System and Method for Cryptographic Identification of Interchangeable Parts

• US 20090327715A1
• Filed: 05/02/2008
• Published: 12/31/2009
• Est. Priority Date: 05/04/2007
• Status: Abandoned Application

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Palmer, Matthew A., Smith, Kevin W., Deville, Derek Dee, Rivera, Carlos, Bales, Thomas
• Application Number:
  US12/114,287
• Publication Number:
  US 20090327715A1
• Time in Patent Office: Days
• US Class Current: 713/168
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61M 2039/1022 additionally providing electrical connection
• CPC Class Codes: A61M 2039/1094 at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014

Abstract

An anti-counterfeiting identification system for a medical tubing system, including a tubing assembly having upstream and downstream tubing portions removably connected to one another in a mechanically coupled state and a mechanically uncoupled state. The mechanically coupled state is a reliable fluid tight connection of the upstream and downstream portions for fluids passing there through from the upstream portion to the downstream portion. A two-part encrypted identification assembly has a first part connected to the upstream portion and a second part connected to the downstream portion. The first and second parts are electrically connected only through one lead and ground and are electrically connected to one another only in the mechanically coupled state. Also provided are methods for identification, anti-piracy, and inventory.

Claims

1. An anti-counterfeiting interchangeable part identification system, comprising:

a power supply;

an identification interface device coupled to said power supply and interchangeably receiving at least one of a set of removable parts, said identification interface device having a 1-wire communication and power interface electrically connected to said power supply; and

an encryption device to be disposed on each one of said set of removable parts and powered solely by said power supply when electrically connected to said identification interface device, said identification interface device and said encryption device being electrically connected only through one lead and ground when a respective one of said set of removable parts is removably connected to said identification interface device, said one lead being a communication and power connection directly connected to said power interface when said encryption device on one of the set of parts is reliably mechanically connected to said identification interface device.

2. The system according to claim 1, wherein said power supply is integral with said identification interface.

3. The system according to claim 2, wherein said power supply is a battery pack.

4. The system according to claim 3, wherein said battery pack is removable.

5. The system according to claim 1, wherein said power supply is an electric mains.

6. The system according to claim 1, wherein said encryption device has a memory storing identification data about a respective one of said parts.

7. The system according to claim 1, wherein said encryption device is one of a Dallas Semiconductor DS2432 chip and a Dallas Semiconductor DS2460 chip.

8. An anti-counterfeiting identification system for a medical tubing system, comprising:

a tubing assembly having;

an upstream tubing portion; and

a downstream tubing portion removably connected to said upstream tubing portion in a mechanically coupled state and a mechanically uncoupled state, said mechanically coupled state being a reliable fluid-tight connection of said upstream and downstream portions for fluids passing through said portions from said upstream tubing portion to said downstream tubing portion; and

a two-part encrypted identification assembly having a first part connected to said upstream portion and a second part connected to said downstream tubing portion, said first part and said second parts being electrically connected only through one lead and ground and being electrically connected to one another only when said mechanically coupled state occurs.

9. The anti-counterfeiting identification system according to claim 8, wherein:

the two-part encrypted identification assembly is operable to perform an encrypted authentication of at least one of said upstream and downstream tubing portions on said one lead when said mechanically coupled state occurs.

10. The anti-counterfeiting identification system according to claim 8, wherein:

said mechanically coupled state occurs only when an electrical connection is made through said one lead and said ground.

11. The anti-counterfeiting identification system according to claim 8, wherein:

said first and second parts are reliably electrically connected through only one lead and ground only during an establishment of said reliable fluid-tight connection between said upstream and downstream portions.

12. A self-authenticating tubing set ensuring that two pieces of the set are reliably connected together, comprising:

a tubing set having at least first and second tubing parts, said first tubing part having a coupler and said second tubing part having a receiver removably interlocking with said coupler;

a first electronic encrypted communication chip at said receiver;

a power supply connected to electrical ground and to said first electronic encrypted communication chip to provide electrical power thereto;

a second electronic encrypted communication chip at said coupler;

said receiver having an electrically insulated communications lead connected to a communications port of said first electronic encrypted communication chip and to the electrical ground;

said second electronic encrypted communication chip having;

a grounding port connected to the electrical ground when said coupler and said receiver are reliably connected together; and

a communications port electrically insulated from said coupler, said communications port being conductively connected to said electrically insulated communications lead when said coupler and said receiver are reliably connected together; and

said first electronic encrypted communication chip and said second electronic encrypted communication chip operable to exchange encrypted data therebetween only when said coupler and said receiver are reliably connected together.

