WO2024186742A1 - Peripherally inserted cannula with active fixation - Google Patents

Abstract

A cannula is described. The cannula has an elongate body having a proximal end, a distal end, and a drainage lumen extending therebetween. The drainage lumen is in fluid communication with a proximal drainage lumen port and a distal tip opening. A first balloon is configured on a distal end of the elongate body, and a second balloon configured on the elongate body distal to the first balloon. A first opening is in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen. A second opening is in the elongate body distal to the second balloon and in fluid communication with the drainage lumen. A cannula system, a method for placing a cannula, and a method for simultaneously draining a left and right atrium of a subject are also described.

Description

PERIPHERALLY INSERTED CANNULA WITH ACTIVE FIXATION

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63/488,245, filed March 3, 2023, incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] Extracorporeal life support modalities (referred to in aggregate as ECMO) have grown by over 900% in the last decade in the United States. These technologies provide temporary cardiac, pulmonary, or cardiopulmonary support for patients with cardiac or respiratory failure across a wide variety of indications including acute respiratory failure, chronic respiratory failure, cardiogenic shock (including secondary to myocardial infarction, worsening heart failure, pulmonary embolism), postcardiotomy syndrome, and in those awaiting heart or lung transplantation. Patients are most commonly supported using peripheral blood cannula that are able to adequately support the circulation both in venoarterial and venovenous modes.

[0003] However, distention of the left ventricle and atrium present several challenges. Firstly, the inability to drain the left atrium can lead to pulmonary edema despite adequate right sided drainage. This can for example be a result of pressure changes, increased fluid flow, inflammation, and compromised oxygenation. Second, the stasis created by the ECMO circulation can result in thrombosis of left sided chambers of the heart, which is nearly always fatal. Adjuncts for “venting” or draining the left side of the heart vary but are complex, risky, and each modality has specific drawbacks. For example, a device currently on the market that is adopted widely can result in limb ischemia requiring fasciotomy or amputation, stroke, and is expensive (typically falling in the $25,000-530,000 range). Conventional cannulas used to drain the left side of the heart have not been widely adopted due to the instability of cannula position and risk of falling out of the left atrium. Pharmacological therapy, such as inotropic agents, is often ineffective in producing sufficient ejection of blood from the left heart.

[0004] Accordingly, there is a need in the art for a cannula design that can adequately drain both the left and right sides of the heart. Embodiments described herein fit this need.

SUMMARY OF THE INVENTION

[0005] In one embodiment, cannula includes an elongate body having a proximal end, a distal end, and a drainage lumen extending therebetween, the drainage lumen in fluid communication with a proximal drainage lumen port and a distal tip opening; a first balloon configured on a distal end of the elongate body, and a second balloon configured on the elongate body distal to the first balloon; a first opening in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen; and a second opening in the elongate body distal to the second balloon and in fluid communication with the drainage lumen. In one embodiment, the first opening is one of a first plurality of openings in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen. In one embodiment, the second opening is one of a second plurality of openings in the elongate body distal to the second balloon and in fluid communication with the drainage lumen. In one embodiment, the cannula includes a third opening in the elongate body between the first and second balloon and in fluid communication with the drainage lumen. In one embodiment, the third opening is one of a third plurality of openings in the elongate body between the first and second balloon and in fluid communication with the drainage lumen. In one embodiment, the cannula includes a first pressure sensor configured on the elongate body distal of the second balloon. In one embodiment, the first pressure sensor is connected to a proximal first pressure sensor port. In one embodiment, the cannula includes a second pressure sensor configured on the elongate body proximal of the first balloon. In one embodiment, the second pressure sensor is connected to a proximal second pressure sensor port. In one embodiment, the first and second balloon are separated by a distance. In one embodiment, the distance is between 2 and 5 millimeters but can range up to 10 millimeters. In one embodiment, the first balloon is in fluid communication with a proximal first balloon port. In one embodiment, the second balloon is in fluid communication with a proximal second balloon port.

[0006] In one embodiment, a cannula system includes the cannula; and a cannula introducer comprising at least one fiducial marker corresponding to a position of at least one of the first and second balloon. In one embodiment, the at least one fiducial marker is part of a set of fiducial markers spaced apart corresponding to a separation distance of the first and second balloon.

