Guidewire insertion aid for percutaneous circulatory assist devices

Abstract

The percutaneous circulatory assist system includes a percutaneous circulatory assist device having a housing, an impeller carried within the housing, and a guidewire insertion aid removably carried within the housing, the guidewire insertion aid lacking a through lumen.

Description

[Technical Field]

[0001] The present disclosure relates to percutaneous circulatory assist devices and related components, and more particularly to guidewire insertion aids for percutaneous circulatory assist devices. [Background technology]

[0002] Percutaneous circulatory assist devices, such as blood pumps, can provide temporary assistance for up to approximately several weeks in patients with reduced cardiac function or cardiac output. Such devices are typically delivered to a patient's heart using a guidewire. More specifically, the distal end of the guidewire is inserted into the patient and positioned within the patient's heart, while the proximal end of the guidewire remains external to the patient. The proximal end of the guidewire is then inserted into a percutaneous circulatory assist device, allowing the device to be moved along the guidewire to the patient's heart. However, inserting the guidewire through the percutaneous circulatory assist device can damage delicate components of the device. Summary of the Invention

[0003] In Example 1, a percutaneous circulatory assist system includes a percutaneous circulatory assist device having a housing and an impeller carried within the housing, and a guidewire insertion aid configured to be removably carried within the housing, the guidewire insertion aid lacking a through lumen.

[0004] In Example 2, the percutaneous circulatory assist system of Example 1, wherein the guidewire insertion aid is configured to be movably coupled to the guidewire. In Example 3, in the percutaneous circulatory assist system of Example 2, the guidewire insertion aid comprises a coupler for movably coupling to the guidewire.

[0005] In Example 4, the percutaneous circulatory assist system of Example 2 is configured such that the percutaneous circulatory assist device has a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

[0006] In Example 5, in the percutaneous circulatory assist system of Example 4, the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned distally relative to the blood inlet.

[0007] In Example 6, in the percutaneous circulatory assist system according to any one of Examples 4 and 5, the proximal end of the guidewire insertion aid is arranged outward from the blood outlet. In Example 7, a percutaneous circulatory assist system includes a percutaneous circulatory assist device having a housing and an impeller carried within the housing, and a guidewire insertion aid configured to be removably carried within the housing, the guidewire insertion aid configured to be movably coupled to a guidewire.

[0008] In Example 8, in the percutaneous circulatory assist system of Example 7, the guidewire insertion aid comprises a coupler for movably coupling to the guidewire. In Example 9, in the percutaneous circulatory assist system described in any of Examples 7 to 8, the percutaneous circulatory assist device has a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

[0009] In Example 10, the percutaneous circulatory assist system of Example 9, wherein the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned distally relative to the blood inlet.

[0010] In Example 11, in the percutaneous circulatory assist system according to any one of Examples 9 and 10, the proximal end of the guidewire insertion aid is arranged outward from the blood outlet. In Example 12, a method of manufacturing a percutaneous circulatory assist system includes providing a percutaneous circulatory assist device having a housing and an impeller carried within the housing, providing a guidewire insertion aid lacking a through lumen, and removably disposing the guidewire insertion aid within the housing of the percutaneous circulatory assist device.

[0011] In Example 13, the method of Example 12, wherein the guidewire insertion aid comprises a coupler for movably coupling to a guidewire. In Example 14, the method of any one of Examples 12-13 further comprises providing the guidewire to be detached from the guidewire insertion aid.

[0012] In Example 15, in the method of any of Examples 12 to 14, the percutaneous circulatory assist device further comprises a cannula coupled to the housing, and further comprises removably disposing the guidewire insertion aid within the cannula.

[0013] In Example 16, a percutaneous circulatory assist system includes a percutaneous circulatory assist device having a housing and an impeller carried within the housing, and a guidewire insertion aid configured to be removably carried within the housing, the guidewire insertion aid configured to be movably coupled to a guidewire.

