Percutaneous EVAD with distal atraumatic tip and tapered nose cone for vessel introduction and dilation

Abstract

A percutaneous ventricular assist device (pVAD) assembly configured for insertion into a patient vasculature at an external access location can include a blood pump, such as with a proximal pump portion and a distal pump portion, and a nose cone body. The nose cone body can include a proximal nose cone portion attached to the distal pump portion, a distal nose cone portion opposite the proximal nose cone portion, and a nose cone surface connecting the proximal nose cone portion and the distal nose cone portion. The nose cone body can be sized, shaped, or otherwise configured to dilate the external access location to allow for passage of the pVAD assembly into the patient vasculature without requiring an adjunct introducer sheath at the external access location.

Description

PERCUTANEOUS EVAD WITH DISTAL ATRAUMATIC TIP AND TAPERED NOSE CONE FOR VESSEL INTRODUCTION AND DILATIONCLAIM OF PRIORITY

[0001] This patent application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 537,459 to Sukumaran Thevathasan Thambar entitled “Delivery and Retrieval of Expandable pVAD” filed on September 8, 2023 and the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 623,120 to Sukumaran Thevathasan Thambar entitled “Percutaneous LVAD with Distal Atraumatic Tip and Tapered Nose Cone for Vessel Introduction and Dilation” filed on January 19, 2024 of which both applications are hereby incorporated by reference in their entirety.BACKGROUND

[0002] A percutaneous ventricular assist device (pVAD) can be used to percutaneously introduce a pump through the vasculature into a left ventricle of a patient, such as to help move blood from the left ventricle into the aorta and provide temporary blood circulatory support for patients with weakened or failing hearts.

[0003] Tuseth (US 10893847) mentions a transcatheter insertion system for the insertion of an intracorporeal device. The system comprises an outer sheath arranged and configure to form a passageway for the intracorporeal device.OVERVIEW

[0004] A percutaneous ventricular assist device (pVAD) is a minimally invasive device that can be at least partially inserted into a patient, such as into a blood vessel of a patient to increase blood flow in patient vasculature. The pVAD can include a collapsed configuration, such as for insertion into patient vasculature, and an expanded configuration, such as for operation of the pVAD in patient vasculature. As a percutaneous device, the pVAD impeller is small in size and rotates at high speeds to generate blood flow sufficient to perfuse the patient.

[0005] The present inventors have recognized, among other things, that a problem to be solved can include providing a way to minimize the diameter of a collapsed pVAD and simplify pVAD implantation into patient vasculature. The present subjectmatter can help provide a solution to this problem, such as by providing a novel dilation instrument as a component of a pVAD assembly that can obviate the need for a standard surgical introducer sheath.[0006 A percutaneous ventricular assist device (pVAD) assembly for inserting a blood pump into a patient vasculature at an external access location using a delivery sheath and a guidewire where both are extendable to a target location within the patient vasculature, without requiring an adjunct introducer sheath located at the external access location. The pVAD assembly can include the blood pump, such as with a proximal pump portion and a distal pump portion and a nose cone body. The nose cone body can include a proximal nose cone portion attached to the distal pump portion, a distal nose cone portion opposite the proximal nose cone portion, a nose cone surface connecting the proximal nose cone portion and the distal nose cone portion, and a nose cone lumen extending from the distal nose cone portion toward the proximal nose cone portion through the nose cone body. The nose cone body is sized, shaped, or otherwise configured to dilate the external access location to allow for passage of the delivery sheath carrying the pVAD assembly into the patient vasculature through the external access location without requiring the adjunct introducer sheath at the external access location.

[0007] An overview of certain non-limiting aspects of the present subject matter is provided below.

[0008] Aspect 1 can include or use subject matter (such as an apparatus, a system, a device, a method, or a means for performing acts), such as a percutaneous ventricular assist device (pVAD) assembly configured for insertion into a patient vasculature at an external access location using a delivery sheath and a guidewire. The delivery sheath and guidewire can each be extendable to a target location within the patient vasculature, without requiring an adjunct introducer sheath located at the external access location. The pVAD assembly can comprise a blood pump with a proximal pump portion and a distal pump portion and a nose cone body. The nose cone body can include a proximal nose cone portion attached to the distal pump portion, a distal nose cone portion opposite the proximal nose cone portion, and a nose cone surface connecting the proximal nose cone portion and the distal nose cone portion. The nose cone body can be sized, shaped, or otherwise configured to dilate the external access location to allow for passage of the delivery sheath carrying thepVAD assembly into the patient vasculature through the external access location, such as without requiring the adjunct introducer sheath at the external access location.

[0009] Aspect 2 can include or use or can optionally be combined with the subject matter of Aspect 1 to optionally include or use a guidewire lumen extending from the distal nose cone portion toward the proximal nose cone portion through the nose cone body.

[0010] Aspect 3 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 or 2 to optionally include or use a guidewire lumen with an ellipsoidal cross-sectional lumen shape, such as to control a bending stiffness of the nose cone body.

[0011] Aspect 4 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 3 to optionally include or use a nose cone body with a bending stiffness. In an example, the bending stiffness of the nose cone body can decrease from the proximal nose cone portion to the distal nose cone portion.

[0012] Aspect 5 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 4 to optionally include or use the nose cone body, such as a nose cone body with a lubricious outer surface.

[0013] Aspect 6 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 5 to optionally include or use a nose cone body with a lubricious outer surface where the lubricious outer surface includes a silicone oil coated surface.

[0014] Aspect 7 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 6 to optionally include or use a nose cone body with a lubricious outer surface where the lubricious outer surface includes a hydrophilic coated surface.

[0015] Aspect 8 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 7 to optionally include or use a nose cone body with a lubricious outer surface where the lubricious outer surface includes a Parylene coated surface.

[0016] Aspect 9 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 8 to optionally include or use the blood pump where the blood pump includes a housing including a body portion. The body portion can include a proximal end portion connected to the body portion, adistal end portion connected to the body portion opposite the proximal end portion, a housing lumen extending from the proximal end portion through the body portion to the distal end portion, and a tip coupler portion attached to the distal end portion.

[0017] Aspect 10 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 9 to optionally include or use the tip coupler portion where the tip coupler portion comprises an appendage, such as including one or more appendages.

[0018] Aspect 11 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 10 to optionally include or use the appendage where the appendage comprises a protuberance including, such as including one or more protuberances.

[0019] Aspect 12 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 11 to optionally include or use a delivery sheath. The delivery sheath can be locatable about a drive cable and define a delivery lumen that is sized and shaped to carry the pVAD, in a collapsed state, such as for insertion into the patient vasculature through the external access location to the target location. The target location can be within the patient vasculature, such as upon reaching the target location, the pump is deployed from a distal portion of the delivery sheath and allowed to expand.

[0020] Aspect 13 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 12 to optionally include or use the delivery sheath, such as the delivery sheath is user-removable from the drive cable without requiring passing the delivery sheath over a proximal end of the drive cable.

[0021] Aspect 14 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 13 to optionally include or use the delivery sheath. The delivery sheath can include a distal delivery sheath end, such an outer diameter of the proximal nose cone portion is at least one of equal to or greater than an outer diameter of the distal delivery sheath end.

[0022] Aspect 15 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 14 to optionally include or use the delivery sheath where the outer diameter of the proximal nose cone portion is equal to the outer diameter of the distal delivery sheath end.

[0023] Aspect 16 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 15 to optionally include or use the delivery sheath where the outer diameter of the proximal nose cone portion is greater than the outer diameter of the distal delivery sheath end.

[0024] Aspect 17 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 16 to optionally include or use the nose cone body. The nose cone body can include a first nose cone segment configured to contact an inner surface of the delivery lumen, such as to form an interference fit between the first nose cone segment and the inner surface of the delivery lumen.

[0025] Aspect 18 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 17 to optionally include or use the nose cone body. The nose cone body can include a first nose cone segment configured to contact an inner surface of the delivery lumen, such as to form a sliding fit between the first nose cone segment and the inner surface of the delivery lumen.

[0026] Aspect 19 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 18 to optionally include or use the delivery sheath. The delivery sheath can include a distal delivery sheath end, such as where an outer diameter of the proximal nose cone portion is at least one of equal to or greater than an inner diameter of the distal delivery sheath end.

[0027] Aspect 20 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 19 to optionally include or use the delivery sheath, such as where the outer diameter of the proximal nose cone portion is equal to the inner diameter of the distal delivery sheath end.

[0028] Aspect 21 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 20 to optionally include or use the delivery sheath, such as where the outer diameter of the proximal nose cone portion is greater than the inner diameter of the distal delivery sheath end.

[0029] Aspect 22 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 21 to optionally include or use the nose cone body. The nose cone body can include a second nose cone segment configured to contact an inner surface of the delivery lumen, such as toform an interference fit between the second nose cone segment and the inner surface of the delivery lumen.

[0030] Aspect 23 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 22 to optionally include or use the nose cone body. The nose cone body can include a second nose cone segment configured to contact an inner surface of the delivery lumen, such as to form a sliding fit between the second nose cone segment and the inner surface of the delivery lumen.