[0007] In one embodiment, a method for placing a cannula in a left and right atrium of a subject, includes providing the cannula; advancing the distal tip opening through a vessel lumen of the subject and into the right atrium; puncturing the interatrial septum; advancing the distal tip opening, first balloon and second balloon into the left atrium; inflating the second balloon in the left atrium; partially withdrawing the cannula so that the first balloon is withdrawn into the right atrium; and inflating the first balloon in the right atrium.

[0008] In one embodiment, a method for simultaneously draining a left and right atrium of a subject, includes applying a negative pressure to the drainage lumen. In one embodiment, the method includes the step of loading the cannula over a guidewire before the step of advancing the distal tip opening though the vessel. In one embodiment, the method includes the step of monitoring pressure in the left atrium by measuring a signal from a first pressure sensor configured of the elongate body distal of the second balloon. In one embodiment, the method includes the step of monitoring pressure in the right atrium by measuring a signal from a second pressure sensor configured of the elongate body proximal of the first balloon.

BRIEF DESCRIPTION OF THE DRAWINGS [0009] The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:

[0010] FIG. 1 is a side view of a cannula according to one embodiment.

[0011] FIG. 2 is a side view of a cannula introducer according to one embodiment.

[0012] FIG. 3 is a diagram of cannula placement when positioned from the right femoral vein according to one embodiment.

[0013] FIG. 4A is a flow chart of a method for placing a cannula according to one embodiment.

[0014] FIG. 4B is a flow chart of an exemplary method for placing a cannula in a left and right atrium of a subject.

[0015] FIG. 4C is a flow chart of an exemplary method for simultaneously draining a left and right atrium of a subject.

[0016] FIG. 5 depicts an illustrative computer architecture for a computer for practicing the various embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION [0017] It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a more clear comprehension of the present invention, while eliminating, for the purpose of clarity, many other elements found in peripherally inserted cannula with active fixation. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

[0018] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are described.

[0019] As used herein, each of the following terms has the meaning associated with it in this section.

[0020] The articles “a” and “an” are used herein to refer to one or to more than one (/.e. , to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.

[0021] “About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1 %, and ±0.1 % from the specified value, as such variations are appropriate.

[0022] Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Where appropriate, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1 , 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

[0023] Referring now in detail to the drawings, in which like reference numerals indicate like parts or elements throughout the several views, in various embodiments, presented herein is a peripherally inserted cannula with active fixation.

[0024] Embodiments of the cannula described herein can reliably drain the left atrium, and can drain the left and right atrium simultaneously, offering several advantages over conventional devices. The cannula is inserted into one of the central veins and the tip is guided into the heart with echocardiography and/or fluoroscopy. The first stage of the cannula is advanced into a suitable position in the left atrium, providing drainage of the left side of the heart. The remainder of drainage holes are positioned along the length of the catheter, which will be in the right atrium and the vena cava. Once in position, balloons are inflated in the left and right atrium, fixing the cannula position relative to the interatrial septum and preventing the cannula from migrating. Importantly, in some embodiments, the cannula has at least one pressure sensor for continuous monitoring of left atrial pressure, which can guide delivery of therapy.

[0025] Advantages of left and right sided drainage during temporary cardiopulmonary support: Generally, the benefits of the embodiments described herein include improved cardiac function. By draining both the left and right atria, the cannula can reduce the volume of fluid in the heart and improve overall cardiac function. This can improve blood flow throughout the body and reduce the risk of complications associated with heart failure. Patient symptoms also benefit from rapid relief. Draining fluid from both atria can quickly reduce the pressure on the lungs and relieve symptoms of pulmonary edema, such as shortness of breath and difficulty breathing. This can improve the patient's comfort and quality of life. Embodiments of the device also provide precise control and positioning, while cannula tip migration is eliminated. The cannula can simultaneously drain both atria and be precisely positioned to ensure optimal drainage, which can improve the efficacy of the procedure and minimize the risk of complications. The risk of complications is also minimized. A cannula that can drain both the left and right atria may reduce the risk of certain complications associated with alternative treatments. For example, in patients with severe mitral valve disease or pulmonary hypertension, left and right atrial cannulation can be an alternative to openheart surgery for the purpose of cannula placement, which carries a higher risk of complications. Patient outcomes are also improved. In instances such as acute heart failure or complex cardiac surgery, simultaneous drainage of both atria can improve patient outcomes, including reducing the length of hospital stay and decreasing mortality and complication rates.

