The present disclosure relates to the field of medical devices, and in particular to a priming device and system for removing air inside a fluid channel.
To comply with safety standards in handling hazardous drugs such as the USP General Chapter 800 (United States Pharmacopeial Convention), hospitals and other healthcare organizations (facilities) are adopting the use of closed system transfer devices (CSTDs) in promoting exposure safe procedures that protects pharmacists, caregivers, patients and the general environment from contaminants arising from spills, aerosols and volatile organic compounds of hazardous drugs. A CSTD ensures that there is nothing from the environment enters the fluid channel containing hazardous drugs and also nothing escapes from the contents of the closed system. Hence by default, priming or the release of entrapped air from a fluid channel or body with closed system components is difficult. To facilitate this, it is common to perform priming in a laminar cabinet or chemical isolators, where the risk of microbial ingress into the devices is reduced. The pharmacist is protected with appropriate apparels and safety masks, unlike open environment in the wards. However, priming at the point of use in the ward is preferred as it controls infection better when safe and aseptic procedures are used just prior to connecting the infusion means to patients.
As will be apparent from the following, the subject matter of this disclosure enables the priming of fluid channels, like those of an intravenous (IV) line, in particular where the distal end of the infusion means or where the components used in creating the fluid communication interface with the patient are fluid and/or air tight. Novel features of this invention support the use of Closed System devices in the most vulnerable environment of a ward where nurses, caregivers, patients, and visitors would potentially be exposed to elements of hazardous drugs during connection, disconnection of an infusion means or any transfer from a fluid source container to the patient.
In one aspect, the present disclosure provides a priming device, the priming device including: a housing having a proximal end and a distal end, the housing defining an axial direction extending substantially from the proximal end to the distal end; and a membrane disposed at the proximal end, wherein the housing defines a fluid communication channel extending substantially axially from an interior surface of the membrane towards the distal end and a filter disposed at the distal end of the housing, the filter being configured to allow a passage of air. In another aspect, there is provided a priming device having an adapter.
The advantages of these and other aspects and features of various embodiments will be described with reference to the appended drawings.
The transfer system may include a pump or any pressure source 850 having a proximal port 830 and a distal port 832. The proximal port 830 of the pump 850 may include a membrane. When the injector 920 is coupled to the pump 850, the needle of the injector 920 pierces the membrane of the proximal port 830, and thereby provides fluid communication between the syringe and the pump. The distal port 832 of the pump 850 may be coupled to a proximal end of a tubing 840. A flow regulator 842 may be provided for use with the tubing 840. A distal end 843 of the tubing 840 may be coupled to a proximal end 821 of an adaptor 820. The adaptor 820 provides a sealable closure to the tubing. The tubing 840 could also be coupled to a pumping mechanism, e.g., a peristaltic pump, to provide a pressure and/or energy source in delivering fluid through the tubing 840. In any case, it can be appreciated that the pump 850 by itself, or with the tubing 840 coupled to the adaptor 820, provides a sealed or closed system whereby fluid in the pump 830 can be safely contained, stored, and/or transported.
The transfer system includes a priming device 100 having a proximal end 101 which is configured so that it can be detachably coupled to a distal end 823 of the adaptor 820. Referring now to
The priming device of the present disclosure can be used in a closed system (such as one shown in
Turning next to
The third housing 150 may also be referred to as a retaining cap or a vent cap 150 in this document. The first housing 120 and the retaining cap 150 may be detachably coupled or be configured to be in a detachable coupling. In this document, detachable coupling includes detachably affixed coupling. For example, the proximal end of the cap 150 may be provided with a luer connect 155 that is complementary to the luer connect 125 at the distal end of the first housing 120. The luer connect 155 of the retaining cap 150 may be configured as a male luer connect, in which the luer thread is disposed on an exterior surface of the retaining cap. The luer connect 125 of the first housing 120 may be configured as a female luer connect, in which the luer thread is disposed on an interior surface of the first housing. The first housing may be further configured with a stem 128, in which the stem is configured to extend substantially axially and be received by an interior passage 159 of the retaining cap 150. In some other applications, the stem 128 and the interior passage 159 may be configured to form a clearance fit so that the retaining cap may be removed by the user. As illustrated, the stem 128 may be configured to extend a substantial length of the interior passage 159. This configuration provides a substantial interfacing area between the wall of the interior passage 159 and an exterior surface of the stem 128, and improves sealing between the retaining cap 150 and the connector 103. In some applications, the stem 128 and the interior passage 159 may be configured to form an interference fit to deter a user from detaching the retaining cap from the connector 103. In other examples of detachably affixed coupling, the retaining cap 150 and the connector 103 are configured to be manufactured as an integral or unitary piece of hardware (as illustrated in
The retaining cap 150 may also have an exterior surface 156 configured to provide a grip for the user. The retaining cap 150 may be configured with flanges 154 so as to define a large enough exterior diameter for a comfortable grip, while providing a small enough interior passage 159/169.
