Transcutaneous circulatory support device including tilted pressure sensor

Abstract

The percutaneous circulatory support device includes a housing having a proximal end, a distal end, and a longitudinal axis extending between these proximal and distal ends. An impeller is located within the housing and is configured to rotate relative to the housing to circulate blood through it. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A pressure sensor is coupled to the housing and positioned at a non-zero angle with respect to the longitudinal axis.

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 to 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 becomes easy to detect an unintentional change in the position of the device within the heart, and (2) it becomes easy to determine cardiac output, and as a result, it becomes easy to evaluate potential treatment changes. However, devices including pressure sensors can have several drawbacks. For example, the detected pressure can be inaccurate due to the influence of dynamic pressure. 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 including a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. An impeller is disposed within the housing, and the impeller is configured to flow blood through the housing by rotating with respect to the housing. A motor is operably coupled to the impeller, and the motor is configured to rotate the impeller with respect to the housing. A pressure sensor is coupled to the housing and is disposed at an angle other than zero with respect to the longitudinal axis.

[0004] In Example 2, in the percutaneous circulatory assist device of Example 1, the housing further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is disposed within the internal chamber.

[0005] In Example 3, the percutaneous circulatory support device of Example 2 has a lateral opening. In Example 4, the percutaneous circulatory support device of any of Examples 2-3 further includes a sensor mount located within the internal chamber and coupled to the pressure sensor.

[0006] In Example 5, in the percutaneous circulatory support device of any of Examples 1 to 4, the housing further includes a plurality of outlet openings defining blood outlets and a plurality of supports positioned between the plurality of outlet openings, wherein the pressure sensor is supported by one of the plurality of supports.

[0007] In Example 6, in any of the percutaneous circulatory support devices of Examples 1 to 5, the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor. In Example 7, in any of the transcutaneous circulatory support devices of Examples 1 to 6, the direction perpendicular to the sensing membrane of the pressure sensor is positioned at an angle other than zero with respect to the longitudinal axis.

[0008] In Example 8, the percutaneous circulatory support device includes a housing having an inlet, a plurality of outlet openings, and a plurality of supports positioned between the plurality of outlet openings. An impeller is disposed within the housing and is configured to rotate relative to the housing to cause blood to flow into the inlet, through the housing, and out through the plurality of outlet openings. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A pressure sensor is supported by one of the plurality of supports.

[0009] In Example 9, the percutaneous circulatory support device of Example 8 further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is located within the internal chamber.

[0010] In Example 10, the percutaneous circulatory support device of Example 9 has a lateral opening. In Example 11, in a percutaneous circulatory support device of any of Examples 9-10, the housing includes a proximal opening connected to the internal chamber.

[0011] Example 12 further includes a sensor cable coupled to the pressure sensor and extending through the proximal opening in the percutaneous circulatory support device of Example 11. In Example 13, in any of the percutaneous circulatory support devices of Examples 11-12, the proximal opening is positioned proximal to the outlet.

[0012] Example 14 further includes a sensor mount located within the internal chamber and coupled to the pressure sensor, in a percutaneous circulatory support device according to any of Examples 9-13. Example 15 further includes a sensor mount located within the internal chamber and coupled to the pressure sensor, in a percutaneous circulatory support device according to any of Examples 9-14.

[0013] In Example 16, the percutaneous circulatory support device includes a housing having an inlet, an outlet, a proximal end, a distal end, and a longitudinal axis extending between the proximal and distal ends. An impeller is disposed within the housing and is configured to rotate relative to the housing to draw blood in through the inlet, pass through the housing, and exit through the outlet. A motor is operably coupled to the impeller and is configured to rotate the impeller relative to the housing. A pressure sensor is coupled to the housing and positioned at a non-zero angle with respect to the longitudinal axis.

[0014] In Example 17, the percutaneous circulatory support device of Example 16 further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is located within the internal chamber.

[0015] In Example 18, the percutaneous circulatory support device of Example 17 has a lateral opening. Example 19 further includes a sensor mount located within the internal chamber and coupled to the pressure sensor, in the percutaneous circulatory support device of Example 17.

[0016] Example 20 further includes a sensor cable coupled to the pressure sensor in the percutaneous circulatory support device of Example 17. In Example 21, in the percutaneous circulatory support device of Example 20, the opening is a lateral opening, the housing further includes a proximal opening leading to the internal chamber, and the sensor cable extends through the proximal opening.

