Percutaneous circulation support device comprising angled pressure sensor

Abstract

A percutaneous circulatory support device includes a housing having a proximal end portion, a distal end portion, and a longitudinal axis extending between the proximal end portion and the distal end portion. An impeller is disposed within the housing, and the impeller is configured to rotate relative to the housing to flow blood through the housing. A motor is operably coupled with the impeller, and the motor is configured to rotate the impeller relative to the housing. A pressure sensor is coupled with the housing and disposed at a non-zero angle relative to the longitudinal axis.

Description

Cross-citation of relevant literature

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 455,936, filed March 30, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to a transdermal circulatory support system, and more specifically, to a transdermal circulatory support device comprising one or more pressure sensors. Background Technology

[0003] Percutaneous circulatory support devices can provide short-term support for patients with heart failure or insufficient cardiac output, lasting up to several weeks. Some percutaneous circulatory support devices are equipped with one or more pressure sensors to measure intravascular pressure. Measuring this pressure helps to achieve several functions, such as: (1) detecting unexpected changes in the device's position within the heart; and (2) calculating cardiac output, thereby providing a basis for assessing potential treatment adjustments. However, devices with pressure sensors have several drawbacks, such as the potential for inaccurate pressure readings due to the effects of dynamic pressure. Therefore, there is an urgent need to improve devices with pressure sensors. Summary of the Invention

[0004] In Example 1: A transdermal circulation support device includes a housing having a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions; an impeller is provided within the housing and configured to rotate relative to the housing to allow blood to flow through the housing; a motor is operatively coupled to the impeller and configured to rotate the impeller relative to the housing; a pressure sensor is coupled to the housing and is positioned at a non-zero angle relative to the longitudinal axis.

[0005] In Example 2: the transdermal circulation support device as described in Example 1, wherein the housing further includes an inner chamber and an aperture connected to the inner chamber, and a pressure sensor is disposed within the inner chamber.

[0006] In Example 3: the transdermal circulation support device as described in Example 2, wherein the hole is a transversely oriented hole.

[0007] In Example 4: the transdermal circulation support device as described in any one of Examples 2-3 further includes a sensor mount disposed within the inner cavity and connected to a pressure sensor.

[0008] In Example 5: the percutaneous circulation support device as described in any one of Examples 1-4, wherein the housing further includes a plurality of outlet holes defining blood outlets, and a plurality of struts disposed between the plurality of outlet holes; a pressure sensor is carried by one of the plurality of struts.

[0009] In Example 6: a transdermal circulation support device as described in any one of Examples 1-5, wherein the pressure sensor includes one of a photoelectric pressure sensor and a voltage pressure sensor.

[0010] In Example 7: the transdermal circulation support device as described in any one of Examples 1-6, wherein the direction perpendicular to the pressure sensor sensing membrane is set at a non-zero angle relative to the longitudinal axis.

[0011] In Example 8: A transdermal circulation support device includes a housing having an inlet, a plurality of outlet holes, and a plurality of struts disposed between the outlet holes; an impeller is disposed within the housing and configured to rotate relative to the housing to allow blood to flow into the inlet, through the housing, and out of the plurality of outlet holes; a motor is operatively coupled to the impeller and configured to rotate the impeller relative to the housing. A pressure sensor is carried by one of the plurality of struts.

[0012] In Example 9: the transdermal circulation support device as described in Example 88, wherein the housing further includes an inner chamber and an aperture communicating with the inner chamber, and a pressure sensor is disposed within the inner chamber.

[0013] In Example 10: a transdermal circulation support device as described in Example 9, wherein the hole is a transversely oriented hole.

[0014] In Example 11: the transdermal circulation support device as described in any one of Examples 9-10, wherein the housing further includes a proximal-facing orifice connected to the inner chamber.

[0015] In Example 12: The transdermal circulation support device as described in Example 11 further includes a sensor cable that is coupled to a pressure sensor and extends through an opening facing the proximal side.

[0016] In Example 13: a transdermal circulation support device as described in any one of Examples 11-12, wherein the orifice facing the proximal side is disposed proximal to the outlet.

[0017] In Example 14: the transdermal circulation support device as described in any one of Examples 9-13 further includes a sensor mount disposed within the inner cavity and connected to a pressure sensor.

