Patent Description:
The present disclosure relates to a connector for connecting ends of separate fluid conduits together, which can be used with a cannula assembly, such as a cannula assembly connected to a pump for removing and reintroducing blood to a patient, and, in particular, to a connector that creates a sterile wet-to-wet connection between portions of the cannula assembly. Prior art documents in this technical field include, i. , <CIT>, <CIT>, <CIT>, <CIT>, <CIT> and <CIT>.

Current therapy for providing assistance to a patient's heart may involve the use of complex cardiac assist systems. As will be appreciated by those skilled in the art, portions of surgical tubing used in such cardiac assist systems must be connected together in a sterile and safe manner, while avoiding introducing contaminants and/or air bubbles into the system. Currently, such sterile connections are formed using a wet-to-wet connection technique, in which one user holds an end of the sections of tubing to be connected together in each hand. The user slowly brings the ends together, while a second user continuously dispenses fluid from a syringe over the ends as the connection is being formed until a seal is made. In other examples, a connection between ends of different sections of tubing can be formed using a priming tray.

Such connectors and connection techniques can be complex and often require at least two people to form the connection. Such techniques can also be messy, allowing a large volume of fluid to spill over a working area as a wet-to-wet connection is being formed. Using a priming tray can also be cumbersome. Accordingly, there is a need in the art for an improved connector and connection technique for making a sterile connection between portions of surgical tubing in a cardiac assist system.

In view of the foregoing, there is a need for improved connectors and connection techniques, which can be performed easily by one person. Such connectors should be capable of quickly and easily connecting pieces of surgical tubing. In comparison, conventional systems are not easily connected and disconnected and thus are more difficult to prime and to change components when complications occur. Systems configured to address these issues are discussed herein and defined by the appended claims.

According to the claimed invention a connector has a hollow body having a first open end spaced apart from a second open end with a lumen extending between the first open end and the second open end. The connector further has a single channel extending through a sidewall of the hollow body. The channel is recessed axially from a terminal surface of the first open end. The first open end of the connector is sized to be received within an open end of a first tubing. When the first open end is partially inserted into the open end of the first tubing, the channel and a terminal surface of the open end of the first tubing defines a single opening positioned so that fluid passes through the opening into or out of the lumen. When the first open end is fully inserted into the open end of the first tubing, the channel is covered by an inner surface of the first tubing to cover the opening.

According to some non-limiting embodiments or aspects of the present disclosure, the channel is U-shaped. The at least one channel may have a curved end and a pair of sides connecting the curved end to the terminal surface of the first open end. A width of the at least one channel may be from <NUM>% to <NUM>% of a length of the at least one channel. An area of the at least one opening, when the first open end of the connector is partially inserted into the open end of the first tubing, may be from <NUM><NUM> to <NUM><NUM>. An area of the at least one opening, when the first open end of the connector is partially inserted into the open end of the first tubing, may be from <NUM>% to <NUM>% of a cross-sectional area of the first tube.

According to some non-limiting embodiments or aspects of the present disclosure, the first open end may have a first tapered portion configured to be inserted in the open end of the first tubing. The first tapered portion may have one or more of a luer connector, a threaded connector, and a snap fit connector. The second open end may be sized to be received within an open end of a second tubing. The second open end may have a second tapered portion configured to be inserted in the open end of the second tubing. The second tapered portion may have one or more of a luer connector, a threaded connector, and a snap fit connector.

According to some non-limiting embodiments or aspects of the present disclosure, at least one ridge or barb may protrude outward relative to an outer surface of the hollow body. The at least one ridge or barb may be a plurality of ridges or barbs axially spaced from each other along a length of the hollow body between the first open end and the second open end. A gripping portion is provided between the first open end and the second open end. The gripping portion has a first end having a first diameter, a second end having a second diameter, and an intermediate portion between the first end and the second end, the intermediate portion having a third diameter less than the first diameter and the second diameter.

According to some non-limiting embodiments or aspects of the present disclosure, a cannula assembly for providing a sterile connection between tubing portions of the assembly may have a first tubing portion with an open end, a second tubing portion with an open end; and a connector having a hollow body with a first open end spaced apart from a second open end and a lumen extending between the first open end and the second open end. The first open end may be sized to be received within the open end of the first tubing. The second open end may be sized to be received within the open end of the second tubing. At least one channel may extend through a sidewall of the hollow body. The at least one channel may be recessed axially from a terminal surface of the first open end. When the first open end is partially inserted into the open end of the first tubing, the at least one channel and a terminal surface of the open end of the first tubing may define an opening positioned so that fluid passes through the opening into or out of the lumen. When the first open end is fully inserted into the open end of the first tubing, the at least one channel may be covered by an inner surface of the first tubing to cover the opening.

According to some non-limiting embodiments or aspects of the present disclosure, a tubing assembly may have a first tubing portion with an open end, and a connector having a hollow body with a first open end spaced apart from a second open end and a lumen extending between the first open end and the second open end. The first open end may be sized to be received within the open end of the first tubing. At least one channel may extend through a sidewall of the hollow body. The at least one channel may be recessed axially from a terminal surface of the first open end. When the first open end is partially inserted into the open end of the first tubing, the at least one channel and a terminal surface of the open end of the first tubing may define an opening positioned so that fluid passes through the opening into or out of the lumen. When the first open end is fully inserted into the open end of the first tubing, the at least one channel may be covered by an inner surface of the first tubing to cover the opening.

According to some non-limiting embodiments or aspects of the present disclosure, a method of providing a sterile connection between tubing joined by a connector may include partially inserting an open end of a first tubing into a first open end of the connector, thereby forming a lumen extending through the first tubing and the connector. The connector may have at least one channel extending through a sidewall of the connector and recessed from a terminal surface of the first open end. The at least one channel and a terminal surface of the open end of the first tubing may define at least one opening positioned so that fluid passes through the at least one opening into or out of the lumen. The method may further include delivering a fluid into the lumen defined by the connected first tubing and the connector such that air present in the lumen escapes from the lumen through the at least one opening.

