Patent Description:
As is known, a three-way medical connector or simply three-way connector (or stopcock) is an auxiliary product which is used in lines or with systems for supply of fluid to, or collection of blood from, a patient. For example, a connector of this type is used in an administration line in order to introduce a drug therein by means of use of a syringe for example. Or, the connector is connected to (or is part of) a catheter, and through it, it is possible not only to administer a drug to the patient, but also to collect his blood.

This connector can also be part of a unit or kit for supply of a fluid endovenously, and which regulates the distribution of the aforementioned fluid to the vascular system of a patient, such as a supply kit used in the administration of drugs, for graduation in the aforementioned supply, for oncological supplies, and for contrast, nutritional and other liquids.

A known three-way connector generally comprises a body with a tubular central part, usually with an overall cylindrical form, with an inner cavity. This cavity is open at a first end of this body, and is closed at a second end thereof.

The inner cavity of the aforementioned tubular central part communicates with inner ducts of connection portions which are usually in the form of three arms which project radially from this central part of the connector. Two of these connection portions (for input) can be connected to means for supply of fluids: in general, a first input portion can be connected to a supply of a physiological solution (for example a bag which is connected by means of a tube to the connector), whereas the second input connection portion receives a medical fluid, for example from a syringe or from a line for administration of a drug.

The third arm or third connection portion (for output) is on the other hand connected to the patient for example by means of a tube which conveys the fluid to the patient (which fluid is received by at least one of the input connection portions). For example, the three-way connector is connected to a tube which can transfer the fluid to be administered to the patient, or it is associated with, or is part of, a catheter which is directly supported on the body of the patient (typically on the arm).

In order to put at least one of the input connection portions selectively into communication with the output portion, a valve element is provided, which is engaged such as to rotate inside the tubular central part of the body of the connector. This valve element comprises a body which is also generally tubular or cylindrical, and projects from the first end of the aforementioned tubular central part with a portion which acts as a grip, usually having arms which project radially in order to facilitate grasping thereof.

On the outer surface of its tubular body, the valve element has a perimetrical groove which is partly annular (i.e. which affects only part of the cylindrical surface of this body, and is not closed on itself in the form of a ring), which groove can connect at least one of the input connection portions selectively to the output portion, or can intercept and close all communication between the input and output. This takes place by means of rotation of the valve element in the central part of the connector, and appropriate selective positioning of the aforementioned groove relative to said portions. It will be appreciated that this groove can be replaced by channels or the like; in all cases, the tubular body of the valve element generally comprises at least one fluid connection unit, which can permit the connection (or interruption of the connection) between at least one input connection portion and the output connection portion, and the passage of a fluid between said portions.

Amongst the primary uses of a three-way connector is that of being able to administer to the patient drugs in addition to the basic supply, by means of the second input connection portion placed between the first input connection portion and the third, output connection portion. This supply normally takes place by means of a syringe which has an end part that is engaged at the second input connection portion according to the known standards, after a safety stopper placed thereon has been removed.

In the case of a simple three-way connector, upon completion of administration of the drug from the second connection portion, a health operator removes the syringe and puts the protective stopper back onto this portion. It can easily be imagined that, in the inner volume of this portion (blind volume) delimited on the one hand by the stopper and on the other hand by the tubular body of the valve element, there remains some of the drug which has shortly beforehand been administered via the syringe, but has not yet reached the patient.

The task of cleaning again this blind volume which still contains some drug is left up to the flow of liquid (physiological solution) of the basic supply. The volume of liquid (for washing) which must pass through the three-way connector in order for the drug to be completely administered (and thus removed from the above-described blind space) is known as the "washing volume".

A three-way connector with a reduced washing volume has the advantages of less waste of drug (which often has a high cost) and of basic solution, as well as a shorter supply time.

<CIT> relates to a blood sampling system comprising a stopcock provided with a sampling part designed to reduce or eliminate the occurrence of stagnation of fluid flowing therethrough; the system, i.e. the stopcock and sampling port device includes a housing, an elastomeric element, a cap, a handle, and a divided septum. The housing defines an internal fluid passageway having a first port, a second port, and a third port, and the divided septum is operably coupled to the housing within the third port. The septum is configured to encourage turbulence of fluid passing through the third port, thereby reducing the occurrence of stagnation of fluid flowing therethrough.

