Device, related system and related method for pressure-feeding 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 pumping chamber of the catheter 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 may 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 intravascular blood pumping device that is optimally effective. Design challenges relate to the need to balance maximizing cannula size for maximum blood flow and reducing cannula size to improve blood flow around and outside the cannula, as well as to allow a smaller profile for insertion through narrow portions of the patient's vasculature. Additionally, elements on the cannula itself may reduce or slow blood flow around the cannula. Improved device safety and manufacturability are also desired. [Prior art documents] [Patent documents]

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

[0005] In one aspect of the disclosure, an intravascular device for pumping blood includes a catheter with 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 disclosure, an intravascular device for pumping blood includes a catheter with a membrane chamber located between a proximal tube portion and a distal tube portion, each of the proximal and distal tube portions having an outer profile smaller than an outer profile of the membrane chamber when viewed along a longitudinal direction of the device. 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 smaller than an outer profile of the membrane chamber when viewed along a longitudinal direction of the device.

[0007] In yet another aspect of the 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 and 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 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 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 disclosure, a method of 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 permit 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 positioned substantially adjacent 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 contract the inflatable membrane. 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.

[0010] In yet another aspect of the disclosure, a method of assisting in the circulation of blood in 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 permit 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 a fluid to the inflatable membrane to inflate and contract the inflatable membrane, where 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.

[0011] According to yet another aspect of the present disclosure, an intravascular device for pumping blood includes a catheter including a membrane chamber located between a proximal tube portion and a distal tube 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 a length of the device and 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 intended to be 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, the device comprising: a catheter comprising a membrane chamber, the membrane chamber being 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 said membrane chamber; a first one-way valve configured to permit blood flow in a first direction; A device comprising: (Item 2) Item 1 . 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, each of the first and second one-way valves forming part of or 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 portions 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 portions 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 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, in 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, in 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 the device 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 assistance. (Item 16) 16. The device of any one of claims 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, the 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 a longitudinal direction 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 a 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 a 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 tube portion extending from an 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 an outer diameter of at least one of the first and second valve chambers is greater than an 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 a 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 25cc to about 50cc. (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 claims 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: 1. An intravascular device, comprising: a catheter comprising a membrane chamber, the membrane chamber being 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 outside the membrane chamber and in fluid communication therewith; an intravascular device comprising: a connector assembly configured to connect to the intravascular device and to 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 a gas that drives the inflation and deflation of the inflatable membrane. (Item 36) The system of claim 34 or 35, wherein the connector assembly comprises an element configured to be received by the pump console, the connector assembly being further configured to allow user access to intravascular device settings via the pump console. (Item 37) 37. The system of any one of claims 34-36, wherein the connector assembly is provided with 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 regarding operational characteristics of the intravascular device to the pump console. (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 claims 34-41, further comprising a pressure transducer configured to measure 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 claims 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 claims 34-44, wherein the inflatable membrane has a volume of about 5 cc to about 20 cc. (Item 47) The system of claim 45 or 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 alter the pump console to display settings associated with asynchronous circulation, copulsating circulation, or counterpulsating circulation. (Item 49) 49. The system of any one of claims 34-48, wherein the intravascular device comprises an anti-thrombogenic coating. (Item 50) 50. The system of claim 49, wherein the anti-thrombogenic coating is on an exterior surface of the device and an interior 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 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 claim 53, wherein forming the at least one valve chamber includes forming the inlet tube 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 longitudinal direction of the device, that is smaller than an outer diameter of the membrane chamber, when viewed along a longitudinal direction 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 such that the first one-way valve is 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 such that the second one-way valve is 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 claims 52-58, wherein forming the at least one valve chamber comprises coating at least an 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 in the circulation of blood in a body, the method comprising: Inserting a catheter into a venous structure, the 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; cyclically supplying a fluid to the expandable membrane to expand and contract the expandable membrane; Including, 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 the other of the renal vein and the hepatic vein. (Item 64) Item 63. The method of item 61 or item 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 in the pulmonary trunk. (Item 65) 65. The method of any one of claims 62-64, wherein positioning at least one of the first, second, and third valve chambers includes viewing under a fluorescent microscope a radiopaque marker associated with each of the first, second, and third valve chambers. (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 claims 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 expandable 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 diameter of the membrane chamber when viewed along the longitudinal direction of the device is greater than the outer diameter of the first valve chamber when viewed along the longitudinal direction of the device. (Item 72) 1. A method of assisting in the circulation of blood in a body, the method comprising: Inserting a catheter into an arterial structure, the 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 such that the first valve chamber is substantially adjacent a renal artery; expanding the membrane chamber from a contracted position to an expanded position; cyclically supplying a fluid to the expandable membrane to expand and contract the expandable membrane; Including, 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) 73. The method of claim 72, wherein the catheter further comprises a second valve chamber forming part of or including a second one-way valve configured to permit 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, the method further comprising positioning the third valve chamber within the aorta. (Item 75) 75. The method of any one of claims 72-74, wherein positioning at least one of the first, second, and third valve chambers includes viewing under a fluorescent microscope a radiopaque marker associated with each of the first, second, and third valve chambers. (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 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 periodically supplying fluid to the expandable 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 expandable 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 diameter of the membrane chamber when viewed along the longitudinal direction of the device is greater than the outer diameter of the first valve chamber when viewed along the longitudinal direction of the device. (Item 82) 1. An intravascular device for pumping blood, the 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 a length of the device and 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 that is 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 exit valve, each of the first exit valve and the second exit 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, each of the first inlet valve and the second inlet valve positioned along a length of the device so as to be located adjacent a respective one of the hepatic vein and the renal vein. [Brief description 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] [Diagram 2] FIG. 2 is a cross-sectional schematic view of a right intravascular device according to another exemplary embodiment of the present disclosure.

