Medical device for treating decompensated heart failure

Abstract

To provide medical device systems and methods for making and using medical device systems.SOLUTION: A medical device system is provided, the system including: a control system having a processor (16) and a pump (18); a first expandable member coupled to the processor (16) and configured to be positioned in the superior vena cava; and a second expandable member coupled to the processor and configured to be positioned in the inferior vena cava. The pump is designed to expand or contract the first expandable member or the second expandable member or both the first and the second expandable members based on a change in a first parameter or a second parameter or a change in both the first and the second parameters.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods of manufacturing medical devices. More particularly, the present disclosure relates to medical devices that include pressure sensors connected to expandable members and other structures, and methods for manufacturing and using such devices. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical use, for example, for intravascular use. Some of these devices include guidewires, balloon catheters, sensors, and the like. These devices can be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of methods. Among the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using the medical devices. Summary of the Invention

[0003] The present disclosure provides medical device designs, materials, manufacturing methods, and use alternatives. An exemplary medical device system for treating the heart includes a control system having a processor and a pump, and a first expandable member coupled to the processor, the first expandable member configured to be positioned within the superior vena cava. The system also includes a second expandable member coupled to the processor, the second expandable member configured to be positioned within the inferior vena cava. The system also includes a first sensing member having a first end positioned adjacent to the first expandable member and a second end coupled to the control system, the first sensing member configured to sense a first parameter. The system also includes a second sensing member having a first end positioned adjacent to the second expandable member and a second end coupled to the control system, the second sensing member configured to sense a second parameter. Further, the pump is configured to expand or contract the first expandable member, the second expandable member, or both the first and second expandable members based on a change in the first parameter, the second parameter, or a change in both the first and second parameters.

[0004] Alternatively or additionally to any of the above embodiments, the first parameter, the second parameter, or both the first parameter and the second parameter is blood pressure.

[0005] Alternatively or additionally to any of the above embodiments, the first sensing member, the second sensing member, or both the first sensing member and the second sensing member comprise a MEMS sensor.

[0006] Alternatively or additionally to any of the above embodiments, the first sensing member, the second sensing member, or both the first sensing member and the second sensing member comprise fiber optic sensors.

[0007] Alternatively or additionally to any of the above embodiments, the first sensing member, the second sensing member, or both the first sensing member and the second sensing member comprise a fluid-filled pressure sensing catheter.

[0008] Alternatively or additionally to any of the above embodiments, the first expandable member is configured to be positioned within the superior vena cava after the first expandable member has passed through a jugular vein, and the second expandable member is configured to be positioned within the inferior vena cava after the second expandable member has passed through a femoral vein.

[0009] Alternatively or additionally to any of the above embodiments, the first expandable member is configured to be positioned within the superior vena cava and the second expandable member is configured to be positioned within the inferior vena cava after both the first expandable member and the second expandable member have passed through the femoral vein.

[0010] Alternatively or additionally, any of the above embodiments may further comprise a third sensing member having a first end disposed adjacent to the first expandable member and a second end coupled to the control system, the third sensing member configured to sense a third parameter.

[0011] Alternatively or additionally, any of the above embodiments may further comprise a fourth sensing member having a first end disposed adjacent to the second expandable member and a second end coupled to the control system, the fourth sensing member configured to sense a fourth parameter.

[0012] Alternatively or additionally to any of the above embodiments, the first expandable member is disposed between a distal end of the first sensing member and a distal end of the third sensing member.

[0013] Alternatively or additionally to any of the above embodiments, further comprising a first elongate shaft having a first end coupled to the first expandable member, a second end coupled to the control system, and a plurality of lumens extending therethrough, wherein at least a portion of the first sensing member extends into at least a portion of a first lumen of the plurality of lumens.

[0014] Alternatively or additionally to any of the above embodiments, at least a portion of the second sensing member extends into at least a portion of a second lumen of the plurality of lumens.

[0015] Alternatively or additionally, any of the above embodiments, further comprising a memory, the memory including a set of instructions executable by the processor, the set of instructions configured to expand both the first expandable member and the second expandable member based on a change in the first parameter, the second parameter, or a change in both the first parameter and the second parameter.

