Catheter-based extracorporeal membrane oxygenation (ECMO)

Abstract

A method and system for performing transseptal extracorporeal membrane oxygenation are disclosed. The method may include the steps of puncturing the septum between the right and left atria, and advancing a catheter system through the puncture and into the aorta. A first portion of the catheter system may remove blood from the patient, in some cases near the inferior vena cava. A second portion may return oxygenated blood to the patient through the transseptal puncture and into the aorta.

Description

Technical Field

[0001] Claim of Priority

[0001] This patent application claims priority to U.S. Patent Application No. 18 / 642,779, filed on April 22, 2024, entitled "METHOD AND APPARATUS FOR CATHETER-BASED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)", and U.S. Patent Application No. 18 / 484,398, filed on October 10, 2023, entitled "METHOD AND APPARATUS FOR CATHETER-BASED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)", now U.S. Patent No. 11,964,091, each of which is hereby incorporated by reference in its entirety into the present specification.

[0002] Incorporation by Reference

[0002] All publications and patent applications described in the present specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] The methods and apparatuses described herein may relate to extracorporeal membrane oxygenation (ECMO). More specifically, the methods and apparatuses described herein may relate to devices that may allow a surgeon to perform an ECMO procedure through a catheter that is guided to the cardiac region of a patient.

Background Art

[0003]

[0004] Historically, cardiopulmonary bypass technology has been used as a core technique for performing open heart procedures such as coronary artery bypass grafting, or complex valve replacement or repair. These procedures are typically performed in an operating room, involving sternotomy and cannulas inserted into cardiac structures such as the right atrium and the aorta.

[0004]

[0005] Percutaneous extracorporeal membrane oxygenation (ECMO) using catheter-based systems has been used for short-term ECMO in critically ill patients with cardiopulmonary disease. Traditionally, a large-bore sheath or cannula placed in the femoral vein is advanced into the iliac vein or possibly the inferior vena cava to allow for high-flow removal of deoxygenated venous blood. The blood is then pumped to an ECMO machine that oxygenates the blood. A second large-bore cannula is placed in the femoral artery, which is connected to the outflow from the ECMO machine and pump to perfuse this oxygenated blood into the iliac artery or distal abdominal aorta. This type of system is commonly referred to as "VA (venous-arterial) ECMO."

[0005]

[0006] Conventional ECMO has been associated with complications leading to severe limb ischemia secondary to large-diameter arterial cannulas / catheters. These complications can occur in up to 10 percent of conventional ECMO procedures and are associated with a higher mortality rate. Therefore, there is a critical need for improved techniques to make catheter-based cardiopulmonary bypass / ECMO more effective. [Overview of the project]

[0006]

[0007] Described herein are apparatus, systems, and methods for providing ECMO therapy to a patient. This therapy may be delivered through one or more catheters that are delivered percutaneously and advanced into the cardiac region. In some examples, at least one catheter may be advanced through a transseptal puncture and through the left atrium and left ventricle into the aorta. Blood may be removed through a venous catheter positioned in the inferior vena cava and returned through an arterial catheter in the aorta.

[0007]

[0008] Any of the methods described herein may be used for transseptal extracorporeal membrane oxygenation. The method may include the steps of: advancing a first inner catheter and a second inner catheter, which taper distally, through a transseptal puncture, wherein the second inner catheter is coaxial with and surrounds the first inner catheter, and the outer surface of the second inner catheter is in close contact with the outer surface of the first inner catheter; deflecting the first inner catheter in the left atrium so that its distal tip is substantially positioned toward the center of the mitral valve; advancing the first inner catheter and the second inner catheter through the center of the mitral valve; deflecting the distal tip of the first inner catheter toward the valve; advancing the first inner catheter and the second inner catheter through the valve; withdrawing the first inner catheter; and receiving oxygen-poor blood from the patient through an outer catheter and returning oxygenated blood through the second inner catheter, wherein the outer catheter surrounds the second inner catheter.

[0008]

[0009] Any of the methods described herein may further include the step of inflating a balloon positioned around the distal end of the first inner catheter in order to center the first inner catheter relative to the mitral valve. Generally, the balloon may be inflated with gas or a liquid such as saline. Any of the methods described herein may also include the step of inflating the balloon before advancing the first and second inner catheters through the mitral valve.

[0009]

[0010] Deflecting the distal tip of the first internal catheter toward the valve by any of the methods described herein may include deflecting the distal tip by more than 170 degrees relative to the proximal portion of the first internal catheter. Generally, the distal tip can be deflected by any feasible amount greater than about 140 degrees (e.g., more than 150 degrees, more than 160 degrees, more than 170 degrees, etc.).

[0010]

[0011] In any of the methods described herein, the second inner catheter may include a plurality of holes arranged around the body of the second inner catheter for returning oxygenated blood.

[0011]

[0012] In any of the methods described herein, the external catheter may include a plurality of holes arranged around the body of the external catheter for receiving oxygen-poor blood (venous blood) and / or blood from the left atrium.

[0012]

[0013] Any of the methods described herein may further include the step of inserting a first guidewire into the first inner catheter, the second inner catheter, and the outer catheter before deflecting the first inner catheter in the left atrium. Furthermore, the method may include the step of withdrawing the first guidewire before deflecting the distal tip of the first inner catheter toward the valve, and after the withdrawal of the first guidewire, inserting a second guidewire that is stiffer than the first guidewire.

[0013]

[0014] Any of the methods described herein may include the step of puncturing the septum between the right and left atria before advancing the first and second medial catheters through transseptal puncture.

[0014]

[0015] An example method for a transseptal extracorporeal membrane oxygenator could include the steps of: advancing a first catheter, comprising an inner sheath and an outer sheath, through a transseptal puncture, wherein the outer sheath is coaxial with and surrounds the inner sheath, and the outer surface of the outer sheath is in close contact with the outer surface of the inner sheath; advancing a second catheter into the inferior vena cava; deflecting the inner sheath in the left atrium such that the distal end of the inner sheath is substantially positioned toward the approximate center of the mitral valve; advancing the inner sheath through the approximate center of the mitral valve; deflecting the distal end of the inner sheath toward the valve; advancing the first catheter through the valve; withdrawing the inner sheath from the first catheter; and receiving oxygen-depleted blood from the patient through the second catheter and returning oxygenated blood through the first catheter.

[0015]

[0016] Any of the methods described herein may further include the step of inflating a balloon positioned around the distal end of the inner sheath to center the first inner catheter relative to the mitral valve. Furthermore, the method may include the step of inflating the balloons of the inner and outer sheaths before advancing them through the mitral valve.

[0016]

[0017] In any of the methods described herein, the step of deflecting the distal tip of the inner sheath toward the valve may include deflecting the distal tip by more than about 140 degrees relative to the proximal region of the inner sheath (e.g., more than about 150 degrees, more than about 160 degrees, more than about 170 degrees, etc.).

[0017]

[0018] In any of the methods described herein, the second catheter may include a plurality of holes arranged around the body of the second catheter for returning oxygenated blood. In a similar manner, in any of the methods described herein, the outer sheath may include a plurality of holes arranged around the body of the outer sheath for receiving oxygen-poor blood.

[0018]

[0019] Any of the methods described herein may further include the step of inserting a first guidewire into the medial and lateral sheaths before deflecting the medial sheath in the left atrium. Furthermore, any of the methods may further include the step of removing the first guidewire before deflecting the distal end of the medial sheath toward the valve, and after removing the first guidewire, inserting a second guidewire that is stiffer than the first guidewire.

[0019]

[0020] Any of the methods described herein may include the step of puncturing the septum between the right and left atria before advancing the medial and lateral sheaths through transseptal puncture.

[0020]

[0021] Furthermore, apparatus (e.g., systems and devices) for carrying out any of these methods are described herein. In particular, systems for administering transseptal extracorporeal membrane oxygenation (ECMO) to patients are described herein. In some cases, the system includes a first inner catheter that tapers distally, an arterial sheath catheter configured to coaxially surround the first inner catheter such that the distal outer surface of the arterial sheath catheter closely overlaps the outer surface of the first inner catheter, and further comprising a plurality of arterial infusion holes in the distal end region of the first inner catheter, and a venous sheath catheter configured to coaxially surround the arterial sheath catheter such that the distal outer surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and further comprising a plurality of lateral venous inflow holes passing through the side wall region, a first proximal connector configured to connect the lumen of the arterial sheath catheter, which is in fluid communication with the plurality of arterial infusion holes, to an artificial lung, and a second proximal connector configured to connect the lumen of the venous sheath catheter, which is in fluid communication with the plurality of lateral venous inflow holes, to a venous suction pump.

[0021]

[0022] Generally, the inner catheter (either the first inner catheter and / or the second inner catheter) may be configured to move independently of the outer catheter and may extend more than 20 cm beyond the distal tip of the outer catheter (e.g., more than 25 cm, more than 30 cm, more than 35 cm, more than 40 cm, more than 50 cm, more than 55 cm, etc., 20-55 cm, 25-50 cm, 30-50 cm, etc.). During use, the inner catheter may, in some cases, be advanced across the entire mitral valve around its cusp and into the ascending aorta. Subsequently, the outer catheter is then advanced over the inner catheter after it has advanced across the entire mitral valve around its cusp and into the ascending aorta. Thus, the inner catheter may be configured so that the outer catheter can move (e.g., slide) freely over the inner catheter. The outer catheter may have a generally smooth shape. In some cases, the inner catheter may be configured to limit the distal extension of the inner catheter to the outer catheter.

