Cannula system

Abstract

A system and method for a percutaneous ventricular assist device is provided, wherein the percutaneous ventricular assist device includes a pump assembly and a cannula assembly. The pump assembly includes one or more connectors at or near the distal end. The cannula assembly includes a cannula and an inflow cage, and a mating connector engageable with the connector of the pump assembly such that the first cannula assembly is attachable to the pump assembly. In various embodiments, the cannula assembly may be fixedly attached to the pump assembly or removably attached to the pump assembly.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 355,355, filed on June 24, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices and, more particularly, to percutaneous ventricular assist devices having cannula assemblies for delivering fluids into, out of, or through a body cavity, such as a blood vessel or the heart. Background Art

[0004] Different types of blood pumps are known, such as axial flow blood pumps, centrifugal blood pumps or hybrid blood pumps, in which the blood flow is generated by both axial and radial forces. One such example of a blood pump is the Impella® series of blood pumps (e.g., Impella 2.5®, Impella CP®, Impella 5.5®, etc.), which is a product of Abiomed, a Danfoss company. An intravascular blood pump can be inserted into a patient's blood vessel, such as via the aorta, by means of a catheter. Summary of the invention

[0005] In some embodiments, a mechanical circulatory support device (MCS) is provided, such as a percutaneous ventricular assist device (PVAD). The PVAD (which may be, for example, a percutaneous catheter-based heart pump) may include a pump assembly and a first cannula assembly. The pump assembly may have one or more connectors at or near a distal end. The first cannula assembly may include a first cannula and a first inflow cage, wherein the proximal end of the first cannula assembly may include one or more mating connectors that may engage with one or more connectors of the pump assembly so that the first cannula assembly may be attached to the pump assembly.

[0006] In some embodiments, the first cannula assembly can be configured to be attached to the pump assembly by a clinician prior to a medical procedure. In some embodiments, the first cannula assembly can be removably attached to the pump assembly.

[0007] In some embodiments, the PVAD may include a pigtail operably connected to a distal portion of the first cannula assembly. In some embodiments, the pigtail may be fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail may be attached to the pump assembly as a single coupling assembly. In some embodiments, the pigtail may be fixedly attached to the first inflow cage. In some embodiments, the pigtail may be removably attached to the first inflow cage.

[0008] In some embodiments, the PVAD may include a second cannula assembly that may include a second cannula and a second inflow cage. The second cannula assembly may be different from the first cannula assembly. The second cannula assembly may have a distal end and a proximal end, wherein the proximal end of the second cannula assembly may include one or more mating connectors that may engage with a connector of a pump assembly such that the second cannula assembly may be attached to the pump assembly. In some embodiments, one of the first cannula assembly and the second cannula assembly may be configured to be attached to the pump assembly by a clinician prior to a medical procedure.

[0009] In some embodiments, the pump assembly can include a motor operably connected to an impeller configured to flow blood through the first inlet cage, the cannula assembly, or a combination thereof.

[0010] In some embodiments, each mating connector may include a threaded portion. In some embodiments, each mating connector, each connector, or both may have a coating including an additive (eg, silicone).

[0011] In some embodiments, one mating connector may include a stop, and one connector may include at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive at least a portion of the stop. In some embodiments, each mating connector may include a stop, and each connector may include at least one wall defining an opening extending at least partially through the wall, each opening being configured to receive at least a portion of the stop of one of the mating connectors. In some embodiments, each mating connector further includes a silicone gasket, the stop being positioned between the silicone gasket and the connector.

[0012] In some embodiments, each mating connector, each connector, or both may include a magnetic element.

[0013] In some embodiments, a system may be provided. The system may include a PVAD as disclosed herein, and a controller configured to control the PVAD.

[0014] In some embodiments, a kit may be provided. The kit may include a pump assembly, a first cannula, and a second cannula different from the first cannula. The pump assembly may have one or more connectors at or near a distal portion. The first cannula assembly may have one or more mating connectors at or near a proximal portion of the first cannula assembly. The one or more mating connectors of the first cannula assembly may engage with one or more connectors of the pump assembly so that the first cannula assembly is coupled to the pump assembly. The second cannula assembly may have one or more mating connectors at or near a proximal portion of the second cannula assembly.

[0015] In some embodiments, the first cannula assembly can be configured to be attached to the pump assembly by a clinician prior to a medical procedure. In some embodiments, the first cannula assembly can be removably attached to the pump assembly.

[0016] The kit may include a pigtail assembly. The pigtail assembly may be configured to connect to a distal portion of the first cannula assembly, the second cannula assembly, or both. In some embodiments, the pigtail may be fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail may be attached to the pump assembly as a single coupling assembly. In some embodiments, the pigtail is fixedly attached to an inflow cage on the first cannula assembly and / or the second cannula assembly. In some embodiments, the pigtail is removably attached to the first inflow cage on the first cannula assembly and / or the second cannula assembly.

[0017] In some embodiments, the first cannula assembly may include a first cannula and a first inflow cage, and the second cannula assembly may include a second cannula and a second inflow cage. In some embodiments, the first cannula is longer than the second cannula. In some embodiments, the first cannula may be curved. In some embodiments, the second cannula may be straight.

[0018] The kit may include a third cannula assembly including a third cannula and a third inflow cage. The third cannula assembly may have one or more mating connectors, wherein the third cannula assembly is different from the first cannula assembly and / or the second cannula assembly.

[0019] In some embodiments, each mating connector may include a threaded portion. In some embodiments, each mating connector, each connector, or both may have a coating including an additive (eg, silicone).

[0020] In some embodiments, one mating connector may include a stop, and one connector may include at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive at least a portion of the stop. In some embodiments, each mating connector may include a stop, and each connector may include at least one wall defining an opening extending at least partially through the wall, each opening being configured to receive at least a portion of the stop of one of the mating connectors. In some embodiments, each mating connector further includes a silicone gasket, the stop being positioned between the silicone gasket and the connector.

[0021] In some embodiments, each mating connector, each connector, or both may include a magnetic element.

[0022] The kit may include a controller configured to control the pump assembly.

[0023] In some embodiments, the kit can include an inflow assembly. The inflow assembly can be attached to the first cannula assembly and / or the second cannula assembly.

