Transcutaneous circulatory support device including proximal pressure sensor

Abstract

The percutaneous circulatory assist device includes a housing and an impeller disposed within the housing. The impeller is configured to rotate relative to the housing to allow blood to flow through the housing. A motor is operably coupled to the impeller, and the motor is configured to rotate the impeller relative to the housing. A catheter is coupled to the motor. A collar is coupled to the catheter and is disposed proximally relative to the housing. The collar includes an internal chamber, and a pressure sensor is disposed within the internal chamber of the collar.

Description

Technical Field

[0001] The present disclosure relates to a percutaneous circulatory assist system. More specifically, the present disclosure relates to a percutaneous circulatory assist device including one or more pressure sensors.

Background Art

[0002] Percutaneous circulatory assist devices can provide temporary assistance for up to about 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. By measuring these pressures, for example, (1) it is possible to detect changes in the unintended device position within the heart, and (2) it is possible to determine cardiac output, and thus it is possible to evaluate potential treatment changes. However, devices including pressure sensors have several drawbacks. For example, the pressure sensor may be damaged during deployment. As another example, the sensed pressure may be inaccurate due to the operating speed of the device and the influence of other dynamic pressures. Therefore, an improved device including a pressure sensor is needed.

Summary of the Invention

[0003] In Example 1, a percutaneous circulatory assist device includes a housing and an impeller disposed within the housing. The impeller is configured to rotate relative to the housing to allow blood to flow through the housing. A motor is operably coupled to the impeller, and the motor is configured to rotate the impeller relative to the housing. A catheter is coupled to the motor. A collar is coupled to the catheter and is disposed proximally relative to the housing. The collar includes an internal chamber, and a pressure sensor is disposed within the internal chamber of the collar.

[0004] In Example 2, in the percutaneous circulatory assist device of Example 1, the collar further includes an opening coupled to the internal chamber. In Example 3, the percutaneous circulatory support device of Example 2 has an opening that faces distally.

[0005] In Example 4, in the percutaneous circulatory support device of Example 2 or 3, the collar further includes an outer surface, the outer surface including a tapered distal portion that forms an opening. In Example 5, the percutaneous circulatory support device of Example 4 further includes a tapered proximal portion on the outer surface.

[0006] In Example 6, the percutaneous circulatory support device of Example 5 has a first incline in the tapered distal portion and a second incline in the tapered proximal portion, with the first incline being greater than the second incline.

[0007] In Example 7, the percutaneous circulatory support device of Example 5 or 6 further includes a cylindrical surface between the tapered distal portion and the tapered proximal portion. In Example 8, the percutaneous circulatory support device of Example 2 has an opening that is oriented laterally.

[0008] In Example 9, the percutaneous circulatory support device of Example 8 further includes a distally facing opening coupled to an internal chamber. In Example 10, in the percutaneous circulatory support device of Example 8 or 9, the laterally oriented opening is a first laterally oriented opening, and the collar further includes a second laterally oriented opening coupled to an internal chamber.

[0009] In Example 11, the percutaneous circulatory support device of Example 2 has an opening that extends at an acute angle with respect to the longitudinal axis of the internal chamber. In Example 12, one of the transcutaneous circulatory support devices from Examples 1 to 11 further includes a sensor mount located within an internal chamber of the collar and coupled to a pressure sensor.

[0010] In Example 13, the percutaneous circulatory support device includes a housing and an impeller positioned within the housing. The impeller is configured to rotate relative to the housing to allow blood to flow through it. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A catheter is coupled to the motor, and a collar is coupled to the catheter and positioned proximal to the housing. The collar includes an internal chamber, a distally facing opening coupled to the internal chamber, and a proximally facing opening coupled to the internal chamber. A pressure sensor is positioned within the internal chamber of the collar. A sensor cable is coupled to the pressure sensor and extends through the proximally facing opening.

