Packaging for Medical Devices

Abstract

A package assembly for transporting a medical device is disclosed. The package assembly includes an outer cartridge and an inner cartridge. The inner cartridge receives the outer cartridge of the package assembly. The inner cartridge extends beyond the outer cartridge. The medical device is disposed within the inner cartridge so as to engage with the inner cartridge.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS The present application, International applications filed on January 14, 2021 Claims the benefit of U.S. Provisional Application No. 62 / 960,767, filed January 14, 2020 This is a national phase application of the international application PCT / US21 / 13497. The above application each No. 6,399,633, the entire disclosure of which is incorporated by reference into the present disclosure.

[0002] Field The present invention relates generally to packaging for medical devices, and more particularly to containers configured to secure a variety of medical devices having similar or common geometries within a single container for sterile transport. [Background technology]

[0003] 2. Background of the Invention As is commonly known, medical devices, such as those used for implantation or use in a patient, must be sterilized, intact, or otherwise compromised before implantation or use in a patient. In particular, medical devices are transported from manufacturers, distributors, medical facilities, and / or areas that may or may not be sterilized to facilities or spaces where sterilization is required. Thus, packaging is used to transport the medical device to a sterile atmosphere.

[0004] However, some packages for medical devices may make the devices unstable or unable to support them during shipping, in which case the medical devices may move around undesirably in the package and be damaged. This is often due to the fact that medical devices are customizable to the patient and the patient's needs. Thus, some types of packaging may not be suitable or accommodate all medical devices to deliver them in a sterile state without damage. Often, a certain type of packaging is used to accommodate many devices, even though the devices have different sizes, contours, and geometric shapes, resulting in some medical devices not being fixed in the package, as the devices may move around in the package. Alternatively, in other examples, a package may be used for all different types of medical devices, which may be very costly.

[0005] Additionally, the focus on facilitating removal or withdrawal of devices in an ergonomic, sterile, and efficient manner is becoming increasingly desirable. Thus, a sealed package that allows its contents to be removed or withdrawn and safely delivered to a sterile zone is desirable. Additionally, it is desirable to store medical devices safely and organized within the packaging.

[0006] It is therefore desirable to have a rigid, sterile medical device package capable of securing multiple related or similar medical devices having a common geometric shape within the same holder, thereby minimizing the costs of manufacturing custom packing. Summary of the Invention

[0007] Summary of the Invention In accordance with the present invention, a rigid, sterile medical device package has surprisingly been discovered that is capable of securing related or similar medical devices having a common geometry in the same holder that minimizes costs in manufacturing custom packing.

[0008] In a first embodiment of the present disclosure, a package assembly for transporting a medical device is disclosed. The package assembly includes an outer cartridge and an inner cartridge. The inner cartridge receives the outer cartridge of the package assembly. The inner cartridge extends beyond the outer cartridge. The medical device is disposed within the inner cartridge so as to engage with the inner cartridge.

[0009] In another embodiment of the present disclosure, a packaging assembly for shipping a medical device is disclosed. The assembly includes an outer cartridge and an inner cartridge that receives the outer cartridge. The inner cartridge extends beyond the outer cartridge. The medical device is disposed within the inner cartridge, the medical device extending beyond the inner cartridge.

[0010] In yet another embodiment of the present disclosure, a packaging assembly for shipping a medical device is disclosed, the assembly includes an outer cartridge including a cap and a body, and an inner cartridge that receives the outer cartridge, the inner cartridge extending beyond the outer cartridge, the inner cartridge including a cap and a body, the medical device being disposed within the inner cartridge, the medical device extending beyond the inner cartridge.

[0011] BRIEF DESCRIPTION OF THE DRAWINGS The above and other features and objects of the present invention, as well as the manner in which they are accomplished, will become more apparent, and the invention itself will be better understood, by reference to the following description of an embodiment of the invention taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is an exploded perspective view of a package assembly according to the present invention.

[0013] [Diagram 2] FIG. 2 is a cross-sectional front view of the packaging assembly of FIG. 1 with a medical device illustrated.

[0014] [Figure 3-5] 3-5 show top perspective views of various embodiments of medical devices that can be inserted into the packaging assembly of FIGS. 1-2.

[0015] [Figure 6] FIG. 6 is an exploded cross-sectional perspective view of a package assembly according to another embodiment of the present disclosure.

[0016] [Figure 7] FIG. 7 is an assembled cross-sectional front view of the package assembly of FIG.

[0017] [Figure 8] FIG. 8 is an exploded perspective view of a package assembly according to another embodiment of the present disclosure.

