Label and packaging system and method

Abstract

Disclosed herein is a label and packaging system comprising a primary package having a top seam and a bottom seam and enclosing a medical device within an interior cavity thereof. The system further comprises a label system comprised of a first body having a front surface and a back surface, the first body extending in a front plane and being attached to a front surface of the primary package. Additionally, the label system comprises a first right handle and a first left handle, both attached to a top edge of the first body. A tear line extends longitudinally from the top edge of the first body and is disposed between the right handle and the left handle. A distance (d) of the tear line is less than a length (L) of the first body. The tear line is designed to facilitate separation when the right handle is pulled in a direction opposite the left handle.

Description

[0001] priority

[0002] This application claims priority to U.S. Patent Application No. 18 / 604,394, filed March 13, 2024, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Labeling and packaging systems are commonly used across various industries to provide information and protection for products. In the medical device field, efficient and secure packaging systems are crucial, ensuring the integrity and safety of devices during storage, transportation, and use. Previous labeling and packaging system approaches focused on different aspects, such as ease of opening, tamper-evident features, and integration with the master packaging.

[0004] Previous methods involved applying labels directly to the main packaging, typically using adhesives or similar methods. These labels usually included printed information about the product, such as its name, instructions for use, and any relevant warnings or regulatory information. While these labels were widely used, they were sometimes difficult to remove without damaging the main packaging. Additionally, these labels could deter access to the contents of the packaging.

[0005] Other methods include incorporating tear lines or perforations into the main packaging itself. These tear lines are designed to facilitate opening the packaging by providing a predetermined path along which the packaging can be torn. However, these tear lines may not always be user-friendly or intuitive, and there is a risk of accidentally tearing or damaging the packaging during transport, storage, or opening, resulting in contents spilling onto floors or non-sterile surfaces and compromising the sterility of the medical device.

[0006] This article discloses a labeling and packaging system and related methods designed to address the aforementioned problems. Summary of the Invention

[0007] In some aspects, the technology described herein relates to a labeling and packaging system comprising: a main package having a top seam and a bottom seam and defining an internal cavity; a medical device disposed within the internal cavity; and a labeling system comprising: a first body extending in a frontal plane and defining a front surface and a rear surface, and having a length (L) and a width (W), the rear surface being coupled to the front surface of the main package; a first right handle coupled to the right side of the top edge of the first body; a first left handle coupled to the left side of the top edge of the first body; and a tear line extending longitudinally from the top edge of the first body between the first right handle and the first left handle, the distance (d) of the tear line being less than the length (L) of the first body, the tear line being configured to facilitate separation along the tear line when the first right handle is pushed in a direction opposite to the first left handle.

[0008] In some respects, the technique described herein relates to a system in which the distance (d) is between 20% and 80% of the length (L) of the first body.

[0009] In some respects, the technology described herein relates to a system in which the length (L) of a first body is equal to or less than the second length (L2) of a main package.

[0010] In some respects, the technology described herein relates to a system that also includes a tear-stopping portion disposed at the bottom end of the tear line.

[0011] In some aspects, the technology described herein relates to a system in which the tear-resistant portion includes a reinforcement exhibiting increased tensile strength to prevent further separation of the first body.

[0012] In some aspects, the technology described herein relates to a system in which the tear-resistant portion includes a bridging line angled relative to the tear line and configured to mitigate further separation along the tear line at a predetermined location on the main packaging.

[0013] In some aspects, the technology described herein relates to a system that also includes a cutting portion extending from the top edge of a first body and disposed between a first right handle and a first left handle, the cutting portion extending through one or both of a portion of the first body and a portion of the top seam of the main package.

[0014] In some respects, the technology described herein relates to a system in which a rear surface is coupled to a front surface of a master package by one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing, and ultrasonic welding.

[0015] In some aspects, the technology described herein relates to a system further comprising: a second right handle extending from the top edge of the first right handle and including a first fold line disposed therebetween; a second left handle extending from the top edge of the first left handle and including a second fold line disposed therebetween; and a second body connected to both the second right handle and the second left handle along a first edge of the second body.

[0016] In some aspects, the technology described herein relates to a system in which, when folded along a first fold line, the outer periphery of a second right handle aligns with the outer periphery of a first right handle, and when folded along a second fold line, the outer periphery of a second left handle aligns with the outer periphery of a first left handle, and the surface of a second body is configured to engage with the rear side of a main package.