[0018] In Example 15: the transdermal circulation support device as described in any one of Examples 9-14 further includes a sensor mount disposed within the inner cavity and connected to a pressure sensor.

[0019] In Example 16: A transdermal circulation support device includes a housing having an inlet, an outlet, a proximal portion, a distal portion, and a longitudinal axis extending between the proximal and distal portions; an impeller is provided within the housing and configured to rotate relative to the housing to allow blood to flow into the inlet, through the housing, and out of the outlet; a motor is operatively connected to the impeller and configured to rotate the impeller relative to the housing; a pressure sensor is connected to the housing and is positioned at a non-zero angle relative to the longitudinal axis.

[0020] In Example 17: the transdermal circulation support device as described in Example 16, wherein the housing further includes an inner chamber and an aperture connected to the inner chamber, and a pressure sensor is disposed within the inner chamber.

[0021] In Example 18: a transdermal circulation support device as described in Example 17, wherein the hole is a transversely oriented hole.

[0022] In Example 19: the transdermal circulation support device as described in Example 17 further includes a sensor mount disposed within the inner cavity and connected to a pressure sensor.

[0023] In Example 20: the transdermal circulation support device as described in Example 17 further includes a sensor cable connected to a pressure sensor.

[0024] In Example 21: the transdermal circulation support device as described in Example 20, wherein the orifice is a transversely oriented orifice, and the housing further includes a proximal-oriented orifice connected to the inner chamber, through which the sensor cable passes.

[0025] In Example 22: the transdermal circulation support device as described in Example 17, wherein the housing further includes a plurality of outlet holes defining an outlet, and a plurality of struts disposed between the plurality of outlet holes; a pressure sensor is carried by one of the plurality of struts.

[0026] In Example 23: a transdermal circulation support device as described in Example 17, wherein the pressure sensor includes one of a photoelectric pressure sensor and a voltage pressure sensor.

[0027] In Example 24: the transdermal circulation support device as described in Example 16, wherein the direction of the pressure sensor sensing membrane is set at a non-zero angle relative to the longitudinal axis.

[0028] Example 25: A transdermal circulation support device includes a housing having an inlet, an outlet having a plurality of outlet holes, and a plurality of struts disposed between the plurality of outlet holes; an impeller is disposed within the housing and configured to rotate relative to the housing to allow blood to flow into the inlet, through the housing, and out of the outlet; a motor is operatively coupled to the impeller and configured to rotate the impeller relative to the housing. A pressure sensor is carried by one of the plurality of struts.

[0029] In Example 26: the transdermal circulation support device as described in Example 25, wherein the housing further includes an inner chamber and an aperture communicating with the inner chamber, and a pressure sensor is disposed within the inner chamber.

[0030] In Example 27: a transdermal circulation support device as described in Example 26, wherein the hole is a transversely oriented hole.

[0031] In Example 28: the transdermal circulation support device as described in Example 27, wherein the housing further includes a proximal-facing aperture connected to the inner chamber.

[0032] In Example 29: The transdermal circulation support device as described in Example 28 further includes a sensor cable that is coupled to a pressure sensor and extends through an opening facing the proximal side.

[0033] In Example 30: a transdermal circulation support device as described in Example 28, wherein the orifice facing the proximal side is positioned proximally relative to the outlet.

[0034] In Example 31: the transdermal circulation support device as described in Example 25 further includes a sensor mount disposed within the inner cavity and connected to a pressure sensor.

[0035] In Example 32: A method of manufacturing a transdermal circulation support device includes: arranging an impeller within a housing such that the impeller is rotatable relative to the housing; operably connecting a motor to the impeller; and connecting a pressure sensor to the housing such that the pressure sensor is positioned at a non-zero angle relative to the longitudinal axis of the housing.

[0036] In Example 33: the manufacturing method as described in Example 32, wherein connecting the pressure sensor to the housing includes: positioning the pressure sensor in the inner cavity of the sensor housing.

[0037] In Example 34: the manufacturing method as described in Example 33, wherein the sensor housing further includes a hole that connects to the inner cavity.

