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A New Percutaneously-Inserted Prosthetic Device for the Control of Urinary Incontinence: An Experimental Study
Accepted 505
506
EFFECTS OF PARENTERAL NUTRITION ON ALTERATIONS IN BODY COMPOSITION INDUCED BY SURGICAL INJURY. Terry W. Hensle,
THE G.F.S. INFLATABLE PENILE PROSTHESIS. Richard L. Fein, M.D., F.A.C.S., North Miami, FL (Presentation to be made by Dr. Fein) This newly developed inflatable penile prosthesis is based on a unit system pump-reservoir and is undergoing clinical evaluation. Ten patients have been implanted to date using the scrotal approach. Results from the first four implants provided the following significant information. Sufficient normal saline (N,S.) was placed in each penile cylinder which produced a rounded detumesced penis. Then only 10~15 ml. of N.S. was required in a 20 ml. pumpreservoir which produced full tumescence and rigidity when the fluid was transfered to the cylinders: Scrotal symmetry was preserved as it was not necessary to remove any testicles. The Mentor Bioflex penile prosthesis cylinders which were used inflated and deflated easier and quicker than the present inflatable penile prostheses systems. The operation is quicker and simpler, as no separate reservoir has to be implanted in the abdomen. The simpli.city of the G,F.S. requires only one day of hospitalization and the patients can easily learn to use the prosthesis. Erection of the penis requires a firm continuous squeeze of the soft testicle shaped reservoir in the scrotum. This maneuver transfers the fluid to the penile cylinders. Squeezing the penis while squeezing anywhere on the deflation valve atop the reservoir, transfers the fluid back into the reservoir, leaving the penis flaccid. Fluid uptake by the system has not yet occurred. Patient satisfaction has been very good. This scrotal pump-reservoir has been developed to be used with the present Mentor inflatable penile prosthesis cylinders to provide a simpler, more functional, cost effective, asthetic, inflatable penile prosthesis. As with any new inflatable penile prosthesis system, greater usage with longer patient follow up, will provide the information necessary for alterations and adaptations.
*Barbara Van DeWiele, *Jeffrey Askanazi, *Paul M. Starker,
*David H. Elwyn, and *John M. Kinney, New York, N.Y. (Presentation to be made by Dr. Hensle) Twenty patients were admitted to the Surgical Metabolism Unit after elective colectomy or radical cystectomy.
Following radical cystectomy, six patients received 5% dextrose and electrolytes as the sole nutrient source and four received total parenteral nutrition. Following colectomy, four patients received 5% dextrose and electrolytes as the sole nutrient source and six patients received TPN. Sodium, nitrogen, and potassium balances, 02 consumption and CO2 production were measured for five days after
surgery. Patients receiving TPN following colectomy and cystectomy were in positive N and K balance, consistent
with restoration of body cell mass. There was a significant correlation between postoperative Na excretion and the Na content of fluids received at operation. Patients who received 5% dextrose and electrolytes exhibited a small decrease in serum Na concentration that was not observed in patients receiving TPN. Routine postoperative administration of 5% dextrose and electrolytes as the sole nutrient source was found to exacerbate the alterations in electrolyte homeostasis which
are associated with injury. The provision of parenteral nutrition to postoperative patients who are unable to maintain their nutrition orally may benefit patients in whom water retention is a par-
ticularly serious complication. Our findings also suggest that changes in the extracellular fluid compartment which occur following operation may be affected by nutrition, with relative water retention occurring in patients receiving 5% dextrose and electrolytes as the sole nutrient source.
507
508
A NE~ PERCUTANEOUSLY-INSERTED PROSTHETIC DEVICE FOR THE CONTROL OF URINARY INCONTINENCE: AN EXPERIMENTAL STUDY. David M. Barrett, Rochester, MN; Anthony A. Malizia, Jr., Atlanta, GA; (Presentation to be made by Dr. Barrett). Credibility has been established for the use of an injectable biocompatible material in the periurethral region to enhance outlet resistance to control urinary incontinence. In an attempt to establish a more reliable yet safe method of delivering this type of incontinence control, a new prosthesis has been developed. The device consists of a percutaneously placed silicone sphere that, when injected with isotonic fluid, will create compression on the periurethral tissues. A special delivery system has been developed which simply transcutaneously inserts the silicone sphere and provides for inflation. An experimental study was undertaken in female mongrel dogs to evaluate 1) the methodology involved in insertion of the sphere, 2) the delivery system, and 3) the ability of the sphere to enhance outlet resistance. Ten dogs were injected with l to 3 inflatable spheres. The dogs were evaluated intraoperatively with intravesical leak pressure before and after the injection and inflation of the silicone sphere. Outlet resistance was perceptively increased to a point which would establish the efficacy of the procedure. Several dogs were sacrificed after 3 months of evaluation for tissue analysis while the remaining dogs continued to be observed for longterm assessment. The delivery system concept, although requiring subtle modifications, proved to be feasible. The specific aspects of the injectable sphere, the delivery system, and the observations in the laboratory animals will be presented in detai 1.
