Patent Description:
The present invention relates to a spike for use with a closed system transfer device wherein the spike includes a pre-cut flash covering the fluid opening to facilitate last drop extraction and to reduce coring.

Medical drugs and solvents are often supplied in glass or plastic containers, such as vials, bottles, or bags, which are sealed by a rubber, plastic or elastomeric bung, stopper, membrane, or puncturable cap. Such sealing members prevent deterioration or contamination of the drug, allow the contents of a container to be mixed by shaking, and prevent the contents of the container from leaking out and contaminating the surroundings. A cannula or a hollow spike comprising a flow channel and an opening that communicates with the flow channel is usually inserted through such a sealing member to supply fluids to the container and to withdraw fluid therefrom.

Conventional devices used for accessing the containers utilize a piercing member that penetrates the sealing member of a container and defines an opening at a distal end of the piercing member. Typically, after the piercing member accesses the vial, the vial is inverted to withdraw the medicament from the container. Once the contents of the fluid container have drained to a level just under the outermost edge of the opening of the piercing member, no more fluid will be able to drain from the fluid container unless the piercing member is withdrawn slightly. Thus, often times the last few drops of the medicament (which may be very expensive and/or toxic) are not fully removed from the container, which results in waste and requires cleaning/disposal of the container. If the piercing member is retracted through the sealing member of the container to remove the remaining medicament in the container, toxic drug or medicament may leak out and contaminate the surrounding environment during such a procedure and non-filtered air containing undesirable particles, such as dust, pollen, or bacteria, may be drawn into the piercing member and contaminate the medicament therein. Accordingly, many conventional devices will be locked to the container or vial after the piercing member fully enters the vial. In some cases, containers are provided with an extra amount of the drug that is to be withdrawn to allow for the fact that not all of the drug will be withdrawn from the container. A user is then able to withdraw the recommended number of doses from the container, but doing so will increase the cost of each container of medical fluid, increase waste, and make cleaning or disposal of the container more complex.

<CIT>, owned by Becton, Dickinson and Company Ltd. , discloses a close system transfer device for transferring fluid to or from a fluid container having a spike for piercing the container sealing member. The spike includes a first opening for communication with a fluid channel and a second opening for communication with a vent. <CIT> describes a piercing member adapted for use with a flow channel. The piercing member has a penetrating member for piercing a solid closure, and is retained to the flow channel, but still allows fluid to flow through the flow channel while retained to the flow channel. <CIT> discloses a cannula assembly adapted to pierce a solid or unslit closure, including a blunt cannula and a piercing member held in cooperation with or contained within the flow channel of the cannula. The piercing member includes a tip capable of piercing an unslit stopper or closure and a means to temporarily retain the piercing member from the cannula and prevent inadvertent disengagement of the piercing member from the blunt cannula.

Because sealing members are available in a wide variety of configurations, sizes, and thicknesses, it is difficult to design a spike that is suitable for use with a plurality of different sealing members, while optimizing the use of the drug in the vial in a safe and convenient manner. Also, coring of the sealing member often occurs at the time of insertion of the spike through the sealing member of the vial and/or upon initial and repeated penetration of the sealing member with an injector cannula. Therefore, there is a need to design a spike that includes a covering to prevent coring during insertion of the spike and initial and/or repeated penetration by the injector cannula. There is also a need for a spike having a design/shape, such as a slanted orifice, to facilitate last drop withdrawal of the vial contents and a need for a spike having a design/shape that can be used with a variety of stopper sizes/thicknesses.

In accordance with an aspect of the disclosure, a device for transferring fluids includes a piercing member having a distal end and a proximal end and defining a longitudinal fluid channel. A first opening is positioned at the distal end of the piercing member. The first opening is in fluid communication with the longitudinal fluid channel. A cover or "flash" is positioned over the first opening. The cover includes a pre-cut pattern, so that this cover breaks and opens along the pre-cut pattern upon application of a distally directed force from the longitudinal fluid channel. In accordance with the invention, a "flash" is defined as a covering that closes the fluid orifice of the piercing member in a molded configuration.

