Circulatory support pump centering anchor and centering device

Abstract

Embodiments in the present disclosure relate to an anchoring and centering device for a circulatory support pump. An exemplary device includes an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged around a central axis. A distal portion of the expandable anchoring device defines a ring through which a heart pump can be arranged and to which the heart pump can be releasably connected. A proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained configuration having a cross-sectional diameter greater than a diameter of the ring. The exemplary device also includes a constraining member arranged on the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration to deliver the anchoring device.

Description

[0001] Priority claim

[0002] This application claims priority to Provisional Application No. 62 / 889,674, filed on August 21, 2019, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to a percutaneous circulatory support device. More specifically, the present disclosure relates to an anchoring and centering device for a circulatory support pump. Background Art

[0004] Circulatory support devices are devices that support the pumping action of the heart. These devices can be placed through valve openings, such as the aortic valve. Typical circulatory support devices are prone to movement, resulting in the need for repositioning before continuing treatment. Summary of the invention

[0005] Embodiments disclosed herein relate to anchoring and centering devices for circulatory support pumps.Exemplary embodiments include, but are not limited to, the following examples.

[0006] In Example 1, an anchoring device for centering a heart pump includes: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged around a central axis, wherein a distal portion of the expandable anchoring device defines a ring through which the heart pump can be arranged and to which the heart pump can be releasably connected, and wherein a proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained form having a cross-sectional diameter greater than a diameter of the ring; a constraining member arranged on the expandable anchoring device to constrain the expandable anchoring device in a constrained form to deliver the anchoring device.

[0007] In Example 2, the device according to Example 1, wherein the proximal portion has a conical shape.

[0008] In Example 3, according to any of Examples 1 or 2, the proximal portion includes a plurality of proximal portions configured to expand equidistantly from the central axis when in an unconstrained configuration.

[0009] In Example 4, the device of Example 3 is described, wherein the plurality of proximal portions comprises a plurality of independent slender members.

[0010] In Example 5, the apparatus of Example 4, wherein the plurality of independent elongated members are barbs.

[0011] In Example 6, the device of any of Examples 3-5, wherein the plurality of proximal portions comprises a plurality of ring elements.

[0012] In Example 7, the apparatus of any of Examples 1-6, wherein the distal portion includes an elongated member secured to a coupling ring of the heart pump via an interference fit.

[0013] In Example 8, the device of any of Examples 1-7, wherein the distal portion includes portions that overlap when in the constrained configuration and that do not overlap when in the unconstrained configuration.

[0014] In Example 9, the apparatus according to any of Examples 1-8 further includes a delivery catheter, wherein the delivery catheter has a tricuspid valve cross-sectional shape, and wherein the anchoring device is arranged on the delivery catheter during delivery of the anchoring device.

[0015] In Example 10, the apparatus of any of Examples 1-9, wherein the plurality of expandable anchoring devices are formed of nitinol.

[0016] In Example 11, a method for delivering an anchoring device for centering a heart pump comprises: arranging an anchoring device on or within a delivery catheter, the anchoring device comprising: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged around a central axis, wherein a distal portion of the expandable anchoring device defines a ring through which a heart pump can be arranged and to which the heart pump can be releasably connected, and wherein a proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained form having a cross-sectional diameter greater than a diameter of the ring; a constraining member arranged on the expandable anchoring device to constrain the expandable anchoring device in a constrained form for delivering the anchoring device; advancing the device onto a heart pump arranged within a subject's heart; releasably connecting the anchoring device to the heart pump; and actuating the anchoring device from its constrained form.

[0017] In Example 12, according to the method of Example 11, the anchoring device also includes an actuation member, wherein the restraining member is a sheath arranged around the proximal portion, which includes at least one hole, and wherein actuating the anchoring device includes actuating the actuation member to cause the anchoring device to protrude through the at least one hole of the sheath.

[0018] In Example 13, according to the method of Example 11, wherein the constraining member is a sheath disposed about the proximal portion, and wherein actuating the anchoring device includes translating the sheath so that it is no longer disposed about the proximal portion.

[0019] In Example 14, according to a method described in any of Examples 11-13, the distal portion includes a slender member, which is fixed to a connecting ring of the heart pump via an interference fit, and wherein releasably connecting the anchoring device to the heart pump includes inserting the slender member through the connecting ring.