[0016] Another medical device system for treating the heart includes a control system having a processor and a pump, and a first expandable member coupled to the processor, the first expandable member configured to be positioned within the superior vena cava. The system also includes a second expandable member coupled to the processor, the second expandable member configured to be positioned within the inferior vena cava. The system also includes a first pressure sensing member having a first end positioned adjacent to the first expandable member and a second end coupled to the control system, the first pressure sensing member designed to sense a first parameter. The system also includes a second pressure sensing member having a first end positioned adjacent to the second expandable member and a second end coupled to the control system, the second pressure sensing member designed to sense a second parameter. The system also includes a third pressure sensing member having a first end positioned adjacent to the first expandable member and a second end coupled to the control system, the third pressure sensing member designed to sense a third parameter. The system also includes a fourth pressure sensing member having a first end disposed adjacent to the second expandable member and a second end coupled to the control system, the fourth pressure sensing member configured to sense a fourth parameter, and the pump configured to expand or contract the first expandable member, the second expandable member, or both the first and second expandable members based on a change in the first parameter, the second parameter, the third parameter, or the fourth parameter.

[0017] Alternatively or additionally to any of the above embodiments, the first parameter, the second parameter, or both the first parameter and the second parameter is blood pressure.

[0018] Alternatively or additionally to any of the above embodiments, the first sensing member, the second sensing member, or the first sensing member and the second sensing member comprise MEMS sensors.

[0019] Alternatively or additionally to any of the above embodiments, the first sensing member, the second sensing member, or both the first sensing member and the second sensing member comprise fiber optic sensors.

[0020] Alternatively or additionally to any of the above embodiments, the first expandable member is disposed between a distal end of the first sensing member and a distal end of the third sensing member.

[0021] Alternatively or additionally, any of the above embodiments, further comprising a memory, the memory including a set of instructions executable by the processor, the set of instructions configured to expand both the first expandable member and the second expandable member based on a change in the first parameter, the second parameter, or a change in both the first parameter and the second parameter.

[0022] An exemplary method for treating the heart includes advancing a first medical device through the jugular vein into the superior vena cava, the first medical device including a first expandable member and a first sensing member, both the first expandable member and the first sensing member coupled to a control system. The method also includes advancing a second medical device through the femoral vein into the inferior vena cava, the second medical device including a second expandable member and a second sensing member, both the second expandable member and the second sensing member coupled to the control system. The method also includes sensing a first parameter using the first sensing member, sensing a second parameter using the second sensing member, and expanding the first expandable member, the second expandable member, or both the first and second expandable members based on a change in the first parameter, a change in the second parameter, or changes in both the first and second parameters.

[0023] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly describe these embodiments. [Brief explanation of the drawings]

[0024] The present disclosure may be more fully understood when considered in conjunction with the accompanying drawings and the following detailed description.

[0025] [Figure 1] 1 illustrates an exemplary medical device system. [Figure 2] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava. [Figure 3] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava. [Figure 4] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava. [Figure 5] 1 illustrates a portion of an exemplary medical device. [Figure 6] FIG. 6 is a cross-sectional view taken along line 6-6 in FIG. 5. [Figure 7] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava. [Figure 8] 1 illustrates a portion of another exemplary medical device. [Figure 9] FIG. 9 is a cross-sectional view taken along line 9-9 in FIG. 8. [Figure 10] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava. [Figure 11] 1 illustrates a portion of another exemplary medical device. [Figure 12] FIG. 12 is a cross-sectional view taken along line 12-12 in FIG. [Figure 13] 1 is a diagrammatic representation of an exemplary medical device placed within the superior and inferior vena cava.

[0026] While the present disclosure is susceptible to various modifications and alternative forms, specifics of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] These definitions shall be applied to the following defined terms, unless a different definition is given in the claims or elsewhere in this specification.

[0028] All numbers herein are presumed to be modified by the term "about," whether or not explicitly stated. The term "about" generally indicates a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0029] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.8, 4, and 5).

[0030] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0031] It should be noted that references herein to "an embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic. Furthermore, when a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should also be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0032] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict specific embodiments and are not intended to limit the scope of the disclosure.

[0033] The heart is an essential human organ responsible for pumping blood throughout the body. Therefore, it is fundamentally important that the heart's mechanical pumping properties function properly. When the heart does not function properly, a variety of adverse symptoms can occur. These adverse symptoms can include a severe form called acute decompensated heart failure (ADHF). This form of heart failure can be characterized by the sudden inability of the heart to pump efficiently. However, cardiac arrest does not occur because the heart does not stop even if its pumping function is severely impaired.

