Patent Description:
The present disclosure relates to percutaneous circulatory support devices. More specifically, the disclosure relates to an anchoring and centering device for a circulatory support pump.

Circulatory support devices are devices that support the pumping action of the heart. These devices may be disposed through a valve opening such as, for example, an aortic valve. Typical circulatory support devices are prone to moving, resulting in a need for repositioning before treatment is continued. Relevant prior art is known from <CIT>.

Embodiments disclosed herein relate to anchoring and centering devices for a circulatory support pump. Exemplary embodiments include, but are not limited, to the following examples. The invention however is defined by independent claim <NUM>.

In an Example <NUM>, an anchoring apparatus for centering a cardiac pump, comprises: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged about a central axis, wherein a distal portion of the expandable anchoring device defines an annulus through which the cardiac pump can be arranged and to which the cardiac pump can be releasable coupled, and wherein a proximal portion of the expandable anchoring device is configured to circumferentially expand to an unconstrained configuration that has a cross-sectional diameter greater than a diameter of the annulus; and a constraining member arranged over the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration for delivery of the anchoring apparatus.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the proximal portion has a conical shape.

In an Example <NUM>, the apparatus of any one of Examples <NUM> or <NUM>, wherein the proximal portion comprises a plurality of proximal portions that are configured to expand equidistant from the central axis when in the unconstrained configuration.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the plurality of proximal portions comprise a plurality of separate, elongate members.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the plurality of separate, elongate members are barbs.

In an Example <NUM>, the apparatus of any one of Examples <NUM>-<NUM>, wherein the plurality of proximal portions comprises a plurality of loop elements.

In an Example <NUM>, the apparatus of any one of Examples <NUM>-<NUM>, wherein the distal portion includes an elongate member that is secured to a coupling loop of the cardiac pump via an interference fit.

In an Example <NUM>, the apparatus of any one of Examples <NUM>-<NUM>, wherein the distal portion comprises portions that are overlapping when in the constrained configuration and are non-overlapping when in the unconstrained configuration.

In an Example <NUM>, the apparatus of any one of Examples <NUM>-<NUM>, further comprising a delivery catheter, wherein the delivery catheter has a tricuspid cross-sectional shape, and wherein the anchoring apparatus is arranged over the delivery catheter during delivery of the anchoring apparatus.

In an Example <NUM>, the apparatus of any one of Examples <NUM>-<NUM>, wherein the plurality of expandable anchoring devices are formed from nitinol.

In an Example <NUM>, a method for delivering an anchoring apparatus for centering a cardiac pump, the method comprising: arranging the anchoring apparatus over or within a delivery catheter, the anchoring apparatus comprising: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged about a central axis, wherein a distal portion of the expandable anchoring device defines an annulus through which the cardiac pump can be arranged and to which the cardiac pump can be releasable coupled, and wherein a proximal portion of the expandable anchoring device is configured to circumferentially expand to an unconstrained configuration that has a cross-sectional diameter greater than a diameter of the annulus; and a constraining member arranged over the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration for delivery of the anchoring apparatus; advancing the apparatus over the cardiac pump arranged within a subject's heart; releasably coupling the anchoring apparatus to the cardiac pump; and actuating the anchoring apparatus from its constrained configuration.

In an Example <NUM>, the method of Example <NUM>, wherein the anchoring apparatus further comprises an actuation member, wherein the constraining member is a sheath arranged around the proximal portion that comprises at least one aperture, and wherein actuating the anchoring apparatus comprises actuating the actuation member so the anchoring apparatus projects through the at least one aperture of the sheath.

In an Example <NUM>, the method of Example <NUM>, wherein the constraining member is a sheath arranged around the proximal portion, and wherein actuating the anchoring apparatus comprises translating the sheath so that it is no longer arranged around the proximal portion.

In an Example <NUM>, the method of any one of Examples <NUM>-<NUM>, wherein the distal portion includes an elongate member that is secured to a coupling loop of the cardiac pump via an interference fit, and wherein releasably coupling the anchoring apparatus to the cardiac pump comprises inserting the elongate member through the coupling loop.

