WO2015066055A1

WO2015066055A1 - Systems and methods for covering tubing connections

Info

Publication number: WO2015066055A1
Application number: PCT/US2014/062696
Authority: WO
Inventors: Michael Dennis; Wayne KLINGLER; Kevin Novak; Thomas GRAZIER; William FISHBACK
Original assignee: Abbvie Inc.
Priority date: 2013-10-28
Filing date: 2014-10-28
Publication date: 2015-05-07

Abstract

Clamshell cover for a connector assembly having a tubing connector is provided. Clamshell cover includes a body defining an interior region sized to receive at least a length of a connector assembly including a tubing connector. The body includes a first sidewall portion hingedly connected to a second sidewall portion. The first sidewall portion is moveable relative the second sidewall portion between an open position and a closed position. The first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region. The first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region.

Description

SYSTEMS AND METHODS FOR COVERING TUBING CONNECTIONS

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent Application No. 61/896,579, filed October 28, 2013, which is incorporated by reference herein in its entirety.

BACKGROUND

Field of the Disclosed Sub ject Matter

The present disclosed subject matter relates to covers for tubing connectors for delivery tube assemblies, including covers and techniques for covering tubing connectors to prevent or inhibit unwanted access to the tubing connectors.

Description of Related Art

Tubing connectors can be used to connect various tubes of tube assemblies, including tubes for a variety of medical applications. For example, a Y-shaped adapter having a tubing connector can be used to connect tubes during percutaneous endoscopic gastrostomy (PEG), such as for a jejunostomy feeding tube (J -tube) into the jejunum. Such connectors generally are located outside the body, and therefore can result in inadvertent snagging or disruption by the action of a patient. As such, there remains a need for systems and methods to prevent or inhibit access to such tubing connectors.

SUMMARY

The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings. To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter includes a clamshell cover for a connector assembly having a tubing connector. The clamshell cover generally includes a body having a first sidewall portion and a second sidewall portion. The body defines an interior region sized to receive at least a length of a connector assembly including a tubing connector. The body includes a first sidewall portion hingedly connected to a second sidewall portion. The first sidewall portion is moveable relative the second sidewall portion between an open position and a closed position. The first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region. The first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region.

Additionally, and as embodied herein, the body can be formed as a single member. The body can have a tubular shape defining the interior region. The cover can include a plurality of hinge portions spaced apart along a length of the first sidewall portion and the second sidewall portion.

Furthermore, and as embodied herein, at least one of the first and second sidewall portions can define a proximal end aperture proximate the proximal end, the proximal end aperture sized to allow the first branch to extend therethrough from the interior region. Each of the first and second sidewall portions can define a portion of the proximal end aperture, and in the closed position, the proximal end aperture can be sized to allow a first branch of the connector assembly to extend therethrough from the interior region. Additionally or alternatively, at least one of the first and second sidewall portions can define a distal end aperture proximate the distal end, the distal end aperture sized to allow access to a distal end of the tubing connector. Each of the first and second sidewall portions can define a portion of the distal end aperture. In the closed position, the distal end aperture can be sized to allow a percutaneous tube joined to the tubing connector to extend through the distal end aperture from the interior region.

Additionally, and as embodied herein, at least one of the first and second sidewall portions can define a side aperture in the body, the side aperture sized to allow the second branch to extend therethrough from the interior region. Each of the first and second sidewall portions can define a portion of a side aperture in the body, and in the closed position, the side aperture can be sized to allow the second branch to extend therethrough from the interior region.

Furthermore, and as embodied herein, the clamshell cover can include locating members extending from the body and configured to locate the connector assembly within the interior region. The locating members can include a first locating member extending from the first sidewall portion and a second locating member extending from the second sidewall portion. At least one of the first and second locating members includes a locating notch to define a locating aperture in the interior region when the first and second sidewall portions are in the closed position to locate the connector assembly therethrough.

In addition, and as embodied herein, the clamshell cover can include one or more circumferential ribs projecting from at least one of the first and second sidewall portions into the interior region when in the closed position and configured to engage a stepped portion of the connector assembly within the interior region. The one or more circumferential ribs can include a first circumferential rib projecting from the first sidewall portion and a second circumferential projecting from the second sidewall portion. In the closed position, the first and second circumferential ribs can radially align to engage the connector assembly substantially about a circumference of the connector assembly.