[0017] In Example 22, the percutaneous circulatory support device of Example 17 further includes a plurality of outlet openings defining the outlet and a plurality of supports positioned between the plurality of outlet openings, wherein the pressure sensor is supported by one of the plurality of supports.

[0018] In Example 23, the percutaneous circulatory support device of Example 17 includes one of an optical pressure sensor and an electrical pressure sensor. In Example 24, in the transcutaneous circulatory support device of Example 16, the direction perpendicular to the sensing membrane of the pressure sensor is positioned at an angle other than zero with respect to the longitudinal axis.

[0019] In Example 25, the percutaneous circulatory support device includes a housing having an inlet, an outlet including a plurality of outlet openings, and a plurality of supports positioned between the plurality of outlet openings. An impeller is disposed within the housing and is configured to rotate relative to the housing to draw blood in through the inlet, 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 pressure sensor is supported by one of the plurality of supports.

[0020] In Example 26, in the percutaneous circulatory assist device of Example 25, the housing further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is disposed within the internal chamber.

[0021] In Example 27, in the percutaneous circulatory assist device of Example 26, the opening is a lateral opening. In Example 28, in the percutaneous circulatory assist device of Example 27, the housing further includes a proximal opening connected to the internal chamber.

[0022] In Example 29, in the percutaneous circulatory assist device of Example 28, it further includes a sensor cable coupled to the pressure sensor and extending through the proximal opening. In Example 30, in the percutaneous circulatory assist device of Example 28, the proximal opening is disposed proximal to the outlet.

[0023] In Example 31, in the percutaneous circulatory assist device of Example 25, it further includes a sensor mount disposed within the internal chamber and coupled to the pressure sensor. In Example 32, a method of manufacturing a percutaneous circulatory assist device includes disposing an impeller within a housing such that the impeller is rotatable relative to the housing; operably coupling a motor to the impeller; and coupling a pressure sensor to the housing such that the pressure sensor is disposed at a non-zero angle relative to the longitudinal axis of the housing.

[0024] In Example 33, in the method of Example 32, coupling the pressure sensor to the housing includes disposing the pressure within an internal chamber of a sensor housing. In Example 34, in the method of Example 33, the sensor housing further includes an opening connected to the internal chamber.

[0025] In Example 35, the method of Example 34, wherein the opening is a horizontal opening, the sensor housing further includes a proximal opening, and coupling the pressure sensor to the housing includes inserting the pressure sensor through the proximal opening.

[0026] Although multiple embodiments are disclosed, still other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary embodiments of the invention. Thus, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0027] [Figure 1] 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] A detailed perspective view of the exemplary percutaneous circulatory assist device of FIG. 1. [Figure 3] Another side cross-sectional view of the exemplary percutaneous circulatory assist device of FIG. 1. [Figure 4] A detailed side cross-sectional view of the exemplary percutaneous circulatory assist device taken along line 4-4 of FIG. 3. [Figure 5] A flow diagram of an exemplary method of manufacturing a percutaneous circulatory assist device according to an embodiment of the subject matter disclosed herein.

Modes for Carrying Out the Invention

[0028] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof are shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0029] Detailed explanation 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 disclosed herein. Device 100 may 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 may facilitate percutaneous delivery of device 100 to a target location within the patient, for example, into the patient’s heart. Alternatively, device 100 may be delivered to different target locations within the patient.

[0030] Continuing to refer to Figure 1, the device 100 typically includes a housing 101 which contains an impeller housing 102 and a motor housing 104. In some embodiments, the impeller housing 102 and the motor housing 104 may be configured 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 later, or the motor housing 104 may be configured integrally with the motor 105 described later.

[0031] 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 deliver blood to the device 100. More specifically, the impeller 112 delivers blood from a blood inlet 114 formed in the impeller housing 102, passes through the impeller housing 102, and exits from a blood outlet 116 formed in the impeller housing 102. In some embodiments, as shown, the impeller shaft 108 and the impeller 112 may be separate parts, and in other embodiments, the impeller shaft 108 and the impeller 112 may be integrated. In some embodiments, as shown, the inlet 114 and / or outlet 116 may each include a plurality of openings. In other embodiments, the inlet 114 and / or outlet 116 may each be a single opening. In some embodiments, as shown, the inlet 114 may be formed at the distal end 118 of the housing 101 and the outlet 116 may be formed on the side of the housing 101. In other embodiments, the inlet 114 and / or outlet 116 may be formed on other parts of the housing 101. In some embodiments, the housing 101 is connected to a distally extending cannula (not shown) that can receive blood and deliver it to the inlet 114.