In an Example <NUM>, the method of any one of Examples <NUM>-<NUM>, further comprising removing the anchoring apparatus by arranging the constraining member over the expandable anchoring device and withdrawing the anchoring apparatus.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the cross-sectional shape of the proximal portion is a disk.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the proximal portion comprises a plurality of proximal portions that are configured to expand equidistant from the central axis when in the unconstrained configuration.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the plurality of proximal portions comprises a plurality of loop elements.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the distal portion includes an elongate member that is secured to a coupling loop of the cardiac pump via an interference fit.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the distal portion comprises overlapping portions when in the constrained configuration and are non-overlapping when in the unconstrained configuration.

In an Example <NUM>, the apparatus of Example <NUM>, further comprising a delivery catheter, wherein the delivery catheter has a tricuspid cross-sectional shape, and wherein the anchoring apparatus is arranged over the delivery catheter during delivery of the anchoring apparatus.

In an Example <NUM>, the apparatus of Example <NUM>, wherein the plurality of expandable anchoring devices are formed from nitinol.

In an Example <NUM>, a method for delivering an anchoring apparatus for centering a cardiac pump, the method comprises: arranging the anchoring apparatus over or within a delivery catheter, the anchoring apparatus comprising: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged about a central axis, wherein a distal portion of the expandable anchoring device defines an annulus through which the cardiac pump can be arranged and to which the cardiac pump can be releasable coupled, and wherein a proximal portion of the expandable anchoring device is configured to circumferentially expand to an unconstrained configuration that has a cross-sectional diameter greater than a diameter of the annulus; and a constraining member arranged over the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration for delivery of the anchoring apparatus; advancing the apparatus over the cardiac pump arranged within a subject's heart; releasably coupling the anchoring apparatus to the cardiac pump; and actuating the anchoring apparatus from its constrained configuration.

In an Example <NUM>, the method of Example <NUM>, wherein the distal portion includes an elongate member that is secured to a coupling loop of the cardiac pump via an interference fit, and wherein releasably coupling the anchoring apparatus to the cardiac pump comprises inserting the elongate member through the coupling loop.

In an Example <NUM>, the method of Example <NUM>, further comprising removing the anchoring apparatus by arranging the constraining member over the expandable anchoring device and withdrawing the anchoring apparatus.

In an Example <NUM>, the method of Example <NUM>, wherein the proximal portion has a conical shape.

In an Example <NUM>, the method of Example <NUM>, wherein the distal portion comprises portions that are overlapping when in the constrained configuration and are non-overlapping when in the unconstrained configuration.

In an Example <NUM>, the method of Example <NUM>, wherein the proximal portion comprises a plurality of proximal portions that are configured to expand equidistant from the central axis when in the unconstrained configuration.

In an Example <NUM>, the method of Example <NUM>, wherein the plurality of proximal portions comprise a plurality of separate, elongate members.

While multiple embodiments are disclosed, still other embodiments of the presently disclosed subject matter will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosed subject matter.

While the disclosed subject matter is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the subject matter disclosed herein to the particular embodiments described. The invention however is defined by the appended claims.

Embodiments disclosed herein include a circulatory support device having an anchoring device configured to be employed with a heart. The anchoring device may be configured to prevent inadvertent migration of the circulatory support device from an exemplary location during operation of the circulatory support device. For example, the anchoring device may be configured to reduce the likelihood of translation of the circulatory support device into or out of the aorta. As another example, the anchoring device may be configured to center the circulatory support device within the aortic valve to prevent the circulatory support device from being biased toward the perimeter of the aortic valve resulting in aortic regurgitation. Centering of the circulatory support device may also have the added benefit of mitigating abrasion to the aortic valve leaflets by the circulatory support device. Furthermore, by reducing the likelihood of device contact with the annulus of the aortic valve, the probability of disrupting calcification from the aortic valve resulting in embolization is reduced, which reduces the risk of stroke or other organ damage. A centered device is also less likely to engage the mitral valve elements such as the papillary heads or chordae tendineae. Another advantage of a centered device is the likelihood of contact with the left ventricle walls is reduced, especially the septal wall which might result in ectopic beats.

