Remote enabling/disabling of a limited-use medical device

• US 7,694,809 B2
• Filed: 12/06/2005
• Issued: 04/13/2010
• Est. Priority Date: 12/06/2005
• Status: Active Grant

• Current Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Original Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Inventors: Garbini, Lex J., Dull, Douglas B.
• Primary Examiner(s): ACKUN, JACOB K
• Application Number:
  US11/295,792
• Publication Number:
  US 20070129684A1
• Time in Patent Office: 1,589 Days
• Field of Search: 206/363, 206/364, 206/367, 206/438, 206/439
• US Class Current: 206/364
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A remotely controlled medical instrument enhances safety and reliability. The medical instrument may be remotely enabled (unlocked) or disabled (locked). The medical instrument may be intended for limited-use. The medical instrument may be enclosed within a medical packaging and subsequently sterilized. After the medical instrument is determined to meet desired specifications, a remote control device may remotely enable the medical instrument. The remote control device may remotely enable the medical instrument through the sterile barrier and without making direct contact with the medical instrument such that the medical instrument remains sterilized. The non-contact interaction between the medical instrument and the remote control device may be via infrared, electromagnetic, magnetic, or other non-contact communication techniques. The remote control device may remotely disable the medical instrument. The remote controller may transmit a key code to prevent the inadvertent and/or unauthorized enabling or disabling of the limited-use medical device.

Claims

1. A medical device comprising:

a catheter configurable to be used a limited number of times or limited amount of time; and

a verified sterile barrier on the catheter, the sterile barrier being formed by packaging;

the catheter operable to be wirelessly and remotely enabled to unlock the catheter in order to allow use of the catheter, the enablement being while still in the packaging and without breaching the sterile barrier, the catheter configured by the unlocking to allow the use for the limited number or amount, the use being for a medical application in a patient, the catheter configured to automatically lock after the number of times or the limited amount of time, the lock preventing subsequent use of the catheter for the medical application in the patient.

2. The device of claim 1, wherein the catheter is operable to be remotely disabled without breaching the sterile barrier.

3. The device of claim 1, wherein the packaging is manufactured from a permeable material that permits passage of a sterilization agent.

4. The device of claim 3, wherein the catheter is sterilized via an ethylene oxide sterilization procedure after the catheter is effectively enclosed within the sterile barrier.

5. The device of claim 1, wherein the catheter is remotely controlled via infrared interaction between the catheter and a remote control device.

6. The device of claim 1, wherein the catheter is remotely controlled via electromagnetic interaction between the catheter and a remote control device.

7. The device of claim 1, wherein the catheter is remotely controlled via magnetic interaction between the catheter and a remote control device.

8. The device of claim 1, wherein the catheter is remotely enabled after receiving an identification code transmitted from a remote control device.

9. The device of claim 1 wherein the catheter is a used catheter, which has been disabled, and wherein the packaging comprises repackaging.

10. The device of claim 1 wherein the catheter is an imaging catheter and the use is for imaging while connected with an imaging system.

11. A medical device comprising:

a medical instrument configurable to be used a limited number of times or limited amount of time; and

medical packaging forming a verified sterile barrier that encloses the medical instrument;

the medical instrument configured to be remotely unlocked prior to use in order to allow use of the medical instrument, the unlocking being while still in the packaging, and without breaching the sterile barrier, the medical instrument configured by the unlocking to allow the use for the limited number or amount, the use being for a medical application in a patient, the medical instrument configured to automatically lock after the number of times or the limited amount of time, the lock preventing subsequent use of the medical instrument for the medical application in the patient.