Circulation support device

Abstract

A circulatory support device includes a flexible cannula having a fluid outlet at a proximal end, and a pump assembly disposed at a distal end of the flexible cannula. The pump assembly includes a pump housing having a fluid inlet defined therein, a motor disposed within the distal end of the housing, and an impeller driven in rotation by the motor, the impeller being configured to push blood toward the fluid outlet.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Provisional Application No. 62 / 782,127, filed December 19, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates to percutaneous circulatory support devices. More particularly, the present invention relates to a circulatory support device having a flexible cannula and reverse flow direction. Background Art

[0004] The circulatory support device may be placed through a valve opening, such as, for example, the aortic valve. In some cases, the size of the device may cause stress on the valve when the valve closes over the device. In the event of a motor failure, a typical circulatory support device may cause a pressure differential between the left ventricle and the aorta. In addition, a typical circulatory support device is prone to movement, resulting in the need for repositioning before continuing treatment. Summary of the invention

[0005] In Example 1, a circulatory support device includes: a flexible cannula having a fluid outlet at a proximal end; and a pump assembly disposed at a distal end of the flexible cannula, the pump assembly including: a pump housing having a fluid inlet defined therein; a motor disposed within the distal end of the housing; and an impeller driven to rotate by the motor, the impeller being configured to push blood toward the fluid outlet.

[0006] In Example 2, the circulation support device of Example 1 further includes a mesh skirt adjacent to the fluid inlet and at least partially surrounding the pump housing.

[0007] In Example 3, the circulatory support device of Example 1 or 2 further includes an expandable cage coupled to the distal end of the pump housing.

[0008] In Example 4, the circulatory support device of any one of Examples 1 to 3 further includes an expandable cage coupled to the proximal end of the flexible cannula.

[0009] In Example 5, the circulatory support device of any one of Examples 1 to 3 further includes: a first expandable cage coupled to a distal end of the pump housing and configured to be disposed within the left ventricle of the subject; and a second expandable cage coupled to a proximal end of the flexible cannula and configured to be disposed within the aorta.

[0010] In Example 6, the circulatory support device of any one of Examples 1 to 5 further includes a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein the one or more wires are disposed within the coiled tube.

[0011] In Example 7, the circulatory support device of any one of Examples 1 to 6, wherein at least a portion of the flexible cannula is configured to be disposed through the aortic valve opening and is configured to be compressible so that the aortic valve can be closed over at least a portion of the flexible cannula.

[0012] In Example 8, a circulatory support device includes: a flexible cannula having a fluid outlet at a proximal end; a pump assembly disposed at a distal end of the flexible cannula, the pump assembly including: a pump housing having a fluid inlet defined therein; a motor disposed within the distal end of the housing; and an impeller driven to rotate by the motor, the impeller being configured to push blood toward the fluid outlet; and a first expandable cage coupled to the distal end of the pump housing; and a second expandable cage coupled to the proximal end of the flexible cannula.

[0013] In Example 9, the circulation support device of Example 8 further includes a mesh skirt adjacent to the fluid inlet and at least partially surrounding the pump housing.

[0014] In Example 10, the circulatory support device of Example 8 or 9, wherein the fluid inlet is disposed between the flexible cannula and the motor.

[0015] In Example 11, the circulatory support device of any of Examples 8 to 10, wherein the first expandable cage is configured to be disposed within a left ventricle of the subject.

[0016] In Example 12, the circulatory support device of any of Examples 8 to 11, wherein the second expandable cage is configured to be disposed within an aorta of the subject.

[0017] In Example 13, the circulatory support device of any one of Examples 8 to 12 further includes a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein the one or more wires are disposed within the coiled tube.

[0018] In Example 14, the circulatory support device of Example 13, wherein the one or more wires are configured to operably connect the motor to the control unit and extend along the exterior of the pump housing from the distal end of the helical tube into the distal end of the pump housing.

