MEDICAL KIT PACKAGE AND PRODUCT MARRYING PROCESS

Abstract

A package for a medical kit and a product marrying process are provided. The package has a tray including a first compartment proximate to a first end of the tray, a second compartment proximate to a second end of the tray, and a rim surrounding the first and second compartments. A flexible cover sheet is sized to cover the first and second compartments of the tray. The cover sheet is heat-sealed to the rim during a first sealing process in which a primary seal is formed to seal the first compartment of the tray, such that access to the second compartment still remains available. The cover sheet is further heat-sealed to the rim during a second sealing process in which a secondary seal is formed along the second end of the tray such that the secondary seal complements the primary seal to seal the second compartment of the tray.

Claims

1. A package for a medical kit, the package comprising: a tray including a first compartment proximate to a first end of the tray, a second compartment proximate to a second end of the tray, and a rim surrounding the first and second compartments; a flexible cover sheet configured to removably cover the first and second compartments of the tray; a primary seal formed between the rim and the cover sheet during a first sealing process to seal the first compartment of the tray; and a secondary seal formed between the rim and the cover sheet on the second end of the tray during a second sealing process, where the secondary seal complements the primary seal to seal the second compartment of the tray.

2. The package according to claim 1, wherein the primary seal is formed on the rim at a first side of the tray and extends from the first end of the tray to the second end of the tray, and wherein the primary seal is further formed on the rim at the second side of the tray and extends from the first end of the tray to the second end of the tray.

3. The package according to claim 2, wherein the primary seal is formed on the rim at the first end of the tray and extends from the first side of the tray to the second side of the tray.

4. The package according to claim 1, wherein the tray further includes a land section disposed between the first compartment and the second compartment, the land section separating the first and second compartments.

5. The package according to claim 4, wherein the land section extends from a portion of the rim at a first side of the tray to a portion of the rim at a second side of the tray.

6. The package according to claim 5, wherein the primary seal is formed on the land section extending from the portion of the rim at the first side of the tray to the portion of the rim at the second side of the tray.

7. The package according to claim 1, wherein the secondary seal is formed on the rim at the second end of the tray and extends from a first side of the tray to a second side of the tray.

8. The package according to claim 1, wherein the first component includes a medical device or a medical device kit.

9. The package according to claim 1, wherein the second component includes a medication container.

10. The package according to claim 8, wherein the second component includes a second medical device or a second medical device kit.

11. The package according to claim 1, wherein a first edge at the first end of the tray is unsealed after the primary seal is formed such that a first edge of the cover sheet forms a first unsealed flap over the corresponding first edge of the tray.

12. The package according to claim 11, wherein a second edge at the second end of the tray is unsealed after the secondary seal is formed such that a second edge of the cover sheet forms a second unsealed flap over the corresponding second edge of the tray.

13. A product marrying process, comprising: providing a tray at a first processing location, the tray including a first compartment proximate to a first end of the tray, a second compartment proximate to a second end of the tray, and a rim surrounding the first and second compartments; filling the first compartment of the tray with a first component; placing a flexible cover sheet over the first and second compartments of the tray; forming a primary seal between the cover sheet and the tray by heat-sealing the cover sheet to the rim of the tray such that the first compartment is sealed by the primary seal and the second compartment is partially sealed by the primary seal; sending the tray to a second processing location; filling the second compartment of the tray with a second component; and forming a secondary seal between the cover sheet and the tray by heat-sealing the cover sheet to the rim at the second end of the tray such that the secondary seal complements the primary seal to seal the second compartment.

14. The product marrying process according to claim 13, wherein the primary seal is formed on the rim at a first side of the tray and extends from the first end of the tray to the second end of the tray, and wherein the primary seal is further formed on the rim at the second side of the tray and extends from the first end of the tray to the second end of the tray.

15. The product marrying process according claim 13, wherein the primary seal is formed on the rim at the first end of the tray and extends from the first side of the tray to the second side of the tray.

16. The product marrying process according to claim 13, wherein the secondary seal is formed on the rim at the second end of the tray and extends from a first side of the tray to a second side of the tray.

17. The product marrying process according to claim 13, wherein the first component includes a medical device.

18. The product marrying process according to claim 13, wherein the second component includes a medication container.

19. The product marrying process according to claim 13, wherein a first edge at the first end of the tray is unsealed after the primary seal is formed such that a first edge of the cover sheet forms a first unsealed flap over the corresponding first edge of the tray.

