Flexible self-adhesive label with radiation sensitive indicator for syringes - Patents.com

Abstract

A flexible, self-adhesive label with a radiation-sensitive indicator for a syringe, the syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip in the front portion, a piston in the rear portion, and an outer surface with markings. The label adheres to at least one portion of the syringe and does not overlap the markings. Also disclosed are labeling methods, kits, and dispensers featuring such labels.

Description

[Technical field]

[0001] The processes, procedures, methods, products, deliverables and / or concepts disclosed herein (collectively referred to herein as "the disclosure or the invention") generally relate to flexible, self-adhesive labels for blood-containing products such as syringes, methods, kits and dispensers featuring such labels. [Background technology]

[0002] Dosimeters that determine the absorbed dose of ionizing radiation received by and deposited on a person or substrate are well known. There are many types of dosimeters, the most common being air capacitor dosimeters, film badges and thermoluminescent dosimeters.

[0003] Air capacitor dosimeters have an inner chamber that acts as an ion chamber and a central collecting electrode. Charge is attracted to the central electrode. When charged, such dosimeters are essentially air capacitors, and the amount of discharge during use is proportional to the absorbed dose of x-ray or gamma radiation received. Inherent in the use of such dosimeters is the need for a power source to apply a voltage between the electrode and the chamber walls.

[0004] Film badge dosimeters are loaded with one or more film packets. The simplest type of film badge consists of a small paper envelope containing the film, such as a dental x-ray, half of which is surrounded by a thin lead foil. The badge must contain one or more filters so that the relative darkening of the developed film can be compared from behind different filters. This comparison reveals the extent of exposure to various types of radiation. Inherent in such badges is the need for a development process to develop the exposed film.

[0005] Thermoluminescent dosimeters work on the principle of thermoluminescence, the property of some materials to emit light when heated after exposure to ionizing radiation. This type of dosimeter inherently requires measuring either the peak intensity or the integrated amount of light emitted.

[0006] While such dosimeters perform satisfactorily, they require external equipment or processes to function and / or be easily readable, i.e., absorbed radiation levels cannot be detected by merely visually observing the exposed material. For this reason, various self-developing dosimeters have gained widespread market acceptance.

[0007] In patent document 1 (U.S. Patent No. 4,001,587 issued January 4, 1977 to Mitrofanovich-Panchenkov et al.), a dosimeter is disclosed which incorporates a variety of dyes, some acid-sensitive and some non-acid-sensitive, which change color upon exposure to radiation.

[0008] Patent documents 2 and 3 (U.S. Pat. Nos. 5,051,597 and 5,084,623) disclose radiation dose indicators having radiation sensitive zones that can change opacity in response to radiation exposure, thereby changing the visibility of indicia in the indicator, and methods for manufacturing such indicators.

[0009] US Patent Publication No. 2016 / 0290859 discloses a film specially manufactured for measuring long-wave ultraviolet (UVA) light, more specifically, a film manufactured for use in indicating and / or measuring long-wave UV exposure dose, typically used in UV-based coating curing, pathogen inactivation, and other industrial and medical applications.

[0010] US Design Patent No. 458,642 discloses an ornamental design for a radiation indicator tag.

[0011] US Pat. No. 4,536,450 discloses nonlinear optical, piezoelectric and pyroelectric waveguides.

[0012] US Pat. No. 7,445,880 discloses photochromic filaments made from lithium salts of co-polymerizable polyacetylenes having carboxylic acid or carboxylate end groups. [Prior art documents] [Patent documents]

[0013] [Patent Document 1] U.S. Pat. No. 4,001,587 [Patent Document 2] U.S. Pat. No. 5,051,597 [Patent Document 3] U.S. Pat. No. 5,084,623 [Patent Document 4] US Patent Publication No. 2016 / 0290859 [Patent Document 5] U.S. Design Patent No. 458,642 [Patent Document 6] U.S. Pat. No. 4,536,450 [Patent Document 7] U.S. Patent No. 7,445,880 Summary of the Invention [Problem to be solved by the invention]

[0014] There are several important parameters to consider when placing a blood product into a syringe. For example, a transfusion technician can transfer an aliquot of the desired units into a syringe at the patient's bedside, thereby controlling the transfusion rate and volume. Furthermore, up to 6 hours of storage in the syringe results in platelets that are generally accepted by FDA standards and are acceptable after passage through the syringe. However, it is desirable to avoid storage at 37° C. and to minimize storage times and storage of reduced volume platelets.

