Patent Description:
<FIG> illustrates a common IV catheter assembly <NUM> that consists of a catheter hub <NUM> and a needle shield <NUM>. Needle shield <NUM> contains a needle hub from which a needle <NUM> extends. Needle <NUM> extends through catheter hub <NUM> and is used to thread the catheter into the vasculature of a patient. IV catheter assembly <NUM> is initially handled by a clinician as a single component. The clinician inserts needle <NUM> into the patient's vasculature and then slides the catheter over top of the needle further into the vasculature. Once the catheter is placed appropriately in the vasculature, needle <NUM> can be retracted into needle shield <NUM>. Then, needle shield <NUM> can be detached from catheter hub <NUM> leaving catheter hub <NUM> for connection of other devices for blood draw or fluid injection.

Because needle shield <NUM> and catheter hub <NUM> are separate components, a certain amount of flexibility may exist between the two components. If this amount of flexibility is too great, the clinician may experience difficulty when inserting needle <NUM> into the patient's vasculature.

Typically, catheter hub <NUM> is configured at a proximal end with a connector that is designed to receive a standard connector of another device. For example, catheter hub <NUM> is often configured to receive a male luer of another device. Because of this, there are limited options for reinforcing the connection between catheter hub <NUM> and needle shield <NUM> to limit the amount of flexibility between the components when needle <NUM> is inserted. Any structural reinforcements must be made in such a way that other devices (e.g. male luers) will still be attachable to catheter hub <NUM>.

Also, many catheter hubs employ a blood control valve that includes components positioned inside of the catheter hub. For example, a catheter hub may include an actuator that is initially positioned near the proximal end of the catheter hub on one side of a septum, and is then forced distally through the septum to open a fluid path through the catheter hub. Because the actuator is positioned near the proximal end of the catheter hub, there is little area for providing structural reinforcements inside the catheter hub.

<FIG> and <FIG> illustrate an example of a catheter assembly <NUM> that includes a blood control valve. Catheter assembly <NUM> includes a catheter hub <NUM> that employs an actuator <NUM> and a needle shield <NUM>. Needle shield <NUM> contains a needle hub <NUM> which contains a needle <NUM>. Actuator <NUM> is designed to be forced through septum <NUM> when another access device is connected to catheter hub <NUM> to thereby open a fluid pathway through catheter hub <NUM>. Because of the presence of actuator <NUM> within catheter hub <NUM>, there is little or no additional space within catheter hub <NUM> into which needle hub <NUM> could extend.

Also, because actuator <NUM> is forced through septum <NUM> by access devices that are connected to catheter hub <NUM>, actuator <NUM> must have a proximal end that the access devices can press against as the access devices are connected to catheter hub <NUM>. Accordingly, the proximal end of actuator <NUM> is typically larger in size (e.g. as shown in <FIG> and <FIG>) which further minimizes the amount of space available at the proximal end of catheter hub <NUM>.

As shown in <FIG>, catheter hub <NUM> and needle shield <NUM> are connected so that the components are coaxially aligned. In contrast, <FIG> illustrates the state of catheter assembly <NUM> while a clinician is handling the assembly to insert needle <NUM> into a patient's vasculature. As shown, the clinician typically grips assembly <NUM> and applies a downward and forward force to propel needle <NUM> through the patient's skin. This downward force causes catheter hub <NUM> and needle shield <NUM> to flex relative to each other as shown in <FIG>.

A substantial amount of flexing may occur because the pivot point between catheter hub <NUM> and needle shield <NUM> is formed where the two components connect. Because of this, the primary structure that resists flexing is the portion of needle shield <NUM> that extends into catheter hub <NUM>. Because this portion is relatively short and thin, it cannot provide significant strength to withstand the flexing forces. As a result, an undesirable amount of flexing often occurs.

The flexing between the catheter hub and the needle shield creates various problems. Primarily, when the components flex, the amount of force transferred to the needle is reduced thereby making it more difficult to insert the needle through the patient's skin. Also, when this flexing occurs, the clinician perceives the components as being weak which may cause the clinician to alter the catheter insertion procedure or to view the catheter assembly as being unsatisfactory. In some cases, this flexing may also lead to failure of the components.