[0014] In Example 17, in the percutaneous circulatory assist system of Example 16, the guidewire insertion aid comprises a coupler for movably coupling to the guidewire. In Example 18, the percutaneous circulatory assist system of Example 16, wherein the percutaneous circulatory assist device has a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

[0015] In Example 19, the percutaneous circulatory assist system of Example 18, wherein the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned relatively distal from the blood inlet.

[0016] In Example 20, the percutaneous circulatory assist system of Example 19, wherein the proximal end of the guidewire insertion aid is positioned outward from the blood outlet. In Example 21, in the percutaneous circulatory assist system of Example 16, the guidewire insertion aid lacks a through lumen.

[0017] In Example 22, the percutaneous circulatory assist system includes a percutaneous circulatory assist device having a housing and an impeller carried within the housing, a guidewire insertion aid removably carried within the housing, and a guidewire, the guidewire insertion aid and the guidewire being configured to be movably coupled, and subsequent removal of the guidewire insertion aid from the housing causes the guidewire to be pulled through the housing.

[0018] In Example 23, the percutaneous circulatory assist system of Example 22, wherein the percutaneous circulatory assist device has a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

[0019] In Example 24, the percutaneous circulatory assist system of Example 23, wherein the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned distally relative to the blood inlet.

[0020] In Example 25, in the percutaneous circulatory assist system of Example 23, the proximal end of the guidewire insertion aid is positioned outward from the blood outlet. In Example 26, in the percutaneous circulatory assist system of Example 22, the guidewire insertion aid comprises a coupler for movably coupling to the guidewire.

[0021] In Example 27, the percutaneous circulatory assist system of Example 22, wherein the guidewire comprises a coupler for movably coupling to the guidewire insertion aid. In Example 28, in the percutaneous circulatory assist system of Example 22, the guidewire insertion aid lacks a through lumen.

[0022] In Example 29, a method of manufacturing a percutaneous circulatory assist system includes providing a percutaneous circulatory assist device having a housing and an impeller carried within the housing; providing a guidewire insertion aid configured to be movably secured to a guidewire; and removably disposing the guidewire insertion aid within the housing of the percutaneous circulatory assist device.

[0023] In Example 30, the method of Example 29, wherein the guidewire insertion aid comprises a coupler for movably coupling to a guidewire. In Example 31, in the percutaneous circulatory assist system of Example 29, the guidewire insertion aid lacks a through lumen.

[0024] In Example 32, the method of Example 29 further includes providing the guidewire detached from the guidewire insertion aid. In Example 33, the method of Example 32, wherein the guidewire comprises a coupler for movably coupling to the guidewire insertion aid.

[0025] In Example 34, the method of Example 29, wherein the percutaneous circulatory assist device further comprises a cannula coupled to the housing and further comprising removably disposing the guidewire insertion aid within the cannula.

[0026] In Example 35, the method of Example 34, wherein the percutaneous circulatory assist device further comprises a flexible distal tip coupled to the cannula opposite the housing, and further comprising removably disposing the guidewire insertion aid on the flexible distal tip.

[0027] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. [Brief explanation of the drawings]

[0028] [Figure 1] FIG. 1 is a side cross-sectional view of an exemplary percutaneous circulatory assist system including a percutaneous circulatory assist device (also interchangeably referred to herein as a "blood pump") and a guidewire insertion aid, in accordance with an embodiment of the subject matter disclosed herein. [Figure 2] FIG. 2 is a side view of the guidewire insertion aid of FIG. 1 and an exemplary guidewire, according to an embodiment of the subject matter disclosed herein. [Figure 3] FIG. 3 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 4] FIG. 4 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 5] FIG. 5 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 6]FIG. 6 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 7] FIG. 7 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 8] FIG. 8 is a side view of another guidewire insertion aid in an initial configuration in accordance with an embodiment of the subject matter disclosed herein. [Figure 9] FIG. 9 is another side view of the guidewire insertion aid of FIG. 8 in a coupled configuration, ie, movably coupled to a guidewire. [Figure 10] FIG. 10 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 11] FIG. 11 is a side view of another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 12] FIG. 12 is a side cross-sectional view of yet another guidewire insertion aid in accordance with an embodiment of the subject matter disclosed herein. [Figure 13] FIG. 13 is a side view of the guidewire insertion aid of FIG. [Figure 14] FIG. 14 is a diagram of a method of manufacturing a percutaneous circulatory assist system according to an embodiment of the presently disclosed subject matter. [Figure 15] FIG. 15 is a diagram of a method of using a percutaneous circulatory assist system according to an embodiment of the presently disclosed subject matter.