[0015] Syringes are often the most problematic device causing cuts or needle sticks for healthcare workers, especially in hospital environments. Improving process flow and reducing safety hazards and risks in this environment is highly beneficial. Hospital processing departments are transitioning or considering irradiation of blood products in syringes for neonatal and pediatric patient populations. With the advent of new x-ray irradiators designed to irradiate syringes, irradiated syringes allow hospitals to operate and handle blood products with greater safety. In syringe applications such as during blood transfusions, a safe, fast and easy to understand distinction is crucial to determine if the blood is sterile or not.

[0016] In syringe applications where blood products are required for the neonatal and pediatric transitional stages, smaller syringes are commonly employed. Current indicators are unacceptable due in part to their size which impedes the ability of healthcare personnel to see the syringe markings. This results in unacceptable safety risks.

[0017] Current commercially available self-developable indicator products in the blood product market are typically supplied in boxes of 8 indicator cards, with 200 indicators (25 cards) per box, which must be opened to cut and handle the indicator cards and individual indicators.

[0018] Therefore, there is a need in the healthcare industry for an indicator that provides a quick and clear indication of radiation exposure when a syringe is exposed to radiation and that allows for a safer, more efficient workflow at reduced cost for healthcare providers. [Means for solving the problem]

[0019] The present disclosure provides a flexible, self-adhesive label with a radiation sensitive indicator for a syringe. The label can be adhesively attached to at least one portion of the syringe without overlapping the marking. The label of the present invention allows for improved fit and easier attachment to irradiated 30mL and 60mL syringes without interfering with the marking on the syringe barrel. In a preferred embodiment, the label includes a bar code and is efficiently packaged and dispensed from a roll.

[0020] One object of the present disclosure is to a flexible, self-adhesive label with a radiation sensitive indicator for a syringe having a barrel portion with a front portion and a rear portion, a tip at the front portion of the barrel, a piston at the rear portion of the barrel, and an exterior surface with a marking, the label adhesively attaches to at least one portion of the syringe and does not overlap the marking.

[0021] Another object of the present disclosure relates to a flexible self-adhesive label with a radiation sensitive indicator and a bar code for a syringe, the syringe having a barrel portion with a front portion and a rear portion, a tip at the front portion, a piston at the rear portion, and an exterior surface with a marking, the label adheres to at least one portion of the syringe and does not overlap the marking, the bar code is printed on the label with information regarding the label.

[0022] Another object of the present disclosure is a method for labeling a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an outer surface with a marking, with a flexible self-adhesive label having a radiation indicator, the method comprising the steps of providing a flexible self-adhesive label having a release layer, removing the release layer from the label, and attaching an adhesive layer of the label to at least one portion of the syringe in such a way that it does not overlap the marking.

[0023] Another object of the present disclosure relates to a kit comprising a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an outer surface with markings, and a flexible, self-adhesive label having a radioactive indicator and, optionally, a bar code that can be attached to the syringe.

[0024] Another object of the present disclosure relates to a dispenser for housing a roll of flexible self-adhesive labels having radiation sensitive indicators, the dispenser comprising a roll of flexible self-adhesive labels, a retaining case, at least one opening in said retaining case for dispensing said labels, and optionally an outer top cover on said retaining case.

[0025] These and other objects of the present invention will become apparent in light of the disclosure set forth below.

