Percutaneous circulation support device including proximal pressure sensor

Abstract

The invention relates to a percutaneous circulation supporting device which comprises a shell and an impeller, and the impeller is arranged in the shell. The impeller is configured to rotate relative to the housing to cause 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 conduit is coupled to the motor. A collar is coupled to the catheter and disposed proximally relative to the housing. The collar includes an interior chamber, and a pressure sensor is disposed within the interior chamber of the collar.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 390,054, filed on July 18, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present disclosure relates to percutaneous circulatory support systems. More particularly, the present disclosure relates to percutaneous circulatory support devices that include one or more pressure sensors. Background of the Invention

[0003] Percutaneous circulatory support devices can provide transient support of up to about a few weeks to patients with impaired cardiac function or cardiac output. Some percutaneous circulatory support devices include one or more pressure sensors for measuring intravascular pressure. Measuring these pressures is useful, for example, for (1) detecting unexpected device position changes within the heart, and (2) determining cardiac output, which in turn facilitates the evaluation of potential treatment changes. However, devices including pressure sensors can have several disadvantages. For example, pressure sensors can be damaged during deployment. As another example, sensed pressure can be inaccurate due to the operating speed of the device and other dynamic pressure effects. Therefore, there is a need for an improved device that includes a pressure sensor. Summary of the invention

[0004] In Example 1, a percutaneous circulatory support device includes a housing and an impeller disposed within the housing. The impeller is configured to rotate relative to the housing to cause 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 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.

[0005] In Example 2, the percutaneous circulatory support device of Example 1, wherein the collar further comprises an orifice coupled to the internal chamber.

[0006] In Example 3, a percutaneous circulatory support device according to Example 2, wherein the orifice is a distal-facing orifice.

[0007] In Example 4, the percutaneous circulatory support device of any of Examples 2 to 3, wherein the collar further comprises an outer surface including a tapered distal portion forming the orifice.

[0008] In Example 5, according to Example 4, the percutaneous circulatory support device, wherein the outer surface further includes a tapered proximal portion.

[0009] In Example 6, according to the percutaneous circulatory support device of Example 5, the tapered distal portion has a first slope, the tapered proximal portion has a second slope, and the first slope is greater than the second slope.

[0010] In Example 7, according to any one of Examples 5 to 6, the outer surface further includes a cylindrical surface between the tapered distal portion and the tapered proximal portion.

[0011] In Example 8, a percutaneous circulatory support device according to Example 2, wherein the orifice is a lateral facing orifice.

[0012] In Example 9, the percutaneous circulatory support device of Example 8, wherein the collar further comprises a distally facing aperture coupled to the internal chamber.

[0013] In Example 10, the percutaneous circulatory support device of any of Examples 8 to 9, wherein the transverse facing aperture is a first transverse facing aperture, and the collar further comprises a second transverse facing aperture coupled to the internal chamber.

[0014] In Example 11, the percutaneous circulatory support device of Example 2, wherein the orifice extends at an acute angle relative to the longitudinal axis of the internal chamber.

[0015] In Example 12, the percutaneous circulatory support device of any one of Examples 1 to 11 further includes a sensor mount disposed within the interior chamber of the collar and coupled to the pressure sensor.

[0016] In Example 13, a percutaneous circulatory support device includes a housing and an impeller disposed within the housing. The impeller is configured to rotate relative to the housing to cause 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, and a collar is coupled to the catheter and disposed proximally relative to the housing. The collar includes an internal chamber, a distally facing orifice, and a proximally facing orifice; the distally facing orifice is coupled to the internal chamber, and the proximally facing orifice is coupled to the internal chamber. A pressure sensor is disposed within the internal chamber of the collar. A sensor cable is coupled to the pressure sensor, and the sensor cable extends through the proximally facing orifice.

[0017] In Example 14, according to Example 13, the percutaneous circulatory support device, wherein the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor.

[0018] In Example 15, the percutaneous circulatory support device of any of Examples 13-14, wherein the pressure sensor is positioned at least 0.001 inches away from the outer surface of the catheter.

