Circulatory support devices, systems, and methods

Abstract

A mechanical circulatory support system may include a blood pump, an elongated tube coupled to and extending proximally from the blood pump, and a flexible elongated shaft configured to be removably positioned within the elongated tube. The blood pump may be configured to pump blood from the ventricles of a patient's heart to the patient's vascular system. Before or during delivery of blood to the heart, the elongated shaft may be inserted into the elongated tube to achieve desired propulsion along the tube. The elongated shaft may be removed from the elongated tube to increase flexibility along the tube and reduce the transmission of movement at the proximal end of the elongated tube to the blood pump within the heart.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 540,916, filed September 27, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to mechanical circulatory support devices. More specifically, this disclosure relates to devices, systems, and methods related to and / or used in the delivery of percutaneous ventricular assist devices (PVADs). Background Technology

[0003] A wide variety of in vivo and extracorporeal medical devices and systems have been developed for medical applications such as cardiac surgery and / or cardiac treatment. Some of these devices and systems include guidewires, catheters, catheter systems, pump devices, cardiac assist devices, etc. These devices and systems are manufactured using any of a variety of different manufacturing methods and can be used according to any of these methods. Each known medical device, system, and method has its own specific advantages and disadvantages. There remains a continued need for alternative medical devices and systems, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0004] This disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices, including ventricular assist devices.

[0005] A first example of a mechanical circulatory support system may include: a blood pump configured to pump blood from the ventricles of a patient's heart to the patient's vascular system; an elongated tube coupled to and extending proximally from the blood pump; and a flexible elongated shaft configured to be removably positioned within the elongated tube.

[0006] Alternatively or additionally, based on any of the above examples, in another example, the stiffness of the flexible slender shaft may be greater than the stiffness of the slender tube.

[0007] Alternatively or additionally, based on any of the above examples, in another example, the stiffness of the flexible slender shaft may be less than the stiffness of the slender tube.

[0008] Alternatively or additionally, based on any of the above examples, in another example, the blood pump may further include a motor and a motor cable extending proximally from the motor, and wherein the elongated tube may include a lumen, and the motor cable extends through the lumen.

[0009] Alternatively or additionally, based on any of the above examples, in another example, the lumen may be configured to receive a motor cable and a flexible elongated shaft.

[0010] Alternatively or additionally, based on any of the above examples, in another example, the lumen may be a first lumen through which the motor cable extends, and the elongated tube may include a second lumen extending along the first lumen and configured to removably receive the flexible elongated shaft.

[0011] Alternatively or additionally, based on any of the above examples, in another example, the second lumen has an internal surface configured to facilitate insertion into and removal of the flexible elongated shaft from the second lumen.

[0012] Alternatively or additionally, based on any of the above examples, in another example, the internal surface may be formed of polytetrafluoroethylene (PTFE) material.

[0013] Alternatively or additionally, based on any of the above examples, in another example, the elongated tube may include a bend at a portion near the distal end of the elongated tube, and the flexible elongated shaft may be configured to extend through the portion near the distal end and straighten the bend.

[0014] In another example, a mechanical circulatory support delivery system may include: a blood pump; an elongated tube coupled to and extending proximally from the blood pump, wherein the elongated tube includes a lumen through which the motor cable extends; a handle coupled to the elongated tube and configured to receive the elongated motor cable; and a flexible elongated shaft configured to be removably positioned within the elongated tube near the handle. The blood pump may include a motor, a motor cable communicating with and extending proximally from the motor, and an impeller communicating with the motor.

[0015] Alternatively or additionally, based on any of the above examples, in another example, the elongated tube may include a side port at a location at the distal end of the handle, and the side port is configured to removably receive the flexible elongated shaft.

[0016] Alternatively or additionally, based on any of the above examples, in another example, the handle may include a side port communicating with an elongated tube, and the side port is configured to removably receive the flexible elongated shaft.

[0017] Alternatively or additionally, based on any of the above examples, in another example, the lumen may be configured to receive the motor cable and the flexible elongated shaft.

[0018] Alternatively or additionally, based on any of the above examples, in another example, the lumen may be a first lumen, and the elongated tube may include a second lumen configured to receive the flexible elongated shaft.

[0019] Alternatively or additionally, based on any of the above examples, in another example, the elongated tube may include a bend at a portion near the distal end of the elongated tube, and the flexible elongated shaft may be configured to extend through the portion near the distal end and straighten the bend.

[0020] In another example, a method may include: inserting a mechanical circulatory support system into a patient's vascular system, delivering blood through the patient's vascular system to the patient's heart, and withdrawing a flexible elongated shaft from an elongated tube. The mechanical circulatory support system may include a blood pump, an elongated tube coupled to and extending proximally from the blood pump, and a flexible elongated shaft removably positioned within the elongated tube.

[0021] Alternatively or additionally, based on any of the above examples, in another example, the extraction of the flexible slender shaft from the slender tube may occur after the blood pump has delivered it to the patient's heart.

[0022] Alternatively or additionally, based on any of the above examples, in another example, the method may further include: inserting a flexible elongated shaft into an elongated tube, wherein the elongated tube includes a bend, and the flexible elongated shaft is inserted into the elongated tube at least to the location of the bend, thereby straightening the elongated tube, and withdrawing the flexible elongated shaft from the elongated tube including withdrawing the distal end of the flexible elongated shaft at least to the location of the proximal end of the bend, so as to allow the elongated tube to reform the shape of the bend before delivering blood to the patient's heart via a blood pump.

