Field of the Invention
The present invention relates to a fluid transfer device for a closed transfer of fluid from a medical device to a patient delivery device, such as an IV line or syringe. More specifically, the invention is directed to a fluid transfer device and packaging therefor configured for engaging/disengaging a connection element on the fluid transfer device using the packaging.
Description of Related Art
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 alarmingly 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.
Generally, a CSTD includes an 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.
In one aspect of the present invention, a fluid transfer system includes 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 configured to be received within the interior cavity and including an inner member configured to be secured to a container 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 provided on at least a portion of the inner member and accessible through at least a portion of the outer member. The locking arrangement is 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.
The at least one protrusion may be a pair of protrusions that are oriented opposite from each other around a circumference of the packaging. The packaging may further include at least one button extending radially outward from an outer portion of the sidewall opposite the at least one protrusion. The at least one protrusion may be configured to deflect radially inward in response to the compressive force directed to the at least one button.
The outer member of the fluid transfer device may define an opening configured to receive the at least one protrusion of the packaging when the fluid transfer device is positioned within the interior cavity of the packaging. The at least one protrusion of the packaging and the opening of the outer member of the fluid transfer device may cooperate to prevent rotation of the fluid transfer device relative to the packaging when the fluid transfer device is positioned within the interior cavity of the packaging.
The at least one protrusion of the packaging may be configured to engage the locking arrangement through the opening in the outer member of the fluid transfer device to prevent rotation of the inner member relative to the outer member when the fluid transfer device is positioned within the interior cavity of the packaging.
The locking arrangement may be a recess defined by the inner member, with the recess having an engagement surface configured to engage the at least one protrusion of the packaging. The inner member may be a luer connection.
The inner member and the outer member may define a ratchet arrangement, where the ratchet arrangement is only engaged when the inner member is in the second position. The inner member may be moveable in an axial direction within the outer member between the first and second positions of the inner member.
The packaging may define a plurality of ribs extending radially inward from the sidewall of the packaging, with the plurality of ribs configured to engage a portion of the fluid transfer device when the fluid transfer device is positioned within the interior cavity of the packaging.
The fluid transfer system may further include a seal arrangement positioned within the outer member, with the seal arrangement moveable within the outer member and configured to engage a mating connector. The seal arrangement having an actuated position adjacent to the inner member and an initial position spaced from the inner member, where the seal arrangement prevents the inner member from moving from the first position to the second position when the seal arrangement is in the actuated position. The inner member and the outer member may define a ratchet arrangement, where the ratchet arrangement is only engaged when the inner member is in the second position.
In a further aspect of the present invention, a fluid transfer device includes an inner member configured to be secured to a container 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 device further includes a seal arrangement positioned within the outer member. The seal arrangement is moveable within the outer member and configured to engage a mating connector. The seal arrangement having an actuated position adjacent to the inner member and an initial position spaced from the inner member, where the seal arrangement prevents the inner member from moving from the first position to the second position when the seal arrangement is in the actuated position.
The inner member and the outer member may define a ratchet arrangement, where the ratchet arrangement is only engaged when the inner member is in the second position.
The device may further include a locking arrangement provided on at least a portion of the inner member and accessible through at least a portion of the outer member. The inner member may be moveable in an axial direction within the outer member between the first and second positions of the inner member. The locking arrangement may be a recess defined by the inner member, the recess having an engagement surface.
In another aspect of the present invention, a patient connector and packaging includes a patient connector having a body and at least one protrusion extending radially outward from the body, and packaging having an open first end, a second end, and a sidewall extending between the first and second ends. The packaging includes a plurality of guide protrusions positioned adjacent to the first end of the packaging. The at least one protrusion is configured to be received between the plurality of guide protrusions of the packaging.