[0019] In Example 16, a percutaneous circulatory support device includes a housing having an inlet and an outlet. An impeller is disposed within the housing, and the impeller is configured to rotate relative to the housing to cause blood to flow into the inlet, flow through the housing, and flow out of the outlet. 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 disposed proximally relative to the housing, and the collar includes an internal chamber. A pressure sensor is disposed within the internal chamber of the collar.

[0020] In Example 17, the percutaneous circulatory support device of Example 16 wherein the collar further comprises an orifice coupled to the internal chamber.

[0021] In Example 18, a percutaneous circulatory support device according to Example 17, wherein the orifice is a distal facing orifice.

[0022] In Example 19, the percutaneous circulatory support device of Example 18, wherein the collar further comprises an outer surface including a tapered distal portion forming a distal-facing orifice.

[0023] In Example 20, a percutaneous circulatory support device according to Example 17, wherein the orifice is a lateral facing orifice.

[0024] In Example 21, the percutaneous circulatory support device of Example 20, wherein the collar further comprises a distal-facing opening coupled to the internal chamber.

[0025] In Example 22, the percutaneous circulatory support device of Example 20 wherein the transverse facing aperture is a first transverse facing aperture and the collar further comprises a second transverse facing aperture coupled to the interior chamber.

[0026] In Example 23, the percutaneous circulatory support device of Example 17 wherein the orifice extends at an acute angle relative to the longitudinal axis of the internal chamber.

[0027] In Example 24, the percutaneous circulatory support device of Example 17 further includes a sensor mount disposed within the internal chamber of the collar and coupled to the pressure sensor.

[0028] In Example 25, the percutaneous circulatory support device of Example 24, wherein the pressure sensor is bonded to the sensor mount.

[0029] In Example 26, the percutaneous circulatory support device of Example 17 further includes a sensor cable connected to the pressure sensor.

[0030] In Example 27, the percutaneous circulatory support device of Example 17, wherein the collar further comprises a proximally facing aperture coupled to the internal chamber, the sensor cable extending through the proximally facing aperture.

[0031] In Example 28, the percutaneous circulatory support device of Example 27, wherein the collar further comprises an outer surface including a tapered proximal portion forming a proximal-facing orifice.

[0032] In Example 29, the percutaneous circulatory support device of Example 17, wherein the collar further comprises an outer surface comprising a tapered distal portion and a tapered proximal portion.

[0033] In Example 30, a percutaneous circulatory support device according to Example 29, wherein the tapered distal portion has a first slope, the tapered proximal portion has a second slope, and the first slope is greater than the second slope.

[0034] In Example 31, the percutaneous circulatory support device of Example 17, wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor.

[0035] In Example 32, a percutaneous circulatory support device includes a housing having an inlet and an outlet. An impeller is disposed within the housing, and the impeller is configured to rotate relative to the housing to cause blood to flow into the inlet, flow through the housing, and flow out of the outlet. 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, a distally facing orifice, and a proximally facing orifice; the distally facing orifice is coupled to the internal chamber, and the proximally facing orifice is coupled to the internal chamber. A pressure sensor is disposed within the internal chamber of the collar. A sensor cable is coupled to the pressure sensor, and the sensor cable extends through the proximally facing orifice.

[0036] In Example 33, the percutaneous circulatory support device of Example 32, wherein the pressure sensor is positioned at least 0.001 inches away from the outer surface of the catheter.

[0037] In Example 34, a method of manufacturing a percutaneous circulatory support device includes: positioning an impeller within a housing so that the impeller is rotatable relative to the housing; operably connecting a motor to the impeller; connecting a catheter to the motor; and connecting a pressure sensor to the catheter; and then connecting the collar and the pressure sensor to the catheter adjacent to the motor.

[0038] In Example 35, the method of Example 34 is described wherein coupling the loop and the pressure sensor to the catheter comprises advancing the loop and the pressure sensor distally along the catheter.

