Percutaneous circulatory support system

Abstract

Various aspects of the disclosure are directed to devices, systems, and methods that are systems for delivering a blood pump. The system can include a blood pump that can include one or more impellers configured to move blood through the pump. The system can include one or more guidewires. The guidewire can include one or more proximal sections and one or more distal sections, the distal sections having a first dimension and the proximal sections having a second dimension, the first dimension can be greater than the second dimension. The guidewire can be tapered, geometrically shaped, have a curved profile, combinations thereof, or other configurations.

Description

[Technical field]

[0001] The present disclosure relates to percutaneous circulatory assist systems, and more particularly, to percutaneous circulatory assist devices and guidewires for positioning such devices within the heart. [Background technology]

[0002] Percutaneous circulatory assist devices, such as blood pumps, can provide temporary assistance to patients with reduced cardiac function or cardiac output for up to about several weeks. Generally, the performance of such devices, more specifically, the blood flow and torque generation characteristics, is improved by increasing the size or diameter of the impeller, motor, or other components, while also reducing device-induced hemolysis (i.e., blood cell rupture or destruction). Such devices are typically delivered to the patient's heart using a guidewire, which is placed between the blood pump and the inner surface of the introducer sheath. The guidewire thus occupies space within the introducer sheath that could otherwise accommodate the blood pump. Summary of the Invention

[0003] In Example 1, a percutaneous circulatory assist system includes a guidewire including a distal section having a first transverse dimension and a proximal section having a second transverse dimension smaller than the first transverse dimension, and a blood pump coupled to the guidewire and configured to be moved along the guidewire, the blood pump including an impeller housing, a motor housing, and an impeller disposed within the impeller housing, the impeller configured to drive blood through the blood pump.

[0004] In Example 2, the percutaneous circulatory assist system of Example 1, wherein the impeller housing has a third lateral dimension and the motor housing has a fourth lateral dimension, the fourth lateral dimension being smaller than the third lateral dimension.

[0005] In Example 3, the third lateral dimension is a diameter and the fourth lateral dimension is a diameter in the percutaneous circulatory assist system of Example 2. In Example 4, the percutaneous circulatory assist system of either Example 2 or Example 3 further comprises an introducer sheath configured to receive a guidewire and a blood pump.

[0006] In Example 5, the percutaneous circulatory assist system of Example 4, the introducer sheath has an inner lateral dimension and the third lateral dimension is within the range of 99.75 percent to 98.25 percent of the inner lateral dimension.

[0007] In Example 6, the percutaneous circulatory assist system of Example 4, the introducer sheath has an inner lateral dimension and the fourth lateral dimension is within the range of 91.25 percent to 91.75 percent of the inner lateral dimension.

[0008] In Example 7, the percutaneous circulatory assist system of any of Examples 1-6, wherein the guidewire further includes a transition section between the proximal and distal sections. In Example 8, in the percutaneous circulatory assist system of any of Examples 1 to 7, the impeller housing includes an inlet and an outlet, and the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0009] In Example 9, the percutaneous circulatory assist system of Example 8, wherein the proximal section of the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0010] In Example 10, the percutaneous circulatory assist system of either Example 8 or 9, wherein the distal section of the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0011] In Example 11, in the percutaneous circulatory assist system of any of Examples 1 to 10, the first lateral dimension is a diameter and the second lateral dimension is a diameter. In Example 12, a percutaneous circulatory assist system includes a guidewire including a proximal section having a guidewire proximal section transverse dimension; a blood pump coupled to the guidewire and configured to be moved along the guidewire, the blood pump including an impeller assembly housing having an impeller assembly housing transverse dimension, and an impeller assembly disposed within the impeller assembly housing, the impeller assembly including an impeller configured to drive blood through the pump; and a motor housing coupled to the impeller housing, the motor housing having a motor housing transverse dimension; a.d ih ≧d mh +2d gps and d ih is the impeller assembly housing lateral dimension, and d mh is the motor housing horizontal dimension, and d gps is the transverse dimension of the guidewire proximal section.

[0012] In Example 13, the percutaneous circulatory assist system of Example 12, wherein the guidewire further includes a distal section coupled to the proximal section, the distal section having a guidewire distal section transverse dimension; a.d ih ≦d mh +2d gds and d gds is the guidewire distal section transverse dimension.

[0013] In Example 14, the percutaneous circulatory assist system of either Example 12 or Example 13 further comprises an introducer sheath configured to receive a proximal section of the guidewire and a blood pump.