[0022]

[0023] In some cases, the first internal catheter may include a distal dilator. For example, the distal dilator may have a balloon. Either of these devices may further include a second internal catheter having a distal end region configured to deflect by 140–190 degrees.

[0023]

[0024] Any of these devices may include a venous sheath hub with a second proximal connector, and the venous sheath catheter extends distally from the venous sheath hub. In some cases, the device may include an arterial sheath hub with a first proximal connector, and the arterial sheath catheter extends distally from the arterial sheath hub. Multiple lateral venous inlet holes may be configured to be positioned within the patient's inferior vena cava when the distal outer surface of the venous sheath catheter is in close contact with the outer surface of the arterial sheath catheter, and when the multiple arterial inlet holes are positioned within the patient's ascending aortic arch.

[0024]

[0025] In any of these devices, the side wall region with a plurality of side venous inflow holes can be configured to be positioned across the patient's cardiac septum when the distal outer surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and when the plurality of arterial infusion holes are positioned within the patient's ascending aortic arch.

[0025]

[0026] Any of these devices may include a first interference fit between the distal inner surface of the arterial sheath catheter and the outer surface of the first inner catheter. Any of these devices may include a second interference fit between the distal inner surface of the venous sheath catheter and the outer surface of the arterial sheath catheter.

[0026]

[0027] For example, described herein is a system for performing transseptal extracorporeal membrane oxygenation (ECMO) on a patient, the system comprising: a first inner catheter that tapers distally; an arterial sheath catheter, wherein the arterial sheath catheter is configured to coaxially surround the first inner catheter such that the distal outer surface of the arterial sheath catheter closely overlaps the outer surface of the first inner catheter, and further wherein the arterial sheath catheter is provided with a plurality of arterial infusion holes in the distal end region of the first inner catheter; a venous sheath catheter, wherein the venous sheath catheter is configured to coaxially surround the arterial sheath catheter such that the distal outer surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and further wherein the venous sheath catheter is provided with a plurality of side venous inflow holes passing through the side wall region; an arterial hub in fluid communication with the plurality of arterial infusion holes; and a venous hub in fluid communication with the plurality of side venous inflow holes.

[0027]

[0028] The arterial hub may be configured to couple the lumen of the arterial sheath catheter to the first connector. The venous hub may be configured to couple the lumen of the venous sheath catheter to the second connector. The first inner catheter may include a distal dilatable dilator configured to center the first inner catheter within the patient's lumen. The arterial hub is configured to deliver oxygenated blood to the arterial infusion holes.

[0028]

[0029] In some cases, the venous hub is configured to receive oxygen-depleted blood from the patient. The plurality of lateral venous inflow holes may be configured to be positioned within the patient's inferior vena cava when the distal outer surface of the venous sheath catheter overlaps exactly with the outer surface of the arterial sheath catheter, and the plurality of arterial infusion holes are positioned within the patient's ascending aortic arch. The side wall region comprising the plurality of lateral venous inflow holes may be configured to be positioned across the patient's cardiac septum when the distal outer surface of the venous sheath catheter overlaps exactly with the outer surface of the arterial sheath catheter, and the plurality of arterial infusion holes are positioned within the patient's ascending aortic arch. Any of these devices may include a second inner catheter having a distal end region configured to be deflected by 140 to 190 degrees. The arterial hub may be configured to be coupled to an oxygenator, and the venous hub is configured to be coupled to a venous suction pump.

[0029]

[0030] As described, the inner catheter may be configured as a guide catheter such that it can extend distally beyond the outer catheter to allow positioning of the inner catheter across the mitral valve around the leaflets and into the ascending aorta, and the outer catheter can then be advanced over the inner catheter and advanced across the mitral valve around the leaflets and into the aorta.

[0030]

[0031] Generally, a system for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient includes a first inner catheter that tapers distally, a first sheath catheter configured to coaxially surround the first inner catheter, and further comprising a first sheath catheter and a second sheath catheter, wherein the distal inner surface of the second sheath catheter is connected to the first sheath catheter. The second sheath catheter is configured to coaxially surround the first sheath catheter so as to fit snugly with the outer surface of the second sheath catheter, and the second sheath catheter may include a second sheath catheter having a plurality of lateral inflow holes passing through the side wall region, a first proximal connector configured to connect the lumen of the first sheath catheter, which is in fluid communication with the plurality of inflow holes, to an artificial lung or suction pump, and a second proximal connector configured to connect the lumen of the second sheath catheter, which is in fluid communication with the plurality of lateral inflow holes, to an artificial lung or suction pump.

[0031]

[0032] For example, a system for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient includes a first inner catheter that tapers distally and an arterial sheath catheter, wherein the arterial sheath catheter is configured to coaxially surround the first inner catheter such that the distal outer surface of the arterial sheath catheter closely overlaps the outer surface of the first inner catheter, and furthermore, the arterial sheath catheter has multiple arterial injection holes in the distal end region of the first inner catheter, and the first inner catheter is configured to extend more than 15 mm distal to the arterial sheath catheter, and a venous sheath catheter. The venous sheath catheter is configured to coaxially surround an arterial sheath catheter such that the distal inner surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and the venous sheath catheter may further include a venous sheath catheter having a plurality of lateral venous inflow holes passing through a lateral wall region, a first proximal connector configured to connect the lumen of the arterial sheath catheter, which is in fluid communication with a plurality of arterial infusion holes, to an artificial lung, and a second proximal connector configured to connect the lumen of the venous sheath catheter, which is in fluid communication with a plurality of lateral venous inflow holes, to a venous suction pump.

[0032]

[0033] The first internal catheter may be configured to extend more than 20 mm distal to the arterial sheath catheter (for example, more than 25 mm, more than 30 mm, more than 35 mm, more than 40 mm, more than 35 mm, more than 50 mm distal to the arterial sheath catheter).

[0033]

[0034] All methods and apparatus described herein, in any combination, may be used to achieve the interests contemplated and described herein.

[0035] A better understanding of the features and advantages of the methods and apparatus described herein is obtained from the following detailed description, which specifies illustrative embodiments, and from reference to the accompanying drawings. [Brief explanation of the drawing]

[0034] [Figure 1]

[0036] This figure shows an example of a catheter-based ECMO system. [Figure 2A]

[0037] This figure shows the distal end of a catheter-based ECMO system. [Figure 2B]

[0038] Another diagram of the distal end of a catheter-based ECMO system. [Figure 3]

[0039] Another diagram of a catheter-based ECMO system. [Figure 4]

[0040] This diagram shows an example of a venous hub. [Figure 5]

[0041] This diagram shows an example of an arterial hub. [Figure 6]

[0042] This is a cross-section diagram of the handle. [Figure 7]

[0043] Figure 7A shows the distal end of the catheter-based ECMO system shown in Figure 1. Figure 7B shows the distal end of the catheter-based ECMO system shown in Figure 1. [Figure 8]

[0044] This is a cross-sectional view of an example vein hub. [Figure 9]

[0045] This is a cross-sectional view of an example arterial hub. [Figure 10A]

[0046] Figure 1 shows a region of the catheter-based ECMO system 100. [Figure 10B]

[0047] This is a cross-sectional view of the region shown in Figure 10A. [Figure 10C]

[0048] This is a detailed cross-sectional view of the tip of the region shown in Figure 10A. [Figure 11A]

[0049] This figure shows an example of a mesh-reinforced shaft. [Figure 11B]

[0050] This is a diagram showing a cross-section of another reinforcing shaft. [Figure 11C]

[0051] These are separate diagrams of the hypotube and polymer jacket. [Figure 12A]

[0052] This figure shows a region of the catheter-based ECMO system shown in Figure 1. [Figure 12B]

[0053] This is a cross-sectional view of the region shown in Figure 12A. [Figure 12C]

[0054] Figure 12B is a detailed cross-sectional view of the tip. [Figure 13A]

[0055] Figure 1 is a partial view of a catheter-based ECMO system. [Figure 13B]

[0056] Figure 1 is a cross-sectional view of a catheter-based ECMO system. [Figure 14A]

[0057] This is a partial view of an internal catheter in an arterial sheath. [Figure 14B]

[0058] This figure shows some example elements of an arterial sheath inner catheter. [Figure 15A]

[0059] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15B] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15C] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15D] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15E] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15F] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15G] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15H] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 15I] Figure 1 shows an example of steps using a catheter-based ECMO system. [Figure 16A]

[0060] Figure 16A shows the potential configurations of venous and arterial sheaths for performing ECMO. [Figure 16B] Figure 16B shows the potential configurations of venous and arterial sheaths for performing ECMO. [Figure 17A]

[0061] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17B] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17C] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17D] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17E] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17F] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17G] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17H] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 17I] This figure shows the steps for an example using two catheter-based ECMO systems. [Figure 18]

[0062] Figure 1 is a flowchart illustrating an example of a method for performing ECMO using a catheter-based ECMO system. [Figure 19]

[0063] This flowchart shows an example method for performing ECMO using two catheter-based ECMO systems. [Figure 20A]

[0064] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20B] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20C] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20D] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20E] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20F] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20G] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Figure 20H] This figure shows one example of how the apparatus described herein is used to perform ECMO. [Modes for carrying out the invention]

[0035]

[0065] This disclosure relates to systems, methods, and apparatus for solving technical problems related to providing extracorporeal membrane oxygenation (ECMO) therapy through a catheter-based system. Two different examples of systems are described herein, and combinations of these two systems may be made, and therefore any of the features of these systems may be incorporated together. A first example of a system and method uses three different catheters. That is, the first system may include a first catheter (sometimes referred to as a sheath), a second catheter surrounded by the first catheter, and a third catheter surrounded by the second catheter. In some examples, the catheters may slide independently among themselves. A pull wire attached to a handle may allow the surgeon to deflect the distal tip of the system to guide the insertion and placement of the system. The three catheters may result in the removal of blood from a first site and the return of blood to a second site. The second system may include two separate (unbound) catheters. The first catheter may be used to remove blood, while the second catheter may be used to return blood.

