Guide wire insertion assisting device for percutaneous circulation supporting device

Abstract

A percutaneous circulation support system includes a percutaneous circulation support device. The device includes a housing, an impeller carried in the housing, and a guidewire insertion assist device removably carried in the housing. The guide wire insertion assisting device is not provided with a through cavity.

Description

Cross - reference to related patent applications

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 384,333, filed on Nov. 18, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0002] The present invention relates to percutaneous circulatory support devices and associated components. More particularly, the present invention relates to a guide wire insertion assistance device for a percutaneous circulatory support device. Background Art

[0003] Percutaneous circulatory support devices, such as blood pumps, can provide short-term support for patients with impaired cardiac function or cardiac output for up to about several weeks. Such devices are typically delivered to a patient's heart using a guide wire. More specifically, the distal end of the guide wire is inserted into the patient's body and positioned within the patient's heart, while the proximal end of the guide wire remains outside the patient's body. The proximal end of the guide wire is then inserted through the percutaneous circulatory support device such that the device can be translated along the guide wire to the patient's heart. However, inserting the guide wire through the percutaneous circulatory support device may damage the delicate components of the device. Summary of the Invention

[0004] In Example 1, a percutaneous circulatory support system includes: a percutaneous circulatory support device including: a housing; an impeller carried in the housing; and a guide wire insertion assistance device configured to be removably carried in the housing, the guide wire insertion assistance device having no through cavity.

[0005] In Example 2, the percutaneous circulatory support system of Example 1, wherein the guide wire insertion assistance device is configured to be translatably coupled to the guide wire.

[0006] In Example 3, the percutaneous circulatory support system of Example 2, wherein the guide wire insertion assistance device includes a coupler for translatably coupling to the guide wire.

[0007] In Example 4, the percutaneous circulatory support system of Example 2, wherein the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assistance device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

[0008] In Example 5, the percutaneous circulatory support system of Example 4, wherein the guide wire insertion assistance device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

[0009] In Example 6, the percutaneous circulatory support system of any one of Examples 4-5, wherein the proximal portion of the guide wire insertion assistance device is disposed outwardly from the blood outlet.

[0010] In Example 7, a percutaneous circulatory support system includes a percutaneous circulatory support device, the percutaneous circulatory support device including: a housing; an impeller carried in the housing; and a guide wire insertion assisting device configured to be removably carried in the housing; wherein the guide wire insertion assisting device is configured to be translatably coupled to a guide wire.

[0011] In Example 8, the percutaneous circulatory support system of Example 7, wherein the guide wire insertion assisting device includes a coupler for translatably coupling to a guide wire.

[0012] In Example 9, the percutaneous circulatory support system of any one of Examples 7 - 8, wherein the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assisting device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

[0013] In Example 10, the percutaneous circulatory support system of Example 9, wherein the guide wire insertion assisting device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

[0014] In Example 11, the percutaneous circulatory support system of any one of Examples 9 - 10, wherein the proximal portion of the guide wire insertion assisting device is disposed outwardly from the blood outlet.

[0015] In Example 12, a method of manufacturing a percutaneous circulatory support system includes: providing a percutaneous circulatory support device including a housing and an impeller carried in the housing; providing a guide wire insertion assisting device having no through - cavity; and removably positioning the guide wire insertion assisting device in the housing of the percutaneous circulatory support device.

[0016] In Example 13, the method of Example 12, wherein the guide wire insertion assisting device includes a coupler for translatably coupling to a guide wire.

[0017] In Example 14, the method of any one of Examples 12 - 13, further comprising providing a guide wire detached from the guide wire insertion assisting device.

[0018] In Example 15, the method of any one of Examples 12 - 14, wherein the percutaneous circulatory support device further includes a cannula coupled to the housing, and the method further includes removably positioning the guide wire insertion assisting device in the cannula.

[0019] In Example 16, a percutaneous circulatory support system includes: a percutaneous circulatory support device including: a housing; an impeller carried in the housing; and a guide wire insertion assisting device configured to be removably carried in the housing; wherein the guide wire insertion assisting device is configured to be translatably coupled to a guide wire.

[0020] In Example 17, the percutaneous circulatory support system of Example 16, wherein the guide wire insertion assisting device includes a connector for translatably coupling to the guide wire.