[0023] Alternatively or additionally, based on any of the above examples, in another example, the method may further include: withdrawing the distal end of the flexible elongated shaft from the elongated tube and reinserting the flexible elongated shaft into the elongated tube.

[0024] Alternatively or additionally, based on any of the above examples, in another example, the flexible elongated shaft may be a first flexible elongated shaft, and the method may further include: withdrawing the distal end of the first flexible elongated shaft from the elongated tube and inserting a second flexible elongated shaft into the elongated tube, wherein the second flexible elongated shaft has a stiffness greater than that of the first flexible elongated shaft.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of this disclosure. The following drawings and detailed description will illustrate some embodiments in more detail. Attached Figure Description

[0026] This disclosure can be more fully understood by considering the following specific embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1 A schematic perspective view of an exemplary loop support system;

[0028] Figure 2 A schematic partial sectional view of the anatomical structure and a schematic side view of an exemplary percutaneous ventricular assist device (PVAD) within the anatomical structure;

[0029] Figure 3 A schematic cross-sectional view of an exemplary PVAD;

[0030] Figure 4 This is a schematic diagram of an exemplary cyclic support system, in which the slender shaft is separate from the slender tube;

[0031] Figure 5 for Figure 4 A schematic diagram of an exemplary cyclic support system, wherein an elongated shaft is inserted into an elongated tube;

[0032] Figure 6 This is a schematic diagram of an exemplary loop support system, wherein the handle portion is a cross-sectional view;

[0033] Figure 7 A schematic cross-sectional view of a portion of an exemplary circulatory support system inserted into a patient's blood vessels;

[0034] Figure 8 This is a schematic cross-sectional view taken at an axial position along an elongated tube in an exemplary cyclic support system, wherein the elongated shaft is inserted into the elongated tube.

[0035] Figure 9 This is a schematic cross-sectional view taken at an axial position along the elongated tube of an exemplary cyclic support system, wherein the elongated shaft is inserted into the elongated tube; and

[0036] Figure 10 This is a schematic diagram of an exemplary method for using a loop support system.

[0037] Although this disclosure can be modified in various variations and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the purpose is not to limit this disclosure to the specific embodiments described. Rather, the purpose is to cover all variations, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0038] The terms defined below shall be subject to these definitions unless otherwise specified in the claims or elsewhere in this specification.

[0039] All numerical values ​​in this document are assumed to be modified by the term "about," whether explicitly stated or not. The term "about" generally refers to a range of numerical values ​​that a person skilled in the art would consider equivalent (i.e., having the same function or result) to the stated value. In many cases, the term "about" may include numerical values ​​rounded to the nearest significant figure.

[0040] The range of values ​​expressed by endpoints includes all values ​​within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0041] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references, unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or,” unless otherwise expressly stated.

[0042] It should be noted that references to "an embodiment," "some embodiments," and "other embodiments" in this specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such expressions do not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that, whether explicitly described or not, such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, unless explicitly stated to the contrary.

[0043] The following detailed description should be read with reference to the accompanying drawings, in which similar structures are numbered the same. The drawings are not necessarily to scale and illustrate exemplary embodiments, and are not intended to limit the scope of this disclosure. Furthermore, it should be noted that in any given drawing, some features may not be shown or may be shown schematically for clarity and / or brevity. Additional details regarding some components and / or method steps may be shown in more detail in other drawings. The apparatus and / or methods disclosed herein may provide several desirable features and advantages as described in more detail below.

[0044] Various circulatory support devices are known to assist or replace the heart's pumping function in patients with severe heart failure and / or other cardiac conditions. Circulatory support devices can be configured to treat patients with cardiogenic shock, myocardial infarction, acute decompensated heart failure, and / or other heart-related conditions. Additionally or alternatively, circulatory support devices can provide support to patients during percutaneous coronary intervention and / or other procedures.

[0045] Exemplary cardiac circulatory support devices include, but are not limited to, ventricular assist devices (VADs), total artificial hearts, intra-aortic balloon pumps (IABPs), and extracorporeal membrane oxygenation (ECMO) devices. Exemplary VADs include left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), and biventricular assist devices (BiVADs). Another exemplary VAD is a percutaneous ventricular assist device (PVAD), which can be delivered via the femoral artery or femoral vein and / or other suitable vascular systems to the ventricles and inserted into a ventricle of the patient's heart (e.g., the left or right ventricle). PVADs can be placed at the desired location on the patient's anatomy via percutaneous access and delivery, which allows PVADs to be used in emergency medicine, catheterization labs, and / or other surgical and non-surgical scenarios.

[0046] Figure 1 A schematic diagram of an exemplary circulatory support system 10 is depicted. System 10 may include a percutaneous support device (e.g., a PVAD, such as blood pump 100), a cannula 40, and an insertion sheath (not shown). In some cases, system 10 may include a guidewire, but this is not required. In some examples, when an insertion sheath is included, the insertion sheath facilitates the percutaneous delivery of blood pump 100 and cannula 40 to a target location within the patient's body (e.g., a target location within the patient's heart). When positioned at the target site within the patient's heart, blood pump 100 may be configured to pump blood from the ventricles of the heart to the patient's vascular system.

