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WO2000028919A1 - Appareil et technique de separation d'organes permettant une therapie thermique agressive - Google Patents

Appareil et technique de separation d'organes permettant une therapie thermique agressive Download PDF

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Publication number
WO2000028919A1
WO2000028919A1 PCT/US1999/026536 US9926536W WO0028919A1 WO 2000028919 A1 WO2000028919 A1 WO 2000028919A1 US 9926536 W US9926536 W US 9926536W WO 0028919 A1 WO0028919 A1 WO 0028919A1
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WO
WIPO (PCT)
Prior art keywords
prostate
fluid flow
treatment
tissue
rectum
Prior art date
Application number
PCT/US1999/026536
Other languages
English (en)
Inventor
John R. Trachtenberg
Original Assignee
Canadian Prostate Centre, Inc.
Kohn, Kenneth, I.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Canadian Prostate Centre, Inc., Kohn, Kenneth, I. filed Critical Canadian Prostate Centre, Inc.
Priority to AU16145/00A priority Critical patent/AU1614500A/en
Publication of WO2000028919A1 publication Critical patent/WO2000028919A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A61F7/123—Devices for heating or cooling internal body cavities using a flexible balloon containing the thermal element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320044—Blunt dissectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material

Definitions

  • the present invention relates generally to an apparatus and method for performing a thermal therapy patient treatment protocol. More particularly, the invention relates to a novel apparatus and method for physically separating organs to enable aggressive thermal therapy to be administered safely and relatively comfortably, on an outpatient basis, if desired.
  • Thermal therapy has been proven to be an effective method of treating various human tissues.
  • Thermal therapy includes tissue freezing, thermotherapy, hyperthermia treatment and various cooling treatments.
  • Thermotherapy treatment is a relatively new method of treating cancerous, diseased and/or undesirably enlarged human prostate tissues.
  • Hyperthermia treatment is well known in the art, involving the maintaining of a temperature between 41.5 degrees Celsius through 45 degrees Celsius.
  • Thermotherapy usually requires energy application to achieve a temperature above 45 degrees Celsius for the purposes of coagulating the target tissue.
  • Tissue coagulation beneficially changes the density of the tissue. As the tissue shrinks, forms scars and is reabsorbed, the impingement of the enlarged tissues, such as an abnormal prostate, is substantially lessened. Further, tissue coagulation and its beneficial effects are useful for treating cancerous tissue, because cancer cells are particularly susceptible to abnormal temperatures. Cancer cells can be treated in accordance with the present invention with temperatures in excess of 100 degrees Celsius without damage to the therapy applicator or discomfort to the patient.
  • thermotherapy requires delivery of larger amounts of energy to the target prostate tissues. At the same time, it is important to protect nontarget tissues from the high thermotherapy temperatures used in the treatment . Providing safe and effective thermal therapy, therefore, requires devices and methods which have further capabilities compared to those which are suitable for hyperthermia .
  • Perineal prostatectomy was an alternatively recommended surgical procedure which involved gland removal through a relatively large incision in the perineum. Infection, incontinence, impotence or rectal injury were more likely with this method than with alternative surgical procedures.
  • Transurethral resection of the prostate gland has been another recommended method of treating benign prostatic hyperplasia.
  • This method required inserting a rigid tube into the urethra 15. A loop of wire connected with electrical current was rotated in the tube to remove shavings of the prostate at the bladder orifice. In this way, no incision was needed. However, strictures were more frequent and repeat operations were sometimes necessary.
  • the other recommended surgical technique for treatment of benign prostatic hyperplasia was retropubic prostatectomy. This required a lower abdominal incision through which the prostate gland was removed. Blood loss was more easily controlled with this method, but inflammation of the pubic bone was more likely.
  • the prostate lies immediately above the rectum.
  • the two structures are separated only by a thin fascial plane called the Denonvillier ' s fascia. This is composed of two layers which are in close contact.
  • the entire prostate including the peripheral zone, must be included in the thermal window.
  • the rectum lies in intimate contact with the prostate, if one were to direct enough noxious agents, in most methods heat, to the periphery of the prostate sufficient to kill the cancer cells, one risks additionally damaging the adjacent rectum. This is the problem that the previously known methods have, which leads either to failure of treatment or morbidity.
  • a hydrodissection apparatus is utilized for treating the prostate of a patient by moving the prostate away from the rectum and then applying sufficient heat to the prostate to kill the cancer cells while protecting the rectum. Also included in the present application is a method of treating the prostate of a patient using the apparatus. Further included is a method of providing thermal therapy to prostate tissue of a patient by providing a fluid flow which thereby causes a physical separation of the prostate from the rectum.
