US20140110296A1 - Packaging for Catheter Treatment Devices and Associated Devices, Systems, and Methods - Google Patents
Packaging for Catheter Treatment Devices and Associated Devices, Systems, and Methods Download PDFInfo
- Publication number
- US20140110296A1 US20140110296A1 US13/840,484 US201313840484A US2014110296A1 US 20140110296 A1 US20140110296 A1 US 20140110296A1 US 201313840484 A US201313840484 A US 201313840484A US 2014110296 A1 US2014110296 A1 US 2014110296A1
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- US
- United States
- Prior art keywords
- catheter
- tray
- sheath
- assembly
- lid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/002—Packages specially adapted therefor ; catheter kit packages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
- A61B50/30—Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
- B65D1/34—Trays or like shallow containers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
- B65D25/02—Internal fittings
- B65D25/10—Devices to locate articles in containers
- B65D25/108—Devices, e.g. plates, presenting apertures through which the articles project
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D43/00—Lids or covers for rigid or semi-rigid containers
- B65D43/14—Non-removable lids or covers
- B65D43/16—Non-removable lids or covers hinged for upward or downward movement
Definitions
- the present technology relates generally to packaging for medical devices.
- 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.
- 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.
- 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).
- energy e.g., electrical energy, radio frequency (RF) electrical energy, pulsed electrical energy, thermal energy
- 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.
- 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 of FIG. 1 .
- FIG. 3 is an isometric view of the sheath assembly of FIGS. 1 and 2 .
- FIG. 4 is an isometric view of the catheter container of FIG. 1 in an open arrangement.
- FIG. 5 is a top plan view of the catheter container of FIG. 4 .
- FIG. 6 is a front view in elevation of the catheter container of FIGS. 4 and 5 .
- FIG. 7 is an end view in elevation of the catheter container of FIGS. 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 of FIG. 8A in a closed configuration.
- FIG. 9 is an isometric view of the catheter container of FIGS. 8A and 8B .
- FIG. 10A is an isometric view of the catheter container of FIGS. 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 of FIG. 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 of FIG. 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 of FIG. 15 .
- FIG. 17 is an isometric view of the catheter package assembly shown in FIG. 15 in a closed configuration.
- FIG. 18 is a top plan view of the catheter package assembly shown in FIG. 17 .
- FIG. 19 is a bottom plan view of the catheter package assembly shown in FIG. 17 .
- FIG. 20 is a right side view in elevation of the catheter package assembly shown in FIG. 17 .
- FIG. 21 is a left side view in elevation of the catheter package assembly shown in FIG. 17 .
- FIG. 22 is a front side view in elevation of the catheter package assembly shown in FIG. 17 .
- FIG. 23 is a back side view in elevation of the catheter package assembly shown in FIG. 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 of FIG. 24A in an open configuration.
- FIG. 25A is an end view of an alternative construction for the box shown in FIG. 24A .
- FIG. 25B is an end view of the box shown in FIG. 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 in FIGS. 25A and 25B .
- 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.
- FIGS. 1-26 Specific details of several embodiments of the technology are described below with reference to FIGS. 1-26 .
- 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.
- 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 to FIGS. 1-26 .
- 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.
- FIG. 1 is a top plan view of a catheter package assembly 5 configured in accordance with an embodiment of the present technology.
- the catheter package assembly 5 includes a catheter container having a tray 50 and a coiled sheath assembly 30 disposed in the tray 50 .
- the catheter package assembly 5 is configured to contain and protect a catheter 10 .
- the catheter 10 includes a handle 2 and an elongated shaft 4 having a proximal end portion 7 and a distal end portion 8 .
- the catheter 10 further includes a therapeutic assembly 6 (e.g., a multi-electrode array such as a spiral/helical tip or the like) at the distal end portion.
- a therapeutic assembly 6 e.g., a multi-electrode array such as a spiral/helical tip or the like
- the catheter 10 may also include a loading tool 12 , which in this case is disposed towards the proximal end portion 7 .
- the loading tool 12 is a tubular structure configured to slidably move along an outer surface of the shaft 4 and the multi-electrode array 6 .
- the loading tool 12 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use.
- the catheter 10 may also include a cable assembly 15 (described in greater detail below with reference to FIG. 10A ).
- FIG. 2 is a top plan view of the sheath assembly 30 of FIG. 1 .
- Sheath assembly 30 may also be referred to as a vertical dispensing hoop.
- the sheath assembly 30 includes a length of tubing 32 arranged in a coil 34 with first and second tangent portions 36 and 38 extending tangentially therefrom.
- the coil portion 34 has a diameter D 1 (e.g., approximately 7.5 inches).
- the tubing 32 comprises a hollow member having an outside diameter D 2 and an inner diameter D 3 .
- D 2 is approximately 0.234 inch and D 3 is approximately 0.193 inch. In other embodiments, however, the diameter D 1 , the inner diameter D 3 , and/or the outer diameter D 2 may vary.
- the inner diameter D 3 defines a lumen 40 sized and configured to receive the shaft 4 of the catheter 10 ( FIG. 1 ).
- the tubing 32 may be formed from a plastic material or another suitable material. In some embodiments, the tubing 32 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, the tubing 32 may be composed of other types of materials and/or have different characteristics.
- the first tangent portion 36 has a length L 1 (e.g., approximately 7.5 inches) extending from the coil portion 34 .
