Procedimento Implante Dura Ii
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DURA II
Positionable Penile Prosthesis 12 Step Procedure Guide
Step 1 Position Patient on the Operating Table - Position the patient’s legs and arrange the drapes so the prosthetic position can be checked after insertion by bending the penis between the legs.
Step 2 Penile Base to Mid-Glans Measurement - Stretch the penis to approximate the length of an erection. Using the sizer, measure the stretched penis from the dorsal Penile Base to Mid-Glans area (Figure 1). (Measurements are commonly in the 8cm to 13cm range).
Figure 1. Penile Base to Mid-Glans Measurement.
Do not press the sizer into the skin or fat pad. Record this measurement on the Patient Information Form (PIF) enclosed with each pair of DURA II body cylinders.
Step 3 Surgical Incision – A sub-coronal incision / approach is recommended (Figure 2). However, the incisional approach is the individual surgeons’ choice. Perform the standard longitudinal corporotomies of two-to-three centimeters in length (Figure 3). When a non-sub-coronal approach is used, it may be necessary to extend the corporotomies to 5cm-7cm to allow the prosthesis to be inserted. However, extension of the corporotomies should be made after dilation. *If patient is not circumcised and a sub-coronal incision is used, circumcision is strongly recommended and should be completed at the end of the case.
Figure 2. Sub-coronal incision.
Note: When the peno-scrotal approach is used, corporotomies must be of sufficient lengths to allow the prosthesis cylinders to be inserted to maximize use of excessive force and severe bending.
Figure 3. Longitudinal corporotomy. The purpose of the registration of implanted prosthesis is to identify and protect the patient in the event of a device recall or warranty claim. Traceability of implanted medical devices is regulated by the U.S. Food and Drug Administration.
Step 4 Corporal Dilation /Prosthesis Diameter Selection - Dilate both corpora proximally and distally to accommodate prosthesis diameter (Figures 4 & 5). If possible, dilate to 14 FR to accommodate a 12mm body. Simultaneously, insert two similar dilators to verify that the penis can accommodate two similarly sized body cylinders.
Step 5 Total Intra-Corporal Length Measurement - Stretch the penis to approximate an erection. Using the prosthesis sizer, measure the stretched corporal length in centimeters in both proximal (Figure 6) and distal (Figure 7) directions and add together to determine the total intracorporal length. Length must be measured for each corpus. Record these measurements on the Patient Information Form supplied.
Figure 4. Brooks dilator for proximal dilation.
Note: Many surgeons subtract 1cm from total intracorporal length to facilitate insertion and placement of prosthesis to prevent erosion.
Figure 5. Brooks dilator for distal dilation.
Figure 6. Measuring proximal intracorporal length.
Figure 7. Measuring distal intracorporal length.
Penile Base to Mid-Glans length (cm)
Step 6
Example:
If the Penile Base Measurement And the Total intra-corporal length Then according to the chart: Distal tip length Proximal tip length
= 11cm = 20cm
= 3cm = 4cm
Note: If the total intra-corporal length varies between right and left corpora, size each corpora for its measured length per the sizing chart (at right).
7 8 9 10 11 12 13 14 15 16 17 18 15 1,1 1,1 1,1 1,1 NA NA NA NA NA NA NA NA Total Intra-Corporal Length (cm)
Selection of Prosthesis Component - Using the measurements for Penile Base to Mid-Glans length and total intra-corporal length, refer to the sizing chart (Figure 8) to select the appropriate proximal and distal tips to be used (Figure 9).