[0014] In Example 15, in the percutaneous circulatory assist system of any of Examples 12 to 14, the impeller assembly housing includes an inlet and an outlet, and the guidewire is configured to extend proximally from the outlet, pass through the impeller assembly housing, and extend distally from the inlet.

[0015] In Example 16, a percutaneous circulatory assist system includes a guidewire including a distal section having a first transverse dimension and a proximal section having a second transverse dimension smaller than the first transverse dimension, and a blood pump coupled to the guidewire and configured to be moved along the guidewire, the blood pump including an impeller housing having a third transverse dimension, a motor housing coupled to the impeller housing and having a fourth transverse dimension smaller than the third transverse dimension, and an impeller disposed within the impeller housing, the impeller configured to move blood through the blood pump.

[0016] In Example 17, the percutaneous circulatory assist system of Example 16, wherein the first lateral dimension is a first diameter and the second lateral dimension is a second diameter. In Example 18, the percutaneous circulatory assist system of Example 16, wherein the third lateral dimension is the first diameter and the fourth lateral dimension is the second diameter.

[0017] In Example 19, the percutaneous circulatory assist system of Example 16, wherein the guidewire further includes a transition section between the proximal section and the distal section. In Example 20, the percutaneous circulatory assist system of Example 16 further comprises an introducer sheath configured to receive a proximal section of the guidewire and a blood pump.

[0018] In Example 21, the percutaneous circulatory assist system of Example 20, the introducer sheath has an inner lateral dimension and the third lateral dimension is within the range of 99.75 percent to 98.25 percent of the inner lateral dimension.

[0019] In Example 22, the percutaneous circulatory assist system of Example 16, wherein the impeller housing includes an inlet and an outlet, and the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0020] In Example 23, the percutaneous circulatory assist system of Example 22, wherein the proximal section of the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0021] In Example 24, the percutaneous circulatory assist system of Example 22, wherein the distal section of the guidewire is configured to extend proximally from the outlet, pass through the impeller housing, and extend distally from the inlet.

[0022] In Example 25, the percutaneous circulatory assist system of Example 20, the introducer sheath has an inner lateral dimension and the fourth lateral dimension is within the range of 91.25 percent to 91.75 percent of the inner lateral dimension.

[0023] In Example 26, a percutaneous circulatory assist system includes a guidewire including a proximal section having a guidewire proximal section transverse dimension; a blood pump coupled to the guidewire and configured to be moved along the guidewire, the blood pump including an impeller assembly housing having an impeller assembly housing transverse dimension, and an impeller assembly disposed within the impeller assembly housing, the impeller assembly including an impeller configured to drive blood through the pump; and a motor housing coupled to the impeller housing, the motor housing having a motor housing transverse dimension; a.d ih ≧d mh +2d gps and d ih is the impeller assembly housing lateral dimension, and d mh is the motor housing horizontal dimension, and d gps is the transverse dimension of the guidewire proximal section.

[0024] In Example 27, the percutaneous circulatory assist system of Example 26, wherein the guidewire further includes a distal section coupled to the proximal section, the distal section having a guidewire distal section transverse dimension; a.d ih ≦d mh +2d gds and d gds is the guidewire distal section transverse dimension.

[0025] In Example 28, the percutaneous circulatory assist system of Example 26 further comprises an introducer sheath configured to receive a proximal section of the guidewire and a blood pump.

[0026] In Example 29, in the percutaneous circulatory assist system of Example 28, the introducer sheath has an inner lateral dimension, and the impeller assembly housing lateral dimension is within the range of 99.75 percent to 98.25 percent of the inner lateral dimension.

[0027] In Example 30, a method for placing a blood pump in a subject includes inserting an introducer sheath into an access point of a blood vessel of the subject; inserting a guidewire into the introducer sheath, the guidewire having a distal section and a proximal section, the distal section having a first transverse dimension and the proximal section having a second transverse dimension, the second transverse dimension being smaller than the first transverse dimension; advancing a blood pump through the introducer sheath and along the proximal section of the guidewire, the blood pump comprising an impeller housing having a third transverse dimension, a motor housing having a fourth transverse dimension smaller than the third transverse dimension, and an impeller disposed within the impeller housing and configured to move blood through the blood pump.

[0028] In Example 31, the method of Example 30 further includes advancing a blood pump along the proximal section of the guidewire through the introducer sheath, followed by advancing a blood pump along the distal section of the guidewire.

[0029] In Example 32, the method of Example 30, advancing the blood pump includes extending a guidewire through the inlet and the outlet of the blood pump. In Example 33, the method of Example 30, advancing the blood pump includes simultaneously advancing the blood pump along a proximal section of the guidewire through the introducer sheath.