[0029] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. It is not, however, the intention to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. DETAILED DESCRIPTION OF THE INVENTION

[0030] FIG. 1 shows a partial side cross-sectional view of an exemplary percutaneous circulatory assist system 100 in accordance with an embodiment of the subject matter disclosed herein. System 100 includes a percutaneous circulatory assist device 102 (also interchangeably referred to herein as a “blood pump”), a guidewire insertion aid 104, a guidewire (shown elsewhere), and an introducer sheath (not shown). Guidewire insertion aid 104 initially extends through device 102 (i.e., guidewire insertion aid 104 extends through device 102 before system 100 is provided to a medical professional), thereby facilitating insertion of the guidewire into device 102 without damaging delicate components of device 102, as described in further detail below. After inserting the guidewire into device 102, the guidewire and introducer sheath can be used to percutaneously deliver device 102 to a target location within a patient. More specifically, device 102 can be moved along the guidewire to deliver device 102 to the target location. This target location may be within the patient's heart. Alternatively, device 102 may be delivered to a different target location within the patient's body. An introducer sheath and / or other devices may be used to facilitate delivery of device 102.

[0031] 1, device 102 generally comprises a flexible distal tip 106, a cannula 108, an impeller portion 110, and a proximal catheter (not shown). In operation, device 102 is positioned with distal tip 106 adjacent to or in contact with the wall of the patient's left ventricle, for example, at the apex of the left ventricle. Cannula 108 may be positioned partially within the left ventricle or may extend through the patient's aortic valve. Impeller portion 110 and the catheter may be positioned within the patient's aorta.

[0032] In some embodiments, the impeller section 110 includes an impeller housing 112 and a motor housing 114. The impeller housing 112 and the motor housing 114 may be integrally or monolithically configured. In other embodiments, the impeller housing 112 and the motor housing 114 may be separate components configured to be removably or permanently coupled. In other embodiments, the device 102 may lack the motor housing 114.

[0033] Impeller housing 112 carries impeller assembly 116 therein. Impeller assembly 116 includes an impeller shaft 118 rotatably supported by at least one bearing, such as bearing 120. Impeller assembly 116 also includes an impeller 122 that rotates relative to impeller housing 112 to drive blood through device 102. More specifically, impeller 122 drives blood to flow from a blood inlet 124 in cannula 108, through cannula 108 and impeller housing 112, and out a blood outlet 126 formed on impeller housing 112. In some embodiments, impeller shaft 118 and impeller 122 may be separate components, as shown, while in other embodiments, impeller shaft 118 and impeller 122 may be integrated. In some embodiments, inlet 124 and / or outlet 126 may each include multiple openings, as shown. In other embodiments, the inlet 124 and / or the outlet 126 may each comprise a single opening. In some embodiments, the inlet 124 may be formed in a side portion of the cannula 108 and the outlet 126 may be formed in a side portion of the impeller housing 112, as shown.

[0034] 1 , the motor housing 114 carries a motor 128 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, which is coupled to a drive magnet 132, the rotation of which causes rotation of a driven magnet 134, which is connected to the impeller assembly 116 and therefore rotates with the impeller assembly 116. More specifically, in embodiments incorporating the impeller shaft 118, the impeller shaft 118 and 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 noted above, rotation of the impeller 122 causes blood to flow through the device 102.