<FIG> depicts a conceptual diagram of a circulatory support device <NUM> having an exemplary anchoring device <NUM> anchored within a heart <NUM>, in accordance with embodiments of the subject matter disclosed herein. According to embodiments, the circulatory support device <NUM> may be a ventricular assist device, such as a pump, that is configured to pump blood from a left ventricle <NUM> of a subject into the subject's aorta <NUM>. More specifically, a distal portion <NUM> of the circulatory support device <NUM> is arranged in the left ventricle <NUM>. The circulatory support device <NUM> extends through the aortic valve <NUM> so that a proximal portion <NUM> extends into the aorta <NUM>. During operation, the circulatory support device <NUM> draws blood from the left ventricle <NUM>, through a cannula <NUM> of the circulatory support device <NUM> and is released into the aorta <NUM>. Additionally, or alternatively, the circulatory support device <NUM> may be used to facilitate pumping blood from some other aspect of the subject's heart and/or vasculature into an adjacent portion of the heart and/or vasculature.

The longitudinal, central axis <NUM> bisects the aortic valve <NUM>. In exemplary embodiments, the cannula <NUM> of the circulatory support device <NUM> is centered and extends along the longitudinal, central axis <NUM> so that the circulatory support device <NUM> is centered in the aortic valve <NUM>. In the event the circulatory support device <NUM> is not centered within the aortic valve <NUM>, the circulatory support device <NUM> may prevent the aortic valve <NUM> from closing, resulting in aortic regurgitation (i.e., where blood flows backward from the aorta <NUM> to left ventricle <NUM>). Such positioning can also damage the leaflets of the aortic valve <NUM>. Furthermore, in exemplary embodiments, the circulatory support device <NUM> should not translate in a distal direction <NUM> or a proximal direction <NUM>. Otherwise, the circulatory support device <NUM> may project farther into the left ventricle <NUM> or the aorta <NUM> than intended, reducing and/or eliminating the usefulness of the circulatory support device <NUM>. Conventional embodiments do not adequately address these problems. The embodiments disclosed herein, however, provide a solution to these problems by including an anchoring device <NUM> releasably coupled to the circulatory support device <NUM> such that the anchoring device <NUM> anchors to the heart <NUM> to prevent translational movement of the circulatory support device <NUM> and/or radial movement of the circulatory support device <NUM>, as described in more detail below.

The illustrative system shown in <FIG> is not intended to suggest any limitation as to the scope of use or functionality of embodiments of the present disclosure. The system also should not be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, various components depicted in <FIG> may be, in embodiments, integrated with various ones of the other components depicted therein (and/or components not illustrated), all of which are considered to be within the ambit of the present disclosure.

<FIG> depicts a conceptual diagram of an exemplary implantation location of a circulatory support device <NUM> having an exemplary anchoring device <NUM>, in accordance with embodiments of the subject matter disclosed herein. In exemplary embodiments, the circulatory support device <NUM> should be positioned so that the outflow windows <NUM> of the circulatory support device <NUM> are approximately <NUM> millimeters (mm) proximal the right coronary artery (RCA) <NUM> and left main artery (LMA) <NUM> to facilitate efficient blood flow out of the circulatory support device <NUM> into the aorta <NUM>. In exemplary embodiments, the outflow windows <NUM> of the circulatory support device <NUM> should also not be positioned over the brachiocephalic artery <NUM>. Instead, the outflow windows <NUM> should be positioned <NUM> distal to the brachiocephalic artery <NUM>.

In embodiments, the anchoring device <NUM> facilitates maintaining the circulatory support device <NUM> in the exemplary position described above. For example, the circulatory support device <NUM> may be positioned in the exemplary position described above. After or during the positioning of the circulatory support device <NUM>, the anchoring device <NUM> may be delivered, in a constrained configuration, over or within a delivery catheter (not shown) so the distal portion 104A is arranged over a proximal portion 102A of the circulatory support device <NUM>. In embodiments, elements of the distal portion 104A may define an annulus (see, e.g., <FIG>) through which the circulatory support device <NUM> can be received. To maintain the anchoring device <NUM> in a constrained state, a constraining member (not shown) may be arranged around the anchoring device <NUM>. The constraining member be a sleeve, a sheath, a catheter, and/or the like. Exemplary constraining members are described in more detail below in relation to <FIG>.