[0020] In Example 15, the method according to any of Examples 11-14 further includes removing the anchoring device by placing the constraining member on the expandable anchoring device and withdrawing the anchoring device.

[0021] In Example 16, an anchoring device for centering a heart pump includes: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged around a central axis, wherein a distal portion of the expandable anchoring device defines a ring through which the heart pump can be arranged and to which the heart pump can be releasably connected, and wherein a proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained form having a cross-sectional diameter greater than a diameter of the ring; a constraining member arranged on the expandable anchoring device to constrain the expandable anchoring device in a constrained form to deliver the anchoring device.

[0022] In Example 17, the device of Example 16, wherein the proximal portion has a conical shape.

[0023] In Example 18, the device of Example 16, wherein the cross-sectional shape of the proximal portion is a disk.

[0024] In Example 19, the device of Example 16, wherein the proximal portion includes a plurality of proximal portions configured to expand equidistantly from the central axis when in the unconstrained configuration.

[0025] In Example 20, the device of Example 19 is described, wherein the plurality of proximal portions comprises a plurality of independent elongated members.

[0026] In Example 21, the apparatus of Example 20, wherein the plurality of independent elongated members are barbs.

[0027] In Example 22, the device of Example 19, wherein the plurality of proximal portions comprises a plurality of ring elements.

[0028] In Example 23, the apparatus of Example 16 wherein the distal portion includes an elongated member secured to a coupling ring of the heart pump via an interference fit.

[0029] In Example 24, the device of Example 16, wherein the distal portion includes portions that overlap when in the constrained configuration and do not overlap when in the unconstrained configuration.

[0030] In Example 25, the device according to Example 16 further includes a delivery catheter, wherein the delivery catheter has a tricuspid valve cross-sectional shape, and wherein the anchoring device is arranged on the delivery catheter during delivery of the anchoring device.

[0031] In Example 26, the apparatus of Example 16 wherein the plurality of expandable anchoring devices are formed of nitinol.

[0032] In Example 27, a method for delivering an anchoring device for centering a heart pump comprises: arranging an anchoring device on or within a delivery catheter, the anchoring device comprising: an expandable anchoring device extending along a longitudinal axis, wherein the expandable anchoring device is arranged around a central axis, wherein a distal portion of the expandable anchoring device defines a ring through which a heart pump can be arranged and to which the heart pump can be releasably connected, and wherein a proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained form having a cross-sectional diameter greater than a diameter of the ring; a constraining member arranged on the expandable anchoring device to constrain the expandable anchoring device in a constrained form for delivering the anchoring device; advancing the device onto a heart pump arranged within a subject's heart; releasably connecting the anchoring device to the heart pump; and actuating the anchoring device from its constrained form.

[0033] In Example 28, a method is described according to Example 27, wherein the anchoring device further includes an actuating member, wherein the restraining member is a sheath arranged around the proximal portion, which includes at least one hole, and wherein actuating the anchoring device includes actuating the actuating member to cause the anchoring device to protrude through the at least one hole of the sheath.

[0034] In Example 29, according to the method of Example 27, wherein the constraining member is a sheath disposed about the proximal portion, and wherein actuating the anchoring device includes translating the sheath so that it is no longer disposed about the proximal portion.

[0035] In Example 30, the method of Example 27 is described, wherein the distal portion includes a slender member that is secured to a connecting ring of the heart pump via an interference fit, and wherein releasably connecting the anchoring device to the heart pump includes inserting the slender member through the connecting ring.

[0036] In Example 31, the method according to Example 27 further includes removing the anchoring device by placing a constraining member on the expandable anchoring device and retracting the anchoring device.

[0037] In Example 32, the method of Example 27 is described, wherein the proximal portion has a conical shape.

[0038] In Example 33, the method of Example 27 is described, wherein the distal portion includes portions that overlap when in the constrained configuration and do not overlap when in the unconstrained configuration.

[0039] In Example 34, the method of Example 27 is described, wherein the proximal portion includes a plurality of proximal portions configured to expand equidistantly from the central axis when in the unconstrained configuration.

[0040] In Example 35, according to the method of Example 33, the plurality of proximal portions comprises a plurality of independent elongated members.

