Patent Application
20070209957
Embodiments relate to packaging systems for medical devices such as surgical instruments, implants, prostheses, and the like. More specifically, the embodiments relate to blister packaging systems for the distribution, storage, and marketing of medical devices.
Modern medicine increasingly utilizes medical devices such as surgical instruments, implants, prostheses, and the like. Implants and prostheses are medical devices that typically augment or replace body structures that are deteriorated, damaged, injured, or otherwise compromised. Exemplary medical implants and prostheses include cardiovascular implants, arterial stents, heart valves, orthopedic implants, dental implants, bone screws, plates, drills, bits, and so forth. Surgical instruments are medical devices that assist a surgeon in performing an operation. Exemplary surgical instruments include forceps, drivers, scapels, cathetars, trocars, syringes, drill bits, endoscopes, and so forth.
Medical devices typically must be sterilized prior to use in order to prevent infection of the patient. Generally, sterilization of the medical device can be done anytime before, during, or subsequent to packaging of the device, so long as the device is sterilized sometime before use. Thus, the medical device typically may be sterilized and ready for use immediately upon removing the device from its packaging. This assumes, of course, that the medical device's packaging is capable of maintaining the device's sterility subsequent to undergoing a sterilization procedure, whether that procedure precedes, occurs during, or is subsequent to packaging of the device.
Choosing an appropriate medical device for use in a given medical procedure may be difficult, if not impossible, to accomplish prior to surgery. Therefore, selection of a medical device, especially a medical implant or prosthesis, for use in medical procedure sometimes must occur during the course of surgery. If the medical device is packaged in a non-transparent packaging material, then it may be necessary to break open the packaging in order to examine the device and determine if it is appropriate for use, thereby exposing the device to a non-sterile external environment. Therefore, opening the packaging material of the medical device in order to inspect the device and determine its utility for a given medical procedure may prevent the subsequent use of the device until it has been re-sterilized and re-packaged.
Besides maintaining a medical device's sterility, another purpose of medical packaging is to protect the packaged device from tampering, and to maintain its authenticity. For example, medical packaging typically is sealed in order to prevent access to the device packaged inside. Once the seal has been broken, it is no longer possible to guarantee that the medical device in the packaging is authentic and conforms to the product standards of the manufacturer. Thus, opening the packaging material of the medical device in order to examine the device and determine if it is appropriate for use also may prevent the subsequent use of the device until it has been inspected, re-sealed, and re-packaged by an authorized party. Those skilled in the art will appreciate that inspection, re-sealing, re-packaging, and sterilization impose significant costs when the wrong device is opened.
What is needed are medical packaging system that are capable of maintaining medical devices in a sterile environment. Additionally, what is needed are packaging systems that allow a medical device to be visually inspected and examined without opening the packaging.
Therefore, in accordance with an embodiment, there is provided a packaging system for medical devices. The system comprises a blister tray that may be at least semi-transparent and has at least one cavity. The cavity may be capable of containing a medical device or a portion thereof. The system further comprises a card having at least one window. The at least one cavity in the blister tray may protrude through the at least one window in the card.
In accordance with another embodiment, there is provided a packaging system for medical devices comprising a blister tray that is at least semi-transparent and has at least one cavity. The system further comprises a blister tray closure removably disposed over the blister tray and covering the cavity in the blister tray. Additionally, the system comprises a carton having at least one window. The blister tray may be positioned inside of the carton and the at least one cavity in the blister tray may be substantially visible through the at least one window in the carton.
These and other features and advantages of the embodiments will be apparent from the description provide herein.
The following description is intended to convey a thorough understanding of the various embodiments by providing a number of specific embodiments and details involving packaging systems for the distribution, storage, and marketing of medical devices. It is understood, however, that the embodiments are not limited to these specific embodiments and details, which are exemplary only. It is further understood that one possessing ordinary skill in the art, in light of known systems and methods, would appreciate the use of the embodiments for their intended purposes and benefits in any number of alternative embodiments.
As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. Thus, for example, a reference to “a window” includes a plurality of windows, and a reference to “a device” is a reference to one or more devices, and so forth.
The expression “medical device,” as used herein, denotes various surgical instruments, prostheses, and implantable devices used in the field of medicine. In general, the packaging systems described in the embodiments may be used to package one or more medical devices, or portions thereof, in a single packaging system. The packaging systems described in the embodiments therefore may be widely applicable in the distribution, storage, and marketing of various medical devices, such as surgical instruments, prostheses, and implantable devices.
