Percutaneous circulatory support device including proximal pressure sensor

Abstract

To provide an improved percutaneous circulatory support device including a pressure sensor.SOLUTION: A percutaneous circulatory support device such as a blood pump (100) includes a housing (102) and an impeller (112) disposed within the housing (102). The impeller (112) is configured to rotate relative to the housing (102) to cause blood to flow through the housing (102). A motor (105) is operably coupled to the impeller (112), and the motor (105) is configured to rotate the impeller (112) relative to the housing (102). A catheter (126) is coupled to the motor (105), and a pressure sensor (132) is coupled to the catheter (126) and disposed proximally relative to the housing (102).SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to percutaneous circulatory assist systems, and more particularly, to percutaneous circulatory assist devices that include one or more pressure sensors. [Background technology]

[0002] Percutaneous circulatory assist devices can provide temporary support for up to several weeks in patients with reduced cardiac function or cardiac output. Some percutaneous circulatory assist devices include one or more pressure sensors for measuring intravascular pressure. Measuring these pressures can, for example, (1) detect unintended changes in device position within the heart and (2) determine cardiac output, thereby enabling evaluation of potential therapeutic changes. However, devices that include pressure sensors have several drawbacks. For example, pressure sensors can be damaged during deployment. As another example, sensed pressures can be inaccurate due to the device's operating speed and other dynamic pressure effects. Therefore, improved devices that include pressure sensors are needed. Summary of the Invention

[0003] In Example 1, the percutaneous circulatory assist device includes a housing, an impeller disposed within the housing and configured to rotate relative to the housing to cause blood to flow through the housing, a motor operably coupled to the impeller and configured to rotate the impeller relative to the housing, a catheter coupled to the motor, and a pressure sensor coupled to the catheter and positioned proximal to the housing.

[0004] In Example 2, the percutaneous circulatory assist device of Example 1 further comprises a sensor housing comprising an internal chamber, the pressure sensor being disposed within the internal chamber. In Example 3, in the percutaneous circulatory assist device of Example 2, the sensor housing includes an opening.

[0005] In Example 4, the percutaneous circulatory assist device of Example 3, wherein the opening is a distally facing opening. In Example 5, the percutaneous circulatory assist device of Example 3, wherein the opening is a laterally oriented opening.

[0006] In Example 6, the percutaneous circulatory assist device of Example 5, wherein the sensor housing further comprises a distally facing opening. In Example 7, the percutaneous circulatory assist device of any of Examples 2 to 6, wherein the sensor housing comprises a ferrule.

[0007] In Example 8, the percutaneous circulatory assist device of any of Examples 2 to 7 further comprises an outer jacket that secures the sensor housing and the pressure sensor to the catheter. In Example 9, the percutaneous circulatory assist device of any one of Examples 2 to 8 further comprises an adhesive that fixes the sensor housing and the pressure sensor to the catheter.

[0008] In Example 10, the percutaneous circulatory assist device of any of Examples 1 to 9 further comprises a sensor cable coupled to the pressure sensor and a cable lumen coupled to the catheter, wherein the sensor cable is disposed within the cable lumen.

[0009] In Example 11, the percutaneous circulatory assist device of any of Examples 1 to 10, wherein the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor. In Example 12, a percutaneous circulatory assist system includes an assist device including a housing, an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow through the housing, a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing, a catheter coupled to the motor, a guidewire lumen coupled to the catheter, and a sensing region; and a guidewire including an elongated flexible body and a pressure sensor coupled to the elongated flexible body, the elongated flexible body being movable within the guidewire lumen to position the pressure sensor within the sensing region.

[0010] In Example 13, the percutaneous circulatory assist system of Example 12 further includes a motor cable coupled to the motor, the motor cable being disposed within the catheter, and the guidewire lumen being disposed radially outward from the motor cable.

[0011] In Example 14, in the percutaneous circulatory assist system of any of Examples 12 to 13, the sensing region is located proximal to the motor. In Example 15, the percutaneous circulatory assist system of any of Examples 12-14 further comprises an outer jacket coupling the guidewire lumen to the catheter.

[0012] In Example 16, a percutaneous circulatory assist device includes a housing having an inlet and an outlet, an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out the outlet, a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing, a catheter coupled to the motor, and a pressure sensor coupled to the catheter and positioned proximal to the housing.