[0026] It is believed that the invention will be better understood from the following description taken in conjunction with the accompanying drawings, in which: The referenced drawings should not be construed as limiting the scope of the invention, and the referenced drawings should not be construed as limiting the scope of the invention with respect to the orientation of the label and dispenser. [Brief description of the drawings]

[0027] [Figure 1]1 shows a flexible self-adhesive label with a radiation sensitive indicator that is sensitive to gamma and x-rays. [Diagram 2] 2 shows a syringe using the label of FIG. 1. [Diagram 3] 1 shows a syringe with a flexible self-adhesive label at room temperature. [Figure 4] 1 shows a flexible self-adhesive label with a 2-D bar code. [Diagram 5] 1 shows a flexible self-adhesive label assembly. [Figure 6] 1 shows a box / package of flexible self-adhesive label roll assemblies. [Figure 7] FIG. 1 shows a flexible self-adhesive label dispenser. Note that these figures are diagrammatic and are not drawn to scale. The relative dimensions and proportions of parts in these figures are shown exaggerated or reduced in size for clarity and convenience of the drawings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Next, exemplary embodiments of the present invention will be described with reference to FIGS.

[0029] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that the present disclosure is not limited to the details of structure and configuration of the components or steps or methodologies set forth in the following description or illustrated in the drawings in this application. The present disclosure is capable of other embodiments or of being practiced or carried out in various ways. Moreover, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0030] Unless otherwise defined herein, technical terms used in connection with this disclosure shall have the meanings commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include the plural and plural terms shall include the singular.

[0031] All patents, published patent applications, and non-patent publications mentioned in this specification are indicative of the level of those skilled in the art to which this disclosure pertains. All patents, published patent applications, and non-patent publications mentioned in any part of this application are expressly incorporated by reference in their entirety into this specification to the same extent as if each individual patent or publication was specifically and individually incorporated by reference.

[0032] All of the articles and / or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. While the articles and / or methods of the present disclosure have been described in terms of preferred embodiments, it will be apparent to those skilled in the art that modifications can be applied to the articles and / or methods described herein, and to the steps or sequence of steps of the methods, without departing from the concept, spirit and scope of the present disclosure. All such similar permutations and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the present disclosure.

[0033] As used in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings:

[0034] The use of the word "a" or "an" when used in connection with the term "comprising" means "one" but is not inconsistent with the meanings of "one or more," "at least one," and "one or more than one." The use of the term "or" is used to mean "and / or" unless expressly indicated to refer to alternatives only when the alternatives are mutually exclusive, however, this disclosure supports a definition that refers to alternatives only as well as "and / or." Throughout this application, the term "about" is used to indicate that a value includes the inherent error variation of the device being quantified and the method employed to determine the value or variation present within the research question.

[0035] References herein to "one embodiment," "one aspect," "one version," "one objective," "another embodiment," "another aspect," "another version," or "another objective" of the invention may include one or more of such embodiments, aspects, versions, or objectives, unless the context clearly indicates otherwise.

[0036] The term "at least one" refers to one as well as any amount greater than one, including but not limited to 1, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term "at least one" can also extend to 100 or 1000 or more based on the accompanying term.

[0037] All percentages, parts, proportions, and ratios used herein are by weight of the total composition unless otherwise specified. All such weights pertaining to listed components are based on the active level and therefore do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

[0038] All references to singular features or limitations of the invention also include the corresponding plural features or limitations, and vice versa, unless otherwise specified or clearly implied to the contrary in the context of the reference.

[0039] As used herein, numerical ranges are intended to include all values ​​and subsets of values ​​contained within the range, whether specifically disclosed or not, and these numerical ranges should be construed as supporting the contemplation of any numerical value or subset of values ​​within that range for the claims.

[0040] As used herein, the words "comprising" (and any variation of "comprising", such as "comprise" and "comprises"), "having" (and any variation of "having", such as "have" and "has"), "including" (and any variation of "including", such as "includes" and "include"), or "containing" (and any variation of "containing", such as "contains" and "contain") are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. As used herein, the terms "or combinations thereof" and "and / or combinations thereof" refer to all permutations and combinations of the listed items preceding the term. For example, "A, B, C, or combinations thereof" is intended to include at least one of A, B, C, AB, AC, BC, or ABC, including, if order is important in a particular context, BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that include one or more repeats of a term, for example, combinations that include BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, etc. One of skill in the art will understand that generally there is no limit on the number of items or the items in any combination unless otherwise clear from the context.

