- Email: [email protected]
Apparatus and Technique for Cryosurgery of the Prostate
Vol. 96, Oct. Printed in U.S.A.
THE .JOURNAL OF UROLOGY
Copyright @ 1966 by The Williams & Wilkins Co.
APPARATUS AKD TECHNIQUE FOR CRYOSURGERY OF THE PROSTATE WARD A. SOANES, MAURICE J. GONDER
AND
SIDNEY SHULJVIAN
From the Millard Fillmore Hospital, the Veterans Administration Hospital, and the School of Medicine, State University of New York at Buffalo, Buffalo, New York
Freezing of the prostate has been found to result in a marked destruction of this gland in both canines and hunian subjects. 1 · 3 Cell death has been attributed to: 1) toxic concentration of electrolytes, 2) infarction, 3) ice crystal formation, 4) denaturization of protein and 5) thermal shock.'1• 6 Liquid nitrogen has properties to make this an ideal refrigerant for controlled cryothermic destruction of tissue. It is chemically inert, colorless and odorless. It has a boiling point of -196C and vaporizes without leaving a residue. It is easily managed under low pressure storage. If the system is closed, pressure can be easily generated by the application of heat. The basic Linde CE-4 cryosurgical unit is a completely integrated system consisting of a liquid nitrogen container (Dewar), vacuum-insulated probe assembly and appropriate controls regulating the liquid nitrogen flow. It has a heating element built in the system so that the probe can be quickly withdrawn from frozen tissue. The weight of the empty unit is approximately 50 pounds and it measures 18 by 1.5 by 16 inches (fig. l).* Accepted for publication October 13, 1965. Supported by a grant from the John A. Hartford Foundation, Inc. One of the authors (S. S.) was the recipient of a Research Career Award (5K6-AI-1377) from the United States Public Health Service. 1 Editorial: Cold as a surgical instrument. Ne"· Engl. .J. Med., 268: 790, 1963. 2 Cooper, I. S.: Cryogenic surgery of the basal ganglia. J.A.M.A., 181: 600, 1962. 3 Cooper, I. S.: Cryogenic surgery-A new method of destruction or extirpation of benign or malignant tissues. New Engl. J. Med., 268: 743, 1963. 1 Gonder, l\!I. J., Soanes, W. A. and Smith, V.: Experimental prostate cryosurgery. Invest. U rol., 1: 610, 1964. 5 Gonder, M. J., Soanes, W. A. and Shulman, S.: Cryosurgical treatment of the prostate. Invest. Urol., 3: 372, 1966. 6 Gonder, M. J., Soanes, W. A. and Smith, V. Chemical and morphologic changes in the prostate following extreme cooling. Ann. N. Y. Acad. Sci., 125, 716, 1965. * Basic and all subsequent equipment has been designed and manufactured by the Union Car-
Initially, a cystoscopic approach seemed desirable allowing direct cryogenic application to the obstructing tissue. A 28F urethroscope with a cryoprobe was developed (fig. 2). The small size of the freezing surface of the probe rendered it impractical for destroying large areas of the prostate. In addition, it was impossible to incorporate into the probe the heating element required for rapid withdrawal. Therefore, further investigation by cystoscopic techniques was discontinued. The LR-3 probe was designed to overcome these disadvantages. It has an outside diameter of 25F (8.6 mm.) and has a moderate curve at its distal encl (fig. 3, A). The probe is fabricated, integrally, with a vacuum-insulated feed and vent line assembly along with an electrical heating systen1 to enable rapid and easy removal as freezing is terminated. An arrangement of 3 concentric tubes allows liquid nitrogen to be fed through the inner tube to the heat transfer chamber at the distal end of the instrument. The heat transfer chamber is 2}'4 inches in length. The freezing surface of the cannula, refrigerated by liquid nitrogen, withdra,rn heat from the prostatic tissue. The consumed refrigerant is exhausted in gas form through the m.iddle tube. The outside tubing makes up the ,,acuum insulation. The actual temperature at the tip is controlled by regu-lating the flow of coolant and is monitored by a thermocouple placed in the probe. This temperature i~ read on a thermometer on the face of the Linde CE-4 unit. A small button is located 1 cm. from the freezing surface which permits accurate placement of the freezing surface in the prostatic urethra. A pistol grip has been added for better manipulation. The tip of the probe was insulated to preclude it from adhering to the bladder surface and to permit its reverse application through a transvesical approach. The entire probe and vacuum-insulated tubing which connects to the Linde CE-4 unit can be removed for adequate sterilization.
