Patent Application
20250152175
The present invention relates generally to the field of medical devices and procedures.
Redistribution of blood from the splanchnic venous circulation to the inferior vena cava (IVC) and/or superior vena cava (SVC) can contribute to increases in central venous pressure (CVP), pulmonary artery pressure, and/or pulmonary capillary wedge pressure (PCWP), particularly during periods of elevated sympathetic tone (e.g., exercise) in heart failure patients.
For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective embodiments associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of inventive aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some embodiments or configurations.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.
Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
The following includes a general description of human cardiac anatomy that is relevant to certain inventive features and embodiments disclosed herein and is included to provide context for certain aspects of the present disclosure.
Total flow to the splanchnic viscera is controlled by resistance vessels in the mesenteric and hepatic arterial systems. The venous effluents from the splanchnic viscera converge to form the portal vein 3, which supplies approximately 75% of the total blood supply to the liver 5. The portal blood not only is high in substrate concentrations resulting from intestinal absorption but also tends to contain bacteria and endotoxin.
Renal veins 12 drain blood from the right kidney 14 and left kidney 16 and connect to the inferior vena cava 10 (IVC). The superior mesenteric vein 6 is a major venous tributary of the abdominal cavity that lies laterally to the superior mesenteric artery and serves to drain the vast majority of the organs of the abdominal cavity. The inferior mesenteric vein 8 drains blood from the large intestine. The splenic vein 12 is a blood vessel that drains blood from the spleen, the stomach fundus, and part of the pancreas.
The portal vein 3 receives blood from the stomach, intestines, pancreas, and spleen 7 and carries it into the liver 5 through the porta hepatis. The porta hepatis serves as the point of entry for the portal vein 3 and the proper hepatic artery, and is the point of exit for the bile passages.
Following processing of the blood by the liver 5, the blood collects in the central vein at the core of the lobule. Blood from these central veins ultimately converges in the right and left hepatic veins 9, which exit the superior surface of the liver 5 and empty into the IVC 10 to be distributed to the rest of the body.
The splanchnic venous circulation 100 is highly compliant and can act as a blood reservoir that can be recruited in order to support the need for increased stressed blood volume during periods of elevated sympathetic tone, such as exertion, in order to support increased cardiac output and vasodilation of peripheral vessels supporting active muscles. However, heart failure patients can have multiple comorbidities that prevent them from using that additional blood volume. Such comorbidities can include chronotropic incompetence, inability to increase stroke volume, and/or peripheral microvascular dysfunction. This can lead to venous congestion and/or abrupt rises in pulmonary capillary wedge pressure (PCWP).
The coeliac artery 19 is the first major division of the abdominal aorta 8, branching at T12 in a horizontal direction ˜1.25 cm in length. It shows three main divisions such as the left gastric artery, common hepatic artery 18, and splenic artery and is the primary blood supply to the stomach 11, upper duodenum, spleen 7, and pancreas 13.
The SMA 21 arises from the abdominal aorta 8 anteriorly at L1, usually 1 cm inferior to the coeliac artery 19. The five major divisions of the SMA 21 are the inferior pancreaticoduodenal artery, intestinal arteries, ileocolic, right colic, and middle colic arteries. The SMA 21 supplies the lower part of the duodenum, jejunum, ileum, caecum, appendix, ascending colon, and two-thirds of the transverse colon. It is the largest of the splanchnic arterial vessels delivering >10% of the cardiac output and therefore has significant implications for embolic mesenteric ischaemia.
The IMA 23 branches anteriorly from the abdominal aorta 8 at L3, midway between the renal arteries and the iliac bifurcation. The main branches of the IMA 23 are the left colic artery, the sigmoid branches, and the superior rectal artery. It forms a watershed with the middle colic artery and supplies blood to the final third of the transverse colon, descending colon, and upper rectum.
Blood flow is conveyed into the liver 5 via the portal vein 3 into sinusoids 25 of the liver 5. The hepatic veins 9 convey the blood from the liver 5 to the IVC 10.
For some patients (especially patients experiencing heart failure) fluid redistribution from the splanchnic venous reservoir 30 to the IVC 10 and/or stressed blood volume can contribute to increases in central venous pressure (CVP), pulmonary artery pressure, and/or PCWP. This can be especially problematic during periods of elevated sympathetic tone, such as exertion, and/or can lead to pulmonary congestion that can impact a patient's quality of life and/or can lead to acute decompensation.
The splanchnic venous circulation 300, and particularly the portal vein 3, can advantageously provide a blood reserve to support the need for increased stressed blood volume during periods of elevated sympathetic tone. Because blood flow from the splanchnic venous circulation 300 is directed through the hepatic veins 9 and into the IVC 10, devices placed into the hepatic veins 9 and/or IVC 10 to limit blood flow can allow the reservoir 30 to expand with increased blood volume.
Embodiments described herein can relate to devices and/or methods that can advantageously limit, stagnate, and/or impede blood flow into the IVC 10 from the hepatic veins 9 to increase the pressure gradient between the IVC 10 and the liver and/or splanchnic venous circulation 300. In some embodiments, one or more flow-regulating implants may be configured for placement at least partially within the hepatic veins 9 and/or IVC 10 and/or at one or more junctions between the hepatic veins 9 and the IVC 10. As a result, blood flowing from the splanchnic venous reservoir 30 into the hepatic veins 9 can be slowed to increase blood volume in the splanchnic venous reservoir 30.
