FERTILITY AND STERILITY Copyright~ 1976 The American Fertility Society
Vol. 27, No. 9, Septemher 1976 Printed in U.S.A.
A CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION BRIAN A. LIEBERMAN, M.D.
Department of Obstetrics and Gynaecology, St. Mary's Hospital, London W2, England
Laparoscopic sterilization using spring-loaded clips promises to reduce complications encountered with other sterilization techniques. A secondpuncture clip applicator for laparoscopic sterilization has been developed which has several advantages over the single-puncture method, allowing a full visual field and more accurate placement of the clips. A description of the applicator, its assembly, operative procedure, and preliminary results are reported.
Diathermy of the fallopian tubes is an effective method of laparoscopic sterilization. 1 In experienced hands the failure rate is low, 0.2 to 0.5%, 2 but increases to 2 to 3% 3 while the technique is being mastered. Operative complications are infrequent, 4 but the risk of visceral damage (0.4 to 0.6% 1 ) associated with diathermy remains a serious and potentially fatal complication. Fatalities have also been reported as a result of complications arising from the general anesthetic and from gas embolisms and cardiac arrhythmias following the use of carbon dioxide for the pneumoperitoneum.5 As the majority of female sterilizations are elective procedures in women with young families, these complications must be eliminated. The use of local anesthetic techniques, 6 • 7 nitrous oxide instead of carbon dioxide for the pneumoperitoneum, and alternatives to diathermy will help to achieve this objective. Laparoscopic sterilization using springloaded clips fulfills these criteria. 8 The Accepted March 29, 1976.
results of a prospective multicenter study9 involving 1000 patients, in which a single-puncture laparoscopic technique was used, are encouraging. No major (i.e., life-threatening) operative complications occurred, but the uncorrected pregnancy rate was high (2.4% ). The majority of these failures (13 of 24) were due to operator error, the clips either not having been placed across the full width of the fallopian tube or placed onto other broad ligament structures. The single-puncture laparoscopic technique undoubtedly reduces the operator's visual field, and this is thought to be the major factor contributing to the high incidence of operator mistakes. A second-puncture laparoscopic approach has several distinct advantages. The operator's visual field is not reduced. The ability to move the optics independently of the applicator enables the operator to ensure that the clip has been placed correctly across the full width of the fallopian tube. The majority of laparoscopists have been trained in secondpuncture techniques, and a single-puncture approach requires retraining.
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Vol. 27, No.9
CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION
1037
FIG. 1. Laparoscopic clip applicator. a, Finger grip; b, safety catch; c, spring ram; d, barrel; e, open clip in breech; f, hollow rod; g, solid ram; i, tracks of spring ram;j, pin; k, open clip; l, closed clip. (Photograph Copyright by the Department of Audio-Visual Communication, St. Mary's Hospital Medical School, London. Reprinted with permission.)
A second-puncture clip applicator* has been developed at the Samaritan Hospital (Figs. 1 to 3). Spring-loaded clips of the Hulka-Clemens type 8 (Fig. 1) have been modified for use with this applicator. These modifications include strengthening of the spring to produce a compressive load of at least 90 gm between the closed jaws of the clip and removal of the Silastic filler at the proximal end of the clip. *Manufactured by Rocket of London Ltd., Imperial Way, Watford, Hertfordshire, England.
MATERIALS AND METHODS
Description of the Clip Applicator. The applicator is made of stainless steel. It consists of a movable finger grip (a), safety catch (b), spring ram (c), and barrel (d). The barrel (diameter, 8 mm; length, 26 em) carries the clip in its distal end (e). A hollow rod {f) passes down the barrel. This rod closes the upper jaw of the clip and prevents accidental displacement of the clip from the applicator. Its movements are controlled by the surgeon's opening and closing the finger grip. A solid ram (g)
FIG. 2. Assembled clip applicator. a, Finger grip; c, spring ram; d, barrel; e,breech for the clip.
1038
LIEBERMAN
September 1976
f
d
e
FIG. 3. Components of the clip applicator. a, Finger grip; c, spring ram; d, barrel; e, clip breech; f, hollow rod; g, solid ram; h, upper end of finger grip;}, pin.