Surgical instruments include, but are not limited to, burrs, cannulas, catheters, cauterizers (including tips and handles), chisels (e.g., bone chisels), clamps (e.g., anastomosis, bulldog, kidney, and kidney pedicle clamps), curettes (e.g., bone curettes), distractors, drill bits, electrodes, endoscopes, evacuators, files (e.g., bone files and rasps), forceps (e.g., arthroscopy, biopsy, grasping, hemorrhoidal, hook-punch, intestinal, and stomach forceps), hooks (e.g., exploring, sharp hooks, and sinus renalis hooks), irrigating tubes, knives (e.g., arthroscopy and meniscus knives), laproscopy devices, needles (e.g., biopsy, guide, ligature, micro, puncture, reverdin, suture, and verres needles), obturators, probes (e.g., duct and fistual probes), reamers (e.g., bone and medullary reamers), retractors (e.g., abdonminal, balfour, deaver, delicate, double-ended, dura, knee, Kocher, Langenbeck, malleable, pelvis, rectal, self-retaining, Volkmann, and Weitlaner retractors), ring cutters, rongeurs (e.g., bone rongeurs), saws (e.g., amputation and metacarpal saws), scalpel blades and handles, scissors (e.g., delicate, dissecting, hook, Mayo, Metzenbaum, micro, and operating scissors), scoops, scopes, (e.g., anosopes, arthroscopes, endoscopes, proctoscopes, and sphincteroscopes) screw drivers, stapels, suture apparati (e.g., clips, hooks, and wire), syringes, trocars, tubes (e.g., aspirating and suction tubes), vein strippers, and so forth. One of skill in the art will appreciate many other surgical instruments that may be packaged using the packaging systems provided by the embodiments.
Prostheses and implantable devices include, but are not limited to, articular cups (e.g., acetabular cups), bone pins, bone screws, cosmetic implants (e.g., breast implants), defibrillators, dental prostheses, external fixation devices (especially pins connecting external fixation devices to internal bony structures), facet arthroplasty devices, femoral head implants, femoral stem implants, heart valves, hip screws, hip sockets, humeral head implants, humeral stem implants, internal fixation rods, intervertebral disc devices (such as total disc replacements, nucleus replacements, and fusion cages), intramedullary nails, knee minicus implants, nail and screw orthopedic plates (e.g., calcaneal, distal radius, fibula, meta, mini condylar, spider, straight, tubular, L-, and T-plates), pacemakers, penile implants, pins (e.g., clavicle and hip pins), spinal fixation systems (e.g., fixation rods, screws, nails, etc.), stents (e.g., arterial and urinary track stents), total ankle replacement devices, total knee replacement devices, and so forth. One of skill in the art will appreciate many other prostheses and implantable devices that may be packaged using the packaging systems provided by the embodiments.
Accordingly, the embodiments herein provide packaging systems for medical devices that may overcome some or all of the disadvantages of the prior art packaging systems. For example, the packaging systems described in the embodiments may allow visual inspection of the medical devices from outside of the package, without requiring that the packaging be opened. Furthermore, the packaging systems of the embodiments may be capable of maintaining a medical device packaged therein in a sterile environment while simultaneously allowing visual inspection of the device. Also, the packaging systems of the embodiments may present additional information to a surgeon or other medical practitioner regarding the medical devices packaged therein. These features of the packaging systems described in the embodiments may assist a surgeon in determining the suitability of the medical device for use in a given medical procedure or surgery, without requiring that the device be removed from its packaging.
In one embodiment, there is provided a packaging system for medical devices. The system comprises a blister tray that is at least semi-transparent and has at least one cavity. The cavity is capable of containing a medical device or a portion thereof. The system further comprises a card having at least one window. The at least one cavity in the blister tray protrudes through the at least one window in the card.
The card having at least one window preferably is an opaque, typically paper-based material. The card may provide additional surface area to the packaging system, on which information about the medical device's manufacturer, the medical device, pricing, use of the medical device, warnings, and so forth may be printed. Furthermore, the additional surface area may enable the packaging system to be easily grasped, held, and handled, especially in the case of a small medical device, where the blister tray that holds the device is correspondingly small.
In alternative embodiments, one or more cavities may be provided in the blister tray. The one or more cavities may collectively or individually contain one or more medical devices and portions thereof. For example, a single blister tray may have three cavities, each of which contains a medical device (e.g., three bone screws of differing lengths, or three bone screws of the same length, or a driver and two bone screws, and so forth). In this way, a single package may contain multiple, preferably complementary, medical devices.
