阅读说明：本技术 由弹性体制成的激光标记的医疗部件 (Laser marked medical parts made of elastomer ) 是由 J·克里赞 S·亚伯拉罕 于 2019-10-15 设计创作，主要内容包括：提供了一种医疗装置部件。所述医疗装置部件可以包括具有第一表面的主体,所述主体至少部分地由具有第一颜色的可标记材料形成,所述可标记材料具有以下特性：暴露于预定波长的紫外光的激光照射下的区域变为与所述第一颜色不同的第二颜色；覆盖所述主体的所述第一表面的至少一部分的膜,所述膜在所述预定波长的紫外光下的透射率为至少5％；以及在由所述膜覆盖的所述主体的所述第一表面处的所述可标记材料上的可见标记。所述可见标记可以包括在所述第一表面处具有所述第二颜色的所述可标记材料的一个或多个区域。还提供了制造所述医疗装置部件的方法。(A medical device component is provided. The medical device component may include a body having a first surface, the body being at least partially formed of a markable material having a first color, the markable material having the following characteristics: a region exposed to laser irradiation of ultraviolet light of a predetermined wavelength becomes a second color different from the first color; a film covering at least a portion of the first surface of the body, the film having a transmittance of at least 5% at the predetermined wavelength of ultraviolet light; and a visible mark on the markable material at the first surface of the body covered by the film. The visible marking may comprise one or more regions of the markable material having the second color at the first surface. Methods of making the medical device components are also provided.)

1. A method for manufacturing a medical device component, the method comprising:

forming a body of the medical device component, the body having a surface and being formed at least in part from a markable material having a first color;

applying a film to at least a portion of the surface of the body, including applying a film to at least a portion of the markable material; and

after forming the film, exposing one or more regions of the at least a portion of the markable material to laser radiation of a predetermined wavelength to form a visible mark on the surface of the body by changing the one or more regions to a second color different from the first color.

2. The method of claim 1, wherein the markable material is an elastomeric material comprising an inorganic filler material.

3. The method of claim 2, wherein the inorganic filler material in the one or more regions of the at least a portion of the markable material absorbs the laser radiation to produce the second color.

4. The method of claim 1, wherein said forming the visible indicia comprises forming a machine readable code.

5. The method of claim 4, wherein the machine-readable code is a data matrix code.

6. The method of claim 1, wherein the predetermined wavelength is in the ultraviolet wavelength range.

7. The method of claim 1, wherein exposing the at least a portion of the markable material to laser radiation comprises raster scanning the laser radiation across a plurality of areas of the at least a portion of the markable material.

8. The method of claim 1, wherein exposing the at least a portion of the markable material to laser radiation comprises translating a laser across multiple regions of the at least a portion of the markable material with an XY carriage.

9. The method of claim 1, further comprising applying a mask on a surface of the at least a portion of the markable material prior to exposing the at least a portion of the markable material to laser radiation.

10. The method of claim 1, wherein the film comprises a material selected from the group consisting of: tetrafluoroethylene, Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyvinylidene fluoride (PVF), polyvinylidene fluoride (PVDF), Polychlorotrifluoroethylene (PCTFE), Perfluoroalkoxyalkane (PFA), Ethylene Chlorotrifluoroethylene (ECTFE), perfluoroelastomer (FFPM), Fluoroelastomer Polymer (FPM), Polyethylene (PE), Cyclic Olefin Polymer (COP), Cyclic Olefin Copolymer (COC), polypropylene (PP), and combinations thereof.

11. A medical device component, comprising:

a body having a first surface, the body being formed at least in part from a markable material having a first colour, the markable material having the following characteristics: a region exposed to laser irradiation of ultraviolet light of a predetermined wavelength becomes a second color different from the first color;

a film covering at least a portion of the first surface of the body, the film having a transmittance of at least 5% at the predetermined wavelength of ultraviolet light; and

a visible marking on the markable material at the first surface of the body covered by the film, the visible marking including one or more areas of the markable material having the second color at the first surface.

12. The medical device component of claim 11, wherein the visible indicia is a machine readable code.

13. The medical device component of claim 12, wherein the machine-readable code is a data matrix code.

14. The medical device component of claim 11, wherein the markable material is an elastomeric material comprising an inorganic filler material.

15. The medical device component of claim 11, wherein the visible indicia includes information related to at least one of manufacturing and patient information of the medical device component.