[0034] ADHF causes the heart to malfunction, making it unable to pump blood forward. Furthermore, the heart's inability to pump blood forward can result in excess blood backflow (e.g., pooling) into one or more chambers of the heart. For example, if a patient's left ventricle is damaged and is unable to efficiently pump blood into the aorta, gradual backflow of blood eventually manifests in the right atrium. Backflow of blood in the right atrium can lead to a variety of harmful complications. For example, excess blood in the right atrium can increase blood pressure in the right atrium, ultimately leading to a shift in the interventricular septum, thereby reducing left ventricular volume and cardiac output.

[0035] Thus, in some cases, it may be desirable to place and expand an expandable medical device within the superior vena cava and / or inferior vena cava to regulate blood flow within the right atrium, thereby counteracting excess blood in the right atrium and resulting in lower blood pressure in the right atrium. Exemplary medical devices designed to be placed within the superior vena cava and / or inferior vena cava to regulate blood flow within the right atrium are disclosed.

[0036] FIG. 1 illustrates an exemplary medical device system 10. The medical device system 10 may include a first medical device 26a and a second medical device 26b. As described in more detail below with reference to FIG. 2, the first medical device 26a and the second medical device 26b may each include a distal end region disposed adjacent a heart 22 of a patient 24. Additionally, the first medical device 26a may include an elongate member 30a extending outwardly and away from the patient 24, such that a proximal end of the elongate member 30a may be coupled to the control system 14. Similarly, the second medical device 26b may include an elongate member 30b extending outwardly away from the patient 24, such that a proximal end of the elongate member 30a may be coupled to the control system 14.

[0037] The control system 14 described above may include a processor 16 and a pump 18. It may be understood that in some instances, the processor 16 and the pump 18 may be located within a single console (e.g., a housing). However, it may be further understood that in other instances, the processor 16 and the pump 18 may be separate components separate from one another. In either configuration, it may be understood that the processor 16 and the pump 18 may be capable of communicating with one another. For example, the processor 16 may communicate with the pump 18 in response to physiological changes in the patient's body. It may be further understood that the processor 16 and the pump 18 may communicate via various channels. For example, the processor 16 and the pump 18 may be wired or wirelessly connected to one another, or may include both wired and wireless connections.

[0038] Additionally, in some examples, the medical device system 10 may include a saline container 20 (e.g., a saline bag) coupled to the control system 14. Specifically, in some examples, the saline container 20 may be attached directly to the pump 18. The pump 18 may draw saline from the saline container 20 in response to the processor 16 sensing physiological changes in the patient's body, as described above.

[0039] Figure 2 shows a detailed view of Figure 1. In particular, Figure 2 shows the distal end region of first medical device 26a positioned within superior vena cava 36. As shown in Figure 2, first medical device 26a can include an expandable member 28a. In some cases, expandable member 28a can be referred to as an expandable medical balloon. Expandable member 28a can include a distal end and a proximal end. The proximal end of expandable member 28a can be coupled to elongate member 30a (described above).

[0040] It will further be appreciated that elongate member 30a may include one or more individual lumens extending therethrough. For example, it will be appreciated that elongate member 30a may include an inflation lumen (not shown in FIG. 2, but shown in FIG. 5) which may be in communication with pump 18 (which may in turn be in communication with saline container 20).

[0041] Additionally, Figure 2 illustrates that elongate member 30a can include one or more additional lumens (in addition to the inflation lumen described above) that are configured to allow a sensing member to extend therethrough. For example, Figure 2 illustrates sensing member 32a extending out from a portion of elongate member 30a, such that a distal end of sensing member 32a can be disposed proximal to expandable member 28a. Additionally, Figure 2 illustrates sensing member 34a extending out from the distal end region of medical device 26a, such that a portion of sensing member 34a is disposed distal to expandable member 28a.

[0042] Similar to the above discussion of first medical device 26a, FIG. 2 illustrates the distal end region of second medical device 26b positioned within inferior vena cava 38. As shown in FIG. 2, second medical device 26b may include an expandable member 28b. In some cases, expandable member 28b may be referred to as an expandable medical balloon. Expandable member 28b may include a distal end and a proximal end. The proximal end of expandable member 28b may be coupled to elongate member 30b (described above).

[0043] It will further be appreciated that elongate member 30b may include one or more individual lumens extending therethrough. For example, it will be appreciated that elongate member 30b may include an inflation lumen (not shown in FIG. 2 but shown in FIG. 5) that communicates with pump 18 (which in turn communicates with saline reservoir 20).

[0044] Additionally, Figure 2 illustrates that elongate member 30b can include one or more additional lumens (in addition to the inflation lumen described above) that are configured to allow a sensing member to extend therethrough. For example, Figure 2 illustrates sensing member 32b extending out from a portion of elongate member 30b, such that a distal end of sensing member 32b can be disposed proximal to expandable member 28b. Additionally, Figure 2 illustrates sensing member 34b extending out from a distal end region of second medical device 26b, such that a portion of second sensing member 34b is disposed distal to first expandable member 28b.