20. The product marrying process according to claim 19, wherein a second edge at the second end of the tray is unsealed after the secondary seal is formed such that a second edge of the cover sheet forms a second unsealed flap over the corresponding second edge of the tray.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order that the present invention may be readily understood, aspects of the medical kit package and product marrying process are illustrated by way of examples in the accompanying drawings, in which like parts are referred to with like reference numerals throughout.

[0032] FIG. 1 illustrates a top perspective view of a dual cavity tray according to an embodiment of the present invention.

[0033] FIG. 2 illustrates a top plan view of the dual cavity tray of FIG. 1.

[0034] FIG. 3 illustrates a side view the dual cavity tray of FIG. 1.

[0035] FIG. 4 illustrates a top perspective view of a dual cavity tray according to another embodiment of the present invention.

[0036] FIG. 5 illustrates a top plan view of the dual cavity tray of FIG. 4.

[0037] FIG. 6 illustrates a side view the dual cavity tray of FIG. 4.

[0038] FIG. 7 illustrates a flow chart depicting steps of a product marrying process according to the present invention.

[0039] FIG. 8 illustrates the step of filling a first compartment of the tray with a first component during the product marrying process.

[0040] FIG. 9 illustrates the step of sealing the first compartment of the tray with a cover sheet during the product marrying process.

[0041] FIG. 10 illustrates the step of filling a second compartment of the tray with a second component during the product marrying process.

[0042] FIG. 11 illustrates the step of sealing the second compartment of the tray with a second component during the product marrying process.

DETAILED DESCRIPTION

[0043] The present invention describes a package for a medical kit, and a product marrying process for packaging components of the medical kit. An example of such a package in accordance with the present invention is depicted in FIGS. 1-3. The package 100 comprises a tray 110 having a first end 112 and a second end 113 spaced apart from the first end. The tray may also be referred to as blister tray. The tray further has a first side 114, and a second side 115 spaced apart from the first side. Both the first and second sides 114, 115 extend from the first end 112 of the tray to the second end 113 of the tray. The tray 110 includes a first or primary compartment 120 configured to receive a first component 20, such as one or more medical devices. The tray further includes a second or secondary compartment 130 configured to receive a second component 30, such as a medication container. For instance, the first compartment may receive an epidural catheter kit, and the second compartment may receive an epidural medication container. Other types of medical devices and medication containers may be respectively received in the first and second compartments. According to some implementations, the tray may be flexible. According to other implementations, the tray may be rigid.

[0044] The first compartment 120 is proximate to the first end 112 of the tray 110, and the second compartment 130 is proximate to the second end 113 of the tray 110. Moreover, the second compartment 130 is adjacent to the first compartment 120. The first compartment 120 defines a first or primary recessed cavity having a pair of spaced apart end walls 121, 122 and a pair of spaced apart side walls 123, 124. A depth of the first recessed cavity may vary depending on the size of a medical device received therein. In some implementations, a base of the first recessed cavity may have a generally rectangular shape, as depicted in FIGS. 1-3. In some aspects, one or more corners 126 of the first recessed cavity may be rounded or curved. In other implementations, the base of the first recessed cavity may have a generally square, triangular, trapezoidal, circular, or oval shape, among others. For instance, FIGS. 4-6 depict a tray 100a including a first compartment 120a defining a first or primary recessed cavity having a pair of spaced apart end walls 121a, 122a and a pair of spaced apart side walls 123a, 124a, wherein the base of the first recessed cavity has a generally square shape.

[0045] The second compartment 130 defines a second or secondary recessed cavity having a pair of spaced apart end walls 131, 132 and a pair of spaced apart side walls 133, 134. A depth of the second recessed cavity may vary depending on the size of a medication container received therein. The first recessed cavity is larger than then second recessed cavity. As shown in FIG. 3, for instance, the depth of the second recessed cavity is less than the depth of the first recessed cavity. In other implementations, the first recessed cavity may be smaller than then second recessed cavity. In still other implementations, the first and second recessed cavities may be the same size and/or shape.

[0046] The depth of the first and second recessed cavities may be based on the tooling used during manufacturing or molding of the tray 110. A base of the second recessed cavity may have a generally rectangular or square shape, among other shapes. In some aspects, one or more corners of the second recessed cavity may be rounded or curved. In other aspects, the side walls 133, 134 of the second cavity may by concave or bulbous to provide extra space for the medication container or other medical device component. Such concave side walls may also allow a user to insert a finger into the second cavity to assist with removal of the medication container from the second cavity during a medical procedure.