[0019] In Example 15, the circulatory support device of any one of Examples 8 to 14, wherein at least a portion of the flexible cannula is configured to be disposed through the aortic valve opening and is configured to be compressible so that the aortic valve can be closed over at least a portion of the flexible cannula.

[0020] In Example 16, a circulatory support device includes: a flexible cannula having a fluid outlet at a proximal end; and a pump assembly disposed at a distal end of the flexible cannula, the pump assembly including: a pump housing having a fluid inlet defined therein; a motor disposed within the distal end of the housing; and an impeller driven in rotation by the motor, the impeller being configured to push blood toward the fluid outlet.

[0021] In Example 17, the circulation support device of Example 16 further includes a mesh skirt adjacent to the fluid inlet and at least partially surrounding the pump housing.

[0022] In Example 18, the circulatory support device of Example 16 further includes an expandable cage coupled to the distal end of the pump housing.

[0023] In Example 19, the circulatory support device of Example 16 further includes an expandable cage coupled to the proximal end of the flexible cannula.

[0024] In Example 20, the circulatory support device of Example 16 further includes: a first expandable cage coupled to a distal end of the pump housing and configured to be disposed within a left ventricle of the subject; and a second expandable cage coupled to a proximal end of the flexible cannula and configured to be disposed within the aorta.

[0025] In Example 21, the circulatory support device of Example 16 further includes a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein the one or more wires are disposed within the coiled tube.

[0026] In Example 22, the circulatory support device of Example 16, wherein at least a portion of the flexible cannula is configured to be disposed through the aortic valve opening and is configured to be compressible such that the aortic valve can be closed over at least a portion of the flexible cannula.

[0027] In Example 23, a circulatory support device includes: a flexible cannula having a fluid outlet at a proximal end; a pump assembly disposed at a distal end of the flexible cannula, the pump assembly including: a pump housing having a fluid inlet defined therein; a motor disposed within the distal end of the housing; and an impeller driven for rotation by the motor, the impeller being configured to push blood toward the fluid outlet; and a first expandable cage coupled to the distal end of the pump housing; and a second expandable cage coupled to the proximal end of the flexible cannula.

[0028] In Example 24, the circulation support device of Example 23 further includes a mesh skirt adjacent to the fluid inlet and at least partially surrounding the pump housing.

[0029] In Example 25, the circulatory support device of Example 23, wherein the fluid inlet is disposed between the flexible cannula and the motor.

[0030] In Example 26, the circulatory support device of Example 23, wherein the first expandable cage is configured to be disposed within a left ventricle of the subject.

[0031] In Example 27, the circulatory support device of Example 23, wherein the second expandable cage is configured to be disposed within an aorta of the subject.

[0032] In Example 28, the circulatory support device of Example 23 further includes a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein the one or more wires are disposed within the coiled tube.

[0033] In Example 29, the circulatory support device of Example 28, wherein the one or more wires are configured to operably connect the motor to the control unit and extend along the exterior of the pump housing from the distal end of the helical tube into the distal end of the pump housing.

[0034] In Example 30, the circulatory support device of Example 23, wherein at least a portion of the flexible cannula is configured to be disposed through the aortic valve opening and is configured to be compressible such that the aortic valve can be closed over at least a portion of the flexible cannula.

