Guidewire insertion aid for percutaneous circulatory support devices

Abstract

The percutaneous circulatory support system includes a percutaneous circulatory support device having an impeller and a distal portion. A guidewire insertion aid is removably carried on the distal portion of the percutaneous circulatory support device. The guidewire insertion aid includes a tapered distal end that is in contact with the distal portion of the percutaneous circulatory support device from the outset. The guidewire insertion aid is configured to connect to a guidewire.

Description

Technical Field

[0001] The present disclosure relates to a percutaneous circulatory assist device and related components. More specifically, the present disclosure relates to a guide wire insertion aid for a percutaneous circulatory assist device.

Background Art

[0002] A percutaneous circulatory assist device such as a blood pump can provide temporary assistance for up to about several weeks in a patient with reduced cardiac function or cardiac output. Such a device is typically delivered to a patient's heart using a guide wire. More specifically, with the proximal end of the guide wire remaining outside the patient, the distal end of the guide wire is inserted into the patient and positioned within the patient's heart. Then, the proximal end of this guide wire is inserted into the percutaneous circulatory assist device, whereby the device can be moved along this guide wire to the patient's heart. However, inserting the guide wire through the percutaneous circulatory assist device may damage the 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 an impeller and a distal portion. The system further includes a guide wire insertion aid removably carried on the distal portion of the percutaneous circulatory assist device. The guide wire insertion aid includes a tapered distal end that is initially in contact with the distal portion of the percutaneous circulatory assist device. The guide wire insertion aid is configured to couple to a guide wire.

[0004] In Example 2, the distal portion of the percutaneous circulatory support system of Example 1 includes a cannula having a cannula lumen and a flexible distal extension including an extension lumen connected to the cannula lumen. The tapered distal end of the guidewire insertion aid is initially positioned within the cannula lumen and in contact with the cannula.

[0005] In Example 3, in the percutaneous circulatory support system of Example 2, the cannula includes a blood inlet, and the percutaneous circulatory support device further includes a blood outlet. The guidewire insertion aid is configured to be detached from the percutaneous circulatory support device through the blood outlet.

[0006] In Example 4, in any of the percutaneous circulatory support systems of Examples 1-2, the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be detached from the percutaneous circulatory support device through the blood outlet.

[0007] In Example 5, in the percutaneous circulatory support system of Example 4, the proximal end of the guidewire insertion aid is positioned outside the blood outlet. In Example 6, the guidewire insertion aid in any of the percutaneous circulatory support systems of Examples 1-5 includes a through lumen.

[0008] In Example 7, the percutaneous circulatory support system of any of Examples 1-5 includes a guidewire insertion aid with a blind-end lumen. In Example 8, in any of the percutaneous circulatory support systems of Examples 1-7, the percutaneous circulatory support device further includes a housing, the impeller is supported within the housing, and the distal portion is coupled to the housing.

[0009] In Example 9, the percutaneous circulatory support system comprises a percutaneous circulatory support device, which includes an impeller, a cannula including a distal adapter having a cannula lumen, and a distal extension coupled to the distal adapter. A guidewire insertion aid is removably carried within the cannula lumen. The guidewire insertion aid includes an enlarged coupling portion that is in contact with the distal adapter from the outset (initial state). The guidewire insertion aid is configured to connect to a guidewire.

[0010] In Example 10, the enlarged connecting portion is the distal end of the guidewire insertion aid in the percutaneous circulatory support system of Example 9. In Example 11, in any of the percutaneous circulatory support systems of Examples 9-10, the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the percutaneous circulatory support device through the blood outlet.

[0011] In Example 12, in the percutaneous circulatory support system of Example 11, the proximal end of the guidewire insertion aid is positioned outside the blood outlet. In Example 13, the guidewire insertion aid in any of the percutaneous circulatory support systems of Examples 9-12 includes a through lumen.

[0012] In Example 14, the guidewire insertion aid in any of the percutaneous circulatory support systems of Examples 9-12 includes a blind-end lumen. In Example 15, in any of the percutaneous circulatory support systems of Examples 9-14, the percutaneous circulatory support device further includes a housing, the impeller is supported within the housing, and the cannula is coupled to the housing.

