USRE50347E1 - Devices for endovascular access through extracorporeal life support circuits - Google Patents

Abstract

Adaptors, cannulas, caps, tube couplers, and systems thereof provide endovascular access through an established ECLS system. Adaptors having curved or angled shafts navigate right angle side ports of standard bypass cannulas and permit hemostatic introduction and direction of an intervention device to the axial flow path of the cannula lumen and bypass system. A modified cannula having an angled side port is also provided for use as an arterial cannula. A cap having an occluding surface may be inserted into the angled side port to prevent blood from stagnating in the angled side port. A tube coupler is also provided having an access port, such as an angled access port, and may be spliced into an established bypass system for vascular access point. Multiple couplers can be used to provide multiple access points. The adaptors and occlusive cap are interchangeable with each other and with secondary circuits.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is divisional reissue of U.S. Reissue application Ser. No. 17/684,028, entitled “DEVICES FOR ENDOVASCULAR ACCESS THROUGH EXTRACORPOREAL LIFE SUPPORT CIRCUITS” and filed Mar. 1, 2022, which is an application for reissue of U.S. Pat. No. 10,576,260, entitled “DEVICES FOR ENDOVASCULAR ACCESS THROUGH EXTRACORPOREAL LIFE SUPPORT CIRCUITS” and filed on Oct. 28, 2016, which claims the benefit of U.S. Provisional Application Ser. No. 62/248,525, entitled “CATHETER SHEATHS” and filed on Oct. 30, 2015, the contents of each of which are incorporated by reference herein in its their entirety.

The present application is also an application for reissue of U.S. Pat. No. 10,576,260, entitled “DEVICES FOR ENDOVASCULAR ACCESS THROUGH EXTRACORPOREAL LIFE SUPPORT CIRCUITS” and filed on Oct. 28, 2016, which claims the benefit of U.S. Provisional Application Serial No. 62/248,525, entitled “CATHETER SHEATHS” and filed on Oct. 30, 2015, the contents of each of which are incorporated by reference herein in their entirety.

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. Atypical ECMO circuit100 as shown inFIG.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, avenous cannula2 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 viabypass tubing3a 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 viabypass tubing3b connected to a return orarterial cannula4, 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 insertion of cannulas into the vascular system, the ECMO circuit itself has the potential to serve as an access point to the cardiovascular system and allow the performance of diagnostic and therapeutic procedures to promote the recovery of the patient. Utilizing the ECMO circuit itself for access to the cardiovascular system would circumvent the challenges and risks associated with attempting to access another blood vessel. However, an ECMO circuit is generally not used as a vascular access point in clinical practice as a safe and facile means of doing so does not exist with currently available technology.

For example, the arterial or in-flow cannula4 generally represents the most proximate component of the ECMO circuit to the patient's cardiovascular system. Thisarterial cannula4 is typically inserted into a large peripheral vessel, such as the femoral or axillary artery, or directly into the aorta. Most commercially produced cannulas have a small,perpendicular side port5 with a Luer connector, as shown inFIG.1. Thisside port5 allows air to be eliminated from the circuit and also allows for establishment of a secondary circuit, such as for perfusion of blood to the ipsilateral limb. Such secondary circuits are established by asecondary circuit connector13 attaching to theside port5 of the arterial cannula.Secondary circuit tubing14 directs blood from theside port5 to asuperficial cannula10, such as a superficial femoral arterial cannula. Both the mainarterial cannula4 and thesuperficial cannula10 may be introduced into the artery at thesame insertion point12, with thecannula4 being directed toward the heart, and thesuperficial cannula10 being directed toward the ipsilateral limb, such as the leg in a femoral arterial setting. The secondary circuit therefore allows perfusion into the ipsilateral leg and prevents ischemia and tissue damage in the leg.

Many patients on ECMO systems will typically require diagnostics and therapeutic interventions, which are commonly facilitated by the placement of anintroducer sheath15, shown inFIG.2, in the patient's artery. Theintroducer sheath15 may also include ahub16 withside arm16a for venting air out of the system throughventing tubing17 by operation of avalve18. Theside port5 of an ECMOarterial cannula4 represents a potential access point to the ECMO circuit for vascular access. However, current vascular introducersheaths15 have no mechanism of interfacing with theside port5. As is evident fromFIG.2,arterial sheaths15 are too long and incompatible with the short rightangle side port5 provided in acannula4. They therefore offer no mechanism to negotiate the right angle presented by theside port5, and no mechanism to direct a diagnostic or interventional wire or catheter in the appropriate direction (toward the patient rather than toward the ECMO pump) once inserted. Because insertion is not possible, introducersheaths15 provide no mechanism for establishing a hemostatic seal to thecannula4, which would be needed for safe insertion of a wire or catheter. Attempts to insert a standardarterial sheath15 into theside port5 of acannula4 would result in uncontrolled bleeding around thesheath15, inability to maintain thesheath15 in appropriate position, kinking of thesheath15, misdirection of intervention devices such as wires or catheters, and inability to pass wires or catheters altogether. For these reasons, currently available arterial sheaths are not amenable for insertion directly into a cannula.

SUMMARY OF THE INVENTION

The present invention is directed to adaptors, caps, cannulas, tube couplers, and systems including combinations thereof to permit the cannulas of an ECLS system, such as an ECMO circuit, to be used as an access point to gain endovascular entry. The various components provide the ability to interchangeably utilize the side port of a cannula not only for introduction of intervention devices, such as wires or catheters, into the cardiovascular system, but also for other purposes as well, such as establishing a secondary circuit for distal perfusion. Full occlusion of the side port is also made possible when the side port is not in use, to prevent blood stagnation and thrombus formation.

Specifically, the present invention is directed to a variety of adaptors that enable the use of an ECMO circuit as a vascular access point, and systems for vascular access that include such adaptors. These adaptors can interface with a standard cannulas currently used in ECLS systems, such as ECMO circuits, and provide an access point for intervention devices such as wires or catheters into the s system. The adaptors of the present invention include curved or straight shafts having an angle that can negotiate the right angle of a standard cannula side port and provide directionality to a wire or catheter inserted therein. A hemostatic membrane allows for insertion of the intervention device without back bleeding.

The present invention is also directed to a modified cannula with an angled side port. Such modified cannulas can be used with an adaptor as described herein. An occlusive cap is also provided that fully blocks the angled side port when vascular access or secondary perfusion is not needed. This occlusive cap prevents blood from stagnating in the angled side port, which could lead to thrombosis. Systems including the modified cannula, adaptor and occlusive cap are also described.

The present invention is further directed to a tube coupler that can be spliced into the tubing of an established or pre-existing ECLS system, including ECMO circuits. The coupler may have a standard right angle side port, or may have an angled side port with interchangeable adaptor and occlusive cap. A series of couplers may be inserted into the tubing of the bypass system, such as when a series of instruments or intervention devices must be inserted simultaneously for vascular access. Systems including the coupler with adaptors and/or occlusive caps, as previously described, are also included.

The adaptors, modified cannula, cap, coupler, and systems including the same, together with their particular features and advantages, will become more apparent from the following detailed description and with reference to the appended drawings.

DESCRIPTION OF THE DRAWINGS

FIG.1 is a diagram of a typical ECMO system of the prior art.

FIG.2 is a diagram demonstrating the difficulties of direct access to an ECMO cannula.

FIG.3 is a partial cross-section of one embodiment of an adaptor of the present invention shown inserted in an ECMO cannula.