[0026] More specifically, embodiments of the cannula described herein include a smart multistage peripherally inserted cannula with active fixation that is capable of draining both the left and right side of the heart simultaneously. This is associated with several advantages. Since the cannula directly drains the left side of the heart, accumulation of undrained blood in the left atrium and ventricle is prevented. This provides several hemodynamic advantages. Namely, left atrial pressure remains low, reducing the risk of pulmonary edema or hemorrhage. Left ventricular end diastolic pressure and end diastolic/systolic volumes are decreased, which reduces myocardial oxygen consumption, left ventricular wall stress, and subendocardial ischemia, promoting recovery of the left side of the heart. The risk of intracardiac thrombus is reduced given active drainage of blood. Importantly, because the cannula is placed into the left atrium across the interatrial septum from the venous circulation, the risk of arterial complications are drastically reduced. As no large bore sheath is placed into the femoral artery for venting purposes, the risk of limb complications such as fasciotomy and amputation are minimal. The active fixation mechanism allows for the distal drainage ports to remain in the left side of the heart, as the device may otherwise fall into the right atrium and not function and pressure monitoring ports aid in guiding drainage parameters as well as in assessing left heart recovery. Simultaneous left and right sided drainage also reduces risk of venous access complications, as only one venous cannula is required for both chambers. Similarly, venous drainage ports in the right atrium and vena cava provide more effective drainage than solely left atrial drainage and also allow for use of a smaller tapered cannula extending across the interatrial septum. Thus, embodiments of the cannula design would adequately drain both the left and right sides of the heart and be more suitable than existing devices.

[0027] With reference now to FIG. 1 , a peripherally inserted cannula with active fixation is described according to some embodiments. The cannula 100 has an elongate body 102 having a proximal end 110, a distal end 112, and a drainage lumen 104 extending therebetween. The drainage lumen 104 is in fluid communication with a proximal drainage lumen port 106 and a distal tip opening 108. A first balloon 114 is configured on the distal end 112 of the elongate body 102, and a second balloon 116 is configured on the elongate body 102 distal to the first balloon 114. Balloons 114, 116 are deployed on either side of the atrial septum. One or more balloon inflation ports 118 and/or one or more connection ports 120 for sensors are integrated into cannula 100. At least one opening 122 (in some examples, referred to as “multiple openings”) is configured in the elongate body 102 proximal to the first balloon 114 and in fluid communication with the drainage lumen 104. At least one opening 124 in the distal cannula allow for left atrial drainage, while at least one opening 122 allows for venous drainage. At least one opening 124 (in some examples referred to as “additional openings” or “sets of openings”) can be placed distal to the second balloon 116 or between the first balloon 114 and second balloon 116. It should be appreciated that in some examples, there are no drainage openings between first balloon 114 and second balloon 116. A first pressure sensor 126 is configured on the elongate body distal of the second balloon. A second pressure sensor 128 is configured on the elongate body proximal to the first balloon. Pressure sensors 126, 128 can be configured distal of the second balloon or proximal of the first balloon and are connected to one or more proximal pressure sensor ports 120. The pressure sensor at the distal end of the cannula (pressure sensor 126) allows for monitoring of left atrial pressure, which obviates the need for additional monitoring devices (pulmonary artery catheters), and a pressure sensor in the mid cannula (pressure sensor 128) may be used to monitor central venous pressure. In some embodiments, the distance between the first and second balloons is between 1 and 10 millimeters, or 2 and 5 millimeters, but can range up to 10 millimeters, or 20 millimeters. It should be appreciated that the first and second balloons (balloon 114 and balloon 116) can be connected to one or more proximal ports or more connectors known in the art for inf lating/def lating each balloon.