Additionally, the first sidewall portion and the second sidewall portion in the closed position can be sized to prevent or inhibit displacement of the connector assembly disposed therein.

According to another aspect, the disclosed subject matter includes a connector assembly with cover system. The system includes a connector assembly including a tubing connector disposed proximate a distal end. The system further includes a clamshell cover including a body defining an interior region sized to receive at least a length of the connector assembly including the tubing connector. The body includes a first sidewall portion hingedly connected to a second sidewall portion. The first sidewall portion is moveable relative the second sidewall portion between an open position and a closed position. The first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region. The first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region. The clamshell cover can include any or all of the features described herein.

According to another aspect, the disclosed subject matter includes a method of using a clamshell cover. The method includes providing a connector assembly having a first branch, a second branch and a tubing connector. The method includes providing a clamshell cover comprising a body formed as a single member defining an interior region sized to receive at least a length of the connector assembly including the tubing connector, the body including a first sidewall portion hingedly connected to a second sidewall portion, the first sidewall portion being moveable relative the second sidewall portion between an open position and a closed position, wherein the first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region, and further wherein the first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region, The method further includes positioning the connector assembly within the interior region of the first sidewall portion or the second sidewall portion. The method further includes moving the first sidewall portion about a hinge toward the second sidewall portion to the closed position, and engaging the first sidewall portion to the second sidewall portion in the closed position.

Additionally, and as embodied herein, the method can further include joining a percutaneous tubing to the tubing connector. Each of the first and second sidewall portions defines a portion of a distal end aperture proximate the distal end. The distal end aperture is sized to allow access to a distal end of the tubing connector. In the closed position, the distal end aperture is sized to allow the percutaneous tube to extend through the distal end aperture from the interior region. The clamshell cover can include any or all of the features described herein.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter claimed. The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an exemplary tubing connector for use with the disclosed subject matter.

FIG. 2 is a rear perspective view of the exemplary tubing connector of FIG. 1.

FIG. 3 is a front perspective view of an exemplary clamshell cover in an open position according to one aspect of the disclosed subject matter.

FIG. 4 is a rear perspective view of the exemplary clamshell cover of FIG. 3.

FIG. 5 is a front side view of the exemplary clamshell cover of FIG. 3.

FIG. 6 is a rear side view of the exemplary clamshell cover of FIG. 3.

FIG. 7 is a left side view of the exemplary clamshell cover of FIG. 3.

FIG. 8 is a right side view of the exemplary clamshell cover of FIG. 3.

FIG. 9 is a top end view of the proximal end of the exemplary clamshell cover of FIG. 3.

FIG. 10 is a bottom end view of the distal end of the exemplary clamshell cover of FIG. 3.

FIG. 1 1 is a front perspective view of the exemplary clamshell cover of FIG. 3 in engagement with the exemplary tubing connector of FIG. 1 , with the clamshell cover in an open position.

FIG. 12 is a front perspective view of the exemplary clamshell cover of FIG. 3 in engagement with the exemplary tubing connector of FIG. 1 , with the clamshell cover in a closed position. FIG. 13 is a rear perspective view of the exemplary clamshell cover of FIG. 3 in engagement with the exemplary tubing connector of FIG. 1 , with the clamshell cover in the closed position.

FIGS. 14-20 each is an additional view of the exemplary clamshell cover of FIG. 3, with exemplary surface features illustrated.

FIGS. 21-25 are various perspective, end and side views, which together illustrate an exemplary cup cover according to another aspect of the disclosed subject matter.

FIGS. 26-32 each is an additional view of the exemplary cup cover of FIGS. 21-25, with exemplary surface features illustrated.

FIGS. 33-38 are various perspective, end and side views, which together illustrate an exemplary ring cover according to another aspect of the disclosed subject matter.

FIGS. 39-45 each is an additional view of the exemplary ring cover of FIG. 33-38, with exemplary surface features illustrated.

FIGS. 46-51 are various perspective, end and side views, which together illustrate an exemplary partial shell cover according to another aspect of the disclosed subject matter.