- the first tangent portion 36 may also include a flared tip 42 to facilitate removal of the sheath assembly 30 from the catheter shaft 4 ( FIG. 1 ).
- the second tangent portion 38 extends a distance L 2 (e.g., approximately 1.7 to 2.0 inches) from the coil portion 34 .
- the second tangent portion 38 extends around a radius of approximately 4 inches.
- the first and/or second tangent portions 36 and 38 may have a different arrangement and/or different features.
- the tubing 32 may be retained in the coil configuration by a plurality of clips 44 .
- the clips 44 are configured to engage the tubing 32 in a snap fit or press fit arrangement.
- the sheath assembly 30 comprises three clips 44 disposed approximately equiangularly from each other. More specifically, the outer two clips 44 are attached to the coiled tubing 32 and spaced apart by an angle A (e.g., approximately 145 degrees). A center clip 44 is disposed between the outer clips 44 (e.g., at an angle of approximately 72.5 degrees). It will be appreciated, however, that while the sheath assembly 30 includes one coil and multiple clips separated by particular angles, in other embodiments the sheath assembly 30 may have multiple coils, a different number of clips 44 , and/or a different arrangement of clips 44 .
- the clips 44 can include a pair of grooves 46 sized and configured to grasp the tubing 32 .
- An inner surface 48 of each groove 46 may include serrations to enhance the grip on tubing 32 .
- the clips 44 in the illustrated embodiment comprise two grooves to accommodate a single coil, it will be appreciated that the clips 44 may be configured with additional grooves to retain multiple coils in a coiled configuration.
- the clips 44 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 the catheter container 20 of FIG. 1 in an open arrangement
- FIGS. 5-7 are additional views of the catheter container 20 .
- the catheter container 20 includes a tray 50 and a mating lid 80 .
- the tray 50 includes a catheter channel 52 sized and configured to receive a catheter 10 therein.
- the channel 52 also includes a pocket 54 sized to receive the multi-electrode array 6 of the catheter 10 .
- the pocket 54 is large enough to accommodate the delicate multi-electrode array 6 without the inner surface of the pocket making contact.
- the tray 50 also includes a handle pocket 56 configured to receive the handle 2 of the catheter 10 .
- the handle pocket 56 can also include a plurality of protrusions 60 arranged around a perimeter of the pocket 56 and positioned to releasably retain the handle 2 within the pocket 56 .
- the protrusions 60 may be formed into the material of the tray 50 and provide a snap fit or press fit arrangement for the handle 2 .
- the catheter channel 52 can also include a coil groove 55 sized and configured to receive the sheath assembly 30 ( FIGS. 1 and 2 ).
- a plurality of protrusions 62 may be arranged about the coil groove 55 and positioned to engage the sheath assembly 30 to removably retain the sheath assembly within the catheter container 20 .
- the protrusions 62 are disposed on an outer diameter of the groove 55 .
- a plurality of positioners 64 may be positioned on an inside diameter of the groove 55 and configured to cooperate with the protrusions 62 to locate the sheath assembly 30 around the groove 55 . Further, opposite each positioner 64 is a relief 66 positioned to facilitate installation of the sheath assembly 30 into the tray 50 .
- the tray 50 can also include a wire path 68 configured to receive the cable assembly 15 ( FIG. 10A ) therealong and a cable assembly cavity 58 located in or at least proximate to the middle of the coil groove 55 as shown.
- the cable path 68 can include a plurality of nubs 70 positioned to cooperate to grasp the cable assembly 15 ( FIG. 10A ).
- the lid 80 of the catheter container 20 is configured to mate with the tray 50 to provide an enclosed container for at least a portion of the catheter 10 ( FIG. 1 ).
- the lid 80 is constructed to cover only the sheath assembly 30 (and the shaft 4 contained therein) and the multi-electrode array 6 .
- the lid 80 includes a channel cover portion 82 with an associated concave pocket cover 84 .
- channel cover 82 and pocket cover 84 correspond to channel 52 and pocket 54 , respectively, of the tray 50 .
- the lid 80 when installed, the lid 80 is positioned to cover the sensitive and delicate portions of the catheter 10 ( FIG. 1 ).
- the lid 80 can include a plurality of reliefs 96 that correspond to protrusions 62 .
- the reliefs 96 provide clearance for protrusions 62 when the lid 80 is mated with the tray 50 .
- the lid 80 can include a plurality of notches 94 that correspond to the positioners 64 .
- the notches 94 and positioners 64 may act in cooperation to index the lid 80 in the proper rotational position relative to the tray 50 .
- the lid 80 may include a button 86 positioned to be inserted into a mating socket 72 located on the tray 50 .
- the button 86 and socket 72 cooperatively provide additional indexing and location control for channel cover 82 and pocket cover 84 .
- the button 86 may be configured to provide a friction fit when installed into the socket 72 .
- the lid 80 may include other features and/or have a different arrangement.
- the lid 80 may be retained on the tray 50 by a latch feature 90 .
- the latch feature 90 comprises a circular male feature including an undercut wall 92 .
- the male latch feature 90 engages a corresponding latch feature 74 formed in the tray 50 .
- the latch feature 74 comprises a circular female feature that also includes an undercut wall.
- Cooperative latch features 90 and 74 may be snapped or pressed together to mate the lid 80 with the tray 50 .
