Medical device for treating decompensated heart failure

Abstract

The present disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example medical device system for treating a heart includes a control system including a display unit. Further, the display unit is configured to display: a first visual representation of a first medical device disposed in a first anatomical location; a second visual representation of a second medical device disposed in a second anatomical location; a third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor disposed at a first location proximate to the first medical device; and a fourth visual representation of a second physiological parameter, wherein the second physiological parameter is measured by a second sensor disposed at a second sensor location proximate to the second medical device.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 542,908, filed October 6, 2023; U.S. Provisional Application No. 63 / 586,982, filed September 29, 2023; and U.S. Provisional Application No. 63 / 540,617, filed September 26, 2023, the entire disclosure of which is hereby incorporated by reference. Technical Field

[0002] This disclosure relates to medical devices and methods for manufacturing medical devices. More specifically, this disclosure relates to medical devices including expandable members and pressure sensing devices connected to other structures, and methods for manufacturing and using such devices. Background Technology

[0003] Various in vivo medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include guidewires, balloon catheters, sensors, etc. These devices are manufactured using any of a variety of different methods and can be used according to any of these methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a continued need for alternative medical devices and alternative methods for manufacturing and using these devices. Summary of the Invention

[0004] This disclosure provides alternatives for the design, materials, manufacturing methods, and uses of medical devices. An example medical device system for treating the heart includes a control system comprising a display unit. Further, the display unit is configured to display: a first visual representation of a first medical device disposed in a first anatomical position; a second visual representation of a second medical device disposed in a second anatomical position; a third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor disposed at a first location near the first medical device; and a fourth visual representation of a second physiological parameter, wherein the second physiological parameter is measured by a second sensor disposed at a second sensor location near the second medical device.

[0005] Alternatively or added to any of the above embodiments, wherein the first anatomical location is the superior vena cava.

[0006] Alternatively or added to any of the above embodiments, wherein the second anatomical location is the inferior vena cava.

[0007] Alternatively or added to any of the above embodiments, wherein the first medical device is a first expandable member and the second medical device is a second expandable member.

[0008] Alternatively or added to any of the above embodiments, wherein the first sensor is disposed near the first expandable member.

[0009] Alternatively or added to any of the above embodiments, wherein the second sensor is disposed on the distal side of the second expandable member.

[0010] Alternatively or added to any of the above embodiments, wherein the first physiological parameter and the second physiological parameter are blood pressure.

[0011] Alternatively or as an addition to any of the above embodiments, wherein the display unit is configured to further display a third anatomical location, and wherein the display unit is configured to further display a fifth visual representation of a third physiological parameter, wherein the third physiological parameter is measured by a sensor disposed along the third anatomical location.

[0012] Alternatively or added to any of the above embodiments, wherein the third anatomical location is the pulmonary artery.

[0013] The third physiological parameter may be used as an alternative to or addition to any of the above embodiments, wherein the third physiological parameter is selected from the group consisting of cardiac output, stroke volume, mean arterial pressure, and blood pressure.

[0014] Alternatively or as an addition to any of the above embodiments, wherein the third medical device includes a pulmonary artery catheter.

[0015] Alternatively or as an addition to any of the above embodiments, wherein the display unit is configured to further display a pressure waveform corresponding to the first physiological parameter.

[0016] Alternatively or as an addition to any of the above embodiments, the display unit is configured to further display an input button, and the input button is configured to allow a user to manipulate the first medical device, the second medical device, or both the first medical device and the second medical device.

[0017] Alternatively or as an addition to any of the above embodiments, wherein the first medical device is an expandable member, and the second medical device is an expandable member, and wherein the input button is configured to allow the user to immediately stop the inflation of the first expandable member, the second expandable member, or both the first expandable member and the second expandable member.

[0018] Another example medical device system for treating the heart includes a control system comprising a display unit. Further, the display unit is configured to display: a first visual representation of a first medical device disposed in a first anatomical position; a second visual representation of a second medical device disposed in a second anatomical position; a third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor disposed at a first location near the first medical device; a fourth visual representation of a second physiological parameter, wherein the second physiological parameter is measured by a second sensor disposed at a second sensor location near the second medical device; a fifth visual representation of a third physiological parameter, wherein the third physiological parameter is measured by a third sensor disposed at a third sensor location near the first medical device; and a sixth visual representation of a fourth physiological parameter, wherein the fourth physiological parameter is measured by a fourth sensor disposed at a fourth sensor location near the second medical device.

[0019] Alternatively or as an addition to any of the above embodiments, wherein the first anatomical location is the superior vena cava, wherein the first medical device is a first expandable member, wherein the first sensor is disposed proximally to the first expandable member, and wherein the third sensor is disposed distally to the first expandable member.

[0020] Alternatively or additional to any of the above embodiments, wherein the second anatomical location is the inferior vena cava, and wherein the second medical device is a second expandable member, and wherein the second sensor is disposed proximally to the second expandable member, and wherein the fourth sensor is disposed distally to the first expandable member.

[0021] Alternatively or as an addition to any of the above embodiments, wherein the display unit is configured to further display a third anatomical location, and wherein the display unit is configured to further display a seventh visual representation of a third physiological parameter, wherein the third physiological parameter is measured by a sensor disposed along the third anatomical location.

[0022] Alternatively or added to any of the above embodiments, wherein the third anatomical location is the pulmonary artery, and wherein the third physiological parameter is selected from the group consisting of cardiac output, stroke volume, mean arterial pressure, and blood pressure.

[0023] Another medical device system for treating the heart includes: a control system having a processor and a display; a catheter shaft having a lumen and a first end connected to a hub; a first expandable member disposed along the catheter shaft and connected to the processor, wherein the first expandable member is configured to be positioned in the superior vena cava; a second expandable member disposed along the catheter shaft and connected to the processor, wherein the second expandable member is configured to be positioned in the inferior vena cava; a first sensing member having a first end located near the first expandable member and a second end connected to the control system, the first sensing member being designed to sense a first physiological parameter; and a second sensing member having a first end located near the second expandable member and a second end connected to the control system, the second sensing member being designed to sense a second physiological parameter. Further, the display is configured to display a first visual representation of the first expandable member disposed in the superior vena cava. Further, the display is configured to display a second visual representation of the second expandable member disposed in the superior vena cava. Furthermore, the display is configured to display a third visual representation of the first physiological parameter, and the display is configured to display a fourth visual representation of the second physiological parameter.

[0024] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation thereof. The following drawings and detailed descriptions illustrate these embodiments in more detail. Attached Figure Description

[0025] This disclosure can be more fully understood by taking into consideration the following detailed description in conjunction with the accompanying drawings, in which:

[0026] Figure 1 An example medical device system positioned inside a patient's body was demonstrated;

[0027] Figure 2 Example medical devices were shown;

[0028] Figure 3 It is along Figure 2 The cross-sectional view taken by line 3-3;

[0029] Figure 4 Showing Figure 2 Part of an example medical device;

[0030] Figure 5 Showing Figure 2 Part of an example medical device;

[0031] Figure 6 Showing Figure 2 Part of an example medical device;

[0032] Figure 7 It is located in the superior vena cava and the inferior vena cava. Figure 2 A schematic diagram of a medical device;

[0033] Figure 8 Example medical devices were shown;

[0034] Figure 9 It is along Figure 8 Example cross-sectional view taken from line 10-10;

[0035] Figure 10 It is along Figure 8 Example cross-sectional view taken from line 10-10;

[0036] Figure 11 Showing Figure 8 Part of an example medical device;

[0037] Figure 12 Showing Figure 8 Part of an example medical device;

[0038] Figure 13 Showing Figure 8 Part of an example medical device;

[0039] Figure 14 It is located in the superior vena cava and the inferior vena cava. Figure 8 A schematic diagram of a medical device;

[0040] Figure 15 This is a schematic diagram of another example medical device positioned in the superior and inferior vena cava;

[0041] Figure 16 It is along Figure 15 A cross-sectional view taken from line 16-16;

[0042] Figure 17 Showing Figure 15 Part of an example medical device;

[0043] Figure 18 Showing Figure 15 Part of an example medical device;

[0044] Figure 19 It is located in the superior vena cava and the inferior vena cava. Figure 15 A schematic diagram of a medical device;

[0045] Figure 20 Showing Figure 1 An example display of the medical device system shown;

[0046] Figure 21 Showing Figure 1 An example display of a medical device system is shown.

[0047] While this disclosure can be modified and alternatively made in various forms, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0048] For terms defined below, those definitions shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0049] All numerical values ​​in this document are assumed to be modified by the word “approximately”, whether explicitly stated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(e.g., having the same function or result). In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0050] The range of numbers listed by endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0051] As used in this specification and the appended claims, the singular forms “a” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its sense that it includes “and / or” unless the context clearly indicates otherwise.

[0052] It should be noted that references to "embodiments," "some embodiments," and "other embodiments" in the specification refer to the fact that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such enumeration does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that, unless expressly stated to the contrary, such feature, structure, and / or characteristic may also be used in conjunction with other embodiments, whether or not explicitly described.

[0053] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered the same. The drawings (not necessarily drawn to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure.

[0054] The heart is a vital organ responsible for pumping blood throughout the body. Therefore, it is fundamentally important that the heart's mechanical pumping function works properly. When the heart does not function correctly, various adverse medical conditions can occur. These adverse medical conditions can include a serious condition called acute decompensated heart failure (“ADHF”). This form of heart failure is characterized by a sudden inability of the heart to pump efficiently. However, this inefficiency is not due to cardiac arrest, because even if the heart's pumping function deteriorates significantly, it does not stop.

[0055] ADHF causes a failing heart to be unable to pump blood forward. Furthermore, this inability to pump forward can lead to excess blood pooling (e.g., accumulating) in one or more chambers of the heart. For example, if a patient's left ventricle is damaged and unable to effectively pump blood into the aorta, progressive blood pooling may eventually occur in the right atrium. Blood pooling in the right atrium can lead to a variety of adverse complications. For instance, excess blood in the right atrium can cause increased blood pressure in the right atrium, eventually leading to ventricular septal displacement and thus reducing left ventricular volume and stroke volume. Furthermore, standard treatment for patients with ADHF involves treating them with intravenous diuretics until sufficient fluid is removed to restore hemodynamic stability. However, many patients develop diuretic resistance. Therefore, if diuretics fail, positive inotropic therapy and transplantation are typical treatment courses.

[0056] Therefore, in some cases, it may be desirable to position and dilate an expandable medical device within the superior and / or inferior vena cava to regulate blood flow into the right atrium, thereby allowing excess blood in the right atrium time to drain and thus lowering blood pressure in the right atrium. Furthermore, in addition to reducing the load on the right side of the heart, dilating the expandable medical device within the superior and / or inferior vena cava can also reduce renal overload, thereby increasing renal blood flow, urine output, and sodium excretion, all of which can improve the patient's response to diuretic therapy. Example medical devices designed to be positioned within the superior and / or inferior vena cava to regulate blood flow into the right atrium are disclosed.

[0057] Figure 1 An example medical device system 10 is shown. Medical device system 10 may include a medical device 12. The following will discuss... Figure 2In more detail, medical device 12 may include a distal region located near the heart 22 of patient 24. Medical device 26 may include an elongated member 26 extending from the proximal region of medical device 12 to the distal region. Additionally, the proximal region of medical device 12 may include a connector 28 (e.g., a manifold) coupled to the proximal end of the elongated member (e.g., a catheter shaft) 26. Further, connector 28 may be coupled to control system 14 (e.g., a console). It is understood that... Figure 1 The connector 28 shown can represent a variety of different connector configurations, some of which will be discussed in this paper.

[0058] The aforementioned control system 14 may include a display 15. Although Figure 1 The illustration shows that the display 15 can be integrated into the control system 14; however, it is conceivable that the display 15 can be a separate, distinct component of the medical device system 10. In other words, the display 15 can be a separate, stand-alone display independent of the control system 14.

[0059] Figure 1 Further illustrating that, among other suitable components, the control system 14 may include one or more processors 16, memory 17, I / O units 19, and pumps 18. The processor 16 of the control system 14 may include a single processor or more than one processor operating independently or collaboratively. The processor 16 may be configured to execute instructions, including instructions that can be loaded into memory 17 and / or other suitable memories. Example processor components may include, but are not limited to, microprocessors, microcontrollers, multi-core processors, graphics processing units, digital signal processors, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), discrete circuit systems, and / or other suitable types of data processing devices. In some examples, the processor 16 of the control system 14 may be configured to execute program instructions. Program instructions may include, for example, firmware, microcode, or application code executed by the processor 16, the microprocessor, and / or the microcontroller. The one or more processors 16 may be configured to each manage different functions. They may also be configured to collectively perform the same function (e.g., a redundant system). Furthermore, they may be configured such that: processor 16 performs a given function, and a second processor 16 checks the correctness of the results of the function performed by processor 16 (e.g., a command monitoring system).

