Medical Device Identification System

• US 20160148027A1
• Filed: 11/24/2015
• Published: 05/26/2016
• Est. Priority Date: 11/25/2014
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Schoutens, Robert J.
• Granted Patent: US 9,911,019 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/98 using electromagnetic means, e.g. transponders
• CPC Class Codes: G06K 19/07749 the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
• CPC Class Codes: G06K 7/10366 the interrogation device being adapted for miscellaneous applications

Abstract

Instrumentation and methods of use are provided for a medical device identification system. The application describes embodiments of a system including a medical device, and an identification tag having an RFID chip and an electrical circuit. The system defines a first configuration in which a first attachment region of the electrical circuit is in electrical communication with a second attachment region of the electrical circuit, and a second configuration in which the first attachment region is electrically isolated from the second attachment region. When the system is in the first configuration the RFID chip is in a first state, and when the system is in the second configuration the RFID chip is in a second state different than the first state.

Claims

1. A medical device identification system comprising:

a medical device; and

an identification tag coupled to the medical device, the identification tag including an RFID chip and an electrical circuit, the electrical circuit including a first attachment region attached to the RFID chip at a first RFID location, and a second attachment region attached to the RFID chip at a second RFID location that is spaced from the first RFID location;

wherein

     1) the system defines a first configuration in which the first attachment region is in electrical communication with the second attachment region along the electrical circuit, and a second configuration in which the first attachment region is electrically isolated from the second attachment region along the electrical circuit, and

     2) the RFID chip is in a first state when the system is in the first configuration, and the RFID chip is in a second state different than the first state when the system is in the second configuration.

2. The system of claim 1, wherein the medical device includes at least one of:

1) an implant configured to be implanted in a human body; and

     2) an instrument configured for use in a medical procedure.

3. The system claim 1, wherein the identification tag includes an electrically conductive wire that defines at least a portion of the electrical circuit, and the electrical circuit is coupled to the medical device such that decoupling of the identification tag from the medical device causes a break in the electrical circuit at a location between the first attachment region and the second attachment region such that the electrical circuit is open.

4. The system of claim 1, wherein the RFID chip is an active chip that emits a radio frequency signal when the electrical circuit is closed, the identification tag includes an antenna configured to transmit the radio-frequency signal, the radio-frequency signal includes information that indicates whether the RFID chip is in the first state or the second state, and the electrically conductive wire defines at least a portion of the antenna.

5. The system of claim 1, wherein the RFID chip is an active chip that emits a radio frequency signal when the electrical circuit is open, the identification tag includes an antenna configured to transmit the radio-frequency signal, the radio-frequency signal includes information that indicates whether the RFID chip is in the first state or the second state, and the electrically conductive wire defines at least a portion of the antenna.

6. The system of claim 5, wherein the medical device defines a portion of the electrical circuit.

7. The system of claim 1, wherein the electrical circuit defines a path between the first attachment region and the second attachment region, the electrical circuit includes a third attachment region positioned on the path between the first attachment region and the second attachment region, the electrical circuit further includes a fourth attachment region positioned on the path between the third attachment region and the second attachment region, when the system is in the first configuration the third attachment region and the fourth attachment region are each attached to the medical device, and when the system is in the second configuration the third attachment region and the fourth attachment region are separated by a gap such that the third and fourth attachment regions are electrically isolated from one another.

8. The system of claim 1, wherein:

the system includes a substrate that carries the identification tag, the substrate including a substrate body and defining a recess that extends into the substrate body, the recess configured to receive the medical device such that when the medical device is inserted into the recess the system is in the first configuration, and when the medical device is removed from the recess the system is in the second configuration;

the medical device is a first medical device, the recess is a first recess, the system comprises a second medical device, and the substrate defines a second recess configured to receive the second medical device; and

the electrical circuit is a first electrical circuit, the identification tag includes a second electrical circuit, at least a portion of the second electrical circuit different than the first electrical circuit, in both the first configuration and the second configuration;

     1) the identification tag is coupled to the second medical device, and

     2) the second electrical circuit is closed, and the system defines a third configuration in which;

     1) the identification tag is decoupled from both the first medical device and the second medical device,

     2) both the first electrical circuit and the second electrical circuit are open, and

     3) the RFID chip defines a third state that is different than both the first state and the second state.