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
Referring to
The packaging 12 also includes projections 28 extending radially inward from the sidewall 26 that are configured to move radially inward upon engagement of the elongate buttons 16. The projections 28 extend in a direction substantially parallel to the longitudinal axis of the packaging 12. In certain aspects, the projections 28 may be angled relative to the longitudinal axis. The projections 28 may have any desired shape, including, but not limited to, square, rectangular, rounded, etc. In one aspect, the projections 28 extend from a region of the inner sidewall 26 proximate to the closed bottom end 20 to an area of the inner sidewall 26 opposite the elongate buttons 16. The projections 28 may be oriented 180 degrees apart around a circumference of the packaging 12 such that each projection 28 is aligned with the elongate button 16. For example, the longitudinal midpoint of each projection 28 may be aligned with an axis extending through the center of each elongate button 16. The projections 28 may define an alignment feature for aligning the fluid transfer device 10 within the interior cavity 14 of the packaging 12. The projections 28 are configured to deflect radially inward in response to a radially-directed force imparted on the elongate buttons 16. Although the projections 28 are separated equally about the circumference of the packaging 12, it is to be appreciated that more than two projections 28 may be provided with equal or unequal separation about the circumference of the container 10.
The packaging 14 may be constructed from any known material, such as a molded, injected, or thermo-formed plastic material. Desirably, the packaging 14 is constructed from a material that provides flexibility of the sidewall 26 in at least the radial direction with respect to the longitudinal axis. In particular, the packaging 14 is desirably constructed from a material that allows the cross-sectional shape of the packaging 14 to change with an application of a radially-directed force, as will be described in greater detail below.
Referring to
Referring to
Referring to
The axial force may be a slight nudge of the inner member 38, although any other suitable axial force may be utilized. Rotation in an opposite direction to remove the container from the fluid transfer device 10, however, will not engage the ratchet arrangement 44 and the inner member 38 will merely rotate within the outer member 34 due to the sloped surface of the ratchet teeth 46. Thus, a container cannot be removed from the inner member 38 of the fluid transfer device 10 when the inner member 38 is in the first or second position without the use of the packaging 12. The container can be removed from the fluid transfer device 10 by inserting the fluid transfer device 10 into the packaging 12 and engaging the elongate buttons 16 of the packaging 12 such that the projections 28 of the packaging 12 are received by the engagement surfaces 42 to lock the inner member 38 relative to the outer member 34. With the inner member 38 locked or rotationally fixed relative to the outer member 34, the container can be removed from the inner member 38 of the fluid transfer device 10.
Referring to
Referring again to
