PACKAGING SYSTEM FOR ELONGATED MEDICAL DEVICES - Patent application

Abstract

To stabilize a ureteral stent during transport, minimize damage to the ureteral stent, and prevent deformation of proximal and distal end portions of the ureteral stent.SOLUTION: A packaging system 24 for use with an elongate medical device (ureteral stent) having an elongate shaft extending between a proximal end portion and a distal end portion includes a tray base 26. The tray base 26 includes at least one first post 32 and a second post 40. The first post 32 is disposed outwardly from a planar surface of the tray base 26, and configured to secure one of the proximal and distal end portions of the elongate medical device to the tray base 26. The second post 40 is disposed outwardly from the planar surface of the tray base 26 and at a distance from the first post 32, and configured to secure the other end portion of the elongate medical device to the tray base 26.SELECTED DRAWING: Figure 4

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to U.S. Provisional Patent Application No. 62 / 788,414, filed January 4, 2019, the entirety of which is hereby incorporated by reference in its entirety. [Background technology]

[0002] Ureteral stents are commonly used today. These stents are used during the treatment of urological disorders affecting the urinary tract, including the removal of kidney and ureteral stones, strictures, tumors, and other diseases that may lead to hydronephrosis. Ureteral stents are placed before or after a procedure to provide drainage through the ureter and to prevent the ureter from constricting and causing a blockage. A tether is placed at the proximal end of the ureteral stent and is used to reposition or remove the ureteral stent. Traditionally, ureteral stents are packaged in a pouch along with all other components required to place the stent (e.g., positioner, pigtail straightener). This can have one or more drawbacks, including kinking or tangling of the stent, entangling of the stent and other components, and the tether wrapping around the stent or other components, which provide more opportunities for damage or loss of sterility, making it difficult or impossible for the end user to prepare the stent and components for use in the procedure.

[0003] The present disclosure can be better understood with reference to the following drawings and description. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numbers indicate corresponding parts throughout the different views. [Brief description of the drawings]

[0004] [Figure 1] FIG. 1 illustrates a perspective view of a ureteral stent including tethers, according to certain aspects of the present disclosure. [Diagram 2]FIG. 1 illustrates a perspective view of a positioner according to certain aspects of the present disclosure. [Diagram 3] FIG. 1 illustrates a perspective view of a positioner including an actuator, according to certain aspects of the present disclosure. [Figure 4] FIG. 2 illustrates a top view of a tray base according to certain aspects of the present disclosure. [Diagram 5] FIG. 5 illustrates a perspective view of the tray base of FIG. 4 according to certain embodiments of the present disclosure. [Figure 5A] FIG. 5 illustrates a bottom perspective view of the tray base of FIG. 4 according to certain embodiments of the present disclosure. [Figure 6] FIG. 5 illustrates another perspective view of the tray base of FIG. 4 according to certain embodiments of the present disclosure. [Figure 7] FIG. 2 illustrates a top view of a packaging system including a tray base and a tray cover, according to certain aspects of the present disclosure. [Figure 8] FIG. 3 shows a perspective view of a tray base loaded with a ureteral stent and the positioner of FIG. 2, according to certain aspects of the present disclosure. [Figure 9] FIG. 3 shows a perspective view of a packaging system including a tray base and a tray cover, according to certain embodiments of the present disclosure, where the tray base includes a ureteral stent and the positioner of FIG. 2. [Figure 10] FIG. 5 illustrates a perspective view of the tray base of FIG. 4 loaded with a ureteral stent and the positioner of FIG. 3, according to certain aspects of the present disclosure. [Figure 11] FIG. 2 illustrates a perspective view of a tray base including flaps and protrusions according to certain aspects of the present disclosure. [Figure 12] FIG. 3 shows a perspective view of a tray base including flaps and protrusions loaded with a ureteral stent and the positioner of FIG. 2 according to certain aspects of the present disclosure. [Figure 13] FIG. 2 illustrates a perspective view of another embodiment of a packaging system including a tray base and a tray cover in accordance with certain aspects of the present disclosure. [Figure 14] FIG. 14 illustrates a perspective view of the packaging system of FIG. 13 with a tray base and a tray cover according to certain embodiments of the present disclosure. [Figure 15] FIG. 14 illustrates an enlarged perspective view of the bottom of a portion of the tray base of FIG. 13 in accordance with certain embodiments of the present disclosure. [Figure 16] FIG. 14 illustrates an enlarged perspective view of the top of a portion of the tray base of FIG. 13 in accordance with certain embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0005] Various aspects are described below with reference to the drawings, in which like elements are generally identified by like numerals. The relationships and functions of the various elements of the aspects may be better understood by reference to the detailed description that follows. However, the aspects are not limited to those shown in the drawings or explicitly described below. It should also be understood that the drawings are not necessarily to scale, and in some cases may omit details that are not necessary to understand the aspects disclosed herein, such as conventional materials, structures, and assemblies.