  • Figure 1 illustrates a front view of a human prostate and rectum in accordance with conventional medical knowledge
  • Figure 2 shows a front view of the prostate and rectum of Figure 1 physically separated by a fluid
  • Figure 3 illustrates a side view of a prostate and rectum physically separated by a fluid
  • Figure 4 shows a front view of the prostate and rectum of Figure 2 showing a device for providing the fluid and a fluid temperature sensor;
  • Figure 5 shows a front view of a delivery system constructed in accordance with one form of the invention.
  • Figures 6 (a) and (b) show (a) a transverse view of the configuration of the equipment used for hydrodissection; and (b) a sagittal view of the configuration of the equipment used for hydrodissection.
  • Figure 1 illustrates a front view of a human prostate 12 located immediately above a human rectum 14 in accordance with well-known anatomical observations.
  • the prostate and the rectum 14 are separated by a thin fascial plane called "Denonviller ' s fascia" or a "biplane fascial layer" 16.
  • Denonviller ' s fascia is composed of two layers of fibrous membrane tissue in close contact.
  • the entire prostate 12 must typically be subjected to the thermal therapy, regardless of whether heating or cooling techniques are utilized.
  • the rectum 14 naturally lies in intimate contact with the prostate 12 and the biplane fascial layer 16, if one subjects the periphery of the prostate 12 to intense thermal therapy to kill all living tissue within, one risks damaging the portions of the rectum 14 close to the prostate 12. Such damage can lead to severe complications such as urethral or vasicle- rectal fistulae.
  • the present invention can use ultrasound or magnetic resonance or other imaging modalities to direct the percutaneous (through trans-perineal techniques or others) instillation of fluid flow 18 under pressure into the biplane fascial layer 16 (Denonvillier ' s fascia) to create a real space 20 from the pre-existing virtual space, thereby physically separating the rectum 14 from the prostate 12.
  • Extremely low fluid pressures i.e., gravity-fed flows
  • the fluid flow 18 tracks into this fascial plane, physically and thermally isolating the rectum 14 from the prostate 12, and isolating the prostate 12 from lateral and inferior lying structures (e.g., the perineal diaphragm, sphincteric mechanism and neurovascular bundles) .
  • Fluid flow 18 can be continuously instilled to cool (or warm, as desired) and separate this space 20 and protect adjacent structures.
  • Thermometry probes can be placed into the periphery of the prostate to ensure adequate temperatures to ablate cancer cells while temperature sensors 22 and pressure monitors in the fluid space can dictate the amount of fluid flow necessary to adequately protect adjacent structures.
  • mapping temperature probes are inserted into the prostate thermometry catheters. These mapping probes provide temperature data of the interstitial space between the prostate and the rectum along the length of the prostate throughout the treatment. Conventional intermittent trans-rectal ultrasound can also help ensure adequate continuing separation of vital tissues by the instilled cooling fluid flow 18.
  • a needle 24 is inserted at a location near or between the prostate 12 and rectum 14 to infuse a fluid flow 18 for cleaving or providing a space 20 physically separating the prostate 12 and rectum 14.
  • the fluid flow 18 can be a cooling solution (ionic or nonionic) , an insulating medium (as in energy absorption) , an energy reflecting medium for use with some trans-urethral therapy applications, a warming solution, air or a gas, or some type of gel. Infusing these types of agents essentially provides a space 20 to either help insulate the rectum 14 from the therapy or can provide a means to either augment the therapy or to provide the actual therapy itself .
  • the fluid flow 18 can be bolused in or continuously infused to provide proper maintenance of the space 20 between the organs and proper temperature of the fluid flow 18.
  • the fluid flow 18 can also be recirculated into and out of the space 20 by the use of a multilumen catheter or by use of multiple catheters.
  • the fluid flow 18 can be cooled to provide cooling to the rectum 14.
  • the fluid flow 18 can be maintained at a minimally therapeutic temperature by monitoring the temperature via a machine. The temperature data is collected to ensure that the cooling systems are effectively cooling the urethra and rectum. Therefore, monitoring of the fluid flow 18 temperature within the space 20 or in the delivered and returned solution temperature can be used to guide or enhance the treatment effectiveness.
  • the fluid flow 18 can be warmed to ensure that the rectum 14 is provided a safety cushion such that the therapy inside the prostate 12 can be as aggressive as possible.
  • This space 20, once created, can also be used to provide a window within which to now deliver therapy, feedback regarding the extent of the treatment by providing more localized control or for various types of imaging (e.g., ultrasound). Further details for implementing those functionalities are described hereinbelow.
  • This technique can be especially useful for prostate cancer which develops predominantly in the posterior and lateral edges of the prostate 12.
  • the close proximity of the thermally sensitive rectum 14 to those commonly afflicted areas of the prostate 12 limits the effectiveness of conventional treatments.
