Catheter with expandable and repositionable sheath anchoring system

Abstract

Catheters with anchoring systems provided by an axially moveable sheath configured to provide an anchoring segment that is controllably deployable to expand outward to anchor the catheter in position in the body while allowing blood flow thereabout. The anchoring segment of the sheath has between 2-32 struts that can be one or both of circumferentially spaced apart and extend axially, optionally with an overlapping strut or struts. A connector is configured to lock the anchoring segment in a first low profile shape and in a second outwardly expanded shape with a selectable outer diameter.

Description

Attorney Docket No. 1632.23.WOCATHETER WITH EXPANDABLE AND REPOSITIONABLE SHEATH ANCHORING SYSTEMRelated Applications

[0001] This patent application claims the benefit of and priority to U.S. Provisional Patent Application Serial Number 63 / 707,249, filed October 15, 2024, the contents of which are hereby incorporated by reference as if recited in full herein.Field of the Invention

[0002] This invention relates generally to catheters and is particularly suitable for positioning catheters such as catheter blood pumps.Background

[0003] It can be desirable to anchor catheters in intrabody locations, such as blood vessels or the heart, without requiring external manual stabilization.

[0004] For example, some patients who have heart conditions or are at risk of developing it can receive therapies such as repairs or interventions that may involve valve replacements, stents, drug therapies or other treatments. It may be beneficial to employ cardiac-assist devices to assist the heart before or during a medical or surgical procedure and / or during a recovery period.

[0005] Some cardiac-assist devices include a pump to supplement the heart’s pumping action. By assuming some of the heart’s pumping function, these “blood pumps” unload the heart, helping it to recover.

[0006] Some blood pumps are percutaneous with the impeller (and in some devices, the pump’s motor) residing within the patient. These blood pumps are often coupled to a catheter and are consequently referred to as “catheter blood pumps.” Some catheter blood pumps are inserted into the patient using established cath-lab techniques, wherein they are advanced through the vascular system (typically entering through the femoral artery or the radial artery) to a patient’s heart. This approach is significantly less invasive than cardiac surgery or other relatively complicated procedures.

[0007] Over the years, various types of blood pumps have been developed for the purpose of augmenting or replacing the blood pumping action of damaged or diseased hearts. The pumps may be designed to provide right and / or left ventricular assist, although left ventricle assist is the most common application in that it is far more common for the left ventricle to become diseased or damaged than it is for the right ventricle.Attorney Docket No. 1632.23.WO

[0008] Blood pumps must pump the fluid at a suitable rate without applying excessive Reynolds shear stress to the fluid. It is well known to those skilled in the art that lysis or cell destruction may result from application of shear stress to cell membranes. Red blood cells are particularly susceptible to shear stress damage as their cell membranes do not include a reinforcing cytoskeleton to maintain cell shape.

[0009] Intravascular blood pumps capable of being percutaneously or surgically introduced into the vascular system of a patient typically provide left and / or right heart support. See, e.g., U.S. Patent Number 4,625,712 which describes a multiple stage intravascular axial-flow blood pump which can be percutaneously inserted into an artery for heart assist and U.S. Patent Number 4,846,152 which describes a single-stage intravascular axial flow blood pump, the contents of which are hereby incorporated by reference as if recited in full herein. These blood pumps position the drive unit / motor outside the body (extracorporeal) and use long cable drive systems. The maneuverability and / or durability of these types of blood pumps was often less than desired. During use, components of these devices tended to deteriorate prematurely due to rotational and pulsatile forces experienced by the blood pumps.

[0010] Other intravascular blood pumps are configured so that the drive unit / motor and the impeller are directly connected to each other, with the motor and the impeller (pump) housing having the substantially the same outer diameter. See, e.g., U.S. Patent Number 6,176,848, the contents of which are hereby incorporated by reference as if recited in full herein. While these systems have been used successfully to pump blood, the flow rates provided are typically under 3-4 liters / minute at a counterpressure of about 100 mm Hg. The pumping rate can be limited by the low torque limitation of the small “micro” motors.

[0011] Because some catheters such as catheter blood pumps are not surgically implanted in a patient, it can be desirable to temporarily fix such catheters in a desired location in the patient’s anatomy. This may be particularly true for catheters exposed to blood flow to avoid migration due to pulsatile cardiac activity. For example, in some embodiments, it is desirable to position a catheter blood pump across the aortic valve. In the absence of some way to stabilize the pump, the distal end with the intake port / cage may migrate out of position, e.g., out of the (left) ventricle. It is desirable to anchor such devices in the heart so that they remain in position over numerous cardiac cycles in the face of pulsatile blood flow without blocking blood flow into the aorta.Attorney Docket No. 1632.23.WOSummary

[0012] Embodiments of the present invention provide a catheter with a sheath that extends about at least a portion of the catheter, with the at least a portion of the catheter held therein. The sheath has an anchoring segment that has a first low profile configuration and that is expandable outward to a second configuration sized and configured to engage local tissue to thereby provide an anchoring system for the catheter.

[0013] Embodiments of the present invention provide a catheter assembly that includes a catheter and an anchoring system comprising a sheath extending axially along at least a portion of the catheter. The sheath has an anchoring segment with a plurality of struts. The anchoring segment is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

[0014] A portion of the catheter can extend distally of the anchoring segment in the first and second configurations.

[0015] The anchoring segment of the sheath has a proximal end portion and a distal end portion. The anchoring segment of the sheath can be configured so that one of the proximal end portion or the distal end portion is slidably axially moveable toward the other of the distal end portion or the proximal end portion whereby at least a portion of the plurality of struts of the anchoring segment between the proximal end portion and the distal end portion are configured to expand outward to engage the local tissue.

[0016] The anchoring segment of the sheath has a proximal end portion and a distal end portion. The distal end portion can be affixed to the catheter and a more proximal end portion can be slidably axially movable relative to the catheter whereby the proximal end portion of the anchoring segment of the sheath is slidably moveable distally toward the distal end portion causing the anchoring segment to expand outward and engage local tissue.

[0017] At least some of the plurality of struts can be circumferentially spaced apart and extend in an axial direction.

[0018] The anchoring segment of the sheath can be integral to the sheath so that the anchoring segment is part of a monolithic sheath structure. The anchoring segment can include an axially extending slit between neighboring struts of at least some of the plurality of struts and residing in a defined subset of the sheath positioned between the distal end portion and the proximal end portion of the anchoring segment of the sheath.Attorney Docket No. 1632.23.WO

[0019] The anchoring segment can include a tubular member that comprises the plurality of struts with the catheter extending therethrough. The tubular member can have a proximal or a distal end portion that is affixed to the sheath.

[0020] The anchoring segment can include a tubular member that has a proximal ring and a distal ring. The proximal ring can be affixed to a first portion of the sheath and the distal ring can be affixed to the catheter.

[0021] The plurality of struts can be configured so that at least one of the plurality of struts overlaps one or more other of the plurality of struts.

[0022] At least some of the plurality of struts can have a flat or round cross-sectional shape.

[0023] At least some of the plurality of struts can have a tapered non-symmetric cross-sectional shape over a length thereof.

[0024] At least some of the plurality of struts can have a symmetrically tapered shape over a length thereof.

[0025] At least some of the struts can comprise surface features configured to enhance grip strength and / or increase a coefficient of static friction relative to other portions of the sheath.

[0026] When in the second configuration, at least some of the plurality of struts can have an undulating configuration when viewed from the side.

[0027] The catheter assembly can include a connector affixed to a portion of the sheath, proximal to the anchoring segment, that can be configured to clamp against the catheter to lock the sheath to the catheter when the anchoring segment is in the first and / or second configuration.

[0028] The connector can be configured to be controllably loosened to allow the sheath to slidably axially move either the proximal end portion of the anchoring segment distally toward the distal end portion of the anchoring segment or slidably axially move the distal end portion of the anchoring segment proximally toward the proximal end portion of the anchoring segment to expand the anchoring segment outward to the second configuration. The connector can be configured to allow a user to tighten the connector against the catheter when the segment is in the second configuration to lock the sheath to the catheter to thereby lock the anchoring segment in the second configuration.