<CIT> discloses an apparatus for peripheral vascular access for insertion of a catheter into a vessel, including a coaxial slidably mounted needle, dilator and catheter components.

<CIT> discloses a device for use in the sampling or infusion of liquids from or to the human or animal body having connecting means for connection to a cannula, connecting means for connection to a source or drain of liquid and valve means operable to open or close a flow path therebetween.

The present disclosure extends to a design of a needle hub and an actuator of a catheter assembly that allows the needle hub and actuator to interlock within the catheter hub. This interlocking allows the needle hub to be inserted into the catheter hub thereby increasing the rigidity of the catheter assembly. The interlocking can be accomplished by forming one or more channels in the proximal end of the actuator and one or more corresponding protrusions that extend from the distal end of the needle hub. In some embodiments, the channels and protrusions can be formed at the top and bottom of the catheter hub and needle hub respectively to thereby increase the vertical rigidity of the catheter assembly. The increase in vertical rigidity can prevent flexing of the catheter hub with respect to the needle shield when a downward force is applied to the catheter assembly such as is common during insertion of the needle.

the present invention is implemented as a catheter assembly comprising a catheter hub and a needle shield. The catheter hub contains an actuator and a septum. The actuator is configured to pierce the septum when a force is applied to the actuator. The needle shield is connected to the catheter hub and contains a needle hub. The needle hub contains a needle that extends through the catheter hub. The needle hub also includes one or more protrusions that extend from a distal end of the needle hub while the actuator includes one or more channels that extend from a proximal end and into the actuator. The one or more protrusions of the needle hub insert into the one or more channels thereby interlocking the needle hub with the actuator to provide greater rigidity between the catheter hub and the needle shield.

In some embodiments, the actuator includes two channels and the needle hub includes two protrusions. These channels can be positioned at the top and bottom of the actuator to provide greater rigidity against vertical forces applied to the catheter assembly.

The actuator is positioned completely within the catheter hub such that the needle hub extends into the catheter hub to interlock with the actuator.

In some embodiments, the protrusions extend distally from the outer diameter of the needle hub. The outer diameter of the protrusions can also match the outer diameter of the channels. In some embodiments, the protrusions extend into the catheter hub.

In some embodiments, the catheter assembly is an intravenous catheter assembly where the needle shield is detachable from the catheter hub to allow another access device to be connected to the catheter hub.

In other embodiments, the present disclosure shows an actuator for use within a catheter hub. The actuator comprises a main body extending from a distal end to a proximal end. The distal end is configured to pierce a septum when a force is applied to the proximal end. The proximal end includes one or more channels that extend towards the distal end. The one or more channels are sized and shaped to receive one or more protrusions of a needle hub contained within a needle shield to thereby interlock the actuator and the needle hub to provide greater rigidity between the catheter hub and the needle shield.

In some embodiments, the proximal end of the actuator includes two channels. The two channels may be positioned at the top and bottom of the proximal end to provide greater rigidity against vertical forces.

In some embodiments, the actuator is positioned completely within the catheter hub such that, when a needle shield is attached to the catheter hub, a needle hub within the needle shield extends into the catheter hub to interlock with the actuator.

In some embodiments, the outer diameter of the channels matches the outer diameter of corresponding protrusions in a needle hub. In some embodiments, the one or more channels extend from the proximal end of the actuator.

In other embodiments, the present disclosure shows a needle hub for use within a needle shield. The needle hub comprises a main body extending from a distal end to a proximal end. The main body contains a needle that extends out from the distal end. The distal end is configured with one or more protrusions that extend distally from the distal end. The one or more protrusions are configured to be inserted into corresponding channels formed in an actuator of a catheter hub.

In some embodiments, the one or more protrusions comprise two protrusions. The two protrusions may be positioned at the top and bottom of the distal end. The one or more protrusions may extend into the catheter hub in which the actuator is contained. In some embodiments, the protrusions extend distally from the outer diameter of the needle hub.