[0032] Continuing to refer to Figure 1, the motor housing 104 houses the motor 105, which is configured to rotationally 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. As the drive magnet 122 rotates, the driven magnet 124 rotates, which is connected to the impeller assembly 106, and thus the impeller assembly 106 also rotates. More specifically, in an embodiment 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 can be coupled to the impeller assembly 106 via other components.

[0033] In some embodiments, a controller (not shown) may be operably coupled to the motor 105 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). In some embodiments, the controller may include multiple components, one or more of which may be located within the motor housing 104. According to some embodiments, the controller is 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 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, and / or instantiated within multiple virtual machines, etc. In other embodiments, the motor 105 may be controlled in other ways.

[0034] Continuing to refer to Figure 1, the motor housing 104 is coupled to the catheter 126 at the proximal end 127 of the housing 101. The catheter 126 can be coupled to the motor housing 104 by various methods, such as laser welding, soldering, adhesive, or polymer reflow. The catheter 126 extends proximal to the motor housing 104. The catheter 126 houses a motor cable 128 within its lumen 130, which can operably couple the motor 105 to a controller (not shown) and / or an external power supply (not shown).

[0035] Referring next to Figures 2-4, the device 100 further includes a sensor assembly 132 for measuring pressure within a patient's blood vessels, for example, within the aorta. The sensor assembly 132 includes a sensor housing 134 having an internal chamber 136 (Figures 3 and 4). A pressure sensor 138 (Figures 3 and 4), such as an optical or electrical pressure sensor, is located within the internal chamber 136. The sensor housing 134 protects the pressure sensor 138 during deployment of the device 100. The sensor housing 134 also includes a lateral distal opening 140 (Figures 2 and 3; the term “lateral” and its variations as used herein mean non-parallel to the longitudinal axis of the impeller housing 102) that leads 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.

[0036] As most clearly shown in Figure 4, the pressure sensor 138 may be positioned at a non-zero angle 142 with respect to the longitudinal axis 144 of the impeller housing 102 (Figure 1). More specifically, the direction 147 perpendicular to the distal surface of the sensing membrane 149 of the sensor 138 may be positioned at a non-zero angle 142 with respect to the longitudinal axis 144 of the impeller housing 102. This positioning of the pressure sensor 138 reduces the inaccuracy of detection related to dynamic pressure. The non-zero angle 142 may be, for example, in the range of 7.5 to 90 degrees. In some embodiments, the angle 142 may be a non-zero acute angle in the range of 7.5 to 45 degrees, more specifically in the range of 7.5 to 30 degrees, more specifically in the range of 7.5 to 12.5 degrees, more specifically in the range of 9 to 11 degrees, and even more specifically in the range of 10 degrees. As shown in the figure, the sensor assembly 132, more specifically the pressure sensor 138 and / or the lateral distal opening 140 of the internal chamber 136, may be positioned on or near one of the struts 145 between the openings of the outlet 116. Such a configuration makes it easier to determine whether the device 100 has unintentionally and improperly moved so that the outlet 116 is located at or near the aortic valve or in the left ventricle, based on a pressure signal that is significantly different from the pressure signal obtained when the outlet 116 is located in the aorta and away from the aortic valve.

[0037] Referring again to Figures 2-4, the sensor housing 134 can take various forms. For example, as shown, the sensor housing 134 may be integrated with the impeller housing 102 or monolithically constructed. Alternatively, the sensor housing 134 may be a separately constructed component such as a tube or ferrule manufactured from one or more metals, one or more plastics, or composite materials. The sensor housing 134 may also include a sensor mount 146 within the internal 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 positions the pressure sensor 138 in the center of the internal chamber 136), thereby facilitating high-precision pressure detection.

