System for sealed transfer of fluids and membrane construction for use therein - Patents.com

Abstract

To provide a syringe adapter preventing drags from being released into the atmosphere while a needle is inside a vial and also provide a system for closed transfer of fluids.SOLUTION: A syringe adapter 210 is provided, comprising: a housing; a cannula; a collet 212; and at least one button 214 provided on at least one of the housing 210 and the collet 212. The collet 212 comprises a locking member and a membrane. The collet 212 is movable from a first position where the locking member is open to receive a mating connector 14 to a second position where radially outward movement of the locking member is restricted and pressing the at least one button 214 disengages the mating connector 14 from the collet.SELECTED DRAWING: Figure 49A

Description

[Technical field]

[0001] The present disclosure relates generally to systems for sealed transfer of fluids, and more particularly to systems that provide a leak-tight seal during fluid transfer from a first container to a second container, and to membrane constructions for use with such systems. [Background technology]

[0002] Healthcare providers who reconstitute, transport, and administer hazardous drugs, such as cancer medications, may put themselves at risk for exposure to these medicines and may pose significant hazards in the healthcare environment. For example, nurses who treat cancer patients risk exposure to chemotherapy drugs and their toxic effects. Unintentional chemotherapy exposure can affect the nervous system, damage the reproductive system, and increase the risk of developing blood cancers in the future. In order to reduce the risk to healthcare providers of exposure to toxic drugs, sealed transport of these drugs becomes important.

[0003] Some drugs must be dissolved or diluted before they are administered, which requires the transfer of a solvent from one container by a needle to a sealed vial containing the drug in powder or liquid form. During withdrawal of the needle from the vial and if a pressure differential exists between the interior of the vial and the surrounding atmosphere, the drug can be inadvertently released into the atmosphere in gas form or by aerosolization while the needle is inside the vial. Summary of the Invention

[0004] In one embodiment, the syringe adapter includes a housing having a first end and a second end, the first end configured to be secured to a first container, a cannula having a first end and a second end, the second end of the cannula being positioned within the housing, and a collet having a first end and a second end. At least a portion of the collet is received within the housing. The collet includes a body defining a passageway, a membrane received by the passageway, and a locking member connected to the body of the collet. The membrane has a body with a first end and a second end. The body of the membrane defines a passageway. The collet is movable from a first position to a second position, where in the first position the locking member is open to receive a mating connector and where in the second position radial outward movement of the locking member is restricted.

[0005] The passageway of the membrane can extend from a first end of the body of the membrane toward a second end of the body of the membrane. The passageway can terminate at a location intermediate the first and second ends of the body of the membrane. The membrane can include a first head portion and a second head portion. The first head portion of the membrane can be positioned within the passageway of the collet and the second head portion can be engaged with an end of the body of the collet. The first head portion can include a frusto-conical surface and the second head portion can include a convex surface. The first end of the collet defines a counterbore and the first head portion of the membrane engages the collet and is positioned within the counterbore. At least a portion of at least one of the cannula and the membrane can include a lubricant, the lubricant configured to reduce friction between the cannula and the membrane.

[0006] In a further aspect, a system for sealed transfer of a fluid includes a syringe adapter, the syringe adapter including a housing having a first end and a second end, the first end configured to be secured to a first container, a cannula having a first end and a second end, the second end positioned within the housing, and a collet having a first end and a second end. At least a portion of the collet is received within the housing. The collet includes a body portion defining a passageway, a first membrane, and a locking member connected to the body portion. The first membrane includes a body portion having a first end and a second end, the body portion of the first membrane defining a passageway. The collet is movable from a first position to a second position, where in the first position the locking member is open to receive a mating connector and where in the second position radial outward movement of the locking member is restricted. The system further includes a second component including a second membrane and a collet interface surface configured to receive and engage a locking member of the collet.

[0007] The second membrane can include a body having a first end and a second end, the first end of the body of the second membrane having a convex surface configured to engage the second end of the first membrane, and the second component can include a membrane seat that receives the second membrane.

[0008] In a further aspect of the invention, a syringe adapter includes a housing having a first end and a second end, the first end configured to be secured to a first container, a cannula having a first end and a second end, the second end of the cannula being positioned within the housing, and a collet having a first end and a second end, at least a portion of the collet being received within the housing. The collet includes a body portion defining a passageway, a membrane received by the passageway, and a locking member connected to the body portion of the collet. The membrane includes a body portion having a first end and a second end, the body portion of the membrane including a first head portion and a second head portion. The first head portion and the second head portion extend radially outward from the body portion. The first head portion of the membrane includes a frusto-conical surface and the second head portion of the membrane includes a convex surface. The collet is movable from a first position to a second position, where in the first position the locking members are open to receive the mating connector and where in the second position radially outward movement of the locking members is restricted.

[0009] The body of the membrane can define a passageway extending from a first end of the body of the membrane to a second end of the body of the membrane.

[0010] The passageway may terminate at a location intermediate the first and second ends of the body of the membrane.