[0045] As mentioned above, FIG. 2 shows sensing members 32a / 34a positioned adjacent to expandable member 28a in the superior vena cava 36. FIG. 2 shows sensing members 32b / 34b positioned adjacent to expandable member 28b in the inferior vena cava 38. In some examples, sensing members 32a / 34a / 32b / 34b may all be configured to sense changes in one or more physiological parameters / characteristics occurring in patient 24. Specifically, in some examples, sensing members 32a / 34a / 32b / 34b may include pressure sensing capabilities. In other words, sensing member 32a may include a pressure sensor designed to measure central venous pressure in the superior vena cava 36, ​​sensing members 34a / 34b may include a pressure sensor designed to measure right atrial pressure in an area adjacent to the right atrium 42, and sensing member 32b may include a pressure sensor designed to measure inferior venous pressure in the inferior vena cava 38.

[0046] It will be appreciated that sensing elements 32a / 34a / 32b / 34b may include a variety of different configurations. For example, in some cases, each sensing element may include a microelectromechanical (MEMS) sensor coupled to an elongated wire. The MEMS pressure sensor may be capable of rapidly detecting and responding to very small changes in blood pressure. Furthermore, the MEMS pressure sensor may be capable of transmitting a signal to processor 16 indicative of a change in blood pressure in the area where the MEMS sensor is located (e.g., the superior vena cava, the inferior vena cava, or adjacent the right atrium).

[0047] In another example, each of sensing members 32a / 34a / 32b / 34b can include a pressure-sensing catheter, whereby the catheter includes a fluid-filled lumen, the distal end of which can be open to the surrounding environment. Furthermore, changes in pressure in the area surrounding the distal end of the fluid-filled catheter can cause fluid to move into the catheter. This movement of fluid into the fluid-filled catheter can be sensed by processor 16.

[0048] Additionally, in other examples, each of the sensing members 32a / 34a / 32b / 34b can include a fiber optic pressure sensing catheter, whereby the fiber optic pressure sensing catheter includes a fiber optic pressure sensor. The fiber optic pressure sensor can sense changes in blood pressure (in an area adjacent to the sensor) based on changes in the intensity of light surrounding the sensor. This change in light intensity can be sensed by the processor 16. In some of the examples described herein, the sensor members can include various sensors. For example, in addition to the sensors described above, the sensor members disclosed herein can include piezoresistive sensors, piezocapacitive sensors, pressure sensors, flow sensors, accelerometers, temperature sensors, or the like.

[0049] As discussed above, when the pumping action of the heart 22 (for example) is impaired by a weakened left ventricle 40, blood may begin to backflow therein. Further, backflow of blood in the left ventricle 40 may lead to backflow of blood in the left atrium 46. Further, backflow of blood in the left atrium 46 may lead to backflow of blood into the pulmonary veins, lungs, and pulmonary artery. Backflow of blood in the pulmonary artery may further lead to backflow of blood into the right ventricle 44, which over time leads to backflow of blood (and increased blood pressure) in the right atrium 42 and areas immediately adjacent to the right atrium 42 (e.g., the superior vena cava 36, ​​the inferior vena cava 38).

[0050] Furthermore, it can be appreciated that once blood backs up into the right atrium 42, additional blood may continue to flow from the superior vena cava 36 and the inferior vena cava 38 into the right atrium 42. Therefore, it may be desirable to temporarily occlude (fully or partially) the superior vena cava 36 and / or the inferior vena cava 38 to regulate the adverse effects (e.g., increased blood volume and blood pressure in the right atrium 42) caused by the backflow of blood into the right atrium 42.

[0051] Thus, in some examples, one or more sensing members 32a / 34a / 32b / 34b may sense a change in a physiological parameter (e.g., an increase in blood pressure) in the region surrounding the superior vena cava 36, ​​the inferior vena cava 38, and / or the right atrium 42. Furthermore, it may be understood that any sensor that senses a change in a parameter may transmit a signal to the processor 16. The processor 16 may include memory and / or algorithms designed to measure, interpret, process, analyze, evaluate, etc., signals received from the one or more sensing members 32a / 34a / 32b / 34b. Furthermore, if necessary, the algorithm may process the signals received from the one or more sensing members 32a / 34a / 32b / 34b and communicate with the pump 18 to fill or empty fluid from the first expandable member 28a and / or the second expandable member 28b. As described above, the pump 18 can pump fluid from the saline reservoir 20 to expand the first expandable member 28a and / or the second expandable member 28b.