[0039] Although multiple embodiments are disclosed, other embodiments of the present invention will be apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. Therefore, the drawings and detailed description should be regarded as illustrative and non-restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1

[0026] An embodiment according to the subject matter disclosed herein is a side cross-sectional view of an illustrative percutaneous circulatory support device (also referred to herein interchangeably as a "blood pump").

[0041] Figure 2 for Figure 1 Detailed view of an exemplary percutaneous circulatory support device within line 2-2 of .

[0042] Figure 3 A side view of an illustrative sensor assembly for a percutaneous circulatory support device according to an embodiment of the subject matter disclosed herein.

[0043] Figure 4 For along Figure 3 A side cross-sectional view of the sensor assembly along line 4-4.

[0044] Figure 5 A side cross-sectional view of an illustrative percutaneous circulatory support system according to an embodiment of the subject matter disclosed herein.

[0045] Figure 6 for Figure 5 Side view of the pressure sensing guidewire of the percutaneous circulatory support system.

[0046] Figure 7

[0026] A side cross-sectional view of another exemplary percutaneous circulatory support device in accordance with an embodiment of the subject matter disclosed herein.

[0047] Figure 8 for Figure 7 Detailed view of an exemplary percutaneous circulatory support device within line 8-8.

[0048] Fig. 9 for Figure 8 Detailed view of an exemplary percutaneous circulatory support device within line 9-9 of .

[0049] Although the present invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and described in detail below. However, the present invention is not limited to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and alternative forms falling within the scope of the present invention, as defined by the appended claims. DETAILED DESCRIPTION

[0050] Figure 1 A partial side cross-sectional view of an exemplary percutaneous circulatory support device 100 (also interchangeably referred to herein as a "blood pump") is shown in accordance with an embodiment of the subject matter disclosed herein. The device 100 can form part of a percutaneous circulatory support system together with a guidewire and an introducer sheath (not shown). More specifically, the guidewire and introducer sheath can facilitate percutaneous delivery of the device 100 to a target location within a patient's body, such as delivery to the patient's heart. Alternatively, the device 100 can be delivered to a different target location within a patient's body.

[0051] Continue to refer 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 can be integrally or integrally constructed. In other embodiments, the impeller housing 102 and the motor housing 104 can be separate components that are configured to be removably or permanently coupled. In some embodiments, the blood pump 100 may not contain 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 integrally constructed with the motor 105 described below.

[0052] The impeller housing 102 carries an impeller assembly 106 therein. The impeller assembly 106 includes an impeller shaft 108 that is rotatably supported by at least one bearing, such as bearing 110. The impeller assembly 106 also includes an impeller 112 that rotates relative to the impeller housing 102 to drive blood through the device 100. More specifically, the impeller 112 causes blood to flow from a blood inlet 114 ( Figure 1 ) flows through the impeller housing 102 and flows away from the blood outlet 116 formed on the impeller housing 102. In some embodiments and as shown, the impeller shaft 108 and the impeller 112 can be separate components; and in other embodiments, the impeller shaft 108 and the impeller 112 can be integrally formed. In some embodiments and as shown, the inlet 114 and / or the outlet 116 can each include a plurality of orifices. In other embodiments, the inlet 114 and / or the outlet 116 can each include a single orifice. In some embodiments and as shown, the inlet 114 can be formed on an end portion of the impeller housing 102, and the outlet 116 can be formed on a side portion of the impeller housing 102. In other embodiments, the inlet 114 and / or the outlet 116 can be formed on other portions of the impeller housing 102. In some embodiments, the impeller housing 102 can be coupled to a distally extending cannula (not shown), and the cannula can receive blood and deliver it to the inlet 114.

