to provide sufficient localization and support for the pump 2. Additionally or alternatively, using multiple angles and / or curvatures for the struts can adequately space a portion of the struts, such as the free end of the struts 19A, from the inner wall of the sheath 28. Spaced-out pads 24A from the inner wall of the sheath 28 can reduce friction and / or damage to the struts 19A and / or the sheath as the pump 2 moves in and / or out of the sheath 28. Furthermore, as described above, flat contact pads 24A can beneficially provide an atraumatic interface between the struts 19A and the vessel wall 37 that provides sufficient localization and / or positioning. The struts 19A can be manufactured, for example, by laser cutting a shape memory alloy, as shown in the laser cut pattern in the sheet of material in FIG. 2C. The shape memory alloy (e.g., Nitinol) can be cut by a laser or other device and shaped to form the struts 19A. The patterned material can be folded and / or rolled into a closed, generally cylindrical profile. In other embodiments, the pattern can be cut from an already formed tube.

[0083] In some embodiments, such as shown in FIG. 2D , the contact pad 24A or distal portion of the strut 19A can include a spherical or dome-shaped profile 42 that serves as the contact surface 67. By way of non-limiting example, the spherical profile 42 may be formed as a ball of plastic or other material formed on a portion of the strut 19A to contact the vessel wall 37. For example, as shown in FIGS. 2B-2D , the spherical profile 42 can be disposed on a radially outer surface 43 of the strut 19A configured to face and engage the vessel wall 37. A radially inner wall 44 can be disposed radially opposite the radially outer surface 43. In FIG. 2C , the struts 19A can be circumferentially spaced such that respective gaps 45 exist between adjacent sides of adjacent struts 19A of the plurality of struts 19A. The spherical contact feature 24A can be beneficially atraumatic and can provide good resistance to pillowing and translation. As shown, the contact pads 24A can comprise generally circular (or oval) pads in profile view having a diameter greater than the width of the adjacent extent of the corresponding elongated strut 19A. The contact pads 24A can comprise elongated members and enlarged vessel wall-contacting surfaces (e.g., surfaces 67 in FIGS. 2D-2G ) disposed at the ends of the elongated members. In various embodiments, the contact pads 24A can comprise a convex cross-sectional profile along the radially outer surfaces 43 of the struts 19A that face the vessel wall 37. For example, the contact pads 24A can comprise a convex profile in a cross-sectional plane disposed across the longitudinal axis L of the pump housing 35. In some embodiments, the contact pads 24A can include a smooth surface without sharp edges or hooks. In some embodiments, each of the contact pads 24A can comprise one or more scalloped edges to allow tissue of the vessel wall 37 to be received therein.

[0084] In some embodiments, the localization system 100A can have the goal of resisting, but not eliminating, translation or rotation of a device (such as the pump 2) relative to the vessel wall 37. As a non-limiting example, the design of some struts 19A and / or contact pads 24A can allow for some small rotation of the device within the vessel, even when deployed. However, such designs can also utilize other features described herein to further increase resistance to rotation during operation of the device, such as increased resistance resulting from propulsion.

[0085] Alternatively, some embodiments of the contact pads may be designed to increase resistance to translation and / or rotation relative to the vessel wall 37. FIG. 3A is an image of a front perspective view of another embodiment of a localization system 100B. FIG. 3B is an image of a side view of the localization system 100B of FIG. 3A. FIG. 3C is a schematic side view of the localization system 100B of FIGS. 3A-3B. FIG. 3D is a schematic close-up view of the second end 39 of the strut 19B of FIGS. 3A-3C. FIGS. 3E and 3F are schematic top views of the localization system 100B in a laser cut pattern prior to assembly. Unless otherwise noted, components in FIGS. 3A-3F may be the same or substantially similar to like-numbered components in FIGS. 1A-2C, and some reference numbers are appended with the letter "B." In some embodiments, the contact element 104 (e.g., the portion of the strut 19B that contacts the wall 37 of the vessel) may include hooks 105 designed to penetrate the vessel wall 37 and provide a stable anchor point with a high level of or resistance to translation and / or rotation. Designs with edges or hooks 105 that are in constant contact with the vessel wall are typically intended to provide stable localization and / or positioning so that there is little or no movement of the hooks 105 or edges relative to the initial contact area of the vessel wall 37 upon deployment.