[0031] Aspect 24 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 23 to optionally include or use a retrieval sheath. The retrieval sheath can be locatable about the drive cable and define a retrieval lumen that is sized and shaped to accommodate the drive cable within the retrieval lumen. The retrieval sheath can include a proximal retrieval end and a distal retrieval end opposite the proximal retrieval end, such as the retrieval sheath can be configured for insertion into the external access location after userremoval of the delivery sheath from the drive cable. The retrieval sheath can also be configured to receive and collapse the pVAD assembly, such as to aid in withdrawing the pVAD assembly from the patient vasculature.

[0032] Aspect 25 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 24 to optionally include or use a retrieval sheath where the distal retrieval end is configured to receive and collapse the pVAD assembly, such as to aid in withdrawing the blood pump from the patient vasculature.

[0033] Aspect 26 can include or use or can optionally be combined with the subject matter (such as an apparatus, a system, a device, a method, or a means for performing acts), or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 25 to optionally include or use a method of using the pVAD assembly. The pVAD assembly can be used to insert a blood pump into a patient vasculature at an external access location using a delivery sheath and a guidewire, each extendable to a target location within the patient vasculature, without requiring an adjunct introducer sheath located at the external access location. The pVAD assembly can include the blood pump with a proximal pump portion and a distal pump portion, and a nose cone body including a proximal nose cone portion attached to the distal pump portion and a distal nose cone portion opposite theproximal nose cone portion. The nose cone body can further include a nose cone surface, such as connecting the proximal nose cone portion and the distal nose cone portion, and a guidewire lumen, such as extending from the distal nose cone portion toward the proximal nose cone portion through the nose cone body. The nose cone body can be sized, shaped, or otherwise configured to dilate the external access location, such as to allow for passage of the delivery sheath carrying the pVAD assembly into the patient vasculature through the external access location without requiring the adjunct introducer sheath at the external access location. The method can include a step of connecting the pVAD assembly to the delivery sheath. The method can include a step of locating the pVAD assembly connected to the delivery sheath onto the guidewire. The method can include a step of inserting the pVAD assembly connected to the delivery sheath over the guidewire into the patient vasculature without the adjunct introducer sheath.

[0034] Aspect 27 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 26 to optionally include or use the method wherein the nose cone body includes a first nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the first nose cone segment to form an interference fit with the delivery sheath.|0035| Aspect 28 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 27 to optionally include or use the method wherein the nose cone body includes a first nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the first nose cone segment to form a sliding fit with the delivery sheath.

[0036] Aspect 29 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 28 to optionally include or use the method wherein the nose cone body includes a second nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the second nose cone segment to form an interference fit with the delivery sheath.

[0037] Aspect 30 can include or use or can optionally be combined with the subject matter of one or any combination of Aspects 1 through 29 to optionally include or use the method herein the nose cone body includes a second nose cone segment and connecting the pVAD assembly to the delivery sheath includesconfiguring the second nose cone segment to form a sliding fit with the delivery sheath.

[0038] This overview is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The detailed description is included to provide further information about the present patent application.BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0040] FIG. 1 A shows an example of a percutaneous ventricular assist device (pVAD) assembly, such as in a collapsed configuration for implantation in a patient vasculature.

[0041] FIG IB shows the example pVAD assembly in an expanded configuration, such as for operation of the assembly 100 in the patient vasculature.

[0042] FIG. 2 shows an example of a housing associated with the blood pump, such as in an expanded configuration.

[0043] FIG. 3 shows an example of the tip coupler portion, such as connected to the distal end portion of the body portion.

[0044] FIG. 4 shows an example of an appendage.

[0045] FIG. 5 shows an example cross-section of the tip coupler portion.

[0046] FIG. 6 shows an example of an atraumatic tip located in the housing.

[0047] FIG. 7 shows an example of a nose cone body located on the housing.

[0048] FIG. 8A shows an example of a nose cone body.

[0049] FIG. 8B shows a second example of a nose cone body.

[0050] FIG. 9A shows a distal tip portion with a generally circular shape and a curl of about 270 degrees.

[0051] FIG. 9B shows a distal tip portion with a slight curl (“elephant trunk”).

[0052] FIG. 9C shows an atraumatic end with no intermediate tip portion and no distal tip portion (“nose cone only”).

[0053] FIG. 10 shows a first example of a pVAD assembly in contact with a delivery sheath.

[0054] FIG. 11 shows a second example of a pVAD assembly in contact with a delivery sheath.

[0055] FIG. 12 shows a third example of a pVAD assembly in contact with a delivery sheath.

[0056] FIG. 13 shows a flow diagram of an example method to form a pVAD assembly.

[0057] FIG. 14 shows an example of a pVAD delivery assembly.

[0058] FIG. 14A shows a transverse cross section of the access sheath.

[0059] FIG. 14B shows a transverse cross section of the retrieval sheath.

[0060] FIG. 14C shows an example of a tool to remove a sheath from a patient.

[0061] FIG. 15 shows an example of the protective sleeve located over the retrieval sheath.

[0062] FIG. 16 shows an example of a pVAD delivery assembly including a delivery sheath and an access sheath.

[0063] FIG. 17 shows an example of a pVAD delivery assembly including a delivery sheath and a retrieval sheath.

[0064] FIG. 18 shows an example method of using a pVAD delivery assembly for delivering and removing a pVAD assembly to vasculature of a patient via an external access location.

[0065] FIG. 19 shows a second example method of using a pVAD delivery assembly for delivering and removing a pVAD assembly into patient vasculature via an external access location.

[0066] FIG. 20 shows an example method of inserting a pVAD assembly into patient vasculature via an external access location.DETAILED DESCRIPTION

[0067] FIG. 1 A shows an example of a percutaneous ventricular assist device (pVAD) assembly 100, such as in a collapsed configuration for implantation in a patient vasculature. FIG IB shows the example pVAD assembly 100 in an expanded configuration, such as for operation of the assembly 100 in the patient vasculature.The pVAD assembly 100 can include a blood pump 200, an atraumatic tip 300, and a nose cone body 400.

[0068] FIG. 2 shows an example of a housing 201 associated with the blood pump 200, such as in an expanded configuration. The housing 201 can include an expandable frame 220 and a fluid-impervious membrane 222 covering at least a portion of the expandable frame, such as the membrane 222 can extend from a proximal membrane edge 224 to a distal membrane edge 226. The housing 201 can assume a tubular shape, such as with a generally circular cross-section centered around a central axis 214. The housing 201 can include a body portion 202, a proximal end portion 204, a distal end portion 206, and a housing lumen 207, such as extending from the proximal end portion 204 through the body portion 202 to the distal end portion 206. In an example, the housing 201 can form a cannula for the blood pump 200, such as locating an impeller within the housing lumen 207 can form the blood pump 200. The housing 201 can include a tip coupler portion 208, such as connected to the distal end portion 206 of the housing 201.

[6069] The expandable frame can be fabricated from at least one of a sheet of material or a tube of material, such as a biocompatible material including at least one of a polymer such as polyurethane (PU) or expanded polytetrafluoroethlyene (ePTFE) or a metal such as a shape memory material including a nickel titanium alloy (or Nitinol™). The material can be processed, such as by laser cutting, to form at least one of an aperture 210 in the body portion 202 or an arm 212 in at least one of the proximal end portion 204 or the distal end portion 206.

[0070] An impeller can be located within the housing 201 and configured to draw fluid from the distal end portion 206 through the body portion 202 for expulsion of the fluid from the proximal end portion 204, such as to form a blood pump. The impeller can connect to a drive cable 102, such as a drive cable 102 located at the proximal end portion 204. The drive cable 102 can include a distal end connected to the impeller and a proximal end connected to a power source, such as an electric motor located outside the patient body.

[0071] FIG. 3 shows an example of the tip coupler portion 208, such as connected to the distal end portion 206 of the housing 201. The tip coupler portion 208 can be configured to receive and locate a component, such as the atraumatic tip 300, with respect to the housing 201. The tip coupler portion 208 can be configured to secure one or more components to the housing 201, such as to secure the nose cone body 400 to the housing 201. The tip coupler portion 208 can be formed from an appendage 230, such as one or more appendages 230.

[0072] FIG. 4 shows an example of an appendage 230. The appendage 230 can include an extension of the expandable frame, such as an extension of the arm 212. The appendage 230 can include a protuberance 232, such as one or more protuberances 232. The protuberance 232 can include any feature configured to secure the nose cone body 400 to the housing 201. In an example, a protuberance 232 can include a window, such as an opening in the appendage 230 connecting a tip interior surface 236 with a tip exterior surface 238, configured to allow material that forms the nose cone body 400 to reflow through the window, such as during a manufacturing process used to form the nose cone body 400, and solidify in the window, such as to more firmly secure the nose cone body 400 to the housing 201.

[0073] The protuberance 232 can include a feature that protrudes from the appendage 230, such as a barb or other projection, and can be configured to secure the nose cone body 400 to the housing 201, such as described below. In an example, the protuberance 232 can be bent or otherwise permanently deformed so as to further secure the nose cone body 400 to the housing 201. Two or more appendages 230 can be attached to a distal end of the distal end portion 206 and distributed uniformly around the central axis 214, such as to form the tip coupler portion 208.