[0041] For purposes of the following detailed description, except for any operating examples or where otherwise indicated, for example, numerical values ​​expressing quantities of ingredients used in the specification and claims are to be understood as being modified in all instances by the term "about." The numerical parameters set forth in the specification and appended claims are approximations that may vary depending on the desired properties obtained in the practice of the invention.

[0042] As used herein, the terms "or combinations thereof," "and combinations thereof," and "combinations thereof" refer to all permutations and combinations of the listed items preceding the term.

[0043] The term "about" refers to a range of +10% of a particular value. For example, the phrase "about 200" includes ±10% of 200, or from 180 to 220.

[0044] The term "polymerization" or "polymerizing" refers to the process of chemically reacting monomer compounds to form polymer chains. The polymer chains can be alternating, blocked, or random. The type of polymerization process can be selected from a wide variety of methods and includes the following non-limiting examples: polycondensation, step-growth polymerization, and free radical polymerization.

[0045] The term "macromolecule" refers to any macromolecule, including polymers. The term "polymer" refers to a macromolecule that includes monomeric residues (repeating units) linked by one or more types of covalent chemical bonds. Non-limiting examples of polymers include monopolymers and non-monopolymers such as copolymers, terpolymers, tetrapolymers and higher analogs.

[0046] The term "syringe" refers to a device constructed of glass, metal, or hard rubber tubing with a narrowed exit and fitted with a piston or rubber bulb, or any other suction device having similar characteristics and purpose, for drawing in a volume of fluid or for expelling the fluid as a stream via a needle, for example, for injecting fluid into the body to irrigate a wound, etc. The syringe can be a neonatal, pediatric, traditional, standard, or general purpose syringe.

[0047] The term "threshold dosage range" refers to the magnitude or intensity of radiation that must be administered to produce or manifest a given reaction, phenomenon, result, or condition. A threshold level in the range is reached before the signal passes and produces no change or reaction in the compound.

[0048] The term "QR Code" or "Quick Response Code" is a 2D matrix code that transfers information by a matrix, i.e. an arrangement of dark and light element cells, so-called "modules", in horizontal and vertical directions. Each dark or light module of a QR Code symbol - a specific instance of the code - represents a 0 or a 1, thus making it machine understandable. The QR Code is detected by a 2D digital image sensor and then digitally analyzed by a programmed processor. The processor finds three distinct squares in the corners of the QR Code image, using a smaller square (or squares) near the fourth corner to normalize the image with respect to size, orientation, and viewing angle. The small dots throughout the QR Code are then converted into binary numbers and enabled with an error-correcting code.

[0049] The present disclosure contemplates a flexible self-adhesive label with a radiation sensitive indicator for a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion of the barrel portion, a piston at the rear portion of the barrel portion, and an exterior surface with a marking, the label adheres to at least one portion of the syringe and does not overlap the marking.

[0050] According to one embodiment, the syringe (100) comprises a main body (11) having a portion for receiving the label (12) and markings (13). The main body, which is the barrel (14) of the syringe, has a forward end (15) and a rearward end (16), and a head (17) as a needle-engaging extension at the forward end of the main body. The head has an aperture (18) for loading or expelling the fluid of the syringe with or without a needle. The syringe further comprises a piston (19) at the rearward end, where the piston has an opening for receiving the forward end of a piston rod. The piston is disposed for sliding movement within the barrel and is releasably coupled to the barrel. The barrel further has opposed side edges (20) that are straight and extend parallel to one another in the longitudinal direction to provide a grip for the user while using the syringe.

[0051] According to one embodiment, the barrel can be marked, marked, shaped, or otherwise customized to indicate to the user the desired amount of a particular fluid to be drawn into the syringe. This allows the syringe (which can be neonatal, pediatric, traditional, standard, or general-purpose syringes) to be consistently and reliably marked. The markings can customize the syringe for a particular purpose to reduce the chance of human error and improve safety. According to another embodiment, the head of the syringe tends to secure the main body longitudinally of the barrel, thereby helping to ensure that the desired amount of marking is placed in the correct location on the barrel. Generally, the aperture need not be completely closed by the head. For example, the aperture can have a slot or notch in the head.