[0086] As shown in FIG. 3C, the strut 19B can include multiple integrally formed and interconnected segments 106a-106d. The first segment 106a can extend distally and radially outward from the base 36B at an angle E relative to the longitudinal axis L. The second segment 106b can extend distally and radially inward from the distal end of the first segment 106a to at least partially define the inflection point and / or knee 102, as described above. The third segment 106c can extend distally and radially outward from the distal end of the second segment 106b at an angle F relative to the longitudinal axis L. The fourth segment 106d can extend proximally rearward from the distal end of the third segment 106c at an angle G relative to the third segment 106c. The third and fourth segments 106c, 106d can function as hooks 105 to secure the pump 2 to the vessel wall 37. As shown in FIG. 3G, which is a plan view of the fourth segment 106d, the fourth segment 106d of the strut 19B can, in some embodiments, include splits 106e with tines that can secure to the vessel wall. As shown, in some embodiments, the tine width t w may be, for example, in the range of 0.01 inches to 0.1 inches, or in the range of 0.01 inches to 0.05 inches.

[0087] As shown in FIG. 3C, struts 19B can have multiple curvatures and / or angular variations along their length. In various embodiments, angle E can range from 30° to 70°, 40° to 60°, or 45° to 55° relative to longitudinal axis L. Angle F can range from 20° to 60°, 30° to 50°, or 35° to 45° relative to longitudinal axis L. Angle G can range from 40° to 80°, 50° to 70°, or 55° to 65° relative to proximally angled segment 106c as shown. Base 36B can have a first height H1 ranging from 0.1 inches to 0.3 inches. In the expanded configuration, the radial separation between the ends of struts 19B along radial axis R can have a second height H2 ranging from 1 inch to 2 inches, or from 1 inch to 1.4 inches. Additionally, as shown in FIG. 3C, the knee portion 102 has a bulge height h that indicates the amount of bulge or prominence defined by the knee portion 102. b The height of the protrusion h b can be measured between the outward apex of the knee portion 102 and the protrusion of the third segment 106c. In various embodiments, the ridge height h b can range from 0.03 inches to 0.09 inches, or from 0.05 inches to 0.07 inches (e.g., about 0.054 inches in one embodiment). Additionally, the fourth segment 106d can function as a tine of the hook 105, with a tine length l extending proximally from the third segment 106c. t The tine length l t may be in the range of 0.03 inches to 0.09 inches, or in the range of 0.05 inches to 0.07 inches (eg, about 0.058 inches in one embodiment).

[0088] Figures 3E-3F show laser patterns for the system 100B of Figures 3A-3D. As shown in Figures 3E-3F, in some embodiments, the struts 19B can be tapered across their width from proximal to distal along their length, i.e., from right to left in Figures 3E-3F. The laser cuts can be non-perpendicular to the longitudinal axis and can form helical or spiral patterns in various configurations.

[0089] FIG. 5A is a schematic perspective view of another embodiment of a localization system 100C. FIG. 5B is a schematic plan view of the laser-cut design of the system 100C of FIG. 5A. Unless otherwise noted, components in FIGS. 5A-5B may be the same or substantially similar to similarly numbered components in FIGS. 1A-4E, and some reference numbers are appended with the letter "C." In some embodiments, as shown in FIGS. 5A-5B, multiple struts 19C may have different lengths. For example, as shown in FIGS. 5A-5B, the system 100C includes struts 19C arranged in a just-a-hat design. As shown, adjacent struts 19C may have different lengths. In some embodiments, every other strut may be designed to have approximately the same length. For example, as shown in FIGS. 5A-5B, a first strut 19C' of the plurality of struts 19C may have a first length, and a second strut 19C'' of the plurality of struts 19C may have a second length 19C'' that is shorter than the first length. The second struts 19C'' may each be circumferentially disposed between the first struts 19C'. Although not shown in FIGS. 5A-5B, the struts 19C may include contact pads 24 at their distal ends. In other embodiments, the struts 19C may include hooks 105 at their distal ends.

[0090] Without being limited by theory, the different lengths may allow the system 100C to be supported against the vessel 37 at multiple longitudinal positions along the length of the vessel 37, thereby improving localization and positioning. For example, in the expanded configuration of the struts 19C', 19C'', the first strut 19C' may engage the vessel wall 37 at a position distal to the position at which the second strut 19C'' engages the vessel wall 37, such that the first strut 19C' and the second strut 19C'' engage the vessel wall 37 at offset longitudinal positions. Engagement of the vessel wall 37 at offset longitudinal positions may beneficially improve stabilization of the pump 2 along multiple planes and may also provide a resistive moment with multiple planes of contact. Additionally, the different lengths of the struts 19C', 19C'' may improve the collapsibility of the struts by allowing the sheath 28 to separately engage the struts 19C' and 19C''. For example, because struts 19C', 19C" have different lengths (and / or curvatures), sheath 28 may first engage with a first set of struts (e.g., struts 19C" in some embodiments) to cause the first set of struts to begin folding. During or after the first set of struts has folded, sheath 28 may subsequently engage with a second set of struts (e.g., struts 19C' in some embodiments) to cause the second set of struts to collapse. Dividing the folding of struts 19C', 19C" into two or more stages can advantageously reduce the amount of force used to fold each strut 19C', 19C".