  • the space 20 or window to now provide a means for directly treating these regions of the prostate 12 in a directional way, the rectum 14 can be protected from thermal damage, and the location of the cancer can be extremely aggressively treated in a safe and relatively comfortable manner.
  • Therapy elements capable of providing desirably asymmetric energy patterns include, without limitation, laser, microwave (especially with some type of shielding (e.g., air) to avoid heating the rectum 14) , cryosurgery, ultrasound (focused or diffuse) and diagnostic ultrasound.
  • the diagnostic ultrasound and the therapeutic ultrasound can be combined into the same probe if desired.
  • the therapeutic element 36 can be directional, shielded or simply conventional.
  • the element 36 can then be used to effectively treat the outer portions of the prostate 12.
  • This approach can be used in conjunction with another form of treatment, either drug or device, and can be used with interstitial or intraluminal treatments. If needed, a conventional endoscope or similar device can be inserted to guide the application of the treatment under direct visualization.
  • the therapeutic element 36 can incorporate a locating means 40 whereby the location of the treatment can be confirmed, adjusted or maintained throughout the treatment.
  • This locating means 40 can include, without limitation, a helium neon laser pointer for direct vision or a mechanical/ultrasound opaque (i.e., metal) indicator on the probe itself . It can also comprise an ultrasound imaging device capable of monitoring the therapeutic effect in the tissue itself.
  • the therapeutic effect is determined by monitoring the expected thermal damage volume of the prostate. This is calculated based upon the treatment temperatures as measured. This is achieved by digitizing the actual locations of the antennas and temperature probe catheters from the ultrasound scans obtained during the procedure. The positions and heating patterns of the antennas are then measured in muscle equivalent phantoms in pre-clinical testing, such that the expected temperatures during treatment are calculated based on the actual power delivered during treatment .
  • prostate treatment uses of the present invention are described herein for illustrative purposes, it will be readily apparent that the present invention can also be used to treat other anatomical structures including, without limitation, structures inherent or attached to the rectum 14 itself (e.g., treating the wall of the rectum 14 or tumors associated with the rectum 14) .
  • Thermal therapy delivery systems 50 can also be used as mechanical separators 28.
  • the delivery system 50 can take a number of forms, such as the one described in co- pending United States Patent Application Serial Number 07/976,232, the Detailed Description of Preferred Embodiments which is incorporated herein in its entirety.
  • the delivery system 50 can include the ability to provide degassed and temperature regulated water flow into the delivery system 50 adjacent tissue to be treated.
  • An example of such a suitable delivery system 50 is a single or multiple lumen device which circulates fluid, gas, gel and the like under pressure within a closed environment.
  • the delivery system 50 is intended to be inserted into body cavities or interstitially .
  • the delivery system 50 can be inserted into the body (organ) targeting a specific treatment site.
  • the delivery system 50 can house a therapeutic element 36 such as laser, microwave, therapeutic or diagnostic ultrasound or simply a temperature sensor 22.
  • the fluid flow 18 or infused agent can be recirculated under pressure or can remain static. This form of the invention can deliver therapeutic energy to internal body structures through a minimally invasive procedure.
  • the delivery system 50 is preferably small in diameter, being 9 French and under. Delivery systems 50 as small as 6 French have been used satisfactorily and are being further miniaturized.
  • the delivery system 50 incorporates 360 degree radial cooling (or warming) which is essential for this intensive thermal therapy, especially for interstitial therapy, because it greatly reduces the potential for exit wounds which could result from both thermal or freezing technologies.
  • the delivery system 50 can be made out of extremely thin polymers, such as PET, which permits the use of very thin wall thicknesses, thereby minimizing the overall device size. This type of material is essentially nondistensible and can withstand high pressures without failure. This permits passage of fluid flow 18 or other media under pressure to provide flow without compromise of the structure.
  • the delivery system 50 can also be made from typical catheter material with the size increasing due to the need for larger wall thicknesses.
  • the delivery system 50 can have a rigid structure that aids in insertion or could be made so thin that it essentially has no rigidity.
  • the latter design can be inflated to provide the handling and insertion stability required. This has the advantage of permitting extremely thin wall thicknesses to be used, thereby maximizing throughput flow and/or minimizing overall size.
  • the rigidity of the delivery system 50 can also be used in conjunction with a conventional sharpened tip at one end of the delivery system 50. The sharpened tip enables interstitial insertion of the delivery system 50.
  • the circulating fluid flow 18 could be either a cooling agent or a warming agent, whichever is required for the particular thermal therapy being utilized.
  • microwave therapy benefits from a cooled device whereby the cooling of the antenna provides a substantial increase in efficiency.
