Patent Application
20090266728
The present invention relates generally to the field of identification and tracking of parts, and more particularly relates to tracking a medical device by associating the medical device with identifying information and providing the medical device in a tray.
Implantable medical devices must be sterile prior to use in order to reduce the risk of infection in patients receiving such devices. Generally, there are two ways to provide sterile surgical devices. One way is to sterilize a device to be implanted immediately prior to implantation. Another way is to sterilize a device during the manufacturing process, and then to ship the device to a user in a sterilized condition. The first way is typically called providing a device “non-sterile,” because the manufacturer ships the device in a condition that is not adequately sterilized for implantation. The second way is typically called providing a device “sterile,” because the device is ready for implantation when shipped from the manufacturer.
There is a strong and growing need to track medical devices from their base materials and manufacture to their use, and throughout the intervening time. Tracking of medical devices may also be referred to as maintaining traceability of the devices. It is sometimes important to track medical devices so that patients can be notified of any information related to the safety or longevity of devices once implanted. The U.S. Food and Drug Administration is currently considering requiring that implantable medical devices be uniquely identified and tracked through the time of use of the devices.
It is relatively straightforward to uniquely identify and track sterile medical devices. Unique labels or other indicia are applied to the product and the labels or other indicia remain associated with the medical device until the device is used. In some instances, sterile product labels include adhesive portions that can be applied to a chart or file of a patient to conveniently associate the sterile medical device with a particular patient.
Non-sterile products provide a greater tracking challenge, although there are several reasons for preferring non-sterile shipment of medical devices. A larger number of non-sterile devices can be provided in groups or sets that present the devices in a manner where the devices are readily available for use. The large number of devices may represent a large number of sizes and optional configurations that provide surgeons with many alternatives in a convenient arrangement. Devices that are not used are simply returned to stock for sterilization prior to a subsequent use. Non-sterile devices do not have a definitively limited shelf life, as sterile products do. Non-sterile devices are less expensive to package and sterilize. Non-sterile devices can typically be more densely packaged into a common carrier than sterile devices. The primary reason that such non-sterile products are difficult to track, however, is that the products are difficult to mark, may not be marked at all, and may be identical to other products with which they are packaged, thus creating a possibility of confusion among parts. In many instances, specific non-sterile products are not tracked beyond their manufacturing facility, and may only be counted when reconciled for payment as one of many products that were not returned to a manufacturer for replenishment.
One way of tracking non-sterile medical devices would be to associate the devices with a mechanism that includes identifying information. The mechanisms may be provided in multiples in, for instance, trays. Such mechanisms may provide ready access to the device by sterilizing material such as steam or other cleaning solutions. It would be advantageous in some tracking systems for non-sterile implants to be resistant to intentional or even incidental tampering that could disassociate identifying information from a medical device.
An embodiment of the invention is a medical device tracking system. The system includes a tray, a medical device carried by the tray, and a mechanism coupled to the tray. The mechanism is associated with the medical device and the mechanism includes a distal portion configured to couple with the tray and an identifier associated with the mechanism. In some embodiments, the mechanism captures the medical device relative to the tray and is configured such that removal of the medical device from at least a portion of the mechanism is thereafter detectable.
Another embodiment of the invention is a medical device tracking system that includes a tray, multiple medical devices carried by the tray, and multiple mechanisms coupled to the tray, the mechanisms being respectively associated with the multiple medical devices. One or more of the mechanisms has a distal portion configured to couple with the tray in a location on the tray that is associated by proximity with the medical device, and an identifier associated with the mechanism. The multiple mechanisms of some embodiments do not contact the respective multiple medical devices.
An embodiment of the invention is a method of tracking medical devices delivered in a set that includes multiple medical devices. The method comprises providing a tray, providing two or more medical devices in the tray, and providing identifiers associated with respective ones of the medical devices. The method may also include giving instructions to detach one or more identifiers to record which medical devices have been used. The act of detaching one or more identifiers may thereafter be detectable.
Yet another embodiment of the invention is a method of tracking multiple medical devices includes providing a tray configured to accept multiple medical devices and respective multiple identifiers, and providing instructions to sterilize the medical devices carried in the tray. The method may also include receiving the tray after one or more of the multiple medical devices has been removed, but with one or more associated identifiers retained and recording the retained identifiers to at least track which medical devices have been used.