[0017] In some aspects, the technology described herein relates to a system in which a second body includes a second tear line extending a second distance (d2) from a first edge of the second body.

[0018] In some aspects, the technology described herein relates to a method of opening a packaging and labeling system, comprising: providing a main package having a top seam and a bottom seam defining an internal cavity, a medical device disposed within the internal cavity, and a labeling system having a body, the rear surface of the body being coupled to the front surface of the main package; grasping a first right handle and a first left handle of the labeling system, the first right handle being coupled to the right side of the top edge of the body, and the first left handle being coupled to the left side of the top edge of the body; pushing the first right handle in a direction opposite to the first left handle along an axis extending at an angle relative to the longitudinal axis of the main package; separating the body along a longitudinally extending tear line; and tearing a portion of the main package to access the medical device.

[0019] In some aspects, the technique described herein relates to a method in which a tear line is a weakening line extending along the body by a distance (d) to facilitate separation along the tear line, the distance (d) being less than the longitudinal length (L) of the body.

[0020] In some respects, the techniques described herein relate to a method in which the distance (d) of the tear line is less than the longitudinal length (L2) of the master package.

[0021] In some aspects, the technology described herein relates to a method that also includes a tear-stopping portion disposed at the bottom end of the tear line and configured to prevent further separation of the body beyond a distance (d).

[0022] In some respects, the technology described herein relates to a system in which the tear-resistant portion includes either a reinforcement or a brittle line, the brittle line being angled relative to the tear line and configured to mitigate further separation along the tear line at a predetermined location on the main packaging.

[0023] In some aspects, the techniques described herein relate to a method in which the rear surface of a body is coupled to the front surface of a main package, including one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing, and ultrasonic welding.

[0024] In some aspects, the technology described herein relates to a method of manufacturing a labeling and packaging system, comprising: forming a main package having a top seam and a bottom seam, a front surface and a rear surface, the main package defining an internal cavity for receiving a medical device; and attaching a rear surface of a body of a labeling system to the front surface of the main package, the labeling system including a first right handle extending from the right side of the top edge of the body and a first left handle extending from the left side of the top edge of the body.

[0025] In some aspects, the technology described herein relates to a method that further includes folding a second right handle relative to a first right handle along a first fold line such that the outer periphery of the second right handle is aligned with the outer periphery of the first right handle, and folding a second left handle relative to a first left handle along a second fold line such that the outer periphery of the second left handle is aligned with the outer periphery of the first left handle.

[0026] In some aspects, the technology described herein relates to a method that also includes attaching the surface of a second body to the rear surface of a main package.

[0027] In some aspects, the techniques described herein relate to a method in which the rear surface of a body is coupled to the front surface of a main package, including one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing, and ultrasonic welding.

[0028] In some aspects, the technology described herein relates to a method that further includes forming a cut portion disposed between a first right handle portion and a first left handle portion and extending from the top edge of the body, the cut portion extending through one or both of the body and a portion of the top seam. Attached Figure Description

[0029] A more specific description of the disclosed text will be presented by reference to specific embodiments of the disclosed text illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail using the accompanying drawings, in which:

[0030] Figure 1 An exploded view of a labeling and packaging system according to an embodiment disclosed herein is shown. The labeling and packaging system typically includes a labeling system, master packaging, and a medical device.

[0031] Figures 2A to 2B The embodiments disclosed herein are shown. Figure 1 A perspective view of the labeling and packaging system in its assembled state.

[0032] Figure 2C A perspective view of a labeling and packaging system without a handle, according to an embodiment disclosed herein, is shown in an assembled state.

[0033] Figure 2D A perspective view of a labeling and packaging system without a handle but with a fragile tear-resistant portion, according to an embodiment disclosed herein, is shown in an assembled state.

[0034] Figure 2E A perspective view of a labeling system and packaging system with offset tear lines according to the embodiments disclosed herein is shown in an assembled state.

[0035] Figures 3A to 3B A foldable tag system in an unfolded configuration according to an embodiment disclosed herein is shown.