[0030] In Example 34, in the method of Example 33, advancing the blood pump further includes simultaneously advancing the blood pump along a proximal section of the guidewire through the introducer sheath and then simultaneously advancing the blood pump along a distal section of the guidewire distally from the introducer sheath.

[0031] In Example 35, the method of Example 30, wherein the introducer sheath has an inner lateral dimension and the third lateral dimension is within the range of 99.75 percent to 98.25 percent of the inner lateral dimension.

[0032] 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 restrictive. [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a side cross-sectional view of several components of an exemplary percutaneous circulatory assist system, according to an embodiment of the subject matter disclosed herein. [Diagram 2]2 is an enlarged cross-sectional side view of a mechanical circulatory assist device (also referred to herein as a "blood pump") of the system within line 2-2 of FIG. 1, according to an embodiment of the subject matter disclosed herein. [Diagram 3] 3 is an enlarged cross-sectional side view of a guidewire of the system within line 2-2 of FIG. 1, according to an embodiment of the subject matter disclosed herein. [Figure 4] FIG. 4 is a side cross-sectional view of the system of FIG. 1 upon initial insertion into a patient's blood vessel in accordance with an embodiment of the subject matter disclosed herein. [Diagram 5] 5 is a side cross-sectional view of the system of FIG. 1 when within a patient's blood vessel and advanced distally from the position shown in FIG. 4, in accordance with an embodiment of the subject matter disclosed herein. [Figure 6A] FIG. 6A is a cross-sectional view of another exemplary guidewire in accordance with an embodiment of the subject matter disclosed herein. [Figure 6B] FIG. 6B is a cross-sectional view of another exemplary guidewire in accordance with an embodiment of the subject matter disclosed herein. [Figure 6C] FIG. 6C is a cross-sectional view of yet another exemplary guidewire in accordance with an embodiment of the subject matter disclosed herein. [Figure 7] FIG. 7 is a perspective cross-sectional view of another exemplary percutaneous circulatory assist system according to an embodiment of the subject matter disclosed herein. [Figure 8] FIG. 8 is a flow diagram of an exemplary method for delivering a blood pump to a patient's heart while using a percutaneous circulatory assist system, according to an embodiment of the subject matter disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the specific 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.

[0035] 1 illustrates a side cross-sectional view of several components of an exemplary percutaneous circulatory assist system 100 according to an embodiment of the subject matter disclosed herein. Generally, the system 100 includes a mechanical circulatory assist device 102 (also referred to herein interchangeably as a "blood pump"), a guidewire 104, and an introducer sheath (shown elsewhere). As described in further detail below, the guidewire 104 and introducer sheath facilitate percutaneous delivery of the blood pump 102 to a target location within a patient, such as within the patient's heart.

[0036] With continued reference to Figure 1 and further reference to Figure 2, the blood pump 102 generally includes an impeller assembly housing 106 and a motor housing 108. In some embodiments, the impeller housing 106 and the motor housing 108 may be integrally or monolithically constructed. In other embodiments, the impeller assembly housing 106 and the motor housing 108 may be separate components configured to be removably or permanently coupled.

[0037] The impeller assembly housing 106 carries therein an impeller assembly 110. The impeller assembly 110 includes an impeller shaft 112 and an impeller 114 that rotates relative to the impeller assembly housing 106 and drives blood through the blood pump 102. More specifically, the impeller 114 directs blood through a blood inlet 116 formed on the impeller assembly housing 106, through the impeller assembly housing 106, and out a blood outlet 118 formed on the impeller housing 106. In some embodiments, the impeller shaft 112 and the impeller 114 may be integrated, while in other embodiments, the impeller shaft 112 and the impeller 114 may be separate components. As shown in FIGS. 1 and 2, the inlet 116 and / or the outlet 118 may each include multiple openings. In other embodiments, the inlet 116 and / or the outlet 118 may each include a single opening. 1 and 2, the inlet 116 may be formed in an end of the impeller assembly housing 106 and the outlet 118 may be formed in a side of the impeller assembly housing 106. In other embodiments, the inlet 116 and / or the outlet 118 may be formed in other portions of the impeller assembly housing 106. In some embodiments, the impeller assembly housing 106 may be coupled to a distally extending cannula (not shown), which can receive blood and deliver blood to the inlet 116.