[0074] FIG. 5 shows an example cross-section of the tip coupler portion 208, such as a tip coupler portion 208 with five appendages 230 distributed uniformly around the central axis 214. The appendages 230 of FIGS. 3 and 4 can be located so that the tip coupler portion 208 assumes a tubular shape, such as to form a piecewise smooth, generally circular coupler lumen 234 centered around the central axis 214. The tip coupler portion 208 can include a tip interior surface 236, such as defined by the surfaces of the appendages 230 generally facing the central axis 214, and a tip exterior surface 238, such as defined by the surfaces of the appendages 230 generally facing away from the central axis 214.

[0075] FIG. 6 shows an example of an atraumatic tip 300 located in the housing 201, such as by inserting the atraumatic tip 300 into the coupler lumen 234 of the tip coupler portion 208. The atraumatic tip 300 can include a tube, such as to receive a surgical guidewire, with a proximal tip portion 302, an intermediate tip portion 304, a distal tip portion 306, and an atraumatic tip lumen 308 (not shown) extending through the length of the atraumatic tip 300. In an example, the proximal tip portion 302 can be located into the tip coupler portion 208, such as to create an interface zone 250 between the tip coupler portion 208 and the atraumatic tip 300.

[0076] FIG. 7 shows an example of a nose cone body 400 located on the housing 201, such as to provide a tapered surface of gradually increasing diameter, such as increasing from a distal nose cone portion 406 toward a proximal nose cone portion 404 as shown in FIG. 8A. In an example the proximal nose cone portion 404 can include at least one of a first nose cone segment 430 or a second nose cone segment 432, such as shown in FIG. 10. In an example, the distal nose cone portion 406 can include at least one of a second nose cone segment 432 or a third nose cone segment 434.

[0077] Upon insertion of the nose cone body 400 into a patient, such as at an external access location, the tapered surface can cause patient tissue at the access location to dilate as the pVAD assembly 100 is introduced into patient vasculature through the external access location, such as to obviate the need for an introducer sheath. In an example, the external access location, such as an external surgical access location, can describe a location on a patient where the pVAD assembly 100 can be inserted into patient vasculature, such as an incision in patient tissue including at least one of patient skin, patient muscle, or patient vasculature. Thus, the nose cone body 400 can be sized, shaped, or otherwise configured to dilate the external access location to allow for passage of a delivery sheath carrying the pVAD assembly 100 into the patient vasculature through the external access location, such as without requiring a adjunct introducer sheath at the external access location.

[0078] The nose cone body 400 can be located on the pVAD assembly 100, such as between the housing 201 and the atraumatic tip 300. The nose cone body 400 can cover at least a portion of the tip coupler portion 208 and at least a portion of the proximal tip portion 302, such as when the proximal tip portion 302 has been inserted into the tip coupler portion 208. In an example, the nose cone body 400 can cover at least a portion of the interface zone 250.

[0079] FIG. 8A shows an example of a nose cone body 400. The nose cone body 400 can include a proximal nose cone portion 404, a distal nose cone portion 406, and a nose cone surface 408 connecting the proximal nose cone portion 404 and the distal nose cone portion 406. The nose cone surface 408 can include a lubricious outer surface, such as a lubricious coating configured to decrease friction between the nose cone surface 408 and the external access location on the patient as the nose cone body 400 is inserted through the external access location into patient vasculature. In anexample, the lubricious coating can include at least one of a silicone oil coating, a Parylene coating, or a hydrophilic coating.

[0080] The nose cone body 400 can include a nose cone cavity 409, such centered on the central axis 214 and extending distally from the proximal nose cone portion 404 toward the distal nose cone portion 406. The nose cone body 400 can include a first location 410 corresponding to a first nose cone diameter, a second location 412 corresponding to a second nose cone diameter, a third location 414 corresponding to a third nose cone diameter, and a fourth location 416 corresponding to a fourth nose cone diameter. The nose cone body 400 can assume a tapered configuration. In an example the nose cone body 400 can generally increase in diameter from the first location 410 to the second location 412, remain at a constant diameter from the second location 412 to the third location 414, and decrease in diameter from the third location 414 to the fourth location 416.

[0081] The first nose cone diameter at the first location 410 can include a range, such as a range of about 2 French (Fr) to about 10 Fr. The second nose cone diameter at the second location 412 and the third nose cone diameter at the third location 414 can include a range, such as a range of about 7 Fr to about 10 Fr. The fourth nose cone diameter at the fourth location 416 can include a range, such as a range of about 2 French (Fr) to about 10 Fr. In an example, the third nose cone diameter at the third location 414 can be selected to approximate a diameter of the collapsed housing 201 and the fourth nose cone diameter at the fourth location 416 can be selected to approximate a diameter of the atraumatic tip 300, such as to facilitate the insertion of the pVAD assembly 100 into a patient vasculature without an introducer sheath.

[0082] A first nose cone segment 430, such as a distance between the first location 410 and the second location 412, can include a first nose cone length, such as in a range of about 0.1 millimeters (mm) to about 10 mm. A second nose cone segment 432, such as a distance between the second location 412 and the third location 414, can include a second nose cone length, such as in a range of about 0.1 millimeters mm to about 10 mm. A third nose cone segment 434, such as a distance between the third location 414 and the fourth location 416, can include a third nose cone length, such as in a range of about 5 mm to about 100 mm. In an example, the length of the third nose cone segment can be selected based on tissue elasticity, such as to ease insertion of the pVAD assembly 100 into patient vasculature through an external access location without an introducer sheath.

[0083] The nose cone body 400 can be attached to the housing 201, such as to secure the atraumatic tip 300 to the housing 201. In an example, the tip coupler portion 208 can be inserted into the nose cone cavity 409 after which the nose cavity can be filled with an adhesive, such as to bond the nose cone body 400 to the housing 201. In an example, nose cone body 400 can be molded to the housing 201, such as further described below.

[0084] The nose cone body 400 can display a bending stiffness, such as bending stiffness configured to control lateral displacement of the distal nose cone portion 406 with respect to the proximal nose cone portion 404. In an example, the bending stiffness of the nose cone body 400 can vary from the proximal nose cone portion 404 to the distal nose cone portion 406, such as the bending stiffness of the nose cone body 400 can decrease from proximal nose cone portion 404 to the distal nose cone portion 406. In an example, the bending stiffness of the nose cone body 400 can be influenced by a material used to form the nose cone body 400, such as by specifying a modulus of elasticity of the material, or a geometry of the nose cone body 400, such at least one of a shape of the nose cone surface 408 or a shape of a guidewire lumen 450.

[0085] Referring again to FIG. 8A, the example nose cone body 400 can include a guidewire lumen 450 and a guidewire port 452 configured to locate the pVAD assembly 100 on a guidewire, such as a guidewire previously inserted into the patient vasculature to enable percutaneous insertion of the pVAD assembly 100 into the patient. The guidewire lumen 450 can extend from the distal nose cone portion 406, such as at the fourth location 416, through the nose cone body 400 in a proximal direction, such as toward the proximal nose cone portion 404. In an example, the nose cone body 400 can be connected to the atraumatic tip 300, such as the guidewire lumen 450 can be in communication with the atraumatic tip lumen 308 to form a clear lumen path from guidewire port 452 through the guidewire lumen 450 into the atraumatic tip lumen 308. The atraumatic tip lumen 308 can extend from the proximal tip portion 302 through the intermediate tip portion 304 to the distal end of the distal tip portion 306.

[0086] The guidewire port 452 can provide access to the guidewire lumen 450. In an example, the guidewire lumen can extend from the distal nose cone portion 406 to a guidewire port 452 located on the nose cone surface 408, such as at a location on the nose cone surface 408 proximal of the fourth location 416. In this configuration, the guidewire port 452 can be located to improve efficiency, such as to reduce the timeand effort required to thread the pVAD assembly 100 onto the guidewire for percutaneous delivery.

[0087] FIG. 8B shows a second example of a nose cone body 400. In FIG. 8B, the guidewire lumen 450 can extend from the distal nose cone portion 406, such as at the fourth location 416, through the nose cone body 400 in a proximal direction, such as toward the proximal nose cone cavity 409. In this configuration, the guidewire port 452 can be located adjacent to (or coincide with) the distal end of the nose cone cavity 409, such as to form a lumen in the nose cone body 400 from the first location 410 to the fourth location 416. In this configuration, the guidewire lumen 450 can be located along the central axis 214 to provide a lumen 450 through which the guidewire can extend, such as when the pVAD assembly 100 is configured to locate the guidewire through at least a portion of the blood pump 200.

[0088] The guidewire lumen 450 can be configured to cause the nose cone body 400 to bend in a preferential direction. In an example, the guidewire lumen 450 can assume a generally uniform circular cross-sectional area over the length of the guidewire lumen 450, such as the bending stiffness of the nose cone body 400 can be substantially equivalent in any bending direction about any axis perpendicular to the central axis 214. In an example, the guidewire lumen 450 can assume a generally ellipsoidal cross-sectional area, such as bending stiffness of the nose cone body 400 about a major axis of the ellipsoidal cross-sectional area perpendicular to the central axis 214 can be less than bending stiffness of the nose cone body 400 about a minor axis of the ellipsoidal cross-sectional area perpendicular to the central axis 214.

[0089] FIGS. 9A-9C show examples of a pVAD assembly 100 with a nose cone body 400 and several example configurations of an atraumatic tip 300.