- the lid 80 may also include a tab 88 that extends over the pocket 56 , thereby providing access to the edge of lid 80 to facilitate removal of the lid 80 .
- the latch features 74 and 90 may have a different configuration and/or the lid 80 may include a different number of latch features.
- the catheter container 20 is thermoformed as a single part.
- the thermoformed components may optionally include a perforated seam 77 between the lid 80 and the tray 50 to facilitate separation of the two components.
- the perforated seam 77 may be recessed help prevent any burrs or protrusions from contacting the pouch or sterile bag 312 (see FIG. 25B ) in which the container is stored.
- the perimeter of the tray 50 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.
- the lid 80 and tray 50 may be thermoformed as a single unit with a living hinge disposed therebetween such that the components form a clamshell arrangement.
- the lid and tray may be formed as separate components.
- the catheter container 20 may be composed of polyethylene terephthalate glycol (PETG).
- the catheter container 20 may be composed of other suitable materials (e.g., High Impact PolyStyrene (HIPS), HDPE, or the like).
- the insertion tool 12 is installed on the catheter shaft 4 and located near handle 2 at the proximal end portion 7 of the shaft 4 .
- the shaft 4 may then be threaded through the sheath assembly 30 .
- the sheath assembly 30 may be snapped into the coil groove 55 and retained therein in the desired orientation by the protrusions 62 and positioners 64 .
- the handle 2 can be positioned in the pocket 56 and retained therein by the protrusions 60 .
- the cable assembly 15 may be installed into the cable pathway 68 and retained therein by the nubs 70 .
- the associated components of the cable assembly 15 such as the cable and connector, may also be positioned in the cable cavity 58 .
- the lid 80 may be removed from the tray portion 50 and positioned over the coil groove 55 as well as the catheter channel 52 and the pocket 54 .
- the lid 80 may be hingedly rotated about a living hinge and positioned over the coil groove 55 as well as the catheter channel 52 and the pocket 54 .
- Reliefs 96 and notches 94 can be aligned with the protrusions 62 and positioners 64 , respectively.
- the cooperative latch feature 90 may be snapped into the associated female feature 74 of the tray 50 , and the button 86 may be engaged with the socket 72 such that the lid 80 covers the most sensitive/delicate portions of the catheter 10 .
- the catheter packaging assembly 5 may then be sealed in a sterile bag and inserted into a protective box (described below with reference to FIGS. 24A-26 ) for packaging and/or shipping.
- a protective box described below with reference to FIGS. 24A-26
- FIGS. 8A-9 illustrates a catheter container 220 configured in accordance with another embodiment of the present technology.
- the catheter container 220 is shown in the open arrangement and includes a tray 250 and a mating lid 280
- FIG. 8B illustrates the catheter container 220 in a closed arrangement.
- the lid 280 is sized and configured to only cover a coil portion of a catheter (not shown) carried by the container 220 , and does not extend to cover a distal end portion of the catheter.
- the catheter container 220 is not configured for use with an additional sheath assembly (such as the sheath assembly 30 described above with reference to FIGS. 1-7 ).
- the cable cavity 258 is divided to provide a pocket for the cable assembly 15 as well as other accessories.
- the catheter shaft 4 is retained in a coiled state by a plurality of channel protrusions 262 .
- the catheter container 220 can be formed with pockets 254 , 256 shaped to hold the catheter 10 in a coiled configuration as shown in FIGS. 10A and 10B .
- Light friction features in the form of protrusions 262 may be provided that allow the catheter 10 to be snapped into the pockets 254 , 256 with minimal force, but will prevent the catheter 10 from shifting and/or falling out of the pockets 254 , 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.
- the lid 280 is connected to the tray 250 with a living hinge 277 ( FIG. 9 ) such that the components form a clamshell arrangement.
- the clamshell may be thermoformed as a single piece structure with a living hinge holding the lid 280 to the tray 250 .
- the hinge could be perforated such that the lid 280 can be torn from the tray 250 as a final manufacturing step. The lid 280 could then be used as a separate piece from the tray 250 .
- the catheter container 220 may have a different arrangement and/or different features.
- the catheter 10 can be provided with a loading tool 212 .
- the loading tool 212 comprises a sliding sleeve carried by the catheter 10 and configured to slide up and down the length of an outside surface of the catheter shaft 4 .
- Loading tool 212 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use.
- the loading tool 212 can be positioned near a distal section of the catheter 10 and held by the friction features of the catheter container to hold the catheter in place. In this arrangement, the loading tool 212 is expected to provide additional support to the distal end portion of the catheter 10 .
- an additional, optional feature e.g., end stop feature 662 in FIG.
- a pocket 254 surrounding the multi-electrode array 6 is formed to be large enough so that the array 6 can be shipped in its expanded arrangement and protected from making damaging contact with an inner surface of the packaging.
- the cable assembly 15 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 in FIG. 11 , when the catheter is removed from the catheter container 220 , 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 a catheter container 420 configured in accordance with another embodiment of the present technology.
- the catheter container 420 includes a tray 450 and a mating lid (not shown) that are similar to the tray and lid described above with respect to FIGS. 5-7 .
- the catheter container 420 does not use an additional sheath assembly (such as the sheath assembly 30 described above with reference to FIGS. 1-7 ).
- the shaft 4 of the catheter 10 is retained in a coiled state by at least one catheter clip 430 and a plurality of channel protrusions 462 .