passes down the rod. This ram pushes the spring over the closed jaws of the clip. Its movement is controlled by the operator's index finger. The safety catch prevents the ram from prematurely pushing the spring over a closed clip. It is released by the surgeon's depressing the catch with his thumb. Assembly of the Clip Applicator (Figs. 1 to 3). The safety catch is depressed, allowing the finger grip to move to the fully open position. The rod is slid into the barrel, ensuring that it engages the upper end of the finger grip (h). The rod should be pushed far enough into the barrel to allow the safety catch to engage. The ram is then slid into the rod by aligning it in its tracts (i) and depressing the pin {j). To place a clip in the applicator the safety catch is depressed, allowing the finger grip and consequently the breech at the distal end of the applicator to open. The clip is then positioned in the breech. The finger grip is closed, and the clip will be held securely in the applicator. The upper jaw of the clip is opened and closed in response to movements of the finger grip. Operative Procedure. The operation can be performed under either a local or general anesthetic. 5 A pneumoperitoneum is created and the laparoscope
inserted at the umbilicus. A 9-mm trocar and cannula are inserted Ph inches below the umbilicus and 1 inch to the right of midline. A tenaculum to antevert and manipulate the uterus is attached to the cervix. 10 The clip is placed in the applicator. The upper jaw of the clip is closed by the surgeon's closing the finger grip with his middle, ring, and little fingers. The applicator is then inserted into the peritoneal cavity through the 9-mm cannula. The operator's index finger is purposely left out of the finger grip. It is used · subsequently to ram the spring over the closed clip. After the fallopian tubes have been identified, the upper jaw of the clip is opened. The lower jaw is positioned beneath the tub~. 1 to 2 em from the uterine cornua. The open jaws of the clip are then gently pushed toward the back of the broad ligament. This maneuver will ensure that the fallopian tube lies close to the apex of the triangle formed by the open jaws of the clip. The upper jaw is closed, grasping the fallopian tube. The operator inspects to ensure that the clip lies across the full width of the fallopian tube. If this is the case, the safety catch is depressed, and the ram is pushed forward by his index finger. The operator continues
r
r
l
Vol. 27, No.9
CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION
to depress the safety catch, removes his index finger from the ram, and at the same time opens the finger grip. This maneuver will release the closed clip and fallopian tube from the applicator. The applicator is then removed from the peritoneal cavity and the procedure repeated on the contralatera side. Finally, before the laparoscope is removed, both fallopian tubes and clips are carefully reinspected.
1039
REFERENCES 1. Wheeless CR Jr, Thompson BH: Laparoscopic
2.
3.
4. 5.
RESULTS AND DISCUSSION
Four hundred and fifty women have 6. been sterilized with this technique. No operative problems or complications attributable to the applicator or clip have 7. been reported. Laparoscopic and surgical complications have occurred in nine 8. patients (difficulty with the pneumoperitoneum, two patients; inability to visual9. ize the fallopian tubes with a fixed, retroverted uterus, one patient; uterine perforation by the controlling tenaculum, four patients; perforated bladder, 10. one patient; bowel perforation by the Verres needle, one patient). These preliminary results strongly suggest that the theoretical advantages of 11. double-puncture over single-puncture clip application do withstand the rigors of clinical evaluation. A detailed report on the first 500 women who were sterilized using the double-puncture technique is being prepared. 11
sterilization: review of 3600 cases. Obstet Gynecol 42:751, 1973 Thompson BH, Wheeless CR: Failures of laparoscopy sterilization. Obstet Gynecol 45: 659, 1975 Hughes G, Liston WA: Comparison between laparoscopic sterilization and tubal ligation. Br Med J 3:637, 1975 Wortman J, Piotrow P: Population Report, Ser C, No 2, 1973 Lieberman BA, Bostock JF, Anderson MC: Evaluation of laparoscopic sterilization using a spring-loaded clip. J Obstet Gynaecol Br Commonw 81:921, 1974 Wheeless CR Jr: Outpatient laparoscope sterilization under local anesthesia. Obstet Gynecol 39:767, 1972 Mercer JP, Hulka JF, Fishburne JI, Kumarasamy T, Omran KF: Spring clip tubal sterilization. Obstet Gynecol 44:449, 1974 Hulka JF: Studies in simpler tubocclusion methods. Am J Obstet Gynecol 122:337, 1975 Hulka JF, Omran KF, Phillips JM Jr, Lefler HT Jr, Lieberman B, Lean HT, Pai DN, Koetsawang S, Castro VM: Sterilization by spring clip: a report of 1000 cases with a 6-month follow-up. Fertil Steril 26:1122, 1975 Kumarasamy T, Hulka JF, Mercer JP, Fishburne JI, Omran KF: Laparoscopic sterilization with a spring-loaded clip. J Obstet Gynaecol Br Commonw 81:913, 1974 Lieberman BA, Gordon AC, Bostock JF, Wright CSW, Niven PAR, Letchworth AT, Noble AD, Baine C, Eliot E: Laparoscopic sterilization with spring-loaded clips: a report on 500 women. To be presented at the 1976 Congress of the American Association of Gynecologic Laparoscopists.