According to some non-limiting embodiments or aspects of the present disclosure, delivering the fluid into the lumen may include delivering the fluid until the lumen is filled with the fluid. After the lumen is filled with the fluid, the method may further include inserting the first open end of the connector into the open end of the first tubing such that an inner surface of the first tubing covers the at least one opening.

According to some non-limiting embodiments or aspects of the present disclosure, delivering the fluid may include filling the lumen through the at least one opening. Filling the lumen through the at least one opening may include dispensing a stream of the fluid from a syringe into the at least one opening. Delivering the fluid into the lumen may include releasing a clamp of a patient line connected to the first tubing, such that fluid from the patient line passes into the first tubing, thereby expelling the air from the first tubing through the at least one opening.

These and other features and characteristics of the present disclosure, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures.

Some of the advantages and features of the preferred aspects or embodiments have been summarized hereinabove. These aspects or embodiments, along with other potential aspects or embodiments will become apparent to those skilled in the art when referencing the following drawings in conjunction with the detailed descriptions as they relate to the figures.

As used in the specification and the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

For purposes of the description hereinafter, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the components as they are oriented in the drawing figures.

When used in relation to surgical tubing and cannulas of a cannula assembly, the term "distal" refers to a portion of the tubing or cannula closest to the patient. For example, a distal end of a cannula is the end of the cannula inserted into the patient's vasculature.

The term "proximal" refers to an end of tubing or a cannula that is opposite the distal end. In some cases, the proximal end of the cannula or tubing is configured to be connected to a medical device, such as a pump or oxygenator.

All numbers and ranges used in the specification and claims are to be understood as being modified in all instances by the term "about". By "about" is meant plus or minus twenty-five percent of the stated value, such as plus or minus ten percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of "<NUM> to <NUM>" should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of <NUM> and the maximum value of <NUM>; that is, all subranges or subratios beginning with a minimum value of <NUM> or more and ending with a maximum value of <NUM> or less. The ranges and/or ratios disclosed herein represent the average values over the specified range and/or ratio.

The terms "first", "second", and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

The term "at least" is synonymous with "greater than or equal to".

As used herein, "at least one of" is synonymous with "one or more of". For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes one or more of A alone; or one or more B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

As used herein, the terms "parallel" or "substantially parallel" mean a relative angle as between two objects (if extended to theoretical intersection), such as elongated objects and including reference lines, that is from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, inclusive of the recited values.

As used herein, the terms "perpendicular" or "substantially perpendicular" mean a relative angle as between two objects at their real or theoretical intersection is from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, or from <NUM>° to <NUM>°, inclusive of the recited values.

It is to be understood, however, that the disclosure may assume alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

With reference to the figures, the present disclosure is generally directed to connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and connection methods. The connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and methods can be used for providing a sterile connection between surgical tubing and cannulas of a cardiac assist system <NUM> in a safe and efficient manner. In some examples, the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are separable connectors mounted or connected to portions of a cannula assembly or network of surgical tubing. For example, portions of the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> could be attached to portions of a cannula assembly using a biocompatible adhesive, by being molded together with the tubing of the cannula assembly, or by use of a fastener or other mechanical connection device. In other examples, portions of the cannula assembly can be formed to include features of the sterile connection described herein to form the sterile connection between the portions of the cannula assembly. Unlike other types of connectors, the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> disclosed herein can be performed easily by a single user (e.g., a clinician or another trained medical professional). The connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> are also configured to allow air to be removed from the system prior to sealing the connection so that air bubbles are not delivered to the patient.

With reference to <FIG>, the cardiac assist system <NUM> is configured to provide cardiac assistance for a patient's heart <NUM>, such as by bypassing the left and/or right ventricle, to provide oxygenated blood to the arterial system via the femoral, axillary, or the pulmonary artery. One example of a cardiac assist system <NUM> which can be adapted for use with the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the present disclosure is disclosed in <CIT> Another cardiac assist system <NUM> and a method of applying the cardiac assist system <NUM> to a patient are disclosed in <CIT> Another cardiac assist system <NUM> is disclosed in <CIT>, which is discussed hereinabove. A further example of a cardiac assist system <NUM> which includes a cannula system blood pump, and patient harness is disclosed in <CIT>.

In accordance with some non-limiting embodiments or aspects, the cardiac assist system <NUM> shown in <FIG> includes a drainage cannula <NUM> that is adapted to extend from the right atrium of the patient's heart <NUM> in fluid communication with a pump <NUM> to provide blood to the pump <NUM>. The cardiac assist system <NUM> also includes a femoral or pulmonary artery cannula <NUM>. The cannulas <NUM>, <NUM> are connected to the pump <NUM> and an oxygenator <NUM>, respectively, via surgical tubing <NUM>, <NUM>. Dimensions of the cannulas <NUM>, <NUM> and surgical tubing <NUM>, <NUM> are dependent upon a desired fluid flow rate through the lumen <NUM> (shown in <FIG>) of the corresponding connection between the cannulas and tubing. For example, the cannulas <NUM>, <NUM> can have an inner diameter of about <NUM> ± <NUM> (<NUM> inch to <NUM> inch) and an outer diameter from about <NUM> ± <NUM> (<NUM> inch to <NUM> inch). The surgical tubing <NUM>, <NUM> can have an inner diameter of <NUM> ± <NUM> ( <MAT> inch) and an outer diameter of <NUM> (<NUM> inch).