[0029] The catheter assembly can have indicia of distance of axial movement of the anchoring segment of the sheath on the catheter at a location proximal to and / or adjacent the connector. The anchoring segment can be configured to allow a user to control axialAttorney Docket No. 1632.23.WO movement of the anchoring segment to allow a user to select a desired maximal outer distance of expansion of the anchoring segment to form the second configuration whereby the second configuration is a user adjustable, selectable second configuration.

[0030] The sheath and connector can be cooperably configured to allow the sheath to be slidably movable when the connector is unlocked to cause the anchoring segment to return to the first configuration or a reduced expanded diameter relative to the second configuration. The anchoring segment can be configured to be re-deployable to the second configuration having the same outer diameter as a first deployment or having a third configuration with a different outer diameter relative to the second configuration and providing an anchoring configuration thereby allowing the catheter and anchoring segment to be repositioned and reanchored while the catheter and sheath are in a body of a patient.

[0031] At least some of the plurality of struts can have a polymer.

[0032] At least some of the plurality of struts have metal, optionally Nitinol.

[0033] At least some of the plurality of struts have a hybrid material that includes a metal and a polymer.

[0034] The plurality of struts can be provided in a number in a range of 2-32.

[0035] The plurality of struts can include a plurality of axially extending struts and at least one strut that overlaps at least some of the plurality of axially extending struts.

[0036] The anchoring system can be configured to allow the anchoring segment to be controllably expanded and locked into position to a selected one of a plurality of different maximal outward distances to form the second configuration.

[0037] The catheter and / or the sheath and / or the anchoring segment can have radiopaque material and / or markers.

[0038] The anchoring segment can have radiopaque material and / or markers.

[0039] One or more of the plurality of struts can have at least one aperture configured to releasably engage local tissue.

[0040] The catheter can be a catheter blood pump that includes an impeller, and the anchoring segment of the sheath can be configured to allow blood to flow thereabout. The anchoring segment can reside proximal to the impeller of the catheter blood pump.

[0041] The anchoring segment in the second configuration can have a maximal outer diameter in a range of about 20 mm to about 60 mm.

[0042] In operative in vivo position, a distal end portion of the catheter can axially extend distally beyond a distal end of the sheath in a range of about 1 inch and 10 inches.Attorney Docket No. 1632.23.WO

[0043] Still other embodiments are directed to a catheter blood pump that includes: a catheter comprising a blood intake portion; an outlet cage in fluid communication with the blood intake portion and at least partially surrounding an impeller; and an anchoring system with a sheath surrounding and extending axially along at least a portion of the catheter. The sheath includes an anchoring segment with a plurality of struts. The anchoring segment is located proximal to the outlet cage and is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

[0044] At least some of the plurality of struts can be circumferentially spaced apart and can extend in an axial direction.

[0045] At least one of the plurality of struts can overlap at least some of the other plurality of struts.

[0046] The outlet cage and the impeller can be expandable.

[0047] The sheath can be a first sheath and the catheter blood pump can have a second sheath that extends axially along at least a portion of the catheter over or under the first sheath. The second sheath can be configured to extend and retract relative to the outlet cage and the impeller to constrain the outlet cage and impeller during intrabody placement and to expose the outlet cage during normal operation.

[0048] The second sheath can reside inside the first sheath and the distal end portion of the first sheath can be affixed to the second sheath.

[0049] One or more of the plurality of struts can include at least one through hole configured to releasably engage local tissue when the anchoring segment is in the second configuration.

[0050] The anchoring system can be configured to allow the anchoring segment to be controllably expanded and locked into position to a selected one of a plurality of different maximal outward distances to form the second configuration.

[0051] The anchoring segment of the sheath can have a proximal end portion and a distal end portion and can be configured so that the proximal end portion is slidably axially moveable toward the distal end portion forcing at least a portion of the anchoring segment between the proximal and distal end portions to move distally and expand outward to engage the local tissue.

[0052] The distal end portion can be affixed to the catheter and a more proximal end portion can be slidably axially movable relative to the catheter whereby the proximal endAttorney Docket No. 1632.23.WO portion of the anchoring segment of the sheath can be slidably moved distally toward the distal end portion causing the anchoring segment to expand outward and engage local tissue.

[0053] The anchoring segment can be integral to the sheath so that the anchoring segment is an integral part of the sheath structure and provided with slits in a defined subset of the sheath between the distal end portion and the proximal end portion of the anchoring segment of the sheath.

[0054] The anchoring segment can be provided as a discrete tubular member that is affixed to the sheath.

[0055] The anchoring segment can have struts that are flat, round or other cross- sectional shapes.

[0056] The anchoring struts can have surface features such as textures, patterns and / or shapes that can increase friction or mechanical engagement with local tissue that can enhance grip strength against tissue while still being atraumatic.

[0057] The anchoring segment can be configured to apply longitudinally spaced apart pressure contact areas against local tissue.

[0058] The anchoring segment can be provided as a polymer such as, for example, a polyamide.

[0059] The anchoring segment can be provided as a metal such as, for example, Nitinol.

[0060] The anchoring segment of the sheath that is expandable can be sized and configured to sufficiently expand from the first configuration to the second configuration to abut tissue such as a wall(s) of anatomy in which it resides, such as the ascending aorta.

[0061] The anchoring system can include a control device that is coupled to a proximal end portion of the sheath and that can tighten to lock against the sheath and loosen to allow a portion of the sheath to be advanced distally to cause the anchoring segment into the second configuration.

[0062] The anchoring system can be configured to allow the anchoring segment to be expanded to a number of different outward distances based on the longitudinal / axial distance that the portion of the sheath is advanced to form the second configuration.

[0063] The anchoring system can include indicia of travel distance of the sheath that can be used to slidably advance the portion of the sheath to form the second configuration.

[0064] Embodiments of the present invention are directed to a catheter blood pump that includes a catheter with an impeller and an outlet cage at least partially surrounding theAttorney Docket No. 1632.23.WO impeller and with the sheath anchoring system arranged about the catheter proximal to the impeller.

[0065] On introduction of the catheter blood pump into the patient, the sheath is in the low-profile first configuration and when the anchoring segment is at a target anchoring site, the anchoring segment is expandable by slidably advancing a proximal end of the anchoring segment relative to the distal end of the anchoring segment and the catheter to project a desired outward distance to form a second expanded configuration. The sheath can be slid proximally to return to the first configuration and withdrawn from the patient with the catheter or repositioned in the patient by again slidably advancing the sheath distally to move the segment to again expand to the second configuration at the same or a different location in the patient and with the same maximum outer diameter or a different outer diameter.

[0066] Other embodiments are directed to a catheter assembly that includes: a catheter; and an anchoring system comprising a sheath extending axially along at least a portion of the catheter. The sheath has an anchoring segment with a plurality of circumferentially spaced apart, axially extending struts. The anchoring segment is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

[0067] The anchoring segment of the sheath can have a proximal end portion and a distal end portion. The anchoring segment of the sheath can be configured so that the proximal end portion is slidably axially moveable toward the distal end portion forcing at least a portion of the anchoring segment between the proximal and distal end portions to expand outward to engage the local tissue.

[0068] The anchoring segment of the sheath can have a proximal end portion and a distal end portion, and the distal end portion can be affixed to the catheter and a more proximal end portion can be slidably axially movable relative to the catheter whereby the proximal end portion of the anchoring segment of the sheath is slidably moved distally toward the distal end portion causing the anchoring segment to expand outward and engage local tissue.

[0069] The anchoring segment of the sheath can be integral to the sheath so that the anchoring segment is part of a monolithic sheath structure. The anchoring segment can have a plurality of circumferentially spaced apart and axially extending slits, one slit between neighboring struts, residing in a defined subset of the sheath positioned between the distal end portion and the proximal end portion of the anchoring segment of the sheath.Attorney Docket No. 1632.23.WO

[0070] The anchoring segment can be provided as a tubular member that has the struts. The tubular member can have a proximal end portion that is affixed to the sheath.