[0011] In Example 14, the percutaneous circulatory support device of Example 13 includes one of an optical pressure sensor and an electrical pressure sensor as the pressure sensor. In Example 15, in the percutaneous circulatory support device of Example 13 or 14, the pressure sensor is positioned at least 0.00254 centimeters (0.001 inches) away from the outer surface of the catheter.

[0012] In Example 16, the percutaneous circulatory support device includes a housing having an inlet and an outlet. An impeller is located within the housing and is configured to rotate relative to the housing so that blood flows in through the housing and out through the outlet. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A catheter is coupled to the motor. A collar is coupled to the catheter and positioned proximal to the housing, and the collar includes an internal chamber. A pressure sensor is located within the internal chamber of the collar.

[0013] In Example 17, the collar further includes an opening coupled to an internal chamber, in the percutaneous circulatory support device of Example 16. In Example 18, the opening of the percutaneous circulatory support device of Example 17 is distally oriented.

[0014] In Example 19, the percutaneous circulatory support device of Example 18 further includes an outer surface, the outer surface including a tapered distal portion that forms a distally facing opening. In Example 20, the percutaneous circulatory support device of Example 17 has an opening that is oriented laterally.

[0015] In Example 21, the percutaneous circulatory support device of Example 20 further includes a distally facing opening coupled to an internal chamber. In Example 22, the transcutaneous circulatory support device of Example 20 is a first transversely oriented opening, and the collar further includes a second transversely oriented opening coupled to an internal chamber.

[0016] In Example 23, the percutaneous circulatory support device of Example 17 has an opening that extends at an acute angle with respect to the longitudinal axis of the internal chamber. In Example 24, the transcutaneous circulatory support device of Example 17 further includes a sensor mount located within an internal chamber of the collar and coupled to a pressure sensor.

[0017] In Example 25, the pressure sensor is bonded to the sensor mount in the percutaneous circulatory support device of Example 24. In Example 26, the percutaneous circulatory support device of Example 17 further includes a sensor cable coupled to a pressure sensor.

[0018] In Example 27, the percutaneous circulatory support device of Example 17 further includes a proximal opening coupled to an internal chamber, and a sensor cable extends through the proximal opening.

[0019] In Example 28, the percutaneous circulatory support device of Example 27 further includes an outer surface, the outer surface including a tapered proximal portion that forms a proximal opening. In Example 29, the percutaneous circulatory support device of Example 17 further includes an outer surface, the outer surface including a tapered distal portion and a tapered proximal portion.

[0020] In Example 30, the percutaneous circulatory support device of Example 29 has a tapered distal portion with a first incline and a tapered proximal portion with a second incline, the first incline being greater than the second incline.

[0021] In Example 31, the percutaneous circulatory support device of Example 17 includes one of an optical pressure sensor and an electrical pressure sensor as the pressure sensor. In Example 32, the percutaneous circulatory support device includes a housing with an inlet and an outlet. An impeller is located within the housing and is configured to rotate relative to the housing to allow blood to flow in through the inlet and out through the housing at the outlet. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A catheter is coupled to the motor. A collar is coupled to the catheter and is located proximal to the housing. The collar includes an internal chamber, a distally facing opening coupled to the internal chamber, and a proximally facing opening coupled to the internal chamber. A pressure sensor is located within the internal chamber of the collar. A sensor cable is coupled to the pressure sensor and extends through the proximally facing opening.

[0022] In Example 33, in the percutaneous circulatory support device of Example 32, the pressure sensor is positioned at least 0.00254 centimeters (0.001 inches) away from the outer surface of the catheter.

[0023] In Example 34, the method for manufacturing a percutaneous circulatory assist device includes arranging an impeller within a housing such that the impeller is rotatable relative to the housing, operably coupling a motor to the impeller, coupling a catheter to the motor, coupling a pressure sensor to a collar, and then coupling the collar and the pressure sensor to the catheter proximal to the motor.