FIGS. 52-58 each is an additional view of the exemplary partial shell cover of FIGS. 46-51 , with exemplary surface features illustrated.

DESCRIPTION

Reference will now be made in detail to the various exemplary embodiments of the disclosed subject matter, exemplary embodiments of which are illustrated in the accompanying drawings. The structure and corresponding method of operation of and method of treatment using the disclosed subject matter will be described in conjunction with the detailed description of the system.

The apparatus and methods presented herein can be used for covering selected portions of a delivery tube system for administering any of a variety of suitable therapeutic agents or substances, such as a drug or biologic agent, to a patient. For example, and as embodied herein, the delivery tube system can include a connector assembly having a tubing connector for joining a delivery tube to a therapeutic agent delivery device, such as a pump, to deliver a therapeutic agent through the tubing system. As used herein, a "therapeutic agent delivery device" or "delivery device" (used interchangeably herein) is intended to refer generally to a device capable of administering a dosage of a fluid substance, such as a therapeutic agent, including a formulation in a liquid or gel form, through the tubing system and to a patient, in some embodiments, the fluid therapeutic agent can include one or more

pharmaceutical or biologic agents. For example and without limitation, one such fluid therapeutic agent can be a central nervous system agent, such as levodopa. The central nervous system agent can be administered alone or in combination with, for example and without limitation, a decarboxylase inhibitor, such as carbidopa.

In accordance with the disclosed subject matter herein, a clamshell cover for a connector assembly having a tubing connector is provided. The clamshell cover generally includes a body having a first sidewall portion and a second sidewall portion. The body defines an interior region sized to receive at least a length of a connector assembly including a tubing connector. The body includes a first sidewall portion hingedly connected to a second sidewall portion. The first sidewall portion is moveable relative the second sidewall portion between an open position and a closed position. The first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region. The first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region.

The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, serve to further illustrate various embodiments and to explain various principles and advantages all in accordance with the disclosed subject matter. For purpose of explanation and illustration, and not limitation, exemplary embodiments of the connector assembly and clamshell cover in accordance with the disclosed subject matter are shown in FIGS. 1-20. Furthermore, and in accordance with additional aspects of the disclosed subject matter, FIGS. 21-58 depict alternative embodiments of a connector cover for a connector assembly having a tubing connector, as described further below.

While the present disclosed subject matter is described with respect to covering connectors for tubing systems with a delivery device to administer a dose of therapeutic agent, one skilled in the art will recognize that the disclosed subject matter is not limited to the illustrative embodiment, and that the covers disclosed herein can be configured for use with any of a variety of components of any suitable tubing system for delivering any suitable substance therethrough. In addition, the

components and the method of using the connector assembly are not limited to the illustrative embodiments described or depicted herein. For example, the covers embodied herein can be used with other tubing assemblies and components thereof for similar benefits and advantages. Likewise, the covers can be configured for use with other device connectors, including conventional adapters, and not be limited for use with the device connectors herein.

Referring to an illustrative embodiment of FIGS. 1 and 2, a tubing system includes a percutaneous tubing 50, which can have an outer G-tube and an inner J- tube extending therethrough. With reference to FIGS. 1 and 2, an end of the percutaneous tubing 50 external to the patient can have a connector assembly 10 joined thereto. The connector assembly 10 can be configured to join to a delivery device or fluid source, and thus joins the percutaneous tubing 50 to such delivery device or fluid source.

For example, as shown in FIGS. 1 and 2, connector assembly 10 can be configured as a Y-shaped adapter having a first branch 20 and a second branch 30. Connector assembly 10 can include a tubing connector 40 to join to percutaneous tubing 50 to the connector assembly 10. In this manner, first branch 20 can be in fluid communication with a first portion of percutaneous tubing 50, for example and without limitation an inner J-tube, and second branch 30 can be in fluid

communication with a second portion of percutaneous tubing 50, for example and without limitation an outer G-tube. Alternatively, first branch 20 and second branch 30 can each be in fluid communication with a single lumen of percutaneous tubing 50.