t
bide Corporation, Linde Division, Speedway, Indiana. t National Electric Instrument Division, Elmhurst, L. I., New York. 508
CRYOSUBGEHY OF PROSTATE
Fi G. l
Linde cr.\·o,m),:ieal
1L11
i L (CE-e) with separat,c 4-elrnmiel thcnnome1 n ntt achme11 I ,-, ,,d prnl,,,
:.-thsrnnb.f v.
Lens_.-·
· Freezmg tip of probe
Dual lrghts Fl(L
2. No. 28F methroscope with nyoprobe
510
SOANES, GONDER AND SHULMAN
"\
h
P\
1/i
/111
)
' Fm. 3. A, schematic drawing of probe tip. B, proper placement of probe by rectal palpation. C, placement of thermocouple in rectal wall. Temperatures in adjacent organs and the periphery of the prostate are routinely monitored. The necessary equipment consists of thermocouple wires placed in 19 gauge, 4 inch needles which are filled with a non-conductive epoxy resin. These are attached to a separate thermometer with a switchbox so that the temperatures can be read at as many as 4 sites. METHOD
The bladder is drained of urine and 200 cc air is inserted. The probe is then passed transurethrally and by rectal palpation, the button placed at the apex of the prostate (fig. 3, B). The probe is then cooled to -15C to fix it in this position A 19 gauge thermocouple needle is then passed perineally into the rectal wall opposite the mid-portion of the prostate (fig. 3, C). A second thermocouple needle is passed perineally and is placed in the periphery of the prostate near
the apex of the prostate gland. The probe is now cooled to -180C. The temperature in the rectal wall and the periphery of the prostate is continuously monitored. Frequent rectal examination is performed during the freezing process. It is readily apparent when the prostate becomes totally frozen. The temperature is reduced in the periphery as far as possible within the limits of safety. 'When the prostate is completely frozen, the unfrozen rectal mucosa can be easily detected clinically as sliding freely over the frozen gland. The average application is 8 minutes but, in unusually large glands, can be safely extended. Temperatures from O to -40C can be attained in the periphery of the prostate without serious reduction in rectal wall temperature. When com-· plete freezing has been reached, the nitrogen flow is terminated and the heater is turned on. Complete withdrawal of the instrument can be attained in approximately 2 minutes. An 18F
CRYOSURGERY OF PROSTATE
catheter is the bladdel' is irrigated.
lbe air is cemoved and
DISCU8SJ0l\~
The enlarging prostate in man is encompassed on all sides and one end a firm, fibrnus capsule duough which the blood to the prostate .flows. Passage of th, instrument tends to tissue prnsrnre against Lhe blood A~ freez .. progresses, the water 1Yithin Tbe tissue, as it becomes ir,c, expands, further avascularizing the pro.state. The adjacent organs (bladder, rectum and urogenital diaphragm) have a sepamte blood supply which remains intact. When t.he emerging iceball reaches this blood it. quickly goes into equilibrium and its Fmlacgement at this point t,:,rmina1es. Freezing in other avaseular areas con .. tinues until equilibrium is rPached on all sides.
when the prostate n1:.u into the rectnl lumen, /.he rectal wa.U J~ tented. This somewhat and allows a reduction in '\iVhen this is the As the temperature within thn frozen there is gas formation and which further 1,he pro~cate. Aftm the freezing injury, there is ex11dation blood and serum it1to the w,,ua·"''"' tissue. Thi,, causes the urine to he dis0olored in all immediately after treatnwn1,. afoo 'tt;' cessitates the 1n·psence of a draining cf1LhP1tr. , the prostate becmnes ne.:,rotic: ,Jc,v,0,.,u.uu,.r
n,f of of elimination of this necrotic
THE .JOURNAL OF UROLOGY
Copyright @ 1966 by The Williams & Wilkins Co.