[0024] In Example 35, in the method of Example 34, coupling the collar and the pressure sensor to the catheter includes advancing the collar and the pressure sensor distally along the catheter.

[0025] Although 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 illustrates and describes exemplary embodiments of the present invention. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0026] [Figure 1] It is a side sectional view of an exemplary percutaneous circulatory assist device (also synonymously referred to as a "blood pump" herein) according to an embodiment of the subject matter disclosed in this specification. [Figure 2] It is a detailed view of the exemplary percutaneous circulatory assist device within the line 2-2 of FIG. 1. [Figure 3] It is a side view of an exemplary sensor assembly of a percutaneous circulatory assist device according to an embodiment of the subject matter disclosed in this specification. [Figure 4] [[ID=CH25]]It is a side sectional view of the sensor assembly along the line 4-4 of FIG. 3. [Figure 5] It is a side sectional view of an exemplary percutaneous circulatory assist system according to an embodiment of the subject matter disclosed in this specification. [Figure 6] It is a side view of the pressure sensing guide wire of the percutaneous circulatory assist system of FIG. 5. [Figure 7]This is a side cross-sectional view of another exemplary percutaneous circulatory support device according to embodiments of the subject matter disclosed herein. [Figure 8] Figure 7 shows a detailed view of an exemplary percutaneous circulatory support device within the line 8-8. [Figure 9] Figure 8 shows a detailed view of an exemplary percutaneous circulatory support device within the line 9-9. [Modes for carrying out the invention]

[0027] While the present invention is open to various modifications and alternative forms, specific embodiments are shown as examples in the drawings and are described in detail below. However, the intention is not to limit the present invention to the specific embodiments described. Rather, the present invention is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the invention as defined by the appended claims.

[0028] Figure 1 shows a partial side section view of an exemplary percutaneous circulatory support device 100 (also interchangeably referred to herein as a “blood pump”) according to embodiments of the subject matter disclosed herein. Device 100, together with a guidewire and an introducer sheath (not shown), may form part of a percutaneous circulatory support system. More specifically, the guidewire and introducer sheath may enable percutaneous delivery of device 100 to a target location within the patient, such as within the patient’s heart. Alternatively, device 100 may be delivered to different target locations within the patient.

[0029] Continuing to refer to Figure 1, the device 100 generally includes a housing 101 which includes an impeller housing 102 and a motor housing 104. In some embodiments, the impeller housing 102 and the motor housing 104 may be constructed integrally or monolithically. In other embodiments, the impeller housing 102 and the motor housing 104 may be separate components configured to be removable or permanently coupled. In some embodiments, the blood pump 100 may not have a separate motor housing 104, and the impeller housing 102 may be directly coupled to the motor 105 described below, or the motor housing 104 may be constructed integrally with the motor 105 described below.

[0030] The impeller housing 102 houses an impeller assembly 106. The impeller assembly 106 includes an impeller shaft 108 rotatably supported by at least one bearing, such as a bearing 110. The impeller assembly 106 also includes an impeller 112 that rotates relative to the impeller housing 102 to pump blood through the device 100. More specifically, the impeller 112 causes blood to flow out from a blood inlet 114 (Figure 1) formed on the impeller housing 102, through the impeller housing 102, and out from a blood outlet 116 formed on the impeller housing 102. In some embodiments, as shown, the impeller shaft 108 and the impeller 112 may be separate components, and in other embodiments, the impeller shaft 108 and the impeller 112 may be a single unit. In some embodiments, as shown, the inlet 114 and / or outlet 116 may each include multiple openings. In other embodiments, the inlet 114 and / or outlet 116 may each include a single opening. In some embodiments, as shown, the inlet 114 may be formed at the end of the impeller housing 102, and the outlet 116 may be formed on the side of the impeller housing 102. In other embodiments, the inlet 114 and / or outlet 116 may be formed on other parts of the impeller housing 102. In some embodiments, the impeller housing 102 may be coupled to a distally extending cannula (not shown) that can receive blood and deliver it to the inlet 114.

