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US-20260123976-A1 - Secure Cryosurgical Treatment System

US20260123976A1US 20260123976 A1US20260123976 A1US 20260123976A1US-20260123976-A1

Abstract

A method for cryogenically treating tissue. A connection is detected between a probe having a disposable secure processor (DSP) to a handpiece having a master control unit (MCU) and a handpiece secure processor (HSP), the probe having at least one cryogenic treatment applicator. The probe is fluidly coupled to a closed coolant supply system within the handpiece via the connection. An authentication process is initiated between the DSP and the HSP using the MCU. As a result of the authentication process, one of at least two predetermined results is determined, the at least two predetermined results being that the probe is authorized and non-authorized.

Inventors

  • Corydon A. Hinton
  • Kyler Mikhail Connelly
  • Bijy Zachariah
  • Jesse Rosen

Assignees

  • PACIRA CRYOTECH, INC.

Dates

Publication Date
20260507
Application Date
20251022

Claims (20)

  1. 1 . (canceled)
  2. 2 . A system comprising: a probe having at least one cryogenic treatment applicator and a disposable secure processor (DSP); a handpiece removeably coupled to the probe and configured to provide cryogen coolant from a coolant supply system to the probe, the handpiece having a microcontroller unit (MCU); wherein the MCU is configured to: detect connection of a first type of probe having a first DSP to the handpiece having the MCU, the handpiece being compatible with a plurality of different types of probes, the first type of probe having at least one cryogenic treatment applicator, the first type of probe being fluidly coupled to a closed coolant supply system within the handpiece via the connection; initiate a communication process between the first DSP and the MCU, wherein the first DSP provides a first type of tip descriptor to the MCU; and as a result of the communication process, initiate a first type of treatment protocol based on the first type of tip descriptor.
  3. 3 . The system of claim 2 , wherein the first type of treatment protocol is provided by the tip descriptor.
  4. 4 . The system of claim 2 , wherein the treatment protocol is retrieved from memory of the handpiece by the MCU based on identification of the tip descriptor.
  5. 5 . The system of claim 2 , wherein the plurality of different types of probes share the same type of cryogenic treatment applicator configuration.
  6. 6 . The system of claim 2 , wherein the MCU is further configured to: detect a second connection of a second type of probe having a second DSP to the handpiece after the first type of probe is decoupled from the handpiece, the second type of probe sharing the same type of cryogenic treatment applicator configuration as the first type of probe, the second type of probe being fluidly coupled to the closed coolant supply system within the handpiece via the second connection; initiate a communication process between the second DSP and the MCU, wherein the second DSP provides a second type of tip descriptor to the MCU; and as a result of the communication process, initiate a second type of treatment protocol based on the second type of tip descriptor, the second type of treatment protocol being different from the first type of treatment protocol.
  7. 7 . The system of claim 2 , wherein the MCU is further configured to verify a compatible tip connection prior to initiating a treatment protocol.
  8. 8 . The system of claim 2 , wherein the tip descriptor comprises operating instructions to control metering of coolant to the cryogenic treatment applicator by way of a controllable valve.
  9. 9 . The system of claim 2 , wherein the tip descriptor includes test parameters.
  10. 10 . The system of claim 2 , wherein the tip descriptor includes expiration information.
  11. 11 . The system of claim 2 , wherein the coolant supply system comprises a cannister disposed within the handpiece.
  12. 12 . The system of claim 11 , further comprising a supply valve disposed between the cannister and the probe to regulate the coolant to the probe.
  13. 13 . The system of claim 12 , wherein the MCU is configured to actuate the supply valve, wherein the operating instructions comprise a protocol for timing opening and closing of the supply valve.
  14. 14 . The system of claim 12 , wherein the MCU is configured to provide control signals to the supply valve to implement an authorized treatment algorithm.
  15. 15 . The system of claim 14 , wherein the authorized treatment algorithm includes control of time, temperature, cycling, pulsing, or ramp rates for cooling or thawing.
  16. 16 . The system of claim 12 , wherein the supply valve comprises an electrically actuated solenoid valve or a motor actuated valve.
  17. 17 . The system of claim 2 , wherein the MCU is configured to control coolant to the probe by regulating a treatment time, coolant flow rate, temperature, or a rate of temperature change.
  18. 18 . The system of claim 2 , wherein the MCU is further configured to: detect connection of the probe to the handpiece; initiate an authentication process between a disposable secure processor (DSP) of the probe and the MCU; and as a result of the authentication process, determining one of at least two predetermined results, the at least two predetermined results comprising that the probe is authorized and non-authorized.