[0036] Figure 3C A foldable tag system in a folded configuration according to an embodiment disclosed herein is shown. Detailed Implementation

[0037] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may optionally be combined with or replace features of any of the many other embodiments disclosed herein. It should be understood that the accompanying drawings are schematic and illustrative representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0038] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps and do not provide for a sequence or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “right,” “left,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Furthermore, the words “comprising,” “having,” and “containing” as used herein (including the claims) shall have the same meaning as the word “including.”

[0039] In the following description, the terms “or” and “and / or” as used herein shall be interpreted as inclusive or referring to either or any combination thereof. For example, “A, B, or C” or “A, B, and / or C” means “any one of the following: A; B; C; A and B; A and C; B and C; A, B, and C”. Exceptions to this definition will only occur if a combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0040] To help describe the implementation scheme described in this article, such as Figure 1As shown, the front-to-back axis extends between the front and back. The longitudinal axis extends between the top and bottom. The frontal axis extends between the left and right. The frontal plane is defined by the longitudinal axis and the frontal axis. The front-to-back plane is defined by the longitudinal axis and the front-to-back axis. The lateral plane is defined by the frontal axis and the front-to-back axis.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0042] Figure 1 An exploded view of a labeling and packaging system 90 is shown, which typically includes a labeling system 100, a master package 80, and a medical device 50. Exemplary medical devices may include catheters, intermittent catheters, Foley catheters, balloon catheters, indwelling catheters, peritoneal catheters, pleural drainage catheters, etc. However, these examples are not intended to be limiting, and it should be understood that other products or other types of medical devices are also contemplated. The master package 80 is configured to house the medical device 50 therein, and the labeling system 100 is configured to be coupled to the master package. Figure 2A The label and packaging system 90 is shown in an assembled state.

[0043] In one embodiment, the master package 80 is formed of one or more layers of material folded and sealed along one or more seams 82 to define an internal cavity therein. In one embodiment, the internal cavity may define a sterile environment. The one or more material layers may include the same material or different materials. Exemplary materials for the one or more material layers include organic or synthetic materials, woven or nonwoven materials, plastics, polymers, metals, alloys, composite materials, foils, paper, waxed paper, combinations thereof, etc.

[0044] In one embodiment, one or more material layers define layers that are impermeable to fluids, liquids, and / or gases. For example, one or more material layers define a water-impermeable layer and / or an oxygen-impermeable layer. Therefore, the medical device 50 can be maintained in a sterile and / or moist environment during storage and transportation until the master package 80 is opened. In one embodiment, one or more seams 82 can be secured using adhesive seals, mechanical seals, electrically activated seals (such as heat seals), ultrasonic welding, combinations thereof, etc.

[0045] In one embodiment, the medical device 50 includes a sterile portion 52 configured to be disposed within a patient's body, and a non-sterile portion 54 configured for user operation to facilitate manipulation of the medical device 50 without contact with the sterile portion 52. For example, in the case where the medical device 50 is an intermittent catheter, the sterile portion 52 may be a catheter fitting configured to be disposed within a patient's urethra or bladder. The non-sterile portion 54 may be a finger grip or funnel configured for user grasping to facilitate manipulation of the medical device 50 without contact with the catheter fitting or the sterile portion 52. In one embodiment, the medical device 50 is oriented within a master package 80, with the non-sterile portion 54 positioned near the top edge 88 of the master package. As described in more detail herein, opening the master package 80 may involve tearing a portion of the master package 80. In one embodiment, tearing the master package may begin near the top edge 88 to initially provide access to the non-sterile portion 54 while retaining the sterile portion 52 within the master package 80.

[0046] In one embodiment, the label system 100 typically includes a body 102 extending in a frontal plane and defining a front surface 104 and a rear surface 106. The body 102 defines a length (L) and a width (W). The label system 100 also includes a tear line 120 extending along a longitudinal axis from a top edge 108 toward a bottom edge 110 at a location above the bottom edge 110 of the body 102. In one embodiment, the tear line 120 extends a distance (d) less than the length (L) of the body 102. In one embodiment, the tear line 120 extends a distance (d) between 20% and 80% of the length (L) of the body 102. However, it should be understood that larger or smaller distances are also contemplated.

