Covering and delivery system for a foldable blood pump

Abstract

A system for inserting a foldable blood pump into a patient, in some embodiments, the system includes an introducer needle comprising an introducer hub and an introducer sheath extending distally from the introducer hub, the introducer sheath comprising an introducer sheath lumen, the introducer hub comprising a hub connector and a distal hub lumen surrounding a proximal end of the introducer shaft, and a delivery tool comprising a delivery sheath comprising a delivery sheath lumen having a diameter substantially equal to a diameter of the introducer sheath lumen and a delivery tool connector adapted to connect to the hub connector, a distal portion of the delivery sheath extending into the distal hub lumen when the delivery tool connector is connected to the hub connector.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. patent application Ser. No. 63 / 297,972, filed January 10, 2022, U.S. patent application Ser. No. 63 / 267,467, filed February 2, 2022, and U.S. patent application Ser. No. 63 / 376,375, filed September 20, 2022, each of which is incorporated by reference in its entirety into this specification. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. [Background technology]

[0002]

[0003] Intravascular blood pumps may benefit from being collapsible to facilitate a smaller delivery profile before being expanded at a pumping location within a patient's heart and / or vasculature. Some such pumps are described in WO2021 / 243263.

[0003]

[0004] Conventional expandable blood pump systems require both an outer sheath and an introducer needle. The outer sheath facilitates folding and expanding the self-expanding pump into an operating profile. The pump is introduced into the patient by folding the pump into the sheath and then inserting the sheath through the introducer needle. This results in material "stacking" and therefore a larger insertion profile, which correlates to a higher rate of vascular complications. There is a need for blood pumps and delivery systems with a reduced insertion profile and a larger operating configuration. There is a need for a system for rapidly introducing an expandable blood pump into a patient. Summary of the Invention [Problem to be solved by the invention]

[0004]

[0005] FIELD OF THE DISCLOSURE The present disclosure relates to intravascular blood pumps and methods of their use. In particular, the present disclosure relates to a system and method for inserting a foldable blood pump into a patient. [Means for solving the problem]

[0005]

[0006] One aspect of the invention provides a system (or device) for inserting a foldable blood pump into a patient. In some embodiments, the system includes an introducer having an introducer hub and an introducer sheath extending distally from the introducer hub, the introducer sheath having an introducer sheath lumen, the introducer hub having a hub connector and a distal hub lumen surrounding a proximal end of the introducer shaft, and a delivery tool having a delivery sheath having a delivery sheath lumen with a diameter substantially equal to a diameter of the introducer sheath lumen and a delivery tool connector adapted to connect to the hub connector, a distal portion of the delivery sheath extending into the hub when the delivery tool connector is connected to the hub connector.

[0006]

[0007] In some embodiments, a distal portion of the delivery sheath extends into the distal hub lumen when the delivery tool connector is connected to the hub connector. In some embodiments, the distal end of the delivery sheath abuts the proximal end of the introducer sheath when the delivery tool connector is connected to the hub connector. In some embodiments, the introducer hub also has a tapered surface extending proximally and radially outward from the distal hub lumen.

[0007]

[0008] In some embodiments, the introducer needle also has a one-way valve disposed on the introducer needle hub proximal to the introducer sheath lumen and configured to seal against vascular pressure, a seal disposed on the introducer needle hub proximal to the introducer sheath and configured to seal against vascular pressure around a device of a range of diameters inserted through said seal, and / or a disk valve disposed on the introducer needle hub proximal to the introducer sheath and configured to seal against vascular pressure around a device of a range of diameters inserted through said valve, hi some embodiments, the introducer needle hub also further has a purge fluid port in fluid communication with the distal hub lumen.

[0008]

[0009] In some embodiments, the hub connector includes a thread disposed on the introducer hub, hi some embodiments, the hub connector and the delivery tool connector are configured to provide an axial force that moves the delivery sheath and the introducer sheath toward one another.

[0009]

[0010] In some embodiments, the transfer tool proximal hub also has a proximal hub surrounding the proximal portion of the transfer sheath. In some such embodiments, the transfer tool proximal hub has a central lumen, the proximal portion of the transfer sheath is disposed in the central lumen, and the central lumen has a reduced diameter portion proximal to the proximal end of the transfer sheath. In some such embodiments, the transfer tool proximal hub also has a purge fluid port in communication with the central lumen and / or a seal adapted to seal around a catheter portion of the blood pump.

[0010]

[0011] In some embodiments, the transfer tool further has a handle surrounding the transfer sheath. In some such embodiments, the handle extends proximally from the transfer tool connector. The transfer tool may also have a proximal hub, with the handle extending from the transfer tool connector to the proximal hub. The transfer tool connector may include a threaded portion (e.g., a rotatable ring with internal threads) disposed at a distal end of the handle, with a distal portion of the transfer sheath extending distally beyond the transfer tool connector.

[0011]

[0012] In some embodiments, the distal portion of the delivery sheath is radially expandable.

[0012]

[0013] Another aspect of the invention provides a method of deploying an expandable blood pump in a patient, the blood pump comprising an expandable and compressible pump housing, an impeller disposed within the pump housing, and a catheter extending proximally from the pump housing. In some embodiments, the method includes moving at least a portion of the pump housing proximally through a distal opening of a transfer sheath of a transfer tool and into the transfer sheath, the pump housing contracting as the pump housing enters the transfer sheath, advancing the transfer sheath distally into a hub of an introducer sheath disposed within a blood vessel of the patient, advancing the pump housing out of the transfer sheath and into the introducer sheath, and advancing the pump housing out of the introducer sheath and into the blood vessel. In some embodiments, the transfer sheath is advanced distally into the introducer hub until a distal end of the transfer sheath abuts a proximal end of the introducer sheath. In some embodiments, the transfer sheath lumen has a diameter substantially equal to a diameter of the introducer sheath lumen.

[0013]

[0014] Some embodiments include connecting a connector of the delivery tool to a connector of the introducer hub, hi some such embodiments, the connecting step includes applying an axial force that moves the delivery sheath and the introducer sheath toward each other.

[0014]

[0015] Some embodiments include expanding the distal end of the delivery sheath as the pump housing moves into the delivery sheath, and some embodiments include compressing the distal end of the delivery sheath before the distal end of the delivery sheath abuts the proximal end of the introducer sheath.

[0015]

[0016] In some embodiments, moving the pump housing proximally into the transfer sheath also includes moving the pump housing proximally until the proximal posts of the pump housing engage the sheath stop at the proximal end of the transfer sheath. Some embodiments include injecting a purge fluid into the proximal end of the transfer sheath while the pump housing is disposed in the transfer sheath.

[0016]

[0017] Yet another aspect of the invention provides a method of deploying an expandable blood pump in a patient, the blood pump comprising an expandable and compressible pump housing, an impeller disposed within the pump housing, and a catheter extending proximally from the pump housing. In some embodiments, the method includes moving the pump housing proximally through a distal opening of a delivery sheath of a delivery tool and into the delivery sheath, where the pump housing contracts as it enters the delivery sheath and a distal end of the delivery sheath expands as the pump housing enters the delivery sheath, advancing the delivery sheath distally into a hub of an introducer sheath disposed within a blood vessel of the patient, compressing the distal end of the delivery sheath into the hub, advancing the pump housing out of the delivery sheath into the introducer sheath, and advancing the pump housing out of the introducer sheath into the blood vessel. In some embodiments, the delivery sheath lumen has a diameter substantially equal to a diameter of the introducer sheath lumen after the compressing step.

[0017]

[0018] Some embodiments include connecting a connector of the delivery tool to a connector of the introducer hub, hi some embodiments, the connecting step includes applying an axial force that moves the delivery sheath and the introducer sheath toward each other.

[0018]

[0019] Some embodiments include compressing the distal end of the delivery sheath before the distal end of the delivery sheath abuts the proximal end of the introducer sheath, hi some such embodiments, moving the pump housing proximally into the delivery sheath further includes moving the pump housing proximally until a proximal post of the pump housing engages a sheath stop at the proximal end of the delivery sheath.

[0019]

[0020] Some embodiments include injecting a purge fluid into the proximal end of the delivery sheath while the pump housing is disposed within the delivery sheath.

[0020]

[0021] Yet another aspect of the invention provides a system for compressing a blood pump into a delivery configuration. In some embodiments, the system includes a delivery sheath having a lumen with a lumen diameter, and a covering tool engaged with a distal end of the delivery sheath, the covering tool having an inlet section and an outlet section, the inlet section having an inner surface defining a lumen whose diameter decreases from the distal end of the inlet section to the proximal end of the inlet section, the outlet section having a lumen extending from the inlet section to the proximal end of the covering tool such that it is aligned with the delivery sheath lumen, the outlet section lumen having a diameter equal to or less than the delivery sheath lumen diameter, and the covering tool being detachable from the delivery sheath.

[0021]

[0022] Some embodiments also include a fastener adapted to fasten the covering tool to the delivery sheath. In some embodiments, the delivery sheath has a splitting seam adapted to split the delivery sheath into two or more pieces. In some embodiments, the delivery sheath has a hub at a proximal end of the delivery sheath. In some such embodiments, the hub has a distal surface and a seal on the distal surface. Alternatively or additionally, the hub may have a splitting seam adapted to split the hub into two or more pieces.