A medical device, such as spinal surgical screw 10 may be placed in the carrier 2 of the tray 1. As shown, a spinal surgical screw 10 is placed in a bay 3 of the carrier 2 of the tray 1. The medical device of this or any other embodiment of the invention may be any implant or instrument used in accomplishing a medical procedure. The medical device of some embodiments is capable of undergoing one or more steam sterilization cycles, or other sterilization procedures, without degrading in a manner that would make the implant unsuitable for use in a medical procedure. The medical device of this or any other embodiment of the invention may consist of materials, by way of example, and without limitation, including titanium and its alloys, ASTM material, cobalt chrome, tantalum, ceramic, poly-ether-ether-ketone (PEEK), PEAK, various plastics, plastic composites, carbon fiber composites, coral, allograft, autograft, zenograft, and can include artificial materials which are at least in part bioresorbable, or any material suitable for human implantation.
In addition to being a spinal surgical screw, the medical device may be, without limitation, a surgical screw of any variety, a spinal or other orthopedic plate, a surgical rod, an interbody spinal device, a vertebral disc arthroplasty device, a nucleus replacement device, a corpectomy device, a vertebrectomy device, a mesh device, a facet fixation or arthroplasty device, a structural bone graft, a staple, a tether of synthetic material or wire, or other spinal fixation instrumentation, an intramedullary nail, an external fixation device, a hip prosthesis or therapeutic device, a knee prosthesis or therapeutic device, or an instrument useful with any of the previously recited devices.
As illustrated in
As illustrated in
In some embodiments, the mechanism 100 captures the medical device relative to the tray 1 and is configured such that removal of the medical device from the mechanism 100 is thereafter detectable. As shown in
In operation, force applied to the mechanism 100 directly, or as a result of force applied through the spinal surgical screw 10 may apply forces to the structurally weakened portion 105 or alternate structurally weakened portions 107. In some embodiments, the structurally weakened portion 105 or alternate structurally weakened portions 107 will rupture, non-resiliently deform, or change color prior to any other portion of the mechanism 100, and the spinal surgical screw 10 will then be removable from the tray 1 and at least a portion from the mechanism 100. A rupture can be a full or partial rupture. Likewise, a non-resilient deformation may be a change in the shape that remains thereafter and is in whole or in part detectable. A discoloration may occur, for example and without limitation, when a polymer material undergoes plastic material deformation. In other embodiments, the detectable alteration may be to any part of the mechanism 100 or the tray 1, or any subcomponent or additional component added to the system. Rupture, non-resilient deformation, change in color, or any other detectable indicia may be evident from observation of any part of the components or subcomponents of an embodiment of the system, and not just evident from alteration to a structurally weakened area.
An identifier 220 is associated with a mechanism 200. The illustrated identifier 220 includes a two dimensional bar code. The identifier 220 may be any device that is capable of retaining identifying information, including but not limited to, all types described in association with the identifier 120 described herein.
In some embodiments, the mechanism 200 captures the medical device relative to the carrier 2 portion of a tray and is configured such that removal of the medical device from the mechanism 200 is thereafter detectable. As shown in
In operation, force applied to the mechanism 200 directly, or as a result of force applied through the spinal surgical screw 10 or capsule 30 may result in the rupture, non-resilient deformation, or change in color of the mechanism 200 or a connection between the mechanism 200 and the carrier 2. The mechanism 200 illustrated includes a first end 201 and a second end 204. Each of the first and second ends 201, 204 shown is coupled to the carrier 2 by a fastener 203. A rupture can be a full or partial rupture of, for example and without limitation, the first end 201, the second end 204, the body of the mechanism 200, or one or both of the fasteners 203. Likewise, a non-resilient deformation may be a change in the shape that remains thereafter and is in whole or in part detectable. A discoloration may occur, for example and without limitation, when a polymer material undergoes plastic material deformation. In other embodiments, the detectable alteration may be to any part of the mechanism 200 or the carrier 2 or other part of a tray, or any subcomponent or additional component added to the system. Rupture, non-resilient deformation, change in color, or any other detectable indicia may be evident from observation of any part of the components or subcomponents of an embodiment of the system.