[0035] In some embodiments, a controller (not shown) may be operably coupled to motor 128 and configured to control motor 128. In some embodiments, the controller may be located inside motor housing 114. In other embodiments, the controller may be located outside motor housing 114 (e.g., in a catheter handle, a separate housing, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located inside motor housing 114. According to embodiments, the controller may be, include, or be comprised in 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. Although the controller is referred to herein in the singular, the controller may be implemented in multiple instances, such as distributed across multiple computing devices, embodied in multiple virtual machines, etc. In other embodiments, motor 128 may be controlled in other ways.

[0036] 1 , as briefly described above, the guidewire insertion aid 104 initially extends through the device 102. More specifically, the guidewire insertion aid 104 passes through the lumen 136 of the distal tip 106, extends through the lumen 138 of the cannula 108, extends into the interior 140 of the impeller housing 112, and extends out through the blood outlet 126 of the impeller housing 112. Thus, the distal end 142 of the guidewire insertion aid 104 may initially be positioned distal to the distal tip 106, and the opposite proximal end 144 of the guidewire insertion aid 104 may initially be positioned proximal to the blood outlet 126. In some embodiments (such as those in which the device 102 does not have a distal tip 106), the guidewire insertion aid 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 through the blood outlet 126 of the impeller housing 112. In such embodiments, the distal end 142 of the guidewire insertion aid 104 may initially be positioned distal to the blood inlet 124 of the cannula 108.

[0037] 1 and 2, guidewire insertion aid 104 may generally be an elongated, flexible wire or cable suitable for pulling a guidewire into device 102. Guidewire insertion aid 104 may be constructed from a variety of suitable materials, such as relatively soft, biocompatible metals, polymers, composites, etc. In some embodiments, guidewire insertion aid 104, or portions thereof, are sufficiently flexible so that guidewire insertion aid 104 does not initially deform distal tip 106 of device 102. For example, in some embodiments, guidewire insertion aid 104 may be heat-set or molded to maintain the shape of distal tip 106. The desired flexibility may be achieved by varying the shape of distal tip 106 along guidewire insertion aid 104, by constructing guidewire insertion portion 104 from different materials, or by other known methods. In some embodiments, the distal portion of the guidewire insertion aid 104 may be configured differently than the proximal portion of the guidewire insertion aid 104 to achieve a desired flexibility at the distal portion.

[0038] Continuing with reference to FIG. 2 , the guidewire insertion aid 104 may include a coupler 146 for movably coupling to a moving guidewire 148 (i.e., both the guidewire insertion aid 104 and the guidewire 148 are movable). As shown, the coupler 146 may be located at the distal end 142 of the guidewire insertion aid 104. The coupler 146 may take a variety of forms. For example, the coupler 146 may be or include a threaded surface, a blind hole (i.e., a hole including a single opening), one or more temporary fasteners such as a snap connector, a press-fit connector, or a magnetic connector, one or more permanent fasteners such as a crimp connector, or any other structure understood herein. Some of these and other examples are described in more detail below. The guidewire 148 may include a coupler 150 for movably coupling to the guidewire insertion aid 104, and more specifically, for coupling to the coupler 146 of the guidewire insertion aid 104. As shown, coupler 150 may be disposed at a proximal end 152 of guidewire 148. Coupler 150 may take a variety of forms. For example, coupler 150 may be or comprise 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 other structure understood herein. In some embodiments, guidewire 148 may be a conventional guidewire (i.e., guidewire 148 may lack coupler 150). In some embodiments, guidewire 148 may include coupler 150 and guidewire insertion aid 104 may lack coupler 146. It is contemplated that various types of guidewires may be used in combination with guidewire insertion aid 104. For example, various sizes of guidewires (including guidewires having diameters of 0.0014 inches (0.03556 mm), 0.0018 inches (0.04572 mm), or common sizes) can be used with guidewire insertion aid 104. It is also envisioned that various sizes of guidewire insertion aids can be used to accommodate various sizes of guidewires.It is further envisioned that coupler 146 may be configured so that guidewire insertion aid 104 may be coupled to a variety of different sized guidewires.