[0028] The drainage openings (e.g., at least one opening 124 and at least opening 126) may be positioned on cannula 100 such that there are no drainage openings between first balloon 114 and second balloon 116. Each balloon (e.g., first balloon 114 and second balloon 116 may be fluidly connected to each other, and one or more balloon inflation ports 118. Although various exemplary embodiments are presented, it should be appreciated that cannula 100 operates based on a pressure sensor (e.g., pressure sensor 128) and a set of openings (e.g., at least one opening 122) positioned proximal on a cannula (e.g., cannula 100) to at least a first balloon (e.g., first balloon 114), a region on the cannula without openings positioned between the first balloon and a second balloon (e.g., second balloon 116), and a pressure sensor (e.g., pressure sensor 126) and at least one opening (e.g., at least one opening 124) positioned distal to the second balloon on the cannula. The balloons of cannula 100 at least partially occlude the lumen of orifice, tube, or cavity and allow a differential pressure sensing from either side of the balloons, as well as a controlled draining of fluids from the proximal and distal ends of the cannula.

[0029] Cannulas can be made from medical grade materials known in the art, such as medical-grade PVC (polyvinyl chloride), as it is lightweight, flexible, durable, and can be sterilized. Other materials such as biocompatible silicone, polyurethane, polycarbonate and other types of thermoplastic material may be used. The size and hole spacing of the cannula can vary depending on the specific surgical procedure and the patient's anatomy. In some embodiments, the drainage cannulas will range in size from 14 French to 32 French. The size of the cannula used can depend for example on the size of the patient's heart and the amount of blood that needs to be drained during the surgery. The hole spacing can also vary. The hole spacing is designed to ensure that blood is evenly drained from the heart, without causing excessive turbulence or damage to the surrounding tissue. In some embodiments, the hole spacing is around 2- 3 millimeters apart. This spacing allows for efficient blood drainage while minimizing tissue damage. The number of holes on an atrial drainage cannula can also vary depending on the design and size of the cannula.

[0030] Balloon materials can include those known in the art, materials such as latex or silicone, which are designed to be inflated with a low-pressure volume of fluid, such as saline. Compliant balloons are typically used for short-term catheterizations and can be easily removed when the catheter is no longer needed. Non-compliant balloons made from materials such as polyurethane or nylon may also be suitable. Uniquely shaped balloons such as tapered balloons designed to conform to the unique shape of patient anatomy may also be used.

[0031] With reference now to FIG. 2, in some embodiments, a cannula introducer can have first and second fiducial markers spaced apart to correspond with spacing of the first and second balloon, or a single fiducial marker can be centered between the balloon positions. This facilitates easier placement of the cannula, with radiopaque and echogenic markers (130) to simplify implantation using either fluoroscopy or echocardiography.

[0032] With reference now to FIG. 3, shown is an exemplary ideal cannula placement when deployed through the right femoral vein according to some embodiments.

[0033] Referring now to FIG. 4A shown is a diagram of an exemplary method for using or placing a cannula (e.g., cannula 100) according to aspects of the present invention. In some embodiments, method 200 for placing the cannula comprises the steps of advancing the distal tip opening through a vessel lumen of the subject and into the right atrium 202, puncturing the interatrial septum 204, advancing the distal tip opening, first balloon and second balloon into the left atrium 206, inflating the second balloon in the left atrium 208, partially withdrawing the cannula so that the first balloon is withdrawn into the right atrium 210, and inflating the first balloon in the right atrium 212.

[0034] Aspects of the present invention relate to an exemplary method for placing a cannula in a left and right atrium of a subject. Referring now to Fig. 4B, shown is a flowchart of an exemplary method 300 for placing a cannula in a left and right atrium of a subject. In some embodiments, method 300 comprises 301 providing a cannula (e.g., cannula 100); 302 advancing the distal tip opening through a vessel lumen of the subject and into the right atrium; 303 puncturing the interatrial septum; 304 advancing the distal tip opening, first balloon and second balloon into the left atrium; 305 inflating the second balloon in the left atrium; 306 partially withdrawing the cannula so that the first balloon is withdrawn into the right atrium; and 307 inflating the first balloon in the right atrium.