[0006] One general aspect of the disclosure includes a packaging system for use with a ureteral stent having an elongated shaft extending between proximal and distal end portions, the tray base including a first extension disposed outwardly from the plane of the tray base and extending along at least a portion of a length of the tray base; at least one first post disposed outwardly from the plane of the tray base and adjacent the first extension, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from the plane of the tray base and positioned a first distance away from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; and a protrusion disposed outwardly from the plane of the tray base and adjacent the second post, the protrusion configured to secure a tether coupled to the proximal end portion of the ureteral stent to the tray base.

[0007] Another general aspect of the present disclosure includes a packaging system for use with a ureteral stent having an elongated shaft extending between proximal and distal end portions, the tray base including at least one first post disposed outwardly from a plane of the tray base, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from the plane of the tray base and positioned a first distance away from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; and a protrusion disposed outwardly from the plane of the tray base and adjacent the second post, the protrusion configured to secure a tether coupled to the proximal end portion of the ureteral stent to the tray base.

[0008] Another general aspect of the present disclosure includes a packaging system for use with a ureteral stent having an elongate shaft extending between proximal and distal end portions, the tray base including at least one first post disposed outwardly from a plane of the tray base, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from the plane of the tray base and positioned a first distance away from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; and an extension disposed outwardly from the plane of the tray base, the extension including a groove extending along at least a portion of an outer edge of the extension for releasably receiving a tether of the ureteral stent therein.

[0009] Referring to FIG. 1, a ureteral stent 10 is shown that includes an elongate shaft extending between a proximal end portion 14 and a distal end portion 16. Although a ureteral stent 10 is specifically described herein, the packaging system 24 can be successfully implemented for stents for other clinical applications, or other elongate medical devices. For the sake of brevity, a packaging system for a ureteral stent is described in detail herein, and one of ordinary skill in the art will readily understand how the packaging system can be implemented for stents for other clinical applications or other medical devices without undue experimentation upon thorough review of the subject specification and figures. In some embodiments, as shown in FIG. 1, the elongate shaft 12 of the ureteral stent 10 can have a relatively straight configuration, and the proximal and distal end portions 14 and 16 can have a pigtail configuration. In use, the ureteral stent 10 may be positioned in the ureter over a wire guide and using a positioner 18 that includes an elongated tubular body 92 (FIG. 2) or an elongated tubular body 92 (FIG. 3) with an actuator 94 coupled to the elongated tubular body 92. The tether 22 may be coupled to the proximal end portion 14 of the ureteral stent 10, or to a portion of the shaft 12 adjacent the proximal end portion 14. The ureteral stent 10 and positioner 18 may be flexible enough to allow them to be curved for packaging, yet sufficiently elastic or resilient to resume their original shape for the implantation procedure.

[0010] With reference to FIGS. 4-12, a packaging system 24 for use with a ureteral stent 10 and a positioner 18 is shown. The packaging system 24 may include a tray base 26 configured to releasably receive the ureteral stent 10 and the positioner 18 therein. The tray base 26 may be formed from any material suitable for releasably receiving the ureteral stent 10 and the positioner 18. For example, the tray base 26 may be formed from plastic materials such as polyethylene, polycarbonate, polyvinyl chloride, polyurethane, and other suitable materials. The tray base 26 may be made by a plastic thermoforming process. In some embodiments, the tray base 26 may be of a generally rectangular configuration with angled or chamfered corners, as shown in FIGS. 8-12. It will be understood that various configurations of the tray base 26 may be provided as needed and / or desired without departing from the scope of the present invention.

[0011] In some embodiments, as shown in Figures 7 and 9, the packaging system 24 may also include a tray cover 20. The tray cover 20 may be configured to releasably fit onto the tray base 26 such that the ureteral stent 10 and the positioner 18 may be placed between the tray base 26 and the tray cover 20. In some embodiments, the tray cover 20 may snap-fit ​​with the tray base 26. In some embodiments, the tray cover 20 may be connected to the tray base 26 with a hinge (Figure 7) such that the tray cover 20 is secured to the tray base, while in other embodiments (Figures 13, 14) an alternative tray cover 120 may be provided that is a separate component from the tray base 26. This embodiment allows the tray cover 120 to be pulled from the tray base while minimizing the space occupied by the packaging system 24 upon opening. In some embodiments, the packaging system 24 may also include a sealable pouch (not shown). The covered tray with the ureteral stent 10 and the positioner 18 may be placed in the sealable pouch for packaging. It will be appreciated that any material and configuration suitable for packaging, sterilization, and storage may be used for the tray cover and pouch.