[0021] In Example 18, the percutaneous circulatory support system of Example 16, wherein the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assisting device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

[0022] In Example 19, the percutaneous circulatory support system of Example 18, wherein the guide wire insertion assisting device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

[0023] In Example 20, the percutaneous circulatory support system of Example 19, wherein the proximal portion of the guide wire insertion assisting device is disposed outwardly from the blood outlet.

[0024] In Example 21, the percutaneous circulatory support system of Example 16, wherein the guide wire insertion assisting device has no through cavity.

[0025] In Example 22, a percutaneous circulatory support system includes: a percutaneous circulatory support device including: a housing; an impeller carried in the housing; a guide wire insertion assisting device removably carried in the housing; and a guide wire; wherein the guide wire insertion assisting device and the guide wire are configured to be translatably coupled such that subsequent removal of the guide wire insertion assisting device from the housing pulls the guide wire through the housing.

[0026] In Example 23, the percutaneous circulatory support system of Example 22, wherein the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assisting device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

[0027] In Example 24, the percutaneous circulatory support system of Example 23, wherein the guide wire insertion assisting device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

[0028] In Example 25, the percutaneous circulatory support system of Example 23, wherein the proximal portion of the guide wire insertion assisting device is disposed outwardly from the blood outlet.

[0029] In Example 26, the percutaneous circulatory support system of Example 22, wherein the guide wire insertion assisting device includes a connector for translatably coupling to the guide wire.

[0030] In Example 27, the percutaneous circulatory support system of Example 22, wherein the guide wire includes a connector for translatably coupling to the guide wire insertion assisting device.

[0031] In Example 28, the percutaneous circulatory support system of Example 22, wherein the wire insertion assisting device has no through cavity.

[0032] In Example 29, a method of manufacturing a percutaneous circulatory support system includes: providing a percutaneous circulatory support device including a housing and an impeller carried in the housing; providing a wire insertion assisting device configured to be translatably fixed to a guide wire; and removably positioning the wire insertion assisting device in the housing of the percutaneous circulatory support device.

[0033] In Example 30, the method of Example 29, wherein the wire insertion assisting device includes a coupler for translatably coupling to the guide wire.

[0034] In Example 31, the method of Example 29, wherein the wire insertion assisting device has no through cavity.

[0035] In Example 32, the method of Example 29, further comprising providing a guide wire detachable from the wire insertion assisting device.

[0036] In Example 33, the method of Example 32, wherein the guide wire includes a coupler for translatably coupling to the wire insertion assisting device.

[0037] In Example 34, the method of Example 29, wherein the percutaneous circulatory support device further includes a cannula coupled to the housing, and the method further comprises removably positioning the wire insertion assisting device in the cannula.

[0038] In Example 35, the method of Example 34, wherein the percutaneous circulatory support device further includes a flexible distal tip portion coupled to the cannula opposite the housing, and the method further comprises removably positioning the wire insertion assisting device in the flexible distal tip portion.

[0039] Although multiple embodiments have been disclosed, other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the present invention. Accordingly, the nature of the drawings and the detailed description should be regarded as illustrative rather than restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 is a side cross-sectional view of an illustrative percutaneous circulatory support system including a percutaneous circulatory support device (also interchangeably referred to herein as a "blood pump") and a wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0041] Figure 2 is according to an embodiment of the subject matter disclosed herein Figure 1 side view of the wire insertion assisting device and an illustrative guide wire;

[0042] Figure 3 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0043] Figure 4 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0044] Figure 5 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0045] Figure 6 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0046] Figure 7 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0047] Figure 8 is a side view of another guide wire insertion assisting device in an initial configuration according to an embodiment of the subject matter disclosed herein;

[0048] Figure 9 is a guide wire insertion assisting device in a coupled configuration that is translatably coupled to a guide wire Figure 8 of another side view;

[0049] Figure 10 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0050] Figure 11 is a side view of another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0051] Figure 12 is a side cross-sectional view of yet another guide wire insertion assisting device according to an embodiment of the subject matter disclosed herein;

[0052] Figure 13 is Figure 12 of a side view of a guide wire insertion assisting device;

[0053] Figure 14 is a diagram of a method of manufacturing a percutaneous circulatory support system according to an embodiment of the subject matter disclosed herein;

[0054] Figure 15 is a diagram of a method of using a percutaneous circulatory support system according to an embodiment of the subject matter disclosed herein.