In embodiments, the distal portion 104A of the anchoring device <NUM> may be releasably coupled to the proximal portion 102A of the circulatory support device <NUM>. To do so, the proximal portion 102A may include loop elements <NUM> through which elongate members <NUM> of the anchoring device <NUM> are inserted. As stated above, the elongate members <NUM> may define an annulus (see, e.g., <FIG>) through which the anchoring device <NUM> can be arranged. In embodiments, the loop elements <NUM> and the elongate members <NUM> may form an interference fit to prevent inadvertent detachment of the elongate members <NUM> by the loop elements <NUM>.

Either before or after coupling the distal portion 104A to the proximal portion 102A, the constraining member may be removed from the anchoring device <NUM> so the anchoring device <NUM> can circumferentially expand to an unconstrained state (as shown). In the unconstrained state, the anchoring device <NUM> may include a proximal portion 104B that expands to have a cross section diameter that is larger than the diameter defined by the annulus of the distal portion 104A. As such, edges 104C of the proximal portion 104B expand so the edges 104C contact and abut the walls of the aorta <NUM>. Due to the contact between the anchoring device <NUM> and the walls of the aorta <NUM>, the anchoring device <NUM> anchors the circulatory support device <NUM> to the heart <NUM>. In embodiments, the anchoring device <NUM> may allow for blood to freely pass along the outside of the circulatory support device <NUM>. In embodiments, the anchoring device <NUM> may expand to have a conical shape as shown. In embodiments, the anchoring device <NUM> may be formed from nitinol. Additional exemplary embodiments of anchoring devices are described below in relation to <FIG>.

The illustration shown in <FIG> is not intended to suggest any limitation as to the scope of use or functionality of embodiments of the present disclosure. The illustration also should not be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, various components depicted in <FIG> may be, in embodiments, integrated with various ones of the other components depicted therein (and/or components not illustrated), all of which are considered to be within the ambit of the present disclosure.

<FIG> depicts a side view of an illustrative circulatory support device <NUM> having an anchoring device <NUM>, in accordance with embodiments of the subject matter disclosed herein. According to embodiments, the circulatory support device <NUM> may be, or be similar to, the circulatory support device <NUM> depicted in <FIG>. Additionally, or alternatively, the anchoring device <NUM> may be or be similar to, the anchoring device <NUM> depicted in <FIG>.

According to embodiments, the circulatory support device <NUM> may be a ventricular assist device configured to pump blood from a left ventricle (e.g., the left ventricle <NUM>) of a subject into the subject's aorta (e.g., the aorta <NUM>). In embodiments, the circulatory support device <NUM> may be used to facilitate pumping blood from some other aspect of the subject's heart and/or vasculature into an adjacent portion of the heart and/or vasculature. As shown in <FIG>, the circulatory support device <NUM> includes a blood pump assembly <NUM> having a distal end <NUM> at least partially surrounded by a flexible inlet tube <NUM>. A number of blood flow outlet apertures <NUM> are disposed in a pump assembly <NUM> proximal to the flexible inlet tube <NUM>. Similar to the embodiment depicted in <FIG>, a distal portion 204A of the anchoring device <NUM> may be coupled to the pump assembly <NUM> either before, during, or after implantation of the circulatory support device <NUM>.