- the catheter clip 430 is disposed in a mating clip pocket 495 formed in tray 450 .
- FIG. 14 illustrates a catheter package assembly including a container 520 configured in accordance with still another embodiment of the present technology.
- the catheter container 520 includes a tray 550 and a mating lid 580 similar to the tray and lid described above with respect to FIGS. 5-7 .
- coil groove 555 does not include any protrusions (such as protrusions 62 described above with reference to FIGS. 1-7 ). Rather, in this embodiment the sheath assembly 530 is retained in the catheter container 520 by the lid 580 .
- FIGS. 15-23 illustrate a catheter container 620 in accordance with a further embodiment of the present technology. More specifically, FIGS. 15 and 16 show the catheter container 620 in an open configuration, while FIGS. 17-23 show the catheter container 620 in a closed configuration.
- the catheter container 620 includes a tray 650 and a mating lid 680 .
- the tray 650 includes a catheter channel 652 sized and configured to receive the catheter 10 therein. Further, the channel 652 includes a pocket 654 sized to receive the multi-electrode array 6 of the catheter 10 .
- the tray 650 also includes a handle pocket 656 configured to receive the handle 2 of the catheter 10 .
- the handle pocket 656 can also include a plurality of protrusions 660 arranged around a perimeter of the pocket 656 and positioned to releasably retain the handle 2 within the pocket 656 .
- the catheter channel 652 can also include a coil groove 655 sized and configured to receive a sheath assembly 630 .
- the sheath assembly 630 is a coil of tubing that is bonded, welded, or otherwise secured to itself to retain the tubing in a coiled configuration.
- coil groove 655 includes a recessed portion 653 and the lid 680 includes a mating recessed portion 657 .
- sheath assembly 630 is held secure in the coil groove 655 against the lid 680 , except the recessed portions 653 and 657 provide space for the sheath coil to overlap.
- the channel 652 includes a retainer feature 664 and an end stop feature 662 .
- the sheath assembly 630 is retained in the channel 652 against the end stop feature 662 by the retainer feature 664 . Accordingly, the end of the sheath assembly 630 is securely located relative to the pocket 654 in order to help prevent the multi-electrode array from touching the inside of pocket 654 during assembly and shipment.
- the tray 650 can also include a wire path 668 configured to receive the cable assembly 15 ( FIG. 10A ) therealong and a cable assembly cavity 658 located in or at least proximate to the middle of the coil groove 655 as shown.
- the cable path 668 can include a plurality of nubs 670 positioned to cooperate to grasp the cable assembly 15 ( FIG. 10A ).
- the lid 680 of the catheter container 620 is configured to mate with the tray 650 to provide an enclosed container for at least a portion of the catheter 10 .
- the lid 680 is constructed to cover only the sheath assembly 630 and the multi-electrode array 6 .
- the lid 680 includes a channel cover portion 682 with an associated concave pocket cover 684 .
- the lid 680 is positioned to cover the sensitive and delicate portions of the catheter 10 .
- the lid 680 may include a button 686 positioned to be inserted into a mating socket 672 located on the tray 650 .
- the button 686 and socket 672 cooperatively provide indexing and location control for the channel cover 682 and the pocket cover 684 .
- the button 686 may be configured to provide a friction fit when installed into the socket 672 .
- the lid 680 may include other features and/or have a different arrangement.
- the lid 680 may be retained on the tray 650 by a latch feature 690 .
- the latch feature 690 is a circular male feature that includes an undercut wall 692 .
- the male latch feature 690 engages a corresponding female latch feature 674 formed in the tray 650 .
- the latch feature 674 is a circular female feature that also includes an undercut wall.
- Cooperative latch features 690 and 674 may be snapped or pressed together to mate the lid 680 with the tray 650 .
- the latch features 674 and 690 may have a different configuration and/or the lid 680 may include a different number of latch features.
- 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 illustrate a protective box 300 configured in accordance with an embodiment of the present technology shown in a closed and an open configuration, respectively.
- the box 300 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.
- the box 300 for example, can be composed of solid bleached sulfate (SBS) and folded into the desired shape including a hinged lid 305 . In other embodiments, the box 300 may be composed of different materials and/or have a different arrangement.
- SBS solid bleached sulfate
- FIGS. 25A and 25B illustrate a protective box 310 configured in accordance with another embodiment of the present technology.
- the catheter package assembly may be enclosed in a sterile bag 312 and inserted into the box 310 for shipping.
- Box 310 includes gussets 318 which are folded inward along perforation lines as the box is closed. Gussets 318 provide added structural support to protect the paperboard box design from corner crushing.
- the protective box 310 can include a pocket divider 314 to separate the IFU manual from the sterile barrier header bag 312 , as well as to pin gussets 318 outward thus preventing contact between the gussets 318 and the sterile bag 312 .
- the pocket divider 314 may be supported by a pair of stanchions 316 .
- the gussets 318 can be modified by creating an indentation bump 320 that helps minimize the sharpened point that would be created once folded.
- the gussets 318 are shown as an indentation 320 or bumped in. Alternatively, they could be formed with a bumped out arrangement.
- the box 310 may have a different arrangement and/or include different features.