[0035] Aspects of the present invention relate to an exemplary method for simultaneously draining a left and right atrium of a subject. Referring now to Fig. 4C, shown is a flowchart of an exemplary method 400 for simultaneously draining a left and right atrium of a subject. In some embodiments, method 400 comprises 401 providing a cannula (e.g., cannula 100); 402 advancing the distal tip opening through a vessel lumen of the subject and into the right atrium; 403 puncturing the interatrial septum; 404 advancing the distal tip opening, first balloon and second balloon into the left atrium;

405 inflating the second balloon in the left atrium; 406 partially withdrawing the cannula so that the first balloon is withdrawn into the right atrium; 407 inflating the first balloon in the right atrium, and 408 applying a negative pressure to the drainage lumen.

[0036] In some embodiments, method 300 and/or 400 further comprises the step of loading the cannula over a guidewire before the step of advancing the distal tip opening though the vessel. In some embodiments, method 300 and/or 400 further comprises the step of monitoring pressure in the left atrium by measuring a signal from a first pressure sensor configured of the elongate body distal of the second balloon. In some embodiments, method 300 and/or 400 further comprises the step of monitoring pressure in the right atrium by measuring a signal from a second pressure sensor configured of the elongate body proximal of the first balloon.

[0037] Deployment of smart multistage peripherally inserted cannula with active fixation for temporary cardiopulmonary support is now described in more detail according to one embodiment. Percutaneous access is obtained using a hollow bore needle into a central vein (right or left femoral vein, internal jugular vein, subclavian vein). Alternatively, these structures can be exposed surgically. Arterial access is similarly obtained in the femoral artery (or alternate intended arterial cannulation site such as axillary artery). A guide wire is advanced into the right atrium using fluoroscopy, transesophageal echocardiography (TEE), or intracardiac echocardiography (ICE), or a combination thereof. A transseptal puncture is performed using standard techniques using a transseptal needle and sheath, with fluoroscopy, TEE, or ICE used to confirm needle position prior to puncture. The guidewire and transseptal sheath are then advanced across the interatrial septum into the left atrium, positioning confirmed, and the patient is systemically anticoagulated. The guidewire is advanced into the left superior or inferior pulmonary vein and access site dilated to accommodate the extracorporeal circulation cannula. The cannula is flushed, then deployed over the wire into the left atrium using fluoroscopy, TEE, or ICE for guidance. The cannula is positioned such that the proximal and distal balloon are in the left atrium, which can be confirmed using imaging and left atrial pressure tracing. The distal balloon is inflated and the cannula withdrawn under image guidance until the distal balloon is apposed to the interatrial septum. The proximal balloon, now in the right atrium, is inflated. The cannula is secured in place, and left atrial and systemic venous drainage lines connected to the extracorporeal circuit. Arterial cannula placement is performed using standard technique and cannula attached to extracorporeal circuit.

[0038] In some aspects of the present invention, software executing the instructions provided herein may be stored on a non-transitory computer-readable medium, wherein the software performs some or all of the steps of the present invention when executed on a processor.

[0039] Aspects of the invention relate to algorithms executed in computer software. Though certain embodiments may be described as written in particular programming languages, or executed on particular operating systems or computing platforms, it is understood that the system and method of the present invention is not limited to any particular computing language, platform, or combination thereof. Software executing the algorithms described herein may be written in any programming language known in the art, compiled, or interpreted, including but not limited to C, C++, C#, Objective-C, Java, JavaScript, MATLAB, Python, PHP, Perl, Ruby, or Visual Basic. It is further understood that elements of the present invention may be executed on any acceptable computing platform, including but not limited to a server, a cloud instance, a workstation, a thin client, a mobile device, an embedded microcontroller, a television, or any other suitable computing device known in the art.

[0040] Parts of this invention are described as software running on a computing device. Though software described herein may be disclosed as operating on one particular computing device (e.g. a dedicated server or a workstation), it is understood in the art that software is intrinsically portable and that most software running on a dedicated server may also be run, for the purposes of the present invention, on any of a wide range of devices including desktop or mobile devices, laptops, tablets, smartphones, watches, wearable electronics or other wireless digital/cellular phones, televisions, cloud instances, embedded microcontrollers, thin client devices, or any other suitable computing device known in the art.