[0091] It should be understood that any of the support structures disclosed herein can include struts having different lengths. For example, in some embodiments, the plurality of struts (e.g., struts 19 or 19A) includes a first plurality of struts and a second plurality of struts. When the plurality of struts is in the expanded configuration, a first contact element (e.g., contact pad 24 or hook 105) of the first plurality of struts can be configured to engage the vessel wall at a first longitudinal position, and a second contact element (e.g., contact pad 24 or hook 105) of the second plurality of struts can be configured to engage the vessel wall at a second longitudinal position spaced from the first longitudinal position. In some embodiments, the first plurality of struts can have a different length than the second plurality of struts. Additionally or alternatively, the first plurality of struts can have a different radius of curvature (or angle of departure) than the second plurality of struts.

[0092] FIG. 6 is a schematic side view of multiple struts 19D according to various embodiments. In some embodiments, as shown in FIG. 6, a first set of struts 19D' can have elongated portions with a first radius of curvature, and a second set of struts 19D" can have elongated portions with a second radius of curvature that is different from (e.g., less than) the first radius of curvature. In the arrangement of FIG. 6, the first struts 19D' have a steeper withdrawal angle relative to the longitudinal axis L compared to the second struts 19D". As shown in FIG. 6, the angle between the longitudinal axis of the pump 2 and the portion of the second struts 19D" adjacent the base to which the struts are connected can be greater than the corresponding angle of the first struts 19D'. The steeper withdrawal angle of the first struts 19D' can cause the sheath 28 to engage the first struts 19D' before engaging the second struts 19D". This can initiate the collapse of the first struts 19D'. As explained above, staging, staggering, or sequencing the folding of the struts 19D', 19D" can advantageously reduce the force used to collapse the struts to improve operation of the pump 2. By staging, staggering, or sequencing the folding of the struts, the force profile can be tailored over the length of movement of the sheath 28 on the struts 19 to be felt from the initial movement before folding, to the initial folding adjacent the base 36, to the final and complete folding of the struts 19 by advancing the sheath adjacent to or beyond the distal end of the struts. The staging, staggering, or sequencing can reduce the maximum force required over the length of movement of the sheath 28 on the struts 19. Furthermore, the different curvatures of the struts 19D', 19D'' can also allow the distal ends of the struts 19D', 19D'' to engage the vessel wall 37 at offset longitudinal positions, which, as described above, can improve stabilization of the pump 2 due to, for example, multiple contact surfaces or rings with the vessel wall 37.

[0093] Thus, FIG. 6 illustrates an embodiment in which struts 19D′, 19D″ can have approximately the same length longitudinally from proximal to distal ends in the retracted state, but can expand to contact the vessel wall at offset longitudinal positions, e.g., as may be defined by two spaced-apart planes disposed transversely, e.g., perpendicularly, to the longitudinal axis of pump 2. Struts 19D′, 19D″, individually or in groups defining a contact area, can at least intermittently contact the vessel wall over a range of positions along the vessel wall that is 2, 3, 4, 5, 6, up to 10, or up to 100 times the contact length of the strut's contact pad or other vessel wall-contacting surface. It will be appreciated that these types of distributed contact areas can also be provided by struts having different lengths in the retracted state, as in FIGS. 5A-5B . In some embodiments, contact element 104 at second free end 39 of strut 19D can be curled or coiled such that the curled portion contacts vessel wall 37. As a non-limiting example, the second free end 39 of the strut 39D may be curled or coiled (eg, at an angle ranging from about 270° to 360°).

[0094] The contact areas of the contact elements 104 of the struts 19-19D can be designed so that endothelialization over a longer duration does not impede or prevent removal of the intravascular device (e.g., pump 2) or increase the likelihood of trauma to the vessel wall 37 when the device is removed. Generally, single-ended contact shapes can be more easily pulled out from under any endothelialization. In contrast, non-single-ended contact shapes may increase the likelihood of trauma to the vessel wall 37 when the device is removed. In some embodiments having hooks 105, the struts 19B can be shaped so that the action of advancing the sheath 28 to collapse the multiple struts 19B moves the struts 19B like darts from a dartboard, pulling the hooks 105 away from the vessel wall 37 or in the opposite direction from which they were inserted. In some embodiments having contact pads 24, 24A, the pads 24, 24A may be tapered so that they can be pulled out from under the endothelialized tissue by translating the intravascular device (e.g., pump 2). Raising edges of the contact pads 24, 24A (e.g., "thread" type designs) may also prevent restrictive endothelialization.