[0036]

[0066] In general, for any system, the catheter is advanced across the atrial septum, through the mitral valve, and into the aorta. This catheter is used to deliver oxygenated blood to the patient. Another catheter, which may be coaxial with or separate from the other catheters, can remove oxygen-poor blood from the patient. In some cases, this catheter may be positioned in the inferior vena cava.

[0037]

[0067] Figure 1 shows an example catheter-based ECMO system 100. As described herein, the catheter-based ECMO system 100 may be implemented as an apparatus, incorporated into or included within any other feasible system. Generally, a catheter-based ECMO system may include three catheters that are coaxial, concentric, and surrounding each other. For example, the catheter-based ECMO system 100 may include an arterial sheath 105, an arterial sheath inner catheter 106, a guidewire 107, a venous sheath 110, a venous hub 115, an arterial hub 120, and a handle 125. The arterial sheath inner catheter 106 may be a first inner catheter, the arterial sheath 105 may be a second inner catheter, and the venous sheath 110 may be an outer catheter. In particular, as used herein, the terms sheath and catheter may be used synonymously. Thus, the venous sheath 110 may also be described as a catheter, sheath, or venous catheter. In other examples, the catheter-based ECMO system 100 may include fewer, more, or different components.

[0038]

[0068] A catheter-based ECMO system 100 can be used to receive oxygen-poor blood (deoxygenated blood) or blood from the left atrium from a patient, oxygenate the blood outside the patient's body, and return the oxygenated blood to the patient. Generally, a catheter-based ECMO system 100 may include three coaxial catheters configured to be guided into various veins and arteries of the patient, providing a means to remove oxygen-poor blood from the patient, pass the blood through an external oxygenator, and then return the already oxygenated blood to the patient. As described herein, the catheter-based ECMO system 100 is advanced through a vein, and the distal tip of one of the catheters is further advanced through a transseptal puncture. Blood is removed from the distal tip through another of the proximal catheters. The oxygenated blood is returned to the patient into the aorta through the distal tip. The operation of the catheter-based ECMO system 100 will be described in more detail in conjunction with Figures 15A–15I and Figure 18.

[0039]

[0069] As described above, the catheter-based ECMO system 100 may include three coaxial catheters: an arterial sheath inner catheter 106, an arterial sheath 105, and a venous sheath 110. The arterial sheath inner catheter 106 is the innermost catheter (first inner catheter), which is surrounded by the arterial sheath 105 (second inner catheter), which is further surrounded by the venous sheath 110 (outer catheter). Blood is removed from the patient via the venous sheath 110 and returned to the patient via the arterial sheath 105. A venous hub 115 is connected to the venous sheath 110, allowing blood to be transported from the catheter-based ECMO system 100 through the tubing 116. Blood from the venous hub 115 is directed to an external oxygenator (not shown).

[0040]

[0070] The arterial hub 120 is connected to the arterial sheath 105 through one or more lumens. The tubing 121 may be connected to the arterial hub 120 and an external oxygenator. Oxygenated blood is returned to the patient via the arterial hub 120 and the arterial sheath 105.

[0041]

[0071] The handle 125 can be used to advance the catheter-based ECMO system 100 toward and away from the patient. In some examples, the handle 125 can be used to deflect the distal end of the arterial sheath-internal catheter 106.

[0042]

[0072] One or more guidewires may be included as part of the system. In some examples, guidewire 107 may have a diameter of approximately 0.0889 cm (0.035 inches). In some other examples, guidewire 107 may have any larger diameter than 0.0889 cm (0.035 inches), including but not limited to 0.1016 cm (0.040 inches), 0.1143 cm (0.045 inches), 0.127 cm (0.050 inches), or any other feasible larger diameter. In some other examples, guidewire 107 may have any other smaller diameter than 0.0889 cm (0.035 inches), including but not limited to 0.0762 cm (0.030 inches), 0.0635 cm (0.025 inches), 0.0508 cm (0.020 inches), or any other feasible smaller diameter. The guidewire 107 can be formed from any feasible material, including nitinol.

[0043]

[0073] Figure 2A shows the distal end of the catheter-based ECMO system 200. In some examples, the catheter-based ECMO system 200 may be an example of the catheter-based ECMO system 100 in Figure 1. Thus, the catheter-based ECMO system 200 may include a guidewire 107, an arterial sheath catheter 106, and an arterial sheath 105. The arterial sheath catheter 106 may be flexible and tapered from the arterial sheath 105 to its distal end. The arterial sheath catheter 106 may include a balloon 201 and a tapered element 202.

[0044]

[0074] The balloon 201, shown here in a deflated state, can be used during the positioning of the catheter-based ECMO system 200. The operation of the balloon 201 is described in more detail below in conjunction with Figures 2A, 2B, 15A–15I, and 17A–17I. The tapered element 202 allows for smooth insertion into the patient. The tapered element 202 can be formed from any durable and generally flexible material. Generally, the tapered element 202 can narrow from a larger diameter proximally to a smaller diameter distally.

[0045]

[0075] The arterial sheath 105 may include a tip 203 and an arterial body 204. The arterial body 204 may include one or more injection holes 205 disposed on the arterial body 204. The arterial body 204 may be coated with a polymer body 206. Generally, the arterial sheath 105 is used to return oxygenated blood to a patient. The oxygenated blood can be pumped through the arterial sheath 105 through the injection holes 205. In some examples, an internal arterial sheath catheter 106 may be withdrawn from the arterial sheath 105, allowing the oxygenated blood to be returned through the opening at the tip 203.

[0046]

[0076] Figure 2B shows another diagram of the distal end of the catheter-based ECMO system 200. In this diagram, the arterial sheath 105 is depicted together with the internal hypotube 207. Generally, the hypotube 207 may be positioned directly beneath the polymer body 206. The hypotube 207 may provide flexural rigidity for the arterial sheath 105; that is, the hypotube 207 may be more rigid toward the handle (not shown) and more flexible toward the tip 203.

[0047]

[0077] Balloon 201 is shown in an inflated state. During insertion into the patient, particularly within the patient's heart, balloon 201 may help guide or center the arterial sheath inner catheter 106 and may also assist in the safe crossing of the mitral valve.

[0048]

[0078] Figure 3 shows another diagram of the catheter-based ECMO system 300. In some examples, the catheter-based ECMO system 300 may be an example of the catheter-based ECMO system 100 in Figure 1. In particular, Figure 3 shows the transition between the venous sheath 310 (another example of the venous sheath 110) and the arterial sheath 320 (which may be another example of the arterial sheath 105).

[0049]

[0079] In some examples, the venous sheath 310 may have a size of approximately 30 Fr, and the arterial sheath 320 may have a size of approximately 22 Fr. Generally, the size of the arterial sheath 320 may be smaller than the size of the venous sheath 310 in order to allow the arterial sheath 320 to be perfectly coaxial with the venous sheath 310. The venous sheath 310 may include a plurality of inflow holes 311 arranged around the sides of the venous sheath 310.

[0050]

[0080] A catheter-based ECMO system 300 may include a flexible and durable seal 330 between a venous sheath 310 and an arterial sheath 320. The seal 330 may be made of any feasible and generally smooth material that can provide a liquid-tight (water-tight) seal to the arterial sheath 320. In some examples, a weak interference fit may exist between the inner diameter of the seal 330 and the outer diameter of the arterial sheath 320.

[0051]

[0081] Figure 4 shows an example venous hub 400. The venous hub 400 may be an example of the venous hub 115 in Figure 1. The venous hub 400 includes a venous sheath 410, a venous lumen 420, a venous port 430, an arterial shaft 460, and a hemostatic valve 450.

[0052]

[0082] A venous sheath 410 may extend distally from the venous hub 400 and may be an example of a venous sheath 110. In particular, a venous lumen 420 may be connected to the venous sheath 410, allowing oxygen-poor blood to flow from the patient through the venous port 430 and further through an optional tubing 440. Typically, the tubing 440 may direct the blood toward an artificial lung. In some examples, the tubing 440 has an inner or outer diameter of 0.9525 cm (3 / 8 inch). However, in other examples, the tubing 440 may have any feasible inner or outer diameter.