[0038] 1 and 2 , the motor housing 108 carries a motor 120 that is configured to rotatably drive the impeller 114 relative to the impeller assembly housing 106. In the illustrated embodiment, the motor 120 rotates a drive shaft 122 that is coupled to a drive magnet 124. Rotation of the drive magnet 124 causes rotation of a driven magnet 126 that is connected to the impeller assembly 110. More specifically, in embodiments incorporating the impeller shaft 112, the impeller shaft 112 and the impeller 114 are configured to rotate with the driven magnet 126. In other embodiments, the motor 120 may be coupled to the impeller assembly 110 via other components.

[0039] In some embodiments, a controller (not shown) may be operably coupled to and configured to control the motor 120. In some embodiments, the controller may be disposed within the motor housing 108. In other embodiments, the controller may be disposed outside the motor housing 108 (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 disposed within the motor housing 108. According to an embodiment, the controller may be, include, or be included 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 in the singular herein, the controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, and / or the like. In other embodiments, motor 120 may be controlled in other manners.

[0040] 1 and 2, the system 100 can provide improved torque and blood flow and reduce device-induced hemolysis as compared to conventional systems. In general, this improved performance is facilitated by the relative dimensions of the different sections of the blood pump 102 and the guidewire 104. More specifically, the guidewire 104 has a first, relatively large transverse dimension d gds and a distal section 128 having a second relatively small transverse dimension d gps(As used herein, "lateral dimension" is understood to refer to the diameter of a circular component or the maximum width dimension of a component having a non-circular cross-section.) Stated another way, the second lateral dimension d of the guidewire 104 is gps is the first transverse dimension d of the guidewire 104 gds The first transverse dimension d of the guidewire 104 is smaller than gds may be similar to a transverse dimension of a conventional guidewire 104 to facilitate advancement through a patient's vasculature, and the second transverse dimension d of the guidewire 104 gps may be smaller than a transverse dimension of a conventional guidewire for reasons that will become more apparent from the following paragraphs. In some embodiments, the first transverse dimension d gds and / or the second transverse dimension d gps is the diameter. In some embodiments, the first transverse dimension d gds may be in the range of 0.014 to 0.035 inches (0.3556 to 0.889 mm). In some embodiments, the second transverse dimension d of the guidewire 104 gps may be in the range of 0.006 to 0.1018 inches (0.1524 to 2.58572 millimeters).

[0041] The impeller assembly housing 106 has a third relatively large lateral dimension d ih and the motor housing 108 includes a fourth relatively small lateral dimension d mh In some embodiments, the fourth lateral dimension d of the blood pump 102 mh is the third lateral dimension d of the blood pump 102 ih In another embodiment, the fourth lateral dimension d of the blood pump 102 is smaller than mh is the third lateral dimension d of the blood pump 102 ih The third lateral dimension d of the blood pump 102 may be similar to or the same as ih may be larger than that of a conventional blood pump, and the fourth lateral dimension d of the blood pump 102 mhmay be similar to or larger than that of a conventional blood pump for reasons that will become more apparent from the following paragraphs. In some embodiments, the third lateral dimension d ih and / or the fourth transverse dimension d mh In some embodiments, the third lateral dimension d of the blood pump 102 is ih may be within the range of 0.205 to 0.211 inches (5.207 to 5.3594 mm), or within the range of 0.189 to 0.195 inches (4.8006 to 4.953 mm). In some embodiments, the fourth lateral dimension d of the blood pump 102 mh may be in the range of 0.1805 to 0.1865 inches (4.5847 to 4.7371 mm), or in the range of 0.189 to 0.195 inches (4.8006 to 4.953 mm).

[0042] 1 and 3, in some embodiments, the guidewire 104 includes a transition section 132 joining the distal section 128 to the proximal section 130. The transition section 132 is tapered to match the dimensions of the proximal section 130 and the distal section 128, resulting in an overall tapered diameter profile of the guidewire 104. In other embodiments, the transition section 132 may be omitted. In some embodiments, the dimensions of the proximal section 130, the transition section 132, and the distal section 128 may be uniform along their lengths, while in other embodiments, the dimensions of the proximal section 130, the transition section 132, and / or the distal section 128 may be non-uniform along their lengths.

[0043] The guidewire 104 may be formed by a variety of methods including, for example, centerless grinding, stamping or rolling, a combination of both, or other shape forming methods. In some embodiments, the guidewire 104 may include a coating (not shown) that promotes trackability within the patient's vasculature and reduces friction during advancement of the blood pump 102 over the guidewire 104. Such coatings may include PTFE, polymeric coatings, or ceramic coatings by chemical vapor deposition processes such as atomic layer deposition. Incorporating a smaller dimensioned proximal section 130 of the guidewire 104 may also reduce the likelihood of peeling off the coating on the edge of the window at the pump outlet 118 (see FIGS. 1 and 2) by forcing the guidewire 104 to exit the window at the pump outlet 118 more nearly parallel to the outer edge of the motor housing 108.