[0090] Referring to FIG. 9 A, the atraumatic tip 300 can include a proximal tip portion 302, an intermediate tip portion 304, and a distal tip portion 306. The distal tip portion 306 can be formed into a shape, such as a circular shape. The circular shape can include a curl, such as curl in a range from about 0 degrees, such as no curl or a straight section, to about 360 degrees, such as a full curl or complete circle. In an example, FIG. 9A shows a distal tip portion 306 with a generally circular shape and a curl of about 270 degrees. In an example, FIG. 9B shows a distal tip portion 306 with a slight curl (“elephant trunk”). In an example, FIG. 9C shows an atraumatic tip 300 with no intermediate tip portion 304 and no distal tip portion 306 (“nose cone only”).

[0091] The atraumatic tip 300 and nose cone body 400 can be formed from a material, such as at least one of a biocompatible polymer including a polyether block amide (PEBA) such as Pebax®, polyethylene, or nylon. The atraumatic tip 300 can be formed as a tube, such as a tube with an atraumatic tip lumen 308. The outer diameter of the atraumatic tip 300 can vary, such as in a range of about 1 Fr (French) to about 8 Fr.

[0092] Referring again to FIG. 9 A, the atraumatic tip 300 can include a bend, such as to form a spacer between the blood pump 200 and the patient anatomy when the pVAD assembly 100 is implanted in the patient. The spacer can be configured to locate the pVAD assembly 100 at a desired location in the patient vasculature. The bend can be characterized by a bend angle, such as the angle formed between a generally straight proximal tip portion 302 and a generally straight intermediate tip portion 304. The angle can vary, such as in a range from about 90 degrees (where the intermediate tip portion 304 can be perpendicular to the proximal tip portion 302) to about 180 degrees (where the intermediate tip portion 304 can be parallel and colinear with the proximal tip portion 302).

[0093] One approach to delivering the expandable pVAD assembly 100 to a target location in the patient vasculature, such as to at least one of a patient left ventricle or aorta, can include loading the compressed pVAD assembly 100 into a delivery sheath, such as a sheath configured to carry the pVAD assembly 100 through the patient vasculature for deployment at the target location. In an example, once the pVAD assembly 100 is located near the heart, the pVAD assembly 100 can be released from the delivery sheath, such as the delivery sheath can be retracted from the pVAD assembly 100 or the pVAD assembly 100 can be moved distally with respect to the delivery sheath, and pVAD assembly 100 expanded to an operational configuration to provide circulatory support to the patient.

[0094] FIG. 10 shows an example connection between the pVAD assembly 100 and a delivery sheath 500, such as to facilitate locating the pVAD assembly 100 to a target location in the patient vasculature. The delivery sheath 500 can include a tube 502 with a delivery lumen 504 and a distal delivery sheath end 505. The delivery lumen 504 can include an inner diameter 506 and the delivery sheath 500 can include an outer diameter 508.

[0095] In FIG. 10, the pVAD assembly 100, such as including drive cable 102, can contact the delivery sheath 500 at the second location 412 corresponding to thesecond nose cone diameter, such as to create an interference fit between the pVAD assembly 100 and the delivery lumen inner diameter 506. In an example, a truncated cone nose cone surface, such as the nose cone surface between the first location 410 corresponding to the first diameter and the second location 412 corresponding to the second diameter where the first diameter is less than the second diameter, can seat the pVAD assembly 100 against the distal delivery sheath end 505. Application of a tensile force to the drive cable 102 can maintain the interference fit between the pVAD assembly 100 and the delivery lumen inner diameter 506, such as to retain the pVAD assembly 100 with the delivery sheath 500.

[0096] In FIG. 11, the pVAD assembly 100, such as including drive cable 102, can contact the delivery sheath 500 on the nose cone surface 408, such as on at least a portion of the second nose cone segment 432. In an example, a diameter of the second nose cone segment 432 can be configured to be slightly greater than an inner diameter 506 of the delivery lumen 504, such as to create a friction fit (or interference fit) between the pVAD assembly 100 and the delivery lumen inner diameter 506. In an example, the diameter of the second nose cone segment 432, such as where the diameter at the second location 412 is equal to the diameter at the third location 414, can be equivalent to the delivery lumen inner diameter 506, such as to form a smooth concentric sliding surface (sliding fit) between second nose cone segment 432 and the delivery lumen inner diameter 506, to seat the pVAD assembly 100 against at least a portion of the inner wall of the lumen 504. Application of a tensile force to the drive cable 102 can retain the second cone segment 432 in the delivery lumen inner diameter 506. In an example, a protuberance can be formed on at least one of the second nose cone segment 432 or the inner wall of the lumen 504 in contact with the second nose cone segment 432, such as to establish a friction fit between the two surfaces.|0097] In FIG. 12, the pVAD assembly 100, such as including drive cable 102, can contact the delivery sheath 500 on the nose cone surface 408, such as on at least a portion of the first nose cone segment 430 to create a stepped transition between the nose cone body 400 and the delivery sheath 500. In an example, an outer diameter of the nose cone body 400 can be at least one of equal to or greater than the delivery sheath outer diameter 508, such as an outer diameter of the distal delivery sheath end 505. This configuration can allow patient tissue to stretch over the outer diameter of the nose cone body 400 and subsequently rebound (or collapse) around the deliverysheath 500 during insertion of the pVAD assembly 100 through the external access location. Transitioning from the outer diameter of the nose cone body 400 to at least one of an equal or smaller delivery sheath outer diameter 508 can minimize a risk of snagging patient tissue on the stepped transition during insertion of the pVAD assembly 100 through the external surgical access location.

[0098] In an example, a diameter of the first nose cone segment 430 can be configured to be slightly greater than an inner diameter 506 of the delivery lumen 504, such as to create a friction fit (or interference fit) between the pVAD assembly 100 and the delivery lumen inner diameter 506. In an example, the diameter of the first nose cone segment 430, such as where the diameter at the first location 410 is equal to the diameter at the second location 412, can be equivalent to the delivery lumen inner diameter 506, such as to form a smooth concentric sliding surface (sliding fit) between first nose cone segment 430 and the delivery lumen inner diameter 506, to seat the pVAD assembly 100 against at least a portion of the inner wall of the lumen 504. Application of a tensile force to the drive cable 102 can retain the first cone segment 430 within the delivery lumen inner diameter 506. In an example, a protuberance can be formed on at least one of the first nose cone segment 430 or the inner wall of the lumen 504 in contact with the first nose cone segment 430, such as to establish a friction fit between the two surfaces.10099] FIG. 13 shows a flow diagram of an example method 1300 to form a pVAD assembly 100, such as the pVAD assembly 100 shown in FIG. 7. The pVAD assembly 100 can include a blood pump 200 with a housing 201, an atraumatic tip 300, and a nose cone body 400, such as to reinforce the connection between the housing 201 and the atraumatic tip 300.

[0100] At 1302, an atraumatic tip 300 with a proximal end and a distal end can be provided. The atraumatic tip 300 can include a proximal tip portion 302, an intermediate tip portion 304, a distal tip portion 306, and an atraumatic tip lumen 308 (not shown) extending through the length of the atraumatic tip 300.109101] At 1304, a housing 201 with a proximal end portion 204 and a distal end portion 206 can be provided. The housing 201 can include a tip coupler portion 208 that can be coupled to the housing 201, such as at the distal end portion 206.

[0102] At 1306, the proximal tip portion 302 of the atraumatic tip 300 can be located in the tip coupler portion 208, such as to create an interface zone 250 between the housing 201 and the atraumatic tip 300. Within the interface zone 250, aprotuberance 232 can interact with the proximal tip portion 302 to inhibit motion of the proximal tip portion 302 with respect to the tip coupler portion 208, such as to retain the atraumatic tip 300 within the tip coupler portion 208.

[0103] At 1308, a nose cone body 400 can be provided, such as between the housing 201 and the atraumatic tip 300. The nose cone body 400 can include a first location 410 corresponding to a first nose cone diameter, a second location 412 corresponding to a second nose cone diameter, a third location 414 corresponding to a third nose cone diameter, and a fourth location 416 corresponding to a fourth nose cone diameter. In an example, the third nose cone diameter at the third location 414 is greater than the fourth nose cone diameter at the fourth location 416.

[0104] Providing a nose cone body 400 can include attaching the nose cone body 400 to the housing 201, such as to cover at least a portion of the tip coupler portion 208. In an example, the nose cone body 400 can cover at least a portion of the interface zone 250.

[0105] Attaching the nose cone body 400 to the housing 201 can include engaging the nose cavity 409 with the tip coupler portion 208. In an example, the nose cone body 400 can be attached to the housing 201 by dimensioning the nose cone cavity 409 and the tip coupler portion 208 to create a friction fit between the nose cone cavity 409 and the tip coupler portion 208. In an example the nose cone body 400 can be attached to the housing 201 with an adhesive, such as to create an intimate physical connection between the nose cone body 400 and the tip coupler portion 208, such as including a physical connection with at least one protuberance 232 of at least one appendage 230.[001.06] Providing a nose cone body 400 can include forming a nose cone body 400 between the housing 201 and the atraumatic tip 300. A nose cone tube can include a quantity of material in the shape of a tube that can be formed into a nose cone body 400, such as after melting (or reflowing) the nose cone tube. The nose cone tube material can include a biocompatible polymer such as at least one of a polyether block amide (PEBA) such as Pebax®, polyethylene, polyurethane, or nylon. In an example, the nose cone tube can be located over at least a portion of an interface zone 250, such as between the housing 201 and the atraumatic tip 300.