[0053] Continue to refer Figure 1, the motor housing 104 carries the motor 105, and the motor 105 is configured to rotatably drive the impeller 112 relative to the impeller housing 102. In the illustrated embodiment, the motor 105 rotates the drive shaft 120, which is coupled to the drive magnet 122. The rotation of the drive magnet 122 causes the rotation of the driven magnet 124, which is coupled to the impeller assembly 106 and rotates therewith. More specifically, in embodiments incorporating the impeller shaft 108, the impeller shaft 108 and the impeller 112 are configured to rotate with the driven magnet 124. In other embodiments, the motor 105 may be coupled to the impeller assembly 106 via other components.

[0054] In some embodiments, a controller (not shown) is operably coupled to the motor 105 and configured to control the motor 105. In some embodiments, the controller may be disposed within the motor housing 104. In other embodiments, the controller may be disposed outside the motor housing 104 (e.g., disposed in 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 104. According to embodiments, the controller may be, may include, or may include one or more field programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (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 mentioned herein in a single instance, the controller may be implemented in multiple instances, may be distributed across multiple computing devices, may be instantiated within multiple virtual machines, and the like. In other embodiments, the motor 105 may be controlled in other ways.

[0055] Continue to refer Figure 1 And additional reference Figure 2, the motor housing 104 is coupled to a conduit 126 opposite the impeller housing 102. The conduit 126 can be coupled to the motor housing 104 in a variety of ways, such as laser welding, brazing, adhesive bonding, thermal polymer reflow, and the like. The conduit 126 extends proximally away from the motor housing 104. The conduit 126 carries a motor cable 128 within the main lumen 130, and the motor cable 128 can operably couple the motor 105 to a controller (not shown) and / or an external power source (not shown). Externally, the conduit 126 carries a sensor assembly 132 for measuring pressure within the patient's vascular system, for example, pressure within the aorta. Advantageously, the sensor assembly 132 is positioned relative to the other components of the device 100 for obtaining highly accurate pressure data. For example, the proximal position of the sensor assembly 132 relative to the motor housing 104 and the motor 105 reduces or eliminates motor speed-related or dynamic pressure-related sensing inaccuracies. Such inaccuracies are typical of other percutaneous circulatory support devices that employ pressure sensors located more distally relative to the motor or impeller assembly, such as devices that employ pressure sensors located near the outlet.

[0056] Special References 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 or electrical pressure sensor, is disposed within the internal chamber 136. Thus, the sensor housing 134 protects the pressure sensor 138 during deployment of the device 100. The sensor housing 134 also includes a distally facing orifice 140 coupled to the internal chamber 136. The orifice 140 allows blood to enter the internal chamber 136, and the orifice 140 thus allows the pressure sensor 138 to sense the pressure of the blood.

[0057] The sensor housing 134 can take a variety of forms. For example, the sensor housing 134 can be a tube or ferrule made of, for example, one or more metals, one or more plastics, a composite, etc. The sensor housing 134 can be coupled to the conduit 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer jacket 144 that surrounds the sensor housing 134 and the conduit 126. The sensor housing 134 can also include a sensor mount 146 within the interior chamber 136. The sensor mount 146 facilitates supporting the pressure sensor 138 away from the wall of the sensor housing 134 (i.e., the sensor mount 146 centers the pressure sensor 138 within the interior chamber 136), which in turn facilitates high-precision pressure sensing.

[0058] Continue to refer Figure 2, the sensor assembly 132 also includes a sensor cable 148 that is coupled to the pressure sensor 138. The sensor cable 148 can operably couple the pressure sensor to a controller (not shown). As shown, the sensor cable 148 can 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 through a cable lumen 150 that is coupled to the catheter 126. The cable lumen 150 can be coupled to the catheter 126 via one or more welds (not shown), an adhesive (not shown), and / or the outer jacket 144. In other embodiments, the cable lumen 150 can be omitted and the sensor cable 148 can extend through the main lumen 130 of the catheter 126 or be located directly below the outer jacket 144.

