Patent Description:
The present invention relates to a syringe adapter and, more particularly, to a spinning connector for a syringe adapter.

Healthcare workers, such as pharmacists and nurses, can be subject to acute and long term health risks upon repeated exposure to drugs or solvents which might escape into the air during drug preparation, drug administration, and other similar handling. This problem is particularly serious when cytotoxins, antiviral drugs, antibiotics, and radiopharmaceuticals are concerned. The health risks faced by exposure to these drugs can include the development of cancer, reproductive problems, genetic conditions, and other serious concerns. Other hazardous areas may be sample taking, such as samples concerning virus infections or the like. When performing infusions, it is often necessary to inject a drug or other medical substance into the infusion fluid, inside an infusion bag or other infusion fluid container. This is often done by means of penetrating a septum or other fluid barrier of an injection port on the infusion bag or on the infusion fluid line with a needle of a syringe filled with the medical fluid in question. However, even before this, it may be necessary to transfer the medical fluid from a vial to a syringe and then from the syringe to a secondary container. In each of these steps, staff may be exposed to the medical fluid by means of contamination. Such contamination may be vaporized medical fluid or aerosol in the air. The contaminations may contaminate the staff through their lungs, or by vaporized medical fluid or aerosol in the air which condensates on the skin to thereafter penetrate the skin of the staff. Some medicaments are even known to penetrate protection gloves and, thereby, contaminate the staff.

Exposure to contaminations like this may, on a long term basis, give rise to high concentrations of medicaments in the blood or the human body of the staff as described above. It has been understood that, due to the many transferring steps between containers e.g., vials, syringes, infusion systems, etc., the risk for contamination during the actual insertion and retraction of a needle from the container, e.g., a vial, needs to be contained. Closed system transfer devices (CSTDs) have been developed to ensure that the medicament is contained in the transfer device during transfer of the medicament.

From <CIT>, a closed fluid transfer system for fluidly interconnecting a syringe to any one of a patient I. set, a vial and an I. bag, is known and includes a first adapter defining a lumen and supporting a seal across a first end of its lumen, the first adapter supporting a rear end of a needle within the lumen, wherein the seal is movable relative to the needle such that a tip of the needle penetrates through the seal; and a second adapter defining a lumen and supporting a seal across a first end of its lumen; wherein when the second adapter is coupled to the first adapter, the second adapter seal abuts the first adapter seal and moves the first adapter seal relative to the tip of the needle such that the tip of the needle penetrates through the abutting first adapter seal and second adapter seal. <CIT> discloses a fluid connector for selectively establishing fluid communication between a first medical container and a second medical container. The fluid connector includes an adapter configured to removably attach to the first container. The adapter includes an access port and a cap. The connector further includes an outer sleeve connected to the adapter and a tubular body retained at least partially within the outer sleeve. The body has a proximal end connected to the adapter and a distal end connected to the second container. The fluid connector is transitionable from a first position in which the first container and the second container are in fluid isolation to a second position in which the first container and the second container are in fluid communication. At least a portion of the cap of the adapter is retained within the outer sleeve.

<CIT>, <CIT> and <CIT> form state of the art according to Art. <NUM> (<NUM>) EPC for the current invention. <CIT> relates to a medical transfer device for transferring fluids from a vial to another vessel, comprising a piercing device having a main body in a tubular shape, a lock member having at least one flexible member, at least one arm for attaching said lock member into the main body, at least one protrusion formed on the lock member being guidable in a guiding channel and a guiding window provided at a connection portion of a connector (<NUM>), a needle holder having a needle functioning as a first flow path through which a liquid can pass, a first barrier member disposed in said lock member made of an elastic material for opening and closing the first flow path, a connector for attaching to the vial, comprising an inner portion having a lumen which functions as a second flow path, at least one elevating member has a portion of, at least partly, helix shape, and a second barrier member disposed in the inner portion and is made of an elastic material for opening and closing the second flow path. Said medical transfer device further comprises, an elevating member follower disposed in the main body for limiting movement of at least one flexible member of the lock member such that an axial movement of the piercing device with respect to the connector is prevented, said elevating member follower being rotatable around a longitudinal axis of the piercing device with respect to the connector and guidable on the elevating member. <CIT> discloses a syringe adapter including a housing having a first end and a second end with the first end configured to be secured to a first container, a cannula having a first end and a second end with the second end positioned within the housing, and a collet having a first end and a second end with at least a portion of the collet received within the housing. The collet includes a body defining a passageway, a seal member received by the passageway, and an arcuate, resilient locking member connected to the body of the collet. The collet is movable from a first position where the locking member is open to receive a mating connector to a second position where radially outward movement of the locking member is restricted.