[0107] Forming the nose cone body 400 can include preparing a mold for the transition from nose cone billet to the desired nose cone body 400. In an example, the nose cone tube located over at least a portion of the interface zone 250 can be coveredin a heat-activated polymer shrink wrap, such as a polymer shrink wrap configured to cause the heated nose cone tube material to assume a desired shape. In an example, a mold, such as a two-part mold, can be placed around the tip coupler portion 208, such as the interface zone 250, in preparation of an overmolding process.|00108] Forming the nose cone body 400 can include heating one or more materials to melt (or otherwise reflow) into a desired shape of the nose cone body 400. Heating the distal nose cone portion can cause the atraumatic tip 300, such as material in the interface zone 250, to reflow into the nose cone tube material and around appendages 230 of the tip coupler portion, such as to secure the nose cone body 400 to the housing 201. In an example, a nose cone tube wrapped in a shrink wrap material can melt (or reflow) into a shape fashioned by positioning of the shrink wrap material. As the shrink wrap material contracts due to increased temperature, the nose cone tube can become malleable and moldable into a desired nose cone shape under the force of the contracting shrink wrap. In an example, reflowed material can be overmolded onto the tip coupler portion 208 to form the nose cone body 400. Cooling of the heated region, such as the heated nose cone tube, can cause the reflowed materials to form a contiguous matrix, such as to intimately contact at least one of an appendage 230 or a protuberance 232 to reinforce the connection between the housing 201 and the atraumatic tip 300.100109] Providing a nose cone body 400 can include forming a nose cone body 400 from the reflowed nose cone tube material, such as into a tapered confirmation. In an example, the tapered confirmation can include a nose cone body 400 defined with a first location 410 corresponding to a first nose cone diameter, a second location 412 corresponding to a second nose cone diameter, a third location 414 corresponding to a third nose cone diameter, and a fourth location 416 corresponding to a fourth nose cone diameter. The nose cone body 400 can be formed, such as with a mold to control the dimensions at the first location 410, the second location 412, the third location 414, and the fourth location 416, to define the shape of the nose cone body 400, such as to optimize utility for a given application.

[0110] Providing a nose cone body 400 can include forming a guidewire lumen 450 and a guidewire port 452, such as a guidewire lumen 450 and guidewire port 452 in the nose cone body 400. Forming the guidewire lumen 450 can include locating a guidewire in an atraumatic tip lumen 308 of the atraumatic tip 300, such as prior to at least one of heating the nose cone tube or forming the nose cone body 400.|O0111] After locating the guidewire in the atraumatic tip lumen 308, heating the nose cone tube material can cause the nose cone tube material to reflow, such as to envelope the guidewire in the reflowed nose cone tube material. Forming the guidewire port 452 can include forming the nose cone body 400, such as with a mold. Cooling of the heated region, such as the heated nose cone tube material, can cause the reflowed materials to form a contiguous matrix. Removing the guidewire from the atraumatic tip lumen 308 and the nose cone body 400 can result in the formation of the guidewire lumen 450 and guidewire port 452. In an example, the guidewire port 452 can be in communication with the atraumatic tip lumen 308 through the guidewire lumen 450.

[0112] As noted previously, one approach to delivering an expandable pVAD assembly 100 into patient vasculature, such as to a left ventricle and aorta, can include providing a delivery sheath to extend from an external access location in the patient to a target position in patient vasculature. After deployment of the pVAD assembly 100, therapy utilizing the pVAD assembly 100 can be initiated, such as with the delivery sheath remaining within the patient during therapy. Once therapy is complete, the delivery sheath can also be used to retract and compress the pVAD assembly 100 for removal from the vasculature. However, the presence of the delivery sheath in the patient vasculature during therapy can contribute to a risk of thrombosis, such as the formation of blood clots during extended periods of therapy. Removal and replacement of the delivery sheath, such as with at least one of an access sheath or a retrieval sheath, can reduce the risk of thrombosis.[001131 The access sheath can include a surgical sheath that is shorter in length than the delivery sheath and configured to minimize regurgitation of blood when located in the external access location. Use of the access sheath can reduce the risk of thrombosis, such as by reducing the length of sheath lumen available for blood coagulation. Further, the access sheath can be configured to retract and compress the pVAD assembly 100 for removal from the vasculature.100114] The retrieval sheath can include a surgical sheath that is longer in length than the access sheath and configured to minimize regurgitation of blood when located in the external access location. Use of the retrieval sheath can reduce the risk of injury to the patient during removal of the pVAD assembly 100 by locating a distal end of the retrieval sheath in closer proximity to the deployed pVAD assembly 100 as compared to a distal end of the access sheath, such as to minimize the distance thepVAD assembly 100 moves through patient vasculature in the expanded configuration. The retrieval sheath can be configured to retract and compress the pVAD assembly 100 for removal from the vasculature. In an example, the retrieval sheath can be configured to locate the distal end of the retrieval sheath in the abdominal aorta, such as superior of the left and right iliac arteries.|00115] FIG. 14 shows an example of a pVAD delivery assembly 1400. The pVAD delivery assembly 1400 can be used to deliver and remove a pVAD assembly 100 from a patient through an external access location on the patient. The pVAD assembly 100 can include a drive cable 102, such as with a distal cable end 103 and a proximal cable end 106. A blood pump 200 can attach to the distal cable end 103 of the drive cable 104. The pVAD assembly 100 can include a motor 107, such as configured to rotate the impeller in the blood pump 200 via the drive cable 102. The motor 107 can be located outside the patient and can be attached to the proximal end 106 of the drive cable 102. The pVAD delivery assembly 1400 can include at least one of a delivery sheath 1410, an access sheath 1420, or a retrieval sheath 1430.

[0116] The delivery sheath 1410 can include a tube-shaped structure with a distal delivery end 1412 and a proximal delivery end 1414. The delivery sheath 1410 can define a delivery lumen, such as a central lumen located along a central longitudinal axis of the delivery sheath 1410. The delivery lumen can extend from the distal delivery end 1412 to the proximal delivery end 1414. The delivery sheath 1410 can be sized and shaped to carry the pVAD assembly 100, such as to locate the blood pump 200 in a collapsed state in the distal delivery end 1412 of the delivery sheath 1410 with the drive cable 102 extending through the delivery lumen 1416 of the delivery sheath 1410.

[0117] The delivery sheath 1410 can be configured for inserting the pVAD assembly 100 through the external access location and positioning the pVAD assembly 100 at a target location within the patient. The target location can be located at least partially in at least one of the heart of the patient, such as within a left ventricle of the patient heart, or within an aorta of the patient. Once the delivery sheath 1410 is located in proximity to the target location, the blood pump 200 can be deployed from the delivery sheath 1410. The blood pump 200 can then be allowed to expand at the target location, such as to prepare the impeller for rotational motion driven by the drive cable 102 in the delivery lumen 1416.

[0118] The delivery sheath 1410 can be user-detachable from the drive cable 102. In an example, this can include passing the delivery sheath 1410 over a proximal end of the drive cable 102. Alternatively, the delivery sheath 1410 can be removed without requiring passing the delivery sheath 1410 over the proximal end of the drive cable 102, such as by providing a toollessly-removable delivery sheath 1410 including at least one of a peel-away or cut-away sheath that can be separated longitudinally into at least two components. 00119] The peel-away delivery sheath 1410 can include a perforation, such as oriented parallel to the delivery lumen 1416. The perforation can extend at least partially along a length of the delivery sheath 1410. Alternatively or additionally, the peel-away delivery sheath 1410 can include a weakened delivery wall section, such as oriented parallel to the delivery lumen 1416. The weakened delivery wall section can extend at least partially along a length of the delivery sheath 1410.100120] The user-detachable delivery sheath 1410 can include a delivery sheath1410 that can be user-detachable with the use of a tool, such as a tool 1411. FIG. 14C shows an example of a tool 1411, such as to remove a sheath from a patient. The tool1411 can include a sheath slitter including a handle 1413 with a finger hole 1415, such as for grasping by a user, and a blade 1419. The blade 1419 can be configured to contact a surface of the delivery sheath 1410, such as contracting a surface of the delivery lumen 1416 or an exterior surface of the delivery sheath 1410.

[0121] The delivery sheath 1410 can include a delivery sheath fluid port 1417. The delivery sheath fluid port 1417 can be in fluid communication with the delivery lumen 1416. This can enable continuous or recurrent flushing, such as while the delivery sheath 1410 is advanced into patient vasculature. The delivery sheath fluid port 1417 can be located on the delivery sheath 1410, such as at or near the proximal delivery end 1414 of the delivery sheath 1410.

[0012] The access sheath 1420 can include a distal access end 1422 and a proximal access end 1424. The access sheath 1420 can be shaped as a tubular elongate member extending from the proximal access end 1424 to the distal access end 1422. The access sheath 1420 can define a central longitudinal access lumen 1426. The access lumen 1426 can be generally circular in profile, such as with an access lumen diameter 1429. FIG. 14A shows a transverse cross section of the access sheath 1420, such as a cross section in a plane perpendicular to the longitudinal axis of the access sheath 1420, showing the access lumen diameter 1429.