[0024] In some embodiments, the first cannula assembly may include a sensor.

[0025] In some embodiments, a method for providing a PVAD having a pump assembly and a plurality of cannula assemblies is provided. The method may include selecting a first cannula assembly from a plurality of cannula assemblies based on characteristics of the patient. The method may also include attaching the first cannula assembly to the pump assembly by connecting one or more connectors of the first cannula assembly to one or more connectors of the pump assembly. In some embodiments, the method may include inserting at least a portion of the PVAD into the patient.

[0026] In some embodiments, the plurality of cannula assemblies may include an inflow assembly having a connector coupled to a proximal portion of the inflow assembly, the connector being configured to connect to a mating connector coupled to a distal portion of a different cannula assembly.

[0027] In some embodiments, the PVAD can include a pigtail assembly configured to connect to the distal portion of the first cannula assembly.

[0028] In some embodiments, the pigtail can be fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail can be attached to the pump assembly as a single coupling assembly. In some embodiments, the pigtail is fixedly attached to the inflow cage on the first cannula assembly and / or the second cannula assembly. In some embodiments, the pigtail is removably attached to the first inflow cage on the first cannula assembly and / or the second cannula assembly.

[0029] In some embodiments, the first cannula assembly may include a first cannula and a first inflow cage, and the second cannula assembly may include a second cannula and a second inflow cage. In some embodiments, the first cannula is longer than the second cannula. In some embodiments, the first cannula may be curved. In some embodiments, the second cannula may be straight.

[0030] In some embodiments, the pump assembly can include a motor operably connected to an impeller configured to cause blood to flow through the first inlet cage, the at least one cannula assembly, or a combination thereof.

[0031] In some embodiments, the PVAD may include a controller configured to control the pump assembly. In some embodiments, the first cannula assembly may be attached to the pump assembly by a clinician prior to a medical procedure. In some embodiments, the first cannula assembly is removably attached to the pump assembly.

[0032] In some embodiments, a percutaneous ventricular assist device may be provided. The PVAD may include a pump assembly having a distal end and a proximal end. The PVAD may include a first cannula assembly having a first cannula and a sensor. The first cannula assembly may have a distal end and a proximal end. The proximal end may be attached to the pump assembly. The distal end may have one or more connectors. The PVAD may include a second cannula assembly, which may have a second cannula and a first inflow cage. The second cannula may include one or more mating connectors that may engage with one or more connectors of the first cannula assembly, such that the second cannula assembly may be attached to the first cannula assembly by a clinician prior to a medical procedure.

[0033] In some embodiments, the PVAD may include a pigtail that can be operably coupled to a distal portion of the second cannula assembly. In some embodiments, the PVAD is a catheter-based heart pump. In some embodiments, the pump assembly can include a motor operably coupled to an impeller. The impeller can be configured to cause blood to flow through the first inlet cage of the second cannula assembly, the first cannula assembly, the second cannula assembly, or a combination thereof. In some embodiments, one or more connectors can include a threaded connector.

[0034] In some embodiments, one or more mating connectors, one or more connectors, or both may have a coating. The coating may include an additive. The additive may include silicone.

[0035] In some embodiments, one or more mating connectors may include a stop. In some embodiments, one or more connectors may include at least one wall defining an opening extending at least partially through the wall. The opening may be configured to receive a portion of the stop.

[0036] In some embodiments, each mating connector, each connector, or both may include a magnetic element.

[0037] In some embodiments, a method may be provided. The method may include providing a ventricular assist device having a pump assembly and a first cannula assembly, wherein the first cannula assembly may have a first cannula. The providing step may include reducing the length of the first cannula of the first cannula assembly to achieve a specified length of the first cannula. In some embodiments, reducing the length of the first cannula may include removing the length of the first cannula. In some embodiments, the providing step may include attaching the first cannula assembly to the pump assembly via one or more connectors and one or more corresponding mating connectors. In some embodiments, the first cannula assembly includes an inlet cage. In some embodiments, the providing step may include attaching the second cannula assembly to the first cannula assembly via one or more connectors and one or more corresponding mating connectors. In some embodiments, the second cannula assembly may include an inlet cage. In some embodiments, each of the first cannula assembly and / or the second cannula assembly may include a sensor. In some embodiments, the first cannula may be permanently attached to the pump assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 is a schematic diagram of an embodiment of a percutaneous ventricular assist device.

[0039] Figure 2A is a partial cross-sectional schematic diagram of an embodiment of a threaded connector and a mating connector.

[0040] Figure 2B is a schematic cross-sectional view of an embodiment of a connector and a mating connector utilizing a stop portion.

[0041] Figure 2C is a partial cross-sectional schematic diagram of an embodiment of a connector and a mating connector utilizing magnets.

[0042] Figure 3A is a schematic diagram of an embodiment of a percutaneous ventricular assist device.

[0043] Figure 3B is a schematic diagram of an embodiment of a percutaneous ventricular assist device.

[0044] Figure 3C is a schematic diagram of an alternative embodiment of a percutaneous ventricular assist device.

[0045] Figure 3D is a schematic diagram of yet another embodiment of a percutaneous ventricular assist device.

[0046] Figure 4 Depicted is a blood pump laid through the aorta, extending through the aortic valve and into the left ventricle.

[0047] Figure 5 is a partial cross-sectional schematic diagram of an embodiment of a third cannula assembly.

[0048] Figure 6 is a flow chart of an embodiment of a method.

[0049] Figure 7 is a schematic diagram of an embodiment of a percutaneous ventricular assist device. DETAILED DESCRIPTION

[0050] Different types of blood pumps are known, such as axial flow blood pumps, centrifugal blood pumps or hybrid blood pumps, in which the blood flow is generated by both axial and radial forces. One such example of a blood pump is the Impella® series of blood pumps (e.g., Impella 2.5®, Impella CP®, Impella 5.5®, etc.), which is a product of Abiomed, a Danfoss company. An intravascular blood pump can be inserted into a patient's blood vessel, such as via the aorta, by means of a catheter.

[0051] Current catheter-based pumps utilize a cannula that is designed to be generally suitable for a specific indication in most patients. Thus, such devices, while designed to cover a broad range of implementations, cannot be modified to cater to a wide range of patients with different conditions. As a result, this may eliminate the ability of clinicians to provide more personalized care and / or allow treatment of more appropriate clinical indications (e.g., pediatrics, direct right ventricular support, and non-cardiac support, such as renal support).