<CIT> describes a fluid transfer system including packaging having a body with a sidewall extending between an open top end and a bottom end and defining an interior cavity, and at least one protrusion extending radially inward from the sidewall into the interior cavity. The system also includes a fluid transfer device including an inner member and an outer member surrounding at least a portion of the inner member. The inner member having a first position where the inner member is configured to rotate freely relative to the outer member and a second position where rotation of the inner member relative to the outer member is restricted in a first rotational direction. The fluid transfer device also including a locking arrangement configured for cooperating with the at least one protrusion to prevent rotation of the inner member relative to the outer member upon an application of a compressive force on the packaging.

Generally, a CSTD includes a syringe adapter for connection to a syringe and an adapter for connection to a vial, a second syringe, or a conduit providing fluid access to the patient's circulatory system. According to one arrangement, the healthcare practitioner may reconstitute a powdered or lyophilized compound with saline or some other reconstitution medium by attaching the syringe to the vial via connection of the respective adapters, reconstituting the drug, aspirating the compound into the syringe, disconnecting the adapters, and then attaching the syringe to the fluid conduit through the respective adapters to a patient delivery device, such as an IV line or syringe for administration to the patient.

One type of an adapter that can be used in a CSTD has a first connector having a male or female luer-lock element that is arranged to be joined with a corresponding female or male luer-lock element of a second connector component. According to one aspect, the second connector component can be a patient delivery device, such as an IV line or a syringe. The luer-lock element can, thus, be screwed into and unscrewed from the corresponding luer-lock element. It is desirable to prevent an accidental or inadvertent unscrewing of the components, which could lead to the disconnection of the fluid passage. Such disconnection may entail a serious contamination risk for a patient and/or any other person in the vicinity of the disconnected medical connector. The issue of safety in administration of hazardous medical compounds is one that has been identified as being of critical importance by professional organizations and government agencies alike.

It is, therefore, desirable to provide an adapter for enabling fluid transfer between the first connector and the second connector by facilitating a positive connection of the connectors and avoiding inadvertent or accidental disconnection of the connectors.

According to one aspect which does not form part of the current invention, a syringe adapter includes a housing having a first end and a second end and defining an interior space, a seal arrangement including a membrane received within the interior space of the housing with the seal arrangement moveable within the housing, a connector body positioned adjacent to the first end of the housing and configured to be connected with a syringe barrel. The seal arrangement includes a membrane. The connector body including a locking projection that cooperates with the retaining ring of the housing to secure the connector body to the housing. The connector body is rotatable relative to the housing in first and second directions. The locking projection engages the retaining ring to restrict axial movement of the connector body relative to the housing. The syringe adapter also includes a cannula secured to the connector body with the seal arrangement configured to cooperate with the cannula to provide a sealed transfer of fluids through the cannula to a mating connector.

According to the present invention, a syringe adapter includes a housing having a first end and a second end and defining an interior space, a seal arrangement received within the interior space of the housing, and a connector body positioned adjacent to the first end of the housing and configured to be connected with a syringe barrel. The connector body is secured to the housing and rotatable relative to the housing in first and second directions. The connector body is axially fixed relative to the housing. The syringe adapter further includes a cannula secured to the connector body, with the seal arrangement configured to cooperate with the cannula to provide a sealed transfer of fluids through the cannula to a mating connector.

The connector body further includes a locking projection and the housing may include a retaining ring, where the locking projection engages the retaining ring to restrict axial movement of the connector body relative to the housing. The housing may define a recess adjacent to the retaining ring, with the recess of the housing receiving the locking projection. The locking projection and the retaining ring may each define an angled surface, with the angled surface of the locking projection configured to engage the angled surface of the retaining ring to bias the locking projection radially outward during connection of the locking projection to the retaining ring. The retaining ring may extend radially outward from the housing. The retaining ring extends circumferentially around the housing. The connector body may include a plurality of locking projections.

The connector body may include a skirt extending in an axial direction, with the skirt of the connector body receiving the first end of the housing. The connector body may define an opening, with the locking projection extending radially inward from the skirt and positioned adjacent to the opening of the connector body. The connector body may be a different color than the housing. The cannula may be entirely positioned within the housing. The seal arrangement may be moveable within the housing, the seal arrangement comprising a membrane. The connector body may include a grip arrangement configured to be engaged by a user. The connector body may be a female luer connector.

These and other features and characteristics of the present invention, 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. 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.

The illustrations generally show preferred and non-limiting aspects of the systems and methods of the present disclosure. While the descriptions present various aspects of the devices, it should not be interpreted in any way as limiting the disclosure. Furthermore, modifications, concepts, and applications of the disclosure's aspects are to be interpreted by those skilled in the art as being encompassed by, but not limited to, the illustrations and descriptions herein.

