Devices, related systems, and related methods for pumping blood

Abstract

To provide a device, a related system and a related method for pressure-feeding blood.SOLUTION: An intravascular device for pressure-feeding blood includes a catheter comprising a membrane chamber which is provided between a proximal end and a distal end of the catheter. An expandable membrane is provided in the membrane chamber. The intravascular device includes: a first one-directional valve configured to allow a blood flow in a first direction; and optionally, a second one-directional valve. The first one-directional valve may be positioned in the vicinity of the membrane chamber, the second one-direction valve may be positioned on the distal part of the membrane chamber. There are provided the intravascular device and methods of use of the same.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates to intravascular blood pumps such as ventricular assist devices (VADs), and more particularly to right ventricular assist devices (RVADs) and left ventricular assist devices (LVADs). [Background technology]

[0002] One prior art intravascular blood pump is described in U.S. Patent No. 5,928,132 to Leschinsky, the entire contents of which are incorporated herein by reference. The Leschinsky device includes a catheter with an inflatable balloon positioned within a pumping chamber at or near the distal end of the catheter. The balloon is alternately inflated and deflated by an external pump drive. Deflation of the balloon within the catheter's pumping chamber allows blood to flow from the heart into the pumping catheter. Inflation of the balloon displaces blood, for example, causing it to exit the catheter through an outlet valve positioned on the pumping chamber, thereby assisting the heart. Leschinsky notes that with minor variations, such a device could be used as a right ventricular assist device.

[0003] Given variations in patient anatomy, such as differences in aortic or vena cava diameters between patients, challenges exist in providing an optimally effective intravascular blood pumping device. Design challenges relate to the need to balance maximizing cannula size for maximum blood flow with reducing cannula size to improve blood flow around and outside the cannula and to allow for a smaller profile for insertion through narrow sections of the patient's vasculature. Additionally, elements on the cannula itself can reduce or slow blood flow around the cannula. Improvements in device safety and manufacturability are also desired. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 5,928,132 Summary of the Invention [Means for solving the problem]

[0005] In one aspect of the present disclosure, an intravascular device for pumping blood includes a catheter having a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and a valve chamber separate from the membrane chamber. The intravascular device includes a first one-way valve configured to allow blood flow in a first direction.

[0006] In another aspect of the present disclosure, an intravascular device for pumping blood includes a catheter having a membrane chamber located between a proximal tube portion and a distal tube portion. Each of the proximal and distal tube portions has an outer profile, when viewed along the longitudinal direction of the device, that is smaller than the outer profile of the membrane chamber. An inflatable membrane is disposed within the membrane chamber. The intravascular device further includes a first one-way valve associated with a first valve chamber of the catheter, the first valve chamber having an outer profile, when viewed along the longitudinal direction of the device, that is smaller than the outer profile of the membrane chamber.

[0007] In yet another aspect of the present disclosure, a system for pumping blood includes an intravascular device including a catheter including a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and an inlet and an outlet positioned exterior to and in fluid communication with the membrane chamber. The system further includes a connector assembly configured to connect to the intravascular device and a pump console, the connector assembly configured to allow settings on the pump console to be modified for use with the intravascular device.

[0008] In yet another aspect of the present disclosure, a method of forming an intravascular device includes forming at least one valve chamber, the chamber including a one-way valve; forming a membrane chamber of an expandable material, the membrane chamber having an expanded configuration and a contracted configuration; coupling the at least one valve chamber to the membrane chamber; and coupling a catheter tube to the valve chamber.

[0009] In yet another aspect of the present disclosure, a method for assisting blood circulation includes inserting a catheter into a venous structure. The catheter includes a membrane chamber located between a proximal end and a distal end of the catheter. An inflatable membrane is disposed within the membrane chamber. The catheter includes a first valve chamber forming part of or including a first one-way valve configured to allow blood flow in a first direction, the first one-way valve being positioned proximal to the membrane chamber. The method further includes positioning the catheter such that the first valve chamber is located substantially adjacent to one of a renal vein and a hepatic vein, expanding the membrane chamber from a contracted position to an expanded position, and cyclically supplying fluid to the inflatable membrane to inflate and deflate the inflatable membrane. Inflating the membrane allows blood to exit the catheter, and deflating the membrane allows blood to enter the catheter through the first one-way valve.

[0010] In yet another aspect of the present disclosure, a method for assisting blood circulation within a body includes inserting a catheter into an arterial structure. The catheter includes a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and a first valve chamber forming part of or including a first one-way valve configured to allow blood flow in a first direction. The first valve chamber is positioned proximal to the membrane chamber. The method further includes positioning the catheter such that the first valve chamber is substantially adjacent a renal artery, expanding the membrane chamber from a contracted position to an expanded position, and cyclically supplying fluid to the inflatable membrane to inflate and deflate the inflatable membrane, wherein membrane expansion allows blood to exit the catheter through the first one-way valve and membrane contraction allows blood to enter the catheter.

[0011] According to yet another aspect of the present disclosure, an intravascular device for pumping blood includes a catheter having a membrane chamber located between a proximal tubing portion and a distal tubing portion with a distal end. At least one one-way valve is located proximal or distal to the membrane chamber. The at least one one-way valve is positioned along the length of the device relative to the distal end such that when the distal end is positioned at a target location relative to a first vascular structure, the at least one one-way valve is positioned adjacent to a second vascular structure different from the first vascular structure.

[0012] Additional objects, features, and / or other advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure and / or claims. At least some of these objects and advantages may be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