[0055] While the present invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will be described in more detail below. However, the present invention is not intended to limit the invention to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claims. Detailed Description

[0056] Figure 1 FIG. 6 depicts a partial side cross-sectional view of an illustrative percutaneous circulatory support system 100 in accordance with an embodiment of the subject matter disclosed herein. System 100 includes a percutaneous circulatory support device 102 (also interchangeably referred to herein as a “blood pump”), a guidewire insertion assist device 104, a guidewire (shown elsewhere), and an introducer sheath (not shown). The guidewire insertion assist device 104 initially extends through the device 102 (i.e., prior to providing the system 100 to a medical practitioner, the guidewire insertion assist device 104 extends through the device 102), and as described in further detail below, facilitates insertion of the guidewire into the device 102 without potentially damaging the delicate components of the device 102. After the guidewire is inserted into the device 102, the guidewire and the introducer sheath can be used to percutaneously deliver the device 102 to a target location within a patient's body. More specifically, the device 102 can be translated along the guidewire to deliver the device 102 to the target location. The target location can be within the patient's heart. Alternatively, the device 102 can be delivered to a different target location within the patient's body. The introducer sheath and / or other devices can be used to facilitate delivery of the device 102.

[0057] Continuing reference Figure 1 FIG. 7, the device 102 generally includes a flexible distal tip portion 106, a cannula 108, an impeller portion 110, and a proximal catheter (not shown). During operation, the device 102 can be positioned such that the distal tip portion 106 is located in close proximity to or in contact with the wall of the patient's left ventricle 16, e.g., at the location of the apex of the left ventricle. The cannula 108 can be partially positioned within the left ventricle and extend through the patient's aortic valve. The impeller portion 110 and the catheter can be positioned within the patient's aorta.

[0058] In some embodiments, the impeller portion 110 includes an impeller housing 112 and a motor housing 114. The impeller housing 112 and the motor housing 114 can be integrally or monolithically constructed. In other embodiments, the impeller housing 112 and the motor housing 114 can be separate components configured to be removably or permanently coupled. In some embodiments, the device 102 may lack the motor housing 114.

[0059] The impeller housing 112 houses the impeller assembly 116 therein. The impeller assembly 116 includes an impeller shaft 118 rotatably supported by at least one bearing, such as bearing 120. The impeller assembly 116 also includes an impeller 122 that rotates relative to the impeller housing 112 to drive blood through the device 102. More specifically, the impeller 122 causes blood to flow from the blood inlet 124 of the cannula 108, through the cannula 108 and the impeller housing 112, and out of the blood outlet 126 formed in the impeller housing 112. In some embodiments and as shown, the impeller shaft 118 and the impeller 122 may be separate components, and in other embodiments, the impeller shaft 118 and the impeller 122 may be integral. In some embodiments and as shown, the inlet 124 and / or the outlet 126 may each include a plurality of holes. In other embodiments, the inlet 124 and / or the outlet 126 may each include a single hole. In some embodiments and as shown, the inlet 124 may be formed on the side of the cannula 108, and the outlet 126 may be formed on the side of the impeller housing 112.

[0060] Continuing to refer Figure 1 , the motor housing 114 houses the motor 128, and the motor 128 is configured to rotatably drive the impeller 122 relative to the impeller housing 112. In the illustrated embodiment, the motor 128 rotates a drive shaft 130 that is coupled to a drive magnet 132. The rotation of the drive magnet 132 causes the rotation of a driven magnet 134 that is connected to and rotates with the impeller assembly 116. More specifically, in embodiments incorporating the impeller shaft 118, the impeller shaft 118 and the impeller 122 are configured to rotate with the driven magnet 134. In other embodiments, the motor 128 may be coupled to the impeller assembly 116 via other components. As described above, the rotation of the impeller 122 causes blood to flow through the device 102.

[0061] In some embodiments, a controller (not shown) may be operably coupled to the motor 128 and configured to control the motor 128. In some embodiments, the controller may be disposed within the motor housing 114. In other embodiments, the controller may be disposed external to the motor housing 114 (e.g., within a catheter handle, a separate housing, etc.). In some embodiments, the controller may include multiple components, one or more of which may be disposed within the motor housing 114. According to embodiments, the controller may be, may include one or more field programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components, or may be included therein. Although the controller is referred to herein in the singular, the controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc. In other embodiments, the motor 128 may be controlled in other ways.