[0011] The above-mentioned and other features and advantages of the present disclosure, as well as the manner of obtaining them, will become more apparent, and the disclosure itself will be better understood, by referring to the following description of the embodiments of the present disclosure in conjunction with the accompanying drawings. [Brief description of the drawings]

[0012] [Figure 1]FIG. 1 is a perspective view of a system according to one embodiment of the present invention. [Diagram 2] 2 is an exploded perspective view of a syringe adapter of the system of FIG. 1 according to one embodiment of the present invention. [Diagram 3] 3 is a front view of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Figure 4] 3 is a left side view of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Diagram 5] 3 is a rear view of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Figure 6] 3 is a top view of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Figure 7] 3 is a bottom view of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Figure 8] 8 is a cross-sectional view of the syringe adapter taken along line 8-8 in FIG. 3 according to one embodiment of the present invention. [Figure 9] 3 is a perspective view of a collet of the syringe adapter of FIG. 2 in accordance with one embodiment of the present invention. [Figure 10] FIG. 3 is a front view of the collet of FIG. 2 according to one embodiment of the present invention. [Figure 11] 11 is a cross-sectional view of the collet taken along line 11-11 in FIG. 10 according to one embodiment of the present invention. [Figure 12] 2 is a perspective view of a patient connector of the system shown in FIG. 1 according to one embodiment of the present invention. [Figure 13] FIG. 13 is a front view of the patient connector of FIG. 12 according to one embodiment of the present invention. [Figure 14] FIG. 13 is a bottom view of the patient connector of FIG. 12 according to one embodiment of the present invention. [Figure 15] FIG. 13 is a top view of the patient connector of FIG. 12 according to one embodiment of the present invention. [Figure 16] FIG. 16 is a cross-sectional view of the patient connector taken along line 16-16 in FIG. 15 according to one embodiment of the present invention. [Figure 17]2 is a rear view of the system of FIG. 1 showing a first stage of securing the syringe adapter to the patient connector according to one embodiment of the present invention. [Figure 18] FIG. 18 is a cross-sectional view of the system taken along line 18-18 in FIG. 17 according to one embodiment of the present invention. [Figure 19] 2 is a rear view of the system of FIG. 1 showing a second stage of securing the syringe adapter to the patient connector according to one embodiment of the present invention. [Figure 20] 20 is a cross-sectional view of the system taken along line 20-20 in FIG. 19 according to one embodiment of the present invention. [Figure 21] 2 is a rear view of the system of FIG. 1 illustrating a third stage of securing the syringe adapter to the patient connector according to one embodiment of the present invention. [Figure 22] FIG. 22 is a cross-sectional view of the system taken along line 22-22 in FIG. 21 according to one embodiment of the present invention. [Diagram 23] 2 is a rear view of the system of FIG. 1 showing a fourth stage of securing the syringe adapter to the patient connector according to one embodiment of the present invention. [Figure 24] FIG. 24 is a cross-sectional view of the system taken along line 24-24 in FIG. 23 according to one embodiment of the present invention. [Diagram 25] 2 is a rear view of the system of FIG. 1 showing the final stage of securing the syringe adapter to the patient connector according to one embodiment of the present invention. [Figure 26] FIG. 26 is a cross-sectional view of the system taken along line 26-26 in FIG. 25 according to one embodiment of the present invention. [Figure 27] FIG. 2 is a perspective view of a system according to a second embodiment of the present invention. [Figure 28] FIG. 28 is an exploded perspective view of the system of FIG. 27 according to one embodiment of the present invention. [Figure 29] FIG. 28 is a rear view of the system of FIG. 27 according to one embodiment of the present invention. [Diagram 30] FIG. 30 is a cross-sectional view of the system taken along line 30-30 in FIG. 29 according to one embodiment of the present invention. [Diagram 31]FIG. 2 is a perspective view of a system according to a third embodiment of the present invention. [Diagram 32] FIG. 32 is an exploded perspective view of the system of FIG. 31 according to one embodiment of the present invention. [Diagram 33] FIG. 32 is a rear view of the system of FIG. 31 according to one embodiment of the present invention. [Diagram 34] FIG. 34 is a cross-sectional view of the system taken along line 34-34 in FIG. 33 according to one embodiment of the present invention. [Diagram 35] FIG. 11 is a perspective view of a system according to a fourth embodiment of the present invention. [Diagram 36] FIG. 36 is an exploded perspective view of the system of FIG. 35 according to one embodiment of the present invention. [Figure 37] FIG. 36 is a rear view of the system of FIG. 35 according to one embodiment of the present invention. [Figure 38] FIG. 38 is a cross-sectional view of the system taken along line 38-38 in FIG. 37 according to one embodiment of the present invention. [Figure 39] FIG. 11 is a perspective view of a system according to a fifth embodiment of the present invention. [Diagram 40] FIG. 40 is an exploded perspective view of the system of FIG. 39 according to one embodiment of the present invention. [Diagram 41] FIG. 40 is a front view of the system of FIG. 39 according to one embodiment of the present invention. [Diagram 42] FIG. 42 is a cross-sectional view of the system taken along line 42-42 in FIG. 41 according to one embodiment of the present invention. [Figure 43A] 1 is a perspective view of a syringe adapter according to yet another aspect of the present invention; [Figure 43B] FIG. 43B is a cross-sectional view of the syringe adapter of FIG. 43A according to one embodiment of the present invention. [Diagram 44] 43B is a cross-sectional view of a patient connector for use in conjunction with the syringe adapter of FIG. 43A according to one embodiment of the present invention. [Figure 45A] FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Figure 45B] FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Figure 45C]FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Figure 45D] FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Figure 45E] FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Fig.45F] FIG. 13 is a perspective view of a collet according to a further aspect of the present invention. [Figure 46] 1 is a cross-sectional view of a system according to another aspect of the present invention. [Figure 47] 1 is a cross-sectional view of a system according to yet another aspect of the present invention. [Figure 48A] FIG. 13 is a perspective view of a system according to a further aspect of the present invention, showing the syringe adapter being detached from the patient connector. [Figure 48B] FIG. 48B is a perspective view of the system of FIG. 48A showing a syringe adapter connected to a patient connector according to another embodiment of the present invention. [Figure 49A] FIG. 49A is a cross-sectional view taken along line 49A-49A in FIG. 48A according to one embodiment of the present invention. [Figure 49B] FIG. 49B is a cross-sectional view taken along line 49B-49B in FIG. 48B, according to one embodiment of the present invention. [Figure 50A] FIG. 13 is a perspective view of a system according to a further aspect of the present invention, showing the syringe adapter being detached from the patient connector. [Figure 50B] FIG. 50B is a perspective view of the system of FIG. 50A showing a syringe adapter connected to a patient connector according to another embodiment of the present invention. [Figure 51A] FIG. 51A is a cross-sectional view taken along line 51A-51A in FIG. 50A, according to one embodiment of the present invention. [Figure 51B] FIG. 51B is a cross-sectional view taken along line 51B-51B in FIG. 50B, according to one embodiment of the present invention. [Figure 52] 1 is a cross-sectional view of a syringe adapter according to another aspect of the present invention. [Figure 53] 11 is a cross-sectional view of a syringe adapter according to a further aspect of the present invention. [Figure 54]11 is a cross-sectional view of a syringe adapter according to yet another aspect of the present invention. [Figure 55A] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Figure 55B] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Figure 55C] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Fig. 55D] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Figure 55E] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Fig. 55F] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Figure 55G] 1 is a cross-sectional view of a first membrane according to various embodiments of the present invention. [Figure 56A] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Figure 56B] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Figure 56C] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Figure 56D] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Figure 56E] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Fig. 56F] FIG. 2 is a cross-sectional view of a second membrane according to various embodiments of the present invention. [Figure 57] 3 is a perspective view of the syringe adapter of FIG. 2 showing the syringe adapter connected to a vial and vial adapter in accordance with an embodiment of the present invention. [Figure 58] 3 is an exploded perspective view of the syringe adapter of FIG. 2, showing the syringe adapter along with a vial and vial adapter, according to one embodiment of the present invention. [Figure 59]3 is a front view of the syringe adapter of FIG. 2 showing the syringe adapter connected to a vial and vial adapter, according to one embodiment of the present invention. [Figure 60] FIG. 60 is a cross-sectional view taken along line 60-60 in FIG. 59 showing a syringe adapter connected to a vial and vial adapter according to one embodiment of the present invention. [Figure 61] FIG. 1 is a perspective view of an IV bag adapter according to one embodiment of the present invention. [Figure 62] FIG. 62 is a cross-sectional view of the IV bag adapter of FIG. 61 according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate exemplary aspects of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any manner.

