Patent Application
20210330422
Embodiments described herein are directed to medical device components, and particularly elastomer components, such as stoppers or plungers, seals, and the like, that are laser marked with data or other identification information, and a method of marking such components, particularly during multiple manufacturing steps.
Prior attempts to serialize or mark 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 at scale. Labels require adhesion, which can risk leachable material into a drug, and can also be difficult to apply. Mold cavity identification is not unique, can wear down over time, and can only provide limited information. Surface printing can also create leachable material, and surface morphology differences can impact sealing or machinability.
In one aspect, the present invention relates to a method for manufacturing a medical device component. The method may comprise forming a body of the medical device component, the body having a surface and being at least partially formed from a markable material having a first color; applying a film to at least a portion of the surface of the body, including at least a portion of the markable material; and after formation of the film, exposing one or more areas of the at least a portion of the markable material to laser irradiation of a predetermined wavelength to form a visible mark on the surface of the body by changing the one or more areas 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 being at least partially formed from a markable material having a first color, the markable material having a characteristic that an area exposed to laser irradiation of a predetermined wavelength of ultraviolet light changes to 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 at the predetermined wavelength of ultraviolet light of at least 5%; and a visible mark on the markable material at the first surface of the body covered by the film. The visible mark comprising one or more areas of the markable material at the first surface having the second color.
In yet another aspect, the present invention relates to method for manufacturing a medical device component. The method may comprise forming a body of the medical device component in a molding process, the body having a surface and being at least partially formed from a markable material having a first color. The method may also comprise forming a film over at least a portion of the surface of the body, including 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 irradiation 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 linking to first data related to the molding and/or film formation steps. In yet another step, the method may comprise washing 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 linking to second data related to the washing step.
These and other aspects of the present invention will be apparent in view of the following description.
The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are 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 drawings:
Certain terminology is used in the following description for convenience only and is not limiting. The words “lower,” “bottom,” “upper,” “top,” “front,” “back,” and “rear” designate directions in the drawings to which reference is made. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the component being discussed, and designated parts thereof, in accordance with the present disclosure. Unless specifically set forth herein, the terms “a,” “an,” and “the” are not limited to one element, but instead should be read as meaning “at least one.” “At least one” may occasionally be used for clarity or readability, but such use does not change the interpretation of “a,” “an,” and “the.” The terminology includes the words noted above, derivatives thereof, and words of similar import.
It should also be understood that the terms “about,” “approximately,” “generally,” “substantially” and like terms, used herein when referring to a dimension or characteristic of a component of the invention, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally similar. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.
In certain aspects, by using an ultraviolet (UV) laser, drug-contact elastomer components can be marked/serialized to produce a safe, clean, and sterilization compatible product. A precise mark can be applied to a molded or finished product, even if an optional film has already been applied. This technology, particularly where the mark is created under the film, poses very little risk to the drug product, as any potentially created extractables would not be present at the surface of the component. Moreover, the technology may be preferable for components used in cryogenic applications because exposure to large temperature differentials are unlikely to substantially affect the mark, unlike labels that utilize adhesives. This technology is broadly applicable to elastomer components utilizing inorganic fillers, and can be extensible to other polymer components, especially those which can be covered in compatible films or other transparent layers.
Referring to
At least a portion of a surface of the body 12, and in certain embodiments preferably at least a portion of the first surface 12a, may be covered by a film 14 (
As shown in
The visible mark 16 is preferably made on a surface of the body 12 using UV laser irradiation such that one or more areas of the markable material in the body 12 exposed to the laser irradiation change to a second color different from the first color. The laser radiation is, for example, absorbed by the inorganic filler materials in the body 12, which subsequently degrade to produce a dark area. In other embodiments, such as those utilizing carbon black, the laser absorption may cause lighter areas exhibiting a “foamed” appearance. Such UV lasers are commercially available from, for example, DPSS Lasers, Inc. of Santa Clara, Calif. In one embodiment, the visible mark 16 can be formed using a laser (not shown) having a 355 nm wavelength, which is in the ultraviolet range. Other wavelengths and/or types of lasers, such as CO2 lasers or the like, can be used as well, depending on the material of the body 12 that is sought to be marked. The process is non-contact, and generates few, if any particles.