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Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred aspects, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed aspects, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any aspect can be combined with one or more features of any other aspect.
This application claims priority to U.S. Provisional Application Ser. Nos. 61/982,049 and 61/982,091, both filed on Apr. 21, 2014, and U.S. Provisional Application Ser. No. 62/050,930 filed on Sep. 16, 2014, which are each hereby incorporated by reference in their entirety.
Number | Name | Date | Kind |
---|---|---|---|
4436125 | Blenkush | Mar 1984 | A |
4564054 | Gustavsson | Jan 1986 | A |
4673404 | Gustavsson | Jun 1987 | A |
4932937 | Gustavsson et al. | Jun 1990 | A |
5052725 | Meyer et al. | Oct 1991 | A |
5104158 | Meyer et al. | Apr 1992 | A |
5122129 | Olson et al. | Jun 1992 | A |
5280876 | Atkins | Jan 1994 | A |
5290254 | Vaillancourt | Mar 1994 | A |
5322518 | Schneider et al. | Jun 1994 | A |
5334188 | Inoue et al. | Aug 1994 | A |
5360011 | McCallister | Nov 1994 | A |
5395348 | Ryan | Mar 1995 | A |
5437650 | Larkin et al. | Aug 1995 | A |
5464123 | Scarrow | Nov 1995 | A |
5472430 | Vaillancourt et al. | Dec 1995 | A |
5478328 | Silverman et al. | Dec 1995 | A |
5487728 | Vaillancourt | Jan 1996 | A |
5507733 | Larkin et al. | Apr 1996 | A |
5509911 | Cottone, Sr. et al. | Apr 1996 | A |
5545152 | Funderburk et al. | Aug 1996 | A |
5607392 | Kanner | Mar 1997 | A |
5609584 | Gettig et al. | Mar 1997 | A |
5611792 | Gustafsson | Mar 1997 | A |
5647845 | Haber et al. | Jul 1997 | A |
5685866 | Lopez | Nov 1997 | A |
5807347 | Bonaldo | Sep 1998 | A |
5897526 | Vaillancourt | Apr 1999 | A |
6063068 | Fowles et al. | May 2000 | A |
6089541 | Weinheimer et al. | Jul 2000 | A |
6113583 | Fowles et al. | Sep 2000 | A |
6132404 | Lopez | Oct 2000 | A |
6139534 | Niedospial, Jr. et al. | Oct 2000 | A |
6221041 | Russo | Apr 2001 | B1 |
6221056 | Silverman | Apr 2001 | B1 |
6343629 | Wessman et al. | Feb 2002 | B1 |
6358236 | DeFoggi et al. | Mar 2002 | B1 |
6378714 | Jansen et al. | Apr 2002 | B1 |
6409708 | Wessman | Jun 2002 | B1 |
6474375 | Spero et al. | Nov 2002 | B2 |
6478788 | Aneas | Nov 2002 | B1 |
6544246 | Niedospial, Jr. | Apr 2003 | B1 |
6551299 | Miyoshi et al. | Apr 2003 | B2 |
6585695 | Adair et al. | Jul 2003 | B1 |
6599273 | Lopez | Jul 2003 | B1 |
6610040 | Fowles et al. | Aug 2003 | B1 |
6629958 | Spinello | Oct 2003 | B1 |
6656433 | Sasso | Dec 2003 | B2 |
6715520 | Andreasson et al. | Apr 2004 | B2 |
6814726 | Lauer | Nov 2004 | B1 |
6852103 | Fowles et al. | Feb 2005 | B2 |
6875203 | Fowles et al. | Apr 2005 | B1 |
6875205 | Leinsing | Apr 2005 | B2 |
6911025 | Miyahara | Jun 2005 | B2 |
6997917 | Niedospial, Jr. et al. | Feb 2006 | B2 |
7040598 | Raybuck | May 2006 | B2 |
7083605 | Miyahara | Aug 2006 | B2 |
7097209 | Unger et al. | Aug 2006 | B2 |
7261707 | Frezza et al. | Aug 2007 | B2 |
7306584 | Wessman et al. | Dec 2007 | B2 |
7326194 | Zinger et al. | Feb 2008 | B2 |
7350535 | Liepold et al. | Apr 2008 | B2 |
7354427 | Fangrow | Apr 2008 | B2 |
7452349 | Miyahara | Nov 2008 | B2 |
7547300 | Fangrow | Jun 2009 | B2 |
7628772 | McConnell et al. | Dec 2009 | B2 |
7648491 | Rogers | Jan 2010 | B2 |
7658734 | Adair et al. | Feb 2010 | B2 |
7743799 | Mosler et al. | Jun 2010 | B2 |
7744581 | Wallen et al. | Jun 2010 | B2 |
7758560 | Connell et al. | Jul 2010 | B2 |