Some approaches to reducing volume redistribution can involve placing fixed orifice flow restrictors at or near the IVC 10. However, while restricting the flow from the hepatic veins 9 can be beneficial in preventing volume redistribution, too much restriction can cause hepatic congestion. It would therefore be advantageous to modulate the response and increase restriction only during volume redistribution.
Some examples presented herein relate to methods and/or devices for increasing the restriction of blood flow from the hepatic veins 9 and/or IVC 10 into the right atrium as pressures increase in the left atrium. In some instances, a device can comprise two or more interconnected balloons and/or similar devices. The term “balloon” is used herein in accordance with its plain and ordinary meaning and may refer to any inflatable, deflatable, compressible, expandable, and/or fillable device. A balloon may be configured to be inflated and/or filled with a gas, liquid, and/or similar substance.
In some examples, a first balloon may be disposed at least partially within the left atrium and/or a second balloon may be disposed at least partially in the IVC 10. One or more balloons within the IVC 10 may be disposed at or near a level of one or more hepatic veins 9. One or more balloons can be filled with fluid and/or gas and/or can modulate preload pressures in the heart by alternately expanding and/or compressing. In some examples, one balloon may be inflated while another balloon is deflated.
The various devices can be implanted using a transcatheter transvenous approach, for example entering through the femoral vein. With a transeptal puncture, the left atrium may be accessed, and one or more balloons can be deployed in the left atrium. Alternatively, one or more balloons may be deployed in the left atrium via navigation through the coronary sinus. The delivery system can then be progressively unsheathed, and other components of the device can be sequentially implanted under fluoroscopic and echo guidance, if necessary.
In some examples, the tube 405 may connect to and/or extend from the first balloon 402 and the second balloon 404 via an open channel and/or a selectively closed channel. For example, one or more flaps may be used to selectively allow flow from the first balloon 402 and/or the second balloon 404 into the tube 405 and/or vice versa. In some examples, the tube 405 may be configured to be disposed at least partially within the right atrium 5 and/or IVC 10.
In some examples, the first balloon 402 can have a dome and/or partial spherical (e.g., hemispherical) shape. For example, the first balloon 402 may comprise half of a sphere and/or may have a generally flat base portion configured to rest against a surface of the atrial septum 18. As the first balloon 402 extends away from the septum 18, the shape of the first balloon 402 may become more rounded. However, the first balloon 402 may have any suitable shape. For example, the first balloon 402 may alternatively comprise a generally circular and/or ovular shape.
The first balloon 402 may be secured to the septum 18 in any suitable manner. In some examples, a support anchor 406 may be configured to anchor the first balloon 402 in place. The anchor 406 may comprise a generally solid and/or hollow structure configured to be disposed opposite the first balloon 402 in the right atrium 5 and/or against the septum 18 on the right atrium 5 side. At least a portion of the septum 18 may be sandwiched between the anchor 406 and the first balloon 402. In some examples, the anchor 406 may comprise an inflatable balloon and/or other expandable device. The anchor 406 may be connected to the first balloon 402 and/or may be an extension of the first balloon 402. Alternatively, the anchor 406 may be a separate device and/or may be joined to the first balloon 402 via the tube 405 and/or other tethering device. In some examples, the anchor 406 may comprise a disc and/or similar device and/or may have a generally circular and/or ring-shaped form.
In some examples, the tube 405 may be configured to extend at least partially through the anchor 406 and/or through the septum 18 as the tube 405 extends from the first balloon 402 towards the IVC 10. The anchor 406 and/or first balloon 402 may comprise apertures and/or openings configured to receive and/or accommodate the tube 405.
The second balloon 404 may be delivered into the heart 1 separately and/or together with the first balloon 402. In some examples, the second balloon 404 may have a generally spherical form and/or may be configured to approximate a cross-sectional shape of the IVC 10. The tube 405 may have a suitable length such that the second balloon 404 may be configured to extend at least partially into the IVC 10 and/or in front of inflow channels from one or more hepatic veins 9. In some examples, the second balloon 404 may be configured to inflate to a diameter that is greater than the one or more hepatic veins 9 and/or approximately equal to or greater than a diameter of the IVC 10.
The first balloon 402, second balloon 404, and/or anchor 406 may have any suitable structure. In some examples, the first balloon 402, second balloon 404, and/or anchor 406 may comprise an outer layer and/or an inner layer. The inner layer may comprise a generally flexible, stretchy, and/or elastic material, which can include rubber, latex, and/or similar materials. The outer layer may have a generally rigid and/or bendable structure and/or may comprise one or more interwoven wires and/or lines of material. The outer layer may be at least partially composed of Nitinol and/or other shape memory alloys.
The first balloon 402 and/or second balloon 404 may be configured to be filled with an incompressible fluid. In some examples, the first balloon 402 and/or second balloon 404 may be implanted through an endovascular transeptal approach.
In some examples, the first balloon 402 and/or the second balloon 404 may comprise various features configured to regulate inflation and/or deflation and/or to regulate a rate of inflation and/or deflation of the first balloon 402 and/or the second balloon 404. For example, one or more springs, coils, and/or similar elements (e.g., Nitinol wire forms) may be attached to an exterior of the first balloon 402 and/or second balloon 404 and/or may be placed inside the first balloon 402 and/or the second balloon 404 to regulate the rate of deflation and/or inflation.