[0060] The memory 17 of the control system 14 may include a single memory component or more than one memory component that operates independently or in conjunction with each other. Example memory types may include random access memory (RAM), EEPROM, flash memory, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read-only memory (ROM), hard disk drive, flash memory, optical disk drive, and / or other suitable persistent memory) and / or other suitable types of memory. Memory 17 may be or may include non-transitory computer-readable media.

[0061] The I / O unit 19 of the control system 14 may include a single I / O component or more than one I / O component that operates independently or together. Example I / O unit 40 may be any type of communication port configured to communicate with other components of the loop system 10. Example I / O unit 19 types may include wired ports, wireless ports, radio frequency (RF) ports, Bluetooth Low Energy ports, Bluetooth ports, near field communication (NFC) ports, HDMI ports, Wi-Fi ports, Ethernet ports, VGA ports, serial ports, parallel ports, component video ports, S-video ports, composite audio / video ports, DVI ports, USB ports, optical ports, and / or other suitable ports.

[0062] Figure 1 The control system is further illustrated to include pump 18. It is understood that in some examples, processor 16 and pump 18 may reside within a single control system (e.g., a console, a housing). However, it is further understood that in other examples, processor 16 and pump 18 may be separate components spaced apart from each other. In either arrangement, it is understood that processor 16 and pump 18 may be able to communicate with each other. For example, processor 16 may communicate with pump 18 in response to physiological changes in the patient's body. It is further understood that processor 16 and pump 18 may communicate through various channels. For example, processor 16 and pump 18 may be hardwired to each other, or they may be wirelessly connected, or a combination of both hardwired and wireless connectivity may be included.

[0063] Additionally, in some examples, the medical device system 10 may include a saline reservoir 20 (e.g., a saline bag) coupled to the control system 14. Specifically, in some examples, the saline reservoir 20 may be directly attached to the pump 18. As described above, the pump 18 may draw saline from the saline reservoir 20 in response to the processor 16 sensing physiological changes in the patient's body.

[0064] Figure 2 Showing Figure 1 The medical device 12 shown. (e.g.) Figure 2As shown, the medical device 12 may include a first expandable member 30 and a second expandable member 32 disposed on an elongated member 26. In some examples, the distal end of the first expandable member 30 may be spaced from the proximal end of the second expandable member 32 by about 2 inches (2) to about 25”, or about 8” to about 22”, or about 12” to about 18”, or about 15”. The second expandable member 32 may be positioned distal to the first expandable member 30. In some instances, each of the first expandable member 30 and the second expandable member 32 may be referred to as an expandable medical balloon. The first expandable member 30 may include a distal end and a proximal end. Both the distal end and the proximal end of the first expandable member 30 may be coupled to the elongated member 26. Further, the second expandable member 32 may include a distal end and a proximal end. Both the distal end and the proximal end of the second expandable member 32 may be coupled to the elongated member 26.

[0065] Figure 2 Further illustration shows that the proximal end of the elongated member 26 can be coupled to the connector 28. As will be described in more detail herein, the connector 28 may include one or more ports that can be in fluid communication with the control system 14 and / or the saline reservoir 20. Additionally, as will be described in more detail herein, the connector 28 may include one or more ports that can allow one or more medical devices (e.g., assistive medical devices) to be inserted therein.

[0066] It can be further understood that, in some examples, a portion of the elongated member 26 may pass through the expandable member 32 and extend distally beyond the expandable member 32 to form a distal end region. However, in other examples, the medical device 12 may include a separate end member that may be attached (e.g., bonded) to the distal waist of the expandable member 32 and / or also attached (e.g., bonded) to a portion of the elongated member 26. In other words, in some examples, the elongated member 26 itself may form the distal end of the medical device 12. However, in other examples, a separate end member may be attached to the expandable member 32, the elongated member 26, or both the expandable member 32 and the elongated member 26 to form the distal end of the medical device 12.

[0067] Figure 3 Showed along Figure 1 The figure shows a cross-section of the elongated member 26 taken by line 3-3. This figure illustrates that the elongated member 26 may include one or more individual lumens extending therein. For example, the elongated member 26 may include a guidewire lumen 34. The guidewire lumen 34 may extend from the proximal end of the elongated member 26 to the distal end of the elongated member 26. In some examples, the diameter of the guidewire lumen 34 may be about 0.020” to about 0.050”, or about 0.025” to about 0.045”, or about 0.034” to about 0.042”, or about 0.036” to about 0.040”, or about 0.038”.

[0068] Understandably, during a medical procedure, the distal end of the elongated member 26 can travel on a guidewire, which can pass through the guidewire lumen 34 and exit the medical device 12 through the port of connector 28. In other words, the guidewire lumen 34 can allow the medical device 12 to travel on the guidewire (previously positioned within the patient) to a treatment site (e.g., the heart) within the patient.

[0069] Figure 3 Further illustration shows that the elongated member 26 may include a first expansion lumen 37 and a second expansion lumen 38, each of which may be in fluid communication with the pump 18 (which in turn may be in fluid communication with the brine reservoir 20). In some examples, the first expansion lumen 37 may be in fluid communication with the first expandable member 30. It is understood that brine from the brine reservoir 20 may pass through the first expansion port on the connector 28 ( Figure 4 As shown), it passes through the first expansion lumen 37 and enters the first expandable member 30 to cause the first expandable member 30 to expand or collapse. In some examples, the diameter of the first expansion lumen 37 may be about 0.020” to about 0.055”, or about 0.025” to about 0.050”, or about 0.030” to about 0.046”, or about 0.036” to about 0.042”, or about 0.040”. Similarly, in some examples, the second expansion lumen 38 may be in fluid communication with the second expandable member 32. It is understood that brine from the brine reservoir 20 may pass through the second expansion port on the connector 28 ( Figure 4 (As shown), it passes through the second inflatable lumen 38 and enters the second expandable member 32 to cause the second expandable member 32 to expand or collapse. In some examples, the diameter of the second inflatable lumen 38 may be about 0.020” to about 0.055”, or about 0.025” to about 0.050”, or about 0.030” to about 0.046”, or about 0.036” to about 0.042”, or about 0.040”.

[0070] Figure 3 It is further shown that the elongated member 26 may include one or more additional lumens 40, 42, 44, 46, which are configured to allow the sensing member to extend therein. For example, Figure 3 A first sensing member lumen 40 is shown, which can be designed to allow the sensing member to extend through the elongated member 26 to a position such that the sensing member is proximal to the first inflatable balloon 30 and within the superior vena cava. Figure 3 The second sensing member lumen 42 is further shown, which can be designed to allow the sensing member to extend through the elongated member 26 to a position such that the sensing member is distal to the first inflatable balloon 30 and within the superior vena cava. Figure 3The third sensing member lumen 44 is further shown, which can be designed to allow the sensing member to extend through the elongated member 26 to a position such that the sensing member is proximal to the second inflatable balloon 32 and within the inferior vena cava. Figure 3 A fourth sensing member lumen 46 is further shown, which can be designed to allow the sensing member to extend through the elongated member 26 to a location such that the sensing member is distal to the second inflatable balloon 30 and within the inferior vena cava. In some examples, the diameters of the sensing member lumens 40, 42, 44, and 46 can each be about 0.005” to about 0.040”, or about 0.010” to about 0.030”, or about 0.015” to about 0.025”, or about 0.018” to about 0.023”, or about 0.021”.

[0071] Figure 3 Further illustration shows that the elongated member 26 may include a working channel 48 (e.g., a working lumen). In some examples, the working channel 48 may extend from the proximal end of the elongated member 26 to the distal end of the elongated member 26. In other examples, the working channel 48 may extend from the proximal end of the elongated member 26 to a location proximal to the distal end of the elongated member 26. For example, the working channel 48 may extend from the proximal end of the elongated member 26 to a location adjacent to the distal end of the first expandable member 30. As will be described in more detail below, the medical device 12 may be designed to allow an auxiliary medical device (e.g., a diagnostic medical device, a thermodilution catheter, etc.) to pass through the connector 28 and enter the working channel 48, wherein the auxiliary device may pass through an opening in the wall of the elongated member 26 and enter the patient's right atrium and / or pulmonary artery. In some examples, the diameter of the working channel 48 may be about 0.075” to about 0.110”, or about 0.080” to about 0.105”, or about 0.085” to about 0.095”, or about 0.088” to about 0.092”, or about 0.090”.

[0072] In some examples, Figure 3 The wall thickness between adjacent lumens 34, 37, 38, 40, 42, 44, 46, and 48 of the elongated member 26 shown may be approximately 0.0015” to approximately 0.0085”, or approximately 0.0025” to approximately 0.0075”, or approximately 0.0035” to approximately 0.0065”, or approximately 0.0045” to approximately 0.0055”, or approximately 0.0050”.

[0073] Figure 4 An example connector 48 (e.g., a manifold) of the medical device 12 is shown. Figure 4 The diagram shows that connector 28 may include eight individual access ports 50, 52, 54, 56, 58, 60, 62, 64 (e.g., orifices, openings, etc.). Although Figure 4The diagram shows that connector 28 includes eight access ports 50, 52, 54, 56, 58, 60, 62, and 64, but it is understood that connector 28 may include one, two, three, four, five, six, seven, eight, nine, ten, or more access ports.

[0074] Figure 4 The diagram further illustrates that connector 48 may include a guidewire port 50. The guidewire port 50 may be in fluid communication with the aforementioned guidewire lumen 34. The guidewire port 50 allows a guidewire to pass through it and be inserted into the guidewire lumen 34.

[0075] Figure 4 It is further shown that the connector 48 may include a first expansion port 52. The first expansion port 52 may be in fluid communication with the first expansion lumen 37 described above. The first expansion port 52 may allow brine (or other expansion medium) to pass through the elongated member 26 and enter the first expandable member 30. Figure 4 It is further shown that the connector 48 may include a second expansion port 54. The second expansion port 54 may be in fluid communication with the aforementioned second expansion lumen 38. The second expansion port 54 may allow brine (or other expansion medium) to pass through the elongated member 26 and enter the second expandable member 32.

[0076] Figure 4 It is further shown that connector 48 may include one or more sensing component ports 56, 58, 60, 62. For example, Figure 4 It is further shown that the connector 28 may include a first sensing component port 56, which can be in fluid communication with the sensing component lumen 40. Figure 4 It is further shown that the connector 28 may include a second sensing component port 58, which can be in fluid communication with the sensing component lumen 42. Figure 4 It is further shown that the connector 28 may include a third sensing component port 60, which may be in fluid communication with the sensing component lumen 44. Figure 4 It is further shown that the connector 28 may include a fourth sensing component port 62, which may be in fluid communication with the sensing component lumen 46.

[0077] Figure 4 It is further shown that connector 28 may include a working channel port 64 which may be in fluid communication with working channel 48. Working channel port 64 may allow an assistive medical device to pass through connector 28 and into working channel 48, wherein the assistive medical device may ultimately pass through an opening in the wall of elongated member 26 and enter the patient's right atrium and / or pulmonary artery.

[0078] It is understood that each of the individual access ports 50, 52, 54, 56, 58, 60, 62, and 64 on connector 28 may include a threaded area that allows a user to attach a medical device to that threaded area. For example, the threaded areas on each of the first expansion port 52 and the second expansion port 54 may allow a user to attach connector 28 to control system 14, pump 18, and / or saline reservoir 20, wherein pump 18 and saline reservoir can be used to expand or collapse the first expandable member 30 and / or the second expandable member 32.

[0079] Figure 5 Showing Figure 2 A detailed view of a portion of the medical device 12 shown. For example, Figure 5 The first expandable member 30 attached to the elongated member 26 is shown. Figure 5 The medical device 26 is shown to include one or more openings positioned along the elongated member 26. In some instances, these one or more openings positioned along the elongated member may be located near the first expandable member 30. For example, Figure 5 The medical device 26 is shown to include a sensing element orifice 66 located proximal to the first expandable member 30. The orifice 66 may extend through the wall of the elongated member 26. Furthermore, it is understood that the orifice 66 may be in fluid communication with the sensing element lumen 40 described herein. Figure 5 Further illustration shows that the medical device 26 may include a sensing element aperture 68 located distal to the first expandable member 30. The aperture 68 may extend through the wall of the elongated member 26. Furthermore, it is understood that the aperture 68 may be in fluid communication with the sensing element lumen 42 described herein. Figure 5 The medical device 26 is further shown to include one or more marker strips 67 positioned below the first expandable member 30 to assist in placing the first expandable member 30 at the target treatment site.

