WO2025057066A1

WO2025057066A1 - Bidirectional flow cannulas and methods of using same

Info

Publication number: WO2025057066A1
Application number: PCT/IB2024/058805
Authority: WO
Inventors: Luke HARRIS; Martina Wan LOCKWOOD; Hillary PIERCE
Original assignee: Total Flow Medical Ltd
Current assignee: Total Flow Medical Ltd
Priority date: 2023-09-11
Filing date: 2024-09-11
Publication date: 2025-03-20
Anticipated expiration: 2026-03-11

Abstract

Bidirectional flow cannulas include a reinforced and unreinforced portions with and an optional tapered portion therebetween. A central lumen extends along the reinforced, unreinforced, and tapered portions so that they are in fluid communication with one another. The unreinforced portion includes a coupling configured to couple to a source of blood flow. The reinforced portion includes an open end and may be configured for insertion into a blood vessel of a patient 's limb and/or groin region so that blood from the source of blood flow may be injected into the blood vessel for delivery to the patient's body/head via the open end. The reinforced portion may include a first and a second plurality of ports with the first plurality of ports being configured and arranged so that a portion blood exiting therefrom travels away from the patient's body and head and toward the patient's limb and/or groin region.

Description

BIDIRECTIONAL FLOW CANNULAS AND METHODS OF USING SAME

RELATED APPLICATION

[0001]This application is an international (PCT) patent application of, and claims priority to, U.S. Provisional Patent Application Number 63/537,805 filed 11 September 2023 and entitled “FEMORAL CANNULAS AND SYSTEMS WITH DISTAL LIMB PERFUSION AND METHODS OF USING SAME,” which is incorporated herein in its entirety.

FIELD

[0002] The invention pertains to bidirectional flow cannulas for use within vessels in the body, such as blood vessels in a limb, that are configured to provided blood flow in two directions to both the body and head as well as the cannulated limb.

BACKGROUND

[0003] Femoral cannulation during, for example, minimally invasive cardiac surgery or extracorporeal membrane oxygenation (ECMO) is often fraught with a host of complications ranging in severity from bleeding to sepsis to death. For example, the presence of a femoral arterial and venous cannula to achieve adequate cardiac output can significantly impair blood flow and venous drainage from the leg, which may lead to ischemic conditions of the cannulated limb and/or reperfusion injuries following decannulation. This presents numerous challenges to the clinician. If not identified early, the consequences of limb ischemia are numerous, often requiring surgical intervention and challenges with blood pressure and hemodynamic patient management. Additional consequences of limb ischemia are significant. Venous thrombosis is a common morbidity, while tissue necrosis would be the ultimate sequelae. Further interventions are routinely required in the presence of limb ischemia such as embolectomies, fasciotomies, and amputations.

[0004] Minimally invasive cardiac surgery (MICS) represents a safe and effective approach for a variety of cardiac surgical diseases. The use of minimally invasive cardiac surgery has continued to increase over the last 10-15 years for the aging population with the number of patients undergoing reoperation for valvular heart disease increasing as the general population ages and has demonstrated better longterm survival in the elderly. [0005] During MICS, the use of peripheral cannulation reduces the chest incision and maximizes the operative space. Femoral cannulation is commonly used for patients undergoing cardiopulmonary bypass in approximately 85-90% of MICS and 20% of all cardiac surgeries. To perform this peripheral cannulation, femoral cannulas are placed into the femoral artery and vein by a cardiac surgeon in preparation for initiating cardiopulmonary bypass. These cannulas remove and return the patient’s blood to and from the cardiopulmonary bypass machine providing extracorporeal circulation during surgery.

[0006] One of the major risks associated with traditional femoral cannulation is limb ischemia. Limb ischemia occurs as a result of a lack of blood flow in a patient’s leg and is associated with increased morbidity and mortality for patients undergoing extracorporeal circulation using femoral cannulation. There are additional factors which may increase the likelihood of developing ischemic limb conditions by affecting perfusion to the ipsilateral leg. These include the use of high vasopressor support and the use of large caliber flow-occlusive systemic femoral cannula.

[0007] It is hypothesized that ischemic limb conditions during traditional femoral cannulation are caused by fluid mechanics (e.g., the Bernoulli principle) that a lack of blood flow to the ipsilateral limb because a higher velocity blood flow exiting the tip of the conventional cannula in the direction of the head and body creates negative pressure in the femoral artery below the tip of the conventional cannula, effectively pulling blood up the artery from the leg, in the direction of the body. This retrograde blood flow is a cause of ischemic limb conditions.

SUMMARY

[0008] The bidirectional flow cannulas disclosed herein may be configured to reduce and/or eliminate ischemic conditions within a cannulated limb (e.g., leg), groin, and/or reperfusion injuries by, for example, directing blood flow to the ipsilateral cannulated limb and/or providing one or more mechanisms (e.g., ports) for the delivery of blood to a cannulated blood vessel, which may serve to reduce a velocity and/or pressure of the blood being introduced into the vessel via the bidirectional flow cannula, which may reduce a likelihood of hemolysis for the patient.

[0009] In many cases, the bidirectional flow cannulas disclosed herein are configured for insertion into a blood vessel (e.g., femoral artery or femoral vein) of a patient’s limb (e.g., leg or arm) and/or groin so that blood may be supplied to the patient during, for example, the use of extracorporeal circulation, extracorporeal membrane oxygenation (ECMO), and/or during heart surgery utilizing cardiopulmonary bypass (CPB). At times, the bidirectional flow cannulas disclosed herein may include a radio-opaque marker configured to assist with the insertion of the bidirectional flow cannula. The radio-opaque marker may be positioned on the distal side of the unreinforced portion. In many circumstances, the bidirectional flow cannulas disclosed herein may be configured so that they may be inserted into the femoral artery and moved into the external iliac artery or common iliac artery where the bidirectional flow cannula, or a portion thereof, may reside during use and/or until removal. Guiding the bidirectional flow cannula through the femoral artery to the external iliac artery or common iliac artery may be performed with the assistance of one or more imaging and/or visualization techniques (e.g., ultrasound and/or X-ray) that may, for example show a position of the radio-opaque marker in the patient’s femoral, external iliac, or common iliac artery.

[00010] A bidirectional flow cannula may include a reinforced portion coupled to an unreinforced portion in fluid communication with one another via a central lumen extending along the length of the bidirectional flow cannula. In some embodiments, the reinforced portion may be joined and/or coupled to an unreinforced portion via a tapered portion positioned between and coupling the unreinforced portion and the reinforced portion together. In these embodiments, the central lumen extends through the unreinforced portion, the tapered portion, and the reinforced portion.

[00011] An open end (e.g., the end not coupled to the tapered portion) of the unreinforced portion may include a coupling configured to couple to a source of blood flow such as an extracorporeal circulation device or circuit, an extracorporeal membrane oxygenation (ECMO) machine and/or circuit and/or a CBP machine and/or circuit. In some embodiments, the bidirectional flow cannulas disclosed herein may include a radio-opaque marker positioned proximate to the open end of the reinforced portion.

[00012] The reinforced portion include an open end opposite the tapered portion and/or coupling of the unreinforced portion and may be configured to be inserted into, and temporarily reside within, a blood vessel of a patient ‘s limb and/or groin (at times collectively referred to herein as “limb”) so that blood from the source of blood flow may be injected into the blood vessel for delivery to the patient’s body and head via the open end. The reinforcing of the reinforced portion may be configured to resist kinking, twisting, compression, and/or undesired bending and, therefore may assist with the insertion of the reinforced portion into the blood vessel and/or maintaining a shape of the reinforce portion once inserted so that blood may continue to flow through the central lumen when in use.

[00013] In some embodiments, the bidirectional flow cannula may be configured for use within a patient’s femoral artery and the blood vessel is the patient’s femoral artery and, in other embodiments, the bidirectional flow cannula may be configured for use within a patient’s femoral vein and the blood vessel is the patient’s femoral vein. [00014] The reinforced portion includes a first plurality of ports and a second plurality of ports spaced apart from one another, wherein the second plurality of ports may be positioned proximate to the open end and the first plurality of ports may be posited closer to the tapered portion and/or coupling of the unreinforced portion than the second plurality of ports. The first plurality of ports may be configured and arranged within reinforced portion so that a portion blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb, which may prevent ischemia of the patient’s cannulated limb and/or groin region. In some embodiments, the portion of blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb ranges between 0-15% when, for example, the bidirectional flow cannula does not include a balloon and/or the balloon is deflated and a ranges between 2-20% when a balloon of a bidirectional flow cannula is inflated.

[00015] The first plurality of ports may include, for example, 2-12 ports, four, five, six, seven, eight, nine, or ten ports and, in some embodiments, a quantity of ports included in the first plurality of ports is larger than a quantity of ports included in the second plurality of ports. The second plurality of ports may include, for example, 2-12 ports, four, five, six, seven, eight, nine, or ten ports and, in some embodiments, a quantity of ports included in the second plurality of ports is larger than a quantity of ports included in the first plurality of ports. In some instances, an interior diameter of the second plurality of ports may be smaller than an interior diameter of the first plurality of ports. In other instances, an interior diameter of the second plurality of ports is larger than an interior diameter of the first plurality of ports. In some embodiments, one or more ports of the first and/or second plurality of ports may be oriented at an angle that is not perpendicular to the reinforced portion [00016] In some embodiments, the reinforced portion may include a first reinforcement member (e.g., a reinforcement member , rolled tube, laser cut tube, etc.) positioned within a sidewall thereof. The first reinforcement member may include a first plurality of holes sized, positioned, and configured, to align with the first plurality of ports. Additionally, or alternatively, the reinforced portion may include a second reinforcement member positioned within a sidewall thereof. The second reinforcement member may include a second plurality of holes sized, positioned, and configured, to align with the second plurality of ports.

[00017] In some embodiments, the bidirectional flow cannulas disclosed herein may include an inflatable balloon positioned on an exterior surface of the reinforced portion between the first and second plurality of ports and an inflation line for inflating and deflating the inflatable balloon. The inflation line may be resident within a sidewall of the reinforced portion and/or affixed to an external surface thereof. The inflatable balloon may be configured to, for example, stabilize the reinforced portion within the patient’s blood vessel and/or assist in directing blood flow exiting the first plurality of ports toward the patient’s cannulated limb and may be configured to fully or partially occlude the patient’s blood vessel when inflated. In these embodiments, the portion blood exiting the first plurality of ports and traveling away from the patient’s body and head towards the patient’s limb ranges between 2% and 20% of the blood provided by the source of blood flow with 98-80% of the blood flow going toward the patient’s head and body.

[00018] The bidirectional flow cannulas disclosed herein may be used to provide blood flow to a patient’s body, head, and cannulated limb and/or groin region with the patient is on extracorporeal circulation and the source of blood flow is an extracorporeal circulation circuit. At times, these methods may include inserting the open end and a portion of the reinforced portion of the bidirectional flow cannula into the blood vessel in the patient’s limb and/or groin region, coupling the coupling of the unreinforced portion to the ECMO circuit, and supplying and/or enabling the supply of a volume of blood to the bidirectional flow cannula via the extracorporeal circulation circuit, wherein a first volume of blood is injected into the patient’s blood vessel for delivery to the patient’s head and body via the open end of the bidirectional flow cannula, and a second volume of blood flows out of the first plurality of ports toward the patient’s cannulated limb. [00019] When the bidirectional flow cannula includes an inflatable balloon, it may be inflated with a volume of inflation media (e.g., saline, gas, etc.) to fully or partially occlude the patient’s blood vessel. In some embodiments, a volume of inflation media supplied to the balloon is responsive to an indication of the vessel size, strength, and/or integrity.

BRIEF DESCRIPTION OF THE DRAWINGS

[00020] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[00021] FIG. 1 A is a side view of an exemplary first bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00022] FIG. 1 B is a top-perspective view of an exemplary proximal reinforcement member included in the first bidirectional flow cannula of FIG. 1A, in accordance with some embodiments of the present invention.

[00023] FIG. 1C is a top-perspective view of an exemplary distal reinforcement member included in the first bidirectional flow cannula of FIG. 1A, in accordance with some embodiments of the present invention.

[00024] FIG. 1 D is a close up view of a distal portion of the first bidirectional flow cannula of FIG. 1A without a distal or proximal reinforcement member, in accordance with some embodiments of the present invention.

[00025] FIG. 1 E is a close up view of a distal portion of the first bidirectional flow cannula of FIG. 1A, in accordance with some embodiments of the present invention.

[00026] FIG. 1 F provides a vertical cross-section view of the first bidirectional flow cannula of FIG. 1A, in accordance with some embodiments of the present invention.

[00027] FIG. 2A is a side view of an exemplary second bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00028] FIG. 2B is a cross-section view of the second bidirectional flow cannula of FIG. 2A, in accordance with some embodiments of the present invention.

[00029] FIG. 3A is a side view of an exemplary third bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00030] FIG. 3B is a cross-section view of the third bidirectional flow cannula of FIG. 3A, in accordance with some embodiments of the present invention. [00031] FIG. 3C is a detailed view of a distal portion of the third bidirectional flow cannula of FIG. 3A, in accordance with some embodiments of the present invention.

[00032] FIG. 3D provides a cut away view of the third bidirectional flow cannula of FIG. 3A when positioned within a patient’s blood vessel and shows a flow of blood through the bidirectional flow cannula of FIG. 3A when the balloon is deflated, in accordance with some embodiments of the present invention.