This summary is not intended to identify key features or essential features of the claimed subject matter.

Additional features and advantages of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the instrument particularly pointed out in the appended claim. These and other features of the present invention will become more fully apparent from the following description and appended claim, or may be learned by the practice of the invention as set forth hereinafter.

The presently preferred embodiments of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

In other embodiments, the present disclosure is implemented as an actuator for use within a catheter hub. The actuator comprises a main body extending from a distal end to a proximal end. The distal end is configured to pierce a septum when a force is applied to the proximal end. The proximal end includes one or more channels that extend towards the distal end. The one or more channels are sized and shaped to receive one or more protrusions of a needle hub contained within a needle shield to thereby interlock the actuator and the needle hub to provide greater rigidity between the catheter hub and the needle shield.

In other embodiments, the present disclosure is implemented as a needle hub for use within a needle shield. The needle hub comprises a main body extending from a distal end to a proximal end. The main body contains a needle that extends out from the distal end. The distal end is configured with one or more protrusions that extend distally from the distal end. The one or more protrusions are configured to be inserted into corresponding channels formed in an actuator of a catheter hub.

<FIG> illustrates a catheter assembly <NUM> in accordance with one or more embodiments of the invention. Catheter assembly <NUM> includes a catheter hub <NUM> that interconnects with a needle shield <NUM>. Catheter hub <NUM> includes a septum <NUM> and an actuator <NUM> for piercing septum <NUM> with another access device is connected to catheter hub <NUM>. Needle shield <NUM> includes a needle hub <NUM> that contains a needle <NUM>. Once needle <NUM> has been used to insert a catheter into a patient's vasculature, needle hub <NUM> can be retracted further into needle shield <NUM> so that needle <NUM> is fully contained within needle shield <NUM>. Needle shield <NUM> can then be disconnected from catheter hub <NUM> to allow other access devices to be connected to catheter hub <NUM>.

As shown, actuator <NUM> and needle hub <NUM> are configured to interlock. In this way, needle hub <NUM> can insert into actuator <NUM>. This interlocking provides greater rigidity between catheter hub <NUM> and needle shield <NUM>. Specifically, because needle hub <NUM> extends into actuator <NUM>, the amount of flexing that can occur between catheter hub <NUM> and needle shield <NUM> is reduced. This reduced amount of flexing will cause more force to be transferred to needle <NUM> during the needle insertion process and will provide the clinician with a better feel.

<FIG> illustrates a perspective view of one example of how actuator <NUM> and needle hub <NUM> can interlock. As shown, actuator <NUM> can include an opening 307a at its proximal end that is sufficiently large to allow the distal end of needle hub <NUM> to insert into the opening. In some implementations, this configuration can provide an increased amount of rigidity between catheter hub <NUM> and needle shield <NUM>.

However, in some cases, this configuration creates additional difficulties. In many cases, in order to have an opening 307a that is sufficiently large to allow needle hub <NUM> to extend sufficiently into actuator <NUM>, the outer wall of actuator <NUM> around opening 307a becomes too narrow to provide an adequate surface against which another access device can press to force actuator <NUM> through septum <NUM>. For example, the outer wall can be required to be so narrow that another access device does not contact the outer wall when the access device is connected to catheter hub <NUM>. Similarly, the outer wall can be so narrow that it lacks sufficient strength to withstand the force necessary to force actuator <NUM> through septum <NUM>. Accordingly, in many implementations, the design shown in <FIG> will not be preferred.

<FIG> and <FIG> illustrate another configuration of an actuator <NUM> and needle hub <NUM> respectively which can be employed to increase the rigidity between the catheter hub and needle shield without sacrificing the structural integrity of the actuator. As shown in <FIG>, actuator <NUM> includes a proximal end <NUM> and a distal end <NUM>. Proximal end <NUM> is configured to be contacted by an access device when the access device is attached to the catheter hub so that actuator <NUM> is forced through a septum by the access device.