[0080] Figure 5Further, it is shown that the medical device 26 may include a working channel aperture 70 located distal to the first expandable member 30. In some examples, the proximal end of the aperture 70 may be spaced from the distal end of the first expandable member 30 by about 0.25” to about 2.25”, or about 0.50” to about 1.75”, or about 0.75” to about 1.5”, or about 0.85” to about 1.25”, or about 1.0”. The aperture 70 may extend through the wall of the elongated member 26. Further, it is understood that the aperture 70 may be in fluid communication with the working channel 48 described herein. Therefore, it is further understood that the working channel aperture 70 may allow an auxiliary medical device already inserted into the connector 28 and passing through the working channel 48 to pass through... The wall of the elongated member 26 allows auxiliary medical devices to extend away from the medical device 26 to access other parts of the patient's anatomy. In some instances, a thermodilution catheter (e.g., a Swan-Ganz catheter) can be inserted into connector 28, through working channel 48, through working channel orifice 70, where the thermodilution catheter can extend away from the medical device 26 and into the patient's right atrium and / or pulmonary artery. It is conceivable that other auxiliary medical devices (besides the thermodilution catheter) can pass through working channel 48 to access parts of the patient's anatomy.

[0081] Figure 6 Showing Figure 2 A detailed view of a portion of the medical device 12 shown. For example, Figure 6 A second expandable member 32 is shown, which is mounted on the elongated member 26. Figure 6 The medical device 26 is shown to include one or more openings positioned along the elongated member 26. In some instances, these one or more openings positioned along the elongated member 26 may be located near the second expandable member 32. For example, Figure 6 The medical device 26 is shown to include a sensing member aperture 72 located proximal to the first expandable member 32. The aperture 72 may extend through the wall of the elongated member 26. Furthermore, it is understood that the aperture 72 may be in fluid communication with the sensing member lumen 44 described herein. Figure 5 Further illustration shows that the medical device 26 may include a sensing element aperture 74 located distal to the second expandable member 32. The aperture 74 may extend through the wall of the elongated member 26. Furthermore, it is understood that the aperture 74 may be in fluid communication with the sensing element lumen 44 described herein.

[0082] It is conceivable that the shapes of the sensing component orifices 66, 68, 70, and 72 can be squares, triangles, rectangles, ovals, polygons, combinations thereof, or any other suitable geometric shapes.

[0083] Furthermore, as described herein, in some examples, each of the sensing member orifices 66, 68, 72, 74 described herein may extend through the wall of the elongated member 26. However, in other examples, it is conceivable that the medical device 12 may include a membrane extending along the outer surface of the elongated member 26, wherein the membrane extends over each of the sensing member orifices 66, 68, 72, 74. In these examples, it is understood that the membrane covering any of the sensing member orifices 66, 68, 70, 72 may be substantially flush with the outer surface of the elongated member 26. Furthermore, the membrane extending over any of the sensing member orifices 66, 68, 72, 74 may allow sensing member lumens 40, 42, 44, 46 in fluid communication with the sensing member orifices 66, 68, 72, 74 to be filled with fluid (e.g., the membrane may maintain the fluid within a fluid column defined by the sensing member lumen), wherein each of the fluid-filled lumens may be in communication with a pressure sensor of the medical device system 12. It is understood that a force change occurring along the membrane at any of the sensing member orifices 66, 68, 72, 74 can be transmitted through the corresponding fluid-filled sensing member lumens 40, 42, 44, 46 to a pressure sensor located in the control system 14. The pressure sensor can then send a signal to the processor 16 of the control system in response to the pressure change occurring at the membrane at any of the sensing member orifices 66, 68, 72, 74.

[0084] Figure 7 Showing Figure 1 Detailed views. In particular, Figure 7 A first expandable member 30 positioned in the superior vena cava 36 and a second expandable member 32 positioned in the inferior vena cava are shown. Although Figure 7 The illustration shows the second expandable member 32 positioned within the inferior vena cava; however, in other examples, it is conceivable that the second expandable member 32 could be positioned near the renal artery or renal vein. Furthermore, Figure 7 An assistive medical device 84 (e.g., a diagnostic catheter, a thermodilution catheter, an assistive sensing component, etc.) is shown, which extends within a working channel 48, through a working channel orifice 70, through the right atrium (RA), and into the patient's pulmonary artery (PA).

[0085] As discussed herein, the elongated member 26 may include one or more separate lumens extending therein. For example, it can be understood that the elongated member 26 may include a first inflatable lumen 37 ( Figure 3 As shown), the first expansion lumen can extend from the first expandable member 30 and is in fluid communication with the pump 18, which in turn is in fluid communication with the brine reservoir 20. Additionally, as discussed herein, the elongated member 26 may include a second expansion lumen 38 (…). Figure 3As shown), the second expansion lumen can extend from the second expandable member 32 and is in fluid communication with the pump 18, which in turn can be in fluid communication with the brine reservoir 20.

[0086] in addition, Figure 7 It is shown that the elongated member 26 may include one or more additional lumens (in addition to the aforementioned inflatable lumens 37, 38), each of which can be configured to allow a sensing member to extend therein. For example, Figure 7 A sensing member 76 extending within a sensing member lumen 40 is shown, wherein the distal end of the sensing member 76 can be positioned proximal to the first expandable member 30. Figure 7 A sensing member 78 extending within a sensing member lumen 42 is further shown, wherein the distal end of the sensing member 78 can be positioned distal to the first expandable member 30. Figure 7 A sensing member 80 extending within a sensing member lumen 44 is further shown, wherein the distal end of the sensing member 80 can be positioned proximal to the second expandable member 32. Figure 7 A sensing member 82 extending within a sensing member lumen 46 is further shown, wherein the distal end of the sensing member 82 can be positioned distal to the second expandable member 32.

[0087] Figure 7 The sensing components 76 and 78 are shown positioned near the first expandable component 30 in the superior vena cava 36. Figure 7 This further demonstrates that the sensing components 80 and 82 are positioned near the second expandable component 32 within the inferior vena cava 38. From Figure 7 It can be understood that when positioned near the target treatment site, the distal ends of sensing components 76 and 78 can be aligned with the sensing component apertures 66 and 68, respectively. Similarly, from Figure 7 It can be understood that when positioned near the target treatment site, the distal ends of sensing components 80 and 82 can be aligned with sensing component orifices 70 and 72, respectively. In some examples, all sensing components 76, 78, 80, and 82 can be configured to sense changes in one or more physiological parameters / characteristics occurring within the patient 24. Specifically, in some examples, sensing components 76, 78, 80, and 82 may include pressure sensing capabilities. In other words, sensing components 76 / 78 may include pressure sensors designed to measure central venous pressure in the superior vena cava 36, ​​and sensing components 80 / 82 may include pressure sensors designed to measure inferior vena cava pressure in the inferior vena cava 38.

[0088] It is understood that any of the sensing components 76, 78, 80, and 82 may include a variety of different configurations. For example, in some instances, sensing components 76, 78, 80, and 82 may include pressure sensing leads integrated into the control system 14. In other examples, sensing components 76, 78, 80, and 82 may be invasive blood pressure sensors (“IBP sensors”). Additionally, in some examples, each of the sensing components may include a microelectromechanical (MEMS) sensor coupled to an elongated lead. The MEMS pressure sensor may be able to detect minute changes in blood pressure and respond quickly. Furthermore, the MEMS pressure sensor may be able to transmit a signal to the processor 16 indicating that blood pressure has changed in the area where the MEMS sensor is located (e.g., the superior vena cava, inferior vena cava, near the right atrium, etc.).

[0089] In other examples, each of the sensing components 76, 78, 80, and 82 may include a pressure-sensing conduit comprising a fluid-filled lumen, the distal end of which may be open to the surrounding environment. Further, pressure changes in the region surrounding the distal end of the fluid-filled conduit can cause fluid displacement within the conduit. This displacement of the fluid within the fluid-filled conduit can be sensed by the processor 16.

[0090] Additionally, in other examples, each of sensing elements 76, 78, 80, and 82 may include a fiber optic pressure sensing conduit, wherein the fiber optic pressure sensing conduit includes a fiber optic pressure sensor. The fiber optic pressure sensor can sense changes in blood pressure (in the region adjacent to the sensor) based on changes in light intensity around the sensor. This change in light intensity can be sensed by processor 16. In any of the examples discussed herein, sensing elements 76, 78, 80, and 82 may include a variety of sensors. For example, in addition to the sensors discussed above, sensing elements 76, 78, 80, and 82 disclosed herein may include piezoresistive sensors, piezoelectric capacitive sensors, pressure sensors, flow sensors, accelerometers, temperature sensors, etc.

[0091] As discussed herein, if the pumping function of the heart22 is impaired due to, for example, a weakening of the left ventricle, blood may begin to pool therein. Further, blood pooling in the left ventricle may lead to blood pooling in the left atrium. Still further, blood pooling in the left atrium may lead to blood pooling in the pulmonary veins, lungs, and pulmonary arteries. Blood pooling in the pulmonary arteries may further lead to blood pooling in the right ventricle, which over time results in blood pooling (and elevated blood pressure) in the right atrium and adjacent regions (e.g., the superior vena cava and inferior vena cava).

[0092] Furthermore, it can be understood that when blood pools in the right atrium, additional blood can continue to flow into the right atrium from the superior and inferior vena cava. Therefore, in order to mitigate the adverse effects caused by blood pooling in the right atrium (e.g., increased blood volume and elevated blood pressure in the right atrium), it may be desirable to temporarily occlude the superior and / or inferior vena cava (completely or partially).

[0093] Therefore, in some examples, one or more of the sensing elements 76, 78, 80, 82, and / or the assistive medical device 84 can sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. Further, it is understood that any sensor sensing changes in parameters can transmit signals to the processor 16. The processor 16 may include memory and / or algorithms designed to measure, interpret, process, analyze, calculate, evaluate, etc., signals received from the one or more sensing elements 76, 78, 80, 82, and / or the assistive medical device 84. Furthermore, the algorithm can process signals received from the one or more sensing elements 76, 78, 80, 82, and / or the assistive medical device 84, and, if necessary, automatically communicate with the pump 18 to fill or drain fluid from the first expandable member 30 and / or the second expandable member 32. As discussed above, pump 18 can draw fluid from brine reservoir 20 to expand the first expandable member 30 and / or the second expandable member 32.

[0094] It is understood that when sensing components 76, 78, 80, 82 and / or the auxiliary medical device 84 may sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava, inferior vena cava, right atrium, and / or pulmonary artery, expanding the first expandable component 30 and / or the second expandable component 32 can restrict blood flow into the region surrounding the right atrium. Restricting blood flow into the region surrounding the right atrium allows excess blood already accumulated in the right atrium to drain (or partially drain) from the right atrium, thereby reducing the blood pressure accumulated in the heart 22.

[0095] In some instances, system 10 may not need to expand the first expandable member 30 and / or the second expandable member 32 to the extent that expandable members 30, 32 completely block the superior vena cava 36 and the inferior vena cava 38, respectively. More specifically, in some instances, processor 16 may process signals received from one or more of the sensing members 76, 78, 80, 82 and / or the assistive medical device 84, and only partially block the superior vena cava 36 and / or the inferior vena cava 38. In other instances, processor 16 may process signals received from one or more of the sensing members 76, 78, 80, 82 and / or the assistive medical device 84, and completely block the superior vena cava 36 or the inferior vena cava 38, while leaving the other of the superior vena cava 36 and the inferior vena cava 38 open or only partially blocked. It is understood that the processor 16 may include an algorithm designed to analyze physiological parameters of changes occurring in the superior vena cava, inferior vena cava, right atrium, and / or pulmonary artery to determine the extent to which the first expandable member 30 and / or the second expandable member 32 should be blocked (if necessary).

[0096] It should be noted that the physiological parameters discussed above, which can be processed by processor 16 to assess the degree to which the first expandable member 30 and / or the second expandable member 32 should be occluded, are not limited to blood pressure in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. More precisely, processor 16 can assess blood flow, blood pressure, cardiac output, stroke volume, heart rate, maximum arterial pressure (MAP), motion of the inferior vena cava, motion of the superior vena cava, respiratory cycle, volume in the inferior vena cava, volume in the superior vena cava, etc.

[0097] Furthermore, in some examples, the algorithm utilized by the processor 16 may include assessing blood pressure readings in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery for a specific patient, wherein the algorithm may further utilize lookup tables or artificial intelligence algorithms to determine the extent to which the first expandable member 30 and / or the second expandable member 32 should be blocked for that specific patient at a given time point.

