EP-3397173-B1 - DEVICES FOR ENDOVASCULAR ACCESS THROUGH EXTRACORPOREAL LIFE SUPPORT CIRCUITS

Inventors

• KACZOROWSKI, DAVID

Dates

Publication Date

20260506

Application Date

20161028

Claims (4)

1. A system (200, 300, 400) for vascular access, comprising: a tube coupler (50, 50') having: (i) a coupler body (51, 51') having first and second end openings (56, 57) selectively mating to independent tube sections (3b', 3b"); (ii) a coupler lumen (54) extending within said coupler body (51, 51') between said first and second end openings (56, 57) defining an axial flow path (70, 70'); (iii) an access port (55, 55') including an access port channel (58, 58') providing exterior access to said coupler lumen (54); and an insertion cap (30s) having a shaft (33) inserted in said access port channel (58, 58'), providing exterior access to said coupler lumen (54), said shaft (33) including an insertion lumen (31d) to receive an intervention device (60) inserted therein and modify an angle of insertion of said intervention device (60) through said insertion lumen (31d) and directing said intervention device (60) within said coupler lumen (31d) consistent with the axial flow path (70'), wherein said insertion cap (30d) further comprises a side arm (37) extending from said insertion cap (30d) and having a side arm passage in fluid communication with said insertion lumen (31d) and said coupler lumen (54) to selectively vent air from said system.
2. The system according to claim 1, wherein said access port (55; 55') is at least one of a right angle access port and an angled access port.
3. The system according to claim 1, wherein said insertion cap (30d) includes a connector (35) selectively restraining said insertion cap (43) to said access port (55, 55').
4. The system according to claim 3, wherein said connector (35) is at least one of a floating Luer connector and a fixed Luer connector.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of pending United States Provisional Application having Serial No. 62/248,525, filed on October 30, 2015. FIELD OF THE INVENTION This invention relates to devices for accessing the interior of a subject, such as the vascular system, through extracorporeal life support (ECLS) system components, such as extracorporeal membrane oxygenation ("ECMO") circuits. More in particular, it relates to cannulas, adaptors, sheaths, tubing, connectors and other medical devices for use as or in connection with bypass system components to gain entry to the vascular system through the bypass system, such as an ECMO circuit. BACKGROUND Extracorporeal membrane oxygenation ("ECMO") is a form of cardio-pulmonary bypass that is employed to support critically ill patients with acute cardiac failure, respiratory failure, or combined cardiopulmonary failure. A typical ECMO circuit 100 as shown in Figure 1 consists of multiple components including cannulas, tubing, an oxygenator, and pump with a controller. A heater-cooler element may be added for temperature management as well. Generally, a venous cannula 2 is inserted either into a large vein, such as a femoral vein, or the right atrium of the heart for drainage of blood from the patient. The blood is carried via bypass tubing 3a to a pump (not shown), which provides forward flow through the circuit, and to an oxygenator (not shown), which both oxygenates the blood and allows removal of carbon dioxide. The blood is then returned to the patient via bypass tubing 3b connected to a return or arterial cannula 4, which is generally placed in either the aorta or a large peripheral vessel, such as the femoral artery. Depending on the configuration, an ECMO circuit can provide gas exchange for patients with acute pulmonary failure, or both gas exchange and hemodynamic support for patients with acute cardiac or combined cardiopulmonary failure. In the setting of acute cardiac and pulmonary failure, ECMO can provide immediate restoration of perfusion and oxygen delivery to tissues, thereby preventing worsening acidosis, shock, multisystem organ failure and ultimately death and allowing for time for either organ recovery or diagnosis and intervention. Use of this form of temporary mechanical circulatory support was initially reported in 1972. Since its introduction, technological advances in all components of the ECMO circuit have occurred. For example, improved cannula design has allowed more facile insertion with less trauma to blood vessels. Advances in pump and oxygenator design have allowed for greater efficiency and less trauma to blood elements. In the context of these advances, it was discovered that ECMO could serve as a valuable tool in supporting critically ill patients afflicted with H1N1 influenza. In its most severe manifestations, H1N1 was associated with a high mortality rate and it was found that ECMO could reduce mortality in these critically ill patients. Improvements in ECMO technology, along with its demonstrated success with critically ill H1N1 patients, have led to a dramatic growth in the use of ECMO for patients with acute cardiopulmonary failure. ECMO is generally considered to be a supportive technology intended to provide oxygen and hemodynamic support to patients with acute cardio-pulmonary failure through a closed system. Many patients that require ECMO also require invasive procedures for diagnosis and potentially intervention. Many of these procedures, such as left and right heart catheterization, percutaneous coronary intervention, or insertion of catheters for instillation of thrombolytics, require access to the cardiovascular system, which is usually established by inserting an introducer sheath into a peripheral vessel after obtaining access with a needle. However, institution of ECMO generally requires thorough systemic anticoagulation to increase blood flow and prevent clotting. Anticoagulation, however, complicates obtaining access to the vascular system for other subsequent diagnostic and therapeutic procedures, as the anticoagulants cause an increased risk of bleeding when attempting to access a vessel. Furthermore, vascular access is often obtained in the clinical setting by palpating a patient's pulse as a landmark for locating the blood vessel. ECMO provides laminar flow and a patient on ECMO may have very little or no difference in systolic or diastolic blood pressure, resulting in a very low pulse pressure. While a patient may have adequate blood pressure, there may be very little pulsatility and it may be difficult or impossible to palpate a pulse while on ECMO. Thus, despite the potential necessity for vascular access for subsequent diagnostic and therapeutic procedures while on ECMO, obtaining vascular access in patients on ECMO may be challenging and result in complications including vascular injury and bleeding. Since establishment of an ECMO circuit requires in