[0022]

[0023] Another aspect of the invention provides a method of loading a foldable blood pump into a transfer sheath, the blood pump comprising a self-expandable housing, a self-expandable impeller disposed in the housing, a catheter extending proximally from the housing, and a drive shaft extending from the impeller through the catheter. In some embodiments, the method includes pulling a portion of the catheter extending proximally from a proximal opening of the transfer sheath proximally to move the housing proximally toward a distal opening of the transfer sheath, engaging the housing with an angled surface of a covering tool disposed at the distal opening of the transfer sheath, compressing the housing and the impeller as the blood pump moves proximally into a lumen of the covering tool relative to the angled surface, the lumen of the covering tool having a diameter equal to or less than a diameter of the lumen of the transfer sheath, and pulling the housing into the transfer sheath lumen.

[0023]

[0024] Some embodiments include terminating proximal pulling of the catheter when the distal end of the blood pump housing is disposed proximal to the distal opening of the transfer sheath. Some embodiments include terminating proximal pulling of the catheter when the self-expandable housing is compressed to the diameter of the transfer sheath lumen. Some embodiments include removing the covering tool from the transfer sheath. Some embodiments include connecting the catheter and drive shaft to a handle and motor. Some embodiments include extending the catheter and drive shaft through the distal opening, lumen, and proximal opening of the transfer sheath.

[0024]

[0025] Yet another aspect of the invention is a foldable blood pump having a self-expandable housing, an impeller disposed in the housing, a catheter extending proximally from a proximal end of the housing, and a drive shaft extending proximally from the impeller through the catheter, the foldable blood pump having an expanded configuration in which the housing has an expanded outer diameter; a delivery sheath having a distal opening, a proximal opening, and an inner lumen having an inner lumen diameter smaller than the expanded outer diameter of the housing; and a covering device engaged with the distal end of the delivery sheath, the covering device having an inlet section and an outlet section, the inlet section decreasing in diameter from the distal end of the inlet section toward the proximal end of the inlet section. and an introducer sheath having an inner surface defining a lumen through which the inlet section extends, the outlet section having a lumen extending from the inlet section to a proximal end of the covering tool such that it is aligned with the delivery sheath lumen, the outlet section lumen having substantially the same diameter as the delivery sheath lumen diameter, the covering tool being detachable from the delivery sheath, and an introducer sheath including a hub on the proximal end, a shaft extending distally from the hub and defining an introducer lumen having a diameter greater than an outer diameter of the delivery sheath, and a distal opening in communication with the introducer lumen, the introducer sheath shaft configured to be inserted into a blood vessel of a patient.

[0025]

[0026] Some embodiments also have a fastener adapted to fasten the covering tool to the delivery sheath. In some embodiments, the delivery sheath further has a dividing line adapted to divide the delivery sheath into two or more pieces.

[0026]

[0027] Some embodiments include a hub at the proximal end of the delivery sheath. In some such embodiments, the delivery sheath hub has a distal face and a seal on the distal face that is adapted to seal against the hub of the introducer sheath. The introducer sheath hub may also have a proximal face and a seal on the proximal face. In some embodiments, the delivery sheath hub may have a split line that is adapted to separate the hub into two or more pieces.

[0027]

[0028] Some embodiments also include an unsheathing aid extending proximally from the transfer sheath hub, the unsheathing aid having a gripping tool adapted to allow a user to releasably grip the blood pump catheter and move the catheter relative to the transfer sheath. In some such embodiments, the gripping tool has a handle and a catheter engagement mechanism in the handle. The catheter engagement mechanism may include a movable button having an engagement position that engages the handle with the catheter and a disengagement (or disengagement) position in which the catheter can be moved relative to the handle, the button may be biased to the disengagement position by a spring. The unsheathing aid may also include a support shell (or shell) that surrounds the catheter, the support shell being disposed between the transfer sheath hub and the handle. In some such embodiments, the handle is movably supported by the support shell. The unsheathing aid may also be detachable from the transfer sheath hub.

[0028]

[0029] In some embodiments, the hub includes a guidewire lumen adapted to receive a guidewire extending from the blood pump housing. Some such embodiments include a seal adapted to close the guidewire lumen.

[0029]

[0030] In some embodiments, the hub has a sheath flush (or irrigation) port in fluid communication with the introducer sheath, hi some embodiments, the catheter extends proximally through the delivery sheath and through a proximal opening in the delivery sheath.

[0030]

[0031] Some embodiments also include a guidewire extending proximally from the blood pump housing, hi some such embodiments, the guidewire extends proximally through the delivery sheath and through a proximal opening in the delivery sheath.

[0031]

[0032] In some embodiments, the introducer sheath shaft has a length extending distally from the introducer sheath hub that is less than a length of the delivery sheath extending distally from the delivery sheath hub, hi some embodiments, the catheter and drive shaft are connectable to a handle and a motor, and the system may include the handle and the motor.

[0032]

[0033] Yet another aspect of the invention provides a method of deploying a blood pump in a patient, the blood pump comprising a self-expandable housing, an impeller disposed within the housing, and a catheter extending proximally from the housing. In some embodiments, the method includes pulling proximally a portion of the catheter extending proximally from a proximal opening of the transfer sheath to move the housing proximally toward a distal opening of the transfer sheath, compressing the housing and impeller as the blood pump moves proximally into a lumen of the transfer sheath, inserting a transfer sheath through a proximal opening of the introducer sheath, the introducer sheath extending distally from its proximal opening disposed outside of the patient into a blood vessel of the patient, advancing the transfer sheath within the introducer sheath until the distal opening of the transfer sheath is at or beyond the distal opening of the introducer sheath, and advancing the blood pump out of the transfer sheath, thereby allowing the blood pump housing and impeller to self-expand to an expanded configuration.

[0033]

[0034] Some embodiments include, prior to the compressing step, engaging the housing with an inclined surface of a covering tool disposed at a distal opening of the delivery sheath. The method may also include disengaging the covering tool from the delivery sheath.

[0034]

[0035] In some embodiments, the delivery sheath has a hub at a proximal end and the introducer sheath has a hub at a proximal end, and advancing the delivery sheath within the introducer sheath comprises advancing the delivery sheath within the introducer sheath until the delivery sheath hub engages the introducer sheath hub. Some embodiments include removing the delivery sheath from around the blood pump catheter after advancing the blood pump out of the delivery sheath.

[0035]

[0036] In some embodiments, the blood vessel is a femoral artery and the introducer sheath has a length of at least 25 cm and no more than 33 cm, and the method further includes advancing the blood pump, in the expanded configuration, distally from the distal end of the introducer sheath to a pumping location within the patient's aorta. Some such embodiments also include moving the blood pump, in the expanded configuration, proximally from the pumping location within the patient's aorta to the distal end of the introducer sheath. The method may also include moving the blood pump proximally into the introducer sheath.

[0036]

[0037] In some embodiments, advancing the blood pump out of the delivery sheath includes engaging the catheter with a grasping tool extending proximally from the delivery sheath and moving the catheter relative to the delivery sheath.

[0037]

[0038] Another aspect of the invention provides a catheter gripping tool, the device comprising a base operatively coupled to a depressible portion, wherein one or more springs can be configured to bias the depressible portion away from the base, and the catheter gripping tool can be configured to regulate movement of the catheter during use.

[0038]

[0039] In some examples, the one or more springs can comprise a plurality of torsion springs, each having an opening that can be configured to engage with the exterior surface of a catheter passed therethrough, and the depressible surface can adjust the diameter of each opening from an engaged position to a disengaged position.

[0039]

[0040] In some instances, the gripping tool can apply pressure to the exterior surface of the catheter to control the position of the catheter passing therethrough.

[0040]

[0041] In some examples, the gripping tool can be configured to adjust the movement of a coated catheter of an intravascular blood pump system.

[0041]

[0042] In some examples, the device can be configured to slidably engage the exterior of the catheter, and the catheter can be frictionally held between the base and the depressible portion in the engaged configuration.

[0042]

[0043] In some examples, the depressible portion can be configured to regulate a transition of the gripping implement from the engaged configuration to the disengaged configuration when a force can be applied against the depressible portion.

[0043]

[0044] In some examples, the spring or springs can be configured to provide a radial force to the catheter.

[0044]

[0045] In general, an intravascular blood pump system can include a catheter shaft extending through a lumen of the catheter, the catheter shaft having a proximal end and a distal end, the catheter shaft distal end operably coupled to an intravascular impeller that can be located within a blood vessel; a catheter gripping tool in operative communication with the catheter, the catheter gripping tool including a base operably coupled to a depressible portion and one or more springs configured to bias the depressible portion away from the base, the catheter gripping tool can be configured to adjust movement of the catheter; a handle including a sealed housing; a motor in operative communication with the catheter shaft proximal end; and a fluid pump operably coupled to the motor.

[0045]

[0046] In some examples, the proximal end of the catheter shaft can be removably coupled to a rigid member that extends through a sealed strain relief at the distal end of the handle.