Connector assembly 10 can be formed as an integral member. Alternatively, connector assembly 10 can include two or more mating portions releasably joined together to form connector assembly 10. Mating portions of connector assembly can be joined together by any suitable engagement. For example and without limitation, and as embodied herein, first branch 20 can be joined in a latching engagement to a remainder of connector assembly 10. As such, in operation, a user can actuate latch button 14 to release first branch 20 from the remainder of connector assembly 10, and can thereby access inner J-tube extending therethrough, if provided. Connector assembly 10 can have one or more stepped portions, for example and as embodied herein, stepped portions 12, 15, which can be disposed proximate opposing ends of latch button 14. Each of stepped portions 12, 15 can define a notch or reduced diameter portion of the connector assembly 10.

Additionally, and as embodied herein, first branch 20 can include a first cap 25, which can prevent access into the first branch 20 until first cap 25 is removed. Additionally or alternatively, second branch 30 can include a second cap 35, which can prevent access into the second branch 30 until second cap 35 is removed. First cap 25 and/or second cap 35 can be any suitable cap, and each of which can be configured, for example and without limitation, as a screw cap, a stopper, a snap-fit cap, a reclosable clasp or any other suitable cap. As embodied herein, first cap 25 and second cap 35 each can be tethered to first branch 20 and second branch 30, respectively.

Furthermore, and as embodied herein, tubing connector 40 can be configured as any suitable connector to join to percutaneous tubing 50. For purpose of illustration and not limitation, as embodied herein, tubing connector 40 can be configured as a clinching nut, which can provide a releasable friction fit with percutaneous tubing 50. Additional details regarding tubing connectors and other aspects of delivery tubing systems are provided in International Patent Application No. PCT/US2014/046229, which is incorporated by reference herein in its entirety.

Referring now to an illustrative embodiment of FIGS. 3-10, an exemplary clamshell cover for a tubing connector is provided. With reference to FIGS. 3-10, for the purpose of illustration and not limitation, as embodied herein, the clamshell cover 100 includes a body 1 10 comprising a first sidewall portion 1 12 and a second sidewall portion 1 14.

Body 1 10 of the clamshell cover 100 can have a tubular shape. The tubular shape of the body 1 10 can define an interior region 130, which can be sized to receive at least a length of the connector assembly 10 including the tubing connector 40. The body 1 10 can include a first sidewall portion 1 12 hingedly connected to a second sidewall portion 1 14 by one or more hinge members 126. As such, the first sidewall portion 1 12 can be moveable relative the second sidewall portion 1 14 between an open position and a closed position. The first and second sidewall portions 1 12, 1 14 in the open position can each define an opening extending between a proximal end 1 16 and a distal end 1 18 of the body 1 10 for transverse access into the interior region 130 by connector assembly 10. The first and second sidewall portions 1 12, 1 14 in the closed position are sized to cover the length of the connector assembly 10 to prevent or inhibit access to tubing connector 40 when disposed within the interior region 130, as shown for example and not limitation in FIGS. 12 and 13 and described further herein.

The first sidewall portion and second sidewall portion can be formed as a single member with a "living hinge" disposed therebetween. Alternatively, body 1 10 can be formed as opposing members, which can be hinged together by any suitable means. The first and second sidewall portions can be formed of the same or different materials, such as a polymer or the like. For example, and as embodied herein, the clamshell cover 100 can be formed from polyethylene.

As embodied herein, at least one of the first and second sidewall portions in the closed position can define a proximal end aperture proximate the proximal end of the body. As embodied herein, and with reference to FIGS. 3-10, each of the first and second sidewall portions 1 12, 1 14 can have a proximal end notch 136, 138

respectively, defining a portion of the proximal end aperture 134. Proximal end aperture 134 can be sized to allow the first branch 20 of the connector assembly 10 to extend from the interior region 130 through the proximal end aperture 134.

In addition, and as embodied herein, at least one of the first and second sidewall portions in the closed position can define a distal end aperture proximate the distal end of the body. As embodied herein, and with reference to FIGS. 3- 10, each of the first and second sidewall portions 1 12, 1 14 can have a distal end notch 142, 144 respectively, defining a portion of the distal end aperture 140. Distal end aperture 140 can be sized to allow the percutaneous tubing 50 joined to the connector assembly 10 to extend from the interior region 130 through the distal end aperture 140. As embodied herein, proximal end aperture 134 can have a greater cross section than distal end aperture 140.