[0041] Similarly, parts of this invention are described as communicating over a variety of wireless or wired computer networks. For the purposes of this invention, the words “network”, “networked”, and “networking” are understood to encompass wired Ethernet, fiber optic connections, wireless connections including any of the various 802.11 standards, cellular WAN infrastructures such as 3G, 4G/LTE, or 5G networks, Bluetooth®, Bluetooth® Low Energy (BLE) or Zigbee® communication links, or any other method by which one electronic device is capable of communicating with another. In some embodiments, elements of the networked portion of the invention may be implemented over a Virtual Private Network (VPN).

[0042] FIG. 5 and the following discussion are intended to provide a brief, general description of a suitable computing environment in which the invention may be implemented. While the invention is described above in the general context of program modules that execute in conjunction with an application program that runs on an operating system on a computer, those skilled in the art will recognize that the invention may also be implemented in combination with other program modules.

[0043] Generally, program modules include routines, programs, components, data structures, and other types of structures that perform particular tasks or implement particular abstract data types. Moreover, those skilled in the art will appreciate that the invention may be practiced with other computer system configurations, including handheld devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, minicomputers, mainframe computers, and the like. The invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0044] FIG. 5 depicts an illustrative computer architecture for a computer 500 for practicing the various embodiments of the invention. The computer architecture shown in FIG. 5 illustrates a conventional personal computer, including a central processing unit 550 (“CPU”), a system memory 505, including a random access memory 510 (“RAM”) and a read-only memory (“ROM”) 515, and a system bus 535 that couples the system memory 505 to the CPU 550. A basic input/output system containing the basic routines that help to transfer information between elements within the computer, such as during startup, is stored in the ROM 515. The computer 500 further includes a storage device 520 for storing an operating system 525, application/program 530, and data.

[0045] The storage device 520 is connected to the CPU 550 through a storage controller (not shown) connected to the bus 535. The storage device 520 and its associated computer-readable media provide non-volatile storage for the computer 500.

Although the description of computer-readable media contained herein refers to a storage device, such as a hard disk or CD-ROM drive, it should be appreciated by those skilled in the art that computer-readable media can be any available media that can be accessed by the computer 500.

[0046] By way of example, and not to be limiting, computer-readable media may comprise computer storage media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computer.

[0047] According to various embodiments of the invention, the computer 500 may operate in a networked environment using logical connections to remote computers through a network 540, such as TCP/IP network such as the Internet or an intranet. The computer 500 may connect to the network 540 through a network interface unit 545 connected to the bus 535. It should be appreciated that the network interface unit 545 may also be utilized to connect to other types of networks and remote computer systems.

[0048] The computer 500 may also include an input/output controller 555 for receiving and processing input from a number of input/output devices 560, including a keyboard, a mouse, a touchscreen, a camera, a microphone, a controller, a joystick, or other type of input device. Similarly, the input/output controller 555 may provide output to a display screen, a printer, a speaker, or other type of output device. The computer 500 can connect to the input/output device 560 via a wired connection including, but not limited to, fiber optic, Ethernet, or copper wire or wireless means including, but not limited to, Wi-Fi, Bluetooth, Near-Field Communication (NFC), infrared, or other suitable wired or wireless connections.

[0049] As mentioned briefly above, a number of program modules and data files may be stored in the storage device 520 and/or RAM 510 of the computer 500, including an operating system 525 suitable for controlling the operation of a networked computer. The storage device 520 and RAM 510 may also store one or more applications/programs 530. In particular, the storage device 520 and RAM 510 may store an application/program 530 for providing a variety of functionalities to a user. For instance, the application/program 530 may comprise many types of programs such as a word processing application, a spreadsheet application, a desktop publishing application, a database application, a gaming application, internet browsing application, electronic mail application, messaging application, and the like. According to an embodiment of the present invention, the application/program 530 comprises a multiple functionality software application for providing word processing functionality, slide presentation functionality, spreadsheet functionality, database functionality and the like.

[0050] The computer 500 in some embodiments can electronically and/or communicatively connect with cannula 100 and can include a variety of sensors 565 for monitoring the environment surrounding and the environment internal to the computer 500 and/or cannula 100. These sensors 565 can include one or more pressure sensors (e.g., pressure sensors 126, 128), temperature sensor, a photosensitive sensor, a gyroscope, a magnetometer, thermometer, a proximity sensor, an accelerometer, a microphone, biometric sensor, barometer, humidity sensor, radiation sensor, or any other suitable sensor.