[0039] In some embodiments, as shown, the guidewire insertion aid 104 lacks a through lumen (i.e., a lumen including two openings) through which a guidewire extends. For example, the guidewire insertion aid 104 may include a short lumen that does not extend the entire length of the aid 104, such that the majority of the length of the aid 104 is lumen-free. An example of such an embodiment includes a guidewire insertion aid 104 including a loading aid connector tube coupled to a loading aid wire. In one such embodiment, the loading aid connector tube includes a lumen, the loading aid wire does not include a lumen, and the loading aid connector tube is used to couple the loading aid wire to the guidewire.

[0040] As shown, the guidewire insertion aid 104 may have the same standard size (more specifically, diameter) as the guidewire 148. In other embodiments, the guidewire insertion aid 104 may have a different standard size (more specifically, diameter) than the guidewire 148.

[0041] Referring to FIG. 3 , a guidewire insertion aid 300 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 300 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 300 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As with other couplers 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 a small outer sleeve 304, such as a polymer sleeve, and coupled to a main wire 306. Inserting the proximal end of the guidewire through the distal opening 308 and the lumen 310 of the collapsible structure 302 expands the collapsible structure 302. However, the small outer sleeve 304 compresses the collapsible structure 302 onto the guidewire, thereby providing a frictional engagement between the collapsible structure 302 and the guidewire. A guidewire is thereby movably coupled to guidewire insertion aid 300, and the guidewire can be pulled through the blood pump by pulling main wire 306 of guidewire insertion aid 300. In some embodiments, the guidewire coupler can include a foldable structure 302.

[0042] Referring to FIG. 4 , a guidewire insertion aid 400 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 400 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 400 has similar features and is used in a similar manner 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 narrowed portions 404 (shown as two narrowed portions 404), or notches or “pinch points,” within a lumen 406. The tube 402 is coupled to a main wire 408. The narrowed portions 404 frictionally engage the guidewire when the proximal end of the guidewire is inserted through a distal opening 410 of the tube 402 and into the lumen 406. A guidewire is thereby movably engaged to the guidewire insertion aid 400, and the guidewire can be pulled through the blood pump by pulling the main wire 408 of the guidewire insertion aid 400. In some embodiments, the guidewire coupler can include a tube 402.

[0043] Referring to FIG. 5 , a guidewire insertion aid 500 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 500 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 500 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 500 specifically includes a tube 502 having one or more relatively narrowed portions 504 (shown as two narrowed portions 504), or notches or inwardly curved “fingers,” within a lumen 506. The tube 502 is coupled to a main wire 508. The narrowed portions 504 frictionally engage the guidewire when the proximal end of the guidewire is inserted through a distal opening 510 of the tube 502 and into the lumen 506. A guidewire is thereby movably engaged to the guidewire insertion aid 500, and the guidewire can be pulled through the blood pump by pulling on the main wire 508 of the guidewire insertion aid 500. In some embodiments, the guidewire coupler can include a tube 502.

[0044] Referring to FIG. 6 , a guidewire insertion aid 600 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 600 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 600 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 600 specifically includes an outer tube 602 carrying an inner flexible sleeve 604, such as an elastic polymer sleeve. The outer tube 602 and 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 guidewire. When the proximal end of the guidewire is inserted into the distal opening 610 and lumen 608 of the inner sleeve 604, the inner sleeve 604 is compressed against the guidewire to frictionally engage the guidewire. The guidewire is thereby movably coupled to the guidewire insertion aid 600, and the guidewire can be pulled through the blood pump by pulling on the main wire 606 of the guidewire insertion aid 600. In some embodiments, the guidewire coupler can include an outer tube 602 and an inner sleeve 604.

[0045] Referring to FIG. 7 , a guidewire insertion aid 700 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 700 is configured to couple to a guidewire, such as the guidewire 148 described herein. The guidewire insertion aid 700 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 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 different 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 inserting the proximal end of a guidewire into the distal opening 708 and lumen 712 of the tube 702, the main wire 706 is pulled by the practitioner, and the bend 704 frictionally engages the guidewire. The guidewire is thereby movably coupled to the guidewire insertion aid 700, and the guidewire may be pulled through the blood pump by pulling on the main wire 706 of the guidewire insertion aid 700. In some embodiments, the tube 702 may be initially straight, and after inserting the guidewire into the tube 702, the tube 702 may be bent by the practitioner to movably couple the guidewire to the guidewire insertion aid 700. In some embodiments, the guidewire coupler may include the tube 702.