[0012] The tray base 26 may include a first extension 28 disposed outwardly from a planar surface 30 of the tray base 26. The first extension 28 may extend along at least a portion of the length of the tray base 26. In some embodiments, as shown, the first extension 28 may have a U-shaped configuration. It will be appreciated that the configuration of the first extension 28 may be varied as desired and / or necessary to accommodate various design needs of the tray base 26. For example, the first extension 28 may be generally rectangular, square, or circular, or any suitable shape that allows at least a portion of the elongated shaft 12 of the ureteral stent 10 to extend around an outer edge 44 of the first extension 28. The tray base 26 may also include at least one first post 32, and as shown, a plurality of first posts 32, configured to releasably secure the distal end portion 16 of the ureteral stent 10 thereto. The tray base 26 may also include a second post 40 disposed outwardly from the plane 30 of the tray base 26 and spaced a first distance 42 from the at least one first post 32. The second post 40 may be configured to releasably secure the proximal end portion 14 of the ureteral stent 10 thereto. In some embodiments, as shown in FIGS. 5 and 8-12, both the first and second posts 32 and 40 may be provided in a cylindrical configuration having a circular cross-section having a similar or slightly smaller diameter than the respective distal and proximal end portions 16 and 14 when the distal and proximal end portions 16 and 14 are disposed in their nominal pigtail-shaped orientation (e.g., the pigtail-shaped distal and proximal end portions 16 and 14 may have an inner diameter ranging from 0.3 inches to 0.7 inches). For example, the inner diameter of the first and second posts 32 and 40 may range from 0.2 inches to 0.7 inches. This allows the pigtail shaped distal and proximal end portions 16 and 14 of the ureteral stent 10 to be positioned around the first and second posts 32 and 40, respectively, such that the distal and proximal end portions 16 and 14 of the ureteral stent 10 can be secured to the tray base 26 while retaining their respective pigtail shapes. Additional configurations of cross-sectional shapes of the first and second posts 32 and 40 are possible, including, but not limited to, oval, square, rectangular, triangular, and combinations thereof.It will be appreciated that the configuration (e.g., shape and size) of the first and second struts 32, 40 can be varied as needed and / or desired to accommodate the configuration of the distal and proximal end portions 16 and 14, respectively, of the ureteral stent 10. This configuration provides the ability to stabilize the ureteral stent 10 during shipping, minimize damage to the ureteral stent 10, and prevent deformation of the proximal and distal end portions 14 and 16 of the ureteral stent 10.

[0013] The plurality of first posts 32 may be disposed adjacent to the first extension 28 outwardly from the plane 30 of the tray base 26. In some embodiments, the plurality of first posts 32 may be disposed along a line 38 extending parallel to at least a portion of the first extension 28. For example, as shown in FIG. 11, the plurality of first posts 32 are disposed along a U-shaped line 38 extending substantially parallel to the U-shaped first extension 28 while being spaced a second distance 36 from the first extension 28. The space above the plane 30 of the tray base 26 between the first extension 28 and the at least one first post 32 (e.g., the plurality of first posts 32 as shown) collectively defines a first valley 34 such that at least a portion of the elongate shaft 12 of the ureteral stent 10 may be releasably received therein (e.g., as shown in FIG. 12). For example, as shown in Figures 8-12, at least a portion of the elongate shaft 12 of the ureteral stent 10 may be releasably snap-attached to the first valley 34 and extends around the outer edge 44 of the first extension 28. It will be appreciated that the configuration of the extension 28, the plurality of first posts 32, and the first valley 34 may be configured to retain the ureteral stent 10 in a desired configuration within the first valley 34 (e.g., the U-shaped configuration shown in Figures 8-12) such that a smaller overall dimension of the tray base 26 may be achieved. In some embodiments, the first extension 28 may include at least one tab 46, and multiple tabs 46 as shown in Figure 11, extending from the outer edge 44 of the first extension 28 to the first valley 34 to facilitate retaining in place the ureteral stent 10 received within the first valley 34. In some embodiments, the at least one tab 46 may extend from the outer edge 44 of the first extension 28 to a void 48 located on the line 38 between two adjacent first posts 32. It will be understood that the configuration, number, spacing, and arrangement of the tabs 46 may be varied as needed and / or desired. In some embodiments, the first extension 28, the at least one first post 32, and the second distance 36 may be configured such that the first valley 34 has a diameter similar to or slightly larger than the outer diameter of the elongate shaft 12 of the ureteral stent 10 (e.g., in the range of 0.4 inches to 0.5 inches).The term "about" is specifically defined herein to include the particular value recited, as well as dimensions within 5% of the dimension both above and below the dimension. This minimizes radial twisting motion of the elongate shaft 12 of the ureteral stent 10 within the first valley 34. It will be appreciated that the configurations (e.g., heights) of the first extension 28 and at least one first post 32, and the length of the second distance 36 can be varied as needed and / or desired to accommodate configurations (e.g., different outer diameters) of the ureteral stent 10.