[0053]

[0083] The hemostatic valve 450 may allow other lumens or shafts to pass through the venous hub 400. As shown, the hemostatic valve 450 may allow an arterial shaft 460 to pass through it.

[0054]

[0084] Figure 5 shows an example of an arterial hub 500. The arterial hub 500 may be an example of the arterial hub 120 in Figure 1. The arterial hub 500 may include an arterial sheath 510, an arterial lumen 520, an arterial port 530, and a hemostatic valve 540.

[0055]

[0085] The arterial sheath 510 may extend distally from the arterial hub 500 toward the proximal end of the venous hub 400 in Figure 4. An arterial lumen 520, which may be coupled to the arterial sheath 510, may allow oxygenated blood to flow from the external oxygenator to the patient. The oxygenated blood may be received through an optional tubing 560. The arterial hub 500 may include a hemostatic valve 540 that is fluid-tight and allows an internal catheter shaft 550 to enter and pass through the arterial hub 500. Like the hemostatic valve 450, the hemostatic valve 540 may be fluid-tight.

[0056]

[0086] Figure 6 shows a cross-sectional view of the handle 600. The handle 600 may be another example of the handle 125 in Figure 1. The handle 600 may include a body 610, a lever 620, a pull wire 630, a balloon inflation port 640, and a guide wire port 650. The handle 600 may be coupled to an arterial sheath inner catheter 660, which may be an example of an arterial sheath inner catheter 106.

[0057]

[0087] The body 610 may function as a housing to contain any of the elements described herein. In particular, the body 610 may support, mount, and / or house a lever 620, a balloon inflation port 640, and a guidewire port 650. The lever 620 is coupled to a pull wire 630. Together, the lever 620 and the pull wire 630 are used to deflect the distal end of the arterial sheath inner catheter 660. The balloon inflation port 640 (sometimes referred to as a Luer port) may receive gas or liquid (saline, CO2, or similar) to inflate a balloon located distal to the handle 600. In a similar manner, the guidewire port 650 may receive a guidewire. The guidewire may be an example of a guidewire 107.

[0058]

[0088] Figures 7A and 7B show the distal end of the catheter-based ECMO system 100 in Figure 1. Both Figures 7A and 7B show the catheter-based ECMO system 100 with the internal catheter of the arterial sheath removed. Figure 7A includes the arterial sheath 710 and the venous sheath 720. The arterial sheath 710 may be an example of the arterial sheath 105 in Figure 1, and the venous sheath 720 may be an example of the venous sheath 110 in Figure 1.

[0059]

[0089] The venous sheath 720 may include a plurality of inflow holes 721 that allow blood to be received into the venous sheath 720. The arterial sheath may include a plurality of injection holes 711, as well as an injection opening 712 located at the distal end of the arterial sheath 710. The injection holes 711 and injection opening 712 allow blood to be returned to the patient.

[0060]

[0090] Figure 7B shows a detailed cross-sectional view of the distal end catheter-based ECMO system 100. For example, the arterial sheath 710 and venous sheath 720 are shown in cross-section. Oxygenated blood can flow out of the arterial sheath 710. Arrow 713 illustrates the blood flow from the catheter-based ECMO system 100. Blood can be removed from the patient through the venous sheath 720. Arrow 722 illustrates the blood flow from the patient and through the venous sheath 720.

[0061]

[0091] It should be noted that in any of the devices described herein, the arterial sheath (e.g., including multiple inlet or “outlet” openings) and the venous sheath (e.g., including multiple inlet openings) may be reversed in the device and method, depending on the intended flow direction and the insertion technique used. For example, in some of the examples shown herein, the arterial sheath is shown nested within the venous sheath (and extending distally to the venous sheath) such that the outlet openings are distal to the inlet openings. Any of these methods and devices may be configured, instead, so that the venous sheath is nested within the arterial sheath (and extends distally to the arterial sheath). Thus, the venous and arterial sheaths may be referred to as the “first” or outer sheath and the second or inner sheath, and the venous or arterial nature of a particular sheath may be determined by the posterior connection. The total opening area for the inlet openings may be equal to the total opening area for the outlet openings (e.g., the sum of the opening areas). Alternatively, in some examples, the total opening area for inlet openings may be smaller than the total opening area for outlet openings.

[0062]

[0092] Figure 8 shows a cross-sectional view of an example venous hub 800. The venous hub 800 may be an example of the venous hub 115 in Figure 1. The venous hub 800 may include a venous port 810, a venous sheath inner liner 820, a venous sheath 840, and a venous sheath lumen 830. In some examples, the venous sheath lumen 830 may be separate from the venous sheath 840 or may be integrated with (combined with) the venous sheath 840. Blood may be received through the venous sheath inner liner 820 from an inflow hole (not shown) on the venous sheath 840, transported through the venous port 810, and directed to an artificial lung. The arterial sheath 850 may substantially pass through the venous hub 800 to reach the arterial hub (not shown).

[0063]

[0093] Figure 9 shows a cross-sectional view of an example arterial hub 900. The arterial hub 900 may be an example of the arterial hub 120 in Figure 1. The arterial hub 900 may include an arterial port 910, an arterial sheath 920, and a hemostatic valve 930. Oxygenated blood may be received through the arterial port 910 and transported through the arterial sheath 920. In Figure 9, the internal catheter of the arterial sheath is not shown (for example, it may be removed from the arterial hub 900). The hemostatic valve 930 is shown closed.

[0064]

[0094] Figure 10A shows region 1000 of the catheter-based ECMO system 100 of Figure 1. Region 1000 may include a venous sheath 1010, a venous hub 1020, a hemostatic valve 1030, and a tip 1050. The venous sheath 1010 may include multiple inflow ports 1040 to receive blood that can be directed to an artificial lung through the venous hub 1020.

[0065]

[0095] The tip 1050 may be positioned distal to the venous hub 1020. In some examples, the tip 1050 may be formed from a radiopaque material (e.g., tungsten-filled pebax). Region 1060 of the venous sheath 1010 may have variable stiffness (e.g., multidurometer). For example, the stiffness or flexibility of the venous sheath 1010 may decrease as it moves away from the hemostatic valve 1030 toward the tip 1050. Variable stiffness of region 1060 may assist in placement and positioning the catheter-based ECMO system within the patient. In some examples, the outer diameter of the venous sheath 1010 may be approximately 28 Fr.

[0066]

[0096] Figure 10B shows a cross-sectional view of region 1000 in Figure 10A. The cross-sectional view shows an inner liner 1070 that can be joined to the venous sheath 1010. An example joining region is shown as region 1011. The joining within region 1011 can seal off blood leakage at the venous hub 1020. The inner liner 1070 may provide a lumen for receiving a guidewire. In some examples, the inner diameter of the inner liner 1070 may be approximately 21 Fr.

[0067]

[0097] Figure 10C shows a detailed cross-sectional view of the tip 1050 of region 1000. In some examples, the tip 1050 may be a two-layer tip that can be joined to the outer jacket 1090 and inner liner 1070 of the venous sheath 1010. Furthermore, the inner diameter of the distal tip 1050 may be approximately 20 Fr. The outer jacket 1090 and inner liner 1070 work together to form a lumen that can carry blood from multiple inflow holes 1040 to the venous hub 1020.

[0068]

[0098] Figure 11A shows an example of a mesh-reinforced shaft 1100. The mesh-reinforced shaft 1100 may be contained within an arterial sheath 105 or a venous sheath 110 in Figure 1. As described herein, each of the arterial sheath 105 and the venous sheath 110 may include a plurality of holes 1110 disposed on the sides of the sheath. In some examples, the holes 1110 may be laser ablated. The mesh-reinforced shaft 1100 may include a polymer outer jacket 1111 bonded to the mesh material. The mesh material may be stainless steel, nitinol, or any other feasible material.

[0069]

[0099] Figure 11B shows a cross-section of another reinforcing shaft 1120. The reinforcing shaft 1120 may include a laser-cut hypotube 1121 and a polymer jacket 1122. In some examples, the polymer jacket 1122 may be bonded to the hypotube 1121. Furthermore, the reinforcing shaft 1120 may be laser-ablated so that holes can be formed simultaneously within the polymer jacket 1122 and the hypotube 1121. Figure 11C shows separate diagrams of the hypotube 1121 and the polymer jacket 1122.

[0070]

[0100] Figure 12A shows region 1200 of the catheter-based ECMO system 100 of Figure 1. Region 1200 includes the arterial sheath 1210, tip 1230, hemostatic valve 1240, and arterial hub 1250. The arterial sheath 1210 may include region 1211 having variable stiffness. For example, the arterial sheath 1210 may become stiffer closer to the arterial hub 1250 and more flexible (less stiff) further away from the arterial hub 1250. The varying stiffness may help position the catheter-based ECMO system 100 within the patient. In some examples, region 1211 may include a reticular reinforcement area closer to the arterial hub 1250 and a coiled area further away from the arterial hub 1250.