This distally directed force can be applied via a cannula extending through the fluid channel which comes into contact with the cover and applies a force to the cover causing the cover to break along the pre-cut pattern.

According to one embodiment, the cover can be a membrane that is molded over the first opening. The cover can include at least one molded hinge connecting the cover to the piercing member. According to a further embodiment, the pre-cut pattern can include a cut along a center portion of the cover dividing the cover into a first portion and a second portion and the at least one molded hinge can comprise a first hinge for securing the first cover portion to a first portion of the piercing member and a second hinge for securing the second cover portion to a second portion of the piercing member at a location opposite from the first portion of the piercing member. During use, upon the application of the distally directed force, the cover opens along the first and second hinges in an outward direction with respect to the first opening.

According to one embodiment, the at least one molded hinge and/or the first and second hinges comprise a living hinge and the cover remains attached to the piercing member via the at least one molded hinge and/or the first and second hinges.

The pre-cut pattern can comprise a cut that partially surrounds the opening, with the exception of the first and second portions, so that during use, the cover remains attached to the piercing member via the first and second hinges.

The distal end of the piercing member including the first opening can include a steep taper to facilitate last drop withdrawal from a container having a sealing member, wherein the steep taper of the piercing member is configured for use with a variety of thicknesses of sealing members.

The piercing member defines a longitudinal vent channel and defines a second opening at the distal end of the piercing member and the device for transferring fluids further comprises a body extending from the proximal end of the piercing member, wherein the body includes a first connecting portion configured to receive a mating connector and a second connecting portion configured to secure the body to a container. The device further includes a pressure equalization arrangement in fluid communication with the longitudinal vent channel of the piercing member.

The first opening of the piercing member extends longitudinally from the distal end of the piercing member. A length of the first opening of the piercing member in a direction extending from the proximal end of the piercing member to the distal end of the piercing member ensures that at least a portion of the first opening of the piercing member is located adjacent an innermost side of a sealing member of a fluid container when the piercing member has penetrated the sealing member.

According to one embodiment, the piercing member can have a cylindrical shape with a pointed tip at the distal end. According to a further embodiment, the piercing member can comprise a first flat portion defining a first planar surface and a second flat portion defining a second planar surface, wherein the first and second flat portions are configured to reduce a penetration force required to pierce a sealing member of a fluid container relative to a piercing member not having the first and second flat portions.

In accordance with another aspect of the disclosure, a device for transferring fluids includes a body having a first side and a second side. A piercing member extends from the second side of the body, wherein the piercing member has a distal end and a proximal end defining a longitudinal fluid channel. At least one opening is positioned at the distal end of the piercing member and the at least one opening is in fluid communication with the longitudinal fluid channel. A cover is positioned over the first opening. The cover includes a pre-cut pattern, wherein the cover opens along the pre-cut pattern upon application of a distally directed force from the longitudinal fluid channel.

According to one embodiment, the cover comprises a membrane that is molded over the first opening and the pre-cut pattern comprises a cut along a center portion of the cover dividing the cover into a first portion and a second portion. The cover also includes a first hinge for securing the first cover portion to a first portion of the piercing member, and a second hinge for securing the second cover portion to a second portion of the piercing member, at a location opposite from the first portion of the piercing member. Upon penetration by the distally directed force, the cover opens along the first and second hinges in an outward direction with respect to the first opening. In order to facilitate this opening, the pre-cut pattern comprises a cut that partially surrounds the opening, with the exception of the first and second portions, so that the cover remains attached to the piercing member via the first and second hinges. The distal end of the piercing member that includes the first opening has a steep taper to facilitate last drop withdrawal from a container having a sealing member, wherein the steep taper of the piercing member is configured for use with a variety of thicknesses of sealing members.