FIG.3A is a cross-section of the adaptor ofFIG.3.

FIG.4A shows the adaptor ofFIG.3 prior to insertion into an ECMO cannula.

FIG.4B shows the adaptor ofFIG.4A being inserted into the ECMO cannula.

FIG.4C shows the adaptor ofFIG.4A fully inserted into the ECMO cannula.

FIG.5A is a cross-section of a second embodiment of an adaptor of the present invention.

FIG.5B is a cross-section of a third embodiment of an adaptor of the present invention.

FIG.6 shows a modified ECMO cannula, cap and adaptor of the present invention.

FIG.7 is a cross-section of the modified ECMO cannula ofFIG.6.

FIG.8 is a cross-section of a modified cap ofFIG.6.

FIG.9 is a cross-section of the adaptor ofFIG.6.

FIG.10 is a cross-section showing the adaptor and modified ECMO cannula ofFIG.6.

FIG.11 is a cross-section showing the cap and modified ECMO cannula ofFIG.6.

FIG.12 is a cross-section of the sideport opening of one embodiment of the modified ECMO cannula of the present invention.

FIG.13 is a cross-section of the occluding surface of one embodiment of the cap of the present invention.

FIG.14 is a cross-section of the occluding surface of the cap ofFIG.13 when inserted in the sideport of the modified ECMO cannula ofFIG.12.

FIG.15 is one embodiment of a system using one version of a tubing connector with various adaptors of the present invention.

FIG.16 is another embodiment of a tubing connector of the present invention.

FIG.17A depicts standard bypass tubing before insertion of a tube coupler.

FIG.17B depicts the tubing ofFIG.17A cut in preparation of receiving a coupler.

FIG.17C shows a coupler placed between sections of bypass tubing, where a cap is in place.

FIG.17D shows the coupler ofFIG.17C where the cap is removed, in preparation for direct access.

FIG.17E shows the coupler ofFIG.17D where an adaptor is placed in the side port of the modified cannula for direct access.

FIG.17F shows the coupler and adaptor ofFIG.17E in which direct access of an insertion device to the ECMO system is achieved through the adaptor and tubing connector.

FIG.18 shows another embodiment of the tube coupler system where multiple couplers are serially spliced into the same bypass tubing and each provides endovascular access for a different insertion device.

FIG.19 shows still another embodiment of the tube coupler system in which a single coupler includes a plurality of access ports, where each access port permits entry of a different insertion device for endovascular access.

Like reference numerals refer to like parts throughout the several views of the drawings.

DETAILED DESCRIPTION

As shown in the accompanying drawings, the present invention is directed to devices, such as adaptors, cannulas, tubing, and connectors that enable the use of an ECLS circuit, such as ECMO, as a vascular access point. The devices and systems enable not only vascular access for an intervention device, such as a wire, catheter or the like, but also provide full occlusion of the side port of the ECMO cannula when not in use. They are interchangeable with each other depending on whether vascular access is desired or not, and are further interchangeable with tubing connectors for secondary circuits, such as to establish secondary perfusion to an ipsilateral limb. This level of accessibility and interchangeability of components with a side port of a long-term use cannula has not been seen before. Further, the need to fully occlude the side port when not in use is of extreme importance in long-term systems, such as ECLS circuits, because of the increased potential for thrombus formation. The present invention addresses all of these needs not seen heretofor.

Although described here in the context of an ECMO system, it should be understood that the adaptors, cannulas, cap, tubing, couplers and systems of the present invention may be used with any appropriate cannulation or ECLS system, and is not limited to vascular applications. In addition, the devices and systems described herein can be used with bypass systems, such as a cardiopulmonary bypass circuit, for temporary support such as during an open heart operation. The inventions described herein may be more preferably used with longer term support circuits, such as those in use over 6 hours or more. In addition, the terms “subject” and “patient” may be used interchangeably and refer to the individual who is on bypass in which intracorporeal access is desired.

Adaptors for Standard Cannulas

As seen inFIGS.3-5B, one aspect of the invention includes a variety ofadaptors30 designed for use with standard ECMOarterial cannulas4 having a rightangle side port5 as an access point. Theseadaptors30 can successfully navigate or circumvent the 90° turn of theside port5 of an arterial or in-flow cannula4 without kinking or damage. They therefore permit access to thecannula lumen7, without obstructing the lumen, for access to the vascular system through thecannula4. Accordingly, theadaptor30 may be used instead of anintroducer sheath15 to access the vascular system, and enables access to the vascular system through the ECMO circuit without further percutaneous action.

As depicted inFIG.3, theadaptor30 includes abody32 that acts as a hub for the remaining components of theadaptor30, and may be manipulated by an operator or user during insertion. Thebody32 is preferably made of a medical-grade plastic or other suitable material for medical use, and may be rigid. In some embodiments, thebody32 may include aside arm37 that can be used for venting and otherwise removing air from the system, described in greater detail below.

Theadaptor30 also includes ashaft33 that extends from one end of thebody32. In at least one embodiment, theshaft33 may extend at least partially into thebody32 on one end, and extends away from thebody32 on the opposite end. Theshaft33 may include an elongate structure dimensioned to be inserted and pass through theside port5 of acannula4, as shown inFIG.3A. For instance, theshaft33 may have a circular or tubular configuration, and a diameter that corresponds to, or is smaller than, the inner diameter of theside port5. Accordingly, theshaft33 may fit inside theside port5, and may provide a snug fit in some embodiments. Theshaft33 is at least as long as theside port5 of acannula4, and may extend into thecannula lumen7. In some embodiments, theshaft33 may extend to the wall of thecannula4, but in at least one preferred embodiment theshaft33 does not extend to the wall of thecannula4. Regardless of the embodiment, however, theshaft33 of thepresent adaptor30 is shorter in length than that of astandard introducer sheath15. The shorter length of thesheath33 facilitates the navigation of the right angle side port5 (discussed below) and prevents kinking of theshaft33 when inserted into theside port5.

Theshaft33 may be made of a semi-flexible plastic material, such as fluorinated ethylene polypropylene or polyethet block amide plastics used in endovascular and other intervention systems, or other suitable medical-grade plastics and materials. Such a semi-flexible material provides sufficient rigidity to maintain its shape for directional guiding of a wire or catheter, but is flexible enough to bend or flex slightly as needed during the insertion process and to prevent damage to theshaft33 upon the introduction of a medical device therein. Thebody32 of theadaptor30 may be made of a similar semi-flexible material as theshaft33, or may be made of more rigid material than theshaft33.