In embodiments, the anchoring device <NUM> also includes a proximal portion 204B that extends proximally and radially outward from a longitudinal, central axis <NUM>. In the illustrated embodiment, the proximal portion 204B includes a plurality of proximal portions 216A, 216B, 216C. Each proximal portion 216A-216C forms a loop. For example, each proximal portion 216A-216C may include a first end <NUM> and a second end <NUM>, each of which are coupled to the pump assembly <NUM>. In embodiments, the first and second ends <NUM>, <NUM> may form an annulus through which the pump assembly <NUM> is inserted. Between the first and second ends <NUM>, <NUM>, the proximal portions 216A-216C extend in a proximal direction <NUM>. After extending in a proximal direction <NUM> for a distance, each proximal portion 216A-216C reaches a distal end <NUM>, then loops back and extends in a distal direction <NUM> back to the first and second ends <NUM>, <NUM>. In embodiments, the distal ends <NUM> may include barbs for securing the anchoring device <NUM> to the aorta. In embodiments, the proximal portions 216A-216C may form a basket structure. In embodiments, the proximal portions 216A-216C may overlap or they may not overlap.

In embodiments, the proximal portions 216A-216C may be delivered in a constrained state by, for example, a constraining member (not shown). The constraining member be a sleeve, a sheath, a catheter, and/or the like. Exemplary constraining members are described in more detail below in relation to <FIG>. The constraining member may be removed from the anchoring device <NUM> so the anchoring device <NUM> can circumferentially expand to an unconstrained state (as shown) in order to fix the circulatory support device <NUM> in an exemplary position, as described above. In embodiments, the proximal portions 216A-216C may be equidistant from the central axis <NUM>.

<FIG> depicts a side view of a portion of a circulatory support device <NUM> having another exemplary anchoring device <NUM>, in accordance with embodiments of the subject matter disclosed herein. <FIG> depicts an end view of the circulatory support device of <FIG>, in accordance with embodiments of the subject matter disclosed herein. According to embodiments, the circulatory support device <NUM> may be, or be similar to, the circulatory support device <NUM> depicted in <FIG> and/or the circulatory support device <NUM> depicted in <FIG>. Additionally, or alternatively, the anchoring device <NUM> may be or be similar to, the anchoring device <NUM> depicted in <FIG> and/or the anchoring device <NUM> depicted in <FIG>.

According to embodiments, the circulatory support device <NUM> may be a ventricular assist device configured to pump blood from a left ventricle (e.g., the left ventricle <NUM>) of a subject into the subject's aorta (e.g., the aorta <NUM>). In embodiments, the circulatory support device <NUM> may be used to facilitate pumping blood from some other aspect of the subject's heart and/or vasculature into an adjacent portion of the heart and/or vasculature. As shown in <FIG>, the circulatory support device <NUM> includes a blood pump assembly <NUM> having a distal end <NUM> at least partially surrounded by a flexible inlet tube <NUM>. Similar to the embodiment depicted in <FIG>, a distal portion 304A of the anchoring device <NUM> may be coupled to the pump assembly <NUM> either before, during, or after implantation of the circulatory support device <NUM>. In embodiments, the anchoring device <NUM> also includes a proximal portion 304B that extends proximally and radially outward from a longitudinal, central axis <NUM>. In the illustrated embodiment, the proximal portion 304B includes a plurality of proximal portions 316A, 316B, 316C. Each proximal portion 316A-316C forms a loop. For example, each proximal portion 316A-316C may include a first end <NUM> and a second end <NUM>, each of which are coupled to the pump assembly <NUM>. In embodiments, the first and second ends <NUM>, <NUM> may form an annulus through which the pump assembly <NUM> is inserted. Between the first and second ends <NUM>, <NUM>, the proximal portions 316A-316C extend in a proximal direction <NUM>. After extending in a proximal direction <NUM> for a first distance, each proximal portion 316A-316C reaches a first intermediate point <NUM>, then extends in a distal direction <NUM> for a second distance that is shorter than the first distance. After extending in a proximal direction <NUM> for the second distance, each proximal portion 316A-316C reaches a second intermediate point <NUM>, then extends in a proximal direction for a third distance. The third distance may be approximately equal to the second distance. After extending in a proximal direction <NUM> for the third distance, each proximal portion 316A-316C reaches a distal end <NUM>. Then each proximal portion 316A-316C extends in a distal direction <NUM> for the third distance then back in a proximal direction <NUM> for the second distance and then back in a distal direction <NUM> for the first distance to the second end <NUM>. In embodiments, the distal ends <NUM> may include barbs for securing the anchoring device <NUM> to the aorta. In embodiments, the proximal portions 316A-316C may form a basket structure. In embodiments, the proximal portions 316A-316C may overlap or they may not overlap.