16 1,2 1,2 1,2 2,1 2,1 NA NA NA NA NA NA NA 17 1,3 1,3 1,3 2,2 3,1 3,1 NA NA NA NA NA NA 18 1,4 1,4 1,4 2,3 3,2 4,1 4,1 NA NA NA NA NA 19 1,5 1,5 1,5 2,4 3,3 4,2 5,1 5,1 NA NA NA NA 20 1,6 1,6 1,6 2,5 3,4 4,3 5,2 6,1 6,1 NA NA NA 21 1,7 1,7 1,7 2,6 3,5 4,4 5,3 6,2 7,1 7,1 NA NA 22 1,8 1,8 1,8 2,7 3,6 4,5 5,4 6,3 7,2 8,1 8,1 NA 23 1,9 1,9 1,9 2,8 3,7 4,6 5,5 6,4 7,3 8,2 9,1 9,1 24 NA 2,9 2,9 2,9 3,8 4,7 5,6 6,5 7,4 8,3 9,2 9,2 25 NA NA 3,9 3,9 3,9 4,8 5,7 6,6 7,5 8,4 9,3 9,3 26 NA NA NA 4,9 4,9 4,9 5,8 6,7 7,6 8,5 9,4 9,4
Step 7 Assemble Prosthesis - The body cylinder is bidirectional. Proximal or distal tips may be applied to either end. To assemble the tip to the body cylinders, use the hex wrench supplied with each pair of the body cylinders to tighten screws securely. The prosthesis is packaged with the screw tightened. Slightly loosen screw to insert tip ‘pin’ into prosthesis and retighten. Insert tip pin fully into receptacle on end of body cylinder. Hold tip in place while tightening set screw with hex wrench. When set screw is firmly seated, continue turning the hex wrench until the wrench shaft slightly flexes (Figure 10). After attaching tips, pull to insure secure attachment.
27 NA NA NA NA 5,9 5,9 5,9 6,8 7,7 8,6 9,5 9,5 Key: First number is distal tip length. Second number is proximal tip length. See complete instructions enclosed with DURA II Penile Prosthesis body cylinders.
Figure 8. Sizing Chart for DURA II™ Positionable Penile Prosthesis Implant.
Note: Tips, hex wrenches and set screws are not interchangeable between 10mm and 12mm diameter prosthesis. An extra wrench/screw set is included in all complete DURA II kits. Figure 9. DURA II Prosthesis Components.
Figure 10. Tip Attachment using Hex Wrench.
Step 8 Insert Prosthesis - When using the sub-coronal approach, first insert the proximal end of the prosthesis into the proximal corpora (Figure 11). Then insert the distal tip of the prosthesis under the glans by lifting and bending the tips while retracting the corpus distally with a vein retractor if necessary (Figure 12). At the same time, press the distal tip of the prosthesis into the corpus under the glans. Caution: Based on ease of dilation, insert the more difficult side first. It may also be helpful to distally extend the corporotomy to assist with cylinder placement.
Figure 11. Proximal placement of device.
Prior to closure - Always bend device in all directions to confirm that there is no springback and to confirm proper placement of bend point. Note: If the prosthesis does not fit (either too long or too short) once inserted, remove, confirm both original measurements and refer to sizing chart for correct tip lengths. Proximal tips over 2cm may be trimmed up to 1cm with scissors, to customize fit. Distal tips are never to be trimmed.
Step 9 Running closure of corporotomies using 2-0 or 3-0 vicryl. (Figure 13).
Figure 12. Distal placement under glans.
Step 10 Completion of circumcision and wound closure, dressing applied. (Figures 14, 15, 16).
Figure 14. Circumcision process. Figure 13. Running closure of corporotomy.
Figure 15. Circumcision completed. (4.0 chromic interrupted sutures)
Figure 16. Vaseline gauze to suture line, loose cling dressing applied.
Sizing Chart for DURA II™ Positionable Penile Prosthesis Implant.
Penile Base to Mid-Glans length (cm) 7 8 9 10 11 12 13 14 15 16 17 18
Total Intra-Corporal Length (cm)
15 1,1 1,1 1,1 1,1 NA NA NA NA NA NA NA NA 16 1,2 1,2 1,2 2,1 2,1 NA NA NA NA NA NA NA 17 1,3 1,3 1,3 2,2 3,1 3,1 NA NA NA NA NA NA 18 1,4 1,4 1,4 2,3 3,2 4,1 4,1 NA NA NA NA NA 19 1,5 1,5 1,5 2,4 3,3 4,2 5,1 5,1 NA NA NA NA 20 1,6 1,6 1,6 2,5 3,4 4,3 5,2 6,1 6,1 NA NA NA 21 1,7 1,7 1,7 2,6 3,5 4,4 5,3 6,2 7,1 7,1 NA NA 22 1,8 1,8 1,8 2,7 3,6 4,5 5,4 6,3 7,2 8,1 8,1 NA 23 1,9 1,9 1,9 2,8 3,7 4,6 5,5 6,4 7,3 8,2 9,1 9,1 24 NA 2,9 2,9 2,9 3,8 4,7 5,6 6,5 7,4 8,3 9,2 9,2 25 NA NA 3,9 3,9 3,9 4,8 5,7 6,6 7,5 8,4 9,3 9,3 26 NA NA NA 4,9 4,9 4,9 5,8 6,7 7,6 8,5 9,4 9,4 27 NA NA NA NA 5,9 5,9 5,9 6,8 7,7 8,6 9,5 9,5
Step 11 Positioning the Implanted Prosthesis - Stabilization in the desired position downward “concealed” or upward “erect”is accomplished by underlaying or overlaying a finger at the dorsal or ventral base of the penis and bending the penis into the desired position (Figures 17 & 18).