[0014] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments, which are intended to practice the present invention. However, various modifications, equivalents, variations, and alternatives will remain readily apparent to those of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0015] For purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and their derivatives shall refer to the present invention as it is oriented in the drawings. However, it should be understood that the present invention is capable of various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0016] 1, one embodiment of a system 10 for sealed transfer of fluid includes a syringe adapter 12 and a patient connector 14. The system 10 provides a substantially leak-tight seal during transfer of fluid from a first container (not shown), such as a vial, to a second container (not shown), such as a syringe, IV bag, or patient IV line. The leak-tight seal of the system 10 substantially prevents leakage of both air and liquid during use of the system 10. Although not shown, the system 10 can further include other components typically utilized in closed system transfer devices, such as a vial adapter, a pressure equalization device, or an IV bag adapter, as well as infusion lines and extension sets.

[0017] 2-14, one embodiment of a syringe adapter 12 includes a housing 16 having a first end 18 and a second end 20 and defining an interior space 22. The first end 18 of the housing 16 of the syringe adapter 12 includes a syringe attachment 24, such as a female Luer connector, defining a passageway 26. The female Luer connector is shown for connection with a corresponding male Luer connector (not shown) of a syringe, although other suitable connection configurations may be utilized for connection to a syringe, container, or any other medical device. The syringe attachment 24 is secured to the first end 18 of the housing 16 via a threaded connection, although any other suitable connection may be utilized. A cannula 28 having a distal end 30 is secured to the syringe attachment 24 and in fluid communication with the passageway 26 of the syringe attachment 24. Syringe adapter 12 further includes a seal arrangement positioned within housing 16 of syringe adapter 12. The seal arrangement includes a collet 32 ​​that receives a first membrane 34. Collet 32 ​​is configured to move within interior space 22 of housing 16 of syringe adapter 12, as discussed in more detail below. Housing 16 of syringe adapter 12 can include structure to enhance gripping of syringe adapter 12 by a user. Additional or alternative gripping structures and surfaces may be provided to assist a user in grasping the body portion of syringe adapter 12.