[0062] Further reference Figure 1 And as briefly described above, the guidewire insertion assist device 104 initially extends through the device 102. More specifically, the guidewire insertion assist device 104 extends through the lumen 136 of the distal tip portion 106, through the lumen 138 of the cannula 108, into the interior 140 of the impeller housing 112, and out of the blood outlet 126 of the impeller housing 112. Thus, the distal portion 142 of the guidewire insertion assist device 104 may initially be disposed distally relative to the distal tip portion 106, and the opposing proximal portion 144 of the guidewire insertion assist device 104 may initially be disposed proximally relative to the blood outlet 126. In some embodiments, such as embodiments in which the device 102 does not have a distal tip portion 106, the guidewire insertion assist device 104 may extend into the blood inlet 124 of the cannula 108, through the cannula 108, into the interior 140 of the impeller housing 112, and out of the blood outlet 126 of the impeller housing 112. In such embodiments, the distal portion 142 of the guidewire insertion assist device 104 may initially be disposed distally relative to the blood inlet 124 of the cannula 108.

[0063] Now refer Figure 1 and Figure 2, the guidewire insertion assist device 104 can generally be an elongate flexible wire or cable suitable for pulling a guidewire into the device 102. The guidewire insertion assist device 104 can be constructed of various suitable materials, such as relatively soft biocompatible metals, polymers, composite materials, and the like. In some embodiments, the guidewire insertion assist device 104 or portions thereof have sufficient flexibility such that the guidewire insertion assist device 104 initially does not deform the distal tip portion 106 of the device 102. For example, in some embodiments, the guidewire insertion assist device 104 can be configured such that it can be heat set or shaped to maintain the shape of the distal tip portion 106. The required flexibility can be achieved by varying the shape along the guidewire insertion assist device 104, constructing the guidewire insertion assist device 104 of various materials, or by other known means. In some embodiments, the distal portion of the guidewire insertion assist device 104 can be constructed differently from the proximal portion of the guidewire insertion assist device 104 to achieve the required flexibility in the distal portion.

[0064] Continue to refer to Figure 2, the guidewire insertion assist device 104 can include a coupler 146 for translatably coupling to a guidewire 148 (i.e., coupling such that the guidewire insertion assist device 104 and the guidewire 148 can be translated together). As shown, the coupler 146 can be disposed at the distal portion 142 of the guidewire insertion assist device 104. The coupler 146 can take various forms. For example, the coupler 146 can be or include one or more temporary fasteners such as a threaded surface, a blind hole (i.e., a hole including a single opening), a snap connector, a press-fit connector, or a magnetic connector, one or more permanent fasteners such as a crimp connector, or any of the other structures contemplated herein. Some of these examples and others are described in further detail below. The guidewire 148 can also include a coupler 150 for translatably coupling to the guidewire insertion assist device 104, and more specifically to the coupler 146 of the guidewire insertion assist device 104. As shown, the coupler 150 can be disposed at the proximal portion 152 of the guidewire 148. The coupler 150 can take various forms. For example, the coupler 150 can be or include one or more temporary fasteners such as a threaded surface, a blind hole, a snap connector, a press-fit connector, or a magnetic connector, one or more permanent fasteners such as a crimp connector, or any of the other structures contemplated herein. In some embodiments, the guidewire 148 can be a conventional guidewire (i.e., the guidewire 148 may lack the coupler 150). In some embodiments, the guidewire 148 can include the coupler 150, and the guidewire insertion assist device 104 may lack the coupler 146. It is contemplated that various types of guidewires can be used in combination with the guidewire insertion assist device 104. For example, guidewires of different sizes, including guidewires having a diameter of 0.014 inches, 0.018 inches, or other common sizes, can be used with the guidewire insertion assist device 104. It is also contemplated that guidewire insertion assist devices of different sizes can be used for corresponding different-sized guidewires. Additionally, it is contemplated that the coupler 146 can be configured such that the guidewire insertion assist device 104 can be coupled to various different-sized guidewires.