Theshaft33 may have a variety of configurations that enables modifying an angle of insertion of an intervention device, such as a wire or catheter, inserted into theadaptor30 and directs the intervention device into thecannula lumen7. For example, in at least one embodiment as depicted inFIGS.3-4C, theshaft33a is curved. The curved shape of theshaft33a provides directionality to a medical device introduced therein, such as a wire or catheter. When positioned correctly, thecurved shaft33a reliably directs the wire or catheter introduced therein toward the patient's heart, rather than back in the direction of the ECMO system. Thecurved shaft33a is long enough to extend into thecannula lumen7 when inserted, but is also short enough in length to easily navigate the right angle of theside port5 during insertion, as depicted throughFIGS.4A-4C. InFIG.4A, anadaptor30a having acurved shaft33a is provided. To gain access to thecannula lumen7, the distal opening of thecurved shaft33a is aligned with the opening of theside port5, as shown inFIG.4B. The distal end of thecurved shaft33a is inserted into theside port5 of thecannula4, and theadaptor30a is rotated along the directional arrow shown inFIG.4B until thecurved shaft33a is passed through theside port5 and extends into thecannula lumen7, as inFIG.4C. Alignment of thecurved shaft33a and rotation of theadaptor30a for insertion of thecurved shaft33a are performed so as to direct the opening of thecurved shaft33a toward the heart of the patient once fully inserted in thecannula4, as depicted throughoutFIGS.4A-4C. The relatively short length of thecurved shaft33a, being slightly longer than the length of theside port5, combined with the curvature of theshaft33a, allows it to be rotated around the right angle of theside port5 during insertion. It also prevents theshaft33a from kinking at the inner wall of thecannula lumen7, since in at least one embodiment thecurved shaft33a is not long enough to reach the opposite wall of thecannula lumen7 during insertion. In some embodiments, thecurved shaft33a may be long enough to reach the opposite wall of thecannula lumen7 during insertion, but in these embodiments the semi-flexible material of thecurved shaft33a allows it to flex and deflect off of the cannula wall, and resiliently keep its curved shape. Once theadaptor30a is in place, as inFIG.4C, aconnector35 can be tightened to selectively and releasable secure theadaptor30a to thecannula4, thereby securing the adaptor in place and preventing bleeding around it.

In other embodiments, as inFIG.5A, theshaft33b has a straight configuration and extends substantially linearly from thebody32 of theadaptor30b. In such embodiments, the distal end of theshaft33b opposite of thebody32 includes adeflector39 that protrudes or extends from an interior wall of theshaft33b at an angle, thereby creating an angled surface for upon which a wire, catheter or other medical device inserted through theadaptor30b may be deflected in a gentle curve to direct it into thecannula lumen7. Accordingly, thedeflector39 changes the angle of theintervention device60 from the initial angle of insertion to a different angle that directs theintervention device60 into thecannula lumen7. Thedeflector39 may be made of the same semi-flexible material as the rest of theshaft33b, as discussed previously, or may be made of a slightly more rigid material that resists flexing when pressure is applied, so as to direct anintervention device60, such as a wire or catheter, appropriately and not lose its shape. As used herein, anintervention device60 may be any diagnostic and therapeutic device used in medical procedures, and is not limited to wires or catheters. In some embodiments, thedeflector39 is made of a hard medical-grade plastic, such as polycarbonate or nylon, although other suitably rigid materials are also contemplated. In further embodiments, theentire shaft33b,c anddeflector39 may be made of a hard plastic, polycarbonate or nylon, or other rigid material. In some embodiments, as inFIG.5A, thedeflector39 may be at theterminal end47 of astraight shaft33b, such that theshaft33b has an angled end.

In other embodiments, as inFIG.5B, thestraight shaft33c may include adeflector39 as before, but has a flat or straightterminal end47 outer end. In these embodiments having astraight shaft33b,c and adeflector39, theshaft33b,c may have anopening38 at the side at theterminal end47. Accordingly, theopening38 is facing or pointed in the direction of the patient's heart, so as to appropriately direct a wire or catheter exiting from theshaft33b,c. Additionally, thestraight shaft33b,c is longer in length than theside port5, but is shorter than the distance to the opposite wall of thecannula4. Accordingly, the rightangle side port5 does not pose a navigational risk in thesestraight shaft33b,c embodiments, since thestraight shaft33b,c easily conforms to the straight channel8 of theside port5, and theinternal deflector39 creates the required angular change to direct an inserted wire or catheter toward the patient's heart.

Regardless of the particular configuration, theshaft33 provides access for anintervention device60 to thecannula lumen7, and modifies the angle of insertion of theintervention device60 and directs theintervention device60 into thecannula lumen7. Specifically, as seen inFIGS.3A,5A and5B, thecannula lumen7 has anaxial flow path70 of fluid (such as blood from an ECMO system) being directed through it. Theshaft33 of theadaptor30 changes the direction of theintervention device60 upon insertion and directs it not only into thecannula lumen7, but specifically in the direction of, or consistent with, theaxial flow path70 of thecannula lumen7. In at least one embodiment, this is toward the patient's heart, for cardiopulmonary intervention.

Theshaft33, and with reference toFIGS.3A,5A and5B, may include aflange34 that has a wider diameter than the remainder of theshaft33. For example, theflange34 may be circumferentially disposed around theshaft33 and extend radially away from theshaft33. Theflange34 is dimensioned to correspond with and abut aterminal lip6 at the outermost edge of theside port5 when theadaptor30 is fitted on theside port5. In this manner, theflange34 may limit how far theshaft33 may enter theside port5 andcannula lumen7.

Theadaptor30 may further include aconnector35, as shown inFIGS.3A,5A and5B. Theconnector35 is a fitting that removably secures theadaptor30 to theside port5 of thecannula4. Theconnector35 may be any suitable fitting for selectively releasable connection, such as a snap fitting, or a Luer connector that connects by screw action through a series of threads on the inside of theconnector35. These threads may interact with thelip6 of theside port5, such that as theconnector35 is turned or rotated about theside port5, thelip6 engages and is moved through the threads of theconnector35. In at least one embodiment, theconnector35 is a floating Luer connector that rotates independently of the remainder of theadaptor30, such as theshaft33. Such floatingconnector35 may be preferable in embodiments where maintaining the direction or alignment of theopening38 of theshaft33 within thecannula lumen7 is important, as inFIGS.3-5B. In other embodiments, as when the orientation or direction of theshaft33 is not critical after insertion, as inFIGS.6 and9-10, theconnector35 may be secured to and/or rotate with theadaptor30 orshaft33. In such embodiments, theconnector35 may be integrated into theadaptor30, such as in thebody32 of theadaptor30.

In at least one embodiment, theflange34 of theshaft33 may act as a washer between theconnector35 and thelip6 of theside port5, forming a seal when theconnector35 is tightened down onto theside port5. Further, in some embodiments, thebody32 may include acavity49 on the underside which is correspondingly shaped to theconnector35, such that at least a portion of theconnector35 may be inserted into thecavity49 of thebody32, as seen inFIG.3A for example.

Theadaptor30 also includes an adaptor lumen31 extending through and connecting the interior of thebody32 andshaft33, shown inFIGS.3A,5A and5B. The adaptor lumen31 provides a hollow interior through which anintervention device60 such as a wire or catheter may be introduced. The adaptor lumen31 may be a single lumen, or may be separate lumens of thebody32 and theshaft33 that are continuous with one another. Accordingly, in some embodiments, theadaptor lumen31a is curved through acurved shaft33a, as inFIG.3A. In other embodiments, theadaptor lumen31b,c is straight through a majority of its length, and is angled at the distal end of theshaft33b,c.

The adaptor lumen31 is in fluidic communication with thecannula lumen7 when theadaptor30 is in place. Specifically, the adaptor lumen31 extends through thebody32 andshaft33 of theadaptor30, and ends at theopening38 of the distal end of theshaft33. Therefore, the adaptor lumen31 provides exterior access to thecannula lumen7 of the ECMO system, including theaxial flow path70 thereof. The adaptor lumen31 may also be in fluidic communication with apassage48 extending through aside arm37 of theadaptor30. In such embodiments, any air that may be present in thecannula lumen7 and the adaptor lumen31 may be removed by selective venting through thepassage48 of theside arm37, such as by operation of a valve connected to theside arm37 throughvent tubing17, as inFIG.3A.