[0046]

[0047] In some examples, the system may further include a mounting assembly that may be positioned about an exterior surface of the motor within the handle, the mounting assembly having one or more surfaces configured to hold a circuit board thereon.

[0047]

[0048] In some examples, the cradle assembly includes one or more routing channels for routing (or guiding) one or more tubes within the sealed housing.

[0048]

[0049] In some examples, the system may further include one or more conduits extending through the proximal strain relief configured to transfer one or more electrical connections to a circuit board on the mounting assembly.

[0049]

[0050] In some examples, the system can further include a catheter introducer needle having a proximal end configured to axially engage the sheath hub.

[0050]

[0051] In some examples, the catheter can be a multi-layer catheter comprising at least one braided layer, the braided layer comprising one or more braid angles configured to preserve rotation from the proximal end of the multi-layer catheter to the distal end of the multi-layer catheter.

[0051]

[0052] In some examples, the housing can be fluid sealed.

[0052]

[0053] In some examples, the system may further include one or more sensors operably connected to the circuit board, which may be located on the mounting assembly.

[0053]

[0054] In some examples, the system may further include a pressure sensor that determines the pressure of the fluid passing through the intravascular pump system.

[0054]

[0055] In some examples, the system may further include a flow sensor that determines a flow rate of the fluid within the intravascular pump system.

[0055]

[0056] In some examples, the system may further comprise a data transmission module configured to transmit data obtained within the system to one or more peripheral devices.

[0056]

[0057] In some examples, the gripping tool comprises a depressible surface that is spring biased away from the base in the disengagement position.

[0057]

[0058] In some examples, the system can further include one or more torsion springs, each having an aperture configured to engage with an exterior surface of a catheter passed therethrough, and the depressible surface adjusts the diameter of each aperture from an engaged position to a disengaged position.

[0058]

[0059] In some instances, the gripping tool can apply pressure to the exterior surface of the catheter to control movement of the catheter.

[0059]

[0060] In some examples, the grasping tool can be configured to adjust the sheath of the introducer needle as the intravascular blood pump system is advanced into the blood vessel.

[0060]

[0061] Generally, a method of operating a self-expanding blood pump within a patient can include inserting a compressed self-expanding blood pump through a proximal opening of an introducer sheath into a transfer sheath, the introducer sheath extending distally from its proximal opening disposed outside the patient into a blood vessel of the patient. The transfer sheath is then advanced within the introducer sheath until the distal opening of the transfer sheath is at or beyond the distal opening of the introducer sheath. The self-expanding blood pump is then advanced out of the transfer sheath to an expanded configuration at a deployment location within the blood vessel, the self-expanding blood pump being advanced by a catheter gripping tool in operative contact with an elongate member extending proximally from the self-expanding blood pump. One or more impellers of the self-expanding blood pump are then rotated with a motor enclosed within a handle body, a drive cable operatively coupled at a distal end to the one or more impellers and operatively coupled at a proximal end to the motor.

[0061]

[0062] In some examples, the method can further include a step of positioning the self-expanding blood pump within the blood vessel by rotating the handle body, where the drive cable catheter can be configured to rotate the self-expanding blood pump in response to the rotation of the handle body.

[0062]

[0063] In some examples, the drive cable extends through a multi-layer drive cable catheter that is coupled to a distal end of the handle body, the multi-layer drive cable catheter being configured to maintain a uniform torque from the handle body to the self-expanding blood pump.

[0063]

[0064] In some examples, the method may further include detecting a flow rate of fluid from the blood pump to the motor assembly in the handle housing, where one or more sensors are configured to detect the flow rate.

[0064]

[0065] Generally, a method of operating a self-expanding blood pump within a patient can include a grasping tool sheathing the self-expanding blood pump within a sheathing catheter. A distal end of the sheathing catheter is then advanced from outside the patient distally through an introducer needle extending into a blood vessel of the patient. The sheathing catheter distal end is then advanced into the blood vessel of the patient to a deployment site. The grasping tool then unsheathes the self-expanding blood pump to an expanded configuration at the deployment site within the blood vessel. A motor enclosed within the handle body then rotates one or more impellers of the self-expanding blood pump, and a drive cable can be operably coupled to the one or more impellers at a distal end and to the motor proximally.

[0065]

[0066] These and other details and aspects are described herein.

[0066]

[0067] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief description of the drawings]

[0067] [Figure 1]

[0068] FIG. 1 illustrates a first embodiment of a foldable blood pump and a system for inserting the blood pump into a patient. [Diagram 2]

[0069] FIG. 2 shows the foldable blood pump of FIG. 1 compressed inside a delivery sheath. [Diagram 3]

[0070] FIG. 3 shows the foldable blood pump and transfer sheath of FIGS. 1 and 2 with the covering removed. [Figure 4]

[0071] FIG. 4 illustrates the collapsible blood pump and transfer sheath of FIGS. 1-3 prior to insertion into an introducer sheath. [Diagram 5]

[0072] FIG. 5 shows the foldable blood pump and transfer sheath of FIG. 4 inserted into an introducer sheath. [Figure 6]

[0073] 6 shows the foldable blood pump of FIG. 5 advanced out of the delivery sheath and expanded to its expanded configuration. [Figure 7]

[0074] FIG. 7 shows the foldable blood pump and introducer sheath of FIG. 6 with the delivery sheath removed. [Figure 8]

[0075] FIG. 13 is an elevational view of a foldable blood pump, its delivery sheath, and a portion of an introducer needle system according to a second embodiment of the present invention. [Figure 9]

[0076] FIG. 9 is a perspective view of a portion of the blood pump, transfer sheath, and introducer needle system of FIG. [Figure 10]

[0077] FIG. 10 is a cross-sectional view of the blood pump, delivery sheath, and introducer needle system of FIGS. 8 and 9. [Figure 11]

[0078] FIG. 1 is a side view of an exemplary blood pump including an expandable framework supporting a housing with an impeller housed therein. [Figure 12A]

[0079] 13A-13D are diagrams illustrating a method of loading a foldable blood pump into an introducer sheath according to a third embodiment of the present invention, showing the introducer and blood pump before loading the blood pump into a transfer tool. [Figure 12B] 13A-13D illustrate a method of loading a foldable blood pump into an introducer sheath according to a third embodiment of the present invention, showing the blood pump partially loaded into a delivery tool. [Figure 12C] FIG. 13 illustrates a method of loading a foldable blood pump according to a third embodiment of the present invention into an introducer sheath, showing details of the foldable blood pump as the pump enters the transfer sheath and the distal portion of the transfer sheath of the transfer device. [Figure 12D]13A-13D show a method of loading a foldable blood pump according to a third embodiment of the present invention into an introducer sheath, showing a delivery tool engaged with the introducer needle. [Figure 12E] 13A-13D illustrate a method of loading a foldable blood pump according to a third embodiment of the present invention into an introducer sheath, and show the use of a grasping tool to advance the blood pump out of the introducer sheath. [Figure 12F] FIG. 13 illustrates a method of loading a foldable blood pump into an introducer sheath according to a third embodiment of the present invention, showing the gripping tool in a retracted position after the blood pump has been advanced out of the introducer sheath. [Figure 12G] 13A-13D show a method of loading a foldable blood pump according to a third embodiment of the present invention into an introducer sheath, with the delivery tool shown retracted from the introducer sheath. [Figure 12H] 13A-13D show a method of loading a foldable blood pump into an introducer sheath according to a third embodiment of the present invention, and show the foldable blood pump retracted from the introducer sheath. [Figure 13A]

[0080] FIG. 13A is a cross-sectional view of a portion of the introducer needle of FIGS. 12A to 12H. [Figure 13B]

[0081] FIG. 13B is a partial cross-sectional view of the delivery device of FIGS. 12A-12H. [Figure 13C]

[0082] FIG. 13C is a detailed cross-sectional view of a distal portion of the delivery sheath of FIG. 13B. [Figure 14A]

[0083] FIG. 14A is a partial perspective cross-sectional view of a proximal portion of the introducer sheath of FIGS. 12A-12H. [Figure 14B]

[0084] FIG. 14B is a partial cross-sectional view of a proximal portion of the delivery device of FIGS. 12A-12H. [Figure 15A]

[0085] FIG. 14 is a side elevational view of a delivery device engaged with the introducer sheath of FIGS. 12A-12H. [Figure 15B]

[0086] FIG. 15B is a perspective view of a delivery device engaged with the introducer sheath of FIG. 15A. [Figure 15C]

[0087] FIG. 15C is a cross-sectional view of a delivery device engaged with the introducer sheath of FIGS. 15A-15B. [Figure 15D]

[0088] FIG. 15C is a partial cross-sectional view of a distal portion of a delivery tool engaged with a proximal portion of the introducer sheath of FIGS. 15A-15C. [Figure 16]

[0089] FIG. 1 shows a catheter grasping tool in place on a catheter. [Figure 17]

[0090] FIG. 17 is a side perspective view of the grasper shown in FIG. 16. [Figure 18]

[0091] FIG. 17 is a rear view of the gripping tool shown in FIG. 16. [Figure 19]

[0092] FIG. 17 is an exploded view of the grasping tool shown in FIG. 16. [Figure 20]

[0093] FIG. 17 is a partial perspective view showing the grasping tool of FIG. 16 engaging a catheter. [Figure 21]

[0094] 17 is a perspective view of the grasping tool of FIG. 16 with one or more components removed to show engagement of the tool with the catheter. [Figure 22]

[0095] 17 is another perspective view of the grasping tool of FIG. 16 with one or more components removed to show engagement of the tool with the catheter. [Diagram 23]

[0096] 17 is yet another perspective view of the grasping tool of FIG. 16 with one or more components removed to show engagement of the tool with the catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068]

[0097] 1-3 show a proximal portion of a blood pump 10 having a compressible and self-expandable outer housing (or housing) 12, a rotatable, compressible and self-expandable impeller 14 adapted to pump blood from an inlet through an outlet 16 (at a distal portion of the pump not shown in FIG. 1), and a drive shaft 18 extending proximally from the impeller through a catheter 20. An optional guidewire 22 extends proximally from the housing 12, along the outside of the catheter 20 as shown, or alternatively through the catheter 20. A handle 24 containing a motor (not shown) is connectable to the catheter 20 and the drive shaft 18 to operate the blood pump 10 by rotating the impeller 14. The housing 12 may also be referred to as a shroud. Alternatively, the present invention may be used in a blood pump 300 described below with reference to FIG. 11.