Further in accordance with the disclosed subject matter, at least one of the first and second sidewall portions in the closed position can define a side aperture in a side of the body. As embodied herein, with reference to FIGS. 3-10, each of the first and second sidewall portions 1 12, 1 14 can have a side notch 120, 122, respectively, defining a portion of the side aperture 124. Side aperture 124 can be sized to allow the second branch 30, if provided, of the connector assembly 10 to extend from the interior region 130 through the side aperture 124.

A clamshell cover can include one or more locating members to locate or secure connector assembly within the interior region of body. For purpose of illustration and as embodied herein, with reference to FIGS. 3-10, body 1 10 can include locating members 146, 148 projecting into interior region 130. As embodied herein, first sidewall portion 1 12 can include a first locating member 146, and second sidewali portion 1 14 can include a second locating member 148. Each of the first and second locating members 146, 148 can include a locating notch 152, 154. In the closed position, first locating notch 1 2 of the first locating member 146 can align with second locating notch 154 of the second locating member 148 to define a locating aperture in the interior region 130 of the body 1 10 sized to receive and locate a portion of the connector assembly 10 within the interior region 130. As embodied herein, first and second locating members 146, 148 can be disposed in the interior region 130 proximate side aperture 124. As such, as embodied herein, first and second locating members 146, 148 can be sized to receive and locate a portion of connector assembly 10 proximate the second branch 30.

Additionally, and as embodied herein, the body can include one or more circumferential ribs projecting into interior region, as shown in FIGS. 3 and 4. As embodied herein, each of the first and second sidewali portions 1 32, 1 14 can have a circumferential rib portion 1 8 defining a portion of the circumferential rib 156. Circumferential rib 156 can be sized to engage a stepped portion 15 of connector assembly 10 defining a corresponding notch or reduced circumference portion. As embodied herein, circumferential rib 156 can be disposed proximate proximal end 1 16 of body 1 10.

Furthermore, and as embodied herein, the body can include any suitable locking configuration to secure the first sidewali portion to the second sidewali portion. For purpose of illustration, and not limitation, at least one of the first and second sidewali portions 1 12, 1 14 can include one or more locking tabs 128, and a corresponding one of the first and second sidewali portions can include one or more receptacles 132 to receive the one or more locking tabs 128 to secure the first and second sidewali portions 1 12, 1 14 in the closed position. A clamshell cover can protect a connector assembly from manipulation by the patient, including manipulation of a tubing connector engaging percutaneous tubing. Additionally or alternatively, the clamshell cover 100 can provide containment of connector assembly. That is, mating of first branch 20 to the remainder of connector assembly 10 can become disconnected, for example due to inadvertent manipulation of latch button 14, if provided, by the action of a patient. Clamshell cover 100 can retain the mating portions of connector assembly 10, for example and as embodied herein, first branch 20 and the remainder of connector assembly 10, within the interior region 130 of the clamshell cover 100, including when the mating portions are joined together and in the event the mating portions become disconnected. In this manner, displacement of one or more portions of connector assembly 10, and percutaneous tubing 50 disposed therein, including inner J-tube (if provided) extending

therethrough, can be prevented or inhibited. Additionally or alternatively, access to the tubing connector 40 can be prevented or inhibited when disposed within interior region 130 of the clamshell cover 100, for example to prevent or inhibit inadvertent disconnection of percutaneous tubing 50.

For purpose of illustration, and not limitation, FIGS. 14-20 illustrate exemplary surface features of a clamshell cover.