[0071] The anchoring segment can have a tubular member that includes a proximal ring and a distal ring. The proximal ring can be affixed to a first portion of the sheath and the distal ring is affixed to the catheter.

[0072] The struts can have a flat cross-sectional shape.

[0073] The struts can have a round cross-sectional shape.

[0074] The struts can have surface features configured to enhance grip strength and / or increase a coefficient of static friction relative to other portions of the sheath.

[0075] When in the second configuration, the struts can have an undulating configuration when viewed from the side.

[0076] The catheter assembly can further include a connector affixed to a portion of the sheath, optionally a proximal end portion of the sheath, proximal to the anchoring segment, that clamps against the catheter to lock the sheath to the catheter when the anchoring segment is in the first configuration.

[0077] The connector can be configured to be controllably loosened to allow the sheath to be axially advanced to slidably axially move the proximal end portion of the anchoring segment distally toward the distal end portion of the anchoring segment and expand the anchoring segment outward to the second configuration.

[0078] The connector can be configured to allow a user to tighten the connector against the catheter when the segment is in the second configuration to lock the sheath to the catheter to thereby lock the anchoring segment in the second configuration.

[0079] The catheter assembly can further include indicia of distance of advancement of the anchoring segment of the sheath on the catheter at a location proximal to and / or adjacent the connector, wherein the axial advancement of the proximal end portion of the anchoring segment is controllable to allow a user to select a desired maximal outer distance of expansion of the anchoring segment.

[0080] The sheath and connector can be further cooperably configured to allow the sheath to be slidably movable in a proximal direction when the connector is unlocked to cause the anchoring segment to return to the first configuration.

[0081] The anchoring segment can be re-deployable to the second configuration to be repositioned while the catheter and sheath are in a body of a patient.

[0082] The struts can be formed of a polymer.

[0083] The struts can be formed of metal, optionally Nitinol.Attorney Docket No. 1632.23.WO

[0084] The struts can be provided in a number in a range of 2-32.

[0085] The anchoring system can be configured to allow the anchoring segment to be controllably expanded to a selected one of a number of different maximal outward distances to form the second configuration based on an axial distance the sheath is advanced to form the second configuration.

[0086] The catheter and / or the sheath can have radiopaque material and / or markers.

[0087] The anchoring segment can include radiopaque material and / or markers.

[0088] The catheter can be a catheter blood pump.

[0089] The anchoring segment of the sheath can be configured to allow blood to flow thereabout.

[0090] The anchoring segment of the sheath can reside proximal to an impeller of the catheter blood pump.

[0091] The second configuration can have a maximal outer diameter in a range of about 20 mm to about 60 mm, optionally about 40 mm.

[0092] Yet other embodiments are directed to a catheter blood pump that includes: an impeller; an outlet cage at least partially surrounding the impeller; a catheter having a blood intake segment and a blood output segment, the blood output segment having an impeller; and an anchoring system that includes a sheath extending axially along at least a portion of the catheter. The sheath has an anchoring segment with a plurality of circumferentially spaced apart, axially extending struts. The anchoring segment is located proximal to the outlet cage and is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

[0093] A distal end portion of the sheath can be configured to be axially moveable relative to the catheter to cause the anchoring segment to return to the first configuration or to a reduced maximal outer diameter relative to the second configuration for repositioning in vivo. The anchoring segment can be configured to be re-deployable to the second configuration having the same outer diameter as a first deployment to an anchoring configuration providing the second configuration or to a third configuration having a different maximal outer diameter relative to the second configuration thereby allowing the catheter and anchoring segment to be repositioned and re-anchored while the catheter and sheath are in a body of a patient, optionally while the anchoring segment remains in a target region of a heart of the patient.

[0094] The outlet cage and impeller can be expandable.Attorney Docket No. 1632.23.WO

[0095] The sheath can be a first sheath and the catheter blood pump can include a second sheath extending axially along at least a portion of the catheter over or under the first sheath. The second sheath can be configured to extend and retract relative to the outlet cage and impeller to constrain the outlet cage and impeller during intrabody placement and to expose the outlet cage during normal operation.

[0096] The second sheath can reside inside the first sheath.

[0097] The distal end portion of the segment of the first sheath can be affixed to the second sheath.

[0098] One or more of the struts can have at least one through hole, optionally, a plurality of longitudinally spaced apart through holes, configured to releasably engage local tissue when the anchoring segment is in the second configuration.

[0099] Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention.

[0100] It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and / or features of any embodiment can be combined in any way and / or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and / or incorporate any feature of any other claim although not originally claimed in that manner. These and other objects and / or aspects of the present invention are explained in detail in the specification set forth below.Brief Description of the Drawings

[0101] FIG. 1A is an enlarged partial side view of a catheter with an anchoring system comprising a sheath with a segment that can be controllably expanded according to embodiments of the present invention.

[0102] FIG. IB is an enlarged side view of a portion of the catheter and anchoring system shown in FIG. 1A with the segment of the sheath expanded to define an anchor according to embodiments of the present invention.

[0103] FIG. 1C is an enlarged side view of a portion of the catheter and anchoring system similar to that shown in FIG. 1A with the segment of the sheath expanded to define an anchor but with the distal end of the anchoring segment configured to move toward theAttorney Docket No. 1632.23.WO proximal end of the anchoring segment to form the expanded configuration according to embodiments of the present invention.

[0104] FIG. 2A is an enlarged partial side view of a catheter with an anchoring system comprising a sheath with a segment that can be controllably expanded according to additional embodiments of the present invention.

[0105] FIG. 2B is an enlarged side view of a portion of the catheter and anchoring system shown in FIG. 2A with the segment of the sheath expanded to define an anchor according to embodiments of the present invention.

[0106] FIG. 3 is a section view taken along line 3-3 in FIG. IB showing the expanded sheath segment about the catheter.

[0107] FIG. 4 is a schematic illustration of the catheter with the anchoring system shown in FIGS. IB or 1C with the anchor expanded in the aorta of the heart according to embodiments of the present invention.

[0108] FIGS. 5A and 5B are side schematic views of example strut configurations according to embodiments of the present invention.

[0109] FIG. 5C is a schematic side view that shows two neighboring struts arranged to have a nested configuration according to embodiments of the present invention.

[0110] FIG. 5D is a top view of an example projection of FIG. 5B illustrating an example aperture therethrough according to embodiments of the present invention.

[0111] FIGS. 6A and 6B are side schematic views of yet other example strut configurations according to embodiments of the present invention.

[0112] FIGS. 7A is a side schematic view of another example strut configuration according to embodiments of the present invention.

[0113] FIG. 7B is a top view of the strut configuration shown in FIG. 7A.

[0114] FIGS. 8A is a side schematic view of another example strut configuration according to embodiments of the present invention.

[0115] FIG. 8B is a top view of the strut configuration shown in FIG. 8A.

[0116] FIG. 8C is an enlarged view of one of the surface features of the strut shown in FIGS. 8A and 8B.

[0117] FIG. 8D are schematic cross-sectional views of example shapes of struts for the expandable sheath segment according to embodiments of the present invention.

[0118] FIG. 9A is an enlarged side view of an example anchoring segment with struts according to embodiments of the present invention.Attorney Docket No. 1632.23.WO

[0119] FIG. 9B is an end view of the segment of the anchoring segment shown in FIG. 9A

[0120] FIG. 9C is an end view of another example anchoring segment with wide struts according to embodiments of the present invention.

[0121] FIGS. 9D-9G are side views of yet other example embodiments of an anchoring segment with example strut configurations according to embodiments of the present invention.

[0122] FIG. 10A is a partial section view of a catheter blood pump with the sheath in a first, low-profile configuration according to embodiments of the present invention.

[0123] FIG. 10B is a partial section view of the catheter blood pump shown in FIG. 10A with the sheath providing an expanded segment defining an anchor according to embodiments of the present invention.

[0124] FIG. 11 is another embodiment of a catheter and sheath anchoring system illustrating a sheath over sheath configuration according to embodiments of the present invention.