[0123] The access sheath 1420 can be sized and shaped to carry the drive cable 102 within the access lumen 126. The access sheath 1420 can be configured to receive and collapse the blood pump 200 into the access sheath lumen diameter 1429. This can provide a reduced lateral profile, which can ease withdrawal of the blood pump 200 from the patient, such as after user-detachment of the delivery sheath 1410. 1001.24] The access sheath 1420 can be configured for insertion into the external access location, such as after user-detachment of the delivery sheath 1410 from the drive cable 102. The access lumen diameter 1429 can be selected to provide a minimized radial clearance between an outer diameter of the drive cable 102 and the access lumen diameter 1429. This can help reduce or minimize regurgitation of blood from the patient vasculature through the access lumen 1426 of the access sheath 1420. [001251 The radial clearance between the outer diameter of the drive cable 1404 and the access lumen diameter 1429 can include a percentage of the diameter of the drive cable 102. In an example, the clearance can include at least one of a range of about 0.1% of the drive cable 102 diameter to about 1% of the drive cable 102 diameter or about 1% of the drive cable 102 diameter to about 5% of the drive cable 102 diameter. 190126] The access sheath 120 can be configured to receive and collapse the blood pump 200 into the access lumen diameter 1429. This can reduce the lateral profile of the blood pump 200, such as before withdrawing the blood pump 200 from the patient after user-detachment of the delivery sheath 110.[001271 The access sheath 1420 can be user-detachable from the drive cable 102. In an example, this can include passing the access sheath 1420 over a proximal end of the drive cable 102. Alternatively, the access sheath 1420 can be removed without requiring passing the access sheath 1420 over the proximal end of the drive cable 104, such as by providing a toollessly-removable access sheath 1420 including at least one of a peel-away or cut-away sheath that can be separated longitudinally into at least two components.100128] The peel-away access sheath 1420 can include a perforation, such as oriented parallel to the access lumen 126. The perforation can extend at least partially along a length of the access sheath 120. Alternatively or additionally, the peel-away access sheath 120 can include a weakened access wall section, such as oriented parallel to the access lumen 1426. The weakened delivery wall section can extend at least partially along a length of the access sheath 1420.

[0019] The user-detachable access sheath 1420 can include an access sheath 1420 that can be user-detachable using a tool 1411. The tool 1411 can include a sheath slitter, such as a tool that can include a handle 1413 with a finger hole 1415, such as for grasping by a user, and a blade 1419, such as can be configured to contact a surface of the access sheath 1410, such as a surface of the access lumen 1426 or an exterior surface of the access sheath 1410.

[0130] The access sheath 1420 can include an access sheath fluid port 1427. The access sheath fluid port 1427 can be communication with the access lumen 1426. This can enable continuous or recurrent flushing, such as while the access sheath 120 is advanced into patient vasculature. The access fluid port 1427 can be located on the access sheath 1420 at or near the proximal access end 1424 of the access sheath 1420.

[0131] The retrieval sheath 1430 can include a distal retrieval end 1432 and a proximal retrieval end 1434. The retrieval sheath 1430 can be shaped as a tubular elongate member extending from the proximal retrieval end 1434. The retrieval sheath 1430 can define a central longitudinal retrieval sheath lumen 1436. The retrieval sheath lumen 1436 can include a generally circular retrieval sheath lumen 1436, such as with a retrieval sheath lumen diameter 1439. FIG. 14B shows a transverse cross section of the retrieval sheath 1430, such as a cross section in a plane perpendicular to the longitudinal axis of the retrieval sheath 1430, showing the retrieval lumen diameter 1439.

[0132] The retrieval sheath 1430 can be sized and shaped to carry the drive cable 102 within the retrieval lumen 1436. The retrieval sheath 1430, such as the distal retrieval end 1432, can be configured to receive and collapse the blood pump 200 into the retrieval sheath lumen diameter 1439. This can provide a reduced lateral profile, which can ease withdrawal of the blood pump 200 from the patient, such as after userdetachment of the access sheath 1420.

[0133] The retrieval sheath 1430 can include a retrieval sheath fluid port 1437. The retrieval sheath fluid port 137 can be in fluid communication with the retrieval lumen 1436. This can enable continuous or recurrent flushing, such as while the retrieval sheath 1430 is advanced into patient vasculature. The retrieval sheath fluid port 1437 can be located on the retrieval sheath 1430, such as at or near the retrieval proximal end 1434 of the retrieval sheath 1430.[001.34] The retrieval sheath 1430 can include a protective sleeve 1438, such as shown in FIG. 15. The protective sleeve 1438 can be located about at least a portionof the retrieval sheath 1430 and can be configured to cover at least a portion of the retrieval sheath 1430. The protective sleeve 1438 can maintain sterility of pVAD delivery assembly 1400, such as during extended use of the pVAD assembly 100.

[0135] The pVAD delivery assembly 1400 can be located on the drive cable 102. In an example, at least one of the delivery sheath 1410, the access sheath 1420, or the retrieval sheath 1430 can be pre-loaded onto the drive cable 102, such as before insertion of the assembly 1400 into the patient.

[0136] The pVAD delivery assembly 1400, including at least one of the delivery sheath 110, the access sheath 120, or the retrieval sheath 130, can include a cross- sectional profile dimension. A cross-sectional profile dimension can refer to the orientation of the specified profile dimension with respect to a central longitudinal axis defined by the pVAD delivery assembly 1400. The central longitudinal axis can be parallel with at least one of the delivery lumen 1416, the access lumen 1426, or the delivery lumen 1436. The lateral cross-sectional profile dimension can be measured in a plane perpendicular to the longitudinal axis of the pVAD delivery assembly 1400.

[0137] The lateral cross-sectional profile dimension of the pVAD delivery assembly 1400 can include a range of about 6 French (Fr) to about 12 Fr. In an example, the lateral cross-sectional profile dimension of the pVAD delivery assembly 1400 can include a measurement of about 9 Fr.

[0138] FIG. 15 shows an example of the protective sleeve 1438 located over the retrieval sheath 1430. The protective sleeve 1438 can be attached to the proximal retrieval end 1434 of the retrieval sheath 130. The protective sleeve 1438 can help provide a barrier between the retrieval sheath 130 and the surrounding environment, such as to minimize contamination of the retrieval sheath 1430. The retrieval sleeve 1438 can include an accordion-like structure that can include one or more ridges or one or more grooves, such as to provide longitudinal elasticity of the elastic sleeve 1438. The one or more ridges or grooves can be oriented orthogonally or obliquely with respect to the longitudinal axis.

[0139] FIG. 16 shows an example of a pVAD delivery assembly 1600 including a delivery sheath 1410 and an access sheath 1420. The assembly 1600 can be located on the drive cable 102. The delivery sheath 1410 and the access sheath 1420 can be pre-loaded onto the drive cable 102 before insertion into the patient.[091.40] FIG. 17 shows an example of a pVAD delivery assembly 1700 including a delivery sheath 1410 and a retrieval sheath 1430. The delivery assembly 1700 can belocated on the drive cable 102. The delivery sheath 1410 and the retrieval sheath 1430 can be pre-loaded onto the drive cable 102, such as before insertion into the patient.

[0141] FIG. 18 shows an example method 1800 of using a pVAD delivery assembly 1400, such as for delivering and removing the pVAD assembly 100 to vasculature of a patient via an external access location. The pVAD assembly 100 can include a blood pump 200 and a drive cable 102, such as a drive cable 102 that can extend proximally from the blood pump 200. The delivery assembly 1400 can include at least one of a delivery sheath 1410, an access sheath 1420, or a retrieval sheath 1430.

[0142] At 1802, a user-detachable delivery sheath 1410 can be located about the drive cable 102. In an example, the drive cable 102 can be inserted through a delivery lumen 1416 defined by the delivery sheath 1410 so that the drive cable 102 extends through the delivery sheath 1410, such as from the proximal delivery end 1412 to the distal delivery end 1414.

[0143] At 1804, a user-detachable access sheath 1420 can be located about the drive cable 102. In an example, the drive cable 102 can be inserted through an access lumen 1426 defined by the access sheath 1420, such that the drive cable 102 extends through the access sheath 1420, such as from the proximal access end 1412 to the distal access end 1414.

[0144] At 1806, a user-detachable retrieval sheath 1430 can be located about the drive cable 102. In an example, the drive cable 102 can be inserted through a retrieval lumen 1436 defined by the retrieval sheath 1430, such that the drive cable 102 extends through the retrieval sheath 1430, such as from the proximal retrieval end 1422 to the distal retrieval end 1424.

[0145] At 1808, at least one of the delivery sheath 1410, the access sheath 1420, or the retrieval sheath 1430 can be provided as an assembly. Providing the assembly can include pre-loading at least one of the delivery sheath 1410, the access sheath 1420, or the retrieval sheath 1430 about the drive cable 102 before insertion of the assembly into a patient. The assembly can be provided as configured for a specific surgical intervention approach. For example, the assembly can be configured for a femoral external access location or an upper limb external access location.[001.46] At 1810, the delivery sheath 1410 can be configured for user-detachment from the drive cable 102, such as without requiring passing the delivery sheath over aproximal end of the drive cable 102. User detachment of the delivery sheath 1410 from the drive cable 102 can include detaching the delivery sheath 1410 after expanding the blood pump 200 at a target location within the patient but before activating the blood pump 200.|00147] User-detachment can be implemented with the use of a tool, such as the tool 1411. The tool 1411 can include a sheath slitter. User-detachment can be implemented toollessly, such as without requiring using a tool. A toollessly user- detachable delivery sheath 1410 can include a peel-away delivery sheath 1410.