[0013] In Example 16, the percutaneous circulatory support system includes a percutaneous circulatory support device, which includes a housing, an impeller supported within the housing, and a distal portion coupled to the housing. A guidewire insertion aid is removably supported inside the housing and distal portion of the percutaneous circulatory support device. The guidewire insertion aid includes a tapered distal end portion that is in contact with the distal portion of the percutaneous circulatory support device from the outset (initial state), and the guidewire insertion aid is configured to connect to a guidewire.

[0014] In Example 17, the distal portion of the percutaneous circulatory support system of Example 16 includes a cannula having a cannula lumen and a flexible distal extension including an extension lumen connected to the cannula lumen. The tapered distal end of the guidewire insertion aid is initially positioned within the cannula lumen and in contact with the cannula.

[0015] In Example 18, the percutaneous circulatory support system of Example 17 is configured such that the cannula includes a blood inlet, the housing includes a blood outlet, and the guidewire insertion aid is detached from the housing through the blood outlet.

[0016] In Example 19, the percutaneous circulatory support system of Example 16 includes a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet.

[0017] In Example 20, in the percutaneous circulatory support system of Example 19, the proximal end of the guidewire insertion aid is positioned outside the blood outlet. In Example 21, the percutaneous circulatory support system of Example 16 includes a guidewire insertion aid with a through lumen.

[0018] In Example 22, the percutaneous circulatory support system of Example 16 includes a guidewire insertion aid with a blind-end lumen. In Example 23, the percutaneous circulatory support system comprises a percutaneous circulatory support device, the percutaneous circulatory support device comprising a housing, an impeller supported within the housing, a cannula coupled to the housing, the cannula having a distal adapter having a cannula lumen, and a distal extension coupled to the distal adapter. The system further comprises a guidewire insertion aid detachably supported within the housing and the cannula lumen. The guidewire insertion aid includes an enlarged coupling portion that is in contact with the distal adapter from the outset (initial state), and the guidewire insertion aid is configured to connect to a guidewire.

[0019] In Example 24, the enlarged connecting portion is the distal end of the guidewire insertion aid in the percutaneous circulatory support system of Example 23. In Example 25, in the percutaneous circulatory support system of Example 23, the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the housing through the blood outlet.

[0020] In Example 26, in the percutaneous circulatory support system of Example 25, the proximal end of the guidewire insertion aid is positioned outside the blood outlet. In Example 27, the percutaneous circulatory support system of Example 23 includes a guidewire insertion aid with a through lumen.

[0021] In Example 28, the percutaneous circulatory support system of Example 23 includes a guidewire insertion aid with a blind-end lumen. In Example 29, in the percutaneous circulatory support system of Example 23, the guidewire insertion aid includes lengths ranging from 6.75 inches (17.145 cm) to 8 inches (20.32 cm).

[0022] In Example 30, a method for manufacturing a percutaneous circulatory assist system includes preparing a percutaneous circulatory assist device, the percutaneous circulatory assist device including a housing, an impeller carried within the housing, and a distal portion coupled to the housing, preparing a guide wire insertion aid including a tapered distal end portion, the guide wire insertion aid being configured to receive a guide wire, and removably disposing the guide wire insertion aid within the housing and the distal portion of the percutaneous circulatory assist device such that the tapered distal end portion contacts the distal portion of the percutaneous circulatory assist device.

[0023] In Example 31, in the method of Example 30, the guide wire insertion aid includes a through lumen. In Example 32, in the method of Example 30, the guide wire insertion aid includes a blind end lumen. In Example 33, the method of Example 30 further includes preparing a guide wire to be removed from the guide wire insertion aid.

[0024] In Example 34, in the method of Example 30, the distal portion includes a cannula, and removably disposing the guide wire insertion aid within the percutaneous circulatory assist device includes contacting a tapered distal end against the cannula.

[0025] In Example 35, in the method of Example 34, the percutaneous circulatory assist device further includes a flexible distal extension coupled to the cannula on an opposite side of the housing, the flexible distal extension including a proximal end portion that contacts the cannula and an opposite distal end portion, and the tapered distal end portion of the guide wire loading aid is disposed proximal to the distal end portion of the flexible extension.