7803140 | Fangrow, Jr. | Sep 2010 | B2 |
7857805 | Raines | Dec 2010 | B2 |
7867215 | Akerlund et al. | Jan 2011 | B2 |
7879018 | Zinger et al. | Feb 2011 | B2 |
7900659 | Whitley et al. | Mar 2011 | B2 |
7927316 | Proulx et al. | Apr 2011 | B2 |
7942860 | Horppu | May 2011 | B2 |
7975733 | Horppu et al. | Jul 2011 | B2 |
8096525 | Ryan | Jan 2012 | B2 |
8122923 | Kraus et al. | Feb 2012 | B2 |
8123738 | Vaillancourt | Feb 2012 | B2 |
8137332 | Pipelka | Mar 2012 | B2 |
8167863 | Yow | May 2012 | B2 |
8177768 | Leinsing | May 2012 | B2 |
8196614 | Kriheli | Jun 2012 | B2 |
8206367 | Warren et al. | Jun 2012 | B2 |
8211069 | Fangrow, Jr. | Jul 2012 | B2 |
8225826 | Horppu et al. | Jul 2012 | B2 |
8226628 | Muramatsu et al. | Jul 2012 | B2 |
8257286 | Meyer et al. | Sep 2012 | B2 |
8267127 | Kriheli | Sep 2012 | B2 |
8277424 | Pan | Oct 2012 | B2 |
8317741 | Kraushaar | Nov 2012 | B2 |
8317743 | Denenburg | Nov 2012 | B2 |
8398607 | Fangrow, Jr. | Mar 2013 | B2 |
8403905 | Yow | Mar 2013 | B2 |
8425487 | Beiriger et al. | Apr 2013 | B2 |
8449521 | Thorne, Jr. et al. | May 2013 | B2 |
8454579 | Fangrow, Jr. | Jun 2013 | B2 |
20030070726 | Andreasson et al. | Apr 2003 | A1 |
20050065495 | Zambaux | Mar 2005 | A1 |
20050182383 | Wallen | Aug 2005 | A1 |
20050215976 | Wallen | Sep 2005 | A1 |
20060178638 | Reynolds | Aug 2006 | A1 |
20070079894 | Kraus et al. | Apr 2007 | A1 |
20080045919 | Jakob et al. | Feb 2008 | A1 |
20080287914 | Wyatt et al. | Nov 2008 | A1 |
20090159485 | Jakob et al. | Jun 2009 | A1 |
20100168638 | Korogi et al. | Jul 2010 | A1 |
20100179506 | Shemesh et al. | Jul 2010 | A1 |
20100217226 | Shemesh | Aug 2010 | A1 |
20110004183 | Carrez et al. | Jan 2011 | A1 |
20110062703 | Lopez et al. | Mar 2011 | A1 |
20110074148 | Imai | Mar 2011 | A1 |
20110106046 | Hiranuma et al. | May 2011 | A1 |
20110257621 | Fangrow | Oct 2011 | A1 |
20110291406 | Kraft et al. | Dec 2011 | A1 |
20120035580 | Fangrow | Feb 2012 | A1 |
20120046636 | Kriheli | Feb 2012 | A1 |
20120123381 | Kraus et al. | May 2012 | A1 |
20120192968 | Bonnal et al. | Aug 2012 | A1 |
20120192976 | Rahimy et al. | Aug 2012 | A1 |
20120203193 | Rogers | Aug 2012 | A1 |
20120265163 | Cheng et al. | Oct 2012 | A1 |
20120279884 | Tennican et al. | Nov 2012 | A1 |
20120316536 | Carrez et al. | Dec 2012 | A1 |
20130006211 | Takemoto | Jan 2013 | A1 |
20130012908 | Yeung | Jan 2013 | A1 |
20130066293 | Garfield | Mar 2013 | A1 |
20130072893 | Takemoto | Mar 2013 | A1 |
20130076019 | Takemoto | Mar 2013 | A1 |
20130079744 | Okiyama et al. | Mar 2013 | A1 |
Number | Date | Country |
---|---|---|
2462971 | Jun 2012 | EP |
0128490 | Apr 2001 | WO |
2005011781 | Feb 2005 | WO |
2006058435 | Jun 2006 | WO |
2006103074 | Oct 2006 | WO |
2009024807 | Feb 2009 | WO |
2009090627 | Jul 2009 | WO |
2011050333 | Apr 2011 | WO |
2011150037 | Dec 2011 | WO |
2012069401 | May 2012 | WO |
2012119225 | Sep 2012 | WO |
2012168235 | Dec 2012 | WO |
2013025946 | Feb 2013 | WO |
2013054323 | Apr 2013 | WO |
2013066779 | May 2013 | WO |
2013115730 | Aug 2013 | WO |
2013179596 | Dec 2013 | WO |
2014122643 | Aug 2014 | WO |
2014181320 | Nov 2014 | WO |
Number | Date | Country | |
---|---|---|---|
20150297881 A1 | Oct 2015 | US |
Number | Date | Country | |
---|---|---|---|
61982049 | Apr 2014 | US | |
61982091 | Apr 2014 | US | |
62050930 | Sep 2014 | US |