[0013] In Example 17, the percutaneous circulatory assist device of Example 16 further comprises a sensor housing comprising an internal chamber, the pressure sensor being disposed within the internal chamber. In Example 18, the percutaneous circulatory assist device of Example 17, wherein the sensor housing comprises an opening.

[0014] In Example 19, the percutaneous circulatory assist device of Example 18, wherein the opening is a distally facing opening. In Example 20, the percutaneous circulatory assist device of Example 18, wherein the opening is a laterally oriented opening.

[0015] In Example 21, the percutaneous circulatory assist device of Example 20, wherein the sensor housing further comprises a distally facing opening. In Example 22, the percutaneous circulatory assist device of Example 17, wherein the sensor housing comprises a ferrule.

[0016] In Example 23, the percutaneous circulatory assist device of Example 17 further comprises an outer jacket that secures the sensor housing and the pressure sensor to the catheter. In Example 24, the percutaneous circulatory assist device of Example 17 further comprises an adhesive that secures the sensor housing and the pressure sensor to the catheter.

[0017] In Example 25, the percutaneous circulatory assist device of Example 16 further includes a sensor cable coupled to the pressure sensor and a cable lumen coupled to the catheter, wherein the sensor cable is disposed within the cable lumen.

[0018] In Example 26, in the percutaneous circulatory assist device of Example 16, the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor. In Example 27, a percutaneous circulatory assist system includes an assist device comprising a housing including an inlet and an outlet, an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out the outlet, a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing, a catheter coupled to the motor, a guidewire lumen coupled to the catheter, and a sensing region; and a guidewire comprising an elongated flexible body and a pressure sensor coupled to the elongated flexible body, the elongated flexible body being movable within the guidewire lumen to position the pressure sensor at the sensing region.

[0019] In Example 28, the percutaneous circulatory assist system of Example 27 further comprises a motor cable coupled to the motor, the motor cable being disposed within the catheter, and the guidewire lumen being disposed radially outward from the motor cable.

[0020] In Example 29, in the percutaneous circulatory assist system of Example 27, the sensing region is located proximal to the motor. In Example 30, the percutaneous circulatory assist system of Example 27 further comprises an outer jacket connecting the guidewire lumen to the catheter.

[0021] In Example 31, a method of manufacturing a percutaneous circulatory assist device includes the steps of positioning an impeller within a housing so that the impeller is rotatable relative to the housing, operably coupling a motor to the impeller, coupling a catheter to the motor, and coupling a pressure sensor to the catheter proximal to the motor.

[0022] In Example 32, in the method of Example 31, the step of coupling the pressure sensor to the catheter includes covering the catheter with an outer jacket. In Example 33, in the method of Example 32, coating the catheter with an outer jacket includes forming the outer jacket on the catheter by a polymer reflow process.

[0023] In Example 34, the method of Example 32 further includes coupling a sensor cable to the pressure sensor. In Example 35, the method of Example 31 further includes the steps of disposing the pressure sensor in a sensor housing and coupling the sensor housing to the catheter.

[0024] 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 explanation of the drawings]

[0025] [Figure 1] 1 is a side cross-sectional view of an exemplary percutaneous circulatory assist device (also interchangeably referred to herein as a "blood pump") according to an embodiment of the subject matter disclosed herein. [Figure 2] 2 is a detailed view of an exemplary percutaneous circulatory assist device within line 2-2 of FIG. 1. [Figure 3] FIG. 1 is a side view of an exemplary sensor assembly of a percutaneous circulatory assist device, according to an embodiment of the subject matter disclosed herein. [Figure 4] 4 is a side cross-sectional view of the sensor assembly taken along line 4-4 of FIG. 3. [Figure 5] 1 is a side cross-sectional view of an exemplary percutaneous circulatory assist system according to an embodiment of the subject matter disclosed herein. [Figure 6] FIG. 6 is a side view of a pressure-sensing guidewire of the percutaneous circulatory assist system of FIG. 5. [Figure 7] 1 is a side cross-sectional view of an exemplary percutaneous circulatory assist system according to an embodiment of the subject matter disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0026] 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. The intention, however, is not 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.

[0027] 1 shows a partial cross-sectional side view of an exemplary percutaneous circulatory assist device 100 (also referred to interchangeably herein as a "blood pump") according to an embodiment of the subject matter disclosed herein. Device 100, along with a guidewire and introducer sheath (not shown), may form part of a percutaneous circulatory assist system. More specifically, the guidewire and introducer sheath may enable percutaneous delivery of device 100 to a target location within a patient, such as within the patient's heart. Alternatively, device 100 may be delivered to a different target location within the patient.

