Vapor ablation systems and methods

• US 10,342,593 B2
• Filed: 01/29/2016
• Issued: 07/09/2019
• Est. Priority Date: 01/29/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: NxThera, Inc (Boston Scientific Corporation)
• Inventors: Hastings, Roger Noel, Carlson, Steven, Schrom, Mark, Hoey, Michael
• Primary Examiner(s): Fowler, Daniel W
• Application Number:
  US15/011,005
• Publication Number:
  US 20160220296A1
• Time in Patent Office: 1,257 Days
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2018/00029 open
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/00744 Fluid flow
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/048 in gaseous form
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61B 2218/007 Aspiration

Abstract

A vapor delivery system and method is provided that is adapted for treating prostate tissue. The vapor delivery system includes a vapor delivery needle configured to deliver condensable vapor energy to tissue. In one method, the vapor delivery system is advanced transurethrally into the patient to access the prostate tissue. The vapor delivery system includes a generator unit and an inductive heating system to produce a high quality vapor for delivery to tissue. Methods of use are also provided.

Claims

1. A vapor delivery system, comprising:

a generator unit;

a cradle disposed in the generator unit;

a syringe assembly disposed in the cradle and configured to interact with the cradle to deliver a fluid at a controlled rate, wherein a barrel of the syringe assembly directly contacts the cradle;

an inductive heating system fluidly coupled to the syringe assembly and configured to receive fluid from the syringe assembly;

a force sensor disposed in the cradle and configured to contact the cradle and/or the syringe assembly to generate an electrical signal proportional to a force exerted on the force sensor by the cradle and/or the syringe assembly; and

an electronic controller configured to control delivery of fluid and RF power to the inductive heating system for the production of vapor, to calibrate the electrical signal as representing a fluid pressure within the syringe assembly, and to stop delivery of the fluid and/or the RF power to the inductive heating system when the fluid pressure falls outside of a predetermined range of fluid pressures.

2. The system of claim 1, wherein the cradle is arranged such that a distal end of the syringe assembly is held at a higher elevation than a proximal end of the syringe assembly.

3. The system of claim 2, wherein the cradle is configured to purge any air from the syringe assembly during a priming procedure.

4. The system of claim 1, wherein the cradle further comprises a piston coupled to a linear motor, wherein the piston interacts with a plunger of the syringe assembly to deliver fluid from the syringe assembly.

5. The system of claim 1, wherein a contact switch is activated by the contact between the barrel and the cradle.

6. The system of claim 1, wherein the inductive heating system comprises an inner fluid coil surrounded by an outer conductive coil.

7. A vapor delivery system, comprising:

a generator unit;

a cradle disposed in the generator unit;

a syringe assembly disposed in the cradle and configured to interact with the cradle to deliver a fluid at a controlled rate;

an inductive heating system fluidly coupled to the syringe assembly and configured to receive fluid from the syringe assembly;

a force sensor disposed between the cradle and the generator and configured to generate an electrical signal proportional to a force exerted on the force sensor by the cradle; and

an electronic controller configured to control delivery of fluid and RF power to the inductive heating system for the production of vapor, to calibrate the electrical signal as representing a fluid pressure within the syringe assembly, and to stop delivery of the fluid and/or the RF power to the inductive heating system when the fluid pressure falls outside of a predetermined range of fluid pressures.

8. The system of claim 7, wherein at least a portion of the cradle is free to move in a lateral direction perpendicular to a longitudinal axis of the syringe assembly, and wherein the force exerted is a lateral force.

9. The system of claim 7, wherein the cradle further comprises a piston coupled to a linear motor, wherein the piston is configured to interact with a plunger of the syringe assembly to deliver fluid from the syringe assembly.

10. The system of claim 9, wherein the interaction of the plunger and the syringe assembly causes the force to be exerted on the force sensor by the cradle.

11. The system of claim 7, wherein the cradle is arranged such that a distal end of the syringe assembly is located at a higher elevation than a proximal end of the syringe assembly.

12. The system of claim 11, wherein the cradle is configured to purge any air from the syringe assembly during a priming procedure.

13. The system of claim 7, wherein a barrel of the syringe directly contacts the cradle.

14. A vapor delivery system, comprising:

a generator unit;

a cradle disposed in the generator unit;

a syringe assembly disposed in the cradle and configured to interact with the cradle to deliver a fluid at a controlled rate;

an inductive heating system fluidly coupled to the syringe assembly and configured to receive fluid from the syringe assembly;

a force sensor disposed in the cradle and configured to contact the cradle and/or the syringe assembly to generate an electrical signal proportional to a lateral force exerted on the force sensor by the cradle and/or the syringe assembly in a lateral direction, wherein the lateral direction is a direction perpendicular to a longitudinal axis of the syringe assembly; and

an electronic controller configured to control delivery of fluid and RF power to the inductive heating system for the production of vapor, to calibrate the electrical signal as representing a fluid pressure within the syringe assembly, and to stop delivery of the fluid and/or the RF power to the inductive heating system when the fluid pressure falls outside of a predetermined range of fluid pressures.

15. The system of claim 14, wherein at least a portion of the cradle is free to move laterally within the generator unit.

16. The system of claim 14, wherein the cradle further comprises a piston coupled to a linear motor, wherein the piston is configured to interact with a plunger of the syringe assembly to deliver fluid from the syringe assembly.

17. The system of claim 16, wherein the interaction of the plunger and the syringe assembly causes the lateral force to be exerted on the force sensor by the cradle.

18. The system of claim 14, wherein the force sensor is disposed between the cradle and the generator.

19. The system of claim 14, wherein a barrel of the syringe directly contacts the cradle.

20. The system of claim 14, wherein the cradle is arranged such that a distal end of the syringe assembly is held at a higher elevation than a proximal end of the syringe assembly.