Vol. 27, No. 9, Septemher 1976 Printed in U.S.A.
A CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION BRIAN A. LIEBERMAN, M.D.
Department of Obstetrics and Gynaecology, St. Mary's Hospital, London W2, England
Laparoscopic sterilization using spring-loaded clips promises to reduce complications encountered with other sterilization techniques. A secondpuncture clip applicator for laparoscopic sterilization has been developed which has several advantages over the single-puncture method, allowing a full visual field and more accurate placement of the clips. A description of the applicator, its assembly, operative procedure, and preliminary results are reported.
Diathermy of the fallopian tubes is an effective method of laparoscopic sterilization. 1 In experienced hands the failure rate is low, 0.2 to 0.5%, 2 but increases to 2 to 3% 3 while the technique is being mastered. Operative complications are infrequent, 4 but the risk of visceral damage (0.4 to 0.6% 1 ) associated with diathermy remains a serious and potentially fatal complication. Fatalities have also been reported as a result of complications arising from the general anesthetic and from gas embolisms and cardiac arrhythmias following the use of carbon dioxide for the pneumoperitoneum.5 As the majority of female sterilizations are elective procedures in women with young families, these complications must be eliminated. The use of local anesthetic techniques, 6 • 7 nitrous oxide instead of carbon dioxide for the pneumoperitoneum, and alternatives to diathermy will help to achieve this objective. Laparoscopic sterilization using springloaded clips fulfills these criteria. 8 The Accepted March 29, 1976.
results of a prospective multicenter study9 involving 1000 patients, in which a single-puncture laparoscopic technique was used, are encouraging. No major (i.e., life-threatening) operative complications occurred, but the uncorrected pregnancy rate was high (2.4% ). The majority of these failures (13 of 24) were due to operator error, the clips either not having been placed across the full width of the fallopian tube or placed onto other broad ligament structures. The single-puncture laparoscopic technique undoubtedly reduces the operator's visual field, and this is thought to be the major factor contributing to the high incidence of operator mistakes. A second-puncture laparoscopic approach has several distinct advantages. The operator's visual field is not reduced. The ability to move the optics independently of the applicator enables the operator to ensure that the clip has been placed correctly across the full width of the fallopian tube. The majority of laparoscopists have been trained in secondpuncture techniques, and a single-puncture approach requires retraining.
1036
Vol. 27, No.9
CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION
1037
FIG. 1. Laparoscopic clip applicator. a, Finger grip; b, safety catch; c, spring ram; d, barrel; e, open clip in breech; f, hollow rod; g, solid ram; i, tracks of spring ram;j, pin; k, open clip; l, closed clip. (Photograph Copyright by the Department of Audio-Visual Communication, St. Mary's Hospital Medical School, London. Reprinted with permission.)
A second-puncture clip applicator* has been developed at the Samaritan Hospital (Figs. 1 to 3). Spring-loaded clips of the Hulka-Clemens type 8 (Fig. 1) have been modified for use with this applicator. These modifications include strengthening of the spring to produce a compressive load of at least 90 gm between the closed jaws of the clip and removal of the Silastic filler at the proximal end of the clip. *Manufactured by Rocket of London Ltd., Imperial Way, Watford, Hertfordshire, England.
MATERIALS AND METHODS
Description of the Clip Applicator. The applicator is made of stainless steel. It consists of a movable finger grip (a), safety catch (b), spring ram (c), and barrel (d). The barrel (diameter, 8 mm; length, 26 em) carries the clip in its distal end (e). A hollow rod {f) passes down the barrel. This rod closes the upper jaw of the clip and prevents accidental displacement of the clip from the applicator. Its movements are controlled by the surgeon's opening and closing the finger grip. A solid ram (g)
FIG. 2. Assembled clip applicator. a, Finger grip; c, spring ram; d, barrel; e,breech for the clip.
1038
LIEBERMAN
September 1976
f
d
e
FIG. 3. Components of the clip applicator. a, Finger grip; c, spring ram; d, barrel; e, clip breech; f, hollow rod; g, solid ram; h, upper end of finger grip;}, pin.