[00033] FIG. 3E provides a cut away view of the third bidirectional flow cannula of FIG. 3A when positioned within the patient’s blood vessel and shows a flow of blood through the bidirectional flow cannula of FIG. 3A when the balloon is inflated, in accordance with some embodiments of the present invention.

[00034] FIG. 4A provides a side view of a distal portion of an exemplary bidirectional flow cylindrically shaped balloon, in accordance with some embodiments of the present invention.

[00035] FIG. 4B provides a side view of a distal portion of an exemplary bidirectional flow cannula with an oval-shaped balloon, in accordance with some embodiments of the present invention.

[00036] FIG. 4C provides a side view of a distal portion of an exemplary bidirectional flow cannula that includes a rounded square-shaped balloon, in accordance with some embodiments of the present invention.

[00037] FIG. 4D provides a side view of a distal portion of an exemplary bidirectional flow cannula that includes a triangularly shaped balloon, in accordance with some embodiments of the present invention.

[00038] FIG. 4E provides a side view of a distal portion of an exemplary bidirectional flow cannula that includes a spherically shaped balloon, in accordance with some embodiments of the present invention.

[00039] FIG. 4F provides a side view of a distal portion of an exemplary bidirectional flow cannula that includes a rhomboid-shaped balloon, in accordance with some embodiments of the present invention.

[00040] FIG. 4G provides a cross section of the bidirectional flow cannulas as shown in FIGs. 4A, 4B, and 4E, in accordance with some embodiments of the present invention.

[00041] FIG. 4H shows a cross-section of an exemplary bidirectional flow cannula with a square-shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention. [00042] FIG. 41 shows a cross-section of an exemplary bidirectional flow cannula with a hexagonally shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00043] FIG. 4J shows a cross-section of an exemplary bidirectional flow cannula with a substantially ovoid-shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00044] FIG. 4K shows a cross-section of an exemplary bidirectional flow cannula with a substantially pentagonal-shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00045] FIG. 4L shows a cross-section of an exemplary bidirectional flow cannula with a substantially rhomboid-shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00046] FIG. 4M shows a cross-section of an exemplary bidirectional flow cannula with a substantially rounded-rectangularly shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00047] FIG. 4N shows a cross-section of an exemplary bidirectional flow cannula with a substantially rounded square shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00048] FIG. 40 shows a cross-section of an exemplary bidirectional flow cannula with a substantially triangularly shaped balloon that surrounds the reinforced portion, in accordance with some embodiments of the present invention.

[00049] FIG. 5A provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes a crescent shaped inflation line, in accordance with some embodiments of the present invention.

[00050] FIG. 5B provides a vertical cross-section view an exemplary bidirectional flow cannula that includes an inflation line lumen resident within an unreinforced portion of the bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00051] FIG. 5C provides a vertical cross-section view a cross-section view of another exemplary bidirectional flow cannula that includes an inflation line lumen resident within a reinforced portion of the bidirectional flow cannula in accordance with some embodiments of the present invention.

[00052] FIG. 5D provides a vertical cross-section view of an exemplary bidirectional flow cannula with a crescent-shaped inflation line lumen resident within a sidewall of a reinforced portion of the bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00053] FIG. 5E provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes an oval-shaped shaped inflation line lumen positioned within a sidewall of the reinforced portion of the bidirectional flow cannula, in accordance with some embodiments of the present invention.

[00054] FIG. 5F provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes an oval-shaped inflation line, in accordance with some embodiments of the present invention.

[00055] FIG. 5G provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes an oval-shaped inflation line with a first type of supports for the inflation line, in accordance with some embodiments of the present invention.

[00056] FIG. 5H provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes an oval-shaped inflation line with a second type of supports for the inflation line, in accordance with some embodiments of the present invention.

[00057] FIG. 51 provides a vertical cross-section view of an exemplary bidirectional flow cannula that includes a circular-shaped inflation line with supports for the inflation line, in accordance with some embodiments of the present invention.

[00058] FIG. 6A1 provides a top view of a portion of a first region and/or second region of an exemplary bidirectional flow cannula that includes a port with an approximately circular shape, in accordance with some embodiments of the present invention.

[00059] FIG. 6A2 is a vertical cross-section view of the bidirectional flow cannula of FIG. 6A1 , in accordance with some embodiments of the present invention.

[00060] FIG. 6B is a top view of a first region and/or a second region of a bidirectional flow cannula that includes an oval-shaped port, in accordance with some embodiments of the present invention.

[00061] FIG. 6C is a top view of a first region and/or a second region of a bidirectional flow cannula that includes a triangularly shaped port, in accordance with some embodiments of the present invention. [00062] FIG. 6D is a top view of a first region and/or a second region of a bidirectional flow cannula that includes a square-shaped port, in accordance with some embodiments of the present invention.

[00063] FIG. 6E is a top view of a first region and/or a second region of a bidirectional flow cannula that includes an array of two ports arranged in a diagonal and linear fashion, in accordance with some embodiments of the present invention.

[00064] FIG. 6F is a top view of a first region and/or a second region of a bidirectional flow cannula that includes an array of three ports arranged in a triangular fashion, in accordance with some embodiments of the present invention.

[00065] FIG. 6G is a top view of a first region and/or a second region of a bidirectional flow cannula that includes an array of three ports arranged in a linear fashion, in accordance with some embodiments of the present invention.

[00066] FIG. 6H is a top view of a first region and/or a second region of a bidirectional flow cannula that includes an array of five ports arranged in a “X”-like fashion, in accordance with some embodiments of the present invention.

[00067] FIG. 7A provides a cross-section view of a portion of an exemplary unreinforced portion with a first pair of ports, in accordance with some embodiments of the present invention.

[00068] FIG. 7B depicts a cross-section view of a portion of an exemplary reinforced portion with a second pair of ports, in accordance with some embodiments of the present invention.

[00069] FIG. 7C is a cross-section view of a portion of an exemplary reinforced portion with a third pair of ports, in accordance with some embodiments of the present invention.

[00070] FIG. 7D is a cross-section view of a portion of an exemplary reinforced portion with a fourth pair of ports, in accordance with some embodiments of the present invention.

[00071] FIG. 7E is a cross-section view of a portion of an exemplary reinforced portion with a fifth pair of ports, in accordance with some embodiments of the present invention.

[00072] FIG. 8 provides a side view of a bidirectional flow cannula positioned within a patient’s blood vessel, in accordance with some embodiments of the present invention. [00073] FIG. 9A is a side view of a first exemplary introducer, in accordance with some embodiments of the present invention.

[00074] FIG. 9B is a side view of a second exemplary introducer, in accordance with some embodiments of the present invention.

[00075] FIG. 9C1 provides a cross-section view of the introducer with feedback mechanism, in accordance with some embodiments of the present invention.

[00076] FIG. 9C2 is a cross section view of the introducer with feedback mechanism of FIG. 9C1 , in accordance with some embodiments of the present invention.

[00077] FIG. 10A provides a horizontal cross-section view of a first introducer/canula system that includes a bidirectional flow cannula with a tapered tip and an introducer, in accordance with some embodiments of the present invention.

[00078] FIG. 10B provides a cross-section view of a second introducer/canula system that includes a bidirectional flow cannula with a narrowed tip and an introducer, in accordance with some embodiments of the present invention.

[00079] FIG. 10C provides a cross-section view of a third introducer/canula system that includes a bidirectional flow cannula with a tapered and narrowed tip and an introducer, in accordance with some embodiments of the present invention.

[00080] FIG. 10D provides a cross-section view of a fourth introducer/canula system that includes a bidirectional flow cannula and the introducer with a feedback mechanism of FIGs. 9C1 and 9C2 positioned within blood vessel, in accordance with some embodiments of the present invention.

[00081] FIG. 10E provides a cross-section view of a fifth introducer/canula system that includes a bidirectional flow cannula and an introducer with a feedback mechanism in the form of tapered proximal end, in accordance with some embodiments of the present invention.

[00082] FIG. 10F provides a cross-section view of a sixth introducer/canula system 1016 that includes a bidirectional flow cannula and an introducer, in accordance with some embodiments of the present invention.

[00083] FIG. 11A is an illustration of a system for mitigating bleeding from a bidirectional flow cannula insertion site that includes a bidirectional flow cannula, in accordance with some embodiments of the present invention. [00084] FIG. 11 B1 is an illustration of an exemplary bidirectional flow cannula that includes a bleeding mitigation mechanism, in accordance with some embodiments of the present invention.

[00085] FIG. 11 B2 is an illustration of the bidirectional flow cannula of FIG. 11 B1 positioned within a patient’s blood vessel with the bleeding mitigation mechanism deployed so it occludes an opening in the blood vessel, in accordance with some embodiments of the present invention.

[00086] FIG. 12A is a side view of a first skirted bidirectional flow canula positioned within a blood vessel, in accordance with some embodiments of the present invention.

[00087] FIG. 12B is a side view of a second skirted bidirectional flow canula positioned within a blood vessel, in accordance with some embodiments of the present invention.

[00088] FIG. 12C is a side view of a third skirted bidirectional flow canula positioned within a blood vessel, in accordance with some embodiments of the present invention.

[00089] FIG. 13 provides a flowchart of an exemplary process for setting parameters for inflation of balloon of a bidirectional flow cannula so that the balloon partially occludes a vessel into which the bidirectional flow cannula is inserted, in accordance with some embodiments of the present invention.

[00090] FIG. 14 provides a flowchart of another exemplary process for setting parameters for inflation of balloon of a bidirectional flow cannula so that the balloon partially occludes a vessel into which the bidirectional flow cannula is inserted, in accordance with some embodiments of the present invention.

[00091] FIG. 15A shows an exemplary bidirectional flow cannula positioned with a patient’s blood vessel with balloon completely deflated, in accordance with some embodiments of the present invention.

[00092] FIG. 15B shows the bidirectional flow cannula of FIG. 15A positioned with a patient’s blood vessel with the balloon inflated so that it partially occludes the patient’s blood vessel, in accordance with some embodiments of the present invention.

[00093] FIG. 15C is a cross section of the patient’s blood vessel when it is partially occluded by the balloon as shown in FIG. 15B, in accordance with some embodiments of the present invention. [00094] FIG. 15D shows the bidirectional flow cannula of FIG. 15A positioned with a patient’s blood vessel with balloon inflated and occluding the patient’s blood vessel, in accordance with some embodiments of the present invention.

[00095] FIG 15E shows a flow of blood through the bidirectional flow cannula of FIG. 15A when positioned within the patient’s blood vessel and the balloon is deflated as shown in FIG. 15A, in accordance with some embodiments of the present invention. [00096] FIG 15F shows a flow of blood through the bidirectional flow cannula of FIG. 15A when positioned within the patient’s blood vessel and the balloon is inflated as shown in FIG. 15D, in accordance with some embodiments of the present invention. [00097] FIG. 16 is a block diagram of an exemplary kit, in accordance with some embodiments of the present invention.

[00098] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.

WRITTEN DESCRIPTION

[00099] The bidirectional flow cannulas disclosed herein may be used to cannulate blood vessels and connect with other extracorporeal circulatory equipment for patients requiring arterial femoral cannulation for extracorporeal circulation during, for example, cardiopulmonary bypass procedures or while on life support and/or life sustaining devices and/or systems. The bidirectional flow cannulas disclosed herein may be used to cannulate vessels and connect with accessory extracorporeal equipment. Insertion and placement of a bidirectional flow cannula within a blood vessel may be facilitated via a cannula introducer that resides in a main lumen of the bidirectional flow cannula during the insertion procedure. The introducer may be configured to add stiffness to the bidirectional flow cannula and/or provide a handle by which to manipulate and control movement of the bidirectional flow cannula during placement within the vessel. When the bidirectional flow cannula is placed within the vessel, the introducer may be extracted from the main lumen and the bidirectional flow cannula may be coupled to a source of extracorporeal circulation during, for example, performance of cardiopulmonary bypass.

[000100] The bidirectional flow cannulas disclosed herein are configured and designed to, for example, replace conventional femoral arterial cannulas for extracorporeal circulation during, for example, cardiopulmonary bypass procedures and are advantageous because they provide, for example, an optional dedicated blood flow to the ipsilateral limb. Dedicated blood flow to the limb can be employed as a preventative measure or activated in response to a decrease in blood flow to the limb, based on the clinician’s medical judgment.

[000101] In some embodiments, the bidirectional flow cannulas disclosed herein may deliver retrograde systemic blood flow to the patient’s head and body while a balloon thereof is deflated and/or inflated. With the inflation of a bidirectional flow cannula balloon to the maximum diameter, blood flow may be directed to the patient’s head and body and directed to the patient’s leg via one or more ports located through a main lumen of the bidirectional flow cannula (carrying oxygenated blood).