[0041] Although multiple embodiments are disclosed, other embodiments of the disclosed subject matter will be apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosed subject matter.Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 depicts a conceptual diagram of a circulatory support device having an exemplary anchoring device anchored within a heart according to an embodiment of the subject matter disclosed herein;

[0043] Figure 2 A conceptual diagram depicting an exemplary implantation location for a circulatory support device with an exemplary anchoring device according to an embodiment of the subject matter disclosed herein;

[0044] Figure 3 depicts a side view of a circulatory support device with an exemplary anchoring device according to an embodiment of the presently disclosed subject matter;

[0045] Figure 4A depicts a side view of a portion of a circulatory support device having another exemplary anchoring device according to an embodiment of the disclosed subject matter;

[0046] Figure 4B Depicts an embodiment according to the subject matter disclosed herein Figure 4A End view of a circulatory support device;

[0047] Figure 5A and 5B depicts a conceptual end view of another exemplary anchoring device according to an embodiment of the subject matter disclosed herein;

[0048] Figure 6 depicts a conceptual cross-sectional delivery catheter according to an embodiment of the subject matter disclosed herein;

[0049] Fig. 7A and 7B is a schematic diagram depicting the operation of an exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0050] Fig. 8A and 8B is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0051] Fig. 9A and 9Bis a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0052] Fig. 10A and 10B is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0053] Fig.11A and 11B is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0054] Figures 12A-12C is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0055] Fig.13A and 13B is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism according to an embodiment of the subject matter disclosed herein;

[0056] Although the disclosed subject matter is subject to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and described in detail below. However, it is not intended to limit the subject matter disclosed herein to the specific embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the subject matter disclosed herein and are defined by the appended claims. DETAILED DESCRIPTION

[0057] Embodiments disclosed herein include a circulatory support device having an anchoring device configured for use with a heart. The anchoring device can be configured to prevent the circulatory support device from accidentally migrating from an exemplary position during operation of the circulatory support device. For example, the anchoring device can be configured to reduce the likelihood of the circulatory support device translating into or out of the aorta. As another example, the anchoring device can be configured to center the circulatory support device within the aortic valve to prevent the circulatory support device from deviating toward the periphery of the aortic valve and causing aortic regurgitation. The centering of the circulatory support device can also have the additional benefit of reducing the wear of the circulatory support device on the aortic valve leaflets. In addition, by reducing the likelihood of contact between the device and the aortic valve annulus, the likelihood of damaging aortic valve calcification and causing embolism is reduced, which reduces the risk of stroke or other organ damage. The centered device is also less likely to engage mitral valve elements, such as the papillary heads or chordae tendineae. Another advantage of the centered device is that it reduces the likelihood of contact with the left ventricular wall, especially the septal wall that may cause ectopic beats.

[0058] Figure 1A conceptual diagram of a circulatory support device 102 with an exemplary anchoring device 104 anchored within a heart 106 is depicted in accordance with an embodiment of the subject matter disclosed herein. According to an embodiment, the circulatory support device 102 may be a ventricular assist device, such as a pump, configured to pump blood from a left ventricle 108 of a subject into an aorta 110 of the subject. More specifically, a distal portion 112 of the circulatory support device 102 is disposed in the left ventricle 108. The circulatory support device 102 extends through an aortic valve 114 such that a proximal portion 116 extends into the aorta 110. During operation, the circulatory support device 102 draws blood from the left ventricle 108, through a cannula 118 of the circulatory support device 102, and is released into the aorta 110. Additionally or alternatively, the circulatory support device 102 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.

[0059] The longitudinal center axis 120 bisects the aortic valve 114. In an exemplary embodiment, the cannula 118 of the circulatory support device 102 is centered and extends along the longitudinal center axis 120, so that the circulatory support device 102 is centered on the aortic valve 114. In the event that the circulatory support device 102 is not centered within the aortic valve 114, the circulatory support device 102 may prevent the aortic valve 114 from closing, resulting in aortic regurgitation (i.e., blood flows backward from the aorta 110 to the left ventricle 108). Such positioning may also damage the leaflets of the aortic valve 114. In addition, in an exemplary embodiment, the circulatory support device 102 should not translate in the distal direction 122 or the proximal direction 124. Otherwise, the circulatory support device 102 may extend further into the left ventricle 108 or the aorta 110 than expected, thereby reducing and / or eliminating the usefulness of the circulatory support device 102. Conventional embodiments do not adequately address these issues. However, embodiments disclosed herein provide solutions to these problems by including an anchoring device 104 that is releasably coupled to the circulatory support device 102 such that the anchoring device 104 is anchored to the heart 102 to prevent translational movement of the circulatory support device 102 and / or radial movement of the circulatory support device 102, as described in more detail below.