[0038] 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 passes through a sensor mount 146 and can support the pressure sensor 138 away from the wall of the sensor housing 134. The sensor cable 148 extends proximal through a proximal-facing opening 150 (Figure 2) of the sensor housing 134, which is located proximal to the blood outlet 116. In some embodiments, the sensor cable 148 may extend further through a cable lumen (not shown) coupled to or configured as part of the catheter 126 (Figure 1).

[0039] Figure 5 shows a flow diagram of an exemplary method 200 for manufacturing a blood pump according to embodiments of the subject disclosed herein. Although method 200 describes the features of blood pump 100, it will be understood that any blood pump assumed herein can be manufactured in a similar manner. In block 202, the method begins by providing an impeller housing 102, a motor 105, an impeller 112, and a sensor 138. In block 204, the impeller 112 is positioned within the housing 101 so that the impeller 112 is rotatable relative to the housing 101. More specifically, the impeller 112 is coupled to an impeller shaft 108. In block 206, the motor 105 is operably coupled to the impeller 112, for example, via a drive magnet 122 and a driven magnet 124. In block 208, the pressure sensor 138 is coupled to the housing 101 so that the pressure sensor 138 is positioned at a non-zero angle 142 with respect to the longitudinal axis 144 of the housing 101. More specifically, the pressure sensor 138 is inserted into the internal chamber 136 of the sensor housing 134 through a proximal opening 150.

[0040] 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 certain features, the scope of the present invention also includes embodiments having different combinations of features, and embodiments that do not include all of the features described. Accordingly, the scope of the present invention is intended to encompass all alternatives, modifications and variations included in the claims, as well as all their equivalents.

Claims

1. A percutaneous circulatory support device, A housing including a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end, An impeller disposed within the housing, configured to rotate relative to the housing to cause blood to flow through the housing, A motor operably coupled to the impeller, configured to rotate the impeller relative to the housing, and A pressure sensor coupled to the housing and positioned at an angle other than zero with respect to the longitudinal axis. A transcutaneous circulatory support device, including [a specific device].

2. The percutaneous circulatory support device according to claim 1, wherein the housing further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is disposed within the internal chamber.

3. The percutaneous circulatory support device according to claim 2, wherein the opening is a lateral opening.

4. The transcutaneous circulatory support device according to claim 2 or 3, further comprising a sensor mount disposed within the internal chamber and coupled to the pressure sensor.

5. The percutaneous circulatory support device according to any one of claims 1 to 4, wherein the housing further includes a plurality of outlet openings defining blood outlets and a plurality of support columns disposed between the plurality of outlet openings, and the pressure sensor is supported by one of the plurality of support columns.

6. The percutaneous circulatory support device according to any one of claims 1 to 5, wherein the pressure sensor includes one of an optical pressure sensor and an electrical pressure sensor.

7. The percutaneous circulatory support device according to any one of claims 1 to 6, wherein the direction perpendicular to the sensing membrane of the pressure sensor is positioned at an angle other than zero with respect to the longitudinal axis.

8. A percutaneous circulatory support device, The entrance and Multiple exit openings, Multiple support columns arranged between the multiple exit openings Housing including An impeller disposed within the housing, configured to rotate relative to the housing so as to cause blood to flow into the inlet, pass through the housing, and flow out from the plurality of outlet openings, A motor operably coupled to the impeller, configured to rotate the impeller relative to the housing, and A pressure sensor supported by one of the aforementioned multiple support columns. A transcutaneous circulatory support device, including [a specific device].

9. The percutaneous circulatory support device according to claim 8, wherein the housing further includes an internal chamber and an opening connected to the internal chamber, and the pressure sensor is disposed within the internal chamber.

10. The percutaneous circulatory support device according to claim 9, wherein the opening is a lateral opening.

11. The percutaneous circulatory support device according to claim 9 or 10, wherein the housing includes a proximal opening connected to the internal chamber.

12. The transcutaneous circulatory support device according to claim 11, further comprising a sensor cable coupled to the pressure sensor and extending through the proximal opening.

13. The percutaneous circulatory support device according to claim 11 or 12, wherein the proximal opening is positioned proximal to the outlet.

14. The percutaneous circulatory support device according to any one of claims 9 to 13, further comprising a sensor mount disposed within the internal chamber and coupled to the pressure sensor.

15. The percutaneous circulatory support device according to any one of claims 9 to 14, further comprising a sensor mount disposed within the internal chamber and coupled to the pressure sensor.

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