[0065] In some embodiments and as shown, the guidewire insertion assist device 104 does not have a through lumen (i.e., a cavity including two openings) through which a guidewire can extend. For example, the guidewire insertion assist device 104 can include a short cavity that does not extend the entire length of the assist device 104 such that most of the length of the assist device 104 does not have a cavity. An example of such an embodiment includes a guidewire insertion assist device 104 that includes a loading assist device connector tube that is coupled to a loading assist device wire. In such an embodiment, the loading assist device connector tube includes a cavity, and the loading assist device wire does not include a cavity, and the loading assist device connector tube is used to couple the loading assist device wire to the guidewire.

[0066] As shown, the guidewire insertion aid 104 may have generally the same dimensions (more specifically, diameter) as the guidewire 148. In other embodiments, the guidewire insertion aid 104 may have generally different dimensions (more specifically, diameter) from the guidewire 148.

[0067] Reference Figure 3 , a guidewire insertion aid 300 according to an embodiment of the subject matter disclosed herein is shown. The guidewire insertion aid 300 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 300 includes similar features and is used in a manner similar to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 300 specifically includes a collapsible structure 302, such as a collapsible braided structure. The collapsible structure 302 is encapsulated within an undersized outer sheath 304, such as a polymeric sheath, and is coupled to a main wire 306. By inserting the proximal end of the guidewire into the distal opening 308 and lumen 310 of the collapsible structure 302, the collapsible structure 302 expands. However, the undersized outer sheath 304 compresses the collapsible structure 302 onto the guidewire and thereby provides a frictional engagement between the collapsible structure 302 and the guidewire. Thereby, the guidewire is translatably coupled to the guidewire insertion aid 300, and the guidewire can be pulled through the blood pump by pulling on the main wire 306 of the guidewire insertion aid 300. In some embodiments, the coupler for the guidewire may include the collapsible structure 302.

[0068] Reference Figure 4 , a guidewire insertion aid 400 according to an embodiment of the subject matter disclosed herein is shown. The guidewire insertion aid 400 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 400 includes similar features and is used in a manner similar to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 400 specifically includes a tube 402 having one or more relatively narrow portions 404 (illustratively, two narrow portions 404), or indentations or "pinches" within a lumen 406. The tube 402 is coupled to a main wire 408. When the proximal end of the guidewire is inserted into the distal opening 410 and lumen 406 of the tube 402, the narrow portions 404 frictionally engage the guidewire. Thereby, the guidewire is translatably coupled to the guidewire insertion aid 400, and the guidewire can be pulled through the blood pump by pulling on the main wire 408 of the guidewire insertion aid 400. In some embodiments, the coupler for the guidewire may include the tube 402.

[0069] Reference Figure 5, shows a guide wire insertion assist device 500 according to an embodiment of the subject matter disclosed herein. The guide wire insertion assist device 500 is configured to couple to a guide wire, such as the guide wire 148 described herein. The guide wire insertion assist device 500 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 500 specifically includes a tube 502 having one or more relatively narrow portions 504 (illustratively, two narrow portions 504), or indentations or inwardly curved "fingers" within a lumen 506. The tube 502 is coupled to a main wire 508. When the proximal end of the guide wire is inserted into the distal opening 510 and the lumen 506 of the tube 502, the narrow portions 504 frictionally engage the guide wire. Thereby, the guide wire is translatably coupled to the guide wire insertion assist device 500, and the guide wire can be pulled through the blood pump by pulling on the main wire 508 of the guide wire insertion assist device 500. In some embodiments, the coupler for the guide wire can include the tube 502.

[0070] Reference Figure 6 , shows a guide wire insertion assist device 600 according to an embodiment of the subject matter disclosed herein. The guide wire insertion assist device 600 is configured to couple to a guide wire, such as the guide wire 148 described herein. The guide wire insertion assist device 600 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 600 specifically includes an outer tube 602 that houses an internal flexible sleeve 604, such as an elastomeric polymer sleeve. The outer tube 602 and the inner sleeve 604 are coupled to a main wire 606. The diameter of the lumen 608 of the inner sleeve 604 is slightly smaller than the diameter of the guide wire. When the proximal end of the guide wire is inserted into the distal opening 610 and the lumen 608 of the inner sleeve 604, the inner sleeve 604 compresses against and frictionally engages the guide wire. Thereby, the guide wire is translatably coupled to the guide wire insertion assist device 600, and the guide wire can be pulled through the blood pump by pulling on the main wire 606 of the guide wire insertion assist device 600. In some embodiments, the coupler for the guide wire can include the outer tube 602 and the inner sleeve 604.