[0052] According to another embodiment, the markings on the barrel have a numerical indication of the amount. The numerical indication of the amount is 1 ml to 200 ml. In another embodiment, there are other possible numerical indication ranges of the amount, including, but not limited to, about 0.1 ml to 10 ml, about 1 ml to about 20 ml, about 1 ml to about 30 ml, about 1 ml to about 40 ml, about 1 ml to about 50 ml, about 1 ml to about 60 ml, about 1 ml to about 70 ml, about 1 ml to about 80 ml, about 1 ml to about 90 ml, about 1 ml to about 100 ml, about 1 ml to about 110 ml, about 1 ml to about 120 ml, about 1 ml to about 130 ml, about 1 ml to about 140 ml, about 1 ml to about 150 ml, about 1 ml to about 160 ml, about 1 ml to about 170 ml, about 1 ml to about 180 ml, about 1 ml to about 190 ml, and about 1 ml to about 200 ml.

[0053] According to one embodiment, the continuous piece of material at the headland surrounds the opening, whereby the border of the opening defines a closed contour. The opening may be circular. The headland is preferably shorter than the main body in the longitudinal direction of the marking. The headland is preferably narrower than the main body in the transverse direction of the marking.

[0054] According to another embodiment, the markings include marks / indications at predetermined longitudinal positions along the main body indicating the longitudinal position in the syringe barrel to which the syringe piston should be pulled to fill the syringe with a predetermined amount of fluid.

[0055] Additionally, markings can be provided at different longitudinal positions to indicate other different predefined amounts for other different predefined fluids. In some embodiments, the markings graphically indicate a longitudinal position and / or longitudinal range that corresponds to a predefined safe dose of the fluid. When fluid is drawn into the syringe (e.g., from an ampoule or vial), the piston is drawn along the barrel to a position that is within the marked longitudinal position and / or graphically indicated range. The syringe is then known (and visible) to contain a safe dose of the fluid. Ranges and / or positions can also be indicated for different safe doses of other different fluids. The marked longitudinal position can indicate a nominal correct dose. This can be theoretically derived from empirical models or can be, for example, an average dose used by the treating surgeon. The average dose can be a median dose.

[0056] According to another embodiment, a flexible self-adhesive label (12) is attached to at least one portion of the outer surface of the syringe, as shown in Figure 2. The label can be of any shape or can be capable of indicating whether the syringe is irradiated or not. The label can be designed so that the ends meet after being wrapped around the barrel of the syringe, thereby ensuring that the ends are abutted against the correct diameter of the syringe.

[0057] According to one embodiment, the radiation sensitive indicator can be adapted from the commercially available Rad-sure™ blood irradiation indicator available from Ashland LLC, which provides reliable visual verification of irradiation at the lowest specified dose. Manufactured from Gafchromic™ film, the world's highest resolution dosimeter, Rad-sure has been the blood irradiation indicator standard for 25 years. The radiation sensitive indicator can be sensitive to gamma and / or x-rays. Sensitive to gamma and / or x-rays radiation sensitivity indicator A flexible self-adhesive label comprising: This is shown in Figure 1. The radiation sensitive indicator has an "IRRADIATED" display portion (an additional display portion that is free of the radiation sensitive element).The gamma radiation sensitivity can be matched to Cesium-137 or Cobalt-60 radiation sources, and the X-ray sensitivity can be matched to X-ray irradiators utilizing X-rays generated from a 160 kVp source filtered by 0.38 mm copper or a 150 kVp source filtered by 1 mm aluminum. Radiation dose indicators and their assemblies are generally disclosed in U.S. Pat. No. 5,084,623 and U.S. Pat. No. 9,797,771.

[0058] According to one embodiment, the radiation dose indicator is exposed to radiation at an energy level of at least about 50 keV to about 10 MeV. In other embodiments, other possible ranges include, but are not limited to, about 40 keV to about 50 keV, about 50 keV to about 60 keV, about 60 keV to about 70 keV, about 70 keV to about 80 keV, about 80 keV to about 90 keV, about 90 keV to about 100 keV, about 1 MeV to about 2 MeV, about 2 MeV to about 3 MeV, or about 3 MeV to about 4 MeV.