[0060] Figure 1 The illustrative system shown in is not intended to imply any limitation on the scope of use or functionality of the disclosed embodiments. The system should also not be interpreted as having any dependency or requirement related to any single component or combination of components shown therein. In addition, Figure 1 Various components depicted in the drawings may be integrated with various other components depicted therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0061] Figure 2A conceptual diagram of an exemplary implantation location of a circulatory support device 102 with an exemplary anchoring device 104 in accordance with an embodiment of the subject matter disclosed herein is depicted. In an exemplary embodiment, the circulatory support device 102 should be positioned such that the outflow window 126 of the circulatory support device 102 is approximately 10 millimeters (mm) proximal to the right coronary artery (RCA) 128 and the left main artery (LMA) 130 to facilitate efficient outflow of blood from the circulatory support device 102 into the aorta 110. In an exemplary embodiment, the outflow window 126 of the circulatory support device 102 should also not be positioned over the brachiocephalic artery 132. Instead, the outflow window 126 should be located 10 mm distal to the brachiocephalic artery 132.

[0062] In embodiments, anchoring device 104 helps maintain circulatory support device 102 in the exemplary positions described above. For example, circulatory support device 102 can be positioned in the exemplary positions described above. After or during positioning of circulatory support device 102, anchoring device 104 can be delivered on or within a delivery catheter (not shown) in a constrained configuration so that distal portion 104A is disposed over proximal portion 102A of circulatory support device 102. In embodiments, elements of distal portion 104A can define a loop (see, e.g., Figure 4B ), the loop support device 102 can be received through the loop. In order to maintain the anchor device 104 in a constrained state, a constraining member (not shown) can be arranged around the anchor device 104. The constraining member is a sleeve, a sheath, a catheter, etc. Exemplary constraining members are described below with respect to Figure 7A-13B Describe in more detail.

[0063] In embodiments, the distal portion 104A of the anchoring device 104 can be releasably coupled to the proximal portion 102A of the cyclic support device 102. To this end, the proximal portion 102A can include a ring element 134 into which the elongated member 136 of the anchoring device 104 is inserted. As described above, the elongated member 136 can define a ring (see, e.g., Figure 4B ), the anchoring device 104 can be arranged through the ring. In an embodiment, the ring element 134 and the slender member 136 can form an interference fit to prevent the slender member 136 from being accidentally separated by the ring element 134.

[0064] Before or after the distal portion 104A is coupled to the proximal portion 102A, the constraining member can be removed from the anchoring device 104 so that the anchoring device 104 can expand circumferentially to an unconstrained state (as shown). In the unconstrained state, the anchoring device 104 can include a proximal portion 104B that expands to have a cross-sectional diameter greater than the diameter defined by the ring of the distal portion 104A. In this way, the edge 104C of the proximal portion 104B expands so that the edge 104C contacts and abuts the wall of the aorta 114. Due to the contact between the anchoring device 104 and the wall of the aorta 114, the anchoring device 104 anchors the circulatory support device 102 to the heart 106. In an embodiment, the anchoring device 104 can allow blood to pass freely along the outside of the circulatory support device 102. In an embodiment, the anchoring device 104 can expand to have a conical shape as shown. In an embodiment, the anchoring device 104 can be formed of nitinol. Additional exemplary embodiments of anchoring devices are described below with respect to Figure 3-5B Give a description.

[0065] Figure 2 The illustrations shown in the are not intended to imply any limitation on the scope of use or functionality of the embodiments of the present disclosure. The description should not be interpreted as having any dependency or requirement related to any single component or combination of components described therein. In addition, Figure 2 The various components depicted in the drawings may, in embodiments, be integrated with various of the other components depicted therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0066] Figure 3 A side view of an illustrative circulatory support device 202 having an anchoring device 204 is depicted in accordance with an embodiment of the subject matter disclosed herein. According to an embodiment, circulatory support device 202 may be or resemble Figure 1 Circulatory support device 102 as depicted in FIG. Additionally or alternatively, anchoring device 204 may be or be similar to Figure 1 Anchoring device 104 depicted in FIG.