The adaptor lumen31 is dimensioned to receive anintervention device60 such as wires and catheters, which may be up to about 7 French in diameter, or greater in some embodiments. Theflange34 of theshaft33 and theconnector35 form a hemostatic seal with theside port5, as mentioned previously, so that blood flowing through the ECMO system will not be lost during vascular access.

Further, theadaptor30 may include amembrane36 opposite of theshaft33 through which a wire, catheter or other suitable diagnostic, therapeutic or othermedical intervention device60 may be passed to enter theadaptor30 and gain access to the ECMO system and vascular system. In at least one embodiment, themembrane36 is a hemostatic diaphragm, such as a silicone or other soft biocompatible plastic disc with a perforating slit(s) for access, as is used ininsertion sheaths15. As shown inFIGS.3A,5A and5B, themembrane36 is disposed in thebody32 of theadaptor30 and spans the distance between the edge of the adaptor lumen31 and the outer edge or exterior of thebody32. In other embodiments, themembrane36 is coextensive with a top surface of theadaptor30, as inFIGS.3A,5A and5B. In other embodiments, the top surface of theadaptor30 may not be uniformly flat, but may recess in, as inFIG.9. Here, themembrane36 spans from the adaptor lumen31 to the outer edge of thebody32, which is the recessed portion. Regardless of configuration, themembrane36 allows access to the adaptor lumen31 while maintaining hemostatic conditions and preventing back bleeding upon insertion of anintervention device60 therein.

The invention also includes various systems forvascular access200. Eachsystem200 includes acannula4 and anadaptor30 as described herein. For instance, at least one embodiment of avascular access system200a includes acannula4 and anadaptor30a having acurved shaft33a, as inFIG.3A. In at least one other embodiment, thevascular access system200b includes acannula4 and anadaptor30b having astraight shaft33d terminating in anangled deflector39, as inFIG.5A. In at least one other embodiment, thevascular access system200c includes acannula4 and anadaptor30c having astraight shaft33c and a flat terminal end, with aninternal deflector39, as inFIG.5B. These are just a few illustrative examples, and are not intended to be limiting.

Modified Cannula, Adaptor and Occlusive Cap

Turning now toFIGS.6-14, the present invention is also directed to a modifiedcannula24 that can be used in an ECLS system in place of a standardarterial cannula4, such as an ECMO vascular cannula. The modifiedcannula24 is made of a flexible medical-grade plastic, silicon, or polymer material, or other material suitable for insertion and residence in a patient. As depicted inFIGS.6 and7, the modifiedcannula24 includes an elongate portion29 extending between aproximal end29a and an oppositedistal end29b. Theproximal end29a is positioned closest to the pump of the bypass system, and has an opening at its terminal end and a diameter sized to receive and form a tight seal with thebypass tubing3b around its perimeter. For example,such bypass tubing3b may be ⅜ inch to ½ inch in diameter, and theproximal end29a may have a diameter ranging from 6 to 51 French depending on the particular application and whether it is used on an adult, child or infant. In some embodiments, theproximal end29a includes ribs, barbs, serrations, or other frictional elements that engage the interior of thebypass tubing3b upon insertion and maintains or facilitates a tight seal with thetubing3b. Accordingly, when attached to thebypass tubing3b, theproximal end29a of the modifiedcannula24 receives blood from the ECLS system, such as an ECMO system.

The oppositedistal end29b of the modifiedcannula24 is dimensioned to be inserted into a subject or patient, such as a blood vessel for vascular access, and more in particular an artery, such as the femoral artery or aorta, or a vein, such as the femoral vein or internal jugular vein. For instance, thedistal end29b may have a diameter ranging from 14 to 22 French, although smaller or larger sizes are also contemplated. Thedistal end29b is preferably narrower than theproximal end29a, as inFIGS.6 and7. In other embodiments, however, thedistal end29b andproximal end29a may have the same diameter, or thedistal end29b may have a larger diameter than theproximal end29a. Thedistal end29b is also made of a flexible medical-grade plastic, silicon, or polymer material, or other suitable material, so as to avoid damaging or puncturing the blood vessel. Thedistal end29b may also include an opening(s) at or near the distal tip to allow reinfusion of blood into the surrounding blood vessel from the modifiedcannula24.

Between theproximal end29a anddistal end29b, the modifiedcannula24 may include a depth guide(s)22 located along the length of the elongate portion29. The depth guide(s)22 provide a visual indicator for a user, such as a medical practitioner, of how far to insert thedistal end29b of the modifiedcannula24 into the subject. For instance, in at least one embodiment, thedistal end29b of the modifiedcannula24 is inserted into the patient at an incision point until the depth guide(s)22 reaches the incision. The depth guide(s)22 therefore provides a maximum limit for insertion. In at least one embodiment, thedepth guide22 may be a collar or series of collars disposed circumferentially around the exterior of the elongate portion29 of the modifiedcannula24. In other embodiments, thedepth guide22 may be a marking or series of markings on or integrally formed in the wall of the modifiedcannula24, such as printed on or engraved in the exterior surface of the modifiedcannula24.

The modifiedcannula24 also includes a modifiedcannula lumen27 extending through the length of the modifiedcannula24 from the opening at theproximal end29a to the opening at thedistal end29b. Accordingly, the modifiedcannula lumen27 provides anaxial flow path70′ through which fluid, such as blood, may pass during ECMO circulation. The modifiedcannula lumen27 has a diameter similar to that of the modifiedcannula24, and in at least one embodiment takes up a majority of the inner volume of the modifiedcannula24.

As shown inFIGS.6 and7, the modifiedcannula24 further includes anangled side port25 that extends from the surface of the modifiedcannula24. Notably, theangled side port25 extends away from the surface at an angle, which may be any angle other than 90°. For instance, theangled side port25 extends from the surface of the modifiedcannula24 at an acute angle less than 90°, such as in the range of 10° to 40° from the modifiedcannula24 wall in at least one embodiment. In another embodiment, the angle of theangled side port25 is in the range of 25° to 35°. These are illustrative examples, and are non-limiting. For instance, depending on the perspective, theangled side port25 could be considered to extend at an obtuse angle from the modifiedcannula24.

Theangled side port25 terminates at alip26 having a wider diameter than the rest of theangled side port25, so as to form an overhanging portion. Theangled side port25 may also have a thread to allow interaction with Luer connections or other counterthreads on theconnector35 ofadaptors30. Theangled side port25 also has an opening at the terminal end, and an angledside port channel28 extending through theangled side port25 in fluid communication with the opening on one end and the modifiedcannula lumen27 on the opposite end. Accordingly, theangled side port25 provides exterior access to the modifiedcannula lumen27, and therefore to the vascular system for endovascular diagnostic and therapeutic procedures.

Theangled side port25 of the modifiedcannula24 provides a number of benefits over the standard rightangle side ports5 of current vasculararterial cannulas4. For instance, the angle of theangled side port25 directs an incoming wire, catheter or other inserted medical device to more closely align with the modifiedcannula lumen27 in a direction toward the heart of the patient. This facilitates the insertion of such a device without having to navigate around a right angle, as withstandard cannulas4, thereby preventing kinking and obstruction of the wire or catheter.