[0047] The system 10 may also include a proximal housing 42 coupled (e.g., connected) to an elongated tube 50 (e.g., a catheter and / or other suitable elongated tube), wherein the elongated tube 50 may be coupled to the blood pump 100 (e.g., the distal end of the elongated tube 50 may be coupled to the proximal end of the blood pump 100). In some examples, at least the proximal housing 42, the elongated tube 50, and / or other components of the system 10 may be configured to deliver the blood pump 100 and the cannula 40 to a target location or site within the patient's body. In some examples, when a guidewire is included, it may also be used to facilitate the delivery of the blood pump 100 and / or the cannula 40.

[0048] Although not shown, the system 10 may additionally or alternatively include one or both of an initiation tube and an initiation tube flushing line. When the initiation tube is included, it may be coupled to a cannula delivery tool (e.g., a delivery sheath) that can be configured to receive the cannula 40 before and during delivery of the blood pump 100 and the cannula 40 to the target site.

[0049] Figure 2 Exemplary positioning of the blood pump 100 (e.g., a percutaneous circulatory support device, such as a PVAD configured as an LVAD, etc.) in the patient's anatomy is depicted. Figure 2In this configuration, the blood pump 100 is positioned with its distal end 103 located in the left ventricle 16 of the heart 18 and its proximal end 107 located in the aorta 20, such that the blood pump 100 extends across the aortic valve 22 between the left ventricle 16 and the aorta 20. With the blood pump 100 extending from the left ventricle 16 to the aorta 20, the blood pump 100 can be configured to pump blood from the left ventricle 16 into the aorta 20 to assist or support blood circulation. Other suitable locations of the blood pump relative to anatomical structures are also contemplated, and include, but are not limited to, the distal end 103 of the blood pump being positioned in the right ventricle of the heart 18, while the proximal end is positioned in the pulmonary artery.

[0050] Figure 3 A schematic cross-sectional view depicting an exemplary configuration of the blood pump 100 is shown. The blood pump 100 may be incorporated, together with a guidewire, infeeding sheath, controller, user interface, one or more sensors, and / or other suitable components, as part of the circulatory support system 10 as discussed.

[0051] The blood pump 100 may include a housing 101 having an impeller housing 102 and a motor housing 104. The impeller housing 102 and the motor housing 104 may be constructed integratedly or integrally, but this is not required, and the impeller housing 102 and the motor housing 104 may also be separate components configured to be removably or permanently coupled. In some configurations, the blood pump 100 may not have a motor housing 104 separate from the impeller housing 102, and the impeller housing 102 may be directly coupled to the motor 105, or the motor housing 104 may be integrated with the motor 105.

[0052] Impeller housing 102 may house impeller assembly 106 and driven magnet 124, which may be part of impeller assembly 106 or separate from it. Impeller assembly 106 may include impeller shaft 108 rotatably supported by at least one bearing (such as bearing 110 and / or other suitable bearing). Impeller assembly 106 may also include impeller 112 rotatable relative to impeller housing 102 to drive blood through blood pump 100. In some configurations, and as illustrated, impeller shaft 108 and impeller 112 may be separate components, while in other configurations, impeller shaft 108 and impeller 112 may be integrated. Impeller assembly 106 as a whole may be considered a driven component, and / or rotating components of impeller assembly 106 (e.g., impeller shaft 108 and / or impeller 112) may be driven components individually or in combination.

[0053] Impeller 112 may be configured within impeller housing 102 such that, as impeller 112 rotates, blood flows in from blood inlet 114 formed on or at impeller housing 102, passes through impeller housing 102, and flows out from blood outlet 116 formed on or at impeller housing 102. In some configurations, impeller housing 102 may be coupled to or include a distally extending sleeve (not shown) that can receive blood and deliver blood to inlet 114 (e.g., from left ventricle 16 of heart 18 and / or from other suitable locations).

[0054] Inlet 114 and outlet 116 may each have any suitable number of orifices configured to facilitate the reception of blood at blood pump 100 and the discharge of blood from blood pump 100, respectively. In some examples, inlet 114 and / or outlet 116 may each include multiple orifices, and in other examples, one or both of inlet 114 and / or outlet 116 may each include a single orifice.

[0055] The inlet and outlet 116 can each be formed at any suitable location along the impeller housing 102 or at other suitable locations along the blood pump 100. In some examples and as shown... Figure 3 As depicted, inlet 114 may be formed at an end of impeller housing 102 (e.g., the distal end), and outlet 116 may be formed on a side of impeller housing 102 (e.g., near the location of inlet 114). Other suitable positioning configurations of inlet 114 and / or outlet 116 on impeller housing 102 are contemplated.

[0056] The motor housing 104 can accommodate the motor 105 and other suitable components. In some examples and such... Figure 3 As depicted, the motor housing 104 can at least accommodate the motor 105, the drive shaft 120, and the drive magnet 122.

[0057] Motor 105 can be any suitable type of motor. In one example, motor 105 can be a brushless DC (BLDC) motor, but other suitable motor types are also expected.

[0058] In operation, motor 105 can be configured to rotatably drive impeller 112 relative to impeller housing 102. In some exemplary configurations, motor 105 can rotate drive shaft 120, which is coupled to drive magnet 122. Rotation of drive magnet 122 can cause driven magnet 124 to rotate, which is part of or connected to impeller assembly 106 and rotates together with impeller assembly 106. That is, when impeller assembly 106 includes impeller shaft 108, impeller shaft 108 and impeller 112 are configured to rotate together with driven magnet 124. Additionally or alternatively, motor 105 can be coupled to impeller assembly 106 via other suitable components.