[0014] The plurality of first pillars 32 may be spaced apart along the line 38. Each of the plurality of first pillars 32 may be disposed at any desired location along the length of the line 38. For example, as shown in FIG. 4, some of the plurality of first pillars 32 may be spaced apart at a substantially uniform distance, while some of the plurality of first pillars 32 may be spaced apart at different distances. The first distance 42 between at least one of the first pillars 32 and the second pillars 40 may be varied to accommodate various lengths of the ureteral stent 10. For example, the first distance 42 may range from about 4 cm to about 40 cm. In some embodiments, when the tray base 26 includes a plurality of first pillars 32 (e.g., as shown in FIG. 4), the first distance 42 between each of the first pillars 32 and the second pillars 40 may be configured to allow proximal and distal end portions 14 and 16 of the ureteral stent 10 having different lengths to be releasably secured to different ones of the second pillars 40 and the first pillars 32. The number of first posts 32 disposed on the tray base 26 can vary as desired and / or needed, and can be any number from 1 to 20, for example. In some embodiments, 15 first posts 32 are provided on the tray base 26. The more first posts 32 disposed on the tray base 26, the more ureteral stents 10 of various lengths can be accommodated. It will be appreciated that the configuration (e.g., overall length) of the first extension 28, the first distance 42, and the number, spacing, and arrangement of the first posts 32 along the line 38 can be varied as needed and / or wanted to accommodate various lengths of the ureteral stents 10. While many suitable configurations and arrangements are contemplated, the configuration and arrangement should be such that the first distance 42 between the second post 40 and at least one of the plurality of first posts 32 allows the proximal and distal end portions of the ureteral stent 10 to be releasably secured to the second post 40 and at least one of the plurality of first posts 32, respectively. Instead of forming tray bases 26 of different configurations, by forming a single tray base 26 having multiple spaced first posts 32 to accommodate ureteral stents 10 of various lengths, waste can be reduced, recyclability can be simplified, manufacturing efficiencies can be increased, and manufacturing costs can be reduced.By spacing the first and second posts 32, 40 apart by a distance corresponding to a particular length of the ureteral stent 10, axial twisting motion of the elongate shaft 12 of the ureteral stent 10 is minimized, thereby reducing potential damage to the ureteral stent 10 during transportation.

[0015] The tray base 26 may include a third extension 50 and a fourth extension 52 disposed outwardly from the plane 30 of the tray base 26 and adjacent to the second post 40. The third and fourth extensions 50 and 52 may extend along at least a portion of the length of the tray base 26. In some embodiments, as shown in FIG. 11, the third and fourth extensions 50 and 52 may extend substantially parallel to one another. The space on the plane 30 of the tray base 26 between the third and fourth extensions 50 and 52 may define a second valley 54 such that at least a portion of the elongate shaft 12 of the ureteral stent 10 may be releasably received therein (e.g., as shown in FIG. 12). In some embodiments, the third and fourth extensions 50 and 52 may be configured such that the second valley 54 is aligned collinearly with at least a portion of the first valley 34. Thus, the ureteral stent 10 may extend through the second valley 54 and the first valley 34 with the proximal end portion 14 and the distal end portion 16 secured to one of the second posts 40 and the first posts 32, respectively. The third and fourth extensions 50 and 52 may provide additional retention force to hold the ureteral stent 10 in place. In some embodiments, as shown in FIG. 11 , the space on the planar surface 30 of the tray base 26 between the first valley 34 and the second valley 54 may define a first notch 58 configured for easy removal of the ureteral stent 10 received within the first and second valleys 34 and 54.

[0016] The tray base 26 may include a first recess 56 configured to releasably receive at least a portion of the elongate shaft 12 of the ureteral stent 10 such that additional retention force may be provided to hold the ureteral stent 10 in place. In some embodiments, the first recess 56 may extend from a first location 60 adjacent the second post 40 to a second location 62 adjacent at least one first post 32 (e.g., as shown in FIG. 11 ). It will be understood that the configuration and length of the first recess 56 may be varied as needed and / or desired to accommodate the configuration and length of the ureteral stent 10 received therein without departing from the scope of the present invention. For example, as shown in FIG. 11 , the first recess 56 may extend through the second valley 54, past the first notch 58, and into at least a portion of the first valley 34. Thus, the elongate shaft 12 of the ureteral stent 10 can be snapped into the first and second valleys 34 and 54 and then into the first recess 56 .

[0017] In some embodiments, as shown in FIGS. 11-12, the tray base 26 may include a protrusion 64 disposed outwardly from the plane 30 of the tray base 26 and adjacent the second post 40. The protrusion 64 may be configured to secure thereto a tether 22 coupled to the proximal end portion 14 of the ureteral stent 10. The protrusion 64 may be positioned such that the tether 22 is wrapped around the protrusion 64 while the proximal end portion 14 of the ureteral stent 10 is disposed around the second post 40. In some embodiments, the protrusion 64 may be provided in a cylindrical configuration having a circular cross-section (e.g., as shown in FIG. 11). Additional configurations of cross-sectional shapes of the protrusion 64 are possible, including, but not limited to, oval, square, rectangular, triangular, and combinations thereof. It will be appreciated that the configuration of the protrusion 64 may be varied as needed and / or desired without departing from the scope of the present invention. In some embodiments, the protrusion 64 may include an undercut 86 at the base of the protrusion 64 to provide the ability to efficiently wrap and secure the tether 22 around the protrusion 64. The undercut 86 is defined by a portion of the protrusion 64 below the top surface of the protrusion 64 that has a smaller circumference or cross-section than the top surface. In some embodiments, the protrusion 64 may be removable from the tray base 26 such that a user may first wrap the tether 22 around the protrusion 64 and then snap the protrusion 64 into the tray base 26.