[0125] FIG. 12 is another embodiment of a catheter and sheath anchoring system illustrating a sheath over sheath configuration according to embodiments of the present invention.

[0126] FIG. 13 is a schematic illustration of a catheter blood pump with the sheath anchoring system with the anchor in the expanded position in the aorta above an impeller and blood outlet cage according to embodiments of the present invention.

[0127] FIG. 14 is a block diagram of a catheter blood pump with the sheath anchoring system according to embodiments of the present invention.Detailed Description

[0128] The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout. The abbreviation “FIG.” may be used interchangeably with “Fig.” and the word “Figure” in the specification and figures. It will be appreciated that although discussed withAttorney Docket No. 1632.23.WO respect to a certain embodiment, features or operation of one embodiment can apply to others.

[0129] In the drawings, the thickness of lines, layers, features, components and / or regions may be exaggerated for clarity and broken lines (such as those shown in circuit of flow diagrams) illustrate optional features or operations, unless specified otherwise. In addition, the sequence of operations (or steps) is not limited to the order presented in the claims unless specifically indicated otherwise.

[0130] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0131] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and / or clarity.

[0132] It will be understood that when a feature, such as a layer, region or substrate, is referred to as being "on" another feature or element, it can be directly on the other element or intervening elements may also be present. In contrast, when an element is referred to as being "directly on" another feature or element, there are no intervening elements present. It will also be understood that, when a feature or element is referred to as being "connected" or "coupled" to another feature or element, it can be directly connected to the other element or intervening elements may be present. In contrast, when a feature or element is referred to as being "directly connected" or "directly coupled" to another element, there are no intervening elements present. Although described or shown with respect to one embodiment, the features so described or shown can apply to other embodiments. The term “about” with respect to aAttorney Docket No. 1632.23.WO number means that the noted number can vary by + / - 20%. The devices described herein are particularly suitable for human use but may be used for animals as well.

[0133] Referring to FIGS. 1 A, IB, 1C, 2A, 2B, 3 and 4, an example catheter assembly 10a is shown with a sheath 20 positioned over a catheter 10 and extending axially along at least a portion of the length of the catheter 10. The sheath 20 comprises an anchoring segment 30 that is expandable and comprises struts 31. Neighboring struts 31 can be separated by a longitudinally extending gap space 36. The anchoring segment 30 can have a first configuration 30i arranged to be low profile as shown in FIGS. 1 A, 2 A and an expanded second configuration 302 as shown in FIGS. IB, 1C, 2B, 3 and 4. In the expanded second configuration, the anchoring segment 30 of the sheath 20 is expanded sufficiently to engage local tissue T. In some embodiments, as shown in FIG. 4, the local tissue T can be the wall of the aorta Aw.

[0134] The anchoring segment 30 of the sheath 20 has a proximal end portion 3 Op and a distal end portion 30d. The distal end portion 30d may define the distal end portion 20d of the sheath 20 or the sheath 20 may extend distally of the distal end portion 30d of the anchoring segment 30.

[0135] In some embodiments, the distal end portion 30d of the anchoring segment 30 can be affixed to the catheter 10. The proximal end portion 30p of the segment 30 can be configured to slidably axially advance from the first position Pl corresponding to a nonexpanded configuration as shown in FIG. 1 A to a second position P2 as shown by way of example in FIG. IB. As shown in FIG. IB, the second position P2 is distal of the first position Pl to be positioned closer to the distal end portion 30d of the segment. Position P2 can be user-selected to be at any desired distance distal of the first position Pl and proximal to the position of the distal end 30d of the anchoring segment 30 when the anchoring segment 30 is in the first non-expanded configuration.

[0136] Referring to FIG. 1C, the distal end portion 30d of the anchoring segment 30 can be configured to slidably axially translate from a first position Pl to a user-selectable second position P2 that is closer to the proximal end portion 30p of the anchoring segment 30 to form the second expanded configuration. The proximal end portion 3 Op can be affixed to the catheter 10.

[0137] In some embodiments, the sheath 20 can comprise one or both of a distal ring 32 and / or a proximal ring 34 with the expandable anchoring segment 30 therebetween. The distal ring 32 or the proximal ring 34 can be affixed to the catheter 10 and be substantially constant in size and shape so as to not change between the first and second configurations ofAttorney Docket No. 1632.23.WO the anchoring segment 30. For the embodiment discussed with respect to FIGS. 1 A and IB, the proximal ring 34, where used, can be attached to a free end portion of the sheath 20 and the proximal ring 34 can also have a substantially constant size and shape, even when the expandable segment 30 expands to the second configuration. The proximal ring 34, where used, can axially slidably travel toward the distal ring 32 to cause the struts 31 to expand outwardly. When retracted axially, the proximal end portion 30p of the anchoring segment 30, which can optionally comprise the proximal ring 34, pulls the struts 31 back to a smaller, partially expanded second configuration (for in vivo repositioning, for example) or to the first configuration (for withdrawal from the body of the patient), while the distal ring 32 can remain in position relative to the catheter 10.

[0138] For the embodiment discussed with respect to FIG. 1C, the distal end portion 30d of the anchoring segment 30, either the sheath 20 and / or the distal ring 32, where used, can axially slidably travel toward a more proximal portion of the sheath and / or the proximal ring 34. When extended axially, the distal ring 32 pulls the struts 31 back to a smaller outer diameter configuration or to the non-expanded configuration for repositioning or withdrawal from the body of the patient. The more proximal portion of the sheath and / or the proximal ring 34 can remain in a fixed position relative to the catheter 10.

[0139] Thus, for in vivo repositioning, the struts 31 can be reconfigured to either have a smaller outer diameter of a second, partially expanded configuration or collapsed to the original non-expanded low-profile configuration 30i (FIG. 1A).

[0140] The proximal ring 34, where used, can have a different axial extent than the distal ring 32, where used. Where both a proximal ring and a distal ring, 34, 32, respectively are used, the proximal ring 34 and the distal ring 32 can be formed of different materials than the sheath 20 and / or each other.

[0141] The anchoring segment 30 can be provided as a separate component from the sheath 20 and can be provided in a different material(s) from the sheath 20.

[0142] The anchoring segment 30 can be provided as an integral part of the sheath structure by forming one or more circumferentially spaced apart and axially extending gap spaces 36, e.g., slits, of suitable size along a subset of the sheath 20 to form the struts 31 as an integrated structure with the sheath body itself thereby simplifying fabrication. In some embodiments, the sheath 20 at the anchoring segment 30 providing the struts 31 can form a base layer of a material of the struts 31 which can be sandwiched between other material layers or which can be provided as an outer or inner layer of a respective strut 31.Attorney Docket No. 1632.23.WO

[0143] The sheath 20 and / or the anchoring segment 30 can be “tuned” to have different thicknesses and / or materials along a respective length of the sheath 20 and / or the anchoring segment 30.

[0144] The anchoring segment 30 can be provided using surgical grade material(s) and can be biocompatible, non-cytotoxic. The anchoring segment 30 can be provided as metal or polymer or copolymer struts 31 or combinations of materials such as hybrid materials comprising one or more polymers, copolymers and metal. The struts 31 can comprise polyamide and / or polyimide material. Multi-layer laminated structures can also be used for the struts 31.

[0145] The struts 31 may comprise a a shape memory alloy (SMA) and / or nickel titanium, also known as “Nitinol.” In some embodiments, the SMA and / or Nitinol is coated with a material that provides at least one of the following benefits: (i) is softer on the arterial wall than Nitinol, (ii) inhibits cell growth, (iii) reduce thrombus / blood clots. With respect to item (ii), the desire is to inhibit cell growth that might otherwise encapsulate the Nitinol, etc., in the arterial wall. The coating material can be a suitably selected grade of PEBAX® MED brand poly ether block amide, commercially available from Arkema Inc., King of Prussia, PA.