Cardiopulmonary bypass cannulas with an angled side arm or a Y-shape have been described in the prior art. However, these cannulas have several disadvantages that limit their utility in an ECMO system. For instance, when a typical bypass cannula is inserted into a vessel, it may occlude blood flow to distally located tissues. As shown inFIG.1, when a cannula is inserted into the femoral artery, blood flow to the entire ipsilateral leg may be jeopardized. In order to prevent ischemia of distal tissue beds, the rightangle side port5 of acannula4 can be used to establish asecondary circuit14 to direct a portion of the blood flow in the opposite direction to thecannula4. Blood flow may be directed out of the rightangle side port5 of thecannula4 and down the ipsilateral leg to separately perfuse the leg. Secondary circuits for distal perfusion are not always necessary, and may not be needed the entire time the patient is supported on the ECMO system, but they are frequently used. Thus, the ability to establish of a downstream flow circuit is an important option when using long-term bypass systems such as ECMO. However, cardiopulmonary bypass cannulas with angled side arm previously described in the prior art lacks the requisite structure to establish a connection for asecondary circuit14 for distal perfusion.

In contrast, the modifiedcannula24 withangled side port25 of the present invention includes alip26 at the terminal end, as seen inFIG.7. Thislip26 provides a surface on which a connector, such as a Luer connector, can be used to engage for secure yet selectively removable connection. Accordingly, a Luer connector commonly used as asecondary tubing connector13, shown inFIG.1, can engage thelip26 of theangled side port25 of the modifiedcannula24, shown inFIG.7, to establish a secondary circuit as previously described for distal perfusion. For example, thelip26 of theangled side port25 is dimensioned to fit within the grooves, threads, or tracks of a connector, such as a Luer connector having internal threading for connection by screwing action. Common cardiopulmonary bypass cannulas, even those with angled side arms, lack this structure. Although Luer connectors are described here as removably engaging thelip26 of theangled side port25, it should be appreciated that other types of connectors could also be used to removably engage thelip26 for a secure connection, such as snap on connectors.

In addition, in an ECMO circuit, blood flow along themain lumen7 of thecannula4 is laminar. A typical angled side arm represents an arm with a blind end, since laminar flow does not penetrate the side arm. The lack of flow in the side arm creates a potential for stagnant blood to pool in the side arm, which may result in thrombus formation, particularly during periods of prolonged support on ECMO. If a thrombus forms and is later dislodged, it may result in devastating complications including stroke, myocardial infarction, ischemic bowel, or ischemia of other tissues. Therefore, known cardiopulmonary bypass cannulas with an angled side arm or a Y-shape cannot be used in ECMO systems. Further, many cardiopulmonary bypass cannulas with an angled side arm or a Y-shape have permanent valves located within the side arm. Such permanent valves may increase the risk of stagnant blood flow and thrombus formation. Theangled side port25 of the modifiedcannula24 of the present invention lacks such permanent valves that would lead to stagnant blood flow and thrombus formation.

In addition, theangled side port25 of the modifiedcannula24 of the present invention is designed to coordinate with aspecialized occlusive cap40 for use when access to asecondary circuit14 or endovascular access is not needed. Specifically, theocclusive cap40 of the present invention is designed to fit inside the angledside port channel28 of theangled side port25 and occlude substantially all of theangled side port25, such that blood does not flow into theangled side port25 from the ECMO system when access is not needed. This prevents blood stagnation and potential thrombus formation, and is not available with known ECMO or cardiovascular bypass cannulas.

As seen inFIGS.7,8 and11, at least a portion of theocclusive cap40 is correspondingly dimensioned in size and shape to fit inside the angledside port channel28 and provide a tight fit therein. Specifically, theocclusive cap40 includes an occludingmember42 terminating in an occludingsurface41, as seen inFIGS.8,11,13 and14. The occludingsurface41 blocks the angledside port channel28 and prevents blood from entering. It therefore prevents blood stagnation and potential thrombus formation. As depicted in the cross-section ofFIG.11 and the view along line14-14 shown inFIG.14, the edges of the occludingsurface41 are adjacent to and abut the interior surface of the angledside port channel28, so as to form a tight fit therewith. In a preferred embodiment, as inFIG.11, the occludingsurface41 is flush or coextensive with the wall of the modifiedcannula lumen27, such that the occludingmember42 of theocclusive cap40 does not extend into the modifiedcannula lumen27 and laminar blood flow through the modifiedcannula lumen27 is not disrupted. However, in some embodiments the occludingmember42 may extend into the modifiedcannula lumen27, such as to ensure the angledside port channel28 is entirely blocked.

In some embodiments, the occludingsurface41 may have a lockingmember44, as shown inFIGS.13 and14. This lockingmember44 is located along the perimeter of the occludingsurface41 and is correspondingly dimensioned with areceiver45 located in the inner perimeter or edge of theangled side port25, such as in the angledside port channel28. As illustrated throughFIGS.12-14, the lockingmember44 andreceiver45 correspondingly fit together to form a tight fit, but may also provide locking engagement for securely retaining the occludingsurface41 in theangled side port25 in a particular orientation. This engagement may also be used to ensure theocclusive cap40 is fully inserted and/or properly aligned within the angledside port channel28 so that the occludingsurface41 is flush or fully coextensive with the wall of the modifiedcannula lumen27, as the lockingmember44 and correspondingreceiver45 may only interact and engage in a particular configuration. In at least the embodiment shown inFIGS.12-14, the lockingmember44 is an extension that extends from the perimeter of the occludingsurface41, and thereceiver45 is a recess formed in theangled side port25 having a corresponding shape, contour and dimension to the lockingmember44. However, it should be understood that in other embodiments, the lockingmember44 may be located in theangled side port25 and thereceiver45 may be located in the perimeter of the occludingsurface41. Similarly, the lockingmember44 andreceiver45 may have any shape, dimension or contour permitted by the occludingsurface41 andangled side port25, so long as they coordinate together. For example, the lockingmember44 may be a keyed extension, thereceiver45 may be a rail or track, and either or both the lockingmember44 andreceiver45 may include threading for coordinated interaction. These are just a few illustrative examples, and are not meant to be limiting.

In at least one embodiment, the occludingmember42 may have an elongate shape, such as a cylinder or shaft that extends at least a portion of the length of theocclusive cap40. In some embodiments, the occludingmember42 extends the entire length of theocclusive cap40. At least a portion of the occludingmember42 has a diameter that is substantially the same as or slightly smaller than the diameter of the angledside port channel28. In one embodiment, the entire length of the occludingmember42 has a diameter corresponding to the diameter of the angledside port channel28 of the modifiedcannula24. In other embodiments, however, only a portion of the occludingmember42 has a diameter corresponding to the diameter of the angledside port channel28. This portion may be located anywhere along the occludingmember42, such as at an end or anywhere along the length of the occludingmember42.

Regardless of the length and diameter of the occludingmember42, it terminates at the occludingsurface41 on one end, as depicted inFIG.8. Therefore, the occludingmember42 may be at least as long as the angledside port channel28 and theangled side port25 in some embodiments. In a preferred embodiment, the occludingmember42 is the same length as the angledside port channel28. In some embodiments, the width or diameter of the occludingmember42 is the same as that of the occludingsurface41. In other embodiments, the width or diameter of the occludingmember42 is less than that of the occludingsurface41, or may vary in its diameter over its length.