[0069]

[0098] To more easily insert the blood pump 10 into the patient's vasculature (e.g., through an opening in the femoral artery) for advancement to the blood pump location (e.g., in the patient's heart and / or the patient's aorta), the housing 12 and impeller 14 may be compressed by the transfer tool into a smaller diameter delivery configuration prior to insertion of the blood pump into the patient, and optionally during advancement of the blood pump through the patient's vasculature after insertion. FIGS. 1-3 show the step of compressing the blood pump housing 12 as it is being inserted into the transfer sheath 30 of the transfer tool. The transfer sheath 30 may have a thin, flexible wall made of, for example, silicone, high density polyethylene, polytetrafluoroethylene, and low density polyethylene. The catheter 20 and the drive shaft it contains may be passed into the distal opening 32, through the internal lumen 34, and out the proximal opening 36 of the transfer sheath 30 before being connected to the handle 24 and the motor therein.

[0070]

[0099] The lumen 34 of the delivery sheath 30 has an inner diameter smaller than the outer diameter of the blood pump housing 12 in the expanded configuration. To collapse and place the blood pump housing 12 within the sheath 30, the catheter 20 of the blood pump 10 is pulled proximally until the housing 12 engages a first angled surface 42 at an inlet section of a rigid sheathing 40 engaged with the distal opening 32 of the sheathing 30. The angled surface 42 has an inner diameter that defines a lumen 45 that decreases proximally from the distal end of the sheathing to a constant diameter lumen 46 in an outlet section that leads to a proximal opening 48 that is aligned with the distal opening 32 and lumen 34 of the delivery sheath. The lumen 46 has a diameter equal to or smaller than the diameter of the inner lumen 34 of the delivery sheath 30. An optional second angled surface 44 surrounding the lumen 45 extends proximally from the first angled surface 42 and is at a shallower angle relative to the longitudinal axis of the lumen 46 .

[0071]

[0100] As the blood pump 10 is pulled proximally relative to the covering tool 40, the inclined surfaces 42 and 44 engage the blood pump 10 to fold the housing 12 and impeller 14 into the folded delivery configuration shown in Figures 2 and 3. Pulling the catheter 20 proximally ends when the distal end of the blood pump 10 is at the distal opening 32 of the transfer sheath 30. Alternatively, pulling the catheter 20 proximally can end when the distal end of the blood pump 10 is not inside the transfer sheath 30, but the housing 12 is compressed to the diameter of the transfer sheath lumen. The covering tool can then be removed, as shown in Figure 3. In some embodiments, a covering tool fastener, such as a ring 49, can be screwed or pressed onto the exterior of the covering tool to compress the covering tool over the outside of the distal end of the transfer sheath 30, and removed to disengage the covering tool from the transfer sheath.

[0072]

[0101] After the blood pump 10 is loaded into the transfer sheath 30, the transfer sheath 30 may be inserted into an introducer sheath 50, which has previously been inserted into the patient's vasculature, for example through an opening in the femoral artery, as shown in FIG. 4. In some embodiments, the introducer sheath 50 is 25-33 cm in length and therefore extends only a short distance into the patient's vasculature. The introducer sheath 50 has a shaft 52 that defines a lumen 54 extending between a proximal opening 56 and a distal opening 58. A hemostatic valve 53 may be disposed in the proximal opening 56. The lumen 54 has a diameter slightly larger than the outer diameter of the transfer sheath 30. The proximal end 51 of the shaft 52 may be widened (in other words, flared) to facilitate insertion of the transfer sheath 30.

[0073]

[0102] The transfer sheath 30 is advanced into the introducer sheath 50 until the distal face of the optional hub 38 on the proximal end of the transfer sheath 30 engages the proximal face of the hub 60 of the introducer sheath 50. As shown in FIG. 5, in this relative position of the transfer sheath 30 and the introducer sheath 50, the blood pump 10 is at the distal opening 58 of the introducer sheath 50. The distal face of the hub 38 and / or the proximal face of the hub 60 may optionally have one or more seals. In some embodiments, the shaft 52 of the introducer sheath 50 may be shorter than the transfer sheath 30 such that when the hubs 38 and 60 are engaged, the distal end of the transfer sheath 30 extends only slightly beyond the distal end of the introducer sheath 50, such as those shown in FIGS. 4-7.

[0074]

[0103] After hub 38 engages hub 60, any further distal movement of catheter 20 advances blood pump 10 out of transfer sheath 30, thereby allowing blood pump 10 to self-expand to its expanded configuration, as shown in Figure 6. Blood pump 10 may then be advanced in its expanded configuration out the distal end of introducer sheath 50, through the patient's vasculature, and to the pumping location. Guidewire 22 may be handled by a single user, as in a standard rapid exchange (Rx) device.

[0075]

[0104] The delivery sheath 30 and its hub 38 may have optional division lines, formed for example as perforations, that allow the sheath 30 to be separated into two or more pieces and removed from around the catheter 20 and guidewire 22 after the blood pump 10 has been advanced out of the sheath 30 as shown in Figure 7. Removal of the delivery sheath 30 and hub 38 may not be necessary if one or more seals are provided between the hubs 38 and 60.

[0076]

[0105] To remove the blood pump 10 from the patient, the blood pump 10 is withdrawn in its expanded configuration from the pumping site (e.g., in the aorta) to the distal end of the introducer sheath 50. Further retraction of the blood pump 10 compresses the blood pump 10 into the introducer sheath for removal from the patient.

[0077]

[0106] 8-10 show portions of a foldable blood pump, transfer tool, and introducer system according to one embodiment of the present invention. The transfer tool's transfer sheath 100 of this embodiment is coupled to a hub 102 that mates with a hub 103 of an introducer sheath (not shown) that extends distally from the hub 103. The hub 102 is used to deliver saline or other flushing fluid to the introducer sheath and may connect to a sheath flush mechanism 104 with a valve 106, an inlet port 107, and a conduit 108. The side arm 110 has a guidewire lumen 112 that leads to the annular space between the transfer sheath 114 into which the foldable blood pump (not shown) is loaded (e.g., as described above) and the foldable blood pump's catheter 116. The foldable blood pump's guidewire (not shown) in the transfer sheath 114 is disposed in the guidewire lumen 112 when the pump is positioned in the transfer sheath. A threaded luer cap 118 may be used to compress a seal 120 to close off the guidewire lumen 112 .

[0078]

[0107] The catheter 116 extends proximally from a foldable blood pump (not shown) disposed within the transfer sheath 100. As explained above, in some embodiments, the foldable blood pump may be disposed at a distal opening of the transfer sheath. Advancement of the blood pump relative to the transfer sheath, for example by pushing a catheter extending proximally from the blood pump, allows the folded blood pump to exit the distal end of the transfer sheath and expand to its expanded configuration. To aid in the advancement and deployment of the blood pump, an unsheathing aid 124 is removably attached to the proximal end of the hub 102, for example by threads 126 that engage corresponding threads of an insert 128. An O-ring seal 130 is disposed between the insert 128 and the hub 102.

[0079]

[0108] Extending proximally from the threaded portion 126 of the unsheathing aid 124 is an annular support shell 132 that surrounds the catheter 116 to prevent kinking while the catheter is advanced. A translatable grasper 134 is attached to the support shell 132 via a grasper arm 146 that slides within an open groove 148 in the support shell 132. A tab 150 extending radially from the distal end of the arm 146 engages a distally facing surface 152 of the open groove 148 to limit proximal movement of the grasper 134 relative to the support shell 132. Distal movement of the grasper 134 is limited by engagement of a distal face 154 of the handle 136 with a proximally facing surface 156 of the support shell 132.

[0080]

[0109] A handle 136 (optionally disposed at the proximal end of the grasping tool, as shown) supports a depressible button 138. A spring 140 biases button 138 to the disengagement position shown in Figures 8-10. When depressed against the bias of spring 140, a surface 142 on the underside of button 138 engages a torsion spring 144 that surrounds catheter 116, causing spring 144 to grippingly engage catheter 116. Releasing button 138 allows spring 140 to move surface 142 away from spring 144, thereby releasing its grip on the catheter.