[0018] The tray base 26 may include a flap 66 hingedly attached at a desired location adjacent the protrusion 64. The flap 66 may include a first groove 70 configured to snap-fit ​​with the protrusion 64. In some embodiments, as shown in FIG. 11, the first groove 70 may be provided with a similar or substantially the same shape as the protrusion 64 while having a slightly larger dimension than the protrusion 64. The flap 66 may be hingedly movable between a third position 72 (e.g., as shown in FIG. 12) and a fourth position 74 (e.g., as shown in FIG. 11). When the flap 66 is moved to the fourth position 74, the flap 66 closes an aperture 68 in the tray base 26 where the flap 66 is held in place by a snap-fit. When the flap 66 is moved to the third position 72, the flap 66 may be secured to the protrusion 64 by a snap-fit ​​with the protrusion 64 with the protrusion 64 received within the first groove 70. This configuration allows the tether 22 wrapped around the prongs 64 to be releasably secured thereto by a snap-fit ​​closure of the flaps 66 and prongs 64 without the need to tightly tie the tether 22 and prongs 64. Thus, the tether 22 may be easily released by lifting the flaps 66. This configuration provides various advantages, such as quick, easy, and simple securement and removal of the tether 22, as well as reducing the chance of damaging the tether 22. The prongs 64 and flaps 66 may also prevent the tether 22 from becoming entangled with the ureteral stent 10 and / or other components packaged therewith, thereby reducing damage to the tether 22 and simplifying the process of preparing the ureteral stent 10 prior to use.

[0019] The tray base 26 may also include a second extension 76 disposed outwardly from the planar surface 30 of the tray base 26. In some embodiments, the second extension 76 may extend along at least a portion of the peripheral portion 78 of the tray base 26. For example, as shown in FIG. 11, the second extension 76 may have a generally U-shape and may extend along three edges of the tray base 26. In some embodiments, at least one first post 32, and as shown, a plurality of first posts 32, may be disposed between at least a portion of the first extension 28 and at least a portion of the second extension 76. The second extension 76 may include a second recess 80 configured to releasably receive the positioner 18 therein (e.g., by a snap fit). It will be appreciated that the configuration of the second extension 76 and the second recess 80 may be varied as needed and / or desired to accommodate positioners 18 of various configurations. For example, the length of the second recess 80 may vary depending on the length of the positioner 18. In some embodiments, as shown in FIG. 12, the positioner 18 may extend substantially the entire length of the second recess 80, thereby minimizing axial twisting motion of the positioner 18 within the second recess 80. The dimensions of the second recess 80 may vary depending on the outer diameter of the positioner 18 such that radial twisting motion of the positioner 18 within the second recess 80 is minimized. In some embodiments, the dimensions of the second recess 80 may vary along the length of the second recess 80 to correspond to different outer diameters along the length of the positioner 18. For example, as shown in FIGS. 4, 7 and 10, a first portion 88 of the second recess 80 is configured to accommodate an elongated tubular body 92 of the positioner 18, and a second portion 90 of the second recess 80 is configured to accommodate an actuator 94 of the positioner 18. In some embodiments, as shown in FIGS. 5 and 8-10, the second recess 80 may include at least one second groove 100 disposed on an inner edge 102 of the second recess 80 for easy removal of the positioner 18 disposed therein.

[0020] 5, the second extension 76 may include at least one second notch 82 configured for easy removal of the positioner 18 received within the second recess 80 and / or to provide a passageway to allow the tether 22 of the ureteral stent 10 to extend from an outer edge 96 of the second extension 76 to the first valley 34. As shown in FIGS. 5-6, the outer edge 96 of the second extension 76 may include a third groove 98 extending along at least a portion of the outer edge 96 of the second extension 76 for releasably receiving at least a portion of the tether 22. In use, as shown in Figures 8-10, when the proximal end portion 14 of the ureteral stent 10 is positioned around the second post 40, the tether 22 coupled to the proximal end portion 14 may extend within the third groove 98, around the outer edge 96 of the second extension portion 76, and through the second notch 82 of the second extension portion 76 into the first valley 34, and then wrapped around the first post 32 around which the distal end portion 16 of the ureteral stent 10 is positioned.

[0021] This configuration allows the tether 22 wrapped around the first post 32 to be releasably secured thereto by the distal end portion 16 of the ureteral stent 10 without the need to tightly tie the tether 22 and the first post 32. At the same time, the tether 22 is further secured to the tray base 26 by the positioner 18 by placing the positioner 18 within the second recess 80 of the second extension 76 and over the portion of the tether 22 extending through the second notch 82, as shown in FIG. 8. Thus, the tether 22 can be easily released by lifting the distal end portion 16 of the ureteral stent 10 and the positioner 18. This configuration provides various advantages, such as quick, easy, and simple fastening and detachment of the tether 22, as well as preventing the tether 22 from becoming entangled around the ureteral stent 10 and / or other co-packaged components, which can reduce damage to the tether 22 and can simplify the process of preparing the ureteral stent 10 prior to use.

[0022] 5 and 5A, the tray base 26 may include multiple recessed cavities 104, 106, and 108. In some embodiments, the recessed cavities 104, 106, and 108 may have the same depth 112 such that the tray base may be laid horizontally and stably on a support 110 (e.g., a table or cart). It will be understood that the number, configuration, orientation, length, depth, and spacing of the recessed cavities may be varied as desired and / or needed, so long as the tray base 26 may be positioned as desired and / or needed.

[0023] In some embodiments, the tray base 26 may include one or more slots 84, which may be used for gripping and holding the tray base 26 for ergonomic reasons. The slots 84 may be provided in a convenient location within the tray base 26, and are typically large enough for a user's fingers to engage the slots 84 (as shown in FIG. 11 ).