[0016] [Diagram 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] [Diagram 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 according to another exemplary embodiment of the present disclosure, shown positioned within a portion of a patient's right heart.

[0025] [Figure 12A] FIG. 12A is a schematic side view of an intravascular device in a compressed state within an insertion / retraction sheath, in accordance with 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 PREFERRED EMBODIMENTS

[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 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 and not described with reference to a second embodiment, the element may nevertheless be claimed as being 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 are to be understood as being modified in all instances by the term "about" unless they have already been so modified. Thus, unless otherwise indicated, the numerical parameters set forth in the following specification and the appended claims are approximations that may vary depending on 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 disclosure. For example, spatially relative terms such as "below," "lower," "lower side," "upper," "upper," "proximal," "distal," and the like 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 positions and orientations depicted in the figures. For example, if the device in the figures is flipped upside down, an element described as "below" or "below" another element or feature would be "above" or "on" the other element or feature. Thus, the exemplary term "below" can encompass both upper and lower positions and orientations. The device may be oriented differently (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, descriptions of movement along and around various axes include various special device positions and orientations. In addition, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context indicates otherwise. Also, the terms "comprises," "comprising," "includes," and the like specify the presence of the described 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 being 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 precise definitions, unless the context of the description indicates otherwise, because one of ordinary skill in the art will understand that, for example, substantially similar elements that function in a substantially similar manner may readily fall within the scope of the descriptive terms, notwithstanding that the terms have similar precise definitions.

[0030] Various exemplary embodiments of the present disclosure contemplate systems, methods, and devices that assist a patient's heart to pump blood through a 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 therein) an inflatable balloon membrane that can be cyclically inflated and deflated to move blood in and out of the intravascular device through the inlet and outlet valves of the device. 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 inlet and / or outlet valves of the intravascular device. For example, in certain exemplary embodiments, the valves can be located on a portion of the intravascular device that has an outer diameter that is smaller than the maximum outer diameter of the membrane chamber that includes the balloon membrane of the intravascular device. Locating the valve away from the membrane chamber serves several purposes, allowing maximum flow around the device in the blood vessel while also allowing the valves to open to their full extent, maximizing the inflow and outflow of blood through the membrane chamber. In addition, the size of the membrane chamber does not need to 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 the 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. Although 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 an embodiment, it may be desirable to position the valve on the chamber in such a way that the size of the membrane chamber does not need to be limited to allow the valve to fully open.

[0031] Locating the valve away from the membrane chamber may also improve the ease of manufacture of 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 valve-less, meaning that no valve is formed in 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 the membrane chamber as well as other portions of the catheter. The valve chamber may take a number of 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 remaining portion 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 tube or an outlet tube. The inlet or outlet tube may include an inlet or outlet valve, respectively, that is placed in fluid communication with the membrane chamber, 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 that includes a valve chamber that includes 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 parts of the intravascular device, such as the membrane chamber and tube, and may be combined with other parts of the intravascular device to form a complete intravascular device. The valve chamber may take other configurations that place the valves contained therein in fluid communication with the membrane chamber, as would be apparent to one skilled in the art.