[0095] The amount of radial force pressing the contact areas at the second free ends 39 of the struts 19-19D against the vessel wall 37 can be varied by changing the number of struts 19-19D, the material of the struts 19-19D, and / or the shape of the struts 19-19D and contact pads 24-24A. Important geometric factors can include, but are not limited to, the length of the struts 19-19D, the cross-section of the struts 19-19D, the angle of attachment of the struts 19-19D to the pump housing 35, and the curvature of the struts 19-19D. Generally, the struts 19-19D have a spring function such that the more the struts 19-19D are compressed by the vessel wall 37, the higher the radial force of the struts 19-19D against the vessel wall 37. The design and shaping of the struts may be selected to reduce this dependency so that the radial force provided by the struts 19-19D is relatively independent of the radius at which the struts are compressed. Equalizing such spring forces among the multiple support columns 19-19D can provide a centering positioning effect.

[0096] In some embodiments, the struts 19-19D can be designed for intermittent contact and have zero radial force unless they are in contact with the vessel wall 37. By way of non-limiting example, the struts 19-19D may have different lengths and / or shapes (e.g., FIGS. 5A-5B). In some embodiments, such as those shown in FIGS. 5A-5B, the struts 19C can be positioned so that not all struts 19C simultaneously contact the vessel wall 37. Additionally, in some examples, the struts 19-19D can be utilized with a device that applies a force to the struts 19-19D during operation (e.g., a gyroscopic effect), thereby varying the force applied to the struts 19-19D. The spring-like nature of the struts 19-19D can facilitate collapse or release in such situations. It should be noted that each strut 19-19D in a plurality of struts can have a different shape or contact area design.

[0097] In some embodiments, the struts 19-19D can have knees 102, as described above. The knees 102 in the struts can function to keep a portion of the struts 19A-19D away from the inner wall of the sheath 28 when the struts 19A-19D are folded within the sheath 28. For example, the knees 102 can function to keep the hooks 105 away from the inner wall of the sheath 28 so that the hooks 105 do not contact the sheath 28 and generate particles through abrasion, cutting, or gouging. The knees 102 can include an inflection zone disposed between the first end 38 and the second end 39, where the second end 39 is resiliently deflectable toward and away from the longitudinal axis L of the pump housing 35. The free state of the strut can keep its second end 39 away from the longitudinal axis L of the pump housing 35. The second ends 39 of the struts can be configured to engage the vessel wall 37 (e.g., to at least intermittently contact the vessel wall 37). The inflection zone can include an S-shaped connection between the first span of the struts and the second span of the struts. The first span and the second span can be arranged along parallel trajectories.

[0098] It can be important to minimize the diameter of the sheath 28 used to implant or retrieve an intravascular device, such as the pump 2. An advantage of the embodiments disclosed herein is that the struts 19-19D can be collapsed to a diameter equal to or less than the diameter of the pump 2 itself, such that a large sheath is not required due to the presence of the struts 19-19D.

[0099] In some embodiments, the multiple struts 19-19D may be designed to contact the vessel wall 37 at multiple cross sections along the central axis of the vessel (e.g., at multiple longitudinal positions). In some embodiments, the multiple struts 19-19D may be attached to the pump 2 at one cross section, but the struts 19-19D may have different shapes and contact the vessel wall 37 at multiple cross sections along the central axis of the vessel. In some embodiments, the multiple struts 19-19D may be attached to the pump 2 at two or more cross sections along the central axis or longitudinal axis L of the pump 2. As a non-limiting example, there may be a set of struts 19-19D at each end of the pump 2 (e.g., at the proximal and distal ends of the pump 2).

[0100] In some embodiments, the plurality of struts 19-19D may be integrated directly into the pump 2 such that the shroud 16 and the struts 19-19D are monolithically formed into a single piece. In other embodiments, the plurality of struts 19-19D may instead be coupled or connected to the pump 2 or may comprise one or more separate pieces. As a non-limiting example, the struts 19-19D may be attached to a ring attached to the pump 2.

[0101] Tether In some embodiments, one or more tethers can be components of the localization and positioning systems 100-100C. Devices such as the pump 2 that utilize a cable or lead for power or infusion can use that cable or lead as a tether. For example, as shown herein, the power lead 20 can function as a tether in the illustrated embodiment. The tether (e.g., the power lead 20) can have an anchor point outside the vessel and / or the patient and can limit translation of the intravascular device (e.g., away from that anchor point). As described herein, for example, the connector 23 at the proximal end 21 of the system 1 can be connected to a console (which can function as an anchor point in some embodiments) outside the patient's body. In some embodiments, the arteriotomy and a pathway through the patient's skin can function as anchor points for the tether. A suture can be used to secure the tether (e.g., the power lead 20) adjacent the proximal end 21 in some procedures.