[0046] 8 and 9, a guidewire insertion aid 800 is illustrated in accordance with an embodiment of the subject matter disclosed herein. FIG. 8 illustrates the guidewire insertion aid 800 in an initial configuration, and FIG. 9 illustrates the guidewire insertion aid 800 in a coupled configuration in which the aid 800 is coupled to a guidewire 802. The guidewire 802 may be the same as or similar to the guidewire 148 described herein. The guidewire insertion aid 800 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 800 specifically includes a plurality of legs 804 (illustrated as two legs 804), a main wire 806, and a slidable collet 808. The legs 804 define a lumen 810 ( FIG. 8 ) for accommodating the guidewire 802 therebetween. After accommodating the guidewire 802 within the lumen 810, an actuator such as a push wire 812 is actuated to slide the collet 808 over the legs 804, compressing the legs 804 and thereby pinching the guidewire 802. The guidewire 802 is thereby movably coupled to the guidewire insertion aid 800, and the guidewire 802 may be pulled through the blood pump by pulling on the main wire 806 of the guidewire insertion aid 800. In some embodiments, the legs 804 may include one or more stops (not shown) to prevent the collet 808 from becoming detached from the legs 804. In some embodiments, the collet 808 may include a textured surface and / or larger features to facilitate gripping the guidewire 802. In some embodiments, the legs 804 may include a textured surface to facilitate gripping the guidewire 802. In some embodiments, the collet 808 may be used with a strong opening and closing tool to facilitate gripping the guidewire 802 and reopening the aid 800. In some embodiments, the aid 800 may include a stop feature (not shown, e.g., a wire or mandrel positioned between the legs 804) to limit the length of the mating interface with the guidewire 802.In some embodiments, the accessory 800 may include different color schemes with strong contrast to facilitate identification and use of the components of the accessory 800. In some embodiments, various ends of the accessory 800 may be chamfered or rounded to reduce or eliminate catch points. In some embodiments, the guidewire coupler may comprise legs 804 and a slidable collet 808.

[0047] Referring to FIG. 10 , a guidewire insertion aid 1000 in accordance with the subject matter disclosed herein is illustrated. The guidewire insertion aid 1000 is configured to couple to a guidewire, such as the guidewire 148 disclosed herein. The guidewire insertion aid 1000 has similar features and is used in a similar manner to the guidewire insertion aid 104 disclosed herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 1000 specifically includes a tube 1002 having one or more longitudinally extending slots 1004 (illustrated as one slot 1004). The tube 1002 is coupled to a main wire 1006. The diameter of a lumen 1008 of the tube 1002 is slightly smaller than the diameter of the guidewire. When the proximal end of the guidewire is inserted into the distal opening 1010 of the tube 1002 and the lumen 1008, the tube 1002 expands at the slot 1004 to sandwich the guidewire. The guidewire is thereby movably coupled to the guidewire insertion aid 1000, and the guidewire can be pulled through the blood pump by pulling the main wire 1006 of the guidewire insertion aid 1000. In some embodiments, the guidewire coupler can include a tube 1002.

[0048] Referring to FIG. 11 , a guidewire insertion aid 1100 is illustrated in accordance with an embodiment of the subject matter disclosed herein. The guidewire insertion aid 1100 is configured to couple to a guidewire, such as the guidewire 148 disclosed herein. The guidewire insertion aid 1100 has similar features and is used in a similar manner to the guidewire insertion aid 104 described herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 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 guidewire. When the proximal end of the guidewire is inserted into the distal opening 1106 of the coil 1102, the coil 1102 expands outward to pinch the guidewire. The guidewire is thereby movably coupled to the guidewire insertion aid 1100, and the guidewire can be pulled through the blood pump by pulling the main wire 1104 of the guidewire insertion aid 1100. In some embodiments, the guidewire coupler may include a coil 1102 .