[0018] [Figure 9] FIG. 9 is a cross-sectional front view of the package assembly of FIG.

[0019] [Figure 10] FIG. 10 illustrates a pair of package assemblies according to another embodiment of the present disclosure, the pair of package assemblies being shown in a side-by-side position.

[0020] [Figure 11] FIG. 11 illustrates the pair of package assemblies of FIG. 10, shown in a stacked position.

[0021] [Figure 12]FIG. 12 illustrates a top view of a sleeve for a package assembly according to another embodiment of the present disclosure.

[0022] [Figure 13] FIG. 13 illustrates a perspective view of a sleeve for receiving a medical device and inserted into a packaging assembly according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Description of the Preferred Embodiments The following detailed description and the accompanying drawings describe and illustrate various exemplary embodiments of the invention. The description and drawings serve to enable one of ordinary skill in the art to make and use the invention, and are not intended to limit the scope of the invention in any manner. With respect to the disclosed methods, the steps presented are exemplary in nature, and thus, the order of the steps is not necessary or critical.

[0024] As used in this disclosure, "a" and "an" indicate the presence of at least one of an item, and where possible, there may be more than one of such items. Spatially relative terms, such as "front," "back," "inside," "outside," "bottom," "top," "horizontal," "vertical," "higher," "lower," "side," "above," "below," "below," and the like, may be used in this disclosure to facilitate describing the relationship of an element or feature to other element(s) or feature(s) as shown in the figures. Spatially relative terms may be intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures.

[0025] As used in this disclosure, substantially is defined as "to a great extent" or "approximately" or as understood by one of ordinary skill in the art. In describing the broadest scope of the present technology, all numerical values ​​in this disclosure should be understood as modified by the word "about", and all geometric and spatial descriptors should be understood as modified by the word "substantially", unless otherwise expressly indicated. "About", when applied to numerical values, indicates that the calculation or measurement allows for slight imprecision in the value (with some approach to the precision of the value; approximately, or reasonably close to the value; approximately). If for any reason the imprecision provided by "about" and / or "substantially" is not understood to its ordinary meaning in the art, then "about" and / or "substantially" as used in this disclosure at least contemplates the variation that may result from ordinary methods of measuring or using such parameters. In the event of any conflict or ambiguity between documents incorporated by reference and this detailed description, this detailed description will control. In the present disclosure, "first", "second", "third", etc. may be used to describe various elements, components, regions, layers, and / or portions, but these elements, components, regions, layers, and / or portions should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or portion from another region, layer, or portion. Terms such as "first", "second", and other numerical terms, when used in the present disclosure, do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer, or portion described below may be referred to as a second element, component, region, layer, or portion without departing from the teachings of the exemplary embodiments.

[0026] The present invention relates to a package for transporting medical devices to a sterile work zone, such as an operating room area. Examples of medical devices are given throughout the disclosure. For example, medical devices can refer to screws, implants, etc., of various sizes or shapes. However, it is understood that the package may be used to transport any other device for any other application. Furthermore, in this application, the term "family" is used, which is meant to refer to devices that are used together on a patient or used at the same time or in the same operating time or operating room. The term "family" may also refer to various medical devices of various sizes and shapes that have at least one common geometric shape that the package can adapt to transport without customizing a new package.

[0027] 1-2 show a packaging assembly 10 according to one embodiment of the present disclosure. The packaging assembly 10 is configured to transport a medical device 12, which is described below. 10 includes an outer cartridge 14 , an inner cartridge 16 , and a device 12 .

[0028] The outer cartridge 14 includes a cap 18 and a main housing 20 that threadably mate with one another. The cap 18 of the outer cartridge 14 includes threads 22 disposed on an inner surface thereof. The main housing 20 of the outer cartridge 14 includes threads 24 disposed on an outer surface thereof. The threads 24 of the main housing 20 are threaded to the cap 18. 18 The cap 18 and main housing 20 cooperate to define an interior chamber 26 of the outer cartridge 14. In the illustrated embodiment, the outer cartridge 14 includes a screw thread 24 that engages with and receives the screw threads 24 of the cap 18 and main housing 20. 4The outer cartridge 14 is substantially cylindrical in shape. However, it is understood that the outer cartridge 14 may be any shape desired, such as a cube, a sphere, a polygonal cross section, an oval cross section, a pyramid, or any shape or combination of shapes desired. Disposed between the shoulder 36 and the end of the cap 18 is an outer cartridge seal 34 configured as an annular resilient seal, such as an O-ring. It is understood that the seal 34 may be configured as a metal seal or a plastic seal or any other seal desired.