[0059] According to one embodiment, the radiation has a threshold dose range of about 2500 rads to about 5000 rads. In other embodiments, other possible ranges include, but are not limited to, about 2500 rads to about 3000 rads, about 3000 rads to about 3500 rads, about 3500 rads to about 4000 rads, about 4000 rads to about 4500 rads, or about 4500 rads to about 5000 rads.

[0060] According to one embodiment, about 10 -8 J / cm 2 rads~about 10 3 J / cm 2 In another embodiment, other possible ranges include, but are not limited to, a threshold dose range of about 10 -8 J / cm 2 rads~about 10 -7 J / cm 2 , about 10 -7 J / cm 2 rads~about 10 -6 J / cm2 , about 10 -6 J / cm 2 rads~about 10 -5 J / cm 2 , about 10 -5 J / cm 2 rads~about 10 -4 J / cm 2 , about 10 -4 J / cm 2 rads~about 10 -3 J / cm 2 , about 10 -3 J / cm 2 rads~about 10 -2 J / cm 2 , about 10 -2 J / cm 2 rads~about 10 -1 J / cm 2 , about 10 -1 J / cm 2 rads~about 1J / cm 2 , about 1J / cm 2 rads~about 10 1 J / cm 2 , or about 10 2 J / cm 2 rads~about 10 3 J / cm 2 There is.

[0061] According to one embodiment, about 10 -3 ~10 8 According to one embodiment, the threshold dose range is about 10 -3 ~10 8 rads, about 10 -3 ~10 -2 ads, about 10 -2 ~10 -1 rads, about 10 -1 ~10rads, about 10~10 1 rads, about 10 1 ~10 2 rads, about 10 2 ~10 3 rads, about 10 3 ~10 4 rads, about 10 4 ~10 5 rads, about 10 5~10 6 rads, about 10 6 ~10 7 rads, or about 10 7 ~10 8 rads, with a threshold dose range of 100 .mu.m.

[0062] According to one of the embodiments, the radiation indicator comprises a radiation-sensitive polyacetylene compound. Non-limiting examples of polyacetylene compounds useful in the present invention are disclosed in U.S. Pat. No. 5,137,964 and U.S. Pat. No. 7,445,880. Strictly speaking, it is also contemplated that any other comparable radiation-sensitive material can be used in the practice of the present invention.

[0063] According to another embodiment, the flexible self-adhesive label further comprises a first adhesive layer, a leader band, a second adhesive layer, and a release layer, where a first side of the adhesive layer, leader band, or release layer is attached to a second side of the radiation sensitive indicator, adhesive layer, leader band, or release layer, as shown in FIG. 5. The radiation sensitive indicator is positioned on the first side of the adhesive layer. The second side of the adhesive layer is attached to the first side of the release layer. Furthermore, the second side of the release layer is attached to the first side of the leader band.

[0064] According to one of the embodiments, the radiation dose indicator is attached to an adhesive layer. Several useful adhesives for forming the adhesive layer are commercially available, such as acrylic adhesives, acrylic-urethane based adhesives, etc. The indicator can be fixed to a double-coated film product having two adhesive layers. The double-coated film product can be a plastic film coated with pressure-sensitive adhesive on both sides.

[0065] In another embodiment, the adhesive layer is positioned on one side of a release layer and the other side of the release layer is positioned on one side of a leader band. The release layer has an attachment film for attaching the radiation dose indicator. Attachment films are commercially available, such as Mactac's Perma Trans PUV2100, IP2100, IB2104, etc.

[0066] According to one embodiment, the flexible self-adhesive label comprises a radioactive indicator and a bar code, as shown in Figure 4. The label can be attached to at least one portion of the syringe and preferably does not overlap the markings. The bar code can be printed on the label and can include information about the label.

[0067] According to another embodiment, the barcode is selected from the group consisting of a radiation sensitive 2D barcode and a radiation insensitive 2D barcode.

[0068] According to another embodiment, the barcode is selected from the group consisting of 2D code, QR code (Quick Response Code), MicroQR, Modified QR code, PDF-417, MaxiCode, Aztec Code, EAN barcode, and Data Matrix.