[0146] The struts 31 for a respective anchoring segment 30 can have the same or different materials, have the same or different thicknesses, the same or different lengths, and / or have the same or different circumferentially extending widths. The struts 31 can be symmetrically positioned or asymmetrically positioned about the catheter 10.

[0147] The proximal end portion 3 Op of the anchoring segment 30 can be controllably axially moved a selected distance as the axial travel / movement determines a maximal outer diameter of the struts 31 in the second configuration (FIG. IB, 1C, 3). This distance can be controlled by a user to allow for selectable outer diameters for different patients or the same patient for different positions of the anchoring segment 30 of the sheath 20 in a body of a patient.

[0148] The struts 31 can have a length L that, with the controlled axial movement, allows a user to select an outer diameter of the second expanded configuration of the expandable anchoring segment 30, that is appropriate for different uses or different patients in view of scarring or other patient-specific anatomical issues / features.

[0149] The length L of the anchoring segment 30, measured in the first configuration corresponding to the non-expanded, fully extended position whereby the struts 31 are at rest and not axially compressed to expand outwardly can be in a range of about 3 mm to about 100 mm.Attorney Docket No. 1632.23.WO

[0150] The length L can be selected to be able to form a maximal outer diameter in the second configuration, measured side-to-side to contact local tissue T (FIG. IB, 1C) thereat across the catheter 10, can be in a range of about 10 mm to about 60 mm, or in a range of about 20 mm to about 40 mm, in some embodiments.

[0151] The anchoring segment 30 can be for anchoring in an aorta of a human adult or child (pediatric use), a user can select the length L providing a user controlled / selectable maximal outer diameter of the expanded anchoring segment 30.

[0152] In some embodiment, each strut 31 can have a maximal outward expansion in a selected second configuration that is in a range of about 3 mm to about 40 mm.

[0153] For positioning in a peripheral vessel location such as a leg, the length L in the first configuration can be in a range of about 5 mm to about 15 mm and / or be configured to provide a maximal outer diameter of the anchoring segment 30 in the second configuration in a range of about 3 mm to about 40 mm.

[0154] A portion of the catheter 10 can extend distally of a distal end 20d of the sheath 20. A portion of the catheter 10 proximal to the proximal end 20p of the sheath 20 can extend externally of the sheath 20.

[0155] A connector 40 can couple the sheath 20 to the catheter 10. The connector 40 can be configured to lock the sheath 20 so that the anchoring segment 30 is in the low-profile configuration 30i for positioning and / or retracting the catheter assembly 10a from the body. The connector 40 can also be configured to lock the sheath 20 to have the anchoring segment 30 in the expanded, second configuration 302 and can also be configured to loosen to reposition or withdraw the catheter assembly 10a from the patient.

[0156] In some embodiments, the connector 40 can be a Touhy-Borst (“T-B”) type connector providing the lock and can be configured to prevent fluid (e.g., blood) backflow. As is known to those of skill in the art, a T-B connector 40 can be configured to clamp down on a seal such as an O-ring when the connector knob is tightened, which then clamps down on an inner sheath or catheter without damaging the inner sheath or catheter. Touhy-Borst connectors / adapters can be obtained from different commercial companies including, for example, Cook Medical, LLC, having a place of business in Bloomington, Indiana. In some embodiments, as will be understood by one of skill in the art, the main body of the Touhy- Borst connector can have external male threads that couple to internal threads of a cap with a receiving channel that rotatably receives the male threads. The main body can rotate relative to the cap to lock and unlock the sheath from the catheter body. Intermediate silicone and metal sleeves can be used to seal the sheath 20 to the outer surface of the catheter body.Attorney Docket No. 1632.23.WO

[0157] The connector 40 can couple to the sheath 20 and tighten to clamp against the catheter 10 to lock the anchoring segment 30 in a desired position. The connector 40 can be loosened to allow the sheath 20 to slidably travel relative to the catheter 10 to cause the anchoring segment 30 to form the expanded second configuration and to return the anchoring segment 30 to the first configuration or to a partially expanded or different size expansion of the anchoring segment 30. The connector 40 can then be tightened to lock the anchoring segment 30 in a selected second expanded configuration. The connector 40 can be loosened to unlock the expanded anchoring segment 30 and allow the sheath 20 to retract axially for some embodiments, e.g., FIGS. 1A, IB, or to extend axially for the embodiment of FIG. 1C, to return the anchoring segment 30 to the first (non-expanded) configuration and / or a different size second expanded configuration. The anchoring segment 30 can be repositioned / redeployed as needed during use by repeating these actions while the catheter and sheath remain in the body of the patient proximate a target anchoring site(s).

[0158] The anchoring segment 30 and / or a distal end portion of the sheath 20 can be configured to be axially moveable relative to the catheter 10 to cause the anchoring segment to return to the first configuration or to a reduced maximal outer diameter relative to the second configuration for repositioning in vivo. The anchoring segment can be configured to be re-deployable to the second configuration having the same outer diameter as a first deployment to an anchoring configuration providing the second configuration or to a third configuration having a different maximal outer diameter relative to the second configuration thereby allowing the catheter and anchoring segment to be repositioned and re-anchored while the catheter and sheath are in a body of a patient.

[0159] In operative in vivo position, a distal end portion of the catheter 10 can axially extend distally beyond a distal end 30d of the anchoring segment and a distal end of the sheath 20 in a range of about 1 inch and 10 inches.

[0160] The connector 40 can have an O-ring that is elastically compressible and attached to the sheath 20 whereby the O-ring compresses to clamp against the catheter 10 when the connector is locked and loosens to decompress the O-ring to unlock the sheath 20 from the catheter 10.

[0161] The catheter assembly 10a can have indicia 50 of travel or axial movement on the catheter 10 so that the indicia are visible and / or provided as a tactile haptic interface and available to a user, typically externally accessible / visible. The indicia 50 is shown as graduated marks or surface features on the catheter 10 adjacent and proximal to the connector 40.Attorney Docket No. 1632.23.WO

[0162] As indicated by the hatch marks in FIG. 1 A, the segment 30, such as one or more of a distal end portion 30d, a proximal end portion 30p and / or one or more struts 31, can comprise radiopaque material 35 which can be the material of one or more of the material of the segment, such as the struts 31 themselves or provided by coatings, beads or markers. By way of example, a platinum ring 35r can provide a radiopaque marker 35. This can allow a user to confirm positioning before or after expanding the segment 30.

[0163] The struts 31 can be provided in any suitable number to provide the desired anchoring support for the location of interest, such as to withstand pulsatile blood flow while blood flows about the struts 31 in the expanded configuration of the segment 30 without obstructing blocking blood flow or causing cell lysis during cardiac cycles. In some embodiments, the struts 31 can be arranged in a number in a range of 2-32 and at least some of the struts 31, typically all, can be spaced apart, such as circumferentially spaced apart and extend axially along all or a portion of the segment 30.

[0164] FIGS. 2 A and 2B illustrate that the anchoring segment 30 can comprise at least one strut 311 that overlaps a plurality of other struts 31, providing adequate spacing so as to not occlude blood flow (BF) as shown by the arrows in FIG. 4 for BF proximal to the outlet cage 240 (FIG. 4) traveling in the aorta when used for a catheter blood pump. The at least one strut 311 can overlie, underlie, extend across or otherwise overlap at least some of the other struts 31. The at least one overlapping strut 311 can comprise a hoop configuration, a spiral configuration, or a cross-configuration whereby the strut extends perpendicular to other struts and can extend circumferentially at least part of an outer diameter of the anchoring segment 30. The struts 31, 311 cooperate to be able to expand and retract to form the desired expandable configurations of the second configuration for anchoring and the fully collapsed, non-expanded first configuration of the anchoring segment 30 for insertion and withdrawal.

[0165] Referring again to FIG. 3, neighboring struts 311, 3 b can be separated by a circumferentially extending gap space 36 having a circumferential extent dl that is smaller adjacent the proximal and distal end portions 30p, 30d of the segment 30 and / or sheath 20 and merges to a larger size d2 of the gap space 36 at an outer diameter when the segment 30 is expanded.