[000102] The blood flow ports (also called “ports” herein) may be located on a distal side of the bidirectional flow cannula on, for example, proximal and/or distal sides of the balloon. The balloon may be configured and/or positioned on the bidirectional flow cannulas disclosed herein so that, when deployed in a blood vessel and inflated, it separates the proximal blood flow ports from distal proximal ports along the insertable length of the cannula, which may allow for targeted blood flow to the ipsilateral limb during surgical and/or cardiac procedures while still providing ample blood flow to the head and body. Stated differently, a balloon of the bidirectional flow cannulas disclosed herein may be configured to occlude, or partially occlude, a blood vessel in which a bidirectional flow cannula resides and this occlusion, or partial occlusion, of the vessel may facilitate bidirectional blood flow from the bidirectional flow cannula’s partitioned (by the inflated balloon) proximal and distal blood flow ports when the balloon is fully or partially inflated. This may address and/or mitigate clinical risks of ischemic limb and/or groin conditions seen in patients undergoing extracorporeal circulation using femoral cannulation while not introducing new risks.

[000103] The bidirectional flow cannulas disclosed herein are configured for insertion into a vessel of a body (e.g., an artery (e.g., femoral artery) and/or vein), oftentimes positioned in a limb and/or groin, while for example, providing cardiopulmonary support and/or extracorporeal circulation (e.g., cardiopulmonary bypass or extracorporeal membrane oxygenation (ECMO)) to a patient. The bidirectional flow cannulas are configured to deliver the bodily fluid (e.g., blood) to the body as well as to the canulated limb and/or groin region. Supplying the canulated limb and/or groin region with blood via one of the bidirectional flow cannulas disclosed herein may reduce, or otherwise mitigate, risks and complications caused by ischemic conditions in the canulated limb and/or groin region and/or reperfusion injuries for the patient following decannulation. Flow of blood toward the canulated limb may be facilitated by use of a partially, or fully, occluding device (e.g., a balloon) positioned on the canula proximate to one or more ports positioned within a reinforced portion from which the blood may exit the bidirectional flow cannula and be delivered toward the limb. The full, or partial, occlusion by the occluding device may prevent blood exiting from the port from being swept up into the blood stream and delivered away from the limb and/or groin region. This provision of blood toward the limb may prevent ischemia of the limb and/or groin region. On some occasions, the occluding device may be configured to disrupt the fluid dynamics of fluid traveling and/or being pushed through the vessel by, for example, creating turbulence and/or back pressure. The ports may be positioned within a sidewall of the reinforced portion proximal to the cannulated limb and/or groin region.

[000104] Various devices may be used as the occluding device such as (but not limited to) balloons and skirts that surround the main canula tube. In some embodiments, the balloons may be inflated with, for example, air, gas, and/or liquid (e.g., saline). Additionally, or alternatively, the balloons may be self-inflating and/or may expand when placed within the vessel via, for example, a memory of the material comprising the balloon or filling the balloon when fluid flows through the main lumen. The skirts may be configured to transition from a closed state (prior to seating within the vessel) to an expanded, or flared, state when in the vessel thereby partially, or wholly, occluding the vessel.

[000105] Many of the bidirectional flow cannulas described herein may include a supporting, or anti-kinking, element such as a wire or coil ribbon embedded within and, on some occasions, spiraling through a sidewall of a reinforced portion. The supporting element may be made from, for example, stainless steel, fluorinated ethylene propylene (FEP), or other similar rigid, but flexible, material. On some occasions, the supporting material may have a diameter that is slightly (e.g., 0.05- 0.7mm) smaller than an inner diameter of the reinforced portion so that the supporting material extends down into a central, or main, lumen of the reinforced portion, which may alter the flow of blood through the reinforced portion by for example, introducing turbulence into the blood flow. This turbulence may, in some instances, increase a rate of blood flow through the ports and/or reduce hemolysis for blood flowing through the main lumen.

[000106] In some instances, the supporting element may be positioned under, or over, a suction line. Additionally, or alternatively, the supporting element may be configured to provide varying stiffness along the length of the bidirectional flow cannula by, for example, varying a pitch of the supporting element, varying a thickness and/or material used for the supporting element along the length of the bidirectional flow cannula, and/or using a wire that is ribbon or laser cut.

[000107] In some embodiments, the bidirectional flow cannulas disclosed herein may include a marker that may be visible to an imaging technology such as a radioopaque marker. The marker may assist with identification of a position of the marker (and therefore the bidirectional flow cannula) within the body of the patient.

[000108] In many cases, the bidirectional flow cannulas disclosed herein may be mechanically coupled to a machine supplying blood to the bidirectional flow cannula, such as an extracorporeal circulation circuit. This mechanical coupling may be achieved by one or more connecters that, in some instances, may be configured with one or more de-airing ports, valves, and/or lines configured to, for example, allow air in the bidirectional flow cannula to escape.

[000109] At times, the bidirectional flow cannulas disclosed herein may be configured to, for example, reduce thrombosis, improve tactile response, improve kink resistance, and/or increase ease of insertion and/or delivery of the bidirectional flow cannula into a blood vessel. The bidirectional flow cannulas disclosed herein may be made from, for example, polyurethane, elast-eon, silicon, pebax, and combinations thereof. In some instances, the bidirectional flow cannulas disclosed herein may be coated with, for example, a pharmaceutical such as an anticoagulant (e.g., heparin) and/or a friction-reducing and/or hydrophilic coating such as or PTFE.

[000110] In some embodiments, the bidirectional flow cannulas disclosed herein may include and/or cooperate with a mechanism (e.g., flow and/or pressure meter) by which to monitor blood flow to, and/or blood pressure within, a cannulated limb so that, for example, an operator may know how much blood is reaching the cannulated limb so that, for example, risks of ischemia may be recognized and timely mitigated. Exemplary blood flow mechanisms include, but are not limited to, flow meters positioned within a bidirectional flow cannula, a device positioned on the limb and/or groin region that monitors blood flow, and/or an oximetry device.

[000111] Turning now to the figures, the terms “proximal” and “distal” are used herein to denote sides of the bidirectional flow cannula relative to a patient’s body and/or vessel in which they would be inserted, wherein the distal side points toward the head and body of a patient when resident within a vessel and the proximal side points away from the head and body of the patient. At times, the distal end may be referred to herein as the end pointing to the head/body of a patient and the proximal end may be referred to herein as the end pointing away from the head/body of the patient.

[000112] One exemplary bidirectional flow cannula disclosed herein is shown in FIG. 1A, which provides a side view of a first bidirectional flow cannula 100 having a proximal and distal side as shown. First bidirectional flow cannula 100 comprises a reinforced, distal, portion 105 and an unreinforced, proximal, portion 160 connected or joined via a tapered portion 104 with a main lumen 185 (see FIG. 1 F) running along its entire length so that reinforced portion 105 unreinforced portion 160, and tapered portion 104 are in fluid communication with one another along main lumen 185. Both reinforced and unreinforced portion 105 and 160 may be made from a flexible (e.g., plastic, vinyl, and/or polyimide) material and reinforced portion 105 may further include a reinforcing material such as a metal wire or reinforcement member embedded within a sidewall thereof, such as a support ribbon 103 (shown in FIG. 1 D and 1 E). Bidirectional flow cannula 100 may further include a balloon 110, an inflation line 120, a tip 125, a plurality of ports 130, a proximal reinforcement member 140 (shown in FIGs. 1 B and 1 E), a distal reinforcement member 145 (shown in FIGs. 1C and 1 E), an inflation line coupling 155, an optional joint 165 with a plug 162, and an optional coupling 170 and may be manufactured using, for example, a dip casting method. Exemplary dimensions for first bidirectional flow cannula 100 include an overall length of 380-430mm, a length of reinforced portion 105 of 220-290mm, an exterior diameter of reinforced portion 105 are 4.5-8mm, and exemplary dimensions for an exterior diameter of inflation line 120 are 0.7-2mm. First bidirectional flow cannula 100 may be used to, for example, supply blood to a patient’s artery or vein during, for example, extracorporeal circulation. [000113] Reinforced portion 105 has a central lumen defined by a sidewall of reinforced portion 105. Reinforced portion 105, or a portion thereof, may be configured to reside within a vessel (e.g., artery and/or vein) of a patient during use and provide blood or other fluids to the vessel via, for example, liquid communication with a source of blood/fluid, such as a heart/lung machine, extracorporeal circulation circuit, and/or an ECMO circuit, wherein the blood and/or fluid flows through the central lumen of unreinforced portion 160 and reinforced portion 105. Reinforced portion 105 may include a tip 125, a balloon 110, a second reinforced segment 102 positioned between balloon 110, and a first reinforced segment 101 positioned on a proximal side of balloon 110. Ribbon 103 may be configured to provide stiffness to reinforced portion 105 to, for example, prevent compression, kinking, twisting, and/or bending of reinforced portion 105 while maintaining enough flexibility of reinforced portion 105 to enable desired bending during, for example, an insertion process and/or while resident within a patient’s vessel.

[000114] Proximal reinforcement member 140 may reside within first reinforced segment 101 and may, for example, be imbedded within a sidewall of first reinforced segment 101 and/or may be positioned to reside along an interior sidewall of first reinforced segment 101 as shown in FIG. 1 D. First reinforced segment 101 may include a plurality of ports 130 positioned on a proximal side of first bidirectional flow cannula 100. Ports 130 may be openings and/or holes within first reinforced segment 101 and proximal reinforcement member 140 configured to allow a flow of fluid/blood therethrough as, for example, discussed below. Additional details regarding proximal reinforcement member 140 are shown in FIG. 1 B and discussed below. Additional details regarding different features and/or configurations of ports 130 are discussed herein and, for example, shown in FIGs. 6A-7F.

[000115] Distal reinforcement member 145 may reside within second reinforced segment 102 and may, for example, be imbedded within a sidewall of second reinforced segment 102 and/or may be positioned to reside along an interior sidewall of second reinforced region. Additional details regarding distal reinforcement member 145 are shown in FIG. 1C and discussed below. Second reinforced segment 102 may include a plurality of ports 130 that may be openings and/or holes within second reinforced segment 102 and distal reinforcement member 145. Ports 130 may be configured to allow a flow of fluid (e.g., oxygenated blood) therethrough as, for example, discussed below. Second reinforced segment 102 terminates with tip 125. Tip 125 may be tapered to, for example, facilitate insertion into the patient’s vessel and, in some embodiments, may be flexible and/or elastic. In some embodiments, tip 125 may be and/or include a radio-opaque marker configured to, for example, be viewable from outside the body via one or more imaging technologies (e.g., ultrasound or X-ray). Additional details regarding exemplary configurations of tip 125 are provided in FIGs. 10A-10F and discussed below. Distal and/or proximal reinforcement members 140 and/or 145 may be embodied as a basket or sheet that is rolled prior to assembling (e.g., dip casting) bidirectional flow cannula 100.

[000116] Inflation line coupling 155 is configured to couple to an inflation/deflation mechanism such as an air and/or vacuum pump (not shown) that may push air and/or liquid (e.g., saline) into inflation line 120 for communication to, and inflation of, balloon 110 once first bidirectional flow cannula 100 is placed in situ within a patient’s blood vessel and/or while first bidirectional flow cannula 100 resides within the patient’s blood vessel. In some embodiments, balloon 110 may be inflated by, for example, 0.2-0.5cc of saline.

[000117] Inflation line 120 may also be configured to facilitate deflation of balloon 110 via, for example, evacuation of inflation gas and/or liquid (i.e., inflation media) from balloon 110 when, for example, negative pressure (e.g., vacuum) is applied to inflation line 120 by, for example, a vacuum pump. Exemplary inflation line couplings 155 include, but are not limited to, push-in couplings, valves, luer locks, and screw-on couplings. Prior to extraction of first bidirectional flow cannula 100 from the patient’s vessel (or on other occasions), balloon 110 may be deflated by an application of negative pressure (or vacuum) by the inflation/deflation mechanism to inflation line 120 so that gas and/or liquid may be evacuated from balloon, 110 thereby deflating balloon 110. As may be seen in FIG. 1 B, inflation line 120 may reside on, and may be coupled to, an exterior surface of reinforced portion 105. Other exemplary configurations or embodiments of inflation line 120 are provided by FIGs. 5A-5I and discussed below.

[000118] Unreinforced portion 160 may be configured to couple to a tapered portion of reinforced portion 105 and/or may extend from a tapered portion of reinforced portion 105. Unreinforced portion 160 and/or the tapered region of reinforced portion 105 may be configured to reside outside the body when first bidirectional flow cannula 100 is being used to provide blood or other fluids to a patient or is otherwise inserted into a vessel. [000119] Optional joint 165 may be sized, shaped, and configured to facilitate easy grasping of first bidirectional flow cannula 100 so that optional coupling 170 may be manually inserted into and/or extracted from a tube (not shown) that may be supplying blood or other fluids to first bidirectional flow cannula 100. In some embodiments, optional joint 165 may be inserted into unreinforced portion 160 and/or retained into unreinforced portion 160 via plug 162 which may be a friction-based coupling with a central lumen therethrough that aligns with a central lumen of reinforced portion 105 (not shown). Approximate dimensions for coupling 170 may be, for example, 0.2-0.8 inches and, in some embodiments, may be a 3/8 inch connector.