[0032] In addition to improving manufacturability, utilizing a valve subassembly in the device also allows for a level of customization of the device. That is, the valve subassembly 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 cause 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 Figures 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). In addition, in other exemplary embodiments of the device, 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 to be positioned adjacent to the hepatic vein and a second inlet valve located on the device to be positioned 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 a working fluid (such as a gas) and alternately inflate and deflate a balloon membrane within a membrane chamber (i.e., a 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 the pump drive operation, such as timing of inflation and deflation cycles, dwell time in an inflated or deflated state, or other aspects of the pump drive 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 the pressure transducer to be used to control aspects of the pump drive operation.

[0034] The pump driver console may include various pre-programmed pumping algorithms that may be selected to provide optimized pumping action 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 procedures, as well as other factors such as the patient's hemodynamics prior to treatment, the degree of valvular dysfunction, and the patient's response to other treatments. In addition, the pump driver console may be configured to allow a physician to manually set aspects of the pumping action based on factors such as those described above. In some exemplary embodiments, the intravascular device may include an identification device that provides information to the pump driver console regarding the operating characteristics of the intravascular device and allows the pump driver console or physician to select suitable operating parameters for the pumping action. 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 cause a display on the pump console to automatically change from operating settings for a first operating mode to a second operating mode that includes operating settings for use with an 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 that is 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, the intravascular device 100 is configured to assist the right heart and may therefore be referred to as a right ventricular assist device ("RVAD"). The intravascular device 100 comprises a membrane chamber 104. A membrane or diaphragm or balloon configured to expand and contract (or inflate and contract or otherwise change the occupied volume within the membrane chamber 104) is positioned within the membrane chamber to provide a pumping function. Such a membrane or diaphragm may be synonymously referred to herein as an expandable or inflatable membrane or balloon membrane or intra-aortic balloon (IAB) (although it is anticipated to use balloon members other than those used on the IAB). 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 that they may incorporate may be found in U.S. Patent No. 6,482,173, issued Nov. 19, 2002, the entire contents of which are incorporated herein by reference. Additionally, in certain embodiments, the balloon may be inflatable, and 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 the membrane chamber 104. A tube 102 is in fluid communication with the membrane chamber 104 and extends proximally therefrom. The tube 102 may be referred to as the proximal tube portion. As used herein, the term "proximal" refers to the direction along the intravascular device 100 toward the end of the device that remains outside the patient's body and is connected to external equipment, such as the pump console 640 (shown in FIGS. 6 and 7), and the term "distal" refers to the direction along the intravascular device 100 toward the end of the device opposite the proximal end, such as the free end of the device that is 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 exterior of the tube 116 may be sealed to prevent blood leakage during pumping.