[0059] Controller ( Figure 3 A controller (not shown) can be operatively coupled to motor 105 and configured to control motor 105 via one or more command signals sent from the controller to motor 105. The controller may be located within motor housing 104 and / or external to motor housing 104 (e.g., in a housing of blood pump 100 separate from motor housing 104, outside the patient, in a housing of circulatory support system 10 separate from blood pump 100, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located within motor housing 104 and / or separately disposed from motor housing 104.

[0060] The motor housing 104 may be connected to an elongated tube 50 (e.g., a conduit and / or other suitable elongated tube) at a location opposite to the impeller housing 102. The elongated tube 50 may be connected to the motor housing 104 in various ways, such as laser welding, brazing, etc. The elongated tube 50 may extend proximally from the motor housing 104.

[0061] The elongated tube 50 may include one or more lumens for receiving one or more components of the circulatory support system, including the blood pump 100. In some cases, the elongated tube 50 may be configured to receive and / or carry motor cables 54 (e.g., one or more cables configured to facilitate operation of the motor 105). In some examples, the elongated tube 50 may receive and / or carry the motor cables 54 within its lumen 56, and the motor cables 54 may operatively connect the motor 105 to a controller (not shown) and / or an external power source (not shown).

[0062] The elongated tube 50 can carry one or more transmission cables from one or more sensors near the blood pump to the controller. In some cases, one or more of the sensors can be configured to sense pressure inside or around the blood pump 100.

[0063] Delivering the blood pump 100 and / or other suitable circulatory support device to the target location can be difficult. Circulatory support devices (e.g., blood pump 100) are typically inserted into the patient through the femoral artery. When the patient has a tortuous femoral artery, delivering the circulatory support device to the patient's heart can be particularly difficult due to the relatively large diameter and rigid portion length of the device. Therefore, a slender tube 50 extending proximally from the blood pump may be necessary to provide greater thrust on the blood pump 100, facilitating its advancement through the femoral artery and / or other suitable vessels to the patient's heart.

[0064] A slender tube 50 with a small diameter extending proximally from the blood pump 100 facilitates "dual access" via a sheath inserted through the patient's skin and blood vessels (e.g., the femoral artery or other suitable vessels). "Dual access" can refer to the simultaneous insertion of two or more catheters or other suitable devices through a sheath (e.g., an infeeding sheath, a delivery sheath, etc.). In some examples, the first catheter may be the slender tube 50 of the circulatory support system 10, and the second catheter may be used for percutaneous coronary intervention (PCI), but this is not essential.

[0065] Furthermore, the slender tube 50 with a small diameter facilitates the use of a small-diameter repositioning sheath, which can replace the introductory sheath at the femoral artery insertion site after the blood pump 100 has been initially positioned at the target site (e.g., within and / or near the patient's heart). Compared to a large-diameter repositioning sheath, the small-diameter repositioning sheath facilitates improved circulation or perfusion in the patient's blood vessels by occupying less space in the patient's vascular system.

[0066] While employing a small-diameter, rigid elongated tube 50 could be an option that addresses the column strength, stiffness, or rigidity (e.g., longitudinal stiffness or rigidity) of the elongated tube 50 required to advance the blood pump 100 to the target site, while providing space for dual access and / or allowing the use of a small-diameter repositioning sheath, the more rigid the elongated tube 50, the more difficult it is to maintain the position of the blood pump 100 at the target site. The difficulty in maintaining the position of the blood pump 100 at the target site may be due to the fact that a rigid elongated tube 50 more easily (e.g., more effectively) transmits patient movement to the blood pump 100 compared to a less rigid elongated tube 50. Furthermore, patient safety is a concern when using a rigid elongated tube 50, as a rigid elongated tube exerts greater forces on the patient than a less rigid elongated tube 50 during long-term placement.

[0067] Therefore, a rigid (e.g., highly rigid and / or including high column strength) and / or kink-resistant elongated tube is desirable during delivery, but disadvantageous during device indwelling (e.g., indwelling can refer to the period during which the blood pump 100 is positioned at the target site and the elongated tube 50 extends from the blood pump 100, through the patient's vascular system, and protrudes outside the patient's body). The concept discussed herein addresses the need for a more rigid or highly rigid elongated tube 50 during delivery, but a small-diameter, flexible or resilient elongated tube 50 during the indwelling period.

[0068] In one exemplary configuration, the circulatory support system 10 may include an elongated shaft (e.g., a flexible elongated shaft) that can be inserted into an elongated tube 50 to achieve desired column strength or stiffness or rigidity (e.g., pushability) along the elongated tube 50 and facilitate the advancement of the blood pump 100 to a target site within the patient's body. When using an elongated shaft that can be inserted into the elongated tube 50, the elongated shaft can be removed from the elongated tube 50 before or after the blood pump 100 is positioned at the target site, allowing the elongated tube 50 (which may be flexible and / or at least partially radially constrictible) to be configured with a small diameter and remain within the patient's body and extend outside the patient's body after the blood pump has been delivered to the patient's heart. This small-diameter and flexible and / or at least partially radially constrictible elongated tube 50 can reduce the transmission of patient motion to the blood pump 100 positioned at the target site.