[0098] Furthermore, in some examples, the control system 14 may also be coupled to a sensor that provides the processor 16 with the patient's ECG. In this case, the degree to which the first expandable member 30 and / or the second expandable member 32 should be blocked for that particular patient at a given time point can be determined using the phase of the cardiac cycle for that specific patient (e.g., the occlusion duty cycle can be matched with the characteristic timing of the ECG).

[0099] As discussed above, the timing of the inflation or deflation of the first expandable member 30 may differ from the timing of the inflation or deflation of the second expandable member 32. In other words, the inflation or deflation of the first expandable member 30 may be asynchronous with that of the second expandable member 32. Allowing the inflation or deflation of the first expandable member 30 to be asynchronous with that of the second expandable member 32 allows for minimal impact on cerebral blood flow while maintaining overall mean arterial pressure, without increasing renal or hepatic venous pressure or reducing cardiac load. The inflation or deflation of the first expandable member 30 and the second expandable member 32 may be actuated intermittently, continuously, synchronously, asynchronously, individually, or automatically based on various physiological parameters (e.g., blood pressure, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal venous pressure).

[0100] Figure 8 Another example medical device 112 that can be used with the system 10 described herein is shown. Figure 8 The medical device 112 shown may be similar in form and function to Figure 1 The medical device 12 shown. For example, the medical device 112 may include a first expandable member 130 and a second expandable member 132 disposed on an elongated member 126. In some examples, the distal end of the first expandable member 130 may be spaced from the proximal end of the second expandable member 132 by about 2” to about 25”, or about 8” to about 22”, or about 12” to about 18”, or about 15”. The second expandable member 132 may be positioned distal to the first expandable member 130. In some instances, each of the first expandable member 130 and the second expandable member 132 may be referred to as an expandable medical balloon. The first expandable member 130 may include a distal end and a proximal end. Both the distal end and the proximal end of the first expandable member 130 may be coupled to the elongated member 126. Further, the second expandable member 132 may include a distal end and a proximal end. Both the distal end and the proximal end of the second expandable member 132 may be coupled to the elongated member 126.

[0101] Figure 8 This further demonstrates that the proximal end of the elongated member 126 can be connected to the connector 128. (As for...) Figure 11 As described in more detail herein, connector 128 may include one or more ports that are in fluid communication with control system 14 and / or saline reservoir 20. Additionally, as will be described in more detail herein, connector 128 may include one or more ports that allow insertion of one or more medical devices (e.g., assistive medical devices).

[0102] It can be further understood that, while in some examples, the elongated member 126 may pass through the expandable member 132 to form a distal end member of the medical device 112, in other examples, the medical device 112 may include a separate end member attached (e.g., coupled) to the distal waist of the expandable member 132 and / or also attached (e.g., coupled) to the elongated member 126. In other words, in some examples, the elongated member 126 itself may form the distal end of the medical device 112; however, in other examples, a separate end member may be attached to the expandable member 132, the elongated member 126, or both the expandable member 132 and the elongated member 126 to form the distal end of the medical device 112.

[0103] Figure 9 Showed along Figure 8 The cross section of the elongated member 26 is taken from line 9-9. Figure 9 An elongated member 126 may include one or more separate lumens extending therein. For example, the elongated member 126 may include a guidewire and sensing member combination lumen 134. The guidewire and sensing member combination lumen 134 may extend from the proximal end of the elongated member 126 to the distal end of the elongated member 126. In some examples, the diameter of the guidewire lumen 134 may be about 0.005” to about 0.040”, or about 0.010” to about 0.030”, or about 0.015” to about 0.025”, or about 0.018” to about 0.023”, or about 0.021”.

[0104] It is understood that during a medical procedure, the distal end of the elongated member 126 can travel on a guidewire, which can pass through the guidewire and sensing member combination lumen 134 and exit the medical device 112 through the port of connector 128. In other words, the guidewire and sensing member combination lumen 134 allows the medical device 112 to travel on the guidewire (previously positioned within the patient) to a treatment site (e.g., the heart) within the patient. As will be described in more detail below, after the medical device 112 has traveled on the guidewire (previously positioned within the patient) to the treatment site, the guidewire can be removed from the patient, where the guidewire and sensing member combination lumen 134 can be used to allow the sensing member to pass through to a position near the treatment site.

[0105] Figure 9 Further illustration shows that the elongated member 126 may include a first expansion lumen 137a and a second expansion lumen 138a, each of which may be in fluid communication with the pump 18 (which in turn may be in fluid communication with the brine reservoir 20). In some examples, the first expansion lumen 137a may be in fluid communication with the first expandable member 130. It is understood that brine from the brine reservoir 20 may pass through the first expansion port on the connector 128 ( Figure 11As shown), it passes through the first expansion lumen 137a and enters the first expandable member 130 to cause the first expandable member 130 to expand or collapse. In some examples, the diameter of the first expansion lumen 137a may be about 0.010” to about 0.045”, or about 0.015” to about 0.040”, or about 0.020” to about 0.036”, or about 0.026” to about 0.034”, or about 0.032”. Similarly, in some examples, the second expansion lumen 138a may be in fluid communication with the second expandable member 132. It is understood that brine from the brine reservoir 20 may pass through the second expansion port on the connector 128 ( Figure 11 (As shown), it passes through the second inflatable lumen 138a and enters the second expandable member 132 to cause the second expandable member 132 to expand or collapse. In some examples, the diameter of the second inflatable lumen 138a may be about 0.010” to about 0.045”, or about 0.015” to about 0.040”, or about 0.020” to about 0.036”, or about 0.026” to about 0.034”, or about 0.032”.

[0106] Figure 9 Further illustration shows that the elongated member 26 may include a lumen 140 and a guidewire and sensing combination lumen 134, each configured to allow the sensing member to extend therein. For example, Figure 9 A sensing element lumen 140 is shown, which can be designed to allow the sensing element to extend through the elongated member 126 to a location such that the sensing element is proximal to the first inflatable balloon 130 and within the superior vena cava. Figure 9 Further illustrated is a guidewire and sensing element combination lumen 134, which can be designed to allow the sensing element to extend through the elongated member 126 to a location such that the sensing element extends from the distal end of the elongated member 126 to a location distal to the second inflatable balloon 132 within the inferior vena cava. In some examples, the diameters of the guidewire combination lumen and the sensing element lumen 140 may be approximately 0.005” to approximately 0.040”, or approximately 0.010” to approximately 0.030”, or approximately 0.015” to approximately 0.025”, or approximately 0.018” to approximately 0.023”, or approximately 0.021”.

[0107] Figure 9Further illustration shows that the elongated member 126 may include a working channel 148 (e.g., a working lumen). In some examples, the working channel 148 may extend from the proximal end of the elongated member 126 to the distal end of the elongated member 126. In other examples, the working channel 148 may extend from the proximal end of the elongated member 126 to a location proximal to the distal end of the elongated member 126. For example, the working channel 148 may extend from the proximal end of the elongated member 126 to a location adjacent to the distal end of the first expandable member 130. As will be described in more detail below, the medical device 112 may be designed to allow an auxiliary medical device (e.g., a diagnostic device, a thermodilution catheter, etc.) to pass through the connector 128, through the working channel 148, through an opening in the wall of the elongated member 126, and into the patient's right atrium and / or pulmonary artery. In some examples, the diameter of the working channel 148 may be about 0.095” to about 0.130”, or about 0.100” to about 0.125”, or about 0.105” to about 0.115”, or about 0.108” to about 0.112”, or about 0.110”.

[0108] In some examples, Figure 9 The wall thickness between adjacent lumens 134, 137a, 138a, 140, and 148 of the elongated member 126 shown may be about 0.0015” to about 0.0085”, or about 0.0025” to about 0.0075”, or about 0.0035” to about 0.0065”, or about 0.0045” to about 0.0055”, or about 0.0050”.

[0109] Figure 10 Showed along Figure 8 Another example cross section of the elongated member 126 taken from line 9-9. Figure 10 The elongated member 126 is shown to include a guidewire and sensing assembly lumen 134, a first inflation lumen 137b, a second inflation lumen 138b, and a sensing member lumen 140. However, Figure 10 As shown, in some examples, the cross-sectional shape of the first inflatable lumen 137b and / or the second inflatable lumen 138b can be oval. However, this is not intended to be limiting. It is conceivable that the cross-sectional shape of the first inflatable lumen 137b and / or the second inflatable lumen 138b can be square, triangular, rectangular, polygonal, a combination thereof, or any other suitable geometry.

[0110] In some examples, Figure 10The wall thickness between adjacent lumens 134, 137b, 138b, 140, and 148 of the elongated member 126 shown may be about 0.0015” to about 0.0085”, or about 0.0025” to about 0.0075”, or about 0.0035” to about 0.0065”, or about 0.0045” to about 0.0055”, or about 0.0050”.

[0111] Figure 11 An example connector 148 (e.g., a manifold) of the medical device 112 is shown. Figure 11 The diagram shows that connector 128 may include five separate access ports 150, 152, 154, 156, and 164 (e.g., orifices, openings, etc.). Although Figure 11 The diagram shows that connector 128 includes five access ports 150, 152, 154, 156, and 164, but it is understood that connector 128 may include one, two, three, four, five, six, seven, eight, nine, ten, or more access ports.

[0112] Figure 11 Furthermore, connector 148 may include a guidewire and sensing component combination port 150. The guidewire and sensing component combination port 150 may be in fluid communication with the aforementioned guidewire and sensing component combination lumen 134. The guidewire and sensing component combination port 150 may allow a guidewire to pass through and be inserted into the guidewire and sensing component combination lumen 134. As described above, after the medical device 112 has advanced along the guidewire to the target treatment site, the guidewire can be removed from the guidewire and sensing component combination lumen 134, wherein the sensing component may pass through the guidewire and sensing component combination port 150 and enter the guidewire and sensing component combination lumen 134.

[0113] Figure 11 It is further shown that connector 148 may include a first expansion port 152. The first expansion port 152 may be in fluid communication with the aforementioned first expansion lumens 137a, 137b. The first expansion port 152 may allow brine (or other expansion medium) to pass through elongated member 126 and enter the first expandable member 130. Figure 11 It is further shown that connector 148 may include a second expansion port 154. The second expansion port 154 may be in fluid communication with the aforementioned second expansion lumens 138a, 138b. The second expansion port 154 may allow brine (or other expansion medium) to pass through elongated member 126 and enter the second expandable member 132.

[0114] Figure 11 It is further shown that connector 48 may include sensing element port 156 and guide wire and sensing combination port 150, each configured to allow the sensing element to extend therein. For example, Figure 11This demonstrates that the sensing component port 156 can be in fluid communication with the sensing component cavity 140.

[0115] Figure 11 Furthermore, it is shown that connector 128 may include a working channel port 164 which may be in fluid communication with working channel 148. Working channel port 164 may allow an assistive medical device (e.g., a diagnostic medical device, a thermodilution catheter, etc.) to pass through connector 128 and enter working channel 148, wherein the assistive medical device may ultimately pass through an opening in the wall of elongated member 126 and enter the patient's right atrium and / or pulmonary artery.

[0116] It is understood that each of the individual access ports 150, 152, 154, 156, and 164 of connector 128 may include a threaded region that allows a user to attach a medical device to the threaded region. For example, the threaded regions on each of the first inflation port 152 and the second inflation port 154 may allow a user to attach connector 128 to pump 18 and / or saline reservoir 20, wherein pump 18 and saline reservoir 20 may be used to expand or retract the first expandable member 130 and / or the second expandable member 132.

[0117] Figure 12 Showing Figure 8 A detailed view of a portion of the medical device 112 shown. For example, Figure 8 The first expandable member 130 is shown on the elongated member 126. Figure 8 The medical device 126 is shown to include one or more openings positioned along the elongated member 126. In some instances, these one or more openings positioned along the elongated member may be located near the first expandable member 130. For example, Figure 12 The medical device 126 is shown to include a sensing element orifice 166 located proximal to a first expandable member 130. The orifice 166 may extend through the wall of the elongated member 126. Furthermore, it is understood that the orifice 166 may be in fluid communication with the sensing element lumen 140 described herein. It is contemplated that the shape of the sensing element orifice 166 may be square, triangular, rectangular, oval, polygonal, a combination thereof, or any other suitable geometry. Figure 12 The medical device 126 is further shown to include one or more marker strips 167 positioned below the first expandable member 130 to assist in placing the first expandable member 130 at the target treatment site.