[0038] Example 35: The manufacturing method as described in Example 34, wherein the hole is a transversely facing hole, and the sensor housing further includes a proximal facing hole; connecting the pressure sensor to the housing includes: inserting the pressure sensor through the proximal facing hole into the inner cavity.

[0039] Although several embodiments of the invention have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which illustrates and demonstrates exemplary embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative rather than restrictive. Attached Figure Description

[0040] Figure 1 : A side sectional view of a percutaneous circulation support device (which may also be referred to interchangeably as a "blood pump" herein) according to an embodiment of the present disclosure.

[0041] Figure 2 : Figure 1 A partial perspective view of the transdermal circulation support device shown.

[0042] Figure 3 : Figure 1 A cross-sectional view of the other side of the transdermal circulation support device shown.

[0043] Figure 4 :along Figure 3 Partial side sectional view of the percutaneous circulation support device in line 4-4.

[0044] Figure 5 : A flowchart of a method for manufacturing a transdermal circulation support device according to an example of this disclosure.

[0045] While the present invention can be modified and alternatively implemented in various ways, specific embodiments have been shown in the accompanying drawings and are described in detail below. However, it should be noted that the present invention is not limited to the specific embodiments described; rather, the present invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. Detailed Implementation

[0046] Figure 1 This is a partial side sectional view of a percutaneous circulatory support device 100 (which may also be interchangeably referred to herein as a "blood pump") according to an example of this disclosure. Device 100 may be used together with a guidewire and a delivery sheath (not shown) to form a percutaneous circulatory support system. More specifically, the guidewire and delivery sheath may assist in the percutaneous delivery of device 100 to a target location (e.g., within the heart) within the patient. Furthermore, device 100 may also be delivered to other target locations within the patient.

[0047] Continue to refer to Figure 1 The device 100 generally 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 integrally formed or have a single-piece structure. In other embodiments, the impeller housing 102 and the motor housing 104 may be separate components, configured for detachable or permanent connection. In some embodiments, the blood pump 100 may not have a separate motor housing 104, and the impeller housing 102 may be directly connected to the motor 105 described below, or the motor housing 104 may be integrally formed with the motor 105 described below.

[0048] An impeller assembly 106 is housed within an impeller housing 102. The impeller assembly 106 includes an impeller shaft 108, which is rotatably supported by at least one bearing (such as bearing 110). The impeller assembly 106 also includes an impeller 112, which is rotatable relative to the impeller housing 102 to drive blood through the device 100. More specifically, the impeller 112 causes blood to flow into a blood inlet 114 formed on the impeller housing 102, and after passing through the impeller housing 102, to flow out from a blood outlet 116 formed on the impeller housing 102. As shown, in some embodiments, 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 integrated. As shown, in some embodiments, the inlet 114 and / or the outlet 116 may each contain multiple orifices; in other embodiments, the inlet 114 and / or the outlet 116 may each contain a single orifice. As shown in the figure, in some embodiments, inlet 114 may be located at the distal portion 118 of housing 101, and outlet 116 may be formed on a side portion of housing 101; in other embodiments, inlet 114 and / or outlet 116 may also be formed on other portions of housing 101. In some embodiments, housing 101 may be coupled to a distally extending cannula (not shown) that receives blood and delivers it to inlet 114.

[0049] Continue to refer to Figure 1 Motor housing 104 carries motor 105, and motor 105 is configured to drive impeller 112 to rotate relative to impeller housing 102. In the illustrated example, motor 105 rotates drive shaft 120, which is connected to active magnet 122. Rotation of active magnet 122 causes driven magnet 124 to rotate, which is connected to impeller assembly 106 and rotates together with impeller assembly 106. More specifically, in embodiments including impeller shaft 108, impeller shaft 108 and impeller 112 are configured to rotate together with driven magnet 124. In other embodiments, motor 105 may also be connected to impeller assembly 106 via other components.

[0050] In some embodiments, a controller (not shown) may be operatively connected to and configured to control motor 105. In some embodiments, the controller may be disposed within motor housing 104. In other embodiments, the controller may be disposed outside 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 disposed within motor housing 104. According to embodiments, the controller may be, include, or be included in one or more of the following components: field-programmable gate array (FPGA), programmable logic device (PLD), complex programmable logic device (CPLD), custom application-specific integrated circuit (ASIC), dedicated processor (e.g., microprocessor), central processing unit (CPU), software, hardware, firmware, or any combination of the foregoing components. Although the controller is referred to herein in the singular, the controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated in multiple virtual machines, etc. In other examples, other methods may also be used to control motor 105.