As previously mentioned, the laser may use a mirror (not shown) to raster across the surface of the body 12 to form the visible mark 16. In another method, an XY carriage may be used to translate a laser over the portion of the surface of the body 12 to which the visible mark 16 will be applied. 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 a laser. The openings may be arranged, such that upon removal of the mask, the desired visible mark 16 is left on the surface of the body 12. Laser parameters, such as power, speed, spot size, and the like may be optimized to achieve the desired effect in the visible mark 16. In addition, the stopper 10 can be stationary during the marking process, or may be in motion, such as on a production line, during marking.
As would be appreciated by one of skill in the art, dimensions of the marks and the cells (squares representing a “bit” of the code) incorporated into the various embodiments of the present invention are not limited. For example, as computing power of devices increases with every new generation of technology, the complexity and number of cells within a mark may also increase, and is, therefore, only limited by the ability of the device to successfully read and process the information provided by the marks, and by the marking resolution capabilities of the laser and material. In some applications, such as anti-counterfeit applications, it may be preferable to design a small, e.g., microscopic, mark having a high cell count. In other applications, such as high-speed manufacturing lines, it may be desirable to have larger area marks that are easily perceptible for inspection and less complex with an optimal number of cells to minimize processing time.
As the area of the visible mark 16 increases, the size of each cell may also proportionally increase in size, so that a device, such as a smartphone, is capable of successfully reading and processing the information provided by the mark 16. The visible mark 16 may also be optimized by reducing the size of the cells within the visible mark 16 to allow for a maximum amount of information to be encoded while still being able to be recognized and processed successfully by the reading device. Preferred minimum cell sizes within a mark having a specified size are provided in Table 1.
According to one embodiment of the present invention, a marking method may be accomplished for a component having a pre-applied film by using a laser that emits light at a wavelength for which the film is transparent. For example, a plurality of components in the form of stoppers may be manufactured in a first step by compression molding a sheet of elastomeric material to produce a panel, such as the molded panel of
Referring to
Optical microscopic observations, such as those shown in
For some methods according to the various embodiments of the present invention, the marking may be applied to the component after the component has been incorporated into an assembly. For example, an elastomeric stopper may be incorporated into a transparent cap, such as the DAIKYO PLASCAP® RUV closures manufactured by Daikyo Seiko Ltd. Upon selection of an appropriate transparent material for the cap and a corresponding wavelength of light emitted by the laser, such that the light will be substantially transmitted through, rather than absorbed by, the cap and film, a marking may be applied to the surface of the elastomeric stopper after being assembled in the transparent cap (
At step 106, after the film 14 is formed, the visible mark 16 may be formed on the surface of the body 12 covered by the film 14 by exposing one or more areas of the markable material to laser irradiation of a predetermined wavelength (such as in the UV wavelength range), thereby changing the color of the exposed areas. This exposure can include, for example, rastering the laser irradiation across a plurality of areas on the body 12 to form spatially extending visible marks 16 (e.g., the machine readable code in
In one aspect, it is desirable to be able to incrementally add information to a medical device component, such as the stopper 10, throughout the manufacturing process. This can be done by, for example, adding additional data matrix codes, or by extending an already present visible mark 16 (i.e., adding more symbols or characters).
At step 206, the stopper 10 is trimmed from its mold and at step 208, a trimming process indicator is formed on the stopper 10 in a second area of the body 12 through laser marking (see e.g., the visible mark 16b in
The above-described process is beneficial in that the need for a server query or operation during a manufacturing process can be removed. A high speed filling line does not tolerate significant latency, and while the visible mark 16 can store limited data, there is no latency in retrieval, and can therefore be implemented on a high speed line.
In certain embodiments, the visible mark 16 can be used for unique serialization. As briefly described earlier, after each processing step, a database (not shown) may be updated with information related to the unique visible mark 16 of each stopper 10. For example, a time stamp and metadata can be appended to entry for the specific visible mark 16 in a table as the component is scanned at each step. In one embodiment, the visible mark 16 can include a short URL or unique ID, and each component can point to a manufacturer controlled website, API, or database with a log where individuals can retrieve data or metadata associated with the component (e.g., lot/batch information, process parameter information, drug safety details, interaction details, administration details, recall information, expiration dates, and the like). Components can then be tracked by geography, time, users, and the like. Drug manufacturers, pharmacies, healthcare providers and the like may also be allowed to add information associated with the particular component.