[0051] The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention.

Claims

CLAIMS What is claimed is:

1. A cannula comprising: an elongate body having a proximal end, a distal end, and a drainage lumen extending therebetween, the drainage lumen in fluid communication with a proximal drainage lumen port and a distal tip opening; a first balloon configured on a distal end of the elongate body, and a second balloon configured on the elongate body distal to the first balloon; a first opening in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen; and a second opening in the elongate body distal to the second balloon and in fluid communication with the drainage lumen.

2. The cannula of claim 1 , wherein the first opening is one of a first plurality of openings in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen.

3. The cannula of claim 1 , wherein the second opening is one of a second plurality of openings in the elongate body distal to the second balloon and in fluid communication with the drainage lumen.

4. The cannula of claim 1 further comprising: a third opening in the elongate body between the first and second balloon and in fluid communication with the drainage lumen.

5. The cannula of claim 4, wherein the third opening is one of a third plurality of openings in the elongate body between the first and second balloon and in fluid communication with the drainage lumen.

6. The cannula of claim 1 , further comprising: a first pressure sensor configured on the elongate body distal of the second balloon.

7. The cannula of claim 6, wherein the first pressure sensor is connected to a proximal first pressure sensor port.

8. The cannula of claim 6 further comprising: a second pressure sensor configured on the elongate body proximal of the first balloon.

9. The cannula of claim 8, wherein the second pressure sensor is connected to a proximal second pressure sensor port.

10. The cannula of claim 1 , wherein the first and second balloon are separated by a distance.

11 . The cannula of claim 10, wherein The distance is between 2 and 5 millimeters, but can range up to 10 millimeters.

12. The cannula of claim 1 , wherein the first balloon is in fluid communication with a proximal first balloon port.

13. The cannula of claim 1 , wherein the second balloon is in fluid communication with a proximal second balloon port.

14. A cannula system comprising: a cannula comprising an elongate body having a proximal end, a distal end, and a drainage lumen extending therebetween, the drainage lumen in fluid communication with a proximal drainage lumen port and a distal tip opening, a first balloon configured on a distal end of the elongate body, and a second balloon configured on the elongate body distal to the first balloon, a first opening in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen, and a second opening in the elongate body distal to the second balloon and in fluid communication with the drainage lumen; and a cannula introducer comprising at least one fiducial marker corresponding to a position of at least one of the first and second balloon.

15. The cannula system of claim 14, wherein the at least one fiducial marker is part of a set of fiducial markers spaced apart corresponding to a separation distance of the first and second balloon.

16. A method for placing a cannula in a left and right atrium of a subject, the method comprising: providing a cannula comprising an elongate body having a proximal end, a distal end, and a drainage lumen extending therebetween, the drainage lumen in fluid communication with a proximal drainage lumen port and a distal tip opening, a first balloon configured on a distal end of the elongate body, and a second balloon configured on the elongate body distal to the first balloon, a first opening in the elongate body proximal to the first balloon and in fluid communication with the drainage lumen, and a second opening in the elongate body distal to the second balloon and in fluid communication with the drainage lumen; advancing the distal tip opening through a vessel lumen of the subject and into the right atrium; puncturing the interatrial septum; advancing the distal tip opening, first balloon and second balloon into the left atrium; inflating the second balloon in the left atrium; partially withdrawing the cannula so that the first balloon is withdrawn into the right atrium; and inflating the first balloon in the right atrium.

17. A method for simultaneously draining a left and right atrium of a subject, the method comprising: the method of claim 16; and applying a negative pressure to the drainage lumen.

18. The method of claim 16 further comprising: loading the cannula over a guidewire before the step of advancing the distal tip opening though the vessel.

19. The method of claim 16 further comprising: monitoring pressure in the left atrium by measuring a signal from a first pressure sensor configured of the elongate body distal of the second balloon.

20. The method of claim 19 further comprising: monitoring pressure in the right atrium by measuring a signal from a second pressure sensor configured of the elongate body proximal of the first balloon.