[0035] In Example 31, a method of deploying a circulatory support device, the circulatory support device comprising a flexible cannula having a fluid outlet at a proximal end; a coiled tube connected to a proximal end of a pump housing and extending through at least a portion of the flexible cannula; a pump assembly disposed at a distal end of the flexible cannula, the pump assembly comprising a pump housing having a fluid inlet defined therein; a motor disposed within the distal end of the housing; and an impeller driven to rotate by the motor, the impeller being configured to propel blood toward the fluid outlet; and an expandable cage connected to the distal end of the pump housing, the method comprising: navigating a delivery sheath to a deployed position, the delivery sheath comprising (1) an insertion manifold having a proximal opening and a distal opening, and (2) a delivery shaft extending from the distal opening; navigating the circulation support device to the delivery sheath, wherein the circulation support device is disposed within a protective tube; inserting the circulation support device and the protective tube into the proximal opening of the insertion manifold, wherein the insertion manifold includes a stop surface disposed therein, the stop surface being configured to engage a distal edge of the protective tube, thereby preventing the protective tube from being pushed into the delivery shaft; pushing the circulation support device into the delivery shaft, wherein the protective tube is prevented from entering the delivery shaft by the stop surface; and pushing the circulation support device out of the distal end of the delivery shaft, wherein upon leaving the delivery shaft, the expandable cage expands and engages the cage position, thereby fixing the circulation support device in a suitable position.

[0036] In Example 32, the method of Example 31, wherein navigating the delivery sheath to the deployed position comprises passing a guidewire through the delivery sheath and tracking at least one of the guidewire and the delivery sheath during navigation.

[0037] In Example 33, the method of Example 31, wherein navigating the delivery sheath to the deployed position includes positioning a distal end of the delivery shaft adjacent to the cage.

[0038] In Example 34, the method of Example 31, wherein pushing the circulating support device into the conveying shaft includes pushing the spiral tube.

[0039] In Example 35, the method of Example 31, wherein deploying the circulation support device includes positioning the circulation support device in a deployed position without inserting a guide wire through the circulation support device.

[0040] Although multiple embodiments are disclosed, other embodiments of the presently 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. Therefore, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 Depicted is a side view of an illustrative percutaneous mechanical circulatory support device according to an embodiment of the presently disclosed subject matter.

[0042] Figure 2 Depicted is a cross-sectional side view of an illustrative circulation support device according to an embodiment of the disclosed subject matter.

[0043] Figures 3A-3D An illustrative circulation stent delivery system is depicted at different stages of a process for deploying a circulation stent according to an embodiment of the disclosed subject matter.

[0044] Figure 4 is a flow chart depicting an illustrative method of deploying a cyclic support device according to an embodiment of the subject matter disclosed herein.

[0045] Although the disclosed subject matter is suitable for various modifications and alternative forms, specific embodiments have been shown in the drawings by way of example and will be described in detail below. However, the present invention is not intended to limit the subject matter disclosed herein to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and substitutes that fall within the scope of the subject matter disclosed herein and as defined by the appended claims.

[0046] As used herein with respect to values ​​(e.g., terms of magnitude, measurement, and / or other qualitative degree and / or quantitative observation used herein with respect to properties (e.g., dimensions, measurements, attributes, components, etc.) and / or ranges thereof of tangible items (e.g., products, inventory, etc.) and / or intangible items (e.g., data, electronic representations of currency, accounts, information, portions of items (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.), “about” and “approximately” may be used interchangeably to refer to values, configurations, orientations, and / or other properties that are equivalent to (or the same as) the stated value, configuration, orientation, and / or other properties that are equal to (or the same as) the stated value, configuration, orientation, and / or are reasonably close to the stated value, configuration, orientation, and / or ranges thereof. Other characteristics and / or other characteristics, but it should be understood that there may be reasonably small differences that can be distinguished and more easily determined by ordinary technicians in the relevant fields, which may be due to measurement errors; differences in calibration of measurement and / or manufacturing equipment; human error in reading and / or setting measurements; adjustments made in view of other measurements (e.g., measurements associated with other things) to optimize performance and / or structural parameters; specific implementations; imprecise adjustments and / or manipulation of things, settings and / or measurements by people, computing devices and / or machines; system tolerances; control loops; machine learning; foreseeable changes (e.g., statistically insignificant changes, chaotic changes, system and / or model instabilities, etc.); preferences, etc.