ARTIFICIAL URINARY SPHINCTER AND PENILE PROSTHESIS USING A SHAPE MEMORY ALLOY. ''Tadashi Harada, *Shigeru Miyagata, *Ruzo Kato, ,\'Masaru Yamamoto, *Teruaki Kigure, *Takumi Kumazaki and
''Kazumi Etori(Presentation to be made by Dr.Harada) New urological prosthetic devices have been developed using a shape memory alloy (Nitinol). Nitinol, employed in this study, recovered to the memory shape and then increased rigidity in the high temperature phase of 45°C. The artificial sphincter is constructed of Nitinol wire or plate core, Ni-Cr heating wire, and silicone-rubber, and
has tow components: 1) a horse shoe shaped thermal actuating sphincter that is placed around the proxymal urethra and 2) a power unit which supplies electric current to the heater connected to the actuater. The device mimics
the opening and closing action of a natural sphincter through the transformation of shape memory alloy. The erectile penile prosthesis consists of a pair of silicone
rubber cylinders which are both implanted into the corpora cavernosa to achieve penile erection. Each silicone
cylinder has a shape memory alloy wire core coiled with heating wire. In our examination of the prosthesis we were concerned with three aspects ; transformation speed, force, and surface temperature of the device. Transformation speed
was regulated by electric power and the force of transformation was controlled by the contents of the shape memory alloy. Surface temperature of the device ranged between 30 and 35°C which was considered acceptable in clinical use. The artificial sphincter was experimentaly implanted in the dog urethra and sphincteric action was examined through monitoring of the bladder pressure and urine flow rate. The results of animal experiments
revealed that the bladder neck was occluded perfectly in the closing phase and urine was voided from the bladder during the opening phase.
230A
506
EFFECTS OF PARENTERAL NUTRITION ON ALTERATIONS IN BODY COMPOSITION INDUCED BY SURGICAL INJURY. Terry W. Hensle,
THE G.F.S. INFLATABLE PENILE PROSTHESIS. Richard L. Fein, M.D., F.A.C.S., North Miami, FL (Presentation to be made by Dr. Fein) This newly developed inflatable penile prosthesis is based on a unit system pump-reservoir and is undergoing clinical evaluation. Ten patients have been implanted to date using the scrotal approach. Results from the first four implants provided the following significant information. Sufficient normal saline (N,S.) was placed in each penile cylinder which produced a rounded detumesced penis. Then only 10~15 ml. of N.S. was required in a 20 ml. pumpreservoir which produced full tumescence and rigidity when the fluid was transfered to the cylinders: Scrotal symmetry was preserved as it was not necessary to remove any testicles. The Mentor Bioflex penile prosthesis cylinders which were used inflated and deflated easier and quicker than the present inflatable penile prostheses systems. The operation is quicker and simpler, as no separate reservoir has to be implanted in the abdomen. The simpli.city of the G,F.S. requires only one day of hospitalization and the patients can easily learn to use the prosthesis. Erection of the penis requires a firm continuous squeeze of the soft testicle shaped reservoir in the scrotum. This maneuver transfers the fluid to the penile cylinders. Squeezing the penis while squeezing anywhere on the deflation valve atop the reservoir, transfers the fluid back into the reservoir, leaving the penis flaccid. Fluid uptake by the system has not yet occurred. Patient satisfaction has been very good. This scrotal pump-reservoir has been developed to be used with the present Mentor inflatable penile prosthesis cylinders to provide a simpler, more functional, cost effective, asthetic, inflatable penile prosthesis. As with any new inflatable penile prosthesis system, greater usage with longer patient follow up, will provide the information necessary for alterations and adaptations.
*Barbara Van DeWiele, *Jeffrey Askanazi, *Paul M. Starker,
*David H. Elwyn, and *John M. Kinney, New York, N.Y. (Presentation to be made by Dr. Hensle) Twenty patients were admitted to the Surgical Metabolism Unit after elective colectomy or radical cystectomy.