- 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
- sheath assembly disposed in the tray, wherein the sheath assembly defines a lumen therethrough configured to receive an elongate shaft of the catheter;
- a plurality of clips removably attached to the sheath assembly and configured to retain the sheath assembly in a coiled configuration in the tray.
- a catheter package assembly for removably containing and protecting a catheter, the catheter container comprising:
- a tray including—
- sheath removably disposed in the coil groove, wherein the sheath comprises a lumen therethrough configured to receive an elongate shaft of the catheter;
- a lid configured to mate with the tray and provide an enclosed container for a portion of the catheter.
- the pocket cover and lid pocket cover cooperatively contain and protect the therapeutic assembly at the distal portion of the catheter
- the channel cover portion and lid channel cover portion cooperatively contain and protect the sheath.
- 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.
- 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
- 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.
- the catheter package assembly of example 13 further comprising a lid pivotably coupled to the tray.
- 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.).
- 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.
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
- 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.
- 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.
- 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.
- 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.
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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 . - 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 to
FIGS. 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.
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FIG. 1 is a top plan view of acatheter package assembly 5 configured in accordance with an embodiment of the present technology. Thecatheter package assembly 5 includes a catheter container having atray 50 and acoiled sheath assembly 30 disposed in thetray 50. Thecatheter package assembly 5 is configured to contain and protect acatheter 10. In the illustrated embodiment, for example, thecatheter 10 includes ahandle 2 and an elongated shaft 4 having a proximal end portion 7 and adistal end portion 8. Thecatheter 10 further includes a therapeutic assembly 6 (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 array 6 of thecatheter 10 is delicate and the catheter container is configured to protect this component during shipping and handling. Similarly, the shaft 4 is a very thin, delicate member that is protected by thesheath assembly 30 as shown. In some embodiments, thecatheter 10 may also include aloading tool 12, which in this case is disposed towards the proximal end portion 7. Theloading tool 12 is a tubular structure configured to slidably move along an outer surface of the shaft 4 and themulti-electrode array 6. Theloading tool 12 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use. Thecatheter 10 may also include a cable assembly 15 (described in greater detail below with reference toFIG. 10A ). -
FIG. 2 is a top plan view of thesheath assembly 30 ofFIG. 1 .Sheath assembly 30 may also be referred to as a vertical dispensing hoop. In this embodiment, thesheath assembly 30 includes a length oftubing 32 arranged in acoil 34 with first and secondtangent portions coil portion 34 has a diameter D1 (e.g., approximately 7.5 inches). Thetubing 32 comprises a hollow member having an outside diameter D2 and an inner diameter D3. In one particular embodiment, D2 is approximately 0.234 inch and D3 is approximately 0.193 inch. In other embodiments, however, the diameter D1, the inner diameter D3, and/or the outer diameter D2 may vary. The inner diameter D3 defines a lumen 40 sized and configured to receive the shaft 4 of the catheter 10 (FIG. 1 ). Thetubing 32 may be formed from a plastic material or another suitable material. In some embodiments, thetubing 32 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, thetubing 32 may be composed of other types of materials and/or have different characteristics. - The first
tangent portion 36 has a length L1 (e.g., approximately 7.5 inches) extending from thecoil portion 34. The firsttangent portion 36 may also include a flared tip 42 to facilitate removal of thesheath assembly 30 from the catheter shaft 4 (FIG. 1 ). The secondtangent portion 38 extends a distance L2 (e.g., approximately 1.7 to 2.0 inches) from thecoil portion 34. In this embodiment, the secondtangent portion 38 extends around a radius of approximately 4 inches. In other embodiments, however, the first and/or secondtangent portions - Referring to
FIGS. 2 and 3 together, thetubing 32 may be retained in the coil configuration by a plurality ofclips 44. Theclips 44, for example, are configured to engage thetubing 32 in a snap fit or press fit arrangement. In the illustrated embodiment, for example, thesheath assembly 30 comprises threeclips 44 disposed approximately equiangularly from each other. More specifically, the outer twoclips 44 are attached to the coiledtubing 32 and spaced apart by an angle A (e.g., approximately 145 degrees). Acenter clip 44 is disposed between the outer clips 44 (e.g., at an angle of approximately 72.5 degrees). It will be appreciated, however, that while thesheath assembly 30 includes one coil and multiple clips separated by particular angles, in other embodiments thesheath assembly 30 may have multiple coils, a different number ofclips 44, and/or a different arrangement ofclips 44. - As best seen in