[0166] FIGS. IB and 2B illustrate that an external facing surface of the struts 31 can comprise a surface feature 37 that can enhance the grip of these struts, such as increase surface area and / or increase a coefficient of static friction and / or provide a mechanical attachment relative to other parts of the sheath 20. The surface feature 37 can be provided byAttorney Docket No. 1632.23.WO roughening the outer surface of the struts 31, by providing an embossed, stamped or printed pattern, by providing small apertures 31a (FIG. 5D) that receive local tissue, by mechanical abrasion, by applying a grit or other surface coating, by media blasting, and / or by chemical or plasma etching, for example. Where small apertures 3 la are used, they can have a maximal lateral and / or longitudinal extent that is less than a width of a respective strut 31. In some embodiments, the apertures 31a can be provided as elongate type slits in a respective strut 31.

[0167] Referring to FIGS. 5A, 5B, 6A and 6B, the struts 3 lean be configured increase strut contact area C with the local tissue T compared to a flat strut (FIG. 2) as the flat strut may provide a constant contact area over a relatively short longitudinal contact distance, when fully expanded.

[0168] One or more of the struts 31 can have longitudinally spaced apart outward projections 3 Ip, which may be provided with undulating shapes (outward and inward segments), optionally a square wave (FIG. 5B), a sinusoidal wave shape (FIG. 5A), a saw wave or “zig-zag” pattern (FIG. 6 A), or a series of outwardly projecting dimples (FIG. 6B) that can provide longitudinally spaced apart contact areas C.

[0169] Each strut 31 can have the same or a different circumferential extent, typically in a range of 10 degrees to 90 degrees of the diameter of the sheath 20.

[0170] Each strut 31 can be provided as a solid surface configuration or be configured as fluid permeable structures and / or with apertures 31a (FIG. 5D) in the projection 3 Ip to promote suctional grip against local target tissue T, when expanded for anchoring.

[0171] In some embodiments, neighboring struts 311, 3 h, can reside closer together when collapsed than when expanded.

[0172] The projections 3 Ip of the struts 31 can be configured to create pressure points against the target tissue T.

[0173] FIGS. 7A and 7B illustrate a configuration of a strut 31 comprising longitudinally spaced apart projections 3 Ip provided on a support surface 31s. The support surface 31s may be planar / flat.

[0174] The projections 3 Ip can be configured to have a “mountain” shape with an outer facing peak.

[0175] FIGS. 8A and 8B illustrate another configuration of a strut comprising longitudinally spaced apart projections 3 Ip provided on a support surface 31s. The support surface 31s can be planar / flat. The projections 3 Ip can be provided as a frustoconical outer facing structure configured with an inwardly extending center cavity or opening (e.g., hole) 31c which may provide mechanical engagement of local tissue.Attorney Docket No. 1632.23.WO

[0176] One or more of the surface features 37 of the struts 31 discussed above can be used with the struts 31 having the projections 3 Ip, such as those shown in FIGS. 5 A, 5B, 6 A, 6B, 7 A, 7B, 8 A and 8B.

[0177] Referring to FIG. 8D, the struts 31 may have a circular, polygonal, triangular, square, rectangular or other cross-sectional shape or can have a flat / planar cross-sectional shape (FIGS. 1A, IB, 1C, 2A, 3 A). Combinations of different configurations of struts 31 may be used for a respective anchoring segment 30.

[0178] Referring to FIGS. 9A and 9B, an example anchoring segment 30 with struts 31 shown with some neighboring struts 31 positioned closer together than others. As shown, a first strut 311 and a second strut 3 h are separated by a gap space 36 having a circumferential extent / di stance d3 and the second strut 3 h is separated from a third strut 3 h by a distance d4, where d4>d3, typically greater than at least two times a width of a respective strut 31. A fourth strut 314 can be separated from the third strut 313 by the distance d3. Positioning struts closer together with others further apart may provide sufficient structural rigidity while providing improved blood flow thereabout.

[0179] A first gap space 361 between neighboring struts 31 can have the same circumferential extent or be different from one or more second gap spaces 362 of other neighboring struts 31.

[0180] FIG. 9C is an end view of an example anchoring segment 30 illustrating first and second struts 31 configured as wide struts 3 Iw that extend greater than 30 degrees and less than 270 degrees, typically less than 180 degrees of a circumference of the sheath 20 according to embodiments of the present invention. As shown, one strut 31 extends greater than 90 degrees and less than 180 degrees. The other strut 31 can have the same or a lesser circumferential extent.

[0181] FIG. 9D is a side view of an example anchoring segment 30 that comprises at least one strut 31 that has an aperture 39 that can extend laterally / circumferentially less than a circumferential extent of the respective strut and less than a longitudinal extent of that strut 31. The aperture 39 can facilitate mechanical engagement with local tissue T and / or facilitate blood flow thereabout in combination with the gap spaces 36 between neighboring struts 31.

[0182] FIG. 9E is a side view of another example anchoring segment 30 comprising asymmetrically shaped struts 31. The asymmetrically shaped struts can taper over its length dimension from a wider thickness to a narrower thickness in one direction. The taper can be in a range of 1-10%, in some embodiments. The wide end can be at the distal end portion 30d of the anchoring segment 30 or at the proximal end portion of the anchoring segment 30.Attorney Docket No. 1632.23.WO

[0183] FIGS. 9F and 9G are side views of additional example anchoring segments 30, each comprising struts 3 Iwith symmetric shapes that taper from end portions 30p, 30d having a first width “dl” to a medial portion with a second width “d2”. The taper to provide the change in width dimensions can be in a range of 1-10%, in some embodiments.

[0184] In the embodiment shown in FIG. 9F, the wider dimension “dl” is adjacent the proximal and distal end portions 30p, 30d, respectively, of the anchoring segment 30.

[0185] In the embodiment shown in FIG. 9G, the wider dimension “d2” is between the proximal and distal end portions, optionally medially positioned between the proximal and distal end portions 30p, 30d, respectively. However, the wider dimension “d2”can be closer to one end of the anchoring segment 30 rather than in the medial position.

[0186] Referring to FIGS. 10A and 10B an example blood pump 100 is shown. The blood pump 100 comprises a motor 214, a catheter 10 comprising a multi-lumen shaft 230 (also described as a multi-lumen catheter body) that encloses a torque or drive cable 225, an inlet cage 233 (blood intake), a (snorkel) tube 235 extending between the inlet cage 233 and an impeller 240, and an outlet cage 244 (pumped blood outlet). A snorkel 231 can be attached to the snorkel tube 235 and be positioned at a distal end lOOd of the catheter blood pump 100. The snorkel / snorkel tube 231, 235 may be provided in a number of configurations such as in a circular spacer shape (FIG. 13) instead of the pigtail shape shown. The catheter blood pump 100 can also include a housing 216 that holds the motor 214 and couples to a proximal portion of the catheter 10. The lock connector 40 holding the sheath 20 to the catheter 10 can reside distal but adjacent to the housing 216. A fluid entry connector 331 and a fluid exit connector 333 can project outward from the housing and be in fluid communication with the catheter 10.

[0187] The catheter blood pump 100 also comprises the sheath anchoring system discussed above. FIG. 10A shows the anchoring segment 30 in the first configuration. FIG. 10B shows the anchoring segment 30 in the second expanded configuration. The first (fully) collapsed, low-profile configuration of the anchoring segment 30 (FIGS. 1A, 2 A, 10 A) can have a 6F-18F profile, and can be 6F, 7F, 8F, 9F, 10F, 1 IF, or 12F, in some embodiments.