[0029] The cap 18 of the outer cartridge 14 includes a plurality of gripping features 38. As shown, the gripping features 38 are a plurality of recesses formed in the outer surface of the cap 18. However, the gripping features 38 may be ridges, finger grips, or any other gripping type features as desired.

[0030] The inner cartridge 16 includes a cap 58 having threads 68 formed on an inner surface thereof and a body 62 having threads 66 formed on an outer surface thereof. 8 4. The threads 66 of the body 62 engage with each other.

[0031] The body 62 includes a threaded portion 4 that includes a thread 66 of the cartridge 16 inside the body 62. 1 and a receiving portion 42 for receiving the medical device 12. The receiving portion 42 is a tube having a threaded portion 4 1 The receiving portion 42 has an inner diameter smaller than the inner diameter of the receiving portion 42. The receiving portion 42 is substantially cylindrical; however, other shapes may be employed as desired. The difference in diameter facilitates stable placement of the medical device 12. A resilient seal, such as an annular elastomeric seal, such as an O-ring, may be provided between the shoulder 80 and the end of the cap 58. Inside A side cartridge seal 78 is disposed. Seal 78 It will be appreciated that the may be configured as a metal seal or a plastic seal or any other seal desired.

[0032] The stabilizer 48 is received through an opening in the threaded portion 41. Teo 1, the inner surface 44 of the threaded portion 41 of the inner cartridge 16 includes a shoulder 46 for resting the stabilizer 48. The stabilizer 48 is annular and has a first end 50 for receiving the medical device 12 and a second end 52 for carrying the medical device 12 into the receiving portion 42 of the inner cartridge 16. The stabilizer 48 includes an inner opening 54 extending therethrough for its length. The inner diameter of the stabilizer 48 at the first end 50 is larger than the inner diameter of the stabilizer 48 at its intermediate portion 56. The cross-sectional shape of the stabilizer 48 at the first end has a frusto-conical portion 72 configured to receive the medical device 12, such as the head 74 of a screw, and the remainder of the inner opening 54 of the stabilizer 48 is for receiving the stem 76 of the elongated portion of the medical device 12. The diameter of the frusto-conical portion 72 increases continuously from adjacent the intermediate portion 56 to the first end 52 of the stabilizer 48. As a result, the head 74 of the medical device 12 is stabilized and supported.

[0033] 2, the body 62 of the inner cartridge 16 extends beyond the main housing 20 of the outer cartridge 14. As shown, the threads of the inner cartridge 16 66 2, which extend beyond the threads 24 of the outer cartridge 14 in a direction along the length of the outer cartridge 14 toward the cap 18 of the outer cartridge 14. The threads of the inner cartridge 16 extending beyond the threads 24 of the outer cartridge 14 66 The stabilizer 48 is advantageous for gripping and receiving the inner cartridge 16 in a sterile setting. 1 4 and extends beyond toward the cap 58 of the inner cartridge 16 .

[0034] The cap 58 of the inner cartridge 16 includes a plurality of gripping features 60. As shown, the gripping features 60 are a plurality of recesses formed in the outer surface of the cap 58. However, the gripping features 60 may be ridges, finger grips, or any other gripping type feature as desired. Threads 68 of the cap 58 engage with threads 66 on the body 62.

[0035] In the application, the inner cartridge 16 is inserted into the outer cartridge 1 4 1. The inner cartridge 16 remains sterile. The cap 58 of the inner cartridge 16 is removed in a sterile environment. Because the stabilizer 48 extends outwardly from the inner cartridge 16, it can be easily removed along with the medical device 12.

[0036] 3-5 show various types of medical devices 12. In this embodiment, each medical device 12 is configured as a screw with a head 74 and a stem 76. However, the medical devices 12 may be any medical device configured with a head and stem as desired and capable of being packaged and shipped within the packaging assembly 10. Each of the illustrated medical devices 12 has a common geometric shape of a head 74 and a stem 76. Thus, even though the lengths and thread designs of the medical devices 12 may differ, each of the illustrated medical devices may be used in the same manner as in the embodiment shown. 1 -figure 2 Package Assembly 10 Advantageously, there is no need to manufacture separate package geometries for each different medical device.

[0037] 6-7 illustrate a package assembly 110 according to another embodiment of the present disclosure. The package assembly 110 of FIGS. 6-7 includes features similar to those of the package assembly 10 of FIGS. 1-2. Features of the package assembly 110 that are similar to those of the package assembly 10 of FIGS. 1-2 are indicated with the same reference numbers, but with a leading "1" for convenience. The package assembly 110 is similar to the package assembly 10 of FIGS. 1-2, except that the stabilizer 148 is different. The package assembly 110 includes ,blood julip 、 It is configured for medical devices having screws and set screws.