[0026] Although a number of embodiments have been disclosed, further other embodiments of the present invention will be apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary embodiments of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0027] [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 an exemplary guide wire insertion aid according to an embodiment of the subject matter disclosed herein. [Figure 2] FIG. 2 is a detailed side cross-sectional view of the percutaneous circulatory assist device and the guide wire insertion aid within line 2-2 of FIG. 1. [Figure 3] FIG. 3 is a side cross-sectional view of the guide wire insertion aid of FIG. 1 and an exemplary guide wire shown by phantom lines according to an embodiment of the subject matter disclosed herein. [Figure 4] FIG. 4 is a side cross-sectional view of another exemplary guide wire insertion aid and an exemplary guide wire shown by phantom lines according to an embodiment of the subject matter disclosed herein. [Figure 5] FIG. 5 is a flow diagram of a method for manufacturing a percutaneous circulatory assist system according to an embodiment of the subject matter disclosed herein. [Figure 6] FIG. 6 is a flow diagram of a method for using a percutaneous circulatory assist system according to an embodiment of the subject matter disclosed herein.

Best Mode for Carrying Out the Invention

[0028] Although the present invention is capable of various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and will be described in detail hereinafter. However, the intention is not to limit the present invention to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternative forms included within the scope of the present invention as defined by the appended claims.

[0029] Figure 1 shows a partial side section view of an exemplary percutaneous circulatory support system 100 according to an embodiment of the subject disclosed herein. The system 100 includes a percutaneous circulatory support device 102 (also interchangeably referred herein as a “blood pump”), a guidewire insertion aid 104, a guidewire (shown separately), and an introducer sheath (not shown). The guidewire insertion aid 104 is initially partially positioned within the device 102 (i.e., the guidewire insertion aid 104 is partially positioned within the device 102 before the system 100 is provided to a healthcare professional) and allows the guidewire to be inserted into the device 102 without potentially damaging the delicate components of the device 102, as will be described in more detail herein. After the guidewire has been inserted into the device 102, the guidewire and introducer sheath may be used to percutaneously deliver the device 102 to a target location within the patient. More specifically, device 102 may be moved along a guidewire to deliver device 102 to a target location, which may be within the patient's heart. Alternatively, device 102 may be delivered to different target locations within the patient.

[0030] Referring again to Figure 1, the device 102 generally includes a distal portion 105, more specifically a flexible distal extension 106 and a cannula 108, an impeller portion 110, and a proximal catheter (not shown). During operation, the device 102 is positioned, for example, at the apex of the left ventricle, with the distal extension 106 approaching or in contact with the wall of the patient's left ventricle. The cannula 108 may be partially positioned within the left ventricle or may penetrate the patient's aortic valve. The impeller portion 110 and the catheter may be positioned within the patient's aorta.

[0031] 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 configured integrally or monolithically. In other embodiments, the impeller housing 112 and the motor housing 114 may be separate components configured to be removable or permanently coupled. In other embodiments, the device 102 may lack the motor housing 114.

[0032] The impeller housing 112 carries an impeller assembly 116 within it. 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 on the impeller housing 112. In some embodiments, 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 integrated. In some embodiments, as shown, the inlet 124 and / or outlet 126 may each include a plurality of openings. In other embodiments, the inlet 124 and / or outlet 126 may each include a single opening. In some embodiments, 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.

[0033] Continuing to refer to Figure 1, the motor housing 114 supports a motor 128, which 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, which is coupled to a drive magnet 132. The rotation of this drive magnet 132 causes the rotation of a driven magnet 134, which is connected to the impeller assembly 116 and therefore rotates together with the impeller assembly 116. More specifically, in embodiments incorporating an impeller shaft 118, the impeller shaft 118 and the impeller 122 are configured to rotate together with the driven magnet 134. In other embodiments, the motor 128 may be coupled to the impeller assembly 116 via other components. As described herein, the rotation of the impeller 122 causes blood to flow through the device 102.

[0034] In some embodiments, the controller may be configured to be operablely coupled to and control the motor 128. In some embodiments, the controller may be located inside the motor housing 114. In other embodiments, the controller may be located outside the motor housing 114 (e.g., in a catheter handle, a separate housing, etc.). In some embodiments, the controller may include a plurality of components, one or more of which may be located inside the motor housing 114. According to embodiments, the controller may include, or may include, one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (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 thereof and / or other components. Although the controller is referred to singly in this specification, it can be implemented in multiple ways, such as being distributed across multiple computer devices or materialized within multiple virtual machines. In other embodiments, the motor 128 can be controlled in other ways.