16. The medical device component of claim 11, wherein the visible indicia comprises a Uniform Resource Locator (URL) pointing to a website containing metadata associated with the medical device component.

17. The medical device component of claim 11, wherein the visible indicia comprises a unique ID found in a database containing metadata associated with the medical device component.

18. A method for manufacturing a medical device component, the method comprising:

forming a body of the medical device component during a molding process, the body having a surface and being formed at least in part from a markable material having a first color;

forming a film on at least a portion of the surface of the body, including on at least a portion of the markable material;

forming a first visible mark on the surface of the body covered by the film by exposing one or more first areas of the at least a portion of the markable material to laser radiation of a predetermined wavelength to change the one or more first areas to a second color different from the first color, the first visible mark containing or linked to first data relating to the moulding and/or film forming step;

cleaning the medical device component from the mold; and

forming a second visible mark on the surface of the body covered by the film by exposing one or more second areas of the at least a portion of the markable material to laser irradiation of the predetermined wavelength to change the one or more second areas to the second color, the second visible mark containing or linked to second data relating to the cleaning step.

19. The method of claim 18, further comprising:

trimming the medical device component from the mold; and

forming a third visible mark on the surface of the body covered by the film by exposing one or more third areas of the at least a portion of the markable material to laser irradiation of the predetermined wavelength to change the one or more third areas to the second color, the third visible mark containing or linked to third data relating to the trimming step.

20. The method of claim 18, further comprising:

visually inspecting the medical device component; and

forming a third visible mark on the surface of the body covered by the film by exposing one or more third areas of the at least a portion of the markable material to laser irradiation of the predetermined wavelength to change the one or more third areas to the second color, the third visible mark containing or linked to third data relating to the visual inspection step.

21. The method of claim 18, wherein the first and second visible indicia are graphical symbols.

22. The method of claim 18, wherein the first visible indicium and the second visible indicium are machine-readable codes.

23. The method of claim 18, wherein the predetermined wavelength is in the ultraviolet wavelength range.

Technical Field

Embodiments described herein relate to medical device components, and in particular elastomeric components, such as stoppers or plungers, seals, and the like, laser marked with data or other identifying information, and in particular methods of marking such components during multiple manufacturing steps.

Background

Previous attempts to serialize or label medical device components utilized Radio Frequency (RF) tags, labels, mold cavity identification, or surface printing. RF tags can be expensive, rigid, and difficult to apply on a large scale. The label needs to be adhesive, which may risk leaching material into the drug, and may also be difficult to apply. The mold cavity identification is not unique, may wear out over time, and provides only limited information. Surface printing may also produce leached material, and differences in surface morphology may affect sealability or processability.

Disclosure of Invention

In one aspect, the present invention relates to a method for manufacturing a medical device component. The method may include forming a body of the medical device component, the body having a surface and being formed at least in part from a markable material having a first color; applying a film to at least a portion of the surface of the body, including applying a film to at least a portion of the markable material; and after forming the film, exposing one or more regions of the at least a portion of the markable material to laser radiation of a predetermined wavelength to form a visible mark on the surface of the body by changing the one or more regions to a second color different from the first color.

In another aspect, the present invention relates to a medical device component comprising a body having a first surface, the body being at least partially formed from a markable material having a first color, the markable material having the following characteristics: a region exposed to laser irradiation of ultraviolet light of a predetermined wavelength becomes a second color different from the first color; a film covering at least a portion of the first surface of the body, the film having a transmittance of at least 5% at the predetermined wavelength of ultraviolet light; and a visible mark on the markable material at the first surface of the body covered by the film. The visible marking comprises one or more regions of the markable material having the second color at the first surface.

In yet another aspect, the present invention relates to a method for manufacturing a medical device component. The method may include: forming a body of the medical device component during a molding process, the body having a surface and being formed at least in part from a markable material having a first color. The method may further comprise: forming a film on at least a portion of the surface of the body, including on at least a portion of the markable material. In another step, the method may comprise: forming a first visible mark on the surface of the body covered by the film by exposing one or more first areas of the at least a portion of the markable material to laser radiation of a predetermined wavelength to change the one or more first areas to a second color different from the first color, the first visible mark containing or linked to first data relating to the moulding and/or film forming step. In yet another step, the method may comprise: cleaning the medical device component from the mold; and forming a second visible mark on the surface of the body covered by the film by exposing one or more second areas of the at least a portion of the markable material to laser irradiation of the predetermined wavelength to change the one or more second areas to the second color, the second visible mark containing or linked to second data relating to the washing step.