[0031] Continuing to refer to Figure 1, the motor housing 104 houses the motor 105, which is configured to rotatably drive the impeller 112 relative to the impeller housing 102. In the illustrated embodiment, the motor 105 rotates a drive shaft 120 coupled to a drive magnet 122. The rotation of the drive magnet 122 causes the rotation of a driven magnet 124, which is connected to the impeller assembly 106 and rotates together with the impeller assembly 106. More specifically, in embodiments incorporating an impeller shaft 108, the impeller shaft 108 and the impeller 112 are configured to rotate together with the driven magnet 124. In other embodiments, the motor 105 may be coupled to the impeller assembly 106 via other components.

[0032] 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., within a separate housing). In some embodiments, the controller may comprise multiple components, one or more of which may be located within the motor housing 104. According to embodiments, the controller may comprise, comprise, or comprise 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 thereof and / or other components. Although the controller is referred to in the singular form herein, the controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, and / or similar. In other embodiments, the motor 105 may be controlled in other ways.

[0033] Continuing to refer to Figure 1, and further to Figure 2, the motor housing 104 is coupled to the catheter 126 on the opposite side of the impeller housing 102. The catheter 126 may be coupled to the motor housing 104 by various methods such as laser welding, soldering, adhesive bonding, thermal polymer reflowing, or similar methods. The catheter 126 extends proximal to the motor housing 104. The catheter 126 holds the motor cable 128 within the main lumen 130, and the motor cable 128 may be operably coupled to the motor 105 to a controller (not shown) and / or an external power supply (not shown). Externally, the catheter 126 is equipped with a sensor assembly 132 for measuring pressure within the patient's vascular system, for example, within the aorta. Advantageously, the sensor assembly 132 is positioned to obtain highly accurate pressure data relative to other components of the device 100. For example, the proximal position 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 transcutaneous circulatory assistance devices that employ pressure sensors located more distally to the motor or impeller assembly, such as devices that employ pressure sensors located near the outlet.

[0034] Referring particularly to Figure 2, the sensor assembly 132 includes a sensor housing 134 having a counterbore-shaped internal chamber 136. A pressure sensor 138, such as an optical pressure sensor or an electrical pressure sensor, is positioned within the internal chamber 136. Thus, the sensor housing 134 protects the pressure sensor 138 during the deployment of the device 100. The sensor housing 134 also includes a distally facing opening 140 coupled to the internal chamber 136. The opening 140 allows blood to enter the internal chamber 136, thereby enabling the pressure sensor 138 to sense the pressure of the blood.

[0035] The sensor housing 134 can take various forms. For example, the sensor housing 134 may be a tube or ferrule made from, for example, one or more metals, one or more plastics, composite materials, or equivalent. 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 an internal 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 positions the pressure sensor 138 in the center within the internal chamber 136), thereby enabling high-precision pressure sensing.

[0036] Continuing to refer to Figure 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 extends through the sensor mount 146 and may support the pressure sensor 138 away from the wall of the sensor housing 134. The sensor cable 148 penetrates the adhesive 142 and extends proximal through 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 an 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 be laid directly beneath the outer jacket 144.

[0037] Figures 3 and 4 show another sensor assembly 200 according to embodiments of the subject disclosed herein. Sensor assembly 200 may be used as part of a percutaneous circulatory support device 100 instead of the sensor assembly 132 described above. Sensor assembly 200 is similar to sensor assembly 132 described above. More specifically, sensor assembly 200 includes a sensor housing 202 having an internal chamber 204, a pressure sensor 206, a sensor cable 208 (Figure 4), and an optional sensor mount 210 (Figure 4) located within the internal chamber 204. The sensor housing 202 also includes a plurality of 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 (Figure 4). The plurality of 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 may include one or more laterally oriented openings, with distally oriented openings omitted. In either case, each opening may be sized to prevent the sensor 206 from passing through the opening if, for example, the sensor 206 becomes detached from the sensor cable 208 during use. The openings may also be elliptical, as shown in Figure 3, or have various other shapes.