At the opposite end of the occludingmember42 from the occludingsurface41, theocclusive cap40 may also include acap connector43, as shown inFIG.8. Thecap connector43 selectively retains theocclusive cap40 on the modifiedcannula side port25 for selectively reversible securing. For instance, thecap connector43 is dimensioned to removably engage thelip26 of theangled side port25 to secure theocclusive cap40 in place upon insertion into theangled side port25. Thecap connector43 may be shaped as a Luer connector, such as a floating or fixed Luer connector, and may include threads disposed along an inner surface for receiving thelip26 of theangled side port25. Of course, other forms of selectively reversible attachment are also contemplated, and are not limited to threaded engagement. Thecap connector43 may be integrally formed with theocclusive cap40, as inFIG.8, although in other embodiments it may be formed separately and attached to theocclusive cap40, such as at the occludingmember42. Thecap connector43 allows theocclusive cap40 to be secured to theangled side port25 when the modifiedcannula24 does not need to be accessed. However, it is selectively reversible to permit removal of theocclusive cap40 for access to the modifiedcannula24 through theangled side port25, such as to establish a secondary circuit as previously discussed or to insert a wire, cannula or other medical device.

Accordingly, theocclusive cap40 and modifiedcannula24 described herein together form anocclusion system300, as seen inFIG.11. When theocclusive cap40 is fully inserted in theangled side port25 of the modifiedcannula24, the laminar blood flow through the bypass system is substantially entirely occluded from theangled side port25. This is important to prevent thrombus formation in long-term use systems such as ECLS.

When access to the modifiedcannula lumen27 is desired, such as for the insertion of a wire or catheter or to establish a secondary circuit for distal perfusion, theocclusive cap40 may be removed from theangled side port25. Thebypass tubing3b may be clamped upstream of the modifiedcannula24 prior to removal of theocclusive cap40, such that blood flow through the system is temporarily interrupted. This prevents blood from seeping into the angledside port channel28 upon removal of the occludingsurface41 and theocclusive cap40. Once theocclusive cap40 is removed, secondary circuit tubing may be connected to theangled side port25 in a similar fashion as it would connect to a rightangle side port5. The clamp on thebypass tubing3b may then be released, reestablishing the blood flow through the system, which now includes a secondary circuit for distal perfusion. On the other hand, if endovascular access is desired, such as through the insertion of a wire or catheter, anadaptor30d may be attached to theangled side port25 during temporary interruption of the ECMO system, as described below. After either is attached, the clamp may be removed and ECMO flows reinstituted.

The present invention also includes anadaptor30d, as seen inFIGS.9 and10. Because theadaptor30d and occlusiveocclusive cap40 are interchangeable, theadaptor30d may also be considered an insertion cap, and the terms are used interchangeably herein. The adaptor/insertion cap30d includes abody32, amembrane36 for hemostatic access, and an adaptor orinsertion lumen31d extending from themembrane36 and through thebody32, similar to those of the previously describedadaptors30a,b,c. However, the adaptor/insertion cap30d is used with theangled side port25 of the modifiedcannula24 to permit exterior access to the modifiedcannula lumen27, and thus the ECMO system for endovascular entry. Theadaptor30d need not provide directionality for the insertion of a wire or catheter since that function is already provided by the angle of theangled side port25. Therefore, in at least one embodiment the adaptor/insertion cap30d may not include ashaft33 or other structure that extends into the angledside port channel28 of theangled side port25. In such embodiments, the adaptor orinsertion lumen31d is in fluid communication with the angledside port channel28 when the adaptor/insertion cap30d is connected to theangled side port25. In other embodiments, as inFIGS.9 and10, the adaptor/insertion cap30d includes ashaft33d. Theadaptor lumen31d is sized to coordinate with the angledside port channel28, and may be the same or similar diameter as the angleside port channel28. Theadaptor lumen31d is sized to allow the passage of wires, catheters and other medical devices that may be used for cardiovascular interventions, such as 7 French or greater. Accordingly, anintervention device60 can be passed through thehemostatic membrane36 and enter theadaptor lumen31d, pass through theadaptor lumen31d directly into the angledside port channel28, and on into the modifiedcannula lumen27.

In other embodiments, the adaptor/insertion cap30d may include ashaft33d that is straight and may be shorter than theshafts33a,b,c of the previously discussedadaptors30a,b,c. When present, theshaft33d may extend into at least a portion of the angledside port channel28, or even into the modifiedcannula lumen27. Accordingly, in some embodiments, theshaft33d may be 7 French in diameter or greater, such as to permit the passage of intervention devices such as medical devices for cardiovascular intervention, but still fits within the angledside port channel28. Theshaft33d may be integrally formed in thebody32 of the adaptor/insertion cap30d, or may attach to thebody32 such as by secure attachment as with adhesive or molding.

The adaptor/insertion cap30d may attach to the exterior of theangled side port25, such as by engaging thelip26 of theangled side port25 with aconnector35 as previously described. Because directionality is not a function of theadaptor30d with anangled side port25, theconnector35 of theadaptor30d may be fixed, formed in or integral with thebody32 of theadaptor30d, as shown inFIG.9. Thus, when theadaptor30d is attached to theangled side port25, theentire body32 may be rotated around theangled side port25, to provide a secure, selectively reversible connection such as by screw-type action of threading of theconnector35 with thelip26 of theangled side port25. Of course, in other embodiments, theconnector35 may be a floating Luer connector as previously described, or a retaining structure that permits theadaptor30d to slide or snap onto thelip26 of theangled side port25, whereby thelip26 retains the adaptor/insertion cap30d in place.

Accordingly, the present invention also include another embodiment of avascular access system200d including a modifiedcannula24 having anangled side port25 and an adaptor/insertion cap30d having ashorter shaft33d as described above, such as depicted inFIG.10. The adaptor/insertion cap30d, and specifically theshaft33d, provides exterior access of anintervention device60 to the modifiedcannula lumen27 so as to change the angle of insertion of theinsertion device60 to be inline with or consistent with theaxial flow path70′. In addition, the cannula may not be limited to one side port. For example the cannula may have one or more angled side ports, right angle side ports, or some combination thereof.

Tube Coupler

In addition, the present invention also includes atube coupler50 that may be inserted or spliced into ECMO or any bypass tubing to provideadditional side ports5,25 for endovascular access. For instance, some patients arrive at a medical facility with an ECMO or other ECLS system already in place, in which thearterial cannula4 may not have aside port5 for endovascular access, and yet endovascular access may become necessary at some point while the patient is on support. In other instances, thearterial cannula4 of the ECLS system may only have asingle side port5, but multiple devices (such as wires, catheters, etc.) may be needed to be inserted at the same time for simultaneous endovascular access, such as for coordinated actions to perform a medical procedure. Theside port5 and itshemostatic membrane36 may allow only one device through at a time, in order to maintain the hemostatic seal and prevent back bleeding. Since multiple couplers could be inserted into an ECLS circuit, thetube coupler50 of the present invention therefore provides a way to introduceadditional side ports5,25 for additional points of access to the ECMO or other ECLS system.

As seen inFIG.15, thetube coupler50 includes afirst end52 having afirst end opening56, and an oppositesecond end53 with a second end opening57, and acoupler body51 disposed there between. The first and second ends52,53 are sized and shaped to accommodate and selectively matingly fit independent or separate sections ofbypass tubing3b, such as ECMO tubing, on an arterial side of the bypass system. The first and second ends52,53 may be slightly narrower in diameter than thecoupler body51 of thetube coupler50, and in some embodiments may taper slightly, to allow a tight hemostatic seal when thetubing3b is attached. In some embodiments, the first and second ends52,53 may have ribs, barbs, serrations, beveling, or other frictional structure to promote a tight seal and retention of the ECMO orbypass tubing3b. Accordingly, the first and second ends52,53 may have a similar structure to theproximal end9a of a standardarterial cannula4, as discussed previously, although it is not required. In some embodiments, the first and second ends52,53 have the same diameters and structural features. In other embodiments, the first and second ends52,53 may have different diameters and structural features from one another.