In some non-limiting embodiments or aspects, the cannula <NUM> can be at least <NUM> in length when configured for insertion into the femoral artery and at least <NUM> in length when configured for insertion into the pulmonary artery, and adapted to extend from the patient's groin to the pulmonary artery of the patient to provide blood to the pulmonary artery for right ventricular support. The cannula <NUM> can be a dual lumen cannula in the internal jugular vein or a surgical cannula connected directly to the heart <NUM>. The cannula <NUM> can be a steerable cannula with a steerable mechanism to control the position and shape of the cannula body. Further, the cannula <NUM> can have a balloon tip to enable self-direction and placement into a flow-directed vessel. An additional lumen can enable placement of additional wires or clot removal devices into the pulmonary artery or vessel. Further, if the cannula <NUM> is a dual lumen cannula, a transition taper between the side holes on the cannula body can have cut-outs to enable strain relief during placement or manipulation or curving of the cannula around a tortuous anatomy. Finally, a coating on the tip of the cannula <NUM> can enable radiopacity for placement and position determination. In some aspects, the cannula <NUM> can be the cannula described in <CIT>.

The pulmonary artery cannula <NUM> is in fluid communication with the pump <NUM> via the tubing <NUM>, whereby the heart's right ventricle is essentially bypassed by draining the right atrium and pumping blood into the pulmonary artery, thereby allowing the right ventricle of the patient to rest and enable right ventricular support. The cannula <NUM> and the tubing <NUM> may be connected together via any of the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein. Preferably, the pump <NUM> is a ventricular assist pump, such as a centrifugal, axial, mixed, or roller pump, as is known in the art, that produces adequate flow rates through the system <NUM> to achieve desired therapeutic results (e.g., either cardiac assist or right ventricular bypass). A suitable pump <NUM> for use with the above-described system <NUM> is disclosed in <CIT>.

The system <NUM> can also include an oxygenator <NUM> in fluid communication with the pump <NUM> and the pulmonary artery cannula <NUM>. A connection between the oxygenator <NUM> and the pump <NUM>, and the oxygenator <NUM> and the pulmonary artery cannula <NUM> can be made using any of the connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein. The oxygenator <NUM> receives blood pumped by the pump <NUM>, oxygenates the blood, and through the pulmonary artery cannula <NUM>, provides oxygenated blood to the pulmonary artery. The oxygenator <NUM> can be a spiral wound sheet membrane type oxygenator or any of the hollow fiber membrane type oxygenators including, but not limited to, the CAPIOX® oxygenator manufactured by the Terumo Cardiovascular Group, the AFFINITY® oxygenator manufactured by Medtronic, the QUADROX® oxygenator manufactured by Maquet, the TANDEMLUNG™ and INSPIRE™ oxygenators manufactured by LivaNova, and others. A controller that may be used for the pump and oxygenator is described in <CIT>.

The system <NUM> can be applied to a patient according to the following method. The method includes inserting a tip of the pulmonary artery cannula <NUM> into a right femoral vein of the patient and moving the tip through the right femoral vein until side holes of the cannula <NUM> in proximity to the tip are disposed in the pulmonary artery. Then, the drainage cannula <NUM> is inserted into the patient's vasculature, and moved through the patient's vasculature until the tip of the drainage cannula <NUM> is disposed in the right atrium. Then, an inlet of the pump <NUM> is connected to the drainage cannula <NUM> with inlet connecting tubing <NUM> to form the fluid tight connection between the drainage cannula <NUM> and inlet connecting tubing <NUM>. Structures and methods for establishing the fluid tight connection between the cannula <NUM> and tubing <NUM>, in accordance with the present disclosure, are described in further detail herein and illustrated in <FIG>. Similarly, the pulmonary artery cannula <NUM> is connected to an outlet of the oxygenator <NUM> through outlet connecting tubing <NUM>. Another piece of auxiliary connecting tubing <NUM> is connected between the outlet of the pump <NUM> and the inlet of the oxygenator <NUM> to form a circuit. Finally, the pump <NUM> and the oxygenator <NUM> are secured to the patient. In operation, blood received by the pump <NUM> from the drainage cannula <NUM> is pumped to the pulmonary artery through the pulmonary artery cannula <NUM> to provide right ventricular and respiratory support without having to bypass the heart and lungs.

Structures and methods for providing the fluid tight connectors <NUM>, <NUM>, <NUM>, <NUM>, <NUM> between portions of the surgical tubing <NUM>, <NUM> and the cannulas <NUM>, <NUM> will now be discussed in detail. For example, a proximal end of a cannula <NUM>, <NUM> may be connected to a distal end of the surgical tubing <NUM>, <NUM>, respectively. The cannulas <NUM>, <NUM> and the surgical tubing <NUM>, <NUM> may be connected directly to each other, or by way of a connector disposed therebetween. As will be appreciated by those skilled in the art, it is important to remove air from the cannula <NUM>, <NUM> and connecting surgical tubing <NUM>, <NUM> to form a secure connection and to prevent contaminates, air bubbles, and other impurities from entering a lumen of the surgical tubing <NUM>, <NUM> and/or cannula <NUM>, <NUM> and being delivered to the patient. As also will be appreciated by those skilled in the art, the structures and methods for connecting portions of tubing disclosed herein can be used for other fluid collection and fluid delivery systems including, but not limited to, powered injectors, IV fluid sets, manual injectors, drug delivery devices, and others.