[0049] 12 and 13, a low-profile guidewire insertion aid 1200 in accordance with an embodiment of the subject matter disclosed herein is illustrated. The guidewire insertion aid 1200 is shown in a coupled configuration, in which the aid 1200 is coupled to a guidewire 1202. The guidewire 1202 may be the same as or similar to the guidewire 148 disclosed herein. The guidewire insertion aid 1200 has similar features and is used in a similar manner as the guidewire insertion aid 102 disclosed herein. As a coupler for coupling to a guidewire, the guidewire insertion aid 1200 specifically includes a body 1204 having a base 1206 and a plurality of legs 1208 (illustrated as two legs 1208). The coupler also includes a slidable collet 1210. The legs 1208 define a lumen 1212 therebetween for receiving the guidewire 1202. After receiving the guidewire 1202 within the lumen 1212, preferably bringing the guidewire 1202 into contact with the main wire 1214 of the loading aid 1200, an actuator such as a push wire (not shown) is actuated to slide the collet 1210 over the legs 1208, compressing the legs 1208 and thereby pinching the guidewire 1202. The guidewire 1202 is thereby movably coupled to the guidewire insertion aid 1200, and the guidewire 1202 may be pulled through the blood pump by pulling on the main wire 1214 of the guidewire insertion aid 1200. In some embodiments, the base 1206 may have an outer diameter larger than the inner diameter of the collet 1210 to prevent the collet 1210 from moving proximally along the main wire 1214. In some embodiments, base 1206 may have an outer diameter of about 0.021 inches (0.5334 mm) to 0.031 inches (0.7874 mm), more specifically about 0.026 inches (0.6604 mm), and collet 1210 may have an inner diameter of about 0.019 inches (0.4826 mm) to 0.029 inches (0.7366 mm), more specifically about 0.024 inches (0.6096 mm). In some embodiments, guidewire coupler may include body 1204 and slidable collet 1210.

[0050] Referring to FIG. 14 , a method of assembling a percutaneous circulatory assist system in accordance with an embodiment of the subject matter disclosed herein is generally as follows. While this method describes features of system 100, it should be understood that any system understood herein may be used in a similar manner. In block 1400, device 102 and guidewire insertion aid 104 are provided. In block 1402, guidewire insertion aid 104 is removably disposed on impeller housing 112, cannula 108, and distal tip 106 of device 102, and arranged, for example, as shown in FIG. 1 . The above actions may be performed in a manufacturing environment (i.e., a non-medical environment). In block 1404, device 102 with guidewire insertion aid 104 positioned therein is packaged for use by a medical professional (e.g., a surgeon, nurse, medical environment manager, etc.). Guidewire 148 may also be detached from guidewire insertion aid 104 and packaged for use by a medical professional.

[0051] Referring to FIG. 15 , a method of using a percutaneous circulatory assist system in accordance with embodiments of the subject matter disclosed herein is generally as follows. This method describes features of system 100, although it should be understood that any system understood herein may be used in a similar manner. In block 1500, device 102 and guidewire 148 are received by a medical professional. Upon receipt of device 102, guidewire insertion aid 104 is removably carried on impeller housing 112 of device 102, positioned, for example, as shown in FIG. 1 . In block 1502, the distal end of guidewire 148 is inserted into a patient and advanced to a target site in the patient. In block 1504, guidewire 148 is coupled to guidewire insertion aid 104, for example, by coupler 146 at distal end 142 of guidewire insertion aid 104 and / or coupler 150 at proximal end 152 of guidewire 148. At block 1506, the guidewire insertion aid 104 is removed from the impeller housing 112 of the device 102, pulling the guidewire 148 into the impeller housing 112. More specifically, the guidewire insertion aid 104 is pulled out of the blood outlet 126, pulling the proximal end 152 of the guidewire 148 through the distal tip 106, through the cannula 108, through the impeller housing 112, and through the blood outlet 126. The guidewire insertion aid 104 may then be removed from the guidewire 148, or the guidewire insertion aid 104 may remain coupled to the guidewire 148. At block 1508, the device 102 is advanced along the guidewire 148 to position it at the target site in the patient. At block 1510, the guidewire 148 is pulled proximally, thereby removing it from the device 102 and removing it from the patient. In block 1512 , the device is activated to rotate the impeller 122 relative to the impeller housing 112 to cause blood to flow through the device 102 .