[0036] The tube 108 is in fluid communication with and extends distally from the membrane chamber 104 and includes an outlet valve 110 and an open distal end 111. The tube 108 may be referred to as a distal tube portion. In exemplary embodiments, the 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 the outlet valve 110. In some exemplary embodiments, the tube 108 may have a "J" shape or be coupled to a "J" shaped extension or pigtail. Such a configuration may prevent the open distal end 111 from becoming occluded by the blood vessel wall when in place within the 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 may be disposed on an extension portion 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 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 in the membrane chamber 104. As a non-limiting example, the gas supplied 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. Gas may be supplied through the shaft 116 of the device, 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 contracted configuration prior to insertion to reduce the overall profile of the device and allow for percutaneous insertion. For right heart circulatory support, the device may be inserted into the right subclavian vein to access the superior vena cava, right atrium, or right ventricle. Additionally, the femoral vein may be used to access the inferior vena cava, right atrium, or right ventricle when used for right heart circulatory support. For left heart support, the left femoral artery may be used to access the aorta. Although various embodiments of the present disclosure are described herein in terms of percutaneous insertion, the present disclosure contemplates insertion in other manners, such as direct aortic insertion or surgical incision insertion. The membrane chamber (and other portions of the device) may incorporate a self-expanding material, for example, to naturally move from a contracted configuration to an expanded configuration after insertion and positioning in a blood vessel. Examples of such structures include those disclosed in, for example, US 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. As non-limiting examples, 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, and shape memory polymers (SMPs) such as polyurethane-based, polystyrene-based, cyanate ester-based, and epoxy-based SMPs. Alternatively, compressible materials (i.e., materials with a sufficiently high modulus) that have sufficient "bounce back" 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 appreciated 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 device and patient specifics. 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, through the pulmonary artery, and / or across the heart to the lungs, and in an 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 in 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 in 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 in the membrane chamber 104 to rise above the pressure in the right atrium or ventricle, closing the inlet valve 112, thereby preventing backflow of blood due to the balloon inflation. The pressure in the membrane chamber 104 causes the outlet valve 110 to open and blood to be ejected 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 such configurations in which the outlet valve 110 is not present. 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 an assembly separate 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 can be formed, in certain embodiments, 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 separate 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, manufacturing the valve chamber 114 separate from the membrane chamber 104 provides additional flexibility regarding the location of the valve relative to the membrane chamber 104. For example, the longitudinal location of the valve assembly relative to the membrane chamber 104 can be altered, 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 location of the valve can be adjusted to improve perfusion of blood to the anatomical structures and, alternatively or additionally, 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 structures 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 dimension of the inlet valve chamber 114 may be smaller than the corresponding outer lateral dimension of the membrane chamber 104. The lateral dimension may also be referred to as the outer dimension or outer contour. The contour 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 tube 108 and the proximal tube 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 may 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 reduces resistance to blood flowing around the outer surface of the intravascular device 100, providing less obstruction than if the inlet valve chamber 114 and the membrane chamber 104 had the same diameter when fully deployed or expanded. 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 within 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, inlet valve chamber 114, and tubes 102, 108 are discussed in terms of diameter, the membrane chamber 104, inlet valve chamber 114, and tubes 102, 108 are not limited to having circular cross sections. For example, the cross sections of the membrane chamber 104, inlet valve chamber 114, tubes 102, and / or tubes 108 may be, by way of non-limiting examples, oval, square, rectangular, or have other polygonal or non-polygonal shapes.

[0043] 1, membrane chamber 104 comprises a length LC and inlet valve chamber 114 comprises a length LH. The length LC of membrane chamber 104 may be greater than the length LH of inlet valve chamber 114. Additionally, membrane chamber 104 may comprise an interior volume defined by an interior shape and dimensions of membrane chamber 104. Inlet valve chamber 114 may comprise an interior volume defined by an interior shape and dimensions of inlet valve chamber 114. The interior volume of membrane chamber 104 may be greater than the interior 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 tube 108 to assist a physician in positioning intravascular device 100 so that the valves are optimally positioned for effective uptake and perfusion of blood. 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 BaSO. 4 (Barium sulfate).

[0045] In some exemplary embodiments, portions of the intravascular device 100 may include an anti-thrombogenic coating to reduce the incidence of thrombus formation. Such coatings may be applied to the entire intravascular device 100 or only portions of the intravascular device 100, such as in, on, and / or near the valve chambers, membrane chambers 104, etc. The coatings 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, an intravascular device 200 includes an inlet tube 218 with an open end 220 and an inlet valve 212 disposed within the inlet tube 218. The intravascular device 200 includes an outlet tube 208 with an outer diameter DT and an outlet valve 210 within the outlet tube 208. In the illustrative example of FIG. 2, the inlet tube 218 is coupled to the membrane chamber 204, the inlet tube 218 is positioned offset from the central axis Ac of the membrane chamber 204, and the tube 202 is positioned coaxially with the central axis Ac of the membrane chamber 204. In other embodiments, the tube 202 may be offset relative to the central axis Ac and the inlet tube 218 may be positioned coaxially or offset relative to the central axis Ac of the membrane chamber 204.