[0081]

[0110] Advancing the gripping tool 134 distally relative to the support shell 132 while the button 138 is depressed and the torsion spring 144 is engaged with the catheter 116 advances the catheter 116 and blood pump distally relative to the transfer sheath 100. In some embodiments, a single advancement of the gripping tool 134 when engaged with the catheter 116 until the handle 136 engages the support shell advances the compressed blood pump completely out of the transfer sheath. In other embodiments, the catheter must be advanced and released by the gripping tool 134 two or more times to move the blood pump out of the transfer sheath. In still other embodiments, the catheter may be provided with indicia (or in other words, a mark) that lines up with the handle 136, for example, when the catheter has been advanced far enough to push the blood pump out of the transfer sheath. Tactile feedback to the user also indicates when the compressed blood pump has fully exited the transfer sheath; when the blood pump is completely outside the transfer sheath, the frictional forces between the folded blood pump and the transfer sheath disappear, making advancement much easier.

[0082]

[0111] The unsheathing aid 124 can also be used to re-sheathe the blood pump. As the catheter 116 and blood pump are withdrawn proximally and engage the distal opening of the introducer sheath, the grasping tool can be used to grab the catheter and pull it into the introducer sheath.

[0083]

[0112] FIG. 11 illustrates a side view of an exemplary intravascular catheter blood pump 300. The blood pump 300 includes an expandable / collapsible blood conduit or housing 302 configured to transition between an expanded state shown in FIG. 11 and a collapsed state (not shown). For example, the housing 302 may be in a collapsed state when restrained within an introducer sheath or delivery catheter for delivery to the heart, expand when released from the introducer sheath or delivery catheter for blood pumping, and collapse back into the introducer sheath or delivery catheter (or other catheter) for removal from the heart. When in the expanded state, the housing 302 is radially expanded to form an inner lumen for blood to pass through. When in the expanded state, the inner lumen of the housing 302 may be configured to accommodate blood pumped by one or more impellers located therein. The one or more impellers may be collapsible such that the housing 302 may collapse to a smaller diameter when the housing 302 is in the collapsed state. The one or more impellers may be positioned in one or more impeller regions within the housing 302. In some examples, the impeller region of the housing 302 is radially stiffer (or in other words, more rigid) than other regions (e.g., adjacent regions) of the housing 302 to prevent the impellers from touching the interior walls of the housing 302.

[0084]

[0113] In this example, the blood pump 300 includes one impeller 304 in a proximal portion of the housing 302. In some cases, the blood pump 300 can include more than one impeller. For example, the blood pump 300 can include a second impeller in a distal region 322 of the housing 302. In some cases, the blood pump 300 can include more than two impellers. The housing 302 includes a first (e.g., proximal) end having a first (e.g., proximal) opening 301 and a second (e.g., distal) end having a second (e.g., distal) opening 303. The first opening 301 and the second opening 303 can be configured as an outlet and an inlet, respectively, for blood pumped by the blood pump 300. For example, blood can enter the housing 302 mostly through the second (e.g., distal) opening 303 and exit the housing 302 through the first (e.g., proximal) opening 301. In such a case, the second opening 303 serves as a blood inlet and the first opening 301 serves as a blood outlet. One or more impellers (e.g., impeller 304) may be configured to pump blood from the inlet to the outlet. In an exemplary operating position, the second opening 303 (e.g., the inlet) may be distal to the aortic valve in the left ventricle and the first opening 301 (e.g., the outlet) may be proximal to the aortic valve (e.g., in the ascending aorta).

[0085]

[0114] The housing 302 includes a tubular expandable / collapsible skeleton 306 that provides structural support for a membrane 308 that covers at least a portion of the inner and / or outer surface of the skeleton (or scaffold) 306. The skeleton 306 includes a material having a pattern of openings, with the membrane 308 covering some or all of the openings (other than the first opening 301 and the second opening 303) to direct blood through the lumen of the housing 302. The skeleton 306 may be unitary and made of a single piece of material. For example, the skeleton 306 may be formed by cutting (e.g., laser cutting) a tubular shaped material. Exemplary materials for the skeleton 306 may include one or more of nitinol, cobalt alloy, and polymer, although other materials may be used.

[0086]

[0115] The blood pump 300 includes a proximal strut 312a extending from the framework 306 and at least partially defining a first opening 301 (e.g., blood outlet region), and a distal strut 312b extending from the framework 306 and at least partially defining a second opening 303 (e.g., blood inlet region). The proximal strut 312a is coupled to a first hub 314a of the proximal shaft 110. The distal strut 312b is coupled to a second hub 314b of the distal portion 314. In this example, the first hub 314a includes a bearing assembly through which a central drive cable 316 extends. The drive cable 316 is operatively coupled to the impeller 304 and configured to rotate the impeller 304.

[0087]

[0116] In some cases, the impeller 304 is positioned axially entirely within the housing 302. In other cases, a proximal portion of the impeller 304 is positioned at least partially outside of the housing 302. That is, at least a portion of the impeller may be positioned in axial alignment with a portion of the post 312a and the opening 301.

[0088]

[0117] The housing 302 and framework 306 may be characterized as having a proximal region 318, a central region 320, and a distal region 322. The central region 320 may be configured to be disposed across a valve (e.g., the aortic valve) such that the proximal region 318 is at least partially within a first heart region (e.g., the ascending aorta) and the distal region 322 is at least partially within a second heart region (e.g., the left ventricle). The proximal region 318 (and optionally the distal region 322) may be configured to house the impeller therein. The proximal region 318 (and optionally the distal region 322) has sufficient stiffness (or, in other words, rigidity) to withstand deformation during operation of the blood pump 300 when within a beating heart and to maintain a spacing (i.e., a gap) between the impeller region of the blood pump 300 and the rotating impeller 304. The distal region 322 includes a second (eg, distal) opening 303 of the housing 302 and serves as a blood inlet for the housing 302 .

[0089]

[0118] The central region 320 may be less stiff than the proximal region 318 (and possibly the distal region 322). The greater flexibility of the central region 320 may allow the central region 320 to flex when a lateral force is applied to the side of the housing 302, such as when the housing 302 traverses through the patient's blood vessels and / or within the heart. For example, the central region 320 may be configured to bend laterally when a lateral force is applied to the distal region 322 and / or the proximal region 318. In some cases, it may be desirable for the central region 320 to bend laterally when the housing 302 traverses the ascending aorta and assumes a temporarily bent configuration as it is positioned across the aortic valve. In this example, the central region 320 includes a helical arrangement of longitudinally extending elongated elements configured to provide flexibility for lateral bending. In some examples, the distal tip 324 of the blood pump 300 is curved to form an atraumatic tip. In some cases, the distal tip 324 is flexible (e.g., capable of bending laterally) to enhance the atraumatic aspects of the distal tip 324. For example, the distal tip 324 can be sufficiently flexible to bend when pressed against tissue (e.g., with a predetermined amount of force) to prevent puncturing the tissue.

[0090]

[0119] The first hub 314a (e.g., the proximal hub) and / or the second hub 314b (e.g., the distal hub) may include features that promote smooth blood flow into and / or out of the housing 302. Such features may prevent or reduce the occurrence of stagnant and / or turbulent blood flow that may otherwise tend to occur in areas near the first opening 301 (e.g., the outlet area) and / or the second opening 303 (e.g., the inlet area) of the housing 302. Because stagnant and / or turbulent blood flow is associated with blood clotting and / or coagulation, measures that reduce this can be beneficial to patient outcomes.

[0091]

[0120] Figures 12A-15D show another embodiment of a system and method for inserting a foldable blood pump, such as pump 300 shown in Figure 11, into a patient. The system includes an introducer needle 400 having an introducer sheath 402 and an introducer hub 404. The system also includes a catheter grasping tool 200 (such as the grasping tool described above with reference to Figures 8-10 and below with reference to Figures 16-23) and a delivery tool 406 having a delivery sheath 408.

[0092]

[0121] A method of using the system to guide a blood pump 300 into a patient is shown in Figures 12A-12H. Figure 12A shows the blood pump and insertion system delivered to a user. As shown, the blood pump 300 has an expandable / collapsible housing 302 proximal to a distal tip 324. A catheter 310 extends proximally from the housing 302 to a handle 326 that houses a motor for operating an impeller disposed within the housing 302, for example. Surrounding the catheter 310 just proximal to the expandable / collapsible housing 302 is a delivery sheath 408 of a delivery tool 406. The catheter gripping tool 200 is engaged with the catheter 310 at a location proximal to the delivery tool 406. The blood pump 300 has not yet been placed within the delivery tool 406 or the introducer needle 400.

[0093]

[0122] A potential target deployment site for the housing 302 (and impeller) portion of the blood pump 300 is a location extending from the patient's aorta into the left ventricle of the patient's heart. When deployed at this target site, the catheter 310 extends proximally from the housing 302 through the patient's vasculature to the handle 326, which remains outside the patient's body. To reach this target site, the housing 302 and distal portion of the catheter 310 must be advanced through the patient's vasculature from an entry point, such as an incision in the patient's femoral artery. An introducer needle 400 may be inserted into the femoral artery through the entry point to provide a lumen through which the blood pump may be inserted and advanced.