The piercing member also defines a longitudinal vent channel and defines a second opening at the distal end of the piercing member. The body of the fluid transfer device extends from the proximal end of the piercing member. The body includes a first connecting portion configured to receiving a mating connector and a second connecting portion configured to secure the body to a container.

For purposes of the description hereinafter, the terms such as "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention 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 embodiments of the invention. Further, it is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary.

Referring to <FIG>, a container access device <NUM>, in accordance with the prior art, includes a body <NUM> having a first side <NUM> and a second side <NUM>, a piercing member <NUM> extending from the second side <NUM> of the body <NUM>, and a retractable sleeve <NUM> surrounding the piercing member <NUM>. The container access device <NUM> is configured to transfer fluid from a fluid container <NUM> having a sealing member <NUM>, which is shown in <FIG>. The fluid container <NUM> may include, but is not limited to, a vial, a bottle, and a bag such as an infusion bag.

Referring to <FIG>, the piercing member <NUM> has a proximal end <NUM> and a distal end <NUM> and defines a longitudinal fluid channel <NUM>. A pointed tip <NUM> is provided at the distal end <NUM> for penetrating the sealing member <NUM> of the container <NUM>. The piercing member <NUM> has a round cross-section, although other suitable cross-sections may be utilized, including, but not limited to, oval, square, and varying cross-sections. Preferably, the piercing member <NUM> has a round cross-section to provide a sufficient seal with the sealing member <NUM> when the device is in use. The piercing member <NUM> defines a fluid opening <NUM> in fluid communication with the longitudinal fluid channel <NUM> that extends from the distal end <NUM> of the piercing member <NUM> towards the proximal end <NUM> of the piercing member <NUM>. The fluid opening <NUM> can be of any suitable shape, including, but not limited to, rectangular, square, circular, oval, or keyhole. In the embodiments shown in <FIG>, the fluid opening <NUM> is oval-shaped. The fluid opening <NUM> extends longitudinally along about <NUM>% of the length of the piercing member <NUM>, either from the distal end <NUM> of the piercing member <NUM> or a few millimeters from the distal end <NUM> of the piercing member <NUM>, to ensure that at least part of the fluid opening <NUM> is located substantially adjacent to an innermost side <NUM> of the sealing member <NUM> when the device <NUM> is in use. The length of the fluid opening <NUM> can be selected based on the thickness of the thinnest sealing member <NUM> that it is intended to penetrate, and the distance which the piercing member <NUM> is intended to penetrate the sealing member <NUM>. As shown in <FIG>, the sealing member <NUM> overlaps the fluid opening <NUM> when the device <NUM> is fully engaged with the container <NUM>. The maximum width of the fluid opening <NUM> may be equal to at least <NUM>% of the maximum width of the piercing member <NUM>, and is preferably at least <NUM>% of the maximum width of the piercing member <NUM>. The fluid opening <NUM> may not necessarily extend in a direction parallel or collinear to the longitudinal axis of the device <NUM> and may extend in a zig-zag pattern along the length of the piercing member <NUM> or may be defined by a plurality of openings that extend transversely to the longitudinal axis of the device <NUM>.