[0069] According to another embodiment, the barcode is selected from the group consisting of 2D code, QR code (Quick Response Code), MicroQR, Modified QR code, PDF-417, MaxiCode, Aztec Code, EAN barcode, and Data Matrix.

[0070] According to one embodiment, the present disclosure relates to a method of labeling a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an exterior surface with a marking, comprising attaching a flexible self-adhesive label as described above, including a radiation sensitive indicator and a release layer, to at least one portion of the syringe, the method comprising the steps of providing a flexible self-adhesive label, removing the release layer of the label, and attaching the adhesive layer of the label to at least one portion of the syringe without overlapping the marking.

[0071] According to one embodiment, there is provided a kit comprising a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an outer surface with markings, and a flexible, self-adhesive label that can be attached to the syringe as summarized above. The label is attached to at least one portion of the syringe so as not to overlap the markings. The label can include a bar code. According to another embodiment, the kit can further comprise educational material for patients and / or health care professionals.

[0072] According to another embodiment, the kit includes one or more self-adhesive labels for attachment to a syringe, as shown in Figure 6. The self-adhesive labels can be one or more labels, a sheet of labels, a roll of a radiological indicator, or a dispenser containing a roll of a radiological indicator.

[0073] According to another embodiment, a dispenser containing a roll of flexible self-adhesive labels includes a roll of flexible self-adhesive labels, a holding case, at least one opening in the holding case for dispensing the labels, and optionally an outer top cover on the holding case, as shown in Figure 7. It is desirable to protect unused indicators from exposure to light. Additionally, this package design allows for a single indicator to be provided to healthcare personnel, reducing handling steps and eliminating the need to separate and handle indicator cards.

[0074] According to another embodiment, the holding case is formed in the shape of a cube, a cylinder, a semi-cylinder or a rectangular parallelepiped.

[0075] According to an alternative embodiment, an outer top cover protects the roll of labels as well as the individual labels.

[0076] According to another embodiment, the label is peeled from the roll before being attached to the syringe.

[0077] The following examples are presented to illustrate some of the features and advantages of various embodiments of the invention. EXAMPLES

[0078] Three syringes with flexible self-adhesive labels were prepared by adhesively attaching a flexible self-adhesive label of the present disclosure to each syringe, and these three syringes were used to analyze the attachment of the labels to the syringes at various temperature storage conditions.

[0079] Example 1: Adhesion Test The adhesive based indicators were attached to plastic syringes at room temperature (20-23°C). Individual indicators were then held at room temperature (see Figure 3), refrigerator temperature (4-10°C), and freezer temperature (-30 to -15°C). After this, the syringes were visually inspected for adhesion to the syringe barrel (see Figure 3).

[0080] The indicator demonstrated non-adhesive performance for the room temperature samples. The refrigerator and freezer samples continued to show adhesion to the syringe. Thus, the indicator of the present application demonstrated excellent adhesion required for pediatric syringe applications.

[0081] While the invention has been described in detail with reference to certain preferred embodiments, it is to be understood that the invention is not limited to those precise embodiments. Rather, many variations and modifications will be apparent to those skilled in the art in light of this disclosure without departing from the scope and spirit of the invention.

Claims

1. A flexible, self-adhesive label comprising a radiation sensitive indicator for a syringe, the syringe having a barrel with a front portion and a rear portion, the barrel having a tip at the front portion, a piston at the rear portion, and an exterior surface with a marking, the label adhering to at least one portion of the syringe and not overlapping the marking; the radiation is x-ray or gamma ray radiation; the radiation sensitive indicator comprises a chemical compound selected from the group consisting of radiation sensitive lithium polyacetylene compounds and polyacetylene compounds; Flexible self-adhesive labels.

2. 10. The flexible self-adhesive label of claim 1, further comprising an adhesive layer, a leader band, and a release layer; A flexible, self-adhesive label, wherein a first side of the adhesive layer, the leader band, or the release layer adheres to a second side of the radiation sensitive indicator, the adhesive layer, the leader band, or the release layer.