[0018] 2-8, syringe adapter 12 includes a first connection interface 36 positioned intermediate first and second ends 18, 20 of housing 16 of syringe adapter 12, the first connection interface 36 including a locking member 38 that is received within a transverse opening 40 in housing 16 of syringe adapter 12. Locking member 38 is configured to move between a closed position and an open position. Locking member 38 defines a central opening 42 and includes a button 44 that is configured to be engaged by a hand of a user or operator of syringe adapter 12. Locking member 38 further includes a cantilever spring 46 that extends longitudinally of syringe adapter 12. Locking member 38 is configured to engage a camming surface that extends radially outward from housing 16 of syringe adapter 12. Notably, locking member 38 is configured to be provided in a closed position in which a portion of locking member 38 adjacent central opening 42 of locking member 38 is positioned within interior space 22 of syringe adapter 12 when no external force is applied to locking member 38. When locking member 38 moves to the open position (in which central opening 42 of locking member 38 is aligned with interior space 22 of syringe adapter 12 or does not create an obstruction or barrier to objects being inserted into interior space 22), cantilever spring 46 engages the cam surface and generates a biasing force that urges locking member 38 back toward the closed position. Thus, when locking member 38 is moving to the open position, locking member 38 will be urged back to the closed position when the external force acting on locking member 38 is released. Although locking member 38 is shown with cantilever spring 46, any other suitable biasing member may be provided, including, but not limited to, a compression spring, a tension spring, an elastomeric material, or the like.

[0019] 2, locking member 38 further includes a pair of protrusions 48 extending radially outward from locking member 38. Pair of protrusions 48 are configured to engage corresponding protrusions provided on housing 16 of syringe adapter 12 to retain locking member 38 relative to housing 16 of syringe adapter 12. In other words, protrusions 48 of locking member 38 are configured to engage protrusions of housing 16 of syringe adapter 12 to prevent locking member 38 from disengaging and being removed from transverse opening 40 of housing 16 of syringe adapter 12.

[0020] 8-11, the collet 32 ​​has a body portion 52 with a first end 54 and a second end 56. The body portion 52 defines a passageway 58 extending therethrough. The body portion 52 is generally cylindrical in shape, although collets of other suitable shapes may be utilized. The collet 32 ​​further includes a locking member 60 connected to the body portion 52 of the collet 32. As discussed in more detail below, the collet 32 ​​is movable from a first position to a second position, where in the first position the locking member 60 is open to receive a mating connector, such as the patient connector 14 (shown in FIG. 18), and where in the second position the locking member 60 is restricted from moving radially outward. The locking member 60 is connected to the body portion 52 via a plurality of arms 62. The locking member 60 is arcuate in shape and is resilient as a result of the locking member 60 connecting to the body portion 52 via the plurality of arms 62. More specifically, the plurality of arms 62 are flexible, allowing the locking member 60 to expand radially outward or radially inward. In one embodiment, the locking member 60 is configured to expand radially outward when a mating connector, such as the patient connector 14, is inserted into the locking member 60, and then move radially inward as the collet 32 ​​transitions from the first position to the second position. Alternatively, the locking member 60 may not move radially inward or outward when a mating connector, such as the patient connector 14, is inserted into the locking member 60, and then move radially inward as the collet 32 ​​transitions from the first position to the second position. The second end 20 of the housing 16 of the syringe adapter 12 defines an annular recess 64 adjacent the interior space 22, which receives the locking member 60 when the collet 32 ​​is in the first position. An annular recess 64 in housing 16 provides space for locking members 60 to expand radially outward.As collet 32 ​​transitions from the first position to the second position, collet 32 ​​moves axially toward first end 18 of syringe adapter 12 with locking member 60 biased radially inward due to engagement between locking member 60 and housing 16 of syringe adapter 12.

[0021] 9, the locking member 60 of the collet 32 ​​defines a pair of openings 66 that extend in a direction perpendicular to the longitudinal axis of the collet 32. The openings 66 bifurcate the locking member 60 into two arcuate portions that are respectively connected to the body portion 52 of the collet 32 ​​by two arms 62. However, as discussed in more detail below, other suitable arrangements and shapes may be utilized for the collet 32 ​​and locking member 60. The locking member 60 of the collet 32 ​​projects radially inward and radially outward relative to the arms 62.

[0022] 8-11, the body portion 52 of the collet 32 ​​includes a second connection interface 70 configured to mate and lock with the first connection interface 36 of the syringe adapter 12. The second connection interface 70 is defined by the body portion 52 of the collet 32, and more specifically, by a locking surface 72. The second connection interface 70 further includes a lead-in surface defined by the first end 54 of the collet 32. The lead-in surface of the second connection interface 70 defines a rounded transition between the body portion 52 of the collet 32 ​​and the lead-in surface. The locking surface 72 is a ring-shaped recess that is recessed relative to the body portion 52 of the collet 32 ​​and is configured to receive the locking member 38 of the first connection interface 36. The locking surface 72 is defined by a 90 degree angle, although other suitable shapes and angles may be utilized. The first end 54 of the collet 32 ​​is configured to be received within the interior space 22 of the syringe adapter 12 when the locking member 38 of the first connection interface 36 is in the open position and to be restricted from moving into the interior space 22 of the syringe adapter 12 when the locking member 38 is in the closed position. The retraction surface of the second connection interface 70 is configured to engage the locking member 38 of the first connection interface 36, further moving the locking member 38 and further biasing the cantilever spring 46. When the second connection interface 70 is fully mated with the first connection interface 36, the locking member 38 of the first connection interface 36 is in the closed position and received within the locking surface 72, configured to lock the first connection interface 36 from longitudinal and lateral movement relative to the second connection interface 70, but still allow rotational movement relative thereto.