Referring still to <FIG>, the body <NUM> includes a first connecting portion <NUM> extending from the first side <NUM> of the body <NUM>. The first connecting portion <NUM> is configured to attach the device <NUM> to a syringe adapter or other suitable device or container to allow removal or insertion of fluid into the fluid container <NUM>. As shown in <FIG>, the first connecting portion <NUM> is shaped and configured to receive a mating connector, such as a collet arrangement, although other suitable connections may be utilized, including, but not limited to, a luer arrangement, a snap-fit mechanism, a threaded luer lock, and other suitable mechanical or non-mechanical connecting arrangements. The longitudinal fluid channel <NUM> extends through the body <NUM> and is in fluid communication with the first connecting portion <NUM>. The first connecting portion <NUM> may include a septum or membrane <NUM> to seal the fluid channel <NUM> at the first connecting portion <NUM>. The body <NUM> may also include a second connecting portion <NUM> extending from the second side <NUM> of the body <NUM> of the device <NUM> that is configured to secure the device <NUM> to the fluid container <NUM>. The second connecting portion <NUM> includes a plurality of resilient arms <NUM> having protrusions <NUM> that engage the rim of the fluid container <NUM> when the piercing member <NUM> has been pushed through the sealing member <NUM> of the fluid container <NUM>, although other suitable arrangements for the second connecting portion <NUM> may be utilized. As shown in <FIG> and <FIG>, the resilient arms <NUM> deflect radially outward when the device <NUM> is in the process of being attached to the fluid container <NUM> and return to their original position after being fully secured to the container as shown in <FIG> and <FIG>.

Referring again to <FIG>, the device <NUM> further includes a pressure equalization arrangement <NUM> that is configured to equalize the pressure within the container <NUM> during fluid transfer through the use of an expansible chamber <NUM>. The piercing member <NUM> defines a longitudinal vent channel <NUM> and a vent opening <NUM> extending from the distal end <NUM> of the piercing member <NUM> or a few millimeters from the distal end <NUM> of the piercing member <NUM> toward the proximal end <NUM> of the piercing member <NUM>. The vent opening <NUM> is in fluid communication with the longitudinal vent channel <NUM>. The longitudinal vent channel <NUM> extends through the body <NUM> of the device <NUM> and is in fluid communication with the expansible chamber <NUM> of the pressure equalization arrangement <NUM>. In particular, during use of the device <NUM>, the longitudinal vent channel <NUM> and the pressure equalization arrangement <NUM> is utilized to regulate the pressure within the fluid container <NUM> and contains the medicament and any vapor thereof within the device <NUM> and within the fluid container <NUM>. The pressure equalization arrangement <NUM> may be the balloon or membrane arrangement shown in <CIT>, which is hereby incorporated by reference in its entirety, although other suitable pressure equalization arrangements may be utilized, such as, but not limited to, a filtered vent exit. Further, although not shown, the pressure equalization arrangement may include a filter, such as a hydrophobic filter, positioned between the chamber <NUM> and the longitudinal vent channel <NUM>. The longitudinal fluid channel <NUM> and longitudinal vent channel <NUM> may have any suitable cross-section including, but not limited to, round, oval, elliptical, semi-circular, and square. As shown more clearly in <FIG>, the cross-sections of the longitudinal fluid channel <NUM> and longitudinal vent channel <NUM> are elliptical or semi-circular, so that their cross-sectional areas can be maximized within the cylindrical piercing member <NUM>.

Referring to <FIG>, the piercing member <NUM> includes first and second flat portions <NUM>, <NUM> positioned circumferentially between the vent opening <NUM> and the fluid opening <NUM> with the first flat portion <NUM> positioned opposite the second flat portion <NUM>. The first and second flat portions <NUM>, <NUM> each include a first end <NUM>, <NUM> and a second end <NUM>, <NUM>. The first and second ends <NUM>, <NUM>, <NUM>, <NUM> of the flat portions <NUM>, <NUM> are generally bulbous-shaped with a tapered middle that is narrower than the first and second ends <NUM>, <NUM>, <NUM>, <NUM>. The first and second flat portions <NUM>, <NUM> are generally planar. The first and second flat portions <NUM>, <NUM> are configured to reduce the force needed for the piercing member <NUM> to penetrate the sealing member <NUM> of the fluid container <NUM>.