[0102] promotion One non-limiting example of an intravascular device that can be used with the disclosed embodiments is a blood pump 2A, as shown in FIGS. 4A-4E. As shown in FIG. 4A and described above, a sheath 28 can be percutaneously inserted into a treatment location within a blood vessel, such as the descending aorta. In some embodiments, as shown in FIG. 4B, after placement of the sheath 28, the pump 2A can be pushed distally within the sheath 28 by a stiffening member or guidewire (not shown), which can be positioned within the central lumen 55. In other embodiments, the pump 2A can be preloaded into the sheath 28, and the sheath 28 and pump 2A can be advanced together to the treatment location. As shown in FIGS. 4C-4D, relative motion can be provided between the sheath 28 and the pump 2A to urge the pump 2A out of the sheath 28. The support structure, including struts 19-19D, can self-expand to contact the inner wall of the blood vessel 37. The struts used in the support structure of pump 2A shown in Figures 4A-4E can include any of struts 19-19D described herein. For example, in some embodiments, as shown in Figure 4C, mesh 47 can extend or span between adjacent struts near the distal end of shroud 16. Mesh 47 can extend partially along the length of the strut, for example, within a range of 10% to 70% of the length of the strut. Strut 19A in Figure 4D is shown with contact pad 24. Strut 19A in Figure 4E is shown with hook 105.

[0103] When the struts are deployed, the impeller 6 can be actuated to pump blood. Some blood pumps 2A eject blood in jets 34 or exert large forces during operation. These pumps 2A can generate a counteracting (or driving) force 33 on the pump 2A in the opposite direction of the pump discharge, for example, by pumping downward as shown in FIG. 4D. Some embodiments may be designed to utilize this driving force 33 as a component of the localization system 100-100C. As a non-limiting example, the struts 19-19D can be provided with a shape that causes an increase in spring-like force as a result of the driving force 33; for example, the driving force 33 can further compress the struts 19-19D, increasing the spring force. In various embodiments, the longitudinal component of the thrust force 33 along the longitudinal axis L can be opposed by tension in the tether (e.g., power lead 20). A lateral component of thrust force 33 directed transverse to longitudinal axis L (e.g., along radial axis R) can be opposed by strain energy stored in at least one of the elongated struts 19-19D upon deflection of the struts 19-19D. As described herein, once the procedure is complete, the clinician can provide further relative motion between sheath 28 and pump 2A to collapse struts 19-19D into sheath 28 (see FIG. 1H).

[0104] Beneficially, in various embodiments disclosed herein, the power lead 20 can function as a tether strong enough to counter loads applied in opposite directions at both ends. In some pumps, the thrust force from the pump 2 can be too strong, and if the proximal end of the tether is not sufficiently anchored and / or the power lead 20 is not strong enough, the pump 2 may move through the blood vessel. In such situations, the pump 2 may stretch the tether and / or the tether may not be sufficiently anchored. Beneficially, embodiments disclosed herein can utilize an elongated hollow member and conductor wire that can be strong enough so that, when anchored outside the blood vessel, the longitudinal component of the thrust force generated by the impeller directed along the longitudinal axis of the pump can be adequately countered by the tether. Thus, in various embodiments, the tether (e.g., the power lead 20) can be configured to maintain the position of the pump 2 within the blood vessel without requiring contact between the pump 2 and the vessel wall 37 of the blood vessel.

[0105] In some embodiments, the support structure struts need not contact the wall 37 during operation of the blood pump 2, and the tether can help properly position the pump 2. In some procedures, the struts may contact the vessel wall 37 at least intermittently (e.g., the struts may only intermittently contact the wall 37). In such a configuration, the struts may intermittently contact the wall 37 and move away from the vessel wall 37 throughout the procedure. Thus, the embodiments disclosed herein do not require constant contact between the pump's support structure and the vessel wall 37. Indeed, in such embodiments, the struts may comprise short and / or sturdy struts that can function as bumpers that atraumatically, e.g., elastically, engage the vessel wall 37 intermittently as the pump 2 moves toward the wall 37, pushing the pump 2 back toward a central position in the vessel. In some embodiments, the struts can be omitted, such that the tether and thrust forces establish the position of the pump during operation. However, in other embodiments, the struts may be shaped or configured to maintain substantially constant contact with the vessel wall 37 when in the deployed configuration during use of the pump 2. In still other embodiments, the pump 2 may not include struts, such that the tether can perform its positioning and / or locating function without the struts.