Following radical cystectomy, six patients received 5% dextrose and electrolytes as the sole nutrient source and four received total parenteral nutrition. Following colectomy, four patients received 5% dextrose and electrolytes as the sole nutrient source and six patients received TPN. Sodium, nitrogen, and potassium balances, 02 consumption and CO2 production were measured for five days after
surgery. Patients receiving TPN following colectomy and cystectomy were in positive N and K balance, consistent
with restoration of body cell mass. There was a significant correlation between postoperative Na excretion and the Na content of fluids received at operation. Patients who received 5% dextrose and electrolytes exhibited a small decrease in serum Na concentration that was not observed in patients receiving TPN. Routine postoperative administration of 5% dextrose and electrolytes as the sole nutrient source was found to exacerbate the alterations in electrolyte homeostasis which
are associated with injury. The provision of parenteral nutrition to postoperative patients who are unable to maintain their nutrition orally may benefit patients in whom water retention is a par-
ticularly serious complication. Our findings also suggest that changes in the extracellular fluid compartment which occur following operation may be affected by nutrition, with relative water retention occurring in patients receiving 5% dextrose and electrolytes as the sole nutrient source.
507
508
A NE~ PERCUTANEOUSLY-INSERTED PROSTHETIC DEVICE FOR THE CONTROL OF URINARY INCONTINENCE: AN EXPERIMENTAL STUDY. David M. Barrett, Rochester, MN; Anthony A. Malizia, Jr., Atlanta, GA; (Presentation to be made by Dr. Barrett). Credibility has been established for the use of an injectable biocompatible material in the periurethral region to enhance outlet resistance to control urinary incontinence. In an attempt to establish a more reliable yet safe method of delivering this type of incontinence control, a new prosthesis has been developed. The device consists of a percutaneously placed silicone sphere that, when injected with isotonic fluid, will create compression on the periurethral tissues. A special delivery system has been developed which simply transcutaneously inserts the silicone sphere and provides for inflation. An experimental study was undertaken in female mongrel dogs to evaluate 1) the methodology involved in insertion of the sphere, 2) the delivery system, and 3) the ability of the sphere to enhance outlet resistance. Ten dogs were injected with l to 3 inflatable spheres. The dogs were evaluated intraoperatively with intravesical leak pressure before and after the injection and inflation of the silicone sphere. Outlet resistance was perceptively increased to a point which would establish the efficacy of the procedure. Several dogs were sacrificed after 3 months of evaluation for tissue analysis while the remaining dogs continued to be observed for longterm assessment. The delivery system concept, although requiring subtle modifications, proved to be feasible. The specific aspects of the injectable sphere, the delivery system, and the observations in the laboratory animals will be presented in detai 1.
ARTIFICIAL URINARY SPHINCTER AND PENILE PROSTHESIS USING A SHAPE MEMORY ALLOY. ''Tadashi Harada, *Shigeru Miyagata, *Ruzo Kato, ,\'Masaru Yamamoto, *Teruaki Kigure, *Takumi Kumazaki and
''Kazumi Etori(Presentation to be made by Dr.Harada) New urological prosthetic devices have been developed using a shape memory alloy (Nitinol). Nitinol, employed in this study, recovered to the memory shape and then increased rigidity in the high temperature phase of 45°C. The artificial sphincter is constructed of Nitinol wire or plate core, Ni-Cr heating wire, and silicone-rubber, and
has tow components: 1) a horse shoe shaped thermal actuating sphincter that is placed around the proxymal urethra and 2) a power unit which supplies electric current to the heater connected to the actuater. The device mimics
the opening and closing action of a natural sphincter through the transformation of shape memory alloy. The erectile penile prosthesis consists of a pair of silicone
rubber cylinders which are both implanted into the corpora cavernosa to achieve penile erection. Each silicone
cylinder has a shape memory alloy wire core coiled with heating wire. In our examination of the prosthesis we were concerned with three aspects ; transformation speed, force, and surface temperature of the device. Transformation speed
was regulated by electric power and the force of transformation was controlled by the contents of the shape memory alloy. Surface temperature of the device ranged between 30 and 35°C which was considered acceptable in clinical use. The artificial sphincter was experimentaly implanted in the dog urethra and sphincteric action was examined through monitoring of the bladder pressure and urine flow rate. The results of animal experiments
revealed that the bladder neck was occluded perfectly in the closing phase and urine was voided from the bladder during the opening phase.
230A