[0069] Figure 4 and Figure 5 A schematic side view depicting an exemplary configuration of a circulatory support system 10 is shown. As depicted, in addition to additional or alternative components, the circulatory support system 10 may include a blood pump 100, a cannula 40, a proximal housing 42, and an elongated tube 50 extending proximally from the blood pump 100 to the proximal housing 42. Further, the system 10 may include an elongated shaft 58 and a port 60 configured to communicate with the lumen of the elongated tube 50, wherein the elongated shaft 58 can be removably positioned within the elongated tube 50 via the port 60. When inserted into the elongated tube 50, the elongated shaft 58 may increase the stiffness or column strength of the circulatory support system along the elongated tube 50, thereby increasing the system's pushability along the elongated tube 50.

[0070] The elongated shaft 58 may have any suitable column strength or stiffness or rigidity along its length. An exemplary suitable column strength for the elongated shaft may range from three to fifteen pounds, but this is not required. An exemplary suitable bending stiffness for the elongated shaft may range from 0.4 to 1.5 pound-foot-square inches. In some cases, the elongated shaft 58 may have column strength or stiffness or rigidity varying along its length and / or circumference. In some examples, the column strength or stiffness or rigidity of the elongated shaft 58 along its length and / or circumference may be varied by changing the outer diameter of the elongated shaft 58, applying a pattern to the elongated shaft 58 (e.g., via laser cutting and / or other suitable techniques), using different materials along the length of the elongated shaft 58, and / or in one or more other suitable ways.

[0071] Figure 4 A circulatory support system 10 is depicted with an elongated tube 50 having a pre-formed (pre-shaped) bend at a portion 62 near the distal end of the elongated tube 50 (e.g., immediately adjacent to the proximal end of the blood pump 100). Figure 4 As depicted, the elongated shaft 58 is not yet inserted into the elongated tube 50, but its distal end is aligned with and spaced apart from a port 60 (e.g., a side port in the elongated tube 50), which is configured to removably receive the flexible elongated shaft 58.

[0072] When a pre-formed bend is included, it facilitates the positioning and maintenance of the blood pump 100 at a target location. For example, the pre-formed bend can be configured to bend the elongated shaft 58 around the aortic arch or other parts of the patient's vascular system, which facilitates the positioning of the blood pump at the target location. Additionally or alternatively, when the blood pump 100 is positioned at a target location in the patient's heart, the pre-formed bend in the elongated tube 50 can facilitate the decoupling of forces acting on the proximal end of the elongated tube 50 and / or the proximal portion of the circulatory support system 10, thereby better maintaining positional stability.

[0073] Figure 5 A loop support system 10 is depicted, in which an elongated shaft 58 is inserted into an elongated tube 50 through a port 60. In some examples and as... Figure 5 As depicted, the elongated shaft 58 can be inserted into and / or through the location 62 where the pre-formed bend is situated, thereby straightening the elongated tube 50. Straightening the elongated tube 50 facilitates the passage of the system 10 through the patient's vascular system. Removing the elongated shaft 58 from its extension across the location 62 allows the bend to automatically recover (e.g., since the elongated tube 50 can be biased to the bend at location 62) and facilitates the positioning and maintenance of the blood pump 100 at a target site in the patient's heart.

[0074] Straightening the elongated tube 50 may include straightening the elongated tube 50 from its static radius of curvature until the axis of the elongated tube 50 at the pre-formed bend portion 62 is aligned with and / or parallel to the central axis of the elongated tube 50 proximal to the bend portion 62 and / or distal to the bend portion 62. Alternatively or additionally, straightening the elongated tube 50 may include straightening the bend portion from its static radius of curvature at least to a smaller bend angle relative to the central axis of the elongated tube 50 proximal to the portion 62.

[0075] Figure 4 and Figure 5 Port 60 is depicted as a side port located near the distal end of the proximal housing 42, at the proximal end of the elongated tube 50, but this configuration is not required. For example, port 60 could be an end port, and / or a port located at one or more other suitable locations along the elongated tube 50 and / or at other suitable components of the loop support system 10. In some examples, port 60 may be located within the proximal housing 42 of the system 10, such as... Figure 6 What is depicted.

[0076] When port 60 is located within the proximal housing 42, port 60 can be positioned at any suitable location along the proximal housing 42. In some examples, port 60 can be located on the side of the proximal housing 42 as needed (e.g., as shown in the image). Figure 6 (The side port depicted), or the proximal end of the proximal housing 42.

[0077] When port 60 is included in proximal housing 42, elongated tube 50 may include a bifurcation at its proximal end (e.g., within proximal housing 42 and / or at any other suitable location). For example, a first portion 50a of elongated tube 50 at the bifurcation may extend along proximal housing 42 to and / or communicate with motor cable port 64, and a second portion 50b of elongated tube 50 at the bifurcation may extend to and / or communicate with port 60. Alternatively, motor cable 54 may exit elongated tube 50 through a side port within proximal housing 42, and the proximal end of elongated tube 50 may communicate with port 60. Other suitable configurations of elongated tube 50 and port 60 are contemplated to facilitate insertion of elongated shaft 58 into and / or removal of elongated shaft 58 from elongated tube 50.

[0078] The slender shaft 58 can be any suitable type of shaft 58. For example, the slender shaft 58 can be a spindle, tube, wire, and / or other suitable slender shaft configuration.