[0106] Exemplary Design The various design features described above can be mixed and matched in any manner desired. The non-limiting example described herein below illustrates one possible embodiment combining the design elements described above and does not represent the boundaries of the potential combinations.

[0107] The systems and methods described herein are used to provide localization and positioning of devices such as intravascular pumps 2, 2A. Multiple struts 19-19D with contact elements 104 protrude from a ring attached to the inlet end of the pump 2. While the embodiment in FIGS. 1A-3G shows four struts 19-19B, any number of struts can be used. For example, as shown in FIGS. 5A-5B, in some embodiments, more than four struts (e.g., six struts 19C) can be used. While the contact pads 24, 24A are shown as circular, contact pads 24, 24A of any shape can be used. The strut shape is designed to provide a set range of radial force at the strut contact pads 24, 24A for vessels within a specific diameter range. The struts 19-19D can also be designed to reduce or minimize the force required for the sheath 28 to collapse the struts 19-19D.

[0108] The circular contact pads 24, 24A can be designed to slide over the arterial inner wall 37 rather than causing trauma. This radial force regulation allows the expansion struts 19-19D to provide consistent positioning of the pump 2, 2a inlet ports 27-27B in the center of the vessel lumen without strictly preventing translation and rotation of the pump 2, 2a. This feature allows for safe translation of the pump 2, 2a, whether intentional (to move the pump 2, 2A to a preferred position) or unintentional (e.g., if the power lead is pulled).

[0109] In some embodiments, providing limited localization is sufficient because the driving force 33 of the pump 2, 2A tends to move it in a superior direction, and / or this movement can be limited by the tether effect of the pump's power lead 20. One advantage of this embodiment is that it provides stable long-term localization while allowing momentary movement of the pump 2, 2A while minimizing or reducing the risk of trauma to the vessel wall 37. This embodiment accommodates greater freedom of movement for patients, for example, when sitting freely, bending at the waist, and / or performing other similar movements.

[0110] In some embodiments, the shape of the struts 19-19D can be modified so that they only intermittently contact the vessel wall 37. In such embodiments, a driving force 33 acting against the tether (e.g., power lead 20) provides localization, and the struts 19-19D maintain the positioning of the ports 27-27B of the pump 2, 2A in the center of the vessel lumen.

[0111] advantage The systems and methods described herein, including but not limited to the embodiments described in detail and illustrated in the drawings, have several advantages, many of which are described above. The following are merely additional, non-limiting examples of advantages, some of which result from the combination of various design elements. a. Struts 19-19D (including struts 19C', 19C'', 19D', and 19D'') are designed so as not to increase the diameter of pump 2 when struts 19-19D are in the collapsed configuration. b. Struts 19-19D (including struts 19C', 19C'', 19D', and 19D'') have knees 102 and hooks 105, whereby knees 102 prevent hooks 105 from contacting the inner surface of sheath 28 during implantation or retrieval of pump 2. c. The atraumatic contact pads 24, 24A are designed to resist but not eliminate translation or rotation of the intravascular device (eg, pump 2, 2A). i. cooperate with the tether (e.g., power lead 20) and propulsion 33; and / or ii. Becomes more resistant to translation over time due to desired endothelialization. d. Intermittent contact positioning (centering) with struts 19-19D (including struts 19C', 19C'', 19D', 19D'') with long-term positioning provided by a propulsive force 33 acting against the tether (e.g., power lead 20).

[0112] The embodiments described herein are included to demonstrate certain aspects of the present disclosure. It should be understood by those skilled in the art that the embodiments described herein merely represent exemplary embodiments (e.g., non-limiting examples) of the present disclosure. In light of this disclosure, those skilled in the art will appreciate that many variations can be made to the specific embodiments described, including various combinations of different elements, components, steps, features, etc., of the described embodiments, and still obtain like or similar results without departing from the spirit and scope of the present disclosure. From the foregoing description, those skilled in the art can readily ascertain the essential features of the present disclosure, and can make various modifications and variations to adapt the present disclosure to various applications and conditions without departing from its spirit and scope. The above-described embodiments are intended to be illustrative only and should not be construed as limiting the scope of the present disclosure.

[0113] Previous work is detailed in U.S. Pat. No. 8,012,079 and U.S. Patent Application Publication No. 2017 / 0087288, both of which are incorporated by reference in their entireties.

[0114] Conditional language such as "can," "could," "might," or "may," unless otherwise specified or understood otherwise within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not. Thus, such conditional language generally does not imply that the features, elements, and / or steps are in any way required for one or more embodiments.

[0115] Terms such as "comprising," "including," and "having" are synonymous and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or" is used in an inclusive (rather than exclusive) sense; for example, when used to connect a list of elements, the term "or" may mean one, some, or all of the elements in the list. Furthermore, the articles "a," "an," and "the," as used in this application and the appended claims, should be construed to mean "one or more" or "at least one," unless otherwise specified.