[0047] A cover sheet or lid 140 is configured to cover and seal both the first and second compartments. The cover sheet may be made from a flexible and peelable material that is strong enough to withstand accidental tearing or puncturing during handling or transport of the package. For medical applications, an example of a preferred cover sheet material is a polymeric sheet material, such as spun bond polyolefin or Tyvek?.

[0048] The cover sheet 140 is heat-sealed to a rim 150 of the tray during a package sealing operation, including the product marrying process. In some implementations, a portion of the cover sheet may be coated with a heat-sealable coating, such as a hot melt adhesive. The bottom tray may be made of a thermoformable material, such as a thermoplastic, which is capable of being heat sealed to the heat-sealable coating of the cover sheet. In other implementations, the tray may be coated with the heat-sealable coating for being heat sealed to the cover sheet. For medical applications, the tray may be made from a clear or opaque plastic. According to other aspects, the tray may be rigid or flexible.

[0049] The rim 150 extends continuously along a periphery of the tray 110 and surrounds both the first compartment 120 and the second compartment 130. In some aspects, the rim 150 may include an outwardly extending flange which increases the surface area of the seal formed with the cover sheet. The cover sheet 140 may be sized to correspond to the rim 150 of the tray. For instance, a length of the cover sheet 140 may correspond with a length of the rim 150 along the first 114 and second 115 sides of the tray extending from the first end 112 of the tray to the second end 113 of the tray. In some aspects, the length of the cover sheet 140 may be greater than the length of the rim 150 along the first 114 and second 115 sides of the tray. Further, a width of the cover sheet 140 may correspond with a width of the rim 150 along the first 112 and second 113 ends of the tray extending from the first side 114 of the tray to the second side 115 of the tray. In some aspects, the width of the cover sheet 140 may be greater than the width of the rim 150 along the first 112 and second 113 ends of the tray.

[0050] The tray 110 includes a narrow land section 152 disposed between the first compartment 120 and the second compartment 130. The land section 152 extends from a portion of the rim 150 at the first side 114 of the tray to a portion of the rim at the second side 115 of the tray. Thus, the narrow land section 152 separates the first compartment 120 from the second compartment 130. This separation formed by the land section helps maintain sterility of the first and second components when they are sealed within the respective first and second compartments. For instance, the land section 152 also helps protect the primary cavity from potential contamination from the secondary cavity when the secondary cavity includes a non-sterile component.

[0051] The cover sheet 140 is heat-sealed to a portion of the rim 150 of the tray 110 by a primary seal 160 and a secondary seal 170 that are applied at different stages of the product marrying process. For instance, during the product marrying process, the primary seal 160 is formed before the secondary seal 170 is formed, as will be further described in detail below. The primary seal 160 is formed on the rim 150 at the first end 112 of the tray and extends from the first side 114 of the tray to the second side 115 of the tray. The primary seal 160 is also formed on the rim 150 at the first side 114 of the tray and extends from the first end 112 of the tray to the second end 113 of the tray. Similarly, the primary seal 160 is further formed on the rim 150 at the second side 115 of the tray and extends from the first end 112 of the tray to the second end 113 of the tray.

[0052] Additionally, the primary seal 160 is formed on the land section 152 extending from a portion of the rim 150 at the first side 114 of the tray to a portion of the rim at the second side 115 of the tray. In this regard, the primary seal 160 formed between the tray 110 and the cover sheet 140 generally resembles an H- shape having a closed-off bottom portion, where the closed-off bottom portion corresponds to the portion of the primary seal formed on the rim 150 of the tray along the first end 112 of the tray, where the cross-bar section of the H-shape corresponds to the portion of the primary seal formed on the land section 152 of the tray, and where each extended side of the H-shape respectively corresponds to the portion of the primary seal formed on the rim of the tray along the first and second sides 114, 115 of the tray. Such a seal design may also be referred to as a legged seal, a dual-cavity legged seal, or an extended bar seal, among others. Accordingly, the primary seal 160 fully surrounds or seals the first compartment 120 and partially surrounds or seals the second compartment 130. In some aspects, a width of the primary seal along the rim 150 may be continuously uniform, while a width of the primary seal along the land section 152 of the tray may be less than the width of the primary seal along the rim. In other aspects, the width of the primary seal may be continuously uniform along the rim and the land section of the tray.