FIG. 3 , theclips 44 can include a pair ofgrooves 46 sized and configured to grasp thetubing 32. Aninner surface 48 of eachgroove 46 may include serrations to enhance the grip ontubing 32. Although theclips 44 in the illustrated embodiment comprise two grooves to accommodate a single coil, it will be appreciated that theclips 44 may be configured with additional grooves to retain multiple coils in a coiled configuration. Theclips 44 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 container 20 ofFIG. 1 in an open arrangement, andFIGS. 5-7 are additional views of thecatheter container 20. Referring toFIGS. 4-7 together (and with reference to thecatheter 10 ofFIG. 1 ), thecatheter container 20 includes atray 50 and amating lid 80. Thetray 50 includes acatheter channel 52 sized and configured to receive acatheter 10 therein. Thechannel 52 also includes apocket 54 sized to receive themulti-electrode array 6 of thecatheter 10. In the illustrated embodiment, for example, thepocket 54 is large enough to accommodate the delicatemulti-electrode array 6 without the inner surface of the pocket making contact. Thetray 50 also includes ahandle pocket 56 configured to receive thehandle 2 of thecatheter 10. In the illustrated embodiment, thehandle pocket 56 can also include a plurality ofprotrusions 60 arranged around a perimeter of thepocket 56 and positioned to releasably retain thehandle 2 within thepocket 56. Theprotrusions 60, for example, may be formed into the material of thetray 50 and provide a snap fit or press fit arrangement for thehandle 2. - The
catheter channel 52 can also include acoil groove 55 sized and configured to receive the sheath assembly 30 (FIGS. 1 and 2 ). A plurality ofprotrusions 62 may be arranged about thecoil groove 55 and positioned to engage thesheath assembly 30 to removably retain the sheath assembly within thecatheter container 20. In this embodiment, for example, theprotrusions 62 are disposed on an outer diameter of thegroove 55. A plurality ofpositioners 64 may be positioned on an inside diameter of thegroove 55 and configured to cooperate with theprotrusions 62 to locate thesheath assembly 30 around thegroove 55. Further, opposite eachpositioner 64 is arelief 66 positioned to facilitate installation of thesheath assembly 30 into thetray 50. Thetray 50 can also include awire path 68 configured to receive the cable assembly 15 (FIG. 10A ) therealong and acable assembly cavity 58 located in or at least proximate to the middle of thecoil groove 55 as shown. Thecable path 68 can include a plurality ofnubs 70 positioned to cooperate to grasp the cable assembly 15 (FIG. 10A ). - The
lid 80 of thecatheter container 20 is configured to mate with thetray 50 to provide an enclosed container for at least a portion of the catheter 10 (FIG. 1 ). In the illustrated embodiment, for example, thelid 80 is constructed to cover only the sheath assembly 30 (and the shaft 4 contained therein) and themulti-electrode array 6. Accordingly, thelid 80 includes achannel cover portion 82 with an associatedconcave pocket cover 84. It will be appreciated from the arrangement illustrated inFIGS. 4-7 thatchannel cover 82 and pocket cover 84 correspond to channel 52 andpocket 54, respectively, of thetray 50. Thus, when installed, thelid 80 is positioned to cover the sensitive and delicate portions of the catheter 10 (FIG. 1 ). In some embodiments, thelid 80 can include a plurality ofreliefs 96 that correspond to protrusions 62. - The
reliefs 96 provide clearance forprotrusions 62 when thelid 80 is mated with thetray 50. Similarly, thelid 80 can include a plurality ofnotches 94 that correspond to thepositioners 64. Thenotches 94 andpositioners 64 may act in cooperation to index thelid 80 in the proper rotational position relative to thetray 50. In addition, thelid 80 may include abutton 86 positioned to be inserted into amating socket 72 located on thetray 50. Thebutton 86 andsocket 72 cooperatively provide additional indexing and location control forchannel cover 82 andpocket cover 84. Furthermore, thebutton 86 may be configured to provide a friction fit when installed into thesocket 72. In other embodiments, thelid 80 may include other features and/or have a different arrangement. - The
lid 80 may be retained on thetray 50 by alatch feature 90. In this embodiment, for example, thelatch feature 90 comprises a circular male feature including an undercutwall 92. Themale latch feature 90 engages acorresponding latch feature 74 formed in thetray 50. In this embodiment, thelatch feature 74 comprises a circular female feature that also includes an undercut wall. Cooperative latch features 90 and 74 may be snapped or pressed together to mate thelid 80 with thetray 50. Thelid 80 may also include atab 88 that extends over thepocket 56, thereby providing access to the edge oflid 80 to facilitate removal of thelid 80. In other embodiments, the latch features 74 and 90 may have a different configuration and/or thelid 80 may include a different number of latch features. - In the illustrated embodiment, the
catheter container 20 is thermoformed as a single part. As shown inFIG. 4 , however, the thermoformed components may optionally include aperforated seam 77 between thelid 80 and thetray 50 to facilitate separation of the two components. It should also be noted that theperforated seam 77 may be recessed help prevent any burrs or protrusions from contacting the pouch or sterile bag 312 (seeFIG. 25B ) in which the container is stored. In addition, the perimeter of thetray 50 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, thelid 80 andtray 50 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 container 20 may be composed of polyethylene terephthalate glycol (PETG). In other embodiments, however, thecatheter container 20 may be composed of other suitable materials (e.g., High Impact PolyStyrene (HIPS), HDPE, or the like). - Referring to
FIGS. 1 and 4 together, now that various features of embodiments of thecatheter packaging assembly 5 have been described, installation of thecatheter 10 into thecatheter packaging assembly 5 in accordance with one embodiment of the present technology may be appreciated. First, theinsertion tool 12 is installed on the catheter shaft 4 and located nearhandle 2 at the proximal end portion 7 of the shaft 4. The shaft 4 may then be threaded through thesheath assembly 30. Once the shaft 4 of thecatheter 10 has been disposed in thesheath assembly 30, thesheath assembly 30 may be snapped into thecoil groove 55 and retained therein in the desired orientation by theprotrusions 62 andpositioners 64. - Meanwhile, the