[0067] According to embodiments, circulatory support device 202 may be a ventricular assist device configured to pump blood from the left ventricle (e.g., left ventricle 108) of the subject to the aorta (e.g., aorta 106) of the subject. In embodiments, circulatory support device 202 may be used to facilitate pumping blood from some other aspect of the subject's heart and / or vasculature to an adjacent portion of the heart and / or vasculature. Figure 3As shown, the circulatory support device 202 includes a blood pump assembly 206 having a distal end 208, which is at least partially surrounded by a flexible inlet tube 210. A plurality of blood flow outlet holes 212 are disposed in the pump assembly 206 proximal to the flexible inlet tube 208. Figure 2 In the embodiment depicted in FIG. 2 , the distal portion 204A of the anchor device 204 can be coupled to the pump assembly 206 before, during, or after implantation of the circulatory support device 202 .

[0068] In an embodiment, the anchoring device 204 also includes a proximal portion 204B extending proximally and radially outward from the longitudinal center axis 214. 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 218 and a second end 220, each of which is coupled to the pump assembly 206. In an embodiment, the first and second ends 218, 220 may form a loop through which the pump assembly 306 is inserted. Between the first and second ends 218, 220, the proximal portions 216A-216C extend in a proximal direction 222. After extending a distance in the proximal direction 222, each proximal portion 216A-216C reaches a distal end 224, then loops back and extends in a distal direction 226 back to the first and second ends 220, 222. In an embodiment, the distal end 224 may include a barb for securing the anchoring device 204 to the aorta. In an embodiment, the proximal portions 216A-216C may form a basket structure. In an embodiment, the proximal portions 216A-216C may overlap or they may not overlap.

[0069] In an embodiment, the proximal portions 216A-216C can be delivered in a constrained state by, for example, a constraining member (not shown). The constraining member is a cannula, sheath, catheter, and / or the like. Exemplary constraining members are described below with respect to Figure 7A-13B The constraining member can be removed from the anchoring device 204 so that the anchoring device 204 can be expanded circumferentially to an unconstrained state (as shown) to fix the circulation support device 202 in an exemplary position, as described above. In an embodiment, the proximal portions 216A-216C can be equidistant from the central axis 214.

[0070] Figure 3 The illustrations shown in the are not intended to imply any limitation on the scope of use or functionality of the embodiments of the present disclosure. The description should not be interpreted as having any dependency or requirement related to any single component or combination of components described therein. In addition, Figure 3The various components depicted in the drawings may, in embodiments, be integrated with various of the other components depicted therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0071] Figure 4A Depicted is a side view of a portion of a circulatory support device 302 with another exemplary anchoring device 304 according to an embodiment of the disclosed subject matter. Figure 4B Depicts an embodiment according to the subject matter disclosed herein Figure 4A According to an embodiment, circulatory support device 302 may be or resemble Figure 1 The circulatory support device 102 and / or Figure 3 Circulatory support device 202 as depicted in FIG. Additionally or alternatively, anchoring device 304 may be or be similar to Figure 1 The anchoring device 104 and / or Figure 3 Anchoring device 204 depicted in FIG.

[0072] According to embodiments, circulatory support device 302 may be a ventricular assist device configured to pump blood from the left ventricle (e.g., left ventricle 108) of a subject into an aorta (e.g., aorta 106) of the subject. In embodiments, circulatory support device 302 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. Figure 4A As shown, circulatory support device 302 includes a blood pump assembly 306 having a distal end 308 that is at least partially surrounded by a flexible inlet tube 310. Figure 3, the distal portion 304A of the anchoring device 304 can be coupled to the pump assembly 306 before, during, or after implantation of the circulatory support device 302. In an embodiment, the anchoring device 304 also includes a proximal portion 304B that extends proximally and radially outward from the longitudinal center axis 314. In the illustrated embodiment, the proximal portion 304B includes a plurality of proximal portions 316A, 316B, 316C. Each proximal portion 316A-316C forms a ring. For example, each proximal portion 316A-316C may include a first end 318 and a second end 320, each of which is coupled to the pump assembly 306. In an embodiment, the first and second ends 318, 320 can form a ring through which the pump assembly 306 is inserted. Between the first and second ends 318, 320, the proximal portions 316A-316C extend in a proximal direction 322. After extending the first distance in the proximal direction 322, each proximal portion 316A-316C reaches a first intermediate point 324 and then extends in the distal direction 326 for a second distance shorter than the first distance. After extending the second distance in the proximal direction 322, each proximal portion 316A-316C reaches a second intermediate point 328 and then extends in the proximal direction for a third distance. The third distance may be approximately equal to the second distance. After extending the third distance in the proximal direction 322, each proximal portion 316A-316C reaches a distal end 330. Each proximal portion 316A-316C then extends the third distance in the distal direction 326 and then returns to the second distance in the proximal direction 322 and then returns to the first distance in the distal direction 326 to the second end 322. In an embodiment, the distal end 324 may include a barb for securing the anchoring device 304 to the aorta. In an embodiment, the proximal portions 316A-316C may form a basket structure. In embodiments, the proximal portions 316A-316C may overlap or they may not overlap.