Proximal end <NUM> has a generally circular shape which provides the area against which the access device applies a force. However, to allow needle hub <NUM> to interlock with actuator <NUM> without sacrificing the structural integrity of actuator <NUM>, two channels <NUM> are formed within proximal end <NUM>. Channels <NUM> are formed at the top and bottom of actuator <NUM>. The purpose of positioning channels <NUM> in this manner will be described below after needle hub <NUM> is described. Even with channels <NUM>, a substantial amount of proximal end <NUM> remains to provide a contact area against which an access device can press to force actuator <NUM> through the septum and to provide structural integrity to actuator <NUM>.

As shown in <FIG>, needle hub <NUM> includes a proximal end <NUM> and a distal end <NUM>. Distal end <NUM> includes protrusions <NUM>. Protrusions <NUM> are positioned at the top and bottom of needle hub <NUM> and are shaped to conform to channels <NUM> formed in actuator <NUM>. Accordingly, protrusions <NUM> can insert into channels <NUM> to interlock actuator <NUM> and needle hub <NUM>.

Channels <NUM> and protrusions <NUM> are positioned at the top and bottom of the respective components to provide reinforcement in the vertical direction. Because the flexing between the catheter hub and needle shield is primarily due to the downward force applied by the clinician during needle insertion, the positioning of channels <NUM> and protrusions <NUM> at the top and bottom provides support against the downward force thereby minimizing the amount of flexing that can occur between the catheter hub and needle shield. Although this design may not provide substantial increases in the rigidity of the components in the horizontal direction, such rigidity in the horizontal direction is generally not critical because it is oftentimes not desired to apply a horizontal force to the catheter assembly during needle insertion.

<FIG> and <FIG> provide a perspective view of actuator <NUM> and needle hub <NUM> in an unlocked and an interlocked configuration respectively. In <FIG>, needle hub <NUM> is adjacent to, but not inserted into, actuator <NUM>. As shown, protrusions <NUM> are configured to match the general shape of channels <NUM>. In <FIG>, needle hub <NUM> is shown as having been inserted into actuator <NUM> such that protrusions <NUM> are interlocked with channels <NUM>.

<FIG> again illustrates actuator <NUM> and needle hub <NUM> in an unlocked configuration with the indications of the side views shown in <FIG>. In <FIG>, a right side view of actuator <NUM> is shown while in <FIG> a left side view of needle hub <NUM> is shown. As shown in <FIG>, channels <NUM> are positioned at the top and bottom of actuator <NUM>. Similarly, in <FIG>, protrusions <NUM> are shown at the top and bottom of needle hub <NUM> corresponding to the position of channels <NUM>.

Although actuator <NUM> and needle hub <NUM> are shown having two channels <NUM> and two protrusions <NUM> respectively, an actuator and needle hub can be configured with one or more channels and protrusions respectively. For example, in some embodiments, an actuator can have a single channel at the top while the corresponding needle hub has a single protrusion at the top. This configuration could still provide an increase in rigidity between the catheter hub and the needle shield, but in many cases will not be as effective as when two channels and protrusions are used.

Similarly, in some embodiments, an actuator can include more than two channels (e.g. two channels positioned on the left and right side in additional to the channels <NUM> shown in <FIG>). In such cases, the needle hub can include corresponding protrusions. This configuration would provide additional rigidity in the horizontal direction if such rigidity is desired. However, as stated above, if an excessive number of channels are formed within the actuator, the structural integrity of the actuator can be compromised. Accordingly, even though more than two channels/protrusions can be used, in preferred embodiments, the actuator includes two channels as has been described.

Referring again to <FIG>, the portions of the distal end <NUM> of actuator <NUM> that extend between channels <NUM> are labeled as <NUM>. Portions <NUM> form the surface area against which another access device applies a force to actuator <NUM> to force actuator <NUM> through the septum. As shown, even with channels <NUM>, a substantial amount of surface area remains to provide adequate structural integrity to actuator <NUM> to receive such forces. Also, because channels <NUM> and protrusions <NUM> are used, the interlocking is accomplished while portions <NUM> remain positioned near the proximal end of the catheter hub. Having portions <NUM> near the proximal end of the catheter hub is important to ensure that actuator <NUM> will be forced through the septum when another access device is connected to the catheter hub.