[0052] In view of the foregoing, the inventors have recognized the benefit of a system that can be configured by the treating clinician to accommodate a greater number of patients and / or procedures.

[0053] Disclosed herein are mechanical circulatory support (MCS) devices (e.g., percutaneous ventricular assist devices or PVADs) having specific combinations of pump assemblies, connectors, cannula assemblies, and / or inflow assemblies to provide greater flexibility to medical personnel in treating specific conditions for specific individuals. In this regard, in some embodiments, the device may include a modular unit that can be configured by a clinician (e.g., a surgeon and / or interventional cardiologist) to appropriately fit a patient prior to implantation.

[0054] In some embodiments, a PVAD may include a catheter-based blood pump or heart pump that provides mechanical circulatory support.

[0055] Turning now to the accompanying drawings, Figure 1 As shown, in some embodiments, a percutaneous ventricular assist device may include a blood pump 100 having a pump assembly 110 and a cannula assembly 120 .

[0056] In some embodiments, the cannula assembly includes a proximal end 161 and a distal end 162. In some embodiments, the cannula assembly can have a cannula 122 and an inlet cage 124 (also referred to herein as an inflow cage). In some embodiments, the inlet cage 124 can be positioned at the distal end of the cannula 122.

[0057] In some embodiments, the cannula 122 may have an inner surface 173 and an outer surface 172 with a sidewall therebetween. The inner surface may define a lumen extending from the cannula proximal end to the cannula distal end. It will be appreciated that in such embodiments, during use of the device, fluid may be passed through the lumen.

[0058] The shape of the cannula 122 can be varied as desired. In some embodiments, the cannula can be curved (see, e.g. Figure 1 In some embodiments, the cannula can be straight (see, e.g. Figure 3A It is understood that in some embodiments, the cannula may also have a straight portion and another curved portion. The cannula may also have different diameters.

[0059] Also like Figure 1 As shown, the pump assembly can have a proximal end 151 and a distal end 152. In some embodiments, the pump assembly can include a motor 114 operably connected to an impeller 118. In some embodiments, the impeller can be configured to cause blood to flow through an opening 126 in the inlet cage 124, through the cannula 122, and out through the opening 116 in the pump assembly 110.

[0060] It will be appreciated that in some embodiments, the pump assembly can be configured to reverse blood flow, i.e., in some embodiments, the impeller can be configured to cause blood to flow through opening 116 in pump assembly 110, through cannula 122, and out through opening 126 in inlet cage 124.

[0061] The pump assembly can have an inner surface 171 and an outer surface 170 with a sidewall therebetween. The inner surface can define a lumen extending at least partially from a distal end of the pump assembly toward a proximal end.

[0062] As described herein, the pump can include modular units so that the clinician can appropriately configure the pump for a specific patient and / or indication. In some embodiments, the pump can be configured so that the clinician can attach the desired cannula assembly to the pump assembly to prepare the pump. In this regard, the pump assembly can have a connector that engages with a corresponding connector on the cannula. For example, the pump assembly can have a connector 112 at the distal end of the pump assembly, which is configured to engage with a mating connector 128 at the proximal end of the cannula assembly. In some embodiments, the connector and the mating connector can be coupled together to form a pump assembly. In some embodiments, the connector and the mating connector can be coupled so that the cannula assembly and the pump assembly can be fixedly attached together.

[0063] In some embodiments, the inner surface 172 of the cannula assembly can interact with the outer surface 170 of the pump assembly. In some embodiments, the outer surface 173 of the cannula assembly can interact with the inner surface 171 of the pump assembly.

[0064] Pump assembly 110 can have one or more connectors at or near the distal end, and cannula assembly 120 can have one or more mating connectors at or near the proximal end that can engage with one or more connectors of the pump assembly so that the first cannula assembly can be attached to the pump assembly. In some embodiments, the mating connector is configured to be fixedly attached to the connector. In some embodiments, the mating connector is configured to be removably attached to the connector.

[0065] In some embodiments, the first cannula assembly can be configured to be attached to the pump assembly by a clinician prior to a medical procedure.

[0066] refer to Figure 2A In some embodiments, the cannula assembly 220 can have a mating connector 240 that includes one or more threads 260 (in some embodiments, each thread can include a separate mating connector), and the pump assembly 210 can have a connector 230 that includes one or more recesses 262 (in some embodiments, each recess is a separate connector) that are configured to receive the threads. It is readily appreciated that the opposite is also contemplated, wherein the pump assembly can have a connector that includes one or more threads, and the cannula assembly can have a mating connector that includes a recess for receiving the threads. Furthermore, it is readily appreciated that while Figure 2A It is shown that the connector 230 will surround the mating connector portion when assembled, but the reverse is easily achieved.

[0067] 2, in some embodiments, to connect the pump assembly and the cannula assembly, the cannula may be threaded onto the pump assembly. In such embodiments, the shape and size of the one or more threads may correspond to the shape and size of the one or more recesses.

[0068] In some embodiments, each mating connector, each connector, or both have a coating comprising an additive. In some embodiments, the coating comprises silicone.

[0069] refer to Figure 2B , in some embodiments, the mating connector 241 may include a stop 270. In such a configuration, the connector 231 may include a connector wall 252, which defines a first opening 272 extending at least partially through the connector wall, wherein the first opening 272 may be configured to receive at least a portion of the stop 270. It will be appreciated that in some embodiments, the first opening may be configured to receive the entire stop. In some embodiments, the mating connector may include more than one stop (each stop is a separate mating connector in some embodiments), and the connector may include more than one opening (each opening in the wall is a separate connector in some embodiments). It will be appreciated that the shape and size of the stop may correspond to the shape and size of the stop. As will be further appreciated, although the connector is shown as one or more openings to receive a mating connector having one or more stops, in some embodiments, the mating connector may include one or more openings for receiving one or more stops of the connector.

[0070] In some embodiments, the connector can include a mating connector wall 250 that defines a second opening 274 that extends at least partially through the mating connector wall, wherein the opening 274 receives at least a portion of the stop 270. In some embodiments, the opening 274 can be partially covered by a collar 278 that is configured to allow at least a portion of the stop to extend out of the mating connector portion 241 and into the first opening of the connector portion 231 when the mating connector and the connector are properly positioned.