[0028] 1 , device 100 generally includes a housing 101 that includes an impeller housing 102 and a motor housing 104. In some embodiments, impeller housing 102 and motor housing 104 may be integrally or monolithically constructed. In other embodiments, impeller housing 102 and motor housing 104 may be separate components configured to be removably or permanently coupled. In some embodiments, blood pump 100 may not include a separate motor housing 104; impeller housing 102 may be directly coupled to motor 105, described below, or motor housing 104 may be integrally constructed with motor 105, described below.

[0029] Impeller housing 102 mounts impeller assembly 106 therein. Impeller assembly 106 includes an impeller shaft 108 rotatably supported by at least one bearing, such as bearing 110. Impeller assembly 106 also includes an impeller 112 that rotates relative to impeller housing 102 to pump blood through device 100. More specifically, impeller 112 pumps blood from a blood inlet 114 ( FIG. 1 ) formed on impeller housing 102, through impeller housing 102, and out a blood outlet 116 formed on impeller housing 102. In some embodiments, impeller shaft 108 and impeller 112 may be separate components, as shown, while in other embodiments, impeller shaft 108 and impeller 112 may be integral. In some embodiments, inlet 114 and / or outlet 116 may each include multiple openings, as shown. In other embodiments, the inlet 114 and / or the outlet 116 may each include a single opening. In some embodiments, the inlet 114 may be formed in an end of the impeller housing 102, as shown, and the outlet 116 may be formed in a side of the impeller housing 102. In other embodiments, the inlet 114 and / or the outlet 116 may be formed in other portions of the impeller housing 102. In some embodiments, the impeller housing 102 may be coupled to a distally extending cannula (not shown), which may receive and deliver blood to the inlet 114.

[0030] 1 , motor housing 104 carries motor 105, which is configured to rotatably drive impeller 112 relative to impeller housing 102. In the illustrated embodiment, motor 105 rotates drive shaft 120, which is coupled to drive magnet 122. Rotation of drive magnet 122 causes rotation of driven magnet 124, which is connected to impeller assembly 106 and rotates with impeller assembly 106. More specifically, in embodiments incorporating impeller shaft 108, impeller shaft 108 and impeller 112 are configured to rotate with driven magnet 124. In other embodiments, motor 105 may be coupled to impeller assembly 106 via other components.

[0031] In some embodiments, a controller (not shown) may be operably coupled to and configured to control the motor 105. In some embodiments, the controller may be located within the motor housing 104. In other embodiments, the controller may be located outside the motor housing 104 (e.g., in a separate housing, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located within the motor housing 104. 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, the motor 105 may be controlled in other ways.

[0032] With continued reference to FIG. 1 and further reference to FIG. 2 , the motor housing 104 is coupled to a catheter 126 opposite the impeller housing 102. The catheter 126 may be coupled to the motor housing 104 in a variety of ways, such as by laser welding, soldering, or similar methods. The catheter 126 extends proximally away from the motor housing 104. The catheter 126 carries a motor cable 128 within a main lumen 130, which may operably couple the motor 105 to a controller (not shown) and / or an external power source (not shown). Externally, the catheter 126 carries a sensor assembly 132 for measuring pressure within the patient's vasculature, e.g., the aorta. Advantageously, the sensor assembly 132 is positioned relative to other components of the device 100 to obtain highly accurate pressure data. For example, the proximal location of the sensor assembly 132 relative to the motor housing 104 and motor 105 reduces or eliminates motor speed-related or dynamic pressure-related sensing inaccuracies. Such inaccuracies are typical of other percutaneous circulatory assist devices that employ pressure sensors located more distally to the motor or impeller assembly, for example, devices that employ pressure sensors located near the outlet.

[0033] 2 , sensor assembly 132 includes a sensor housing 134 having a counterbore-shaped interior chamber 136. A pressure sensor 138, such as an optical or electrical pressure sensor, is disposed within interior chamber 136. Sensor housing 134 therefore protects pressure sensor 138 during deployment of device 100. Sensor housing 134 also includes a distally facing opening 140 coupled to interior chamber 136. Opening 140 allows blood to enter interior chamber 136, thereby enabling pressure sensor 138 to sense the pressure of the blood.