9. The system of claim 8, further comprising a case configured to carry the substrate.

10. The system of claim 1, wherein:

the system includes a substrate that carries the identification tag, the substrate including a substrate body and defining a recess that extends into the substrate body, the recess is configured to receive the medical device such that when the medical device is inserted into the recess the system is in the first configuration, and when the medical device is removed from the recess the system is in the second configuration, the substrate body includes an inner surface, the recess is a through hole defined at least in part by the inner surface, the through hole includes a first opening, a second opening spaced from the first opening along a first direction, and a hole axis that extends in along the first direction and passes through both the first opening and the second opening; and

when the system is in the first configuration the medical device is positioned within the substrate such that a first portion of the medical device extends through the first opening and a second portion of the medical device extends through the second opening.

11. The system of claim 1, wherein the system includes a substrate that carries the identification tag, the substrate including a substrate body and defining a recess that extends into the substrate body, the recess is configured to receive the medical device such that when the medical device is inserted into the recess the system is in the first configuration, and when the medical device is removed from the recess the system is in the second configuration, and the substrate body includes a base portion, a first arm that extends from the base portion in a first direction, and a second arm that extends from the base portion in the first direction and is spaced from the first arm along a second direction that is different than the first direction, the first arm including a first inner surface that faces the second arm, the second arm including a second inner surface that faces the first arm, and the recess includes a gap defined at least in part by the first inner surface and the second inner surface.

12. The system of claim 1, wherein the electrical circuit defines a path between the first attachment region and the second attachment region, and the path defines a first area with an outer perimeter defined by the path, and a second area with an inner perimeter defined by the path, such that when the system is in the first configuration at least a portion of the implant is positioned within the first area.

13. A method of assembling a medical device identification system, the method comprising the steps of:

coupling an identification tag to a medical device such that

     1) a first attachment region of an electrical circuit of the identification tag that is attached to an RFID chip of the identification tag at a first RFID location on the RFID chip is in electrical communication with a second attachment region of the electrical circuit of the identification tag that is attached to the RFID chip at a second RFID location on the RFID chip that is spaced from the first location;

placing the coupled medical device and identification tag into an interior of an enclosure.

14. The method of claim 13, wherein the medical device includes an implant configured to be inserted into a human body, and the interior of the enclosure is a sterile interior, the coupling step includes inserting the medical device into a recess of a substrate such that the medical device defines a portion of the electrical circuit, and the inserting step includes moving the medical device into contact with both 1) a third attachment region of the electrical circuit that is positioned between the first attachment region and the second attachment region and 2) a fourth attachment region of the electrical circuit that is positioned between the third attachment region and the second attachment region.

15. The method of claim 14, wherein the moving step includes at least one of:

1) rotating the medical device about an axis with respect to the substrate, and

     2) translating the medical device along an axis with respect to the substrate.

16. A method of implanting an implant, the method comprising the steps of:

selecting an implant for implantation into a patient, wherein the implant is coupled to an identification tag that includes an RFID chip and an electrical circuit, the electrical circuit having a first attachment region attached to the RFID chip at a first RFID location and a second attachment region attached to the RFID chip at a second RFID location spaced from the first RFID location, wherein the first attachment region is in electrical communication with the second attachment region along the electrical circuit, and the RFID chip is in a first state;

decoupling the identification tag from the implant so as to cause a break in the electrical circuit, thereby electrically isolating the first attachment region from the second attachment region along the circuit;

in response to the decoupling step, causing the RFID chip to define a second state that is different than the first state;

implanting the decoupled implant into the patient; and

sensing the second state of the RFID chip.

17. The method of claim 16, wherein the decoupling step includes removing the implant from a recess of a substrate of the system, the removing step includes moving the implant out of contact with both 1) a third attachment region of the electrical circuit that is positioned between the first attachment region and the second attachment region and 2) a fourth attachment region of the electrical circuit that is positioned between the third attachment region and the second attachment region, and the moving step includes rotating the implant about an axis with respect to the substrate.

18. The method of claim 16, wherein the decoupling step includes removing the implant from a recess of a substrate of the system, the removing step includes moving the implant out of contact with both 1) a third attachment region of the electrical circuit that is positioned between the first attachment region and the second attachment region and 2) a fourth attachment region of the electrical circuit that is positioned between the third attachment region and the second attachment region, and the moving step includes translating the implant along an axis with respect to the substrate.

19. The method of claim 16, wherein the decoupling step includes removing a portion of the implant from a first area having an outer perimeter defined by a wire of the identification tag.

20. The method of claim 16, further comprising the steps of:

transmitting the second state of the RFID chip;

storing the second state of the RFID chip; and

associating the second state of the RFID chip with the patient, wherein the associating step includes recording the state of the RFID chip in a file associated with the patient.