[0038] In some embodiments, as shown in Figures 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 joining a separate member to the rest 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. In other embodiments, the tapered portion 218 may be created using a counterboring process from the proximal end of the sensor housing 202.

[0039] In some embodiments, as shown in Figures 3 and 4, the sensor 206 is at least partially aligned with the first lateral opening 214 and the second lateral opening 216. This position of the sensor 206 relatively reduces the space within the sensor housing 202 where bubbles that may degrade sensing accuracy could form. Alternatively, the sensor 206 may be located at other positions within the sensor housing 202. In some embodiments, the sensor 206 includes a surface energy reduction coating (not shown), such as silicone, to suppress bubble formation on the sensor 206 or within the sensor housing 202.

[0040] Figure 5 shows a partial side section view of an exemplary percutaneous circulatory support system 300 according to embodiments of the subject disclosed herein. System 300 includes a percutaneous circulatory support device 302 similar to device 100 described above. More specifically, the distal portion (not shown) of device 302 generally includes an impeller housing and an impeller, such as an impeller housing 102 and an impeller 112, as described above and shown elsewhere. The proximal portion of device 302 includes a motor housing 304 that houses a motor 306, and the motor housing 304 is coupled to a catheter 308 on the opposite side of the motor 306. The catheter 308 extends proximal to the motor housing 304. The catheter 308 holds a motor cable 310 within a main lumen 312, and the motor cable 310 may operably couple the motor 306 to a controller (not shown) and / or an external power supply (not shown). Externally, the catheter 308 holds a guidewire lumen 314 that receives a pressure-sensing guidewire 316. The pressure-sensing guidewire 316 may be operably coupled to a controller, and the guidewire 316 may take on various specific forms. However, referring further to Figure 6, the pressure-sensing guidewire 316 generally includes an elongated flexible body 318 that holds a pressure sensor 320, such as an optical sensor or an electropressure sensor. The pressure-sensing guidewire 316 is advanced from the proximal end (not shown) of the guidewire lumen 314 to the distal end 322 of the guidewire lumen 314 (either before or after the device 302 is placed in the patient's vascular system). The sensor 320 extends distally from the guidewire lumen 314 and is located within the sensing region 324 of the catheter 308. The sensing region 324 is located proximal to the motor housing 304 and motor 306, which allows for very accurate pressure data to be obtained, as previously stated. The guidewire 316 may, in addition or alternatively, sense pressure at various other locations relative to the catheter 308.

[0041] In other embodiments, the system 300 may take other forms or include additional components. For example, device 302 may include a sensor housing, such as the sensor housing 134 or sensor housing 202 described above and shown elsewhere, to receive and protect the pressure sensor 320 of the guidewire 316. Such a sensor housing may be coupled to the catheter 308 in various ways, including the methods described above in relation to the catheter 126 and the sensor housing 134 or sensor housing 202. As another example, the guidewire 316 may be fixed to the catheter 126.

[0042] The method for manufacturing the percutaneous circulatory support device 100 is as follows, and the method for manufacturing the device 302 is similar. The impeller 112 is positioned 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 positioned adjacent to the motor housing 104. The cable lumen 150 is positioned adjacent to the catheter 126 and coupled to the catheter 126 via a process, which may include forming the outer jacket 144 by at least one polymer reflow process. The pressure sensor 138 and sensor cable 148 are then coupled to the sensor housing 134 so that the sensor 138 is positioned within the internal chamber 136 of the sensor housing 134. The sensor cable 148 is positioned within the cable lumen 150, and the sensor housing 134 and pressure sensor 138 are positioned adjacent to the catheter 126. The sensor housing 134 and the pressure sensor 138 within the sensor housing 134 are connected to the catheter 126 via one or more of the following methods: welding, bonding, 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] Figure 7 shows a partial side section view of an exemplary percutaneous circulatory support device 400 (also interchangeably referred to herein as a “blood pump”) according to embodiments of the subject matter disclosed herein. The device 400, together with a guidewire and an introducer sheath (not shown), may form part of a percutaneous circulatory support system. More specifically, the guidewire and introducer sheath may enable percutaneous delivery of the device 400 to a target location within the patient, such as within the patient’s heart. Alternatively, the device 400 may be delivered to different target locations within the patient.