[0035] Referring further to Figure 1, the guidewire insertion aid 104 is initially partially positioned within the device 102. More specifically, the guidewire insertion aid 104 extends from within the distal portion 105, more specifically from the lumen 138 of the cannula 108, into the interior 140 of the impeller housing 112, and outward from the blood outlet 126 of the impeller housing 112. Thus, the distal end 142 of the guidewire insertion aid 104 is initially positioned proximal to the distal end 143 of the distal extension 106, and the opposite proximal end 144 of the guidewire insertion aid 104 is initially positioned outside the blood outlet 126.

[0036] Referring here to Figures 2 and 3, the guidewire insertion aid 104 may typically be a long, flexible tube suitable for receiving the guidewire 148 (Figure 3). The guidewire insertion aid 104 may be made of a variety of suitable materials, such as relatively soft and flexible biocompatible polymers (e.g., polyetheretherketone (PEEK)), metals, or composite materials.

[0037] Continuing to refer to Figures 2 and 3, the guidewire insertion aid 104 typically includes a cylindrical wall 150 defining a guidewire lumen 152 for receiving a guidewire 148 (Figure 3). The guidewire insertion aid 104 also includes a coupling portion 154, which may be the distal end 142 of the guidewire insertion aid 104, radially widened outward relative to the wall 150 of the guidewire insertion aid 104. The coupling portion 154 initially contacts the flexible extension adapter 156 of the cannula 108 to which the distal portion (Figure 2) 105 of the device 102, more specifically the proximal end 158 of the distal extension 106, is attached, thereby securing the guidewire insertion aid 104 within the device 102. In some embodiments, as shown, the coupling portion 154 includes a tapered or funnel shape. In other embodiments, the connecting portion 154 may take on other forms.

[0038] In some embodiments, as illustrated, the lumen 152 of the guidewire insertion aid 104 is a through lumen (i.e., a lumen with two openings at the distal end 142 and the proximal end 144 of the guidewire insertion aid 104), through which the guidewire can extend. The interaction between the guidewire insertion aid 104 with such a through lumen 152 and the guidewire 148 is described in further detail herein. In other embodiments, the lumen 152 may take other forms, as described in further detail herein.

[0039] The guidewire insertion aid 104 may have any of a variety of suitable dimensions. For example, the guidewire insertion aid 104 may have a length ranging from 6.75 inches (17.145 cm) to 8 inches (20.32 cm). As another example, the wall 150 of the guidewire insertion aid 104 may have a thickness ranging from 0.004 inches (0.01016 cm) to 0.008 inches (0.02032 cm), more specifically 0.006 inches (0.01524 cm). As yet another example, the guidewire lumen 152 may have a diameter ranging from 0.015 inches (0.0381 cm) to 0.025 inches (0.0635 cm), more specifically 0.020 inches (0.0508 cm). As another example, the enlarged connector 154 may have a maximum outer diameter in the range of 0.041 inches (0.10414 cm) to 0.042 inches (0.10668 cm). As yet another example, the opening of the guidewire lumen 152 in the enlarged connector 154 may flare outward at an angle in the range of 52 to 62 degrees. It is also conceivable that various types of guidewires may be used in combination with the guidewire insertion aid 104. For example, guidewires of various sizes in diameter (including guidewires with diameters of 0.014 inches (0.03556 cm) or 0.018 inches (0.04572 cm) or guidewires of common sizes) may be used with the guidewire insertion aid 104. It is also conceivable that guidewire insertion aids of various sizes may be used to accommodate guidewires of various sizes.

[0040] The guidewire insertion aid according to embodiments of the subject disclosed herein may take other forms. For example, Figure 4 shows an exemplary guidewire insertion aid 200 according to embodiments of the subject disclosed herein. The guidewire insertion aid 200 may replace the guidewire insertion aid 104 and constitute part of the percutaneous circulatory support system 100 (as shown separately) by being partially positioned within the device 102 from the outset. The guidewire insertion aid 200 is substantially similar to the guidewire insertion aid 104, except that the guidewire insertion aid 200 is a blind guidewire lumen 202 (i.e., a lumen including an opening at the distal end 204 and a closed end at the proximal end 206). Thus, when the guidewire 148 is advanced proximal within its blind lumen 202 and brought into contact with the closed proximal end 206, the guidewire 148 allows the guidewire insertion aid 200 to be pushed out of the device 102. The interaction between the guidewire insertion aid 200, which includes such a blind-end lumen 202, and the guidewire 148 is described in further detail herein.