These and other aspects of the invention will be apparent from the following description.

Drawings

The foregoing summary, as well as the following detailed description of the embodiments, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the figure:

FIG. 1 is a front perspective view of a stopper having laser-generated visible indicia thereon according to an embodiment of the present invention;

FIG. 2 is a schematic cross-sectional elevation view of a stopper including laser-produced visible indicia thereon according to another embodiment of the present invention;

FIG. 3 is a top perspective view of a stopper including a laser-generated visible mark thereon formed on the stopper using a method according to an embodiment of the present invention, according to yet another embodiment of the present invention;

FIG. 4A is an enlarged plan view of a portion of the laser-generated visible mark on the stopper of FIG. 3 with the focal point at the top of the cover film surface;

FIG. 4B is an enlarged plan view of a portion of the laser-generated visible mark on the stopper of FIG. 3 with the focal point on the surface of the stopper material located below the cover film;

FIG. 5 is a schematic flow chart of an exemplary method of manufacturing a stopper according to another embodiment of the present invention;

FIG. 6 is a schematic flow chart of an exemplary method of manufacturing and continuously marking a stopper according to yet another embodiment of the present invention;

FIG. 7 is an enlarged partial top view of a stopper including a plurality of laser-produced visible indicia thereon according to various embodiments of the present invention;

fig. 8A and 8B are top perspective views of a plunger rod having surface markings according to another embodiment of the present invention;

FIG. 9A is an enlarged top view of a plastic closure with a surface marked seal according to another embodiment of the present invention;

FIG. 9B is an enlarged side view of an aluminum seal having surface markings according to another embodiment of the present invention;

FIG. 10A is a top perspective view of an elastomeric plug having surface markings assembled in a closure having a transparent cover in accordance with another embodiment of the present invention;

FIG. 10B is an enlarged view of one of the surface markings in the assembly of FIG. 10A;

FIG. 11 is a top perspective view of various elastomeric plungers having surface markings according to yet another embodiment of the present invention;

FIG. 12A is a top view of a molded plate containing a plurality of molded stoppers; and is

Fig. 12B is an enlarged view of the top surface of the molded stopper of fig. 12A with surface markings according to yet another embodiment of the present invention.

Detailed Description

In the following description, certain terminology is used for convenience only and is not limiting. The words "lower," "bottom," "upper," "top," "front," "back," and "back" refer to the orientation in the drawings to which reference is made. In accordance with the present disclosure, the terms "inwardly" and "outwardly" refer to directions toward and away from, respectively, the geometric center of the component in question and designated parts thereof. The terms "a/an" and "the" are not limited to one element, but rather are read to mean "at least one" unless expressly stated herein. Sometimes "at least one" is used for clarity or readability, but such use does not alter the interpretation of "a/an" and "the". The terminology includes the words noted above, derivatives thereof, and words of similar import.

It will also be understood that the terms "about," "approximately," "substantially," and "substantially," as used herein in reference to a dimension or characteristic of an element of the invention, indicate that the dimension/characteristic being described is not a strict boundary or parameter and does not preclude minor variations thereof that are functionally similar. At the very least, such reference to include numerical parameters is intended to include variations that do not alter the lowest significant digit using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.).

In certain aspects, elastomeric components that come into contact with the drug can be marked/sequenced by using an Ultraviolet (UV) laser to produce a product that is safe, clean, and sterilization compatible. Even if an optional film has been applied, precise indicia can be applied to the molded article or finished product. This technique, particularly where the mark is produced under the film, poses little risk to the pharmaceutical product, since any extractables that may be produced do not appear at the surface of the component. Furthermore, this technique may be more preferred for components used in low temperature applications because, unlike labels utilizing adhesives, exposure to large temperature differences is substantially unlikely to affect the marking. This technique is broadly applicable to elastomeric parts that utilize inorganic fillers and can be extended to other polymeric parts, particularly those that can be covered in a compatible film or other transparent layer.