[0094]

[0123] Because the femoral artery has a much smaller diameter than the aorta, the inner lumen 420 of the introducer sheath 402 has a diameter smaller than the expanded diameter of the housing 302. The housing 302 is therefore collapsed by the delivery tool 406 prior to insertion of the housing into the introducer sheath 402. As shown in FIG. 12B and FIG. 12C, pulling the catheter 310 proximally while holding the delivery tool 406 stationary (i.e., fixed) pulls the housing 302 proximally into the distal end 410 of the delivery sheath 408, which has a diameter smaller than the expanded diameter of the housing 302. As shown in FIG. 12C, as the housing 302 enters the delivery sheath 408, the atraumatic distal portion 438 of the delivery sheath 408 expands and the housing 302 collapses. As the housing 302 enters the delivery sheath 408, the impeller within the housing 302 may also collapse.

[0095]

[0124] An engageable and releasable catheter gripping tool, such as gripping tool 200 described below with reference to Figures 16-23, or gripping tool 134 described above with reference to Figures 8-10, may be used to advance or retract catheter 310. For example, gripping tool 200 may be disengaged (or disengaged) from catheter 310, advanced from the position shown in Figure 12A to the position shown in Figure 2B, and then reengaged with catheter 310. Grip tool 200 may then be used to pull catheter 310 further proximally to move housing 302 into sheath 408. The disengagement of gripping tool 200, movement of gripping tool 200 relative to catheter 310, reengagement of gripping tool 200 with catheter 310, and joint proximal movement of gripping tool 200 and catheter 310 may be repeated until housing 302 is completely within sheath 408.

[0096]

[0125] After the collapsible portion of the blood pump 300 is completely within the sheath 408, the delivery tool 406 is advanced towards the introducer needle 400. The sheath 402 of the introducer needle 400 has already been inserted into the patient's femoral artery (or other entry point) and the introducer needle hub 404 remains outside the patient. As shown in FIG. 12D, the distal end of the delivery sheath 408 is inserted into the introducer needle hub 404 until the distal end 410 of the delivery sheath meets the proximal end 412 of the introducer needle sheath 402. As shown in FIGS. 15A-15D, when the distal end 410 of the delivery sheath 408 meets the proximal end 412 of the introducer needle sheath 402, the delivery tool connector 414 may connect to a corresponding connector 416 on the introducer needle hub 404 to lock the two elements in place.

[0097]

[0126] The internal diameters of the transfer sheath lumen 418 and the introducer sheath lumen 420 can be substantially equal to facilitate smooth movement of the folded blood pump out of the transfer sheath 406 and into the introducer sheath 402 when the distal end 410 of the transfer sheath 408 meets the proximal end 412 of the introducer sheath 402. The internal lumen of the introducer hub 404 can have a chamfered or angled surface 430 (shown in FIGS. 13A, 14A, 15D) that engages the distal end of the transfer sheath 408 as the transfer sheath moves into the introducer hub 404 to reduce the previously expanded diameter of the distal end 410 of the transfer sheath 408 when it meets the proximal end 412 of the introducer sheath 402.

[0098]

[0127] After the delivery tool 406 is engaged with and locked to the introducer needle 400, the expandable portion of the blood pump may be advanced out of the delivery sheath 406 into the introducer needle sheath 402 and then from the introducer needle sheath 402 into and through the patient's vasculature to a target deployment site, as shown in Figures 12E-12F. Until the expandable housing 302 reaches the target deployment site, the grasping tool 200 may be repeatedly used to grasp the catheter for advancement, disengaged from the catheter 310 for movement to a more proximal position on the catheter, and reengaged with the catheter for further grasping and advancement of the catheter. The delivery tool 406 and grasping tool 200 may then be moved proximally toward the blood pump handle 326 to reduce load at the incision site, as shown in Figure 12G. After completion of the blood pumping procedure, the blood pump may be removed from the patient by pulling the catheter 310 proximally through the introducer sheath 402 (possibly with the grasping tool 200), as shown in FIG. 12H. As described below, a distal portion of the introducer sheath 402 may expand as the blood pump housing advances to help collapse the housing into the sheath.

[0099]

[0128] 13A-15D show further details of the introducer and delivery tool. The introducer sheath 402 is a flexible composite shaft formed from laser cut hypotube 460, with a PTFE liner 464, and an outer jacket of ChronoFlex® thermoplastic urethane 462 reflowed through a laser cut opening for hypotube attachment. The introducer sheath may be, for example, 24 cm in length and may have an expandable and atraumatic distal tip, as described below with reference to FIG. 13C. A stopcock 423 and fluid line 424 (formed, for example, from Tygon® tubing) leads to a fluid port 426 in the hub 404, for example, to provide a purge fluid inlet for use during a blood pumping procedure or for aspiration.

[0100]

[0129] The hub 404 has an internal lumen extending therethrough. The proximal end of the introducer sheath 402 is disposed in a distal portion 428 of the hub lumen. A chamfered surface 430 is disposed at the proximal end of the distal lumen portion 428 to guide and compress the distal end 410 of the delivery sheath 408 as it is inserted into the distal lumen portion 428 of the introducer hub 404.

[0101]

[0130] A one-way valve 432 (e.g., a cross-slit duckbill valve) is disposed within the larger diameter portion of the introducer hub lumen proximal to the chamfered surface 430. The valve 432 seals against vascular pressure prior to insertion of the transfer sheath and pump into the introducer needle 400. The valve 432 is configured to maintain sealing function after extended use because it closes as a result of back pressure and not as a result of material elasticity. The valve 432 can be constructed from an elastomeric material with a durometer hardness that can range from approximately 25A to 90A. In some examples, the valve can be made from 50A silicone. A radial seal 434 (e.g., a silicone open valve) is disposed within the introducer hub lumen proximal to the duckbill valve 432. The seal 434 can accommodate a range of diameter devices inserted therethrough (e.g., 1mm to 6mm diameter). The seal 434 seals around the delivery sheath 406 and the catheter 310 when inserted. In the illustrated embodiment, the seal 434 is convoluted (i.e., spiraled) to maintain a seal even when a sheath or catheter is inserted through the seal at an angle to the longitudinal axis of the hub. The radial seal 434 can be constructed from an elastomeric material with a durometer that can range from approximately 25A to 90A Shore. In some examples, the valve can be made from a silicone material with a high degree of elongation. An elastomeric disk valve 436 is disposed proximal to the radial seal 434 within the introducer hub lumen to provide an additional seal around any guidewire on the outside of the catheter and the catheter itself. In the illustrated embodiment, the valve 436 is made of an elastomeric material having a thickness of approximately 0.1 mm to 10 mm. The durometer can range from approximately 25A to 90A Shore. The valve 436 includes a plurality of crosscuts on each side of the thickness that extend at least partially through the thickness. In some examples, the valve can be a silicone disk made from a 30A durometer material, with the crosscuts on each side oriented at a 90 degree angle to each other.

[0102]

[0131] In some embodiments, the valves and seals are arranged from distal to proximal: one-way valve 432, radial seal 434, disk valve 436. In another embodiment, one-way valve 432 may not be present and only radial seal 434 and disk valve 436 are used. In another embodiment, disk valve 436 is used alone. In another embodiment, one-way valve 432 and radial seal 434 are disposed in the introducer needle hub and disk valve 436 is disposed in a separate removable component.

[0103]

[0132] The introducer hub connector 416 has a connector configured to abut the delivery sheath connector. This connector may include a twist lock bayonet feature, a living hinge snap fit, a spring engagement, and / or female / male threads. These connection features function to align and provide an axial force that pulls the distal end of the delivery sheath tip towards the proximal end of the introducer shaft. In the illustrated embodiment, the introducer hub connector 416 is an externally threaded surface on the proximal end of the introducer hub 404, and the delivery tool connector 414 is a rotatable ring with female threads. In this embodiment, as shown in FIG. 15D, when the delivery tool connector 414 is threaded onto the introducer hub connector 416, the distal end of the delivery sheath advances into the introducer hub lumen to place the distal end 410 of the delivery sheath 408 into contact with the proximal end 412 of the introducer sheath 402.

[0104]

[0133] The transfer sheath 408 is comprised of tubing with sufficient column strength to cover the pump housing. The sheath 408 may be comprised of tubing made from a rigid and / or smooth polymer such as PTFE, or may be a composite structure. In some embodiments, the composite structure is comprised of laser cut metal tubing with laser cut patterns for flexibility and / or stiffness in desired areas. In some embodiments, the laser cut metal tubing may be lined with a smooth polymer and jacketed with a polymer to bond with the liner. In one embodiment, the transfer sheath 408 is a flexible composite shaft formed from a rigid laser cut hypotube 460, a PTFE liner 464, and an outer jacket 462 of ChronoFlex® thermoplastic urethane reflowed through laser cut openings onto the outer surface of the hypotube 460 and the PTFE liner 464. As shown diagrammatically in FIG. 12C, a flexible distal portion 438 at the distal end of the transfer sheath 408 expands as the blood pump housing enters the sheath to minimize damage to the blood pump while the housing is compressed within the transfer sheath 408.