[0071] Reference Figure 7, shows a guide wire insertion assist device 700 according to an embodiment of the subject matter disclosed herein. The guide wire insertion assist device 700 is configured to couple to a guide wire, such as the guide wire 148 described herein. The guide wire insertion assist device 700 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 700 specifically includes a tube 702 having one or more bends 704. Illustratively, the tube 702 includes two bends 704 in a common plane. In other embodiments, the tube 702 may include bends 704 in various planes (i.e., the tube 702 may be bent in a three-dimensional manner). In any case, the tube 702 is coupled to a main wire 706. After the proximal end of the guide wire is inserted into the distal opening 708 and lumen 712 of the tube 702, the main wire 706 is pulled by a practitioner, and the bends 704 frictionally engage the guide wire. Thereby, the guide wire is translatably coupled to the guide wire insertion assist device 700, and the guide wire can be pulled through the blood pump by pulling the main wire 706 of the guide wire insertion assist device 700. In other embodiments, the tube 702 may initially be straight, and after the guide wire is inserted into the tube 702, the tube 702 may be bent by a practitioner to translatably couple the guide wire to the guide wire insertion assist device 700. In some embodiments, the coupler for the guide wire may include the tube 702.

[0072] Reference Figure 8 and Figure 9 , shows a guide wire insertion assist device 800 according to an embodiment of the subject matter disclosed herein. Figure 8 Shows the guide wire insertion assist device 800 in its initial configuration, and Figure 9 shows the guide wire insertion assist device 800 in a coupled configuration, where the assist device 800 is coupled to a guide wire 802. The guide wire 802 may be the same or similar to the guide wire 148 described herein. The guide wire insertion assist device 800 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 800 specifically includes a plurality of legs 804 (illustratively, two legs 804), a main wire 806, and a slidable chuck 808. The legs 804 define a lumen 810 therebetween ( Figure 8) for receiving a guide wire 802. After the guide wire 802 is received in the cavity 810, an actuator, such as a push wire 812, is actuated to cause the chuck 808 to slide on the legs 804 to compress the legs 804 and thereby clamp the guide wire 802. Thus, the guide wire 802 is translatably coupled to the guide wire insertion assist device 800, and the guide wire 802 can be pulled through the blood pump by pulling on the main wire 806 of the guide wire insertion assist device 800. In some embodiments, the legs 804 may include one or more stoppers (not shown) to prevent the chuck 808 from detaching from the legs 804. In some embodiments, the chuck 808 may include a textured surface and / or a greater profile to facilitate gripping the guide wire 802. In some embodiments, the legs 804 may include a textured surface to facilitate gripping the guide wire 802. In some embodiments, the chuck 808 may be used with a high-force on / off tool to facilitate gripping the guide wire 802 and allow for easy reopening of the assist device 800. In some embodiments, the assist device 800 may include a stop feature (not shown - e.g., a wire or mandrel disposed between the legs 804) to limit the length of the coupling interface with the guide wire 802. In some embodiments, the assist device 800 may include a high-contrast differential color scheme to facilitate easy identification and use of the components of the assist device 800. In some embodiments, the various edges of the assist device 800 may be chamfered or rounded to reduce or eliminate catch points. In some embodiments, the coupler for the guide wire may include the legs 804 and the slidable chuck 808.

[0073] Reference Figure 10 , shows a guide wire insertion assist device 1000 according to an embodiment of the subject matter disclosed herein. The guide wire insertion assist device 1000 is configured to couple to a guide wire, such as the guide wire 148 described herein. The guide wire insertion assist device 1000 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 1000 specifically includes a tube 1002 having one or more longitudinally extending slots 1004 (illustratively, one slot 1004). The tube 1002 is coupled to the main wire 1006. The diameter of the cavity 1008 of the tube 1002 is slightly smaller than the diameter of the guide wire. When the proximal end of the guide wire is inserted into the distal opening 1010 and the cavity 1008 of the tube 1002, the tube 1002 expands at the slot 1004 and clamps the guide wire. Thus, the guide wire is translatably coupled to the guide wire insertion assist device 1000, and the guide wire can be pulled through the blood pump by pulling on the main wire 1006 of the guide wire insertion assist device 1000. In some embodiments, the coupler for the guide wire may include the tube 1002.