[0023] 2 and 8, the first membrane 34 includes a body portion 82 having a first end 84 and a second end 86. The first end 84 and the second end 86 of the body portion 82 of the first membrane 34 include a first head portion 88 and a second head portion 90, respectively. The body portion 82 of the first membrane 34 defines a passageway 92 that extends from the first end 84 toward the second end 86 of the body portion 82. The passageway 92 terminates intermediate the first and second ends 84, 86 of the body portion 82. As shown in FIG. 8, the body portion 82 of the first membrane 34 is received by the passageway 58 of the collet 32 ​​and secured to the collet 32. The first head portion 88 of the first membrane 34 engages a counterbored portion of the collet 32 ​​adjacent the passageway 58 of the collet 32. The second head portion 90 extends beyond the passage 58 of the body portion 52 of the collet 32, and the second head portion 90 engages the body portion 52 of the collet 32. The second head portion 90 defines a convex surface, although other suitable membrane configurations may be provided, as discussed in more detail below. The cannula 28 is received within the passage 92 of the first membrane 34, and the distal end 30 of the cannula 28 is positioned within the passage 92 when the collet 32 ​​is in the first position. The distal end 30 of the cannula 28 is configured to pierce and extend through the first membrane 34 when the collet 32 ​​transitions from the first position to the second position. The first membrane 34 is configured to engage and seal with an intermediate portion of the cannula 28 to maintain a sealed, leak-free connection with the patient connector 14 or a mating component during use of the syringe adapter 12.

[0024] As discussed in more detail below, collet 32 ​​is configured to move toward first end 18 of syringe adapter 12, transitioning from a first position to a second position, upon engagement of first membrane 34 by a corresponding membrane during use, such as a membrane from patient connector 14, a vial adapter, or an IV bag spike, such that distal end 30 of cannula 28 pierces first membrane 34 and places syringe adapter 12 in fluid communication with a corresponding device secured to syringe adapter 12. When collet 32 ​​is returned to the first position, first membrane 34 may be released from the corresponding membrane, thereby positioning distal end 30 of cannula 28 within passages 58, 92 of collet 32 ​​and first membrane 34. Such an arrangement shields the distal end 30 of the cannula 28 to prevent accidental needle sticks and also to prevent any fluid leakage during fluid transfer when the syringe adapter 12 is used.

[0025] 12-16, the patient connector 14 includes a body portion 102 having a first end 104 and a second end 106 and defining a passageway 108 extending therethrough. The first end 104 of the patient connector 14 also includes a collet interface 110. The collet interface 110 is defined by a portion of the body portion 102 of the patient connector 14 that is recessed relative to the first end 104 of the body portion 102 of the patient connector 14. The first end 104 of the body portion 102 of the patient connector 14 also includes a membrane seat 112 that receives a second membrane 114. As discussed above in connection with syringe adapter 12, second membrane 114 of patient connector 14 is configured to engage first membrane 34 of syringe adapter 12 and provide a substantially leak-free connection with syringe adapter 12 during fluid transfer. Second end 106 of patient connector 14 includes an IV line attachment 116, such as a male Luer connector, although any other suitable connection configuration may be utilized.

[0026] 17-26, the process of mating the syringe adapter 12 with the patient connector 14 is illustrated. Although the syringe adapter 12 is shown connected to the patient connector 14, the syringe adapter 12 would similarly connect to other components having a structure similar to the patient connector 14, including, but not limited to, vial adapters and IV bag adapters. As shown in FIGS. 17 and 18, the interior space 22 of the syringe adapter 12 is aligned with the patient connector 14. In particular, the longitudinal axis of the syringe adapter 12 is aligned with the longitudinal axis of the patient connector 14, and the locking member 38 of the first connection interface 36 is in a closed position. As shown in FIGS. 19 and 20, the patient connector 14 is moved into the interior space 22 of the syringe adapter 12 toward the collet 32, which is provided in a first position with the locking member 60 open to receive the patient connector 14.

[0027] 21 and 22 , further movement of the patient connector 14 towards the first end 18 of the syringe adapter 12 causes the first membrane 34 to engage the second membrane 114 and the first end 104 of the patient connector 14 to pass through the locking member 60 of the collet 32. As discussed above, movement of the patient connector 14 within the locking member 60 can urge the locking member 60 radially outward, or alternatively, can receive the first end 104 of the patient connector 14 without any radial movement of the locking member 60. Due to interference between the locking member 60 and the housing 16 of the syringe adapter 12 and contact of the locking member 60 with the first end 104 of the patient connector 14, the collet 32 ​​will not move toward the first end 18 of the syringe adapter 12 until the first and second membranes 34, 114 are sufficiently compressed and the locking member 60 is received within the collet interface 110 of the patient connector 14. Once the first and second membranes 34, 114 are sufficiently compressed, the locking member 60 will be forced into the collet interface 110 of the patient connector 14 due to engagement of the locking member 60 with the housing 16 of the syringe adapter 12 and continued axial movement of the collet 32 ​​toward the first end 18 of the syringe adapter 12.

[0028] 23 and 24, further continued movement of the patient connector 14 towards the first end 18 of the syringe adapter 12 causes the collet 32 ​​to move towards the first end 18 of the syringe adapter 12 via the engagement between the first membrane 34 and the second membrane 114. At this stage, the collet 32 ​​is in the second position and the first end 104 of the patient connector 14 is locked and secured to the collet 32 ​​due to the engagement of the locking member 60 of the collet 32 ​​with the collet interface 110. The locking member 60 of the collet 32 ​​cannot expand radially outward to release the patient connector 14 until the collet 32 ​​is returned to the first position. Further, during continued movement at this stage, the locking member 38 of the first connection interface 36 engages the second connection interface 70 of the collet 32, which transitions the locking member 38 from the closed position (shown in FIG. 22) to the open position (shown in FIG. 24).