Thecoupler body51 extends between the first and second ends52,53 and may have an elongate length. In a preferred embodiment, thecoupler body51 may be a cylinder, although other shapes and configurations are contemplated. Acoupler lumen54 extends through at least a portion of thetube coupler50 at thecoupler body51. In at least one embodiment, thecoupler lumen54 extends from the first end opening56 to the second end opening57 and through thecoupler body51 such that thecoupler lumen54 provides anaxial flow path70′ for fluid such as blood to flow entirely through thetube coupler50 when inserted in a bypass system. Thecoupler lumen54 thus allows thetube coupler50 to be inserted into, and become part of, an established bypass system and permit the continued functioning of the bypass system.

Thetube coupler50 further includes aaccess port55 located along thecoupler body51. Theaccess port55 may be a rightangle side port5, as shown inFIG.15, such as is provided on commercially availablearterial cannulas4 as described above. Specifically, theaccess port55 includes a length that extends away from thecoupler body51 of thetube coupler50. Theaccess port55 defines aaccess port channel58 extending through at least a portion of the interior of theaccess port55, which is in fluid communication with thecoupler lumen54 at one end, and has an opening at the other end for receiving theshaft33 of anadaptor30 as previously described, such asadaptors30a,b,c. Accordingly, theaccess port channel58 provides exterior access to thecoupler lumen54 such that a wire, catheter orother intervention device60 may be inserted through ahemostatic membrane36 withinsuch adaptor30, as previously described, and be inserted into theaccess port channel58 of thetube coupler50, and on into thecoupler lumen54 consistent with theaxial flow path70′ andbypass tubing3b.

In other embodiments, as seen inFIG.16, thetube coupler50′ includes anangled access port55′, such as theangled side port25 previously described in connection with the modifiedcannula24. Accordingly, it should be appreciated that thetube coupler50,50′ may include atraditional access port55 or angledaccess port55′ providing an access point to the interior of thetube coupler50,50′, and therefore, the endovascular system. Theangled access port55′ is located along thecoupler body51 of thetube coupler50′, and may have any angle relative to thecoupler body51 as may promote ease of insertion ofintervention devices60. For instance, as previously discussed, the angle of theangled access port55′ may be any angle between 0° up to 90°. Theangled access port55′ extends from thecoupler body51 and defines an angledaccess port channel58′ extending through at least a portion of the interior of theangled access port55′, which is in fluid communication with thecoupler lumen54 at one end, and has an opening at the other end for receiving an adaptor/insertion cap30d and/orshaft33d as previously described. Accordingly, the angledaccess port channel58′ provides exterior access to thecoupler lumen54 andaxial flow path70″ therein such that a wire, catheter orother intervention device60 may be inserted through ahemostatic membrane36 withinsuch adaptor30d, as previously described, and be inserted into theaccess port channel58′ andaxial flow path70″ of thetube coupler50′, and on into thecoupler lumen54 andbypass tubing3b, as shown inFIG.17F.

Thetube coupler50′ may also coordinate with the adaptor/insertion cap30d andocclusive cap40 as previously described, either to provide endovascular access through thetube coupler50′ or to seal off and occlude theangled access port55′ when access is not desired. Accordingly, thetube coupler50,50′ may comprise a part of avascular access system400,400′, respectively, in conjunction with anadaptor30 as described herein, such as inFIG.17F. Thetube coupler50,50′ may also be part of anocclusion system300′ in conjunction with aocclusive cap40, as inFIG.17C. Theangled access port55′ of thetube coupler50′ can also be used to establish a secondary circuit for distal perfusion, as previously described.

FIGS.17A-17F demonstrate the steps of inserting atube coupler50,50′ into an already established ECLS system. Atube coupler50′ withangled access port55′ is shown, but it should be appreciated that atube coupler50 with a rightangle access port55 would be inserted in a similar manner. To begin, as inFIG.17A, a location along thebypass tubing3b where thetube coupler50′ is to be inserted is identified. This location may be anywhere in the bypass system, but is preferably on the arterial side of the bypass system. In at least one embodiment, the location is proximate to, and upstream or proximal to, the location for intervention device use.

Once an insertion location is identified, the bypass system is temporarily interrupted, such as by clamping, crimping or otherwise restricting thebypass tubing3b on either side, or at least upstream of, the insertion location. This prevents the flow of blood through the ECMO system, and allows the tubing to be cut without loss of blood. Thebypass tubing3b is then cut downstream of the restriction point, resulting in two pieces of bypass tubing, as seen inFIG.17B. Theproximal piece3b′ of bypass tubing is located with the restriction point, and is closer to the pump of the ECMO system. Thedistal piece3b″ of bypass tubing is located downstream of the cut in the tubing, and is closer to thearterial incision12 where the bypass system is reintroduced back into the subject or patient.

Once thetubing3b is cut, thetube coupler50′ is then inserted between theproximal piece3b′ anddistal piece3b″ of bypass tubing, as shown inFIG.17C. For instance, thefirst end52 of thetube coupler50′ is joined to theproximal piece3b′ of the bypass tubing, and the oppositesecond end53 of thetube coupler50′ is joined to thedistal piece3b″ of bypass tubing. The first and second ends52,53 of thetube coupler50′ will be oriented such that theangled access port55′ opens toward theproximal piece3b′ of bypass tubing, such that anintervention device60 inserted therein is directed toward thedistal piece3b″ and toward the heart of the subject. When thetube coupler50′ is first inserted and joined to the proximal anddistal pieces3b′,3b″ of the bypass tubing, aocclusive cap40 may already be inserted in theangled side port25 in a fully occluding position.

Once the bypass tubing is joined and a hemostatic seal is established at the first and second ends52,53, the clamp or other restriction device temporarily interrupting the flow through the bypass system is removed, and flow through the system is re-established. Thecoupler lumen54 is in fluid communication with both theproximal piece3b′ anddistal piece3b″ of bypass tubing, defining a flow path with the tubing such that as blood flows through the bypass tubing it enters theproximal piece3b′, then thecoupler lumen54, then thedistal piece3b″ of bypass tubing on its path from the oxygenator to the patient's heart. When theocclusive cap40 is included in theangled access port55′ of atube coupler50′, or when a standard cap is inserted in the rightangle access port55 of atube coupler50, theaccess port channel58,58′ is occluded and blood is prevented from pooling and stagnating in theaccess port55,55′.

When access to the bypass system is desired, such as to establish a secondary circuit as previously described or to gain endovascular access for medical intervention, theocclusive cap40 may be removed from theaccess port55,55′, as depicted inFIG.17D. Anadaptor30d, as previously described, is then inserted and attached to theaccess port55,55′, as shown inFIG.17E. Once theadaptor30d is in place, anintervention device60 such as a wire or catheter or other suitable device may be inserted into thetube coupler50′, as inFIG.17F. Specifically, theintervention device60 enters through themembrane36 of theadaptor30d and continues to advance through theshaft33d, into thecoupler lumen54, and on into thedistal piece3b″ of bypass tubing until the particular site for intervention is reached.