[0047] Although the term "frame" can be used to imply different elements of illustrative adoption in this article, the term should not be interpreted as implying any requirement or specific order among or between the various frames disclosed herein. Similarly, although the illustrative method can be represented by one or more figures (e.g., flow charts, communication processes, etc.), the figures should not be interpreted as implying any requirement or specific order among or between the various steps disclosed herein. However, some embodiments may require certain steps and / or certain orders between certain steps, as may be clearly described herein and / or may be understood according to the nature of the steps themselves (e.g., the execution of some steps may depend on the result of the previous step). In addition, a "set", "subset" or "group" (e.g., input, algorithm, data value, etc.) of a project may include one or more projects, and similarly, a subset or subgroup of a project may include one or more projects. "Multiple" means more than one. DETAILED DESCRIPTION

[0048] Embodiments of the disclosed subject matter include bearing designs that can promote reduced heat formation and reduce mechanical blood damage by preventing blood from entering the bearing surface through the use of lubrication. Bearing designs including recessed depressions and closed chambers facilitate preventing blood from entering the bearing surface. Lubrication can be used to provide a fluid film on the bearing surface to minimize wear. According to embodiments, any number and different types of lubricants can be used, such as, for example, a hydrophobic water-insoluble lubricant (e.g., a synthetic lubricant of perfluoropolyether or polyalphaolefin class) can be used.

[0049] Figure 1 A side view of an illustrative percutaneous mechanical circulatory support device 100 according to an embodiment of the subject matter disclosed herein is depicted. According to an embodiment, circulatory support device 100 may be a ventricular assist device configured to pump blood from the left ventricle of a subject into the subject's aorta. In an embodiment, circulatory support device 100 may be used to assist in pumping blood from some other aspect of the subject's vasculature into an adjacent portion of the vasculature.

[0050] like Figure 1 As shown, the circulatory support device 100 includes a flexible cannula 102 having a fluid outlet 104 at a proximal end 106 and connected to a pump assembly 110 at a distal end 108. According to embodiments, the flexible cannula 102 or at least a portion thereof may be configured to be disposed through a heart valve opening, such as, for example, an aortic valve opening. In embodiments, the flexible cannula 102 may be configured to be compressible so that a heart valve may be closed on the cannula (or a portion thereof) but without causing leakage through the valve. In this manner, for example, embodiments of the subject matter may be configured to prevent (or at least mitigate) a pressure differential between the left ventricle and the aorta in the event of a motor failure of the device 100.

[0051] like Figure 1 As further shown, the pump assembly 110 includes a pump housing 112 having a fluid inlet 114 defined therein. Figure 1 The motor may be configured to drive an impeller (not shown) in a distal portion 116 of the housing 112. Figure 1 104, the impeller 102 is disposed proximal to the motor, and the impeller can be configured to push blood toward the fluid outlet 104. In an embodiment, the circulatory support device 100 includes a mesh skirt 118 adjacent to the fluid inlet 114 and at least partially surrounding the pump housing 112. The mesh skirt 118 can be configured to promote blood flow into the fluid inlet 114 and / or prevent larger particles from entering the fluid inlet 114. As shown, the mesh skirt 118 can be configured as a cone with an opening 120 facing distally.

[0052] The first expandable cage 122 can be coupled to the distal end 124 of the pump housing 112. In embodiments, the first expandable cage 122 can be configured to be disposed in a first portion of the subject's vasculature, such as, for example, within the subject's left ventricle. Figure 1 As shown, the second expandable cage 126 may be coupled to (or adjacent to) the proximal end 106 of the flexible cannula 102. In embodiments, the second expandable cage 126 may be configured to be disposed within a second portion of the subject's vasculature, such as, for example, within the subject's aorta. In this manner, for example, the circulatory support device 100 may be used as a ventricular assist device having an impeller disposed in the ventricle to pump blood to a blood outlet disposed in the aorta. The first and / or second expandable cages 122, 126 may help maintain the device 100 in place even during patient movement. According to embodiments, use of the designs described herein having an impeller disposed in the ventricle for pumping blood from the ventricle into the aorta may allow the aortic valve to close on the flexible cannula, thereby preventing backflow while simulating heart pumping.