Referring to fig. 1-3, examples of medical device components, such as a stopper 10, according to various preferred embodiments are shown. The stopper 10 includes a body 12, the body 12 preferably being at least partially formed of an elastomeric material having a first color, such as synthetic or natural rubber, e.g., butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber (e.g., bromobutyl rubber), ethylene propylene terpolymer, silicone rubber, Ethylene Propylene Diene Monomer (EPDM) rubber, combinations thereof, and the like, the elastomeric material preferably containing an inorganic filler material, such as titanium dioxide and the like. In other embodiments, the body 12 may be made at least in part of a polymer with a significant amount of carbon black, such that the first color of the body 12 material is darker. Such materials are markable, as will be explained further below. The body 12 preferably has a longitudinal axis L and a first surface 12a, the first surface 12a being oriented transverse, and more preferably substantially perpendicular, to the longitudinal axis L. In some embodiments, the first surface 12a may be in contact with an agent. The body 12 includes additional surfaces that may be connected to or adjacent the first surface 12a, which may extend parallel to or coaxial with the longitudinal axis L, etc. For example, the body 12 may have a cylindrical shape such as shown in fig. 1, with one or more ribs formed coaxially about the longitudinal axis L to seal the stopper 10 within a container or the like such as a syringe (not shown).

At least a portion of the surface of body 12, and preferably at least a portion of first surface 12a in certain embodiments, may be covered by a membrane 14 (fig. 2, 4A), which membrane 14 acts as a barrier material between the elastomeric material of body 12 and any pharmaceutical agent (not shown) with which body 12 may come into contact. Common membranes 14 used for such purposes may include, but are not limited to, materials comprising tetrafluoroethylene, Ethylene Tetrafluoroethylene (ETFE), Polytetrafluoroethylene (PTFE), Perfluoroalkoxyalkane (PFA), polyvinylidene fluoride (PVDF), Fluorinated Ethylene Propylene (FEP), polyvinylidene fluoride (PVF), Polychlorotrifluoroethylene (PCTFE), Ethylene Chlorotrifluoroethylene (ECTFE), perfluoroelastomers (FFPM), Fluoroelastomer Polymers (FPM), Polyethylene (PE), Cyclic Olefin Polymers (COP), Cyclic Olefin Copolymers (COC), polypropylene (PP), combinations thereof, and the like.

As shown in fig. 1-4B and 7, the stopper 10 preferably includes visible indicia 16 formed on the surface of the body 12. Preferably, the visible indicia 16 is formed on a surface of the body 12 that is highly visible at least during manufacture of the stopper, such as the first surface 12a, and may also be visible during use of the final medical device (not shown). The visible indicia 16 may be at least one of machine readable or human readable. The visible mark 16 shown in fig. 3, 4A and 4B is the data matrix ECC 200 code, primarily due to the high data density and error correction characteristics of the code. However, other machine-readable codes may be used, such as other data matrix codes, other two-dimensional barcodes (e.g., QR codes, etc.), one-dimensional or tiered barcodes, and so forth. For human-readable visible indicia 16 such as that shown in fig. 7, alphanumeric characters, logos, illustrative images or information, etc. may be used. The visible indicia 16 may encode or provide data relating to, for example, a unique product or component identifier, manufacturing data, tracking information, expiration data, instructions for use, and the like. The stopper 10, which is human readable, readable by a smartphone or the like, or has a dedicated vision system, may be tracked by the manufacturer and its user, caregiver and/or patient.

Preferably, visible indicia 16 are made on the surface of body 12 using UV laser radiation such that one or more areas of the markable material in body 12 exposed to the laser radiation change to a second color different from the first color. The laser radiation is absorbed, for example, by the inorganic filler material in the body 12, which subsequently degrades to create dark regions. In other embodiments, such as those utilizing carbon black, laser light absorption may result in lighter regions exhibiting a "foamy" appearance. Such UV Lasers are commercially available from DPSS Lasers, inc. In one embodiment, the visible mark 16 may be formed using a laser (not shown) having a wavelength of 355nm in the ultraviolet range. Other wavelengths and/or types of lasers, such as a CO2 laser or the like, may also be used depending on the material of the body 12 that is intended to be marked. The process is contactless and produces few, if any, particles.

As previously described, the laser may use a mirror (not shown) to raster scan across the surface of the body 12 (raster) to form the visible indicia 16. In another approach, an XY carriage may be used on the portion of the surface of the body 12 to which the visible mark 16 is to be applied to translate the laser. In yet another method, a mask having a plurality of openings may be applied to the surface of the body 12 prior to irradiating the surface with the laser. The openings may be arranged such that upon removal of the mask, the desired visible indicia 16 are left on the surface of the body 12. Laser parameters such as power, speed, spot size, etc. may be optimized to achieve the desired effect in the visible mark 16. In addition, the stopper 10 may be stationary during the marking process or may be in motion, such as on a production line, during the marking process.