handle 2 can be positioned in thepocket 56 and retained therein by theprotrusions 60. Thecable assembly 15 may be installed into thecable pathway 68 and retained therein by thenubs 70. The associated components of thecable assembly 15, such as the cable and connector, may also be positioned in thecable cavity 58. Thelid 80 may be removed from thetray portion 50 and positioned over thecoil groove 55 as well as thecatheter channel 52 and thepocket 54. In an another embodiment, thelid 80 may be hingedly rotated about a living hinge and positioned over thecoil groove 55 as well as thecatheter channel 52 and thepocket 54.Reliefs 96 andnotches 94 can be aligned with theprotrusions 62 andpositioners 64, respectively. Finally, thecooperative latch feature 90 may be snapped into the associatedfemale feature 74 of thetray 50, and thebutton 86 may be engaged with thesocket 72 such that thelid 80 covers the most sensitive/delicate portions of thecatheter 10. Thecatheter packaging assembly 5 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. -
FIGS. 8A-9 illustrates acatheter container 220 configured in accordance with another embodiment of the present technology. InFIGS. 8A and 9 , for example, thecatheter container 220 is shown in the open arrangement and includes atray 250 and amating lid 280, whileFIG. 8B illustrates thecatheter container 220 in a closed arrangement. As best seen inFIG. 9 , thelid 280 is sized and configured to only cover a coil portion of a catheter (not shown) carried by thecontainer 220, and does not extend to cover a distal end portion of the catheter. As further seen inFIG. 9 , it will be appreciated that thecatheter container 220 is not configured for use with an additional sheath assembly (such as thesheath assembly 30 described above with reference toFIGS. 1-7 ). In this embodiment, thecable cavity 258 is divided to provide a pocket for thecable assembly 15 as well as other accessories. - In the illustrated embodiment, the catheter shaft 4 is retained in a coiled state by a plurality of
channel protrusions 262. Thecatheter container 220 can be formed withpockets catheter 10 in a coiled configuration as shown inFIGS. 10A and 10B . Light friction features in the form ofprotrusions 262 may be provided that allow thecatheter 10 to be snapped into thepockets catheter 10 from shifting and/or falling out of thepockets - In the embodiment illustrated in
FIGS. 8A-10B , thelid 280 is connected to thetray 250 with a living hinge 277 (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 thelid 280 to thetray 250. 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 thelid 280 can be torn from thetray 250 as a final manufacturing step. Thelid 280 could then be used as a separate piece from thetray 250. In still further embodiments, thecatheter container 220 may have a different arrangement and/or different features. - As best seen in
FIG. 10B , thecatheter 10 can be provided with aloading tool 212. In this arrangement, theloading tool 212 comprises a sliding sleeve carried by thecatheter 10 and configured to slide up and down the length of an outside surface of the catheter shaft 4.Loading tool 212 is used to straighten the distal helical structure for back loading of a guide wire used to straighten the electrode during use. Theloading tool 212 can be positioned near a distal section of thecatheter 10 and held by the friction features of the catheter container to hold the catheter in place. In this arrangement, theloading tool 212 is expected to provide additional support to the distal end portion of thecatheter 10. In another embodiment, an additional, optional feature (e.g.,end stop feature 662 inFIG. 16 ) could be added to thetray 250 that works as a hard stop to prevent theloading tool 212 from inadvertently sliding towards themulti-electrode array 6 of thecatheter 10 and straightening out the spirally-/helically-shaped array during shipping. Because themulti-electrode array 6 may be composed of shape memory material, shipping the catheter with themulti-electrode array 6 in a straightened configuration could alter the array's desired expanded configuration. Accordingly, apocket 254 surrounding themulti-electrode array 6 is formed to be large enough so that thearray 6 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 the
cable assembly 15 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 container 220, 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 container 420 configured in accordance with another embodiment of the present technology. InFIG. 12 , for example, thecatheter container 420 includes atray 450 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 container 420 does not use an additional sheath assembly (such as thesheath assembly 30 described above with reference toFIGS. 1-7 ). Instead, the shaft 4 of thecatheter 10 is retained in a coiled state by at least onecatheter clip 430 and a plurality ofchannel protrusions 462. As best seen inFIG. 13 , for example, thecatheter clip 430 is disposed in amating clip pocket 495 formed intray 450. -
FIG. 14 illustrates a catheter package assembly including acontainer 520 configured in accordance with still another embodiment of the present technology. Thecatheter container 520 includes atray 550 and amating lid 580 similar to the tray and lid described above with respect toFIGS. 5-7 . In this embodiment, however,coil groove 555 does not include any protrusions (such asprotrusions 62 described above with reference toFIGS. 1-7 ). Rather, in this embodiment thesheath assembly 530 is retained in thecatheter container 520 by thelid 580. -
FIGS. 15-23 illustrate acatheter container 620 in accordance with a further embodiment of the present technology. More specifically,FIGS. 15 and 16 show thecatheter container 620 in an open configuration, whileFIGS. 17-23 show thecatheter container 620 in a closed configuration. With reference toFIGS. 15 and 16 , thecatheter container 620 includes atray 650 and amating lid 680. Thetray 650 includes acatheter channel 652 sized and configured to receive thecatheter 10 therein. Further, thechannel 652 includes apocket 654 sized to receive themulti-electrode array 6 of thecatheter 10. Thetray 650 also includes ahandle pocket 656 configured to receive thehandle 2 of thecatheter 10. In the illustrated embodiment, thehandle pocket 656 can also include a plurality ofprotrusions 660 arranged around a perimeter of thepocket 656 and positioned to releasably retain thehandle 2 within thepocket 656. - The