[0073] In an embodiment, the proximal portions 316A-316C can be delivered in a constrained state by, for example, a constraining member (not shown). The constraining member is a cannula, sheath, catheter, and / or the like. Exemplary constraining members are described below with respect to Figure 7A-13B The constraining member can be removed from the anchoring device 304 so that the anchoring device 304 can be expanded circumferentially to an unconstrained state (as shown) to fix the circulation support device 302 in an exemplary position, as described above. In an embodiment, the proximal portions 316A-316B can be equidistant from the central axis 314.

[0074] Figures 4A-4BThe illustrated embodiments are not intended to limit the scope of use or functionality of the embodiments of the present disclosure. The description should not be interpreted as having any dependency or requirement associated with any single component or combination of components described therein. In addition, in embodiments, the various components depicted in 4A-4B can be integrated with various components in other components depicted therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0075] Figure 5A and 5B A conceptual end view of another exemplary anchoring device 400 is depicted in accordance with an embodiment of the subject matter disclosed herein. More specifically, Figure 5A A conceptual end view of another exemplary anchoring device 400 in a constrained configuration is depicted, and Figure 5B Depicted Figure 5A A conceptual end view of an exemplary anchoring device 400 in an unconstrained configuration is depicted in FIG. According to an embodiment, the anchoring device 400 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , and / or the anchoring device 304 depicted in FIG. 4 .

[0076] In the illustrated embodiment, the anchoring device 400 has a proximal portion 402 that includes a plurality of elongated members 404 surrounded by a membrane 406. In an embodiment, the elongated members 404 and the membrane 406 are centered about a central axis 408. When in the constrained configuration, the proximal portion 404 and the membrane 406 are constrained by a constraining member 410. In an embodiment, the constraining member 408 can be a cannula, a sheath, a catheter, etc. In an embodiment, the membrane 406 includes an overlapping portion 412 that overlaps when the anchoring device 400 is in the constrained configuration, such as Figure 5A However, when the constraining member 410 is removed from the proximal portion 402, the elongated member 402 and the surrounding membrane 406 expand circumferentially around the central axis to an unconstrained configuration, as shown. Figure 5B In the unconstrained configuration, the film 406 may no longer include the overlapping portion 412. In an embodiment, the outer edge of the film 406 may be equidistant from the central axis 314.

[0077] Figure 5A and 5BA conceptual cross-sectional view of a circulatory support device with another exemplary anchoring device according to an embodiment of the subject matter disclosed herein is depicted. Another embodiment includes a sheathed frame that folds on itself. When unsheathed, it lies against the aortic wall. This design functions like a folding balloon on a balloon catheter. This can be a selectively deployable anchoring device as well as a non-selectively deployable device depending on the introducer sheath used. The sheathed frame needs to be flexible enough to fold on itself over the sheath of the device and easily fold back onto the surface of the sheath when recaptured for removal.

[0078] Figure 6 A conceptual cross-sectional delivery catheter 500 is depicted in accordance with an embodiment of the subject matter disclosed herein. As described above, the anchoring devices 104, 204, 304, 400 can be deployed on the circulatory support device via a delivery catheter. In an embodiment, the delivery catheter 500 can have a tricuspid valve cross-sectional shape, such as Figure 6 As shown. In embodiments, the tricuspid valve shape can mimic the shape of an aortic valve (e.g., aortic valve 114). This shape can improve the coaptation of the leaflets to the aortic valve itself. Additionally or alternatively, the shape can aid in centering the anchoring device 104, 204, 304, 400 to reduce the likelihood of aortic regurgitation.