[0047] The inlet tube 218 may have an outer diameter DT and a length L selected to position an 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 and into the membrane chamber 204. As with the embodiment of Figure 1, the configuration of the inlet tube 218, such as the length L, may be selected to avoid occlusion 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, the intravascular device 300 is configured to assist the left heart and may be referred to as a left ventricular assist device ("LVAD"). The intravascular device 300 includes a membrane chamber 304 including 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 the 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 the 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 the inlet valve chamber 114 discussed in connection with the embodiment of FIG. 1, the outlet valve chambers 322 and 324 may be fabricated separately from the membrane chamber 304 and then attached to the membrane chamber 304, such as the outlet valve chamber 324 in the exemplary embodiment of FIG. 3, or may be attached to the membrane chamber 304 by a portion of the inlet tube 308, as shown in the exemplary embodiment of FIG. 3 with respect to the outlet valve chamber 322. Alternatively, the outlet valve chambers 322, 324 may be formed by expanding a portion of the tube 308 and positioning the outlet valve 310 within the expanded portion of the tube 308. Positioning multiple outlet valve chambers (e.g., outlet valve chambers 322 and 324) along the length of the intravascular device 300 may allow blood flow to be directed to specific areas to optimize perfusion, e.g., cerebral and renal perfusion of blood from the intravascular device 300. For example, in the embodiment of FIG. 3, the outlet valve chambers 322 and 324 are configured to be positioned adjacent to the common carotid artery and the 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 the inlet valve chamber 114 discussed in connection with the embodiment of FIG. 1, the outlet valve chambers 322 and 324 have an outer diameter Dh that is smaller than the outer diameter Dc of the membrane chamber 304. Such a configuration may prevent interference with or blockage of the outlet valve 310 when the intravascular device is positioned with the anatomical structure, particularly in a configuration in which the outlet valve 310 opens outward, as shown in FIG. 3. This also allows for increased blood flow within the vessel and around the membrane chamber 304. Additionally, while the inlet valve 312 is shown as being contained within the end of the tube 308 in FIG. 3, the present disclosure also contemplates that the inlet valve 312 may be contained within the chamber. Additionally, the present disclosure also contemplates that the outer diameter Dh of the chambers 322 and 324 may be larger than the outer diameter DT of the tubes 302 and 308. Additionally, in some embodiments, the outer diameter Dh of the chambers (such as chambers 322 and 324) may be larger than the outer diameter Dc of the 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 allow for 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 into and positioning within 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 modulus of elasticity, such as those listed above in connection with the embodiment of FIG. 1. In such an embodiment, 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 chambers may occur through other mechanical methods, such as those disclosed in, for example, U.S. Pat. No. 4,444,186 (incorporated herein in its entirety by reference), and by those disclosed in 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 markers 317, that allow the housing to be viewed 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, for example, cerebral or renal perfusion.The present application contemplates that the markers may be located near or adjacent to the valve, rather than always on the valve chamber. For example, the markers 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) the perfusion of blood to a particular anatomical structure, 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, an outlet valve positioned further from the membrane chamber 304 may have a lower flow rate compared to an outlet valve positioned closer to the membrane chamber 304 due to losses (e.g., friction coefficient) in the tube 308. In addition, the 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 such 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 the renal arteries may be greater than the flow rate adjacent the common carotid, brachiocephalic, and subclavian arteries if such an arrangement would be beneficial to patient recovery. Alternatively, the flow rate of the device may be greater in that area to ensure adequate flow to the upper bifurcation of the aorta. FIG. 4 shows a left intravascular device 400 similar to the intravascular device 300 of FIG. 3. In the embodiment of FIG. 4, the outlet valve 410 is proximal to the membrane chamber 404 and the inlet tube 408 and distal to the proximal tube 402 having an outer diameter DT. The inlet tube 408 has an outer diameter DT, 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 the 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 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, or may be adjusted to compensate for anatomical differences between patients, compared to the embodiment of Figure 3.