In at least one embodiment, as described above with reference toFIGS.17A-17F, thetube coupler50,50′ may be inserted, such as spliced, into an already established ECLS system, such as an ECMO system. In other embodiments, thetube coupler50,50′ may be included in an ECLS system when it is being assembled for use. It may take the place of anarterial cannula4, and it may be used in conjunction with anarterial cannula4 or a modifiedcannula24 as described above. In at least one embodiment, as shown inFIG.18, the bypass system may include one ormore couplers50,50′ in series in thebypass tubing3b, so thatmultiple intervention devices60 can gain access to the endovascular system at the same time, such as when multiple devices are needed to perform an endovascular procedure. Eachtube coupler50,50′ provides one access point to the system, and asmany couplers50,50′ can be include in the system as may be needed for a particular procedure. In other embodiments, eachtube coupler50,50′ may also have more than oneaccess port55,55′, as shown inFIG.19, where eachaccess port50,50′ provides entry for oneinsertion device60, such as a wire or catheter, or anocclusive occlusive cap40, or establishing a secondary circuit for distal perfusion.

Since many modifications, variations and changes in detail can be made to the described preferred embodiments, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents. Now that the invention has been described,

Claims (27)

What is claimed is:

1. An occlusive cap for a cannula side port having an angled cannula side port channel with a terminal opening in a wall of a cannula lumen, said side port channel disposed at an acute angle relative to said cannula lumen, said occlusive cap comprising:

a cap connector threadably received on the exterior of said side port for selectively retaining said occlusive cap on said cannula side port; and

an occluding member extending from said cap into said cannula side port channel and extending to and filling said terminal opening when said occlusive cap connector is fully retained on said cannula side port for thereby preventing inflow of fluid into said terminal opening and said cannula side port channel;

said occluding member terminating in an occluding surface at said terminal opening that is disposed at an acute angle relative to the direction of extension of said occluding member and flush with said cannula lumen wall whereby laminar flow through said cannula lumen is not disrupted, edges of said occluding surface being adjacent to and abutting interior surfaces of said side port channel to thereby form a tight fit therewith;

said occluding member further including a locking member disposed between said occluding member and said side port channel for retaining the orientation of said occluding surface flush with said terminal opening when said occlusive cap connector is fully retained on said cannula side port, and

said cap connector including a floating Luer connection securing said occlusive member to said cannula side port.

2. The occlusive cap according toclaim 1, wherein said occluding member has a diameter corresponding to said cannula side port channel.

3. A method, comprising:

providing endovascular access through an extracorporeal life support system, which includes providing an access port having a port opening at its terminal end and a port channel extending through it for the introduction of an intervention device to a flow path of the extracorporeal life support system; and

when endovascular access through the extracorporeal life support system is not in use, inserting and securing an occlusive cap having an occluding surface into the access port, thereby sealing off the port channel by way of the occluding surface,

wherein a perimeter of the occluding surface is positioned adjacent to a wall defining the port channel and a wall defining the flow path.

4. The method ofclaim 3, further comprising removing the occlusive cap from the access port when endovascular access through the extracorporeal life support system is in use.

5. The method ofclaim 3, wherein the extracorporeal life support system is an extracorporeal membrane oxygenation circuit.

6. The method ofclaim 3, wherein providing endovascular access through the extracorporeal life support system includes providing access into a patient's cardiovascular system.

7. The method ofclaim 6, further comprising introducing one or more intervention devices into the patient's cardiovascular system.

8. The method ofclaim 3, wherein providing endovascular access through the extracorporeal life support system includes establishing secondary perfusion for distal perfusion.

9. The method ofclaim 3, wherein providing the access port includes splicing a tube coupler into the extracorporeal life support system.

10. The method ofclaim 9, further comprising restricting the flow path of the extracorporeal life support system at a location upstream of the splice location prior to splicing the tube coupler into the extracorporeal life support system.

11. The method ofclaim 9, wherein splicing the tube coupler into the extracorporeal life support system includes coupling a first end of the tube coupler adjacent a proximal end of a cannula and coupling a second end of the tube coupler to tubing of the extracorporeal life support system.

12. The method ofclaim 11, wherein the first and second ends of the tube coupler include one or more ribs, barbs, serrations, or bevels.

13. The method ofclaim 3, wherein providing the access port includes providing multiple access ports by splicing two or more tube couplers, each having an access port, into the extracorporeal life support system.

14. The method ofclaim 3, wherein providing the access port includes providing multiple access ports by splicing a single tube coupler having a plurality of access ports into the extracorporeal life support system.

15. The method ofclaim 3, wherein providing the access port includes providing a cannula having an angled side port.

16. The method ofclaim 3, wherein inserting and securing the occlusive cap in the access port includes locking an orientation of the occluding surface.

17. The method ofclaim 16, wherein, in the locked orientation, the occluding surface is flush or coextensive with the wall defining the flow path of the extracorporeal life support system.

18. The method ofclaim 16, wherein locking the orientation of the occluding surface includes engaging a locking projection located at the perimeter of the occlusive surface with a locking recess located in the port channel.

19. The method ofclaim 3, wherein securing the occlusive cap in the access port includes engaging a luer lock connection between the occlusive cap and the access port.

20. The method ofclaim 19, wherein a connector of the occlusive cap is threadably received by an exterior rim of the port opening.

21. The method ofclaim 3, wherein inserting and securing the occlusive cap in the access port includes simultaneously forming an occlusion arrangement configured to prevent-blood stagnation or thrombus formation in the port channel.

22. The method ofclaim 3, wherein inserting and securing the occlusive cap in the access port includes simultaneously forming an occlusion arrangement configured to maintain-laminar blood flow in the flow path of the extracorporeal life support system.

23. The method ofclaim 3, wherein the flow path of the extracorporeal life support system is maintained open for 6 hours or more, regardless of whether the endovascular access is in use or not.

24. A method, comprising:

providing endovascular access through an extracorporeal life support system, which includes providing an access port having a port opening at its terminal end and a port channel extending through it for the introduction of an intervention device to a flow path of the extracorporeal life support system; and

when endovascular access through the extracorporeal life support system is not in use, inserting and securing an occlusive cap having an occluding surface into the access port, thereby sealing off the port channel by way of the occluding surface,

wherein inserting and securing the occlusive cap includes locking an orientation of the occluding surface in the access port, and wherein, in the locked orientation, the occluding surface is flush or coextensive with a wall defining the flow path of the extracorporeal life support system.

25. The method ofclaim 24, wherein locking the orientation of the occluding surface includes engaging a locking projection of the occlusive cap with a locking recess in the port channel.

26. An occlusive cap for a cannula side port having an angled cannula side port channel with a terminal opening in a wall of a cannula lumen, said side port channel disposed at an acute angle relative to said cannula lumen, said occlusive cap comprising:

a cap connector threadably received on the exterior of said side port for selectively retaining said occlusive cap on said cannula side port; and

an occluding member extending from said cap into said cannula side port channel and extending to and filling said terminal opening when said occlusive cap connector is fully retained on said cannula side port for thereby preventing inflow of fluid into said terminal opening and said cannula side port channel;

said occluding member terminating in an occluding surface at said terminal opening that is disposed at an acute angle relative to the direction of extension of said occluding member and flush with said cannula lumen wall whereby laminar flow through said cannula lumen is not disrupted, edges of said occluding surface being adjacent to and abutting interior surfaces of said side port channel to thereby form a tight fit therewith;

said occluding member further including a locking member disposed between said occluding member and said side port channel for retaining the orientation of said occluding surface flush with said terminal opening when said occlusive cap connector is fully retained on said cannula side port; and

said cap connector including a floating Luer connection securing said occlusive member to said cannula side port.

27. The occlusive cap according toclaim 26, wherein said occluding member has a diameter corresponding to said cannula side port channel.

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