Further, for purposes of the description hereinafter, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. The term "proximal" refers to the direction toward the center or central region of the device. The term "distal" refers to the outward direction extending away from the central region of the device. However, it is to be understood that the disclosure may assume various 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. For the purpose of facilitating understanding of the disclosure, the accompanying drawings and description illustrate preferred aspects thereof, from which the disclosure, various aspects of its structures, construction and method of operation, and many advantages may be understood and appreciated.

Referring to <FIG>, one aspect of a system <NUM> includes a syringe adapter <NUM> and a patient connector <NUM>. The syringe adapter <NUM> is configured to receive the patient connector <NUM> and form a sealed connection therewith. The syringe adapter <NUM> may be utilized to transfer fluid from a syringe (not shown) connected to the syringe adapter <NUM> to a patient line (not shown) connected to the patient connector <NUM>. The syringe adapter <NUM> may also be utilized in connection with other components of a closed system transfer device including, but not limited to, a vial adapter, IV bag spike, and an IV line.

Referring to <FIG>, the syringe adapter <NUM> includes a housing <NUM>, a connector body <NUM>, a seal arrangement <NUM>, and a cannula <NUM>. The housing <NUM> has a first end <NUM> and a second end <NUM> and defines an interior space <NUM> that receives the seal arrangement <NUM>. The connector body <NUM> is configured to be secured to a container, such as a syringe barrel. In particular, the connector body <NUM> includes a female luer connector <NUM> that is configured to mate with a male luer connector of a syringe barrel, although other suitable connector arrangements may be utilized. The connector body <NUM> is positioned adjacent to the first end <NUM> of the housing <NUM> and is secured to the housing <NUM>. More specifically, the connector body <NUM> includes an axially extending skirt <NUM> that receives the first end <NUM> of the housing <NUM>. The connector body <NUM> includes a plurality of locking projections <NUM> that extend radially inward from the skirt <NUM>. The locking projections <NUM> of the connector body <NUM> cooperate with a retaining ring <NUM> that extends radially outward from the housing <NUM> adjacent to the first end <NUM> of the housing <NUM>. The retaining ring <NUM> of the housing <NUM> extends circumferentially around the housing <NUM>. The connector body <NUM> also includes a grip arrangement <NUM> configured to provide a gripping surface and visual indication of a location to grip the syringe adapter <NUM>. The grip arrangement <NUM> is shown as two pairs of elliptical recesses, although other suitable grip arrangements may be utilized. Further, the connector body <NUM> may have a different color than the housing <NUM> or other visual indication that the connector body <NUM> is separate from the housing <NUM>.

Upon assembly of the housing <NUM> to the connector body <NUM>, the locking projections <NUM> of the connector body <NUM> are received within a recess <NUM> defined by the housing <NUM> below the retaining ring <NUM>. The locking projections <NUM> of the connector body <NUM> engage the retaining ring <NUM> of the housing <NUM> to restrict axial movement of the connector body <NUM> relative to the housing <NUM> in a direction extending from the second end <NUM> of the housing <NUM> to the first end <NUM> of the housing <NUM>. Further, the skirt <NUM> of the connector body <NUM> abuts a radially extending flange <NUM> of the housing <NUM> to restrict axial movement of the connector body <NUM> relative to the housing <NUM> in a direction extending from the first end <NUM> of the housing <NUM> to the second end <NUM> of the housing <NUM>. The connector body <NUM>, however, is rotatable relative to the housing <NUM> in both rotational directions about the longitudinal axis of the housing <NUM>.

Referring still to <FIG>, the connector body <NUM> includes four locking projections <NUM>, although one or more locking projections <NUM> may be provided. The skirt <NUM> of the connector body <NUM> also defines a plurality of openings <NUM> adjacent to each of the locking projections <NUM>. The locking projections <NUM> of the connector body <NUM> and the retaining ring <NUM> of the housing <NUM> each include an angled surface <NUM>, <NUM> to facilitate assembly of the connector body <NUM> to the housing <NUM>. As shown in <FIG>, when the connector body <NUM> is moved onto the first end <NUM> of the housing <NUM>, the angled surfaces <NUM> of the locking projections <NUM> will engage the angled surface <NUM> of the retaining ring <NUM> to bias the locking projections <NUM> of the connector body <NUM> radially outward. Continued movement of the connector body <NUM> onto the housing <NUM> causes the locking projections <NUM> to slide completely over the retaining ring <NUM> with the skirt <NUM> of the connector body <NUM> snapping back to its unbiased position. As discussed above, after assembly, the locking projections <NUM> of the connector body <NUM> are received by the recess <NUM> of the housing <NUM> below the retaining ring <NUM>.