passes down the rod. This ram pushes the spring over the closed jaws of the clip. Its movement is controlled by the operator's index finger. The safety catch prevents the ram from prematurely pushing the spring over a closed clip. It is released by the surgeon's depressing the catch with his thumb. Assembly of the Clip Applicator (Figs. 1 to 3). The safety catch is depressed, allowing the finger grip to move to the fully open position. The rod is slid into the barrel, ensuring that it engages the upper end of the finger grip (h). The rod should be pushed far enough into the barrel to allow the safety catch to engage. The ram is then slid into the rod by aligning it in its tracts (i) and depressing the pin {j). To place a clip in the applicator the safety catch is depressed, allowing the finger grip and consequently the breech at the distal end of the applicator to open. The clip is then positioned in the breech. The finger grip is closed, and the clip will be held securely in the applicator. The upper jaw of the clip is opened and closed in response to movements of the finger grip. Operative Procedure. The operation can be performed under either a local or general anesthetic. 5 A pneumoperitoneum is created and the laparoscope
inserted at the umbilicus. A 9-mm trocar and cannula are inserted Ph inches below the umbilicus and 1 inch to the right of midline. A tenaculum to antevert and manipulate the uterus is attached to the cervix. 10 The clip is placed in the applicator. The upper jaw of the clip is closed by the surgeon's closing the finger grip with his middle, ring, and little fingers. The applicator is then inserted into the peritoneal cavity through the 9-mm cannula. The operator's index finger is purposely left out of the finger grip. It is used · subsequently to ram the spring over the closed clip. After the fallopian tubes have been identified, the upper jaw of the clip is opened. The lower jaw is positioned beneath the tub~. 1 to 2 em from the uterine cornua. The open jaws of the clip are then gently pushed toward the back of the broad ligament. This maneuver will ensure that the fallopian tube lies close to the apex of the triangle formed by the open jaws of the clip. The upper jaw is closed, grasping the fallopian tube. The operator inspects to ensure that the clip lies across the full width of the fallopian tube. If this is the case, the safety catch is depressed, and the ram is pushed forward by his index finger. The operator continues
r
r
l
Vol. 27, No.9
CLIP APPLICATOR FOR LAPAROSCOPIC STERILIZATION
to depress the safety catch, removes his index finger from the ram, and at the same time opens the finger grip. This maneuver will release the closed clip and fallopian tube from the applicator. The applicator is then removed from the peritoneal cavity and the procedure repeated on the contralatera side. Finally, before the laparoscope is removed, both fallopian tubes and clips are carefully reinspected.
1039
REFERENCES 1. Wheeless CR Jr, Thompson BH: Laparoscopic
2.
3.
4. 5.
RESULTS AND DISCUSSION
Four hundred and fifty women have 6. been sterilized with this technique. No operative problems or complications attributable to the applicator or clip have 7. been reported. Laparoscopic and surgical complications have occurred in nine 8. patients (difficulty with the pneumoperitoneum, two patients; inability to visual9. ize the fallopian tubes with a fixed, retroverted uterus, one patient; uterine perforation by the controlling tenaculum, four patients; perforated bladder, 10. one patient; bowel perforation by the Verres needle, one patient). These preliminary results strongly suggest that the theoretical advantages of 11. double-puncture over single-puncture clip application do withstand the rigors of clinical evaluation. A detailed report on the first 500 women who were sterilized using the double-puncture technique is being prepared. 11
sterilization: review of 3600 cases. Obstet Gynecol 42:751, 1973 Thompson BH, Wheeless CR: Failures of laparoscopy sterilization. Obstet Gynecol 45: 659, 1975 Hughes G, Liston WA: Comparison between laparoscopic sterilization and tubal ligation. Br Med J 3:637, 1975 Wortman J, Piotrow P: Population Report, Ser C, No 2, 1973 Lieberman BA, Bostock JF, Anderson MC: Evaluation of laparoscopic sterilization using a spring-loaded clip. J Obstet Gynaecol Br Commonw 81:921, 1974 Wheeless CR Jr: Outpatient laparoscope sterilization under local anesthesia. Obstet Gynecol 39:767, 1972 Mercer JP, Hulka JF, Fishburne JI, Kumarasamy T, Omran KF: Spring clip tubal sterilization. Obstet Gynecol 44:449, 1974 Hulka JF: Studies in simpler tubocclusion methods. Am J Obstet Gynecol 122:337, 1975 Hulka JF, Omran KF, Phillips JM Jr, Lefler HT Jr, Lieberman B, Lean HT, Pai DN, Koetsawang S, Castro VM: Sterilization by spring clip: a report of 1000 cases with a 6-month follow-up. Fertil Steril 26:1122, 1975 Kumarasamy T, Hulka JF, Mercer JP, Fishburne JI, Omran KF: Laparoscopic sterilization with a spring-loaded clip. J Obstet Gynaecol Br Commonw 81:913, 1974 Lieberman BA, Gordon AC, Bostock JF, Wright CSW, Niven PAR, Letchworth AT, Noble AD, Baine C, Eliot E: Laparoscopic sterilization with spring-loaded clips: a report on 500 women. To be presented at the 1976 Congress of the American Association of Gynecologic Laparoscopists.