[0079] Fig. 7A and 7B is a schematic diagram depicting the operation of an exemplary anchor deployment mechanism 600 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, an anchor device 502 is disposed within a catheter 504. In an embodiment, the anchor device 502 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0080] In an embodiment, the catheter 504 includes an opening 506 through which the anchoring device 502 protrudes. In an embodiment, the distal end 502A of the anchoring device 502 is coupled to the distal end 508 of the catheter 504. Additionally or alternatively, an actuation member 510 can be attached to the proximal end 502B of the anchoring device 502. In the illustrated embodiment, the actuation member 510 is a push-pull rod. In the constrained configuration, the actuation member 510 is arranged along a proximal position, such as Figure 7B To actuate the anchoring device 502, the actuating member 510 is biased in the distal direction toward the distal end 508 of the catheter 504 to a distal position, such as Fig. 7A Once in the distal position, the anchoring device 502 extends from the opening 506 and expands circumferentially to an expanded configuration, such as Fig. 7A shown.

[0081] Fig. 8A and 8B 604 is a schematic diagram depicting the operation of an exemplary anchor deployment mechanism 700 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the anchor device 602 is disposed within a catheter 604. In an embodiment, the anchor device 602 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0082] In an embodiment, the catheter 604 includes an opening 606 through which the anchoring device 602 protrudes. In an embodiment, the distal end 602A of the anchoring device 602 is coupled to the distal end 608 of the catheter 604. Additionally or alternatively, an actuation member 610 can be attached to the proximal end 602B of the anchoring device 602. In an embodiment, the actuation member 610 is a push-pull wire 610. In the constrained configuration, the actuation member 610 is arranged along a proximal position, such as Figure 8B To actuate the anchoring device 602, the actuating member 610 is biased in the distal direction toward the distal end 608 of the catheter 604 to a distal position, such as Fig. 8A Once in the distal position, the anchoring device 602 extends from the opening 606, as shown. Fig. 8A shown.

[0083] Fig. 9A and 9B is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism 800 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the anchor device 702 is disposed within the catheter 704. In an embodiment, the anchor device 702 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0084] In an embodiment, the catheter 704 includes an opening 706 through which the anchoring device 702 protrudes. In an embodiment, an actuation member 708 can be attached to the anchoring device 702. In the illustrated embodiment, the actuation member 708 is a push-pull rod. In the constrained configuration, the actuation member 708 is disposed in a distal position, such as Fig. 9B To actuate the anchoring device 702, the actuating member 708 is biased in the proximal direction to a distal position, such as Fig. 9A Once in the proximal position, the anchoring device 702 extends from the opening 706, as shown. Fig. 9A shown.

[0085] Fig. 10Aand 10B 804 is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism 900 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, an anchor device 802 is disposed within a catheter 804. In an embodiment, the anchor device 802 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0086] In an embodiment, the catheter 804 includes an opening 806 through which the anchoring device 802 protrudes. In an embodiment, the opening 806 may include a cutout so that the anchoring device 802 is completely contained within the catheter 804. In an embodiment, an actuation member 808 may be attached to the anchoring device 802. In the illustrated embodiment, the actuation member 808 is a push-pull rod. In the constrained configuration, the actuation member 808 is disposed in a distal position, such as Fig. 10B To actuate the anchoring device 802, the actuating member 808 is biased in the proximal direction to a distal position, such as Fig. 10A Once in the proximal position, the anchoring device 802 extends from the opening 806, as shown. Fig. 10A shown.

[0087] Fig.11A and 11B 1 is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism 1000 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the anchor device 902 is disposed on the exterior of the catheter 904. In an embodiment, the anchor device 902 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0088] In an embodiment, the catheter 904 includes a restraining member 906 disposed about the catheter 904. In an embodiment, an actuating member 908 can be attached to the restraining member 906. In the illustrated embodiment, the actuating member 908 is a pulley system. In the restrained configuration, the restraining member 906 is disposed in a proximal position, such as Fig. 10B In the proximal position, the constraining member 906 is arranged around the anchoring device 902 and holds the anchoring device 902 against the exterior of the catheter 904. To actuate the anchoring device 902, the actuating member 908 is actuated to move the constraining member 906 in the distal direction to the distal position, as shown. Fig.11A Once in the distal position, the anchoring device 902 is no longer constrained by the exterior of the catheter 904 and thus the anchoring device 902 protrudes outwardly from the side of the catheter 904.