[0079] The elongated shaft 58 can be formed of any suitable material. The selection of material can be based on one or more considerations, including but not limited to kink resistance, lubricity, flexibility, stiffness or rigidity, resilience, and / or other suitable considerations. Exemplary suitable materials include, but are not limited to, metals, polymers, nickel-titanium alloys (e.g., NITINOL and / or other suitable nickel-titanium alloys), stainless steel, polytetrafluoroethylene (PTFE), polyamides (e.g., VESTAMID and / or other suitable polyamide materials), and / or other suitable materials. In some examples, the elongated shaft 58 may be at least partially formed of a nickel-titanium alloy to reduce the likelihood of kinking when the elongated shaft 58 passes through the elongated tube 50 and / or within the vascular system, and / or formed of other suitable materials that reduce the likelihood of kinking when the elongated shaft 58 passes through the elongated tube 50 and / or within the vascular system. In some examples, the elongated shaft 58 may include a metal core (e.g., a stainless steel core) coated with PTFE and / or other materials that facilitate the sliding of the elongated shaft 58 within the elongated tube 50.

[0080] The elongated shaft 58 can have any suitable length. For example, the length of the elongated shaft 58 can be equal to or greater than the length of the elongated tube 50, but this is not required. In some examples, the length of the elongated shaft 58 can be at least as long as the distance from the port 60 to the portion 62 in which the pre-formed bend is positioned in the elongated tube 50 (e.g., when the pre-formed bend is positioned in the elongated tube 50), so that the elongated shaft 58 can straighten the elongated tube 50 at the portion 62 of the pre-formed bend relative to the stationary state of the elongated tube 50.

[0081] The elongated shaft 58 can have any suitable outer diameter. In some examples, the outer diameter of the elongated shaft 58 can be determined based on the following factors: the inner diameter of the elongated tube 50, the outer diameter of the motor cable 54, the rigidity along the elongated tube 50 required to deliver the blood pump 100 to the target site (e.g., a larger diameter elongated shaft 58 is generally more rigid than a smaller diameter elongated shaft 58 of the same material) and / or one or more other suitable considerations.

[0082] The slender shaft 58 can employ any suitable combination of properties (e.g., material, diameter, rigidity, etc.). In some cases, the user (e.g., physician, clinician, etc.) may have two or more slender shafts 58 and can select the initial shaft based on the desired degree of tortuosity of the patient's vascular system. During surgery and / or at other times, the initially selected slender shaft 58 can be switched to a different slender shaft 58 having one or more properties different from the initial slender shaft 58. In some examples, two or more slender shafts 58 can be used simultaneously. In some examples, the slender shaft 58 can be selected based on the required rigidity or stiffness along the length of the slender tube 50 to facilitate passage through the patient's vascular system.

[0083] The elongated tube 50 can have any suitable construction and can be formed from one or more layers. The one or more layers can be formed by extrusion, bending, and / or other suitable processes. In some examples, the elongated tube 50 can have an outer polymer layer (e.g., a polyamide layer), an inner polymer layer, and a stainless steel braided layer sandwiched between the inner and outer polymer layers. In some cases, the outer polymer layer can be remelted onto the braided layer, but this is not required. In some examples, the elongated tube 50 can be a single layer. The elongated tube 50 can have radial flexibility and / or shrinkability, but this is not required.

[0084] The inner layer or at least the inner surface of the elongated tube 50 may be formed of a lubricating material. In one example, the inner surface of the elongated tube 50 may be made of PTFE material or formed of PTFE material to facilitate slidable reception of the elongated shaft 58.

[0085] The elongated shaft 58 may be flexible, thus enabling it to pass through a tortuous vascular system, but is rigid enough to provide sufficient rigidity or stiffness to the elongated tube 50 to facilitate the travel of the blood pump 100 through the tortuous vascular system to reach the patient's heart. In some examples, the elongated shaft 58 may be flexible and more rigid than the elongated tube 50 (e.g., the elongated shaft 58 may be more rigid than the elongated shaft 50 or have greater stiffness than the elongated tube 50) to provide the required amount of pushability along the elongated tube 50 and / or to straighten the elongated tube 50 at the pre-formed bend location 62. Alternatively, in some examples, the elongated shaft 58 may be flexible and less rigid than the elongated tube 50 (e.g., the elongated shaft 58 may have less stiffness than the elongated tube 50), but is still rigid enough to provide the required amount of pushability along the elongated tube 50 upon insertion through it.

[0086] Figure 7A schematic cross-sectional view of a blood vessel is depicted, wherein a sheath 66 is at least partially inserted into the blood vessel V. An elongated tube 50 may extend within and / or through the sheath 66 and into the blood vessel V. The elongated tube 50 may include a motor cable 54 and an elongated shaft 58 within its lumen 56. In some examples, the inner surface 68 of the elongated tube 50 may be formed of and / or include a lubricating material (e.g., PTFE, etc.) to facilitate slidably receiving the elongated shaft 58. The elongated shaft 58 may extend proximally from a port 60 and may be configured to be slidably adjustable relative to the elongated tube 50 to increase or decrease stiffness along the elongated tube 50, as discussed herein.

[0087] Figure 8 A schematic cross-sectional view taken along the axial position of an exemplary configuration of an elongated tube 50 is depicted, wherein an elongated shaft 58 and a motor cable 54 are inserted into a lumen 56 of the elongated tube 50, which has a single lumen (e.g., lumen 56). Although only a single motor cable 54 is depicted within the lumen 56, one or more motor cables 54 and / or other cables (e.g., sensor cables, pressure sensor cables, fiber optic cables, etc.) extending proximally from the blood pump 100 may extend within the lumen 56. The motor cable 54 may include one or more conductors 72 as needed. Furthermore, although only a single elongated shaft 58 is depicted within the lumen 56, one or more elongated shafts 58 may be employed to achieve the required stiffness along the length of the elongated tube 50.