[0044] As briefly described above, the system 100 may also include an introducer sheath (shown elsewhere). Generally, the introducer sheath has a lumen with an inner diameter and an outer diameter. The introducer sheath may be constructed from a variety of suitable materials, such as silicone, Vestamid®, polyethylene, low density polyethylene, high density polyethylene polyurethane, thermoplastic rubber, polypropylene, Pebax®, or other medical grade composites or plastics. Metals such as stainless steel and Nitinol may be used to provide the introducer sheath with structural integrity, flexibility, expansion / contraction properties, or other such characteristics. In other embodiments, the guidewire 104 and blood pump 102 may be delivered without the use of an introducer sheath. Alternatively, the guidewire 104 and blood pump 102 may be delivered via a graft anastomosed to a blood vessel, forming a Y-connection with the anatomical structure. In some embodiments, the introducer sheath can have an inner transverse dimension (more specifically, inner diameter) within the range of 0.209 to 0.214 inches (5.3086 to 5.4356 millimeters).

[0045] 4 shows the system 100 during initial insertion into a blood vessel V, such as the femoral artery of a patient. More specifically, an introducer sheath 134 is inserted into the blood vessel V, and the guidewire 104 is inserted through the introducer sheath 134 such that a proximal section 130 is disposed within the introducer sheath 134 and a distal section 128 (shown elsewhere) is disposed distally from the introducer sheath 134. The blood pump 102 is initially disposed within the introducer sheath 134 and movably coupled to the guidewire 104. More specifically, the proximal section 130 of the guidewire 104 extends distally from the pump inlet 116, through the impeller assembly housing 106, and extends proximally from the pump outlet 118.

[0046] Figure 5 shows the system 100 as it has been advanced distally from the position shown in Figure 4. More specifically, the distal section 128 of the guidewire 104 and the blood pump 102 are positioned within the blood vessel V, distal to the introducer sheath 134. The distal section 128 of the guidewire 104 extends distally from the pump inlet 116, through the impeller assembly housing 106, and extends proximally from the pump outlet 118.

[0047] 4 and 5 also facilitate further illustration of the advantages provided by the dimensions of the sections of blood pump 102 and guidewire 104. As shown in FIG. 4, proximal section 130 of guidewire 104 has a relatively small transverse dimension d gps1, provides additional clearance within the introducer sheath 134. As a result, the proximal section 130 of the guidewire 104 allows the blood pump 102 to move through the introducer sheath 134 while also allowing the blood pump 102 to be relatively large compared to conventional blood pumps. For example, one or more components of the blood pump 102 proximal to the outlet 118, such as the motor 120, the drive magnet 124, and / or the driven magnet 126 (all shown in FIG. 1 ), may have a relatively large size compared to those of conventional blood pumps. As another example, one or more components distal to the outlet 118, such as the impeller assembly housing 106 and the impeller 114, may have a relatively large size compared to those of conventional blood pumps. As a particular example, the impeller assembly housing 106 has a relatively large lateral dimension d, as described above. ih Providing these components of the blood pump 102 with relatively large dimensions may allow more torque to be generated by the motor 120, the driving magnet 124, and / or the driven magnet 126, or may allow the impeller 114 to provide increased blood flow and / or reduced hemolysis. For example, by increasing the size of certain components, such as the impeller 114, the blood pump 102 may achieve a greater blood flow rate at a lower rotational speed of the impeller 114, reducing the likelihood of hemolysis. Such a configuration may also allow the rigid body length of the blood pump 102 to be relatively short compared to conventional blood pumps, which may facilitate navigating a patient's vasculature with the blood pump 102.

[0048] In addition, in contrast to conventional blood pumps, the lateral dimension d of the impeller assembly housing 106 is ih may be only slightly smaller than the internal lateral dimension of the introducer sheath 134 (e.g., the inner diameter of the introducer sheath 134). More specifically, the lateral dimension d ihmay be within 99.75 percent to 98.25 percent, 99.5 percent to 98.5 percent, or 99.25 percent to 98.75 percent of the internal lateral dimension of the introducer sheath 134. Similarly, unlike conventional blood pumps, the lateral dimension d ih is the lateral dimension d of the motor housing 108 mh and the transverse dimension d of the proximal section 130 of the guidewire 104 gps More specifically, the lateral dimension d of the impeller assembly housing 106 may be similar to the sum of ih can be as shown in Equation 1.