[0148] At 1812, the access sheath 1420 can be configured for user-detachment from the drive cable 102, such as without requiring passing the access sheath 1420 over a proximal end of the drive cable 102. User detachment of the access sheath 1420 from the drive cable 102 can include detaching the access sheath 1420 after deactivating the blood pump 200.100149] FIG. 19 shows a second example method 1900 of using a pVAD delivery assembly 1700, such as for delivering and removing a pVAD assembly 100 into patient vasculature via an external access location. The pVAD assembly 100 can include a blood pump 200 and a drive cable 102, such as a drive cable 102 that can extend proximally from the blood pump 200. The delivery assembly 1700 can include a delivery sheath 1410 and the retrieval sheath 1430, such as located around the drive cable 102. The delivery assembly 1700 can be located on the drive cable 102. The delivery assembly 1700, such as components of the delivery assembly 1700, can be pre-loaded onto the drive cable 102, such as before insertion into the patient.100150] At 1902, the user-detachable delivery sheath 1410 can be located about the drive cable 102. In an example, the drive cable 102 can be inserted through a delivery lumen 1416 defined by the delivery sheath 1410 so that the drive cable 102 extends through the delivery sheath 1410, such as from the proximal delivery end 1412 to the distal delivery end 1414.100151] At 1904, the user-detachable retrieval sheath 1430 can be located about the drive cable 102. In an example, the drive cable 102 can be inserted through a retrieval lumen 1436 defined by the retrieval sheath 1430, such that the drive cable 102 extends through the retrieval sheath 1430, such as from the proximal retrieval end 1422 to the distal retrieval end 1424.

[0152] At 1906, at least one of the delivery sheath 1410 or the retrieval sheath 1430 can be provided as an assembly 1700. Providing the assembly can include pre-loading at least one of the delivery sheath 1410 or the retrieval sheath 1430 about the drive cable 102 before insertion of the assembly 1700 into a patient. The assembly 1700 can be configured for a specific surgical intervention approach. For example, the assembly 1700 can be configured for a femoral external surgical access approach or an upper limb external surgical access approach.100.1.53] At 1908, the delivery sheath 1410 can be detached by a user from the drive cable 102, such as without requiring passing the delivery sheath over a proximal end of the drive cable 102. User detachment of the delivery sheath 1410 from the drive cable 102 can include detaching the delivery sheath 1410 after expanding the blood pump 200 at a target location within the patient but before activating the blood pump 200.

[0154] User-detachment can be implemented with the use of a tool, such as the tool 1411. The tool 1411 can include a sheath slitter. User-detachment can be implemented toollessly, such as without requiring using a tool. A toollessly user- detachable delivery sheath 1410 can include a peel-away delivery sheath 1410.

[0155] At 1910, the retrieval sheath 1430 can be removed from the patient, such as from patient vasculature through the external access location. Removing the retrieval sheath 1430 from the patient can include collapsing the pump assembly 100 into the retrieval sheath 1430, such as collapsing the pump assembly 100 into a distal retrieval end 1432 of the retrieval sheath 1430. Collapsing the pump assembly 100 can include reducing the diameter of the pump assembly 100, such as from an expanded configuration to a collapsed configuration. In an example, at least a portion of the pump assembly 100 can be located within the retrieval sheath lumen 1436 after collapse. Removing the retrieval sheath 1430 can include withdrawing the delivery sheath 1430, such as the delivery sheath 1430 with at least a portion of the pump assembly 100 located within the retrieval sheath lumen 1436 of the delivery sheath 1430, from at least one of patient vasculature or the external access location.Removing the retrieval sheath 1430 can include occluding the access location, such as at least one of the external access location (e.g., the access location into the body through patient skin) or a vasculature access location (e.g., the access location into the vasculature through a blood vessel wall in the patient), to prevent blood loss from the patient.100.1.50] FIG. 20 shows an example method 2000, such as of inserting a pVAD assembly 100 into patient vasculature via an external access location. The pVADassembly 100 can include a blood pump 200, an atraumatic tip 300, and a nose cone body 400.[001571 2002, the pVAD assembly 100 can be connected to a delivery sheath500. Connecting the pVAD assembly 100 to the delivery sheath 500 can include locating the blood pump 200, such as at least a portion of the blood pump 200, in the delivery lumen 504 in preparation for insertion of the pVAD assembly 100 into patient vasculature.

[0058] Connecting the pVAD assembly 100 can include contacting the delivery sheath 500 with a portion of the nose cone body 400, such as at the second location 412 corresponding to a second nose cone diameter. In an example, a truncated cone nose cone surface, such as the nose cone surface between the first location 410 corresponding to the first diameter and the second location 412 corresponding to the second diameter where the first diameter is less than the second diameter, can seat the pVAD assembly 100 against the distal delivery sheath end 505. Application of a tensile force to the drive cable 102 can maintain the interference fit between the pVAD assembly 100 and the delivery lumen inner diameter 506, such as to retain the pVAD assembly 100 with the delivery sheath 500.

[0159] Connecting the pVAD assembly 100 can include contacting the delivery sheath 500 with a portion of the nose cone body 400, such as at least a portion of the second nose cone segment 432. In an example, the second nose cone segment 432 can be configured to create a friction fit (or interference fit) between the pVAD assembly 100 and the inner diameter 506 of the delivery lumen 504. In an example, a protuberance can be formed on at least one of the second nose cone segment 432 or the inner wall of the delivery lumen 504 in contact with the second nose cone segment 432, such as to establish a friction fit between the two surfaces. In an example, the second nose cone segment 432 can be configured to create a sliding surface (or sliding fit) between the second nose cone segment 432 and the delivery lumen inner diameter 506.100160] Connecting the pVAD assembly 100 can include contacting the delivery sheath 500 with a portion of the nose cone body 400, such as at least a portion of the first nose cone segment 430. In an example, the first nose cone segment 430 can be configured to create a friction fit (or interference fit) between the pVAD assembly 100 and the inner diameter 506 of the delivery lumen 504. In an example, a protuberance can be formed on at least one of the first nose cone segment 430 or theinner wall of the delivery lumen 504 in contact with the first nose cone segment 430, such as to establish a friction fit between the two surfaces. In an example, the first nose cone segment 430 can be configured to create a sliding surface (or sliding fit) between the first nose cone segment 430 and the delivery lumen inner diameter 506. |00161 ] At 2004, the pVAD assembly 100, such as connected to the delivery sheath 500, can be located on a guidewire, such as a guidewire that has been previously positioned within patient vasculature with a Seidinger technique. Locating the pVAD assembly 100 on the guidewire can include threading the guidewire through at least a portion of the pVAD assembly 100, such as to guide the pVAD assembly 100 along the guidewire to a desired location in the patient vasculature.

[0162] Locating the pVAD assembly 100 can include threading the pVAD assembly 100 from the distal end of the atraumatic tip 300 onto the pVAD assembly 100. In an example, the guidewire can be inserted into the atraumatic tip lumen 308 at the distal end of the distal tip portion 306 and advanced through the atraumatic tip lumen 308 into the guidewire lumen 450 to emerge from the nose cone body 400 at the guidewire port 452. In an example, the guidewire can be inserted into the atraumatic tip lumen 308 at the distal end of the distal tip portion 306 and advanced through the atraumatic tip lumen 308 into the guidewire lumen 450 to emerge from the nose cone body 400 at the nose cone cavity 409, such as the distal end of the nose cone cavity 409.

[0163] Locating the pVAD assembly 100 can include threading the pVAD assembly 100 from the guidewire port 452 onto the pVAD assembly 100. In an example, the guidewire can be inserted into the guidewire port 452 and advanced through the guidewire lumen 450 into the atraumatic tip lumen 308 to emerge from the atraumatic tip 300 at the distal end of the atraumatic tip 300. In an example, the guidewire port 452 can be located on the nose cone surface 408, such as at a location on the nose cone surface 408 proximal of the fourth location 416. The location of the guidewire port 452 can be configured to optimize a surgical procedure, such as to implement a rapid exchange strategy.

[0164] In an example, the guidewire port 452 can be located in the nose cone body 400, such as adjacent to (or coincide with) a distal end of the nose cone cavity 409, such as to form a lumen in the nose cone body 400 from the first location 410 to the fourth location 416. The location of the guidewire port 452 can facilitate a deliverstrategy associated with the pVAD assembly 100, such as to locate the guidewire along a central axis 214 of the pVAD assembly 100.[001651 2006, the pVAD assembly 100 and the delivery sheath 500 can be inserted through the external access location into patient vasculature, such as without requiring an introducer sheath. In an example, the introducer sheath can include a shorter adjunct tubular introducer sheath to access patient vasculature at the external access location. Inserting the pVAD assembly 100 can include advancing the pVAD assembly 100 over the guidewire into patient vasculature to locate the pVAD assembly 100 near a target location, such as in at least one of a left ventricle or an aorta of the patient’s heart.