[0047] In one implementation scheme, such as Figure 2A As shown, the label system 100 can be coupled to the main packaging 80, wherein the central longitudinal axis of the body 102 is aligned with the central longitudinal axis of the main packaging 80. In one embodiment, the label system 100 can be coupled to the main packaging 80 at an offset position, wherein the central longitudinal axis of the body 102 is arranged to the right or left of the central longitudinal axis of the main packaging 80. In one embodiment, the left edge of the body 102 can be aligned with the left edge of the main packaging 80. In one embodiment, the right edge of the body 102 can be aligned with the right edge of the main packaging 80.

[0048] Tear line 120 is a die-cutting line, laser-cutting line, perforation, weak line, notch line, groove, or similar weakening line, configured to facilitate separation of body 102 along the tear line, as described in more detail herein. In one embodiment, tear line 120 separates along its entire length (distance (d)). In one embodiment, tear line 120 separates along distance (d) of tear line 120 along one or more portions, for example, to form a weak perforation, etc. In one embodiment, tear line 120 is continuous along distance (d) of tear line 120, for example, to form a notch line, groove line, etc. As shown, tear line 120 extends linearly; however, other shapes of tear lines are also contemplated, including curved, wavy, closed curves, etc. In one embodiment, as... Figure 2A As shown, the tear line 120 extends parallel to the longitudinal axis of the body 102. In one embodiment, the tear line 120 extends at an angle to the longitudinal axis of the body 102.

[0049] In one implementation scheme, such as Figure 2A As shown, the label system 100 includes a reinforcement 122 or tear-resistant portion 122 disposed between the bottom of the tear line 120 and the bottom edge 110 of the body 102. The tear-resistant portion 122 is configured to prevent the body 102 from separating further along the tear line 120. In one embodiment, the tear-resistant portion 122 is a reinforcing portion made of the same material as the body 102. In another embodiment, the tear-resistant portion 122 is a reinforcing portion made of a different material than the body 102, having increased tensile strength to mitigate or prevent tearing.

[0050] In one implementation scheme, such as Figure 2D As shown, the tear-resistant portion 122 includes one or more weak lines extending at an angle relative to the axial length of the tear line 120, such as die-cut lines, laser-cut lines, perforations, weak lines, scoring lines, grooves, or similar weakening lines, as described herein. For example, as Figure 2D As shown, the tear-resistant portion 122 includes a first fragile line extending from the bottom end of the tear line 120 through a first arc, and a second fragile line extending from the bottom end of the tear line 120 through a second arc (in the opposite direction to the first arc). One or both of the first and second arcs may extend through an arc radius between 5° and 275°. However, it should be understood that larger or smaller arc radii are also contemplated. It should also be understood that other numbers, angles, shapes, and configurations of fragile lines to be included in the tear-resistant portion 122 are also contemplated. Advantageously, the fragile line tear-resistant portion 122 redirects the tear direction from the axis of the tear line 120 to prevent further separation of the package 80 along the tear line. For example, as... Figure 2DAs shown, the semi-circular shape of the anti-tear portion 122 redirects the tear direction back to itself to reduce further tearing momentum along the axis of the tear line 120, and terminates the separation of the main package 80 at a predetermined position thereon.

[0051] The label system 100 also includes a right handle 130 and a left handle 140, each extending upward from the top edge 108 of the body 102. The right handle 130 is coupled to the right side of the top edge 108 of the body 102, and the left handle 140 is coupled to the left side of the top edge 108 of the body 102. In one embodiment, one or both of the right and left handles are integrally formed with the body 102 as a single integral piece. In one embodiment, one or both of the right and left handles are formed separately and coupled to the body 102 using adhesive seals, mechanical seals, electrically actuated seals (such as heat seals), ultrasonic welding, combinations thereof, etc. In one embodiment, one or more of the right handle, left handle, and body 102 are formed of the same material. In one embodiment, one or more of the right handle, left handle, and body 102 are formed of different materials.

[0052] Each of the right handle portion 130 and the left handle portion 140 is configured to facilitate the user's grip on the body 102. For example, as Figure 1 As shown, the right stem portion 130 defines a right finger ring having a hole 132 and configured to receive a user's first finger through which it passes. Similarly, the left stem portion 140 defines a left finger ring having a hole 142 and configured to receive a user's second finger through which it passes. However, it should be understood that the finger ring stem portions of the right stem portion 130 and the left stem portion 140 are not intended to be limiting, and other shapes of stem portions for the right stem portion 130 and the left stem portion 140 are also contemplated. Exemplary stem portions include stem portions having two or more holes (each hole configured to receive at least one finger of the user), finger rings configured to receive two or more fingers, straight stem portions, curved stem portions, T-shaped stem portions, combinations thereof, etc.