[0034] The sensor housing 134 may take a variety of forms. For example, the sensor housing 134 may be a tube or ferrule manufactured from, for example, one or more metals, one or more plastics, composite materials, etc. The sensor housing 134 may be coupled to the catheter 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer jacket 144 surrounding the sensor housing 134 and the catheter 126. The sensor housing 134 may also include a sensor mount 146 located within the interior chamber 136. The sensor mount 146 allows the pressure sensor 138 to be supported away from the walls of the sensor housing 134 (i.e., the sensor mount 146 centers the pressure sensor 138 within the interior chamber 136), thereby enabling highly accurate pressure sensing.

[0035] 2 , the sensor assembly 132 further includes a sensor cable 148 coupled to the pressure sensor 138. The sensor cable 148 may operably couple the pressure sensor to a controller (not shown). As shown, the sensor cable 148 may extend through the sensor mount 146 and support the pressure sensor 138 away from the wall of the sensor housing 134. The sensor cable 148 extends proximally through the adhesive 142 and a cable lumen 150 coupled to the catheter 126. The cable lumen 150 may be coupled to the catheter 126 via one or more welds (not shown), adhesive (not shown), and / or the outer jacket 144. In other embodiments, the cable lumen 150 may be omitted and the sensor cable 148 may extend through the main lumen 130 of the catheter 126 or may be routed directly beneath the outer jacket 144.

[0036] 3 and 4 illustrate another sensor assembly 200 according to an embodiment of the subject matter disclosed herein. The sensor assembly 200 may be used as part of the percutaneous circulatory assist device 100 in place of the sensor assembly 132 described above. The sensor assembly 200 is similar to the sensor assembly 132 described above. More specifically, the sensor assembly 200 includes a sensor housing 202 having an internal chamber 204, a pressure sensor 206, a sensor cable 208 ( FIG. 4 ), and an optional sensor mount 210 ( FIG. 4 ) disposed within the internal chamber 204. The sensor housing 202 also includes multiple openings coupled to the internal chamber 204. More specifically, the sensor housing 202 includes a distally facing opening 212, a first laterally facing opening 214, and a second laterally facing opening 216 ( FIG. 4 ). The multiple openings facilitate blood flow through the sensor housing 202, thereby reducing thrombus formation. Alternatively, the sensor housing 202 may include a different number of openings. For example, the sensor housing 202 can include one or more laterally facing openings and omit the distally facing openings. In either case, each of the openings can be sized to prevent the sensor 206 from passing through the opening, for example, if the sensor 206 becomes detached from the sensor cable 208 during use. The openings can also have an oval shape, as shown in FIG. 3, or a variety of other shapes.

[0037] 3 and 4, the distally facing opening 212 is formed by a tapered portion 218 of the sensor housing 202. The tapered portion 218 may be formed by crimping or bonding a separate member to the remainder of the sensor housing 202. In other embodiments, the distally facing opening 212 may be a flat feature perpendicular to the axis of the internal chamber 204.

[0038] 3 and 4, the sensor 206 is at least partially aligned with the first laterally oriented opening 214 and the second laterally oriented opening 216. This location of the sensor 206 provides a relatively small space within the sensor housing 202 where air bubbles may form, which may reduce sensing accuracy. Alternatively, the sensor 206 may be positioned elsewhere within the sensor housing 202. In some embodiments, the sensor 206 includes a surface energy reducing coating (not shown), such as silicone, to inhibit air bubble formation on the sensor 206 or within the sensor housing 202.

[0039] FIG. 5 shows a partial side cross-sectional view of an exemplary percutaneous circulatory assist system 300 according to an embodiment of the subject matter disclosed herein. System 300 includes a percutaneous circulatory assist device 302 similar to device 100 described above. More specifically, a distal portion (not shown) of device 302 generally includes an impeller housing and an impeller, such as impeller housing 102 and impeller 112, respectively, described above and shown elsewhere. A proximal portion of device 302 includes a motor housing 304 that mounts motor 306, which couples to a catheter 308 on an opposite side from motor 306. Catheter 308 extends proximally away from motor housing 304. Catheter 308 carries a motor cable 310 within a main lumen 312, which may operably couple motor 306 to a controller (not shown) and / or an external power source (not shown). Externally, catheter 308 carries a guidewire lumen 314 that receives a pressure-sensing guidewire 316. The pressure-sensing guidewire 316 may be operably coupled to a controller, and guidewire 316 may take a variety of specific forms. However, with further reference to FIG. 6 , pressure-sensing guidewire 316 generally includes an elongated, flexible body 318 that carries a pressure sensor 320, such as an optical or electrical pressure sensor. Pressure-sensing guidewire 316 is advanced (either before or after device 302 is placed within the patient's vasculature) from a proximal end (not shown) of guidewire lumen 314 to a distal end 322 of guidewire lumen 314. Sensor 320 extends distally from guidewire lumen 314 and is disposed within a sensing region 324 of catheter 308. Sensing region 324 is located proximally from motor housing 304 and motor 306, which, as previously described, allows for highly accurate pressure data to be obtained. Guidewire 316 may additionally or alternatively sense pressure at various other locations relative to catheter 308 .