According to another aspect of the disclosed subject matter, a connector assembly with cover system is provided. With reference to FIGS. 1 -13, for purpose of illustration and not limitation, the system includes a connector assembly 10 including a tubing connector 40 disposed proximate a distal end. The system further includes a clamshell cover 100 including a body 1 10 defining an interior region 130 sized to receive at least a length of the connector assembly 10 including the tubing connector 40. The body 1 10 includes a first sidewall portion 1 12 hingedly connected to a second sidewall portion 1 14. The first sidewall portion 1 12 is moveable relative the second sidewall portion 1 14 between an open position and a closed position. The first and second sidewall portions 1 12, 1 14 in the open position define an opening extending between a proximal end 116 and a distal end 1 18 of the body for transverse access of the length of the connector assembly 10 into the interior region 130. The first and second sidewall portions 1 12, 1 14 in the closed position cover the length of the connector assembly 10 to prevent or inhibit access to the tubing connector 40, and/or latch button 14, if provided, when disposed within the interior region 130. The clamshell cover can include any or all of the features described herein.

According to another aspect of the disclosed subject matter, an exemplary method of installing a clamshell cover to a connector assembly is provided. The method includes providing a connector assembly having a tubing connector. The tubing connector can include a portion to join to percutaneous tubing. The method can further include providing a clamshell cover having any or all of the features described herein. For purpose of illustration and not limitation, reference is made to FIG. 1 1 to demonstrate the method described herein. As shown in FIG. 1 1, as embodied herein, the method can include positioning the first branch 20 of the connector assembly 10 within the interior region 130 of the first sidewall portion 1 12 or the second sidewall portion 1 14. In this manner, the first sidewall portion 1 12 or second sidewall portion 1 14 of the clamshell cover 100 can at least partially surround connector assembly 10.

Referring now to FIGS. 12 and 13, as embodied herein, a user can urge first and second sidewall portions 1 12, 1 14 toward each other about hinge portions 126 and engage locking tabs 128 into locking receptacles 132 to secure clamshell cover 100 in the closed position. As discussed above, in the closed configuration, clamshell cover 100 can protect connector assembly 10 from inadvertent manipulation by the patient. For example, and as embodied herein, disconnection of first branch 20 from the remainder of connector assembly 10, for example due to inadvertent manipulation of latch button 14 by the action of a patient, can be prevented or inhibited. Clamshell cover 100 can retain mating portions of connector assembly 10, for example and as embodied herein, first branch 20 and the remainder of connector assembly 10, within the interior region 130 of the clamshell cover 100, including when the mating portions are joined together and in the event the mating portions become disconnected, in this manner, displacement of one or more portions of connector assembly 10, and percutaneous tubing 50 disposed therein, including inner J -tube extending

therethrough (if provided) can be prevented or inhibited. Additionally or

alternatively, access to the tubing connector 40 can be prevented or inhibited when disposed within interior region 130 of the clamshell cover 100, for example to prevent or inhibit inadvertent disconnection of percutaneous tubing 50 due to inadvertent snagging or disruption by the action of a patient. To move clamshell cover 100 into the open position, for purpose of illustration, the user can urge each of locking tabs 128, if provided, out of engagement with receptacles 132 to allow First sidewall portion 1 12 to move about hinge portions 126 away from second sidewall portion 1 14. With clamshell cover 100 in the open position, connector assembly 10 can be removed from the clamshell cover 100.

According to an alternative aspect of the disclosed subject matter, an exemplary cup cover for a connector assembly is provided. With reference to FIGS. 14-18, for the purpose of illustration and not limitation, as embodied herein, the cup cover 200 includes a body 202, which can be formed as a single member. For example, and as embodied herein, the cup cover 200 can be formed from polyethylene. The body 202 can have an annular sidewall 204 with an outer surface and an inner surface. The inner surface can be sized for the body to be disposed on the first branch 20 of tubing connector 40 to prevent or inhibit access thereto. The outer surface can include a recessed region 208 defined therein to receive at least a portion of the second branch 30 of the tubing connector. The cup cover 200 can also include a flange 210 extending radially inwardly proximate one end of the sidewall. For example and as embodied herein, the flange 210 can be integrally formed with the base. The flange can be sized to engage the connector, for example proximate latch button 14 of the connector assembly 10 to prevent or inhibit access to and inadvertent manipulation of latch button 14 by the action of a patient.

For purpose of illustration, and not limitation, FIGS. 26-32 illustrate exemplary surface features of a cup cover.