[0053] like Figures 2A to 2C As shown, in one embodiment, the body 102 can be coupled to the main package 80. For example, adhesive seals, mechanical seals, electrically actuated seals (such as heat seals), ultrasonic welding, combinations thereof, etc., can be used to join the rear surface 106 of the body 102 to the front surface 84 of the main package 80. In one embodiment, as... Figure 2A As shown, the top edge 108 of the body 102 can be aligned with the top edge 88 of the main package 80. In one embodiment, as... Figure 2B As shown, the top edge 108 of the body 102 can be positioned above the top edge 88 of the main package 80, that is, the body 102 can be positioned such that the top edge 108 extends beyond the top edge 88 of the main package 80. In one embodiment, as... Figure 2C As shown, the top edge 108 of the body 102 can be positioned below the top edge 88 of the main package 80, that is, the body 102 can be positioned such that the top edge 88 of the main package 80 extends beyond the top edge 108 of the body 102. In one embodiment, as... Figure 2C As shown, the label system 100 can be configured to not have one or both of the right handle portion 130 and the left handle portion 140, and includes one or more of the body 102, tear line 120 and tear stop portion 122.

[0054] In one embodiment, the length (L) of the body 102 is equal to or less than the length (L2) of the main packaging 80. For example, the length (L) of the body 102 may be between 10% and 100% of the length (L2) of the main packaging 80. However, it should be understood that a larger or smaller length (L) of the body 102 is also contemplated. In one embodiment, the width (W) of the body 102 is equal to or less than the width (W2) of the main packaging 80. For example, the width (W) of the body 102 may be between 10% and 100% of the width (W2) of the main packaging 80. However, it should be understood that a larger or smaller width (W) of the body 102 is also contemplated.

[0055] In an exemplary manufacturing method, a main package 80 is provided that defines an internal cavity, the internal cavity defining a sterile environment and including a medical device 50 disposed therein. The labeling system 100 is attached to the main package by attaching the surface of the body 102 of the labeling system 100 to the surface of the main package 80. The top edge 108 of the body is aligned with the top edge 88 of the main package 80.

[0056] In one embodiment, the cut 124 may pass through a portion of the seal 82 of the main package 80 and a portion of the body 102, or both. The cut 124 extends downward from the top edge 88 of the main package 80 and / or the top edge 108 of the body 102, and is aligned with and / or positioned between the right handle 130 and the left handle 140. The cut 124 extends to a location above the bottom edge of the seal 82. In one embodiment, the cut 124 extends less than half the height of the seal 82. Therefore, the cut 124 does not compromise the sterile environment defined by the main package 80, but rather facilitates opening the main package, as described in more detail herein. In one embodiment, the cut 124 is positioned 1.5 cm from either the left or right edge of the body 102 or the main package 80. However, it should be understood that larger or smaller distances are also contemplated. In one embodiment, the cut 124 extends 0.5 cm from the top edge 88. However, it should be understood that larger or smaller distances are also contemplated. In one embodiment, the cutting portion 124 defines a straight cutting portion or a shaped notch, such as a triangular notch or a "V" shaped notch, a square notch, a rectangular notch, a semi-circular notch, or a similar suitable shaped notch, but is not limited thereto.

[0057] In one implementation scheme, such as Figure 1 and Figure 2A As shown, one or both of the tear line 120 and the cutting line 124 are centrally located on the body 102, equidistant from the right and left edges of the body 102. In one embodiment, one or both of the tear line 120 and the cutting line 124 may be located to the left or right of the center position on the body 102, i.e., closer to the left or right edge of the body 102. For example, as... Figure 2E As shown, the tear line 120 and the cutting line 124 are arranged to the left of the central longitudinal axis 70 of the label system 100.