[0088] Figure 9 A schematic cross-sectional view is depicted taken along an axial position of an exemplary configuration of an elongated tube 50, in which an elongated shaft 58 and a motor cable 54 are inserted, the elongated tube 50 having a first lumen 56a and a second lumen 56b. In some examples, the elongated tube 50 may at least partially define the first lumen 56a, and a separator 74 (e.g., a tube, wall, etc.) may at least partially define the second lumen 56b. Although the two lumens are located in... Figure 9 The configuration of the slender tube 50 described herein may employ a single lumen or more than two lumens.

[0089] In some configurations and such Figure 9 As depicted, a first lumen 56a is defined by an inner surface 76 of an elongated tube 50 and a first surface 78 of a separator 74 (e.g., an outer surface when the separator 74 is tubular), the separator 74 having a second surface 80 defining a second lumen 56b (e.g., an inner surface when the separator 74 is tubular). A motor cable 54 may be received in and / or extend through the first lumen 56a. In some cases, one of the elongated tube 50 and the separator 74 (when configured as a tube) may be considered as a first tube, and the other of the elongated tube 50 and the separator 74 may be considered as a second tube.

[0090] In some cases, the partition 74 can be a complete tube on its own, wherein the second surface 80 defines the entire circumference of the second lumen 56b. Alternatively or additionally, the partition 74 can form a tube together with the elongated tube 50, wherein the second surface 80 of the partition 74 defines a portion of the circumference of the second lumen 56b, and the inner surface 76 of the elongated tube 50 defines a portion of the second lumen 56b. Although Figure 9 The median separator 74 is depicted as having a circular cross-section, but this is not required, and the cross-section may take one or more other suitable shapes. In some cases, the elongated shaft 58 may be removably received in the second lumen 56b and / or removably extended through the second lumen 56b.

[0091] The first lumen 56a and the second lumen 56b can be formed in any suitable manner. In some examples, the first lumen 56a and the second lumen 56b can be dual-cavity extruders, can be formed by co-extrusion, can be extruded separately, and / or can be formed and / or interconnected in any suitable manner. In some examples, the first lumen 56a can be defined by the inner surface of a first tube, the second lumen 56b can be defined by the inner surface of a second tube, and a third tube body can extend around the outer surfaces of the first and second tubes, wherein the third tube can define the outer surface of the elongated tube 50. Alternatively, in some examples, the first lumen 56a and the second lumen 56b can be located within a single tube and separated by the wall of that single tube. Other suitable configurations of the elongated tube 50 are contemplated, with or without one or more other sub-tubes.

[0092] The separator 74 can be formed from any suitable material. For example... Figure 9 As described, the separator 74 can be formed of a different material than the elongated shaft 58, but this is not necessary, and the separator 74 can also be formed of the same material used to form the elongated tube 50, and / or can be integral with the elongated tube. Similar to other surfaces that can contact the elongated shaft 58, the inner surface 80 defining the second lumen 56b can be configured to facilitate the insertion and removal of the flexible elongated shaft from the second lumen 56b. For example, the inner surface 80 can be formed of or have formed with a lubricating material or other suitable material (such as PTFE and / or other materials that facilitate slidable reception of the elongated shaft 58). However, in some cases, the inner surface 80 can be formed of a material other than a lubricating material.

[0093] Figure 10A schematic diagram of an exemplary method or technique 200 is depicted. Method 200 can be configured to facilitate the delivery and / or positioning of a blood pump at a target site in a patient's heart, and to maintain the position of the blood pump at the target site. The blood pump can employ the blood pump configuration described herein and / or one or more other suitable blood pump configurations.

[0094] The method 200 may include inserting a mechanical circulation system (MCS) into the vascular system of a patient 202. The MCS may have any suitable configuration, including one or more configurations described herein and / or other configurations. In some examples, the MCS may include a blood pump, an elongated tube coupled to and extending proximally from the blood pump, and an elongated shaft, wherein the elongated shaft may be removably positioned within the elongated tube. Exemplarily, the elongated shaft may be selectively employed to adjust the rigidity or stiffness along its length to facilitate delivery of the blood pump to a target site and / or to facilitate maintenance of the blood pump at the target site.

[0095] Before, during, or after the initial insertion of the MCS into a patient's vascular system, the user (e.g., a physician, clinician, etc.) can select an elongated shaft (e.g., a flexible elongated shaft) whose rigidity or stiffness will allow for desired propulsion along the length of the elongated tube as the blood pump travels through the vascular system toward the patient's heart. Once one or more elongated shafts are selected, they can be inserted into the elongated tube. In some examples, an elongated shaft can be selected and inserted into the elongated tube before the initial insertion of the MCS device (e.g., a blood pump) into the patient's vascular system. In some cases, the MCS device package may include an elongated shaft pre-loaded into the elongated tube.

[0096] The elongated shaft can be inserted into the elongated tube at any desired distance. In some cases, when the elongated tube includes bends at one or more locations along the length of the elongated shaft (e.g., near the distal end of the elongated shaft adjacent to the blood pump, and / or one or more other suitable locations), the elongated shaft can be inserted to the depth of at least one of the bends to straighten the elongated tube at the location of the bend and improve the pushability of the MCS through the patient's vascular system.