[0013] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not limitations of the claims, which rather are to be accorded their full scope, including equivalents. The present invention provides, for example, the following. (Item 1) 1. An intravascular device for pumping blood, said device comprising: a catheter comprising a membrane chamber located between a proximal end and a distal end of the catheter; an inflatable membrane disposed within the membrane chamber; a valve chamber separate from the membrane chamber; a first one-way valve configured to allow blood flow in a first direction; A device comprising: (Item 2) Item 10. The device of item 1, further comprising a second one-way valve configured to allow blood flow in the first direction, the second one-way valve being positioned distal to the membrane chamber. (Item 3) 3. The device of claim 1 or 2, wherein one of the first and second one-way valves forms part of or is located within the valve chamber. (Item 4) Item 4. The device of item 3, further comprising a second valve chamber separate from the membrane chamber, wherein each of the first and second one-way valves forms part of or is located within a respective one of the valve chambers. (Item 5) 5. The device of any one of items 1-4, wherein the membrane chamber comprises a chamber wall that does not have a valve. (Item 6) 6. The device of any one of items 1-5, wherein one of the first and second one-way valves is an outlet valve, and the at least one valve chamber has an outer dimension, when viewed along a longitudinal direction of the device, that is smaller than an outer dimension of the membrane chamber, when viewed along the longitudinal direction of the device. (Item 7) 7. The device of any one of items 1-6, wherein one of the first and second one-way valves is an inlet valve, and the at least one valve chamber has an outer dimension, when viewed along a longitudinal direction of the device, that is smaller than an outer dimension of the membrane chamber, when viewed along the longitudinal direction of the device. (Item 8) 8. The device of any one of items 1-7, wherein the catheter further comprises first and second tubing segments extending proximally and distally, respectively, from the membrane chamber, and wherein at least one valve chamber has an outer diameter, when viewed along a longitudinal direction of the device, that is equal to or greater than an outer diameter of the tubing segments of the catheter when viewed along the longitudinal direction of the device. (Item 9) 9. The device of any one of items 1-8, wherein the second one-way valve is configured as an inlet valve formed at the distal end of the catheter, and the first one-way valve is configured as an outlet valve and is positioned between the membrane chamber and the proximal end of the catheter. (Item 10) 10. The device of claim 9, further comprising a third one-way valve positioned between the second one-way valve and the membrane chamber. (Item 11) Item 11. The device of item 10, wherein the third one-way valve is configured to allow blood flow in a second direction opposite the first direction. (Item 12) 12. The device of any one of items 1-11, wherein at least one of the first and second one-way valves is positioned on the device such that, during use, it is positioned adjacent to at least one of a left common carotid artery, a right common carotid artery, and a renal artery. (Item 13) 13. The device of any one of items 1-12, wherein at least one of the first and second one-way valves is positioned on the device such that, during use, it is positioned in the pulmonary artery. (Item 14) 9. The device of any one of items 1-8, wherein the first one-way valve is configured as an inlet valve and is positioned between the membrane chamber and the proximal end of the catheter, and the second one-way valve is configured as an outlet valve and is positioned distal to the membrane chamber. (Item 15) 15. The device of any one of items 1-8, 13, and 14, wherein at least one of the first and second one-way valves is positioned on the device such that it is positioned adjacent to at least one of a renal vein and a hepatic vein when the device is positioned within a patient's heart for left ventricular assist. (Item 16) 16. The device of any one of items 1-15, wherein one of the first and second one-way valves configured as an inlet valve is disposed within a valve chamber formed as an inlet tube connected to the membrane chamber. (Item 17) 17. The device of any one of items 1-16, wherein one of the first and second one-way valves configured as an outlet valve is disposed within a valve chamber formed as an outlet tube connected to the membrane chamber. (Item 18) 18. The device of any one of items 1-17, wherein a marker is associated with at least one of the first and second one-way valves to facilitate positioning of the device via fluoroscopic imaging. (Item 19) 1. An intravascular device for pumping blood, said device comprising: a catheter comprising a membrane chamber located between a proximal tube portion and a distal tube portion, the membrane chamber having an outer shape when viewed along a longitudinal direction of the device, and each of the proximal and distal tube portions having an outer shape when viewed along a longitudinal direction of the device that is smaller than the outer shape of the membrane chamber; an inflatable membrane disposed within the membrane chamber; a first one-way valve associated with a first valve chamber of the catheter; Equipped with A device wherein the first valve chamber has an outer dimension, when viewed along the length of the device, that is smaller than the outer dimension of the membrane chamber. (Item 20) 20. The device of claim 19, further comprising a second one-way valve and a second valve chamber, the first one-way valve forming part of or positioned within the first valve chamber and the second one-way valve forming part of or positioned within the second valve chamber. (Item 21) 21. The device of claim 19 or 20, wherein a central axis of at least one of the first valve chamber and the second valve chamber is offset from the longitudinal axis of the catheter. (Item 22) 22. The device of any one of items 19-21, wherein the first valve chamber comprises a tube extending from the proximal end of the membrane chamber, the tube being substantially parallel to a proximal tube portion of the catheter. (Item 23) 23. The device of any one of items 19-22, wherein each valve chamber receives a portion of the catheter tubing extending from the end of the membrane chamber. (Item 24) 24. The device of any one of items 19-23, wherein at least one of the first and second valve chambers is attached to an open-ended tube extending from a distal end of the membrane chamber. (Item 25) 25. The device of any one of items 19-24, wherein the outer diameter of at least one of the first and second valve chambers is larger than the outer diameter of each one of the first and second tube portions. (Item 26) 26. The device of any one of items 19-25, further comprising a pressure transducer configured to measure pressure within the membrane chamber. (Item 27) Item 27. The device of item 26, wherein the pressure transducer comprises a fiber optic pressure transducer. (Item 28) 28. The device of any one of items 19-27, wherein at least one of the first and second valve chambers has a length that is shorter than the length of the membrane chamber. (Item 29) 29. The device of any one of items 19-28, wherein at least one of the first and second valve chambers has a volume smaller than the volume of the membrane chamber. (Item 30) 30. The device of any one of items 19-29, wherein the inflatable membrane has a volume of about 25 cc to about 50 cc. (Item 31) 30. The device of any one of items 19-29, wherein the inflatable membrane has a volume of about 5 cc to about 20 cc. (Item 32) 32. The device of any one of items 19-31, wherein the membrane chamber comprises a housing framework. (Item 33) Item 33. The device of item 32, wherein the housing framework comprises a shape memory material. (Item 34) 1. A system for pumping blood, the system comprising: An intravascular device, the intravascular device comprising: a catheter comprising a membrane chamber located between a proximal end and a distal end of the catheter; an inflatable membrane disposed within the membrane chamber; an inlet and an outlet positioned external to and in fluid communication with the membrane chamber; an intravascular device comprising: a connector assembly configured to connect to the intravascular device and a pump console; Equipped with The system, wherein the connector assembly is configured to allow settings on the pump console to be modified for use with the intravascular device. (Item 35) Item 35. The system of item 34, wherein the pump console is configured to provide gas that drives inflation and deflation of the inflatable membrane. (Item 36) Item 36. The system of item 34 or item 35, wherein the connector assembly comprises an element configured to be received by the pump console, and the connector assembly is further configured to allow user access to intravascular device settings via the pump console. (Item 37) 37. The system of any one of items 34-36, wherein the connector assembly comprises an identification device. (Item 38) Item 38. The system of item 37, wherein the identification device comprises a passive electronic component. (Item 39) Item 38. The system of item 37, wherein the identification device comprises an electronic memory. (Item 40) 40. The system of any one of items 34-39, wherein the identification device is configured to provide information to the pump console regarding operational characteristics of the intravascular device. (Item 41) The system of any one of items 34-40, wherein the identification device is configured to automatically modify the pump console to display settings associated with an operating mode for the intravascular device, the settings relating to at least one of alarm settings, detection settings, alarm conditions, device cycle triggering, device cycle timing, and user interface settings. (Item 42) 42. The system of any one of items 34-41, further comprising a pressure transducer configured to measure the pressure in the membrane chamber. (Item 43) Item 43. The system of item 42, wherein the pressure transducer is configured to provide data regarding the pressure in the membrane chamber to the pump console. (Item 44) 44. The system of claim 42 or 43, wherein the pressure transducer comprises a fiber optic pressure transducer. (Item 45) 45. The system of any one of items 34-44, wherein the inflatable membrane has a volume of about 25 cc to about 50 cc. (Item 46) 45. The system of any one of items 34-44, wherein the inflatable membrane has a volume of about 5 cc to about 20 cc. (Item 47) Item 47. The system of item 45 or item 46, wherein the identification device is configured to automatically modify the pump console to display a setting associated with a circulation rate based on the volume of the inflatable membrane. (Item 48) 48. The system of any one of items 34-47, wherein the identification device is further configured to automatically modify the pump console to display settings associated with asynchronous circulation, copulsating circulation, or counterpulsating circulation. (Item 49) 49. The system of any one of items 34-48, wherein the intravascular device comprises an anti-thrombogenic coating. (Item 50) 50. The system of claim 49, wherein the antithrombogenic coating is on an outer surface of the device and an inner surface of the device. (Item 51) 50. The system of claim 49, wherein the intravascular device further comprises at least one valve chamber comprising at least one one-way valve, and wherein the anti-thrombogenic coating is within the at least one valve chamber. (Item 52) 1. A method of forming an intravascular device, the method comprising: forming at least one valve chamber, said chamber comprising a one-way valve; forming a membrane chamber of an expandable material, the membrane chamber having an expanded configuration and a contracted configuration; coupling at least one valve chamber to said membrane chamber; coupling a catheter tube to the valve chamber; A method comprising: (Item 53) Item 53. The method of item 52, wherein forming at least one valve chamber includes forming a valve subassembly including a valve and a valve housing. (Item 54) 54. The method of claim 52 or 53, wherein forming the at least one valve chamber includes forming the inlet pipe with an inlet valve disposed therein. (Item 55) 55. The method of any one of items 52-54, wherein coupling the at least one valve chamber to the membrane chamber comprises coupling the at least one valve chamber to the membrane chamber at a location offset from a central axis of the membrane chamber. (Item 56) 56. The method of any one of items 52-55, wherein forming at least one valve chamber comprises forming a valve chamber having an outer diameter, when viewed along a length of the device, that is smaller than an outer diameter of the membrane chamber, when viewed along a length of the device. (Item 57) 57. The method of any one of items 52-56, wherein coupling the at least one valve chamber to the membrane chamber comprises: placing a first valve chamber having a first one-way valve in fluid communication with the membrane chamber, the first one-way valve being positioned to allow flow in a first direction; and placing a second valve housing having a second one-way valve in fluid communication with the membrane chamber, the second one-way valve being positioned to allow flow in a second direction opposite the first direction. (Item 58) 58. The method of any one of items 52-57, further comprising positioning an inflatable membrane within the membrane chamber. (Item 59) 59. The method of any one of items 52-58, wherein forming the at least one valve chamber comprises coating at least the interior of the at least one valve chamber with an anti-thrombogenic coating. (Item 60) 60. The method of any one of items 52-59, further comprising coating at least one of the interior and exterior surfaces of the intravascular device with an anti-thrombogenic coating. (Item 61) 61. The method of any one of items 52-60, further comprising positioning an inflatable membrane within the membrane chamber, the inflatable membrane having a volume of about 5 cc to about 20 cc or a volume of about 25 cc to about 50 cc. (Item 62) 1. A method of assisting blood circulation in a body, said method comprising: Inserting a catheter into a venous structure, said catheter comprising: a membrane chamber located between the proximal and distal ends of the catheter; an inflatable membrane disposed within the membrane chamber; a first valve chamber forming part of or including a first one-way valve configured to permit blood flow in a first direction; Equipped with the first one-way valve is positioned proximal to the membrane chamber; and positioning the catheter such that the first valve chamber is positioned substantially adjacent one of a renal vein and a hepatic vein; expanding the membrane chamber from a contracted position to an expanded position; periodically supplying a fluid to the inflatable membrane to inflate and deflate the inflatable membrane; Including, The method wherein expansion of the membrane allows blood to exit the catheter and contraction of the membrane allows blood to enter the catheter through the first one-way valve. (Item 63) Item 62. The method of item 61, wherein the catheter further comprises a second valve chamber forming part of or including a second one-way valve configured to allow blood flow in the first direction, the method further comprising positioning the second valve chamber substantially adjacent to the other of the renal vein and the hepatic vein. (Item 64) Item 63. The method of item 61 or 62, wherein the catheter further comprises a third valve chamber distal to the membrane chamber, the third valve chamber forming part of or including a third one-way valve configured to allow blood flow in the first direction, and the method further comprises positioning the third valve chamber within the pulmonary trunk. (Item 65) 65. The method of any one of items 62-64, wherein positioning at least one of the first, second, and third valve chambers includes viewing a radiopaque marker associated with each of the first, second, and third valve chambers under a fluoroscopic microscope. (Item 66) 66. The method of any one of items 62-65, further comprising connecting the catheter to a pump console and periodically supplying fluid to the inflatable membrane. (Item 67) Item 67. The method of item 66, wherein connecting the catheter to the pump console includes connecting a connector assembly of the catheter to the pump console, the connector assembly being configured to identify the catheter to the pump console as an intravascular device. (Item 68) 68. The method of any one of items 62-67, wherein periodically supplying fluid to the inflatable membrane further comprises selecting a circulation rate based on one of asynchronous circulation, counterpulsating circulation, and co-pulsating circulation. (Item 69) Item 69. The method of item 68, wherein the circulation rate is generally inversely proportional to the volume of the inflatable membrane. (Item 70) 70. The method of any one of items 62-69, wherein the volume of the membrane chamber is greater than the volume of the first valve chamber. (Item 71) 71. The method of any one of items 62-70, wherein the outer dimension of the membrane chamber when viewed along the length of the device is greater than the outer dimension of the first valve chamber when viewed along the length of the device. (Item 72) 1. A method of assisting blood circulation in a body, said method comprising: Inserting a catheter into an arterial structure, said catheter comprising: a membrane chamber located between the proximal and distal ends of the catheter; an inflatable membrane disposed within the membrane chamber; a first valve chamber forming part of or including a first one-way valve configured to permit blood flow in a first direction; Equipped with the first valve chamber is positioned proximal to the membrane chamber; and positioning the catheter so that the first valve chamber is substantially adjacent a renal artery; expanding the membrane chamber from a contracted position to an expanded position; periodically supplying a fluid to the inflatable membrane to inflate and deflate the inflatable membrane; Including, The method wherein expansion of the membrane allows blood to exit the catheter through the first one-way valve and contraction of the membrane allows blood to enter the catheter. (Item 73) Item 73. The method of item 72, wherein the catheter further comprises a second valve chamber forming part of or including a second one-way valve configured to allow blood flow in a second direction opposite the first direction, and positioning the catheter further comprises positioning the catheter such that the second valve chamber is positioned substantially adjacent to a common carotid artery. (Item 74) 74. The method of claim 72 or 73, wherein the catheter further comprises a third valve chamber forming part of or including a third one-way valve, the third one-way valve configured to allow blood to flow in the first direction, and the method further comprises positioning the third valve chamber within the aorta. (Item 75) 75. The method of any one of items 72-74, wherein positioning at least one of the first, second, and third valve chambers includes viewing a radiopaque marker associated with each of the first, second, and third valve chambers under a fluoroscopic microscope. (Item 76) 76. The method of any one of items 73-75, further comprising connecting the catheter to a pump console and periodically supplying fluid to the inflatable membrane. (Item 77) Item 77. The method of item 76, wherein connecting the catheter to the pump console includes connecting a connector assembly of the catheter to the pump console, the connector assembly being configured to identify the catheter to the pump console as an intravascular device. (Item 78) 78. The method of any one of items 72-77, wherein cyclically supplying fluid to the inflatable membrane further comprises selecting a circulation rate based on counterpulsating circulation and co-pulsating circulation. (Item 79) Item 79. The method of item 78, wherein the circulation rate is generally inversely proportional to the volume of the inflatable membrane. (Item 80) 80. The method of any one of items 72-79, wherein the volume of the membrane chamber is greater than the volume of the first valve chamber. (Item 81) 81. The method of any one of items 72-80, wherein the outer dimension of the membrane chamber when viewed along the length of the device is greater than the outer dimension of the first valve chamber when viewed along the length of the device. (Item 82) 1. An intravascular device for pumping blood, said device comprising: a catheter comprising a membrane chamber located between a proximal tube portion and a distal tube portion with a distal end; at least one one-way valve located proximal or distal to the membrane chamber; Equipped with The at least one one-way valve is positioned along the length of the device relative to the distal end such that when the distal end is positioned at a target location relative to a first vascular structure, the at least one one-way valve is positioned adjacent to a second vascular structure different from the first vascular structure. (Item 83) Item 83. The device of item 82, wherein the first vascular structure comprises a left ventricle. (Item 84) Item 84. The device of item 83, wherein the at least one one-way valve comprises a first outlet valve and the second vascular structure comprises one of a carotid artery and a renal artery. (Item 85) Item 85. The device of item 84, wherein the at least one one-way valve further comprises a second outlet valve, each of the first outlet valve and the second outlet valve positioned along a length of the device so as to be located adjacent a respective one of the carotid artery and the renal artery. (Item 86) Item 83. The device of item 82, wherein the first vascular structure comprises a pulmonary artery. (Item 87) Item 87. The device of item 86, wherein the at least one one-way valve comprises a first inlet valve and the second vascular structure comprises one of a hepatic vein and a renal vein. (Item 88) Item 88. The device of item 87, wherein the at least one one-way valve comprises a second inlet valve, and each of the first inlet valve and the second inlet valve is positioned along the length of the device so as to be located adjacent to a respective one of the hepatic vein and the renal vein. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a cross-sectional schematic view of a right intravascular device according to an exemplary embodiment of the present disclosure.

