TAMPER-RESISTANT ENCLOSURES FOR FLUID LINES

A tamper-resistant device for holding a portion of an access port of a fluid line can include a first housing member that includes a first recess and a first stopping shelf. The device can further include a second housing member that includes a second recess and a second stopping shelf. The second housing member can couple with the first housing member such that the first and second stopping shelves cooperate to retain the portion of the access port within the device. The device can include a locking mechanism configured maintain the first and second housing members in a coupled state when engaged. The device can further include a tamper-evident indicator that, when activated, permits the first and second housing members to transition from the coupled state to a decoupled state to permit access to the access port of the fluid line.

BACKGROUND

The present disclosure relates to medical fluid lines and accessories thereof. In particular, the present disclosure relates to tamper-resistant enclosures for access portions of medical fluid lines.

DETAILED DESCRIPTION

In various circumstances, it can be desirable to prevent tampering with an access end of a medical fluid line. For example, in some instances it can be desirable to prevent a patient from accessing an IV line or other catheter system that is in fluid communication with the patient, such as for dispensing injectable narcotics or other drugs to the patient (e.g., for purposes of abusing the narcotics). In some instances, the patient may have a peripherally inserted central catheter (PICC) line, and may be treated on an outpatient basis. It can be desirable to ensure that the patient does not self-medicate or otherwise abuse drugs between visits to the hospital or between home visits from medical professionals. A tamper-resistant and/or tamper-evident enclosure about the access end of the PICC line can help prevent such unauthorized access and/or detect the unauthorized access after it has occurred. In other or further instances, it can be desirable to ensure that a sterility cap that is placed on the access end of the medical fluid line remains in place. These and/or other advantages can be achieved via embodiments disclosed herein, as will be appreciated from the drawings and description that follows.

As used herein, the term “tamper-resistant” encompasses both the ability to physically resist tampering, as well as resist tampering due, at least in part, to a deterrent effect. For example, a tamper-resistant feature may be present where the feature provides little to no physical barrier to tampering, yet readily demonstrates (e.g., visibly indicates) that tampering has occurred. Such a feature is considered “tamper-resistant,” in that it resists the tampering by dissuading or otherwise providing disincentives to tampering.

FIG. 1depicts an embodiment of a tamper-resistant enclosure100, which may also be referred to as a tamper-resistant apparatus or tamper-resistant device. The tamper-resistant enclosure100includes a first housing member101and a second housing member102. In the illustrated embodiment, the first and second housing members101,102are in a closed state or configuration and enclose within an interior thereof a proximal end of a medical fluid line50. The terms “enclose” and “enclosure” do not necessarily imply an ability or necessity to enclose completely. For example, although in the illustrated embodiment, the first and second housing members101,102of the tamper-resistant enclosure100fully encompass the proximal end of the medical fluid line50, such that the proximal end is obscured, hidden from view, or otherwise inaccessible from all angles, other arrangements are possible. For example, in some embodiments, one or more windows or other openings may be present, yet the tamper-resistant device may sufficiently encompass the proximal end of the medical fluid line50to prevent access to the fluid line.

The medical fluid line50can be of any suitable variety, such as an IV line or a catheter line. For example, the fluid line50may include a PICC catheter that includes a medical connector54at a proximal end thereof, with a distal end of the catheter positioned within a patient. In the illustrated embodiment, the fluid line50includes a catheter52with a medical connector54attached to a proximal end thereof. The medical connector54may be of any suitable variety. In the illustrated embodiment (as discussed further below), the connector54is a luer connector.

The illustrated embodiment includes three tamper-evident indicators110,111,112. The tamper-evident indicator110comprises a pair of irreversible locks120(only one lock120is visible inFIG. 1), the tamper-evident indicator111comprises a removable hinge130, and the temper-evident indicator112comprises a tamper-evident sticker140.

More or fewer tamper-evident indicators are possible. In the illustrated embodiment, each tamper-evident indicator110,111,112is in an undisrupted state when the tamper-resistant enclosure100is in the closed configuration depicted inFIG. 1. Further, each tamper-evident indicator110,111,112can physically assist in maintaining the enclosure100in the closed state.