[0053] like Figure 1 As further shown, the circulatory support device 100 includes a coiled tube 128 coupled to the proximal end 130 of the pump housing 112 and extending through at least a portion of the flexible cannula 102, wherein one or more wires 132 are disposed within the coiled tube 128. That is, for example, the coiled tube 128 provides a conduit therein for enclosing control and / or power wires extending from a control unit to a motor, wherein the wires help control the motor. In an embodiment, the coiled tube 128 may be enclosed by a conduit sleeve 134. As further shown, in an embodiment, the one or more wires 132 may be configured to extend from the distal end of the coiled tube 128 along the exterior of the pump housing 112 into the distal end 124 of the pump housing 112. A housing sleeve 136 may be disposed over at least a portion of the one or more wires 132 for protection.

[0054] Figure 1 The illustrative cycle support device 100 shown in is not intended to suggest any limitation on the scope of use or functionality of the embodiments of the invention. The illustrative cycle support device 100 should also not be interpreted as having any dependency or requirement related to any single component or combination of components shown herein. In addition, in the embodiments, Figure 1 The various components depicted in the drawings may be integrated with various other components depicted herein (and / or components not shown), all of which are considered to be within the scope of the present invention.

[0055] Figure 2 A cross-sectional side view of an illustrative circulation support device 200 according to an embodiment of the disclosed subject matter is depicted. According to an embodiment, the circulation support device 200 may be or be similar to Figure 1 The cyclic support device 100 depicted in FIG. Figure 2 As shown, the circulatory support device 200 includes a flexible cannula 202 having a fluid outlet at a proximal end (not shown). Figure 2 ) and connected to the pump assembly 206 at the distal end 204. As explained above, Figure 1 , the flexible cannula 202 or at least a portion thereof may be configured to be disposed through a heart valve opening, such as, for example, an aortic valve opening. In embodiments, the flexible cannula 202 may be configured to be compressible so that a heart valve may close over the cannula (or a portion thereof) without causing leakage through the valve. In this manner, for example, embodiments of the subject matter may be configured to prevent (or at least mitigate) a pressure differential between the left ventricle and the aorta in the event of a motor failure of the device 200.

[0056] like Figure 2 As further shown, the pump assembly 206 includes a pump housing 208 having a fluid inlet 210 defined therein. According to an embodiment, the fluid inlet 210 may be disposed adjacent to an impeller 212, which is also disposed within the pump housing 208. A motor 214 may be disposed within a distal portion 216 of the housing 208. The motor 214 may be configured to drive the impeller 212 via a drive shaft 215, and the impeller 212 and the drive shaft 215 may be disposed proximal to the motor 214, and the impeller 212 may be configured to push a fluid (e.g., blood) toward a fluid outlet. In an embodiment, the distal portion 216 of the housing 208 may be laser welded to the motor 214. In an embodiment, the circulatory support device 200 includes a mesh skirt (such as, for example, a mesh skirt) adjacent to the fluid inlet 210 and at least partially surrounding the pump housing 208. Figure 1 210 ). The mesh skirt 118 can be configured to facilitate blood flow into the fluid inlet 210 and / or prevent larger particles from entering the fluid inlet 210 .

[0057] The expandable cage 218 can be coupled to the distal end 220 of the pump housing 208. In embodiments, the expandable cage 218 can be configured to be disposed in a first portion of the subject's vasculature, such as, for example, within the subject's left ventricle. Figure 2 As shown in Figure 1 As shown, the second expandable cage may be coupled to (or adjacent to) the proximal end of the flexible cannula 202. In embodiments, the second expandable cage may be configured to be disposed in a second portion of the subject's vasculature, such as, for example, within the subject's aorta. Figure 2As further shown, the circulatory support device 200 includes a coiled tube 222 coupled to a proximal end 224 of the pump housing 208 and extending through at least a portion of the flexible cannula 202, wherein one or more wires 226 are disposed within the coiled tube 222. According to an embodiment, the proximal end 224 of the pump housing 208 may be crimped onto the distal end 228 of the coiled tube 222, and the two may be laser welded together. As further shown, in an embodiment, the one or more wires 226 may be configured to extend from the distal end 228 of the coiled tube 222 along the exterior of the pump housing 208 into the distal end 220 of the pump housing 208. A housing sleeve (not shown) may be disposed over at least a portion of the one or more wires 226 for protection.