[0015] [Figure 2] FIG. 2 is a cross-sectional schematic view of a right intravascular device according to another exemplary embodiment of the present disclosure.

[0016] [Figure 3] FIG. 3 is a cross-sectional schematic view of a left intravascular device according to yet another exemplary embodiment of the present disclosure.

[0017] [Figure 4] FIG. 4 is a cross-sectional schematic view of a left intravascular device according to yet another exemplary embodiment of the present disclosure.

[0018] [Figure 5] FIG. 5 is a cross-sectional schematic view of a right intravascular device according to yet another exemplary embodiment of the present disclosure.

[0019] [Figure 6] FIG. 6 is a schematic side view of an intravascular device, a deployment / retraction sheath, and a pump device console in a reduced profile configuration, in accordance with an exemplary embodiment of the present disclosure.

[0020] [Figure 7] FIG. 7 is a schematic side view of the intravascular device, insertion device, and pump device console of the embodiment of FIG. 6 with the intravascular device in an expanded configuration.

[0021] [Figure 8] FIG. 8 is an enlarged view of a portion of the schematic diagram of FIG.

[0022] [Figure 9] FIG. 9 is an enlarged view of a portion of an intravascular device according to an exemplary embodiment of the present disclosure.

[0023] [Figure 10] FIG. 10 is a schematic side view of an intravascular device shown positioned within a portion of a patient's left heart, according to an exemplary embodiment of the present disclosure.

[0024] [Figure 11] FIG. 11 is a schematic side view of an intravascular device shown positioned within a portion of a patient's right heart, according to another exemplary embodiment of the present disclosure.

[0025] [Figure 12A] FIG. 12A is a schematic side view of an intravascular device in a compressed state within an insertion / retraction sheath, according to an embodiment of the present disclosure.

[0026] [Figure 12B] FIG. 12B is a schematic side view of the intravascular device of FIG. 12A in an expanded state partially removed from an insertion / retraction sheath. DETAILED DESCRIPTION OF THE INVENTION

[0027] This description and the accompanying drawings illustrating exemplary embodiments should not be construed as limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this description and the claims, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the present disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated features described in detail with reference to one embodiment may, whenever practical, be included in other embodiments where they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment but not with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment.

[0028] For purposes of this specification and the appended claims, unless otherwise indicated, all numbers expressing quantities, percentages, or proportions, and other numerical values ​​used in the specification and claims, unless they are already so modified, are to be understood as being modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the following specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed at least in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0029] Furthermore, the terminology of this description is not intended to limit the present disclosure. For example, spatially relative terms such as "below," "lower," "lower side," "upper," "superior," "proximal," and "distal" may be used to describe the relationship of one element or feature to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e., rotational installations) of the device during use or operation, in addition to the position and orientation shown in the figures. For example, if a device in a figure were turned upside down, elements described as "below" or "below" other elements or features would be "above" or "on" the other elements or features. Thus, the exemplary term "below" can encompass both upper and lower positions and orientations. A device may be oriented differently (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein may be interpreted accordingly. Similarly, descriptions of movement along and around various axes include various particular device positions and orientations. Additionally, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context dictates otherwise. Also, the terms "comprises," "comprising," "includes," etc., specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups. Components described as coupled may be directly coupled electrically or mechanically, or they may be indirectly coupled through one or more intermediate components. Mathematical and geometric terms are not necessarily intended to be used according to their strict definitions unless the context of the description dictates otherwise, as one of ordinary skill in the art will understand that, for example, substantially similar elements that function in a substantially similar manner will readily fall within the scope of the descriptive terms despite the terms having similar strict definitions.

[0030] Various exemplary embodiments of the present disclosure contemplate systems, methods, and devices that assist a patient's heart in pumping blood through the left or right heart chamber. According to the present disclosure, an intravascular device (also referred to herein as a device for pumping blood and a ventricular assist device) includes a membrane chamber for moving blood in and out of the intravascular device. The membrane chamber includes (or is otherwise configured to receive) an inflatable balloon membrane that can be cyclically inflated and deflated to move blood in and out of the intravascular device through the device's inlet and outlet valves. According to one aspect of the present disclosure, the intravascular device can be configured to reduce (e.g., minimize) interference between the patient's anatomy and the intravascular device's inlet and / or outlet valves. For example, in certain exemplary embodiments, the valve can be located on a portion of the intravascular device that has an outer diameter smaller than the maximum outer diameter of the membrane chamber that includes the intravascular device's balloon membrane. Locating the valve away from the membrane chamber serves several purposes: it allows maximum flow around the device within the blood vessel while also allowing the valve to open to its full extent, maximizing blood inflow and outflow through the membrane chamber. Additionally, the size of the membrane chamber need not be limited by the need for a valve on the chamber to open, thus allowing the size of the membrane chamber to be maximized. In other words, the size of the membrane chamber is limited when a valve is located on the membrane chamber because the chamber must be small enough to allow the valve to open without contacting the surrounding blood vessel. While the present disclosure provides some embodiments in which all valves are located away from the membrane chamber, it is also within the scope of the present disclosure to include one or more valves on the membrane chamber, as will be discussed with respect to the exemplary embodiment of FIG. 11 below. In such embodiments, it may be desirable to position the valve on the chamber in a way that the size of the membrane chamber need not be limited to allow the valve to fully open.

[0031] Locating the valve away from the membrane chamber may also improve the ease of manufacturing the device. In certain exemplary embodiments, the valve may be located in a valve chamber separate from the membrane chamber. In certain embodiments, the membrane chamber is valveless, meaning that no valve is formed within the membrane chamber, in any sidewalls of the membrane chamber, or on any sidewalls of the membrane chamber. The valve chamber may comprise a volume that is in fluid communication with not only the membrane chamber but also other portions of the catheter. The valve chamber may take several different forms. For example, the valve chamber may be part of one or both of the proximal or distal tube portions of the catheter. In such embodiments, a portion of the proximal or distal tube may be expanded or inflated to have a larger diameter than the remainder of the proximal or distal tube, and a one-way valve, such as an inlet or outlet valve, may be located within the expanded or inflated portion of the tube (i.e., within the valve chamber). In another exemplary embodiment, the valve chamber may take the form of an inlet or outlet tube. The inlet or outlet tube may include an inlet or outlet valve, respectively, positioned in fluid communication with the membrane chamber, with the inlet or outlet tube extending substantially parallel to the proximal or distal tube portion of the catheter. Additionally or alternatively, the valve chamber may take the form of a separate valve assembly including one or more valves, such as an inlet valve or an outlet valve, which may include respective valve housings or may be housed by a common housing. In such cases, the valve assembly may be manufactured separately from other portions of the intravascular device, such as the membrane chamber and tube, and combined with the other portions of the intravascular device to form a complete intravascular device. The valve chamber may have other configurations for positioning the valve contained therein in fluid communication with the membrane chamber, as will be apparent to those skilled in the art.

[0032] In addition to improving manufacturability, utilizing valve subassemblies in devices also allows for a level of customization of the device. That is, the valve subassemblies can be positioned to accommodate variations in patient anatomy and to direct blood flow to preferred anatomical areas. For example, according to another aspect of the present disclosure, the inlet and / or outlet valves of an intravascular device can be positioned to optimally deliver flow to various anatomical locations, such as to provide or otherwise induce improved (e.g., optimal) cerebral and / or renal perfusion. For example, in some exemplary embodiments of the present disclosure, an intravascular device can include multiple outlet valve locations. For example, as illustrated in FIGS. 3 and 4 , an intravascular device according to the present disclosure can include a first outlet valve located distal or proximal to the membrane chamber. Optionally, the intravascular device can have a second outlet valve located proximal to the membrane chamber (when the first outlet valve is located distal to the membrane chamber) or distal to the membrane chamber (when the first outlet valve is located proximal to the membrane chamber). Additionally, in other exemplary device embodiments, the intravascular device may include multiple inlet locations. For example, an intravascular device according to the present disclosure, when adapted for right heart assist applications, may include a first inlet valve located on the device adjacent to the hepatic vein and a second inlet valve located on the device adjacent to the renal vein. Both inlet valves in such a configuration may be located proximal to the membrane chamber, and the intravascular device may have an outlet located at its distal end region. Alternatively, or in addition, one of the inlet valves may be located on the membrane chamber, as shown in the exemplary embodiment of FIG. 11.

[0033] According to another aspect of the present disclosure, an intravascular device may include features configured to interface with a console of a pump driver that provides a flow of working fluid (e.g., gas) and alternately inflate and deflate a balloon membrane within a membrane chamber (i.e., balloon membrane housing). For example, in some exemplary embodiments, the intravascular device includes a transducer, such as a pressure transducer, configured to provide a pressure signal to the pump driver. The pressure signal may be used to control aspects of pump operation, such as the timing of inflation and deflation cycles, dwell time in an inflated or deflated state, or other aspects of pump operation. Additionally or alternatively, the pressure signal may be used to provide pressure information at a user interface of the pump driver console. Other transducers, such as audio transducers, may also be utilized in place of or in addition to pressure transducers to be used to control aspects of pump operation.