It is desirable to seal the blister tray in order to hold the medical device in place in the at least one cavity of the blister tray. Sealing of the blister tray may be accomplished via several different methods, including securing a blister cover to the blister tray and securing a backing card to the blister tray. The blister cover or backing card may close the cavity in the blister tray, thereby trapping and holding the medical device in the cavity. Preferably, the blister cover or backing card may be hermetically sealed to the blister tray in order to prevent the passage of infectious agents to the medical device that is sealed in the cavity in the tray. Sealing may be accomplished by the application of a suitable adhesive such as the CR-27® heat-sealing adhesive commercially available from Perfecseal, Oshkosh, Wis., to seal the blister cover or backing card to the blister tray. If desired, for extra protection, the blister tray may be sealed both with both a blister cover and a backing card.
Also, the blister cover or backing card preferably may be removable from the blister tray, so that the cover or card may be removed by a surgeon or other medical practitioner in order to access the medical device in the blister tray. This may be preferred to non-removable blister covers and backing cards because cutting or breaking a blister tray itself often is difficult, potentially time consuming, and may cause damage to the device when compared to simply removing the cover or card. Thus, the adhesive used to secure the blister cover or backing card to the tray may be chosen such that the resulting seal is not too difficult to break, when intended.
Blister covers may be flexible, peelable sheets of materials that are capable of being secured to the blister tray. Blister covers may be made from a wide variety of materials, including spun-bonded polymeric fabrics, such as the spun-bonded polyolefin fabric sold commercially under the name Tyvek® by Dupont, Wilmington, Del. Another exemplary blister cover is a metallic, in particular aluminum, foil-type material. For example, the blister cover may be an aluminum foil that is layered on either side with a polyolefin such as polyethylene.
Preferably, the medical device and at least the interior of the cavity in the blister tray may be sterilized either prior or subsequent to sealing the device in the cavity of the blister tray. In order to sterilize the medical device and interior of the cavity after sealing the device therein, at least one of the blister cover, blister card, or blister tray preferably may be permeable to a sterilizing agent such as gamma radiation or gaseous ethylene oxide. Thus, the material used for the blister cover, blister card, and blister tray may be limited in some instances to those materials that are permeable to the sterilizing agent that is desired to be used, if any. Other appropriate sterilizing agents include electron-beam (E-beam) radiation, gas plasma, ultraviolet radiation (UV), and hydrogen peroxide (H2O2).
In one embodiment, the blister tray may be positioned between the card having at least one window and a backing card. The two cards may be secured together, for example, using an adhesive. Additionally, the blister tray preferably may itself be secured to the backing card with, for example, an adhesive. The blister tray may be secured to the backing card by applying an appropriate adhesive to a lip or flange on the perimeter of the blister tray and pressing the adhesive-covered lip or flange of the blister tray to the backing card. Preferably, securing the blister tray to the backing card creates a hermetic seal around the cavity in the blister tray. In this way, the cavity in the blister tray and the medical device, at least a portion of which is positioned in the cavity, may be sterilized, if desired, either before or after sealing the blister tray to the backing card, and the sterilized environment maintained subsequent to sealing the tray to the card.
While this embodiment is illustrated with reference to a blister tray with a single cavity, it will be appreciated that more than one cavity may be present in the blister tray, and that the cavities each may hold one or more medical devices or portions thereof. For example, a two-cavity blister tray may hold several bone screws in one cavity, and a driver for the screws in the other cavity. Endless variations in multiple-cavity arrangements are possible. Additionally, it will be appreciated that the at least one window in the card may be large enough for more than one cavity to protrude therethrough. Thus, the packaging systems of the embodiments may comprise multiple cavities in the blister tray protruding through multiple windows in the card, each cavity holding one or more medical devices or portions thereof.
In another embodiment, a clam-shell card arrangement may be used to position the blister tray between opposing sides of a folded card. In this embodiment, a card having at least one window is folded into two sections. The two sections need not be equal in size, but preferably are at least approximately equal. The card preferably is folded so that the one or more windows in the card each are disposed entirely on either of the two sections of the card (i.e., so that the fold does not run through any of the windows). The blister tray may be placed against the card such that the at least one cavity in the blister tray protrudes through at least one window in the card. The two sections of the card may be folded together so that the blister tray is positioned between the two sections.
In another alternative embodiment, the clam-shell arrangement may have two or more windows, and the windows may be disposed on one or more sections of the folded card. One or more cavities in the blister tray may protrude through the one or more windows of the card. In another embodiment, the clam-shell arrangement may have a card that is folded into more than two sections, wherein at least one of the sections comprises at least one window through which the cavity in the blister tray may protrude and at least one of the sections acts as a backing card, substantially covering the cavity in the blister tray. As in the other embodiments, it will be appreciated that, alternatively, the blister tray may be sealed with a blister cover, and optionally additionally secured to the card, thus affording extra protection to the medical device contained in the blister tray.