[0041] Referring to Figure 5, a method 300 for assembling a percutaneous circulatory support system according to embodiments relating to the subject matter disclosed herein is typically as follows. Although this method 300 exemplifies the features of system 100, guidewire insertion aid 104, and guidewire insertion aid 200, it should be understood that any system or guidewire insertion aid understood herein may be used in a similar manner. Block 302 provides device 102 and guidewire insertion aid 104. In block 304, guidewire insertion aid 104 or 200 is detachably positioned within device 102 such that guidewire insertion aid 104 or 200 extends from within the distal portion 105, more specifically from the cannula lumen 138, extends into the interior 140 of the impeller housing 112, and extends outward from the blood outlet 126 of the impeller housing 112. As a result, the guidewire insertion aid 104 or 200 is positioned as shown in Figures 1 and 2, more specifically, the distal end 142 of the guidewire insertion aid 104 is positioned proximal to the distal end 143 of the distal extension 106. Consequently, the guidewire insertion aid 104 does not come into contact with the distal extension 106, which could alter the shape of the distal extension 106. The above actions may be performed in a manufacturing environment (i.e., an environment other than a medical environment). In block 306, the device 102 with the guidewire insertion aid 104 or 200 positioned inside the device 102 is packaged for use by healthcare professionals (e.g., surgeons, nurses, medical environment managers, etc.). The guidewire 148 may also be removed from the guidewire insertion aid 104 and packaged for use by healthcare professionals.

[0042] Referring to Figure 6, a method 400 for using a percutaneous circulatory support system according to embodiments relating to the subject matter disclosed herein is typically as follows: Although this method 400 exemplifies the features of system 100, guidewire insertion aid 104, and guidewire insertion aid 200, it should be understood that any system or guidewire insertion aid understood herein may be used in a similar manner. In block 402, device 102 and guidewire 148 are received by a healthcare professional. Upon receiving device 102, the guidewire insertion aid 104 or 200 is detachably mounted on device 102 and positioned as shown in Figures 1 and 2. In block 404, the distal end of guidewire 148 is inserted into the patient's body and advanced to a target location in the patient, such as the left ventricle. In block 406, the guidewire 148 is inserted through the extension lumen 160 of the distal extension 106 into the lumen 152 or 202 of the guidewire insertion aid 104 or 200 and advanced proximal. More specifically, in the case of the guidewire insertion aid 104, this operation involves advancing the proximal end of the guidewire 148 outward through the through lumen 152 from the proximal end 144 of the guidewire insertion aid 104, which is positioned outside the blood outlet 126 of the device 102. More specifically, in the case of the guidewire insertion aid 200, this operation involves advancing the proximal end of the guidewire 148 within the blind end lumen 202 and lightly contacting the occluded proximal end 206 of the guidewire insertion aid 200. In both cases, the guidewire insertion aid 104 or 200 remains inside the device 102 due to the contact and resulting frictional force between the enlarged connecting portion 154 of the guidewire insertion aid 104 or 200 and the adapter 156 of the cannula 108. In block 408, the guidewire insertion aid 104 is removed from the device 102 and the guidewire 148 by overcoming the frictional force between the guidewire insertion aid 104 or 200 and the cannula 108.More specifically, in the case of the guidewire insertion aid 104, the guidewire insertion aid 104 is moved from the blood outlet 126 of the device 102 by being pulled proximal along the guidewire 148, thereby detaching the guidewire insertion aid 104 from the guidewire 148. More specifically, in the case of the guidewire insertion aid 200, the guidewire 148 is advanced proximal through the device 102, pushing the guidewire insertion aid 200 out of the blood outlet 126 of the device 102, and then the guidewire insertion aid 200 is pulled proximal along the proximal end of the guidewire 148, thereby detaching the guidewire insertion aid 104 from the guidewire 148. In block 410, the device 102 is advanced along the guidewire 148 and positioned at the target location in the patient. In block 412, the guidewire 148 is pulled proximal, thereby detaching it from the device 102 and removing it from the patient. In block 414, the device is activated (electrically energized) to rotate the impeller 122 relative to the impeller housing 112, thereby causing blood to flow through the device 102.