[0071]

[0101] The injection hole 1220 may be located on the side of the arterial sheath 1210. In some examples, the arterial sheath 1210 may include a tip 1230 which may be radiopaque. In some implementations, the tip 1230 may be formed from tungsten-filled pebax, but any other feasible material may be used. In some examples, the outer diameter of the arterial sheath 1210 may be approximately 20 Fr.

[0072]

[0102] Figure 12B shows a cross-sectional view of region 1200 of the catheter-based ECMO system 100 of Figure 1. The arterial sheath 1210 may include an inner lumen 1212. In some examples, the inner lumen 1212 may have an inner diameter of approximately 18 Fr. In some examples, the inner lumen 1212 may be coated with a smooth coating such as polytetrafluoroethylene (PTFE), but is not limited to this.

[0073]

[0103] Figure 12C shows a detailed cross-sectional view of the tip 1230 of region 1200. In some examples, the tip 1230 can be joined to the outer jacket 1290 and inner liner of the venous sheath 1010. Furthermore, the inner diameter of the distal tip 1050 may be approximately 17 Fr.

[0074]

[0104] Figure 13A shows a partial Figure 1300 of the catheter-based ECMO system 100 of Figure 1. In particular, Figure 1300 may show a portion of the intraarterial sheath catheter including the handle 1310 and the distal region 1320. The distal region 1320 may generally be the distal region of the arterial sheath, such as the arterial sheath 105 in Figure 1. Figure 1300 may include the tip 1321, balloon 1322, marker 1323, and tapered element 1324.

[0075]

[0105] The tip 1321 can be formed from any feasible material, such as radiopaque material. Generally, the tip 1321 is formed from a soft material. The balloon 1322 can be inflated to help center the intraarterial sheath catheter relative to the mitral valve. The use of the catheter-based ECMO system 100 in general, and the balloon 1322 in particular, will be described in more detail below with respect to Figures 15A–15I and Figure 18. A radiopaque marker 1323 may be surrounded by the balloon 1322. In some examples, the marker 1323 may be used to help position the balloon 1322 in the patient as a catheter-based ECMO system 100. A tapered element 1324 may surround the hypotube.

[0076]

[0106] The handle 1310 may include a lever 1311, a balloon inflation port 1312, and a guidewire port 1313. The balloon inflation port 1312 may be connected to a lumen leading to a balloon 1322. The balloon 1322 may be inflated by the application of a liquid or gas through the balloon inflation port 1312. The guidewire port 1313 may receive a guidewire (such as guidewire 107 in Figure 1) to help guide and position the catheter-based ECMO system 100 within the patient. The lever 1311 may be used to move a pull wire (not shown) and deflect the tip 1321.

[0077]

[0107] Figure 13B shows a cross-sectional view of a catheter-based ECMO system 100 which may include a lumen 1325, a deflection pull wire 1314, and a balloon-inflated lumen 1315. The lumen 1325 may be used by a guidewire. One end of the deflection pull wire 1314 may be connected to a lever 1311, while the other end of the deflection pull wire 1314 may be connected to a tip 1321.

[0078]

[0108] Figure 14A shows a partial view of the arterial sheath catheter 1400. The arterial sheath catheter 1400 may be an example of the arterial sheath catheter 106 in Figure 1. The arterial sheath catheter 1400 may include a first fused region 1410, a non-fused region 1420, and a second fused region 1430. The first and second fused regions 1410 and 1430 may be regions of the arterial sheath catheter 1400 where various layers and elements are fused together. In contrast, the non-fused region 1420 may include the same or similar elements, but they do not have to be fused together. The non-fused region 1420 may allow the arterial sheath catheter 1400 to bend more easily in response to a pull wire such as a pull wire 1411. In some examples, the non-fused region 1420 may be approximately 7–9 centimeters. In other examples, the non-fused region 1420 may be any feasible length.

[0079]

[0109] Figure 14B shows several elements of the arterial sheath inner catheter 1400. Region 1440 may correspond to the first fused region 1410 and may include a pull wire 1441 that fuses to the distal band 1442. Region 1450 shows various hypotube structures that may be contained within the non-fused region 1420. Such structures may allow the arterial sheath inner catheter 1400 to bend in response to forces provided through the pull wire 1441. For example, the hypotube may be a laser-cut hypotube 1451 with a dorsal portion to control planar deflection. In another example, the hypotube may be a coiled hypotube 1452. The coiled hypotube 1452 may also be a spring hypotube.

[0080]

[0110] Region 1460 may correspond to a second fusion region 1430. Region 1460 shows the pull wire 1441 together with a smooth lumen 1461 for the pull wire 1441. The lumen 1461 may allow the pull wire 1441 to move freely within the catheter-based ECMO system 100.

[0081]

[0111] Figures 15A–15I illustrate example steps using the catheter-based ECMO system 100 of Figure 1. The steps described herein are illustrative and not intended to limit the scope of the procedure. Other steps may be used, and in some cases, these steps may be performed in a different order.

[0082]

[0112] In Figure 15A, the catheter-based ECMO system 100 is advanced through the atrial septum. In some cases, a 0.0889 cm (0.035 inch) guidewire may be used to help position the catheter-based ECMO system 100. As shown, the venous sheath 110 may be in the inferior vena cava while the arterial sheath 105 and the arterial sheath inner catheter 106 may puncture the septum. The arterial sheath inner catheter 106 may be rotated / bent / deflected into the left atrium (e.g., via a pull wire).

[0083]

[0113] Next, in Figure 15B, the guidewire can be advanced into the left ventricle. For example, the surgeon may carefully guide the guidewire through the mitral valve. In some cases, the guidewire may be a relatively flexible (soft) guidewire.

[0084]

[0114] Next, in Figure 15C, the arterial sheath 105 and the arterial sheath inner catheter 106 can be advanced toward the mitral valve. In some cases, the surgeon may adjust the deflection of the inner catheter to position a balloon (such as balloon 201 in Figure 2) across the mitral valve. After positioning the balloon, it can be inflated. In some cases, the balloon can be inflated with saline or gas. Inflating the balloon can help center the arterial sheath inner catheter toward the mitral valve and prevent the catheter from passing between the chordae tendineae of the mitral valve. Note that the advancement of the arterial sheath 105 and the arterial sheath inner catheter 106 may be independent of the venous sheath 110. Therefore, the venous sheath 110 may remain within the inferior vena cava.

[0085]

[0115] Next, in Figure 15D, after crossing the mitral valve apparatus, the balloon is deflated, and the arterial sheath 105 and the arterial sheath inner catheter 106 can be advanced into the left ventricle. Generally, surgeons may take care to position the arterial sheath inner catheter 106 and / or guidewire using an inflatable balloon to avoid any chordae tendineae.

[0086]

[0116] Next, in Figure 15E, the distal end of the arterial sheath catheter 106 is deflected until it is positioned approximately centered relative to the aortic valve. In some cases, the arterial sheath catheter 106 may be deflected by approximately 140 degrees (e.g., greater than 150 degrees, greater than 160 degrees, greater than 170 degrees, etc.). In other cases, the arterial sheath catheter 106 may be deflected by more or less than 170 degrees. The deflection of the distal end of the arterial sheath catheter 106 may be performed by moving the pull wire using a lever on the handle.

[0087]

[0117] Next, in Figure 15F, a rigid guidewire may be introduced into the catheter-based ECMO system 100 and advanced forward through the left ventricular outflow and across the aortic valve, ascending the aorta and descending the aorta. In some examples, the guidewire may be rigider than the guidewire previously used in Figures 15A–15D.

[0088]

[0118] Next, in Figure 15G, the arterial sheath 105 and the internal arterial sheath catheter 106 can be advanced along the guidewire until the tip of the arterial sheath 105 crosses the aortic valve and is positioned within the ascending aorta.

[0089]

[0119] Next, in Figure 15H, the intraarterial sheath catheter 106 is completely withdrawn from the catheter-based ECMO system 100. In Figure 15I, the guidewire is removed. The catheter-based ECMO system 100 is now positioned appropriately to remove oxygen-poor blood through the venous sheath 110 and return blood through the arterial sheath 105.

[0090]

[0120] Figures 16A and 16B show potential configurations of the venous sheath 110 and arterial sheath 105 for performing ECMO. In Figure 16A, the venous sheath 110 is positioned within the inferior vena cava, with the arterial sheath positioned across the aortic valve. Figure 16B shows an alternative configuration in which the venous sheath may be positioned across the septum, with lateral openings located within the left and right atria to allow for “decompression” and volume reduction of the left and / or right cardiac chambers. In either configuration, oxygenated blood can be readily exchanged percutaneously with oxygen-poor blood using a single entry point into the patient.

[0091]

[0121] In some cases, slightly different methods may be used to perform ECMO for a patient. For example, a catheter-based ECMO system may include two separate catheters: a venous sheath for removing blood and an arterial sheath for returning blood. Generally, the arterial sheath may include the arterial sheath 105 and the arterial sheath inner catheter 106 of the catheter-based catheter system 100. The venous sheath may simply be a single catheter including the venous sheath 110 in Figure 1. This method may allow for a larger (larger catheter cross-sectional area) to enable more blood flow from the pump. In this configuration, the first catheter may be used to remove blood, and the second (separate) catheter may be used to return blood to the patient. Steps illustrating the use of this alternative catheter-based ECMO system are described with respect to Figures 17A–17I.