<CIT> relates to a flushable fluid handling assembly including a housing element defining a central bore and at least first, second and third ports, the first and third ports being line connection ports and the second port being a syringe connection port. A handle element is selectably positionable relative to the housing element, at least one fluid passageway communicating between at least two of the at least first, second and third ports. The at least one fluid passageway is selectably defined by rotational positioning of the handle element relative to the housing element. A first fluid flow guide extends radially to an inner facing wall of the central bore, the first fluid flow guide being associated with the at least one fluid flow passageway and a syringe being fixedly connected to the second port, the syringe including an axially displaceable plunger.

<CIT> relates to a multiport valve comprising a casing having at least one fluid inlet port and at least one fluid outlet port, a seal disposed adjacent to each outlet port, a cylinder disposed within a central opening in the casing and having an axial channel with a channel surface and at least one depression within the channel and balls biased toward the cylinder and away from each outlet port. Rotating the cylinder such that the depression aligns with the ball forces the biased ball into the depression and away from the seal opening the outlet port allowing for fluid flow therethrough and rotating the cylinder such that the depression is misaligned with respect to the depression causes the channel surface to overcome the bias and force the ball against the seal thus closing the outlet port. The multiport valve may include a bearing assembly disposed between the valve casing and cylinder and a ball biasing member angled to point towards the cylinder and bearing assembly, providing for ease in rotation of the cylinder.

Three-way connectors provided with inner means which can facilitate the washing of the blind volume have been known for some time. These connectors are mainly of two types, i.e. according to a first type, the valve element has a form such as to facilitate the flow of the washing liquid towards the blind volume, and according to a second type, there is also a bulkhead (for washing) inside the second input connection portion.

In a connector of the first type (such as, for example, the one described in <CIT>) the valve element has its body provided at the fluid connection unit with a wall or flow deflector which can divert the flow obtained from the first input connection portion into a blind volume, thus generating the washing volume required in order to remove the residues of drug (or other bodily fluid) which are present in the blind volume. In a connector of the second type (such as the one which is the subject of <CIT> or <CIT>), the flow deflector, also known as the washing deflector, is present inside the second connection portion. For example, in the aforementioned US patents, this washing bulkhead can cooperate with the flow deflector of the rotary valve element, in order to determine the washing volume required to remove whatever is present from the blind volume.

In addition, again with reference to the second type of connector, this washing bulkhead can be integral with the connector (i.e. with the second input connection portion), as in <CIT>, or it can be produced separately from the connector, and subsequently connected in hot conditions, welded on, snapped on, or otherwise connected to the body of the connector (as described in <CIT>).

The present invention relates to a medical connector of the second type, and with a washing bulkhead which is produced separately from the body of the connector, but is secured thereto.

The objective of the present invention is to provide a three-way connector which is improved compared with the corresponding known connectors.

In particular, the objective of the present invention is to provide a medical connector wherein a high volume of washing liquid is directed towards the blind volume when necessary.

Another objective of the invention is to provide a medical connector of the above-described type, which can however be created with known instruments and restricted costs, and which can be used in a conventional manner.

A further objective of the invention is to provide a medical connector wherein it is possible to optimise the conveying of the washing fluid towards the blind volume, such as, for example, to prevent the formation of turbulence of liquid which is stagnating inside the blind volume.

These objectives and others, which will become apparent to persons skilled in the art, are achieved by a three-way connector according to the main claim.

For better understanding of the present invention, the following drawings are appended purely by way of non-limiting example, wherein:.

With reference to the aforementioned figures, a three-way connector according to the invention is generally indicated as <NUM>. It comprises a body <NUM> with a tubular central part <NUM> which is open at a first end <NUM>, and closed at a second end <NUM>. The central part has a cavity <NUM> to which there are connected ducts <NUM>, <NUM> and <NUM> provided respectively inside connection portions <NUM>, <NUM> and <NUM> projecting radially from the tubular central part <NUM>. The first and the second (input) portions <NUM> and <NUM> can be connected to corresponding supplies of fluid to be supplied to a patient, in a controlled manner, through the three-way connector, and through the third connection portion (for output of the fluid) <NUM>. For example, the first input connection <NUM> can be connected to a line for supply of a physiological solution, whereas the second input connection <NUM> can be connected in a known manner to a syringe, for supply of a drug to a patient.

In the cavity <NUM> of the central part <NUM>, there is inserted a valve element <NUM> having a tubular body <NUM>, which is introduced from the first end <NUM> of the central part <NUM>. The tubular body <NUM> has an end gripping portion <NUM> placed outside the cavity <NUM>, and having radial arms 16A. Inside a surface <NUM> of this tubular body <NUM>, which can face an inner surface <NUM> of the aforementioned cavity <NUM>, a (semi-annular) groove <NUM> is provided, the function of which is to put the portions <NUM>, <NUM> and <NUM> into selective communication and permit or prevent the supply of fluid, of fluid and a drug, or only the drug, to the patient. The body <NUM> is thus shaped so as to have said function.