In the illustrated embodiment, when actuated, or moved to a release state, each tamper-evident indicator110,111,112can permit the first and second housing members101,102to transition from the coupled state, as depicted, to a decoupled state to permit access to the proximal end of the medical fluid line50. In some instances, one or more of the tamper-evident indicators110,111,112must be actuated, or moved to the release state, in order to decouple the first and second housing members101,102from each other. As discussed further below, in the illustrated embodiment, it is not possible to separate the first and second housing members101,102from each other unless the tamper-evident indicator112is actuated (e.g., the sticker140is removed or otherwise altered to permit separation of the first and second housing members101,102). In contrast, once the tamper-evident indicator112has been removed, the first and second housing members101,102can be separated from each other by either actuating the tamper-evident indicator110, the tamper-evident indicator111, or both of the tamper-evident indicators110,111.

In the illustrated embodiment, the depicted irreversible lock120includes a pair of interlocking arms121a,122a. Operation of the arms121a,122ais described further below. For example, in some embodiments, one or more of the arms121a,122ais configured to deform, break, or otherwise indicate that tampering has occurred when the lock120are transitioned from the locking mode depicted inFIG. 1to an unlocked mode.

In other embodiments, the locks120may be selectively opened after having been closed, or may not have the ability to demonstrate that they have been opened after having been in a locking state. Stated otherwise, the locks120may not have the capacity to demonstrate that tampering has occurred—for example, neither of the arms121a,122amay demonstrate deformation, damage, separation, or other tampering evidence when moved out of the locking mode. In such instances, the tamper-evident indicator110is omitted. Rather, the locks120merely serve the function of maintaining the first and second housing members101,102in the coupled state.

Operations of the removable hinge130of the tamper-evident indicator111and the sticker140of the tamper-evident indicator112are discussed further below.

FIGS. 2A-2Idepict various stages of an illustrative method of using the tamper-resistant enclosure100.FIG. 2Ais a perspective view of the tamper-resistant enclosure100in an open state that represents an early stage of the illustrative method.

The first housing member101defines a recess151, and the second housing member102defines a second recess152. As shown inFIGS. 2B and 4, when the housing members101,102are in the coupled state, the first and second recesses151,152cooperate do define a cavity into which the proximal end of the medical fluid line50is received. In the illustrated embodiment, each of the first and second housing members is substantially pill shaped. Stated otherwise, the housing members101,102are elongated in a longitudinal direction and include a rounded end. A central body portion of each housing member101,102is substantially cylindrical.

In the illustrated embodiment, the first housing member101includes a closed end155. Opposite the closed end155, the first housing member101defines a first stopping shelf157. Similarly, the second housing member102includes a closed end156. Opposite the closed end156, the second housing member102defines a second stopping shelf158. Each stopping shelf157,158defines a rounded opening surface161,162, respectively. As shown inFIG. 5, the opening surfaces161,162can cooperate to define an opening163through which a portion of the medical fluid line50can extend when the enclosure100is in the closed state.

With continued reference toFIG. 2A, the hinge130can include a first hinge member131attached to the first housing member101via a first frangible section or frangible connection133. The hinge130can likewise include a second hinge member132attached to the second housing member102via a second frangible section or frangible connection134. In the illustrated embodiment, each frangible connection133,134is defined as a narrow neck of material that can easily snap, break, or otherwise permit disconnection of the hinge members131,132from the housing members101,102when the hinge130is twisted, bent (e.g., repeatedly bent back and forth), or otherwise ruptured. Any other suitable breakable or frangible connection is contemplated. Stated otherwise, the hinge130is connected to the housing members101,102via breakaway mechanisms. Any suitable breakaway mechanisms are contemplated.

The hinge130can further include a hinging region135at which bending is facilitated. In the illustrated embodiment, the hinging region135is a region of reduced material thickness. For example, the hinging region135may be a living hinge.

The first housing member101can define the locking arm121a, as well as a locking arm121b. In the illustrated embodiment, each locking arm121a,121bdefines a camming surface123a,123band a recessed surface124a,124b, respectively. Further, the second housing member102defines the locking arms122a,122b. These features are described further with respect toFIGS. 3A and 3B.

In the illustrated embodiment, the housing members101,102and the hinge130are integrally formed from a unitary piece of material. Any suitable material may be used, and may desirably exhibit sufficient rigidity to protect the proximal end of the medical fluid line50when such is located therein, yet may exhibit flexibility or even resilience in other regions, such as regions of reduced thickness. For example, the material may readily bend at the hinging region135and/or may define locking arms122a,122bthat are resiliently deformable. In various embodiments, the material can comprise, for example, plastic, including, without limitation, polypropylene (PP), polyethylene (PE), acetal, polyvinylchloride, silicone, or acrylonitrile butadiene styrene. In other embodiments, one or more components may be formed of one or more different or further materials.