[0052] When sensing member 32a / 34a / 32b / 34b senses a change in a physiological parameter (e.g., an increase in blood pressure) in the area surrounding superior vena cava 36, ​​inferior vena cava 38, and / or right atrium 42, expanding first expandable member 28a and / or second expandable member 28b may restrict blood flow into the area surrounding right atrium 42. Restricting blood flow into the area surrounding right atrium 42 can allow excess blood accumulating in right atrium 42 to be diverted (or partially diverted) from right atrium 42, thereby reducing built-up blood pressure in heart 22.

[0053] In some cases, it may not be necessary for the system 10 to expand the first expandable member 28a and / or the second expandable member 28b to the point where the expandable members 28a / 28b completely occlude the superior vena cava 36 and the inferior vena cava 38, respectively. Rather, in some cases, the processor 16 may process signals received from one or more sensing members 32a / 34a / 32b / 34b and only partially occlude the superior vena cava 36 and / or the inferior vena cava 38. In other cases, the processor 16 may process signals received from one or more sensing members 32a / 34a / 32b / 34b and completely occlude 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 occluded. It will be appreciated that the processor 16 may include algorithms designed to analyze various physiological parameters occurring in the superior vena cava 36, ​​the inferior vena cava 38, and / or the right atrium 42 and determine the degree to which either the first expandable member 28a and / or the second expandable member 28b should occlude (if at all).

[0054] It should be noted that the above-mentioned physiological parameters that may be processed by the processor 16 to assess the degree to which the first expandable member 28a and / or second expandable member 28b should occlude are not limited to simply blood pressure in the superior vena cava 36, ​​the inferior vena cava 38, and / or the right atrium 42. Rather, the processor 16 may assess blood flow, blood pressure, 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.

[0055] Additionally, in some cases, the algorithm used by the processor 16 may include an evaluation of blood pressure values ​​in the superior vena cava 36, ​​the inferior vena cava 38, and / or the right atrium 42 for a particular patient, whereby the algorithm may further use a look-up table or artificial intelligence algorithm to determine the degree to which either the first expandable member 28a and / or the second expandable member 28b should occlude for a particular patient at a given time.

[0056] Additionally, in some instances, the control system 14 may also be coupled to a sensor that provides the patient's ECG to the processor 16. In that case, the cardiac cycle timing of a particular patient may be used to determine the degree to which either the first expandable member 28a and / or the second expandable member 28b should occlude for a particular patient at a given time. Additionally, in some instances, the control system 14 may also be coupled to a chest accelerometer (e.g., a wearable patch) that can sense the inspiratory cycle for a particular patient. The timing of the inspiratory cycle for a particular patient may be used to determine the degree to which either the first expandable member 28a and / or the second expandable member 28b should occlude for a particular patient at a given time.

[0057] As described above, the timing of inflation or deflation of the first expandable member 28a can differ from the timing of inflation or deflation of the second expandable member 28b. In other words, the inflation or deflation of the first expandable member 28a may not coincide with the inflation or deflation of the second expandable member 28b. Allowing the inflation or deflation of the first expandable member 28a to not coincide with the inflation or deflation of the second expandable member 28b may allow for minimal impact on cerebral blood flow while maintaining systemic mean arterial pressure without increasing renal or hepatic venous pressure and reducing cardiac workload.

[0058] Figure 3 illustrates the first medical device 26a positioned within the aforementioned superior vena cava 36. Additionally, Figure 3 illustrates the first expandable member 28a in a collapsed configuration (e.g., a configuration in which blood flow through the superior vena cava 36 toward the right atrium 42 may be unrestricted). Similarly, Figure 3 illustrates the second medical device 26b positioned within the aforementioned inferior vena cava 38. Figure 3 illustrates the second expandable member 26b in a collapsed configuration (e.g., a configuration in which blood flow through the inferior vena cava 38 toward the right atrium).

[0059] Figure 4 illustrates the first medical device 26a positioned within the aforementioned superior vena cava 36. Additionally, Figure 4 illustrates the first expandable member 28a in an expanded configuration (e.g., a configuration that may restrict blood flow through the superior vena cava 36 toward the right atrium 42). Similarly, Figure 4 illustrates the second medical device 26b positioned within the aforementioned inferior vena cava 38. Additionally, Figure 4 illustrates the second expandable member 26b in an expanded configuration (e.g., a configuration that may restrict blood flow through the inferior vena cava 38 toward the right atrium).