[0074] Reference Figure 11, shows a guide wire insertion assist device 1100 according to an embodiment of the subject matter disclosed herein. The guide wire insertion assist device 1100 is configured to be coupled to a guide wire, such as the guide wire 148 described herein. The guide wire insertion assist device 1100 includes similar features and is used in a manner similar to the guide wire insertion assist device 104 described herein. As a coupler for coupling to a guide wire, the guide wire insertion assist device 1100 specifically includes a coil 1102 coupled to a main wire 1104. The inner diameter of the coil 1102 is slightly smaller than the diameter of the guide wire. When the proximal end of the guide wire is inserted into the distal opening 1106 of the coil 1102, the coil 1102 expands outwardly and clamps the guide wire. Thereby, the guide wire is translatably coupled to the guide wire insertion assist device 1100, and the guide wire can be pulled through the blood pump by pulling on the main wire 1104 of the guide wire insertion assist device 1100. In some embodiments, the coupler for the guide wire may include the coil 1102.

[0075] Reference Figure 12 and Figure 13, shows a low-profile guidewire insertion assist device 1200 according to an embodiment of the subject matter disclosed herein. The guidewire insertion assist device 1200 is shown in a coupled configuration, where the assist device 1200 is coupled to a guidewire 1202. The guidewire 1202 may be the same or similar to the guidewire 148 described herein. The guidewire insertion assist device 1200 includes similar features and is used in a manner similar to the guidewire insertion assist device 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion assist device 1200 specifically includes a body 1204 having a base portion 1206 and a plurality of legs 1208 (illustratively, two legs 1208). The coupler also includes a slidable chuck 1210. The legs 1208 define a cavity 1212 therebetween for receiving the guidewire 1202. After the guidewire 1202 is received in the cavity 1212 and preferably contacts the guidewire 1202 against the main wire 1214 of the loading assist device 1200, an actuator, such as a push wire 812 (not shown), is actuated to slide the chuck 1210 along the legs 1208 to compress the legs 1208 and thereby clamp the guidewire 1202. Thereby, the guidewire 1202 is translatably coupled to the guidewire insertion assist device 1200, and the guidewire 1202 can be pulled through the blood pump by pulling on the main wire 1214 of the guidewire insertion assist device 1200. In some embodiments, the outer diameter of the base portion 1206 may be greater than the inner diameter of the chuck 1210 to prevent the chuck 1210 from translating proximally along the main wire 1214. In some embodiments, the base portion 1206 may have an outer diameter of about 0.021 inches to 0.031 inches, more specifically, about 0.026 inches, and the chuck 1210 may have an inner diameter of about 0.019 inches to 0.029 inches, more specifically, about 0.024 inches. In some embodiments, the coupler for the guidewire may include a body 1204 and a slidable chuck 1210.

[0076] Reference Figure 14 , a method of assembling a percutaneous circulatory support system according to an embodiment of the subject matter disclosed herein may be generally as follows. The method describes the features of the system 100, but it should be understood that any system contemplated herein may be used in a similar manner. At block 1400, a device 102 and a guidewire insertion assist device 104 are provided. At block 1402, the guidewire insertion assist device 104 is removably positioned in the impeller housing 112, cannula 108, and distal tip portion 106 of the device 102 and set up as Figure 1As shown above. The above actions can be performed in a manufacturing environment (i.e., a non-medical environment). At block 1404, the device 102 having the guide wire insertion assist device 104 positioned therein is packaged for use by a medical practitioner (e.g., a surgeon, a nurse, a medical environment manager, etc.). The guide wire 148 removed from the guide wire insertion assist device 104 can also be packaged for use by a medical practitioner.