[0118] Furthermore, as described herein, in some examples, the sensing member apertures 166 described herein may each extend through the wall of the elongated member 26. However, in other examples, it is conceivable that the medical device 12 may include a membrane extending along the outer surface of the elongated member 26, wherein the membrane extends over the sensing member apertures 166. In these examples, it is understood that the membrane covering the sensing member apertures 166 may be substantially flush with the outer surface of the elongated member 26. Furthermore, the membrane extending over the sensing member apertures 166 may allow a sensing member lumen 156 in fluid communication with the sensing member apertures 166 to be filled with fluid (e.g., the membrane may maintain the fluid within a fluid column defined by the sensing member lumen), wherein the fluid-filled lumen may be in communication with a pressure sensor of the medical device system 12. It is understood that force changes occurring along the membrane of the sensing member apertures 166 can be transmitted to a pressure sensor located in the medical device system 10 through its corresponding fluid-filled sensing member lumen 156. The pressure sensor can then send a signal to the processor 16 of the control system 14 in response to a pressure change occurring at the membrane of the sensing component orifice 166.

[0119] Figure 12 Further illustration shows that the medical device 126 may include a working channel orifice 170 located distal to the first expandable member 130. The orifice 170 may extend through the wall of the elongated member 126. Further, it is understood that the orifice 170 may be in fluid communication with the working channel 148 described herein. Therefore, it is further understood that the working channel orifice 170 may allow an auxiliary medical device (e.g., a diagnostic catheter, a thermodilution catheter, etc.) already inserted in the connector 128 and passing through the working channel 148 to pass through the wall of the elongated member 126, wherein the auxiliary medical device may extend away from the medical device 126 to access other parts of the patient's anatomy. In some instances, a thermodilution catheter may be inserted in the connector 128, passing through the working channel 148, through the working channel orifice 170, and extending away from the medical device 126 to access the patient's right atrium and / or pulmonary artery. It is conceivable that other auxiliary medical devices (besides thermodilution catheters) may pass through the working channel 148 to access a portion of the patient's anatomy.

[0120] Figure 13 Showing Figure 8 A detailed view of a portion of the medical device 112 shown. For example, Figure 13 A second expandable member 132 is shown on the elongated member 126. Figure 13 A guidewire and sensing component combination lumen 134 extending within an elongated member 126 is shown. As discussed herein, the guidewire and sensing component combination lumen 134 allows both the guidewire and the sensing component to extend through it.

[0121] Figure 14The medical device 112 is shown after being advanced to a target treatment site adjacent to the heart 22 of the patient 24. The medical device 112 can travel on a guidewire extending through the lumen 134 of the guidewire and sensing component assembly described herein. After being advanced to... Figure 14 After reaching the target treatment site, the guidewire can be removed, thereby allowing the sensing component to be advanced through the guidewire and sensing component combined lumen 134. Figure 14 A first expandable member 130 located in the superior vena cava 36 and a second expandable member 132 located in the inferior vena cava 138 are further shown. Although Figure 14 The illustration shows the second expandable member 132 positioned within the inferior vena cava; however, in other examples, it is conceivable that the second expandable member 132 could be positioned near the renal artery or renal vein. Furthermore, Figure 14 An assistive medical device 184 (e.g., a diagnostic medical device, a thermodilution catheter, an assistive sensing component, etc.) is shown, which extends within a working channel 148, through a working channel orifice 170, through the right atrium (RA), and into the patient's pulmonary artery (PA).

[0122] As discussed herein, the elongated member 126 may include one or more separate lumens extending therein. For example, it can be understood that the elongated member 126 may include a first inflatable lumen 137 ( Figure 9 As shown), the first expansion lumen can extend from the first expandable member 130 and is in fluid communication with the pump 18 (which in turn can be in fluid communication with the brine reservoir 20). Additionally, as discussed herein, the elongated member 126 may include a second expansion lumen 138 ( Figure 9 As shown), the second expansion lumen can extend from the second expandable member 132 and is in fluid communication with the pump 18 (which in turn can be in fluid communication with the brine reservoir 20).

[0123] in addition, Figure 14 It is shown that the elongated member 126 may include one or more additional lumens (in addition to the aforementioned inflatable lumen), which can be configured to allow a sensing member to extend therein. For example, Figure 14 A sensing member 176 extending within a sensing member lumen 140 is shown, wherein the distal end of the sensing member 176 can be positioned proximal to the first expandable member 130. Figure 14 It is understood that when positioned near the target treatment site, the distal end of the sensing member 176 can be aligned with the sensing member aperture 166 described herein. Furthermore, Figure 14A sensing member 78 extending within a guidewire and sensing member combination lumen 134 is shown, wherein the distal end of the sensing member 182 can extend from the distal end of the elongated member 126, such that the distal end of the sensing member 182 is positioned distal to the second expandable member 132.

[0124] Figure 14 The sensor 176 is shown positioned proximal to the first expandable member 130 in the superior vena cava 36. Figure 14 Further illustration shows sensing member 182 positioned distal to the second expandable member 132 within the inferior vena cava 38. In some examples, sensing members 176 and 182 can both be configured to sense changes in one or more physiological parameters / characteristics occurring within the patient 24. Specifically, in some examples, sensing members 176 and 182 may include pressure sensing capabilities. In other words, sensing members 176 and 182 may include pressure sensors designed to measure central venous pressure within the superior vena cava 36, ​​and pressure sensors designed to measure inferior vena cava pressure within the inferior vena cava 38.

[0125] It is understood that any of the sensing components 176 and 182 may include a variety of different configurations. For example, in some instances, sensing components 176 and 182 may include pressure sensing leads integrated into the control system 14. In other examples, sensing components 176 and 182 may be invasive blood pressure (IBP) sensors. For example, in some instances, each of the sensing components may include a microelectromechanical (MEMS) sensor coupled to an elongated lead. The MEMS pressure sensor may be able to detect minute changes in blood pressure and respond quickly. Furthermore, the MEMS pressure sensor may be able to transmit a signal to the processor 16 indicating that blood pressure has changed in the area where the MEMS sensor is located (e.g., the superior vena cava, inferior vena cava, or near the right atrium).

[0126] In other examples, each of the sensing components 176, 182 may include a pressure-sensing conduit comprising a fluid-filled lumen, the distal end of which may be open to the surrounding environment. Further, pressure changes in the region surrounding the distal end of the fluid-filled conduit can cause displacement of the fluid within the conduit. This displacement of the fluid within the fluid-filled conduit can be sensed by the processor 16.

[0127] Additionally, in other examples, each of sensing elements 176, 182 may include a fiber optic pressure sensing conduit, wherein the fiber optic pressure sensing conduit includes a fiber optic pressure sensor. The fiber optic pressure sensor can sense changes in blood pressure (in the region adjacent to the sensor) based on changes in light intensity around the sensor. This change in light intensity can be sensed by processor 16. In any of the examples discussed herein, the sensing element may include a variety of sensors. For example, in addition to the sensors discussed above, the sensing elements disclosed herein may include piezoresistive sensors, piezoelectric capacitive sensors, pressure sensors, flow sensors, accelerometers, temperature sensors, etc.

[0128] As discussed herein, if the pumping function of the heart22 is impaired due to, for example, a weakening of the left ventricle, blood may begin to pool therein. Further, blood pooling in the left ventricle may lead to blood pooling in the left atrium. Still further, blood pooling in the left atrium may lead to blood pooling in the pulmonary veins, lungs, and pulmonary arteries. Blood pooling in the pulmonary arteries may further lead to blood pooling in the right ventricle, which over time results in blood pooling (and elevated blood pressure) in the right atrium and adjacent regions (e.g., the superior vena cava and inferior vena cava).

[0129] Furthermore, it can be understood that when blood pools in the right atrium, additional blood can continue to flow into the right atrium from the superior and inferior vena cava. Therefore, in order to mitigate the adverse effects caused by blood pooling in the right atrium (e.g., increased blood volume and elevated blood pressure in the right atrium), it may be desirable to temporarily occlude the superior and / or inferior vena cava (completely or partially).

[0130] Therefore, in some examples, one or more of the sensing elements 176, 182 and / or the assistive medical device 184 can sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. Further, it is understood that any sensor sensing changes in parameters can transmit signals to the processor 16. The processor 16 may include memory and / or algorithms designed to measure, interpret, process, analyze, calculate, evaluate, etc., the signals received from the one or more sensing elements 176, 182, and / or the assistive medical device 184. Furthermore, the algorithm can process the signals received from the one or more sensing elements 176, 182, and / or the assistive medical device 184, and, if necessary, communicate with the pump 18 to fill or drain fluid from the first expandable member 130 and / or the second expandable member 132. As discussed above, pump 18 can draw fluid from brine reservoir 20 to expand the first expandable member 130 and / or the second expandable member 132.

[0131] It is understood that when sensing members 176, 182 and / or the auxiliary medical device 184 may sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery, expanding the first expandable member 130 and / or the second expandable member 132 can restrict blood flow into the region surrounding the right atrium. Restricting blood flow into the region surrounding the right atrium allows excess blood already accumulated in the right atrium to drain (or partially drain) from the right atrium, thereby reducing the blood pressure accumulated in the heart 22.

[0132] In some instances, system 10 may not need to expand the first expandable member 130 and / or the second expandable member 132 to the extent that expandable members 130, 132 completely block the superior vena cava 36 and the inferior vena cava 38, respectively. More specifically, in some instances, processor 16 may process signals received from one or more of the sensing members 176, 182 and / or the assistive medical device 184, and only partially block the superior vena cava 36 and / or the inferior vena cava 38. In other instances, processor 16 may process signals received from one or more of the sensing members 176, 182 and / or the assistive medical device 184, and completely block the superior vena cava 36 or the inferior vena cava 38, while leaving the other of the superior vena cava 36 and the inferior vena cava 38 open or only partially blocked. It is understood that the processor 16 may include an algorithm designed to analyze physiological parameters of changes occurring in the superior vena cava, inferior vena cava, right atrium, and / or pulmonary artery to determine the extent to which the first expandable member 130 and / or the second expandable member 132 should be blocked (if necessary).

[0133] It should be noted that the physiological parameters discussed above, which can be processed by processor 16 to assess the degree to which the first expandable member 130 and / or the second expandable member 132 should be occluded, are not limited to blood pressure in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. More precisely, processor 16 can assess blood flow, blood pressure, cardiac output, stroke volume, heart rate, maximum arterial pressure (MAP), motion of the inferior vena cava, motion of the superior vena cava, respiratory cycle, volume in the inferior vena cava, volume in the superior vena cava, etc.

[0134] Furthermore, in some examples, the algorithm utilized by the processor 16 may include assessing blood pressure readings in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery for a specific patient, wherein the algorithm may further utilize lookup tables or artificial intelligence algorithms to determine the extent to which the first expandable member 130 and / or the second expandable member 132 should be blocked for that specific patient at a given time point.

[0135] Furthermore, in some examples, the control system 14 may also be coupled to a sensor that provides the processor 16 with the patient's ECG. In this case, the degree to which the first expandable member 130 and / or the second expandable member 132 should be blocked for that particular patient at a given time point can be determined using the phase of the cardiac cycle for that specific patient (e.g., the occlusion duty cycle can be matched with the characteristic timing of the ECG).

[0136] As discussed above, the timing of the inflation or deflation of the first expandable member 130 may differ from the timing of the inflation or deflation of the second expandable member 132. In other words, the inflation or deflation of the first expandable member 130 may be asynchronous with that of the second expandable member 132. Allowing the inflation or deflation of the first expandable member 130 to be asynchronous with that of the second expandable member 132 allows for minimal impact on cerebral blood flow while maintaining overall mean arterial pressure, without increasing renal or hepatic venous pressure or reducing cardiac load. The inflation or deflation of the first expandable member 230 and the second expandable member 232 may be actuated intermittently, continuously, synchronously, asynchronously, individually, or automatically based on various physiological parameters (e.g., blood pressure, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal venous pressure).

[0137] Figure 15 Another example medical device 212 that can be used with the system 10 described herein is shown. Figure 15 The illustrated medical device 212 may be similar in form and function to other medical devices described herein. For example, the medical device 212 may include a first expandable member 230 disposed on a first elongated member 226 and a second expandable member 232 disposed on a second elongated member 227. The second expandable member 232 may be positioned distal to the first expandable member 230. In some instances, each of the first expandable member 230 and the second expandable member 232 may be referred to as an expandable medical balloon. The first expandable member 230 may include a distal end and a proximal end. Both the distal and proximal ends of the first expandable member 230 may be connected to the elongated member 226. Further, the second expandable member 232 may include a distal end and a proximal end. Both the distal and proximal ends of the second expandable member 232 may be connected to the elongated member 227.