In embodiments, the proximal portions 316A-316C may be delivered in a constrained state by, for example, a constraining member (not shown). The constraining member be a sleeve, a sheath, a catheter, and/or the like. Exemplary constraining members are described in more detail below in relation to <FIG>. The constraining member may be removed from the anchoring device <NUM> so the anchoring device <NUM> can circumferentially expand to an unconstrained state (as shown) in order to fix the circulatory support device <NUM> in an exemplary position, as described above. In embodiments, the proximal portions 316A-316B may be equidistant from the central axis <NUM>.

The illustration shown in <FIG> is not intended to suggest any limitation as to the scope of use or functionality of embodiments of the present disclosure. The illustration also should not be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, various components depicted in 4A-4B may be, in embodiments, integrated with various ones of the other components depicted therein (and/or components not illustrated), all of which are considered to be within the ambit of the present disclosure.

<FIG> depict a conceptual end view of another exemplary anchoring device <NUM>, in accordance with embodiments of the subject matter disclosed herein. More specifically, <FIG> depicts a conceptual end view of another exemplary anchoring device <NUM> in a constrained configuration and <FIG> depicts a conceptual end view of the exemplary anchoring device <NUM> depicted in <FIG> in an unconstrained configuration. According to embodiments, the anchoring device <NUM> may be or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In the illustrated embodiment, the anchoring device <NUM> has a proximal portion <NUM> including plurality of elongate members <NUM> surrounded by a membrane <NUM>. In embodiments, the elongate members <NUM> and membrane <NUM> are centered about a central axis <NUM>. When in a constrained configuration, the proximal portions <NUM> and the membrane <NUM> are constrained by a constraining member <NUM>. In embodiments, the constraining member <NUM> may be a sleeve, a sheath, a catheter, and/or the like. In embodiments, the membrane <NUM> includes overlapping portions <NUM> that overlap when the anchoring device <NUM> is in a constrained configuration, as illustrated in <FIG>. However, when the constraining member <NUM> is removed from the proximal portion <NUM>, the elongate members <NUM> and surrounding membrane <NUM> circumferentially expand about the central axis to an unconstrained configuration, as illustrated in <FIG>. In the unconstrained configuration, the membrane <NUM> may no longer include overlapping portions <NUM>. In embodiments, the outer edges of the membrane <NUM> may be equidistant from the central axis <NUM>.

<FIG> depict a conceptual cross-sectional view of a circulatory support device having another exemplary anchoring device, in accordance with embodiments of the subject matter disclosed herein. Another embodiment consists of a sheathed frame that is folded on itself. When unsheathed, it opposes the aortic walls. This design functions like a folded balloon on a balloon catheter. This could be a selectively deployable anchoring device as well as a non-selectively deployable device dependent on the introducer sheath that is used. The sheathed frame would need to be resilient enough to survive folding upon itself over the canula of the device and fold easily back onto the surface of the cannula when being recaptured for removal.

<FIG> depicts a conceptual cross-sectional delivery catheter <NUM>, in accordance with embodiments of the subject matter disclosed herein. As set forth above, the anchoring devices <NUM>, <NUM>, <NUM>, <NUM> may be arranged over a circulatory support device via a delivery catheter. In embodiments, the delivery catheter <NUM> could have a tricuspid cross-sectional shape, as illustrated in <FIG>. In embodiments, the tricuspid shape could mimic the shape of the aortic valve (e.g., the aortic valve <NUM>). This shape could allow for improved leaflet coaptation against the aortic valve itself. Additionally, or alternatively, this shape may facilitate centering of the anchoring device <NUM>, <NUM>, <NUM>, <NUM> to reduce the likelihood of aortic regurgitation.