[0071] In some embodiments, the mating connector may include a gasket 276 , such as a silicone gasket. The gasket may be arranged such that the stop 270 is positioned between the gasket 276 and the connector 231 .

[0072] In various embodiments, one or more stops may be utilized. In some embodiments, one mating connector includes a stop and one connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop. In some embodiments, each mating connector includes a stop and each connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

[0073] In other embodiments, the pump assembly and the cannula assembly can be secured together by magnetic forces. For example, in some embodiments, the connector can have one or more magnets and / or one or more ferromagnetic portions to which magnets can be coupled. In some embodiments, the mating connector can have one or more magnets and / or one or more ferromagnetic portions to which magnets can be coupled. In some embodiments, the one or more magnets can include permanent magnets. In some embodiments, the one or more magnets can include electromagnets.

[0074] refer to Figure 2C , the pump assembly 212 can have a connector portion 232 with magnets 280, 281. The cannula assembly 222 can have a mating connector portion 242 that includes one magnet 282 and a ferromagnetic portion 283. In this manner, when the mating connector is inserted into the connector, the first magnet 280 in the connector will couple to the magnet 282 in the mating connector, and the second magnet 281 in the connector will couple to the ferromagnetic portion 283. If more than one magnet or ferromagnetic portion is present, each magnet or ferromagnetic portion can be included with a separate connector or mating connector as appropriate.

[0075] It will be appreciated that the mating connector and the connector may have other suitable engagements (e.g., press fit and / or snap fit arrangements) for attaching the cannula assembly to the pump assembly. As will be further appreciated, in some embodiments, attaching the cannula assembly and the pump assembly (or other suitable assembly) to each other may lock the assemblies together so that they do not become disconnected during use of the pump.

[0076] In some embodiments, there can be a 1:1 correlation between the connector and the mating connector. For example, in some embodiments, there can be a single stop that is received in a single opening in the wall. In other embodiments, the number of connectors and mating connectors can vary. For example, in some embodiments, the correlation can be between 3:1-1:3. In other embodiments, the correlation is 10:1-1:10.

[0077] It will be appreciated that in some embodiments, more than one type of connector may be used to connect the pump assembly and the cannula assembly of the pump, such as for redundancy. For example, in some embodiments, the mating connector may include both threads and a stop that engages a connector having corresponding threads and a wall opening.

[0078] Reference again Figure 1 In some embodiments, the pump can include a pigtail 130. The pigtail can be operably connected to the distal portion of the cannula assembly 120.

[0079] In some embodiments, the pigtail 130 may be fixedly attached to the distal end 162 of the cannula assembly 120 such that the cannula assembly 120 and the pigtail 130 may be attached to the pump assembly as a single coupled assembly. In some embodiments, the pigtail 130 may be fixedly attached to the inflow cage 124 .

[0080] In some embodiments, the pigtail 130 can be removably attached to the inflow cage 124. This can be accomplished in a variety of ways. For example, the proximal end of the pigtail can include a snap-on connection, an interference fit, a screw-type connector, or any other suitable reversible or removable connector, and the cannula assembly will include appropriate corresponding components for providing the connection.

[0081] As described herein, the pump may include a modular system so that the clinician can select the desired pump style and installation. Figure 3A In some embodiments, the PVAD may include a second cannula assembly 121 having a proximal end 163 and a distal end 164. The second cannula assembly may include a second cannula 123 and a second inflow cage 125. The second inflow cage may have one or more openings 127 configured to allow blood to enter or exit the second cannula 123. The second cannula assembly may include a mating connector 129 that may also engage with a connector of a pump assembly so that the second cannula assembly may be attached to the pump assembly. In this regard, each of the first cannula and the second cannula may have the same mating connector for engaging with a connector on the pump assembly.

[0082] In some embodiments, at least one characteristic of the second cannula assembly 121 is different from the first cannula assembly 120. For example, in some embodiments, the second cannula assembly can have a straight cannula, while the first cannula assembly can have a curved cannula (or a cannula that is at least partially curved). In some embodiments, the maximum outer diameter of the second cannula assembly can be different from the maximum outer diameter of the first cannula assembly. In some embodiments, the distance from the proximal end to the distal end of the second cannula assembly (e.g., the length of the proximal cannula) is different from the distance from the proximal end to the distal end of the first cannula assembly.

[0083] In some embodiments, the first cannula assembly or the second cannula assembly is configured to be attached to the pump assembly by a clinician prior to a medical procedure. In this regard, the physician can select a cannula of appropriate length and / or style for an appropriate surgery and / or patient.

[0084] In some embodiments, a system for ventricular assist is provided. The system may include an embodiment of a percutaneous ventricular assist device as disclosed herein, and a controller configured to control the percutaneous ventricular assist device.

[0085] In some embodiments, the pump device may include two or more components that can be coupled together. Figure 3B As shown, the connector portion 112 at the distal end of the pump assembly 110 can be coupled to a mating connector 302 at the proximal end 301 of a first cannula assembly 300 including a cannula 303. The connector 304 at the distal end 305 of the cannula 303 can then be coupled to a mating connector portion 312 at the proximal end 311 of a cannula 313 of a second cannula assembly 310 (the inflow cannula assembly). The inflow cannula assembly 310 can include an inflow cage 314 coupled to the distal end of the cannula 313. It will be appreciated that various designs of these cannula assemblies can be utilized. Furthermore, while Figure 3B A single intermediate cannula assembly 300 (eg, a first cannula assembly) is shown in FIG. 1 , but multiple such cannulas may be coupled together prior to connection to an inlet cannula assembly 310 (also referred to as an inlet assembly).

[0086] In some embodiments, Figure 3D As shown, the first cannula assembly can include a sensor 326, such as a pressure or flow sensor, which is configured to measure one or more parameters of the patient and / or the pump. In some embodiments, the sensor can be used to help determine whether the pump is operating correctly and / or provide appropriate support for the patient. For example, the sensor can help determine the appropriate position of the pump in the patient's body and / or the appropriate speed of the pump. In such an embodiment, the first cannula assembly can be configured so that the length of the first cannula will provide the best position of the sensor in the body (e.g., in the heart). It will be appreciated that the pump can also have a second sensor located in another suitable position.