[0049] d ih ≧d mh +2d gps (1) Similarly, in contrast to conventional blood pumps, the lateral dimension d of the motor housing 108 mh may be only slightly smaller than the inner lateral dimension of the introducer sheath 134. More specifically, the lateral dimension d of the motor housing 108 mh may be within the range of 90.75 percent to 92.25 percent, within the range of 91.00 percent to 92.00 percent, or within the range of 91.25 percent to 91.75 percent of the inner lateral dimension of the introducer sheath 134.

[0050] Referring now to FIG. 5, the lateral dimension d of the distal section 128 of the guidewire 104 is gds is the lateral dimension d of the proximal section 130 gps , and in some embodiments, may be similar to the transverse dimensions of a conventional guidewire because (1) distal section 128 is configured to be disposed distally from introducer sheath 134 so that distal section 128 does not cause interference with blood pump 102 as it moves through introducer sheath 134, and (2) facilitates advancement through a patient's vasculature. In some embodiments, transverse dimension d of distal section 128 may be greater than d gdsis the lateral dimension d of the impeller assembly housing 106, as shown in Equation 2. ih and the lateral dimension d of the motor housing 108 mh may be related to.

[0051] d ih ≦d mh +2d gds (2) The exemplary system 100 illustrated in Figures 1-5 is not intended to suggest any limitation as to the scope of use or functionality of the embodiments of the present disclosure, nor should the exemplary system 100 be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. In addition, the various components illustrated in Figures 1-5 may, in some embodiments, be integrated with various of the other components illustrated therein (and / or components not illustrated), all of which are deemed to be within the scope of the present disclosure.

[0052] The system according to the present disclosure may be modified into various other forms. For example, the guidewire according to the present disclosure may be modified into various other forms. More specifically, the distal section of the guidewire may include one or more flexible portions, for example to reduce or eliminate potential trauma to the patient's vasculature during insertion. As another example, the proximal section of the guidewire may have a different cross-sectional shape than the distal section of the guidewire and / or the transition section of the guidewire. FIGS. 6A-6C show several embodiments of guidewires, etc., that may be used in the system 100 in place of the guidewire 104. However, like the guidewire 104, the guidewire shown in FIGS. 6A-6C includes a relatively narrow proximal section, providing more space for the blood pump 102 within the introducer sheath 134 than if the proximal section were the same size and / or shape as the distal section of the guidewire, and / or compared to a conventional guidewire.

[0053] 6A illustrates another embodiment of a guidewire 300 in accordance with the present disclosure. Guidewire 300 has a relatively flat shape. More specifically, proximal section 302, transition section (not shown), and / or distal section (not shown) may have a relatively flat shape. In some embodiments, the distal section may have a transverse dimension (more specifically, a thickness) in the range of 0.014-0.035 inches (0.3556-0.889 mm) and proximal section 302 may have a transverse dimension (more specifically, a thickness) in the range of 0.003-0.014 inches (0.0762-0.3556 mm).

[0054] 6B and 6C show another embodiment of a guidewire 400 according to the present disclosure. The guidewire 400 has a generally curved profile. More specifically, the guidewire 400 includes an outer surface 402 and an inner surface 404 that are the same as or similar to the inner surface 136 of the introducer sheath 134 and the outer surface of the motor housing 108 of the blood pump 102 (both shown in FIG. 1), respectively. In some embodiments, the proximal section 406, the transition section (not shown), and / or the distal section (not shown) may have a curved profile. In some embodiments, the curved profile has rounded corners, as shown in FIG. 6C. These rounded corners help prevent the guidewire from rubbing against the introducer sheath 134 and / or the blood pump 102.

[0055] 7 illustrates another exemplary percutaneous circulatory assist system 500 according to an embodiment of the subject matter disclosed herein. In the illustrated embodiment, the system 500 includes an introducer sheath 502, a guidewire 504, and a blood pump 506. The blood pump 506 may be the same as the blood pump 102 described above, or the blood pump 506 may be a conventional blood pump. The guidewire 504 may be the same as any of the guidewires described above, or the guidewire 504 may be a conventional guidewire. The introducer sheath 502 includes separate lumens for the guidewire 504 and the blood pump 506. More specifically, the introducer sheath 502 includes a guidewire lumen 508 that receives the guidewire 504 and a blood pump lumen 510 that receives the blood pump 506. Because the guidewire 504 does not occupy space between the blood pump 506 and the introducer sheath 502 in the blood pump lumen 510, the guidewire lumen 508 provides a relatively large space in the introducer sheath 502 for the blood pump 506. In addition, the guidewire 504 does not contact the blood pump 506. Because the guidewire 504 does not occupy space in the blood pump lumen 510, one or more components of the blood pump, such as the magnet, motor, impeller assembly housing, impeller assembly, etc., can have a relatively large size and can provide one or more of the aforementioned advantages. In some embodiments, the guidewire lumen 508 can be permanently or removably coupled to the introducer sheath 502. In other embodiments, the guidewire lumen 508 can be separate from the introducer sheath 502. The guidewire lumen 508 and the introducer sheath 502 can be coupled to each other when ready for use.