[0188] FIG. 11 shows another embodiment of a catheter blood pump with a sheath anchoring system comprising the anchoring segment 30. In this embodiment, the catheter blood pump 100 comprises a second sheath 200 that extends axially a distance sufficient to enclose the outlet cage that surrounds the impeller for intrabody placement. This second sheath 200 is then slid axially in a proximal direction (action A arrow) to expose the outlet cage 244 and the impeller 240 therein. This allows the outlet cage 244 and impeller 240 toAttorney Docket No. 1632.23.WO expand outward to a greater outer diameter. The sheath 20, which can be referred to as a “first sheath” in this embodiment, can then be extended distally (action B arrow) to cause the proximal end portion of the anchoring segment 30 to travel toward the distal end portion 30d of the anchoring segment 30 and cause the struts 31 to expand outward as discussed above. As shown, the second sheath 200 is an inner sheath that extends inside the first sheath 20 as the outer sheath. The distal end portion 30d, optionally the distal ring 32, of the anchoring segment 30 can be affixed to the second sheath 200 while the proximal end portion 3 Op, optionally with the proximal ring 34, of the anchoring segment 30 is free to travel axially when the connector 40 is unlocked. In this embodiment a connector 140 can be used to control the travel of the second sheath 200.

[0189] FIG. 12 shows another embodiment of a catheter blood pump 100 with a second sheath 200 as discussed with respect to FIG. 11. However, in this embodiment, the second sheath 200 is the outer sheath that extends about the first sheath 20 with the anchoring segment 30. The distal end portion 30d of the anchoring segment 30 is attached to the catheter 10 as discussed with respect to FIGS. 1 A, IB, . The second / outer sheath 200 is first slid axially (action A arrow) in a proximal direction to expose the impeller / outlet cage 240 / 244 and then the sheath 20 is translated distally (action B arrow) to move the proximal end portion 30p of the anchoring segment toward the distal end portion 30d to expand the struts 31. It is noted that this configuration may require a longer and larger outer sheath for the second sheath 200 relative to the embodiment in FIG. 11 which may not be desirable for some uses.

[0190] FIG. 13 illustrates a catheter blood pump 100 in an example position in a heart of a patient / subject with the anchoring segment 30 in the second configuration to anchor against local tissue T, e.g., the aortic wall.

[0191] Generally stated, when the proximal end portion of the torque cable 225 is electromechanically rotated by a motor shaft of the motor 214, typically located outside the patient's body, it conveys the rotational force through the length of the catheter 10, causing the impeller 240 to spin at high speed in the heart. However, it is noted that catheter blood pumps may be configured with internal motors not requiring the long torque cable and extracorporeal motor.

[0192] The catheter blood pump 100 can be particularly suitable in providing ventricular assist during surgery or providing temporary bridging support to help a patient survive a crisis. The catheter 10 provides continuous lubrication by a biocompatible (purge) liquid via connectors 331, 332. A part of this liquid can exit through a bearingAttorney Docket No. 1632.23.WO housing / impeller shaft interface and thus enter the blood stream. The remaining part can be directed to flow through an out-flow path and be collected extracorporeally after passing through a lumen provided in the catheter 10 that holds the drive cable 225.

[0193] FIG. 14 is a block diagram of an example catheter blood pump system 1000 comprising the catheter blood pump 100 and the sheath with the anchoring segment 20. The system 1000 also includes a flush fluid source 1333 in fluid communication with the intake connector 331 and a waste receptacle / bag 1331 in fluid communication with the egress / outlet fluid connector 333 provided by the housing 216 holding the motor 214 in some embodiments. The system also includes a control circuit 1100 that can be held in a housing 1 lOOh that is in communication with electronics 1449 in the housing 216 with the motor 214. The control circuit 1100 can comprise a number of modules 1100m including, by way of example only, a motor control module 1101, pressure sensor module 1102 and monitoring module 1103 configured to monitor defined patient bioparameters and / or functional output / input of the catheter blood pump 100.

[0194] It is to be understood that the disclosure describes a few embodiments and that many variations of the invention can easily be devised by those skilled in the art after reading this disclosure and that the scope of the present invention is to be determined by the following claims.

[0195] While described as particularly suitable for use with catheter blood pumps 100, the sheath anchoring system with the anchoring segment 30 can be used with a number of different catheters desiring intrabody stability / anchoring. Non-limiting examples of catheters 10 for the catheter assembly 10a include: percutaneous heart valve replacement (e.g., mitral, aortic), percutaneous stent delivery (e.g., cardiac), percutaneous ablation including cardiac and / or peripheral arteries, percutaneous vascular grafts (e.g., aortic aneurism graft), and percutaneous drug delivery.

[0196] Where used for a catheter blood pump 100, it can be sized and configured for trans-valvular use, such as for left and / or right ventricular assist procedures. By way of example only, such ventricular assist procedures may be employed in cardiac operations including, but not limited to, coronary bypass graft (CABG), cardiopulmonary bypass (CPB), open chest and closed chest (minimally invasive) surgery, bridge-to-transplant and / or failure- to-wean-from-bypass situations. It is to be readily understood, however, that the intravascular blood pump assembly and methods of the present invention are not to be limited to such applications. Moreover, while illustrated and described largely with reference to left-heart assist applications, it is to be readily understood that the principles of the present inventionAttorney Docket No. 1632.23.WO apply equally with regard to right-heart assist application, which are contemplated as within the scope of the present invention. These and other variations and additional features will be described throughout.

[0197] The blood pump 100 can be configured to pump blood through the outlet cage 244 at a rate in a range of 2-7 liters / minute over at least 6 days of continuous intravascular use while continuously providing biocompatible fluid to the in-flow path via at least one inflow lumen, then to the out-flow path.

[0198] The blood pump 100 may be configured to provide axial or mixed-flow. As used herein, the term “axial flow” is deemed to include flow characteristics which include both an axial and slight radial component.

[0199] The catheter assembly 10a may be dimensioned to any suitable diameter for intravascular applications. For example, the range of sizes may include, but is not necessarily limited to, 9 French to 30 French, although the range is typically in a range of 12 French to 24 French, and more typically in a range of 12 French to 18 French. Cardiologists can thus insert the small device minimally invasively. In some preferred embodiments, the outer diameter can be about 12 French (4.0 mm) or less providing a low-profile device that can minimize bleeding.

[0200] Where used for a catheter blood pump, the catheter blood pump 100 can be configured to provide right and / or left heart support whereby blood is deliberately re-routed through and past the right and / or left ventricle in an effort to reduce the volume of blood to be pumped by the particular ventricle. While “unloading” the ventricle in this fashion is preferred in certain instances, it is to be readily understood that the pump and cannula arrangements described herein may also be employed to “preload” the ventricles. Ventricular preloading may be accomplished by positioning the outflow cage from the pump into a given ventricle such that the pump may be employed to fill or preload the ventricle with blood. This may be particularly useful with the right ventricle. On occasion, the right ventricle is not supplied with sufficient levels of blood from the right atrium such that, upon contraction, the right ventricle delivers an insufficient quantity of blood to the pulmonary artery. This may result when the right ventricle and / or right atrium are in a stressed or distorted condition during surgery. Preloading overcomes this problem by actively supplying blood into the right ventricle, thereby facilitating the delivery of blood into the pulmonary artery. The same technique can be used to preload the left ventricle and thus facilitate the delivery of blood from the left ventricle into the aorta.Attorney Docket No. 1632.23.WO

[0201] In the drawings and specification, there have been disclosed embodiments of the invention and, although specific terms are employed, they are used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention being set forth in the following claims.

[0202] Thus, the foregoing is illustrative of the present invention and is not to be construed as limiting thereof. More particularly, the workflow steps may be carried out in a different manner, in a different order and / or with other workflow steps or may omit some or replace some workflow steps with other steps. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention.

Claims

Attorney Docket No. 1632.23.WOWhat is Claimed:

1. A catheter assembly, comprising: a catheter; and an anchoring system comprising a sheath extending axially along at least a portion of the catheter, wherein the sheath has an anchoring segment with a plurality of struts, wherein the anchoring segment is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

2. The catheter assembly of Claim 1, wherein the anchoring segment of the sheath has a proximal end portion and a distal end portion, wherein a portion of the catheter extends distally of the anchoring segment in the first and second configurations, wherein the anchoring segment of the sheath is configured so that one of the proximal end portion or the distal end portion is slidably axially moveable toward the other of the distal end portion or the proximal end portion whereby at least a portion of the plurality of struts of the anchoring segment between the proximal end portion and the distal end portion are configured to expand outward to engage the local tissue.