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

[0055] The offset of the inlet valve chamber 514 may be selected to avoid occluding a portion of a patient's anatomy when the intravascular device 500 is inserted into the patient's body and / or to position the inlet valve chamber 514 to better accommodate redirection within the patient's circulatory system. As a non-limiting example, in an RVAD device such as device 500, an offset configuration of the inlet valve chamber 514 may avoid occlusion of the hepatic vein, while in an LVAD device, a similar offset valve chamber may avoid occlusion of the celiac artery, for example. The offset may be flexible. The offset may be helical in configuration or it may be provided by a non-helical curve. The offset of the valve chamber 514 and the positioning of the intravascular device 500 may be configured such that the offset configuration of the valve chamber 514 allows the 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 DT of tube 502. As a 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 similarly configured to be contracted 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 into deployment / retraction sheath 636. Intravascular device 600 may be placed into 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. In the exemplary embodiment of Figures 6 and 7, the intravascular device 600 includes a coil 660 comprising an elastic material positioned within the membrane chamber 604 in a reduced profile configuration. In this reduced profile configuration, the 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 the intravascular device 600 or the needs of the patient, the intravascular device 600 can be inserted into the axillary, subclavian, or brachiocephalic artery or vein. In some exemplary embodiments, the 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 the deployment / retraction sheath 636, a guidewire (not shown) may be first inserted and its distal end positioned within the desired anatomical location, such as the pulmonary trunk for an RVAD device or the left ventricle for an LVAD device. The 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, the components of the intravascular device 600 in the reduced profile position, such as, for example, the membrane chamber 604 and the valve chambers (e.g., valve chambers 114, 322, 324, and 514), may expand to their expanded configurations, for example, 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 when 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 difference to a shape memory alloy. The deployment / retraction sheath 636 is withdrawn a sufficient distance to expose the valves 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 the valves on the intravascular device 600 .

[0061] Removal of intravascular device 600 may include reversal of 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 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 that their rigidity is sufficient to withstand intra-arterial pressures. However, these structures may be configured to have 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 pressures, 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 may 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 the deployment / retraction sheath 636. Depending on the configuration of the intravascular device 600, the membrane balloon (e.g., membrane balloon 106 (FIG. 1)) and associated shaft 116 (FIG. 1) may have been inserted into the intravascular device 600 prior to insertion of the device into the patient, such as during manufacturing or packaging, or may be inserted through the hemostatic valve 638 once the intravascular device 600 is in position within the patient. For example, in an exemplary embodiment, the intravascular device without the 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, the membrane balloon 106 and shaft 116 are then inserted through the hemostatic valve 638 and advanced until the balloon 106 is located within the membrane chamber (e.g., membrane chamber 104 of FIG. 1).

[0063] Intravascular device 600 may be connected to a pump driver console 640. Pump driver console 640 may provide alternating fluid pressure through shaft 116 (FIG. 1) to membrane balloon 106 to alternately inflate and deflate 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 medical 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, that includes an 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 include passive electronic components, such as resistors or jumper wires, or may include electronic memory components, 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 mode of operation 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 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 utilizing 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 through connector portion 642 to pump driver console 640 (FIGS. 6 and 7) when connector portion 642 is mated with a complementary connector on pump driver console 640. Additionally or alternatively, blood pressure measurements may 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 tube 908, although in an exemplary embodiment, one or more pressure transducers may be included adjacent an inlet valve and / or an outlet valve, such as adjacent inlet valve 112 (FIG. 1) and outlet valve 110 (FIG. 1).

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

[0067] In an exemplary embodiment, the pump driver console 640 can control various operating characteristics, such as, for example, the timing of inflation and deflation events, based on the pressure in 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 is 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 in the membrane balloon 106 reaches 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 the membrane chamber 104 (FIG. 1). For example, assuming the membrane chamber is not a completely rigid structure, blood flow into the membrane chamber 104 may be such that the membrane chamber 104 does not fill as quickly as the membrane balloon 106 deflates, and a dwell time at maximum deflation may be used to ensure that the membrane chamber 104 completely fills with blood. Similarly, in some embodiments, a dwell time at maximum inflation is used to ensure complete drainage of the membrane chamber 104. Such dwell times may be equal or unequal, for example, based on uneven flow resistance into and out of the membrane chamber 104, and such dwell times may be based on the properties 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 the intravascular device according to the exemplary embodiments of the present disclosure. For example, the pump driver console 640 may include a manual setting mode that allows the physician to manually set the timing of the inflation / deflation cycle, including the dwell time. Such a manual mode may also allow the physician to configure the pump driver console 640 to operate in a co-pulsating mode, in which the intravascular device provides a pumping action in phase with the patient's heartbeat, or a counter-pulsating mode, in which the intravascular device provides a pumping action out of phase with the patient's heartbeat. A signal representative of the patient's cardiac activity may be obtained through other cardiac activity monitoring signals, such as, for example, an electrocardiogram (EKG) signal or a pressure signal from the pulmonary artery. In some embodiments, the pump console 640 may be configured to detect cardiac activity and supplement the cardiac activity as necessary to maintain a particular 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, may be optimized for use with intravascular devices according to the present disclosure.