[0058] In the exemplary usage method, such as Figure 2AAs shown, a labeling and packaging system 90 is provided, which includes a labeling system 100 coupled to a main package 80, as described herein. A medical device 50 is housed within the main package 80 in a sterile environment. A user can grasp the labeling system 100 by gripping the right handle 130 and the left handle 140. For example, the user can place a first finger through a hole 132 in the right handle 130 and a second finger through a hole 142 in the left handle 140. The user can then push the right handle 130 and the left handle 140 in opposite directions, for example, along a frontal axis, a front-rear axis, or along an axis extending at an angle thereto. When the right handle 130 and the left handle 140 are pushed in opposite directions, one or both of the cutting portion 124 and the tear line 120 facilitate the separation of the right portion and the left portion of the body 102. When the right handle 130 and the left handle 140 are pushed in opposite directions, one or both of the cutting part 124 and the tear line 120 facilitate the separation of the right part of the main package 80 and the left part of the package 80.

[0059] The user can continue separating the body 102 and the package 80 along the tear line 120 until the bottom of the tear line 120 is reached. In one embodiment, the body 102 also includes a tear stop 122 to prevent further separation beyond the bottom of the tear line 120. Advantageously, the tear line 120 and the optional tear stop 122 guide the separation of the body 102 and the main package 80 to a predetermined distance, e.g., distance (d). This allows the user to open the main package 80 and approach the medical device 50 while still allowing the main package 80 to hold the medical device 50 within it. For example, if the package 80 is allowed to separate along most or the entire length (L2) of the package 80, the medical device 50 will fall out of the package 80 and compromise the sterility of the medical device 50, for example, by falling onto a floor or non-sterile surface. Furthermore, the user will not be able to return the medical device 50 to the main package 80 after use to accommodate any debris and facilitate disposal. In contrast, the labeling system 100 will separate the constraints to a predefined length and / or path, thereby maintaining a portion of the main package 80 intact to define the pocket and hold the medical device 50 therein.

[0060] In one embodiment, the body 102 includes an adhesive disposed on a surface of the body 102 (e.g., front surface 104) and configured to adhere the label system 100 and main packaging 80 components to the surface for ease of use. For example, once the main packaging 80 has been opened, the adhesive front surface 104 allows the label and packaging system 90 to adhere to a wall in a convenient location, as described herein, to facilitate use of the medical device 50. In one embodiment, the adhesive front surface 104 facilitates attachment of the label and packaging system 90 to the surface to prevent the label system 100 and main packaging 80 components from detaching from the surface. In one embodiment, the adhesive surface disposed on the front surface 104 also includes a release layer (not shown) disposed thereon and configured to protect the adhesive surface during transport and storage.

[0061] Figures 3A to 3C An embodiment of a labeling system 200 for use with a master package 80 and a medical device 50, as described herein, is shown. The labeling system 200 includes a first body 202A, a first right handle portion 230A, and a first left handle portion 240A. The first body 202A includes a first tear line 220A extending from a top edge 208A of the first body 202A. The labeling system 200 also includes a second right handle portion 230B extending from the top edge of the first right handle portion 230A and a second left handle portion 240B extending from the top edge of the first left handle portion 240A. The labeling system 200 includes a first fold line 228A extending along a frontal axis and equidistantly disposed between the first right handle portion 230A and the second right handle portion 230B, and a second fold line 228B equidistantly disposed between the first left handle portion 240A and the second left handle portion 240B and extending along a frontal axis. The second right handle 230B and the second left handle 240B are connected to the first edge 208B of the second body 202B.

[0062] In one embodiment, the label system 200 may be folded along one or both of the first fold line 228A and the second fold line 228B, such that the first right handle portion 230A is aligned with the second right handle portion 230B, the first left handle portion 240A is aligned with the second left handle portion 240B, and the second body 202B is aligned with the first body 202A. For example, one or more of the following may be true: the outer periphery of the first right handle portion 230A is aligned with the outer periphery of the second right handle portion 230B, the outer periphery of the first left handle portion 240A is aligned with the outer periphery of the second left handle portion 240B, the hole in the first right handle portion 230A is aligned with the hole in the second right handle portion 230B, the hole in the first left handle portion 240A is aligned with the hole in the second left handle portion 240B, and the first edge 208B of the second body 202B is aligned with the top edge 208A of the first body 202A, or a combination thereof.