The first balloon 502 and the second balloon 504 may be fluidically connected via one or more tubes 505 configured to convey gas and/or fluid into and/or between the first balloon 502 and/or the second balloon 504. While only a single tube 505 is shown in
In some examples, the system may comprise one or more anchors 506 configured to anchor the first balloon 502 and/or tube 505 in place and/or in a desired position. For example, an anchor 506 may be configured to hold the first balloon 502 against the septum 18 and/or within the left atrium 2. In some examples, an anchor 506 may be disposed in the right atrium 5 and/or in contact with the right atrium 5 side of the septum 18. The anchor 506 may have any suitable size and/or shape. For example, the anchor 506 may have a form of a disc.
As the left atrial pressure returns to normal, the first balloon 602 and/or second balloon 604 can be configured to return to the forms shown in
The first balloon 602, second balloon 604 and/or tube 605 may be configured to be internally filled with a bio-inert incompressible fluid, such as saline. Deflation of one balloon can be configured to cause subsequent inflation of the other balloon. For example, during use, the system can alternate between the resting state of
In some examples, one or more anchors 606 may be configured to anchor the first balloon 602 and/or the tube 605 in place and/or at desired positions. The one or more anchors 606 may be generally hollow and/or may be inflated with gas and/or fluid conveyed via the tube 605. Alternatively, the one or more anchors 606 may be generally solid and/or may be configured to remain constantly inflated. For example, when the first balloon 602 is deflated and/or compressed, the one or more anchors 606 may remain in a constant expanded form.
In some examples, the second balloon 704 may be held in place and/or at least partially enclosed by a stent 708 and/or cage-like structure. The stent 708 may be configured to prevent the second balloon 704 from migrating up into the right atrium 5 and/or further down into the IVC 10. In some examples, the stent 708 may comprise an uncovered wire frame forming struts that may allow some blood flow through the wire frame.
The stent 708 may have a generally cylindrical and/or tubular form and/or may be configured to approximate a shape and/or size of the IVC 10. In some examples, the stent 708 may have a length that may be greater than the second balloon 704 such that the stent 708 may be configured to fully enclose the second balloon 704 lengthwise as well as circumferentially.
In some examples, the stent 708 may be configured to extend at least partially across and/or in front of one or more hepatic veins 9 branching into the IVC 10. The stent 708 may be at least partially porous and/or may be configured to form cells through which blood flow from the hepatic veins 9 can flow through. The stent 708 may be configured to have no or minimal effect on blood flow from the hepatic veins 9. As the second balloon 704 inflates and/or expands, the second balloon 704 may be configured to close cells formed by the stent 708 to potentially obstruct and/or limit blood flow from the hepatic veins 9.
The stent 708 may be expandable (e.g., balloon expandable) and/or may be configured to be expanded following delivery into the IVC 10. In some examples, a separate expansion balloon may be used to expand the stent 708. However, expansion and/or inflation of the second balloon 704 may be configured to cause expansion of the stent 708. For example, the second balloon 704 may be placed into the stent 708 in a compressed and/or uninflated state. When the second balloon 704 expands, the second balloon 704 may cause expansion of at least a portion of the stent 708. In some examples, the stent 708 may have a generally non-elastic structure and/or may be configured to maintain an expanded form following expansion by the second balloon 704.
In some examples, the stent 708 may be configured to attach to the second balloon 704 and/or to the tube 705. For example, the second balloon 704 and/or stent 708 may comprise one or more tethers, hooks, latches, anchors, and/or other features configured to establish one or more connections between the second balloon 704 and the stent 708. As a result, the second balloon 704 may be prevented from migrating relative to the stent 708.
The stent 708 may comprise one or more anchoring features (e.g., anchors) configured to anchor the stent 708 to the IVC 10. For example, the stent 708 may comprise one or more hooks, arms, and/or similar features configured to anchor into tissue of the IVC 10. However, the stent 708 may be configured to anchor to the IVC 10 independently of anchors. For example, the stent 708 may be configured to expand to a diameter that is approximately equal to and/or greater than the diameter of the IVC 10 such that the stent 708 may be configured to expand to a size that presses against the walls of the IVC 10 and holds the stent 708 in place.
The system may comprise one or more anchors 706 configured to anchor the first balloon 702 in place. The one or more anchors 706 may have a shape and/or size configured to prevent the one or more anchors 706 from passing through an opening in the septum 18.
In some examples, the second balloon 814, third balloon 816, and/or fourth balloon 818 may be disposed at least partially within hepatic veins 9 and/or may not be disposed within and/or extend into the IVC 10. In this way, the second balloon 814, third balloon 816, and/or fourth balloon 818 may advantageously avoid obstructing the IVC 10 while limiting inflow from the hepatic veins 9. The second balloon 814, third balloon 816, and/or fourth balloon 818 may have generally smaller diameters than balloons described herein for placement within the IVC 10. For example, a diameter of a hepatic vein 9 may be smaller than a diameter of the IVC 10. Accordingly, the second balloon 814, third balloon 816, and/or fourth balloon 818 may be configured to expand to smaller diameters than expanded forms of other balloons described herein.