[0077] Reference Figure 15 , according to an embodiment of the subject matter disclosed herein, a method of using a percutaneous circulatory support system can be generally as follows. The method describes the features of the system 100, but it should be understood that any system contemplated herein can be used in a similar manner. At block 1500, the device 102 and the guide wire 148 are received by a medical practitioner. When the device 102 is received, the guide wire insertion assist device 104 is removably carried and set by the impeller housing 112 of the device 102, e.g., as Figure 1 shown. At block 1502, the distal portion of the guide wire 148 is inserted into a patient and advanced to a target location within the patient. At block 1504, the guide wire 148 is coupled to the guide wire insertion assist device 104, e.g., via a coupler 146 at the distal portion 142 of the guide wire insertion assist device 104 and / or a coupler 150 at the proximal portion 152 of the guide wire 148. At block 1506, the guide wire insertion assist device 104 is removed from the impeller housing 112 of the device 102 to pull the guide wire 148 into the impeller housing 112. More specifically, the guide wire insertion assist device 104 is pulled out from the blood outlet 126 to pull the proximal portion 152 of the guide wire 148 through the distal tip portion 106, the cannula 108, the impeller housing 112, and the blood outlet 126. The guide wire insertion assist device 104 can then be detached from the guide wire 148, or the guide wire insertion assist device 104 can remain coupled to the guide wire 148. At block 1508, the device 102 is advanced along the guide wire 148 and positioned at a target location within the patient. At block 1510, the guide wire 148 is pulled proximally and thereby removed from the device 102 and the patient. At block 1512, the device is powered on to rotate the impeller 122 relative to the impeller housing 112 and cause blood to flow through the device 102.

[0078] As described above, the guide wire insertion assist device according to the present invention initially extends through the percutaneous circulatory support device and facilitates the insertion of the guide wire into the device. Due to the guide wire insertion assist device being positioned within the device located in a manufacturing environment (i.e., not positioned by a medical practitioner) and / or due to the material of the guide wire insertion assist device, embodiments according to the present invention avoid damage to the delicate components of the percutaneous circulatory support device that might otherwise be caused by the insertion of the guide wire.

[0079] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the above embodiments relate to specific features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the recited features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, as well as all equivalents thereof.

Claims

1. A percutaneous circulatory support system, comprising: A percutaneous circulatory support device, the percutaneous circulatory support device comprising: A housing; An impeller carried in the housing; and A guide wire insertion assisting device configured to be removably carried in the housing, the guide wire insertion assisting device having no through cavity.

2. The percutaneous circulatory support system according to claim 1, wherein, The guide wire insertion assisting device is configured to be translatably coupled to a guide wire.

3. The percutaneous circulatory support system according to claim 2, wherein, The guide wire insertion assisting device includes a coupler for translatably coupling to the guide wire.

4. The percutaneous circulatory support system according to claim 2, wherein, The percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assisting device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

5. The percutaneous circulatory support system according to claim 4, wherein, The guide wire insertion assisting device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

6. The percutaneous circulatory support system according to any one of claims 4 to 5, wherein, The proximal portion of the guide wire insertion assisting device is disposed outwardly from the blood outlet.

7. A percutaneous circulatory support system, comprising: A percutaneous circulatory support device, the percutaneous circulatory support device comprising: A housing; An impeller carried in the housing; and A guide wire insertion assisting device configured to be removably carried in the housing; wherein the guide wire insertion assisting device is configured to be translatably coupled to a guide wire.

8. The percutaneous circulatory support system according to claim 7, wherein, The guide wire insertion assisting device includes a coupler for translatably coupling to the guide wire.

9. The percutaneous circulatory support system according to any one of claims 7 to 8, wherein, The percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guide wire insertion assisting device is configured to be removed from the housing through the blood outlet to pull the guide wire through the blood outlet.

10. The percutaneous circulatory support system according to claim 9, wherein, The guide wire insertion assisting device includes a proximal portion and a distal portion, and the distal portion is disposed distally relative to the blood inlet.

11. The percutaneous circulatory support system according to any one of claims 9 to 10, wherein, The proximal portion of the guide wire insertion assisting device is disposed outwardly from the blood outlet.

12. A method of manufacturing a percutaneous circulatory support system, the method comprising: Provided is a percutaneous circulatory support device, the percutaneous circulatory support device including a housing and an impeller carried in the housing; Provided is a guide wire insertion assisting device, the guide wire insertion assisting device having no through cavity; And Positioning the guide wire insertion assisting device removably in the housing of the percutaneous circulatory support device.

13. The method according to claim 12, wherein, The guide wire insertion assisting device includes a coupler for translatably coupling to the guide wire.

14. The method according to any one of claims 12 to 13, further comprising providing the guide wire detached from the guide wire insertion assisting device.

15. The method according to any one of claims 12 to 14, wherein, The percutaneous circulatory support device further includes a cannula coupled to the housing, and the method further includes removably positioning the guide wire insertion assisting device in the cannula.

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