[0071] In addition, the inflation / deflation cycles of the pump console 640 may be asynchronous with the pulsation of the patient's heart. Although the pulsatile nature of the pumping action of the intravascular device 600 is described above, various aspects of the 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 tubes of the intravascular device 600 may affect the flow from the intravascular device 600 to approximate a more consistent flow rate. As an additional example, the volume of the membrane chamber 104 (FIG. 1) and the 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 the membrane balloon 106 is reduced, each inflation / deflation cycle of the 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 of a complete inflation / deflation cycle may be reduced. Thus, smaller, more frequent pulses can be delivered by an intravascular device, which from a physiological standpoint can more closely approximate continuous flow. With such a system, when used in the right heart, it is not necessary to pace with the natural heart rate. In addition, 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 co-pulsating (in-phase) mode, counter-pulsating (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, where 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 co-pulsating nor counter-pulsating, 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 displacement of the membrane balloon may be reduced, for example, by 50% or less, and the cycle time of 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 supplementation 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 in the desired physiological target range. In one exemplary embodiment, the balloon membrane may 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 expandable membrane. As will be appreciated by one of ordinary skill in the art, variables such as the time to fill and empty the membrane chamber will affect this proportionality.

[0074] In addition, the length and diameter of the membrane balloon can be varied while keeping the volume of the membrane balloon constant, for example to allow the use of a relatively longer and narrower membrane chamber, 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 disclosure, connection of a 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 structure 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 a 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. The distance dv may be selected to position the valve chamber 1024 and associated outlet valve 1010 adjacent to the renal artery 1052. Such positioning of the valve chamber 1024 may facilitate perfusion of blood draining from the outlet valve 1010 into the renal artery 1052. Positioning the valve chamber 1024 adjacent to the 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 may 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. Stated another way, when the distal end of the distal tube 1008 is positioned at the 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 may facilitate cerebral perfusion of blood exiting the outlet valve 1010 associated with the valve chamber 1022. Positioning of the valve chamber 1022 may be aided 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 orientation of the outlet valve 1010 may be reversed to direct blood flow toward the brachiocephalic trunk 1054, the left common carotid artery 1056, and the left subclavian artery 1058.

[0078] 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 a non-limiting example of an alternative configuration, 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, and the like. 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 venous structure of the patient, 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 venous structure of the patient, such as a hepatic vein 1178.

[0080] Stated another way, 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 that is inserted into a patient's blood vessel 1282. A membrane balloon 1206 within the chamber 1204 is in a contracted 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 the chamber 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 provide 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's valve by the anatomy and positioning the device's valve in selected areas to improve perfusion of blood exiting the intravascular device. In addition, 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 is to be understood that the specific examples and embodiments described herein are non-limiting, and modifications in structure, dimensions, materials, and methodology may be made without departing from the scope of the present teachings. Although several embodiments of the present disclosure are shown in the drawings, the present disclosure is not intended to be limited thereto, as the present 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. Thus, the above description should not be construed as limiting, but merely as exemplifications of specific 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 a body, comprising: The system includes a catheter configured to be inserted into a venous structure; The catheter comprises: 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 be expanded 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 being configured to allow blood flow in a first direction, the first one-way valve being 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 contract 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 of claim 1, wherein the catheter further comprises a 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. The system 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 configured to allow blood flow in the first direction, and the third valve chamber configured to be positioned within the pulmonary trunk.

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

5. A system as described in any one of claims 1 to 4, further comprising a pump console, the catheter being 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 expandable 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 comprises: 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 be expanded 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 being configured to allow blood flow in a first direction, the first valve chamber being 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 contract 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 of claim 11, wherein the catheter further comprises a second valve chamber forming part of or including a second one-way valve, the second one-way valve configured to allow blood flow in a second direction opposite to the first direction, and the catheter is configured to be positioned such that the second valve chamber is positioned substantially adjacent to the common carotid artery.

13. The system of claim 11 or claim 12, 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 third valve chamber being positioned within the aorta.

14. The system of claim 11, 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 as described in any one of claims 12 to 14, further comprising a pump console, the catheter being 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 as claimed 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 expandable 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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