Referring to <FIG>, <FIG>, <FIG>, and <FIG>, the retractable sleeve <NUM> has a distal end <NUM> and a proximal end <NUM> and surrounds the piercing member <NUM>. The retractable sleeve <NUM> may be made from an elastomeric material including, but not limited to, thermoplastic or thermosetting elastomers including, but limited to, silicone rubber. The retractable sleeve <NUM> has a proximal opening <NUM> that surrounds the proximal end <NUM> of the piercing member <NUM> and a distal opening <NUM> that is positioned beyond the distal end <NUM> of the piercing member <NUM> in the longitudinal direction. Thus, there is a space between the distal opening <NUM> of the sleeve <NUM> and the distal end <NUM> of the piercing member <NUM>. An inner surface of the retractable sleeve <NUM> has a shape approximating the shape of the outer surface of the piercing member <NUM>. A gap <NUM> is defined between the inner surface of the retractable sleeve <NUM> and the outer surface of the piercing member <NUM>. The gap <NUM> may have a substantially uniform width, i.e., the distance between the inner surface of the retractable sleeve <NUM> and the outer surface of the piercing member <NUM> is substantially uniform. The distal opening <NUM> of the retractable sleeve <NUM> is in fluid communication with the gap <NUM>, so that sterilizing gases or liquids, such as ETO gas, can enter the gap <NUM> to sterilize both the inner surface of the retractable sleeve <NUM> and the outer surface of the piercing member <NUM>. A seal is present between the proximal end <NUM> of the retractable sleeve <NUM> and the proximal end <NUM> of the piercing member <NUM>. The mating surfaces of the seal between the proximal end <NUM> of the retractable sleeve <NUM> and the proximal end <NUM> of the piercing member <NUM> are never exposed to the atmosphere even during use of the device <NUM>.

Referring to <FIG> and <FIG>, the seal between the retractable sleeve <NUM> and the piercing member <NUM> may be formed by an interference fit between the proximal end <NUM> of the retractable sleeve <NUM> and the proximal end <NUM> of the piercing member <NUM>. The interference fit may be accomplished by increasing the cross-sectional thickness of the retractable sleeve <NUM> at its proximal end <NUM>. The retractable sleeve <NUM> may also be provided with a lip <NUM> at the proximal end <NUM>. This lip <NUM> is configured to abut the second side <NUM> of the body <NUM> and may be accommodated by an annular groove <NUM> defined by the body <NUM> of the device <NUM>. The lip <NUM> allows the retractable sleeve <NUM> to be easily assembled over the piercing member <NUM> by placing the retractable sleeve <NUM> into a rigid tubular tool, such that an end of the tool abuts the lip <NUM>. The tool can then be used to push the retractable sleeve <NUM> onto the piercing member <NUM>.

Referring to <FIG> and <FIG>, a further embodiment of a container access device <NUM> is shown. The access device <NUM> is similar to the device <NUM> shown in <FIG> and like reference numbers are used for like elements. The access device <NUM> shown in <FIG>, however, includes a lip <NUM> adjacent the distal opening <NUM> in order to provide a better seal with the sealing member <NUM> of the fluid container <NUM> when the device <NUM> is in use.

Referring to <FIG> and <FIG>, another embodiment of a container access device <NUM> is shown. The access device <NUM> is similar to the device <NUM> shown in <FIG> and like reference numbers are used for like elements. The access device <NUM> in <FIG>, however, obtains an interference fit between the retractable sleeve <NUM> and the piercing member <NUM> by increasing the thickness of a portion <NUM> of the piercing member <NUM> at its proximal end <NUM>. Also, as shown in <FIG>, the access device <NUM> may only have a longitudinal fluid channel <NUM> and no vent opening.