[000120] FIG. 1 B provides a top-perspective view of proximal reinforcement member 140 as a flat sheet prior to being rolled and deployed within first region 101 of reinforced portion 105 as shown in FIGs. 1A and 1 B. Proximal reinforcement member 140 includes a plurality of rounded rectangular perforations, three holes 175 arranged in a triangular formation, a first partial hole 175’ and a second partial hole 175” as shown. When proximal reinforcement member 140 is rolled into a cylinder prior to deployment in first region 101 , first partial hole 175’ and second partial hole 175” may meet and form a complete hole like holes 175. Proximal reinforcement member 140 may be, for example, a sheet of stainless steel, or other appropriate material, and the perforations and/or holes 175 therein may be produced via, for example, stamping and/or laser cutting. The rounded rectangular perforations of proximal reinforcement member 140 may be configured to provide flexibility to proximal reinforcement member 140 when deployed within first region 101. Holes 175 as well as first and second partial holes 175’ may be sized, positioned, and configured to align with the holes or openings in first region 101 that form ports 130 so that proximal reinforcement member 140 does not occlude any of the ports 130 of first region 101 .

[000121] FIG. 1C provides a top-perspective view of distal reinforcement member 145 as a flat sheet prior to being rolled and deployed within second region 102 of reinforced portion 105. Distal reinforcement member 145 includes a plurality of rounded rectangular perforations, three holes 175 arranged in a diagonal and linear fashion, a first partial hole 175’ and a second partial hole 175” as shown. When distal reinforcement member 145 is rolled into a cylinder prior to deployment in second region 102, first partial hole 175’ and second partial hole 175” may meet and form a complete hole like holes 175. Distal reinforcement member 145 may be, for example, a sheet of stainless steel, or other appropriate material, and the perforations and/or holes 175 therein may be produced via, for example, stamping and/or laser cutting. The rounded rectangular perforations of distal reinforcement member 145 may be configured to provide flexibility to distal reinforcement member 145 when deployed within second region 102. Holes 175 and first and second partial holes may be sized, positioned, and configured to align with the holes or openings in second region 102 of ports 130 so that distal reinforcement member 145 does not occlude any of the ports 130 of second region 102.

[000122] Proximal reinforcement member 140 and/or distal reinforcement member 145 may be configured and arranged to provide additional support to and/or scaffolding for first region 101 and second region 102, respectively, that may operate to, for example, prevent kinking, bending, or twisting of first region 101 and/or second region 102, respectively. This may be of particular importance within first and second regions 101 and 102 because their respective structural integrity may be compromised by ports 130 and proximal and/or distal reinforcement members 140 and/or 145 may compensate for the decreased structural integrity of reinforced portion caused by ports 130. Proximal reinforcement member 140 and/or distal reinforcement member 145 may be embedded within a sidewall of first region 101 and second region 102, respectively, and, in some cases, may be overlaid upon, or reside underneath, ribbon 103 when, for example, ribbon 103 runs along a length of first region 101 and second region 102, respectively.

[000123] FIG. 1 D provides a side view of a portion of reinforced portion 105 without proximal or distal reinforcement members 140/145 so that a manner in which ribbon 103 extends in a spiral-like fashion along a length of reinforced portion 105 may be seen. FIG. 1 E is a close-up view of a distal portion of first bidirectional flow cannula

100 that includes first region 101 and second region may be seen. As may be seen in FIG. 1 E, proximal reinforcement member 140 extends through first region 101 and may reside within a side wall of first region 101 either on top of, or below, ribbon 103. Distal reinforcement member 145 may extend through second region 102 and may reside within a side wall of second region 102 either on top of, or below, ribbon 103. In some embodiments, ribbon 103 may not extend through first and/or second region

101 and/or 102. FIG. 1 E also shows optional reinforced regions 190 on either side of balloon 110. Optional reinforced regions 190 may operate to affix balloon 110 to an exterior diameter of reinforced portion 105 and/or further prevent kinking or bending of first bidirectional flow cannula 100 at, or near, balloon 110.

[000124] FIG. 1 F provides a cross section view of reinforced portion 105 taken at a vertical cross section of reinforced portion 105 or 205 and inflation lumen 120 that is perpendicular to reinforced portion 105 and inflation lumen 120. FIG. 1 F shows reinforced portion 105 and also illustrates a main lumen 185 enclosed within the sidewall of reinforced portion 105A and an inflation line lumen 180 of inflation line 120. Inflation line 120 may be affixed to reinforced portion 105 via, for example, heat, chemical, and/or vibration bonding. Additionally, or alternatively, first bidirectional flow cannula 100 may be manufactured so that reinforced portion 105 and inflation line 120 are simultaneously extruded and/or molded (e.g., injection molding) by manufacturing equipment.

[000125] FIGs. 2A and 2B provide a top and a cross-section view, respectively, of a second exemplary second bidirectional flow cannula 200 having a proximal and distal side as shown. Second bidirectional flow cannula 200 includes tip 125, a first plurality 231 of ports 130, a second 232 plurality of ports 130, a proximal reinforcement member 245, a distal reinforcement member 240, an unreinforced portion 160, an optional coupling 270, and a reinforced portion 205. Reinforced region 205 may include a first reinforced segment 201 positioned on a proximal side of reinforced region 205 and a second reinforced segment 202 positioned proximate to tip 125. Second bidirectional flow cannula 200 further includes a support ribbon 247 that runs along a length of reinforced portion 205, with the exception of distal and proximal reinforcement members 240 and 245 (i.e., support ribbon 247 does not extend through distal and proximal reinforcement members 240 or 245). Support ribbon 247 may be positioned within a sidewall of reinforced portion 205 between an inner surface 210 and an outer surface 207 of reinforced portion 205 as shown in, for example, the cross section of FIG. 2B. In some embodiments, support ribbon 247 may be similar to ribbon 103. Exemplary dimensions for second bidirectional flow cannula 200 include an overall length of 380-430mm, a length of reinforced portion 105 of 220-290mm, an exterior diameter of reinforced portion 105 are 3-14mm, and exemplary dimensions for an exterior diameter of inflation line 120 are 0.7-2mm. Second bidirectional flow cannula 200 may be used to, for example, supply blood to a patient’s artery or vein during, for example, extracorporeal circulation. [000126] Second bidirectional flow cannula 200 includes eight ports in first reinforced segment 201 and two ports in second reinforced segment 202. The eight ports 130 of first reinforced segment 201 may be arranged in, for example, four columns of two ports 130 with each column of two ports 130 being offset from an adjacent column of two ports 130 by approximately 90 degrees. Further, a position of ports 130 in each column may be offset from one another by approximately 3-15mm as shown. The arrangement of the eight ports 130 of first reinforced segment 201 may be configured to disperses force exerted on the vessel wall by blood exiting the eight ports 130 of first reinforced segment 201 over a greater surface area while still achieving limb and/or groin region perfusion targets.

[000127] Proximal reinforcement member 245 and/or distal reinforcement member 240 may be functionally similar to proximal and distal reinforcement members 140 and 145, respectively, in that they may be configured and arranged to provide additional support to and/or scaffolding for reinforced portion 205 that may operate to, for example, prevent kinking, bending, or twisting of reinforced portion 205 as it is inserted into a patient’s blood vessel, particularly in view of the ports, or openings, therein. Additionally, or alternatively, proximal and/or distal reinforcement members 240 and/or 245 may be configured to add structural integrity to reinforced portion 205 proximate to ports 130 which may assist with prevention of compression, or collapse, of reinforced portion 205 when resident inside an blood vessel and, in particular, an arterial blood vessel where reinforced portion 205 may be subject to compressive force from arterial walls and/or rapid changes in blood pressure as blood is pushed through an arterial vessel in which reinforced portion 205 (or a portion thereof) is resident.

[000128] Proximal reinforcement member 245 and/or distal reinforcement member 240 may be, for example, laser cut tubes of, for example, steel embedded within a sidewall of reinforced portion 205 as shown in, for example, FIG. 3C. Bidirectional flow cannula 200 and/or 300 may be made by assembling reinforcement members 240 and/or 245 with support ribbon 247 and the assembly may be exposed to a reflow and/or extrusion process to cover them with the material of the used to make the outer and inner surfaces of reinforced and unreinforced portions. Proximal reinforcement member 245 provides for eight different ports 130 for first plurality of ports 231. The eight ports 130 of first plurality of ports 231 are arranged in four columns of two ports each. The four columns are separated from one another around the circumference of reinforcement member 245 by, approximately, ninety degrees. In addition, each set of ports 130 in a column may be offset along a length of proximal reinforcement member 245 from a set of ports 130 in an adjacent column so that the sets of ports 130 alternate in position along the length of proximal reinforcement member 245 as may be seen in, for example, the detailed view of FIG. 3C. Distal reinforcement member 240 provides for two ports 130 positioned approximately 180 degrees relative to one another and may be offset from ports 130 of proximal reinforcement member 240 by approximately 45 or 225 degrees as may be seen in FIG. 3C.

[000129] Unreinforced portion 260 may be configured to couple to a tapered portion of reinforced portion 205 and/or may extend from a tapered portion of reinforced portion 205. Unreinforced portion 160 and/or the tapered region of reinforced portion 205 may be configured to reside outside a patient’s body when second bidirectional flow cannula 200 is being used to provide blood or other fluids to a patient or is otherwise inserted into a vessel. Optional coupling 270 may be sized, shaped, and configured to facilitate easy grasping and/or manipulation of second bidirectional flow cannula 200 during insertion of reinforced portion 205 into a patient’s vessel and/or coupling/decoupling of unreinforced portion 160 from a tube (not shown) that may be supplying blood or other fluids to second bidirectional flow cannula 200 from, for example, an extracorporeal circulation circuit. In some embodiments, optional coupling 270 may be inserted into unreinforced portion 160 and/or retained within unreinforced portion 160 via coupling 270, which may be a friction-based coupling with a central lumen therethrough that aligns with a central lumen 215 (see FIG. 2D) of reinforced portion 105. Approximate dimensions for coupling 270 may be, for example, 0.2-0.8 inches and, in some embodiments, may be a 3/8 inch connector. [000130] FIG. 3A provides a side view, FIG. 3B provides a cross-section view along line 3B of FIG. 3A, and FIG. 3C provides a detailed view of a distal portion of a third exemplary third bidirectional flow cannula 300 having a proximal and distal side as shown. Third bidirectional flow cannula 300 is similar to second bidirectional flow cannula in that includes tip 125, first plurality 231 of ports 130, second 232 plurality of ports 130, a proximal reinforcement member 245, a distal reinforcement member 240, a unreinforced portion 160, an optional coupling 270, reinforced portion 205, support ribbon 247 that runs along a length of reinforced portion 205, with the exception of distal and proximal reinforcement members 240 and 245 (i.e., support ribbon 247 does not extend through distal and proximal reinforcement members 240 or 245). However, unlike second bidirectional flow cannula 200, third bidirectional flow cannula 300 further includes inflation line 120, balloon 110, and inflation line coupling 155. Second and/or third bidirectional flow cannula(s) 200 and/or 300 may be made using, for example, an extrusion and reflow process.

[000131] FIG. 3D provides a schematic diagram of a cutaway view of bidirectional flow cannula 300 when in position within a patient’s blood vessel, in this case, the external iliac artery and/or femoral artery 196 when balloon 110 is deflated and FIG. 3E provides a schematic diagram of a cutaway view of bidirectional flow cannula 100 when in the same position as that shown in FIG. 3D but with balloon 110 inflated. Inflation line coupling 155 is coupled to a source of inflation media 310, which is embodied in this instance as a syringe with a leur coupling. Source of inflation media 310 may hold a volume of inflation media, such as saline, contrast, diluted contrast, and/or or water that may be pushed into inflation line 120 via depressing of a plunger of source of inflation media 310 into a barrel of same. Bidirectional flow cannula 300 is coupled to an extracorporeal circulation circuit (e.g., an extracorporeal circulation machine/circuit, a cardiopulmonary bypass machine/circuit, a heart and lunch machine/circuit, and/or ECMO machine/circuit) 195 via tube 192 coupled to coupling 170 via, for example, a friction fit and/or a clamp. Tube 192 may be in fluid communication with central lumen 215. Oxygenated blood may flow from extracorporeal circulation circuit 195 via tube 192 into unreinforced portion 160 and then into reinforced portion 105 for injection into external iliac artery and/or femoral artery 196 for communication to the patient’s head and body as shown. In addition, blood may also exit ports 130 of first plurality of ports 231 to form a first port flow 334 comprising a blood flow 332 that flows toward the patient’s head and body as well as a second port flow 344 comprising a blood flow 342 via ports 130 of the second plurality of ports 232 that flows toward the patient’s head and body. When deflated as shown in FIG. 3D, a small volume of blood (represented by the thin arrow in iliac artery and/or femoral artery 196) will flow toward the cannulated limb.

[000132] Once balloon 110 is inflated as shown in FIG. 3E, it partially, or wholly, occludes external iliac artery and/or femoral artery 196, which reverses the flow direction of blood from ports 130 of the first plurality 231 of ports 130 proximal to the inflated balloon, thereby creating a flow of blood toward the cannulated limb as shown. In particular, blood may also exit ports 130 of the first plurality of ports 231 to form first port flow 334 comprising a blood flow 332 that flows away from the patient’s head and body toward the cannulated limb as well as a second port flow 344 comprising a blood flow 342 via ports 130 of second plurality of ports 232 that flows toward the patient’s head and body.

