1. Field of the Invention
The present invention relates to cancer surgery and more particularly to a computer guided system for ablative surgery with enhanced feedback.
There is reference in the prior art to the use of computer control systems for providing and/or enhancing cryosurgical techniques. For example, U.S. Pat. No. 4,672,963, issued to I. Barken, discloses an automated and integrated system including a cryosurgery device, an imaging probe and a computer system for use in performing internal surgery.
U.S. Pat. No. 5,647,868, issued to D. O. Chinn, discloses another cryosurgical integrated control and monitoring system.
U.S. Pat. No. 6,139, 544, issued to P. W. Mikus et al, discloses a system for assisting surgeons in performing cryosurgery of the prostate by calculating optimal positions for cryoprobes and providing display based templates for overlay over an ultrasound image display, and displaying actual cryoprobe ultrasound images together with template images so that the surgeon may compare suggested and actual placement of the cryoprobes, and adjust placement accordingly.
The presently utilized CryoCare® Surgical System which is currently manufactured and marketed by Endocare, Inc., Irvine, Calif., utilizes cryoprobes to deliver cold temperatures to the targeted tissue and temperature probes (marketed under the trademark TempProbe®) to monitor temperatures in the surrounding tissue. The CryoCare® Surgical System presently requires a certain degree of skill for operation since the physician requires an understanding of the temperature mapping of the cryoprobes in order to operate them to deliver an effective treatment.
The present invention is a system for providing computer guided ablation of tissue of a patient. The system includes, in a broad aspect, an imaging device, an ablative surgical computer system, and a set of surgical devices. The imaging device receives imaging data from a treatment region of a patient, processes the imaging data and provides imaging output data and imaging signals. The imaging output data is available to an operator. The ablative surgical computer system includes a guidance module for processing the imaging signals and providing a treatment guidance plan to the operator; and, a treatment module for acquiring and processing surgical device output data, for optimally controlling treatment parameters and providing feedback information to the operator based on the treatment guidance plan. The set of surgical devices includes at least one ablative device for providing ablation of the treatment region based on the treatment parameters and operator input; and, at least one temperature sensing device for acquiring temperature data from the treatment region and providing a temperature sensing device output signal. The temperature sensing device output signal is a portion of the surgical device output data. The treatment guidance plan is utilized for placing the ablative device and the temperature sensing device into the treatment region.
The feedback described above provides enhanced automation and minimizes the potential for operator error resulting in an ineffective or unsuccessful treatment. This enhancement to the CryoCare® Surgical System, discussed above, will be marketed by the present assignee, Endocare, Inc., under the trademark AutoFreeze®.
a is flow diagram of the freeze cycle for the first anterior cryoprobe and the second anterior cryoprobe.
b is a flow diagram of the freeze cycle for the first posterior lateral cryoprobe and the second posterior lateral cryoprobe.
Referring now to the drawings and the characters of reference marked thereon,
The ablative surgical computer system 24 includes a guidance module 26 for processing the imaging signals 22 and providing a treatment guidance plan 23 to the operator 20. The computer system 24 also includes a treatment module 28 for acquiring and processing surgical device output data 30, for optimally controlling treatment parameters 32 and providing feedback information 34 to the operator 20 based on the treatment guidance plan 23.
A set of surgical devices, designated generally as 36, includes at least one ablative device 38 for providing ablation of the treatment region based on the treatment parameters 32 and operator input 40. The set 36 of surgical devices also includes at least one temperature sensing device 52 for acquiring temperature data 42 from the treatment region of the patient 16. The set 36 of surgical devices provides the surgical device output data 30. A temperature sensing device output signal is provided which is a portion of the surgical device output data 30.
In a primary application of the present invention the ablative devices 38 are cryosurgical probes, as will be explained in detail below. However, it is understood that various other types of ablative devices 38 may be used in accordance with the principles of the present invention to provide the necessary ablation. The ablative devices 38 may comprise, for example, radio frequency electrodes, laser fibers, microwave catheters, high-intensity focused ultrasound, and other suitable ablative devices.
Referring now to
The computer system 24 is programmed with software capable of: determining the dimensions of the prostate; determining the dimensions of a treatment zone; and, utilizing the determined dimensions of the prostate and treatment zone for computing the number and location of ablative elements needed to treat the treatment zone. An IBM-compatible microprocessor serves as the host computer.
The transrectal ultrasound probe 48 is used to visualize the prostate and the cryosurgical probes. A stepper assembly 50 provides the required advance. The ablative devices (e.g. cryoprobes 38) are illustrated as well as temperature probes 52. The set of surgical devices, i.e ablative devices and temperature sensing devices, are introduced through a grid (i.e. reference plate) 54.
Treatment planning preferably includes the following steps:
Step 1
Capturing Image
The live ultrasound image is displayed in the ultrasound image window.
At least one image is captured. However, there is an option, for example, to capture two images at the widest portion of the prostate gland, one with the brachy grid displayed and one without it displayed, then capture additional images at the base and apex of the gland.