3. The catheter assembly of Claim 1, wherein the anchoring segment of the sheath has a proximal end portion and a distal end portion, wherein the distal end portion is affixed to the catheter and a more proximal end portion is slidably axially movable relative to the catheter whereby the proximal end portion of the anchoring segment of the sheath is slidably moveable distally toward the distal end portion causing the anchoring segment to expand outward and engage local tissue.

4. The catheter assembly of Claim 1, wherein at least some of the plurality of struts are circumferentially spaced apart and extend in an axial direction.

5. The catheter assembly of Claim 1, wherein the anchoring segment of the sheath is integral to the sheath so that the anchoring segment is part of a monolithic sheath structure, wherein the anchoring segment comprises an axially extending slit between neighboring struts of at least some of the plurality of struts and residing in a defined subset of the sheathAttorney Docket No. 1632.23.WO positioned between a distal end portion and a proximal end portion of the anchoring segment of the sheath.

6. The catheter assembly of Claim 1, wherein the anchoring segment comprises a tubular member that comprises the plurality of struts, and wherein the tubular member has a proximal or a distal end portion that is affixed to the sheath.

7. The catheter assembly of Claim 1, wherein the anchoring segment comprises a tubular member that comprises a proximal ring and a distal ring, and wherein the proximal ring is affixed to a first portion of the sheath and the distal ring is affixed to the catheter.

8. The catheter assembly of Claim 1, wherein the plurality of struts are configured so that at least one of the plurality of struts overlaps one or more other of the plurality of struts.

9. The catheter assembly of Claim 1, wherein at least some of the plurality of struts comprises a flat or round cross-sectional shape.

10. The catheter assembly of Claim 1, wherein at least some of the plurality of struts have a tapered non-symmetric cross-sectional shape over a length thereof.

11. The catheter assembly of Claim 1, wherein at least some of the plurality of struts have a symmetrically tapered shape over a length thereof.

12. The catheter assembly of Claim 1, wherein at least some the plurality of struts comprise surface features configured to enhance grip strength and / or increase a coefficient of static friction relative to other portions of the sheath.

13. The catheter assembly of Claim 1, wherein, when in the second configuration, at least some of the plurality of struts have an undulating configuration when viewed from the side.

14. The catheter assembly of Claim 1, further comprising a connector affixed to a portion of the sheath, proximal to the anchoring segment, that is configured to clamp againstAttorney Docket No. 1632.23.WO the catheter to lock the sheath to the catheter when the anchoring segment is in the first and / or second configuration.

15. The catheter assembly of Claim 14, wherein the connector is configured to be controllably loosened to allow the sheath to slidably axially move either the proximal end portion of the anchoring segment distally toward the distal end portion of the anchoring segment or slidably axially move the distal end portion of the anchoring segment proximally toward the proximal end portion of the anchoring segment to expand the anchoring segment outward to the second configuration, and wherein the connector is configured to allow a user to tighten the connector against the catheter when the segment is in the second configuration to lock the sheath to the catheter to thereby lock the anchoring segment in the second configuration.

16. The catheter assembly of Claim 14, further comprising indicia of distance of axial movement of the anchoring segment of the sheath on the catheter at a location proximal to and / or adjacent the connector, wherein the anchoring segment is configured so that axial movement thereof is controllable by a user to allow a user to select a desired maximal outer distance of expansion of the anchoring segment to form the second configuration whereby the second configuration is a user adjustable, selectable second configuration.

17. The catheter assembly of Claim 14, wherein the sheath and connector are further cooperably configured to allow the sheath to be slidably movable when the connector is unlocked to cause the anchoring segment to return to the first configuration or to a reduced maximal outer diameter relative to the second configuration, and wherein the anchoring segment is configured to be re-deployable to the second configuration having the same outer diameter as a first deployment to an anchoring configuration providing the second configuration or to a third configuration having a different maximal outer diameter relative to the second configuration thereby allowing the catheter and anchoring segment to be repositioned and re-anchored while the catheter and sheath are in a body of a patient.

18. The catheter assembly of Claim 1, wherein at least some of the plurality of struts comprise a polymer.Attorney Docket No. 1632.23.WO19. The catheter assembly of Claim 1, wherein at least some of the plurality of struts comprise metal, optionally Nitinol.

20. The catheter assembly of Claim 1, wherein at least some of the plurality of struts comprise a hybrid material comprising a metal and a polymer.

21. The catheter assembly of Claim 1, wherein the plurality of struts are provided in a number in a range of 2-32.

22. The catheter assembly of Claim 1, wherein the plurality of struts comprises a plurality of axially extending struts and at least one strut that overlaps at least some of the plurality of axially extending struts.

23. The catheter assembly of Claim 1, wherein the anchoring system is configured to allow the anchoring segment to be controllably expanded and locked into position to a selected one of a plurality of different maximal outward distances to form the second configuration.

24. The catheter assembly of Claim 1, wherein the catheter and / or the sheath and / or anchoring segment comprise radiopaque material and / or markers.

25. The catheter assembly of Claim 1, wherein the anchoring segment comprises radiopaque material and / or markers.

26. The catheter assembly of Claim 1, wherein one or more of the plurality of struts comprise at least one aperture configured to releasably engage local tissue.

27. The catheter assembly of any of Claims 1-26, wherein the catheter is a catheter blood pump comprising an impeller, and wherein the anchoring segment of the sheath is configured to allow blood to flow thereabout, and wherein the anchoring segment resides proximal to the impeller of the catheter blood pump.

28. The catheter assembly of Claim 1, wherein the anchoring segment in the second configuration has a maximal outer diameter in a range of about 20 mm to about 60 mm.Attorney Docket No. 1632.23.WO29. A catheter blood pump comprising: a catheter comprising a blood intake portion; an outlet cage in fluid communication with the blood intake portion and at least partially surrounding an impeller; and an anchoring system comprising a sheath surrounding and extending axially along at least a portion of the catheter, wherein the sheath comprises an anchoring segment with a plurality of struts, and wherein the anchoring segment is located proximal to the outlet cage and is configured to have a first low profile configuration that is expandable outward to a second configuration to engage local tissue to thereby provide an anchoring system for the catheter.

30. The catheter blood pump of Claim 29, wherein at least some of the plurality of struts are circumferentially spaced apart and extend in an axial direction.

31. The catheter blood pump of Claim 29, wherein at least one of the plurality of struts overlaps at least some of the other plurality of struts.

32. The catheter blood pump of Claim 29, wherein the outlet cage and the impeller are expandable, wherein the sheath is a first sheath, wherein the catheter blood pump comprises a second sheath extending axially along at least a portion of the catheter over or under the first sheath, and wherein the second sheath is configured to extend and retract relative to the outlet cage and the impeller to constrain the outlet cage and impeller during intrabody placement and to expose the outlet cage during normal operation.

33. The catheter blood pump of Claim 32, wherein the second sheath resides inside the first sheath, and wherein the distal end portion of the first sheath is affixed to the second sheath.

34. The catheter blood pump of Claim 29, wherein one or more of the plurality of struts comprise at least one through hole configured to releasably engage local tissue when the anchoring segment is in the second configuration.Attorney Docket No. 1632.23.WO35. The catheter blood pump of Claim 29, wherein the anchoring system is configured to allow the anchoring segment to be controllably expanded and locked into position to a selected one of a plurality of different maximal outward distances to form the second configuration.

36. The catheter blood pump of Claim 29, wherein the anchoring segment of the sheath is configured to be axially moveable relative to the catheter to cause the anchoring segment to return to the first configuration or to a reduced maximal outer diameter relative to the second configuration for repositioning in vivo, and wherein the anchoring segment is configured to be re-deployable to an anchoring configuration having the second configuration with the same outer diameter as a first deployment providing the second configuration or to a third configuration having a different maximal outer diameter relative to the second configuration thereby allowing the anchoring segment to be repositioned and re-anchored while the anchoring segment remains in a target region in a heart of a patient.

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