A mechanism 300 in the illustrated embodiment is coupled to the tray 1. The mechanism 300 depicted is associated with a medical device within the capsule 40 by both contact and proximity to the capsule 40. The mechanism 300 shown has a distal portion 301 configured to couple with the tray 1, and as particularly illustrated, the distal portion 301 couples into a hole 4 in the tray 1. In other embodiments, the mechanism 300 may couple, without limitation, with a side, bottom, lid, separator, or other feature of a tray. The distal portion 301, shown more clearly in
The medical device of this or any other embodiment of the invention may be any implant or instrument used in accomplishing a medical procedure. The medical device may be, without limitation, similar to any of the medical devices described in association with
An identifier 320 is associated with the mechanism 300. The identifier 320 may include a two dimensional bar code, an RFID tag, or any device that is capable of retaining identifying information, including but not limited to, devices described in association with the identifier 120 herein. The identifier 320 that is shown has a proximal end 321 and a distal end 322. The proximal end 321 illustrated is hinged and the distal end 322 is connectable to capture the capsule 40 in the mechanism 300. The mechanism 300 of this and other embodiments captures the medical device relative to the tray 1 and is configured such that removal of the medical device from the mechanism 300 is thereafter detectable. Once captured in this position, the mechanism 300 or tray 1 must be altered in some way to thereafter remove the capsule 40 and medical device. Alteration to the mechanism 300 of the embodiment illustrated in
In operation, force applied to the mechanism 300 directly, or as a result of force applied through the capsule 40 may apply forces to the structurally weakened portion 305. In some embodiments, the structurally weakened portion 305 will rupture, non-resiliently deform, or change color prior to any other portion of the mechanism 300, and the capsule 40 containing the medical device will then be removable from the tray 1. A rupture can be a full or partial rupture. Likewise, a non-resilient deformation may be a change in the shape that remains thereafter and is in whole or in part detectable. A discoloration may occur, for example and without limitation, when a polymer material undergoes plastic material deformation. In other embodiments, the detectable alteration may be to any part of the mechanism 300 or the tray 1, or any subcomponent or additional component added to the system. Rupture, non-resilient deformation, change in color, or any other detectable indicia may be evident from observation of any part of the components or subcomponents of an embodiment of the system, and not just evident from alteration to a structurally weakened area. For example, the proximal end 321 or the distal end 322 or any portion of the identifier 320 may manifest alteration of the mechanism 300 due to removal of the medical device from the mechanism.
In some embodiments, the multiple mechanisms 400 do not contact the respective multiple medical devices. Instead, respective medical devices may be associated with mechanisms 400 by proximity. In other embodiments, there may be contact and interdigitation between respective mechanisms 400 and medical devices, such as spinal surgical screws 10. In some embodiments, a mechanism 400 may not be releasable from the tray 70 unless the medical device is first removed. For example, and without limitation, the system of
An identifier 520 may be associated with one or more of the mechanisms 500. As illustrated, the identifier 520 is incorporated into a hinged lid having proximal portion 502 and distal portion 501 that is coupled with the tray 80. The identifier 520 may include a two dimensional bar code, RFID tag, or any device that is capable of retaining identifying information, including but not limited to, devices described in association with the identifier 120 herein. In some embodiments, the identifier 520 is removable from the tray 80. For example, hinged distal portion 501 may be weakened along the hinged connection such that the identifier may be readily grasped and pulled or twisted from the tray 80. The mechanism 500 may be any functional cross-sectional shape such as, and without limitation, generally circular, oval, square, triangular, rectangular or any partial or combination shape that effectively contains a medical device or portion of a medical device.
In some embodiments, the multiple mechanisms 600 do not contact the respective multiple medical devices. Instead, respective medical devices may be associated with mechanisms 600 by proximity. In other embodiments, there may be contact and interdigitation between respective mechanisms 600 and medical devices, such as spinal surgical screws 10. In some embodiments, a mechanism 600 may not be releasable from the tray 90 unless the medical device is first removed.