[000133] FIGs. 4A-4F are side views of balloons 110 of different shapes that, by way of example and not limitation, circumferentially surround main canula tube 105 with an exterior wall of reinforced portion 105 being illustrated with a solid line and an interior wall of reinforced portion 105 being illustrated with a dashed, or broken, line. First-sixth balloons 110A-110F may also be configured to surround another tube, such as reinforced portion 205 of second and third bidirectional flow cannulas 200 and/or 300. First-sixth balloons 110A-110F may be made from any flexible material (e.g., silicon, plastic, etc.) capable of inflating and holding air, gas, and/or liquid (e.g., saline or contrast) and deflating or releasing the air/gas/liquid held within the balloon via, for example, an inflation line like inflation line 120 (not shown). Further details regarding exemplary balloon inflation mechanisms are provided below with regard to, for example, FIGs. 5A-5I.

[000134] In particular, FIG. 4A provides a side view of an exemplary cylindrically shaped balloon 110A surrounding reinforced portion 105; FIG. 4B provides a side view of an exemplary oval-shaped balloon 110B surrounding reinforced portion 105; FIG. 4C provides a side view of an exemplary rounded square-shaped balloon 110C that surrounds reinforced portion 105; FIG. 4D provides a side view of an exemplary triangularly shaped balloon 110D that surrounds reinforced portion 105; FIG. 4E provides a side view of an exemplary spherically shaped balloon 110E that surrounds reinforced portion 105; and FIG. 4F provides a side view of an exemplary rhomboidshaped balloon 11 OF that surrounds reinforced portion 105.

[000135] FIGs. 4G-4O provide cross sections of bidirectional flow cannulas like bidirectional flow cannulas 100 and/or 300 that include balloons 110 of various shapes and sizes. The cross-sections are taken in a direction perpendicular to reinforced portion 105 or 205 through an approximate center of balloon 110. In particular, FIG. 4G provides a cross section of substantially round, or circular, balloon 110 such as cylindrical balloon 110A, oval-shaped balloon 110B and/or spherically-shaped balloon 110E that surround reinforced portion 105. FIG. 4H shows a cross-section of a substantially square-shaped balloon 11 OH that surrounds reinforced portion 105 or 205. FIG. 4I shows a cross-section of a substantially hexagonal balloon 1101 that surrounds reinforced portion 105205. FIG. 4J shows a cross-section of a substantially ovoid balloon 110 J that surrounds reinforced portion 105 or 205. FIG. 4K shows a cross-section of a substantially pentagonal balloon 11 OK that surrounds reinforced portion 105 or 205. FIG. 4L shows a cross-section of a substantially rhomboid balloon 110L that surrounds reinforced portion 105 or 205. FIG. 4M shows a cross-section of a substantially rounded-rectangular balloon 110M that surrounds reinforced portion 105 or 205. FIG. 4N shows a cross-section of a substantially rounded square balloon 110N that surrounds reinforced portion 105 or 205. FIG. 40 shows a cross-section of a substantially triangular balloon 110O that surrounds reinforced portion 105 or 205.

[000136] Each of the differently shaped balloons 100 shown in FIGs. 4A-4O may operate differently when positioned within a patient’s blood vessel. For example, spherical or ovoid shapes of balloons 110B and 110E as in FIGs. 4B and 4E, respectively, may be configured to partially and/or fully occlude the vessel when inflated and positioned within the vessel. Alternatively, a shape of balloon 110A, 110C, 110D, 110F, 110G, 110H, 110J, 110L, 110M, 110N, and/or 1000 may fully or partially occlude the vessel. When the vessel is partially occluded, some bodily fluid (e.g., blood) flows past the balloon toward, for example, a limb downstream of, for example, bidirectional flow cannula 100 or 300, or reinforced portion 105 or 205, which in the case of positioning bidirectional flow cannula 100 or 200 within a blood vessel may assist with facilitating enough blood flow to a limb in which the vessel is present (e.g., a leg or arm) to prevent ischemia of the limb. In some embodiments, a shape and/or size of a balloon 110 may be configured to, for example, disrupt the Bernoulli effect within the vessel (i.e., as velocity increases from the main lumen of the cannula, the pressure decreases). This may cause the blood in the limb to be pulled from a region of relatively high blood pressure to region of relatively low blood pressure, towards the head and body, which may allow a dedicated source of fluid, or blood, toward the limb to be established.

[000137] In some embodiments, one or more of the balloons shown in FIGs. 4A- 40 (e.g., balloon 110B, 110D, 110F, 110G, 110H, 110J, 110L, 110M, and/or 110O) may be configured to provide less apposition to a vessel wall in which a corresponding bidirectional flow cannula is resident when fully or partially occluded. This may act to, for example, decrease a likelihood of the bidirectional flow cannula and/or a balloon thereof causing, or contributing to, development of intimal hyperplasia and/or damage to the vessel wall. Additionally, or alternatively, one or more of the balloons (e.g., balloon 110A, 110B, 110C, 110M, and/or 110N), shown in FIGs. 4A-4O may be configured to distribute any force encountered by a vessel in which a corresponding bidirectional flow cannula is resident over a relatively (compared with, for example, a spherically shaped balloon) larger surface area, which may decrease a likelihood of vessel damage. Additionally, or alternatively, one or more of the balloons shown in FIGs. 4A-4O may be configured to reduce a likelihood of occluding branching blood vessels proximate to a location of the bidirectional flow cannula. This may be accomplished by, for example, having a balloon with a relatively small surface area (e.g., balloon 110E or 110C) and/or a balloon that may not fully occlude the vessel (e.g., balloon 110D, 110F, 110G, 110H, 110J, 110L, 110M, and/or 1100). Additionally, or alternatively, one or more of the balloons (e.g., balloon 110B, 110D, 110F, 110H, 110K, 110L, 110M, and/or 1100) shown in FIGs. 4A-4O may be configured to improve blood flow mechanics around and/or past the balloon, which may, for example, decrease a likelihood of a thromboembolic event.

[000138] Additionally, or alternatively, one or more of the balloons (e.g., balloon 110A, 110C, 110M and/or 11 ON) shown in FIGs. 4A-4O may be configured to provide support to a vessel wall in which a corresponding bidirectional flow cannula is resident. This support may assist with prevention of a blockage of one or more of ports 130 in the event of, for example, vessel spasm and/or collapse. Additionally, or alternatively, one or more of the balloons (e.g., balloon 110A, 11 OB, 110C, 110M, and/or 11 ON), shown in FIGs. 4A-4O may be configured to support to the bidirectional flow cannula and/or hold it in place so that it remains in place during use.

[000139] In some embodiments, one or more of the balloons shown in FIGs. 4A- 40 (e.g., balloon 110B, 110D, 110F, 110G, 110H, 110J, 110L, 110M, and/or 110O) may be configured to have less surface area of the balloon in contact with a vessel wall in which a corresponding bidirectional flow cannula is resident when fully or partially occluded. This may act to, for example, decrease a likelihood of the bidirectional flow cannula and/or a balloon thereof causing, or contributing to, development of intimal hyperplasia, stress to the vessel wall, and/or damage to the vessel wall.

[000140] FIGs. 5A-5I are cross sections of various reinforced portion 505 and suction line/suction lumen 525 configurations that may be used with a bidirectional flow cannula such as bidirectional flow cannulas 100 and/or 300 instead of the reinforced portion 105 and inflation line 120 combination shown in FIGs. 1A-1 F and/or reinforced portion 205 and inflation line 120 combination shown in FIGs. 3A and 3B. The cross-sections of FIGs. 5A-5I may be taken at any point along a length of the reinforced portion 105 or 205 between tapered region 104 and the balloon 110. Each of FIGs. 5A-5I shows a sidewall of a reinforced portion 505 that has a main lumen 185 positioned inside the sidewall defining reinforced portion 505. Main lumens 185 may be configured to allow for the flow of fluids (e.g., blood) therethrough. Each of FIGs. 5A-5I also show different configurations for an inflation line 520 that includes an inflation line lumen 525 configured to facilitate a flow of air, gas, and/or liquid into and/or out of balloon 110 (not shown) to facilitate inflation and deflation of balloon 110. Inflation line lumens 525 may be configured with interior diameters ranging from, for example, 0.5-5mm and exterior diameters ranging from, for example, 0.7-7mm.

[000141] FIG. 5A provides a vertical cross-section view of an exemplary reinforced portion 505A of a bidirectional flow cannula that includes a crescent shaped inflation line 120A that includes a corresponding crescent shaped inflation line lumen 525A positioned therein. Inflation line 120A extends from an exterior surface of a reinforced portion 505A and includes a main lumen 185A.

[000142] FIG. 5B shows another exemplary reinforced portion 505B that includes a second inflation line lumen 525B that is resident within the sidewall of reinforced portion 505B so that reinforced portion 505B surrounds both inflation line lumen 525B and main lumen 185B. In another example, FIG. 5C shows a cross-section view of an exemplary reinforced portion 505C that is similar to reinforced portion 505B except that a relative thickness of reinforced portion 505C is larger (i.e., thicker) than the thickness of reinforced portion 505B. Inflation line lumens 525B and 525C have an approximately circular cross-section.

[000143] FIGs. 5D-5I provide cross-section views of exemplary inflation lines that have a non-circular cross section. In particular, FIG. 5D shows a cross-section view of an exemplary reinforced portion 505D, which has a substantially circular outer circumference and a crescent-shaped shaped inflation line lumen 525D positioned with a sidewall of reinforced portion 505D proximate to a fourth main lumen 185D as shown. FIG. 5E shows a cross-section view of an exemplary reinforced portion 505E, which has a substantially circular outer circumference with an oval-shaped shaped inflation line lumen 525E positioned within a sidewall of reinforced portion 505E proximate to a fifth main lumen 185E as shown. FIG. 5F shows a cross-section view of an exemplary reinforced portion 505F with a main lumen 185F positioned in an approximate center of reinforced portion 505F and an oval-shaped shaped inflation line 120F positioned on an outer surface with a correspondingly oval-shaped inflation line lumen 525F positioned therein. Inflation line 520F is positioned on an exterior surface of reinforced portion 505F as shown and may be affixed thereto in a manner similar to how inflation line 120 is affixed to reinforced portion 105 as shown and described above with regard to, for example, FIGs. 1A-1 F.

[000144] FIG. 5G is a cross-section view of an exemplary reinforced portion 505G with a main lumen 185G positioned in an approximate center of reinforced portion 505G and an oval-shaped shaped inflation line 520G with a correspondingly ovalshaped inflation line lumen 525G positioned therein. The embodiment of FIG. 5G also includes two inflation line lumen supports 530A positioned on either side (left and right as shown in FIG. 5G) of inflation line 520G between a lower (as oriented in FIG. 5G) exterior surface of inflation line 520G and an upper (as oriented in FIG. 5G) exterior surface of reinforced portion 505G. Supports 530A may be configured to support inflation line 520G so that it, for example, does not move (e.g., left, or right) independently of reinforced portion 505G, provide a location for the collection of clotted blood, and/or cause irritation when reinforced portion 505G is in a patient’s vessel. In some embodiments, supports 530, such as support 530B shown in FIG. 5H may be configured to smooth a vertical cross-sectional profile so that an outer profile of an inflation line 520H blends into an outer profile of a reinforced portion 505H as shown in FIG. 5H. FIG. 5H also shows a main lumen 185H positioned within reinforced portion 505H and an inflation line lumen 525H positioned within inflation line 520H. FIG. 5I is a cross section of a main line cannula 505I and a circular inflation line 520I with a corresponding inflation line lumen 525I positioned therein. Inflation line 520I is positioned on an exterior surface of a reinforced portion 1051 with a main lumen 1851 and is supported on either side by supports 530C, which are similar to supports 530A and 530B with the exception that their shape is adjusted to accommodate the different shape of inflation line 1201.

[000145] On some occasions, a position and/or orientation of an inflation line and/or inflation line lumen may serve as a marker visible to a clinician that helps them see the inflation line and/or inflation line lumen and/or identify an orientation of a bidirectional flow cannula, and corresponding ports (e.g., ports 130), during insertion and/or use the bidirectional flow cannula.

[000146] FIGs. 6A1-6H provide illustrations for various port 130 shapes and arrangements within reinforced portion 105, 205, and/or 505A-505I. Ports 130 may be made via any appropriate means including, but not limited to, punching, scoring, cutting, and/or molding and may be reinforced with, for example, a reinforcement member such as the reinforcement members disclosed herein. Ports 130 may be of any appropriate size and/or shape (e.g., circular, oval, triangle, or square) or combination thereof. In some embodiments, one or more ports 130 on a proximal side of balloon 110 may be smaller than one or more ports 130 on a distal side of balloon 110 and vice versa. In some embodiments, a quantity of ports (e.g., 2-16) on a proximal side of balloon 110 may be smaller than a quantity of ports 130 on a distal side of balloon 110 (e.g., 1-15). Alternatively, a quantity of ports (e.g., 2-16) on a distal side of balloon 110 may be smaller than a quantity of ports 130 on a proximal side of balloon 110 (e.g., 1-15).