Referring again to <FIG>, <FIG>, and <FIG>, the retractable sleeve <NUM> is configured to abut against an outermost side <NUM> of the sealing member <NUM> when the device <NUM> has been inserted into a fluid container <NUM> and to retract as the piercing member <NUM> penetrates more deeply into the sealing member <NUM>. When the device <NUM> is fully inserted into the sealing member <NUM> of the fluid container <NUM>, as shown in <FIG>, at least a portion of the fluid opening <NUM> is exposed to the interior of the fluid container <NUM>, while the remaining portion of the fluid opening <NUM> is sealed by the sealing member <NUM> of the fluid container <NUM>, thereby preventing deterioration or contamination of the contents of the fluid container <NUM> and preventing the contents of the fluid container <NUM> from leaking out and contaminating the surrounding environment. More specifically, as shown in <FIG> and <FIG>, as the piercing member <NUM> is entering the fluid container <NUM>, the fluid opening <NUM> spans the thickness of the sealing member <NUM> of the fluid container <NUM>. Without the retractable sleeve <NUM>, toxic vapors or substances could potentially be expelled to the surrounding atmosphere or contaminants could potentially enter into the fluid container <NUM>. The retractable sleeve <NUM> provides a seal with the sealing member <NUM> of the fluid container <NUM> and retracts as the piercing member <NUM> is inserted into the fluid container <NUM> to prevent any leakage into or out of the fluid container <NUM>. Further, the elongated size and shape of the fluid opening <NUM> allows the fluid container <NUM> to be completely emptied when the fluid container <NUM> is inverted, which is typical during the withdrawal of medicament from the fluid container <NUM>. If the entirety of the fluid opening <NUM> were positioned within the fluid container <NUM>, all of the medicament may not be emptied from the fluid container <NUM> depending on the size of the sealing member <NUM>.

As the piercing member <NUM> is inserted through the sealing member <NUM> and into the fluid container <NUM>, the retractable sleeve <NUM> is compressed between the sealing member <NUM> and body <NUM> of the device <NUM>, as shown in <FIG>. This forms a seal between the retractable sleeve <NUM> and the sealing member <NUM> and between the retractable sleeve <NUM> and the body <NUM> of the device <NUM>, thereby assuring that none of the contents of the fluid container <NUM> is exposed to the atmosphere during transfer of the fluid.

The length of the piercing member <NUM>, the fluid opening <NUM>, and the retractable sleeve <NUM> may be selected, such that several conditions are met when the device <NUM> is inserted into the sealing member <NUM> of the fluid container <NUM>. First, a portion of the fluid opening <NUM> is disposed within the fluid container <NUM> to allow fluid to flow into or out of the fluid container <NUM> via the longitudinal fluid channel <NUM> in the piercing member <NUM>. Second, the retractable sleeve <NUM> is compressed, such that the distal end <NUM> of the retractable sleeve <NUM> forms a seal with the sealing member <NUM> and the proximal end <NUM> of the retractable sleeve <NUM> forms a seal with the body <NUM> of the device <NUM>.

Further, the configuration of the device <NUM> allows for the last drop of fluid to be withdrawn from a variety of the fluid containers <NUM> having different configurations and different thickness sealing members <NUM>. At the same time, the configuration of the retractable sleeve <NUM> assures that access to the fluid container <NUM> and transfer of the fluid occurs in a sealed manner, so that no fluids or gases escape from or enter the system while still allowing the entire system to be sterilized. In particular, the gap <NUM> between the retractable sleeve <NUM> and the piercing member <NUM> allows the piercing member <NUM> and the inner surface of the retractable sleeve <NUM> to be sterilized. The retractable sleeve <NUM> also prevents contact contamination of the piercing member <NUM> before it is inserted into the fluid container <NUM>.

Reference is now made to <FIG>, which show a piercing member, generally indicated as <NUM>, for use with a fluid transfer device, generally indicated as <NUM>, in accordance with the invention. The piercing member <NUM> has a distal end <NUM> and a proximal end <NUM> and defines a longitudinal fluid channel <NUM>. The piercing member <NUM> can have a round cross-section, however, it can be appreciated that the piercing member can have other cross-sections, including but not limited to, oval, square, and varying cross-sections. A first opening <NUM> is positioned at the distal end <NUM> of the piercing member <NUM>. The first opening <NUM> is in fluid communication with the longitudinal fluid channel <NUM>. A cover or "flash" <NUM> is positioned over the first opening <NUM>. The cover <NUM> includes a pre-cut pattern <NUM>, so that the cover <NUM> opens along the pre-cut pattern <NUM> upon application of a distally directed force from the longitudinal fluid channel. In accordance with the invention, a "flash" is defined as a covering that closes the fluid orifice or first opening <NUM> of the piercing member <NUM> in a molded configuration.