APPARATUS AKD TECHNIQUE FOR CRYOSURGERY OF THE PROSTATE WARD A. SOANES, MAURICE J. GONDER
AND
SIDNEY SHULJVIAN
From the Millard Fillmore Hospital, the Veterans Administration Hospital, and the School of Medicine, State University of New York at Buffalo, Buffalo, New York
Freezing of the prostate has been found to result in a marked destruction of this gland in both canines and hunian subjects. 1 · 3 Cell death has been attributed to: 1) toxic concentration of electrolytes, 2) infarction, 3) ice crystal formation, 4) denaturization of protein and 5) thermal shock.'1• 6 Liquid nitrogen has properties to make this an ideal refrigerant for controlled cryothermic destruction of tissue. It is chemically inert, colorless and odorless. It has a boiling point of -196C and vaporizes without leaving a residue. It is easily managed under low pressure storage. If the system is closed, pressure can be easily generated by the application of heat. The basic Linde CE-4 cryosurgical unit is a completely integrated system consisting of a liquid nitrogen container (Dewar), vacuum-insulated probe assembly and appropriate controls regulating the liquid nitrogen flow. It has a heating element built in the system so that the probe can be quickly withdrawn from frozen tissue. The weight of the empty unit is approximately 50 pounds and it measures 18 by 1.5 by 16 inches (fig. l).* Accepted for publication October 13, 1965. Supported by a grant from the John A. Hartford Foundation, Inc. One of the authors (S. S.) was the recipient of a Research Career Award (5K6-AI-1377) from the United States Public Health Service. 1 Editorial: Cold as a surgical instrument. Ne"· Engl. .J. Med., 268: 790, 1963. 2 Cooper, I. S.: Cryogenic surgery of the basal ganglia. J.A.M.A., 181: 600, 1962. 3 Cooper, I. S.: Cryogenic surgery-A new method of destruction or extirpation of benign or malignant tissues. New Engl. J. Med., 268: 743, 1963. 1 Gonder, l\!I. J., Soanes, W. A. and Smith, V.: Experimental prostate cryosurgery. Invest. U rol., 1: 610, 1964. 5 Gonder, M. J., Soanes, W. A. and Shulman, S.: Cryosurgical treatment of the prostate. Invest. Urol., 3: 372, 1966. 6 Gonder, M. J., Soanes, W. A. and Smith, V. Chemical and morphologic changes in the prostate following extreme cooling. Ann. N. Y. Acad. Sci., 125, 716, 1965. * Basic and all subsequent equipment has been designed and manufactured by the Union Car-
Initially, a cystoscopic approach seemed desirable allowing direct cryogenic application to the obstructing tissue. A 28F urethroscope with a cryoprobe was developed (fig. 2). The small size of the freezing surface of the probe rendered it impractical for destroying large areas of the prostate. In addition, it was impossible to incorporate into the probe the heating element required for rapid withdrawal. Therefore, further investigation by cystoscopic techniques was discontinued. The LR-3 probe was designed to overcome these disadvantages. It has an outside diameter of 25F (8.6 mm.) and has a moderate curve at its distal encl (fig. 3, A). The probe is fabricated, integrally, with a vacuum-insulated feed and vent line assembly along with an electrical heating systen1 to enable rapid and easy removal as freezing is terminated. An arrangement of 3 concentric tubes allows liquid nitrogen to be fed through the inner tube to the heat transfer chamber at the distal end of the instrument. The heat transfer chamber is 2}'4 inches in length. The freezing surface of the cannula, refrigerated by liquid nitrogen, withdra,rn heat from the prostatic tissue. The consumed refrigerant is exhausted in gas form through the m.iddle tube. The outside tubing makes up the ,,acuum insulation. The actual temperature at the tip is controlled by regu-lating the flow of coolant and is monitored by a thermocouple placed in the probe. This temperature i~ read on a thermometer on the face of the Linde CE-4 unit. A small button is located 1 cm. from the freezing surface which permits accurate placement of the freezing surface in the prostatic urethra. A pistol grip has been added for better manipulation. The tip of the probe was insulated to preclude it from adhering to the bladder surface and to permit its reverse application through a transvesical approach. The entire probe and vacuum-insulated tubing which connects to the Linde CE-4 unit can be removed for adequate sterilization.