[0051] Continue to refer to Figure 1 The motor housing 104 is connected to the conduit 126 at the proximal portion 127 of the housing 101. The conduit 126 is connected to the motor housing 104 in various ways, such as laser welding, brazing, bonding, polymer reflow soldering, etc. The conduit 126 extends proximally away from the motor housing 104 and carries a motor cable 128 within a cavity 130. The motor cable 128 can operatively connect the motor 105 to a controller (not shown) and / or an external power source (not shown).

[0052] Now refer to Figure 2-4 The device 100 also includes a sensor assembly 132 for measuring pressure within a patient's blood vessels (such as the aorta). The sensor assembly 132 includes a sensor housing 134 having an internal chamber 136 (see...). Figure 3 , Figure 4 A pressure sensor 138 is installed inside the inner chamber 136 (see...). Figure 3 , Figure 4 The pressure sensor can be an optical pressure sensor or an electrical pressure sensor. During the deployment of device 100, sensor housing 134 protects pressure sensor 138. Sensor housing 134 also includes a laterally facing distal aperture 140 (see [reference needed]) that connects to inner chamber 136. Figure 2 , Figure 3 (In this document, "lateral" and similar terms refer to a direction that is not parallel to the longitudinal axis of the impeller housing 102). The orifice 140 allows blood to enter the inner chamber 136, thereby enabling the pressure sensor 138 to sense blood pressure.

[0053] like Figure 4As most clearly shown, pressure sensor 138 is relative to the longitudinal axis 144 of impeller housing 102 (see... Figure 1 The sensor 138 is positioned at a non-zero angle 142. More specifically, the distal surface of the sensor 138 is positioned at a non-zero angle 142 relative to the longitudinal axis 144 of the impeller housing 102, perpendicular to the direction 147 of the sensing diaphragm 149 of the sensor 138. This arrangement of the pressure sensor 138 reduces sensing errors related to dynamic pressure. The range of the non-zero angle 142 can be, for example, 7.5°–90°; in some embodiments, the angle 142 can be a non-zero acute angle, specifically ranging from 7.5°–45°, more specifically from 7.5°–30°, further specifically from 7.5°–12.5°, and even more specifically from 9°–11°, or even precisely 10°. As shown, the sensor assembly 132 (more specifically, the pressure sensor 138 and / or the lateral distal aperture 140 of the inner chamber 136) can be positioned on or near one of the support rods 145 between the apertures of the outlet 116. Based on pressure signals, which are significantly different from those obtained when outlet 116 is located in the aorta and far from the aortic valve, this structure helps determine whether device 100 has been accidentally and improperly moved, resulting in outlet 116 being located at or near the aortic valve, or in the left ventricle.

[0054] The current overall reference Figure 2-4 The sensor housing 134 can adopt various structural forms. For example, as shown in the figure, the sensor housing 134 can be integrally formed with the impeller housing 102 or be a single piece. Alternatively, the sensor housing 134 can also be a separately formed component, such as a tube or collar made of one or more metals, one or more plastics, composite materials, etc. The sensor housing 134 also includes a sensor mounting base 146 disposed within the inner chamber 136. This sensor mounting base 146 helps to support the pressure sensor 138 away from the wall of the sensor housing 134 (i.e., the sensor support 146 positions the pressure sensor 138 at the center of the inner chamber 136), thereby contributing to high-precision pressure sensing.

[0055] Sensor assembly 132 also includes a sensor cable 148 that is coupled to pressure sensor 138. This sensor cable 148 operatively connects the pressure sensor to a controller (not shown). As shown, sensor cable 148 extends through sensor mount 146, supporting pressure sensor 138 away from the wall of sensor housing 134. Figure 2 The proximal orifice 150 is positioned proximal to the blood outlet 116. In some examples, the sensor cable 148 may also extend through a cable cavity (not shown) that is connected to or is part of the catheter 126.