[0092]

[0122] Figures 17A–17I illustrate the steps of an example using two catheter-based ECMO systems. The steps described herein are illustrative and not intended to be limiting. Other steps may be used, and in some cases these steps may be performed in a different order. The first catheter may be a catheter that supports venous sheath function (performing the operation of venous sheath 110 in Figure 1). The second catheter may be a catheter that supports arterial sheath and intra-arterial sheath catheter function (performing the operation of arterial sheath 105 and arterial sheath 105 in Figure 1).

[0093]

[0123] Firstly, in Figure 17A, the arterial sheath and the catheter inside the arterial sheath are advanced over the guidewire through the atrial septum. A separate venous sheath is also advanced into the inferior vena cava.

[0094]

[0124] Next, in Figure 17B, a flexible guidewire can be advanced into the left ventricle.

[0125] Next, in Figure 17C, the arterial sheath 105 and the intra-arterial catheter are advanced toward the mitral valve. The balloon is positioned across the mitral valve and can be inflated. In this configuration, the intra-arterial catheter can be advanced across the mitral valve.

[0095]

[0126] Next, in Figure 17D, the balloon is inflated, and the arterial sheath and the catheter inside the arterial sheath can be advanced across the mitral valve into the left ventricle.

[0127] Next, in Figure 17E, after balloon deflation, the distal tip of the intraarterial sheath catheter is deflected until it is approximately centered relative to the aortic valve. In some cases, the intraarterial sheath catheter may be deflected by only about 140–190 degrees (e.g., 170 degrees).

[0096]

[0128] Next, in Figure 17F, a rigid guidewire can be introduced into the catheter-based ECMO system and advanced forward through the left ventricular outflow and across the aortic valve, ascending the aorta and descending the aorta.

[0097]

[0129] Next, in Figure 17G, the arterial sheath and the catheter inside the arterial sheath can be advanced along the guidewire until the tip of the arterial sheath crosses the aortic valve and is positioned within the ascending aorta.

[0098]

[0130] Next, in Figure 17H, the intra-arterial sheath catheter is completely removed. Then, in Figure 17I, the guidewire is removed and the venous sheath can be positioned within the inferior vena cava. In particular, the steps illustrating Figures 17A to 17I may be similar to the steps described with respect to Figures 15A to 15I, which is due in particular to the similarity in function of the arterial sheath and intra-arterial sheath catheter used in both examples.

[0099]

[0131] Figure 18 is a flowchart illustrating an example of Method 1800 for performing ECMO using a catheter-based ECMO system. Several examples may perform the operations described herein with additional, fewer, different sequences of, parallel, and some operations differing. Method 1800 is described below with respect to the catheter-based ECMO system 100 of Figure 1, but Method 1800 may be performed with any other suitable system or device.

[0100]

[0132] Method 1800 is initiated in block 1802 when transseptal puncture is performed. In some examples, this action may be optional, as indicated here by the dashed line. Transseptal puncture may be performed by the distal end of a catheter-based ECMO system 100, or by any other feasible device.

[0101]

[0133] Next, in block 1804, the catheter-based ECMO system is advanced into the patient. For example, the catheter-based ECMO system 100 may be inserted percutaneously into the patient's femoral vein. The catheter-based ECMO system 100 may include a venous sheath 110, an arterial sheath 105, and an arterial sheath-internal catheter 106.

[0102]

[0134] Next, in block 1806, the arterial sheath inner catheter and arterial sheath are advanced across the atrial septum. In addition, the arterial sheath inner catheter 106 is deflected within the left atrium. In some examples, the venous sheath 110 may be positioned within the inferior vena cava. The operation of block 1806 can be further described above with respect to Figures 15A and 15B. Either of these devices may include an outer member 110, e.g., a sheath or a venous sheath, which includes multiple openings (holes, gaps, windows, etc.) to allow the inflow of deoxygenated blood, which is removed, oxygenated, and returned through an inner catheter placed together with its distal end within the ascending aortic arch, as described herein.

[0103]

[0135] Next, in block 1808, the balloon is advanced and inflated within the mitral valve to center the catheter. For example, balloon 201 in Figure 2 may be inflated through handle 125. The operation of block 1808 can be further described above with respect to Figure 15C.

[0104]

[0136] Next, in block 1810, the balloon is deflated, and the arterial sheath and the intra-arterial catheter are advanced into the left ventricle. For example, the arterial sheath 105 and the intra-arterial catheter 106 may be advanced into the left ventricle. The operation of block 1810 can be further described above with reference to Figure 15D.

[0105]

[0137] Next, in block 1812, the arterial sheath catheter is deflected until it is centered relative to the aortic valve. For example, in the catheter-based ECMO system 100, the arterial sheath catheter 106 is deflected until its distal tip is directed toward the center of the aortic valve. The operation of block 1812 can be further described above with reference to Figure 15E.

[0106]

[0138] Next, in block 1814, the arterial sheath catheter and arterial sheath are advanced over the aortic valve, and then the arterial sheath catheter is withdrawn. For example, the arterial sheath catheter 106 and arterial sheath 105 are advanced over the aortic valve. After this advancement, the arterial sheath catheter 106 can be withdrawn from at least the arterial sheath 105. The operation of block 1814 can be further explained with reference to Figures 15F to 15I.

[0107]

[0139] Next, in block 1816, ECMO is performed.

[0140] Figure 19 is a flowchart illustrating an example method 1900 for performing ECMO using a two-catheter-based ECMO system. Such a system may include a first catheter for removing blood from the patient and a second catheter for returning blood to the patient. The first catheter may include a venous sheath similar to the venous sheath 110 in Figure 1. The second catheter may include an arterial sheath and an arterial sheath catheter similar to the arterial sheath 105 and arterial sheath inner catheter 106 in Figure 1.

[0108]

[0141] Method 1900 is initiated in block 1902 when transseptal puncture is performed. In some cases, this action may be optional, as indicated here by the dashed line.

[0109]

[0142] Next, in block 1904, the venous sheath may be advanced into the patient. The arterial sheath and the internal arterial catheter may also be advanced into the patient. In some cases, the venous sheath may be advanced through the first femoral artery, while the arterial sheath and the internal arterial catheter may be advanced through the second femoral artery.

[0110]

[0143] Next, in block 1906, the arterial sheath medial catheter and arterial sheath are advanced across the atrial septum. In addition, the arterial sheath medial catheter is deflected within the left atrium. The venous sheath may be positioned within the inferior vena cava. The operation of block 1906 can be further described above with reference to Figures 17A and 17B.

[0111]

[0144] Next, in block 1908, the balloon is advanced and inflated within the mitral valve to center the catheter. The operation of block 1908 can be further described above with reference to Figure 17C.

[0112]

[0145] Next, in block 1910, the balloon is deflated, and the arterial sheath and the catheter inside the arterial sheath are advanced into the left ventricle. The operation of block 1910 can be further described above with reference to Figure 17D.

[0113]

[0146] Next, in block 1912, the intra-arterial sheath catheter is deflected until it is centered relative to the aortic valve. For example, the intra-arterial sheath catheter is deflected until its distal tip is directed toward the center of the aortic valve. The operation of block 1912 can be described above with reference to Figure 17E.

[0114]

[0147] Next, in block 1914, the intra-arterial sheath catheter and the arterial sheath are advanced over the aortic valve, and then the intra-arterial sheath catheter is withdrawn. After this advancement, the intra-arterial sheath catheter can be withdrawn at least from the arterial sheath 105. The operation of block 1914 can be further described above with reference to Figures 17F to 17I.

[0115]

[0148] Next, in block 1916, ECMO is performed.

[0149] Further described herein is a method by which the inner catheter is advanced over the mitral valve around its cusp and into the ascending aorta, without advancing the outer catheter (e.g., arterial sheath) until the inner catheter is positioned within the ascending aorta, as described above. Subsequently, the outer catheter may then be advanced over the inner catheter, completely over the mitral valve around its cusp and into the ascending aorta.