[0034] The pump driver console may include various pre-programmed pumping algorithms that can be selected to provide optimized pumping based on parameters such as the type of intravascular device being used, certain aspects of the patient's anatomy, and the patient's response to adjunctive treatments, as well as other factors such as the patient's hemodynamic status prior to treatment, the degree of valvular dysfunction, and the patient's response to other therapies. Additionally, the pump driver console may be configured to allow a physician to manually set aspects of pumping based on factors such as those described above. In some exemplary embodiments, the intravascular device may include an identification device that provides information about the operating characteristics of the intravascular device to the pump driver console, allowing the pump driver console or a physician to select preferred operating parameters for pumping. According to one aspect of the present disclosure, connection to the identification device may cause the pump console to display a user interface configured for the intravascular device. For example, connection to the identification device may automatically change the display on the pump console from operating settings for a first operating mode to a second operating mode that includes operating settings for use with the intravascular device. The types of settings related to the intravascular device that can be viewed and controlled through the pump console can relate to, for example, alarm settings, detection settings, alarm conditions, device cycle triggering, device cycle timing, and user interface settings. In an embodiment, the identification device is a radio frequency identification (RFID) device incorporated into the intravascular device.

[0035] Referring now to FIG. 1 , an exemplary embodiment of an intravascular device 100 is shown. In the embodiment of FIG. 1 , intravascular device 100 is configured to assist the right heart and may therefore be referred to as a right ventricular assist device (“RVAD”). Intravascular device 100 includes a membrane chamber 104. A membrane or diaphragm or balloon configured to expand and contract (or inflate and deflate or otherwise change the volume occupied within membrane chamber 104) is positioned within the membrane chamber to provide a pumping function. Such a membrane or diaphragm may be referred to interchangeably herein as an expandable or inflatable membrane or balloon membrane or intra-aortic balloon (IAB) (although it is anticipated that balloon members other than those used on IABs may also be used). These membranes may be formed, for example, from a polymer or other flexible material. By way of non-limiting example, the membrane may comprise polyurethane, silicone, or other polymer. Further examples of membranes and materials they may incorporate can be found in U.S. Patent No. 6,482,173, issued November 19, 2002, the entire contents of which are incorporated herein by reference. Additionally, in certain embodiments, the balloon may be inflatable, while in other embodiments, the balloon may be non-inflatable. In the exemplary embodiment of FIG. 1 , an inflatable membrane balloon 106 used in an intra-aortic balloon (IAB) device is positioned within membrane chamber 104. Tube 102 is in fluid communication with membrane chamber 104 and extends proximally therefrom. Tube 102 may be referred to as the proximal tube portion. As used herein, the term “proximal” refers to the direction along intravascular device 100 toward the end of the device that remains outside the patient's body and connects to external equipment, such as pump console 640 (shown in FIGS. 6 and 7 ), and the term “distal” refers to the direction along intravascular device 100 toward the end of the device opposite the proximal end, such as the free end of the device configured for placement within the patient's right or left heart. The tube 102 may extend all the way outside the patient, for example to the pump console 640, or the tube 102 may not extend all the way outside the patient, and the outer surface of the tube 116 may be sealed to prevent blood leakage during pumping.

[0036] Tubing 108 is in fluid communication with membrane chamber 104 and extends distally therefrom, and includes an outlet valve 110 and an open distal end 111. Tubing 108 may be referred to as a distal tubing portion. In exemplary embodiments, outlet valve 110 may be a one-way valve, such as a check valve, that opens or closes based on the relative pressure present on either side of outlet valve 110. In some exemplary embodiments, tubing 108 may have a "J" shape or be coupled to a "J"-shaped extension or pigtail. Such a configuration may prevent open distal end 111 from becoming occluded by the blood vessel wall when in place within a patient. Extensions having such configurations are shown, for example, in U.S. Patent Application Publication No. US2010 / 0268017 A1 to Siess, published October 21, 2010, and U.S. Patent No. 9,545,468 to Aboul-Hosn, issued January 17, 2017, the entire contents of each of which are incorporated herein by reference. An inlet valve 112 is disposed within an inlet valve chamber 114, which is located between and in fluid communication with the tube 102 and the membrane chamber 104. Similar to the outlet valve 110, in exemplary embodiments, the inlet valve 112 may be a one-way valve, such as a check valve, that operates based on a pressure differential across the inlet valve 112. The inlet valve 112 and the inlet valve chamber 114 may be referred to as a valve subassembly. In some exemplary embodiments, the inlet valve 112 may be disposed directly on the tube 102 or on an extension of the tube 102. In an exemplary embodiment, the inlet valve 112 may comprise one or more film flaps connected at one end to the inlet valve chamber 112 or the tube 102. In other exemplary embodiments, the valve 112 may comprise a flapper valve, a duckbill valve, or other valve configurations.

[0037] The membrane balloon 106 is connected to an external fluid source, such as a source of shuttle gas from a pump console 640 (shown in connection with FIGS. 6 and 7 ), which alternately inflates and deflates the membrane balloon 106 within the membrane chamber 104. By way of non-limiting example, the supplied gas may be helium to prevent the formation of emboli if the gas escapes from the intravascular device 100 into the patient's bloodstream. As will be understood by those skilled in the art, other suitable gases or fluids may also be used to inflate the membrane balloon 106. The gas may be supplied through the device's shaft 116, which is in fluid communication with the membrane balloon 106, passes through the tube 102, and receives a supply of gas from the pump console 640.

[0038] In use, the membrane chamber 104 of the device is in a compressed or collapsed configuration prior to insertion to reduce the overall profile of the device and enable percutaneous insertion. For right-sided circulatory support, the device may be inserted into the right subclavian vein to access the superior vena cava, right atrium, or right ventricle. Additionally, when the femoral vein is used for right-sided circulatory support, it may be used to access the inferior vena cava, right atrium, or right ventricle. For left-sided circulatory support, the left femoral artery may be used to access the aorta. While various embodiments of the present disclosure are described herein in terms of percutaneous insertion, the present disclosure contemplates insertion in other ways, such as direct aortic insertion or surgical cutdown insertion. The membrane chamber (and other portions of the device) may incorporate a self-expanding material to naturally move from a collapsed configuration to an expanded configuration, for example, after insertion and positioning within a blood vessel. Examples of such structures include those disclosed in, for example, U.S. Patent Application Publication No. US2012 / 0172655 and PCT Publication No. WO2012094525 to Campbell et al. and PCT Publication No. WO2013173245 to Zeng et al. (the entire contents of each publication are incorporated herein by reference). Examples of materials that can be used for such self-expanding structures include shape memory materials. By way of non-limiting example, such shape memory materials can include shape memory alloys (SMAs) such as nitinol (NiTi), Fe-Mn-Si, Cu-Zn-Al, Cu-Al-Ni, or other SMAs, as well as shape memory polymers (SMPs) such as polyurethane-, polystyrene-, cyanate ester-, and epoxy-based SMPs. Alternatively, compressible materials (i.e., materials with a sufficiently high modulus of elasticity) that have sufficient "rebound" to expand after being compressed for insertion can be used. Examples of suitable materials include, for example, stainless steel or other metals or metal alloys, or polymers such as polyimide or polyetheretherketone (PEEK). In such embodiments, it may be desirable to use a sheath or other sleeve-like member to maintain the membrane chamber in a compressed configuration during insertion. The sheath can be withdrawn after placement of the device.As another alternative, the material used may not be self-expandable. In such cases, expansion and retraction of the membrane chamber may occur through other mechanical methods, such as those disclosed in U.S. Pat. No. 4,444,186 (incorporated herein by reference in its entirety). With the membrane chamber in a compressed or contracted configuration, the distal end 111 of the device is percutaneously inserted through an incision in the patient's body into an arterial or venous structure, such as the femoral artery or femoral vein. As will be understood by those skilled in the art, other insertion sites, such as the axillary, subclavian, or brachiocephalic artery or vein, may also be used depending on the specifics of the device and the patient. The exemplary embodiment shown in FIG. 1 is an RVAD configured to assist in moving blood from the vena cava, right atrium, or right ventricle, via the pulmonary artery, and / or across the heart to the lungs. In exemplary use, the device may be inserted through the femoral vein and guided into the inferior vena cava (IVC), with the distal end 111 of the outlet tube 108 positioned to provide outlet flow from the outlet valve 110 to the patient's pulmonary trunk. The inlet valve chamber 114 may be positioned within the IVC, right atrium, or right ventricle. In other exemplary embodiments, the device may be inserted through the superior vena cava, depending on the patient's specific treatment needs and factors related to the patient's anatomy. When the balloon is in a deflated state, blood pressure within the vena cava, right atrium, or right ventricle, depending on where the inlet valve chamber 114 is positioned, causes the inlet valve 112 to open, allowing blood to flow into the membrane chamber 104 around the deflated membrane balloon 106. The outlet valve 110 remains closed while the membrane chamber 104 fills with blood. Once the membrane chamber 104 is filled, inflation of the membrane balloon 106 causes the pressure within the membrane chamber 104 to rise above the pressure in the right atrium or ventricle, closing the inlet valve 112 and thereby preventing backflow of blood due to the balloon inflation. The pressure within the membrane chamber 104 causes the outlet valve 110 to open and blood to be expelled from the membrane chamber 104, through the outlet tube 108, and into the pulmonary artery. In this way, the intravascular device 100 assists the right heart in pumping blood from the vena cava, right atrium, or right ventricle into the pulmonary artery.

[0039] Various configurations of the inlet valve 112 and the outlet valve 110 are possible, including those in which the outlet valve 110 is absent. For example, in the exemplary embodiment of FIG. 1 , the inlet valve 112 is contained within the inlet valve chamber 114. The inlet valve chamber 114 and the inlet valve 112 can be manufactured as a separate assembly from the membrane chamber 104 and coupled to the membrane chamber 104 and the tube 102 to form the intravascular device 100. For example, the assembly of the inlet valve chamber 114 and the inlet valve 112 can be coupled to the membrane chamber 104 or the tube 102 by bonding using, for example, adhesives, ultrasonic, friction, or welding, such as laser welding, or any other method. The valve chamber 114, in certain embodiments, can be formed as an enlarged or inflated portion of the tube 102, as described below. Forming the inlet valve assembly separate from the membrane chamber 104 provides flexibility in manufacturing the inlet valve assembly and the membrane chamber. For example, in some exemplary embodiments, manufacturing or bonding of the valve elements to other components of the device involves thermal or chemical processes. By manufacturing the valve assembly separately from the other components of the device, the adverse effects of such thermal or chemical processes on the other components of the device can be reduced or eliminated.