As will be understood by those skilled in the art, the size of the marks and cells (squares representing "bits" of the code) incorporated in various embodiments of the present invention are not limited. For example, as the computational power of the device increases with each new generation of technology, the complexity and number of cells within the marking may also increase, and thus is limited only by the ability of the device to successfully read and process the information provided by the marking and by the marking resolution capabilities of the laser and the material. In some applications, such as anti-counterfeiting applications, it may be preferable to design small (e.g., microscopic) indicia with high cell counts. In other applications, such as high speed production lines, it may be desirable to have large area markings that are easy to inspect and less complex, with an optimal number of units that minimize processing time.

As the area of the visible indicia 16 increases, the size of each cell may also increase proportionally so that devices such as smartphones can successfully read and process the information provided by the indicia 16. The visible mark 16 may also be optimized by reducing the size of the cells within the visible mark 16 to allow a maximum amount of information to be encoded while still being able to be successfully identified and processed by a reading device. The preferred minimum cell size within a tag having a specified size is provided in table 1.

TABLE 1

Total mark size (mm)	Cell size (μm)
		1.0	71.
1.4	100
		2.1	150
2.8	200

According to one embodiment of the invention, the marking process can be done on a part with a pre-applied film by using a laser emitting light of a certain wavelength for which the film is transparent. For example, in a first step, a plurality of components in the form of plugs may be manufactured by compression molding a sheet of elastomeric material to make a plate, such as the molded plate of fig. 12A. A polymer film such as ETFE may be applied to one or more surfaces of the stopper during or after the compression molding step. After the film is applied, the surface of the one or more plugs that may be coated with the ETFE film may be marked using a laser that emits light at a wavelength of 355nm, since the ETFE is transparent with respect to that particular wavelength of light. Thus, even after the ETFE film 14 is formed on the body 12, a laser can be used to form the visible mark 16 on the body 12, as radiation can pass through the film 14 without damaging it. The film 14 has a transmission at the laser wavelength (typically the predetermined wavelength in the UV range) of at least 5%, more preferably at least 10%, more preferably at least 20%, more preferably at least 30%, more preferably at least 40%, more preferably at least 50%, more preferably at least 60%, more preferably at least 70%, and most preferably at least 80%.

Referring to fig. 12B, indicia 17 may be applied to the top surface of the plug 10, preferably outside of the target zone 11. The target area 11 bounded by a circle identifies the area into which a syringe needle (not shown) should be inserted in order to extract the contents of a container (not shown) sealed by the stopper 10. The marking 17 is preferably outside the target area to prevent potential contact between the contents of the container and the portion of the stopper 10 treated by the laser forming the marking 17. As known to those skilled in the art, after the indicia 17 are formed, each stopper 10 may be removed from the mold plate by cutting or trimming excess elastomeric material around each stopper 10 using a blade or similar tool.

Optical microscopy observations, such as those shown in fig. 4A and 4B, have demonstrated that the laser does not visibly degrade the membrane 14. Thus, other lasers may be paired with other polymeric films or caps that are substantially transparent to the corresponding wavelengths (e.g., polypropylene or Fluorinated Ethylene Propylene (FEP) caps, etc.) to achieve the same result of forming visible markings on the surface of the part and under the pre-applied film or covering. Due to this effect, the visible mark 16 can be produced at any time after the stopper 10 is molded, allowing additional data to be included throughout the manufacturing process with minimal impact on the current manufacturing process. The visible indicia 16 also appear to withstand steam sterilization temperatures for various materials (e.g., up to 121 c).

For some methods according to various embodiments of the present invention, the indicia may be applied to the component after the component is incorporated into the assembly. For example, an elastomeric stopper may be bonded to a transparent cover (such as DAIKYO manufactured by Daikyo Seiko LtdRUV closure). Once an appropriate transparent material for the cover and corresponding wavelength of light emitted by the laser is selected so that the light will be substantially transmitted through the cover and membrane rather than being absorbed by the cover and membrane, indicia may be applied to the surface of the elastomeric plug after it is assembled in the transparent cover (fig. 10A and 10B). Similarly, in another example, the surface of various types of elastomeric plungers may be marked with a laser of appropriate wavelength (fig. 11) either before or after inserting the plunger into a transparent syringe or cartridge. Again, the wavelength of the light should be selected such that the light is not substantially absorbed by the cartridge or syringe barrelIs absorbed by a transparent material (e.g., glass, polymeric material, etc.).