While the second balloon 814, third balloon 816, and/or fourth balloon 818 are shown without enclosures (e.g., stents), the second balloon 814, third balloon 816, and/or fourth balloon 818 may be at least partially enclosed by one or more stents and/or may otherwise be anchored within the hepatic veins 9 to prevent the second balloon 814, third balloon 816, and/or fourth balloon 818 from migrating out of the hepatic veins 9 and/or deeper into the hepatic veins 9. The second balloon 814, third balloon 816, and/or fourth balloon 818 may be configured to be positioned at or near branching ends of the hepatic veins 9 and/or near the IVC 10. In some examples, the system may comprise a stent placed in the IVC 10 to prevent the second balloon 814, third balloon 816, and/or fourth balloon 818 from exiting the hepatic veins 9 and/or entering the IVC 10. For example, a cylindrical stent may be placed in the IVC 10 and/or may extend across inflow junctions of one or more hepatic veins 9. The stent may be delivered before and/or following placement of the second balloon 814, third balloon 816, and/or fourth balloon 818 in the hepatic veins 9.
In some examples, the system may comprise multiple tubes 805 and/or the tube 805 may be configured to branch into multiple branching tubes 807 which may individually extend to the various hepatic vein 9 balloons. Branching tubes 807 may have smaller diameters than the main tube 805.
The system may comprise one or more anchors 806 configured to anchor the first balloon 802 in place. The one or more anchors 806 may have a shape and/or size configured to prevent the one or more anchors 806 from passing through an opening in the septum 18.
The second balloon 904 may be configured for placement in the IVC 10 and/or the third balloon 914 may be configured for placement within a superior vena cava (SVC) 22 of the heart 1. Thus, the second balloon 904 may be configured to obstruct blood flow upwards into the right atrium 5 and/or the third balloon 914 may be configured to obstruct blood flow downwards into the right atrium 5.
While the second balloon 904 and the third balloon 914 are shown inflated and/or expanded in
The second balloon 904 and the third balloon 914 may be configured to inflate and/or deflate simultaneously and/or near simultaneously. For example, the second balloon 904 and the third balloon 914 may be configured to have generally equal responses to changes in left atrial pressure. The second balloon 904 and the third balloon 914 may have generally equal and/or different sizes. For example, the second balloon 904 may be configured to expand to fill the IVC 10 and/or the third balloon 914 may be configured to expand to fill the SVC 22. Depending on the sizes of the IVC 10 and SVC 22, the second balloon 904 and the third balloon 914 may have different expanded sizes and/or form and/or may be configured to fill in different amounts of time.
The system may comprise one or more anchors 906 configured to anchor the first balloon 902 in place. The one or more anchors 906 may have a shape and/or size configured to prevent the one or more anchors 906 from passing through an opening in the septum 18.
In some examples, the caval balloons 1004 may form a cluster of balloons and/or may at least partially contact each other and/or at least partially overlap. As shown in
The system may comprise one or more anchors 1006 configured to anchor the first balloon 1002 in place. The one or more anchors 1006 may have a shape and/or size configured to prevent the one or more anchors 1006 from passing through an opening in the septum 18.
In some embodiments, the implant may be configured to extend at least partially across one or more junctions between the IVC 10 and one or more hepatic veins 9. For example, when the balloon 1104 is inflated as shown in
The position of the implant may be adjusted following deployment of the implant within the IVC 10. For example, the implant may be configured such that a length of the implant exceeds a width of a hepatic vein 9 and/or such that a midsection 1117 of the stent 1108 extends across the hepatic vein 9. Thus, the implant may be adjusted upward and/or downward within the IVC 10 while maintaining complete and/or partial coverage of the hepatic vein 9. The implant may be configured for delivery via the IVC 10 and/or may be deployed at a position such that the implant simultaneously obstructs multiple hepatic veins 9.
In some embodiments, the stent 1108 may be configured to be expanded using a balloon expander and/or other means. The implant may be configured to be retrievable following deployment within the IVC 10. In some embodiments, an impact on blood flow of the implant may be evaluated while the implant is tethered to a delivery system. If the blood flow impact is less than or more than desired, the implant may be retrieved and/or adjusted. Upon determination that a desired blood flow impact has been reached, any tethering between the delivery systems and the implant may be removed.
The implant may have any suitable size to allow the implant to fit within the IVC 10. In some cases, differently sized implants may be used depending on a determination of a size of a patient's IVC 10.
The stent 1108 may comprise a middle portion 1117 (e.g., midsection) situated between a first end portion 1115 and a second end portion 1119 of the stent 1108. The middle portion 1117, first end portion 1115, and/or second end portion 1119 may comprise generally circular and/or ovular rings. The first end portion 1115 and/or the second end portion 1119 may have greater diameters than the middle portion 1117.
The struts 1116 may be configured to bend and/or navigate with respect to each other to provide flexibility to the stent 1108. For example, the struts 1116 may be configured to bend to allow the stent 1108 to assume a generally compressed form within a catheter and/or other delivery device. Upon removal from the catheter and/or other delivery device, the stent 1108 and/or struts 1116 may be configured to relax and/or assume a default expanded and/or relaxed form.