FIG. 2Bis a perspective view of the tamper-resistant enclosure100in the open state with a proximal end51of the medical fluid line50positioned within the recess152of the second housing member102. In this example, the luer connector54is coupled with a needleless medical connector60of any suitable variety, which is in turn connected to a sterilizing or disinfecting cap70of any suitable variety. Accordingly, the cavity153defined by the first and second housing members101,102is sufficiently large to accommodate multiple connected components at the proximal end51of the medical fluid line50.

In the illustrated arrangement, the needleless medical connector60is the access port of the medical fluid line50, as fluid may be introduced into or withdrawn from the line50thereat. In other instances, the needleless medical connector60may be omitted, and the luer connector54may instead be the access port of the medical fluid line50. Any suitable access port configuration is contemplated.

The tamper-resistant enclosure100can prevent unauthorized access of the medical fluid line50via the access port (e.g., the connector50or the needleless connector60). In further instances, such as the illustrated arrangement, the tamper-resistant enclosure100can ensure that the sterilization or disinfection cap70remains in sterilizing or disinfecting contact with the access port.

FIG. 2Cis a perspective view of the tamper-resistant enclosure being transitioned from the open state to the closed state. The first and second housing members101,102and the hinge130may be referred to as a clamshell configuration.

FIG. 2Dis a perspective view of the tamper-resistant enclosure100in the closed state encompassing the proximal end51of the medical fluid line50and preventing undetected access thereto. In the illustrated stage of operation, the tamper-evident indicators110and111serve to ensure that the first and second housing members101,102cannot be separated without leaving a trace that tampering has occurred. In particular, the irreversible lock120cannot be opened at the distal end of the enclosure100without being damaged or deformed in some manner (as discussed below). Likewise, the hinge130cannot be opened to permit access from the proximal end of the enclosure100, but instead must first be removed to permit the access, which would provide evidence of tampering.

In some embodiments, only the tamper-evident indicators110,111are used with the tamper-resistant enclosure100. Accordingly, in such embodiments,FIG. 2Drepresents a fully assembled, fully closed device. However, in other embodiments, the additional tamper-evident indicator112, such as the tamper-evident sticker140, may also be used, as depicted in the optional stages ofFIGS. 2E and 2F. The tamper-evident sticker140can provide a further level of tamper resistance, whether that tamper resistance is physical and/or dissuading in nature.

FIG. 2Eis a perspective view of an early stage of application of the tamper-evident sticker140to the tamper-resistant enclosure100in the closed state. Any suitable variety of tamper-evident sticker140is contemplated, including, without limitation, such as stickers used for tamper evident sterile seals manufactured by Steri-Tamp® of Woodmere, N.Y. The tamper-evident sticker140can contact both the first and second housing members101,102and assist in physically maintaining them in the coupled orientation.

FIG. 2Fis a perspective view of a late stage of application of the tamper-evident sticker140to the tamper-resistant enclosure100in the closed state. In the illustrated embodiment, the sticker140has been applied in a manner that leaves the lock120exposed. In other instances, the sticker140may be applied at a more distal position so as to cover the lock120and provide a further level of tamper-evidence, should someone attempt to open the enclosure100via the lock120. The tamper-resistant sticker140can include a tab142to facilitate removal of the sticker.

In some embodiments, access to the proximal end51of the medical fluid line50, such as by an authorized medical professional, may again be achieved by opening the device100. In certain methods for achieving access, the tamper-resistant sticker140may first be removed, such as by pulling the tab142and pulling the sticker in the direction opposite the arrows inFIGS. 2E and 2F. As previously mentioned, such removal of the sticker140may be referred to as actuation or activation of the tamper-evident indicator112. Of course, in some instances, the sticker140may indicate tampering when it is only partially removed, and not fully removed from both the housing members101,102. For example, such partial removal may evidence an aborted attempt to gain access to the proximal end51of the medical fluid line50.

FIG. 2Gis a perspective view of the tamper-resistant enclosure100in the closed state after removal of the tamper-evident sticker140. Quick access to the proximal end51of the medical fluid line50may be achieved by removing the hinge130. In the illustrated method, the hinge130is removed by rotating it to break the frangible connections133,134. Rotation of the hinge130is depicted by curved arrows.