[0060] 1-4, it can be seen that in some instances, a first medical device 26a can be inserted through an incision in the patient's neck and can be routed through the jugular vein to the superior vena cava 36. Additionally, it can be seen that in some instances, a second medical device 26b can be inserted through an incision in the patient's groin and can be routed through the femoral vein to the inferior vena cava 38.

[0061] FIG. 5 illustrates an exemplary medical device 26. Briefly, the exemplary medical device may refer to medical device 26a or medical device 26b described above. FIG. 5 illustrates that medical device 26 may include an expandable member 28. Expandable member 28 may be coupled to the distal end of elongate member 30. As described above, the proximal end of the elongate shaft may be coupled to control system 14 (including processor 16 and pump 18). Additionally, elongate shaft 30 may include a first sensing member lumen 50 extending therethrough and a second sensing member lumen 52 extending therethrough. First sensing member lumen 50 and second sensing member lumen 52 may extend along the entire length of elongate shaft 30 or along only a portion of elongate member 30.

[0062] 5 further illustrates sensing member 32 extending with first sensing member lumen 50, whereby sensing member 32 exits elongate member 30 through opening 55. FIGURE 5 also illustrates sensing member 34 extending with second sensing member lumen 52, whereby sensing member 34 exits elongate member 30 out the distal end opening of elongate member 30. FIGURE 5 further illustrates an exemplary sensor 54 disposed along the distal end of sensing member 32 and another exemplary sensor 56 disposed along the distal end of sensing member 56. It can be understood that sensing member 32 / 34 can include any type of sensing member described herein.

[0063] 5 further illustrates that the elongate member 30 can include an inflation lumen 48 extending within the elongate member 30. The inflation lumen 48 can be in communication with the control system 14 (including the pump 18 and the saline container 20). It can be seen that the distal end of the inflation lumen 48 opens into the expandable cavity of the expandable member 28.

[0064] Figure 6 is a cross-sectional view taken along line 6-6 of Figure 5. Figure 6 shows first sensation member lumen 50, second sensation member 52, and inflation lumen 48 extending within elongate member 30. Additionally, Figure 6 shows first sensation member 32 extending within first sensation member lumen 50 and second sensation member 34 extending within second sensation member lumen 52.

[0065] 7 illustrates another exemplary medical device system 110 positioned adjacent to a heart 22. The medical device 110 may be similar in form and function to the medical device system 10 described above. However, unlike the medical device system 10 described above, the medical device system 110 may include an elongate member 130 that bifurcates into a proximal elongate shaft 158 ​​and a distal elongate member 160. The proximal end of the elongate member 130 may be coupled to the control system 14 (including the pump 18 and processor 16) described above.

[0066] 7 further illustrates that the distal elongate member 160 is coupled to the first expandable member 128 and the proximal elongate shaft is coupled to the second expandable member 129. As described above with respect to the medical device system 10, the first expandable member 128 and / or the second expandable member 129 can be expanded to occlude the superior vena cava 36 and / or the inferior vena cava 38.

[0067] 8 shows that the medical device 110 can include an elongate member 130 that bifurcates into a proximal elongate member 158 and a distal elongate member 160. FIG. 8 also shows a first expandable member 128 and a second expandable member 129. The first expandable member 128 can be coupled to a distal end of the distal elongate member 160, and the second expandable member 129 can be coupled to a distal end of the proximal elongate member 158. Additionally, the proximal end of the elongate member 130 can be coupled to the control system 14 (including the processor 16 and the pump 18), as described above.

[0068] Additionally, the elongate member 130 may include a first sensing member lumen 162 extending therethrough and a second sensing member lumen 165 extending therethrough. The first sensing member lumen 162 and the second sensing member lumen 165 may extend along the entire length of the elongate member 130 or along only a portion of the elongate member 130.

[0069] Additionally, Figure 8 shows the two sensing members 133 / 135 extending with the first sensing member lumen 162, such that the sensing member 133 exits the distal elongate member 160 through opening 167. Figure 8 also shows the sensing member 135 extending within the first sensing member lumen 162, such that the sensing member 135 exits the distal elongate member 160 out an opening at the distal end of the elongate member 160. Additionally, Figure 8 shows the two sensing members 132 / 134 extending within the second sensing member lumen 165, such that the sensing member 132 exits the proximal elongate shaft 158 ​​through opening 166. Figure 8 also shows the sensing member 134 extending through the second sensing member lumen 165, such that the sensing member 134 exits the proximal elongate member 158 out an opening at the distal end of the proximal elongate shaft 158. It can be appreciated that the sensing members 132 / 133 / 134 / 135 can include any type of sensing member described herein.