The balloon 1104 may be disposed around an outer surface of the middle portion 1117 and/or may be disposed within a lumen formed by the middle portion 1117. The middle portion 1117 may be configured to hold the balloon 1104 in the deflated form shown in
The balloon 1104 may be attached to and/or may extend into one or more tubes (not shown) which may interconnect the balloon 1104 to one or more additional balloons. For example, the balloon 1104 may be fluidly connected to a balloon disposed in the left atrium (not shown). Accordingly, the balloon 1104 may be configured to selectively obstruct the IVC 10 and/or hepatic veins 9 in response to increased pressure in the left atrium.
In some examples, the balloon 1104 may have a ring-shaped and/or donut-shaped form, in which the balloon 1104 may have a circular and/or ovular shape around an interior lumen.
The balloon 1204 may be attached to and/or may extend into one or more tubes (not shown) which may interconnect the balloon 1204 to one or more additional balloons. For example, the balloon 1204 may be fluidly connected to a balloon disposed in the left atrium (not shown). Accordingly, the balloon 1204 may be configured to selectively obstruct the IVC 10 and/or hepatic veins 9 in response to increased pressure in the left atrium.
In some examples, the balloon 1204 may be coupled and/or anchored to at least the inner frame 1208. As left atrial pressure increases, additional gas and/or fluid may be driven into the balloon 1204 such that the balloon 1204 may at least partially inflate and/or expand. As a result, the balloon 1204 may press against the outer frame 1209 and/or may press the outer frame 1209 outwardly and/or into contact with walls of the IVC 10 and/or against inflow junctions of one or more hepatic veins 9. In some examples, the inner frame 1208 and/or outer frame 1209 may be generally porous (e.g., having a wire frame form) and/or may provide generally minimal resistance to blood flow. Alternatively, the inner frame 1208 and/or outer frame 1209 may comprise coverings and/or may have generally solid forms to effectively obstruct blood flow. For example, the balloon 1204 may be configured to press the outer frame 1209 against an inflow junction of a hepatic vein 9 such that the outer frame 1209 at least partially obstructs the inflow junction of the hepatic vein 9. The implant may be configured to provide minimal obstruction of the IVC 10.
The sensor 1311 may be configured to sense pressure increases within the right atrium 5 and/or left atrium 2. In response to detecting pressure changes, the sensor 1311 may be configured to transmit a signal and/or to send a current to the obstruction element 1302 to cause the obstruction element 1302 to adjust and/or move to increase an amount of obstruction of the IVC 10 to reduce blood flow into the right atrium 5. For example, movement of the obstruction element 1302 may close an orifice formed by the obstruction element 1302. In some examples, the obstruction element 1302 may form a ring with an orifice through a center portion of the obstruction element 1302.
In some examples, the obstruction element 1302 may be at least partially composed of Nitinol and/or other shape memory alloys and/or materials configured to alter and/or adjust in response to an electric and/or thermal stimulus. In another example, the obstruction element 1302 can comprise carbon nanotubes configured to move and/or adjust in response to an electric and/or thermal stimulus.
The generator 1323 may be configured to provide power to the sensor 1311. For example, the generator 1323 may provide electric power to the sensor 1311 to allow the sensor 1311 to sense pressure changes and/or transmit electric currents.
In some examples, the tube 1405 may connect to and/or extend from the first balloon 1402 and the second balloon 1414 via an open channel and/or a selectively closed channel. For example, one or more flaps may be used to selectively allow flow from the first balloon 1402 and/or the second balloon 1414 into the tube 1405 and/or vice versa. In some examples, the tube 1405 may be configured to be disposed at least partially within the right atrium 5 and/or SVC 22.
In some examples, the first balloon 1402 can have a dome and/or partial spherical (e.g., hemispherical) shape. For example, the first balloon 1402 may comprise half of a sphere and/or may have a generally flat base portion configured to rest against a surface of the atrial septum 18. As the first balloon 1402 extends away from the septum 18, the shape of the first balloon 1402 may become more rounded. However, the first balloon 1402 may have any suitable shape. For example, the first balloon 1402 may alternatively comprise a generally circular and/or ovular shape.
The first balloon 1402 may be secured to the septum 18 in any suitable manner. In some examples, a support anchor 1406 may be configured to anchor the first balloon 1402 in place. The anchor 1406 may comprise a generally solid and/or hollow structure configured to be disposed opposite the first balloon 1402 in the right atrium 5 and/or against the septum 18 on the right atrium 5 side. At least a portion of the septum 18 may be sandwiched between the anchor 1406 and the first balloon 1402. In some examples, the anchor 1406 may comprise an inflatable balloon and/or other expandable device. The anchor 1406 may be connected to the first balloon 1402 and/or may be an extension of the first balloon 1402. Alternatively, the anchor 1406 may be a separate device and/or may be joined to the first balloon 1402 via the tube 1405 and/or other tethering device. In some examples, the anchor 1406 may comprise a disc and/or similar device and/or may have a generally circular and/or ring-shaped form.
In some examples, the tube 1405 may be configured to extend at least partially through the anchor 1406 and/or through the septum 18 as the tube 1405 extends from the first balloon 1402 towards the SVC 22. The anchor 1406 and/or first balloon 1402 may comprise apertures and/or openings configured to receive and/or accommodate the tube 1405.