[0040] Additionally, fabricating the valve chamber 114 separate from the membrane chamber 104 provides additional flexibility regarding the position of the valve relative to the membrane chamber 104. For example, the longitudinal position of the valve assembly relative to the membrane chamber 104 can be varied, for example, by including a desired length of tubing between the membrane chamber 104 and the valve assembly (as shown and discussed in connection with the exemplary embodiment of FIG. 3). In this manner, the position of the valve can be adjusted to improve perfusion of blood to the anatomical structure and, alternatively, or in addition, to improve (e.g., optimize) the effectiveness of the intravascular device by positioning the valve in a location that reduces the tendency of the anatomical structure to partially or completely occlude the valve.

[0041] As an illustrative alternative to providing a separate chamber 114 for the valve, the inlet valve chamber 114 may be formed by expanding a portion of the tube 102 to form the inlet valve chamber 114. For example, the portion of the tube 102 may be expanded by heating and pressurizing the tube 102 in a mandrel that forms the tube 102 into the desired shape, by swaging the tube 102, or by any other method. As a further non-limiting example, the inlet valve chamber 114 may be formed as a reduced diameter tube in fluid communication with the membrane chamber 104 that is mechanically or chemically bonded to the tube 102.

[0042] The outer lateral dimensions of the inlet valve chamber 114 may be smaller than the corresponding outer lateral dimensions of the membrane chamber 104. The lateral dimensions may also be referred to as outer dimensions or outer contours. The contours may refer to the outer contour of the membrane chamber 104 as viewed along the longitudinal direction of the device. For example, the inlet valve chamber 114 may have an outer diameter Dh that is smaller than the outer diameter Dc of the membrane chamber 104. The diameter Dh of the inlet valve chamber 114 may be larger than the outer diameter DT of the outlet tubing 108 and the proximal tubing 102. The reduced outer diameter of the intake valve chamber 114 relative to the diameter Dc of the membrane chamber 104 may facilitate operation of the valve without occlusion by anatomical structures. For example, because the diameter Dh of the inlet valve chamber 114 is smaller than the diameter Dc of the membrane chamber 104, when the membrane chamber 104 is in place within the patient's heart, the smaller diameter Dh of the inlet valve chamber 114 can provide clearance between the anatomical wall and the inlet valve 112, thereby potentially avoiding blockage of the inlet valve 112. This also allows for increased blood flow within the vessel and around the membrane chamber 104. The smaller diameter of the inlet valve chamber 114 also provides less obstruction than if the inlet valve chamber 114 and the membrane chamber 104 had the same diameter when fully deployed or expanded, reducing resistance to blood flowing around the outer surface of the intravascular device 100. Additionally, while the optional outlet valve 110 is shown as being included within the tube 108 in FIG. 1 , the present disclosure also contemplates that the outlet valve 110 may be included in a housing separate from the tube 108 or formed within an expanded portion of the tube 108. Although the outer lateral dimensions of the membrane chamber 104, the inlet valve chamber 114, and the tubes 102, 108 are discussed in terms of diameter, the membrane chamber 104, the inlet valve chamber 114, and the tubes 102, 108 are not limited to having circular cross sections. For example, the cross sections of the membrane chamber 104, the inlet valve chamber 114, the tubes 102, and / or the tubes 108 may be oval, square, rectangular, or have other polygonal or non-polygonal shapes, by way of non-limiting example.

[0043] 1 , membrane chamber 104 has a length LC, and inlet valve chamber 114 has a length LH. Length LC of membrane chamber 104 can be greater than length LH of inlet valve chamber 114. Additionally, membrane chamber 104 can have an internal volume defined by the internal shape and dimensions of membrane chamber 104. Inlet valve chamber 114 can have an internal volume defined by the internal shape and dimensions of inlet valve chamber 114. The internal volume of membrane chamber 104 can be greater than the internal volume of inlet valve chamber 114.

[0044] In some exemplary embodiments, intravascular device 100 may include markers 117 positioned adjacent the ends of inlet valve 112 and outlet tubing 108 to assist a physician in positioning intravascular device 100 so that the valves are optimally positioned for effective blood uptake and perfusion. Markers 117 may comprise radiopaque materials that are visible in x-rays and under fluoroscopy, such as halogen or metal compounds. Non-limiting examples of such radiopaque materials include tungsten, tantalum, or BaSO4 (barium sulfate).

[0045] In some exemplary embodiments, portions of intravascular device 100 may include an anti-thrombogenic coating to reduce the incidence of thrombus formation. Such a coating may be applied to the entire intravascular device 100 or only portions of intravascular device 100, such as in, on, and / or near the valve chamber, membrane chamber 104, etc. The coating may be applied to the exterior and / or interior of the device. The coating may be an immobilized heparin coating formed by alternating layers of egg white and heparin, or may include other combinations of heparin and / or egg white. One example of such an immobilized heparin coating is BIOLINE®, available from Maquet Cardiovascular, LLC (45 Barbour Pond Drive, Wayne, New Jersey, 07470 USA).

[0046] In some embodiments, the inlet valve chamber may comprise an inlet tube with an open end and an inlet valve positioned within the inlet tube. For example, referring now to FIG. 2 , intravascular device 200 includes an inlet tube 218 with an open end 220 and an inlet valve 212 disposed within inlet tube 218. Intravascular device 200 includes an outlet tube 208 with an outer diameter D and an outlet valve 210 within outlet tube 208. In the illustrative example of FIG. 2 , inlet tube 218 is coupled to membrane chamber 204, inlet tube 218 is positioned offset from a central axis Ac of membrane chamber 204, and tube 202 is positioned coaxially with central axis Ac of membrane chamber 204. In other embodiments, tube 202 may be offset relative to central axis Ac, and inlet tube 218 may be positioned coaxially with or offset relative to central axis Ac of membrane chamber 204.

[0047] The inlet tube 218 may have an outer diameter DT and a length L selected to position the open end 220 of the inlet tube 218 in an optimal location for drawing blood from the anatomy in which the intravascular device is positioned into the membrane chamber 204. As with the embodiment of FIG. 1, the configuration of the inlet tube 218, such as the length L, may be selected to avoid blockage of the open end 220 of the inlet tube 218 by the patient's anatomy.

[0048] Referring now to FIG. 3 , another exemplary embodiment of an intravascular device 300 is shown. In the embodiment of FIG. 3 , intravascular device 300 is configured to support the left heart and may be referred to as a left ventricular assist device (“LVAD”). Intravascular device 300 includes a membrane chamber 304, which includes a membrane balloon 306 configured to communicate with a pump console (e.g., pump device console 640 shown in FIGS. 6 and 7 ). An inlet tube 308 extends from a distal portion of membrane chamber 304 and includes an inlet valve 312 located at a location distal to the membrane chamber, such as at an open end 330 of inlet tube 308. The intravascular device includes first and second outlet valve chambers 322 and 324, each of which may be provided with a housing including an outlet valve 310. A first outlet valve chamber 322 is positioned distal to the membrane chamber 304 and proximal to the inlet valve 312 , and a second outlet valve chamber 324 is positioned proximal to the membrane chamber 304 .

[0049] Like inlet valve chamber 114 discussed in connection with the embodiment of FIG. 1 , outlet valve chambers 322 and 324 can be fabricated separately from membrane chamber 304 and then attached to membrane chamber 304, such as outlet valve chamber 324 in the exemplary embodiment of FIG. 3 , or can be attached to membrane chamber 304 by a portion of inlet tubing 308, as shown in the exemplary embodiment of FIG. 3 with respect to outlet valve chamber 322. Alternatively, outlet valve chambers 322, 324 can be formed by expanding a portion of tubing 308 and positioning outlet valve 310 within the expanded portion of tubing 308. Positioning multiple outlet valve chambers (e.g., outlet valve chambers 322 and 324) along the length of intravascular device 300 can allow blood flow to be directed to specific areas, optimizing perfusion, e.g., cerebral and renal perfusion of blood from intravascular device 300. For example, in the embodiment of FIG. 3 , outlet valve chambers 322 and 324 are configured to be positioned adjacent to the common carotid artery and renal artery. Although the embodiment of FIG. 3 is illustrated with two outlet valve chambers, it is within the scope of this disclosure to provide additional valve chambers either proximal and / or distal to the membrane chamber depending on physiological needs.

[0050] Similar to inlet valve chamber 114 discussed in connection with the embodiment of FIG. 1 , outlet valve chambers 322 and 324 have an outer diameter Dh that is smaller than the outer diameter Dc of membrane chamber 304. Such a configuration can prevent interference with or blockage of outlet valve 310 when the intravascular device is positioned with an anatomical structure, particularly in a configuration in which outlet valve 310 opens outward, as shown in FIG. 3 . This also allows for increased blood flow within the vessel and around membrane chamber 304. Furthermore, while inlet valve 312 is shown as being contained within the end of tube 308 in FIG. 3 , the present disclosure contemplates that inlet valve 312 can also be contained within the chamber. Furthermore, the present disclosure contemplates that the outer diameter Dh of chambers 322 and 324 can be greater than the outer diameter Dt of tubes 302 and 308. Additionally, in some embodiments, the outer diameter Dh of a chamber (such as chambers 322 and 324) can be greater than the outer diameter Dc of membrane chamber 304.

[0051] In use, the membrane chamber 304 of the device is in a compressed or contracted configuration prior to and during insertion to reduce the overall profile of the device and enable percutaneous insertion. Additionally, one or both of the tubes 302 and 308 may be introduced in a collapsed (i.e., reduced diameter) state to reduce the overall diameter of the device and facilitate insertion. The membrane chamber (and other portions of the device) may incorporate a self-expanding material to naturally move from a contracted configuration to an expanded configuration, for example, after insertion and positioning into a blood vessel. Examples of such self-expanding materials include shape-memory materials such as SMAs and SMPs listed above in connection with the embodiment of FIG. 1. Alternatively, a compressible material with sufficient "bounce back" to expand after being compressed for insertion may be used. Examples of suitable materials include materials exhibiting a high elastic modulus, such as those listed above in connection with the embodiment of FIG. 1. In such embodiments, it may be desirable to use a sheath or other sleeve-like member to maintain the membrane chamber in a compressed configuration during insertion. The sheath can be withdrawn after deployment of the device. As another alternative, the material used may not be self-expandable. In such cases, expansion and retraction of the membrane chambers may occur through other mechanical methods, such as those disclosed in U.S. Pat. No. 4,444,186 (incorporated herein by reference in its entirety) and U.S. Pat. No. 5,928,132 (also incorporated herein by reference). With the membrane chambers in a compressed or contracted configuration, the intravascular device 300 may be percutaneously inserted, for example, through the patient's femoral artery until the inlet tube 308 is positioned within the patient's left ventricle and the outlet valve chambers 322, 324 and membrane chamber 304 are positioned within the patient's aorta. As described above, one or more of the outlet valve chambers may have markings, such as radiopaque marker 317, that allow the housing to be visualized during insertion via fluoroscopy. This allows the surgeon to adjust and then observe the position of one or both of the outlet valves to maximize perfusion, e.g., cerebral or renal perfusion.The present application contemplates that the marker may be located near or adjacent to the valve, rather than always on the valve chamber. For example, the marker may be located on the tubing just proximal or just distal to the valve chamber.