[0105]

[0134] 13C shows details of the distal portion 438. The laser cut hypotube 460 is covered by an outer jacket 462 of thermoplastic urethane that extends beyond the distal end of the hypotube 460 into the distal portion 438. A PTFE liner 464 extends through the hypotube 460, through the portion of the outer jacket 462 that extends beyond the hypotube 460, and around the distal end of the outer jacket 462 to cover the distal end of the outer jacket 462. A flexible ring 466 (e.g., made of Pebax® elastomer) is disposed on the outer surface of the jacket 462 proximal to the outer portion of the liner 464 and then reflowed with the thermoplastic material of the outer jacket 462 to shape and attach the elements together. The elastomeric properties of the ring 466 allow the distal region 438 to expand as the pump housing is pulled into the sheath 408 and to collapse the pump housing without damaging the pump. This same expandable and atraumatic structure (outer jacket extending over the end of the hypotube, a liner extending around the end of the outer jacket, and an elastomeric ring on the outside of the outer jacket) can be employed at the proximal end of the delivery sheath 408, as well as the distal and proximal ends of the introducer sheath 402.

[0106]

[0135] The proximal end of the transfer sheath 408 is disposed within a proximal section 444 of a transfer tool housing 442 within a transfer tool hub 440. A silicone O-ring 446 disposed between the housing 442 and the hub 440 provides a seal against vascular pressure. The housing 442 extends from the hub 440 and the transfer tool connector 414 to provide a grip for relative movement between the blood pump and the transfer tool. A raised edge 448 at the distal end of the housing 442 provides a surface about which the connector 414 rotates.

[0107]

[0136] The sheathing stop 450 provides a proximal limit to pump housing movement during sheathing and protects the struts at the proximal end of the housing from damage. The sheathing stop 450 also provides smooth guidewire introduction and transition during guidewire loading. In some embodiments, the sheathing stop 450 is formed from a molded or machined polymer and is configured to be atraumatic to the pump legs and guidewire. This can be achieved as a result of either material selection or internal geometry. In one embodiment, the sheathing stop 450 is formed from ChronoFlex® thermoplastic urethane and is disposed within the hub 440 proximal to the proximal section 444 of the housing 442. In one embodiment, the sheathing stop 450 has a tapered internal lumen 452 that decreases in diameter from its distal end toward its proximal end.

[0108]

[0137] The seal 452 (e.g., a Tuohy-Borst seal) provides a seal around the blood pump catheter as it extends proximally through the transfer tool. The molded polymer spacer 454 provides a nominal compression of the Tuohy-Borst seal to minimize the amount of Tuohy-Borst seal adjustment required to be made by the user. The spacer 454 also provides an introduction for a guidewire. A fluid line 456 (e.g., formed from Tygon® tubing) leads through the hub 440 to a fluid port, for example, to provide access for a purge fluid to the interior lumen of the transfer sheath 408. For example, saline fluid can be supplied through the fluid line 456 to replace air within the transfer sheath and / or blood pump during loading of the blood pump into the transfer tool 406. When the transfer tool is connected to the introducer, saline fluid can be supplied to the introducer through the fluid line 424 up to the introducer sheath 402.

[0109]

[0138] 16-23 show another embodiment of a catheter gripping tool that can be used as part of a system for inserting a foldable blood pump described herein into a patient. FIG. 16 shows a gripping tool 200 in operative contact with an elongate member 215 (e.g., catheter or sheath), such as a blood pump catheter described above. In this example, the gripping tool is positioned proximal to an introducer hub 265 and can be configured to advance, rotate, retract, or otherwise manipulate an elongate member (e.g., catheter) passing through the hub 265. For example, the blood pump system can have a drive cable extending through a drive cable catheter, as described herein, which can be an elongate member controllable by the gripping tool. In such an example, the gripping tool can apply a gripping force to the drive cable catheter to advance, retract, rotate, or otherwise manipulate the drive cable catheter, which can translate to manipulation of one or more structures distal or proximal to the elongate member.

[0110]

[0139] As shown in FIG. 17, the gripping tool 200 has a housing with an actuating element 205 and a body portion 210. An example section of a catheter 215, such as the proximal shaft 110 of the blood pump 100 shown in FIG. 11, is shown extending through the gripping tool 200. In some examples, the actuating element 205 is configured to operate a holding element (not shown in FIG. 17) within the gripping tool. For example, the actuating element 205 is shown in FIG. 17 as a depressible element (e.g., a button). The actuating element 205 can have one or more external alignment features 220 (e.g., channels) configured to engage corresponding alignment elements of the body portion 210 to guide the depressible element during movement between a depressed state and an extended state.

[0111]

[0140] In some examples, the gripping tool may have one or more manipulation support features configured to aid in the alignment and / or manipulation of the gripping tool. Examples of manipulation support features are shown in FIG. 17 as the raised area 225 of the actuation element 205 and the raised area of ​​the lower portion 226 of the gripping tool body portion 210. In this exemplary arrangement of manipulation support features, the raised area may be perceived in the orientation of the gripping tool during use. For example, a user may grasp the gripping tool so that the distal ends of their fingers (e.g., their thumb) abut against the support features and position their thumb on the actuation element upon tactile confirmation of the orientation of the gripping tool relative to the elongated member being controlled and the user's grip position on the gripping tool. In some examples, the manipulation support features may increase the maximum amount of lateral force that can be applied to the gripping tool when maneuvering an elongated member held through the gripping tool.

[0112]

[0141] 18 shows a rear view of the grasping tool 200 of FIG. 17. The manipulation support features 225 are shown in an example arrangement such that the upper manipulation support feature is distal to the viewing side of the grasping tool 200. The body portion 210 can be configured to receive an elongate member (e.g., a catheter) extending into and / or through the grasping tool at an opening 230 in the body portion 210. In some examples, the opening 230 may be an opening, lumen, passageway, channel, tunnel, tube, or other structural aspect of the grasping tool configured to receive, guide, or otherwise facilitate an elongate member extending therethrough.

[0113]

[0142] Figure 19 is an exploded view of the gripping tool 200 of Figures 17 and 18, showing some of the internal features. The housing comprises three main portions: an actuation element 205, a body portion 210, and a base 211. The base 211 can be coupled to the body portion 210 on a side of the gripping tool 200 generally opposite the actuation element 205. The opening 230 is defined by a generally concave channel extending laterally through the body portion 210 and a corresponding protrusion extending upwardly from the base 211 to form an opening or passageway for an elongated member, such as a catheter, to extend therethrough.

[0114]

[0143] In some examples, base 211 may be configured to couple to body portion 210 and provide a mounting or foundation for retaining element 235. Alignment element 240 may be configured to engage with corresponding alignment elements of body portion 210 and / or base 211. The alignment elements may be configured to stabilize the manipulation (e.g., depression) of actuation element 205. For example, when actuation element 205 is depressed relative to body portion 210 and base 211, alignment element 240 may slidingly engage with corresponding alignment element to facilitate steady depression and retraction of actuation element 205.

[0115]

[0144] The retaining element may comprise one or more elongate member retaining elements. For example, in FIG. 19, the exemplary retaining element 235 comprises one or more springs (e.g., torsion springs) that form an adjustable opening 236 configured to engage with an exterior surface of an elongate member (e.g., a catheter) passing therethrough. In some examples, when the actuating element 205 is depressed to exert a downward force against the spring bias of the torsion spring arms 237, the arms 237 move away from each other and exert a radial force against the exterior surface of the elongate member disposed in the opening 236 by reducing the diameter of the opening 236. In some examples, when the actuating element 205 is released, the arms 237 move back toward their at-rest position to move the element 205 upward and release any elongate member extending through the opening 236 by increasing the diameter of the opening 236.

[0116]

[0145] In some examples, the force exerted by the retaining element may be measurable in pounds (lb) of force. In some examples, the retaining element may be configured to deliver 1 lb, 5 lb, 10 lb, 15 lb, 20 lb, 25 lb, 30 lb, 35 lb, 40 lb, or any amount of force therebetween. In some examples, the deliverable force of the retaining element may be measurable in Newton-meters (Nm) of force. In some examples, the retaining element may be configured to deliver a torsional force of 0-1 Nm.

[0117]

[0146] In some examples, the amount of force exerted by the actuation element on the retention element (e.g., a torsion spring) is moderated depending on the strength of the grip on the user and their gripping tool. In some examples, the retention element is configured to increase the gripping force (e.g., radial force) on the elongate member extending therethrough when the actuation element is depressed. In some examples, the retention element is configured to decrease the gripping force (e.g., radial force) on the elongate member extending therethrough when the actuation element is depressed. In some examples, the retention element is configured to decrease the gripping force (e.g., radial force) on the elongate member extending therethrough when the actuation element is released (e.g., retracted). In some examples, the retention element is configured to increase the gripping force (e.g., radial force) on the elongate member extending therethrough when the actuation element is released (e.g., retracted).