According to another aspect of the disclosed subject matter, an exemplary ring cover for a connector assembly is provided. With reference to FIGS. 19-24, for the purpose of illustration and not limitation, as embodied herein, the ring cover 300 includes a body 302, which can be formed of a single member. For example, and as embodied herein, the ring cover 300 can be formed from polyethylene. The body 302 can have an annular sidewall 304 with an outer surface and an inner surface. The inner surface can be sized for the body 302 to be disposed on the first branch 20 of the connector assembly 10 to prevent or inhibit access to the tubing connector 40. The outer surface can have a recessed region 308 defined therein to receive at least a portion of the second branch 30 of the connector assembly 10. The ring cover 300 can further include one or more clips 310 extending from the body 302. For example and as embodied herein, the one or more clips 310 can be integrally formed with the body 302. The one or more clips 310 can be configured to engage the connector assembly 10, for example proximate latch button 14 of the connector assembly 10 to prevent or inhibit access to and inadvertent manipulation of latch button 14 by the action of a patient.

For purpose of illustration, and not limitation, FIGS. 39-45 illustrate exemplary surface features of a ring cover.

According to yet another aspect of the disclosed subject matter, a partial shell cover for a connector assembly is provided. With reference to FIGS. 25-30, for the purpose of illustration and not limitation, as embodied herein, the partial shell cover 400 includes a body 402 formed as a single member. For example, and as embodied herein, the partial shell cover 400 can be formed from polyethylene. The partial shell cover 400 can have a tubular shape. The tubular shape of the partial shell cover 400 can define an interior region 404, which can be sized to receive at least a length of the connector assembly 10 including the tubing connector 40 to prevent or inhibit access thereto. The body 402 can include a sidewall 406 with a proximal end 408 and a distal end 410 and an opening 412 defined therein extending between the proximal end 408 and the distal end 410 for transverse access to the interior region 404. For example, and as embodied herein, the opening 408 can have a width less than a cross dimension of the tubing connector 40. The sidewall 406 of the body 402 can be capable of being flexed without permanent deformation to enlarge the width of the opening 408 to receive the length of the connector assembly 10 therethrough.

A partial shell cover can protect a connector assembly from manipulation by the patient, including manipulation of a tubing connector engaging percutaneous tubing. Additionally or alternatively, a partial shell cover can provide containment of connector assembly. That is, mating of first branch 20 to the remainder of connector assembly 10 can become disconnected, for example due to inadvertent manipulation of latch button 14 by the action of a patient. Partial shell cover 400 can retain one or more mating portions of connector assembly 10, for example and as embodied herein, first branch 20 and the remainder of connector assembly 10, within the interior region 404 of the partial shell cover 400. In this manner, displacement of one or more portions of connector assembly 10, and percutaneous tubing 50 disposed therein, including inner J-tube (if provided) extending therethrough, can be prevented or inhibited. Additionally or alternatively, access to the tubing connector 40 can be prevented or inhibited when disposed within interior region 404 of the partial shell cover 400, for example to prevent or inhibit inadvertent disconnection of

percutaneous tubing 50.

For purpose of illustration, and not limitation, FIGS. 52-58 illustrate exemplary surface features of a partial shell cover.

The covers and techniques of the disclosed subject matter can be used for covering a connector assembly and tubing system used for delivery of any of a variety of suitable fluid substances of corresponding volume or dose.

While the disclosed subject matter is described herein in terms of certain preferred embodiments, those skilled in the art will recognize that various

modifications and improvements can be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter can be discussed herein or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment can be combined with one or more features of another embodiment or features from a plurality of embodiments.

In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.

It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

AI3V S

1. A clamshell cover for a connector assembly, the cover comprising: a body defining an interior region sized to receive at least a length of a connector assembly including a tubing connector, the body including a first sidewall portion hingedly connected to a second sidewall portion, the first sidewall portion being moveable relative the second sidewall portion between an open position and a closed position,

wherein the first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region, and further wherein the first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region.

2. The clamshell cover of claim 1 , wherein the body is formed as a single member.

3. The clamshell cover of claim 1 , wherein the body has a tubular shape defining the interior region.

4. The clamshell cover of claim 1 , further comprising a plurality of hinge portions spaced apart along a length of the first sidewall portion and the second sidewall portion.