[0097] Once the MCS has been inserted into the patient's vascular system, the blood pump can deliver 204 through the patient's vascular system to the patient's heart (e.g., to a target site within the patient's heart). In some cases, if the user experiences resistance while the blood pump is being delivered, and the thrust on the tube causes it to bend along a particularly tortuous section of the vascular system, making it difficult to pass through, the user can slide the slender shaft out of the tube or otherwise withdraw it without removing the tube from the patient's body, and insert a more rigid slender shaft into the tube, continuing the blood pump delivery.

[0098] As discussed, the elongated shaft can be withdrawn from the elongated tube 206 at any suitable time before, during, or after the blood pump is delivered to the target site. Furthermore, withdrawing the elongated shaft from the elongated tube 206 includes completely withdrawing the shaft from the elongated tube and / or partially withdrawing the elongated shaft from the elongated tube.

[0099] In some cases, when the blood pump is approaching the aortic arch, the user can at least partially withdraw the slender shaft from the tube, so that the distal end of the tube is proximal to the location of a pre-formed bend in the tube. Withdrawing the slender shaft to at least this position allows the tube to automatically reform the shape of the bend, facilitating the blood pump's passage through the aortic arch and into the patient's heart.

[0100] Although not strictly necessary, once the blood pump has been delivered to the target site at the patient's heart, the slender shaft can be completely withdrawn from the slender tube (e.g., the distal end of the slender shaft is positioned outside the slender tube). Completely withdrawing the slender shaft from the slender tube facilitates the desired rigidity or flexibility along the slender tube during the indwelling time or period, thereby reducing the likelihood that movement at the proximal end of the slender tube will cause the blood pump to move.

[0101] If the blood pump is accidentally adjusted during the indwelling period, and / or needs to be adjusted for one or more other reasons, the user can reinsert the same or a different elongated shaft (e.g., a second elongated shaft) to adjust the position of the blood pump. In some cases, when the blood pump is already located at the heart, a less stiff elongated shaft can be reinserted (e.g., reinsertion—this operation is still referred to as “reinsertion” even if the shaft is different) into the elongated tube to provide sufficient rigidity along the elongated tube, allowing the user to transmit movement at the proximal end of the MCS to the blood pump and position the blood pump at the target site or a new target site. Furthermore, in some cases, the elongated shaft can be reinserted into the elongated tube to facilitate the withdrawal of the blood pump from the patient and / or for other suitable reasons. The ability to reinsert the elongated shaft can be beneficial when the elongated tube loses rigidity in the patient due to polymer absorption of fluid, and / or for other reasons.

[0102] It should be understood that this disclosure is exemplary in many respects only. Modifications to the details, particularly regarding shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include using any feature used in one exemplary embodiment in other embodiments. Of course, the scope of this disclosure is defined in the language of the appended claims.

Claims

1. A mechanical circulation support system, comprising: A blood pump configured to pump blood from the ventricles of a patient’s heart to the patient’s vascular system; A slender tube, which is connected to the blood pump and extends proximally from the blood pump; as well as A flexible elongated shaft, which is configured to be removably positioned within the elongated tube.

2. The system of claim 1, wherein, The stiffness of the flexible slender shaft is greater than that of the slender tube.

3. The system of claim 1 or claim 2, wherein, The stiffness of the flexible slender shaft varies along its length.

4. The system according to any one of claims 1 to 3, wherein: The blood pump also includes: Electric motor; and Motor cables extending proximally from the motor, and The elongated tube includes a cavity, and the motor cable extends through the cavity.

5. The system of claim 4, wherein, The cavity is configured to receive the motor cable and the flexible elongated shaft.

6. The system according to claim 4 or claim 5, wherein: The cavity is a first cavity, and the motor cable extends through the first cavity. The elongated tube includes a second lumen that extends along the first lumen and is configured to removably receive the flexible elongated shaft.

7. The system of claim 6, wherein, The second lumen has an inner surface configured to facilitate the insertion and removal of the flexible elongated shaft from the second lumen.

8. The system according to claim 7, wherein, The internal surface is formed of polytetrafluoroethylene (PTFE) material.

9. The system according to any one of claims 1 to 8, wherein, The elongated tube includes a bend at a portion near its distal end, and the flexible elongated shaft is configured to extend through the portion near the distal end and straighten the bend.

10. A mechanical circulating support conveying system, comprising: Blood pump, the blood pump comprising: Electric motor; Motor cable, the motor cable being connected to the motor and extending proximally from the motor; and Impeller, the impeller being connected to the motor; A slender tube connected to the blood pump and extending proximally from the blood pump, wherein the slender tube includes a lumen through which the motor cable extends; A housing, connected to the elongated tube and configured to receive the elongated motor cable; and A flexible elongated shaft is configured to be removably positioned within the elongated tube, near the housing.

11. The system according to claim 10, wherein, The elongated tube includes a side port at a location distal to the housing, and the side port is configured to removably receive the flexible elongated shaft.

12. The system according to claim 10 or claim 11, wherein, The housing includes a side port communicating with the elongated tube, and the side port is configured to removably receive the flexible elongated shaft.

13. The system according to any one of claims 10 to 12, wherein, The cavity is configured to receive the motor cable and the flexible elongated shaft.

14. The system according to any one of claims 10 to 13, wherein: The lumen is a first lumen; and The elongated tube includes a second lumen configured to receive the flexible elongated shaft.

15. The system according to any one of claims 10 to 14, wherein, The elongated tube includes a bend at a portion near its distal end, and the flexible elongated shaft is configured to extend through the portion near the distal end and straighten the bend.

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