[0116]

[0150] For example, in any of these devices, the venous and arterial sheaths may be positioned near the aortic valve. Figures 20A–20H illustrate one example in which the venous sheath may be positioned adjacent to the aortic arch, with the venous sheath proximal offset, so that oxygenated blood can be easily exchanged percutaneously with oxygen-poor blood using a single entry point into the patient. In this example, the medial and lateral components may be independently positionable. Initially, the septum may be expanded as described above, and the first (medial) catheter is delivered to the left atrium as shown in Figure 20A. The medial sheath (e.g., arterial sheath) may then be driven over (or delivered together with) the medial catheter and placed across the septum with its distal end region inside the left atrium. A larger lateral sheath (e.g., venous sheath) is shown proximal to the medial sheath (in some cases, it may be placed just inside the left atrium). The distal end region of the first internal catheter may include a balloon, as described above, which can be inflated, for example, across a valve. A guidewire may be inserted into the ventricle through the first internal catheter, as shown in Figure 20B. The first internal catheter may then be advanced into the apex region, for example, beyond the insertion of chordae tendineae, with or without a fully deflated balloon, and the distal end may be deflected in a sharp curve, for example using a J-wire, to deflect it 180 degrees, as shown in Figure 20C, so that it is oriented toward the aortic arch, as shown in Figure 20D. The balloon may be fully or partially inflated during this procedure, and the distal end region of the first internal catheter may be advanced into the center left ventricular cavity. A guidewire (either the same guidewire or a different guidewire) can then be advanced into the aortic arch through the aortic valve (e.g. distally) and along the aortic arch (further into the descending aorta), as shown in Figure 20E. Once in place, the first internal catheter can then be advanced along the wire into the aortic arch, while the first (e.g., arterial) and second (e.g., venous) sheath catheters remain in place as shown.In Figure 20F, while the second sheath catheter is initially held in its proximal position, the first sheath catheter is advanced over the first medial catheter until it is positioned within the aortic arch and beyond the aortic valve. Finally, the second sheath catheter may be advanced over the first sheath catheter (while it is held in place), as shown in Figure 20G, until the second sheath catheter enters the aortic arch region proximal to the first sheath catheter. The first medial catheter may be removed, and the medial and lateral sheath catheters may be connected for both draining and draining blood, as shown in Figure 20H and described above. Note that the openings (e.g., inlet / outlet holes) shown on the first and second sheaths in Figures 20A–20H are illustrative only and may not be to scale, and / or may not reflect the actual number and / or location of holes / openings.

[0117]

[0151] In any of the devices described herein, the balloon may be highly biocompatible. For example, the balloon may be formed from a highly biocompatible material such as synthetic silicone. In some cases, the synthetic silicone material includes a crosslinked polymer reinforced with silica.

[0118]

[0152] It should be understood that all combinations of the aforementioned concepts and additional concepts, which will be discussed in more detail below (provided that such concepts are not mutually contradictory), are intended to be part of the subject matter of the inventions disclosed herein and may be used to achieve the benefits described herein.

[0119]

[0153] The process parameters and sequences of steps described and / or illustrated herein are provided merely as examples and may be modified as desired. For example, the steps described and / or illustrated herein may be shown or discussed in a particular order, but these steps do not necessarily have to be performed in the order illustrated or discussed. The various exemplary methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein, or may include additional steps in addition to those disclosed.

[0120]

[0154] When a feature or element is referred to herein as being "on top of" another feature or element, it may be directly on top of the other feature or element, or there may be an intervening feature or / or element. In contrast, when a feature or element is referred to as being "directly on top of" another feature or element, there is no intervening feature or element. When a feature or element is referred to as being "connected," "attached," or "combined" to another feature or element, it should be understood that it may be directly connected to, attached to, or combined with the other feature or element, or there may be an intervening feature or element. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly combined" to another feature or element, there is no intervening feature or element. Features and elements described or shown in relation to one embodiment may apply to other embodiments. It will also be understood by those skilled in the art that references to structures or features located "adjacent" to another feature may have overlapping or underlying portions with the adjacent feature.

[0121]

[0155] The terms used herein are for the sole purpose of describing specific embodiments and are not intended to be limitations of the invention. For example, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms likewise unless the context explicitly indicates otherwise. It should be further understood that the terms “comprises” and / or “comprising,” as used herein, indicate the presence of the described features, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. As used herein, the terms “and / or” include any combination of one or more of the associated enumerated items and may be abbreviated as “ / ”.

[0122]

[0156] Spatially relative terms such as “under,” “below,” “lower,” “over,” “upper,” and similar terms may be used herein for ease of explanation to describe the relationship between one element or feature and another as illustrated in the figures. It should be understood that spatially relative terms are intended to encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figure is inverted, an element described as “below” or “directly below” another element or feature will be oriented “above” the other element or feature. Thus, the illustrative term “below” may encompass both up and down orientations. A device may be oriented separately (rotated 90 degrees or to other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upward,” “downward,” “vertical,” “horizontal,” and similar terms are used herein for illustrative purposes only, unless otherwise specifically indicated.

[0123]

[0157] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless otherwise indicated by the context. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of the invention, the first feature / element discussed below may be called the second feature / element, and similarly, the second feature / element discussed below may be called the first feature / element.

[0124]

[0158] Throughout this specification and the claims thereafter, unless the context requires otherwise, the word “comprise,” and variations such as “comprises” and “comprising,” mean a variety of components that may be used together in a method and article (e.g., a composition and apparatus including a device, and a method). For example, the term “comprising” is understood to imply the inclusion of any described element or step, but not the exclusion of any other element or step.

[0125]

[0159] Generally, any apparatus and method described herein should be understood as inclusive, however all or a subset of components and / or steps may be alternatively exclusive and may be expressed as "consisting of" or alternatively "essentially consisting of" various components, steps, subcomponents, or substeps.

[0126]

[0160] Where used herein and in the claims, including where used in examples, and unless otherwise expressly specified, all numbers may be read as if preceded by the words “about” or “approximately,” even if the term does not appear expressly. The expressions “about” or “approximately” may be used when describing magnitude and / or location to indicate that the value and / or location described is within a reasonable range of predictable values ​​and / or locations. For example, a number may have a value that is + / -0.1% of the stated value (or range of values), + / -1% of the stated value (or range of values), + / -2% of the stated value (or range of values), + / -5% of the stated value (or range of values), + / -10% of the stated value (or range of values), and so on. Any number provided herein should also be understood to include its value approximately or approximate unless the context indicates otherwise. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any number ranges enumerated herein are intended to include all subranges incorporated therein. It should also be understood, as will be well understood by those skilled in the art, that when a value is disclosed, the ranges of "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values ​​are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, if X is a number) are also disclosed. Throughout this application, it should be understood that data is provided in numerous different formats, and that this data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it should be understood that greater than 10 and 15, greater than or equal to, less than, less than or equal to, and between 10 and 15 are also disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0127]

[0161] While various illustrative embodiments are described above, any of the numerous modifications can be made to various embodiments without departing from the scope of the invention as described in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped together. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as actually expressed in the claims.

[0128]

[0162] The examples and illustrations contained herein illustrate, not limit, specific embodiments in which the subject matter may be put into practice. As stated, other embodiments may be utilized and derived from specific embodiments so that structural and logical substitutions and modifications may be made without departing from the scope of this disclosure. Such embodiments of the subject matter of the invention may be referred to herein, individually or collectively, by the term “invention,” solely for convenience and without the intention of voluntarily limiting the scope of this application to any single invention or concept of invention, when two or more are actually disclosed. Thus, while specific embodiments are illustrated and described herein, any arrangement calculated to achieve the same objective may substitute for the specific embodiments shown. This disclosure is intended to cover all possible adaptations or variations of various embodiments. Combinations of the embodiments described above, and other embodiments not specifically described herein, will be obvious to those skilled in the art in considering the above description.

Claims

1. A system for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient, The first internal catheter, which narrows distally, An arterial sheath catheter, wherein the arterial sheath catheter is configured to coaxially surround the first inner catheter such that the distal outer surface of the arterial sheath catheter closely overlaps with the outer surface of the first inner catheter, and further, the arterial sheath catheter is provided with a plurality of arterial injection holes in the distal end region of the first inner catheter, and the first inner catheter is configured to extend distally to the arterial sheath catheter by more than 15 mm, A venous sheath catheter, wherein the venous sheath catheter is configured to coaxially surround the arterial sheath catheter such that the distal inner surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and furthermore, the venous sheath catheter is provided with a plurality of lateral venous inflow holes passing through the side wall region, A first proximal connector configured to connect the lumen of the arterial sheath catheter, which is in fluid communication with the plurality of arterial injection holes, to an artificial lung, and A second proximal connector configured to connect the lumen of the venous sheath catheter, which is in fluid communication with the plurality of lateral venous inflow holes, to a venous suction pump. A system that includes these features.

2. The system according to claim 1, wherein the first internal catheter is configured to extend more than 30 mm distal to the arterial sheath catheter.

3. The system according to claim 1, wherein the first internal catheter comprises a distal dilator.

4. A system according to claim 2, wherein the distal dilating dilator comprises a balloon.

5. The system according to claim 1, further comprising a second internal catheter having a distal end region configured to be deflected by 140 to 190 degrees.

6. The system according to claim 1, further comprising a venous sheath hub having the second proximal connector, wherein the venous sheath catheter extends distally from the venous sheath hub.

7. The system according to claim 1, further comprising an arterial sheath hub having the first proximal connector, wherein the arterial sheath catheter extends distally from the arterial sheath hub.

8. A system according to claim 1, wherein the plurality of lateral venous inflow holes are configured to be located in the inferior vena cava of the patient when the distal outer surface of the venous sheath catheter is in close contact with the outer surface of the arterial sheath catheter, and the plurality of arterial infusion holes are located in the ascending aortic arch of the patient.

9. A system according to claim 1, wherein the side wall region having the plurality of lateral venous inflow holes is configured to straddle the patient's cardiac septum when the plurality of arterial infusion holes are located within the patient's ascending aortic arch, when the distal outer surface of the venous sheath catheter is in close contact with the outer surface of the arterial sheath catheter.