[0043] As described herein, the guidewire insertion aid according to this disclosure is positioned from the outset partially within the percutaneous circulatory support device, facilitating the insertion of the guidewire into the device. Because the guidewire insertion aid is positioned within the device in the manufacturing environment (i.e., not by a healthcare professional) and / or due to the material of the guidewire insertion aid, embodiments according to this disclosure avoid damage to the delicate components of the percutaneous circulatory support device that may be caused by guidewire insertion. In addition, because the guidewire insertion aid does not extend into the distal extension of the device, the guidewire insertion aid does not alter the shape of the distal extension or otherwise affect its functionality.

[0044] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all such alternative forms, modifications, and variations included in the claims, along with all their equivalents.

Claims

1. A percutaneous circulatory support system, A percutaneous circulatory support device including an impeller and a distal portion, The percutaneous circulatory support device comprises a guidewire insertion aid that is removably carried within the distal portion of the percutaneous circulatory support device, A percutaneous circulatory support system, wherein the guidewire insertion aid includes a tapered distal end that is in contact with the distal portion of the percutaneous circulatory support device from the outset, and the guidewire insertion aid is configured to connect to the guidewire.

2. The distal portion of the transcutaneous circulatory support device is The cannula, including the cannula lumen, A flexible distal extension portion including an extension lumen coupled to the cannula lumen, The percutaneous circulatory support system according to claim 1, wherein the tapered distal end of the guidewire insertion aid is positioned within the cannula lumen from the outset and is in contact with the cannula.

3. The percutaneous circulatory support system according to claim 2, wherein the cannula includes a blood inlet, the percutaneous circulatory support device further includes a blood outlet, and the guidewire insertion aid is configured to be removed from the percutaneous circulatory support device through the blood outlet.

4. The percutaneous circulatory support system according to claim 1 or 2, wherein the percutaneous circulatory support device includes a blood inlet and a blood outlet, and the guidewire insertion aid is configured to be removed from the percutaneous circulatory support device through the blood outlet.

5. The percutaneous circulatory support system according to claim 4, wherein the proximal end of the guidewire insertion aid is positioned outside the blood outlet.

6. The percutaneous circulatory support system according to any one of claims 1 to 5, wherein the guide wire insertion aid includes a through lumen.

7. The percutaneous circulatory support system according to any one of claims 1 to 5, wherein the guide wire insertion aid includes a blind end lumen.

8. The percutaneous circulatory support system according to any one of claims 1 to 7, wherein the percutaneous circulatory support device further includes a housing, the impeller is supported within the housing, and the distal portion is coupled to the housing.

9. A percutaneous circulatory support system, The device comprises a transcutaneous circulatory support device, and the transcutaneous circulatory support device is impeller and, A cannula including a distal adapter having a cannula lumen, A distal extension connected to the distal adapter, The device includes a guidewire insertion aid that is removably supported within the cannula lumen, A percutaneous circulatory support system comprising a guidewire insertion aid including an enlarged connecting portion that is in contact with the distal adapter from the outset, and the guidewire insertion aid configured to connect to a guidewire.

10. The percutaneous circulatory support system according to claim 9, wherein the enlarged connecting portion is the distal end of the guide wire insertion aid.

11. The percutaneous circulatory support device includes a blood inlet and a blood outlet, The percutaneous circulatory support system according to claim 9 or 10, wherein the guidewire insertion aid is configured to be removed from the percutaneous circulatory support device through the blood outlet.

12. The percutaneous circulatory support system according to claim 11, wherein the proximal end of the guidewire insertion aid is positioned outside the blood outlet.

13. The percutaneous circulatory support system according to any one of claims 9 to 12, wherein the guide wire insertion aid includes a through lumen.

14. The percutaneous circulatory support system according to any one of claims 9 to 12, wherein the guidewire insertion aid includes a blind-end lumen.

15. The percutaneous circulatory support system according to any one of claims 9 to 14, wherein the percutaneous circulatory support device further includes a housing, the impeller is supported within the housing, and the cannula is coupled to the housing.

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