The size of channels <NUM> (and as a result, the size of protrusions <NUM>) can be selected to maximize the rigidity between the catheter hub and needle shield without sacrificing the structural integrity of actuator <NUM>. This size can vary depending on the type of material from which actuator <NUM> is made, the intended use of a catheter assembly employing actuator <NUM> such as the types of access devices that will be attached to the catheter hub, etc..

The number of channels formed in actuator <NUM> can also be based on such considerations. For example, in some cases, it may be more desirable to provide greater rigidity to the catheter assembly in the horizontal direction than to maintain a certain level of structural integrity within the actuator. For example, in some cases, it may be necessary to apply downward and sideward forces to the catheter adapter during needle insertion. In such cases, an actuator having channels on the sides can be used to increase rigidity in the horizontal direction as well.

<FIG> and <FIG> depict a cross-sectional view of a catheter assembly <NUM> that is similar to catheter assembly <NUM> of <FIG> and <FIG>. However, catheter assembly <NUM> includes actuator <NUM> and needle hub <NUM>. As shown, actuator <NUM> includes channels <NUM> (represented by lines running upwards to the right) while needle hub <NUM> includes protrusions (represented by lines running downwards to the right). The area where channels <NUM> and protrusions <NUM> interlock is represented by the cross-hatching.

In contrast to catheter assembly <NUM> shown in <FIG>, in catheter assembly <NUM>, the positions of actuator <NUM> and needle hub <NUM> within catheter hub <NUM> substantially overlap. This overlapping increases the rigidity of catheter assembly <NUM>.

The increase in the rigidity of catheter assembly <NUM> is primarily due to the spreading of the pivot point between catheter hub <NUM> and needle shield <NUM>. For example, as shown in <FIG>, the pivot point is spread along the length of the interface between actuator <NUM> and needle hub <NUM>. In other words, the interlocked area created by channels <NUM> and protrusions <NUM> forms the pivot point for any flexing between catheter hub <NUM> and needle shield <NUM>. Because this pivot point is substantially longer than the pivot point shown in <FIG>, a much greater force is required to cause flexing between catheter hub <NUM> and needle shield <NUM>.

Also, because the interlocked area is created using channels <NUM> and protrusions <NUM> (i.e. by using a portion of the end of each component rather than overlapping the entire ends as shown in <FIG>), the increased rigidity can be provided without sacrificing the structural integrity of actuator <NUM>.

<FIG> provides a photograph of an actual implementation of a catheter assembly in accordance with one or more embodiments of the invention. The tip of the interlocking actuator is identified and would be similar to distal end <NUM> of actuator <NUM>. Also, a protrusion is identified as extending past the identified tip of the interlocking actuator and into a channel of the interlocking actuator. A similar protrusion extends into a corresponding channel on the bottom of the depicted catheter assembly. Because the interlocking needle hub extends substantially into the catheter hub, and because the needle hub interlocks with the actuator, a greater amount of rigidity is provided between the needle shield and catheter hub.

Claim 1:
A catheter assembly comprising:
a catheter hub (<NUM>) containing a septum (<NUM>) and an actuator (<NUM>) the actuator (<NUM>) comprising a main body extending from a distal end to a proximal end, the distal end configured to pierce the septum when a force is applied to the proximal end;
a needle shield (<NUM>) connected to the catheter hub (<NUM>), the needle shield containing a needle hub (<NUM>), the needle hub (<NUM>) containing a needle (<NUM>) that extends through the catheter hub (<NUM>)
characterized in that
the needle hub (<NUM>) inserts into the actuator (<NUM>) to interlock and provide greater rigidity between the catheter hub (<NUM>) and the needle shield (<NUM>), wherein the needle hub (<NUM>) is configured to retract further into the needle shield (<NUM>) so that the needle (<NUM>) is fully contained within the needle shield (<NUM>).