[0058] Figure 2 The illustrative cycle support device 200 shown in is not intended to suggest any limitation on the scope of use or functionality of the embodiments of the invention. The illustrative cycle support device 200 should also not be interpreted as having any dependency or requirement related to any single component or combination of components shown herein. In addition, in the embodiments, Figure 2 The various components depicted in the drawings may be integrated with various other components depicted herein (and / or components not shown), all of which are considered to be within the scope of the present invention.

[0059] Compared to a typical circulation support device delivery process, the embodiments of the circulation support device disclosed herein can be configured to deploy without passing the guide wire through the housing of the circulation support device. Typically, the guide wire is set through the housing of the circulation support device and tracks the guide wire itself during delivery. For example, in many typical systems, the guide wire is loaded into the circulation support device outlet, passes around the impeller and exits the fluid inlet of the device. In many cases, bending the guide wire around the circulation support device and setting it through it may cause dragging during delivery, thereby scraping the Teflon on the guide wire, etc.

[0060] Embodiments of the disclosed subject matter herein can alleviate these problems by allowing the clinician to locate and track the circulatory support device without requiring a guidewire to pass through the device (e.g., without requiring a guidewire to pass through the inlet and outlet of the device). That is, in an embodiment, the guidewire is tracked to the left ventricle, and once located, the delivery sheath is tracked over the guidewire. Once the delivery sheath is in the proper position, the guidewire is removed. Subsequently, the circulatory support device is pushed into the delivery sheath and tracked to the proper position. The deployment process of the circulatory support device according to an embodiment of the disclosed subject matter herein can be simpler than a typical deployment process, can reduce dragging during positioning, and thus can reduce the risk of damaging the device and / or the guidewire during deployment.

[0061] Figures 3A-3DAn illustrative circulation support device delivery system 300 is depicted at various stages in the process of deploying a circulation support device 302 according to an embodiment of the disclosed subject matter. According to an embodiment, the illustrative circulation support device 302 may be or may be similar to Figure 1 The loop support device 100 and / or Figure 2 The circulating support device 200 is depicted in FIG.

[0062] like Figure 3A As shown, a circulation support device system 300 includes a circulation support device 302 and a delivery sheath 306, which is initially disposed in a protective tube 304 of the circulation support device. The delivery sheath 306 may include an insertion manifold 308 having a proximal opening 310, and a delivery shaft 312 extending from a distal opening 314 of the insertion manifold 308. The delivery sheath 306 may be configured to be positioned using a guidewire inserted therethrough so that a distal end 316 of the delivery shaft 312 is disposed adjacent to a deployment position. In embodiments, the delivery sheath may be tracked by a tracking system and may include any number of features configured to facilitate its identification and tracking within a subject. In embodiments, the delivery sheath is navigated (e.g., by tracking the delivery sheath 306 and / or the guidewire) to a deployment position. At the deployment position, the distal end 316 of the delivery sheath 306 may be positioned at a first cage position—i.e., a position where a first expandable cage 318 is to be disposed (e.g., in the left ventricle). Circulatory support device 302 and protective tube 304 may be configured to be inserted into the vasculature of a subject and navigated to delivery sheath 306 .