[0024] In use, a user may place the positioner 18 on the tray base 26 such that the positioner 18 rests at least partially within the second recess 80. A user may place the ureteral stent 10 on the tray base such that the proximal end 14 of the ureteral stent 10 is disposed about the second post 40, the elongated shaft 12 of the ureteral stent 10 rests at least partially within and extends along at least a portion of the first and second valleys 34 and 54, and the distal end portion 16 of the ureteral stent 10 is disposed about the first post 32. The tether 22 coupled to the proximal end portion 14 of the ureteral stent 10 may then be wrapped around the protrusion 64. The flap 66 may then be folded over and pressed down on top of the tether 22 such that the tether 22 is secured by a snap-fit ​​connection between the flap 66 and the protrusion 64. In some embodiments, the user may first place the tether 22 in the third groove 98 along the outer edge 96 of the second extension 76, wrap the tether 22 around the first post 32, and then place the distal end portion 16 of the ureteral stent 10 around the first post 32 around which the tether 22 is wrapped, and place the positioner 18 in the second recess 80 over the tether 22, such that the tether 22 is secured to the tray base 26 by the positioner 18 and the distal end portion 16 of the ureteral stent 10.

[0025] The tray base 26 may provide security for the components loaded thereon to prevent damage during shipping. A separate snap-fit ​​location within the tray base 26 for each component loaded thereon (e.g., positioner 18, elongate shaft 12, proximal end portion 14, distal end portion 16, and tether 22) provides an organized display to prevent entanglement of the components. In some embodiments, a tray cover may then be snapped into place to cover the tray base 26 and the ureteral stent 10 and positioner 18 loaded thereon. The tray base 26 or the covered tray base may then be packaged in a pouch for sterilization and storage. The pouch is then sealed and sterilized in a conventional manner. Any type of sterilization procedure known to those skilled in the art for sterilizing medical devices may be used. The sterilized tray base 26 and the ureteral stent 10 and positioner 18 loaded thereon may then be stored in the pouch until used in a medical procedure.

[0026] 13-16, further embodiments are provided that modify the embodiments described above. Where structures shown in these figures are not specifically discussed herein, the structures of these embodiments are consistent with those described above. As noted above, in some embodiments, an alternative tray cover 120 may be provided that is a separate component from the tray base 26. This embodiment allows the tray cover 20 to be removed from the tray base while minimizing the space taken up by the packaging system 24 upon opening.

[0027] In the embodiment shown in Figures 13-16, the tray 26 may include a protrusion 250 positioned to receive a portion of the tether 22 extending from the proximal end 16 of the device. The protrusion 250 may be positioned proximate some of the first posts 32, and in some embodiments, may be positioned at or proximate a center point of the collective first posts 32 arranged along a curve as designated by W, where the location of the center point is designated generally by point X. As shown in Figure 13, in this embodiment, the tray 26 may include a raised portion by a first extension 28a, which is at a height less than the height of the first posts 32, and in some embodiments, the height of the protrusion 250 is the same as the height of the first posts 32. The protrusion 250 may include an undercut 252 to receive the tether 22 and align the tether relative to the protrusion 250 for ease of assembly. In some embodiments, the undercut 252 may extend only around about half of the circumference of the protrusion 250, such as in the case of embodiments in which the tether is not wrapped completely around the circumference of the protrusion 250 (FIG. 16, although tether 22 is not shown disposed within the undercut 252 in this figure), while in other embodiments, the undercut 252 may wrap around the entire circumference of the protrusion 250 to align the tether when the tether is configured to wrap completely around the protrusion 250 one or more times.

[0028] 13 and 14, the tray base 26 and tray cover (either the hinged cover 20 or the removable cover 120) may include a space 312 for receiving the free end portion of the tether, typically after the tether has wrapped around the protrusion 250. The free end portion 22a may be bunched within the space 312 (shown diagrammatically in FIG. 14) or may exit through an opening 310 between the base 26 and the tray cover, as shown in FIG.

[0029] In some embodiments, the tray base 26 may have a second valley 156 formed between the third and fourth extensions 152, 154, similar to the third and fourth extensions 52, 54 described above. The second valley 156 is configured to receive, frictionally support, and removably lock the central portion 15 of the stent therein. As best understood with reference to FIGS. 13 and 15, the second valley 156 is configured to receive and hold elongated components of various different sizes (e.g., different diameters or cross-sections), such as stents, positioners, expanders, or other tubular components having central portions of different diameters, or to hold two separate components in a stacked orientation, as shown in FIG. 13, for example. In some embodiments, one or both of the third and fourth extensions 152, 154 may include two sets of locking features located at different heights. The first set of locking features 156b may be disposed proximate the floor of the tray 26 and configured to hold devices that are a first size (e.g., diameter or cross-sectional area) (such as the central portion 15 disposed relative to the first set of locking features 156a). The second set of locking features 156a may be disposed along a plane that is further from the floor of the tray 26 than a plane passing through the first set of locking features 156b and configured to hold devices having a second size that is larger than the first size (associated with the device held by the first set of locking features 156b). As shown in Figure 13, the central portion 15 has a smaller size than the tube 15a which is aligned with the second set of locking features 156a which in this embodiment are located on both the third and fourth extensions. Figure 15 is a bottom perspective view showing the smaller central portion 15 aligned with the first set of locking features 156b (shown on the fourth extension in this view, but the third extension's locking features 156b could be similar) and the larger tube 15a aligned with the second set of locking features 156b.In embodiments in which locking features 156a, 156b extend from both the third and fourth extensions 152, 154, each locking feature may be positioned in the same relative position on the opposite extension and contact the retained device at the same longitudinal position, or they may be offset and contact the retained device at different positions from the opposite side.