[0044] Continuing to refer to Figure 7, the device 400 generally includes a housing 401 which includes an impeller housing 402 and a motor housing 404. In some embodiments, the impeller housing 402 and the motor housing 404 may be constructed integrally or monolithically. In other embodiments, the impeller housing 402 and the motor housing 404 may be separate components configured to be removable or permanently coupled. In some embodiments, the blood pump 400 may not have a separate motor housing 404, and the impeller housing 402 may be directly coupled to the motor 405 described below, or the motor housing 404 may be constructed integrally with the motor 405 described below.

[0045] The impeller housing 402 houses an impeller assembly 406. The impeller assembly 406 includes an impeller shaft 408 rotatably supported by at least one bearing, such as a bearing 410. The impeller assembly 406 also includes an impeller 412 that rotates relative to the impeller housing 402 to pump blood through the device 400. More specifically, the impeller 412 causes blood to flow out from a blood inlet 414 (Figure 7) formed on the impeller housing 402, through the impeller housing 402, and out of a blood outlet 416 formed on the impeller housing 402. In some embodiments, as shown, the impeller shaft 408 and the impeller 412 may be separate components, and in other embodiments, the impeller shaft 408 and the impeller 412 may be integrated. In some embodiments, as shown, the inlet 414 and / or outlet 416 may each include multiple openings. In other embodiments, the inlet 414 and / or outlet 416 may each include a single opening. In some embodiments, as shown, the inlet 414 may be formed at the end of the impeller housing 402 and the outlet 416 may be formed on the side of the impeller housing 402. In other embodiments, the inlet 414 and / or outlet 416 may be formed on other parts of the impeller housing 402. In some embodiments, the impeller housing 402 may be coupled to a distally extending cannula (not shown) that can receive blood and deliver it to the inlet 414.

[0046] Continuing to refer to Figure 7, the motor housing 404 houses the motor 405, which is configured to rotatably drive the impeller 412 relative to the impeller housing 402. In the illustrated embodiment, the motor 405 rotates a drive shaft 420 coupled to a drive magnet 422. The rotation of the drive magnet 422 causes the rotation of a driven magnet 424, which is connected to the impeller assembly 406 and rotates together with the impeller assembly 406. More specifically, in embodiments incorporating an impeller shaft 408, the impeller shaft 408 and the impeller 412 are configured to rotate together with the driven magnet 424. In other embodiments, the motor 405 may be coupled to the impeller assembly 406 via other components.

[0047] In some embodiments, a controller (not shown) may be operably coupled to and configured to control the motor 405. In some embodiments, the controller may be located within the motor housing 404. In other embodiments, the controller may be located outside the motor housing 404 (e.g., within a separate housing). In some embodiments, the controller may comprise multiple components, one or more of which may be located within the motor housing 404. According to embodiments, the controller may comprise, comprise, or comprise 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 thereof and / or other components. Although the controller is referred to in the singular form herein, the controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, and / or similar. In other embodiments, the motor 405 may be controlled in other ways.