FIG. 2His a perspective view of the tamper-resistant enclosure100depicting application of force to the twisted hinge130in a proximal direction (the direction of the straight arrow) to remove the hinge130from housing portions101,102of the tamper-resistant enclosure100.FIG. 2Iis a perspective view of the tamper-resistant enclosure100depicting the hinge130having been removed from the housing portions101,102of the tamper-resistant enclosure100. In this condition, the housing members101,102can be readily separated from each other. For example, the locks at the opposite end of the enclosure100can be situated such that they provide little resistance to separation of the housing members101,102when the hinged ends (or, rather, de-hinged ends) of the housing members101,102are rotated away from each other or otherwise separated. Removal of the hinge130in manners such as just discussed may be referred to as activation of the tamper-evident indicator111.

FIG. 3Ais an end-on elevation view taken along a view line similar to the view line3B-3B inFIG. 2Ddepicting the tamper-resistant enclosure100transitioning from the open state to the closed state. Here, the camming surfaces123a,123bof the locking arms121a,121burge the locking arms122a,122blaterally outward as the upper housing member101is urged downward.

FIG. 3Bis an end-on elevation view taken along the view line3B-3B inFIG. 2Ddepicting the tamper-resistant enclosure100in the closed state with two locking mechanisms120thereof in a locked state. Opposing surfaces125a,126aand125b,126bof the locking arms121a,122aand121b,122b, respectively can abut and prevent separation of the first and second housing members101,102. The locking arms122a,122bcan be resiliently flexible so as to automatically snap into the configuration shown inFIG. 3B. Stated otherwise, the locking arms121a,121b,122a,122bautomatically engage each other when the housing members101,102are moved into the closed state.

Whereas the locking mechanisms120in the illustrated embodiment are accessible when the housing members101,102are in the closed state, in other embodiments, the locking mechanisms120are inaccessible. For example, the mechanisms may be internal to the housing members101,102and thus not visible or accessible when the housing members101,102are coupled. Such an arrangement may enhance the tamper resistance of the locking mechanisms120.

In the illustrated embodiment, the locking mechanisms120are irreversible, such that one or more of the locking arms121a,121b,122a,122bmust be deformed, broken, or otherwise altered to unlock the locking mechanism120. For example, in various embodiments, the locking arms121a,121bmay include a frangible region or may be plastically deformable about an axis that is perpendicular to the longitudinal axis of the closed device100(e.g., plastically deformable when rotated out of the page toward the reader) such that unlocking the mechanism120permanently deforms the locking arms121a,121b. In this manner, unlocking the locking mechanism120as just discussed may be referred to as activation of the tamper-evident indicator110.

FIGS. 4A and 4Bare cross-sectional views of the tamper-resistant enclosure100in the closed state and encompassing a proximal portion of an embodiment of the medical connector54at a proximal end of a medical fluid line. In this arrangement, the first and second stopping shelves157,158encompass a neck portion80of the connector54and prevent a threaded region82from passing distally through the opening163defined by the opening surfaces161,162. In particular, the threading region82can define a maximum diameter DT, which may also be referred to as a major diameter. The maximum diameter DTof the threading region82can exceed a maximum diameter DO, which may also be referred to as a major diameter, of the opening163. Accordingly, the first and second stopping shelves157,158can constrict the threading region82of the connector54and prevent it from being retracted out of the enclosure100.

In some embodiments, it can be desirable to ensure that the threading or threaded region82of the connector54may not be manipulated or rotated against the base end of the housing to extract the connector54from the housing. To this end, a thickness T of a base portion of the housing, which is defined by the first and second stopping shelves157,158in the present embodiment, is greater than a separation distance DSbetween adjacent threading portions of the threaded region82. In some embodiments, it may be sufficient for just one of the shelves157,158to be thicker than the separation distance DS. In other embodiments, such as that illustrated, both stopping shelves157,158may be thicker than the separation distance DS.

FIG. 5is a cross-sectional view of another embodiment of a tamper-resistant enclosure200in a closed state. The tamper-resistant enclosure200resembles the tamper-resistant enclosure100described above in certain respects. Accordingly, like features are designated with like reference numerals, with the leading digits incremented to “2.” Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the enclosure200may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and/or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the enclosure200and related components depicted inFIG. 5. Any suitable combination of the features, and variations of the same, described with respect to the enclosure100can be employed with the enclosure200, and vice versa. This pattern of disclosure applies equally to further embodiments depicted in subsequent figures and described hereafter, wherein the leading digits may be further incremented.