With reference to <FIG> and <FIG>, an example of the connector <NUM>, which can be configured to establish fluid communication between a portion of the cannulas <NUM>, <NUM> and a portion of the surgical tubing <NUM>, <NUM>, is illustrated. In some non-limiting embodiments or aspects as exemplified in <FIG>, the connector <NUM> is integral with the cannula <NUM>, <NUM>. In other non-limiting embodiments or aspects, the connector <NUM> is formed as a separate component from the cannula <NUM>, <NUM> and may be removably or non-removably connected to the cannula <NUM>, <NUM>. While <FIG> shows the connector <NUM> as being integral with the cannula <NUM>, <NUM>, in other non-limiting embodiments or aspects, the connector <NUM> may be integral with the surgical tubing <NUM>, <NUM>. In further non-limiting embodiments or aspects, the connector <NUM> may be formed as a separate component from the tubing <NUM>, <NUM> and may be removably or non-removably connected to the tubing <NUM>, <NUM>.

The connector <NUM> has an outer surface <NUM> in close proximity with the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>. For example, the outer surface <NUM> of the connector <NUM> can be in direct physical contact with the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>. In some non-limiting embodiments or aspects, one or more ridges or barbs <NUM> of the connector wall <NUM> protruding from the outer surface <NUM> of the connector <NUM> may contact the inner surface <NUM> of the surgical wall <NUM>. In other non-limiting embodiments or aspects, only the ridges or barbs <NUM> may contact the inner surface <NUM>. When the connector <NUM> is connected to the inner wall <NUM> of the surgical tubing <NUM>, <NUM>, the cannula <NUM>, <NUM> is in fluid communication with the surgical tubing <NUM>, <NUM> through the sterile connector <NUM>. The surgical tubing wall <NUM> of surgical tubing <NUM>, <NUM> and cannula <NUM>, <NUM> can be formed from any suitable inert flexible material, as are commonly used in construction of catheters and medical tubing, including flexible biocompatible plastic materials and metals. In some examples, surgical tubing is transparent so that the user can see the fluid level in the tubing during filling. The surgical tubing <NUM>, <NUM> can have an inner diameter ID of about <NUM> ( <MAT> inch) to <NUM> ( <MAT> inch) and an outer diameter OD of about <NUM> ( <MAT> inch) to <NUM> ( <MAT> inch).

As shown in <FIG> and <FIG>, the surgical tubing <NUM>, <NUM> and cannula <NUM>, <NUM> are connected by inserting an open end <NUM> of the connector <NUM> into the open end <NUM> of the surgical tubing <NUM>, <NUM>, thereby forming a continuous lumen <NUM> extending through the surgical tubing <NUM>, <NUM>, the connector <NUM>, and the cannulas <NUM>, <NUM>. The continuous lumen <NUM> is configured to transport fluid F, such as blood.

With continued reference to <FIG> and <FIG>, surgical tubing <NUM>, <NUM> and the connector <NUM> are structured such that, when the connector <NUM> is partially inserted in the surgical tubing <NUM>, <NUM>, the connector wall <NUM> defines at least one opening positioned such that fluid can be introduced to or pass through the at least one opening into the continuous lumen <NUM>. For example, as shown in <FIG> and <FIG>, the connector <NUM> can include at least one fluid port or opening <NUM> having a diameter D1 extending through a sidewall <NUM> thereof for establishing fluid communication with the continuous lumen <NUM>. Also, the opening <NUM> can establish fluid communication with the continuous lumen.

With continued reference to <FIG> and <FIG>, an opening <NUM> is sized and positioned to allow a user to fill the lumen <NUM> with the fluid F to remove air from the lumen <NUM>, which could form air bubbles in the system <NUM> (shown in <FIG>), while connecting the surgical tubing <NUM>, <NUM> to the connector <NUM>. In some examples, the connector <NUM> includes a single circular opening <NUM>. Desirably, the opening <NUM> is sized to allow a sufficient volume of the fluid F to pass into the lumen <NUM> through the opening <NUM> so that the lumen <NUM> can be filled relatively quickly. However, the opening <NUM> should also be sized and positioned so that a sufficient seal is formed between the outer surface <NUM> of the connector <NUM> and the inner surface <NUM> of the surgical tubing <NUM>, <NUM>. A size of the opening <NUM> can also impact a hoop strength of the connector <NUM>. For example, a thin and long channel (e.g., Width << Length) may create an overhang which flexes during use and could fracture. A size of the opening <NUM> should be selected so that this fracture does not occur. Another consideration in determining a size of the opening <NUM> is surface tension. For example, if the opening <NUM> is too thin or narrow, drops of fluid will form on the opening <NUM> and will not pass through the opening <NUM> into the lumen <NUM>. Accordingly, the opening <NUM> should be wide enough so that fluid easily passes through the opening <NUM>. Another consideration is closing force. For example, the force required to form the connection between the surgical tubing <NUM>, <NUM> and the connector <NUM> is dependent upon how far the connector <NUM> must be inserted into the surgical tubing <NUM>, <NUM> to seal the opening <NUM>. Therefore, a shorter opening <NUM> will require less force to close. In particular, the opening <NUM> should be small enough so that an average strength user can easily insert connector <NUM> into the surgical tubing <NUM>, <NUM> without unreasonable effort.

Still referring to <FIG> and <FIG>, in some embodiments or aspects, when used with connector <NUM> having an inner diameter of <NUM> (<NUM> inch), a single circular opening <NUM> may have a diameter D1 of about <NUM> to <NUM>, preferably about <NUM> to about <NUM>, and an area of about <NUM><NUM> to <NUM><NUM>, preferably about <NUM><NUM> to <NUM><NUM>. An area of the opening <NUM> can be about <NUM>% to <NUM>% and, preferably, <NUM>% to <NUM>%, of an inner cross-sectional area of the connector <NUM>.

In other embodiments or aspects, the size, shape, and number of openings can be selected based on a size of the lumen <NUM> or how much fluid will need to be provided to fill the lumen <NUM>. In some embodiments or aspects, the connector <NUM> can include multiple openings <NUM>, such as openings <NUM> arranged axially along the connector wall <NUM> of the connector <NUM>. In other embodiments or aspects, the openings <NUM> could comprise one or more axially extending slits rather than circular openings.