[0116] Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof. Phrases such as "up to," "at least," "greater than," "less than," "between," and the like, include the recited numbers. Numbers preceded by terms such as "about" or "approximately" are inclusive of the recited numbers and should be interpreted in context (e.g., as precisely as reasonably possible under the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 1" includes "1." Phrases preceded by terms such as "substantially," "generally," and the like, are inclusive of the recited numbers and should be interpreted in context (e.g., as precisely as reasonably possible under the circumstances). For example, "approximately spherical" includes "spherical." Unless otherwise specified, all measurements are made at standard conditions, including temperature and pressure.

[0117] As used herein, a phrase referring to "at least one of" a list of items refers to any combination of those items, including single members. As an example, "at least one of A, B, or C" is intended to encompass A, B, C, A and B, A and C, B and C, and A, B, and C. Connecting words such as "at least one of X, Y, and Z" are otherwise understood in the context in which they are generally used to convey that an item, term, etc. can be at least one of X, Y, or Z, unless otherwise specified. Thus, such connecting words are not generally intended to imply that a particular embodiment requires at least one of X, at least one of Y, and at least one of Z, respectively, to be present.

[0118] While specific embodiments and examples have been described herein, it should be emphasized that many variations and modifications can be made to the humeral head assembly shown and described in this disclosure, and that its elements can be differently combined and / or changed to form further embodiments or acceptable examples. All such modifications and variations are intended to be within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or essential.

[0119] Some embodiments are described in conjunction with the accompanying drawings. However, it should be understood that the drawings are not drawn to scale. Distances, angles, and the like are merely illustrative and do not necessarily bear an exact relationship to the actual dimensions and layout of the depicted devices. Components may be added, removed, and / or rearranged. Furthermore, any particular features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. disclosed herein relating to various embodiments may be used in all other embodiments described herein. Furthermore, it will be recognized that any method described herein may be implemented using any apparatus suitable for performing the recited steps.

[0120] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. It is to be understood that not all such advantages may necessarily be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or implemented to achieve one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0121] Furthermore, while exemplary embodiments are described herein, it will be understood by those skilled in the art that the scope of the present invention extends beyond the specifically disclosed embodiments to any and all embodiments having equivalent elements, modifications, omissions, combinations or subcombinations, adaptations, and / or substitutions of certain features and aspects of the embodiments (e.g., of aspects across various embodiments), and uses of the present invention as would be understood by those skilled in the art based on this disclosure. Any limitations in the claims should be fairly interpreted based on the language used in the claims, and not limited to the examples described herein or during prosecution of the application; the examples should be construed as non-exclusive. Furthermore, the operations of the disclosed processes and methods can be modified in any manner, including rearranging operations and / or inserting additional operations and / or deleting operations. Accordingly, it is intended that the specification and examples be considered exemplary only, with the true scope and spirit being indicated by the appended claims and their full scope of equivalents.

Claims

1. 1. A blood flow assist system comprising: an impeller disposed within a pump housing of the pump, the pump including a longitudinal axis, the impeller generating a thrust force as it operates within a blood vessel to pump blood; a motor operably coupled to the impeller; a tether coupled to a first end of the pump, the tether comprising a hollow elongate member surrounding a conductor disposed therein, the conductor configured to transmit electrical current between the motor and a source connectable to a proximal end of the tether, the tether configured to resist loads applied in opposite directions at both ends thereof; a plurality of elongated struts having a first end coupled to a second end of the pump and a second end opposite the first end, each strut of the plurality of elongated struts comprising an elongated body extending between the first end and the second end, each strut of the plurality of elongated struts configured to store strain energy when a lateral load is applied; a contact pad disposed at the second end of each of the elongated struts of the plurality of elongated struts, each contact pad having an enlarged width compared to the width of the immediately adjacent extent of the corresponding elongated strut of the plurality of elongated struts; Equipped with In use, a longitudinal component of the thrust force generated by the impeller, which is directed along the longitudinal axis of the pump, is opposed by a tension force acting on the tether. Blood flow support system.

2. the contact pads comprise generally circular pads having a diameter greater than the width of the immediately adjacent extent of the corresponding elongated struts; The blood flow assist system of claim 1 .

3. the elongate struts include at least one bend along their elongate bodies to facilitate folding the struts into the lumen of the sheath; The blood flow assist system of claim 1 .

4. each of said contact pads includes a smooth surface without sharp edges or hooks; The blood flow assist system of claim 1 .

5. each of the contact pads having a convex cross-sectional profile on a side facing the blood vessel; The blood flow assist system of claim 1 .