[0056] The example system illustrated in Figure 7 is not intended to suggest any limitation as to the scope of use or functionality of the embodiments of the present disclosure, nor should the example system be interpreted as having any dependency or requirement relating to any single component or combination of components illustrated therein. In addition, the various components illustrated in Figure 7 may, in some embodiments, be integrated with various of the other components illustrated therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0057] FIG. 8 shows a flow diagram of an exemplary method 600 for using a percutaneous circulatory assist system and delivering a blood pump to a patient's heart according to an embodiment of the subject matter disclosed herein. The method 600 describes features of the system 100, but it is understood that any of the systems contemplated herein may be used as well. In step 602, a physician inserts an introducer sheath 134 into a patient's blood vessel, such as the patient's femoral artery, or places a suture graft anastomosed to the blood vessel, forming a Y-connection with the blood vessel. The physician can then insert a guide catheter (not shown) through the introducer sheath 134 to facilitate passage of the guidewire 104 through the patient's vasculature. Alternatively, the guidewire 104 may be delivered through the introducer sheath 134 without a guide catheter. In step 604, the physician inserts the guidewire 104 through the introducer sheath 134 and advances the guidewire 104 through a blood vessel such that the distal tip of the guidewire 104 is positioned at a target location within the patient, such as the left ventricle of the heart. Outside the patient's body, the physician positions the blood pump 102 over the proximal section 130 of the guidewire 104. More specifically, the physician inserts the proximal end of the guidewire 104 into the blood inlet 116 and advances the proximal section 130 of the guidewire 104 through the impeller assembly housing 160 until the proximal section 130 emerges from the outlet 118. As a result, the physician positions the blood pump 102 such that the proximal section 130 of the guidewire 104 extends proximally from the outlet 118, through the impeller assembly housing 106, and distally from the inlet 116. In step 606, the physician advances the blood pump 102 over the proximal section 130 of the guidewire 104 and into and through the introducer sheath 134. After distally exiting the introducer sheath 134, in step 608, the physician advances the blood pump 102 over the transition section 132 and distal section 128 of the guidewire 104 until the blood pump 102 reaches the target location.For example, the physician may advance the blood pump 102 so that a cannula (not shown) coupled to the impeller assembly housing 106 is positioned in the left ventricle and the outlet 118 is positioned proximal to the aortic valve, e.g., in the aorta. In step 610, the physician withdraws the guidewire 104 from the patient.

[0058] The example method illustrated in Figure 8 is not intended to suggest any limitation as to the scope of use or functionality of the embodiments of the present disclosure, nor should the example method be interpreted as having any dependency or requirement relating to any single step or combination of steps illustrated therein.