[0053] The secondary seal 170 is formed on the rim 150 at the second end 113 of the tray and extends from the first side 114 of the tray to the second side 115 of the tray. In some aspects, a portion of the secondary seal 170 may overlap corresponding portions of the primary seal 160 at the first and second sides 114, 115 of the tray. The secondary seal 170 complements the primary seal 160 to fully surround or seal the second compartment 130. In some aspects, a width of the secondary seal may be approximately the same width as the primary seal along the rim. A bar sealer may be used to apply the secondary seal 170. In some implementations, a tray sealer may be used to apply the secondary seal.

[0054] The rim 150 includes a first edge 116 at the first end 112 of the tray. The first edge 116 of the rim extends from the first side 114 of the tray to the second side 115 of the tray. Furthermore, the first edge 116 of the rim is adjacent to the primary seal 160 formed between the tray and the cover sheet. As such, the first edge 116 of the rim is not sealed by the primary seal 160 during the product marrying process. In other words, the first edge 116 of the rim remains unsealed when the cover sheet 140 is heat-sealed to the tray 110 to form the primary seal 160 during the product marrying process.

[0055] The first edge 116 of the rim remains unsealed so that a corresponding first edge of the cover sheet 140 forms a first flap over the unsealed portion of the rim for ease of opening. For instance, a user is able to grasp the first flap of the cover sheet by pulling it away from the tray, thus unsealing the primary seal to access the first compartment 120 from the first end 112 of the tray. Continued pulling of the cover sheet allows the user to completely remove the cover sheet from the tray if desired. In some aspects, a width of the first flap may be approximately 0.75 inches. In other aspects, a width of the first flap may be approximately 0.875 inches. The first flap may be larger or smaller depending on the size of the tray in order to adjust the amount of grip area. For instance, the first flap may be greater than the aforementioned dimensions to ensure the user is able to easily grip the overhang portion of the flap. In some aspects, one or more corners of the first edge 116 of the rim 150 may be chamfered to make it easier for the user to grasp the first flap and initiate peeling the sealed cover sheet off of the tray. For instance, the cover sheet may overhang the tray to create a flap which the user may grip to facilitate separating the cover sheet from the tray. The overhang portion of the cover sheet may also include a fold-down or hang-down portion on which identifying indicia may be printed. Such identifying indica may include information about the medical device components and/or the medication stored in the tray. In some implementations, the identifying indicia may be color coded for quick reference.

[0056] The rim 150 includes a second edge 117 at the second end 115 of the tray. The second edge 117 of the rim extends from the first side 114 of the tray to the second side 115 of the tray. The second edge 117 of the rim is adjacent to the secondary seal 170 formed between the tray and the cover sheet. As such, the second edge 117 of the rim is not sealed by the secondary seal 170 during the product marrying process. In other words, the second edge 117 of the rim remains unsealed when the cover sheet 140 is heat-sealed to the tray 110 to form the secondary seal 170 during the product marrying process. The second edge 117 of the rim remains unsealed so that a corresponding second edge of the cover sheet forms a second flap over the unsealed portion of the rim for ease of opening. Specifically, a user is able to grasp the second edge of the cover sheet by pulling it away from the tray, thus unsealing the secondary seal to access the second compartment 130. Continued pulling of the cover sheet allows the user to completely remove the cover sheet from the tray. In some aspects, a width of the second flap may be approximately 0.75 inches. In other aspects, a width of the second flap may be approximately 0.875 inches. In some aspects, one or more corners of the second edge 117 of the rim 150 may be chamfered to make it easier for the user to grasp the second flap and initiate peeling the sealed cover sheet off of the tray. The second flap may be larger or smaller depending on the size of the tray in order to adjust the amount of grip area. For instance, the second flap may be greater than the aforementioned dimensions to ensure the user is able to easily grip the overhang portion of the flap

[0057] Both the first and second flaps of the cover sheet allow the user the ability to open the package from the first end 112 of the tray and/or the second end 113 of the tray. Additionally, one or more tack seals 162 may be applied to the second edge 117 of the rim for temporarily securing the second edge of the cover sheet to the tray to prevent the second flap formed by the second edge of the cover sheet from inadvertently opening prior to filling the second compartment during the product marrying process.

[0058] A product marrying process for packaging components of a medical kit is depicted in FIG. 7. In a first step S1 of the process, a tray or pouch is formed at a first manufacturing location or facility by molding a thermoplastic material into the desired shape. As described in detail above, such a tray 110 may include first 120 and second 130 compartments surrounded by a continuous rim 150 defining an outwardly extending flange. The bottom tray may be made of a thermoplastic material capable of being heat sealed to a cover sheet. In some applications, the tray may be made from a clear plastic so that a user is able to inspect the contents of the various compartments without opening the package.