[0089] Figures 12A-12C 1 is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism 1100 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the anchor device 1002 is disposed within the restraining member 1004. In an embodiment, the anchor device 1002 may be or may be similar to Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0090] In an embodiment, the constraining member 1004 can be disposed on the exterior of the catheter 1006. In the constrained configuration, the constraining member 1004 is disposed in a distal position, such as Fig. 12A In the distal position, the restraining member 1006 longitudinally restrains the anchoring device 1002, as shown. Fig. 12A To actuate the anchoring device 1002, the constraining member 1004 is moved in the proximal direction. When the constraining member 1004 is moved in the proximal direction, the anchoring device 1002 is no longer constrained and extends out of the distal end 1008 of the constraining member 1004, as shown in FIG. Fig. 12B and 12C After extending from the distal end 1008 of the constraining member 1004, the anchoring device 1002 assumes its predetermined shape, namely a spiral around the catheter 1006, as shown in FIG. Fig. 12C shown.

[0091] Fig.13A and 13B 1 is a schematic diagram depicting the operation of another exemplary anchor deployment mechanism 1200 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the anchor device 1102 is disposed within the interior of the catheter 1104. In an embodiment, the anchor device 1102 may be or resemble Figure 1 The anchoring device 104 depicted in Figure 3 The anchoring device 204 depicted in FIG. 4 , the anchoring device 304 depicted in FIG. 4 , and / or the anchoring device 400 depicted in FIG. 5 .

[0092] In an embodiment, the catheter 1104 includes a proximal portion 1104A and a distal portion 1104B. In an embodiment, an actuation member 1106 can be attached to the proximal portion 1104A. In the illustrated embodiment, the actuation member 1106 is an electrical wire. In the constrained configuration, the proximal portion 1104A abuts the distal portion 1104B, such as Fig.13A In the constrained configuration, the catheter 1104 constrains the anchoring device 1102 within the catheter 1104. To actuate the anchoring device 1102, the actuation member 1106 is actuated to move the proximal portion 1104A in the proximal direction to a proximal position, such as Fig. 13BOnce the proximal portion 1104A is in the proximal position, the anchoring device 1102 is no longer constrained within the catheter 1104 and thus the anchoring device 1102 protrudes outward.

[0093] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the above-described embodiments relate to specific features, the scope of the present disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Therefore, the scope of the present disclosure is intended to include all such substitutions, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. An anchoring device for centering a heart pump, comprising: a heart pump comprising a cannula configured to draw blood from a left ventricle of a subject's heart into an inflow distal portion of the heart pump, and the heart pump configured to release the blood from a plurality of outflow windows in an outflow proximal portion thereof into an aorta of the subject; 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 a ring through which the heart pump can be arranged and to which the heart pump can be releasably connected, and wherein a proximal portion of the expandable anchoring device is configured to expand circumferentially to an unconstrained configuration having a cross-sectional diameter greater than a diameter of the ring; wherein, when the expandable anchoring device is coupled to the heart pump, the plurality of outflow windows of the heart pump are located distally and upstream of the proximal portion of the expandable anchoring device; and a constraining member disposed over the expandable anchoring device to constrain the expandable anchoring device in a constrained configuration for delivery of the anchoring device; Wherein, the proximal portion includes a plurality of proximal portions configured to expand equidistantly from the central axis when in the unconstrained configuration.

2. The device according to claim 1, wherein The proximal portion has a conical shape.

3. The device according to claim 1, wherein: The plurality of proximal portions include a plurality of independent elongated members.

4. The device according to claim 3, wherein: The plurality of independent elongated members are barbs.

5. The device according to any one of claims 1, 3 and 4, wherein: The plurality of proximal portions include a plurality of ring elements.

6. The device according to any one of claims 1 to 4, wherein: The distal portion includes an elongated member secured to a coupling ring of the heart pump via an interference fit.

7. The device according to any one of claims 1 to 4, wherein: The distal portion includes portions that overlap when in the constrained configuration and that do not overlap when in the unconstrained configuration.

8. The device according to any one of claims 1-4 further comprises a delivery catheter, wherein the delivery catheter has a tricuspid valve cross-sectional shape, and wherein the anchoring device is arranged on the delivery catheter during delivery of the anchoring device.

9. The device according to any one of claims 1 to 4, wherein: The plurality of expandable anchoring devices are formed from Nitinol.

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