Step 12 Implant Registration - American Medical Systems requires implantation of penile prosthesis to be registered within 15 days from implant date. In the United States, this is done by completing and returning to AMS the Patient Information Form supplied with each pair of DURA II body cylinders. Outside the United States, return the appropriate information to the distributor who sold you the prosthesis. Figure 17. DURA II Post-operative cosmetic result - erect.
This information is intended as an overview only. Please refer to the Instructions for Use included with this device for indications, contradictions, cautions, precautions, warnings complications and other important information about the DURA II Positionable Penile Prosthesis.
DURA II is a registered trademark of American Medical Systems, Inc.
Figure 18. Concealed.
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 USA Phone: 952 930 6000 Fax: 952 930 6157 www.AmericanMedicalSystems.com A Publicly Traded Company (Nasdaq: AMMD)
American Medical Systems Australia Pty. Ltd. Suite 2, Level 2 460 Church Street North Parramatta 2150 NSW AUSTRALIA Phone: Fax:
61 2 8838 8800 61 2 9890 9899
American Medical Systems Canada Inc. P.O. Box 461 Guelph, Ontario N1H6K9 CANADA Phone: Fax:
519 826 5333 519 821 1356
American Medical Systems U.K. Ltd. 9 Ironbridge House Windmill Place 2-4 Windmill Lane Hanwell Middlesex UB2 4NJ UNITED KINGDOM Phone: Fax:
44 208 606 9955 44 208 606 9988
©2003 American Medical Systems, Inc. All rights reserved. Printed in USA. Order Number: 23600042 (09/03)
DURA II
Positionable Penile Prosthesis 12 Step Procedure Guide
Step 1 Position Patient on the Operating Table - Position the patient’s legs and arrange the drapes so the prosthetic position can be checked after insertion by bending the penis between the legs.
Step 2 Penile Base to Mid-Glans Measurement - Stretch the penis to approximate the length of an erection. Using the sizer, measure the stretched penis from the dorsal Penile Base to Mid-Glans area (Figure 1). (Measurements are commonly in the 8cm to 13cm range).
Figure 1. Penile Base to Mid-Glans Measurement.
Do not press the sizer into the skin or fat pad. Record this measurement on the Patient Information Form (PIF) enclosed with each pair of DURA II body cylinders.
Step 3 Surgical Incision – A sub-coronal incision / approach is recommended (Figure 2). However, the incisional approach is the individual surgeons’ choice. Perform the standard longitudinal corporotomies of two-to-three centimeters in length (Figure 3). When a non-sub-coronal approach is used, it may be necessary to extend the corporotomies to 5cm-7cm to allow the prosthesis to be inserted. However, extension of the corporotomies should be made after dilation. *If patient is not circumcised and a sub-coronal incision is used, circumcision is strongly recommended and should be completed at the end of the case.
Figure 2. Sub-coronal incision.
Note: When the peno-scrotal approach is used, corporotomies must be of sufficient lengths to allow the prosthesis cylinders to be inserted to maximize use of excessive force and severe bending.
Figure 3. Longitudinal corporotomy. The purpose of the registration of implanted prosthesis is to identify and protect the patient in the event of a device recall or warranty claim. Traceability of implanted medical devices is regulated by the U.S. Food and Drug Administration.
Step 4 Corporal Dilation /Prosthesis Diameter Selection - Dilate both corpora proximally and distally to accommodate prosthesis diameter (Figures 4 & 5). If possible, dilate to 14 FR to accommodate a 12mm body. Simultaneously, insert two similar dilators to verify that the penis can accommodate two similarly sized body cylinders.