[000147] In some embodiments, ports 130 may be shaped, sized, and/or configured to, for example, direct exiting blood flow in a particular direction, reduce a likelihood of clotting, and/or control a speed and/or velocity of blood flowing out of a port 130 and/or tip 125. Ports 130 may be of a variety of shapes and/or may be arranged any orientation/angle; some of which are shown in FIG. 6A1-6H and FIGs. 7A-7E. FIG. 6A1 provides a top view of a portion of first or second reinforced portion 105A or 205A that includes a port 130A with an approximately circular shape and FIG. 6A2 is a cross-section view of first or second reinforced portion 105A or 205A taken along bisecting line A-A. On some occasions, ports 130 may be positioned circumferentially around first or second reinforced portion 105A of 205B and/or on a top and a bottom of first or second reinforced portion 105A or 205B as shown in FIG. 6A2, which shows a first port 130A positioned on a top of first or second reinforced portion 105A or 205A (as oriented in FIG. 6A2) and a second port 130A positioned on a bottom of first or second reinforced portion 105A or 205A (as oriented in FIG. 6A2). [000148] FIGs. 6B-6D provide top views of a portion of first or second reinforced portion 105 or 205 that include ports 130 of different shapes, wherein FIG. 6B is a top view of a portion of first or second reinforced portion 105B or 205B that includes an oval-shaped port 130B; FIG. 6C is a top view of a portion of first or second reinforced portion 105C or 205C with a triangularly-shaped port 130C; and FIG. 6D is a top view of a portion of first or second reinforced portion 105D or 205D with a square-shaped port 130D. It is noted that a bidirectional flow cannula may use any one or more of these shapes (or other, different, shapes not shown in FIGs. 6A-6D) for ports 130 and that they may be used in combination (e.g., circular and triangular; square and oval, etc.) within the same first or second reinforced portion 105 or 205.

[000149] FIGs. 6E-6H provide top views of exemplary portions of first or second reinforced portion 105 or 205 that each include an array of ports 130 arranged in different configurations. For ease of illustration, the port shape shown in FIGs. 6E-6H is that of a circular port like circular port 130A of FIG. 6A1 but it is to be understood that a shape of a port 130 shown in the arrays of FIGs. 6E-6H may be of any shape including, but not limited to, the oval, triangular, and square shapes shown in FIGs. 6B-6D. In particular, FIG. 6E is a top view of a portion of first or second reinforced portion 105E or 205E that includes an array of two ports 130 arranged in a diagonal and linear fashion; FIG. 6F is a top view of a portion of first or second reinforced portion 105F or 205F that includes an array of three ports 130 arranged in a triangular fashion; FIG. 6G is a top view of first or second reinforced portion 105G or 205G that includes an array of three ports 130 arranged in a linear fashion along a length offirst or second reinforced portion 105G or 205G; FIG. 6H is a top view of a portion of first or second reinforced portion 105H or 205H that includes an array of five ports 130 arranged in a “X”-like fashion. In some embodiments, a bidirectional flow cannula may include different arrays (e.g., quantity of ports and/or arrangement of ports within first or second reinforced portion 105 or 205). For example, a first side (e.g., a top or bottom) of a bidirectional flow cannula, first reinforced portion 105 and/or second reinforced portion 205 may include the array of three ports 130 shown in FIG. 6F on a proximal side and a single port 130 on a distal side of balloon 110.

[000150] On some occasions, ports 130 may be cut and/or manufactured into the body of reinforced portion 105 at different angles and/or orientations in order to, for example, direct exiting blood flow in a particular direction, reduce a likelihood of clotting, and/or control a speed and/or velocity of blood flowing out of a port 130. On some occasions, an angle or orientation of edges of a port 130 may be the same and, at other times, a port 130 may have two or more edges that are oriented and/or cut at different angles relative to one another. For example, FIGs. 7A-5E provide crosssection views of a portion of exemplary first or second reinforced portion 105M/205M, 105N/205N, 1050/2050, 105P/205P, and 105Q/205Q, respectively, each with a pair of ports 130 disposed therein.

[000151] More particularly, FIG. 7A provides a cross-section view of a portion of first or second reinforced portion 105M or 205M with a first pair of ports 130A1 and 130A2 that have a right and left side (as oriented in the figure) that are oriented at an approximate right angle (e.g., approximately 90 degrees) relative to the exterior surface of first or second reinforced portion 105M or 205M as shown. FIG. 7A also shows a central, or main blood flow 710, that travels through a lumen of first or second reinforced portion 105M or 205M toward a patient’s heart and also shows two secondary blood flows 720 that exit from the first pair of ports 130BA1 and 130A2 and travel toward the patient’s limb.

[000152] FIG. 7B depicts a cross-section view of a portion of an exemplary first or second reinforced portion 105N or 205N with a second pair of ports 130B oriented at different angles relative to one another wherein a top second port 130B1 has a left and a right (as oriented in the figure) side that are approximately parallel to one another and at an angle of approximately 30-70 degrees relative to the interior surface of first or second reinforced portion 105N or 205N. Bottom second port 130B2 has a left and a right (as oriented in the figure) side that are oriented approximately parallel to one another and at an angle of approximately 110-160 degrees relative to an exterior surface of first or second reinforced portion 105N or 205N. FIG. 7B also shows primary blood flow 710 traveling through a main lumen of first or second reinforced portion 105N or 205N and secondary blood flows 720 from each of top second port 130B1 and bottom second port 130B2 that flow toward the cannulated limb.

[000153] FIG. 7C is a cross-section view of a portion of an exemplary first or second reinforced portion 1050 or 2050 with a third pair of ports 130C manufactured so that a top third port 130C1 has a right side (as oriented in the figure) that is oriented at an angle of approximately 30-70 degrees relative to the interior surface of exemplary reinforced portion 1050 and a left side that is oriented at an angle of approximately 110-160 degrees relative to the interior surface of exemplary first or second reinforced portion 1050 or 2050 in a point-like configuration so that an inner diameter of top third port 130C1 is smaller than an outer diameter of top third port 130C1 as shown. Bottom third port 130C2 is a mirror image of top third port 130C1 and has a right side (as oriented in the figure) that is oriented at an angle of approximately 110-160 degrees relative to the exterior surface of exemplary first or second reinforced portion 1050 or 2050 and a left side that is oriented at an angle of approximately 30-70 degrees relative to the exterior surface of exemplary first or second reinforced portion 1050 or 2050 in a point-like configuration so that an inner diameter of bottom third ports 130C2 is smaller than an outer diameter of bottom third ports 130C2 as shown. FIG. 7C also shows primary blood flow 710 traveling through a main lumen of first or second reinforced portion 1050 or 2050 and secondary blood flows 720 from each of top third port 130C1 and bottom third port 130C2 that flow toward the cannulated limb.

[000154] FIG. 7D is a cross-section view of a portion of an first or second exemplary reinforced portion 105P or 205P with a fourth pair of ports 130D arranged and manufactured so that a top fourth port 130D1 has a right side (as oriented in the figure) that is oriented at an angle of approximately 110-160 degrees relative to the interior surface of exemplary first or second reinforced portion 105P or 205P and a left side that is oriented at an angle of approximately 30-70 degrees relative to the interior surface of exemplary first or second reinforced portion 105P or 205P in a point-like configuration so that an inner diameter of top fourth port 130D1 is larger than an outer diameter of top fourth port 130D1 as shown. Bottom fourth port 130D2 is a mirror image of top fourth port 130D1 and has a right side (as oriented in the figure) that is oriented at an angle of approximately 30-70 degrees relative to the exterior surface of exemplary first or second reinforced portion 105P or 205P and a left side that is oriented at an angle of approximately 110-160 degrees relative to the exterior surface of exemplary first or second reinforced portion 105P or 205P in a point-like configuration so that an inner diameter of bottom fourth port 130D2 is larger than an outer diameter of bottom fourth port 130D2 as shown. FIG. 7D also shows primary blood flow 710 traveling through a main lumen of first or second reinforced portion 105P or 205P and secondary blood flows 720 from each of top fourth port 130D1 and bottom fourth port 130D2 flow toward cannulated limb.

[000155] FIG. 7E is a cross-section view of a portion of an exemplary first or second reinforced portion 105Q or 205Q with a fifth pair of ports 130E manufactured and arranged at different angles to one another wherein a top fifth port 130E1 has a left and a right (as oriented in the figure) side that are manufactured at angles that are approximately parallel to one another and are of approximately 110-160 degrees relative to the interior surface of exemplary reinforced portion 105Q. Bottom fifth port 130E2 has a left and a right (as oriented in the figure) side that are manufactured at angles that are approximately parallel to one another and are of approximately 30-80 degrees relative to the exterior surface of exemplary reinforced portion 105Q. FIG. 7E also shows primary blood flow 710 traveling through a main lumen of first or second reinforced portion 105Q or 205Q and secondary blood flows 720 from each of top fifth port 130E1 and bottom fifth port 130E2 that flow toward the cannulated limb.

[000156] FIG. 8 provides a side view of a bidirectional flow cannula 800 with an unreinforced portion 805 that includes a balloon 810, a tip 825, a plurality of ports 830, a narrow segment 810 with a thicker sidewall than a proximate portion of reinforced portion 805 so that reinforced portion 805 has a reduced inner diameter relative to the inner diameter of the remainder of reinforced portion 805 within narrow segment 810. Narrow segment 810 includes two ports 130 positioned on the top and bottom (as oriented in FIG. 8) of narrow segment 810. Narrow segment 810 may be configured to, for example, disrupt laminar blood flow through one or more ports 830 and/or tip 825. Additionally, or alternatively, a configuration of narrow segment 810 may assist with provision of blood flowing toward the limb region by, for example, causing turbulent flow near ports 830, increasing a velocity of the flow of blood through port 830, and/or decreasing a velocity of blood flowing through tip 825. Balloon 810, tip 825, and plurality of ports 830 may be similar to balloon 110, tip 125, and ports 130 as discussed herein.

[000157] On some occasions, the bidirectional flow cannulas disclosed herein may be configured for cooperation with a cannula introducer (also referred to herein as an “introducer”) configured to be inserted through the main lumen of a reinforced portion and assist with insertion of the bidirectional flow cannula into a blood vessel and placement therein. Once the bidirectional flow cannula is in a desired position within the blood vessel via manipulation of the introducer, it is extracted from the bidirectional flow cannula so that blood may flow through the main lumen of the bidirectional flow cannula while it is seated within the blood vessel. FIG. 9A is a side view of a first exemplary bidirectional flow cannula introducer 901 that includes a tip 920, a body 910, and a handle 980. FIG. 9B is a side view of a second exemplary bidirectional flow cannula introducer 902 that includes a tip 922, a body 912, and a handle 981 that, in some embodiments, may include a hemostasis cap 982 that may be configured to fit over a corresponding coupling of one or more of the cannulas disclosed herein like coupling 170 or 270. FIG. 9C1 provides a vertical cross-section view of an introducer with a feedback mechanism 903. Introducer 903 includes a tip 924, a body 914, a tapered, or thin, portion 916 and a top and bottom channel 925. FIG. 9C2 is a cross section view of introducer 903 taken at line A-A showing an exemplary placement of channels 925 within the sidewalls of introducer 903. Further details regarding how introducer 903 may be used are provided below with regard to the discussion of FIG. 10D.

[000158] Introducer(s) 901 , 902, and/or 903 may be configured to assist with the insertion, or introduction, of a bidirectional flow cannula such as the bidirectional flow cannulas disclosed herein through a surgical opening in a patient (typically the patient’s leg (e.g., femoral artery or vein) or arm) and into a blood vessel of the patient. Introducers 901 , 902, and/or 903 may be configured to be flexible but, may be more rigid than the bidirectional flow cannula they are introducing to the vessel so that, for example, the bidirectional flow cannula/introducer system may be maneuvered through tissue and into the target blood vessel without bending, kinking, or twisting. Introducers 901 , 902, and/or 903 may provide feedback to the user (tactile, signal with blood flow, etc.) regarding the position of the bidirectional flow cannula in the vessel, such as when the proximal ports are inserted into the vessel. Once a system including introducer 901 , 902, or 902 and a bidirectional flow cannula such as the bidirectional flow cannulas disclosed herein are in position within the patient’s vessel, introducer 901 , 902, or 903 may be extracted, or otherwise removed, from the central lumen of the bidirectional flow cannula thereby opening a central lumen of the bidirectional flow cannula and readying it for use (e.g., coupling to an extracorporeal circulation circuit). [000159] FIGs. 10A-10F provide horizontal (i.e., parallel to a length of bidirectional flow cannula 100 or 300) cross-section views of exemplary systems 1011 , 1012, 1013, 1014, 1015, and 1016, respectively, that include a bidirectional flow cannulas like the bidirectional flow cannulas disclosed herein and introducer 901 , 902, or 903. In particular, FIG. 10A provides a cross-section view of a first introducer/canula system 1011 that includes a bidirectional flow cannula with a tapered tip 1001 and introducer 901 , 902, or 903. Bidirectional flow cannula with a tapered tip 1001 is similar to bidirectional flow cannulas 100 and 300 and includes balloon 110 and a reinforced portion 105 or 205 that has a tapered tip, or end, 1010 positioned proximate to introducer tip 920, 922, or 924. Tapered tip 1010 may be configured so that an outer profile, or diameter, of the first introducer/canula system 1011 gradually increases in size along its length, which may, for example, make insertion of the first introducer/canula system 1011 into a vessel easier, reduce trauma to tissues caused by insertion of the first introducer/canula system 1011 into the blood vessel, and/or may prevent the tip of bidirectional flow cannula 1001 from pulling away, or otherwise separating, from introducer 901 , 902, or 903 upon, for example, insertion of first introducer/canula system 1011 into the body (e.g., through skin, muscle, and facia) and/or a blood vessel.