[0029] As the locking member 38 moves from the closed position to the open position, the cantilever spring 46 will engage a cam surface on the housing 16 of the syringe adapter 12, which generates a biasing force urging the locking member 38 to return to the closed position. However, such movement back to the closed position is prevented by the engagement of the locking member 38 with the body portion 52 of the collet 32. Although FIG. 24 illustrates overlap between the collet 32 ​​and the first connection interface 36, the collet 32 ​​will move the first connection interface 36 as described herein. Similarly, the locking member 60 of the collet 32 ​​will not overlap the housing 16 of the syringe adapter 12, but will be pushed inwardly as described herein. With the locking member 38 of the first connection interface 36 in the open position, the second connection interface 70 is permitted to continue its movement within the interior space 22 of the syringe adapter 12 to continue the process of mating the syringe adapter 12 to the patient connector 14. During this step, the distal end 30 of the cannula 28 pierces the first and second membranes 34 , 114 and is placed in fluid communication with the passageway 108 of the patient connector 14 .

[0030] 25 and 26, the patient connector 14 and collet 32 ​​are moved toward the first end 18 of the syringe adapter 12 until the first membrane 34 abuts the syringe attachment 24 of the syringe adapter 12 and / or the second end 106 of the patient connector 14 abuts the second end 20 of the syringe adapter 12. At this stage, the second connection interface 70 of the collet 32 ​​is aligned with the locking member 38 of the first connection interface 36 such that the locking member 38 is received within the second connection interface 70. The locking member 38 is biased toward the closed position by the cantilever spring 46, and when the locking member 38 reaches the second connection interface 70, the locking member 38 is free to move to the closed position where a portion of the locking member 38 is positioned within the interior space 22 of the syringe adapter 12.

[0031] 26, the first connection interface 36 is fully mated and locked relative to the second connection interface 70. In such position, the syringe adapter 12 is prevented from disengaging from the patient connector 14 due to the engagement between the locking member 38 of the first connection interface 36 and the second connection interface 70. The locked engagement between the first connection interface 36 and the second connection interface 70 prevents axial and transverse movement relative to one another, but the first connection interface 36 and the second connection interface 70 are free to rotate relative to one another when locked to one another, which advantageously prevents IV line entanglement and / or other inadvertent disengagement or device failure associated with a lack of rotation between components. Notably, the patient connector 14 is typically attached to a patient IV line, and rotation of the first connection interface 36 relative to the second connection interface 70 helps prevent kinking of the patient IV line connected to the patient connector 14. However, the first and second connection interfaces 36, 70 may be provided with keyed surface configurations that prevent such relative rotation, if desired.

[0032] 17-26, to disengage the first connection interface 36 from the second connection interface 70, the button 44 of the locking member 38 of the first connection interface 36 is engaged and pushed radially inward by a user to transition the locking member 38 from the closed position to the open position. The patient connector 14 may then be removed from the interior space 22 of the syringe adapter 12 in the reverse order of the steps of connecting the syringe adapter 12 to the patient connector 14. When the second connection interface 70 is separated from the first connection interface 36, the locking member 38 is moved to the closed position. The patient connector 14 cannot be separated from the syringe adapter 12 until the collet 32 ​​is returned to the first position shown in FIG. 22, where the locking member 60 of the collet 32 ​​is allowed to expand radially outward into the annular recess 64 of the housing 16, thereby allowing separation of the patient connector 14 from the collet 32. Although not shown, syringe adapter 12 may be provided with one or more indication structures to provide a visual, tactile, or audible indication to a user during connection of the syringe adapter to a mating component.

[0033] The system 10 described above, and further embodiments of the system 10 described below, can include one or more structures that reduce friction between the first membrane 34 and the cannula 28. Such structures can be a lubricant, provided on or in the first membrane 34 and / or on the cannula 28. The lubricant can be a silicone-based lubricant, although any other suitable lubricant, coating, layer, material, or the like can be utilized. The first membrane 34 and / or needle 28 can be made of a lubricating or friction-reducing material, coated with a lubricant, and / or impregnated with a lubricant. The structure that reduces friction between the first membrane 34 and the needle 28 can be a wet and / or dry lubrication system.

[0034] 27-30, a further embodiment of a system 140 for sealed transfer of fluids is shown. The system 140 shown in FIGS. 27-30 is similar to the system 10 shown in FIGS. 1-26 and discussed above. However, in the system 140 shown in FIGS. 27-30, the locking member 60 of the collet 32 ​​is ring-shaped and defines only one opening 142 extending transversely to the longitudinal axis of the collet 32. Additionally, the system 140 includes an anti-disengagement mechanism 144 that prevents inadvertent disengagement of the syringe from the syringe adapter 12. When the collet 32 ​​is fully displaced toward the first end 18 of the syringe adapter 12, the collet 32 ​​engages the anti-disengagement mechanism 144, which can substantially prevent disengagement of the syringe from the syringe adapter 12 by allowing the syringe attachment 24 to rotate freely. The patient connector 14 can also include a membrane sheet 146 having at least one protrusion and an upper rim portion 148 that receives and engages a correspondingly shaped portion of the second membrane 114. The second membrane 114 can be secured to the membrane sheet 146 via ultrasonic welding, by swaging the sheet 146, or by adhesive, although other suitable attachment configurations can also be utilized.