catheter channel 652 can also include acoil groove 655 sized and configured to receive asheath assembly 630. In this embodiment, thesheath assembly 630 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 groove 655 includes a recessedportion 653 and thelid 680 includes a mating recessedportion 657. Thus,sheath assembly 630 is held secure in thecoil groove 655 against thelid 680, except the recessedportions pocket 654, thechannel 652 includes aretainer feature 664 and anend stop feature 662. Thesheath assembly 630 is retained in thechannel 652 against the end stop feature 662 by theretainer feature 664. Accordingly, the end of thesheath assembly 630 is securely located relative to thepocket 654 in order to help prevent the multi-electrode array from touching the inside ofpocket 654 during assembly and shipment. - The
tray 650 can also include awire path 668 configured to receive the cable assembly 15 (FIG. 10A ) therealong and acable assembly cavity 658 located in or at least proximate to the middle of thecoil groove 655 as shown. Thecable path 668 can include a plurality ofnubs 670 positioned to cooperate to grasp the cable assembly 15 (FIG. 10A ). - The
lid 680 of thecatheter container 620 is configured to mate with thetray 650 to provide an enclosed container for at least a portion of thecatheter 10. In the illustrated embodiment, for example, thelid 680 is constructed to cover only thesheath assembly 630 and themulti-electrode array 6. Accordingly, thelid 680 includes achannel cover portion 682 with an associatedconcave pocket cover 684. When installed, thelid 680 is positioned to cover the sensitive and delicate portions of thecatheter 10. Thelid 680 may include abutton 686 positioned to be inserted into amating socket 672 located on thetray 650. Thebutton 686 andsocket 672 cooperatively provide indexing and location control for thechannel cover 682 and thepocket cover 684. Furthermore, thebutton 686 may be configured to provide a friction fit when installed into thesocket 672. In other embodiments, however, thelid 680 may include other features and/or have a different arrangement. - The
lid 680 may be retained on thetray 650 by alatch feature 690. In this embodiment, for example, thelatch feature 690 is a circular male feature that includes an undercutwall 692. Themale latch feature 690 engages a correspondingfemale latch feature 674 formed in thetray 650. In this embodiment, thelatch feature 674 is a circular female feature that also includes an undercut wall. Cooperative latch features 690 and 674 may be snapped or pressed together to mate thelid 680 with thetray 650. In other embodiments, the latch features 674 and 690 may have a different configuration and/or thelid 680 may include a different number of latch features. - 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 box 300 configured in accordance with an embodiment of the present technology shown in a closed and an open configuration, respectively. Thebox 300 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. Thebox 300, for example, can be composed of solid bleached sulfate (SBS) and folded into the desired shape including a hingedlid 305. In other embodiments, thebox 300 may be composed of different materials and/or have a different arrangement. -
FIGS. 25A and 25B illustrate aprotective box 310 configured in accordance with another embodiment of the present technology. As best seen inFIG. 25B , the catheter package assembly may be enclosed in asterile bag 312 and inserted into thebox 310 for shipping.Box 310 includesgussets 318 which are folded inward along perforation lines as the box is closed.Gussets 318 provide added structural support to protect the paperboard box design from corner crushing. Theprotective box 310 can include apocket divider 314 to separate the IFU manual from the sterilebarrier header bag 312, as well as to pingussets 318 outward thus preventing contact between thegussets 318 and thesterile bag 312. Thepocket divider 314 may be supported by a pair ofstanchions 316. - As shown in the flat pattern of
FIG. 26 , thegussets 318 can be modified by creating anindentation bump 320 that helps minimize the sharpened point that would be created once folded. Thegussets 318 are shown as anindentation 320 or bumped in. Alternatively, they could be formed with a bumped out arrangement. In still further embodiments, thebox 310 may have a different arrangement and/or include different features. - 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 example 1 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.
- 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)
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 claim 1 wherein the tray further comprises a handle pocket configured to receive a handle of the catheter.
3. The catheter package assembly of claim 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 of claim 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 of claim 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 claim 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 of claim 5 , further comprising a cable assembly cavity in the coil groove.
9. The catheter package assembly of claim 5 wherein the coiled sheath is secured to itself, thereby retaining the sheath in a coiled configuration.
10. The catheter package assembly of claim 9 wherein the coiled sheath is welded to itself.
11. The catheter package assembly of claim 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 of claim 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 claim 13 further comprising a lid pivotably coupled to the tray.
15. The catheter package assembly of claim 14 wherein the tray and lid each include cooperative latching features.
16. The catheter package assembly of claim 14 wherein the lid includes a pocket cover.
17. The catheter package assembly of claim 13 wherein the tray includes a handle pocket.
18. The catheter package assembly of claim 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 of claim 18 wherein the tray includes a plurality of protrusions positioned to retain the coiled sheath in the tray.
20. The catheter package assembly of claim 13 wherein the tray includes protrusions configured to grasp the sheath and retain the sheath in a coiled configuration.
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Also Published As
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US20150352316A1 (en) | 2015-12-10 |
US10080864B2 (en) | 2018-09-25 |
US20180021542A1 (en) | 2018-01-25 |
US9744333B2 (en) | 2017-08-29 |
WO2014063119A1 (en) | 2014-04-24 |
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