10. The system according to claim 1, further comprising a first interference fit between the distal inner surface of the arterial sheath catheter and the outer surface of the first inner catheter.

11. The system according to claim 1, further comprising a second interference fit between the distal inner surface of the venous sheath catheter and the outer surface of the arterial sheath catheter.

12. A system for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient, The first internal catheter, which narrows distally, A first sheath catheter, wherein the first sheath catheter is configured to coaxially surround the first inner catheter, and further, the first sheath catheter has a plurality of injection holes in the distal end region of the first inner catheter. A second sheath catheter, wherein the second sheath catheter is configured to coaxially surround the first sheath catheter such that the distal inner surface of the second sheath catheter fits snugly with the outer surface of the first sheath catheter, and further, the second sheath catheter is provided with a plurality of lateral inflow holes passing through the side wall region, A first proximal connector configured to connect the lumen of the first sheath catheter, which is in fluid communication with the plurality of injection holes, to an artificial lung or suction pump, and A second proximal connector is configured to connect the lumen of the second sheath catheter, which is in fluid communication with the plurality of side inlet holes, to a suction pump or artificial lung. A system that includes these features.

13. The system according to claim 12, wherein the first internal catheter comprises a distal dilator.

14. A system according to claim 13, wherein the distal dilating dilator comprises a balloon.

15. The system according to claim 12, further comprising a second internal catheter having a distal end region configured to be deflected by 140 to 190 degrees.

16. The system according to claim 12, further comprising a second sheath hub having the second proximal connector, wherein the second sheath catheter extends distally from the second sheath hub.

17. The system according to claim 12, further comprising a first sheath hub having the first proximal connector, wherein the first sheath catheter extends distally from the first sheath hub.

18. A system according to claim 12, wherein the plurality of lateral second inflow holes are configured to be located in the inferior vena cava of the patient when the distal outer surface of the second sheath catheter is in close contact with the outer surface of the first sheath catheter, and the plurality of first injection holes are located in the ascending aortic arch of the patient.

19. A system according to claim 12, wherein the side wall region having a plurality of side second inflow holes is configured to straddle the patient's intercardiac septum when the plurality of first injection holes are located within the patient's ascending aortic arch, when the distal outer surface of the second sheath catheter is in close contact with the outer surface of the first sheath catheter.

20. The system according to claim 12, further comprising a first interference fit between the distal inner surface of the first sheath catheter and the outer surface of the first inner catheter.

21. The system according to claim 12, further comprising a second interference fit between the distal inner surface of the second sheath catheter and the outer surface of the first sheath catheter.

22. A system for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient, The first internal catheter, which narrows distally, An arterial sheath catheter, wherein the arterial sheath catheter is configured to coaxially surround the first inner catheter such that the distal outer surface of the arterial sheath catheter closely overlaps the outer surface of the first inner catheter, and further, the arterial sheath catheter is provided with a plurality of arterial injection holes in the distal end region of the first inner catheter. A venous sheath catheter, wherein the venous sheath catheter is configured to coaxially surround the arterial sheath catheter such that the distal outer surface of the venous sheath catheter closely overlaps the outer surface of the arterial sheath catheter, and furthermore, the venous sheath catheter is provided with a plurality of lateral venous inflow holes passing through the side wall region, The arterial hub in fluid communication with the aforementioned plurality of arterial injection holes, and The venous hub is in fluid communication with the aforementioned plurality of lateral venous inflow holes. A system that includes these features.

23. The system according to claim 22, wherein the arterial hub is configured to connect the lumen of the arterial sheath catheter to the first connector.

24. The system according to claim 22, wherein the venous hub is configured to connect the lumen of the venous sheath catheter to a second connector.

25. The system according to claim 22, wherein the first internal catheter comprises a distal dilator configured to center the first internal catheter within the lumen of the patient.

26. The system according to claim 22, wherein the arterial hub is configured to deliver oxygenated blood to the arterial infusion hole.

27. The system according to claim 22, wherein the venous hub is configured to receive oxygen-poor blood from the patient.

28. A system according to claim 22, wherein the plurality of lateral venous inflow holes are configured to be located in the inferior vena cava of the patient when the distal outer surface of the venous sheath catheter is in close contact with the outer surface of the arterial sheath catheter, and the plurality of arterial infusion holes are located in the ascending aortic arch of the patient.

29. A system according to claim 22, wherein the side wall region having the plurality of lateral venous inflow holes is configured to straddle the patient's cardiac septum when the plurality of arterial infusion holes are located within the patient's ascending aortic arch, when the distal outer surface of the venous sheath catheter is in close contact with the outer surface of the arterial sheath catheter.

30. The system according to claim 22, further comprising a second internal catheter having a distal end region configured to be deflected by 140 to 190 degrees.

31. The system according to claim 22, wherein the arterial hub is configured to be connected to an artificial lung, and the venous hub is configured to be connected to a venous suction pump.

32. A method for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient, Steps include advancing the first internal catheter through transseptal puncture, A step of deflecting the first internal catheter within the left atrium such that the distal tip of the first internal catheter is substantially positioned toward the mitral valve, Steps include advancing the first internal catheter through the mitral valve, A step of deflecting the distal tip of the first internal catheter toward the aortic valve, Steps include advancing the first internal catheter through the aortic valve so that the distal end of the second internal catheter is inside the ascending aorta, A step of advancing a second internal catheter distally over the first internal catheter, wherein the second internal catheter is coaxial with and surrounds the first internal catheter. The steps of removing the first internal catheter and The step of receiving oxygen-poor blood from the patient through an external catheter and returning oxygenated blood to the ascending aortic arch through a second internal catheter. Methods that include...

33. A method according to claim 32, wherein the outer surface of the second inner catheter is in close contact with the outer surface of the first inner catheter.

34. A method according to claim 32, wherein the outer catheter surrounds the second inner catheter.

35. A method according to claim 32, further comprising the step of inflating a balloon disposed around the distal end of the first internal catheter in order to center the first internal catheter relative to the mitral valve.

36. A method according to claim 35, further comprising the step of advancing the first internal catheter through the mitral valve and then deflating the balloon.

37. A method according to claim 32, wherein deflecting the distal tip of the first internal catheter toward the valve includes deflecting the distal tip by more than 3240 degrees relative to the proximal portion of the first internal catheter.

38. A method according to claim 32, wherein the second internal catheter includes a plurality of holes arranged around the body of the second internal catheter for returning the oxygenated blood.

39. A method according to claim 32, wherein the outer catheter includes a plurality of holes arranged around the body of the outer catheter for receiving the oxygen-poor blood.

40. A method according to claim 32, further comprising the step of inserting a first guidewire into the first internal catheter, the second internal catheter, and the external catheter before deflecting the first internal catheter in the left atrium.

41. The method according to claim 40, Before deflecting the distal tip of the first internal catheter toward the valve, the first guidewire is removed, and The step of removing the first guidewire and then inserting a second guidewire that is stiffer than the first guidewire. Methods that further include the above.

42. A method for administering transseptal extracorporeal membrane oxygenation (ECMO) to a patient, Steps to advance the medial sheath through transseptal puncture, Steps include advancing the second catheter into a large peripheral vein or inferior vena cava. A step of deflecting the medial sheath within the left atrium such that the distal tip of the medial sheath is substantially positioned toward the mitral valve, Steps of advancing the inner sheath through the mitral valve, A step of deflecting the distal tip of the inner sheath toward the aortic valve, Steps of advancing the inner sheath through the aortic valve and into the ascending aorta, A step of advancing the outer sheath distally over the inner sheath until the distal end of the outer sheath is located within the ascending aorta, wherein the outer sheath is coaxial with and surrounds the inner sheath, and the outer surface of the outer sheath closely overlaps the outer surface of the inner sheath. The step of removing the inner sheath, and The step of receiving oxygen-poor blood from the patient through the second catheter and returning the oxygenated blood to the ascending aorta through the outer sheath. Methods that include...

43. A method according to claim 11, further comprising the step of inflating a balloon disposed around the distal end of the inner sheath in order to center the first inner catheter relative to the mitral valve.

44. A method according to claim 12, further comprising the step of advancing the inner sheath through the mitral valve and then deflating the balloon.

45. A method according to claim 11, wherein deflecting the distal tip of the inner sheath toward the valve includes deflecting the distal tip by more than 140 degrees relative to the proximal portion of the inner sheath.

46. A method according to claim 11, wherein the second catheter includes a plurality of holes arranged around the body of the second catheter for returning the oxygenated blood.

47. A method according to claim 11, wherein the outer sheath includes a plurality of holes arranged around the body of the outer sheath for receiving the oxygen-poor blood.

48. A method according to claim 11, further comprising the step of inserting a first guidewire into the inner sheath and the outer sheath before deflecting the inner sheath in the left atrium.

49. The method according to claim 17, The steps include: removing the first guidewire before deflecting the distal end of the inner sheath toward the valve, and The step of removing the first guidewire and then inserting a second guidewire that is stiffer than the first guidewire. Methods that further include the above.

50. A method according to claim 11, further comprising the step of puncturing the septum between the right atrium and the left atrium before advancing the medial sheath and the lateral sheath through the transseptal puncture.

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