[0138] Figure 15 It is further shown that the first elongated member 226 and the second elongated member 227 can be separate, different shafts, wherein the second elongated member 227 can extend within the lumen of the first elongated shaft 226. Figures 16 to 17The diagram illustrates a second elongated member 227 extending within the lumen of the first elongated member 226. Accordingly, it is understood that the second elongated member 227 can be translated (e.g., displaced, moved, or extended) relative to the first elongated member 226. In other words, a user can adjust the spacing between the first expandable member 230 and the second expandable member 232 by sliding the second elongated member 227 within the lumen of the first elongated member 226. In some examples, the distal end of the first expandable member 30 may be spaced from the proximal end of the second expandable member 32 by about 2” to about 25”, or about 8” to about 22”, or about 12” to about 18”, or about 15”.

[0139] Figure 15 This further demonstrates that the proximal end of each of the first elongated member 226 and the second elongated member 227 can be coupled to a joint. For example, Figure 15 The diagram shows that the proximal end of the first elongated member 226 can be coupled to the first connector 228, and the proximal end of the second elongated member 227 can be coupled to the second connector 229. Each of connectors 228 and 229 may include one or more ports that are in fluid communication with the control system 14 and / or the saline reservoir 20. Additionally, each of connectors 228 and 229 may include one or more ports that allow insertion of one or more medical devices (e.g., assistive medical devices).

[0140] It can be further understood that connectors 228 and 229 can be used to translate the second expandable member 232 relative to the first expandable member 230. In other words, moving connector 229 relative to connector 248 allows the second expandable member 232 to translate relative to the first expandable member 230, thereby allowing the user to adjust the distance between the second expandable member 232 and the first expandable member 230 (e.g., increase or decrease this distance). In some examples, the second expandable member 232 may be able to extend away from the first expandable member 230 by about 2” to about 25”, or about 8” to about 22”, or about 12” to about 18”, or about 15”. It can be understood that the user can manipulate connectors 228 and 229 such that the first expandable member 230 is positioned in the superior vena cava and the second expandable member 232 is positioned in the inferior vena cava. In other examples, the user can manipulate connectors 228 and 229 such that the first expandable member 230 is positioned in the superior vena cava and the second expandable member 232 is positioned near the renal vein.

[0141] In some examples, the elongated member 227 may pass through the expandable member 232 and extend distally beyond the expandable member 232 to define the distal end of the medical device 21. In other examples, the medical device 212 may include a separate end member attached (e.g., coupled) to the distal waist of the expandable member 232 and / or also attached (e.g., coupled) to the elongated member 227. In other words, in some examples, the elongated member 227 may form the distal end of the medical device 212 on its own; however, in other examples, a separate end member may be attached to the expandable member 232, the elongated member 227, or both the expandable member 232 and the elongated member 227 to form the distal end of the medical device 212.

[0142] Figure 16 Showed along Figure 15 The cross-section of medical device 212 is taken from line 16-16. As described herein, Figure 16 The second elongated member 227 extends within the working channel 248 of the first elongated member 226. In some examples, the diameter of the working channel 248 may be about 0.090” to about 0.145”, or about 0.100” to about 0.135”, or about 0.115” to about 0.125”, or about 0.116” to about 0.120”, or about 0.118”.

[0143] in addition, Figure 16 The second elongated member 227 is shown to include a guidewire and sensing member combination lumen 234. The guidewire and sensing member combination lumen 234 can extend from the proximal end of the second elongated member 227 to the distal end of the second elongated member 227. In some examples, the diameter of the sensing and guidewire combination lumen 234 can be about 0.010” to about 0.045”, or about 0.015” to about 0.035”, or about 0.019” to about 0.029”, or about 0.022” to about 0.027”, or about 0.025”.

[0144] Understandably, during a medical procedure, the distal end of the elongated member 227 can travel on a guidewire, through which the guidewire and sensing member combination lumen 234 can exit the medical device 212 via the port of connector 249. In other words, the guidewire and sensing member combination lumen 234 allows the medical device 212 to travel on the guidewire (previously positioned within the patient) to a treatment site (e.g., the heart) within the patient. As will be described in more detail below, after the medical device 212 has traveled on the guidewire (previously positioned within the patient) to the treatment site, the guidewire can be removed from the patient, where the guidewire and sensing member combination lumen 234 can be used to allow the sensing member to pass through to a position near the treatment site.

[0145] Figure 16Further illustration shows that the first elongated member 226 may include a first inflatable lumen 237 which may be in fluid communication with the pump 18 (which in turn may be in fluid communication with the brine reservoir 20). In some examples, the first inflatable lumen 237 may be in fluid communication with the first expandable member 230. It is understood that brine from the brine reservoir 20 may pass through the first inflatable port on the connector 228, through the first inflatable lumen 237, and into the first expandable member 230 to cause the first expandable member 230 to expand or collapse. In some examples, the diameter of the first inflatable lumen 237 may be about 0.010” to about 0.045”, or about 0.015” to about 0.035”, or about 0.019” to about 0.029”, or about 0.022” to about 0.027”, or about 0.025”.

[0146] In some examples, Figure 9 The wall thickness between adjacent lumens 237 and 240 of the elongated member 126 shown may be about 0.0015” to about 0.0085”, or about 0.0025” to about 0.0075”, or about 0.0035” to about 0.0065”, or about 0.0045” to about 0.0055”, or about 0.0050”.

[0147] Figure 16 Further illustration shows that the second elongated member 227 may include a second inflatable lumen 238, which may be in fluid communication with the pump 18 (which in turn may be in fluid communication with the brine reservoir 20). In some examples, the second inflatable lumen 238 may be in fluid communication with the second expandable member 232. It is understood that brine from the brine reservoir 20 may pass through the second inflatable port on the connector 229, through the second inflatable lumen 238, and into the second expandable member 232 to cause the second expandable member 232 to expand or collapse. Figure 16 As shown, the second inflatable lumen 238 may include a crescent shape (e.g., a curved shape that is wider in the middle than at its ends). This is not intended to be limiting. It is conceivable that the second inflatable lumen 238 may include a square, triangle, oval, rectangular, polygonal, combination thereof, or any other suitable geometry.

[0148] Figure 16 Further illustration shows that the first elongated member 226 may include a lumen 240 and a guidewire and sensing combination lumen 234, each configured to allow the sensing member to extend therein. For example, Figure 16A sensing element lumen 240 is shown, which can be designed to allow the sensing element to extend through the elongated member 226 to a location such that the sensing element is near the first inflatable balloon 230 and within the superior vena cava. In some examples, the diameter of the sensing element lumen 240 can be about 0.010” to about 0.045”, or about 0.015” to about 0.035”, or about 0.019” to about 0.029”, or about 0.022” to about 0.027”, or about 0.025”, as discussed herein. Figure 16 Further illustrated is a guidewire and sensing element combination lumen 234, which can be designed to allow the sensing element to extend through the second elongated member 227 to a location such that the sensing element extends from the distal end of the elongated member 227 to a location distal to the second dilatant balloon 232 and within the inferior vena cava.

[0149] Figure 17 Showing Figure 15 A detailed view of a portion of the medical device 212 shown. For example, Figure 17 The first expandable member 230 is shown on the elongated member 226. Figure 17 The medical device 226 is shown to include a sensing element aperture 266 positioned along the elongated member 226. In some instances, the sensing element aperture 266 positioned along the elongated member may be located near the first expandable member 230. The aperture 266 may extend through the wall of the elongated member 226. Furthermore, it is understood that the aperture 266 may be in fluid communication with the sensing element lumen 240 described herein. It is contemplated that the shape of the sensing element aperture 266 may be square, triangular, rectangular, oval, polygonal, a combination thereof, or any other suitable geometry.

[0150] Furthermore, as described herein, in some examples, the sensing member apertures 266 described herein may each extend through the wall of the elongated member 226. However, in other examples, it is conceivable that the medical device 212 may include a membrane extending along the outer surface of the elongated member 226, wherein the membrane extends over the sensing member apertures 266. In these examples, it is understood that the membrane covering the sensing member apertures 266 may be substantially flush with the outer surface of the elongated member 226. Furthermore, the membrane extending over the sensing member apertures 266 may allow a sensing member lumen 240 in fluid communication with the sensing member apertures 266 to be filled with fluid (e.g., the membrane may maintain the fluid within a fluid column defined by the sensing member lumen), wherein the fluid-filled lumen may be in communication with a pressure sensor of the medical device system 212. It is understood that force changes occurring along the membrane of the sensing member apertures 266 can be transmitted to a pressure sensor located in the medical device system 10 via its corresponding fluid-filled sensing member lumen 240. The pressure sensor can then send a signal to the processor 16 of the control system 14 in response to a pressure change occurring at the membrane of the sensing component orifice 266.

[0151] Figure 17 Further demonstration Figure 15 A detailed view showing the distal region of medical device 212. As described herein, Figure 17 The second elongated member 227 extends within the working channel 248 of the first elongated member 226. Furthermore, it can be understood that the working channel 248 can be designed to allow an auxiliary medical device (e.g., a thermodilution catheter) to pass through the connector 228 and the working channel 248, wherein the auxiliary medical device can exit the working channel 248 at the distal end of the first elongated member 226. After exiting the working channel 248, the auxiliary medical device can extend into the patient's right atrium and / or pulmonary artery.

[0152] Figure 18 Showing Figure 15 A detailed view of a portion of the medical device 212 shown. For example, Figure 18 A second expandable member 232 is shown, which is disposed on the elongated member 227. Figure 18 A guidewire and sensing component combination lumen 234 extending within an elongated member 227 is shown. As discussed herein, the guidewire and sensing component combination lumen 234 allows both the guidewire and the sensing component to extend through it.

[0153] Figure 19 The medical device 212 is shown after being advanced to a position near the target treatment site 22 of the patient 24, adjacent to the heart 22. The medical device 212 can travel on a guidewire extending through the lumen 234 of the guidewire and sensing component assembly described herein. After being advanced to... Figure 19After the target treatment site is shown, the guidewire can be removed from the guidewire and sensing member combination lumen 234, thereby allowing the sensing member to be advanced through the guidewire and sensing member combination lumen 234. Figure 19 A first expandable member 230 located in the superior vena cava 36 and a second expandable member 232 located in the inferior vena cava 38 are further shown. Although Figure 19 The illustration shows the second expandable member 232 positioned within the inferior vena cava; however, in other examples, it is conceivable that the second expandable member 232 could be positioned near the renal artery or renal vein. Furthermore, Figure 19 An assistive medical device 284 (e.g., a diagnostic medical device, a thermodilution catheter, an assistive sensing component, etc.) is shown, which extends within a working channel 248, exits from the distal end of the first elongated component 226, extends through the right atrium (RA), and enters the patient's pulmonary artery (PA).

[0154] As discussed herein, the elongated member 226 may include one or more separate lumens extending therein. For example, it can be understood that the elongated member 226 may include a first inflatable lumen 237 ( Figure 16 As shown), the first expansion lumen can extend from the first expandable member 230 and is in fluid communication with the pump 18 (which in turn can be in fluid communication with the brine reservoir 20). Additionally, as discussed herein, the elongated member 227 may include an expansion lumen 286 ( Figure 16 As shown), the expansion lumen can extend from the second expandable member 232 and is in fluid communication with the pump 18 (which in turn can be in fluid communication with the brine reservoir 20).

[0155] in addition, Figure 19 It is shown that the elongated member 226 may include one or more additional lumens (in addition to the aforementioned inflatable lumen), which can be configured to allow the sensing member to extend therein. For example, Figure 19 A sensing member 276 extending within a sensing member lumen 240 is shown, wherein the distal end of the sensing member 276 can be positioned proximal to the first expandable member 230. Figure 19 It is understood that the distal end of the sensing member 276 can be aligned with the sensing member aperture 266 described herein. Furthermore, Figure 19 A sensing member 282 extending within a guidewire and sensing member combination lumen 234 is shown, wherein the distal end of the sensing member 282 may extend from the distal end of the elongated member 227, such that the distal end of the sensing member 282 is positioned distal to the second expandable member 232.

[0156] Figure 19 The sensor 276 is shown positioned near the first expandable member 230 in the superior vena cava 36. Figure 19Further illustration shows sensing member 282 positioned distal to second expandable member 232 within inferior vena cava 38. In some examples, sensing members 276, 282 may be configured to sense changes in one or more physiological parameters / characteristics occurring within patient 24. Specifically, in some examples, sensing members 276, 282 may include pressure sensing capabilities. In other words, sensing members 276, 282 may include pressure sensors designed to measure central venous pressure within superior vena cava 36, ​​and sensing members 276, 282 may include pressure sensors designed to measure inferior vena cava pressure within inferior vena cava 38.