[0052] The shaft 316 connects the membrane balloon 306 to a pump console 640 (FIGS. 6 and 7) and allows for cyclic inflation of the balloon membrane 306 with gas or other fluid supplied by the pump console 640 to inflate and deflate the balloon membrane 306. In use, when the membrane balloon 306 is in a deflated state, blood pressure in the left ventricle causes the inlet valve 312 to open and blood to enter the membrane chamber 304 through the tube 308. When the membrane balloon 306 is inflated, the increased pressure in the membrane chamber 304 causes the inlet valve 312 to close, preventing backflow through the opening 330, and blood to exit the membrane chamber 304 through the outlet valve 310.

[0053] In addition to adjusting the position of each of the outlet valves 310 to increase (e.g., optimize) blood perfusion to particular anatomical structures, the flow rate of each of the outlet valves 310 may constitute a different percentage of the total flow rate from the intravascular device 300. For example, outlet valves positioned further from the membrane chamber 304 may have a lower flow rate compared to outlet valves positioned closer to the membrane chamber 304 due to losses (e.g., friction coefficients) within the tubing 308. Additionally, different outlet valves 310 may have different flow areas (e.g., cross-sectional areas) to provide different overall flow rates between the different valves. For example, the outlet valves 310 may be configured so that half the pumped volume passes through the proximal valve and half the pumped volume passes through the distal valve. However, depending on the estimated needs of the patient, the division of the total flow volume to the proximal and distal outlet valves 310 may be divided 60:40, 70:30, 40:60, or 30:70, as desired, depending on the valve configuration and the desired perfusion strategy. As a non-limiting example, the flow rate adjacent to the renal arteries may be greater than the flow rate adjacent to the common carotid, brachiocephalic, and subclavian arteries if such an arrangement would be beneficial to patient recovery. Alternatively, the device's flow rate may be greater in that area to ensure adequate flow to the upper bifurcation of the aorta. FIG. 4 shows an intravascular device 400 similar to the intravascular device 300 of FIG. 3. In the embodiment of FIG. 4, an outlet valve 410 is distal to a proximal tube 402 having an outer diameter D, proximal to the membrane chamber 404 and the inlet tube 408. The inlet tube 408 has an outer diameter D, extends distally from the membrane chamber 404, and includes an inlet valve 412 and another outlet valve 410. The potential for interference with or blockage of the outlet valve 410 by anatomical structures when the intravascular device is positioned within a patient's body is reduced by locating the outlet valve 410 within a portion of the intravascular device having an outer diameter smaller than the outer diameter of the membrane chamber 404. In the embodiment of Figure 4, the outlet valve 410 is incorporated into the structure of the device 400 having an outer diameter similar to or equal to the outer diameter DT of the inlet tube 408 and the proximal tube 402. For example, the outlet valve 410 may be located within a valve chamber (not shown in Figure 4) similar to the embodiment of Figure 3, or the outlet valve 410 may be located within an expanded portion of the tube 402 or the inlet tube 408.The outlet valve 410, located distally of the membrane chamber 404, is in a more proximal location compared to the similar outlet valve 310 shown in Figure 3. Such different valve placement may facilitate perfusion to different areas of the patient's anatomy compared to the embodiment of Figure 3, or may be adjusted to compensate for anatomical differences between patients.

[0054] Referring now to FIG. 5, yet another embodiment of an intravascular device 500 is shown. Intravascular device 500 is a right-handed intravascular device similar in function to intravascular devices 100 and 200 described in connection with FIGS. 1 and 2. In the embodiment of FIG. 5, intravascular device 500 includes an inlet valve chamber 514 having an inlet valve 512 positioned therein. Inlet valve chamber 514 is coupled to a membrane chamber 504 that includes a membrane balloon 506. Inlet valve chamber 514 is offset relative to the central axis of membrane chamber 504, such that inlet valve chamber 514 can be connected to proximal tube 502 at a location offset from where inlet valve chamber 514 is connected to membrane chamber 504. Membrane chamber 504 is connected to a distal outlet tube 508 that is provided with an outlet valve 510.

[0055] The offset of inlet valve chamber 514 can be selected to prevent occlusion of a portion of a patient's anatomy when intravascular device 500 is inserted into the patient's body and / or to position inlet valve chamber 514 to better accommodate redirection within the patient's circulatory system. By way of non-limiting example, in an RVAD device such as device 500, an offset configuration of inlet valve chamber 514 can avoid occlusion of the hepatic vein, while in an LVAD device, a similar offset valve chamber can avoid occlusion of, for example, the celiac artery. The offset can be flexible. The offset can be helical in configuration, or it can be provided by a non-helical curve. The offset of valve chamber 514 and the positioning of intravascular device 500 can be configured such that the offset configuration of valve chamber 514 can allow valve chamber 514 to be positioned radially away from, for example, the hepatic vein in an RVAD device or the celiac artery in an LVAD device to avoid occlusion of those structures.

[0056] In various embodiments of the intravascular devices described in connection with Figures 1-5, the membrane chambers (e.g., membrane chambers 104, 204, 304, 404, and 504) and valve chambers (e.g., valve chambers 114, 322, 324, and 514) may be configured to be collapsible to facilitate insertion and removal from a patient's body. For example, in the embodiment of Figure 5, valve chamber 514 may be collapsible to an overall outer diameter that does not substantially exceed the outer diameter D of tube 502. By way of non-limiting example, inlet valve chamber 514 may include a material such as a shape memory alloy or elastic structure that can be collapsed for insertion within the body and returned to an expanded configuration once in place within the patient. Similarly, the structure of membrane chambers 104, 204, 304, 404, and 504 and valve chambers 114 (FIG. 1) and 322, 324 (FIG. 3) may be configured to similarly contract to a reduced diameter compared to the expanded configuration to facilitate insertion of the intravascular device within the patient's body. For example, membrane chambers 104, 204, 304, 404, and 504 and valve chambers 114, 322, and 324 may comprise materials such as shape memory alloys, elastic materials, or other materials and configurations configured as a contractible scaffold, framework, or mesh.

[0057] 6 and 7 , devices and procedures for inserting intravascular device 600 into a patient's body will be shown and discussed. Intravascular device 600 is placed within deployment / retraction sheath 636. Intravascular device 600 may be placed within deployment / retraction sheath 636 during manufacturing, packaging, or at another time. Various components of intravascular device 600 may be configured to be placed in a reduced profile configuration to facilitate insertion of intravascular device 600 within deployment / retraction sheath 636. For example, as discussed above, components such as membrane chambers (e.g., any of membrane chambers 104, 204, 304, 404, and 504) and one or more valve chambers (e.g., valve chambers 114, 322, 324, and 514) may have a reduced profile configuration in which they fit within deployment / retraction sheath 636 as shown in FIG. 6 . 6 and 7, intravascular device 600 includes a coil 660 comprising a resilient material positioned within membrane chamber 604 in a reduced profile configuration. In this reduced profile configuration, deployment / retraction sheath 636 can be inserted (e.g., through an incision through body tissue) into an anatomical structure such as the femoral artery (in the case of an LVAD) or femoral vein (in the case of an RVAD). In other exemplary embodiments, depending on the configuration of intravascular device 600 or the needs of the patient, intravascular device 600 can be inserted into the axillary, subclavian, or brachiocephalic artery or vein. In some exemplary embodiments, deployment / retraction sheath 636 can include a stiffening coil. Additional details regarding catheter structures and sheaths including similar coils can be found in U.S. Patent No. 6,935,999, issued August 30, 2017, the entire contents of which are incorporated herein by reference.

[0058] In some exemplary embodiments, prior to insertion of deployment / retraction sheath 636, a guidewire (not shown) may be first inserted and its distal end positioned within a desired anatomical location, such as the pulmonary trunk for an RVAD device or the left ventricle for an LVAD device. Deployment / retraction sheath 636 and endovascular device 600 are guided along the guidewire to the desired location.

[0059] 1, in some exemplary embodiments, intravascular device 600 may include markers at various locations on the device to assist a physician in properly positioning the device within a patient using fluoroscopic visualization. For example, in one exemplary embodiment, the valves of the device, such as the inlet and / or outlet valves, may include radiopaque markers to allow a physician to position the valves in the optimal anatomical location, as discussed above.

[0060] Once the intravascular device is properly positioned within the patient's body, the deployment / retraction sheath 636 is withdrawn a distance. Upon removal of the deployment / retraction sheath 636, components of the intravascular device 600 in the reduced profile position, such as the membrane chamber 604 and valve chambers (e.g., valve chambers 114, 322, 324, and 514), may expand to their expanded configurations, as shown diagrammatically in dashed lines in FIG. 7 . For example, in the embodiment of FIGS. 6 and 7 , the coil 660 resiliently expands to place the membrane chamber 604 in the expanded configuration shown in FIG. 7 once the sheath is removed from the intravascular device 600. Alternatively, the membrane chamber 604 and the valve chambers may be configured to expand upon command, such as by application of an electric current or a temperature differential to a shape memory alloy. The deployment / retraction sheath 636 is withdrawn a sufficient distance to expose the valve of the intravascular device 600. Thus, the distance that the deployment / retraction sheath is withdrawn may depend, at least in part, on the number and location of valves in intravascular device 600 .

[0061] Removal of intravascular device 600 may include reversing one or more of the insertion acts described above. For example, to remove intravascular device 600, deployment / retraction sheath 636 may be advanced over components of intravascular device 600, such as over the membrane chambers and / or valve chambers, to compress the components to a diameter or size that fits within deployment / retraction sheath 636, which may be withdrawn from the patient's body with intravascular device 600 positioned therein. When deployed, the various described membrane and valve chambers possess sufficient rigidity to retain their fully deployed shape within the patient's vasculature, meaning their rigidity is sufficient to withstand intra-arterial pressure. However, these structures may be configured with sufficient flexibility to manually collapse when pulled through the patient's vasculature. Because the forces exerted by the walls of smaller blood vessels can exceed intra-arterial pressure, they can be sufficient to cause these chambers to collapse when the intravascular device is pulled through the more distal vessel and the access incision through which it was originally inserted. Additionally, the sheath can exhibit sufficient hoop strength to manually cause the structure to collapse when pulled into the sheath.

[0062] The guidewire may be withdrawn from the patient before or after withdrawal of deployment / retraction sheath 636. Depending on the configuration of intravascular device 600, membrane balloon (e.g., membrane balloon 106 (FIG. 1)) and associated shaft 116 (FIG. 1) may be inserted into intravascular device 600 prior to insertion of the device into the patient, such as during manufacturing or packaging, or may be inserted through hemostasis valve 638 once intravascular device 600 is in position within the patient. For example, in an exemplary embodiment, the intravascular device without membrane balloon 106 and shaft 116 may be inserted and positioned within the patient at a desired location to provide treatment. Once the intravascular device is in position, membrane balloon 106 and shaft 116 are then inserted through hemostasis valve 638 and advanced until balloon 106 is located within the membrane chamber (e.g., membrane chamber 104 of FIG. 1).