[0070] 8 further illustrates that distal elongate member 160 can include an inflation lumen 164 extending within elongate member 160, and that proximal elongate member 158 can include an inflation lumen 163 extending within proximal elongate member 158. Inflation lumens 164 / 163 can be in communication with control system 14 (including pump 18 and saline reservoir 20). It can be seen that the distal end of inflation lumen 164 opens into the expandable cavity of expandable member 128, and the distal end of inflation lumen 163 opens into the expandable cavity of expandable member 129.

[0071] With reference to Figures 7-8, it can be seen that the medical device 110 can be inserted into the femoral vein through an incision in the patient's groin and further directed towards and positioned within the patient's superior vena cava 36 and inferior vena cava 38 as described above.

[0072] Figure 9 is a cross-sectional view taken along line 9-9 of Figure 8. Figure 9 shows first sensing member lumen 162, second sensing member lumen 165, inflation lumen 163 and inflation lumen 164 extending within elongate lumen 130. Additionally, Figure 9 shows sensing members 133 / 135 extending within first sensing member lumen 162 and second sensing members 132 / 134 extending within second sensing member lumen 165.

[0073] 10 illustrates another exemplary medical device system 210 positioned adjacent to a heart 22. The medical device 210 may be similar in form and function to the other medical device systems described above. However, unlike the medical device systems described above, the medical device system 210 may include an elongate member 230 that extends through a second expandable member 229 to a first expandable member 228. The proximal end of the elongate member 230 may be coupled to the control system 14 (including the pump 18 and processor 16) as described above.

[0074] Additionally, FIG. 10 illustrates that the first expandable member 228 and / or the second expandable member 229 can be expanded to occlude the superior vena cava 36 and / or the inferior vena cava 38, as described above with respect to the medical device system 10.

[0075] FIG. 11 illustrates the distal end region of the exemplary medical device 210 described above. FIG. 11 illustrates that the medical device 210 can include an elongate member 230 attached to both the second expandable member 229 and the first expandable member 228 (e.g., a portion of the elongate member 230 passes through the second expandable member 229 and is attached to the first expandable member 228). FIG. 11 further illustrates that the medical device 210 can include a first expandable member 228 and a second expandable member 229. The first expandable member 228 can be coupled to a distal end of the elongate member 230, and the second expandable member 229 can be coupled to an intermediate portion of the elongate member 230. Additionally, the proximal end of the elongate member 230 can be coupled to the control system 14 (including the processor 16 and the pump 18), as described above.

[0076] Additionally, the elongate member 230 may include a first sensing member lumen 262, a second sensing member lumen 268, a third sensing member lumen 269, and a fourth sensing member lumen 265 extending therethrough. The first sensing member lumen 262, the second sensing member lumen 268, the third sensing member lumen 269, and / or the fourth sensing member lumen 265 may extend along the entire length of the elongate member 230 or along only a portion of the elongate member 230.

[0077] Additionally, FIG. 11 shows sensing member 232 extending with first sensing member lumen 262, second sensing member 234 extending with second sensing member lumen 268, third sensing member 233 extending with third sensing member lumen 269, and fourth sensing member 235 extending with fourth sensing member lumen 265.

[0078] 11 further illustrates that the elongate member 230 can include a first inflation lumen 264 and a second inflation lumen 263. The inflation lumens 263 / 264 can be in communication with the control system 14 (including the pump 18 and the saline container 20). It can be appreciated that the distal end of the first inflation lumen 264 can open into the expandable cavity of the first expandable member 228, and the distal end of the second inflation lumen 263 can open into the expandable cavity of the second expandable member 229.

[0079] 10-11, it can be seen that the medical device 210 can be inserted into the femoral vein through an incision in the patient's groin and further directed toward and positioned within the patient's superior and inferior vena cava 38 as described above.

[0080] Figure 12 is a cross-sectional view taken along line 12-12 of Figure 11. Figure 12 shows first sensing member lumen 262, second sensing member lumen 268, third sensing member lumen 269, fourth sensing member lumen 265, inflation lumen 263 and inflation lumen 264 extending within elongate member 230. Additionally, Figure 12 shows sensing member 232 extending with first sensing member lumen 262, second sensing member 234 extending with second sensing member lumen 268, third sensing member 233 extending with third sensing member lumen 269, and fourth sensing member 235 extending with fourth sensing member lumen 265.