[0157] It is understood that any of the sensing components 276 and 282 may include a variety of different configurations. For example, in some instances, sensing components 276 and 282 may include pressure sensing leads integrated into the control system 14. In other examples, sensing components 276 and 282 may include invasive blood pressure (IBP) sensors. For example, in some instances, each of the sensing components may include a microelectromechanical (MEMS) sensor coupled to an elongated lead. The MEMS pressure sensor may be able to detect minute changes in blood pressure and respond quickly. Furthermore, the MEMS pressure sensor may be able to transmit a signal to the processor 16 indicating that blood pressure has changed in the area where the MEMS sensor is located (e.g., the superior vena cava, inferior vena cava, or near the right atrium).

[0158] In other examples, each of sensing elements 276, 282 may include a pressure-sensing conduit comprising a fluid-filled lumen, the distal end of which may be open to the surrounding environment. Further, pressure changes in the region surrounding the distal end of the fluid-filled conduit can cause fluid displacement within the conduit. This displacement of the fluid within the fluid-filled conduit can be sensed by processor 16.

[0159] Additionally, in other examples, each of sensing elements 276, 282 may include a fiber optic pressure sensing conduit, wherein the fiber optic pressure sensing conduit includes a fiber optic pressure sensor. The fiber optic pressure sensor can sense changes in blood pressure (in the region adjacent to the sensor) based on changes in light intensity around the sensor. This change in light intensity can be sensed by processor 16. In any of the examples discussed herein, the sensing element may include a variety of sensors. For example, in addition to the sensors discussed above, the sensing elements disclosed herein may include piezoresistive sensors, piezoelectric capacitive sensors, pressure sensors, flow sensors, accelerometers, temperature sensors, etc.

[0160] As discussed herein, if the pumping function of the heart22 is impaired due to, for example, a weakening of the left ventricle, blood may begin to pool therein. Further, blood pooling in the left ventricle may lead to blood pooling in the left atrium. Still further, blood pooling in the left atrium may lead to blood pooling in the pulmonary veins, lungs, and pulmonary arteries. Blood pooling in the pulmonary arteries may further lead to blood pooling in the right ventricle, which over time results in blood pooling (and elevated blood pressure) in the right atrium and adjacent regions (e.g., the superior vena cava and inferior vena cava).

[0161] Furthermore, it can be understood that when blood pools in the right atrium, additional blood can continue to flow into the right atrium from the superior and inferior vena cava. Therefore, in order to mitigate the adverse effects caused by blood pooling in the right atrium (e.g., increased blood volume and elevated blood pressure in the right atrium), it may be desirable to temporarily occlude the superior and / or inferior vena cava (completely or partially).

[0162] Therefore, in some examples, one or more of the sensing elements 276, 282 and / or the assistive medical device 284 can sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. Further, it is understood that any sensor sensing changes in parameters can transmit signals to the processor 16. The processor 16 may include memory and / or algorithms designed to measure, interpret, process, analyze, calculate, evaluate, etc., the signals received from the one or more sensing elements 276, 282 and / or the assistive medical device 284. Furthermore, the algorithm can process the signals received from the one or more sensing elements 276, 282 and / or the assistive medical device 284 and, if necessary, communicate with the pump 18 to fill or drain fluid from the first expandable member 230 and / or the second expandable member 232. As discussed above, pump 18 can draw fluid from brine reservoir 20 to expand the first expandable member 230 and / or the second expandable member 232.

[0163] It is understood that when sensing components 276, 282 and / or the auxiliary medical device 284 may sense changes in physiological parameters (e.g., changes in blood pressure, cardiac output, stroke volume, blood flow, HR, MAP, etc.) in the region surrounding the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery, expanding the first expandable component 230 and / or the second expandable component 232 can restrict blood flow into the region surrounding the right atrium. Restricting blood flow into the region surrounding the right atrium allows excess blood already accumulated in the right atrium to drain (or partially drain) from the right atrium, thereby reducing the blood pressure accumulated in the heart 22.

[0164] In some instances, system 10 may not need to expand the first expandable member 230 and / or the second expandable member 232 to the extent that expandable members 230, 232 completely block the superior vena cava 36 and the inferior vena cava 38, respectively. More specifically, in some instances, processor 16 may process signals received from one or more of the sensing members 276, 282 and / or the assistive medical device 284, and only partially block the superior vena cava 36 and / or the inferior vena cava 38. In other instances, processor 16 may process signals received from one or more of the sensing members 276, 282 and / or the assistive medical device 284, and completely block the superior vena cava 36 or the inferior vena cava 38, while leaving the other of the superior vena cava 36 and the inferior vena cava 38 open or only partially blocked. It is understood that the processor 16 may include an algorithm designed to analyze physiological parameters of changes occurring in the superior vena cava, inferior vena cava, right atrium, and / or pulmonary artery to determine the extent to which the first expandable member 230 and / or the second expandable member 232 should be blocked (if necessary).

[0165] It should be noted that the physiological parameters discussed above, which can be processed by processor 16 to assess the degree to which the first expandable member 230 and / or the second expandable member 232 should be occluded, are not limited to blood pressure in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery. More precisely, processor 16 can assess blood flow, blood pressure, cardiac output, blood volume, movement of the inferior vena cava, movement of the superior vena cava, respiratory cycle, volume in the inferior vena cava, volume in the superior vena cava, etc.

[0166] Furthermore, in some examples, the algorithm utilized by the processor 16 may include assessing blood pressure readings in the superior vena cava 36, ​​inferior vena cava 38, right atrium, and / or pulmonary artery for a specific patient, wherein the algorithm may further utilize lookup tables or artificial intelligence algorithms to determine the extent to which the first expandable member 230 and / or the second expandable member 232 should be blocked for that specific patient at a given time point.

[0167] Furthermore, in some examples, the control system 14 may also be coupled to a sensor that provides the processor 16 with the patient's ECG. In this case, the degree to which the first expandable member 230 and / or the second expandable member 232 should be blocked for that particular patient at a given time point can be determined using the phase of the cardiac cycle for that specific patient (e.g., the occlusion duty cycle can be matched with the characteristic timing of the ECG).

[0168] As discussed above, the inflation or deflation phase of the first expandable member 230 may differ from the inflation or deflation phase of the second expandable member 232. In other words, the inflation or deflation of the first expandable member 230 may be asynchronous with that of the second expandable member 232. Allowing the inflation or deflation of the first expandable member 230 to be asynchronous with that of the second expandable member 232 allows for minimal impact on cerebral blood flow while maintaining overall mean arterial pressure, without increasing renal or hepatic venous pressure or reducing cardiac workload.

[0169] Figures 20 to 2 Example displays 300, 400, and 500 are shown that can be used with the medical device system 10 described herein. Example displays 300, 400, and 500 can represent the information described herein regarding... Figure 1 The described display 15. In some examples, displays 300, 400, and 500 may include CRT, LED, 3D displays, GUI, or other similar types of displays. Displays 300, 400, and 500 may present information related to the functional and operational parameters of the medical device system 10, the circulatory support devices 12, 112, and 212, and / or the physiological parameters of the patient 24 in a simple format useful to clinicians.

[0170] Displays 300, 400, and 500 can be configured to display one or more visual representations. In some examples, displays 300, 400, and 500 can be configured to include one, two, three, four, five, six, seven, eight, nine, ten, or more visual representations. In other examples, displays 300, 400, and 400 can be configured to include: a first visual representation of a medical device (e.g., an expandable balloon) positioned in a specific anatomical location (e.g., the superior vena cava); a second visual representation of another medical device (e.g., an expandable balloon) positioned in another anatomical location (e.g., the inferior vena cava); a third visual representation of a physiological parameter; and a fourth visual representation of a second physiological parameter. Example physiological parameters that can be displayed in any visual representation on displays 300, 400, and 500 are described in more detail herein. Furthermore, in some examples, the physiological parameters represented in the third visual representation and / or the fourth visual representation can be measured by a first sensor located at a first location near the medical device (e.g., a pulmonary artery catheter, a thermodilution catheter) and / or a second sensor located at a second location near the medical device (e.g., a pulmonary artery catheter, a thermodilution catheter).

[0171] In other examples, displays 300, 400, and 500 may be configured to display a first visual representation of a first medical device positioned in an anatomical location (e.g., superior vena cava), a second visual representation of a second medical device positioned in another anatomical location (e.g., inferior vena cava), a third visual representation of a first physiological parameter, a fourth visual representation of a second physiological parameter, a fifth visual representation of a third physiological parameter, and a sixth visual representation of a fourth physiological parameter. Additionally, in some examples, these physiological parameters may be measured by a sensor located at a first location near the medical device (e.g., pulmonary artery catheter, thermodilution catheter), a second sensor located at a second sensor location near the medical device (e.g., pulmonary artery catheter, thermodilution catheter), a third sensor located at a second location near the medical device (e.g., pulmonary artery catheter, thermodilution catheter), and / or a fourth sensor located at a second location near the medical device (e.g., pulmonary artery catheter, thermodilution catheter).

[0172] As illustrated herein, a visual representation may include anything that can be seen on a display. For example, a visual representation may include visual illustrations, graphic representations, graphic diagrams, depictions, symbols, icons, etc., corresponding to: the patient's anatomical features, the location of the patient's anatomical features, a medical device positioned within the patient's body, the percentage of inflation of a first expandable member and / or a second expandable member positioned at the anatomical location, advanced hemodynamic parameters received from an assistive medical device (e.g., a thermodilution catheter), various physiological parameters (including, but not limited to, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure proximal to the occlusion balloon, superior vena cava pressure distal to the occlusion balloon, inferior vena cava pressure proximal to the occlusion balloon, inferior vena cava pressure distal to the occlusion balloon, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal vein pressure), gradients (e.g., increases and / or decreases) between any values ​​or differences of any physiological parameters disclosed herein, any physiological parameter measurements obtained from the thermodilution catheter, and any combination or temporal pattern of signals corresponding to one or more of the physiological parameters listed herein. It is understood that any of the example displays 300, 400, 500 described herein may be designed to display any one or more visual representations, visual illustrations, graphic representations, symbols, icons, etc., either alone or in any combination with any other visual representation, graphic representation, symbol, icon, etc. described herein.

[0173] Furthermore, additional parameters (e.g., flow rate through pump 18) can be derived by processing any combination or time pattern of signals corresponding to one or more of the parameters listed herein in a time-dependent manner. Furthermore, displays 300, 400, and 500 can indicate whether system 10 is operating normally, whether system 10 has detected a specific problem that may require additional (e.g., non-routine) procedures / adjustments, and / or whether system 10 has detected a specific problem requiring emergency procedures. Additionally, displays 300, 400, and 500 can include information conveying the need for a specific response (e.g., action). For example, displays 300, 400, and 500 may be able to convey information that pump 22 has failed during a medical procedure and needs immediate replacement. Displays 300, 400, and 500 may also convey: in response to changes in the patient's anatomical features, the percentage of inflation of the first expandable member and / or the second expandable member, advanced hemodynamic parameters received from the assistive medical device (e.g., a thermodilution catheter), various physiological parameters (including but not limited to cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure proximal to the occlusion balloon, superior vena cava pressure distal to the occlusion balloon, inferior vena cava pressure proximal to the occlusion balloon, inferior vena cava pressure distal to the occlusion balloon, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal vein pressure, etc.), gradients (e.g., increases and / or decreases) between any values ​​or differences of any physiological parameters disclosed herein, any physiological parameter measurements obtained from the thermodilution catheter, and any combination or temporal pattern of signals corresponding to one or more of the physiological parameters listed herein, indicating a need for further inflation or collapse of the first expandable member and / or the second expandable member.

[0174] It is understood that displays 300, 400, and 500 may be designed to provide a simplified summary of visual information designed to easily convey the status of one or more functional, operational, anatomical, and / or physiological parameters of the medical device system 10 and / or the patient 16. In some examples, the graphical user interface of displays 300, 400, and 500 may allow users to select, input, and control various functions of the medical device system 10. For example, the graphical user interface of displays 300, 400, and 500 may allow users to immediately stop the inflation and / or collapse of the first and / or second expandable member based on feedback received, for example, from one or more sensing elements that may be represented on displays 300, 400, and 500.

[0175] Figure 20 This is a schematic depiction of the example display 300 discussed herein. Figure 20The display 300 is shown to be able to display (e.g., illuminate) one or more of the following: an example arrangement and relative position of one or more anatomical symbols (e.g., icons, visual representations, text, labels, visual alarms, etc.); a graphical display of pressure waveforms; and a graphical display of physiological parameters (e.g., blood pressure, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, and renal vein pressure). As will be discussed in more detail below, one or more of these symbols may be illuminated on the display 300 in a variety of different configurations.