  • the delivery system 50 preferably incorporates the therapeutic elements 36 with complete cooling or warming (via submersion) along the therapeutic element's 36 entire length. This configuration is the most efficient use of space, thereby resulting in a smaller profile.
  • the outer structure (lumen) 52 of the delivery system 50 can be made either nondistensible or moderately to fully distensible.
  • a distensible outer lumen diameter can be changed even during a treatment to maintain desired contact with the surrounding tissue. This is important for therapies that benefit from intimate contact between the applicator and the tissue for efficient transmission of energy such as microwave, laser, ultrasound and the like.
  • the change in lumen 52 diameter can be accomplished via an active increase in the internal pressure of the delivery system 50.
  • the pressure can be increased (inflated) , decreased or otherwise controlled automatically (or manually) and triggered via the recording of reflected or lost power transmission which can be monitored real time.
  • a conventional pump 60 or other inflation system can be controlled electronically for this purpose. This can be a feedback circuit to improve the efficient transmission of energy throughout the duration of the treatment. In this way, intimate contact between the delivery system 50 and the surrounding tissue can be maintained throughout the treatment, increasing the efficiency of the energy transmission.
  • Pressurization can also be a useful feature of the delivery system 50 for: clearing the pathway of air or impurities; cooling or warming; and reducing or eliminating modifications in the environment resulting from the treatment.
  • the cooling medium is typically a deionized solution such as distilled water.
  • the microbubbles are produced along the antenna resulting in an increase in reflected power. This can develop into an almost total stoppage of emitted energy into the tissue.
  • Pressurization desirably changes the degassing characteristics of the medium and can minimize the effect of microbubbles out of the energy emitting pathway. Air will block the transmission of most energy sources such as microwave and ultrasound.
  • Laser will also see this as another interface which can result in overheating of the delivery system 50 in that region, possibly resulting in delivery system 50 or laser malfunction. Pressurization can therefore reduce or eliminate reflected power and can be varied throughout a treatment to compensate for changes in the reflected power levels that may occur.
  • Reflected power will also change according to the matching/mismatching characteristics of the environment surrounding the delivery system 50. This is especially true for microwave energy. Therefore, the measurement of reflected power can be used to correlate with tissue changes in the surrounding tissue. This measurement can, therefore, be used as a feedback mechanism for the progression of a treatment or for a regulating mechanism during a treatment. It can be used as a surrogate measure of tissue temperature or tissue destruction, and can also be used to determine if the treatment is being applied too aggressively. For example, if the therapy is too aggressive, the interface between the delivery system 50 and the surrounding tissue may change (e.g., dehydrate) which will impact the matching between the two entities. The severity of the mismatch will be reflected in an increase in the reflected power.
  • the interface between the delivery system 50 and the surrounding tissue may change (e.g., dehydrate) which will impact the matching between the two entities. The severity of the mismatch will be reflected in an increase in the reflected power.
  • This mismatch clinically results in a less effective administered treatment.
  • the aggressiveness of the treatment can be modified to manage this event.
  • Reflected power will change with changes in the temperature of the environment surrounding the delivery system 50. Accordingly, this measure can be used to estimate the temperature of the environment. This is the same for actual physical changes in the surrounding environment (e.g., denaturization, carbonization, dehydration, etc.); therefore, this measure can also estimate effects of a treatment upon the surrounding environment.
  • the patient is administered prophylactic antibiotics on call to the operating room.
  • the patient In the operating room, the patient is placed on the cystoscopy table and a general anesthetic is administered.
  • the suprapubic area and the perineum of the patient is then prepped and draped in the dorsal lithotomy position.
  • the scrotum of the patient is secured to the anterior abdominal wall .
  • the bladder is drained and a 16 French Foley catheter is then placed in the urethra 15.
  • a transrectal ultrasound transducer is then placed in the rectum and the volume and configuration of the prostate 12 is confirmed.
  • the Foley catheter is visualized in the urethra 15 in the sagittal plane.
  • the position and number of interstitial microwave antenna assemblies (MAA) to be inserted is based upon the volume and configuration of the prostate 12 which will be determined and planned using pretreatment transrectal ultrasound.
  • the actual number of interstitial microwave assemblies (MAA) used will be determined based upon the volume and shape of the gland, as specified below:
  • the treatment zone locations and number will be determined as to yield complete therapeutic heating of the prostate 12.
  • the sites are plotted on a treatment map during pretreatment planning prior to insertion to achieve efficient isothermic heating of the tissue.
  • Placement of the intra-prostatic MAA is preceded by repeat topical antibacterial preparation of the perineum.
  • a needle and sheath assembly is first inserted, this assembly is a peel-away assembly.
  • the needle and sheath assembly will be placed transperineally into the left lateral lobe of the prostate 12.