[0059] 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 above embodiments refer to certain features, the scope of the present 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 present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof. The technical ideas contained in this disclosure are described below as appendices. (Appendix 1) A guidewire comprising: a distal section having a first transverse dimension; a proximal section having a second lateral dimension smaller than the first lateral dimension; A guidewire comprising: a blood pump coupled to the guidewire and configured to be moved along the guidewire, An impeller housing; A motor housing; an impeller disposed within the impeller housing and configured to move blood through the blood pump; a blood pump, A percutaneous circulatory support system comprising: (Appendix 2) 2. The percutaneous circulatory assist system of claim 1, wherein the impeller housing has a third lateral dimension and the motor housing has a fourth lateral dimension, the fourth lateral dimension being smaller than the third lateral dimension. (Appendix 3) 3. The percutaneous circulatory assist system of claim 2, wherein the third lateral dimension is a diameter and the fourth lateral dimension is a diameter. (Appendix 4) 4. The percutaneous circulatory assist system of any of claims 2 or 3, further comprising an introducer sheath configured to receive the guidewire and the blood pump. (Appendix 5) 5. The percutaneous circulatory assist system of claim 4, wherein the introducer sheath has an inner lateral dimension and the third lateral dimension is within the range of 99.75 percent to 98.25 percent of the inner lateral dimension. (Appendix 6) 5. The percutaneous circulatory assist system of claim 4, wherein the introducer sheath has an inner lateral dimension and the fourth lateral dimension is within the range of 91.25 percent to 91.75 percent of the inner lateral dimension. (Appendix 7) 4. The percutaneous circulatory assist system of any one of claims 1 to 3, wherein the guidewire further comprises a transition section between the proximal section and the distal section. (Appendix 8) 4. The percutaneous circulatory assist system of any one of claims 1 to 3, wherein the impeller housing includes an inlet and an outlet, and the guidewire is configured to extend proximally from the outlet, through the impeller housing, and extend distally from the inlet. (Appendix 9) 9. The percutaneous circulatory assist system of claim 8, wherein the proximal section of the guidewire is configured to extend proximally from the outlet, through the impeller housing, and extend distally from the inlet. (Appendix 10) 9. The percutaneous circulatory assist system of claim 8, wherein the distal section of the guidewire is configured to extend proximally from the outlet, through the impeller housing, and extend distally from the inlet. (Appendix 11) 4. The percutaneous circulatory assist system according to any one of claims 1 to 3, wherein the first lateral dimension is a diameter and the second lateral dimension is a diameter. (Appendix 12) a guidewire including a proximal section having a guidewire proximal section transverse dimension; a blood pump coupled to the guidewire and configured to be moved along the guidewire, an impeller assembly including an impeller assembly housing having a lateral dimension and an impeller assembly disposed within the impeller assembly housing, the impeller assembly being configured to move blood through the blood pump; a motor housing coupled to the impeller assembly housing, the motor housing having a motor housing lateral dimension; A blood pump including: Equipped with d ih ≧d mh +2d gps and d ih is the impeller assembly housing lateral dimension, d mh is the motor housing lateral dimension, d gps is the lateral dimension of the proximal section of the guidewire, percutaneous circulatory assist system. (Appendix 13) The guidewire further includes a distal section coupled to the proximal section, the distal section having a guidewire distal section transverse dimension; d ih ≦d mh +2d gds and d gds is the lateral dimension of the guidewire distal section. (Appendix 14) 14. The percutaneous circulatory assist system of any of claims 12 or 13, further comprising an introducer sheath configured to receive the proximal section of the guidewire and the blood pump. (Appendix 15) 14. The percutaneous circulatory assist system of any of claims 12 or 13, wherein the impeller assembly housing includes an inlet and an outlet, the guidewire being configured to extend proximally from the outlet, through the impeller assembly housing, and extend distally from the inlet.

Claims

1. A guidewire comprising: a distal section having a first transverse dimension; a proximal section having a second lateral dimension smaller than the first lateral dimension; A guidewire comprising: a blood pump coupled to the guidewire and configured to be moved along the guidewire, An impeller housing; A motor housing; an impeller disposed within the impeller housing and configured to move blood through the blood pump; a blood pump, the impeller housing has a third lateral dimension and the motor housing has a fourth lateral dimension, the fourth lateral dimension being less than the third lateral dimension.

2. The percutaneous circulatory assist system of claim 1 , wherein the third lateral dimension is a diameter and the fourth lateral dimension is a diameter.

3. The percutaneous circulatory assist system of claim 1 or 2, further comprising an introducer sheath configured to receive the guidewire and the blood pump.

4. 4. The percutaneous circulatory assist system of claim 3, wherein the introducer sheath has an inner lateral dimension and the third lateral dimension is within a range of 99.75 percent to 98.25 percent of the inner lateral dimension.

5. 4. The percutaneous circulatory assist system of claim 3, wherein the introducer sheath has an inner lateral dimension and the fourth lateral dimension is within a range of 91.25 percent to 91.75 percent of the inner lateral dimension.

6. The percutaneous circulatory assist system of claim 1 or 2, wherein the guidewire further comprises a transition section between the proximal and distal sections.

7. 3. The percutaneous circulatory assist system of claim 1, wherein the impeller housing includes an inlet and an outlet, the guidewire configured to extend proximally from the outlet, through the impeller housing, and distally from the inlet.

8. 8. The percutaneous circulatory assist system of claim 7, wherein the proximal section of the guidewire is configured to extend proximally from the outlet, through the impeller housing, and extend distally from the inlet.

9. 8. The percutaneous circulatory assist system of claim 7, wherein the distal section of the guidewire is configured to extend proximally from the outlet, through the impeller housing, and extend distally from the inlet.

10. The percutaneous circulatory assist system of claim 1 or 2, wherein the first lateral dimension is a diameter and the second lateral dimension is a diameter.

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