The second balloon 1414 may be delivered into the heart 1 separately and/or together with the first balloon 1402. In some examples, the second balloon 1414 may have a generally spherical form and/or may be configured to approximate a cross-sectional shape of the SVC 22. The tube 1405 may have a suitable length such that the second balloon 1414 may be configured to extend at least partially into the SVC 22 and/or in front of inflow channels from one or more hepatic veins 9. In some examples, the second balloon 1414 may be configured to inflate to a diameter that is greater than the one or more hepatic veins 9 and/or approximately equal to or greater than a diameter of the SVC 22.
The first balloon 1402, second balloon 1414, and/or anchor 1406 may have any suitable structure. In some examples, the first balloon 1402, second balloon 1414, and/or anchor 1406 may comprise an outer layer and/or an inner layer. The inner layer may comprise a generally flexible, stretchy, and/or elastic material, which can include rubber, latex, and/or similar materials. The outer layer may have a generally rigid and/or bendable structure and/or may comprise one or more interwoven wires and/or lines of material. The outer layer may be at least partially composed of Nitinol and/or other shape memory alloys.
The first balloon 1402 and/or second balloon 1414 may be configured to be filled with an incompressible fluid. In some examples, the first balloon 1402 and/or second balloon 1414 may be implanted through an endovascular transeptal approach.
In some examples, the first balloon 1402 and/or the second balloon 1414 may comprise various features configured to regulate inflation and/or deflation and/or to regulate a rate of inflation and/or deflation of the first balloon 1402 and/or the second balloon 1414. For example, one or more springs, coils, and/or similar elements (e.g., Nitinol wire forms) may be attached to an exterior of the first balloon 1402 and/or second balloon 1414 and/or may be placed inside the first balloon 1402 and/or the second balloon 1414 to regulate the rate of deflation and/or inflation.
In some examples, the tube 1505 may connect to and/or extend from the first balloon 1502 and the second balloon 1504 via an open channel and/or a selectively closed channel. For example, one or more flaps may be used to selectively allow flow from the first balloon 1502 and/or the second balloon 1504 into the tube 1505 and/or vice versa. In some examples, the tube 1505 may be configured to be disposed at least partially within the right atrium 5 and/or IVC 10 and/or may be configured to extend through the coronary sinus 16 to extend from the right atrium 5 to the left atrium 2.
In some examples, the first balloon 1502 can have a spherical and/or other shape. The tube 1505 may be configured to enter the left atrium 2 via the coronary sinus 16 and/or one or more branching blood vessels. The first balloon 1502 may be configured to extend into the left atrium 2 and/or away from a junction between the left atrium 2 and the coronary sinus 16 and/or branching blood vessels to avoid blockage of the coronary sinus 16. In some examples, the first balloon 1502 may be placed in the left atrium 2 with a stent, anchor and/or similar device configured to hold the first balloon 1502 distally from the coronary sinus 16 and/or to maintain a flow pathway between the left atrium 2 and the coronary sinus 16. The first balloon 1502 may be anchored to one or more walls of the left atrium 2, which can include the septum 18.
The second balloon 1504 may be delivered into the heart 1 separately and/or together with the first balloon 1502. In some examples, the second balloon 1504 may have a generally spherical form and/or may be configured to approximate a cross-sectional shape of the IVC 10. The tube 1505 may have a suitable length such that the second balloon 1504 may be configured to extend at least partially into the IVC 10 and/or in front of inflow channels from one or more hepatic veins 9. In some examples, the second balloon 1504 may be configured to inflate to a diameter that is greater than the one or more hepatic veins 9 and/or approximately equal to or greater than a diameter of the IVC 10.
The first balloon 1502 and/or second balloon 1504 may have any suitable structure. In some examples, the first balloon 1502 and/or second balloon 1504 may comprise an outer layer and/or an inner layer. The inner layer may comprise a generally flexible, stretchy, and/or elastic material, which can include rubber, latex, and/or similar materials. The outer layer may have a generally rigid and/or bendable structure and/or may comprise one or more interwoven wires and/or lines of material. The outer layer may be at least partially composed of Nitinol and/or other shape memory alloys.
The first balloon 1502 and/or second balloon 1504 may be configured to be filled with an incompressible fluid. In some examples, the first balloon 1502 and/or second balloon 1504 may be implanted through an endovascular transeptal approach.
In some examples, the first balloon 1502 and/or the second balloon 1504 may comprise various features configured to regulate inflation and/or deflation and/or to regulate a rate of inflation and/or deflation of the first balloon 1502 and/or the second balloon 1504. For example, one or more springs, coils, and/or similar elements (e.g., Nitinol wire forms) may be attached to an exterior of the first balloon 1502 and/or second balloon 1504 and/or may be placed inside the first balloon 1502 and/or the second balloon 1504 to regulate the rate of deflation and/or inflation.
The first tube 1605 and/or second tube 1615 may provide a fluidic connection and/or channel between the first balloon 1602 and the second balloon 1614. For example, as a fluid and/or gas is pressed out of the first balloon 1602, the fluid and/or gas may be passed from the first balloon 1602 to the second balloon 1614 (e.g., via the second tube 1615), and vice versa.