The enclosure200encompasses a proximal portion of an embodiment of the medical connector54at a proximal end of a medical fluid line. In this arrangement, first and second stopping shelves257,258encompass a catheter portion52of the fluid line50. The stopping shelves257,258define a smaller opening263than the opening163described above, and are configured to prevent any of the connector54from passing distally through the opening263. In particular, a distal end of the medical connector54can define a maximum diameter, which may also be referred to as a major diameter. The maximum diameter of the distal end of the medical connector54can exceed a maximum diameter, which may also be referred to as a major diameter, of the opening263. Accordingly, the first and second stopping shelves257,258can constrict the distal end of the medical connector54and prevent it from being retracted out of the enclosure200.

FIGS. 6-18Bdepict embodiments of a tamper-resistant enclosure configured for use with a catheter system that has two luer ends. The device includes two cavities for receiving two separate luer ends.FIGS. 19-27depict another embodiment that has a single cavity that can be used with a single luer end. Any other suitable number of cavities is contemplated.

The tamper-resistant enclosures can receive the luer ends and/or sterility caps that are coupled thereto and prevent tampering. As previously mentioned, the enclosures can define an opening through which a portion of a luer or other suitable catheter communication device can extend, and the cavity of the housing can be sufficiently large to receive the proximal end of the luer or other device and/or a cap coupled thereto. When the enclosure is closed and locked, the proximal end and/or cap are retained securely inside and cannot be removed without breaking the locking mechanism. This can inhibit and/or prevent tampering. This can also provide a tamper-evident feature.

In the illustrated embodiments below, the locking is provided by a zip tie. In other or further embodiments, a tamper-evident sticker is applied from one side of the enclosure to the other. Any other suitable locking mechanism and/or tamper-evident mechanism is contemplated.

FIG. 6is a perspective view of an embodiment of another embodiment of a tamper-resistant enclosure300in an open state. The enclosure300includes a locking mechanism320. In particular, the locking mechanism320is a fastener of any suitable variety. In the illustrated embodiment, the fastener is a zip tie380.

FIG. 7is a perspective view of the tamper-resistant enclosure300in a closed state, and further, in a locked state. In particular, the zip tie380has been cinched to a tightly locked condition.

FIG. 8is a perspective view of a housing portion of the tamper-resistant enclosure ofFIG. 6in a fully open configuration, wherein the interior of the housing is depicted. Two housing members each define an opening385,386through which the fastener380extends to lock the housing when in a closed state.

FIG. 9is another perspective view of the housing portion ofFIG. 8in the fully open configuration, wherein the exterior of the housing is depicted.FIG. 10is a side elevation view of the housing.FIG. 11is a top plan view of the housing showing the interior.FIG. 12is an opposite side elevation view of the housing.FIG. 13is a bottom plan view of the housing showing the exterior.FIG. 14is an end elevation view of the housing.FIG. 15is an opposite end elevation view of the housing.

FIG. 16is an image of an embodiment of a catheter system with which the enclosure ofFIG. 6is compatible.FIG. 17is an image of the tamper-resistant enclosure ofFIG. 6in use with the catheter system ofFIG. 16, wherein luers at the end of the catheter ofFIG. 16are fitted with sterility or disinfectant caps (such as the cap depicted inFIG. 19), and proximal ends of the luers and the caps that are engaged therewith are received within the tamper-resistant enclosure, and further, the tamper-resistant enclosure is in a closed and locked state to prevent undesired tampering with the enclosed luers.

FIG. 18Ais a cross-sectional view of the housing in the open state with the proximal end of the luer positioned at an interior of the housing with a neck of the luer positioned at an opening in the housing.FIG. 18Bis another cross-sectional view of the housing, where the housing has been transitioned to the closed state,FIG. 13Bdemonstrating that the neck of the luer fits within the opening defined by the housing (whether snugly or loosely), and the threaded proximal end of the luer is incapable of passing through the opening defined by the housing;

FIG. 19is an image of two samples of another embodiment of a tamper-resistant enclosure400, with one sample shown in a closed and locked state and the other sample (in the foreground) shown in an open and unlocked state.

FIGS. 20-27are various views of a housing portion of the tamper-resistant enclosure ofFIG. 19, which depict perspectives of the housing portion such as those described relative toFIGS. 8-15, respectively.

References to approximations are made throughout this specification, such as by use of the terms “about” or “approximately.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about,” “substantially,” and “generally” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially planar” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely planar orientation.

Any reference throughout this specification to “certain embodiments” or the like means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this specification are not necessarily all referring to the same embodiment or embodiments.

The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements specifically recited in means-plus-function format, if any, are intended to be construed in accordance with 35 U.S.C. §112(f). Embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows.