US20140110296A1 - Packaging for Catheter Treatment Devices and Associated Devices, Systems, and Methods - Google Patents

Abstract

Packaging for catheter treatment devices, such as catheters including multi-electrode arrays, are disclosed herein. In one embodiment, for example, a catheter package assembly comprises a tray, a lid, and a coiled sheath disposed in the tray. The tray includes at least one pocket adapted to receive a distal end portion of a catheter. The tray and lid each include cooperative latching features. The sheath defines a lumen that is configured to receive an elongate shaft of the catheter.

Description

CROSS REFERENCE TO RELATED APPLICATION(S)
• The present application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/716,451, filed Oct. 19, 2012, which is incorporated herein by reference in its entirety.
TECHNICAL FIELD
• The present technology relates generally to packaging for medical devices. In particular, various embodiments of the present technology are directed to packaging for catheter treatment devices configured to protect delicate portions of the catheter while maintaining the catheter in a relatively small package size.
BACKGROUND
• Catheters are generally tubular medical devices configured for insertion into canals, vessels, passageways, lumens, or other suitable body cavities (e.g., to deliver energy to target tissue, to permit injection and/or withdrawal of fluids, to keep a passage open, etc.). Many advanced catheters are equipped with sophisticated therapeutic assemblies at distal end portions that are configured for delivery to various target treatment sites within the body. Such therapeutic assemblies are often delicate and complex components that require careful handling.
• One example of such a device is a catheter treatment device having a multi-electrode array movable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally spiral/helical shape). The electrodes or energy delivery elements carried by the array can be configured to deliver energy (e.g., electrical energy, radio frequency (RF) electrical energy, pulsed electrical energy, thermal energy) to a target treatment site after being advanced via catheter along a percutaneous transluminal path (e.g., a femoral artery puncture, an iliac artery and the aorta, a radial artery, or another suitable intravascular path). The multi-electrode array can be sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the target artery when the array is in the deployed (e.g., spiral/helical) state within the artery. The multi-electrode array of the catheter treatment device can be particularly delicate, and can be susceptible to damage during shipping and handling if not packaged appropriately. Conventional catheter packaging generally includes a sheath that contains the catheter within its internal lumen contained in long, cumbersome boxes that allow catheters to be shipped in a straight configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
• Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent.
• FIG. 1 is a top plan view of a catheter package assembly including a catheter container and a sheath assembly configured in accordance with an embodiment of the present technology.
• FIG. 2 is a top plan view of the sheath assembly ofFIG. 1.
• FIG. 3 is an isometric view of the sheath assembly ofFIGS. 1 and 2.
• FIG. 4 is an isometric view of the catheter container ofFIG. 1 in an open arrangement.
• FIG. 5 is a top plan view of the catheter container ofFIG. 4.
• FIG. 6 is a front view in elevation of the catheter container ofFIGS. 4 and 5.
• FIG. 7 is an end view in elevation of the catheter container ofFIGS. 4-6.
• FIG. 8A is an isometric view of a catheter container configured in accordance with another embodiment of the present technology.
• FIG. 8B is an isometric view of the catheter container ofFIG. 8A in a closed configuration.
• FIG. 9 is an isometric view of the catheter container ofFIGS. 8A and 8B.
• FIG. 10A is an isometric view of the catheter container ofFIGS. 8A-9 with a representative catheter installed therein.
• FIG. 10B is an enlarged partial view of the catheter container illustrating a distal end of the catheter installed therein.
• FIG. 11 is an exploded isometric view of the catheter container and catheter ofFIG. 10A.
• FIG. 12 is a top plan view of a catheter package assembly in accordance with another embodiment of the present technology.
• FIG. 13 is an enlarged partial view of the catheter package assembly ofFIG. 12 illustrating a catheter clip attached to the catheter.
• FIG. 14 is an isometric view of a catheter package assembly in accordance with another embodiment of the present technology.
• FIG. 15 is an isometric view of a catheter package assembly configured in accordance with another embodiment of the present technology.
• FIG. 16 is an isometric view of the catheter package assembly ofFIG. 15.
• FIG. 17 is an isometric view of the catheter package assembly shown inFIG. 15 in a closed configuration.
• FIG. 18 is a top plan view of the catheter package assembly shown inFIG. 17.
• FIG. 19 is a bottom plan view of the catheter package assembly shown inFIG. 17.
• FIG. 20 is a right side view in elevation of the catheter package assembly shown inFIG. 17.
• FIG. 21 is a left side view in elevation of the catheter package assembly shown inFIG. 17.
• FIG. 22 is a front side view in elevation of the catheter package assembly shown inFIG. 17.
• FIG. 23 is a back side view in elevation of the catheter package assembly shown inFIG. 17.
• FIG. 24A is an isometric view of a box configured in accordance with an embodiment of the present technology for storing a catheter container.
• FIG. 24B is an isometric view of the box ofFIG. 24A in an open configuration.
• FIG. 25A is an end view of an alternative construction for the box shown inFIG. 24A.
• FIG. 25B is an end view of the box shown inFIG. 25A illustrating a catheter container in a sealed bag disposed in the box.
• FIG. 26 is a top plan view of a flat pattern of the box shown inFIGS. 25A and 25B.
DETAILED DESCRIPTION
• The present technology is directed to packaging for catheter treatment devices, such as catheters including multi-electrode arrays. Because such arrays are so delicate, packaging that protects the array is required. The packaging designs described in this disclosure are configured to support and protect the multi-electrode array at the tip of the catheter during transit, while also providing a significantly smaller footprint than traditional packaging arrangements. The disclosed packaging arrangements are also expected to require less components/materials than many conventional catheter packages.
• Specific details of several embodiments of the technology are described below with reference toFIGS. 1-26. Although various embodiments of catheter packaging are described herein with respect to catheter treatment devices including multi-electrode arrays, it will be appreciated that the disclosed technology may also be used for other types of catheters, particularly those that have delicate parts and/or therapeutic assemblies. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described below with reference toFIGS. 1-26.
• As used herein, the terms “distal” and “proximal” define a position or direction with respect to the treating clinician or clinician's control device (e.g., a handle assembly). “Distal” or “distally” are a position distant from or in a direction away from the clinician or clinician's control device. “Proximal” and “proximally” are a position near or in a direction toward the clinician or clinician's control device.
I. Catheter Package Assemblies
• FIG. 1 is a top plan view of acatheter package assembly5 configured in accordance with an embodiment of the present technology. Thecatheter package assembly5 includes a catheter container having atray50 and acoiled sheath assembly30 disposed in thetray50. Thecatheter package assembly5 is configured to contain and protect acatheter10. In the illustrated embodiment, for example, thecatheter10 includes ahandle2 and an elongated shaft4 having a proximal end portion7 and adistal end portion8. Thecatheter10 further includes a therapeutic assembly6 (e.g., a multi-electrode array such as a spiral/helical tip or the like) at the distal end portion. As mentioned above, themulti-electrode array6 of thecatheter10 is delicate and the catheter container is configured to protect this component during shipping and handling. Similarly, the shaft4 is a very thin, delicate member that is protected by thesheath assembly30 as shown. In some embodiments, thecatheter10 may also include aloading tool12, which in this case is disposed towards the proximal end portion7. Theloading tool12 is a tubular structure configured to slidably move along an outer surface of the shaft4 and themulti-electrode array6. Theloading tool12 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use. Thecatheter10 may also include a cable assembly15 (described in greater detail below with reference toFIG. 10A).
• FIG. 2 is a top plan view of thesheath assembly30 ofFIG. 1.Sheath assembly30 may also be referred to as a vertical dispensing hoop. In this embodiment, thesheath assembly30 includes a length oftubing32 arranged in acoil34 with first and secondtangent portions36 and38 extending tangentially therefrom. Thecoil portion34 has a diameter D₁(e.g., approximately 7.5 inches). Thetubing32 comprises a hollow member having an outside diameter D₂and an inner diameter D₃. In one particular embodiment, D₂is approximately 0.234 inch and D₃is approximately 0.193 inch. In other embodiments, however, the diameter D₁, the inner diameter D₃, and/or the outer diameter D₂may vary. The inner diameter D₃defines a lumen40 sized and configured to receive the shaft4 of the catheter10 (FIG. 1). Thetubing32 may be formed from a plastic material or another suitable material. In some embodiments, thetubing32 may be transparent or translucent. In general, it may be desirable for the materials in the catheter packaging to be E-beam (electron-beam) sterilization compatible. In other embodiments, however, thetubing32 may be composed of other types of materials and/or have different characteristics.
• The firsttangent portion36 has a length L₁(e.g., approximately 7.5 inches) extending from thecoil portion34. The firsttangent portion36 may also include a flared tip42 to facilitate removal of thesheath assembly30 from the catheter shaft4 (FIG. 1). The secondtangent portion38 extends a distance L₂(e.g., approximately 1.7 to 2.0 inches) from thecoil portion34. In this embodiment, the secondtangent portion38 extends around a radius of approximately 4 inches. In other embodiments, however, the first and/or secondtangent portions36 and38 may have a different arrangement and/or different features.
• Referring toFIGS. 2 and 3 together, thetubing32 may be retained in the coil configuration by a plurality ofclips44. Theclips44, for example, are configured to engage thetubing32 in a snap fit or press fit arrangement. In the illustrated embodiment, for example, thesheath assembly30 comprises threeclips44 disposed approximately equiangularly from each other. More specifically, the outer twoclips44 are attached to the coiledtubing32 and spaced apart by an angle A (e.g., approximately 145 degrees). Acenter clip44 is disposed between the outer clips44 (e.g., at an angle of approximately 72.5 degrees). It will be appreciated, however, that while thesheath assembly30 includes one coil and multiple clips separated by particular angles, in other embodiments thesheath assembly30 may have multiple coils, a different number ofclips44, and/or a different arrangement ofclips44.
• As best seen inFIG. 3, theclips44 can include a pair ofgrooves46 sized and configured to grasp thetubing32. Aninner surface48 of eachgroove46 may include serrations to enhance the grip ontubing32. Although theclips44 in the illustrated embodiment comprise two grooves to accommodate a single coil, it will be appreciated that theclips44 may be configured with additional grooves to retain multiple coils in a coiled configuration. Theclips44 may be comprised of a variety of suitable materials (e.g., high density polyethylene (HDPE) or another suitable plastic material).
• FIG. 4 is an isometric view of thecatheter container20 ofFIG. 1 in an open arrangement, andFIGS. 5-7 are additional views of thecatheter container20. Referring toFIGS. 4-7 together (and with reference to thecatheter10 ofFIG. 1), thecatheter container20 includes atray50 and amating lid80. Thetray50 includes acatheter channel52 sized and configured to receive acatheter10 therein. Thechannel52 also includes apocket54 sized to receive themulti-electrode array6 of thecatheter10. In the illustrated embodiment, for example, thepocket54 is large enough to accommodate the delicatemulti-electrode array6 without the inner surface of the pocket making contact. Thetray50 also includes ahandle pocket56 configured to receive thehandle2 of thecatheter10. In the illustrated embodiment, thehandle pocket56 can also include a plurality ofprotrusions60 arranged around a perimeter of thepocket56 and positioned to releasably retain thehandle2 within thepocket56. Theprotrusions60, for example, may be formed into the material of thetray50 and provide a snap fit or press fit arrangement for thehandle2.
• Thecatheter channel52 can also include acoil groove55 sized and configured to receive the sheath assembly30 (FIGS. 1 and 2). A plurality ofprotrusions62 may be arranged about thecoil groove55 and positioned to engage thesheath assembly30 to removably retain the sheath assembly within thecatheter container20. In this embodiment, for example, theprotrusions62 are disposed on an outer diameter of thegroove55. A plurality ofpositioners64 may be positioned on an inside diameter of thegroove55 and configured to cooperate with theprotrusions62 to locate thesheath assembly30 around thegroove55. Further, opposite eachpositioner64 is arelief66 positioned to facilitate installation of thesheath assembly30 into thetray50. Thetray50 can also include awire path68 configured to receive the cable assembly15 (FIG. 10A) therealong and acable assembly cavity58 located in or at least proximate to the middle of thecoil groove55 as shown. Thecable path68 can include a plurality ofnubs70 positioned to cooperate to grasp the cable assembly15 (FIG. 10A).
• Thelid80 of thecatheter container20 is configured to mate with thetray50 to provide an enclosed container for at least a portion of the catheter10 (FIG. 1). In the illustrated embodiment, for example, thelid80 is constructed to cover only the sheath assembly30 (and the shaft4 contained therein) and themulti-electrode array6. Accordingly, thelid80 includes achannel cover portion82 with an associatedconcave pocket cover84. It will be appreciated from the arrangement illustrated inFIGS. 4-7 thatchannel cover82 and pocket cover84 correspond to channel52 andpocket54, respectively, of thetray50. Thus, when installed, thelid80 is positioned to cover the sensitive and delicate portions of the catheter10 (FIG. 1). In some embodiments, thelid80 can include a plurality ofreliefs96 that correspond to protrusions62.
• Thereliefs96 provide clearance forprotrusions62 when thelid80 is mated with thetray50. Similarly, thelid80 can include a plurality ofnotches94 that correspond to thepositioners64. Thenotches94 andpositioners64 may act in cooperation to index thelid80 in the proper rotational position relative to thetray50. In addition, thelid80 may include abutton86 positioned to be inserted into amating socket72 located on thetray50. Thebutton86 andsocket72 cooperatively provide additional indexing and location control forchannel cover82 andpocket cover84. Furthermore, thebutton86 may be configured to provide a friction fit when installed into thesocket72. In other embodiments, thelid80 may include other features and/or have a different arrangement.
• Thelid80 may be retained on thetray50 by alatch feature90. In this embodiment, for example, thelatch feature90 comprises a circular male feature including an undercutwall92. Themale latch feature90 engages acorresponding latch feature74 formed in thetray50. In this embodiment, thelatch feature74 comprises a circular female feature that also includes an undercut wall. Cooperative latch features90 and74 may be snapped or pressed together to mate thelid80 with thetray50. Thelid80 may also include atab88 that extends over thepocket56, thereby providing access to the edge oflid80 to facilitate removal of thelid80. In other embodiments, the latch features74 and90 may have a different configuration and/or thelid80 may include a different number of latch features.
• In the illustrated embodiment, thecatheter container20 is thermoformed as a single part. As shown inFIG. 4, however, the thermoformed components may optionally include aperforated seam77 between thelid80 and thetray50 to facilitate separation of the two components. It should also be noted that theperforated seam77 may be recessed help prevent any burrs or protrusions from contacting the pouch or sterile bag312 (seeFIG. 25B) in which the container is stored. In addition, the perimeter of thetray50 may be raised to allow for a recessed fit between the lid and the tray when assembled together, thereby helping to prevent burrs or rough edges from contacting the sterile bag. As an alternative to a perforated seam, thelid80 andtray50 may be thermoformed as a single unit with a living hinge disposed therebetween such that the components form a clamshell arrangement. In other embodiments, the lid and tray may be formed as separate components. In one embodiment, for example, thecatheter container20 may be composed of polyethylene terephthalate glycol (PETG). In other embodiments, however, thecatheter container20 may be composed of other suitable materials (e.g., High Impact PolyStyrene (HIPS), HDPE, or the like).
II. Catheter Installation
• Referring toFIGS. 1 and 4 together, now that various features of embodiments of thecatheter packaging assembly5 have been described, installation of thecatheter10 into thecatheter packaging assembly5 in accordance with one embodiment of the present technology may be appreciated. First, theinsertion tool12 is installed on the catheter shaft4 and located nearhandle2 at the proximal end portion7 of the shaft4. The shaft4 may then be threaded through thesheath assembly30. Once the shaft4 of thecatheter10 has been disposed in thesheath assembly30, thesheath assembly30 may be snapped into thecoil groove55 and retained therein in the desired orientation by theprotrusions62 andpositioners64.
• Meanwhile, thehandle2 can be positioned in thepocket56 and retained therein by theprotrusions60. Thecable assembly15 may be installed into thecable pathway68 and retained therein by thenubs70. The associated components of thecable assembly15, such as the cable and connector, may also be positioned in thecable cavity58. Thelid80 may be removed from thetray portion50 and positioned over thecoil groove55 as well as thecatheter channel52 and thepocket54. In an another embodiment, thelid80 may be hingedly rotated about a living hinge and positioned over thecoil groove55 as well as thecatheter channel52 and thepocket54.Reliefs96 andnotches94 can be aligned with theprotrusions62 andpositioners64, respectively. Finally, thecooperative latch feature90 may be snapped into the associatedfemale feature74 of thetray50, and thebutton86 may be engaged with thesocket72 such that thelid80 covers the most sensitive/delicate portions of thecatheter10. Thecatheter packaging assembly5 may then be sealed in a sterile bag and inserted into a protective box (described below with reference toFIGS. 24A-26) for packaging and/or shipping. In other embodiments, it will be appreciated that one or more steps of the foregoing installation process may be modified and/or eliminated.
III. Additional Embodiments of Catheter Containers for Catheter Package Assemblies
• FIGS. 8A-9 illustrates acatheter container220 configured in accordance with another embodiment of the present technology. InFIGS. 8A and 9, for example, thecatheter container220 is shown in the open arrangement and includes atray250 and amating lid280, whileFIG. 8B illustrates thecatheter container220 in a closed arrangement. As best seen inFIG. 9, thelid280 is sized and configured to only cover a coil portion of a catheter (not shown) carried by thecontainer220, and does not extend to cover a distal end portion of the catheter. As further seen inFIG. 9, it will be appreciated that thecatheter container220 is not configured for use with an additional sheath assembly (such as thesheath assembly30 described above with reference toFIGS. 1-7). In this embodiment, thecable cavity258 is divided to provide a pocket for thecable assembly15 as well as other accessories.
• In the illustrated embodiment, the catheter shaft4 is retained in a coiled state by a plurality ofchannel protrusions262. Thecatheter container220 can be formed withpockets254,256 shaped to hold thecatheter10 in a coiled configuration as shown inFIGS. 10A and 10B. Light friction features in the form ofprotrusions262 may be provided that allow thecatheter10 to be snapped into thepockets254,256 with minimal force, but will prevent thecatheter10 from shifting and/or falling out of thepockets254,256 during transit. The friction features holding the catheter body may also be configured to hold various loops of catheter length, i.e. could allow for holding longer length catheters that would be looped in several rotations as opposed to a shorter length catheter that would only form a single loop.
• In the embodiment illustrated inFIGS. 8A-10B, thelid280 is connected to thetray250 with a living hinge277 (FIG. 9) such that the components form a clamshell arrangement. In one embodiment, for example, the clamshell may be thermoformed as a single piece structure with a living hinge holding thelid280 to thetray250. One feature of this arrangement is that the single piece construction is expected to help minimize the number of stock-keeping units (SKUs) to be managed. In another embodiment, however, the hinge could be perforated such that thelid280 can be torn from thetray250 as a final manufacturing step. Thelid280 could then be used as a separate piece from thetray250. In still further embodiments, thecatheter container220 may have a different arrangement and/or different features.
• As best seen inFIG. 10B, thecatheter10 can be provided with aloading tool212. In this arrangement, theloading tool212 comprises a sliding sleeve carried by thecatheter10 and configured to slide up and down the length of an outside surface of the catheter shaft4.Loading tool212 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use. Theloading tool212 can be positioned near a distal section of thecatheter10 and held by the friction features of the catheter container to hold the catheter in place. In this arrangement, theloading tool212 is expected to provide additional support to the distal end portion of thecatheter10. In another embodiment, an additional, optional feature (e.g.,end stop feature662 inFIG. 16) could be added to thetray250 that works as a hard stop to prevent theloading tool212 from inadvertently sliding towards themulti-electrode array6 of thecatheter10 and straightening out the spirally-/helically-shaped array during shipping. Because themulti-electrode array6 may be composed of shape memory material, shipping the catheter with themulti-electrode array6 in a straightened configuration could alter the array's desired expanded configuration. Accordingly, apocket254 surrounding themulti-electrode array6 is formed to be large enough so that thearray6 can be shipped in its expanded arrangement and protected from making damaging contact with an inner surface of the packaging.
• Another feature of the disclosed catheter packaging assemblies is that thecable assembly15 may be removed from the packaging and plugged into an external energy generator (not shown) for testing while the remainder of the cable and catheter remain contained within the packaging. Further, as shown inFIG. 11, when the catheter is removed from thecatheter container220, it is configured to remain in a coiled configuration. This arrangement may be desirable such that the user can unravel the catheter in its natural state.
• FIGS. 12 and 13 illustrate acatheter container420 configured in accordance with another embodiment of the present technology. InFIG. 12, for example, thecatheter container420 includes atray450 and a mating lid (not shown) that are similar to the tray and lid described above with respect toFIGS. 5-7. As further seen inFIG. 12, it will be appreciated that thecatheter container420 does not use an additional sheath assembly (such as thesheath assembly30 described above with reference toFIGS. 1-7). Instead, the shaft4 of thecatheter10 is retained in a coiled state by at least onecatheter clip430 and a plurality ofchannel protrusions462. As best seen inFIG. 13, for example, thecatheter clip430 is disposed in amating clip pocket495 formed intray450.
• FIG. 14 illustrates a catheter package assembly including acontainer520 configured in accordance with still another embodiment of the present technology. Thecatheter container520 includes atray550 and amating lid580 similar to the tray and lid described above with respect toFIGS. 5-7. In this embodiment, however,coil groove555 does not include any protrusions (such asprotrusions62 described above with reference toFIGS. 1-7). Rather, in this embodiment thesheath assembly530 is retained in thecatheter container520 by thelid580.
• FIGS. 15-23 illustrate acatheter container620 in accordance with a further embodiment of the present technology. More specifically,FIGS. 15 and 16 show thecatheter container620 in an open configuration, whileFIGS. 17-23 show thecatheter container620 in a closed configuration. With reference toFIGS. 15 and 16, thecatheter container620 includes atray650 and amating lid680. Thetray650 includes acatheter channel652 sized and configured to receive thecatheter10 therein. Further, thechannel652 includes apocket654 sized to receive themulti-electrode array6 of thecatheter10. Thetray650 also includes ahandle pocket656 configured to receive thehandle2 of thecatheter10. In the illustrated embodiment, thehandle pocket656 can also include a plurality ofprotrusions660 arranged around a perimeter of thepocket656 and positioned to releasably retain thehandle2 within thepocket656.
• Thecatheter channel652 can also include acoil groove655 sized and configured to receive asheath assembly630. In this embodiment, thesheath assembly630 is a coil of tubing that is bonded, welded, or otherwise secured to itself to retain the tubing in a coiled configuration. As best shown inFIG. 16,coil groove655 includes a recessedportion653 and thelid680 includes a mating recessedportion657. Thus,sheath assembly630 is held secure in thecoil groove655 against thelid680, except the recessedportions653 and657 provide space for the sheath coil to overlap. Proximate thepocket654, thechannel652 includes aretainer feature664 and anend stop feature662. Thesheath assembly630 is retained in thechannel652 against the end stop feature662 by theretainer feature664. Accordingly, the end of thesheath assembly630 is securely located relative to thepocket654 in order to help prevent the multi-electrode array from touching the inside ofpocket654 during assembly and shipment.
• Thetray650 can also include awire path668 configured to receive the cable assembly15 (FIG. 10A) therealong and acable assembly cavity658 located in or at least proximate to the middle of thecoil groove655 as shown. Thecable path668 can include a plurality ofnubs670 positioned to cooperate to grasp the cable assembly15 (FIG. 10A).
• Thelid680 of thecatheter container620 is configured to mate with thetray650 to provide an enclosed container for at least a portion of thecatheter10. In the illustrated embodiment, for example, thelid680 is constructed to cover only thesheath assembly630 and themulti-electrode array6. Accordingly, thelid680 includes achannel cover portion682 with an associatedconcave pocket cover684. When installed, thelid680 is positioned to cover the sensitive and delicate portions of thecatheter10. Thelid680 may include abutton686 positioned to be inserted into amating socket672 located on thetray650. Thebutton686 andsocket672 cooperatively provide indexing and location control for thechannel cover682 and thepocket cover684. Furthermore, thebutton686 may be configured to provide a friction fit when installed into thesocket672. In other embodiments, however, thelid680 may include other features and/or have a different arrangement.
• Thelid680 may be retained on thetray650 by alatch feature690. In this embodiment, for example, thelatch feature690 is a circular male feature that includes an undercutwall692. Themale latch feature690 engages a correspondingfemale latch feature674 formed in thetray650. In this embodiment, thelatch feature674 is a circular female feature that also includes an undercut wall. Cooperative latch features690 and674 may be snapped or pressed together to mate thelid680 with thetray650. In other embodiments, the latch features674 and690 may have a different configuration and/or thelid680 may include a different number of latch features.
IV. Protective Boxes
• In some embodiments, the disclosed catheter package assemblies may also be packaged in a protective box. Conventional catheter boxes typically open at one end and require users to reach deep into the box to pull out the catheter. Such boxes also tend to use corrugate, which has an unclean stigma to it.FIGS. 24A and 24B, however, illustrate aprotective box300 configured in accordance with an embodiment of the present technology shown in a closed and an open configuration, respectively. Thebox300 is configured to hold the catheter package as well as user instructions (e.g., a paper IFU) that may be required by some regulatory authorities. Thebox300, for example, can be composed of solid bleached sulfate (SBS) and folded into the desired shape including a hingedlid305. In other embodiments, thebox300 may be composed of different materials and/or have a different arrangement.
• FIGS. 25A and 25B illustrate aprotective box310 configured in accordance with another embodiment of the present technology. As best seen inFIG. 25B, the catheter package assembly may be enclosed in asterile bag312 and inserted into thebox310 for shipping.Box310 includesgussets318 which are folded inward along perforation lines as the box is closed.Gussets318 provide added structural support to protect the paperboard box design from corner crushing. Theprotective box310 can include apocket divider314 to separate the IFU manual from the sterilebarrier header bag312, as well as to pingussets318 outward thus preventing contact between thegussets318 and thesterile bag312. Thepocket divider314 may be supported by a pair ofstanchions316.
• As shown in the flat pattern ofFIG. 26, thegussets318 can be modified by creating anindentation bump320 that helps minimize the sharpened point that would be created once folded. Thegussets318 are shown as anindentation320 or bumped in. Alternatively, they could be formed with a bumped out arrangement. In still further embodiments, thebox310 may have a different arrangement and/or include different features.
V. Examples
• The following examples are illustrative of several embodiments of the present technology:
• 1. A catheter package assembly for removably storing a catheter, the catheter package assembly comprising:
• a tray including at least one pocket adapted to receive a multi-electrode array at a distal portion of the catheter;
• a lid pivotably attached to the tray, wherein the tray and lid each include cooperative latching features;
• a sheath assembly disposed in the tray, wherein the sheath assembly defines a lumen therethrough configured to receive an elongate shaft of the catheter; and
• a plurality of clips removably attached to the sheath assembly and configured to retain the sheath assembly in a coiled configuration in the tray.
• 2. The catheter package assembly of example1 wherein the tray further comprises a handle pocket configured to receive a handle of the catheter.
• 3. The catheter package assembly of example 1 or example 2 wherein the tray further comprises a plurality of protrusions positioned to engage the sheath assembly and removably retain the sheath assembly in the tray in a snap fit arrangement.
• 4. The catheter package assembly of any one of examples 1 to 3 wherein the lid, when cooperatively mated with the tray, is configured to cover only the sheath assembly and the multi-electrode array of the catheter.
• 5. A catheter package assembly for removably containing and protecting a catheter, the catheter container comprising:
• a tray including—
• • a pocket configured to receive a therapeutic assembly at a distal portion of the catheter;
  • a handle pocket configured to receive a handle of the catheter; and
  • a channel extending between the pocket and handle pocket, wherein the channel includes a coil groove;
• a sheath removably disposed in the coil groove, wherein the sheath comprises a lumen therethrough configured to receive an elongate shaft of the catheter; and
• a lid configured to mate with the tray and provide an enclosed container for a portion of the catheter.
• 6. The catheter package assembly of example 5 wherein the tray includes a plurality of protrusions adjacent the handle pocket and positioned to removably retain the handle in the handle pocket.
• 7. The catheter package assembly of example 5 or example 6 wherein the lid comprises a lid pocket cover and a lid channel cover portion, and wherein, when the lid is mated with the tray in a closed configuration—
• the pocket cover and lid pocket cover cooperatively contain and protect the therapeutic assembly at the distal portion of the catheter; and
• the channel cover portion and lid channel cover portion cooperatively contain and protect the sheath.
• 8. The catheter package assembly of any one of examples 5 to 7, further comprising a cable assembly cavity in the coil groove.
• 9. The catheter package assembly of any one of examples 5 to 8 wherein the sheath is secured to itself, thereby retaining the sheath in a coiled configuration.
• 10. The catheter package assembly of any one of examples 5 to 9 wherein the coiled sheath is welded to itself.
• 11. The catheter package assembly of any one of examples 5 to 10 wherein the channel further comprises a retainer feature proximate the pocket, and wherein the retainer feature is configured to removably retain the sheath in the channel.
• 12. The catheter package assembly of example 11 wherein the channel comprises an end stop feature between the retainer feature and the pocket, and wherein the sheath assembly is configured to be retained in the channel against the end stop feature by the retainer feature.
• 13. A catheter package assembly, comprising:
• a tray including at least one pocket adapted to receive a therapeutic assembly at a distal portion of a catheter; and
• a coiled sheath removably disposed in the tray, wherein the sheath defines a lumen therethrough, and wherein the lumen is configured to receive an elongate shaft of the catheter.
• 14. The catheter package assembly of example 13 further comprising a lid pivotably coupled to the tray.
• 15. The catheter package assembly of example 14 wherein the tray and lid each include cooperative latching features.
• 16. The catheter package assembly of example 14 or example 15 wherein the lid includes a pocket cover.
• 17. The catheter package assembly of any one of examples 13 to 16 wherein the tray includes a handle pocket.
• 18. The catheter package assembly of any one of examples 13 to 17, further comprising a plurality of clips attached to the sheath and positioned to retain the sheath in a coiled configuration.
• 19. The catheter package assembly of any one of examples 13 to 18 wherein the tray includes a plurality of protrusions positioned to retain the coiled sheath in the tray.
• 20. The catheter package assembly of any one of examples 13 to 17 wherein the tray includes protrusions configured to grasp the sheath and retain the sheath in a coiled configuration.
VI. Conclusion
• The above detailed descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, the catheter package assemblies and catheter containers described herein may be used with catheters having therapeutic assemblies with a variety of different configurations (e.g., single electrode, expandable basket, expandable balloon, one or more transducers, etc.). Further, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
• From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
• Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims (20)

I/we claim:

1. A catheter package assembly for removably storing a catheter, the catheter package assembly comprising:

a tray including at least one pocket adapted to receive a multi-electrode array at a distal portion of the catheter;

a lid pivotably attached to the tray, wherein the tray and lid each include cooperative latching features;

a sheath assembly disposed in the tray, wherein the sheath assembly defines a lumen therethrough configured to receive an elongate shaft of the catheter; and

a plurality of clips removably attached to the sheath assembly and configured to retain the sheath assembly in a coiled configuration in the tray.

2. The catheter package assembly ofclaim 1 wherein the tray further comprises a handle pocket configured to receive a handle of the catheter.

3. The catheter package assembly ofclaim 1 wherein the tray further comprises a plurality of protrusions positioned to engage the sheath assembly and removably retain the sheath assembly in the tray in a snap fit arrangement.

4. The catheter package assembly ofclaim 1 wherein the lid, when cooperatively mated with the tray, is configured to cover only the sheath assembly and the multi-electrode array of the catheter.

5. A catheter package assembly for removably containing and protecting a catheter, the catheter package assembly comprising:

a tray including—

a pocket configured to receive a therapeutic assembly at a distal portion of the catheter;

a handle pocket configured to receive a handle of the catheter; and

a channel extending between the pocket and handle pocket, wherein the channel includes a coil groove;

a sheath removably disposed in the coil groove, wherein the sheath comprises a lumen therethrough configured to receive an elongate shaft of the catheter; and

a lid configured to mate with the tray and provide an enclosed container for a portion of the catheter.

6. The catheter package assembly ofclaim 5 wherein the tray includes a plurality of protrusions adjacent the handle pocket and positioned to removably retain the handle in the handle pocket.

7. The catheter package assembly ofclaim 5 wherein the lid comprises a lid pocket cover and a lid channel cover portion, and wherein, when the lid is mated with the tray in a closed configuration—

the pocket cover and lid pocket cover cooperatively contain and protect the therapeutic assembly at the distal portion of the catheter; and

the channel cover portion and lid channel cover portion cooperatively contain and protect the sheath.

8. The catheter package assembly ofclaim 5, further comprising a cable assembly cavity in the coil groove.

9. The catheter package assembly ofclaim 5 wherein the coiled sheath is secured to itself, thereby retaining the sheath in a coiled configuration.

10. The catheter package assembly ofclaim 9 wherein the coiled sheath is welded to itself.

11. The catheter package assembly ofclaim 5 wherein the channel further comprises a retainer feature proximate the pocket, and wherein the retainer feature is configured to removably retain the sheath in the channel.

12. The catheter package assembly ofclaim 11 wherein the channel comprises an end stop feature between the retainer feature and the pocket, and wherein the sheath assembly is configured to be retained in the channel against the end stop feature by the retainer feature.

13. A catheter package assembly, comprising:

a tray including at least one pocket adapted to receive a therapeutic assembly at a distal portion of a catheter; and

a coiled sheath removably disposed in the tray, wherein the sheath defines a lumen therethrough, and wherein the lumen is configured to receive an elongate shaft of the catheter.

14. The catheter package assembly ofclaim 13 further comprising a lid pivotably coupled to the tray.

15. The catheter package assembly ofclaim 14 wherein the tray and lid each include cooperative latching features.

16. The catheter package assembly ofclaim 14 wherein the lid includes a pocket cover.

17. The catheter package assembly ofclaim 13 wherein the tray includes a handle pocket.

18. The catheter package assembly ofclaim 13, further comprising a plurality of clips attached to the sheath and positioned to retain the sheath in a coiled configuration.

19. The catheter package assembly ofclaim 18 wherein the tray includes a plurality of protrusions positioned to retain the coiled sheath in the tray.

20. The catheter package assembly ofclaim 13 wherein the tray includes protrusions configured to grasp the sheath and retain the sheath in a coiled configuration.

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