It can be seen from the cross-sectional view of
Alternatively described, the fluid communication channel 102 may extend substantially axially from an interior surface 141 of the membrane 140 towards the distal end of the priming device 100. A filter 160 may be disposed at the distal end of the housing, such that the filter is configured to allow the passage of air therethrough. The fluid communication channel 102 is partially defined by the interior surface 141 of the membrane. The fluid communication channel 102 may be described as further having a fluid chamber which is configured to retain liquid. The fluid chamber 159/169 may be at least partially defined by an interior surface 121 of the housing. The fluid communication channel may extend substantially axially away from the interior surface of the membrane towards the distal end of the housing, and terminate at the fluid contact surface of the filter.
In some embodiments, the housing of the priming device can be made up of a connector 103 and a retaining cap 150. The retaining cap may be detachably coupled to the connector, for example, the retaining cap may be detachable from the connector, or the retaining cap may be undetachable from the connector. The fluid communication channel 102 may include: a first passage 129, wherein the first passage is partially defined by the interior surface of the membrane 140; and a second passage 159, wherein the second passage extending substantially axially from the first passage towards the distal end of the housing, and wherein the second passage is defined by an interior surface of the connector. The second passage may be further defined by a distal end of the connector. The fluid communication channel may further include: a third passage 169 extending from the second passage, wherein the third passage is at least partially defined by an interior surface 153 of the retaining cap. The priming device may further include a filter 160 disposed at the retaining cap, and wherein the third passage terminates in the filter.
The fluid communication channel 102 is configured to receive a needle. For example, the axial dimensions of the fluid communication channel 102 are such that the fluid communication channel can accommodate a length of a needle, that is, a needle pierced through the membrane 140 will remain housed within the priming device 100.
Alternatively, the fluid communication channel 102 may extend from a proximal end of the priming device 100 generally towards a distal end of the priming device, but this does not preclude the fluid communication channel 102 from being configured with at least one bend along its length. Further the fluid communication channel 102 may comprise a circular cross section or as an alternative, the fluid communication channel 102 may comprise a non-circular cross section, or as yet another alternative, the fluid communication channel 102 may comprise an irregular cross section along its length.
Further, the priming device 100 includes a filter 160 coupled to the third housing portion 150 defining a venting portion 106 of the priming device 100. The filter 160 may be disposed at the distal end of the retaining cap, in which the filter is configured to allow the passage of air therethrough. The filter may include a hydrophobic fluid contact surface 107 which at least partially faces the fluid communication channel 102. The filter 160 may be characterized by hydrophobic properties on its fluid contact surface 107. In the embodiment of
The proximal end 104 of the priming device 100 may be configured as a dry seal connector 103 suitable to operatively couple with an injector/adaptor 820 of a transfer system, such as an intravenous system. In some embodiments, when the proximal end 104 is coupled a complementary device such as an injector/adaptor 820, a relative sliding engagement provides a needle through the proximal end 104, resulting in a fluid communication path being established through the proximal end 104 between the injector/adaptor 820 and the priming device 100. In some other embodiments, the proximal end 104 pushes open a valve or gland of another transfer device, resulting in a fluid communication path being established between the other transfer device and the priming device 100.
As an example, illustrated in
In an example, the adaptor 820 includes an adaptor distal end, where the proximal end of the priming device 100 and the adaptor distal end are configured to provide a detachably affixed coupling. The adaptor 820 may be detachably affixed to the priming device 100, that is, the adaptor 820 may be detachable from the priming device 100, or the adaptor 820 may be undetachable from the priming device 100. Fluid communication is established between an interior of the adaptor 820 and the fluid communication channel 102 of the priming device by the detachably affixed coupling. Alternatively, the adaptor 820 and the priming device 100 may be integrally formed.