This distally directed force can be applied via a cannula <NUM>, as shown in <FIG>, extending through the fluid channel <NUM> having a distal tip <NUM>, which comes into contact with the cover <NUM> and applies a force to the cover <NUM> causing the cover to break along the pre-cut pattern <NUM>.

According to one embodiment, the cover <NUM> can be a membrane that is molded over the first opening <NUM>. The cover <NUM> can include at least one molded hinge <NUM> connecting the cover <NUM> to the piercing member <NUM>. According to a further embodiment, the pre-cut pattern <NUM> can include a cut along a center portion <NUM> of the cover dividing the cover into a first cover portion 137a and a second cover portion 137b and the at least one molded hinge <NUM> can comprise a first hinge 143a for securing the first cover portion 137a to a first portion 118a of the piercing member <NUM> and a second hinge 143b for securing the second cover portion 137b to a second portion 118b of the piercing member <NUM>. The second hinge 143b securing the second cover portion 137b to the second portion 118b of the piercing member <NUM> is at a location that is opposite from the first hinge 143a securing the first cover portion 137a of the first portion 118a of the piercing member <NUM>. During use of the device <NUM>, application of the distally directed force causes the cover <NUM> to open along the first and second hinges 143a, 143b in an outward direction with respect to the first opening <NUM>, as shown in <FIG>.

According to one embodiment, the at least one molded hinge <NUM> and/or the first and second hinges 143a, 143b can be living hinges and the cover <NUM> remains attached to the piercing member <NUM> via the at least one molded hinge <NUM> and/or the first and second hinges 143a, 143b.

With reference to <FIG>, the pre-cut pattern can include cuts <NUM> that partially surround the first opening <NUM>, with the exception of the first and second portions 118a, 118b, so that during use, the cover <NUM> remains attached to the piercing member <NUM> via the first and second hinges 143a, 143b.

The distal end <NUM> of the piercing member <NUM>, at the location of the first opening <NUM> can include a steep taper <NUM>, such as shown in <FIG>. The steep taper <NUM> forms a slanted orifice for the first opening <NUM> which facilitates last drop withdrawal from a container, such as container <NUM> shown in <FIG>. As shown in <FIG>, the container <NUM> has a sealing member <NUM>. Providing a steep taper <NUM> on the piercing member <NUM> of the invention enables the piercing member <NUM> to be used with sealing members <NUM> having varying thicknesses and/or sizes.

With continuing reference to <FIG>, the piercing member <NUM> defines a longitudinal vent channel <NUM> and defines a second opening <NUM> at the distal end <NUM> of the piercing member <NUM>. With further reference to <FIG> and <FIG>, the fluid transfer device <NUM> further comprises a body <NUM> extending from the proximal end <NUM> of the piercing member <NUM>. This body <NUM> can include a first connecting portion <NUM> configured for receiving a mating connector, such as a collet arrangement, although other suitable connections may be utilized, including, but not limited to, a luer arrangement, a snap-fit mechanism, a threaded luer lock, and other suitable mechanical or non-mechanical connecting arrangements. A second connecting portion <NUM> is configured to secure the body <NUM> to a container. The second connecting portion <NUM> can include a plurality of resilient arms <NUM> having protrusions <NUM> that engage the rim of the fluid container when the piercing member <NUM> has been pushed through the sealing member of the fluid container, although other suitable arrangements for the second connecting portion <NUM> may be utilized. The resilient arms <NUM> are designed to deflect radially outward when the device <NUM> is in the process of being attached to the fluid container and return to their original position after being fully secured to the container.