In some examples, the first tube 1605 and/or second tube 1615 may connect to and/or extend from the first balloon 1602 and the second balloon 1614 via an open channel and/or a selectively closed channel. For example, one or more flaps may be used to selectively allow flow from the first balloon 1602 and/or the second balloon 1614 into the first tube 1605 and/or second tube 1615 and/or vice versa. In some examples, the first tube 1605 and/or second tube 1615 may be configured to be disposed at least partially within the right atrium 5 and/or SVC 22.
In some examples, the first balloon 1602 can have a dome and/or partial spherical (e.g., hemispherical) shape. For example, the first balloon 1602 may comprise half of a sphere and/or may have a generally flat base portion configured to rest against a surface of the atrial septum 18. As the first balloon 1602 extends away from the septum 18, the shape of the first balloon 1602 may become more rounded. However, the first balloon 1602 may have any suitable shape. For example, the first balloon 1602 may alternatively comprise a generally circular and/or ovular shape.
The first balloon 1602 may comprise a support device 1610 configured to facilitate expansion and/or deflation of the first balloon 1602. The support device 1610 can comprise a spring, coil, and/or similar mechanism. In some examples, the support device 1610 may be disposed at least partially within a membrane 1612 and/or covering of the first balloon 1602. The support device 1610 may extend at least partially within a hollow interior formed by the membrane 1612 and/or may be encased and/or enclosed by the membrane 1612. For example, the support device 1610 may form a skeleton for the membrane 1612.
In some examples, the support device 1610 may have an internal bias. For example, the support device 1610 may be biased to the expanded form shown in
The second balloon 1614 may be delivered into the heart 1 separately and/or together with the first balloon 1602. In some examples, the second balloon 1614 may have a generally spherical form and/or may be configured to approximate a cross-sectional shape of the SVC 22. The first tube 1605 and/or second tube 1615 may have a suitable length such that the second balloon 1614 may be configured to extend at least partially into the SVC 22 and/or in front of inflow channels from one or more hepatic veins. The second balloon 1614 may be at least partially enclosed by a stent 1608 and/or similar device. The stent 1608 may be configured to hold the second balloon 1614 in place within the SVC 22.
In some examples, the first balloon 1602 and/or second balloon 1614 may comprise an outer layer and/or an inner layer. The inner layer may comprise a generally flexible, stretchy, and/or elastic material, which can include rubber, latex, and/or similar materials. The outer layer may have a generally rigid and/or bendable structure and/or may comprise one or more interwoven wires and/or lines of material. The outer layer may be at least partially composed of Nitinol and/or other shape memory alloys.
The first balloon 1602 and/or second balloon 1614 may be configured to be filled with an incompressible fluid. In some examples, the first balloon 1602 and/or second balloon 1614 may be implanted through an endovascular transeptal approach.
The support device 1710 can have any of a variety of forms. In the example shown in
While
In some examples, the device 1710 may be biased to the expanded configuration and/or may move to the compressed configuration only in response to increased external pressure (e.g., increased left atrial pressure). The device 1710 may be configured to move to the compressed configuration only in response to a threshold amount of external pressure. For example, the device 1710 may be configured to resist moving to the compressed configuration until external pressure exceeds a threshold amount. The transition from the expanded configuration to the compressed configuration and/or from the compressed configuration to the expanded configuration may be quick and/or may be completed in a single motion. In some examples, the device 1710 may comprise one or more features configured to increase a resistance in configuration changes of the device 1710. For example, the device 1710 may comprise one or more tabs, dimples, cavities, notches, pegs, and/or similar mechanisms configured to hold the device in the expanded and/or compressed configuration. In one or example, the joint 1725 may comprise one or more raised bumps configured aligned with sides of the proximal portions 1726 of the legs 1724 to provide some resistance to movement of the proximal portions 1726 relative to the joint 1725 and/or distal portions 1726.
The balloon 2002 may be configured to transition from the expanded configuration to the compressed configuration and/or from the compressed configuration to the expanded configuration. In some examples, the balloon 2002 and/or device 2010 may be configured to transition in a single pulse in response to external pressure rising above and/or falling below a threshold value. A threshold pressure level required to cause the balloon 2002 to transition from the expanded configuration to the collapsed configuration may be different than the threshold pressure level required to cause the balloon 2002 to transition from the collapsed configuration to the expanded configuration. For example, the balloon 2002 may be configured to transition from the expanded configuration to the collapsed configuration only once external pressure exceeds a first pressure level. However, the balloon 2002 may not transition back from the collapsed configuration to the expanded configuration in response to external pressure falling below the first pressure level. Rather, the balloon 2002 may be configured to transition back from the collapsed configuration to the expanded configuration in response to external pressure falling below a second pressure level that is less than the first pressure level.
The first tube 2105 and/or second tube 2115 may provide a fluidic connection and/or channel between the first balloon 2102 and the second balloon 2114. For example, as a fluid and/or gas is pressed out of the first balloon 2102, the fluid and/or gas may be passed from the first balloon 2102 to the second balloon 2114 (e.g., via the second tube 2115), and vice versa.
In some examples, the first tube 2105 and/or second tube 2115 may connect to and/or extend from the first balloon 2102 and the second balloon 2114 via an open channel and/or a selectively closed channel. For example, one or more flaps may be used to selectively allow flow from the first balloon 2102 and/or the second balloon 2114 into the first tube 2105 and/or second tube 2115 and/or vice versa. In some examples, the first tube 2105 and/or second tube 2115 may be configured to be disposed at least partially within the right atrium 5 and/or SVC 22.