[0087] The cannula and inflow cage combination can be used with Figure 3B The different combinations shown are shown. For example, Figure 3CAs shown, the inflow assembly 330 may include an inflow cage 332 and a connector portion 331. In some embodiments, the thread 335 is a connector connected to the proximal portion of the inflow assembly. The thread may also be formed integrally with the inflow cage. In such an embodiment, the connector is configured to connect to a mating connector in a mating connector portion 323 (the connector is connected to the distal portion of the first cannula assembly, here the cannula assembly 320). In this embodiment, the cannula assembly 320 includes a cannula 322 and a mating connector 321 at the proximal end 324 of the cannula assembly, the mating connector being configured to connect to a connector in the connector portion 112, the connector being connected to the distal portion of the pump assembly, here the thread 340.

[0088] In some embodiments, Figure 3D As shown, a first cannula assembly 300 can be attached (e.g., fixedly and / or permanently attached) to a pump assembly, wherein the only cannula assembly 300 has a connector 304 that couples to a mating connector 311 on a second inflow cannula assembly 310. It will be appreciated that in such an embodiment, the inflow cannula assembly 310 can be formed with different lengths, wherein the clinician selects the desired inflow cannula assembly to attach to the pump assembly 300.

[0089] Figure 4 An embodiment of an intravascular blood pump having a catheter 410 is shown being introduced into the heart of a patient. For example, as shown in this figure, in some embodiments, the blood pump can be retrogradely inserted into the descending aorta 411. As is known, the descending aorta is a portion of the aorta 412 that first ascends from the heart and then descends and has an aortic arch 414. At the beginning of the aorta 412, an aortic valve 415 is located that connects the left ventricle 416 to the aorta 412, and the intravascular blood pump can extend through the aortic valve 415. It will be appreciated that the blood pump can be inserted into other suitable parts of the body.

[0090] As will be understood in view of the above, the intravascular blood pump assembly may include a pump assembly 450 and a cannula assembly 453, the pump assembly 450 being coupled at the distal end of the catheter hose 420 and having a motor section 451 and a pump assembly 452 disposed at an axial distance from the motor section 451, the cannula assembly 453 protruding from the distal end of the pump assembly 452 in the distal direction. The cannula assembly may include an inflow cage 430 located at its end, the inflow cage having an opening 454, as described above, or the pump assembly may include an inflow cage assembly. A tip 455 is disposed distally of the inflow cage 454, which may be a flexible tip that may be configured, for example, as a "pigtail" or J-shaped. Different lines and devices are extended through the catheter hose 420, which may be important for operating the pumping device 450. As will be understood in view of the above, the clinician may select an appropriate pump assembly, a first catheter assembly and / or a second catheter assembly and / or an inflow assembly, and assemble the desired pump for implantation in the patient, as shown.

[0091] In some embodiments, the pump may include one or more electrical connections 428 and / or one or more optical fibers 429 attached at its proximal end to the controller 490. The optical fiber may be, for example, part of an optical sensor (such as a pressure sensor), the sensor head of which may be located near the inflow cage 430 (see, e.g., Figure 3D In some embodiments, the controller converts the electrical or optical signal into information, which can then be displayed on, for example, a display screen 491.

[0092] In some embodiments, a PVAD kit may be provided. Figure 3A In some embodiments, the kit can include a pump assembly 110 having a connector portion 112, which can include one or more connectors at or near a distal portion. In some embodiments, the kit can include a first cannula assembly 120 having a mating connector portion 128, which can include one or more mating connectors at or near a proximal portion of the first cannula assembly. In some embodiments, the kit can include a second cannula assembly (e.g., Figure 3A The second cannula assembly 121, Figure 3C The second cannula 320 and / or Figure 3B and Figure 3D The second inflow cannula 310 in the second cannula assembly has a corresponding mating connector at or near the proximal portion of the second cannula assembly. In other embodiments, the kit can include an inflow cage assembly with one or more connectors or mating connectors.

[0093] In some embodiments, the second cannula assembly can be identical to the first cannula assembly. In some embodiments, the second cannula assembly can be different from the first cannula assembly.

[0094] In some embodiments, one or more mating connectors of the first cannula assembly may be configured to engage with one or more connectors of the pump assembly such that the first cannula assembly is or may be coupled to the pump assembly.

[0095] In some embodiments, one or more mating connectors of the second cannula assembly may be configured to engage with one or more connectors of the pump assembly such that the second cannula assembly is or may be coupled to the pump assembly.

[0096] In some embodiments, the kit can include a pigtail assembly 130 configured to connect to a distal portion of the first cannula assembly, the second cannula assembly, or both.

[0097] In some embodiments, the pigtail 130 can be fixedly attached to the distal end 162 of the cannula assembly 120 so that the cannula assembly 120 and the pigtail 130 can be attached to the pump assembly as a single coupled assembly. In some embodiments, the pigtail 130 can be fixedly attached to the first inflow cage 124. In some embodiments, the pigtail 130 can be fixedly attached to the second inflow cage 125.

[0098] In some embodiments, the pigtail 130 can be removably attached to the first inflow cage 124. In some embodiments, the pigtail 130 can be removably attached to the second inflow cage 125.

[0099] In some embodiments, at least one characteristic of the second cannula assembly 121 is different from that of the first cannula assembly 120. For example, in some embodiments, the second cannula assembly can have a straight cannula, while the first cannula assembly can have a curved cannula. In some embodiments, the maximum outer diameter of the second cannula assembly is different from the maximum outer diameter of the first cannula assembly. In some embodiments, the distance from the proximal end to the distal end of the second cannula assembly is different from the distance from the proximal end to the distal end of the first cannula assembly. In some embodiments, the first cannula is longer than the second cannula. In some embodiments, one of the first cannula and the second cannula may include a sensor.

[0100] In some embodiments, the kit may include a third cannula assembly. Figure 5 As shown, the third cannula assembly 500 may include a third cannula 510 and a third inflow cage 520. The third cannula assembly may include a mating connector portion 530. The mating connector portion may include one or more mating connectors 532, 533 (here, threads 532 and magnets 530).