  • the needle will be advanced along an axis 1.5 centimeters away from (as close as medically feasible) and roughly parallel to the prostatic capsule, adjacent to the bladder neck. The position is confirmed using transrectal ultrasound and the needle is repositioned as necessary.
  • the MAA will be inserted into the lumen of the peel-away needle and sheath assembly and advanced until the distal tip reaches the end of the sheath. Proper MAA placement is confirmed when the MAA reaches the sheath hub.
  • the peel-away sheath is then removed, leaving the MAA in place. This procedure is repeated until the predetermined MAA therapy plan has been accomplished.
  • thermosensor array Using a similar technique, a 2 -sensor thermosensor array will be inserted at a three or nine o'clock position laterally inside the gland at the capsule. Another 2 -sensor array will be placed at the five or seven o'clock position. A single thermosensor array will be placed at the posterior mid line (recto- prostate interface) margins of the prostate 12.
  • the recto-prostatic interface will be delineated by transrectal ultrasound.
  • a needle and sheath assembly will be guided with transrectal ultrasound into this space.
  • the rectum will be separated from the prostate 12 by hydrodissection within the recto-prostatic space. This will be accomplished by inserting a needle and sheath assembly into the recto-prostatic space and connecting a continuous saline solution drip infusion.
  • the hydrodissection will be confirmed by transrectal ultrasound.
  • a single array thermosensor will be inserted via a Y-connector through the needle and sheath assembly into this space.
  • the temperature within the hydrodissection space will be continually monitored.
  • the infusion flow rate will be adjusted to maintain a maximum temperature of 43.5 degrees Celsius within the space.
  • the flow rate will be increased. If the increased flow rate does not decrease the temperature below 45 degrees, the power of the respective treatment zone(s) will be turned down as described below.
  • a rectal probe with two thermosensors spaced two centimeters apart in length will be placed in the patient's rectum.
  • a transrectal ultrasound transducer with the same two thermosensor array may be used to monitor rectal temperatures and hydrodisection.
  • a urethral cooling assembly will be coated with sterile lubricant and inserted into the urethra 15 with the anchor balloon inside the urinary bladder.
  • the anchor balloon will be inflated with 7 cc of sterile water and traction will be applied to ensure that the applicator is in the proper position. The proper position will be with the proximal side of the anchor balloon seated against the urinary bladder neck.
  • Either a rectal probe or a transrectal ultrasound transducer will be inserted into the rectum 14.
  • the rectal probe or transrectal ultrasound transducer will have a two sensor thermosensor array spaced by two centimeters. It is preferred to use the transrectal ultrasound transducer/thermosensor array to visually monitor the hydrodissection space.
  • MAAs, thermosensor fiber arrays, and water connections for the urethral and rectal cooling devices will be attached to the respective system connectors and the treatment program will be initiated.
  • the microwave power will be initiated at 5 watts.
  • the power will be manually increased in 5 watt increments every two minutes to a maximum of 25 watts.
  • the power of the respective treatment zone will be turned down in 2.5 watt increments when the interstitial thermosensor reaches 75 degrees Celsius.
  • the power will be lowered 2.5 watts every one minute until the interstitial temperatures within the respective treatment zone(s) are stabilized within the target treatment temperature range, 55 to 75 degrees Celsius.
  • the treatment time will start when all interstitial thermosensors have reached the treatment range, 55 to 75 degrees Celsius. A minimum temperature of 55 degrees Celsius must be attained to start the treatment clock.
  • the treatment will be 15 minutes at temperatures within the treatment range. If the treatment range is not attained, the treatment will be 20 minutes in length plus the 10 minute power ramp-up time, or 30 minutes total.
  • the rectal temperature limit will be 43.5 degrees Celsius as measured on the surface of the cooled rectal probe or ultrasound transducer/thermosensor array. If the rectal temperature limit is exceeded, the power will be decreased as described above.
  • the target intraprostatic temperature during treatment is 75 degrees Celsius for 15 minutes within the target temperature zone to 0.5 centimeters of the margin of the prostate 12. A gradient of 75 to 45 degrees Celsius within this lateral heating zone of the prostate 12 has been calculated.
  • the target temperature zone is a cylinder of tissue extending the length of the prostate 12, roughly parallel with and centered 0.2 centimeters lateral to the urethra 15, extending outward to the prostatic capsule.
  • the urethral cooling assembly consists of a 9 French catheter which inflates to 18 French during treatment. This assembly constantly circulates 30 degrees Celsius cooled water to cool the urethral mucosa.
  • the rectal probe contains two thermosensors in a linear array designed to interrupt the treatment and shut down the microwave power if the rectal mucosa temperature exceeds 43.5 degrees Celsius. Additionally, the operator will be alerted via a "pop-up" dialogue box on the treatment screen prior to interruption of treatment.