[0035] 31-34, a further embodiment of a system 152 for the sealed transfer of a fluid is shown. The system 152 shown in FIGURES 31-34 is similar to the system 10 shown in FIGURES 1-26 and discussed above. However, in the system 152 shown in FIGURES 31-34, the first membrane 154 is generally T-shaped with a flange portion 156 that is received in a corresponding seat 158 ​​defined by the collet 32.

[0036] 35-38, a further embodiment of a system 162 for sealed transfer of a fluid is shown. The system 162 shown in FIGs. 35-38 is similar to the system shown in FIGs. 1-26 and discussed above. However, in the system 162 shown in FIGs. 35-38, the collet 32 ​​receives a pair of spaced apart membranes 164 that define a space therebetween within the collet 32. The pair of membranes 164 are received by first and second membrane sheets 166, respectively.

[0037] 39-42, a further embodiment of a system 170 for sealed transfer of fluid is shown. The system 170 shown in FIGS. 39-42 is similar to the system 10 shown in FIGS. 1-26 and discussed above. However, in the system 170 shown in FIGS. 39-42, the first membrane 171 defines an annular recess 172 that is received by a corresponding protrusion 174 of the collet 32. Additionally, the first membrane 171 is contoured and is received by a corresponding contoured portion of the collet 32. Additionally, the second membrane 175 defines an annular recess 176 that is received by a corresponding protrusion 178 of the patient connector 14. The body portion 104 of the patient connector 14 is defined by an outer portion 180 and an inner portion 182 that are secured to one another via any suitable fastening construction, such as ultrasonic welding, spin welding, or laser welding.

[0038] 43A, 43B, and 44, another embodiment of a syringe adapter 12A is shown. The syringe adapter 12A shown in FIG. 43A, 43B, and 44 is similar to the syringe adapter 12 shown in FIG. 1-11 and discussed above. However, the syringe adapter 12A shown in FIG. 43A, 43B, and 44 provides a first connection interface 36 at or near the second end 20 of the syringe adapter 12A. Additionally, rather than providing a second connection interface 70 on the collet 32, the patient connector 14 includes both the collet interface 110 and the second connection interface 70. The syringe adapter 12A operates in the same manner as described above in connection with FIG. 1-26.

[0039] 45A-45F, further embodiments of the collet 32 ​​of FIGS. 9-11 are shown. In FIG. 45A, the locking member 60 of the collet 32 ​​is continuous ring-shaped and defines a number of cutouts configured to allow the locking member 60 to expand radially outward. In FIG. 45B, the locking member 60 is ring-shaped and defines a small slit extending transversely to the longitudinal axis of the collet. In FIG. 45C, the body portion 52 of the collet 32 ​​is secured to the locking member 60 via an extension portion 202 of the body portion 52, the locking member 60 is ring-shaped and defines a slit 204 configured to allow the locking member 60 to expand radially outward. In Fig. 45D, a plurality of arms 62 each include a respective locking member 60, each formed with an enlarged head portion at the end of each arm 62. In Fig. 45E, the locking member 60 is half-ring shaped. In Fig. 45F, the locking member 60 is arcuate and defines a single opening.

[0040] Referring to Figure 46, a further embodiment of the syringe adapter 12 of Figures 1-11 is shown. In particular, the first membrane 34 is generally sleeve-like and configured to retract upon engagement with the patient connector 14.

[0041] Referring to Figure 47, a further embodiment of syringe adapter 12 of Figures 1-11 is shown. In particular, first membrane 34 is generally cylindrical in shape with convex portions at first and second ends of first membrane 34.

[0042] 48A-49B, a further embodiment of the syringe adapter 12 of FIGS. 1-11 is shown. The syringe adapter 210 shown in FIGS. 48A-49B includes a collet 212 having a pair of resilient buttons 214 integral therewith. When the syringe adapter 210 is fully connected and in fluid communication with a mating connector, such as the patient connector 14, the buttons 214 are received by a pair of openings 216 in the housing 16 of the syringe adapter 210, locking the collet 212. Depressing the buttons 214 allows the mating connector to be released and removed from the syringe adapter 210.

[0043] 50A-51B, rather than providing button 214 on collet 212 as shown in FIGS. 48A-49B, an indirect button arrangement may be provided. In particular, housing 16 of syringe adapter 210 is provided with a pair of buttons 220 configured to be depressed inwardly into interior space 22 of syringe adapter 210. Collet 212 includes a resilient button interface portion 222 configured to lock collet 212 when syringe adapter 210 is fully connected to and in fluid communication with a mating connector, such as patient connector 14. Depressing button 220 causes button interface portion 222 of collet 212 to release, allowing the mating connector to be released and removed from syringe adapter 210.

[0044] 52-54, further embodiments of the collet 32 ​​of FIGS. 9-11 are shown. Notably, rather than providing a collet formed as a unitary or single molded part, the collet 32 ​​may be formed from one or more pieces that are secured together to form the collet 32. The multi-piece collet 32 ​​embodiment allows for a variety of membrane configurations, in which a membrane may be placed prior to final assembly of the collet 32. The multiple pieces forming the collet 32 ​​may be secured together via any suitable joining method, such as ultrasonic welding, spin welding, or laser welding, etc.