[0030] This specification can be readily understood by reference to the following numbered paragraphs: Numbered paragraph 1: A packaging system for use with a ureteral stent including an elongate shaft extending between a proximal end portion and a distal end portion, A tray base is included, a first extension disposed outwardly from a plane of the tray base and extending along at least a portion of the length of the tray base; at least one first post disposed outwardly from a plane of the tray base and adjacent to the first extension, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from a plane of the tray base and disposed a first distance away from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; a protrusion disposed outwardly from the plane of the tray base and adjacent to the second post, the protrusion configured to secure a tether coupled to a proximal end portion of the ureteral stent to the tray base; A packaging system comprising:

[0031] Numbered paragraph 2: A packaging system as described in numbered paragraph 1, wherein the tray base further includes a plurality of first posts arranged along a line extending parallel to at least a portion of the first extension portion.

[0032] Numbered paragraph 3: A packaging system as described in numbered paragraph 1, wherein a space in a plane of the tray base between the first extension portion and the at least one first pillar collectively defines a first valley, the first valley being configured to receive at least a portion of an elongated shaft of a ureteral stent.

[0033] Numbered paragraph 4: A packaging system as described in numbered paragraph 1, wherein the first extension portion has a U-shape.

[0034] Numbered paragraph 5: A packaging system as described in numbered paragraph 1, wherein the protrusion comprises an undercut structure.

[0035] Numbered paragraph 6: The packaging system described in numbered paragraph 1, wherein the tray base further includes a flap hingedly attached to the planar surface of the tray base, the flap being positioned adjacent to the protrusion and configured to fit over the protrusion.

[0036] Numbered paragraph 7: A packaging system as described in numbered paragraph 1, further comprising a tray cover configured to fit over the tray base with the ureteral stent loaded into the tray base.

[0037] Numbered paragraph 8: The packaging system described in numbered paragraph 1, further comprising a tray base and a pouch configured to receive a ureteral stent loaded thereon.

[0038] Numbered paragraph 9: A packaging system as described in numbered paragraph 1, wherein the tray base further includes a second extension portion disposed outwardly from a plane of the tray base and extending along at least a portion of a peripheral portion of the tray base, the second extension portion including a second recess configured to receive a positioner.

[0039] Numbered paragraph 10: A packaging system as described in numbered paragraph 1, wherein the first distance is in the range of about 4 cm to about 40 cm.

[0040] Numbered paragraph 11: The packaging system described in numbered paragraph 1, further comprising a third extension portion and a fourth extension portion disposed outwardly from the plane of the tray base and adjacent to the second pillar, the third extension portion and the fourth extension portion defining a second valley therebetween in the plane of the tray base.

[0041] Numbered paragraph 12: The packaging system of numbered paragraph 1, further comprising a first recess extending between the second post and the at least one first post.

[0042] Numbered paragraph 13: The packaging system described in numbered paragraph 1, further comprising a plurality of concave cavities configured to enable the tray base to be positioned horizontally and stably on the support.

[0043] Numbered paragraph 14: A packaging system as described in numbered paragraph 2, wherein the plurality of first posts are spaced apart along a line extending parallel to at least a portion of the first extension.

[0044] Numbered paragraph 15: A packaging system described in numbered paragraph 9, wherein at least one first post is disposed between at least a portion of the first extension and at least a portion of the second extension.

[0045] Numbered paragraph 16: A packaging system as described in numbered paragraph 9, wherein the second extension portion further includes a second notch configured to allow for easy removal of a positioner received within the second recess.

[0046] Numbered paragraph 17: A packaging system as described in numbered paragraph 11, wherein a space in a planar surface of the tray base between the first valley and the second valley defines a first notch configured to facilitate removal of a ureteral stent received within the first recess.

[0047] Numbered paragraph 18: A packaging system for use with a ureteral stent including an elongate shaft extending between a proximal end portion and a distal end portion, The tray base includes: at least one first post disposed outwardly from a plane of the tray base, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from a plane of the tray base and disposed a first distance away from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; a protrusion disposed outwardly from the plane of the tray base and adjacent to the second post, the protrusion configured to secure a tether coupled to a proximal end portion of the ureteral stent to the tray base; A packaging system comprising:

[0048] Numbered paragraph 19: A packaging system according to numbered paragraph 18, wherein the tray base further comprises a flap hingedly attached to the planar surface of the tray base, the flap being configured to fit over the protrusion.