[0052] As explained above, a guidewire insertion aid according to the present disclosure may be initially inserted into a percutaneous circulatory assist device to facilitate insertion of a guidewire into the device. Because the guidewire insertion aid is positioned within the device in the manufacturing environment (i.e., not by a medical professional) and / or because of the material of the guidewire insertion aid, embodiments according to the present disclosure may avoid damage to delicate components of the percutaneous circulatory assist device that may be caused by guidewire insertion.

[0053] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of the present invention also includes embodiments comprising various combinations of features and embodiments that do not comprise any of the described features. Accordingly, the scope of the present invention is intended to encompass all such alternatives, modifications, and variations, together with all equivalents thereof, as fall within the scope of the claims.

Claims

1. 1. A percutaneous circulatory assist system, comprising: Housing and an impeller carried within the housing; A percutaneous circulatory assist device comprising: a guidewire insertion aid configured to be removably carried within the housing, the guidewire insertion aid lacking a through lumen; A percutaneous circulatory support system comprising:

2. The percutaneous circulatory assist system of claim 1 , wherein the guidewire insertion aid is configured to movably couple to a guidewire.

3. The percutaneous circulatory assist system of claim 2 , wherein the guidewire insertion aid comprises a coupler for movably coupling to the guidewire.

4. 3. The percutaneous circulatory assist system of claim 2, wherein the percutaneous circulatory assist device comprises a blood inlet and a blood outlet, and wherein the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

5. 5. The percutaneous circulatory assist system of claim 4, wherein the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned distally relative to the blood inlet.

6. The percutaneous circulatory assist system according to any one of claims 4 to 5, wherein the proximal end of the guidewire insertion aid is disposed outward from the blood outlet.

7. 1. A percutaneous circulatory assist system, comprising: Housing and an impeller carried within the housing; A percutaneous circulatory assist device comprising: a guidewire insertion aid configured to be removably carried within the housing; The guidewire insertion aid is configured to be movably coupled to a guidewire. Percutaneous circulatory support system.

8. The percutaneous circulatory assist system of claim 7 , wherein the guidewire insertion aid comprises a coupler for movably coupling to the guidewire.

9. 9. The percutaneous circulatory assist system according to claim 7, wherein the percutaneous circulatory assist device comprises a blood inlet and a blood outlet, and wherein the guidewire insertion aid is configured to be removed from the housing through the blood outlet to pull the guidewire through the blood outlet.

10. 10. The percutaneous circulatory assist system of claim 9, wherein the guidewire insertion aid includes a proximal end and a distal end, the distal end being positioned distally relative to the blood inlet port.

11. The percutaneous circulatory assist system according to any one of claims 9 to 10, wherein the proximal end of the guidewire insertion aid is disposed outward from the blood outlet.

12. 1. A method of manufacturing a percutaneous circulatory assist system, comprising: providing a percutaneous circulatory assist device comprising a housing and an impeller carried within the housing; providing a guidewire insertion aid lacking a through lumen; Removably disposing the guidewire insertion aid within the housing of the percutaneous circulation assist device; A method comprising:

13. The method of claim 12 , wherein the guidewire insertion aid comprises a coupler for movably coupling to a guidewire.

14. The method of any of claims 12-13, further comprising providing the guidewire to be detached from the guidewire insertion aid.

15. The method of any of claims 12 to 14, wherein the percutaneous circulatory assist device further comprises a cannula coupled to the housing, and further comprising removably disposing the guidewire insertion aid within the cannula.

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