  • the rectal probe is cooling and protecting the rectal mucosa. Furthermore, the rectal mucosa has been separated by hydrodissection from direct contact with the heated prostate 12 and the created hydrodissection from direct contact with the heated prostate, and the created hydrodissection space is actively cooled via a saline infusion.
  • the location and size of the target temperature zone will allow for glandular asymmetry and normal anatomic variation in the angle and curvature of the urethra 15 through the prostate 12.
  • the thermosensor ' s readings will be visually monitored throughout the therapy treatment.
  • the microwave power will be lowered at 2.5 watt increments every one minute until the intra-prostatic temperatures are stabilized within the treatment range, 55 to 75 degrees Celsius. Due to the variable heat transfer rates in tissue, some overshot and lag response in temperature beyond the 75 degree Celsius limit is expected and the operator must take each patient's response characteristics into consideration when adjusting the microwave power levels. If the intra-prostatic temperature continues to fall after the microwave power has been decreased, the procedure described for lowering the power will be reversed to maintain the intra- prostatic temperatures within the treatment range.
  • the space was maintained by continuously infusing a sterile saline solution such that separation of the prostate from the rectum and prostate from the GU diaphragm was visualized on transrectal ultrasound.
  • a fibre optic temperature sensor was placed through the infusion cannula into the area of hydrodissection to monitor recto-prostate interface temperatures. The rate of infusion of the saline solution could be adjusted to maintain a predetermined safe temperature.
  • the Foley catheter was removed.
  • Urethral and rectal cooling assemblies (Dornier MedTech, Inc. Kennesaw, GA) were inserted and water circulated to further protest these tissues. Power was applied to the antenna assemblies at five watt increments every two minutes to a peak wattage of 40, or until the target temperature was reached.
  • Magnetic Resonance (MR) Imaging All MR imaging was performed on a superconducting 1.5T unit (General Electric Medical Systems, Milwaukee, WI) .
  • Tl-weighted images (TR 534, minimum TE) were obtained in the axial plane pre and post gadopentetate dimeglumine (Magnevist; Berlex; Montreal, Canada) administration (0.2 ml/kg) .
  • coronal and sagittal Tl-weighted images (534, minimum TE) were also acquired after contrast administration. All enhanced Tl-weighted images were obtained with chemical fat suppression.
  • thermotherapy has been designed to be used as mono therapy to destroy viable prostate cancer by high (>45°C) temperatures alone. While heating the prostate to this temperature is feasible by a variety of techniques (laser, focused ultrasound, RF) , the system reported above is unique by virtue of the combination of multi-antenna microwave heating of the prostate and protection of the rectum and sphincteric mechanism by a separation and cooling technique called hydrodissection, and the integration of on line magnetic resonance scanning to visualize the extent of heating in the entire prostate. These three factors have been utilized to improve upon prior attempts of thermoablation of the prostate.
  • Hydrodissection has been the enabling element of the treatment .
  • heating of the prostate is achievable by a variety of means, ablation of the peripheral zone of the prostate necessitates intense heating of not only the prostate, but of the adjacent tissues.
  • Hydrodissection separates the prostate from surrounding tissues leaving a fluid filled space that acts as a heat sink that can, if necessary, be actively cooled.
  • a thermosensor placed in this space allowed for measurement of this interface temperature. This added both a safety and function aspect by allowing active cooling if necessary.
  • Placement of the antenna assemblies, thermosensors, and hydrodissection cannula was done by conventional transrectal ultrasound technology which simplified the learning of the procedure.
  • An additional, but optional procedure, used in five of our patients has been magnetic resonance imaging. This procedure has been used to verify placement of the antennas, devascularization of the gland at the end of the procedure with gadolinium enhanced images, and online measurement of tissue temperature. This last technique has added a further degree of precision to the procedure. "Cold" or poorly heated spots anywhere in the prostate are immediately visible. This imaging process allows for more precise heating of the prostate. It also adds a further degree of safety by visualizing where heating is adequate and where it is not or should not be occurring (e.g. the rectum) .
  • Time to treatment failure Time to disease progression. Quality of life.
  • This number of patients provides a 0-13.72% confidence interval (based on a p value of 0.05) on the probability that the procedure results in no major side effects based on the assumption that no major side effects are observed in these 25 patients.
  • the study is terminated if any major side effects caused by the treatment are observed.
  • the possible side effect of most concern is a rectal fistula. Selection of Patients
  • Inclusion criteria All of the following criteria must be satisfied: - Patients must have histologic proof of adenocarcinoma of the prostate 12 months or longer following definitive radiotherapy (external brachytherapy; or combination external and interstitial radiation) . - Patients must have disease confined to the prostate and or local area (Stage A, B, or C disease) without evidence of regional and or distant disease.