[0059] In a second step S2 of the process, the first compartment 120 of the tray is filled with a primary product, as depicted in FIG. 8. In some aspects, the primary product may be a medical device. Forming the tray and forming the primary seal may occur inline on a Form Fill Seal (FFS) machine, or a pre-formed dual cavity tray (i.e., formed offline) may be supplied and then the primary seal placed when the product is loaded into the first compartment.

[0060] In a third step S3 of the process, the cover sheet 140 is applied over the tray and heat-sealed therewith. More particularly, the cover sheet 140 is heat-sealed to a portion of the rim 150 of the tray 110 to form primary seal 160 between the cover sheet and the tray. As shown in FIG. 9, the primary seal 160 is formed at the first end 112 of the tray and extends from the first side 114 of the tray to the second side 115 of the tray. The primary seal 160 is also formed on the rim 150 at the first side 114 of the tray and extends from the first end 112 of the tray to the second end 113 of the tray. Similarly, the primary seal 160 is also formed on the rim 150 at the second side 115 of the tray and extends from the first end 112 of the tray to the second end 113 of the tray. Additionally, the primary seal 160 is formed on the land section 152 extending from a portion of the rim 150 at the first side 114 of the tray to a portion of the rim at the second side 115 of the tray. The primary seal 160 does not extend along the rim at the second end 113 of the tray. Accordingly, the primary seal 160 fully surrounds or seals the first compartment 120 and only partially surrounds or seals the second compartment 130.

[0061] At least one tack seal 162 is applied between the cover sheet and the tray at or near the second edge 117 of the tray. The tack seal 162 is heat-sealed concurrently with the initial heat-sealing operation that forms the primary seal 160. For instance, the tack seal 162 may comprise a piece of sealing gasket, so that when a platen applies the primary seal 160 it also places each tack seal at the same time.

[0062] In a fourth step S4 of the product marrying process, the package 100 is sent to a secondary processing location for filling the second compartment. This secondary processing location may be another fill line in the same facility in which the first compartment was filled. Alternatively, the secondary processing location may be at an entirely different facility. In another implementation, the second compartment may be filled at the first processing location but at a time after the first compartment has already been filled with the primary product. The aforementioned tack seal 162 prevents the portion of the cover sheet over the second edge 117 of the tray from completely opening up during transit to the secondary processing location.

[0063] In a fifth step S5 of the process, the second end of the cover sheet is lifted away from the second edge 117 of the tray such that the tack seal 162 between the cover sheet and the tray is unsealed while the primary seal 160 remains sealed. Thus, to add a product to the second compartment, the flap of the lid is separated from the tray at the unsealed side of the tray, by separating any tack seals without separating the primary seal, to gain full access to the second cavity and introduce the second component therein. Lifting the second end of the cover sheet provides access to the second compartment of the tray. As shown in FIG. 10, a secondary product, such as a medication container, is then inserted into the second compartment of the tray.

[0064] In a final step S6 of the product marrying process, the portion of the cover sheet covering the second compartment is flattened and sealed by applying a secondary seal 170 along the rim 150 at the second end 113 of the tray, as shown in FIG. 11. A sealer, such as bar sealer or a tray sealer, may be used to from the secondary seal 170 to enclose the second cavity. A portion of the secondary seal 170 may overlap corresponding portions of the primary seal 160 at the first and second sides 114, 115 of the tray. The packaged products are then handled as a single sterile barrier or packaging system so they may be sterilized together. Moreover, an end user is able to open the package as a single packaging system. For instance, the package may be opened at either end so that the user can access the primary product without having to open and expose the secondary cavity, and vice versa. In other aspects, the package may be opened at both end so that the user can access the primary product and the secondary product at the same time.

[0065] While a package for a medical kit, and a product marrying process for packaging components of the medical kit, have been described in terms of what may be considered to be specific aspects, the present invention is not limited to the disclosed aspects. Additional modifications and improvements to the present invention may be apparent to those skilled in the art. Moreover, the many features and advantages of the disclosure are apparent from the detailed specification, and thus, it is intended by the appended claims to cover all such features and advantages of the present invention which fall within the spirit and scope of the disclosure. Further, it is not desired to limit the disclosure to the exact construction and operation illustrated and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure. The present disclosure should therefore be considered as illustrative and not restrictive. As such, this disclosure is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, which should be accorded their broadest interpretation so as to encompass all such modifications and similar structures.