[0063] In one embodiment, the surface of the first right handle 230A is joined to the surface of the second right handle 230B using adhesive seals, mechanical seals, electrically activated seals (such as heat seals), ultrasonic welding, or combinations thereof, and the surface of the first left handle 240A is joined to the surface of the second left handle 240B. In one embodiment, the surface of the first body 202A is joined to the front surface of the main package 80 using adhesive seals, mechanical seals, electrically activated seals (such as heat seals), ultrasonic welding, or combinations thereof, and the surface of the second body 202B is joined to the rear surface of the main package 80. For example, one or both of the first body 202A and the second body 202B include an adhesive disposed on their surfaces. Figure 3C As shown, when the label system 200 is folded along the first fold line 228A and the second fold line 228B, the first body 202A can be adhered to the front side of the main package 80, and the second body 202B can be adhered to the rear side of the main package 80.

[0064] In one implementation scheme, such as Figure 3A As shown, the first body 202A and the second body 202B can have different dimensions, that is, a length and / or width different from the length (L) and / or width (W) of the first body 202A. In one embodiment, as... Figure 3B As shown, the first body 202A and the second body 202B can have the same dimensions, that is, the same length (L) and / or width (W). In one embodiment, as... Figure 3A As shown, the first body 202A may include one or more of the tear line 220, the tear-stopping part 222, and the cutting part 224.

[0065] In one implementation scheme, such as Figure 3B As shown, the first body 202A includes one or more of a first tear line 220A, a first tear-resistant portion 222A, and a first cutting portion 224A, and the second body 202B includes one or more of a second tear line 220B, a second tear-resistant portion 222B, and a second cutting portion 224B. In one embodiment, the second tear line 220B extends a second distance (d2). The second distance of the second tear line 220B may be the same as or different from the distance (d) of the first tear line 220A.

[0066] In the exemplary usage method, such as Figure 3C As shown, the first right handle portion 230A and the second right handle portion 230B can move in the opposite direction to the first left handle portion 240A and the second left handle portion 240B to tear both the first body 202A and the second body 202B along at least the first tear line 220A to separate both the first body 202A and the second body 202B and the main package 80 disposed therebetween.

[0067] Advantageously, the labeling systems 100 and 200 can be applied to the main packaging 80 after it has been formed. This allows for the addition of labeling systems at a later time to facilitate opening the main packaging, for example, by adding them to an existing product before sale, or by attaching them to the packaging by an end user with reduced dexterity. The labeling systems can be modified to display different information about the main packaging 80 and / or the medical device 50 disposed therein, and can be attached to the main packaging 80 after its formation. Exemplary information may include information about the brand, manufacturer, model, serial number, batch number, instructions for use, instructions on how to open, instructions on disposal, etc., of the medical device. Advantageously, the labeling systems 100 and 200 may include instructions printed thereon to indicate how to use the labeling systems 100 and 200 to open the main packaging 80, for example, to help with which end to open the main packaging 80, where to begin separating along the tear line 120 or at the cutting line 124, how to hold the finger handles 130 and 140, etc.

[0068] Advantageously, a single type of labeling system (e.g., one of labeling systems 100 or 200) can be linked to master packages 80 of various types, sizes, and shapes, thereby simplifying manufacturing and reducing associated costs. Advantageously, labeling systems 100 or 200 can indicate to the user which end is the correct end to open the master package 80 (i.e., starting from the top edge 88 near the non-sterile portion 54 of the medical device 50). This mitigates the risk of the user accidentally opening the master package 80 from different edges not adjacent to the non-sterile portion 54 and compromising the sterility of the sterile portion 52.

[0069] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise in those skilled in the art, and are also encompassed in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A labeling and packaging system, comprising: The main packaging has a top seam and a bottom seam as well as defining an internal cavity; Medical devices, which are arranged within the internal cavity; and A labeling system, the labeling system comprising: A first body extends on a frontal plane and defines a front surface and a rear surface, and has a length (L) and a width (W), the rear surface being connected to the front surface of the main package; The first right handle is connected to the right side of the top edge of the first body; A first left handle portion, which is connected to the left side of the top edge of the first body; and A tear line extends longitudinally from the top edge of the first body, located between the first right handle and the first left handle, the distance (d) of the tear line being less than the length (L) of the first body, the tear line being configured to facilitate separation along the tear line when the first right handle is pushed in a direction opposite to the first left handle.

2. The system of claim 1, wherein the distance (d) is between 20% and 80% of the length (L) of the first body.

3. The system of claim 2, wherein the length (L) of the first body is equal to or less than the second length (L2) of the main package.

