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05/31/07 - USPTO Class 607 |  87 views | #20070123947 | Prev - Next | About this Page  607 rss/xml feed  monitor keywords

Medical device packaging system

USPTO Application #: 20070123947
Title: Medical device packaging system
Abstract: A system, comprising a sterilizable package; an implantable medical device placed inside the sterilizable package; and an electrical interface electrically coupled to the implantable medical device and extending from inside the sterilizable package to outside the sterilizable package. In various embodiments, the interface may include package contacts electrically coupled to electrode terminals on the implantable medical device, patient terminals and conductors extending between the package contacts and the patient terminals. (end of abstract)



Agent: Medtronic, Inc. - Minneapolis, MN, US
Inventors: William K. Wenger, Paul G. Krause, William J. Plombon, Steven N. Lu, Sean B. McAdams, Brian B. Lee, Lee Stylos, Judy B. Salzer, G. Jordan Montgomery
USPTO Applicaton #: 20070123947 - Class: 607032000 (USPTO)

Related Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Electrical Therapeutic Systems, Heart Rate Regulating (e.g., Pacing), Communicating With Pacer (e.g., Telemetry)

Medical device packaging system description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070123947, Medical device packaging system.

Brief Patent Description - Full Patent Description - Patent Application Claims
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TECHNICAL FIELD

[0001] The invention relates generally to implantable medical devices, and, in particular, to configurations of implantable medical device packaging systems.

BACKGROUND

[0002] Implantable medical devices (IMDs) such as cardiac pacemakers, implantable cardiovertor defibrillators (ICDs), implantable loop recorders (ILRs), implantable drug pumps, neurostimulators, etc. are generally provided by manufactures in a sterilized package. The package commonly includes an external carton or container for holding a sterilized inner tray or pouch containing the IMD. The IMD is sterilized within the inner tray or pouch using appropriate sterilization methods such as steam, gas or ultrasonic sterilization. The inner tray or pouch is generally provided with a peelable or tearable seal that can be opened to drop the sterile IMD contained therein into a sterile field without compromising the sterility of the IMD or the sterile field. For example, an IMD packaging tray having an open top may be sealed closed with a paper lid that is peeled back at the time of an implant procedure to allow the IMD to be dropped out of the tray into the sterile field.

[0003] Some packaging systems may include within the external carton or container an outer tray or pouch for carrying the sterilized inner tray or pouch. The inner tray or pouch and device contained therein may be sterilized within the outer tray or pouch. The outer tray or pouch may then be peeled open to drop the inner tray or pouch into the sterile field at the time of implant. An implanting physician or assistant may then open the inner tray or pouch within the sterile field.

[0004] Pre-implant testing, electrophysiological mapping, or system testing is commonly performed at the beginning of an implantation procedure to ensure that a patient meets implantation criteria and/or to determine an optimal implant location for the IMD and/or associated electrodes. Such testing may be performed using the IMD since using the IMD itself would generally provide the most reliable test results. However, during pre-implant testing, considerable care must be taken to ensure that the IMD and associated leads remain sterile for implantation. Once the IMD is removed from the sterile packaging, the IMD cannot be re-shelved should the patient not meet implantation criteria. As such, external equipment is often substituted for making physiological measurements or performing electrophysiological mapping. Use of external equipment for performing testing or mapping includes certain limitations, however, since the electronics of the external equipment will generally be different than the electronics of the IMD. Signals measured by external equipment may not be the same as signals measured at the same location by the IMD. Even minor signal differences can limit the usefulness or reliability of such measurements for the purposes of pre-implant tests.

[0005] Since IMDs tend to be costly devices, it is undesirable to open the IMD sterile packaging prior to knowing with reasonable certainty that the IMD is appropriate for the patient and that an acceptable implantation site for the device and/or leads can be identified. Furthermore, external equipment needed for performing pre-implant testing may not be readily available and requires extra space within the operating theater, which is often already crowded with equipment and personnel. Often a programmer that supports surface ECG recording in addition to receiving telemetry signals from the IMD is needed to perform pre-implant testing. Such full-function programmers can be bulky and costly to provide to all clinical centers.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 is an illustration of one type of IMD in which an embodiment of the invention may be implemented.

[0007] FIG. 2 is an illustration of an alternative IMD with which the invention may be practiced.

[0008] FIG. 3 is a functional block diagram representing components that may be included in an IMD electronics module along with associated memory.

[0009] FIG. 4A is a block diagram providing an overview of an IMD packaging system including an electrical interface according to various embodiments of the invention.

[0010] FIG. 4B is a diagram of an IMD packaging system wherein an electrical interface is provided in the form of a flexible circuit.

[0011] FIG. 5 is a perspective view of one type of sterilizable package that may be used in various embodiments of the invention.

[0012] FIG. 6A is a side cut-away view of one embodiment of a packaging system including an electrical interface used for accessing IMD electronics while the IMD is contained within a sterile package.

[0013] FIG. 6B is a side, sectional view of an alternative embodiment of packaging system including a pressure generating member for promoting reliable electrical contact between an electrical interface and an IMD enclosed in a sterile package.

[0014] FIG. 6C shows a pressure generating member 121 packaged within an inner tray, around an IMD and electrical interface for promoting good electrical contact between the IMD and electrical interface.

[0015] FIG. 7 is a top view of the packaging system shown in FIG. 6A.

[0016] FIG. 8 is a partial, side, cut-away view of an IMD packaging system according to an alternative embodiment of the invention wherein an electrical interface is formed on a substrate that includes a surface of the sterilizable package.

[0017] FIG. 9 is a bottom view of the inner tray lid shown in FIG. 8.

[0018] FIG. 10A is a top view of an alternative embodiment of a flexible circuit electrical interface formed on the inner surface of an inner tray lid.

[0019] FIG. 10B is a top view of the flexible circuit shown in FIG. 10A after folding the flexible substrate along fold lines to provide insulation to the exterior portions of conductors.

[0020] FIG. 10C is a top view of the electrical interface shown in FIG. 10B further including elements for protecting the electrical interface.

[0021] FIG. 11 is a perspective view of an alternative embodiment of an electrical interface.

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Previous Patent Application:
Methods for the prediction of arrhythmias and prevention of sudden cardiac death
Next Patent Application:
Protocol implementation for telemetry communications involving implantable medical devices
Industry Class:
Surgery: light, thermal, and electrical application

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