With continued reference to <FIG> and <FIG>, the open end <NUM> of the connector <NUM> can include one or more structures for securely anchoring the open end <NUM> of the connector <NUM> into the surgical tubing <NUM>, <NUM>. For example, as shown in <FIG>, the connector <NUM> can include a tapered nozzle or connector <NUM>, such as a male luer connecter, for establishing a fluid connection between the cannulas <NUM>, <NUM> and surgical tubing <NUM>, <NUM>. Other connectors, such as threaded connectors or snap fit connectors, can also be used for securing the connector <NUM> to the surgical tubing <NUM>, <NUM>. The connector <NUM> also can include one or more structures for preventing or restricting a user from detaching the connector <NUM> from the surgical tubing <NUM>, <NUM>. For example, as shown in <FIG>, the connector <NUM> includes one or more annular ridges or barbs <NUM> protruding radially outwardly from the connector wall <NUM> of the connector <NUM> configured to contact an inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>. The ridges or barbs <NUM> can extend radially outwardly from portions of the connector wall <NUM> of the connector <NUM> by about <NUM> to <NUM>, such that an outer diameter of the portion of the connector <NUM> including the ridge(s) is about <NUM> to <NUM>. In other embodiments or aspects, the connector <NUM> can include axially extending ridges, protrusions, detents and similar structures for securing the connector <NUM> to the surgical tubing <NUM>, <NUM>. In other embodiments or aspects, the surgical tubing <NUM>, <NUM> can include one or more protrusions extending radially inwardly from the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM> to secure the connector <NUM> to the surgical tubing <NUM>, <NUM>.

In some non-limiting embodiments or aspects, as shown in <FIG>, an outer diameter OD2 at the open end <NUM> of the connector <NUM> is about <NUM> (<NUM> inches), an outer diameter OD3 of the connector <NUM> with the ridge <NUM> is <NUM> (<NUM> in), and an outer diameter OD4 of a second barb or ridge <NUM>, if present, with the connector wall <NUM> is about <NUM> (<NUM> in).

In order to connect the connector <NUM> and the surgical tubing <NUM>, <NUM>, a user performs the following actions, as shown in <FIG>. As described herein, the actions desirably can be performed by a single user. First, the user holds one of the tubes (e.g., either the connector <NUM> or the surgical tubing <NUM>, <NUM>) in place against a surface and, with a second hand, partially inserts the connector <NUM> into the surgical tubing <NUM>, <NUM> in a direction shown by arrow A1, as shown in <FIG>. The connector <NUM> is partially inserted in the surgical tubing <NUM>, <NUM>, when the surgical tubing <NUM>, <NUM> covers a portion of the outer surface <NUM> of the connector <NUM>, but does not cover the at least one opening <NUM>. In this partially inserted position, as shown in <FIG>, the at least one opening <NUM> is at least partially exposed, so that fluid can be applied to the lumen <NUM> through the at least partially exposed opening <NUM>. In contrast, the connector <NUM> is fully inserted in the surgical tubing <NUM>, <NUM> when the surgical tubing <NUM>, <NUM> covers the at least one opening <NUM>.

Once the surgical tubing <NUM>, <NUM> and the connector <NUM> are in the partially inserted position, as shown in <FIG>, the user applies or delivers a fluid F, such as saline, to the continuous lumen <NUM> defined by the surgical tubing <NUM>, <NUM>, the connector <NUM>, and the cannula <NUM>, <NUM> through the at least one opening <NUM> of the connector <NUM>, such that air present in the continuous lumen <NUM> escapes from the lumen through the at least one opening <NUM> as shown by arrow A2. The fluid F can be delivered or applied as a stream <NUM> of fluid. The stream <NUM> of fluid can be provided from a syringe <NUM> including a nozzle <NUM> for directing the fluid stream <NUM> towards the opening <NUM>, as shown by arrow A3. In other examples, the fluid stream <NUM> can be provided by a syringe including a needle capable of being inserted through the opening <NUM>. In other examples, the fluid stream <NUM> can be provided by different types of injectors, pumps, and similar devices, as are known in the art.

The user continues to apply or deliver the fluid stream <NUM> until the lumen <NUM> is filled and/or over flowing with fluid, as shown in <FIG>, thereby ensuring that no air is trapped in the lumen <NUM>, which could form air bubbles. For example, a fluid meniscus <NUM> may extend slightly over the opening <NUM> indicating that the lumen <NUM> is filled. Once the lumen <NUM> is filled, the user pushes the connector <NUM> further into the surgical tubing <NUM>, <NUM> in the direction of arrow A4. Inserting the connector <NUM> further into the surgical tubing <NUM>, <NUM> decreases a volume of the lumen <NUM>, which causes additional fluid to flow out of the at least one opening <NUM> until the surgical tubing <NUM>, <NUM> covers the at least one opening <NUM>. Beneficially, this continuous outflow of fluid F out of the opening <NUM> prevents inflow of air into the lumen <NUM>, which creates the fluid tight sealed connection, in which, as shown in <FIG> and <FIG>, the opening <NUM> is sealed against the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>.

In another exemplary method of use, the wet-to-wet connection between the surgical tubing <NUM>, <NUM> and connector <NUM> can be formed by a back-bleeding technique. In this technique, the connector <NUM> is partially inserted into the surgical tubing <NUM>, <NUM> so that the opening <NUM> remains exposed, as described above. The user then unclamps a patient line or cannula, which allows fluid (e.g., blood and/or saline) pushed by the patient's blood pressure to flow into the surgical tubing <NUM>, <NUM> from the connector <NUM>. As the fluid enters the connector <NUM>, air is pushed out of the connector <NUM> through the opening <NUM>. When the surgical tubing <NUM>, <NUM> is filled with fluid, such that the fluid starts to spill out of the opening <NUM>, the user can push connector <NUM> fully into the surgical tubing <NUM>, <NUM> to seal the connection.