[000160] FIG. 10B provides a cross-section view of a second introducer/canula system 1012 that includes a bidirectional flow cannula with a narrowed tip 1002 and an introducer 901 , 902, or 903. Bidirectional flow cannula with a narrowed tip 1002 is similar to first and third bidirectional flow cannula 100 and 300 and includes balloon 110 and reinforced portion 105 or 205 that has a narrowed tip, or end, 1015 positioned proximate to introducer tip 920, 922, or 924. Narrowed tip 1015 may be configured so that an outer profile of the first introducer/canula system 1012 gradually increases in size along its length, which may, for example, make insertion of the second introducer/canula system 1012 easier, reduce trauma to tissues caused by insertion of the second introducer/canula system 1012 into the blood vessel and/or surrounding tissue, and/or may prevent narrow tip 1015 from pulling away, or otherwise separating, from introducer 901 , 902, or 903 upon, for example, insertion of second introducer/canula system 1011 into the body (e.g., through skin, muscle, and facia) and/or a blood vessel.

[000161] FIG. 10C provides a cross-section view of a third introducer/canula system 1013 that includes a bidirectional flow cannula with a tapered and narrowed tip 1003 and an introducer 901 , 902, or 903. Bidirectional flow cannula with a tapered and narrowed tip 1020 is similar to first and third bidirectional flow cannulas 100 and 300 and includes balloon 110 and reinforced portion 105 or 205 that has a narrowed tip, or end, 1015 positioned proximate to introducer tip 920, 922, or 924. Tapered and narrowed tip 1020 may be configured so that an outer profile of the third introducer/canula system 1013 gradually increases in size along its length, which may make insertion of the third introducer/canula system 1013 easier, reduce trauma to tissues caused by insertion of the third introducer/canula system 1013 into the blood vessel, and/or may prevent the tip of first bidirectional flow cannula 1003 from pulling away, or otherwise separating, from introducer 901 , 902, or 903 upon, for example, insertion of third introducer/canula system 1013 into the body (e.g., through skin, muscle, and facia) and/or a blood vessel.

[000162] FIG. 10D provides a cross-section view of a fourth introducer/canula system 1014 that includes a bidirectional flow cannula, such as bidirectional flow cannula 100, 300, 1001 , 1002, or 1003 and introducer with a feedback mechanism 903 positioned within blood vessel 840. Introducer with a feedback mechanism 903 may be configured in a manner similar to introducer 901 or 902 with the exception that it includes a mechanism that provides feedback to an operator (e.g., surgeon) who is inserting fourth introducer/canula system 1014 into a blood vessel 840 that he/she/they have correctly placed fourth introducer/canula system 1014 in blood vessel 840. In the embodiment shown in FIG. 10D, the feedback mechanism is a channel 925 that carries blood that enters ports 130 and travels upward in channel 925 along a length of introducer 903 so that it may be observed/seen as feedback to the operator that the fourth introducer/canula system 1014 has been successfully placed within vessel 840.

[000163] FIG. 10E provides a cross-section view of a fifth introducer/canula system 1015 that includes a bidirectional flow cannula, such as bidirectional flow cannula 100, 300, 1001 , 1002, or 1003 and an introducer with a feedback mechanism in the form of tapered proximal end 1055 that is positioned within blood vessel 840. Introducer with the tapered proximal end feedback mechanism 1055 may be configured in a manner similar to introducer 901 or 902 with the exception that it includes a mechanism that provides feedback to an operator (e.g., surgeon) who is placing fifth introducer/canula system 1015 in blood vessel 840 of the patient. The feedback mechanism of introducer 1055 is provided by a tapered proximal end 1030 of the introducer that provides a space, or opening, between an inner diameter of bidirectional flow cannula 100, 300, 1001 , 1002, or 1003 and tapered proximal end 1030. This opening (along the length of fifth introducer/canula system 1015) provides a space for blood that enters ports 130 travel up the space that exists between first bidirectional flow cannula 100 4 and introducer 1055 along the length of introducer 1055 so that it may be observed as feedback to the operator that the fifth introducer/canula system 1015 has been successfully placed within vessel 840.

[000164] FIG. 10F provides a cross-section view of a sixth introducer/canula system 1016 that includes a bidirectional flow cannula, such as first bidirectional flow cannula 100, 1001 , 1002, or 1003 and an introducer 1060 with a narrow FEP, or support section. Narrow FEP section 1035 may, in some instances, disturb a flow of blood entering ports 130 and/or flowing through first bidirectional flow cannula 100 that may facilitate delivery of blood to a cannulated limb.

[000165] FIGs. 11A and 11 B are illustrations of a bidirectional flow cannula 1105 inserted in blood vessel 840 and a bleeding mitigation mechanism 1110 used at, or near, the bidirectional flow cannula insertion site. In particular FIG. 11A is an illustration of a system for mitigating bleeding from a bidirectional flow cannula insertion site that includes a bidirectional flow cannula like bidirectional flow cannulas 100, 1001 , 1002, or 1003 and a bleeding mitigation mechanism 1110 positioned outside vessel 840 at the insertion site that acts as a physical barrier for blood escaping from vessel 840. Bleeding mitigation mechanism may be, for example, a patch, bandage, or material adhered to the vessel at the insertion site. Exemplary bleeding mitigation mechanisms 1110 include but are not limited to fabric or polymer materials applied to vessel 840 at the insertion site.

[000166] FIG. 11 B1 is an illustration of an exemplary bidirectional flow cannula 1100 that includes a bleeding mitigation mechanism 1120 in the form of a skirt that, once positioned within vessel 840 (as shown in FIG. 11 B2) may flare outwards to occlude any portions of the insertion cite not occluded by bidirectional flow cannula 1150 thereby providing a physical barrier for blood that may otherwise escape from the insertion site and/or vessel 840.

[000167] On some occasions, a skirt and/or a flared device may be used with one or more of the bidirectional flow cannulas disclosed herein. The skirt and/or flared device may be configured to, for example, approximate one or more features (e.g., flexibility, shape, and/or size) of a vessel and/or vessel wall which may, at times, enable a backflow of blood toward the limb. The skirts may, or may not, be used with a balloon such as balloon 110. Skirts, or flared devices, used with bidirectional flow cannulas may be made from any flexible material (e.g., silicon, fabric, a thin polymer sheet, or plastic) and may be attached to one end of the exterior of, for example, first or second reinforced portion 105 or 205. FIGs. 12A-9C provide side views of a few exemplary skirts, or flared devices, 1220 that may be included with and/or attached to a bidirectional flow cannula like bidirectional flow cannulas 100, 200, 300, 1001 , 1002, or 1003 and/or a reinforced portion like first or second reinforced portion 105 or 205. In particular, FIG. 12A is a side view of a first skirted bidirectional flow canula 1201A, positioned within a blood vessel 840, and oriented so that a portion of blood vessel 840 extending toward the head or body of a patient is on the left of FIG. 12A and a portion of blood vessel 840 extending toward the limb (e.g., leg or arm) is on the right side of FIG. 12A. First skirted bidirectional flow canula 1201A includes reinforced portion 105 with a first skirt 1220A affixed thereto and positioned proximate to a port 130. Port 130 may be configured to facilitate secondary blood flow 720 toward the patient’s limb region by allowing blood to flow out of first or second reinforced portion 105 or 205 through port 130 and be directed toward the limb as shown in FIG. 12A.

[000168] Once in position within blood vessel 840, first skirt 1220A may be configured to flare out, or open, as shown in FIG. 12A to partially, or fully, occlude blood vessel 840 so that blood exiting port 130 is forced to travel down intoward the limb. On some occasions, negative pressure created within blood vessel 840 may assist with the deploying, opening, or flaring of first skirt 1220A into an open configuration as shown in FIG. 12A. The negative pressure within blood vessel 840 may be caused by, for example, the Bernoulli effect and/or greater blood pressure in the vessel proximal to the body that may be caused by, for example, insertion of first skirted bidirectional flow canula 1201A into vessel 840. The back-pressure assistance provided by first skirt 1220A may assist with, for example, pushing of secondary blood flow 720 in a reverse direction (as oriented in FIG. 12A) toward the limb through, for example, a space 1280 between first or second reinforced portion 105 or 205 and an interior surface of vessel 840 as shown in FIG. 12A while the primary blood flow 710 passes through first or second reinforced portion 105 or 205 to the patient’s head and body.

[000169] Second skirted bidirectional flow canula 1201 B of FIG. 12B is similar to first skirted bidirectional flow canula 1201A except that it includes a second skirt 1220B, that is oriented in a different direction (e.g., 180 degrees) than first skirt 1220A as shown in FIG. 12B. Third skirted bidirectional flow canula 1201C of FIG. 12C is similar to first and second skirted bidirectional flow cannulas 1201 A and 1201 B except that it includes a third skirt 1220C that includes a first component, or skirt, that is oriented in a manner similar to first skirt 1220A and a second component, or skirt, that is oriented in a manner similar to second skirt 1220B as shown in FIG. 12C. Bidirectional flow cannula 1201 C may be configured to take advantage of negative pressure within the vessel caused by blood flow to expand in the proximal and distal directions as shown to, for example, isolate one or more proximal ports 130.

[000170] The configurations of FIGs. 12B and 12C assist with creating secondary blood flow 720 back toward the patient’s limb while the primary blood flow 710 passes through unreinforced and reinforced portions 160/260 and 105/205 to the patient’s head and body. Possible advantages to using skirted bidirectional flow cannulas 1201A, 1201 B, and/or 1201C are that the skirts provide very gentle apposition to the vessel wall, so it occludes vessel 840 using the suction/pressure within vessel 840 to create the vessel occlusion without exerting much pressure on the vessel wall. This may serve to reduce a likelihood of damage to the vessel wall caused by bidirectional flow cannulas 1201A, 1201 B, or 1201C when in use. Additionally, or alternatively, an advantage of using skirted bidirectional flow cannulas 1201A, 1201 B, and/or 1201C may be the creation of a low profile and soft feature (relative to, for example, a balloon) that effectively ‘self-inflates’ to create isolation of the proximal ports using the pressure/blood flow in the vessel which may, for example, decrease a likelihood of damage when inserting/removing skirted bidirectional flow cannulas 1201 A, 1201 B, and/or 1201C from the vessel.

[000171] In some embodiments, full occlusion of a vessel in which a bidirectional flow cannula such as the bidirectional flow cannulas disclosed herein may noy be desired so that, for example, blood may flow past an occluding device such as balloon 110 toward a patient’s limb in addition to, or in leu of, a secondary blood flow 720 emanating from a port 130 positioned within second region 102 and/or on a distal side of balloon 110. Partial occlusion of a vessel like vessel 840 may be accomplished via, for example, partial inflation of an occluding device and/or use of an occluding device that may not sufficiently expand to fully occlude the vessel (e.g., a balloon with an inflated outer diameter smaller than an inner diameter of a vessel into which a bidirectional flow cannula is inserted).

[000172] A size of an inflatable occluding device may be set, maintained, regulated and/or changed via, for example, measuring the air and/or liquid pressure within the inflatable occluding device using, for example, a gauge so that the inflatable occluding device is inflated and/or maintained at a desired air pressure. Additionally, or alternatively, a supply of air and/or liquid provided to the inflatable occluding device may be measured so that the amount of air and/or liquid provided to the inflatable occluding device corresponds with a desired level of inflation of the inflatable occluding device, which may, in turn, correspond to the size of the inflatable occluding device when placed within the vessel and/or a degree of occlusion of the vessel achieved via inflating the inflatable occluding device.

[000173] The occluding devices and/or balloons disclosed herein may be configured to completely and/or partially occlude a vessel (e.g., blood vessel) into which they are placed. Full occlusion of the vessel may be achieved via, for example, inflating the occluding device so that it comes into contact with (e.g., touches) and/or presses against an interior diameter of the vessel thereby blocking a flow of liquid (e.g., blood) through the vessel. Partial occlusion of the of the vessel may be achieved via, for example, partially inflating an occlusion device so that it partially (e.g., 40-90%) occludes the vessel and, in these cases, the occlusion device may not come into contact with (e.g., touch) an interior diameter of the vessel. This may allow for some liquid to travel past the occlusion device and on through the vessel toward, for example, a cannulated limb.