[0101] In some embodiments, at least one characteristic of the third cannula assembly 500 is different from the first cannula assembly 120, the second cannula assembly 121, or both. For example, in some embodiments, the second cannula assembly and the third cannula assembly can each have a straight cannula, while the first cannula assembly can have a curved cannula. In some embodiments, the maximum outer diameter of the third cannula assembly is different from the maximum outer diameter of the first cannula assembly, the second cannula assembly, or both. In some embodiments, the distance from the proximal end to the distal end of the third cannula assembly is different from the distance from the proximal end to the distal end of the first cannula assembly, the second cannula assembly, or both. In some embodiments, the third cannula is longer than the first cannula, the second cannula, or both.

[0102] like Figure 1 , Figure 2A , Figure 2C and Figure 5 As shown, it should be understood that the mating connector portion of any disclosed cannula assembly can be related to its associated cannula in different ways. Figure 5 In some embodiments, the side wall 535 forming the mating connector 530 can be coupled to a surface of the cannula. For example, the outer surface 536 of the side wall 535 is coupled (via adhesive, thermal bonding, etc.) to the inner surface 526 of the side wall 525 of the cannula 520. In other embodiments, the proximal portion of the side wall forming the cannula can be considered the mating connector portion.

[0103] In some embodiments, each mating connector may include a threaded portion. In some embodiments, each mating connector, each connector, or both may have a coating including an additive (eg, silicone).

[0104] In some embodiments, one mating connector may include a stop, and one connector may include at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive at least a portion of the stop. In some embodiments, each mating connector may include a stop, and each connector may include at least one wall defining an opening extending at least partially through the wall, each opening being configured to receive at least a portion of the stop of one of the mating connectors. In some embodiments, each mating connector further includes a silicone gasket, the stop being positioned between the silicone gasket and the connector.

[0105] In some embodiments, each mating connector, each connector, or both may include a magnetic element.

[0106] In some embodiments, the kit may include a controller configured to control the pump assembly. In some embodiments, the first cannula assembly may be attached to the pump assembly by a clinician prior to a medical procedure. In some embodiments, the first cannula assembly is removably attached to the pump assembly.

[0107]

[0013] In some embodiments, a method for providing a percutaneous ventricular assist device having a pump assembly and a plurality of cannula assemblies can be utilized.

[0108] refer to Figure 6 , method 600 may include selecting 610 a first cannula assembly from the plurality of cannula assemblies based on characteristics of the patient and / or a procedure being performed on the patient.

[0109] In some embodiments, the characteristic may include a diagnosis or test result, the patient's age, the patient's size, and / or another condition of the patient.

[0110] The method may include attaching 620 the first cannula assembly to the pump assembly by connecting one or more connectors of the first cannula assembly to one or more connectors of the pump assembly.

[0111] In some embodiments, the method includes attaching a second cannula assembly (eg, a cannula inflow assembly) to the first cannula assembly. In some embodiments, the method includes attaching an inflow assembly to the cannula assembly.

[0112] In some embodiments, the method may include inserting 630 some or all of the percutaneous ventricular assist devices into the patient (see, e.g., Figure 4 ).

[0113] In some embodiments, the plurality of cannula assemblies may include a second cannula assembly and / or a third cannula assembly. In some embodiments, the second cannula assembly includes a cannula and an inflow cage.

[0114] In some embodiments, the plurality of cannula assemblies includes an inflow assembly having a connector coupled to a proximal portion of the inflow assembly, the connector configured to connect to a mating connector coupled to a distal portion of a different cannula assembly.

[0115] In some embodiments, the first cannula assembly and / or one of the second or third cannula can include a pigtail assembly configured to connect to a distal portion of the first cannula assembly, the second cannula assembly, or both.

[0116] In some embodiments, the pigtail can be fixedly attached to the distal end of the cannula assembly such that the cannula assembly and the pigtail can be attached to the pump assembly as a single coupled assembly. In some embodiments, the pigtail can be fixedly attached to the first inflow cage. In some embodiments, the pigtail can be fixedly attached to the second inflow cage.

[0117] In some embodiments, the pigtail may be removably attached to the first inflow cage.

[0118] In some embodiments, at least one characteristic of the second cannula assembly is different from that of the first cannula assembly. For example, in some embodiments, the second cannula assembly can have a straight cannula, while the first cannula assembly can have a curved cannula. In some embodiments, the maximum outer diameter of the second cannula assembly is different from the maximum outer diameter of the first cannula assembly. In some embodiments, the distance from the proximal end to the distal end of the second cannula assembly is different from the distance from the proximal end to the distal end of the first cannula assembly.

[0119] In some embodiments, the first cannula assembly or the second cannula assembly is configured to be attached to the pump assembly by a clinician prior to a medical procedure.

[0120] In some embodiments, the pump assembly can include a motor operably connected to the impeller. In some embodiments, the impeller can be configured to cause blood to flow through an opening in the inlet cage, through the cannula, and out through an opening in the pump assembly.

[0121] In some embodiments, the method 600 includes controlling 640 a pump assembly using a controller to cause blood to flow through one or more of a plurality of cannula assemblies of the assembled pump. In some embodiments, the method may include sensing one or more characteristics of the patient and / or the pump via a sensor and controlling the pump based on the sensed data. For example, in some embodiments, controlling the pump may include changing the speed of the pump and / or changing the position of the pump.

[0122] In some embodiments, method 600 includes removing 650 the pump assembly from the patient, for example after treatment has ended.

[0123] Although embodiments are shown and described in which a desired pump is formed by connecting one or more components (e.g., a pump assembly, a cannula assembly, and / or an inflow assembly) together, in other embodiments, a desired pump may be provided in other suitable ways. Figure 7In some embodiments, the pump may include a large cannula assembly 720 that can be reduced in size to accommodate the patient's size and / or surgery. For example, in some embodiments, the cannula may include one or more regions 721, 722, 723 that can be selectively removed to achieve a desired length. In some embodiments, the distal region 721 and / or one or more intermediate regions 722 may be removed. In some embodiments, the proximal region 723 and / or one or more intermediate regions 722 may be removed. In some embodiments, each region may include a first portion 725 that will be cut through or otherwise used as a separation point, and a second portion 724 that will not be cut through or otherwise used as a separation point. For example, in some embodiments, a clinician may cut and remove a certain length of the cannula assembly until the desired length is achieved. In other embodiments, the entire length of the cannula may be configured so that the clinician can cut and remove any desired length. In some embodiments, the cannula assembly may be fixedly attached to the pump assembly (e.g., without the need to attach via one or more connectors prior to use), such that the clinician only needs to remove the extra length of the cannula assembly before inserting the cannula assembly into the patient's body. It will be appreciated that lengths of the cannula assembly may also be removed via other suitable means, such as via breaking and / or stripping a length of the cannula, by having one or more telescoping portions that are retractable into another portion of the cannula assembly and / or pump assembly, or via other suitable means.