[0166] Whereas other percutaneous ventricular assist devices require the use of an introducer sheath, such as a relatively short cannula providing a clear access lumen from an external access location into patient vasculature, the tapered shape associated with the nose cone body 400, such as described throughout this application, can replace the function of the introducer sheath during insertion of the pVAD assembly 100. The tapered shape of the nose cone body 400 can be configured to stretch patient skin at the external access location as the pVAD assembly 100 is advanced over the guidewire. By stretching patient skin, the tapered shape allows for passage of the pVAD assembly 100 into patient vasculature and can obviate the need for a separate introducer sheath for implantation as required by other percutaneous ventricular assist devices.

[0167] Inserting the pVAD assembly 100 can include advancing the pVAD assembly 100 with a tapered shape nose cone body 400 over the guidewire into patient vasculature. The nose cone body 400 can be configured as a decreasing tapered shape, such as decreasing from the proximal nose cone portion 404 to the distal nose cone portion 406. In an example, the decreasing tapered shape can be applied to a third nose cone segment 434 of the nose cone body 400, such as a third nose cone segment 434 that tapers from a third location 414 corresponding to a third nose cone diameter to a fourth location 416 corresponding to a fourth nose cone diameter where the third nose cone diameter is greater than the fourth nose cone diameter.

[0168] Inserting the pVAD assembly 100 can include advancing the pVAD assembly 100 with a tapered shape nose cone body 400 connected to the delivery sheath 500 over the guidewire into patient vasculature. In an example, a decreasingtapered shape can be applied to a third nose cone segment 434 of the nose cone body 400 to advance the pVAD assembly 100 through the external access location without requiring an introducer sheath. The pVAD assembly 100 connected to the delivery sheath 500 can then be further advanced through the external access location, such as to locate the pVAD assembly 100 near a target location, such as in at least one of a left ventricle or an aorta of the patient’s heart.

[0169] The above description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0170] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.100171] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0172] Geometric terms, such as “parallel”, “perpendicular”, “round”, or “square”, are not intended to require absolute mathematical precision, unless the context indicates otherwise. Instead, such geometric terms allow for variations due tomanufacturing or equivalent functions. For example, if an element is described as “round” or “generally round,” a component that is not precisely circular (e.g., one that is slightly oblong or is a many-sided polygon) is still encompassed by this description.

[0173] Method examples described herein can be machine or computer- implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

[0174] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:

1. A percutaneous ventricular assist device (pVAD) assembly configured for insertion into a patient vasculature at an external access location using a delivery sheath and a guidewire, each extendable to a target location within the patient vasculature, without requiring an adjunct introducer sheath located at the external access location, the pVAD assembly comprising: a blood pump with a proximal pump portion and a distal pump portion; and a nose cone body, including a proximal nose cone portion attached to the distal pump portion, a distal nose cone portion opposite the proximal nose cone portion, and a nose cone surface connecting the proximal nose cone portion and the distal nose cone portion, wherein the nose cone body is sized, shaped, or otherwise configured to dilate the external access location to allow for passage of the delivery sheath carrying the pVAD assembly into the patient vasculature through the external access location without requiring the adjunct introducer sheath at the external access location.

2. The pVAD assembly of claim 1, further comprising a guidewire lumen extending from the distal nose cone portion toward the proximal nose cone portion through the nose cone body.

3. The pVAD assembly of claim 2, wherein the guidewire lumen includes an ellipsoidal cross-sectional lumen shape to control a bending stiffness of the nose cone body.

4. The pVAD assembly of claim 3, wherein a bending stiffness of the nose cone body decreases from the proximal nose cone portion to the distal nose cone portion.

5. The pVAD assembly of claim 1, wherein the nose cone body includes a lubricious outer surface.

6. The pVAD assembly of claim 5, wherein the lubricious outer surface includes a silicone oil coated surface.

7. The pVAD assembly of claim 5, wherein the lubricious outer surface includes a hydrophilic coated surface.

8. The pVAD assembly of claim 5, wherein the lubricious outer surface includes a Parylene coated surface.

9. The pVAD assembly of claim 1, wherein the blood pump includes a housing including a body portion, a proximal end portion connected to the body portion, a distal end portion connected to the body portion opposite the proximal end portion, a housing lumen extending from the proximal end portion through the body portion to the distal end portion, and a tip coupler portion attached to the distal end portion.

10. The pVAD assembly of claim 9, wherein the tip coupler portion comprises an appendage including one or more appendages.

11. The pVAD assembly of claim 10, wherein the appendage comprises a protuberance including one or more protuberances.

12. The pVAD assembly of claim 1, further comprising the delivery sheath, locatable about a drive cable and defining a delivery lumen that is sized and shaped to carry the pVAD, in a collapsed state, for insertion into the patient vasculature through the external access location to the target location within the patient vasculature at which the pump is deployed from a distal portion of the delivery sheath and allowed to expand.

13. The pVAD assembly of claim 12, wherein the delivery sheath is userremovable from the drive cable without requiring passing the delivery sheath over a proximal end of the drive cable.

14. The pVAD assembly of claim 12, wherein the delivery sheath includes a distal delivery sheath end and wherein an outer diameter of the proximal nose cone portion is at least one of equal to or greater than an outer diameter of the distal delivery sheath end.

15. The pVAD assembly of claim 14, wherein the outer diameter of the proximal nose cone portion is equal to the outer diameter of the distal delivery sheath end.

16. The pVAD assembly of claim 14, wherein the outer diameter of the proximal nose cone portion is greater than the outer diameter of the distal delivery sheath end.

17. The pVAD assembly of claim 14, wherein the nose cone body includes a first nose cone segment configured to contact an inner surface of the delivery lumen to form an interference fit between the first nose cone segment and the inner surface of the delivery lumen.

18. The pVAD assembly of claim 14, wherein the nose cone body includes a first nose cone segment configured to contact an inner surface of the delivery lumen to form a sliding fit between the first nose cone segment and the inner surface of the delivery lumen.

19. The pVAD assembly of claim 12, wherein the delivery sheath includes a distal delivery sheath end and wherein an outer diameter of the proximal nose cone portion is at least one of equal to or greater than an inner diameter of the distal delivery sheath end.

20. The pVAD assembly of claim 19, wherein the outer diameter of the proximal nose cone portion is equal to the inner diameter of the distal delivery sheath end.

21. The pVAD assembly of claim 19, wherein the outer diameter of the proximal nose cone portion is greater than the inner diameter of the distal delivery sheath end.

22. The pVAD assembly of claim 19, wherein the nose cone body includes a second nose cone segment configured to contact an inner surface of the delivery lumen to form an interference fit between the second nose cone segment and the inner surface of the delivery lumen.

23. The pVAD assembly of claim 19, wherein the nose cone body includes a second nose cone segment configured to contact an inner surface of the delivery lumen to form a sliding fit between the second nose cone segment and the inner surface of the delivery lumen.

24. The pVAD assembly of claim 12, further comprising a retrieval sheath, locatable about the drive cable and defining a retrieval lumen that is sized and shaped to accommodate the drive cable within the retrieval lumen, the retrieval sheath including a proximal retrieval end and a distal retrieval end opposite the proximal retrieval end, the retrieval sheath configured for insertion into the external access location after user-removal of the delivery sheath from the drive cable and to receive and collapse the pVAD assembly to aid in withdrawing the pVAD assembly from the patient vasculature.

25. The pVAD assembly of claim 24, wherein the distal retrieval end is configured to receive and collapse the pVAD assembly to aid in withdrawing the blood pump from the patient vasculature.

26. A method of using a pVAD assembly to insert a blood pump into a patient vasculature at an external access location using a delivery sheath and a guidewire, each extendable to a target location within the patient vasculature, without requiring an adjunct introducer sheath located at the external access location, the pVAD assembly including the blood pump with a proximal pump portion and a distal pump portion, and a nose cone body including a proximal nose cone portion attached to the distal pump portion, a distal nose cone portion opposite the proximal nose cone portion, a nose cone surface connecting the proximal nose cone portion and the distal nose cone portion, and a guidewire lumen extending from the distal nose cone portion toward the proximal nose cone portion through the nose cone body, wherein the nose cone body is sized, shaped, or otherwise configured to dilate the external access location to allow for passage of the delivery sheath carrying the pVAD assembly into the patient vasculature through the external access location without requiring the adjunct introducer sheath at the external access location, the method comprising: connecting the pVAD assembly to the delivery sheath;locating the pVAD assembly connected to the delivery sheath onto the guidewire; and inserting the pVAD assembly connected to the delivery sheath over the guidewire into the patient vasculature without the adjunct introducer sheath.

27. The method of claim 26, wherein t .

28. The method of claim 26, wherein the nose cone body includes a first nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the first nose cone segment to form a sliding fit with the delivery sheath.

29. The method of claim 26, wherein the nose cone body includes a second nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the second nose cone segment to form an interference fit with the delivery sheath.

30. The method of claim 26, wherein the nose cone body includes a second nose cone segment and connecting the pVAD assembly to the delivery sheath includes configuring the second nose cone segment to form a sliding fit with the delivery sheath.

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