[0063] Intravascular device 600 may be connected to pump driver console 640. Pump driver console 640 may provide alternating fluid pressure to membrane balloon 106 through shaft 116 (FIG. 1), alternately inflating and deflating membrane balloon 106 as discussed above. The timing of the inflation and deflation cycles of pump driver console 640 may be manually set by a physician based on factors such as the operating characteristics of intravascular device 600 and factors related to the patient's condition and needs.

[0064] In some exemplary embodiments, pump driver console 640 may include a system that controls the timing of inflation and deflation cycles of pump driver console 640 based on information received from intravascular device 600. For example, referring now to FIG. 8 , intravascular device 600 ( FIGS. 6 and 7 ) may include a connector assembly, such as connector portion 642, with identification device 644 configured to provide information regarding the operational characteristics of intravascular device 600 to pump driver console 640 ( FIGS. 6 and 7 ). Identification device 644 may comprise a passive electronic component, such as a resistor or jumper wire, or may include an electronic memory component, such as a form of non-volatile memory (e.g., EEPROM). Pump driver console 640 may be configured to read information from identification device 644 and determine an appropriate operating mode based, at least in part, on the information conveyed by identification device 644. In some embodiments, information regarding intravascular device 600 may be shared with pump driver console 640 using an RFID tag on intravascular device 600 and other components, such as an RFID sensor of pump driver console 640.

[0065] Additionally or alternatively, intravascular device 600 may be configured to provide pump driver console 640 with real-time information regarding pressure conditions within a membrane chamber (e.g., membrane chamber 104 (FIG. 1)). For example, referring now to FIG. 9, right intravascular device 900 includes a pressure transducer 946 within outlet tube 908 and configured to detect pulmonary artery pressure. Pressure transducer 946 may be, for example, a fiber optic pressure transducer that utilizes an optical cavity that changes in response to applied pressure or other optical configurations and / or components. Pressure information obtained from pressure transducer 946 may be transmitted to pump driver console 640 (FIGS. 6 and 7) through connector portion 642 when connector portion 642 is mated with a complementary connector on pump driver console 640. Additionally or alternatively, blood pressure measurements can be made using a side port (not shown) of deployment / retraction sheath 636 (FIGS. 6 and 7). Blood pressure may be measured, for example, in the superior vena cava (in the case of an RVAD) or the aorta (in the case of an LVAD). Pressure transducer 946 is shown in outlet tubing 908, although in an exemplary embodiment, one or more pressure transducers may be included adjacent the inlet and / or outlet valves, such as adjacent inlet valve 112 (FIG. 1) and outlet valve 110 (FIG. 1).

[0066] Information regarding the pressure within a membrane balloon (e.g., membrane balloon 106 of FIG. 1) can be used to control the operation of pump driver console 640. For example, the pressure within membrane balloon 106 can be detected by a pressure transducer within pump driver console 640 or by a pressure transducer similar to pressure transducer 946 (FIG. 9) located within membrane balloon 106 itself.

[0067] In an exemplary embodiment, the pump driver console 640 can control various operating characteristics, such as the timing of inflation and deflation events, based on the pressure within the membrane balloon 106. For example, based on the pressure waveform of the membrane balloon, the pump driver console 640 can detect when the membrane balloon 106 has been fully deflated and immediately switch to inflation to re-inflate the membrane balloon 106. Additionally or alternatively, the pump driver console 640 can detect when the pressure within the membrane balloon 106 has reached a plateau and immediately begin deflating the membrane balloon 106.

[0068] In some exemplary embodiments, a time delay between deflation and inflation may be utilized to enhance filling and draining of membrane chamber 104 ( FIG. 1 ). For example, assuming the membrane chamber is not a perfectly rigid structure, blood flow into membrane chamber 104 may be such that membrane chamber 104 does not fill as quickly as membrane balloon 106 deflates, and a dwell time at maximum deflation may be used to ensure membrane chamber 104 completely fills with blood. Similarly, in some embodiments, a dwell time at maximum inflation is used to ensure complete drainage of membrane chamber 104. Such dwell times may be equal or unequal, for example, based on uneven flow resistance into and out of membrane chamber 104, and such dwell times may be based on the characteristics of the intravascular device, anatomical conditions, or both.

[0069] Additionally or alternatively, in some exemplary embodiments, the pressure in either the membrane chamber 104 or the membrane balloon 106 may be monitored by the pump driver console 640, and the change in pressure over time may be used to control the inflation or deflation of the membrane balloon 106. For example, the change in pressure over time (dP / dt) may be monitored, and when this value approaches zero, blood flow into and out of the membrane chamber 104 is minimal. The pump driver console 640 may use this pressure information to minimize dwell times in the inflated and deflated states, subject to the additional considerations described above regarding the potential need for extended dwell times.

[0070] Additional aspects of the operation of the pump driver console 640 may be based on various factors related to the characteristics of an intravascular device according to an exemplary embodiment of the present disclosure. For example, the pump driver console 640 may include a manual setting mode that allows a physician to manually set the timing of the inflation / deflation cycle, including the dwell time. Such a manual mode may also allow a physician to configure the pump driver console 640 to operate in a co-pulsation mode, in which the intravascular device provides pumping action in phase with the patient's heartbeat, or in a counter-pulsation mode, in which the intravascular device provides pumping action out of phase with the patient's heartbeat. A signal representative of the patient's cardiac activity may be obtained, for example, through an electrocardiogram (EKG) signal or other cardiac activity monitoring signal, such as a pressure signal from the pulmonary artery. In some embodiments, the pump console 640 may be configured to detect cardiac activity and supplement cardiac activity as needed to maintain a specific flow rate. In other words, if the patient's cardiac activity is relatively weak, the pump console 640 will drive the intravascular device 600 to provide a relatively higher supplemental flow rate than if the patient's cardiac activity is relatively stronger. Additionally, certain features of the pump driver console 640, such as alarms or alarm settings based on pressure conditions, user interface settings, or other settings, can be optimized for use with intravascular devices according to the present disclosure.

[0071] Additionally, the inflation / deflation cycles of pump console 640 may be asynchronous with the pulsation of the patient's heart. While the pulsating nature of the pumping action of intravascular device 600 is described above, various aspects of intravascular device 600 may be modified to provide flow with a waveform that more closely resembles a continuous flow. For example, the size and configuration of the valves and tubing of intravascular device 600 may affect the flow from intravascular device 600 to approximate a more consistent flow rate. As an additional example, the volume of membrane chamber 104 ( FIG. 1 ) and membrane balloon 106 ( FIG. 1 ) may be altered to modify the pumping characteristics of the intravascular device. For example, if the volume or displacement of membrane balloon 106 is reduced, each inflation / deflation cycle of balloon 106 will pump a smaller volume of blood. To compensate and provide the same flow rate as a device with a relatively larger membrane balloon 106, the cycle time for a complete inflation / deflation cycle may be reduced. Thus, smaller, more frequent pulses can be delivered by intravascular devices, which, from a physiological standpoint, can more closely approximate continuous flow. With such a system, when used in the right heart, pacing with the natural heart rate is not necessary. Additionally, in the right heart, circulation can be asynchronous.

[0072] As a non-limiting example of device size, a membrane balloon for use in an adult using copulsating (in-phase) mode, counterpulsating (out-of-phase to a certain degree) mode, or asynchronous cycling (i.e., where the phase shift between the heart and the pumping membrane varies over time, and asynchronous cycling may, for example, cycle the device at a rate other than the natural heart rate, or at the patient's heart rate but neither copulsating nor counterpulsating, but rather at a timing somewhere in between) may have a displacement ranging from about 25 cubic centimeters (cc) to about 50 cc per cycle. To provide smaller, more frequent flow pulses, the membrane balloon displacement may be reduced, for example, by 50% or less, and the cycle time for a full inflation / deflation cycle may be reduced by a corresponding (e.g., proportional) amount. Thus, when using a smaller pumping membrane, a higher rate of circulation is required to achieve the same degree of blood flow compensation as can be achieved by a larger pumping membrane circulation at a slower rate, but the amount of supplemental blood flow provided by the intravascular device in combination with the patient's own cardiac output substantially maintains systemic blood flow within the desired physiological target range. In one exemplary embodiment, the balloon membrane can have a volume ranging from about 5 cc to about 20 cc, and cycle times are reduced from typical co-pulsating or counter-pulsating cycles, ranging from about 40% to about 90% less.

[0073] In one exemplary embodiment, the circulation rate may be generally inversely proportional to the volume of the inflatable membrane. As will be understood by one skilled in the art, variables such as the time to fill and empty the membrane chamber will affect this proportionality.

[0074] Additionally, the length and diameter of the membrane balloon can be varied while keeping the volume of the membrane balloon constant, for example, to allow for the use of relatively longer, narrower membrane chambers, which can improve blood flow around the device. Furthermore, multiple membrane balloons within a single membrane chamber, or multiple chambers each with one or more respective balloons, can be used.

[0075] According to one aspect of the present disclosure, connection of connector assembly, e.g., connector portion 642 with identification device 644, to a pump console may cause the pump console to automatically switch between operational modes (e.g., from a first general operational mode to a second operational mode specific to an intravascular device). In such an embodiment, when switching to the second operational mode, the pump console may display operational settings associated with the intravascular device. Examples of such operational settings include, but are not limited to, alarm settings, detection settings, alarm conditions, device cycle triggering, device cycle timing, and user interface settings.

[0076] 10 , an intravascular device 1000 according to an exemplary embodiment is shown positioned within a schematic drawing of a patient's left heart and aortic artery anatomy 1048. This exemplary embodiment may be characterized as a left-heart intravascular device. The intravascular device 1000 includes a membrane chamber 1004 within which a membrane balloon 1006 is disposed. The intravascular device 1000 includes a one-way inlet valve 1012 positioned at the distal end of a distal tube 1008. The distal end of the distal tube 1008 extends into the patient's left ventricle 1050. An outlet valve 1010 is disposed within valve chambers 1022 and 1024 positioned distal and proximal to the membrane chamber 1004. The valve chamber 1024 is positioned along the tube 1002 and is located a distance dv from the membrane chamber 1004. Distance dv may be selected to position valve chamber 1024 and associated outlet valve 1010 adjacent to renal artery 1052. Such positioning of valve chamber 1024 may facilitate perfusion of blood ejected from outlet valve 1010 into renal artery 1052. Positioning of valve chamber 1024 adjacent to renal artery 1052 may be facilitated by a radiopaque marker, such as, for example, radiopaque marker 117 (FIG. 1).