Fig. 5 illustrates one exemplary method 100 for manufacturing a medical device component, such as a stopper 10. At step 102, a body 12 may be provided, the body 12 having a surface and being at least partially formed of a markable material, such as the rubber with inorganic filler material described above. The body 12 may be molded according to conventional techniques. At step 104, the film 14 may thereafter be formed, such as the ETFE described above, to cover at least a portion of the surface of the body 12 and include covering at least a portion of the markable material (e.g., the body 12 may be formed in part from the markable material and in part from some other material designed for structural support and/or aesthetics).

At step 106, after forming film 14, visible indicia 16 may be formed on the surface of body 12 covered by film 14 by exposing one or more areas of the markable material to laser radiation of a predetermined wavelength (such as in the UV wavelength range) to change the color of the exposed areas. The exposure may include, for example, raster scanning the laser radiation across multiple areas on the body 12 to form a spatially-extending visible mark 16 (e.g., the machine-readable code in fig. 1-4B) and/or multiple visible marks 16 (e.g., the visible marks 16a-16d in fig. 7).

In one aspect, it is desirable to be able to incrementally add information to a medical device component (such as stopper 10) throughout the manufacturing process. This may be done, for example, by adding additional data matrix code, or by extending an already existing visible marker 16 (i.e., adding more symbols or characters).

Fig. 6 shows an example of a portion of a manufacturing process 200 for the stopper 10 in this manner. At step 202, the stopper 10 is molded in a conventional manner, which preferably includes applying the membrane 14 in place. At step 204, the stopper 10 is laser marked in the first region of the body 12 with a molding process indicator before moving the stopper 10 to the next process. The molding process indicator and other similar process indicators may be coded indicia (similar to visible indicia 16 in fig. 1-4B) containing data (e.g., time stamps, parameter information related to the molding process, etc.) or a unique ID or URL linked to an updatable database in which information related to a completed process step (e.g., molding) may be identified and described. Alternatively, the molding process indicator may be a graphical symbol (e.g., visible mark 16a in fig. 7) or other similar mark indicating that the molding step has been completed.

At step 206, the stopper 10 from its mold is trimmed, and at step 208, a trimming process indicator (see, e.g., visible indicia 16b in fig. 7) is formed on the stopper 10 in the second region of the body 12 by laser marking. At step 210, the stopper 10 is cleaned in a conventional manner. At step 212, the stopper 10 is laser marked with a cleaning process indicator in a third region of the body 12 (see, e.g., visible mark 16c in fig. 7). At step 214, the plug 10 may be visually inspected for defects either manually or by an inspection machine. At step 216, a visual inspection process indicator is laser marked onto the stopper 10 in a fourth region of the body 12 (see, e.g., visible mark 16d in fig. 7). Where the visible indicia 16 is machine readable code added to it after each associated process, the various indicia areas may be adjacent to one another, or each step may invoke its own separate and independent code. Although various processing steps are shown in fig. 6, each followed by a laser-generated process indicator, the illustrated process is not limiting and variations in steps, number of laser-generated process indicators, etc. may be made without departing from the spirit and scope of the present invention.

The above process is beneficial in that the need for server queries or operations during the manufacturing process can be eliminated. High speed filling lines cannot tolerate significant latency and although the visible markings 16 may store limited data, there is no latency to retrieve and therefore can be implemented on high speed lines.

In some embodiments, the visible label 16 may be used for unique serialization. As briefly mentioned previously, after each processing step, a database (not shown) may be updated with information relating to the unique visible indicia 16 of each stopper 10. For example, as the component is scanned at each step, a timestamp and metadata may be appended to the table in the entry for a particular visible label 16. In one embodiment, the visible indicia 16 may include a short URL or unique ID, and each component may point to a manufacturer-controlled website, API, or database with a journal where an individual may retrieve data or metadata associated with the component (e.g., lot/lot information, process parameter information, medication security details, interaction details, administrative details, recall information, expiration dates, etc.). The component may then be tracked by geographic location, time, user, etc. It may also allow a pharmaceutical manufacturer, pharmacy, healthcare provider, etc. to add information associated with a particular component.