With this process, information can be used to, for example, find defective mold cavities, identify where waste is being generated in a manufacturing system, provide traceability, assign unique patient IDs for emerging cell therapies, or to inform a patient about every person who enabled their treatment. The database can, in some instances, be pre-fetched prior to device manufacturing (for example, if a plurality of stoppers are all already uniquely marked) in order to reduce lag.
The process also serves as anti-counterfeit means. By tracking each component, identification and prevention of the re-use of components is achievable where serialization is copied. It may also be desirable to prevent a hostile third party from predicting serial numbers. To prevent such activity, a visible mark 16 may contain encrypted information that can only be read by the customer. For example, the visible mark 16 may include a digital signature. As understood by those of skill in the art, the data encoded in visible mark 16 may be digitally signed. The end user can then confirm the authenticity of the message and therefore the component. Various other one-way hash, or cryptographic authentication methods (e.g., Pretty Good Privacy (PGP) encryption or the like) can also be used to verify that messages in the visible mark 16 actually come from the component manufacturer and optionally protect those messages. Depending on the application, cryptographic keys may be used differently. In one example, the manufacturer may choose to encrypt a message with their private key, so that all authorized users may decrypt and verify the message. In another example, messages for a specific customer could be encrypted with the customer's public key, so that only the specific customer could decrypt the message.
The process can also serve to serialize components to be tracked together as part of one medical device. For example, each component may have one or more visible marks 16 that can be related to one another in the database. In this manner, manufacture, sale, shipping, and usage of an entire device can be tracked, and be correlated to individual components. For example, if the visible mark 16 on the stopper 10 does not correlate with the visible mark on one of the other device components, early detection of either improper manufacture or the use of counterfeit components may be detected. Similarly, recalls of particular components can be easily traced to devices in which those components are incorporated. In another embodiment, a single one of the components may include a laser-created visible mark 16, which then serves to link to a database for which all subsequent device information (e.g., manufacturing details, drug information, gene therapy information, patient information, expiration date, serial number) and the like can be stored and tracked. Patient information may include the patient's identity, intended treatment schedule, treatment administration information (e.g., frequency and type of medical therapy/device used), and any other patient metadata, so that the visible marking 16 may be used by a system that includes a personalized treatment application. The personalized treatment application may be available on a system, such as an electronic device, e.g., smartphone, tablet, laptop, or the like.
Similarly, entire shipments of components can be tracked and manufacturing information may be maintained by tying visible marks 16 together in the database. For example, a bag may contain a plurality of stoppers 10 each having an individual serial number in the form of a laser-created visible mark. Those serial numbers may be associated with one another in the database. In one exemplary operation, when the bag undergoes sterilization, the data for each stopper 10 in the bag can be updated either by scanning a tag on the bag affiliated with the stopper 10 serial numbers, or by scanning the visible mark 16 of one of the stoppers 10 and using previously established links to update the remaining stopper data.
While the above embodiments illustrate a single visible mark 16 or describe a series of similar visible marks (e.g., multiple data matrix codes or graphical symbols), multiple visible marks of different characteristics may also be applied to the components. For example, one visible mark 16 may contain the relevant manufacturing data, while a second visible mark 16 may be a logo of the manufacturer. Other types of visible marks, such as visual indicators to caregivers, such as a location for needle insertion, can be used as well.
While the above embodiments have been discussed in relation to elastomeric medical device components, laser marking in accordance with the invention can be utilized in other medical device components as well. For example, the laser marking may be applied to one or more surfaces of a plunger rod (
While specific and distinct embodiments have been shown in the drawings, various individual elements or combinations of elements from the different embodiments may be combined with one another while in keeping with the spirit and scope of the invention. Thus, an individual feature described herein only with respect to one embodiment should not be construed as being incompatible with other embodiments described herein or otherwise encompassed by the 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 disclosure herein.
This application claims the benefit of and priority to U.S. Provisional application having Ser. No. 62/746,216, filed on Oct. 16, 2018, the content of which is incorporated by reference herein in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US19/56287 | 10/15/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62746216 | Oct 2018 | US |