t
bide Corporation, Linde Division, Speedway, Indiana. t National Electric Instrument Division, Elmhurst, L. I., New York. 508
CRYOSUBGEHY OF PROSTATE
Fi G. l
Linde cr.\·o,m),:ieal
1L11
i L (CE-e) with separat,c 4-elrnmiel thcnnome1 n ntt achme11 I ,-, ,,d prnl,,,
:.-thsrnnb.f v.
Lens_.-·
· Freezmg tip of probe
Dual lrghts Fl(L
2. No. 28F methroscope with nyoprobe
510
SOANES, GONDER AND SHULMAN
"\
h
P\
1/i
/111
)
' Fm. 3. A, schematic drawing of probe tip. B, proper placement of probe by rectal palpation. C, placement of thermocouple in rectal wall. Temperatures in adjacent organs and the periphery of the prostate are routinely monitored. The necessary equipment consists of thermocouple wires placed in 19 gauge, 4 inch needles which are filled with a non-conductive epoxy resin. These are attached to a separate thermometer with a switchbox so that the temperatures can be read at as many as 4 sites. METHOD
The bladder is drained of urine and 200 cc air is inserted. The probe is then passed transurethrally and by rectal palpation, the button placed at the apex of the prostate (fig. 3, B). The probe is then cooled to -15C to fix it in this position A 19 gauge thermocouple needle is then passed perineally into the rectal wall opposite the mid-portion of the prostate (fig. 3, C). A second thermocouple needle is passed perineally and is placed in the periphery of the prostate near
the apex of the prostate gland. The probe is now cooled to -180C. The temperature in the rectal wall and the periphery of the prostate is continuously monitored. Frequent rectal examination is performed during the freezing process. It is readily apparent when the prostate becomes totally frozen. The temperature is reduced in the periphery as far as possible within the limits of safety. 'When the prostate is completely frozen, the unfrozen rectal mucosa can be easily detected clinically as sliding freely over the frozen gland. The average application is 8 minutes but, in unusually large glands, can be safely extended. Temperatures from O to -40C can be attained in the periphery of the prostate without serious reduction in rectal wall temperature. When com-· plete freezing has been reached, the nitrogen flow is terminated and the heater is turned on. Complete withdrawal of the instrument can be attained in approximately 2 minutes. An 18F
CRYOSURGERY OF PROSTATE
catheter is the bladdel' is irrigated.
lbe air is cemoved and
DISCU8SJ0l\~
The enlarging prostate in man is encompassed on all sides and one end a firm, fibrnus capsule duough which the blood to the prostate .flows. Passage of th, instrument tends to tissue prnsrnre against Lhe blood A~ freez .. progresses, the water 1Yithin Tbe tissue, as it becomes ir,c, expands, further avascularizing the pro.state. The adjacent organs (bladder, rectum and urogenital diaphragm) have a sepamte blood supply which remains intact. When t.he emerging iceball reaches this blood it. quickly goes into equilibrium and its Fmlacgement at this point t,:,rmina1es. Freezing in other avaseular areas con .. tinues until equilibrium is rPached on all sides.
when the prostate n1:.u into the rectnl lumen, /.he rectal wa.U J~ tented. This somewhat and allows a reduction in '\iVhen this is the As the temperature within thn frozen there is gas formation and which further 1,he pro~cate. Aftm the freezing injury, there is ex11dation blood and serum it1to the w,,ua·"''"' tissue. Thi,, causes the urine to he dis0olored in all immediately after treatnwn1,. afoo 'tt;' cessitates the 1n·psence of a draining cf1LhP1tr. , the prostate becmnes ne.:,rotic: ,Jc,v,0,.,u.uu,.r
n,f of of elimination of this necrotic