In another alternative embodiment, two blister trays may be secured together with an adhesive such that the cavities in the two trays are aligned. The aligned cavities may form one or more volumes in which one or more medical devices or portions thereof may be positioned. The joined blister trays may be secured to a first card having at least one window, through which at least one of the cavities of the joined blister trays is capable of protruding. The joined blister trays also may be secured to a second card having at least one window, where the second card is placed on the side of the joined blister trays opposite the first card. This embodiment therefore provides windows on either side of the packaging system, so that the medical device may be viewed from either side of the package.
In accordance with another embodiment, there is provided a packaging system for medical devices comprising a blister tray that is at least semi-transparent and has at least one cavity. The system further comprises a blister tray closure removably disposed over the blister tray and covering the cavity in the blister tray. Additionally, the system comprises a carton having at least one window. The blister tray is positioned inside of the carton and the at least one cavity in the blister tray is substantially visible through the at least one window in the carton.
The blister tray has been described previously. Generally, the blister tray may comprise a transparent or semi-transparent polymeric material, such as PET or PETG. The blister tray closure may be any appropriate closure for affixing to the blister tray, and more preferably closures that are capable of maintaining a sterile environment in the blister tray once it has been sterilized. The blister tray closure may be a blister cover or a backing card, both of which have been described previously. The blister cover, for example, may be a peelable polymeric or foil material that is secured to the back of the blister tray using an adhesive, or using the material itself and applying external energy. A backing card may be a paper-based material that also adheres to the blister tray by use of an appropriate adhesive. The blister tray closure thus seals the one or more cavities in the blister tray. Each of the one or more cavities is capable of containing one or more medical devices, or portions thereof.
Preferably, an appropriate adhesive is chosen when securing the blister tray closure to the blister tray in order to hermetically seal the blister cavity or cavities in the tray, so that the medical device or devices that are at least partially contained in the cavities can be maintained in a sterile environment. The medical device or devices and interior of the blister cavity or cavities may be sterilized before, during, or after assembly of the blister tray, for example, using a sterilizing agent such as gamma radiation or gaseous ethylene oxide.
The assembled blister tray, medical devices, and blister tray closure may be inserted into a carton having at least one window. The carton, like the card having at least one window and backing card previously described, may be a paper-based material. The one or more windows in the carton may be positioned so that the medical devices in the blister tray are substantially viewable through the windows in the carton. In this way, analogous to the blister tray/card combination, the medical device in the blister tray may be capable of being viewed and inspected from outside of the packaging, and without opening the packaging. Thus, the blister tray/carton combination may provide a packaging system that facilitates visual inspection of the medical devices packaged therein, without the deleterious effects of opening the packaging (e.g., contamination of the devices, voiding the manufacturer's warranty of authenticity, and so forth).
The embodiments herein provide packaging systems for medical devices that may possess superior characteristics over previously known packaging systems. One advantageous quality of the packaging systems provided herein is that the medical device packaged therein may be at least substantially viewable from outside the package. This is desirable because visual inspection of the medical device may allow a surgeon or other medical practitioner to visually inspect and assess the suitability of the medical device for use in a given procedure without removing the device from its packaging. In this way, the authenticity and/or sterility of the medical device can be maintained even as the surgeon or other medical practitioner visually inspects the medical device. This may not only speed the selection of the medical device for use by the surgeon, but also reduce unnecessary re-packaging and re-sterilization of medical devices that are not found to be suitable for use in a given procedure or surgery after visual inspection of the device.
Additionally, the embodiments may provide improved methods to store and display the devices contained therein. Preferably, the cards and cartons as described in the embodiments may be hole-punched so that the cards and cartons may be hung on a peg. In this way, the hanging packaging systems may provide an improved method to package, store, and display medical devices.
Other embodiments provide packaging systems with measuring indicia on the outside of the card or carton and adjacent to the at least one window in the card or carton through which the cavity in the blister tray and the enclosed medical device may be observed. Preferably, the measuring indicia may be calibrated to one or more dimensions of the medical device or portion thereof contained in the package. The measuring indicia may be used to visually determine the size of the medical device by observing the measurements of its dimensions as indicated by the measuring indicia. The measuring indicia thus may enhance the utility of the packaging system in respect to a surgeon's ability to visually inspect the medical device and determine if it is appropriate for use in a medical procedure or surgery.
The foregoing detailed description is provided to describe the embodiments in detail, and is not intended to limit the embodiments. Those skilled in the art will appreciate that various modifications may be made to the embodiments without departing significantly from the spirit and scope thereof.