[0063] The circulatory support device 302 and the protective tube 304 can be configured to be inserted into the proximal opening 310 of the insertion manifold 308. The insertion manifold 308 can include a stop surface 320 configured to engage a distal edge 322 of the protective tube 304, thereby preventing the protective tube 304 from passing through the insertion manifold 308 into the delivery shaft 312. According to an embodiment, the delivery sheath 306 can include a tapered proximal end 308 configured to facilitate receiving the device 302. In operation, as shown in FIG. Figure 3B As shown, the circulation support device 302 and the protective tube 304 can be inserted into the insertion manifold 308 by pushing the spiral tube of the device 302. After the distal edge 322 of the protective tube 304 engages the stop surface 320, the clinician can push the spiral tube to push the device 302 into the delivery shaft 312, leaving the protective tube 304 behind.

[0064] The device 302 can then be pushed through the delivery shaft 312 until it exits the distal end 316 of the delivery sheath 306, as shown. Figure 3C As shown. Once the distal end 316 of the delivery sheath 306 is left, the first expandable cage 318 can be expanded, as shown. Figure 3D In the embodiment, as shown. Figure 3DAs further shown, the device 302 can include a mesh skirt 324 that at least partially surrounds an inlet 326 of a pump housing 328 and is configured to be compressed until the mesh skirt 324 is pushed out of the delivery shaft 312, at which time the mesh skirt 324 can be configured to expand.

[0065] Figures 3A-3D The illustrative circulatory support device delivery system 300 shown in is not intended to suggest any limitation on the scope of use or functionality of the embodiments of the invention. The illustrative circulatory support device delivery system 300 should also not be interpreted as having any dependency or requirement related to any single component or combination of components shown herein. Additionally, in the embodiments, Figures 3A-3D The various components depicted in the drawings may be integrated with various other components depicted herein (and / or components not shown), all of which are considered to be within the scope of the present invention.

[0066] As mentioned above, reference Figures 3A-3D , embodiments of the subject matter disclosed herein can facilitate improved device deployment procedures. Figure 4 FIG. 4 is a flow chart depicting an illustrative method 400 for deploying a circulation support device according to an embodiment of the disclosed subject matter. According to an embodiment, the circulation support device may be or be similar to Figure 1 The circulating support device 100 depicted in Figure 2 The circulating support device 200 and / or Figures 3A-3D The circulating support device 302 is depicted in FIG.

[0067] That is, for example, an embodiment of a circulatory support device may include a flexible cannula having a fluid outlet at a proximal end, and a pump assembly disposed at a distal end of the flexible cannula. The pump assembly may include a pump housing having a fluid inlet defined therein, a motor disposed within the distal end of the housing, and an impeller driven to rotate by the motor, the impeller being configured to push blood toward the fluid outlet. The circulatory support device may also include a helical tube connected to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein one or more wires are disposed within the helical tube. Embodiments of the circulatory support device also include a mesh skirt adjacent to the fluid inlet and at least partially surrounding the pump housing; an expandable cage connected to the distal end of the pump housing, and the like.

[0068] According to an embodiment, method 400 may facilitate deployment of a circulatory support device by positioning the circulatory support device in a deployed position without inserting a guidewire through the circulatory support device. Figure 4As shown, an embodiment of method 400 includes navigating a delivery sheath to a deployed position following a guidewire (block 402). In an embodiment, the delivery sheath includes (1) an insertion manifold having a proximal opening and a distal opening, and (2) a delivery shaft extending from the distal opening. According to an embodiment, navigating the delivery sheath to the deployed position includes passing a guidewire through the delivery sheath and tracking at least one of the guidewire and the delivery sheath during navigation. In an embodiment, navigating the delivery sheath to the deployed position includes positioning a distal end of the delivery shaft at a position adjacent to the cage.

[0069] As shown, an embodiment of method 400 also includes navigating the circulation support device to the delivery sheath (block 404). In an embodiment, during this step, the circulation support device is disposed within a protective tube. An embodiment of method 400 also includes inserting the circulation support device and the protective tube into the proximal opening of the insertion manifold (block 406). In an embodiment, the insertion manifold includes a stop surface disposed therein, the stop surface being configured to engage a distal edge of the protective tube, thereby preventing the protective tube from being pushed into the delivery shaft.