Step 5 Total Intra-Corporal Length Measurement - Stretch the penis to approximate an erection. Using the prosthesis sizer, measure the stretched corporal length in centimeters in both proximal (Figure 6) and distal (Figure 7) directions and add together to determine the total intracorporal length. Length must be measured for each corpus. Record these measurements on the Patient Information Form supplied.
Figure 4. Brooks dilator for proximal dilation.
Note: Many surgeons subtract 1cm from total intracorporal length to facilitate insertion and placement of prosthesis to prevent erosion.
Figure 5. Brooks dilator for distal dilation.
Figure 6. Measuring proximal intracorporal length.
Figure 7. Measuring distal intracorporal length.
Penile Base to Mid-Glans length (cm)
Step 6
Example:
If the Penile Base Measurement And the Total intra-corporal length Then according to the chart: Distal tip length Proximal tip length
= 11cm = 20cm
= 3cm = 4cm
Note: If the total intra-corporal length varies between right and left corpora, size each corpora for its measured length per the sizing chart (at right).
7 8 9 10 11 12 13 14 15 16 17 18 15 1,1 1,1 1,1 1,1 NA NA NA NA NA NA NA NA Total Intra-Corporal Length (cm)
Selection of Prosthesis Component - Using the measurements for Penile Base to Mid-Glans length and total intra-corporal length, refer to the sizing chart (Figure 8) to select the appropriate proximal and distal tips to be used (Figure 9).
16 1,2 1,2 1,2 2,1 2,1 NA NA NA NA NA NA NA 17 1,3 1,3 1,3 2,2 3,1 3,1 NA NA NA NA NA NA 18 1,4 1,4 1,4 2,3 3,2 4,1 4,1 NA NA NA NA NA 19 1,5 1,5 1,5 2,4 3,3 4,2 5,1 5,1 NA NA NA NA 20 1,6 1,6 1,6 2,5 3,4 4,3 5,2 6,1 6,1 NA NA NA 21 1,7 1,7 1,7 2,6 3,5 4,4 5,3 6,2 7,1 7,1 NA NA 22 1,8 1,8 1,8 2,7 3,6 4,5 5,4 6,3 7,2 8,1 8,1 NA 23 1,9 1,9 1,9 2,8 3,7 4,6 5,5 6,4 7,3 8,2 9,1 9,1 24 NA 2,9 2,9 2,9 3,8 4,7 5,6 6,5 7,4 8,3 9,2 9,2 25 NA NA 3,9 3,9 3,9 4,8 5,7 6,6 7,5 8,4 9,3 9,3 26 NA NA NA 4,9 4,9 4,9 5,8 6,7 7,6 8,5 9,4 9,4
Step 7 Assemble Prosthesis - The body cylinder is bidirectional. Proximal or distal tips may be applied to either end. To assemble the tip to the body cylinders, use the hex wrench supplied with each pair of the body cylinders to tighten screws securely. The prosthesis is packaged with the screw tightened. Slightly loosen screw to insert tip ‘pin’ into prosthesis and retighten. Insert tip pin fully into receptacle on end of body cylinder. Hold tip in place while tightening set screw with hex wrench. When set screw is firmly seated, continue turning the hex wrench until the wrench shaft slightly flexes (Figure 10). After attaching tips, pull to insure secure attachment.
27 NA NA NA NA 5,9 5,9 5,9 6,8 7,7 8,6 9,5 9,5 Key: First number is distal tip length. Second number is proximal tip length. See complete instructions enclosed with DURA II Penile Prosthesis body cylinders.
Figure 8. Sizing Chart for DURA II™ Positionable Penile Prosthesis Implant.
Note: Tips, hex wrenches and set screws are not interchangeable between 10mm and 12mm diameter prosthesis. An extra wrench/screw set is included in all complete DURA II kits. Figure 9. DURA II Prosthesis Components.
Figure 10. Tip Attachment using Hex Wrench.
Step 8 Insert Prosthesis - When using the sub-coronal approach, first insert the proximal end of the prosthesis into the proximal corpora (Figure 11). Then insert the distal tip of the prosthesis under the glans by lifting and bending the tips while retracting the corpus distally with a vein retractor if necessary (Figure 12). At the same time, press the distal tip of the prosthesis into the corpus under the glans. Caution: Based on ease of dilation, insert the more difficult side first. It may also be helpful to distally extend the corporotomy to assist with cylinder placement.
Figure 11. Proximal placement of device.