  19. 19 . The system of claim 18 , the handpiece further comprising a handpiece secure processor (HSP), wherein the authentication process comprises the HSP requesting a certificate from the DSP.
  20. 20 . The system of claim 19 , wherein the probe is authorized after the DSP provides a valid certificate to the HSP in response to this request or non-authorized after the DSP fails to provide a valid certificate to the HSP in response to this request.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS The present application is a Continuation of U.S. patent application Ser. No. 18/196,778 filed May 12, 2023 (Allowed); which is a Continuation of U.S. patent application Ser. No. 17/091,366 filed Nov. 6, 2020 (now U.S. Pat. No. 11,690,661); which is a Continuation of U.S. patent application Ser. No. 16/168,551 filed Oct. 23, 2018 (now U.S. Pat. No. 10,864,033); which is a Continuation of U.S. patent application Ser. No. 14/534,120 filed Nov. 5, 2014 (now U.S. Pat. No. 10,130,409); which claims the benefit of U.S. Provisional Application No. 61/900,345 filed Nov. 5, 2013, the disclosures which are incorporated herein by reference in their entirety for all purposes. BACKGROUND OF THE INVENTION Medical devices can include a handpiece for operational control of a detachable tip used for applying a therapy, such as electrocautery or cryogenic therapy. In many instances, the detachable tip is designed and approved for a single use, or a limited amount of uses, and should be disposed afterwards. For example, a detachable tip can have a very fine cryogenic needle that dulls after use, and thus rendered unable to pierce tissue in an intended manner. In other cases, the detachable tip cannot be safely sterilized after use. Unfortunately, some users reuse detachable tips in spite of these dangers. This can cause problems such as patient injury or infection. Additionally, fraudsters may produce duplicate tips without authorization. These duplicate tips can be unsafe because of faulty construction or sterilization methods, since manufacture is unregulated. Accordingly, there is a need to address these issues. BRIEF SUMMARY OF THE INVENTION Embodiments of the invention can include a therapy system having a disposable device and a durable device. Each device can include a secure microprocessor with applications code and configuration data. In some embodiments, one secure processor can be located in the handheld/durable device, such a cryogenic therapy device, and the other secure processor can be located in a disposable/consumable device (e.g. a detachable probe with at least one cryogenic needle), which is adapted to receive cryogenic cooling fluid from the handheld device, interface with tissue to provide direct therapy to a patient, and mechanically couple and decouple with the handheld device. In some embodiments, the handheld device can include a microprocessor control unit (MCU) with software applications code, communication links and related electronic circuitry. The secure processor (HSP) in the handheld device contains custom software and configuration data, and may include one or more X509 digital certificates. The secure processor in the disposable device (DSP) can also contain custom software and configuration data, including one or more ITU-T X 509 (ISO/IEC 9594-8) digital certificates. Such configuration data can include a predetermined amount of treatment cycles, treatment cycle parameters, tip identification, and performance test parameters. In some embodiments, the two secure processors can communicate with one another by way of electronic circuitry of the MCU. Software in the MCU and the secure processors implements communication protocols, including commands and replies. The software contains logic to perform an authentication according to a protocol, such as public key infrastructure (PKI)-based authentication, between the durable and consumable patient treatment devices. This software uses cryptographic techniques to establish trusted identity and secure communication. In some embodiments, the disposable device can be authenticated using PKI signing challenge methods issued by the HSP. The DSP may refuse a request to provide the application configuration data if authentication has not been completed. This feature, optionally in conjunction with a design in which the handpiece or disposable device requires this external data for operation, provides a way of denying use of the system in cases where trust has not been established that the disposable device is authentic. The authentication method may be extended to two-way authentication. Accordingly, one or more disposable device components authenticate one or more handheld device components in addition to the authentication processes initiated by the one or more durable components. In some embodiments, the disposable device may authenticate the handpiece in a one-way authentication process. In some embodiments, the authentication method can be extended to cover multiple types of disposable devices (e.g., pain treatment needles, cosmetic needles, etc.). This design alternative could enforce an electronic manifest, configured in the disposable device, which would authenticate the set(s) of disposable devices. In some embodiments, interprocessor communication devices and protocols may be used including I2C, SPI, serial, or ISO7816. In some embodiments, the disposable device and handheld device can communicate wirele