3. 3. The flexible, self-adhesive label of claim 2, wherein the radiation sensitive indicator is positioned on the first side of the adhesive layer.

4. 3. The flexible, self-adhesive label of claim 2, wherein the second side of the adhesive layer adheres to the first side of the release layer.

5. 3. The flexible, self-adhesive label of claim 2, wherein said second side of said release layer adheres to said first side of said leader band.

6. 10. The flexible, self-adhesive label of claim 1, wherein the radiation sensitive indicator is sensitive to energy levels of at least about 40 keV to about 10 MeV.

7. 10. The flexible, self-adhesive label of claim 1, wherein the radiation sensitive indicator has a threshold sensitivity dose range of about 2500 rads to about 5000 rads.

8. 10. The flexible, self-adhesive label of claim 1, wherein the radiation has a threshold sensitivity dose range of about 3000 rads to about 4500 rads.

9. 2. The flexible self-adhesive label of claim 1, wherein the radiation is about 10 －８ J / cm ２ ~about 10 ３ J / cm ２ A flexible, self-adhesive label having a threshold sensitivity dose range of .

10. 2. The flexible self-adhesive label of claim 1, wherein the radiation is about 10 －３ rads~10 ８ A flexible, self-adhesive label having a threshold sensitive dose range of rads.

11. 10. The flexible, self-adhesive label of claim 1, wherein the markings on the barrel of the syringe include a numerical indicia of a quantity.

12. 12. The flexible, self-adhesive label of claim 11, wherein the numerical indication of the amount is between 10 ml and 200 ml.

13. 2. The flexible, self-adhesive label of claim 1, wherein the syringe is a pediatric or neonatal syringe.

14. 2. The flexible, self-adhesive label of claim 1, wherein said headland has a circular opening.

15. 2. The flexible, self-adhesive label of claim 1, wherein said piston comprises an axially movable ram.

16. 2. The flexible, self-adhesive label of claim 1, wherein the radiation indicator has an additional display portion free of radiation sensitive elements for marking purposes.

17. 1. A flexible, self-adhesive label having a radiation sensitive indicator and a bar code for a syringe, the syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an outer surface with markings, the label adheres to at least one portion of the syringe and does not overlap the markings, the bar code is printed with information on the label, and the radiation is x-ray or gamma ray radiation.

18. 18. The flexible, self-adhesive label of claim 17, wherein the bar code is selected from the group consisting of radiation sensitive and radiation insensitive 2-D bar codes.

19. 18. The flexible, self-adhesive label of claim 17, wherein the 2-D barcode is selected from the group consisting of QR Code (Quick Response Code), Micro QR, Modified QR Code, PDF-417, MaxiCode, Aztec Code, EAN Barcode, and Data Matrix.

20. 1. A method of applying a label to a syringe having a barrel portion having a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an exterior surface with markings, the label adhering to at least one portion of the syringe and not overlapping the markings, the method comprising: Providing the flexible self-adhesive label having the radiation indicator of claim 2; removing the release layer of the label; and attaching the adhesive layer of the label to the syringe so as not to overlap the marking; A labeling method comprising:

21. a syringe having a barrel portion with a front portion and a rear portion, the barrel portion having a tip at the front portion, a piston at the rear portion, and an exterior surface with markings; and a flexible, self-adhesive label capable of being attached to the syringe, the label having the radiation indicator of claim 1; A kit comprising the combination of The label is attachable to at least one portion of the syringe such that it does not overlap the marking.

22. 10. A dispenser containing a roll of flexible self-adhesive labels having a radiation sensitive indicator according to claim 1, comprising: A roll of the flexible self-adhesive label of claim 1; A holding case and at least one opening in the holding case for dispensing the labels; and, optionally, an outer top cover of the holding case; A distributor comprising:

23. 23. The dispenser of claim 22, wherein the retaining case has a cubic, cylindrical, semi-cylindrical or rectangular shape.

24. 23. The dispenser of claim 22, wherein the outer top cover protects a roll of labels.

25. 23. The dispenser of claim 22, wherein the label is peeled from a roll prior to application to the syringe.

Images