[0038] The stabilizer 148 of FIGS. 6-7 is configured as a cap insert. The stabilizer 148 is cylindrical and includes a closed end 190 and an open end 191. An opening 192 extends inwardly through the stabilizer 148 from the open end 191 of the stabilizer 148. The diameter of the opening 192 adjacent the open end 191 is larger than the diameter of the interior portion of the stabilizer. The opening 192 adjacent the open end 191 is configured to receive a medical device 112, such as a set screw or locking screw. The stabilizer 148 is configured to have an outer contour that substantially fills the inner contour of the cap 158 of the inner cartridge 116. The open end 191 has a pair of notches 193 formed therein to facilitate removal of the medical device 112 disposed therein.

[0039] To assemble, a first portion of the medical device 112 is received within the inner cartridge 116. As shown, the inner cartridge 116 has an inner contour for receiving the medical device 112. The stabilizer 148 is adapted to engage a first portion of the medical device 112, such as a set screw. 31 into its open end 191. The stabilizer 148 is then positioned to engage a first portion of the medical device 112. The cap 158 of the inner cartridge 116 is then screwed onto the body 162 to secure the stabilizer 148 and medical device 112 therein. The inner cartridge 116 is then secured within the outer cartridge 114. Once assembled, the packaging assembly 110 can then be transported to a desired location and disassembled in a sterile environment.

[0040] Figures 8-9 show a package assembly 210 according to another embodiment of the present disclosure. The package assembly 210 of Figures 8-9 includes features similar to those of the package assemblies 10, 110 of Figures 1-2 and 6-7. Features of the package assembly 210 that are similar to features of the package assembly 10 of Figures 1-2 are numbered with the same reference numerals but with leading zeros for convenience. To " 1-2. Package assembly 210 is similar to package assembly 10 of FIGS. 1-2, except that stabilizer 248 is different. Package assembly 210 is ,blood julip 、 It is configured for a medical device having a screw and a set screw. Additionally, an inner cartridge is not used, where a clamshell container 295 is used.

[0041] The stabilizer 248 is shown in FIG. 8 -figure 9 The clamshell container 295 includes a first side 296 and a second side 297 having features configured to receive the medical device 212. The first side 296 and the second side 297 may be substantially mirror images of one another and may be folded along a pivot portion 298a. . capacity The container 295 can receive likenesses of the medical device 212 even though the medical device 212 has a variety of lengths and widths. A common geometric shape of likenesses of the medical device 212 can be received within the container 295.。

[0042] Figure 1 0 -Figure 1 1 3 shows an outer package 300 that can be used to house a medical device 312. A blow molded housing 302 is used to house the medical device 312. The housing 302 has a recess 303 for receiving another of the stackable outer packages 300 having a protrusion 304 formed therein.

[0043] 12-13 show a card 400 for receiving a medical device 412. The card 400 includes a plurality of pop-out u-shaped holders 408 for receiving the medical device 412. 3 As shown in FIG. 1, the medical device 412 is coupled to the u-shaped holder 408 and the card 400 is fitted around the medical device 412. Bend R 。