[0040] In other embodiments, system 300 may take other forms or include additional components. For example, device 302 may include a sensor housing, such as sensor housing 134 or sensor housing 202 described above and shown elsewhere, to receive and protect pressure sensor 320 on guidewire 316. Such a sensor housing may be coupled to catheter 126 in a variety of ways, including those described above in connection with catheter 308 and sensor housing 134 or sensor housing 202. As another example, guidewire 316 may be fixed relative to catheter 126.

[0041] FIG. 7 shows a partial side cross-sectional view of an exemplary percutaneous circulatory assist system 400 according to an embodiment of the subject matter disclosed herein. System 400 includes a percutaneous circulatory assist device 402 similar to device 100 described above. More specifically, a distal portion (not shown) of device 402 generally includes an impeller housing and an impeller, such as impeller housing 102 and impeller 112, respectively, described above and shown elsewhere. A proximal portion of device 402 includes a motor housing 404 that mounts motor 406, which couples to a catheter 408 on an opposite side from motor 406. Catheter 408 extends proximally away from motor housing 404. Catheter 408 is a dual-lumen catheter. That is, catheter 408 carries a motor cable 410 within a main lumen 412, which may operably couple motor 406 to a controller (not shown) and / or an external power source (not shown). Catheter 408 also includes a guidewire lumen 414 that receives a pressure-sensing guidewire 416. Pressure-sensing guidewire 416 may be operably coupled to the controller, and guidewire 416 may be similar to pressure-sensing guidewire 316 (shown elsewhere). Pressure-sensing guidewire 416 is advanced (either before or after device 402 is placed within the patient's vasculature) from a proximal end (not shown) of guidewire lumen 414 to a distal end 420 of guidewire lumen 414. A sensor 422 on guidewire 416 extends distally from guidewire lumen 414 through an opening in the distal end 420 of guidewire lumen 414 and is disposed within a sensing region 424 of catheter 408. Sensing region 424 is located proximally from motor housing 404 and motor 406, which, as described above, allows for highly accurate pressure data to be obtained. Guidewire 416 may additionally or alternatively sense pressure at various other locations relative to catheter 408 .

[0042] The percutaneous circulatory assist device 100 is manufactured as follows, and the device 302 is manufactured in a similar manner. The impeller 112 is disposed within the impeller housing 102 so that the impeller 112 is rotatable relative to the impeller housing 102. The impeller 112 is operably coupled to the motor 105, and the catheter 126 is disposed adjacent to the motor housing 104. The cable lumen 150 is disposed adjacent to the catheter 126 and coupled to the catheter 126 via a process that may include forming the outer jacket 144 via at least one polymer reflow process. The pressure sensor 138 and the sensor cable 148 are then coupled to the sensor housing 134 so that the sensor 138 is disposed within the internal chamber 136 of the sensor housing 134. The sensor cable 148 is disposed within the cable lumen 150, and the sensor housing 134 and the pressure sensor 138 are disposed adjacent to the catheter 126. The sensor housing 134 and the pressure sensor 138 within the sensor housing 134 are coupled to the catheter 126 via, for example, one or more of welding, gluing, and covering the components with an outer jacket 144. Covering these components with the outer jacket 144 may include forming the outer jacket 144 by a polymer reflow process.