[0056] Figure 5 This is a flowchart of a blood pump manufacturing method 200 according to an example of this disclosure. Method 200 describes the features of a blood pump 100, but it should be understood that any blood pump described herein can be manufactured using a similar method. At block 202, the method first provides an impeller housing 102, a motor 105, an impeller 112, and a sensor 138. At block 204, the impeller 112 is positioned within the housing 101 such that the impeller 112 is rotatable relative to the housing 101. More specifically, the impeller 112 is coupled to an impeller shaft 108. At block 206, the motor 105 is operatively coupled to the impeller 112, for example via an active magnet 122 and a driven magnet 124. At block 208, the pressure sensor 138 is coupled to the housing 101 such that the pressure sensor 138 is positioned at a non-zero angle 142 relative to the longitudinal axis 144 of the housing 101. More specifically, the pressure sensor 138 is inserted through the proximal-facing hole 150 and into the inner chamber 136 of the sensor housing 134.

[0057] Various modifications and additions can be made to the above exemplary examples without departing from the scope of the invention. For example, although the above examples refer to specific features, the scope of the invention also includes examples with different combinations of features and examples that do not include all of the stated features. Therefore, the scope of the invention is intended to cover all alternatives, modifications, and variations that fall within the scope of the appended claims, as well as all their equivalents.

Claims

1. A transdermal circulation support device, comprising: A housing having a proximal portion, a distal portion, and a longitudinal axis extending between the proximal portion and the distal portion; An impeller disposed within the housing and configured to rotate relative to the housing to allow blood to flow through the housing; An electric motor, operably connected to the impeller, the motor being configured to rotate the impeller relative to the housing; as well as A pressure sensor is connected to the housing and is set at a non-zero angle relative to the longitudinal axis.

2. The transdermal circulation support device of claim 1, wherein the housing further includes an inner chamber and an aperture connected to the inner chamber, and the pressure sensor is disposed within the inner chamber.

3. The transdermal circulation support device as claimed in claim 2, wherein the hole is a transversely oriented hole.

4. The transdermal circulation support device according to any one of claims 2-3, further comprising a sensor mounting base disposed within the inner cavity and connected to the pressure sensor.

5. The percutaneous circulation support device according to any one of claims 1-4, wherein the housing further includes a plurality of outlet holes defining a blood outlet, and a plurality of support rods disposed between the plurality of outlet holes, and the pressure sensor is carried by one of the plurality of support rods.

6. The transdermal circulation support device according to any one of claims 1-5, wherein the pressure sensor comprises one of an optical pressure sensor and an electrical force sensor.

7. The transdermal circulation support device according to any one of claims 1-6, wherein the direction perpendicular to the pressure sensor sensing membrane is set at a non-zero angle relative to the longitudinal axis.

8. A transdermal circulation support device, characterized in that, include: Housing, the housing comprising: Entrance; Multiple outlet holes; Multiple support rods are disposed between the multiple outlet holes; An impeller disposed within the housing and configured to rotate relative to the housing to allow blood to flow into the inlet, through the housing, and out of the plurality of outlet holes; An electric motor, operatively connected to the impeller, the motor being configured to rotate the impeller relative to the housing; and A pressure sensor, which is carried by one of the plurality of support rods.

9. The transdermal circulation support device of claim 8, wherein the housing further includes an inner chamber and an aperture connected to the inner chamber, and the pressure sensor is disposed within the inner chamber.

10. The transdermal circulation support device of claim 9, wherein the hole is a transversely oriented hole.

11. The transdermal circulation support device according to any one of claims 9-10, wherein the housing includes a proximal-facing aperture connected to the inner chamber.

12. The transdermal circulation support device of claim 11, further comprising a sensor cable connected to the pressure sensor and extending through the proximal-facing aperture.

13. The transdermal circulation support device as claimed in any one of claims 11-12, wherein the proximal-facing orifice is disposed proximal to the outlet.

14. The transdermal circulation support device according to any one of claims 9-13, further comprising a sensor mounting base disposed within the inner cavity and connected to the pressure sensor.

15. The transdermal circulation support device according to any one of claims 9-14, further comprising a sensor mounting base disposed within the inner cavity and connected to the pressure sensor.

Images