[0176] like Figure 20 As shown, the example display 300 may include a visual representation of the patient's superior vena cava 336 and a visual representation of the patient's inferior vena cava 338. Figure 20 The illustration shows a visual representation of the display 300 potentially including a first expandable member 330 located in the superior vena cava 336 and a visual representation of a second expandable member 332 located in the inferior vena cava 338. It is understood that the first expandable member 330 may represent the first expandable members 30, 130, 230 described herein, and the second expandable member 332 may represent the second expandable members 32, 132, 232 described herein.

[0177] Figure 20 The display 300 further illustrates a visual representation 340 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the superior vena cava (e.g., parameters sensed by sensing members 76, 176, 276 placed proximal to the expandable member located in the superior vena cava). Figure 20 The display 300 is further shown to include a visual representation 342 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the superior vena cava (e.g., parameters sensed by a sensing member 78 located distal to the expandable member located in the superior vena cava). Figure 20 The display 300 is further shown to include a visual representation 344 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the inferior vena cava (e.g., parameters sensed by a sensing member 80 placed proximal to the expandable member located in the inferior vena cava). Figure 20 The display 300 is further shown to include a visual representation 346 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the inferior vena cava (e.g., parameters sensed by sensing members 82, 182, 282 placed proximal to the expandable member located in the inferior vena cava).

[0178] in addition, Figure 20The display 300 may include one or more visual representations 348, 350 of physiological parameters and / or hemodynamic data (e.g., right arterial blood pressure, right ventricular pressure, cardiac output, stroke volume, etc.) sensed by sensing elements 84, 184, 284 placed near the right atrium and / or pulmonary artery. As discussed herein, sensing elements 84, 184, 284 may include a thermodilution catheter.

[0179] Figure 20 The display 300 is further shown to include a visual representation 352 that may include a blood pressure waveform, wherein the blood pressure waveform conveys the blood pressure value of the right atrium over time. The visual representation 352 may further include a visual representation 356 of the minimum blood pressure of the right atrium over a given time period, a visual representation 358 of the maximum blood pressure of the right atrium over a given time period, and a visual representation 360 of the average blood pressure of the right atrium over a given time period.

[0180] Figure 20 The display 300 is further shown to include a visual representation 354 that may include a blood pressure waveform, wherein the blood pressure waveform conveys the blood pressure value of the pulmonary artery over time. The visual representation 354 may further include a visual representation 362 of the minimum blood pressure of the pulmonary artery over a given time period, a visual representation 364 of the maximum blood pressure of the pulmonary artery over a given time period, and a visual representation 366 of the average blood pressure of the pulmonary artery over a given time period.

[0181] Figure 20 Visual representations of blood pressure waveforms including those of the right atrium and pulmonary artery are shown in 352 and 354, respectively. However, this is not intended to be limiting. Rather, it is conceivable that visual representations 352 and 354 may include visual representations of various physiological parameters, including but not limited to cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal vein pressure, combinations thereof, or any other physiological parameter.

[0182] Figure 21 This is a schematic depiction of the example display 400 discussed herein. Figure 21The illustration shows an example arrangement and relative position of one or more visual representations (e.g., visual diagrams, graphic representations, illustrations, depictions, symbols, icons, text, logos, visual alerts, charts, etc.) of one or more anatomical features, anatomical locations, and / or physiological parameters (e.g., blood pressure, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal vein pressure) that the display 400 can display (e.g., illuminate). As will be discussed in more detail below, one or more of these visual representations can be illuminated on the display 400 in a variety of different configurations.

[0183] like Figure 21 As shown, the example display 400 may include a visual representation of the patient's superior vena cava 436 and a visual representation of the patient's inferior vena cava 438. Figure 21 The illustration shows a visual representation of a first expandable member 430 located in the superior vena cava 436 and a visual representation of a second expandable member 432 located in the inferior vena cava 438. It is understood that the first expandable member 430 may represent the first expandable members 30, 130, 230 described herein, and the second expandable member 432 may represent the second expandable members 32, 132, 232 described herein.

[0184] Figure 21 The display 400 further illustrates a visual representation 440 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the superior vena cava (e.g., parameters sensed by sensing members 76, 176, 276 placed proximal to the expandable member located in the superior vena cava). Figure 21 The display 400 is further shown to include a visual representation 442 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the superior vena cava (e.g., parameters sensed by a sensing member 78 located distal to the expandable member located in the superior vena cava). Figure 21 The display 400 is further shown to include a visual representation 444 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the inferior vena cava (e.g., parameters sensed by a sensing member 80 placed proximal to the expandable member located in the inferior vena cava). Figure 21 The display 400 is further shown to include a visual representation 446 of physiological parameters (e.g., blood pressure) sensed near the expandable member located in the inferior vena cava (e.g., parameters sensed by sensing members 82, 182, 282 placed proximal to the expandable member located in the inferior vena cava).

[0185] in addition, Figure 21 A visual representation 450 is shown on the display 400, which may include a “baseline” value of one or more physiological parameters and / or hemodynamic data of the patient (e.g., right artery blood pressure, right ventricular pressure, cardiac output, stroke volume, etc.). For example, Figure 21 The data displays baseline values ​​for the patient's pulmonary artery pressure (452), right atrial pressure (454), mean arterial pressure (456), and heart rate (458). These baseline values ​​represent the patient's pulmonary artery pressure, right atrial pressure, mean arterial pressure, and heart rate prior to undergoing the medical procedure.

[0186] in addition, Figure 21 A visual representation 450 is shown on the display 400, which may include real-time values ​​of one or more physiological parameters and / or hemodynamic data of the patient (e.g., right artery blood pressure, right ventricular pressure, cardiac output, stroke volume, etc.). For example, Figure 21 This displays the real-time values ​​of the patient's pulmonary artery pressure (460), right atrial pressure (462), mean arterial pressure (464), and heart rate (466). These values ​​represent the actual real-time values ​​of the patient's pulmonary artery pressure, right atrial pressure, mean arterial pressure, and heart rate previously obtained during the medical procedure.

[0187] Figure 21 The visual representation shown includes, in addition to the real-time values ​​of pulmonary artery pressure 460, right atrial pressure 462, mean arterial pressure 464, and heart rate 466, baseline values ​​of pulmonary artery pressure 452, right atrial pressure 454, mean arterial pressure 456, and heart rate 458. However, this is not intended to be limiting. Rather, it is conceivable that the visual representation shown on display 400 may include visual representations of various physiological parameters, including but not limited to cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, renal vein pressure, combinations thereof, or any other physiological parameter.

[0188] It can be further understood that during the procedure, the user (e.g., a clinician) can compare the real-time values ​​460, 462, 464, 466 of these physiological parameters with reference parameters 452, 454, 456, 458. Furthermore, the user can select, input, and control various functions of the medical device system 10 based on the comparison of the real-time values ​​460, 462, 464, 466 of the physiological parameters with the reference parameters 452, 454, 456, 458. For example, the user can select the "emergency stop" button 468 to immediately stop the inflation and / or collapse of the first expandable member and / or the second expandable member when comparing the real-time values ​​460, 462, 464, 466 of the physiological parameters with the reference parameters 452, 454, 456, 458. In other examples, the user can use the “SVC balloon” button 474 or the “IVC balloon” button 476, combined with the “inflation” button 470 or the “collapse” button 472 and the “volume distribution” selector 473 to inflate or collapse the first expandable member 430 and / or the second expandable member 432 based on a comparison of real-time values ​​of physiological parameters 460, 462, 464, 466 with reference parameters 452, 454, 456, 458.

[0189] In addition, the medical device system 10 (and / or other systems or components of the medical system disclosed herein) can collect cloud-based data on physiological parameters (e.g., blood pressure, cardiac output, stroke volume, arterial pressure, venous pressure, superior vena cava pressure, inferior vena cava pressure, right atrial pressure, pulmonary artery pressure, mean arterial pressure, heart rate, renal artery pressure, and renal vein pressure), device sensor information, occlusion duty cycle, occlusion duration, and occlusion location, and use artificial intelligence or other advanced computing algorithms to optimize treatment for individual patients.

[0190] The materials that can be used in the various components of System 10 (and / or other systems disclosed herein) may include those typically associated with medical devices. However, this is not intended to limit the devices and methods described herein, as these discussions can be applied to other components, devices, or systems disclosed herein.

[0191] Components of the medical device system 10 (and / or other systems disclosed herein) may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene copolymer (FEP), polyoxymethylene (POM, such as DELRIN® commercially available from DuPont), polyether block esters, polyurethanes (such as polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (such as ARNITEL® commercially available from DSM Engineering Plastics), ether- or ester-based copolymers (such as butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® commercially available from DuPont), and polyamides (such as DURETHAN® or Elf commercially available from Bayer). Atochem commercially available CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., commercially available under the trade name PEBAX®), ethylene-vinyl acetate copolymer (EVA), silicones, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American) Commercially available Grilon materials include GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol copolymers, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0192] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linearly elastic and / or hyperelastic nickel-titanium alloys; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®; other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0193] In at least some embodiments, some or all components of system 10 (and / or other systems disclosed herein) may also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material should be understood as a material capable of producing a relatively bright image on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user of components of system 10 (and / or other systems disclosed herein) determine their location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials doped with radiopaque fillers, and so on. Additionally, other radiopaque marking strips and / or coils may also be incorporated into the design of components of system 10 (and / or other systems disclosed herein) to achieve the same result.

[0194] In some embodiments, System 10 (and / or other systems disclosed herein) is endowed with a degree of magnetic resonance imaging (MRI) compatibility. For example, components of System 10 (and / or other systems disclosed herein) may be made of materials that substantially do not distort the image and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce artifacts in MRI images. Components or portions of System 10 (and / or other systems disclosed herein) may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), nickel-titanium, and other materials.

[0195] It should be understood that this disclosure is illustrative in many respects only. Changes in detail, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include using any feature of one example embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A medical device system for treating the heart, the system comprising: A control system, comprising a display unit configured to display: A first visual representation of a first medical device positioned in a first anatomical location; The second visual representation of the second medical device positioned in the second anatomical location; A third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor located at a first position near the first medical device; and The fourth visual representation of the second physiological parameter, wherein the second physiological parameter is measured by a second sensor located at a second sensor position near the second medical device.

2. The medical device system as claimed in claim 1, wherein, The first anatomical location is the superior vena cava.

3. The medical device system as described in any one of claims 1 to 2, wherein, The second anatomical location is the inferior vena cava.

4. The medical device system as described in any one of claims 1 to 3, wherein, The first medical device is a first expandable member, and the second medical device is a second expandable member.

5. The medical device system as described in any one of claims 1 to 4, wherein, The first sensor is positioned near the first expandable member.

6. The medical device system as claimed in any one of claims 1 to 5, wherein, The second sensor is located on the distal side of the second expandable member.

7. The medical device system as claimed in any one of claims 1 to 6, wherein, The first physiological parameter and the second physiological parameter are blood pressure.

8. The medical device system as claimed in any one of claims 1 to 7, wherein, The display unit is configured to further display a third anatomical location, and wherein the display unit is configured to further display a fifth visual representation of a third physiological parameter, wherein the third physiological parameter is measured by a sensor disposed along the third anatomical location.

9. The medical device system of claim 8, wherein, The third anatomical location is the pulmonary artery.

10. The medical device system as described in any one of claims 8 to 9, wherein, The third physiological parameter is selected from a group consisting of cardiac output, stroke volume, mean arterial pressure, and blood pressure.

11. The medical device system according to any one of claims 1 to 10, wherein, The third medical device includes a pulmonary artery catheter.

12. The medical device system according to any one of claims 1 to 11, wherein, The display unit is configured to further display the pressure waveform corresponding to the first physiological parameter.

13. The medical device system according to any one of claims 1 to 12, wherein, The display unit is configured to further display input buttons, wherein the input buttons are configured to allow a user to manipulate the first medical device, the second medical device, or both the first medical device and the second medical device.

14. The medical device system of claim 13, wherein, The first medical device is an expandable member, and the second medical device is an expandable member, wherein the input button is configured to allow the user to immediately stop the inflation of the first expandable member, the second expandable member, or both the first expandable member and the second expandable member.

15. A medical device system for treating the heart, the system comprising: A control system, comprising a display unit configured to display: A first visual representation of a first medical device positioned in a first anatomical location; The second visual representation of the second medical device positioned in the second anatomical location; A third visual representation of a first physiological parameter, wherein the first physiological parameter is measured by a first sensor located at a first position near the first medical device; and A fourth visual representation of the second physiological parameter, wherein the second physiological parameter is measured by a second sensor located at a second sensor position near the second medical device; The fifth visual representation of the third physiological parameter, wherein the third physiological parameter is measured by a third sensor located at a third sensor position near the first medical device; The sixth visual representation of the fourth physiological parameter, wherein the fourth physiological parameter is measured by a fourth sensor located at a fourth sensor position near the second medical device.

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