With reference to <FIG>, another embodiment of a connector <NUM> for connecting a cannula <NUM>, <NUM> to surgical tubing <NUM>, <NUM> is illustrated including an inner tube <NUM> configured to be inserted into the surgical tubing <NUM>, <NUM>. As in previously described examples, the connector <NUM> creates a sterile, fluid tight connection and can be performed easily by a single user. The connector <NUM> is similar to the connector <NUM> described above and is used in a similar manner. In particular, a tapered section <NUM> of the connector <NUM> is configured to be partially inserted into the surgical tubing <NUM>, <NUM>. Once in the partially inserted position, a fluid stream is applied to remove air from a continuous lumen <NUM> formed by the surgical tubing <NUM>, <NUM> and the connector <NUM>. However, unlike in previously described examples, the connector <NUM> includes a port or opening <NUM> covered by a septum <NUM>. The septum <NUM> forms a fluid tight seal over the opening <NUM>, which prevents fluid F in the lumen <NUM> from escaping through the opening <NUM>. In some examples, using a septum <NUM> may be preferable so that the user does not come into contact with the fluids F in the lumen <NUM>. The septum <NUM> is desirably impermeable to liquids, but is permeable to air so that air in the lumen <NUM> can escape through the septum <NUM> and opening <NUM>. For example, the septum <NUM> can be formed from various hydrophobic films and fabrics, as are known in the art, including polytetrafluoroethylene (e.g., Gore-Tex®). In order to fill the lumen <NUM>, the user inserts a needle of a syringe through the septum <NUM> and expels fluid F into the lumen <NUM> through the needle. Once the lumen <NUM> is filled, the user pushes the connector <NUM> farther into the surgical tubing <NUM>, <NUM>, such that the opening <NUM> and septum <NUM> are covered by the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>. In other examples, the septum <NUM> may be impenetrable both to liquids and air. In that case, a syringe needle including a venting lumen could be inserted through the septum <NUM> to deliver fluid F to the lumen <NUM>. In such an embodiment, as fluid, such as saline, is injected into the lumen <NUM>, air is permitted to escape through the venting lumen.

With reference to <FIG>, another example of a connector <NUM> for connecting a cannula <NUM>, <NUM> to surgical tubing <NUM>, <NUM> is illustrated. As in previous examples, the connector <NUM> is configured to be inserted into the surgical tubing <NUM>, <NUM>. In this example, the circular opening shown in <FIG> is replaced with a slot, notch, or channel <NUM> extending axially inwardly from an open end <NUM> of the connector <NUM>. As shown in <FIG>, the channel <NUM> has a curved or semi-circular proximal end <NUM> and a straight distal end <NUM> which is coextensive with the distal end <NUM> of the connector <NUM>. As in previous examples, the channel <NUM> is sized so that the lumen <NUM> can be filled quickly, while still allowing a good seal to form between the connector <NUM> and the surgical tubing <NUM>, <NUM>. For example, the channel <NUM> can have a length L1 of about <NUM> to <NUM> or, preferably about <NUM> to <NUM>, and a width W1 of about <NUM> to <NUM> or, preferably about <NUM> to <NUM>. As in previous examples, an area of the channel <NUM> can be about <NUM>% to about <NUM>% and, preferably, about <NUM>% to <NUM>%, of an inner cross sectional area of the connector <NUM>.

Dimensions for a number of different examples of channels <NUM> constructed in accordance with the current disclosure are shown in the following Table. The channels <NUM> are configured to be used for connecting together sections of <NUM>/<NUM> inch tubing having an inner diameter of <NUM> (<NUM> inch) and an inner cross section area of about <NUM><NUM> (<NUM> inch<NUM>). While not intending to be bound by these examples, Connectors <NUM>-<NUM> in the Table were found to work well during testing.

The connection between the surgical tubing <NUM>, <NUM> and the connector <NUM> is formed in the same manner as in the previously described examples. Specifically, the user partially inserts the connector <NUM> into the surgical tubing <NUM>, <NUM>, such that at least a portion of the channel <NUM> remains exposed. The user then applies a stream of fluid F into the lumen <NUM> through the partially exposed portion of the channel <NUM>. Once the lumen <NUM> is filled, such that fluid overflows through the channel <NUM>, the user pushes the connector <NUM> farther into the surgical tubing <NUM>, <NUM>, such that the inner surface <NUM> of the surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM> entirely covers the channel <NUM>, thereby forming the fluid tight connection between the surgical tubing <NUM>, <NUM> and the connector <NUM>.