In an embodiment, the membrane 140 is configured to be penetrable by the needle 826 creating an opening in the membrane 140, thus allowing fluid communication between the needle 826 and the fluid communication channel 102. Further, the membrane 140 is configured to elastically deform and seal the opening upon retraction of the needle 826 from the priming device 100. Additionally, the membrane 140 is configured with a membrane thickness 144 such that the membrane 140 seals the opening upon retraction of the needle 826. The membrane thickness is configured to be of a sufficient thickness to allow the elastically deformed part of the membrane to revert to its original volume and hence re-seal the opening made by the needle. The membrane thickness 144 is further configured to be of a sufficient thickness to provide a “wiping” effect on the needle as the needle is extracted out from the fluid communication channel 102, such that substantially no trace fluid remains on the surface of the needle after the extraction.
A similar arrangement may be provided between the syringe 900 and corresponding connector 830 of the transfer system 800 in achieving fluid communication between the syringe 900 and the connector 830 of the transfer system 800. Therefore, fluid communication is established between priming device 100, syringe 900 and the transfer system 800.
As an example, illustrated by
Referring to
Referring to
When the coupling interface 204 of the priming device 200 is coupled with a corresponding adaptor 820, the membrane 240 of the priming device 200 is disposed adjacent to and abutting the sealing element 824 of the adaptor 820, forming a fluid seal therebetween. The fluid seal prohibits fluid from exiting through a coupling interface between the priming device 200 and the adaptor 820. Similar to above-described embodiments, the needle 826 of the adaptor 820 penetrates the sealing element 824 and subsequently the membrane 240, thereby allowing fluid communication between the adaptor 820 of the transfer system 800 and the fluid communication channel 202 of the priming device 200. During priming, fluid 70 provided by the syringe 900 is delivered into and through the transfer system 800 into the priming device 200 from the syringe 900. Air within the transfer system 800 is delivered together with the fluid 70 into the priming device 200, wherein air within the fluid communication channel 102 of the priming device 200 is trapped within the fluid communication channel 202 by the sealed portion 206. Subsequently, the air 75 is removed via decoupling the priming device 200 from the transfer system 800.
Referring to
In another embodiment of a priming device 400, the priming device 400 comprises an integrally formed housing 420 defining a fluid communication channel 402 therethrough. Additionally, the priming device 400 includes a membrane 440 configured such that when the priming device 400 is not connected to any complementing system, a fluid communication between the fluid communication channel 402 and the atmosphere through the membrane 440 is prevented. The membrane 440 is coupled to a connecting end 432 of the housing 420, such that the membrane 440 and the connecting end 432 defines a coupling interface 404 of the priming device 400. Further, portion 406 of the housing 420 may be configured as either a venting portion or a sealed portion.
In another embodiment as illustrated in
The priming device 500 is coupled to an adaptor 820 of a transfer system (not shown), as illustrated in
During priming, air within the transfer system 800 is delivered together with the fluid 70 into the priming device 500, wherein air within the fluid communication channel 502 of the priming device 500 is trapped within the fluid communication channel 502 by the sealed portion 506. Subsequently, the air can be removed through the venting portion 506 of the priming device 500. Alternatively, air can be trapped in the sealed portion 506 and removed via disconnection of the priming device 500 from the transfer system 800.
It will be readily understood that the components of the embodiments, as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations in addition to the described example embodiments. Thus, the following more detailed description of the example embodiments, as represented in conjunction with the figures, is not intended to limit the scope of the embodiments, as claimed, but is merely representative of example embodiments.
Reference throughout this specification to “one embodiment”, “another embodiment” or “an embodiment” (or the like) means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearance of the phrases “in one embodiment” or “in an embodiment” or the like in various places throughout this specification are not necessarily all referring to the same embodiment.
Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a thorough understanding of embodiments. One skilled in the relevant art will recognize, however, that the various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, some or all known structures, materials, or operations may not be shown or described in detail to avoid obfuscation.
As used herein, the singular “a” and “an” may be construed as including the plural “one or more” unless clearly indicated otherwise.
This disclosure has been presented for purposes of illustration and description but is not intended to be exhaustive or limiting. Many modifications and variations will be apparent to those of ordinary skill in the art. The example embodiments were chosen and described in order to explain principles and practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.
Thus, although illustrative example embodiments have been described herein with reference to the accompanying figures, it is to be understood that this description is not limiting and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.
This claims priority to U.S. Patent Application Ser. No. 62/913,344 filed Oct. 10, 2019, the disclosure of which is hereby incorporated by reference as if set forth in its entirety herein.
Number | Date | Country | |
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62913344 | Oct 2019 | US |