[0070] Embodiments of method 400 also include pushing the cyclic support device into the delivery shaft (block 408). As described above, the protective tube may be prevented from entering the delivery shaft by a stop surface. In embodiments, pushing the cyclic support device into the delivery shaft may include pushing the spiral tube. Method 400 may also include pushing the cyclic support device out of the distal end of the delivery shaft (block 410). According to embodiments, upon exiting the delivery shaft, one or more expandable cages may be configured to expand and engage the cage position, thereby securing the cyclic support device in place.

[0071] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, while the embodiments described above relate to specific features, the scope of the invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Therefore, the scope of the invention is intended to include all such alternatives, modifications and variations that fall within the scope of the claims, and all equivalents thereof.

Claims

1. A circulating support device, comprising: a flexible cannula having a fluid outlet at a proximal end; as well as A pump assembly disposed at the distal end of the flexible cannula, the pump assembly comprising: a pump housing having a fluid inlet defined therein; a mesh skirt at least partially surrounding the pump housing, wherein a base of the mesh skirt is proximal to the fluid inlet, the mesh skirt being conical in shape with a distal end defining a distally facing opening, the mesh skirt being configured to promote blood flow into the fluid inlet; a motor disposed within the distal end of the housing; and An impeller is driven in rotation by the motor and is configured to propel blood toward the fluid outlet.

2. The circulatory support device of claim 1 further comprising an expandable cage coupled to a distal end of the pump housing.

3. The circulatory support device of claim 1, further comprising an expandable cage coupled to a proximal end of the flexible cannula.

4. The cyclic support device according to claim 1, further comprising: a first expandable cage coupled to the distal end of the pump housing and configured to be positioned within the left ventricle of a subject; as well as A second expandable cage is coupled to the proximal end of the flexible cannula and is configured to be disposed within the aorta.

5. The circulatory support device of claim 1 or 2, further comprising a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein one or more wires are disposed within the coiled tube.

6. The circulatory support device of claim 1, wherein at least a portion of the flexible cannula is configured to be disposed through an aortic valve opening and is configured to be compressible such that the aortic valve can be closed over at least a portion of the flexible cannula.

7. A circulating support device, comprising: a flexible cannula having a fluid outlet at a proximal end; A pump assembly disposed at the distal end of the flexible cannula, the pump assembly comprising: a pump housing having a fluid inlet defined therein; a mesh skirt at least partially surrounding the pump housing, wherein a base of the mesh skirt is proximal to the fluid inlet, the mesh skirt being conical in shape with a distal end defining a distally facing opening, the mesh skirt being configured to promote blood flow into the fluid inlet; a motor disposed within the distal end of the housing; and an impeller driven to rotate by the motor, the impeller being configured to propel blood toward the fluid outlet; and a first expandable cage coupled to a distal end of the pump housing; and A second expandable cage is coupled to the proximal end of the flexible cannula.

8. The circulatory support device of claim 7, wherein the fluid inlet is disposed between the flexible cannula and the motor.

9. The circulatory support device of claim 7, wherein the first expandable cage is configured to be disposed within a left ventricle of a subject.

10. The circulatory support device of claim 7, wherein the second expandable cage is configured to be disposed within an aorta of a subject.

11. The circulatory support device of any one of claims 7 to 10, further comprising a coiled tube coupled to the proximal end of the pump housing and extending through at least a portion of the flexible cannula, wherein one or more wires are disposed within the coiled tube.

12. The circulatory support device of claim 11, wherein the one or more wires are configured to operably connect the motor to a control unit and extend along the exterior of the pump housing from the distal end of the coiled tubing into the distal end of the pump housing.

13. A circulatory support device according to any one of claims 7 to 10, wherein at least a portion of the flexible cannula is configured to be disposed through an aortic valve opening and is configured to be compressible so that the aortic valve can be closed over at least a portion of the flexible cannula.

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