[0081] FIG. 13 illustrates another exemplary medical device system 310. The medical device system 310 may include a first medical device 326a and a second medical device 326b. The first medical device 326a and the second medical device 326b may each include a distal end region positioned adjacent the heart 22 of the patient 24 (not shown in FIG. 13, but shown in FIG. 1). Additionally, the first medical device 326a may include an elongate member 330a extending outwardly away from the patient 24, such that a proximal end of the elongate member 330a may be coupled to the control system 14 (not shown in FIG. 13, but shown in FIG. 1). Similarly, the second medical device 326b may include an elongate member 330b extending outwardly away from the patient 24, such that a proximal end of the elongate member 330a may be coupled to the control system 14.

[0082] FIG. 13 further illustrates that the first medical device 326a can include an expandable member 328a. The distal end region of the first medical device 326a can be positioned within the superior vena cava 36. In some cases, the expandable member 328a can be referred to as an expandable medical balloon. The expandable member 328a can include a distal end and a proximal end. The proximal end of the expandable member 328a can be coupled to the elongate member 330a (described above). Furthermore, it can be understood that the elongate member 330a can include one or more individual lumens extending therethrough. For example, it can be understood that the elongate member 330a can include an inflation lumen that can communicate with the pump 18 (which can, in turn, communicate with the saline container 20). Both the pump 18 and the saline container 20 are shown in FIG. 1.

[0083] Additionally, Figure 13 illustrates that a distal end region of second medical device 326b can be positioned within inferior vena cava 38. As shown in Figure 13, second medical device 326b can include an expandable member 328b. In some cases, expandable member 328b can be referred to as an expandable medical balloon. Expandable member 328b can include a distal end and a proximal end. The proximal end of expandable member 328b can be coupled to elongate member 330b (described above).

[0084] Additionally, FIG. 13 illustrates that medical device 310 can include one or more sensing members disposed adjacent to first expandable member 328a and / or second expandable member 328b. The sensing members shown in FIG. 13 may not extend through the inner lumen of elongate member 330a or elongate member 330b. For example, FIG. 13 illustrates sensing members 332a and 334a disposed adjacent to first expandable member 328a and sensing members 332b and 334b ​​disposed adjacent to second expandable member 328b. Sensing members 332a, 334a, 332b, and 334b ​​can be similar in form and function to any of the sensing members described above. For example, sensing members 332a, 334a, 332b, and 334b ​​can sense any physiological parameter described herein.

[0085] Materials that may be used for the various components of system 10 (and / or other systems disclosed herein) may include those commonly associated with medical devices, but are not intended to be limiting of the devices and methods described herein, as the discussion may apply to other components, devices, or systems disclosed herein.

[0086] Components of system 10 (and / or other systems disclosed herein) may be formed from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, and combinations thereof, or other suitable materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and combinations thereof. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex® high density polyethylene, Marlex® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS AmericanThe sheath may include GRILAMID® (available from Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable material, or mixtures, combinations, copolymers, and polymer / metal composites thereof. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may include up to about 6 percent LCP.

[0087] Some examples of suitable metals and metal alloys include stainless steels, e.g., 304V, 304L, and 316LV stainless steels, mild steels, nickel-titanium alloys, e.g., linear elastic and / or superelastic Nitinol, other nickel alloys, e.g., nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; HASTELLOY® C27®), and the like. 6 (UNS:N10276, and other HASTELLOY® alloys), nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC® 400, and NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY® B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, and other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY® and PHYNOX®), platinum strengthened stainless steels, titanium, and combinations thereof, or any other suitable metal.

[0088] In at least some embodiments, some or all components of system 10 (and / or other systems disclosed herein) may be doped with, formed with, or otherwise include a radiopaque material. It is understood that a radiopaque material is a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids a user of the components of system 10 (and / or other systems disclosed herein) in determining their placement. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the components of system 10 (and / or other systems disclosed herein) to achieve the same results.

[0089] In some embodiments, magnetic resonance imaging (MRI) compatibility is provided to system 10 (and / or other systems disclosed herein). For example, components of system 10 (and / or other systems disclosed herein) may be formed of materials that do not substantially distort images and do not create substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in MRI images. Components of system 10 (and / or other systems disclosed herein), or portions thereof, may also be formed of materials that are imageable by MRI equipment. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), and nitinol, among others.

[0090] It should be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any feature of one example embodiment with that of another embodiment. The scope of the disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

[Claim 1] The invention described in the specification.

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