[0044] From the above description, those skilled in the art can easily ascertain the essential features of the present invention, and can make various changes and modifications to the present invention to adapt it to various applications and conditions without departing from the true spirit and scope of the present invention. [Configuration 1] 1. A packaging assembly for shipping a medical device, comprising: An outer cartridge; an inner cartridge that receives the outer cartridge and extends beyond the outer cartridge; a medical device disposed within the inner cartridge; A package assembly comprising: [Configuration 2] 2. The packaging assembly of claim 1, wherein the outer cartridge comprises a cap and a body. [Configuration 3] 2. The packaging assembly of claim 1, wherein the inner cartridge comprises a cap and a body. [Configuration 4] 4. The packaging assembly of configuration 3, wherein a stabilizer is disposed between the cap and the body of the inner cartridge. [Configuration 5] 5. The package assembly of claim 4, wherein the stabilizer is configured to receive a screw. [Configuration 6] 4. The package assembly of claim 3, wherein the stabilizer is cylindrical. [Configuration 7] 4. The package assembly of configuration 3, wherein the stabilizer is a clamshell container. [Configuration 8] 4. The package assembly of claim 3, wherein the stabilizer is blow molded plastic. [Configuration 9] 2. The packaging assembly of claim 1, wherein the outer cartridge has a cap that engages with the body. [Configuration 10] 2. The packaging assembly of configuration 1, wherein the medical device is a screw. [Configuration 11] 1. A packaging assembly for shipping a medical device, comprising: An outer cartridge; an inner cartridge that receives the outer cartridge and extends beyond the outer cartridge; a medical device disposed within the inner cartridge, the medical device extending beyond the inner cartridge; A package assembly comprising: [Configuration 12] 12. The packaging assembly of claim 11, wherein the inner cartridge includes a stabilizer that receives the medical device. [Configuration 13] 13. The package assembly of embodiment 12, wherein the stabilizer is an insert. [Configuration 14] 13. The package assembly of embodiment 12, wherein the stabilizer is a tube. [Configuration 15] 13. The package assembly of embodiment 12, wherein the stabilizer is a clamshell container. [Configuration 16] 13. The package assembly of embodiment 12, wherein the stabilizer is a blow molded container. [Configuration 17] 12. The package assembly of claim 11, wherein the outer cartridge includes a cap and a body, and the inner cartridge includes a cap and a body. [Configuration 18] 18. The packaging assembly of claim 17, wherein a seal is disposed between the cap and the body of the outer cartridge. [Configuration 19] 18. The packaging assembly of claim 17, wherein a seal is disposed between the cap and the body of the inner cartridge. [Configuration 20] 1. A packaging assembly for shipping a medical device, comprising: an outer cartridge including a cap and a body; an inner cartridge for receiving the outer cartridge, the inner cartridge extending beyond the outer cartridge and including a cap and a body; a medical device disposed within the inner cartridge, the medical device extending beyond the inner cartridge; A package assembly comprising:

Claims

1. 1. A packaging assembly for transporting a medical device having a first portion and a second portion, wherein a first direction and a second direction extend in opposite directions along an axis of the packaging assembly, the packaging assembly comprising: A first cartridge; a second cartridge received in the first cartridge, the second cartridge including a second cartridge body and a second cartridge cap coupled to an open end of the second cartridge body, the second cartridge body including an inner surface defining an opening having a shoulder and a receiving portion extending from the shoulder in the second direction; a stabilizer, at least a portion of which is disposed outside the opening of the second cartridge body and within an opening defined by an inner surface of the second cartridge cap, a first end of the stabilizer being stopped in the first direction within the opening of the second cartridge cap by a closed end of the second cartridge cap, and a second end of the stabilizer being stopped in the second direction by one of the shoulder of the second cartridge body or the first portion of the medical device; Equipped with when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, the first portion of the medical device is stopped in the first direction by the closed end of the second cartridge cap and in the second direction by the stabilizer, and the second portion of the medical device extends from the first portion of the medical device in the second direction through an inner bore of the stabilizer to the position of the shoulder of the second cartridge body; when the second end of the stabilizer is arrested in the second direction by the first part of the medical device, the first part of the medical device is disposed along the axis between the second end of the stabilizer and the shoulder of the second cartridge body, the second part of the medical device extends from the first part of the medical device in the second direction and into the receiving part of the second cartridge body, the medical device is an assembly, the first part of the medical device is a tulip of the assembly, the second part of the medical device is a screw of the assembly, the medical device further includes a third part provided as a set screw of the assembly, the second end of the stabilizer is open and leads to a hole formed in the stabilizer, and the set screw is received in the hole of the stabilizer through the open second end of the stabilizer. Package assembly.

2. 2. The package assembly of claim 1, wherein the first cartridge includes a first cartridge body and a first cartridge cap coupled to an open end of the first cartridge body, the first cartridge body and the first cartridge cap cooperating to define an inner chamber of the first cartridge, the inner chamber of the first cartridge configured to receive the second cartridge therein.

3. 3. The package assembly of claim 2, wherein when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, a portion of the second cartridge body extends outside the axis of the first cartridge body and into an opening defined by an inner surface of the first cartridge cap.

4. The package assembly of claim 3, wherein when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, the closed end of the second cartridge cap is stopped in the first direction by the closed end of the first cartridge cap.

5. The packaging assembly of claim 1, wherein when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, the medical device is a screw, the first portion of the medical device is a head of the screw, and the second portion of the medical device is a stem of the screw.

6. The package assembly of claim 1 , wherein the stabilizer is cylindrical.

7. The packaging assembly of claim 1, wherein when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, the inner bore of the stabilizer includes a tapered portion at the first end of the stabilizer, and the first portion of the medical device is received within the tapered portion of the inner bore.

8. 8. The packaging assembly of claim 7, wherein when the second end of the stabilizer is stopped in the second direction by the shoulder of the second cartridge body, the tapered portion of the inner bore of the stabilizer is frustoconical.

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