With reference to <FIG>, another example of a connector <NUM> for connecting a cannula <NUM>, <NUM> to a surgical tubing <NUM>, <NUM> is illustrated. As in previous examples, the connector <NUM> is configured to be inserted into the surgical tubing <NUM>, <NUM>. In this example, the opening <NUM> extends through a surgical tubing wall <NUM> of the surgical tubing <NUM>, <NUM>. As shown in <FIG>, the surgical tubing wall <NUM> can include a channel <NUM> extending axially inwardly from an open end <NUM> thereof. In other examples, as described previously, the opening <NUM> on the surgical tubing wall <NUM> can be a circular or elliptical shaped opening. In some examples, the channel <NUM> has a curved or semi-circular proximal end <NUM> and a straight distal end <NUM> which is coextensive with the distal end <NUM> of the surgical tubing <NUM>, <NUM>. As in previous examples, the channel <NUM> is sized so that the lumen <NUM> (shown in <FIG>) can be filled quickly, while still allowing a good seal to form between the surgical tubing <NUM>, <NUM> and the connector <NUM>. As in previous examples, the connector <NUM> is inserted in the surgical tubing <NUM>, <NUM> in a direction of the arrow A8 (shown in <FIG>). As shown in <FIG>, an outer surface <NUM> of the connector <NUM> seals the opening <NUM> to prevent fluid in the lumen <NUM> from passing through the opening <NUM>. In order to enhance an integrity of the seal, the connector <NUM> can include a sealing structure, such as an annular ridge or protrusion <NUM>, extending from an outer surface of the inner tube <NUM> which engages an inner surface of the outer tube <NUM>. The ridge or protrusion <NUM> is positioned so that it can be inserted into the surgical tubing <NUM>, <NUM> past the proximal end <NUM> of the opening <NUM> as shown in <FIG>, thereby sealing the lumen <NUM> from the opening <NUM>.

With reference to <FIG>, another example of a connector <NUM> for connecting a cannula <NUM>, <NUM> to a surgical tubing <NUM>, <NUM> is illustrated. Rather than being integrally formed with one of the cannula <NUM>, <NUM> or the surgical tubing <NUM>, <NUM>, the connector <NUM> shown in <FIG> is formed as a separate component that is configured for removably or non-removably connecting to one of the cannula <NUM>, <NUM> or the surgical tubing <NUM>, <NUM>.

With continued reference to <FIG>, the connector <NUM> has a hollow body <NUM> having a first open end <NUM> and a second open end <NUM> with a lumen <NUM> extending between the first open end <NUM> and the second open end <NUM>. In some non-limiting embodiments or aspects, the first open end <NUM> may be spaced apart from the second open end <NUM> along a longitudinal axis. The first open end <NUM> is sized to be received within an open end of a first tubing, such as one of the surgical tubing <NUM>, <NUM> (shown in <FIG>). Similarly, the second open end <NUM> is sized to be received within an open end of a second tubing, such as one of the cannulas <NUM>, <NUM> (shown in <FIG>).

With continued reference to <FIG>, the body <NUM> has at least one channel <NUM>, similar to the at least one channel <NUM> described herein with reference to <FIG>. The at least one channel <NUM> extends through a sidewall of the hollow body <NUM> proximate to the first open end <NUM>. The at least one channel <NUM> may be recessed axially from a terminal surface <NUM> of the first open end <NUM>. The channel <NUM> is sized and positioned to allow a user to fill the lumen <NUM> with fluid to remove air from the lumen <NUM> during connection of the connector <NUM> with the first tubing, such as one of the surgical tubing <NUM>, <NUM> (shown in <FIG>). In some non-limiting embodiments or aspects, the connector <NUM> includes a U-shaped channel <NUM> that is sized to allow a sufficient volume of the fluid to pass into the lumen <NUM> through the channel <NUM> so that the lumen <NUM> can be filled relatively quickly. The channel <NUM> may have a curved end <NUM> and a pair of sides <NUM> connecting the curved end <NUM> to the terminal surface <NUM> of the first open end <NUM>.

A size of the channel <NUM> can also impact a hoop strength of the connector <NUM>. Another consideration in determining a size of the channel <NUM> is surface tension. For example, if the channel <NUM> is too thin or narrow, drops of fluid will form on the channel <NUM> and will not pass through the channel <NUM> into the lumen <NUM>. Accordingly, the channel <NUM> should be wide enough so that fluid easily passes through the channel <NUM>. Another consideration is closing force. For example, the force required to form the connection between the surgical tubing <NUM>, <NUM> and the connector <NUM> is dependent upon how far the connector <NUM> must be inserted into the surgical tubing <NUM>, <NUM> to seal the channel <NUM>. Therefore, a shorter channel <NUM> will require less force to close. In particular, the channel <NUM> should be small enough so that an average strength user can easily insert connector <NUM> into the surgical tubing <NUM>, <NUM> without unreasonable effort. In some non-limiting embodiments or aspects, a width of the at least one channel <NUM> is from <NUM>% to <NUM>% of a length of the at least one channel <NUM>. In other embodiments or aspects, the size, shape, and number of channels <NUM> can be selected based on a size of the lumen <NUM> or how much fluid will need to be provided to fill the lumen <NUM>. In some embodiments or aspects, the connector <NUM> can include multiple channels <NUM>, such as channels <NUM> arranged circumferentially around the first open end <NUM>.

With continued reference to <FIG>, the first and second open ends <NUM>, <NUM> of the connector <NUM> can include one or more structures for securely anchoring the open ends <NUM>, <NUM> to the surgical tubing <NUM>, <NUM> or the cannulas <NUM>, <NUM>. For example, the connector <NUM> can include a tapered portion <NUM> at the first and second open ends <NUM>, <NUM> to facilitate insertion of the first and second open ends <NUM>, <NUM> into the open ends of the cannulas <NUM>, <NUM> or surgical tubing <NUM>, <NUM>. Other connectors, such as threaded connectors or snap fit connectors, can also be used for securing the connector <NUM> to the surgical tubing <NUM>, <NUM>. In various embodiments or aspects, the second open end <NUM> may be removably or non-removably connected to the open end of the cannulas <NUM>, <NUM>, such as shown in <FIG>. For example, the second open end <NUM> may be connected to the open end of the cannulas <NUM>, <NUM> using adhesive or by being molded integrally with the open end of one of the cannulas <NUM>,<NUM>. The first open end <NUM> of the connector <NUM> may have one or more structures for preventing or restricting a user from detaching the connector <NUM> from the surgical tubing <NUM>, <NUM>. For example, as shown in <FIG>, the connector <NUM> includes one or more annular ridges or barbs <NUM> protruding radially outwardly from the outer surface of the body <NUM>. The one or more ridges or barbs <NUM> are configured to contact an inner surface <NUM> of the surgical tubing wall of the surgical tubing <NUM>, <NUM> (shown in <FIG>).