[0124] As will be further understood, in some embodiments, the length of the cannula assembly can be adjusted and the cannula assembly can then be attached to the pump assembly and / or the inflow assembly. For example, in some embodiments, the cannula assembly can be configured so that one or more connectors (e.g., mating connectors) can be attached to the cannula assembly so that the cannula assembly can thereafter be attached to the pump assembly. In this regard, shortening of the cannula assembly can occur at the proximal end of the cannula assembly. In other embodiments, the distal end of the cannula assembly can be shortened, wherein the distal end of the cannula assembly has a plurality of connectors that can engage with the inlet assembly to attach the inlet assembly to the cannula assembly.

[0125] Embodiments of the present disclosure are described in detail with reference to the accompanying drawings, wherein the same reference numerals identify similar or identical elements. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in various forms. Well-known functions or configurations are not described in detail to avoid obscuring the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be interpreted as restrictive, but only as the basis for the claims, and as a representative basis for teaching those skilled in the art to adopt the present disclosure differently with almost any appropriately detailed structure.

[0126] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

Claims

1. A percutaneous ventricular assist device, comprising: a pump assembly having a distal end and a proximal end, the pump assembly having one or more connectors at or near the distal end; and A first cannula assembly comprising a first cannula, the first cannula assembly having a distal end and a proximal end, the proximal end comprising one or more mating connectors engageable with the one or more connectors of the pump assembly; wherein the first cannula assembly is configured to be attached to the pump assembly by a clinician prior to a medical procedure.

2. The percutaneous ventricular assist device according to claim 1, wherein: The first cannula assembly includes a first inflow cage attached to the first cannula assembly.

3. The percutaneous ventricular assist device according to claim 1, wherein: The first cannula assembly is removably attached to the pump assembly.

4. The percutaneous ventricular assist device of claim 1 further comprising a pigtail operably connected to a distal portion of the first cannula assembly.

5. The percutaneous ventricular assist device according to claim 4, wherein: The pigtail is fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail can be attached to the pump assembly as a single coupled assembly.

6. The percutaneous ventricular assist device according to claim 5, wherein: The pigtail is fixedly attached to the first inflow cage of the first cannula assembly.

7. The percutaneous ventricular assist device according to claim 4, wherein: The pigtail is removably attachable to a first inflow cage of the first cannula assembly.

8. The percutaneous ventricular assist device of claim 1, further comprising a second cannula assembly, the second cannula assembly comprising a second cannula and a second inflow cage; in, the second cannula assembly having a distal end and a proximal end, the proximal end of the second cannula assembly comprising one or more mating connectors engageable with the connector of the pump assembly such that the second cannula assembly can be attached to the pump assembly; wherein the second cannula assembly is different from the first cannula assembly; and Wherein the first cannula assembly or the second cannula assembly is configured to be attached to the pump assembly by a clinician prior to a medical procedure.

9. The percutaneous ventricular assist device according to claim 1, wherein: The percutaneous ventricular assist device is a catheter-based heart pump.

10. The percutaneous ventricular assist device according to claim 8, wherein: The pump assembly includes a motor operably connected to an impeller configured to cause blood to flow through the first inlet cage of the first cannula assembly, the first cannula assembly, or a combination thereof.

11. The percutaneous ventricular assist device according to claim 1, wherein: Each mating connector includes a threaded portion.

12. The percutaneous ventricular assist device according to claim 11, wherein: Each mating connector, each connector, or both have a coating that includes an additive.

13. The percutaneous ventricular assist device according to claim 12, wherein: The additive includes silicone.

14. The percutaneous ventricular assist device according to claim 1, wherein: A mating connector includes a stop, and a connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

15. The percutaneous ventricular assist device according to claim 1, wherein: Each mating connector includes a stop, and each connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

16. The percutaneous ventricular assist device according to claim 15, wherein: Each mating connector also includes a silicone gasket, the stopper being positioned between the silicone gasket and the connector.

17. The percutaneous ventricular assist device according to claim 1, wherein: Each mating connector, each connector, or both include a magnetic element.

18. A system for ventricular assist, comprising: A percutaneous ventricular assist device according to any one of claims 1 to 17; and A controller is configured to control the percutaneous ventricular assist device.

19. A kit comprising: a pump assembly having one or more connectors at or near the distal portion; a first cannula assembly having one or more mating connectors at or near a proximal portion of the first cannula assembly; a second cannula assembly having one or more mating connectors at or near a proximal portion of the second cannula assembly, the second cannula assembly being different from the first cannula assembly; wherein the one or more mating connectors of the first cannula assembly engage with the one or more connectors of the pump assembly such that the first cannula assembly is coupled to the pump assembly.

20. The kit of claim 19, further comprising a pigtail assembly configured to connect to a distal portion of the first cannula assembly, the second cannula assembly, or both.

21. The kit of claim 20, wherein: The pigtail is fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail can be attached to the pump assembly as a single coupled assembly.

22. The kit of claim 21, wherein: The first cannula assembly includes a first cannula and a first inflow cage, and the pigtail is fixedly attached to the first inflow cage.

23. The kit of claim 20, wherein: The first cannula assembly includes a first cannula and a first inflow cage, and wherein the pigtail is removably attachable to the first inflow cage.

24. The kit of claim 19, wherein: The first cannula assembly includes a first cannula and a first inflow cage; and wherein the second cannula assembly includes a second cannula and a second inflow cage.

25. The kit of claim 19, wherein: The first cannula is longer than the second cannula.

26. The kit of claim 25, wherein: The first cannula is curved.

27. The kit of claim 26, wherein: The second cannula is straight.

28. The kit of claim 19, further comprising a third cannula assembly comprising a third cannula and a third inflow cage, the third cannula assembly having one or more mating connectors, wherein the third cannula assembly is different from the first cannula assembly, the second cannula assembly, or both.