[0077] The location of the valve chamber 1022 distal to the chamber 1004 can be selected such that the valve chamber 1022 is positioned adjacent to one or more of the brachiocephalic artery 1054, the left common carotid artery 1056, and the left subclavian artery 1058. In other words, when the distal end of the distal tube 1008 is positioned at a target location (e.g., within the left ventricle 1050), one outlet valve 1010 is positioned adjacent to an artery in the aortic arch (e.g., the brachiocephalic artery 1054, the left common carotid artery 1056, and the left subclavian artery 1058), while the other outlet valve 1010 is positioned adjacent to a renal artery 1052. For example, positioning the valve chamber 1022 adjacent to the common carotid artery can promote cerebral perfusion of blood ejected from the outlet valve 1010 associated with the valve chamber 1022. Positioning of the valve chamber 1022 may be facilitated by a radiopaque marker, such as radiopaque marker 117 (FIG. 1). In some exemplary embodiments, the valve chamber 1022 may be positioned closer to the distal end of the distal tube 1008 than the position shown in FIG. 11, and the direction of the outlet valve 1010 may be reversed to direct blood flow toward the brachiocephalic trunk 1054, left common carotid artery 1056, and left subclavian artery 1058.

[0078] Referring now to FIG. 11 , an intravascular device 1100 according to another embodiment of the present disclosure is shown positioned within a patient's venous structure, such as a portion of the patient's right heart 1160 and inferior vena cava. This exemplary embodiment may be characterized as a right-heart intravascular device. The intravascular device 1100 includes a membrane chamber 1104 within which a membrane balloon 1106 is positioned. A distal tube 1108 with a one-way outlet valve 1110 extends distally from the membrane chamber 1104. In the embodiment of FIG. 11 , the membrane chamber 1104 is positioned within the inferior vena cava (IVC) 1162. However, as non-limiting examples of alternative configurations, the present disclosure contemplates positioning the membrane chamber 1104 within the superior vena cava 1164, the right atrium 1166, or the right ventricle 1168. To facilitate such positioning, the configuration of the intravascular device 1100 may feature different shapes and sizes of the membrane chamber 1104, different lengths of the distal tube 1108, etc. In the embodiment of FIG. 11, the distal tube 1108 extends from the membrane chamber 1104 in the IVC, through the right atrium 1166, past the tricuspid valve 1170, through the left ventricle 1168, past the pulmonary valve 1172, and into the pulmonary artery 1174.

[0079] The intravascular device 1100 includes an inlet valve 1112 positioned within an inlet valve chamber 1114. The inlet valve chamber 1114 is positioned proximal to the membrane chamber 1104, and the location of the inlet valve chamber 1114 may be selected to place the inlet valve 1112 in proximity to a patient's venous structure, such as a renal vein 1176. Additionally, in the exemplary embodiment of FIG. 11 , an additional inlet valve 1112 may be positioned on the membrane chamber 1104, and the additional inlet valve 1112 may be located proximal to another patient's venous structure, such as a hepatic vein 1178.

[0080] In other words, the device 1100 may be configured such that when the distal tube 1108 is positioned within a target location within the pulmonary artery 1174, the inlet valve 1112 may be positioned adjacent to an anatomical structure, such as, for example, a hepatic vein 1178, one or more renal veins (not shown), or other anatomical structure.

[0081] The procedures discussed above with respect to Figures 10 and 11 are not necessarily mutually exclusive. That is, it is possible to use left and right intracardiac devices together to provide biventricular support, as described and embodied herein. Thus, a system for providing biventricular support may include both left and right intracardiac devices. The system may be used with a single pump console or two pump consoles.

[0082] 12A and 12B illustrate an exemplary embodiment of an expansion chamber 1204 of an intravascular device 1200. In the embodiment of FIG. 12A, the chamber 1204 includes a mesh structure 1280, and the chamber 1204 and mesh structure 1280 are compressed within an insertion / retraction sheath 1236, which is inserted into a patient's blood vessel 1282. A membrane balloon 1206 within the chamber 1204 is in a deflated state in FIG. 12A. Once the chamber 1204 has been advanced to a desired location, the insertion / retraction sheath 1236 is withdrawn as discussed in connection with FIGS. 6 and 7, causing the mesh structure 1280 to expand within the blood vessel 1282, as shown in FIG. 12B. The mesh structure 1280 may comprise, without limitation, an elastic material such as a metal or polymer, a shape-memory material such as a metal or polymer, a composite material, or other material, as discussed above. As the chamber 1204 is expanded, the balloon membrane 1206 may be cyclically inflated and deflated to generally provide a pumping action as discussed in the above embodiments.

[0083] Ventricular assist devices according to the present disclosure offer advantages over previous devices. For example, intravascular devices according to the present disclosure provide improved interaction with the patient's anatomy, such as avoiding blockage of the intravascular device valve by the anatomy and positioning the device's valve in selected areas to improve perfusion of blood exiting the intravascular device. Additionally, pump driver consoles according to embodiments of the present disclosure feature operating configurations and algorithms that enhance (e.g., maximize) the effectiveness of the intravascular device.

[0084] It should be understood that the specific examples and embodiments described herein are non-limiting, and that modifications in structure, dimensions, materials, and methodology may be made without departing from the scope of the present teachings. While several embodiments of the present disclosure are shown in the drawings, the disclosure is not intended to be limited thereto, as the disclosure is as broad in scope as the art will permit, and the specification is intended to be read in the same manner. Any combination of the above embodiments is also contemplated and within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims

1. A system for assisting blood circulation in the body, comprising: The system includes a catheter configured to be inserted into a venous structure; The catheter a membrane chamber disposed between a proximal end and a distal end of the catheter, the membrane chamber comprising a chamber wall without a valve, the membrane chamber configured to expand from a contracted position to an expanded position, the membrane chamber having a first diameter; an inflatable membrane disposed within the membrane chamber; a first valve chamber forming part of or including a first one-way valve, the first one-way valve configured to allow blood flow in a first direction, the first one-way valve positioned proximal to the membrane chamber, the first valve chamber having a second diameter smaller than the first diameter of the membrane chamber; Equipped with the catheter is configured to be positioned such that the first valve chamber is positioned substantially adjacent one of a renal vein and a hepatic vein; A system in which fluid is cyclically supplied to the inflatable membrane to inflate and deflate the inflatable membrane, the expansion of the membrane allowing blood to exit the catheter and the contraction of the membrane allowing blood to enter the catheter through the first one-way valve.

2. The system described in claim 1, wherein the catheter further comprises a second valve chamber, the second valve chamber forming part of or including a second one-way valve, the second one-way valve configured to allow blood flow in the first direction, and the second valve chamber configured to be positioned substantially adjacent to the other of the renal vein and the hepatic vein.

3. A system as described in claim 1 or claim 2, wherein the catheter further comprises a third valve chamber distal to the membrane chamber, the third valve chamber forming part of or including a third one-way valve, the third one-way valve being configured to allow blood flow in the first direction, and the third valve chamber being configured to be positioned within the pulmonary trunk.

4. A system described in any one of claims 1 to 3, wherein a radiopaque marker is associated with each of the first valve chamber, the second valve chamber and the third valve chamber to facilitate positioning of at least one of the first valve chamber, the second valve chamber and the third valve chamber, and is visible under a fluorescent microscope.

5. A system described in any one of claims 1 to 4, further comprising a pump console, and the catheter is connected to the pump console so as to periodically supply fluid to the inflatable membrane.

6. The system described in claim 5, wherein the catheter further comprises a connector assembly connected to the pump console, the connector assembly configured to identify the catheter to the pump console as an intravascular device.

7. A system described in any one of claims 1 to 6, wherein the circulation rate is selected based on one of asynchronous circulation, counterpulsating circulation, and copulsating circulation.

8. The system described in claim 7, wherein the circulation rate is generally inversely proportional to the volume of the inflatable membrane.

9. A system described in any one of claims 1 to 8, wherein the volume of the membrane chamber is greater than the volume of the first valve chamber.

10. A system described in any one of claims 1 to 9, wherein when viewed along the longitudinal direction of the device, the outer shape of the membrane chamber is larger than the outer shape of the first valve chamber when viewed along the longitudinal direction of the device.

11. A system for assisting blood circulation in a body, comprising: The system includes a catheter configured to be inserted into an arterial structure; The catheter a membrane chamber disposed between a proximal end and a distal end of the catheter, the membrane chamber comprising a chamber wall without a valve, the membrane chamber configured to expand from a contracted position to an expanded position, the membrane chamber having a first diameter; an inflatable membrane disposed within the membrane chamber; a first valve chamber forming part of or including a first one-way valve, the first one-way valve configured to allow blood flow in a first direction, the first valve chamber positioned proximal to the membrane chamber, the first valve chamber having a second diameter smaller than the first diameter of the membrane chamber; Equipped with the catheter is configured to be positioned such that the first valve chamber is substantially adjacent a renal artery; A system in which fluid is cyclically supplied to the inflatable membrane to inflate and deflate the inflatable membrane, the expansion of the membrane allowing blood to exit the catheter through the first one-way valve and the contraction of the membrane allowing blood to enter the catheter.

12. The system described in claim 11, wherein the catheter further comprises a second valve chamber, the second valve chamber forming part of or including a second one-way valve, the second one-way valve being configured to allow blood flow in a second direction opposite to the first direction, and the catheter being configured to be positioned such that the second valve chamber is positioned substantially adjacent to the common carotid artery.

13. A system as described in claim 11 or claim 12, wherein the catheter further comprises a third valve chamber, the third valve chamber forming part of or including a third one-way valve, the third one-way valve configured to allow blood to flow in the first direction, and the third valve chamber being positioned within the aorta.

14. A system described in any one of claims 11 to 13, wherein a radiopaque marker is associated with each of the first valve chamber, the second valve chamber and the third valve chamber to facilitate positioning of at least one of the first valve chamber, the second valve chamber and the third valve chamber, and is visible under a fluorescent microscope.

15. A system described in any one of claims 12 to 14, further comprising a pump console, and the catheter is connected to the pump console so as to periodically supply fluid to the inflatable membrane.

16. The system described in claim 15, wherein the catheter comprises a connector assembly connected to the pump console, the connector assembly configured to identify the catheter to the pump console as an intravascular device.

17. A system described in any one of claims 11 to 16, wherein the circulation rate is selected based on counterpulsating circulation and copulsating circulation.

18. The system described in claim 17, wherein the circulation rate is generally inversely proportional to the volume of the inflatable membrane.

19. A system described in any one of claims 11 to 18, wherein the volume of the membrane chamber is greater than the volume of the first valve chamber.

20. A system described in any one of claims 11 to 19, wherein when viewed along the longitudinal direction of the device, the outer shape of the membrane chamber is larger than the outer shape of the first valve chamber when viewed along the longitudinal direction of the device.

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