  • - Patients must have prostatic volume ⁇ 50 gm as determined by calculated volume using transrectal prostatic ultrasound.
  • - Patients must have serum prostatic specific antigen (PSA) equal to or less than 50 ng/ml using Hybritech or Abbott assay.
  • PSA serum prostatic specific antigen
  • CBC complete blood count
  • PSA Hybritech assay
  • prostatic acid phosphatase enzyme method
  • SMA urinalysis
  • thermotherapy Radiologic studies to include within 2 months of thermotherapy: chest x-ray, bone scan, and abdominal and pelvic CT or MR scan.
  • Transrectal prostatic ultrasound with volume determination calculated based on length, width and height using formula L x W x H/2.
  • thermotherapy probes The microwave antennas, thermotherapy probes, and cooling mechanisms are inserted as shown in Figures 6 A and B. This probe placement is based on computational models, laboratory tests and animal experiments to determine the heating patterns of the microwave antennas.
  • thermometry probes are inserted through peel away sheaths that are inserted into the tissue under transrectal ultrasound guidance.
  • the antennas extend to a point 1 cm from the superior edge of the prostate.
  • the catheters for the thermometry probes extend to the superior edge of the prostate (the thermometry probes map the entire length of the prostate) .
  • the Foley catheter is inserted into the urethra under transrectal ultrasound guidance and is secured at the distal end in the bladder by injecting fluid into the Foley balloon. Mapping temperature probes are inserted into the three interstitial prostate thermometry catheters and into the thermometry catheter attached to the Foley.
  • the hydrodissection tube is inserted into the tissue between the prostate and rectum under transrectal ultrasound guidance. Saline is injected until a space of at least 1 cm is created between the prostate and rectum.
  • thermometry catheter probe is inserted into the tube through a locking dam to a point posterior to the superior edge of the prostate.
  • a mapping temperature probe is inserted into the catheter to provide temperature data in the interstitial space between prostate and rectum along the length of the prostate throughout the treatment .
  • the transrectal ultrasound is removed and a cooled plastic insert is placed in the rectum with a sixth mapping temperature probe inserted into a thermometry catheter that is attached to the insert.
  • the BSD machine is turned on and temperature data collected to ensure that the cooling systems are effectively cooling the urethra and rectum. Power to the antennas a) and c) is then turned to 15 Watts each. The power is adjusted to achieve an approximately equal rate of temperature rise at each of the prostate tissue measurement points. A delay of a few minutes is observed before temperatures rise significantly at the prostate margin. Urethral and rectal temperatures should not be allowed to rise above 42C. The interstitial space between rectum and prostate should also remain below 42C. The prostate tissue margins should be reached in excess of 55C and be maintained above that temperature for 15 minutes. This will result in complete destruction of living tissue in the target area of the prostate. The thermal mapping will be used to determine the extent of damage along the length of the prostate.
  • Postoperative Assessment See Appendix A: Post-treatment measurement: 4 weeks : la digital rectal examination of the prostate; lb urinalysis; lc prostatic specific antigen; Id uroflowmetry; le quality of life and performance questionnaire ; If prostatic ultrasound with volume measurements . 8 weeks : 2a digital rectal examination of the prostate; 2b urinalysis;
  • the first objective of this study is to determine the safety of thermotherapy for treatment of recurrent prostatic carcinoma following radiation therapy. All patients are to be followed at 3 months intervals with careful assessment for any adverse affects. Should major complications ensue, the study will be terminated.
  • the second objective of this study is to evaluate the efficacy of thermotherapy to eradicate malignant disease recurrent or persistent, following radiation therapy.
  • Treatment failure Less than 50% reduction in serum PSA or absence of normalization of PSA, and or positive prostatic biopsy at one year following completion of treatment. Patients failing treatment are to be withdrawn from the study and offered alternative therapy.
  • the results of the simulated treatment are used to calculate the expected damage volume (volume where at least 99.9% cell death should be produced) .
  • This volume is correlated with pre-clinical assessments of tumor stage and outcome measures described above. This data provides information as to the importance of completely destroying the target volume during microwave thermotherapy .
  • New Implant Catheters to house the BSD temperature probes New design allowing easy assembly of the hydrodisection space unit, and convenient access for saline coolant and the BSD temperature probe
  • Implant Catheters for temperature probe insertion (supplied by Cook Canada Inc.) :
  • the splittable needles are cumbersome to manipulate, require two people to place properly, and have very sharp edges that can easily cut a finger.
  • the Implant Catheter consists of a closed-ended, pionted polyethylene catheter (6 French size, 15 cm length, to be replaced by a 20 cm model) Luer-locked to an insertion trocar. This two-piece set was originally designed for radioisotope delivery. After implantation of the set , the trocar is removed and the BSD temperature probe conduit is Luer-locked to the cathter.