This takes place in a manner which in itself is known to persons skilled in the art, and will therefore not be described further.

In the embodiment shown in the figures, the gripping portion <NUM> is perforated centrally by means of a through-hole <NUM> which defines a first open end of the inner cavity <NUM> of the valve element. This cavity <NUM> is also open at a second end <NUM> thereof, placed at the front of the second, closed end <NUM> of the tubular part <NUM> of the body <NUM>.

A stopper <NUM> of a type which in itself is known can be disposed in the hole <NUM>.

The cavity <NUM> of the valve unit <NUM> has a transverse wall <NUM> which subdivides this cavity into two sections, i.e. a first (upper) section <NUM> which communicates with the hole <NUM>, and a second (lower) section <NUM> which is closed by the second end <NUM> of the cavity <NUM>. In this transverse wall <NUM> there is present a known through-hole <NUM> which puts the two sections <NUM> and <NUM> of the cavity <NUM> into communication.

The first input connection portion <NUM> is provided on an outer surface thereof with fins <NUM> which can allow it to be connected to a tube of a medical line (which is connected for example to a bag of physiological solution), not shown. The fins define a (partial, as in the figures) or complete thread.

Similar fins <NUM> and <NUM> are present on the exterior of the second input connection portion <NUM> and of the output connection portion <NUM>; these fins can cooperate by screwing respectively and alternatively with closure bodies and connection bodies. For example, the fins <NUM> cooperate with a closure body or stopper <NUM> which can reclose the second input connection portion <NUM> when it is not being used, whereas the fins <NUM> can cooperate with a tubular body <NUM> which is threaded in the interior, and for example can tighten on the output connection portion <NUM> a tube which is directed to a patient; in this last case, the body <NUM> is engaged on an outer connection body, which body is typically connected to a tube directed to the patient (not shown).

In the case of the second connection portion <NUM>, instead of the above-described closure stopper, a syringe for introduction of a drug into the portion <NUM> can be connected to the fins <NUM>.

Preferably, the stopper <NUM> can be provided with parts which can yield and/or be opened, in order to permit the passage of a needle of a syringe in order to inject into the connector <NUM> a drug that is then conveyed by the fluid, which enters through the first connection portion <NUM>, and exits from the third connection portion <NUM>, towards the patient.

At least partly inside the duct <NUM> (and also inside the second connection portion <NUM>) there is present a unit <NUM> which acts as a deflector for the flow of fluid which reaches the first input connection portion <NUM>, and directs the flow into the second connection portion <NUM>, in order to remove the medical liquid which is present in the blind volume of this second portion delimited by the cavity <NUM> of the central part <NUM> of the body <NUM> of the connector, and by the stopper <NUM> which recloses the second connection portion <NUM> when it does not need to be used in order to insert a drug in the connector.

More particularly, with reference to <FIG>, the unit or deflector <NUM> comprises a body <NUM> with a first end <NUM> and a second end <NUM>. The body <NUM> is inserted axially (i.e. along the longitudinal axis) inside the duct <NUM>, but its first end <NUM> projects into the cavity <NUM> of the body <NUM> of the connector (at the groove <NUM> provided in the tubular body <NUM> of the valve element <NUM>). From this first end <NUM>, there extend towards the second end <NUM> four walls <NUM>-<NUM> disposed substantially orthogonally to one another and longitudinally along the body <NUM>.

More particularly, the first and third walls <NUM>, <NUM> or "diverting walls", which are opposite one another, are disposed orthogonally to the flow of the fluid in the groove <NUM> of the valve element <NUM>. These walls <NUM> and <NUM> have a (slightly) arched surface, with spokes such as to "close" towards the first connection portion <NUM>. In other words, as can be seen in <FIG>, the first and third diverting walls have a surface which is concave, or with concavity <NUM> facing in the direction of input of the fluid into the first input connection portion. Thanks to this form, and to the fact that the first end <NUM> of the body of the deflector <NUM> penetrates (slightly) into the groove <NUM> of the valve element <NUM>, when a fluid enters the first connection portion <NUM> and goes into the groove <NUM> in order to reach the output connection portion <NUM>, this flow is intercepted substantially by the diverting walls <NUM> and <NUM> (orthogonal to the aforementioned flow), and is directed (or diverted) as a washing volume into the duct <NUM>, and then into the second input connection portion <NUM>. This washing liquid or volume goes into said second connection portion and exits therefrom (since the portion is closed by the stopper <NUM>), still moving along the diverting walls <NUM> and <NUM>, but on the side opposite the concave surface <NUM>, in order to go into the output connection portion <NUM>.