5. The clamshell cover of claim 1 , wherein at least one of the first and second sidewall portions defines a proximal end aperture proximate the proximal end, the proximal end aperture sized to allow a first branch of the connector assembly to extend therethrough from the interior region.

6. The clamshell cover of claim 5, wherein each of the first and second sidewall portions defines a portion of the proximal end aperture, and wherein in the closed position, the proximal end aperture is sized to allow the first branch to extend therethrough from the interior region.

7. The clamshell cover of claim 1 , wherein at least one of the first and second sidewall portions defines a distal end aperture proximate the distal end, the distal end aperture sized to allow access to a distal end of the tubing connector.

8. The clamshell cover of claim 7, wherein each of the first and second sidewall portions defines a portion of the distal end aperture.

9. The clamshell cover of claim 7, wherein in the closed position the distal end aperture is sized to allow a percutaneous tube joined to the tubing connector to extend through the distal end aperture from the interior region.

10. The clamshell cover of claim 1 , wherein at least one of the first and second sidewall portions defines a side aperture in the body, the side aperture sized to allow a second branch of the connector assembly to extend therethrough from the interior region.

1 1. The clamshell cover of claim 10, wherein each of the first and second sidewall portions define a portion of the side aperture in the body, and wherein in the closed position, the side aperture is sized to allow the branch to extend therethrough from the interior region.

12. The clamshell cover of claim 1 , further comprising locating members extending from the body and configured to locate the connector assembly within the interior region.

13. The clamshell cover of claim 12, wherein the locating members comprise a first locating member extending from the first sidewall portion and a second locating member extending from the second sidewall portion.

14. The clamshell cover of claim 13, wherein at least one of the first and second locating members comprises a locating notch to define a locating aperture in the interior region when the first and second sidewall portions are in the closed position to locate the connector assembly therethrough.

15. The clamshell cover of claim 1 , further comprising one or more circumferential ribs projecting from at least one of the first and second sidewall portions into the interior region when in the closed position and configured to engage a stepped portion of the connector assembly within the interior region.

16. The clamshell cover of claim 15, wherein the one or more

circumferential ribs comprise a first circumferential rib projecting from the first sidewall portion and a second circumferential projecting from the second sidewall portion.

17. The clamshell cover of claim 16, wherein in the closed position, the first and second circumferential ribs radially align to engage the connector assembly substantially about a circumference of the connector assembly.

18. The clamshell cover of claim 1 , wherein the first sidewall portion and the second sidewall portion in the closed position are sized to prevent or inhibit displacement of the connector assembly disposed therein.

19. A connector assembly and cover system, the system comprising:

a connector assembly including a tubing connector disposed proximate a distal end; and

a clamshell cover comprising: a body defining an interior region sized to receive at least a length of the connector assembly including the tubing connector, the body including a first sidewall portion hingedly connected to a second sidewal! portion, the first sidewall portion being moveable relative the second sidewall portion between an open position and a closed position,

20. A method of using a clamshell cover, comprising:

providing a connector assembly having a tubing connector;

providing a clamshell cover comprising a body formed as a single member defining an interior region sized to receive at least a length of the connector assembly including the tubing connector, the body including a first sidewall portion hingedly connected to a second sidewall portion, the first sidewall portion being moveable relative the second sidewall portion between an open position and a closed position, wherein the first and second sidewall portions in the open position define an opening extending between a proximal end and a distal end of the body for transverse access of the length of the connector assembly into the interior region, and further wherein the first and second sidewall portions in the closed position cover the length of the connector assembly to prevent or inhibit access to the tubing connector when disposed within the interior region positioning the connector assembly within the opening of the clamshell cover with the first sidewall portion and the second sidewall portion in the open position; and

moving the first sidewall portion about a hinge relative the second sidewall portion to the closed position; and

engaging the first sidewall portion and the second sidewall portion in the closed position with the tubing connector disposed within the interior region.

21. The method of claim 20, further comprising joining a percutaneous tubing to the tubing connector, wherein each of the first and second sidewall portions defines a portion of a distal end aperture proximate the distal end, the distal end aperture sized to allow access to a distal end of the tubing connector, and wherein in the closed position the distal end aperture is sized to allow the percutaneous tube to extend through the distal end aperture from the interior region.