In some non-limiting embodiments or aspects, the connector <NUM> has a gripping portion <NUM> configured for being grasped by the user's fingers during handling of the connector <NUM>. The gripping portion <NUM> is positioned between the first open end <NUM> and the second open end <NUM>. The gripping portion <NUM> may have a curved shape with a first end 923a having a first diameter, a second end 923b having a second diameter, and an intermediate portion 923c between the first end 923a and the second end 923c. The intermediate portion 923c may have a third diameter less than the first diameter and the second diameter.

In order to connect the first open end <NUM> of the connector <NUM> and the surgical tubing <NUM>, <NUM>, a user performs the following actions, as shown in <FIG>. As shown in <FIG><NUM>, the second open end <NUM> is connected to the cannula <NUM>, <NUM>. As described herein, the actions desirably can be performed fry a single user. First, the user holds either the connector <NUM> or the surgical tubing <NUM>, <NUM> in place with one hand and, with a second hand, partially inserts the first open end <NUM> of the connector <NUM> into the open end of the surgical tubing <NUM>, <NUM> in a direction shown by arrow B1, as shown in <FIG>. The connector <NUM> is partially inserted in the surgical tubing <NUM>, <NUM>, when the surgical tubing <NUM>, <NUM> covers a portion of the outer surface at the terminal end of the first open end <NUM> of the connector <NUM>, but does not cover the at least one channel <NUM>. In this partially inserted position, as shown in <FIG>, the at least one channel <NUM> and a terminal surface of the open end of the surgical tubing <NUM>, <NUM> define an opening <NUM> positioned so that fluid can pass through the opening <NUM> into or out of the lumen <NUM> of the connector <NUM> and the lumen <NUM> of the surgical tubing <NUM>, <NUM> and the cannula <NUM>, <NUM>. The opening <NUM> may have a surface area of <NUM> mm2 to <NUM> mm2. In some embodiments or aspects, the opening <NUM> may have a surface area that is <NUM>% to <NUM>% of a cross-sectional area of the surgical tubing <NUM>, <NUM>.

Once the surgical tubing <NUM>, <NUM> and the first open end <NUM> of the connector <NUM> are in the partially inserted position, as shown in <FIG>, the user applies or delivers a fluid F, such as saline, to fill the lumen <NUM> of the connector <NUM> and the lumen <NUM> of the surgical tubing <NUM>, <NUM> and the cannula <NUM>, <NUM>. The fluid F can be delivered from a syringe <NUM> including a nozzle <NUM> for directing a fluid stream <NUM> towards the opening <NUM>. In other examples, the fluid stream <NUM> can be provided by a syringe including a needle capable of being inserted through the opening <NUM>. In other examples, the fluid stream <NUM> can be provided by different types of injectors, pumps, and similar devices, as are known in the art.

The user continues to apply or deliver the fluid stream <NUM> until the lumens of the surgical tubing <NUM>, <NUM>, the connector <NUM>, and the cannula <NUM>, <NUM> are filled and/or over flowing with fluid, thereby ensuring that no air is trapped. For example, a fluid meniscus may extend slightly over the opening <NUM> indicating that the lumens of the surgical tubing <NUM>, <NUM>, the connector <NUM>, and the cannula <NUM>, <NUM> are filled. Once the lumens are filled, the user pushes the first open end <NUM> of the connector <NUM> further into the surgical tubing <NUM>, <NUM> in the direction of arrow B2 shown in <FIG>. Inserting the connector <NUM> further into the surgical tubing <NUM>, <NUM> decreases a volume of the lumen, which causes additional fluid to flow out of the at least one opening <NUM> until the surgical tubing <NUM>, <NUM> covers the at least one opening <NUM>. Beneficially, this continuous outflow of fluid out of the opening <NUM> prevents inflow of air into the lumen, which creates the fluid tight sealed connection, in which the opening <NUM> is sealed against the inner surface of the surgical tubing <NUM>, <NUM>.

Claim 1:
A connector (<NUM>) comprising:
a hollow body (<NUM>) having a first open end (<NUM>) spaced apart from a second open end (<NUM>) with a lumen (<NUM>) extending between the first open (<NUM>) end and the second open end (<NUM>);
a gripping portion (<NUM>) between the first open end (<NUM>) and the second open end (<NUM>), the gripping portion (<NUM>) having a first end (923a) having a first diameter, a second end (923b) having a second diameter, and an intermediate portion (923c) between the first end (923a) and the second end (923b), the intermediate portion (923c) having a third diameter less than the first diameter and the second diameter; and
a single U-shaped channel (<NUM>) extending through a sidewall of the hollow body (<NUM>), the U-shaped channel (<NUM>) being recessed axially from a terminal surface (<NUM>) of the first open end (<NUM>),
wherein the first open end (<NUM>) is sized to be received within an open end of a first tubing (<NUM>, <NUM>),
wherein, when the first open end (<NUM>) is partially inserted into the open end of the first tubing (<NUM>, <NUM>), the U-shaped channel (<NUM>) and a terminal surface of the open end of the first tubing (<NUM>, <NUM>) define a single opening (<NUM>) positioned so that fluid passes through the opening (<NUM>) into or out of the lumen (<NUM>), and fluid delivered through the opening fills the lumen of the hollow body and the first tubing, and
wherein, when the first open end (<NUM>) is fully inserted into the open end of the first tubing (<NUM>, <NUM>), the U-shaped channel (<NUM>) is covered by an inner surface of the first tubing to cover the opening (<NUM>).