[0059] Figure 3 and Figure 4 Another sensor assembly 200 is shown according to an embodiment of the subject matter disclosed herein. Instead of the sensor assembly 132 described above, the sensor assembly 200 can be used as part of the percutaneous circulatory support device 100. 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 ( Figure 4 ) and optional sensor mounting 210 ( Figure 4 ), the sensor mount 210 is disposed within the internal chamber 204. The sensor housing 202 also includes a plurality of apertures coupled to the internal chamber 204. More specifically, the sensor housing 202 includes a distally facing aperture 212, a first lateral facing aperture 214, and a second lateral facing aperture 216 ( Figure 4 ). The plurality of apertures facilitates blood flow through the sensor housing 202 and thereby reduces thrombosis. Alternatively, the sensor housing 202 may include a different number of apertures. For example, the sensor housing 202 may include one or more lateral-facing apertures and omit distal-facing apertures. In any case, each of the apertures may be sized to inhibit passage of the sensor 206, for example, in the event that the sensor 206 is detached from the sensor cable 208 during use. The aperture may also have an elliptical shape (e.g., Figure 3 ), or various other shapes.

[0060] In some embodiments and Figure 3 and Figure 4As shown, the distal-facing aperture 212 is formed by a tapered portion 218 of the sensor housing 202. The tapered portion 218 can be formed by crimping or coupling a separate piece of material to the remainder of the sensor housing 202. In other embodiments, the distal-facing aperture 212 can be a flat feature perpendicular to the axis of the interior chamber 204. In other embodiments, the tapered portion 218 can be formed from the proximal end of the sensor housing 202 via a countersinking process.

[0061] In some embodiments and Figure 3 and Figure 4 As shown, the sensor 206 is at least partially aligned with the first facing transverse aperture 214 and the second facing transverse aperture 216. This position of the sensor 206 provides a smaller space within the sensor housing 202 in which bubbles can form, which can reduce sensing accuracy. Alternatively, the sensor 206 can be disposed at other locations within the sensor housing 202. In some embodiments, the sensor 206 includes a surface energy reducing coating (not shown) (such as silicone) to inhibit bubble formation on the sensor 206 or within the sensor housing 202.

[0062] Figure 5 A partial side cross-sectional view of an exemplary percutaneous circulatory support system 300 is shown according to an embodiment of the subject matter disclosed herein. System 300 includes a percutaneous circulatory support 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 described above or shown elsewhere, respectively. A proximal portion of device 302 includes a motor housing 304 that carries a motor 306; and motor housing 304 is coupled to a catheter 308 opposite motor 306. Catheter 308 extends proximally away from motor housing 304. Catheter 308 carries a motor cable 310 within a main lumen 312, and motor cable 310 can 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 the controller, and the guidewire 316 may take a variety of specific forms. However, additional references to Figure 6, the pressure sensing guidewire 316 generally includes an elongated flexible body 318, which carries a pressure sensor 320, such as an optical or electrical pressure 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 (before or after the device 302 is located in the patient's vascular system). The sensor 320 extends distally from the guidewire lumen 314 and is located in a sensing area 324 of the catheter 308. The sensing area 324 is positioned proximally from the motor housing 304 and the motor 306; as described above, this is conducive to obtaining high-precision pressure data. The guidewire 316 can additionally or alternatively sense pressure at various other locations relative to the catheter 308.

[0063] In other embodiments, the system 300 may take other forms, or may include additional components. For example, the device 302 may include a sensor housing (such as the sensor housing 134 or the sensor housing 202 described above and shown elsewhere) for receiving and protecting the pressure sensor 320 of the guide wire 316. Such a sensor housing may be coupled to the catheter 308 in various ways, including those described above in conjunction with the catheter 126 and the sensor housing 134 or the sensor housing 202. As another example, the guide wire 316 may be fixed relative to the catheter 126.

[0064] The method of manufacturing the percutaneous circulatory support device 100 may be as follows, and the method of manufacturing the device 302 may be similar. The impeller 112 is located within the impeller housing 102 such that the impeller 112 is rotatable relative to the impeller housing 102. The impeller 112 is operably coupled to the motor 105, and the conduit 126 is positioned adjacent to the motor housing 104. The cable lumen 150 is positioned adjacent to the conduit 126 and is coupled to the conduit 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 such that the sensor 138 is located within the interior chamber 136 of the sensor housing 134. The sensor cable 148 is located in the cable lumen 150, and the sensor housing 134 and the pressure sensor 138 therein are positioned adjacent to the conduit 126. For example, sensor housing 134 and pressure sensor 138 therein are coupled to conduit 126 via one or more of welding, bonding, and covering the components with outer jacket 144. Covering these components with outer jacket 144 may include forming outer jacket 144 via a polymer reflow process.

[0065] Figure 7A partial side cross-sectional view of an exemplary percutaneous circulatory support device 400 (also interchangeably referred to herein as a "blood pump") is shown in accordance with an embodiment of the subject matter disclosed herein. The device 400 can form part of a percutaneous circulatory support system together with a guidewire and an introducer sheath (not shown). More specifically, the guidewire and introducer sheath can facilitate percutaneous delivery of the device 400 to a target location in a patient's body, such as delivery to the patient's heart. Alternatively, the device 400 can be delivered to a different target location in a patient's body.

[0066] Continue to refer 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 can be integrally or integrally constructed. In other embodiments, the impeller housing 402 and the motor housing 404 can be separate components that are configured to be removably or permanently coupled. In some embodiments, the blood pump 400 may not contain 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 integrally constructed with the motor 405 described below.

[0067] The impeller housing 402 carries an impeller assembly 406 therein. The impeller assembly 406 includes an impeller shaft 408 that is rotatably supported by at least one bearing, such as bearing 410. The impeller assembly 406 also includes an impeller 412 that rotates relative to the impeller housing 402 to drive blood through the device 400. More specifically, the impeller 412 causes blood to flow from a blood inlet 414 ( Figure 7 ) flows through the impeller housing 402, and flows out of the blood outlet 416 formed on the impeller housing 402. In some embodiments and as shown, the impeller shaft 408 and the impeller 412 can be separate components; and in other embodiments, the impeller shaft 408 and the impeller 412 can be integrated. In some embodiments and as shown, the inlet 414 and / or the outlet 416 can each include a plurality of orifices. In other embodiments, the inlet 414 and / or the outlet 416 can each include a single orifice. In some embodiments and as shown, the inlet 414 can be formed on an end portion of the impeller housing 402, and the outlet 416 can be formed on a side portion of the impeller housing 402. In other embodiments, the inlet 414 and / or the outlet 416 can be formed on other portions of the impeller housing 402. In some embodiments, the impeller housing 402 can be coupled to a distally extending cannula (not shown), and the cannula can receive blood and deliver it to the inlet 414.

[0068] Continue to refer Figure 7, the motor housing 404 carries the motor 405, and the motor 405 is configured to rotatably drive the impeller 412 relative to the impeller housing 402. In the illustrated embodiment, the motor 405 rotates the drive shaft 420, which is coupled to the drive magnet 422. The rotation of the drive magnet 422 causes the rotation of the driven magnet 424, which is coupled to the impeller assembly 406 and rotates therewith. More specifically, in embodiments incorporating the impeller shaft 408, the impeller shaft 408 and the impeller 412 are configured to rotate with the driven magnet 424. In other embodiments, the motor 405 may be coupled to the impeller assembly 406 via other components.

[0069] In some embodiments, a controller (not shown) is operably coupled to the motor 405 and configured to control the motor 405. In some embodiments, the controller may be disposed within the motor housing 404. In other embodiments, the controller may be disposed outside the motor housing 404 (e.g., disposed in 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 404. According to embodiments, the controller may be, may include, or may include one or more field programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (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 mentioned herein in a single instance, the controller may be implemented in multiple instances, may be distributed across multiple computing devices, may be instantiated within multiple virtual machines, and the like. In other embodiments, the motor 405 may be controlled in other ways.

[0070] Continue to refer Figure 7 And additional reference Figure 8, the motor housing 404 is coupled to a conduit 426 opposite the impeller housing 402. The conduit 426 can be coupled to the motor housing 404 in various ways, such as laser welding, brazing, etc. The conduit 426 extends proximally away from the motor housing 404. The conduit 426 carries a motor cable 428 within the main lumen 430, and the motor cable 428 can operably connect the motor 405 to a controller (not shown) and / or an external power source (not shown). Externally, the conduit 426 carries a sensor assembly 432, which is used to measure the pressure within the patient's vascular system, for example, the pressure within the aorta. Advantageously, the sensor assembly 432 is positioned in an appropriate position relative to the other components of the device 400 for obtaining highly accurate pressure data. For example, the proximal position of the sensor assembly 432 relative to the motor housing 404 and the motor 405 reduces or eliminates motor speed-related or dynamic pressure-related sensing inaccuracies. Such inaccuracies are typical of other percutaneous circulatory support devices that employ pressure sensors located more distally relative to the motor or impeller assembly, such as devices that employ pressure sensors located near the outlet.

[0071] Special References 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 or electrical pressure sensor) is disposed 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 orifice 440, which is coupled to the internal chamber 436. The orifice 440 allows blood to enter the internal chamber 436, and the orifice 440 thus allows the pressure sensor 438 to sense the pressure of the blood. The collar 434 also includes a transversely facing orifice 441, and the distally facing orifice 440 and the transversely facing orifice 441 facilitate blood flow through the collar 434, and thus reduce thrombosis. In some embodiments, the collar 434 includes one or more additional orifices, such as a transversely facing orifice. Such orifices may be derived from different angles on the collar 434 to facilitate blood flow. More specifically, such apertures may extend diagonally or at an acute angle relative to the longitudinal axis of the interior chamber 436. Such apertures may have various shapes, such as circular, cylindrical, or the apertures may be elongated slots.

[0072] Collar 434 extends at least partially around conduit 426. Collar 434 may be coupled to conduit 426 via an outer jacket (not shown) at least partially surrounding collar 434 and conduit 426, via crimping, via one or more adhesives, and / or via one or more welds (not shown).

[0073] Continue to refer Figure 8 And additional reference Fig. 9, the collar 434 may also carry a sensor mount 446 within the interior chamber 436. The sensor mount 446 facilitates supporting the pressure sensor 438 away from the walls of the collar 434 (i.e., the sensor mount 446 centers the pressure sensor 438 within the interior chamber 436), which in turn facilitates high-precision pressure sensing. The pressure sensor 438 may be bonded to the sensor mount 446.

[0074] Continue to refer Figure 8 and Fig. 9 , the sensor assembly 432 also includes a sensor cable 448 that is coupled to the pressure sensor 438. The sensor cable 448 can operably couple the pressure sensor to a controller (not shown). As shown, the sensor cable 448 can extend through the sensor mount 446 and the proximal-facing aperture 449 ( Figure 8 ).

[0075] Reference again Figure 8 , the collar 434 supports the pressure sensor 438 relatively away from the outer surface 451 of the catheter 426, where blood flow is relatively slow. Therefore, the collar 434 facilitates blood flow therethrough and thereby reduces thrombosis. In some embodiments, the pressure sensor 438 is disposed at least 0.003 inches away from the outer surface 451 of the catheter 426, and more specifically, at least 0.001 inches away.

[0076] Continue to refer Figure 8 , the shape of the outer surface 452 of the collar 434 can be set to inhibit the formation of vortices of blood flowing near the collar 434. More specifically, the outer surface 452 of the collar 434 may include a tapered distal portion 454 and a tapered proximal portion 456. The tapered distal portion 454 and the tapered distal portion 456 may be separated by a non-tapered or cylindrical portion 458. As shown, the tapered distal portion 454 can form a distal-facing orifice 440, and the tapered proximal portion 456 can form a proximal-facing orifice 449. The tapered distal portion 454 can have a larger slope than the tapered proximal portion 456. In other words, the tapered distal portion 454 has a first slope, the tapered proximal portion 456 has a second slope, and the first slope can be greater than the second slope. In other embodiments, the outer surface 452 of the collar 434 can have a different shape. For example, the tapered distal portion 454 and the tapered proximal portion 456 may have equivalent slopes.

[0077] The method of manufacturing the percutaneous circulatory support device 400 may be as follows. The impeller 412 is located within the impeller housing 402 so that the impeller 412 is rotatable relative to the impeller housing 402. The impeller 412 is operably coupled to the motor 405, and the catheter 426 is positioned adjacent to the motor housing 404. The pressure sensor 438 and the sensor cable 448 are then coupled to the collar 434 so that the sensor 438 is located within the interior chamber 436 of the collar 434 and the sensor cable 448 extends from the proximal-facing orifice 449. The collar 434 and the pressure sensor 438 therein are then advanced distally along the catheter 426. Next, the collar 434 is 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).

[0078] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above refer to specific features, the scope of the present invention also includes embodiments with different combinations of features and embodiments that do not include all of the described features. Therefore, the scope of the present invention is intended to cover all such alternatives, modifications and variations that fall within the scope of the claims, as well as all equivalents thereof.

Claims

1. A percutaneous circulatory support device, comprising: shell; an impeller disposed within the housing, the impeller configured to rotate relative to the housing to induce blood flow through the housing; a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a conduit coupled to the motor; a collar coupled to the catheter and disposed proximally relative to the housing, the collar comprising an internal chamber; and A pressure sensor is disposed within the interior chamber of the collar.

2. The percutaneous circulatory support device of claim 1, wherein the collar further comprises an orifice coupled to the internal chamber.

3. A percutaneous circulatory support device according to claim 2, wherein the orifice is a distal-facing orifice.

4. The percutaneous circulatory support device according to any one of claims 2 to 3, wherein the collar further comprises an outer surface including a tapered distal portion forming an orifice.

5. The percutaneous circulatory support device of claim 4, wherein the outer surface further comprises a tapered proximal portion.

6. The percutaneous circulatory support device according to claim 5, wherein the tapered distal portion has a first slope, the tapered proximal portion has a second slope, and the first slope is greater than the second slope.

7. The percutaneous circulatory support device according to any one of claims 5 to 6, wherein the outer surface further comprises a cylindrical surface between the tapered distal portion and the tapered proximal portion.

8. The percutaneous circulatory support device of claim 2, wherein the orifice is a lateral facing orifice.

9. The percutaneous circulatory support device of claim 8, wherein the collar further comprises a distally facing aperture coupled to the interior chamber.

10. The percutaneous circulatory support device of any one of claims 8 to 9, wherein the transversely facing aperture is a first transversely facing aperture and the collar further comprises a second transversely facing aperture coupled to the interior chamber.

11. The percutaneous circulatory support device of claim 2, wherein the orifice extends at an acute angle relative to a longitudinal axis of the internal chamber.

12. The percutaneous circulatory support device of any one of claims 1 to 11, further comprising a sensor mount disposed within the interior chamber of the collar and coupled to the pressure sensor.

13. A percutaneous circulatory support device comprising: shell; an impeller disposed within the housing, the impeller configured to rotate relative to the housing to induce blood flow through the housing; a motor operably coupled to the impeller, the motor configured to rotate the impeller relative to the housing; a conduit coupled to the motor; a collar coupled to the catheter and disposed proximally relative to the housing, the collar comprising: internal chamber; a distal-facing aperture coupled to the interior chamber; a proximal-facing aperture coupled to the interior chamber; a pressure sensor disposed within the interior chamber of the collar; and A sensor cable is coupled to the pressure sensor, the sensor cable extending through the proximally facing aperture.

14. The percutaneous circulatory support device of claim 13, wherein the pressure sensor comprises one of an optical pressure sensor and an electrical pressure sensor.

15. The percutaneous circulatory support device of any one of claims 13 to 14, wherein the pressure sensor is disposed at least 0.001 inches away from the outer surface of the catheter.

Images