[0045] 55A-55G, further embodiments of the first membrane 34 are shown. Notably, various shapes, configurations, and cavities may be utilized for the first membrane. Additionally, as shown in FIG. 55G, the first membrane may include an insert 228 positioned within the first membrane 34. The geometries shown in FIG. 55A-55G may be pushed or pulled into a mating component and retained without the need for a secondary assembly process or a multi-piece housing. The embodiment of the first membrane 34 shown in FIG. 55D, FIG. 55E, and FIG. 55F includes a sealing portion 230 at the top of the first membrane 34 that engages and seals with an intermediate portion of the cannula 28 during use.

[0046] 56A-56F, further embodiments of the second membrane are shown. Notably, a variety of shapes, configurations, and cavities may be utilized for the second membrane.

[0047] 57-60, the syringe adapter 12 is shown engaged in use with a vial adapter 240. As shown in FIG. 60, the vial adapter 240 includes a collet interface 110 and a second membrane 114, which is disposed on the patient connector 14. The syringe adapter 12 is connected to the vial adapter 240 in the same manner that the syringe adapter 12 is connected to the patient connector 14 as described above. The vial adapter 240 is secured to a vial and provides the collet interface 110 such that the syringe adapter 12 may be placed in fluid communication with the vial, and the vial adapter 240 provides a pressure equalization arrangement to prevent fluid from escaping to the outside environment.

[0048] 61 and 62, one embodiment of an IV bag adapter 260 is shown. As discussed above, the syringe adapter 12 may be connected to various components typically utilized in a closed transfer device system. The IV bag adapter 260 also includes a collet interface 110 and a second membrane 114, which are provided over the patient connector 14 and the vial adapter 240. The IV bag adapter 260 includes a spike member 262 having first and second channels 264, 266 that allow the syringe adapter 12 to be placed in fluid communication with an infusion or IV set.

[0049] While this disclosure has been described as having an exemplary design, the disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains, which fall within the limits of the appended claims.

Claims

1. 1. A syringe adapter, comprising: a housing having a first end and a second end, the first end of the housing configured to be secured to a first container; a cannula having a first end and a second end, the second end of the cannula being positioned within the housing; a collet having a first end and a second end, at least a portion of the collet being received within the housing, the collet comprising: a body defining a passageway; a locking member connected to the body portion of the collet; a membrane received by the passage in the body, the membrane including a body defining a membrane passage; and a collet comprising: At least one button provided on the collet; Including, the collet is movable from a first position in which the locking members are open to receive a mating connector to a second position in which radially outward movement of the locking members is restricted; when the collet is in the first position, the at least one button is disposed within the housing; when the collet is in the second position, the at least one button is received by a corresponding opening in the housing; and pressing the at least one button to release the mating connector from the collet; A syringe adapter, wherein the collet is rotatable relative to the housing about a longitudinal axis of the housing at any position between the first position and the second position.

2. 2. The syringe adapter of claim 1, wherein said at least one button is resilient and integral with said collet.

3. 2. The syringe adapter of claim 1, wherein the passageway in the membrane extends from a first end of the body portion of the membrane to a second end of the body portion of the membrane.

4. 4. The syringe adapter of claim 3, wherein said passageway terminates at a location intermediate said first end and said second end of said body portion of said membrane.

5. 5. The syringe adapter of claim 4, wherein the membrane includes a first head portion and a second head portion.

6. 6. The syringe adapter of claim 5, wherein the first head portion of the membrane is positioned within the passage of the collet and the second head portion is engaged with an end of the body portion of the collet.

7. 6. The syringe adapter of claim 5, wherein the first head portion includes a frusto-conical surface.

8. 8. The syringe adapter of claim 7, wherein the second head portion includes a convex surface.

9. 6. The syringe adapter of claim 5, wherein the first end of the collet defines a counterbore, and the first head portion of the membrane engages the collet and is positioned within the counterbore.

10. 1. A system for the enclosed transfer of a fluid, comprising:

1. A syringe adapter, comprising: a housing having a first end and a second end, the first end of the housing configured to be secured to a first container; a cannula having a first end and a second end, the second end of the cannula being positioned within the housing; a collet having a first end and a second end, at least a portion of the collet being received within the housing, the collet comprising: a body defining a passageway; a locking member connected to the body portion of the collet; a first membrane including a body portion defining a membrane passage; a collet including At least one button provided on the collet; a second component including a second membrane and a collet interface surface configured to receive and engage the locking members of the collet; Including, the collet is movable from a first position in which the locking members are open to receive a mating connector to a second position in which radially outward movement of the locking members is restricted; when the collet is in the first position, the at least one button is disposed within the housing; releasing the second component from the collet by pressing the at least one button; when the collet is in the second position, the at least one button is received by a corresponding opening in the housing; The collet is rotatable relative to the housing about a longitudinal axis of the housing at any position between the first position and the second position.

11. 11. The system of claim 10, wherein said at least one button is resilient and integral with said collet.

12. 11. The system of claim 10, wherein the second membrane includes a body portion having a first end and a second end, the first end of the body portion of the second membrane having a convex surface configured to engage the second end of the body portion of the first membrane.

13. 13. The system of claim 12, wherein the passageway of the first membrane extends from the first end of the body portion of the first membrane to the second end of the body portion of the first membrane.

14. 14. The system of claim 13, wherein the passageway in the first membrane terminates at a location intermediate the first end and the second end of the body portion of the first membrane.

Images