[0048] Continuing to refer to Figure 7, and further to Figure 8, the motor housing 404 is coupled to a catheter 426 opposite to the impeller housing 402. The catheter 426 may be coupled to the motor housing 404 by various methods such as laser welding, soldering, or similar methods. The catheter 426 extends proximal to the motor housing 404. The catheter 426 holds a motor cable 428 within the main lumen 430, and the motor cable 428 may be operably coupled to a controller (not shown) and / or an external power supply (not shown) for the motor 405. Externally, the catheter 426 is equipped with a sensor assembly 432 for measuring pressure within the patient's vascular system, e.g., within the aorta. Advantageously, the sensor assembly 432 is positioned to obtain highly accurate pressure data relative to other components of the device 400. For example, the proximal position of the sensor assembly 432 relative to the motor housing 404 and motor 405 reduces or eliminates motor speed-related or dynamic pressure-related sensing inaccuracies. Such inaccuracies are typical of other transcutaneous circulatory support devices that employ pressure sensors located more distally to the motor or impeller assembly, such as devices that employ pressure sensors located near the outlet.

[0049] Referring particularly to Figure 8, the sensor assembly 432 includes a collar 434 having a counterbore-shaped internal chamber 436. A pressure sensor 438, such as an optical pressure sensor or an electrical pressure sensor, is located within the internal chamber 436. Thus, the collar 434 protects the pressure sensor 438 during deployment of the device 400. The collar 434 also includes a distally facing opening 440 coupled to the internal chamber 436. The opening 440 allows blood to enter the internal chamber 436, thereby enabling the pressure sensor 438 to sense the pressure of the blood. The collar 434 further includes a laterally facing opening 441, and both the distally facing opening 440 and the laterally facing opening 441 allow blood flow to pass through the collar 434, thereby reducing thrombus formation. In some embodiments, the collar 434 includes one or more additional openings, such as a laterally facing opening. Such openings may be formed at different angles on the collar 434 to facilitate blood flow. More specifically, such openings may extend obliquely or at an acute angle to the longitudinal axis of the internal chamber 436. Such openings may have various shapes, such as circular or cylindrical, or the opening may be an elongated slot.

[0050] The collar 434 extends at least partially around the catheter 426. The collar 434 may be attached to the catheter 426 via an outer jacket (not shown) that at least partially surrounds the collar 434 and the catheter 426, crimping, one or more adhesives, and / or one or more welds (not shown).

[0051] Referring further to Figure 8 and then to Figure 9, the collar 434 may also have a sensor mount 446 mounted inside the internal chamber 436. The sensor mount 446 allows the pressure sensor 438 to be supported away from the wall of the collar 434 (i.e., the sensor mount 446 positions the pressure sensor 438 in the center of the internal chamber 436), thereby enabling high-precision pressure sensing. The pressure sensor 438 may be bonded to the sensor mount 446.

[0052] Continuing to refer to Figures 8 and 9, the sensor assembly 432 further includes a sensor cable 448 coupled to the pressure sensor 438. The sensor cable 448 may operably couple the pressure sensor to a controller (not shown). As illustrated, the sensor cable 448 may extend through an opening 449 (Figure 8) facing proximal to the sensor mount 446 and collar 434.

[0053] Referring again to Figure 8, the collar 434 supports the pressure sensor 438 relatively far from the outer surface 451 of the catheter 426, where blood flow is relatively slow. As a result, the collar 434 promotes blood flow through the collar 434, thereby reducing thrombus formation. In some embodiments, the pressure sensor 438 is positioned at least 0.00762 centimeters (0.003 inches), more specifically at least 0.00254 centimeters (0.001 inches), from the outer surface 451 of the catheter 426.