<FIG> are schematic diagrams depicting operation of an exemplary anchoring deployment mechanism <NUM>, in accordance with embodiments of the subject matter disclosed herein. In the illustrated embodiment, the anchoring device <NUM> is arranged within a catheter <NUM>. In embodiments, the anchoring device <NUM> may be, or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In embodiments, the catheter <NUM> includes openings <NUM> through which the anchoring device <NUM> protrudes. In embodiments, a distal end 502A of the anchoring device <NUM> is coupled to a distal end <NUM> of the catheter <NUM>. Additionally, or alternatively, an actuation member <NUM> may be attached to a proximal end 502B of the anchoring device <NUM>. In the illustrated embodiment, the actuation member <NUM> is a push-pull rod. In a constrained configuration, the actuation member <NUM> is arranged along a proximal position, as illustrated in <FIG>. To actuate the anchoring device <NUM>, the actuation member <NUM> is biased in a distal direction towards the distal end <NUM> of the catheter <NUM> to a distal position, as illustrated in <FIG>. Once in the distal position, the anchoring device <NUM> projects out of the openings <NUM> and circumferentially expands to an expanded configuration, as illustrated in <FIG>.

In embodiments, the catheter <NUM> includes openings <NUM> through which the anchoring device <NUM> protrudes. In embodiments, a distal end 602A of the anchoring device <NUM> is coupled to a distal end <NUM> of the catheter <NUM>. Additionally, or alternatively, an actuation member <NUM> may be attached to a proximal end 602B of the anchoring device <NUM>. In the illustrated embodiment, the actuation member <NUM> are push-pull wires <NUM>. In a constrained configuration, the actuation member <NUM> is arranged along a proximal position, as illustrated in <FIG>. To actuate the anchoring device <NUM>, the actuation member <NUM> is biased in a distal direction towards the distal end <NUM> of the catheter <NUM> to a distal position, as illustrated in <FIG>. Once in the distal position, the anchoring device <NUM> projects out of the openings <NUM>, as illustrated in <FIG>.

<FIG> are schematic diagrams depicting operation of another exemplary anchoring deployment mechanism <NUM>, in accordance with embodiments of the subject matter disclosed herein. In the illustrated embodiment, the anchoring device <NUM> is arranged within a catheter <NUM>. In embodiments, the anchoring device <NUM> may be, or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In embodiments, the catheter <NUM> includes openings <NUM> through which the anchoring device <NUM> protrudes. In embodiments, an actuation member <NUM> may be attached to the anchoring device <NUM>. In the illustrated embodiment, the actuation member <NUM> is a push-pull rod. In a constrained configuration, the actuation member <NUM> is arranged in a distal position, as illustrated in <FIG>. To actuate the anchoring device <NUM>, the actuation member <NUM> is biased in a proximal direction to a distal position, as illustrated in <FIG>. Once in the proximal position, the anchoring device <NUM> projects out of the openings <NUM>, as illustrated in <FIG>.

In embodiments, the catheter <NUM> includes openings <NUM> through which the anchoring device <NUM> protrudes. In embodiments, the openings <NUM> may include cut-outs so the anchoring device <NUM> is entirely contained within the catheter <NUM>. In embodiments, an actuation member <NUM> may be attached to the anchoring device <NUM>. In the illustrated embodiment, the actuation member <NUM> is a push-pull rod. In a constrained configuration, the actuation member <NUM> is arranged in a distal position, as illustrated in <FIG>. To actuate the anchoring device <NUM>, the actuation member <NUM> is biased in a proximal direction to a distal position, as illustrated in <FIG>. Once in the proximal position, the anchoring device <NUM> projects out of the openings <NUM>, as illustrated in <FIG>.

<FIG> are schematic diagrams depicting operation of another exemplary anchoring deployment mechanism <NUM>, in accordance with embodiments of the subject matter disclosed herein. In the illustrated embodiment, the anchoring device <NUM> is arranged on an exterior of a catheter <NUM>. In embodiments, the anchoring device <NUM> may be, or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In embodiments, the catheter <NUM> includes a constraining member <NUM> arranged around the catheter <NUM>. In embodiments, an actuation member <NUM> may be attached to the constraining member <NUM>. In the illustrated embodiment, the actuation member <NUM> is a pulley system. In a constrained configuration, the constraining member <NUM> is arranged in a proximal position, as illustrated in <FIG>. In the proximal position, the constraining member <NUM> is arranged around the anchoring device <NUM> and holds the anchoring device <NUM> against the exterior of the catheter <NUM>. To actuate the anchoring device <NUM>, the actuation member <NUM> is actuated to move the constraining member <NUM> in a distal direction to a distal position, as illustrated in <FIG>. Once in the distal position, the anchoring device <NUM> is no longer constrained against the exterior of the catheter <NUM> so the anchoring device <NUM> projects outward from the sides of the catheter <NUM>.