The device further includes a pressure equalization arrangement <NUM> in fluid communication with the longitudinal vent channel <NUM> of the piercing member <NUM>. The pressure equalization arrangement <NUM> is configured to equalize the pressure within the container during fluid transfer through the use of an expansible chamber, as shown as <NUM> in <FIG>. As further shown in <FIG> and discussed above, the piercing member <NUM> defines a longitudinal vent channel <NUM> and a vent opening or second opening <NUM> extending from the distal end <NUM> of the piercing member <NUM> or a few millimeters from the distal end <NUM> of the piercing member <NUM> toward the proximal end <NUM> of the piercing member <NUM>. The vent opening or second opening <NUM> is in fluid communication with the longitudinal vent channel <NUM>. The longitudinal vent channel <NUM> extends through the body <NUM> of the device <NUM> and is in fluid communication with the expansible chamber of the pressure equalization arrangement <NUM>. In particular, during use of the device <NUM>, the longitudinal vent channel <NUM> and the pressure equalization arrangement <NUM> is utilized to regulate the pressure within the fluid container and contains the medicament and any vapor thereof within the device <NUM> and within the fluid container. The pressure equalization arrangement <NUM> may be the balloon or membrane arrangement shown in <CIT> or <CIT>, although other suitable pressure equalization arrangements may be utilized, such as, but not limited to, a filtered vent exit. Further, although not shown, the pressure equalization arrangement may include a filter, such as a hydrophobic filter, positioned between the chamber and the longitudinal vent channel <NUM>. The longitudinal fluid channel <NUM> and longitudinal vent channel <NUM> may have any suitable cross-section including, but not limited to, round, oval, elliptical, semi-circular, and square.

The first opening <NUM> of the piercing member <NUM> extends longitudinally from the distal end <NUM> of the piercing member <NUM>. A length of the first opening <NUM> of the piercing member <NUM> in a direction extending from the proximal end <NUM> of the piercing member <NUM> to the distal end <NUM> of the piercing member <NUM> ensures that at least a portion of the first opening <NUM> of the piercing member <NUM> is located adjacent an innermost side of a sealing member of a fluid container, when the piercing member <NUM> has penetrated the sealing member, such as shown for illustration purposes in <FIG>, which shows sealing member <NUM> of fluid container <NUM> wherein the fluid opening <NUM> is adjacent the innermost side of the sealing member <NUM>.

According to one embodiment, the piercing member <NUM> can have a cylindrical shape with a pointed tip <NUM> at the distal end <NUM>. According to a further embodiment and with reference to <FIG>, the piercing member <NUM> can comprise a first flat portion <NUM> defining a first planar surface and a second flat portion <NUM> defining a second planar surface, wherein the first and second flat portions <NUM>, <NUM> are configured to reduce a penetration force required to pierce a sealing member of a fluid container relative to a piercing member not having the first and second flat portions.

Although not shown in <FIG>, it can be appreciated that the fluid transfer device <NUM> of the invention can include the retractable sleeve <NUM> of the prior art as shown in <FIG>, <FIG>, and <FIG> of the present disclosure.

Claim 1:
A device (<NUM>) for transferring fluids comprising:
a piercing member (<NUM>) having a distal end (<NUM>) and a proximal end (<NUM>) and defining a longitudinal fluid channel (<NUM>), a first opening (<NUM>) positioned at the distal end (<NUM>) of the piercing member (<NUM>), the opening (<NUM>) in fluid communication with the longitudinal fluid channel (<NUM>); and
characterized by a cover (<NUM>) positioned over the first opening (<NUM>), the cover including a pre-cut pattern (<NUM>) wherein the cover (<NUM>) breaks and opens along the pre-cut pattern (<NUM>) upon application of a distally directed force from the longitudinal fluid channel (<NUM>).