Thanks to the projection of the first end <NUM> into the body <NUM> and into the groove <NUM>, a relatively substantial quantity of fluid is intercepted while it is flowing towards the output connection portion <NUM>, thus ensuring optimal washing of the blind volume and optimal safety for the operators who are operating on the patient, as well as for the patient himself (who are thus not at risk of coming into contact with potentially dangerous fluids).

The other two walls <NUM> and <NUM> of the body <NUM> of the deflector <NUM> are placed orthogonally to the above-described diverting walls <NUM> and <NUM>, and act as separators for the fluid input into the duct <NUM>, which by this means can "wash" the blind volume in an optimal manner thanks to the diverting walls <NUM> and <NUM>, and can flow better out of the duct <NUM> towards the duct <NUM> of the output connection portion <NUM>.

At the end <NUM>, the body <NUM> of the deflector <NUM> comprises opposite projecting arms <NUM> and <NUM> which are placed below the walls <NUM> and <NUM>, and are resiliently deformable. These arms preferably have a triangular form, and taper at the free end, which provides them with rigidity in the direction orthogonal thereto.

Each arm supports an element which is semi-spherical, or (at least) has a spherical end cap <NUM> which can be snapped into seats <NUM> which are radiated or have a curvilinear surface provided inside an inner wall <NUM> of the second output connection portion <NUM>.

This form of the end elements <NUM> and of the corresponding seats facilitates the insertion of the deflector <NUM> inside the duct <NUM>, and its retention in position. A contribution in this respect is also made by a triangular area <NUM> of the diverting walls <NUM> and <NUM>, which area is supported on the wall <NUM> of the connection portion <NUM>, said triangular area <NUM> being close to the second end <NUM> of the body <NUM> of the deflector <NUM>.

It should be noted that the first end <NUM> of the body <NUM> of the deflector <NUM> has arched surfaces <NUM> for connection with the ends <NUM> and <NUM> of the walls <NUM> and <NUM>. Each of these surfaces can cooperate with a corresponding end part (not shown) of the groove <NUM> of the tubular body <NUM> of the valve element <NUM>, when it rotates in the cavity <NUM> of the body <NUM> of the connector <NUM>, in order to form the required connection between at least one of the input portions <NUM>, <NUM> and the output connection portion <NUM> of this body, or to interrupt this connection.

Thanks to the connection surface <NUM>, which is arched with a cavity facing towards the cavity <NUM>, the body <NUM> of the valve element <NUM> can rotate freely in the aforementioned cavity <NUM>. When it meets the first end <NUM> of the body <NUM> of the deflector <NUM>, this body <NUM> "slides" on the adjacent connection surface <NUM>, thus thrusting the deflector <NUM> towards the interior of the duct <NUM> and of the second input connection portion <NUM>. Thanks to the resilience of the arms <NUM> and <NUM> and the insertion of their semi-spherical elements <NUM> into the respective seats <NUM>, displacement of the body <NUM> of the deflector <NUM> takes place towards the interior of said connection portion <NUM>, and the body <NUM> of the valve element <NUM> can rotate freely in the cavity <NUM> of the body of the connector <NUM>. When the rotation is completed, the resilient arms <NUM> and <NUM> take the body <NUM> back into position in the duct <NUM>, with the first end <NUM> inserted in the cavity <NUM>, and in particular in the groove <NUM> of said valve element.

The invention thus makes it possible to direct a quantity of washing volume towards the second connection portion <NUM> without any modification in the production of the valve element (which need not be specific: in order to obtain the washing of the blind volume). This washing volume is created by collecting the fluid which penetrates into the groove <NUM> directly from the groove (thanks to the first end <NUM> of the deflector <NUM> projecting into the groove <NUM>) and directing the fluid into the aforementioned connection portion thanks to the deflector <NUM>. The deflector, which is resiliently connected (by being snapped in or also welded by ultrasound or by means of another method) to the wall <NUM> of the second connection portion <NUM>, permits normal movement of the valve element in the cavity <NUM> of the body of the connector <NUM>.