6. each of said contact pads comprising a spherical portion; 6. The blood flow assist system of claim 5.

7. the contact pad comprising a hole configured to allow vessel wall tissue to be received therein; The blood flow assist system of claim 1 .

8. each of the contact pads includes one or more scalloped edges that allow vessel wall tissue to be received therein; The blood flow assist system of claim 1 .

9. each of the contact pads comprises a dome-shaped portion; The blood flow assist system of claim 1 .

10. the hollow elongated member is configured to receive a stiffening member to facilitate introduction of the pump housing; The blood flow assist system of claim 1 .

11. the pump further comprising a motor housing coupled to a proximal portion of the pump housing, the motor being disposed within the motor housing. The blood flow assist system of claim 1 .

12. a lateral component of the thrust force directed in a direction transverse to the longitudinal axis of the pump is opposed by a stress in at least one of the plurality of elongated struts upon deflection of one or more of the elongated struts. The blood flow assist system of claim 1 .

13. a sheath sized and shaped to receive the pump housing, the motor, the tether, and the plurality of elongated struts; kit.

14. the contact pad on each of the plurality of elongated struts is configured to at least intermittently contact a wall of the blood vessel to maintain spacing of the pump housing from the wall in which the pump housing is disposed. The blood flow assist system of claim 1 .

15. the contact pad on each of the plurality of elongate struts is configured to contact the wall of the blood vessel only intermittently, such that the contact pad moves in and out of contact with the wall throughout the procedure.

15. The blood flow assist system of claim 14.

16. each strut of the plurality of elongated struts tapering radially outward and distally from the pump housing to its free end; The blood flow assist system of claim 1 .

17. the second end of each strut is disposed distal to the first end of each strut; The blood flow assist system of claim 1 .

18. the convex cross-sectional profile includes a convex surface transverse to the length of the strut; 6. The blood flow assist system of claim 5.

19. a blood inlet port and a blood outlet port, the blood outlet port being disposed between the blood inlet port and the tether; The blood flow assist system of claim 1 .

20. 1. A blood flow assist system comprising: an impeller disposed within a pump housing of the pump, the pump including a longitudinal axis, the impeller generating a thrust force as it operates within a blood vessel to pump blood; a tether extending away from the pump housing, the tether configured to resist loads applied in opposite directions at both ends thereof; Equipped with a longitudinal component of the thrust force generated by the impeller directed along the longitudinal axis of the pump is opposed by tension acting on the tether, the tether being configured to maintain the position of the pump within the blood vessel without requiring contact between the pump and a vessel wall of the blood vessel. Blood flow support system.

21. a support structure coupled to or formed with the pump housing, the support structure configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed.

21. The blood flow assist system of claim 20.

22. the support structure comprises a plurality of elongated struts having a first end coupled to the pump housing and a second end opposite the first end, each elongated strut of the plurality of struts having an elongated body and extending between the first end and the second end; 22. The blood flow assist system of claim 21.

23. further comprising a convex contact pad disposed on a distal portion of each of the plurality of struts, the convex contact pad configured to at least intermittently contact the vessel wall to maintain spacing of the pump housing from the vessel wall in which the pump housing is disposed.

23. The blood flow assist system of claim 22.

24. the plurality of struts includes a first plurality of struts and a second plurality of struts, and when the plurality of struts is in an expanded configuration, first contact pads of the first plurality of struts are configured to engage the vessel wall at a first longitudinal position and second contact pads of the second plurality of struts are configured to engage the vessel wall at a second longitudinal position spaced from the first longitudinal position; 24. The blood flow assist system of claim 23.

25. the contact pad is disposed distally and radially outwardly of the pump housing and configured to be reversibly deflectable to retain the pump housing within the blood vessel to hold the pump housing away from the vessel wall.

21. The blood flow assist system of claim 20.

26. the contact pad comprises a convex periphery surrounding a convex vessel-engaging surface; 21. The blood flow assist system of claim 20.

27. the contact pad having a convex profile in a cross-sectional plane disposed across the longitudinal axis of the pump; 21. The blood flow assist system of claim 20.

28. the tether comprising a conductor configured to transmit electrical current from a source connectable to a proximal end of the tether to a motor operably coupled to the impeller.

21. The blood flow assist system of claim 20.

29. the pump further comprising a motor housing coupled to a proximal portion of the pump housing, the motor being disposed within the motor housing.

29. The blood flow assist system of claim 28.

30. the tether comprising a rotatable drive shaft connected to a motor located outside the patient's body; 21. The blood flow assist system of claim 20.

31. 21. A kit comprising the blood flow assist system of claim 20 and a sheath sized and shaped to receive the pump housing, the tether, and the support structure.

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