In some examples, the first balloon 2102 can have a dome and/or partial spherical (e.g., hemispherical) shape. For example, the first balloon 2102 may comprise half of a sphere and/or may have a generally flat base portion configured to rest against a surface of the atrial septum 18. As the first balloon 2102 extends away from the septum 18, the shape of the first balloon 2102 may become more rounded. However, the first balloon 2102 may have any suitable shape. For example, the first balloon 2102 may alternatively comprise a generally circular and/or ovular shape.
The first balloon 2102 may comprise a support device 2110 configured to facilitate expansion and/or deflation of the first balloon 2102. The support device 2110 can comprise a platform and/or one or more flexible and/or extendible mechanisms. For example, the device 2110 can comprise one or more legs configured to bend (e.g., at one or more joints). The device 2110 can additionally or alternatively comprise a generally flexible midsection extending between the platform and a base portion of the device 2110.
In some examples, the support device 2110 may be disposed at least partially within a membrane 2112 and/or covering of the first balloon 2102. The support device 2110 may extend at least partially within a hollow interior formed by the membrane 2112 and/or may be encased and/or enclosed by the membrane 2112. For example, the support device 2110 may form a skeleton for the membrane 2112. Movement of the device 2110 may be configured to cause corresponding movement of the first balloon 2102. For example, where the device 2110 is disposed within the hollow interior of the first balloon 2102 and/or not encased within the membrane 2112, the platform of the device 2110 may be attached to the membrane 2112 such that when the platform moves towards the septum 18, the membrane 2112 may be pulled with the device 2110.
In some examples, the support device 2110 may have an internal bias. For example, the support device 2110 may be biased to the expanded form shown in
The first balloon 2102 may be configured to transition from the expanded configuration of
In some examples, the first balloon 2102 may comprise multiple devices 2110, with each device 2110 configured to transition between expanded and collapsed configurations. Where multiple devices 2110 are used, each device 2110 may be configured to transition between the expanded and collapsed configurations at different pressures, thereby creating a staggered transition of the first balloon 2102. Moreover, one or more devices 2110 may comprise multiple transition states. For example, a device 2110 may be configured to transition from an expanded configuration to a medium configuration and/or vice versa and/or from the medium configuration to a collapsed configuration and/or vice versa.
The first balloon 2102 may be secured to the septum 18 in any suitable manner. In some examples, a support anchor may be configured to anchor the first balloon 2102 in place.
The second balloon 2114 may be delivered into the heart 1 separately and/or together with the first balloon 2102. In some examples, the second balloon 2114 may have a generally spherical form and/or may be configured to approximate a cross-sectional shape of the SVC 22. The first tube 2105 and/or second tube 2115 may have a suitable length such that the second balloon 2114 may be configured to extend at least partially into the SVC 22 and/or in front of inflow channels from one or more hepatic veins 9. The second balloon 2114 may be at least partially enclosed by a stent 2108 and/or similar device. The stent 2108 may be configured to hold the second balloon 2114 in place within the SVC 22.
In some examples, the first balloon 2102 and/or second balloon 2114 may comprise an outer layer and/or an inner layer. The inner layer may comprise a generally flexible, stretchy, and/or elastic material, which can include rubber, latex, and/or similar materials. The outer layer may have a generally rigid and/or bendable structure and/or may comprise one or more interwoven wires and/or lines of material. The outer layer may be at least partially composed of Nitinol and/or other shape memory alloys.
The first balloon 2102 and/or second balloon 2114 may be configured to be filled with an incompressible fluid. In some examples, the first balloon 2102 and/or second balloon 2114 may be implanted through an endovascular transeptal approach.
Described herein are various example medical implants and/or delivery methods. Some examples described herein may be used in combination and/or may be used independently.
Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes.
Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.
It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above but should be determined only by a fair reading of the claims that follow.
It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which example embodiments belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
Delivery systems as described herein may be used to position catheter tips and/or catheters to various areas of a human heart. For example, a catheter tip and/or catheter may be configured to pass from the right atrium into the coronary sinus. However, it will be understood that the description can refer or generally apply to positioning of catheter tips and/or catheters from a first body chamber or lumen into a second body chamber or lumen, where the catheter tips and/or catheters may be bent when positioned from the first body chamber or lumen into the second body chamber or lumen. A body chamber or lumen can refer to any one of a number of fluid channels, blood vessels, and/or organ chambers (e.g., heart chambers). Additionally, reference herein to “catheters,” “tubes,” “sheaths,” “steerable sheaths,” and/or “steerable catheters” can refer or apply generally to any type of elongate tubular delivery device comprising an inner lumen configured to slidably receive instrumentation, such as for positioning within an atrium or coronary sinus, including for example delivery catheters and/or cannulas. It will be understood that other types of medical implant devices and/or procedures can be delivered to the coronary sinus using a delivery system as described herein, including for example ablation procedures, drug delivery and/or placement of coronary sinus leads.
This application is a continuation of International Patent Application No. PCT/US2023/071215, filed Jul. 28, 2023, which claims the benefit of U.S. Provisional Application No. 63/370,632, filed Aug. 5, 2022, the disclosures of which are hereby incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63370632 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/071215 | Jul 2023 | WO |
| Child | 19020029 | US |
