Medical device

• US 10,086,216 B2
• Filed: 11/21/2016
• Issued: 10/02/2018
• Est. Priority Date: 10/12/2010
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Tanis, Kevin J., Zhang, Jin, Arrington, Debra Ann, Umstead, Kelly Ann
• Primary Examiner(s): Cattungal, Sanjay
• Application Number:
  US15/357,883
• Publication Number:
  US 20170065837A1
• Time in Patent Office: 680 Days
• Field of Search: 600437-469
• CPC Class Codes: A61B 2034/258 providing specific settings for specific users
• CPC Class Codes: A61B 2090/0803 Counting the number of times an instrument is used
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61N 2007/0013 Fracture healing
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

A medical device includes a treatment module configured to apply a treatment to a patient. The medical device includes an interface configured to operatively connect to a removable storage device storing authorization data that identifies a level of treatment authorization. The medical device includes a processing device configured to perform operations in response to receiving user input indicating a treatment should be initiated. The operations include determining whether the removable storage device is valid for use with the medical device. If the removable storage device is determined to be valid, the authorization data is accessed. The processing device determines whether the treatment is authorized based on the accessed authorization data. If the treatment is determined to be authorized, the treatment module is controlled to apply the treatment. If the treatment is determined to not be authorized, the treatment module is controlled such that the treatment is not applied.

Claims

1. An apparatus for treating a patient, the apparatus comprising:

a treatment source configured to apply therapy to damaged tissue to facilitate healing of the damaged tissue;

a memory device configured to store authorization data;

a communication receiver configured to receive an update to the authorization data; and

a processor configured to;

prior to receipt of the update with the communication receiver,

determine from the authorization data that the treatment source is authorized for use in a first geographic area and unauthorized for use in a second geographic area,

determine a first location of the treatment source in response to receipt of a first user input,

permit application of therapy by the treatment source in response to determinations that the first location is in the first geographic area and that the treatment source is authorized for use in the first geographic area,

determine a second location of the treatment source in response to receipt of a second user input, and

prevent application of therapy by the treatment source in response to determinations that the second location is in the second geographic area and that the treatment source is unauthorized for use in the second geographic area, and

subsequent to receipt of the update with the communication receiver,

determine from the authorization data and the update that the treatment source is authorized for use in the second geographic area,

determine a third location of the treatment source in response to receipt of a third user input, and

permit application of therapy by the treatment source in response to determinations that the third location is in the second geographic area and that the treatment source is authorized for use in the second geographic area.

2. The apparatus of claim 1, wherein the processor is configured to:

cause the treatment source to initiate application of therapy in response to determinations that the first location is in the first geographic area and that the treatment source is authorized for use in the first geographic area; and

cause the treatment source to initiate application of therapy in response to determinations that the third location is in the second geographic area and that the treatment source is authorized for use in the second geographic area.

3. The apparatus of claim 1, wherein

the treatment source comprises a driver circuit configured to control application of therapy to the damaged tissue, and

the processor is configured to permit application of therapy by activation of the driver circuit or by failure to deactivate the driver circuit.

4. The apparatus of claim 1, wherein

the treatment source comprises a driver circuit configured to control application of therapy to the damaged tissue, and

the processor is configured to prevent application of therapy by failure to activate the driver circuit or by deactivation of the driver circuit.

5. The apparatus of claim 1, wherein the processor is configured to determine one or more of the first location, the second location, and the third location from location data from a wireless communications network.

6. The apparatus of claim 1, further comprising a GPS receiver configured to determine a geographical location of the treatment source, the processor being configured to determine one or more of the first location, the second location, and the third location using the GPS receiver.

7. The apparatus of claim 1, further comprising a user interface configured to receive one or more of the first user input, the second user input, and the third user input as a selection of at least one element of the user interface.

8. The apparatus of claim 1, wherein the processor is configured to, prior to receipt of the update with the communication receiver, activate an alarm in response to determinations that the second location is in the second geographic area and that the treatment source is unauthorized for use in the second geographic area.

9. The apparatus of claim 1, wherein the communication receiver is configured to receive the update via a wireless communications network.

10. The apparatus of claim 1, further comprising a sensor, the processor being configured to:

prior to receipt of the update with the communication receiver,

determine from a first authentication input from the sensor that a first patient using the treatment source matches a prescribed patient, and

further require that the first patient using the treatment source matches the prescribed patient prior to application of therapy by the treatment source being permitted in response to determinations that the first location is in the first geographic area and that the treatment source is authorized for use in the first geographic area, and

subsequent to receipt of the update with the communication receiver,

determine from a second authentication input from the sensor that a second patient using the treatment source matches the prescribed patient,

further require that the second patient using the treatment source matches the prescribed patient prior to application of therapy by the treatment source being permitted in response to determinations that the third location is in the second geographic area and that the treatment source is authorized for use in the second geographic area.

11. The apparatus of claim 10, wherein the first authentication input comprises a fingerprint image, a retinal image, or a voice recording.

12. The apparatus of claim 1, wherein

the memory device is configured to store a device identifier,

the authorization data is encrypted, and

the processor is configured to decrypt the authorization data using the device identifier.

13. A method of controlling an apparatus for treating a patient, the method comprising:

determining from authorization data stored in a memory device that a treatment source is authorized for use in a first geographic area and unauthorized for use in a second geographic area;

receiving a first user input via a user interface;

determining a first location of the treatment source in response to receiving the first user input;

performing first therapy to damaged tissue with the treatment source to facilitate healing of the damaged tissue in response to determining that the first location is in the first geographic area and that the treatment source is authorized for use in the first geographic area;

subsequent to said performing first therapy, receiving an update to the authorization data using a communication receiver;

determining from the authorization data and the update that the treatment source is authorized for use in the second geographic area;

receiving a second user input via the user interface;

determining a second location of the treatment source in response to receiving the second user input; and

performing second therapy to the damaged tissue with the treatment source to facilitate healing of the damaged tissue in response to determining that the second location is in the second geographic area and that the treatment source is authorized for use in the second geographic area.

14. The method of claim 13, wherein said determining the first location comprises determining the first location from location data from a wireless communications network.

15. The method of claim 13, wherein said determining the first location comprises determining the first location using a GPS receiver.

16. The method of claim 13, further comprising, prior to said receiving the update, activating an alarm in response to determining that the second location is in the second geographic area and that the treatment source is unauthorized for use in the second geographic area.

17. The method of claim 13, wherein said receiving the update comprises receiving the update via a wireless communications network using the communication receiver.

18. The method of claim 13, further comprising:

receiving an authentication input using a sensor; and

determining from the authorization data and the authentication input that the treatment source is authorized for use in the first geographic area.

19. The method of claim 18, wherein the authentication input comprises a fingerprint image, a retinal image, or a voice recording.

20. The method of claim 13, further comprising:

storing a device identifier in the memory device; and

decrypting the authorization data using the device identifier.