13. A method for improving security of interchangeable parts from counterfeiting, the method comprising:

storing encrypted unique identification data in each one of a set of 1-wire encryption devices;

physically coupling a different one of the 1-wire encryption devices to each one of a plurality of interchangeable parts to be inventoried, thereby associating a particular identification data to each of the parts; and

making a reliable mechanical connection between at least one of the parts to be inventoried and an encryption reader and, only upon an existence of the reliable mechanical connection;

creating a reliable electrical connection between the encryption device associated with the part and an encrypted communication device of the encryption reader;

reading the encrypted unique identification data associated with the part with the encryption reader; and

determining an acceptance state of the part dependent upon the encrypted unique identification data read.

14. The method according to claim 13, which further comprises, repeating the making, creating, reading and determining steps for at least one more part.

15. A method for preventing an end user from using unauthorized parts, which comprises:

supplying interchangeable parts with an encrypted identification tag;

making a reliable mechanical connection between one of the parts and an encryption reading device to, thereby, create a reliable electrical connection between the encryption reading device and the encrypted identification tag;

authenticating the part with the encryption reading device dependent upon encrypted identification data associated with the part; and

one of;

permitting a use of the part if authentication is positive; and

prohibiting a use of the part if authentication is negative.

16. The method according to claim 15, which further comprises:

supplying the interchangeable parts with a number of different groups of encrypted identification tags, each of the groups being associated with one of a number of different keys;

providing reading devices and associating one of the keys to each of the reading devices;

coupling one of the interchangeable parts with one of the reading devices; and

enabling use of the coupled one of the reading devices if the particular key of the coupled one of the interchangeable parts is authenticated by the one of the reading devices.

17. The method according to claim 16, which further comprises:

storing data within the encrypted identification tag prior to use; and

changing the stored data the encrypted identification tag during use of the part.

18. The method according to claim 17, wherein the stored data includes manufacturer-specific information.

19. The method according to claim 18, wherein the manufacturer-specific information includes at least one of:

“

built by machine number”

data;

“

final test performed by”

data;

“

inspected by operator on date”

data; and

“

use by”

data.

20. The method according to claim 19, which further comprises, prior to use of the part, determining whether or not a “

time of use”

is contained within a “

use by”

date of the stored data and permitting use of the part if the “

time of use”

is contained within a “

use by”

date or prohibiting use of the part if the “

time of use”

is outside the “

use by”

date.

21. The method according to claim 15, which further comprises:

using the part and recording data with the tag during use; and

detecting whether or not a user properly used the part by examining the tag after use and determining if the part use;

was used within a “

use by”

date; and

was used with an authorized device.

22. The method according to claim 15, which further comprises:

sensing at least one physical parameter of an environment of the part before use of the part; and

permitting use of the part dependent upon a result of the physical parameter sensed.

23. The method according to claim 15, which further comprises:

using the part and recording data with the tag during use; and

subsequently determining if the part use was authorized dependent upon the recorded data.

24. The method according to claim 23, wherein the stored data includes at least one of:

time of use;

date of use;

temperature of environment around part at time of use;

duration of use;

speed of use;

physical parameters existing during use;

imparted forces experienced during use;

how the part was connected to the encryption reading device;

what occurred with the part when it was connected to the encryption reading device; and

whether misuse or error occurred during use.

25. The method according to claim 24, which further comprises examining the used part to determine, based upon the stored data, at least one of:

whether or not the part was faulty; and

whether or not user error occurred and, if so, supplying the user with remedial measures or training to prevent future similar occurrences.

26. The method according to claim 15, which further comprises:

using the part and storing data within the identification tag during use; and

supplying the stored data to the encryption reading device after use of the part.

27. The method according to claim 26, wherein the stored data includes at least one of:

time of use;

date of use;

temperature of environment around part at time of use;

duration of use;

speed of use;

physical parameters existing during use;

imparted forces experienced during use;

how the part was connected to the encryption reading device;

what occurred with the part when it was connected to the reading device; and

whether misuse or error occurred during use.

28. The method according to claim 26, which further comprises examining the used part to determine, based upon the stored data, at least one of:

whether or not the part was faulty; and

whether or not user error occurred and, if so, supplying the user with remedial measures or training to prevent future similar occurrences.