4. The system according to any one of the preceding claims further includes a tear-stopping portion disposed at the bottom end of the tear line.

5. The system of claim 4, wherein the tear-resistant portion includes a reinforcement exhibiting increased tensile strength to prevent further separation of the first body.

6. The system of claim 4, wherein the tear-resistant portion includes a bridging line angled relative to the tear line and configured to mitigate further separation along the tear line at a predetermined location on the main packaging.

7. The system according to any one of the preceding claims further includes a cutting portion extending from the top edge of the first body and disposed between the first right handle portion and the first left handle portion, the cutting portion extending through one or both of a portion of the first body and a portion of the top seam of the main package.

8. The system according to any one of the preceding claims, wherein the rear surface is connected to the front surface of the main package by one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing and ultrasonic welding.

9. The system according to any one of the preceding claims further comprises: The second right handle extends from the top edge of the first right handle and includes a first fold line disposed therebetween. And a second left handle portion, which extends from the top edge of the first left handle portion and includes a second fold line disposed therebetween; And a second body, which is connected to both the second right handle and the second left handle along the first edge of the second body.

10. The system of claim 9, wherein when folded along the first fold line, the outer periphery of the second right handle is aligned with the outer periphery of the first right handle, and when folded along the second fold line, the outer periphery of the second left handle is aligned with the outer periphery of the first left handle, and the surface of the second body is configured to connect with the rear side of the main package.

11. The system of claim 9, wherein the second body includes a second tear line extending from the first edge of the second body along a second distance (d2).

12. A method for opening a packaging and labeling system, comprising: A main package having a top seam and a bottom seam and defining an internal cavity, a medical device disposed within the internal cavity, and a labeling system having a body, the rear surface of the body being coupled to the front surface of the main package; The first right handle and the first left handle of the label system are gripped, the first right handle being connected to the right side of the top edge of the body, and the first left handle being connected to the left side of the top edge of the body; The first right handle is pushed along an axis that extends at an angle relative to the longitudinal axis of the main package in a direction opposite to the first left handle. The body is separated along a longitudinally extending tear line; as well as Tear a portion of the main packaging to access the medical device.

13. The method of claim 12, wherein the tear line is a weakening line extending a distance (d) along the body to facilitate separation along the tear line, the distance (d) being less than the longitudinal length (L) of the body.

14. The method of claim 13, wherein the distance (d) of the tear line is less than the longitudinal length (L2) of the main package.

15. The method of claim 13 or 14, further comprising a tear-stopping portion disposed at the bottom end of the tear line and configured to prevent the body from separating further beyond the distance (d).

16. The method of claim 15, wherein the tear-resistant portion comprises either a reinforcement or a brittle line, the brittle line being angled relative to the tear line and configured to mitigate further separation along the tear line at a predetermined location on the main packaging.

17. The method according to any one of claims 12 to 16, wherein attaching the rear surface of the body to the front surface of the main package comprises one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing, and ultrasonic welding.

18. A method for manufacturing a labeling and packaging system, comprising: A main package is formed having a top seam and a bottom seam, a front surface and a rear surface, the main package defining an internal cavity for accommodating the medical device; as well as The rear surface of the body of the labeling system is attached to the front surface of the main packaging. The labeling system includes a first right handle extending from the right side of the top edge of the body and a first left handle extending from the left side of the top edge of the body.

19. The method of claim 18, further comprising folding a second right handle relative to the first right handle along a first fold line such that the outer periphery of the second right handle is aligned with the outer periphery of the first right handle, and folding a second left handle relative to the first left handle along a second fold line such that the outer periphery of the second left handle is aligned with the outer periphery of the first left handle.

20. The method of claim 18 or 19, further comprising attaching a surface of the second body to the rear surface of the main package.

21. The method according to any one of claims 18 to 20, wherein attaching the rear surface of the body to the front surface of the main package comprises one or more of adhesive sealing, mechanical sealing, electrically induced sealing, thermal sealing, and ultrasonic welding.

22. The method according to any one of claims 18 to 21, further comprising forming a cut portion disposed between the first right handle portion and the first left handle portion and extending from the top edge of the body, the cut portion extending through one or both of the body and a portion of the top seam.

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