[0049] Numbered paragraph 20: A packaging system as described in numbered paragraph 18, wherein the tray base further includes a plurality of first posts spaced apart on the plane of the tray base to accommodate ureteral stents of various lengths.

[0050] Numbered paragraph 21: A packaging system described in numbered paragraph 18, wherein the tray base further includes a first recess configured to receive at least a portion of the elongate shaft of a ureteral stent.

[0051] Numbered paragraph 22: A packaging system as described in numbered paragraph 18, further comprising a plurality of concave cavities configured to enable the tray base to be positioned horizontally and stably on the support.

[0052] Numbered paragraph 23: A packaging system for use with a ureteral stent including an elongate shaft extending between a proximal end portion and a distal end portion, A tray base is included, at least one first post disposed outwardly from a plane of the tray base, the at least one first post configured to secure a distal end portion of the ureteral stent to the tray base; a second post disposed outwardly from a plane of the tray base and spaced a first distance from the at least one first post, the second post configured to secure a proximal end portion of the ureteral stent to the tray base; an extension disposed outwardly from the plane of the tray base, the extension including a groove extending along at least a portion of an outer edge of the extension for releasably receiving a tether of a ureteral stent therein; A packaging system comprising:

[0053] Numbered paragraph 24: A packaging system described in numbered paragraph 23, wherein the extension portion includes a notch configured to provide a passage for a tether of a ureteral stent to pass therethrough, such that a tether extending along an outer edge of the extension portion is wrapped around at least one first post.

[0054] Numbered paragraph 25: A packaging system as described in numbered paragraph 23, further comprising a plurality of concave cavities configured to enable the tray base to be positioned horizontally and stably on the support.

[0055] Although various embodiments of the present disclosure have been described, the present disclosure should not be limited except in light of the appended claims and their equivalents. Those skilled in the art will recognize that numerous variations and modifications can be made to the above-described embodiments without departing from the scope of the present invention as defined by the appended claims. Furthermore, although some advantages are described herein, the advantages of the present disclosure are not necessarily limited thereto, and it is not necessarily expected that all embodiments of the present disclosure will achieve all the advantages described.

Claims

1. 1. A packaging system for use with a ureteral stent including an elongate shaft extending between a proximal end portion and a distal end portion, comprising: a tray base, the tray base comprising: a plurality of first posts disposed outwardly relative to a plane of the tray base, each first post configured to wrap one of a proximal end portion and a distal end portion of a ureteral stent therearound to secure the ureteral stent to the tray base; a second post disposed outwardly relative to the plane of the tray base, the second post being configured to wrap the other of the proximal and distal end portions of the ureteral stent therearound to secure the ureteral stent to the tray base; a protrusion disposed outwardly relative to the plane of the tray base, the protrusion being configured to wrap a tether coupled to a proximal or distal end portion of a ureteral stent therearound to secure the stent to the tray base; A packaging system comprising:

2. The packaging system of claim 1 , wherein the plurality of first posts are spaced on the tray base to accommodate ureteral stents of various lengths.

3. The packaging system of claim 2 , wherein the protrusion comprises an undercut structure.

4. The packaging system of claim 1, further comprising a tray cover configured to be attached to the tray base while loaded onto the ureteral stent.

5. The packaging system of claim 4, wherein when the tray cover is placed on the tray base, a space is formed therebetween, the space being configured to receive a free end portion of a tether coupled to a proximal or distal end portion of a ureteral stent on the tray base.

6. The packaging system of claim 4, wherein when the tray cover is placed on the tray base, an opening is formed therebetween, the opening being configured to allow a free end portion of a tether coupled to a proximal or distal end portion of a ureteral stent on the tray base to exit through the opening.

7. 2. The packaging system of claim 1, wherein the tray base further includes a pair of extensions disposed outwardly relative to the plane of the tray base, the pair of extensions defining a valley therebetween, the valley adapted to receive and frictionally support an elongated component of a ureteral stent therein.

8. The packaging system of claim 7 , wherein the valley is disposed between the second pillar and at least one of the plurality of first pillars.

9. The packaging system of claim 7 , wherein the valleys are configured to receive and frictionally support different sized elongated components of a ureteral stent therein.

10. 8. The packaging system of claim 7, wherein one or both of the pair of extensions includes first and second pairs of locking features disposed at different heights above the plane of the tray base, the first and second pairs of locking features adapted to retain elongated components of a ureteral stent.

11. The packaging system of claim 10 , wherein the first pair of locking features are positioned closer to the plane of the tray base than the second pair of locking features.

12. 11. The packaging system of claim 10, wherein the first pair of locking features is configured to receive an elongated component having a first size and the second pair of locking features is configured to receive an elongated component having a second size.

13. The packaging system of claim 12 , wherein the first size is smaller than the second size.

14. Further comprising a ureteral stent, one of the proximal and distal end portions of the ureteral stent is wrapped around and fixed to one of the first plurality of posts; The packaging system of claim 1 , wherein the other of the proximal and distal end portions of the ureteral stent is wrapped around and fixed to the second post.

15. The packaging system of claim 10 , wherein the first and second pairs of locking features extend from one or both of the pair of extensions.

16. The packaging system of claim 1 , wherein at least one of the plurality of first posts and the protrusion are disposed in different planes.

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