29. The kit of claim 19, wherein: Each mating connector includes a threaded portion.

30. The kit of claim 19, wherein: A mating connector includes a stop, and a connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

31. The kit of claim 19, wherein: Each mating connector includes a stop, and each connector includes at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

32. The kit of claim 19, wherein: Each mating connector also includes a silicone gasket with a stop positioned between the silicone gasket and the connector.

33. The kit of claim 19, wherein: Each mating connector, each connector, or both include a magnetic element.

34. The kit of claim 19, further comprising a controller configured to control the pump assembly.

35. The kit of claim 19, wherein: The first cannula assembly is configured to be attached to the pump assembly by a clinician prior to a medical procedure.

36. The kit of claim 19, wherein: The first cannula assembly is removably attached to the pump assembly.

37. The kit of claim 19, further comprising an inflow assembly, wherein: The inflow assembly is attachable to the first cannula assembly and / or the second cannula assembly.

38. The kit of claim 19, wherein: The first cannula assembly includes a sensor.

39. A method for providing a percutaneous ventricular assist device having a pump assembly and a plurality of cannula assemblies, the method comprising: selecting a first cannula assembly from the plurality of cannula assemblies based on a characteristic of the patient; and The first cannula assembly is attached to the pump assembly by connecting one or more connectors of the first cannula assembly to one or more connectors of the pump assembly.

40. The method of claim 39, further comprising inserting the percutaneous ventricular assist device into a patient.

41. The method of claim 39, further comprising attaching an inflow assembly to the first cannula via a connector coupled to a proximal portion of the inflow assembly, the first cannula comprising a mating connector coupled to a distal portion of the first cannula assembly.

42. The method of claim 39, wherein: The first cannula assembly includes a first cannula and a first inlet cage.

43. The method of claim 39, wherein: The percutaneous ventricular assist device includes a pigtail assembly configured to be connected to a distal portion of the first cannula assembly.

44. The method of claim 43, wherein: The pigtail is fixedly attached to the distal end of the first cannula assembly such that the first cannula assembly and the pigtail can be attached to the pump assembly as a single coupled assembly.

45. The method of claim 44, wherein: The first cannula assembly includes a first cannula and a first inflow cage, and the pigtail is fixedly attached to the first inflow cage.

46. ​​The method of claim 43, wherein: The first cannula assembly includes a first cannula and a first inflow cage, and wherein the pigtail is removably attachable to the first inflow cage.

47. The method of claim 39, wherein: The first cannula assembly includes a first cannula and a first inflow cage.

48. The method of claim 47, wherein: The plurality of cannula assemblies includes a second cannula assembly including a second cannula and a second inflow cage.

49. The method of claim 48, wherein: The first cannula is longer than the second cannula.

50. The method of claim 49, wherein: The first cannula is curved.

51. The method of claim 50, wherein: The second cannula is straight.

52. The method of claim 39, wherein: The pump assembly includes a motor operably connected to an impeller configured to cause blood to flow through the first inlet cage, at least one of the plurality of cannula assemblies, or a combination thereof.

53. The method of claim 39, wherein: The percutaneous ventricular assist device also includes a controller configured to control the pump assembly.

54. The method of claim 39, wherein: The first cannula assembly is attached to the pump assembly by a clinician prior to a medical procedure.

55. The method of claim 39, wherein: The first cannula assembly is removably attached to the pump assembly.

56. A percutaneous ventricular assist device, comprising: a pump assembly having a distal end and a proximal end; a first cannula assembly having a first cannula and a sensor, the first cannula assembly having a distal end and a proximal end, the proximal end being attached to the pump assembly and the distal end having one or more connectors; A second cannula assembly having a second cannula and a first inflow cage, wherein the second cannula includes one or more mating connectors engageable with the one or more connectors of the first cannula assembly such that the second cannula assembly can be attached to the first cannula assembly by a clinician prior to a medical procedure.

57. The percutaneous ventricular assist device of claim 56 further comprising a pigtail operably coupled to a distal portion of the second cannula assembly.

58. The percutaneous ventricular assist device of claim 56, wherein: The percutaneous ventricular device is a catheter-based heart pump.

59. The percutaneous ventricular assist device of claim 56, wherein: The pump assembly includes a motor operably connected to an impeller configured to cause blood to flow through a first inlet cage of the second cannula assembly, the first cannula assembly, the second cannula assembly, or a combination thereof.

60. The percutaneous ventricular assist device of claim 56, wherein: The one or more connectors include threaded connectors.

61. The percutaneous ventricular assist device of claim 56, wherein: The one or more mating connectors, the one or more connectors, or both have a coating that includes an additive.

62. The percutaneous ventricular assist device of claim 61, wherein: The additive includes silicone.

63. The percutaneous ventricular assist device of claim 56, wherein: The one or more mating connectors include a stop, and the one or more connectors include at least one wall defining an opening extending at least partially through the wall, the opening being configured to receive a portion of the stop.

64. The percutaneous ventricular assist device of claim 56, wherein: Each mating connector, each connector, or both include a magnetic element.

65. A method comprising: Providing a ventricular assist device having a pump assembly and a first cannula assembly, wherein the first cannula assembly has a first cannula, the providing step comprising: The length of the first cannula of the first cannula assembly is reduced to achieve a specified length of the first cannula.

66. The method of claim 65, wherein: Reducing the length of the first cannula includes removing a length of the first cannula.

67. The method of claim 65, wherein: The providing step includes attaching the first cannula assembly to the pump assembly via one or more connectors and one or more corresponding mating connectors.

68. The method of claim 65, wherein: The first cannula assembly includes an inlet cage.

69. The method of claim 65, wherein: The providing step includes attaching a second cannula assembly to the first cannula assembly via one or more connectors and one or more corresponding mating connectors.

70. The method of claim 69, wherein: The second cannula assembly includes an inlet cage.

71. The method of any one of claims 68 to 70, wherein: Each of the first cannula assembly and / or the second cannula assembly includes a sensor.

72. The method of claim 65, wherein: The first cannula is permanently attached to the pump assembly.

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