<FIG> are schematic diagrams depicting operation of another exemplary anchoring deployment mechanism <NUM>, in accordance with embodiments of the subject matter disclosed herein. In the illustrated embodiment, the anchoring device <NUM> is arranged within a constraining member <NUM>. In embodiments, the anchoring device <NUM> may be, or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In embodiments, the constraining member <NUM> may be arranged on an exterior of a catheter <NUM>. In a constrained configuration, the constraining member <NUM> is arranged in a distal position, as illustrated in <FIG>. In the distal position, the constraining member <NUM> constrains the anchoring device <NUM> longitudinally, as illustrated in <FIG>. To actuate the anchoring device <NUM>, the constraining member <NUM> is moved in a proximal direction. As the constraining member <NUM> is moved in a proximal direction the anchoring device <NUM> is no longer constrained and projects out of a distal end <NUM> of the constraining member <NUM>, as illustrated in <FIG>. After projecting out of the distal end <NUM> of the constraining member <NUM>, the anchoring device <NUM> assumes its predefined shape which is a helix that surrounds the catheter <NUM>, as illustrated in <FIG>.

<FIG> are schematic diagrams depicting operation of another exemplary anchoring deployment mechanism <NUM>, in accordance with embodiments of the subject matter disclosed herein. In the illustrated embodiment, the anchoring device <NUM> is arranged on an interior a catheter <NUM>. In embodiments, the anchoring device <NUM> may be, or be similar to, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, the anchoring device <NUM> depicted in <FIG>, and/or the anchoring device <NUM> depicted in <FIG>.

In embodiments, the catheter <NUM> includes a proximal portion 1104A and a distal portion 1104B. In embodiments, an actuation member <NUM> may be attached to the proximal portion 1104A. In the illustrated embodiment, the actuation member <NUM> is an electrical wire. In a constrained configuration, the proximal portion 1104A abuts the distal portion 1104B, as illustrated in <FIG>. In the constrained configuration, the catheter <NUM> constrains the anchoring device <NUM> within an interior of the catheter <NUM>. To actuate the anchoring device <NUM>, the actuation member <NUM> is actuated to move the proximal portion 1104A in a proximal direction to a proximal position, as illustrated in <FIG>. Once the proximal portion 1104A is in the proximal position, the anchoring device <NUM> is no longer constrained within an interior of the catheter <NUM> so the anchoring device <NUM> projects outward.

Claim 1:
An apparatus, comprising:
a cardiac pump (<NUM>, <NUM>, <NUM>) configured to draw blood from a left ventricle (<NUM>) of a heart (<NUM>) of a subject through a cannula (<NUM>) of the cardiac pump (<NUM>), the cardiac pump (<NUM>, <NUM>, <NUM>) configured to release the blood into the aorta (<NUM>) of the subject; an expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) extending along a longitudinal axis, wherein the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) is arranged about a central axis (<NUM>), wherein a distal portion (104A, 204A, 304A) of the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) defines an annulus through which the cardiac pump can be arranged and to which a proximal portion (102A) of the cardiac pump (<NUM>, <NUM>, <NUM>) can be releasably coupled, and wherein a proximal portion (104B, 204B, 304B) of the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) is configured to circumferentially expand to an unconstrained configuration that has a cross-sectional diameter greater than a diameter of the annulus and to contact the walls of the aorta (<NUM>); and
a constraining member arranged over the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) to constrain the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>) in a constrained configuration for delivery of the expandable anchoring device (<NUM>, <NUM>, <NUM>, <NUM>).