Embodiments may also include giving instructions to detach one or more identifiers to record which medical devices have been used. An identifier may be removed from a portion of a tray or from a medical device, capsule, tag, or other component associated with respective medical devices. The instructions my be directed to a healthcare provider, a company sales representative, a computing device, or any other person or machine capable of effectively recording some or all of the information associated with the identifier and its associated medical implant or instrument. A healthcare provider may include physicians, nurses, technicians, hospitals, purchasing agents, governmental agencies, administrative staff, and others. Information on an identifier and that is associated with a medical device may also include a date of use, a time of use, a condition treated, a particular surgical procedure, a procedure type, a number of times sterilized, and other information that might be useful in tracking the safety, utility, and efficacy of a medical device. An identifier and medical device may also be associated in some embodiments with manufacturing information, such as but not limited to, material type, lot number, country where manufactured, manufacturing facility, time of manufacture, and manufacturing process employed.
The identifier, a part of the identifier, or information from the identifier may be physically or virtually associated with the chart or medical information of a patient. In some embodiments, instructions to specifically associate one or more medical devices with a patient who receives a medical device or with whom an instrument is used are given. Instructions may also be given to specifically associate one or more medical devices used with particular locations of use in particular patients. For example and with out limitation, the fact that a spinal surgical screw was implanted in the right pedicle of the L5 vertebra of a particular patient may be associated with an identifier. Consequently, if a corrective action such as a recall for the screw were initiated, a patient may only have to undergo replacement of the particular screw rather than all screws used in the procedure. Identifiers may be physically retained, sent to a specified party, or information from the identifiers may be collected, and the identifiers themselves discarded.
In some embodiments, detaching one or more identifiers is detectable after the identifiers have been detached. Detection may be by any effective means and includes, but is not limited to, the devices described in association with
Embodiments may also include giving instructions to return identifiers to a provider of the associated medical devices. A provider may be the original manufacturer or an agent or otherwise authorized party acting on behalf of the original manufacturer. For example, an agent could be a data processing or data collection organization, or a sales representative or employee of the original manufacturer.
Some embodiments of the invention further include checking the medical device, tray, or associated mechanism to detect whether a medical device has been removed from the mechanism or tray. If a medical device has been removed from the mechanism or tray, the medical device or tray may be returned to a manufacturing or processing facility to be identified properly, or scrapped if tracking has been lost for the device. If not, a method under the invention may include subsequently transferring a previously delivered and returned medical device to a previous potential user or to a new user. The term new user as used herein may also refer to a new potential user.
After sterilization, one or more of the medical devices may be used or consumed in a medical procedure. After the need for the medical devices provided has concluded, the tray with medical devices may be returned to a provider. The provider may be the original manufacturer or an agent or otherwise authorized party acting on behalf of the original manufacturer.
The provider or authorized party in another act of the embodiment receives the tray after one or more of the multiple medical devices have been removed. In some embodiments, one or more associated identifiers are retained in the tray for use by the provider or authorized party. In other embodiments, identifiers may be processed by another route. For example, information from identifiers may be stored in a file system or electronic database as associated with particular instruments or implants provided. Alternatively, or in addition, the physical identifiers may be retained by a user or at the direction of a user. In any circumstance, one or both of identifiers and medical devices may be associated with a patient in connection with whom the medical devices were used or may be associated with the user of the medical devices. A user may be a healthcare provider or related entity such as physicians, nurses, technicians, hospitals, purchasing agents, governmental agencies, administrative staff, and others.
Embodiments of the invention may also include recording the retained identifiers to at least track which medical devices have been used. The recorded information may be recorded and maintained by either or both of a user of the medical device and an original manufacturer or agent of either. Information may be passed between users, patients, and original manufactures under some embodiments.
In any of the embodiments of the present invention, the medical devices may include, be made of, treated, coated, filled, used in combination with, or have a hollow space or opening for containing artificial or naturally occurring materials and/or substances suitable for implantation in the human body. These materials, and/or substances, may include any source of osteogenesis, bone growth promoting materials, bone derived substances or products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic proteins, hydroxyapatite, genes coding for the production of bone, and bone including, but not limited to, cortical bone, antibiotics, cancer treating substances, infection treating substances, substances to therapeutically affect clotting or stenosis, or other disease treating substances. The medical devices can include, at least in part materials that are bioabsorbable and/or resorbable in the body.
While the invention has been described with reference to particular embodiments, it will be appreciated by those of ordinary skill in the art that various modifications can be made to the invention itself without departing from the spirit and scope thereof. All changes and modifications that are within the spirit of the invention are hereby anticipated and claimed.