Step 2
Calibration
Typically, there is a calibration step.
Step 3
Outlining
Three image option:
Referring now to
Another section on the display screen 48 is the instruction box 60 that provides the user with detailed instructions at each step and makes the system easier to use. Additionally, the system has controls for specifying the patient details (name, age, etc.), calibration, adding/deleting probes and for the simulation of the ablation. The system also provides a pull down menu for switching rendering views and to toggle the display of the probe placements.
Step 4
Placing Probes
Step 5
Measure
This enables the user to display key distance measurements as well as view customized measurement distances.
Step 6
TempProbe® Temperature Probe Placement
Although the aforementioned treatment planning and placement steps have been described with reference to a drag ball or mouse interface device, it is understood that other interface devices can be used such as touch screens, joysticks, etc.
The ultrasound probe image 48 can be seen in
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The cryoprobes particularly adapted for this computer guided placement are those manufactured by the present assignee, Endocare, Inc., Irvine, Calif. The urethra, which passes through the prostate, is one of the anatomic structures that usually should not be frozen during this surgery. Accordingly, the urethra is protected and kept warm with the urethral warming catheter. The bladder neck sphincter and the external sphincter are also structures that should be protected from freezing, and these are protected from freezing by the warming catheter. A transrectal probe is inserted into the rectum in order to visualize the placement of the probes and the growth of the iceballs formed by the cryoprobes. (As noted above, alternative imaging means may be utilized.) To assist in placement of the cryosurgical probes, a template 21 is used which supports the probes 22 during insertion and while they are installed in the body. The patient is placed in the lithotomic position, i.e. horizontally on an operating table with legs positioned to provide access for the ultrasound probe to be inserted into the rectum and cryoprobes to be inserted through the perineal area into the prostate.
Thus, we have described a system for assisting surgeons in performing cryosurgery of the prostate by calculating optimal positions for cryoprobes and providing display based templates for overlay over an ultrasound image display, and displaying actual cryoprobe ultrasound images together with template images so that the surgeon may compare suggested and actual placement of the probes, and adjust placement accordingly. The method and system is described above in relation to our newly enhanced CRYOCARE® cryosurgical system, which is provided with up to eight independently controlled argon powered cryoprobes. The enhanced CRYOCARE® cryosurgical system utilizes the feedback described above to provide the AutoFreeze® system functionality.
The system cools the probes to cryosurgically effective temperatures (typically below −120° C.) through Joule-Thomson cooling within the probe tips. If used for cryogenic ablation the system may be implemented with other cooling systems such as liquid nitrogen cryoprobes and mixed gas cryoprobes. The placement of probes is calculated based on this system, and the calculations may be adjusted for different systems and numbers of probes. The system may be adapted to other forms of ablation and treatment of the prostate, with adjustments in the calculations being made to account for the ablative range of the devices. Other ablative elements may include, for example, radio frequency devices, microwave devices, high intensity focused ultrasound devices, lasers, radioactive seeds and ablation agents such as chemicals, e.g. alcohol-based substances.
Although the system 10 has been described wherein the physician provides input to start and stop the ablation cycle it is understood that the treatment module may alternatively control the ablative elements automatically based upon a sensing device output signal such as, but not limited to, temperature sensing device measurements, ultrasound images of the rate of ice growth, tissue impedance measurements within the treatment zone. Such a feedback could direct the system to stop the treatment resulting in the system turning off one or more ablative elements automatically without the need for operator intervention.
Thus, while the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the invention. Other embodiments and configurations may be devised without departing from the spirit of the invention and the scope of the appended claims.
This application is a continuation of U.S. Ser. No. 10/700,326 entitled “Computer Guided Ablation of Tissue Using Integrated Ablative/Temperature Sensing Devices”, filed Nov. 3, 2003, which is a continuation in part of U.S. Ser. No. 10/307,036; (now U.S. Pat. No. 6,643,535) entitled “System For Providing Computer Guided Ablation of Tissue”, filed Nov. 27, 2002, which is a continuation in part of U.S. Ser. No. 09/957,306, (now U.S. Pat. No. 6,544,176) entitled “Computer Guided Cryosurgery”, filed Sep. 20, 2001, which is a continuation of U.S. Ser. No. 09/699,938, (now U.S. Pat. No. 6,485,422) entitled “Computer Guided Cryosurgery”, filed Oct. 30, 2000, which is a continuation of U.S. Ser. No. 09/318,710 (now U.S. Pat. No. 6,139,544) entitled “Computer Guided Cryosurgery”, filed May 26, 1999.
Number | Date | Country | |
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Parent | 10700326 | Nov 2003 | US |
Child | 12025619 | US | |
Parent | 09699938 | Oct 2000 | US |
Child | 09957306 | US | |
Parent | 09318710 | May 1999 | US |
Child | 09699938 | US |
Number | Date | Country | |
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Parent | 10307036 | Nov 2002 | US |
Child | 10700326 | US | |
Parent | 09957306 | Sep 2001 | US |
Child | 10307036 | US |