Prior to closure - Always bend device in all directions to confirm that there is no springback and to confirm proper placement of bend point. Note: If the prosthesis does not fit (either too long or too short) once inserted, remove, confirm both original measurements and refer to sizing chart for correct tip lengths. Proximal tips over 2cm may be trimmed up to 1cm with scissors, to customize fit. Distal tips are never to be trimmed.
Step 9 Running closure of corporotomies using 2-0 or 3-0 vicryl. (Figure 13).
Figure 12. Distal placement under glans.
Step 10 Completion of circumcision and wound closure, dressing applied. (Figures 14, 15, 16).
Figure 14. Circumcision process. Figure 13. Running closure of corporotomy.
Figure 15. Circumcision completed. (4.0 chromic interrupted sutures)
Figure 16. Vaseline gauze to suture line, loose cling dressing applied.
Sizing Chart for DURA II™ Positionable Penile Prosthesis Implant.
Penile Base to Mid-Glans length (cm) 7 8 9 10 11 12 13 14 15 16 17 18
Total Intra-Corporal Length (cm)
15 1,1 1,1 1,1 1,1 NA NA NA NA NA NA NA NA 16 1,2 1,2 1,2 2,1 2,1 NA NA NA NA NA NA NA 17 1,3 1,3 1,3 2,2 3,1 3,1 NA NA NA NA NA NA 18 1,4 1,4 1,4 2,3 3,2 4,1 4,1 NA NA NA NA NA 19 1,5 1,5 1,5 2,4 3,3 4,2 5,1 5,1 NA NA NA NA 20 1,6 1,6 1,6 2,5 3,4 4,3 5,2 6,1 6,1 NA NA NA 21 1,7 1,7 1,7 2,6 3,5 4,4 5,3 6,2 7,1 7,1 NA NA 22 1,8 1,8 1,8 2,7 3,6 4,5 5,4 6,3 7,2 8,1 8,1 NA 23 1,9 1,9 1,9 2,8 3,7 4,6 5,5 6,4 7,3 8,2 9,1 9,1 24 NA 2,9 2,9 2,9 3,8 4,7 5,6 6,5 7,4 8,3 9,2 9,2 25 NA NA 3,9 3,9 3,9 4,8 5,7 6,6 7,5 8,4 9,3 9,3 26 NA NA NA 4,9 4,9 4,9 5,8 6,7 7,6 8,5 9,4 9,4 27 NA NA NA NA 5,9 5,9 5,9 6,8 7,7 8,6 9,5 9,5
Step 11 Positioning the Implanted Prosthesis - Stabilization in the desired position downward “concealed” or upward “erect”is accomplished by underlaying or overlaying a finger at the dorsal or ventral base of the penis and bending the penis into the desired position (Figures 17 & 18).
Step 12 Implant Registration - American Medical Systems requires implantation of penile prosthesis to be registered within 15 days from implant date. In the United States, this is done by completing and returning to AMS the Patient Information Form supplied with each pair of DURA II body cylinders. Outside the United States, return the appropriate information to the distributor who sold you the prosthesis. Figure 17. DURA II Post-operative cosmetic result - erect.
This information is intended as an overview only. Please refer to the Instructions for Use included with this device for indications, contradictions, cautions, precautions, warnings complications and other important information about the DURA II Positionable Penile Prosthesis.
DURA II is a registered trademark of American Medical Systems, Inc.
Figure 18. Concealed.
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 USA Phone: 952 930 6000 Fax: 952 930 6157 www.AmericanMedicalSystems.com A Publicly Traded Company (Nasdaq: AMMD)
American Medical Systems Australia Pty. Ltd. Suite 2, Level 2 460 Church Street North Parramatta 2150 NSW AUSTRALIA Phone: Fax:
61 2 8838 8800 61 2 9890 9899
American Medical Systems Canada Inc. P.O. Box 461 Guelph, Ontario N1H6K9 CANADA Phone: Fax:
519 826 5333 519 821 1356
American Medical Systems U.K. Ltd. 9 Ironbridge House Windmill Place 2-4 Windmill Lane Hanwell Middlesex UB2 4NJ UNITED KINGDOM Phone: Fax:
44 208 606 9955 44 208 606 9988
©2003 American Medical Systems, Inc. All rights reserved. Printed in USA. Order Number: 23600042 (09/03)
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