[0054] Continuing with Figure 8, the outer surface 452 of the collar 434 may be shaped to prevent vortex formation in the blood flow near the collar 434. More specifically, the outer surface 452 of the collar 434 may include a tapering distal portion 454 and a tapering proximal portion 456. The tapering distal portion 454 and the tapering proximal portion 456 may be separated by a non-tapering portion or a cylindrical portion 458. As shown, the tapering distal portion 454 may form a distally facing opening 440, and the tapering proximal portion 456 may form a proximal facing opening 449. The tapering distal portion 454 may have a greater slope than the tapering proximal portion 456 (it may have a greater slope). In other words, the tapered distal portion 454 has a first incline, and the tapered proximal portion 456 has a second incline, the first incline may be greater than the second incline. In other embodiments, the outer surface 452 of the collar 434 may have a different shape. For example, the tapered distal portion 454 and the tapered proximal portion 456 may have equal inclines.

[0055] The percutaneous circulatory support device 400 is manufactured as follows: The impeller 412 is positioned within the impeller housing 402 so that the impeller 412 is rotatable relative to the impeller housing 402. The impeller 412 is operably connected to the motor 405, and the catheter 426 is positioned adjacent to the motor housing 404. Next, the pressure sensor 438 and the sensor cable 448 are coupled to the collar 434 so that the sensor cable 448 extends from a proximal opening 449 so that the sensor 438 is positioned within the internal chamber 436 of the collar 434. Next, the collar 434 and the pressure sensor 438 within the collar 434 are advanced distally along the catheter 426. The collar 434 can then be coupled to the catheter 426 by forming an outer jacket (not shown) that at least partially surrounds the collar 434 and the catheter 426, by crimping the collar 434, by applying one or more adhesives, and / or by forming one or more welds (not shown).

[0056] 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 device, A housing having an entrance and an exit, An impeller disposed within the housing, configured to rotate relative to the housing so that blood flows into the inlet and out through the housing and out through 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 collar that is coupled to the catheter and positioned proximal to the housing, the collar includes an internal chamber having a distal opening and a lateral opening, the distal opening opening into the internal chamber, the lateral opening opening into the internal chamber, and the distal opening being located distal to the lateral opening, the collar and A transcutaneous circulatory support device comprising a pressure sensor disposed within the internal chamber of the collar.

2. The percutaneous circulatory support device according to claim 1, wherein the collar further includes an outer surface, the outer surface including a tapered distal portion that forms the opening.

3. The percutaneous circulatory support device according to claim 2, wherein the outer surface further includes a tapered proximal portion.

4. The percutaneous circulatory support device according to claim 3, wherein the tapered distal portion has a first incline, the tapered proximal portion has a second incline, and the first incline is greater than the second incline.

5. The percutaneous circulatory support device according to claim 3, wherein the outer surface further includes a cylindrical surface between the tapered distal portion and the tapered proximal portion.

6. The transcutaneous circulatory support device according to claim 1, wherein the laterally oriented opening is a first laterally oriented opening, and the collar further includes a second laterally oriented opening coupled to the internal chamber.

7. The percutaneous circulatory support device according to claim 1, wherein the opening extends at an acute angle with respect to the longitudinal axis of the internal chamber.

8. The percutaneous circulatory support device according to any one of claims 1 to 7, further comprising a sensor mount disposed within the internal chamber of the collar and coupled to the pressure sensor.

9. A percutaneous circulatory support device, A housing having an entrance and an exit, An impeller disposed within the housing, configured to rotate relative to the housing so that blood flows into the inlet and out through the housing and out through 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 collar that is coupled to the catheter and positioned proximal to the housing, Internal chamber and The distally facing opening that is opening into the internal chamber, An opening facing proximal to the internal chamber, The collar includes a laterally oriented opening located proximal to the distally oriented opening and opening into the internal chamber, A pressure sensor is disposed within the internal chamber of the aforementioned color, A percutaneous circulatory support device comprising a sensor cable coupled to the pressure sensor, the sensor cable extending through the proximal opening.

10. The transcutaneous circulatory support device according to claim 9, wherein the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor.

11. The percutaneous circulatory support device according to claim 9 or 10, wherein the pressure sensor is positioned at least 0.00254 centimeters (0.001 inches) away from the outer surface of the catheter.

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