By this procedure, the information can be used, for example, to find defective mold cavities; identifying a location in a manufacturing system where waste is generated; providing traceability; the emerging cell therapies are assigned a unique patient ID or the patient is informed of each person that can be treated. In some cases, the database may be pre-fetched prior to device manufacture (e.g., if multiple plugs have all been uniquely marked) in order to reduce latency.

The process is also used as an anti-counterfeiting means. By tracking each component, identification and prevention of reuse of components can be achieved in the context of replication serialization. It may also be desirable to prevent hostile third parties from predicting serial numbers. To prevent such activity, the visible indicia 16 may contain encrypted information that can only be read by a user. For example, the visible indicia 16 may include a digital signature. As will be appreciated by those skilled in the art, the data encoded in the visible indicia 16 may be digitally signed. The end user can then confirm the authenticity of the message and thus the component. Various other one-way hashing or cryptographic authentication methods (e.g., good privacy (PGP) encryption, etc.) may also be used to verify that the information in the visible indicia 16 actually came from the component manufacturer and optionally protect that information. The encryption key may be used differently depending on the application. In one example, the manufacturer may choose to encrypt the information using its private key so that all authorized users can decrypt and verify the information. In another example, information for a particular user may be encrypted using the user's public key so that only the particular user can decrypt the information.

The process may also be used to serialize the components to be tracked together as part of one medical device. For example, each component may have one or more visible indicia 16 that may be related to each other in a database. In this manner, the manufacture, sale, transport, and use of the entire device may be tracked and associated with the various components. For example, if the visible mark 16 on the stopper 10 is not correlated with the visible mark on one of the other device components, early detection of improper manufacture or use of counterfeit components may be detected. Similarly, recalls of particular components can be easily traced to the devices incorporating those components. In another embodiment, individual ones of the components may include laser-generated visible indicia 16, which visible indicia 16 are then used to link to a database for which all subsequent device information (e.g., manufacturing details, medication information, gene therapy information, patient information, expiration dates, serial numbers) and the like may be stored and tracked. The patient information may include the identity of the patient, the expected treatment schedule, treatment management information (e.g., frequency and type of medication treatments/devices used), and any other patient metadata, such that the visible indicia 16 may be used by the system including the personalized treatment application. The personalized therapy application may be available on a system such as an electronic device (e.g., a smartphone, a tablet, a laptop, etc.).

Similarly, the entire shipment of parts can be tracked by tying the visible indicia 16 together in a database, and manufacturing information can be maintained. For example, the bag may contain a plurality of stoppers 10, each having a separate serial number in the form of a laser-produced visible mark. Those serial numbers may be associated with each other in a database. In one exemplary operation, as the bag is sterilized, the data for each stopper 10 in the bag may be updated by scanning a label on the bag associated with the serial number of the stopper 10, or by scanning the visible indicia 16 of one of the stoppers 10 and updating the remaining stopper data using the previously established link.

While the above embodiments show a single visible indicium 16 or describe a series of similar visible indicia (e.g., multiple data matrix codes or graphic symbols), multiple visible indicia having different characteristics may be applied to the component. For example, one visible indicium 16 may contain relevant manufacturing data, while a second visible indicium 16 may be a manufacturer's logo. Other types of visible indicia may also be used, such as a visual indicator to the caregiver, such as the location of the insertion needle.

While the above embodiments have been discussed with respect to elastomeric medical device components, laser marking according to the present invention may also be used in other medical device components. For example, laser markings may be applied to one or more surfaces of the plunger rod (fig. 8A and 8B) before or after insertion of the plunger rod into the transparent syringe barrel. In another example, the TiO containing material formed on the aluminum sidewall by marking the top surface of the plastic cover or by marking₂Or the aluminum itself through a clear lacquer to mark the aluminum seal with a plastic flip top (fig. 9A and 9B). Plastic seals and other colored plastics and line seals made from elastomeric sheets are compatible with the laser marking process. CO may be used₂Laser, etc., burning and/or ablating material to laser mark glass components, as well as glass replacement components (such as using CRYSTAL manufactured by Daikyo Seiko, Ltd. of Japan)A component made of a material).

While certain and unique embodiments are shown in the drawings, various individual elements or combinations of elements from different embodiments may be combined with one another without departing from the spirit and scope of the invention. Thus, a single feature described herein with respect to only one embodiment should not be construed as being incompatible with other embodiments described herein or otherwise encompassed by the present invention.

It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the present disclosure.