[0043] 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-described embodiments refer to particular 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 concepts that can be understood from the above-described embodiment will be described below as supplementary notes. [Appendix 1] A percutaneous circulatory assist device, comprising: Housing and an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow through the housing; a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a catheter coupled to the motor; a pressure sensor coupled to the catheter and positioned proximally relative to the housing. [Appendix 2] 10. The percutaneous circulatory assist device of claim 1, further comprising a sensor housing having an internal chamber, the pressure sensor being disposed within the internal chamber. [Appendix 3] 3. The percutaneous circulatory assist device of claim 2, wherein the sensor housing includes an opening. [Appendix 4] 4. The percutaneous circulatory assist device of claim 3, wherein the opening is a distally facing opening. [Appendix 5] 4. The percutaneous circulatory assist device of claim 3, wherein the opening is a laterally oriented opening. [Appendix 6] 6. The percutaneous circulatory assist device of claim 5, wherein the sensor housing further comprises a distally facing opening. [Appendix 7] 7. The percutaneous circulatory assist device of any one of claims 2 to 6, wherein the sensor housing comprises a ferrule. [Appendix 8] 7. The percutaneous circulatory assist device of any one of claims 2 to 6, further comprising an outer jacket that secures the sensor housing and the pressure sensor to the catheter. [Appendix 9] 7. The percutaneous circulatory assist device of any one of claims 2 to 6, further comprising an adhesive that secures the sensor housing and the pressure sensor to the catheter. [Appendix 10] a sensor cable coupled to the pressure sensor; 7. The percutaneous circulatory assist device of any one of claims 1 to 6, further comprising: a cable lumen coupled to the catheter, the sensor cable being disposed within the cable lumen. [Appendix 11] 7. The percutaneous circulatory assist device of any one of claims 1 to 6, wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor. [Appendix 12] 1. A percutaneous circulatory assist system, comprising: 1. An auxiliary device, comprising: Housing and an impeller disposed within the housing, the impeller configured to rotate relative to the housing to cause blood to flow through the housing; a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a catheter coupled to the motor; a guidewire lumen coupled to the catheter; the auxiliary device including a sensing area; A guidewire, an elongated flexible body; and a guidewire including a pressure sensor coupled to the elongated flexible body, the elongated flexible body being movable within the guidewire lumen to position the pressure sensor within the sensing area. [Appendix 13] 13. The percutaneous circulatory assist system of claim 12, further comprising a motor cable coupled to the motor, the motor cable being disposed within the catheter, and the guidewire lumen being disposed radially outward from the motor cable. [Appendix 14] 14. The percutaneous circulatory assist system of claim 12 or 13, wherein the sensing region is located proximal to the motor. [Appendix 15] The percutaneous circulatory assist system of Appendices 12 or 13, further comprising an outer jacket connecting the guidewire lumen to the catheter.

Claims

1. A percutaneous circulatory assist device, comprising: a housing including an inlet and an outlet; an impeller disposed within the housing and configured to rotate relative to the housing such that blood flows through the inlet, passes through the housing, and flows out the outlet; a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a catheter coupled to the motor; a sensor housing coupled to the catheter and positioned proximally relative to the motor, the sensor housing having a wall defining an interior chamber, a laterally facing opening extending through the wall, and a distally facing opening; a pressure sensor disposed within the internal chamber, the pressure sensor impinging upon blood flow through the internal chamber from the distally facing opening to the laterally facing opening.

2. The percutaneous circulatory assist device of claim 1 , wherein a distal end of the pressure sensor is located distal to a proximal end of the laterally directed opening.

3. The percutaneous circulatory assist device of claim 2 , wherein a distal end of the pressure sensor is located proximal to a distal end of the laterally directed opening.

4. The percutaneous circulatory assist device according to any one of claims 1 to 3, wherein the pressure sensor is supported within the internal chamber by a sensor mount.

5. a sensor cable coupled to the pressure sensor; The percutaneous circulatory assist device of claim 4 , wherein the sensor cable extends through the sensor mount and supports the pressure sensor spaced from a wall of the sensor housing.

6. The percutaneous circulatory assist device of any one of claims 1 to 3, further comprising an outer jacket that secures the sensor housing to the catheter.

7. The percutaneous circulatory assist device according to any one of claims 1 to 3, further comprising an adhesive that secures the sensor housing to the catheter.

8. The percutaneous circulatory assist device according to any one of claims 1 to 3, wherein the sensor housing comprises a ferrule.

9. The percutaneous circulatory assist device according to any one of claims 1 to 3, wherein the pressure sensor includes a silicone coating.

10. a sensor cable coupled to the pressure sensor; The percutaneous circulatory assist device according to any one of claims 1 to 3, further comprising: a cable lumen coupled to the catheter, the sensor cable being disposed within the cable lumen.

11. The percutaneous circulatory assist device according to any one of claims 1 to 3, wherein the pressure sensor is an optical pressure sensor.

12. The percutaneous circulatory assist device according to any one of claims 1 to 3, wherein the pressure sensor is an electrical pressure sensor.

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