[0118]

[0147] In some examples, the one or more retaining elements may comprise a retaining assembly. For example, the retaining assembly may have one or more retaining elements in operative contact with the actuation element (e.g., a depressible portion) and configured to engage the elongated member. In some examples, the retaining assembly may have one or more spring-loaded retaining elements (e.g., torsion springs) configured to provide a force configured to selectively retain the elongated member. In some examples, the retaining assembly may have a retaining element (e.g., a strap, a sling, etc.) and a compression mechanism configured to be selectively adjustable by the actuation element to create and / or increase a compressive force to engage the elongated member. In some examples, the actuation element may be configured to reduce and / or eliminate the compressive force provided by the retaining element on the elongated member.

[0119]

[0148] FIG. 20 illustrates the gripping tool 200 shown with the actuating element 205 and body portion 210 translucent (for visualization purposes). In this example, three retention elements are provided in operable contact with the elongate member 215 extending through the retention element 235. Here, one example of operation can be seen, with each retention element 235 in operable contact with the actuating element 205 and base 211, and thus each torsion spring arm touching the actuating element 205 in preparation for selectable operation to adjust the radial force (e.g., grip) on each aperture and thereby the elongate member 215 extending therethrough. While this example illustrates three retention elements in the gripping tool, it should be understood that other embodiments can include any number of retention elements in the gripping tool, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more retention elements.

[0120]

[0149] 21 is a perspective view of the gripping tool 200 with the base 211 and body portion 210 removed to show the interaction between the retaining element 235 and the actuation element 205. The elongate member 215 can extend through the retaining element 235 as shown. In some examples, the actuation element 205 has one or more alignment elements 239 disposed within an interior of the actuation element 205 and configured to engage with corresponding alignment elements on the body portion, the base, or other portions of the gripping tool housing.

[0121]

[0150] 22 is a perspective view of gripping tool 200 shown without actuation element 205 to show detail in body portion 210. A corresponding alignment element 240 in the body portion can be configured to operatively contact or receive an alignment element of actuation element 239 of actuation element 205 (shown in FIG. 21). Here, elongate member 215 is shown extending through body portion 210 and retention element 235. In some examples, an additional alignment element 221 can be configured to contact the actuation element for a steady and smooth operation (e.g., depressing and / or retracting).

[0122]

[0151] 23 is a perspective view of the grasping tool 200 shown without the actuation element 205 or body portion 210. A retaining element 235 forming a retaining assembly is supported by the base 211. An elongate member 215 (e.g., a catheter) extends through an opening in the retaining element as shown. In some examples, the base may further include a channel, groove, or other structural feature that stabilizes the elongate member extending therethrough.

[0123]

[0152] In some examples, the depressible portion of the grasping tool can be configured such that when depressed, the force being supplied by the retaining element is released, reduced, dissipated, or otherwise adjusted to allow the grasping tool to move independently of the coated catheter and / or the coated catheter to move independently of the grasping tool. For example, the depressible portion can be depressed to cause the retaining element to release the coated catheter and allow the coated catheter to slide / advance through the grasping tool.

[0124]

[0153] In this specification, when a feature or element is referred to as being "on" another feature or element, it can be directly on the other feature or element, or there may be intervening features and / or elements. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features and / or elements. It will also be understood that when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements. Although described or illustrated with reference to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. It will also be apparent to one of ordinary skill in the art that a reference to a structure or feature being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0125]

[0154] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, it will be understood that the term "comprising" as used herein specifies the presence of stated features, steps, operations, elements, and / or components, but does not exclude the presence and addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0126]

[0155] Spatial relative terms such as "below," "belower," "lower," "above," and "upper" may be used herein for ease of description to describe the relationship of one element or feature shown in the drawings to another element or feature. It will be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the drawings. For example, if the device in the drawings were inverted, elements described as being "below" or "below" the other element or feature would be oriented "above" the other element or feature. In this manner, the exemplary term "below" can encompass both an above and below orientation. The device may be otherwise oriented (rotated 90 or to other orientations) and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," and "parallel" are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0127]

[0156] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context clearly indicates otherwise. These terms may be used to distinguish one feature / element from another. In this manner, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0128]

[0157] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprising" and variations thereof mean that various components can be employed in conjunction with one another in methods and articles (e.g., apparatus and method-containing compositions and devices). For example, it will be understood that the term "comprising" implies the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0129]

[0158] As used herein in the specification and claims, including as used in the examples, unless expressly specified otherwise, all numbers may be read as if they are prefaced by, for example, "about" or "approximately" even if the term does not explicitly appear. The terms "about," "substantially," or "approximately" may be used when describing a magnitude and / or location indicating that the stated value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Also, any numerical value given herein should be understood to include about that value or approximately that value unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical ranges given herein are intended to include all subranges subsumed therein. Also, as will be appreciated by those skilled in the art, when a value is disclosed, "less than or equal to" that value, "more than or equal to" that value, and possible ranges between values ​​are also disclosed. For example, if a value "X" is disclosed, it is understood that "less than or equal to" and "more than or equal to X" (e.g., X is a number) are also disclosed. It is also understood that throughout this application, data is given in several different formats, and this data represents end and starting points, and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than 10 and 15, greater than or equal to 10 and 15, less than or equal to 10 and 15, and equal to 10 and 15 are also disclosed, and between 10 and 15 are also considered to be similar. It is also understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0130]

[0159] Although various exemplary embodiments have been described above, any of a number of modifications may be made to the various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which the various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments and not in others. Thus, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0131]

[0160] The examples and figures contained herein show, by way of illustration and not by way of limitation, specific embodiments in which the subject matter may be practiced. As stated, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively under the term "invention" for mere convenience, without any intention to autonomously limit the scope of this application to any single invention or inventive concept when in fact more than one is disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment illustrated. This disclosure is intended to cover any and all adaptations or variations of the various embodiments. Upon reviewing the above description, combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. 1. A system for inserting a foldable blood pump into a patient, comprising: an introducer needle comprising an introducer hub and an introducer sheath extending distally from the introducer hub, the introducer sheath comprising an introducer sheath lumen, the introducer hub comprising a hub connector and a distal hub lumen surrounding a proximal end of the introducer shaft; a delivery device comprising a delivery sheath, the delivery sheath comprising a delivery sheath lumen having a diameter substantially equal to a diameter of the introducer sheath lumen, and a delivery device connector adapted to connect to the hub connector, a distal portion of the delivery sheath extending into the hub when the delivery device connector is connected to the hub connector; A system comprising:

2. The system of claim 1 , wherein the distal portion of the delivery sheath extends into the distal hub lumen when the delivery tool connector is connected to the hub connector.

3. 3. The system of claim 1 or claim 2, wherein the distal end of the delivery sheath abuts the proximal end of the introducer sheath when the delivery tool connector is connected to the hub connector.

4. The system of any one of claims 1 to 3, wherein the introducer needle hub further comprises a tapered surface extending proximally and radially outward from the distal hub lumen.

5. 5. The system of claim 1, wherein the introducer needle further comprises a one-way valve disposed in the introducer needle hub proximal to the introducer needle sheath lumen and configured to seal against vascular pressure.

6. 6. The system of claim 1, wherein the introducer needle further comprises a seal disposed on the introducer needle hub proximal to the introducer needle sheath and configured to seal against vascular pressure around a device of a diameter range inserted through the seal.

7. 7. The system of claim 1, wherein the introducer needle further comprises a disk valve disposed on the introducer needle hub proximal to the introducer needle sheath and configured to seal against vascular pressure around devices of a diameter range inserted through the valve.

8. The system of any one of claims 1 to 7, wherein the introducer needle hub further comprises a purge fluid port in fluid communication with the distal hub lumen.

9. The system of any one of claims 1 to 8, wherein the hub connector comprises a threaded portion disposed on the introducer hub.

10. The system of any one of claims 1 to 9, wherein the hub connector and the delivery tool connector are configured to provide an axial force that urges the delivery sheath and the introducer sheath toward each other.

11. The system of any one of claims 1 to 10, wherein the delivery tool further comprises a proximal hub surrounding a proximal portion of the delivery sheath.

12. 12. The system of claim 11, wherein the delivery tool proximal hub comprises a central lumen, the proximal portion of the delivery sheath is disposed in the central lumen, and the central lumen has a reduced diameter portion proximal to the proximal end of the delivery sheath.

13. The system of claim 12 , wherein the transfer tool proximal hub further comprises a purge fluid port in communication with the central lumen.

14. 14. The system of claim 12 or claim 13, wherein the delivery tool proximal hub further comprises a seal adapted to seal around a catheter portion of a blood pump.

15. The system of any one of claims 1 to 14, wherein the delivery tool further comprises a handle surrounding the delivery sheath.

16. The system of claim 15 , wherein the handle extends proximally from the transfer tool connector.

17. The system of claim 16 , wherein the delivery tool further comprises a proximal hub, and the handle extends from the delivery tool connector to the proximal hub.

18. 18. The system of claim 15, wherein the delivery tool connector comprises a threaded portion disposed on a distal end of the handle, and wherein the distal portion of the delivery sheath extends distally beyond the delivery tool connector.

19. 20. The system of claim 18, wherein the transfer tool connector comprises a rotatable ring having internal threads.

20. The system of any one of claims 1 to 19, wherein the distal portion of the delivery sheath is radially expandable.

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