[000174] In some instances, a size of the vessel may be known, approximated, and/or measured based on, for example, imaging data (e.g., MRI or ultrasound) and/or approximations correlating to a patient’s size, weight, and/or type of vessel into which the bidirectional flow cannula is inserted. When a measured and/or approximated size of a vessel is known, a desired size of the inflatable occluding device may be determined along with a volume of air and/or liquid that may be provided to the inflatable occluding device to achieve the desired size/diameter and/or degree of vessel occlusion when a bidirectional flow cannula including the inflatable occluding device is placed within the vessel. FIGs. 13 and 14 provide flowcharts of exemplary processes 1300 and 1400, respectively, for setting parameters for inflation of balloon, like balloon 110, of a bidirectional flow cannula so that the balloon partially occludes a vessel into which the bidirectional flow cannula is inserted. Processes 1300 and 1400 may be performed singularly or in combination by, for example, a computer or processor that may be in communication with an inflation device (e.g., pump) coupled directly, or indirectly to the balloon and/or a health care provider inserting the bidirectional flow cannula into the patient’s vessel. In process 1300, an indication of a size of a blood vessel into which a bidirectional flow cannula is to be inserted may be received (step 1305). The indication may be, for example, an image (e.g., ultrasound, X-ray, CT scan, etc.) from which an internal diameter of the vessel may be measured, deduced, and/or inferred. A desired external diameter for the balloon may then be determined (step 1310) based on, for example, a desired level of occlusion of the vessel. The determination of step 1310 may be based upon, for example, the indication received in step 1305 and/or a patient characteristic (e.g., health, width of vessel wall, etc.). A volume of inflation gas and/or liquid needed to inflate the balloon to the desired external diameter of step 1310 may then be determined (step 1315) and optionally provided to the balloon (step 1320) via, for example, metered provision of gas and/or liquid to the balloon by the inflation device. [000175] Execution of process 1400 may include receiving an indication of gas or liquid pressure within a balloon of a bidirectional flow cannula when the bidirectional flow cannula is in situ within the patient’s vessel (step 1405). The indication may be received from, for example, a pressure gauge and/or an individual who received back pressure feedback when pushing the inflation air and/or gas into the balloon. If the pressure is sufficient to achieve partial occlusion (step 1410), process 1400 may end. If the pressure is not sufficient to achieve partial occlusion (step 1410), inflation gas and/or liquid may be added or subtracted from the balloon as appropriate (step 1415). [000176] FIGs. 15A, 15B, and 15D show a process for inflation of a balloon 110 of a bidirectional flow cannula like the bidirectional flow cannulas disclosed once the bidirectional flow cannula is situated in vessel 760 and an introducer like introducer 901 has been removed from the bidirectional flow cannula. In particular, FIG. 15A shows first bidirectional flow cannula 100 with balloon completely deflated. FIG. 15B shows first bidirectional flow cannula 100 with balloon 110 partially (or fully) inflated so that it partially occludes vessel 760 as shown. FIG. 15C is a cross section of vessel 760 when it is partially occluded by balloon 110 and a pathway 1510 for a flow of blood toward, for example, a patient’s limb is positioned between an exterior surface of balloon 110 and an interior surface of vessel 760. On some occasions (e.g., when partial occlusion of vessel 760 is desired), the deployment process for inflating balloon 110 may end following the process step shown in FIGs. 15B and 15C. On other occasions (e.g., when full occlusion of vessel 760 is desired), balloon 110 may be inflated so that it fully occludes vessel 760 as shown in FIG. 15D.

[000177] FIG. 15E provides a schematic diagram of a cutaway view of bidirectional flow cannula 100 when in position within a patient’s blood vessel, in this case, the external iliac artery and/or femoral artery 196 when balloon 110 is deflated and FIG. 15F provides a schematic diagram of a cutaway view of bidirectional flow cannula 100 when in the same position as that shown in FIG. 15E but with balloon 110 inflated. Bidirectional flow cannula 100 is coupled to a cardiopulmonary bypass and/or extracorporeal circulation circuit 195 via a tube 192 coupled to coupling 170 via, for example, a friction fit and/or a clamp. Tube 192 may be in fluid communication with main lumen 185. Oxygenated blood may flow from extracorporeal circulation circuit 195 via a tube 192 into unreinforced portion 160 and then into reinforced portion 105 for injection into external iliac artery and/or femoral artery 196 for communication to the patient’s head and body. In addition, blood may also exit ports 130 to form a first port flow 134 comprising a blood flow 132 that flows toward the patient’s head and body via a port 130 on the proximal side of balloon 110 as well as a second port flow 144 comprising a blood flow 142 via ports 130 on the distal side of balloon 110 that flows toward the patient’s head and body.

[000178] Once balloon 110 is inflated as shown in FIG. 15F, it partially occludes external iliac artery and/or femoral artery 196, which reverses the flow direction of blood from ports proximal to the inflated balloon, thereby creating a flow of blood toward the cannulated limb as shown. In particular, blood may also exit ports 130 to form a first port flow 134 comprising a blood flow 132 that flows away from the patient’s head and body toward the cannulated limb via a port 130 on the proximal side of balloon 110 as well as a second port flow 144 comprising a blood flow 142 via ports 130 on the distal side of balloon 110 that flows toward the patient’s head and body.

[000179] FIG. 16 provides a block diagram of an exemplary kit that includes one or more bidirectional flow cannulas disclosed herein (e.g., bidirectional flow cannulas 100, 200, 300, 1001 , 1002, and/or 1003), source of inflation media 310, an introducer such as introducer 901 and/or 902, and an optional tube for coupling the one or more bidirectional flow cannulas to extracorporeal circulation circuit 195 via tube 192 via coupling 170.

[000180] The bidirectional flow cannulas disclosed herein may be configured for insertion into a vessel with a minimum size (e.g., internal diameter) with a range of 4- 14mm, 5-12mm, 6-10mm, or 7mm and/or may be configured to work with vessels. Approximate blood flow values for bidirectional flow cannulas disclosed herein are 85- 100% of blood flow going toward the head and body and 0-15% toward the distal limb when balloon 110 is deflated and 80-98% of blood flow going to the head and body and 2-20% toward the distal limb when balloon 110 is inflated.

Claims

CLAIM \Ne claim:

1. A bidirectional flow cannula with a central lumen, the bidirectional flow cannula comprising: an unreinforced portion with a coupling configured to couple to a source of blood flow; a reinforced portion with an open end, the reinforced portion being configured to be inserted into, and temporarily reside within, a blood vessel of a patient ‘s limb and/or groin region so that blood from the source of blood flow may be injected into the blood vessel for delivery to the patient’s body and head via the open end, wherein the reinforced portion includes a first plurality of ports and a second plurality of ports spaced apart from the first plurality of ports and positioned proximate to the open end, the first plurality of ports being configured and arranged so that a portion blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb; and a tapered portion positioned between and coupling the unreinforced portion and the reinforced portion, the central lumen extending through the unreinforced portion, the tapered portion, and the reinforced portion.

2. The bidirectional flow cannula of claim 1 , wherein the portion blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb ranges between 0% and 15% of the blood provided by the source of blood flow.

3. The bidirectional flow cannula of claim 1 or 2, wherein the first plurality of ports includes four, five, six, seven, eight, nine, or ten ports.

4. The bidirectional flow cannula of claim 1 or 2, wherein the first plurality of ports includes eight ports.

5. The bidirectional flow cannula of any of claims 1-4, wherein a quantity of ports included in the first plurality of ports is larger than a quantity of ports included in the second plurality of ports.

6. The bidirectional flow cannula of any of claims 1 -5, wherein an interior diameter of the second plurality of ports is smaller than an interior diameter of the first plurality of ports.

7. The bidirectional flow cannula of any of claims 1 -5, wherein an interior diameter of the second plurality of ports is larger than an interior diameter of the first plurality of ports.

8. The bidirectional flow cannula of any of any of claims 1 -7, wherein the bidirectional flow cannula is configured for use within a patient’s femoral artery and the blood vessel is the patient’s femoral artery.

9. The bidirectional flow cannula of any of any of claims 1 -7, wherein the bidirectional flow cannula is configured for use within a patient’s femoral vein and the blood vessel is

10. The bidirectional flow cannula of any of claims 1-9, further comprising: a first reinforcement member positioned within a sidewall of the reinforced portion and including a first plurality of holes sized, positioned, and configured, to align with the first plurality of ports.

11.The bidirectional flow cannula of any of claims 1-10, further comprising: a second reinforcement member positioned within a sidewall of the reinforced portion and including a second plurality of holes sized, positioned, and configured, to align with the second plurality of ports.

12. The bidirectional flow cannula of any of claims 1-11 , wherein a port of at least one of the first plurality of ports and the second plurality of ports is oriented at an angle that is not perpendicular to the reinforced portion.

13. The bidirectional flow cannula of any of claims 1-12, further comprising: an inflatable balloon positioned on an exterior surface of the reinforced portion between the first and second plurality of ports; and an inflation line for inflating and deflating the inflatable balloon.

14. The bidirectional flow cannula of claim 13, wherein the portion of blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb ranges between 2% and 20% of the blood provided by the source of blood flow when the balloon is inflated.

15. The bidirectional flow cannula of claim 13 or 14, wherein the inflatable balloon is configured so that it does not fully occlude a patient’s blood vessel when positioned therein and inflated.

16. The bidirectional flow cannula of any of claims 13-15, wherein the inflatable balloon is configured so that it fully occludes a patient’s blood vessel when positioned therein and inflated.

17. The bidirectional flow cannula of any of claims 13-16, wherein the inflation line is resident within a sidewall of the unreinforced and reinforced portion.

18. The bidirectional flow cannula of any of claims 13-17, wherein the inflation line is positioned within a sidewall of the reinforced portion and is not positioned within a sidewall of the unreinforced portion.

19. The bidirectional flow cannula of any of the above claims, wherein the second plurality of ports includes four, five, six, seven, eight, nine, or ten ports.

20. The bidirectional flow cannula of any of the above claims, wherein the second plurality of ports includes eight ports.

21. A method comprising using the bidirectional flow cannula of any of claims 1-20 to provide blood flow to a patient’s body, head, and cannulated limb and/or groin region with the patient is on extracorporeal circulation and the source of blood flow is an extracorporeal circulation circuit.

22. A method of claim 21 , further comprising: inserting the open end and a portion of the reinforced portion of the bidirectional flow cannula into the blood vessel in the patient’s limb and/or groin region; coupling the coupling of the unreinforced portion to the extracorporeal circulation circuit; and supplying a volume of blood to the bidirectional flow cannula via the extracorporeal circulation circuit, wherein a first volume of blood is injected into the patient’s blood vessel for delivery to the patient’s head and body via the open end of the bidirectional flow cannula, and a second volume of blood flows out of the first plurality of ports toward the patient’s cannulated limb.

23. The method of claim 21 or 22, wherein the bidirectional flow cannula includes an inflatable balloon, the method further comprising: inflating the inflatable balloon to a volume that partially occludes the patient’s blood vessel.

24. The method of claim 23, wherein the bidirectional flow cannula includes an inflatable balloon, the method further comprising: inflating the inflatable balloon to a volume that fully occludes the patient’s blood vessel.

25. The method of any of claims 21-24, further comprising: receiving an indication of a size of the blood vessel prior to insertion of the bidirectional flow cannula into the blood vessel, wherein a volume of inflation media provided to the inflatable balloon is responsive to the received indication.

26. A method comprising using the bidirectional flow cannula of any of claims 1-20 to provide extracorporeal circulation while a patient is undergoing coronary bypass surgery.

27. A method comprising using the bidirectional flow cannula of any of claims 1-20 to provide extracorporeal circulation while a patient is on life support.

28. A kit comprising: the bidirectional flow cannula of any of claims 13-20; an introducer; and an inflation media source configured to couple to the inflation line of the bidirectional flow cannula of any of claims 13-20

29. A bidirectional flow cannula with a central lumen, the bidirectional flow cannula comprising: an unreinforced portion configured to couple to a source of blood flow; a reinforced portion with an open end, the reinforced portion being configured to be inserted into, and temporarily reside within, a blood vessel of a patient ‘s limb and/or groin region so that blood from the source of blood flow may be injected into the blood vessel for delivery to the patient’s body and head via the open end, wherein the reinforced portion includes a first plurality of ports and a second plurality of ports spaced apart from the first plurality of ports and positioned proximate to the open end, the first plurality of ports being configured and arranged so that a portion blood exiting the first plurality of ports travels away from the patient’s body and head and toward the patient’s limb; an inflatable balloon extending around an exterior surface of the reinforced portion, the inflatable balloon being positioned between the first and second plurality of ports; and an inflation line in communication with the inflatable balloon and configured to facilitate inflation of the inflatable balloon.

30. A kit comprising: the bidirectional flow cannula of claim 29; an introducer and an inflation media source configured to couple to the inflation line of the bidirectional flow cannula of claim 29.

31. A method comprising using the bidirectional flow cannula of claim 29 to provide blood flow to a patient’s body, head, and cannulated limb and/or groin region with the patient is on extracorporeal circulation and the source of blood flow is an extracorporeal circulation circuit.

32. A method of claim 31 , further comprising: inserting the open end and a portion of the reinforced portion of the bidirectional flow cannula into the blood vessel in the patient’s limb and/or groin region coupling the coupling of the unreinforced portion to the extracorporeal circulation circuit supplying a volume of blood to the bidirectional flow cannula via the extracorporeal circulation circuit, wherein a first volume of blood is injected into the patient’s blood vessel for delivery to the patient’s head and body via the open end of the bidirectional flow cannula, and a second volume of blood flows out of the first plurality of ports toward the patient’s cannulated limb.

33. The method of claim 31 or 32 further comprising: inflating the inflatable balloon to a volume that partially occludes the patient’s blood vessel.

34. The method of claim 31 or 32 , further comprising: inflating the inflatable balloon to a volume that fully occludes the patient’s blood vessel.

35. The method of any of claims 31-34, further comprising: receiving an indication of a size of the blood vessel prior to insertion of the bidirectional flow cannula into the blood vessel, wherein a volume of inflation media provided to the inflatable balloon is responsive to the received indication.

36. A method comprising using the bidirectional flow cannula of claim 29 to provide extracorporeal circulation while a patient is undergoing coronary bypass surgery.

37. A method comprising using the bidirectional flow cannula of claim 29 to provide extracorporeal circulation while a patient is on life support.