  • FIG. 2 shows a schematic of the new design for easy assembly of the hydrodisection space unit, and the convenient saline and temperature probe access through this unit.
  • the outer conduit is a modified Flexi-Needle (supplied by Best Medical International, VA) .
  • the Flexi-Needle comes as a closed-ended, pointed teflon catheter (13 Ga . , approx. 8 French, 15 cm length) Luer-locked to a square-ended insertion trocar.
  • This two-piece set was also designed for radioisotope delivery.
  • We modify this set in our laboratory by removing the trocar, grinding the insertion end of the trocar to a sharp point with an electric grinder, cutting the pointed, closed-ended tip of the catheter, and replacing the trocar. This permits easy implantation of the unit due to the sharp trocar, and leaves an open end inside the hydrodisection space once the trocar is removed, through which room temperature saline may flow.
  • a "Tuohy-Borst" Side- Arm connector (Cook Canada Inc.) Luer locks onto the hydrodisection space conduit.
  • the temperature probe catheter is passed straight through the locking dam of the connector, into the hydrodisection space.
  • the locking dam consists of a thumb-wheel surrounding a rubber seal. As the wheel is turned, the seal tightens against the catheter to secure it. Then, the temperature probe is fed through the catheter.
  • the saline supply Luer-locks to the angled side-arm portion of the connector. As observed in the Figure, saline flows freely through the connector and around the temperature probe catheter into the hydrodisection space.
  • new temperature probe catheters (16 Ga, 13" length) supplied by Best Medical International are used for the BSD temperature probes in the hydrodisection space and rectal cooling units. These were purchased to prevent the need to open packages of splittable needle sets only to use the enclosed temperature probe catheter while discarding the splittable need portion of the set.
  • the "Zipshot" framegrabber mentioned in item 1 on page 2 of the September 24 report, was purchased. It was expected to provide co-ordinates of the microwave antennas and temperature probes shown in the pretreatment ultrasound images. Unfortunately, it was found after extensive testing that the "Zipshot” does not work on laptop computers, even though it was marketed to work on laptops. We are in the process of returning it, and are investigating other framegrabbers .

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

Appareil d'hydrodissection (24) pour le traitement de la prostate d'un patient consistant à utiliser un appareil mobile (18) pour éloigner la prostate du rectum contigu, et à chauffer la prostate tout en protégeant le rectum contre toute lésion pouvant être provoquée par la chaleur.
PCT/US1999/026536 1998-11-12 1999-11-09 Appareil et technique de separation d'organes permettant une therapie thermique agressive WO2000028919A1 (fr)

Priority Applications (1)

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AU16145/00A AU1614500A (en) 1998-11-12 1999-11-09 Apparatus and method of separating organs to enable aggressive thermal therapy

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US19078698A 1998-11-12 1998-11-12
US09/190,786 1998-11-12

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US10272164B2 (en) 2009-12-15 2019-04-30 Incept, Llc Implants and biodegradable tissue markers

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US5620479A (en) * 1992-11-13 1997-04-15 The Regents Of The University Of California Method and apparatus for thermal therapy of tumors
US5683382A (en) * 1995-05-15 1997-11-04 Arrow International Investment Corp. Microwave antenna catheter
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US5620479A (en) * 1992-11-13 1997-04-15 The Regents Of The University Of California Method and apparatus for thermal therapy of tumors
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Cited By (10)

* Cited by examiner, † Cited by third party
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CN102548616A (zh) * 2009-10-15 2012-07-04 皇家飞利浦电子股份有限公司 用于超声换能器的超声电源
US20120203098A1 (en) * 2009-10-15 2012-08-09 Koninklijke Philips Electronics N.V. Ultrasound power supply for an ultrasound transducer
JP2013508003A (ja) * 2009-10-15 2013-03-07 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ 超音波振動子用超音波電源
CN102548616B (zh) * 2009-10-15 2016-12-28 皇家飞利浦电子股份有限公司 用于超声换能器的超声电源
US10272164B2 (en) 2009-12-15 2019-04-30 Incept, Llc Implants and biodegradable tissue markers
US10786581B2 (en) 2009-12-15 2020-09-29 Incept, Llc Implants and biodegradable tissue markers
US11083802B2 (en) 2009-12-15 2021-08-10 Incept, Llc Echolucent implant compositions and methods
US11154624B2 (en) 2009-12-15 2021-10-26 Incept, Llc Echolucent implant compositions and methods
US11160883B2 (en) 2009-12-15 2021-11-02 Incept, Llc Echolucent implant composition and methods
US11786612B2 (en) 2009-12-15 2023-10-17 Incept, Llc Implant and biodegradable tissue marker compositions and methods

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