A description has been provided of a specific embodiment of the invention. However, on the basis of the foregoing description, persons skilled in the art can obtain other solutions, such as the one wherein the deflector <NUM> comprises only two opposite diverting walls <NUM> and <NUM>, or wherein the diverting walls <NUM> and <NUM> do not have a curvilinear development. Furthermore, the resilient arms <NUM> and <NUM> can be associated with the wall <NUM> without providing the semi-spherical elements <NUM>, but, for example, by being welded or glued directly on this wall. It should be noted that the seats <NUM> can have a semi-spherical form, or they can be defined by a single groove which is toroidal (or axisymmetric) provided in the wall <NUM> of the second connection portion <NUM>. In this case, a coupling will be provided between the body <NUM> and this wall in order to prevent the rotation of the deflector <NUM> around the longitudinal axis of the duct <NUM> / second connection portion <NUM>.

It should also be noted that the diverting walls <NUM> and <NUM> define sections of the duct <NUM> which are different because of the arched form of the surface <NUM>. However, these sections can also have a substantially identical volume.

<FIG> show a variant of the invention. In these figures, parts corresponding to those already described are indicated with the same numerical references as the corresponding parts described with reference to <FIG>.

In the figures in question, the deflector unit has the body <NUM> provided with the first end <NUM> and the second end <NUM>. However, in this embodiment of the invention, the first end has a surface <NUM> which is continuously concave above the walls <NUM> and <NUM>, i.e. it is raised at the ends <NUM> and <NUM> of these walls. In addition, there is a resiliently deformable element, substantially in the form of an "S" or a serpentine shape <NUM> at the end <NUM>, with opposite end edges <NUM> and <NUM> which are arched but not curvilinear (i.e. they are broken) (corresponding to the above-described spherical caps <NUM>), which edges can cooperate with the seats <NUM> similarly to what takes place in the case of the aforementioned caps <NUM>.

This (resilient) element <NUM> permits the movement of the deflector unit <NUM> towards the interior of the connection portion <NUM>, when the valve element <NUM> is rotated.

The movement in particular is generated by bosses <NUM> projecting inside the groove <NUM>, which, with the rotation of the valve element <NUM>, come into contact with the adjacent ends <NUM> and <NUM> of the wall <NUM> or <NUM>, and, by pressing on the end itself, displace the deflector towards the interior of the connection portion <NUM> (see <FIG>).

In fact, in this case also, when at rest, the first end <NUM> of the body <NUM> of the deflector unit <NUM> projects into the groove <NUM>, such as to direct a quantity of washing volume towards the portion <NUM>.

Thanks to the fact that the deflector unit <NUM> is separate from the body <NUM> of the connector <NUM>, the invention makes it possible to form said unit differently, such as to optimise the divergence of the flow of the fluid defining the washing volume, and avoiding turbulence of liquid stagnating inside the blind volume.

Claim 1:
Three-way medical connector (<NUM>) comprising a body (<NUM>) having a tubular central part (<NUM>) from which connection portions (<NUM>, <NUM>, <NUM>) project radially, a first (<NUM>) and a second (<NUM>) input connection portion being able to receive fluids, at least one of these fluids being administered to a patient through a third, output connection portion (<NUM>), inside a cavity (<NUM>) of said tubular central part (<NUM>) there being disposed such as to rotate a tubular valve element (<NUM>) with a perimetrical groove (<NUM>) which can put at least one out of said first and second connection portions (<NUM>, <NUM>) selectively into communication with the third connection portion (<NUM>), inside said second connection portion (<NUM>) there being provided a washing bulkhead or flow deflector (<NUM>) which can direct a washing fluid obtained from the first connection portion (<NUM>) into said second connection portion (<NUM>), said washing bulkhead or deflector (<NUM>) being an autonomous element relative to the body (<NUM>) of the connector (<NUM>), characterised in that the deflector or washing bulkhead projects into the cavity (<NUM>) of the tubular central part (<NUM>) of the body (<NUM>) of the connector (<NUM>) where the rotary tubular valve element (<NUM>) is present, said deflector (<NUM>) comprising a body (<NUM>) having a first end (<NUM>) and a second end (<NUM>), said body (<NUM>) being disposed inside said second connection portion (<NUM>) and along the longitudinal axis of this second portion (<NUM>), the first end (<NUM>) projecting into the cavity (<NUM>) of the tubular central part (<NUM>) of the body (<NUM>) of the connector and into the perimetrical groove (<NUM>) of the tubular valve element (<NUM>), the second end (<NUM>) being at least partly resiliently deformable and connected to an inner wall (<NUM>) of said second connection portion (<NUM>) so as to allow the deflector member (<NUM>) to move within the second connection portion (<NUM>).