Referring to <FIG>, <FIG>, <FIG>, and <FIG>, the connector body <NUM> receives the cannula <NUM> with the female luer connector <NUM> in fluid communication with the cannula <NUM>. The cannula <NUM> is received within the interior space <NUM> of the housing <NUM> and is entirely surrounded by the housing <NUM>. The seal arrangement <NUM> is positioned within the interior space <NUM> of the housing <NUM> and is moveable between the first and second ends <NUM>, <NUM> of the housing <NUM>. The seal arrangement <NUM> includes a membrane <NUM> and a collet <NUM> and is configured to cooperate with a mating connector, such as the patient connector <NUM>, to provide for the sealed transfer of fluid through the cannula <NUM> into the mating connector. In use, the collet <NUM> receives the patient connector <NUM> with the membrane <NUM> engaging a membrane <NUM> on the patient connector <NUM>. The collet <NUM> receives a portion of the patient connector <NUM> and moves the collet <NUM> toward the first end <NUM> of the housing <NUM>, which secures the collet <NUM> to the patient connector <NUM> and causes the cannula <NUM> to pierce the membranes <NUM>, <NUM> of the seal arrangement <NUM> and the patient connector <NUM>. The seal arrangement <NUM> enables the sealed, closed transfer of fluids from a first container, such as a syringe, to a second container, such as an IV bag, by ensuring the membranes of the syringe adapter <NUM> and patient connector <NUM> are engaged during fluid transfer and by isolating the cannula <NUM> when fluids are not being transferred. Further, as noted above, the collet <NUM> is secured to a mating connector during use such that the syringe adapter <NUM> cannot be disengaged from the mating connector during fluid transfer to cause leakage of fluids being transferred. Although a specific seal arrangement is shown, the syringe adapter <NUM> may be utilized in connection with other suitable seal arrangements.

Referring again to <FIG>, during use of the syringe adapter <NUM>, a syringe (not shown) is connected to the female luer connector <NUM> of the connector body <NUM> by gripping the connector body <NUM> to restrain rotational movement of the connector body <NUM> relative to the housing <NUM> while securing the syringe to the female luer connector <NUM>. The connector body <NUM> may be restrained using the gripping arrangement <NUM>. The syringe is removed in the same manner by gripping the connector body <NUM> to restrain rotational movement of the connector body <NUM> relative to the housing <NUM> and removing the syringe from the female luer connector <NUM>. Accordingly, the syringe adapter <NUM> allows for purposeful connection and disconnection of the syringe to the syringe adapter <NUM> while preventing accidental disconnection by allowing the connector body <NUM> to rotate relative to the housing <NUM>. For example, when the syringe adapter <NUM> is connected to an IV line via the patient connector <NUM>, movement of the IV line is not translated to the connector body <NUM>, which can torque the connector body <NUM> and accidentally disconnect a syringe or other container from the connector body <NUM>.

Referring to <FIG> and <FIG>, further aspects of the grip arrangement <NUM> are shown. The grip arrangement <NUM> may be a spherical recess <NUM> defined by the skirt <NUM> of the connector body <NUM> (<FIG>) or may be a plurality of generally rectangular projections <NUM> extending radially outward from the skirt <NUM> of the connector body <NUM> (<FIG>). As noted above, other suitable grip arrangements <NUM> may be provided to improve the grip ergonomics and various colors and textures can be utilized to reinforce that the connector body <NUM> is separate from the housing <NUM> and rotatable relative to the housing <NUM> thereby requiring gripping of the connector body <NUM> for attachment and detachment of the syringe from the female luer connector <NUM>. The grip arrangement <NUM> may have different numbers, shapes, and sizes and may also utilize a logo or other branding for the grip arrangement <NUM>.

Claim 1:
A syringe adapter (<NUM>) comprising:
a housing (<NUM>) having a first end (<NUM>) and a second end (<NUM>) and defining an interior space (<NUM>);
a seal arrangement (<NUM>) received within the interior space (<NUM>) of the housing (<NUM>);
a connector body (<NUM>) positioned adjacent to the first end (<NUM>) of the housing (<NUM>) and configured to be connected with a syringe barrel, the connector body (<NUM>) comprises a locking projection (<NUM>), and the housing (<NUM>) comprises a retaining ring (<NUM>), the locking projection (<NUM>) engages the retaining ring (<NUM>) to restrict axial movement of the connector body (<NUM>) relative to the housing (<NUM>); and
a cannula (<NUM>) secured to the connector body (<NUM>), the seal arrangement (<NUM>) configured to cooperate with the cannula (<NUM>) to provide a sealed transfer of fluids through the cannula (<NUM>) to a mating connector,
characterized in that
the connector body (<NUM>) is secured to the housing (<NUM>) and freely rotatable relative to the housing (<NUM>) in first and second directions, when the connector body (<NUM>) is secured to and axially fixed relative to the housing (<NUM>) and
the retaining ring (<NUM>) extends circumferentially around the housing (<NUM>).