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The titanium/silicone rubber clip for female sterilization.

A composite titanium/silicone rubber clip has been developed for female sterilization. The 12.7 mm long metal clip is lined with silicone rubber and is bent round the Fallopian tube by means of an applicator that can be used laparoscopically. As tubal necorsis occurs, the rubber expands to keep the lumen blocked. The tube eventually divides and the stumps heal closed. Since the Mark 3 version of the clip was introduced, over 5700 women in several countries have been sterilized. The first 540 British women who were followed-up for five to 17 months experienced one method failure (ectopic) and tow operator failures, to total failure rate of 5.5/1000. Clip-related complications were minimal and long-term sequelae were comparable to tubal ligation. The clip causes minimal destruction but still seems effective for tubal occlusion and it can accommodate thick tubes.

Adolescent↗

Hormonal and menstrual changes after laparoscopic sterilization by Falope-rings or Filshie-clips.

OBJECTIVE: To evaluate the influence of laparoscopic sterilization by Falope-rings (Cabot Medical Corp., Langhorne, PA) or Filshie-clips (Femcare, Nottingham, United Kingdom) on menstrual pattern and ovulatory function. DESIGN: A prospective, nonrandomized study of women sterilized by Falope-rings (n = 6) or Filshie-clips (n = 5). Menstrual charts were kept. Serum follicle-stimulating hormone (FSH), estradiol (E2) and progesterone (P) were measured by means of radioimmunoassay in one cycle before and 3, 6, and 12 months after the sterilization. Blood samples were drawn on day -6, -2, 0, +6, +10 of the menstrual cycle, ovulation corresponding to day 0. The women sterilized by Filshie-clips had abdominal ultrasonography of the ovaries measuring the leading follicle on day -6, -2, 0, +6 of the menstrual cycle. PATIENTS: Twelve women, 25 to 38 years old, with regular menstrual cycles and no use of oral contraceptives or intrauterine contraceptive device at least 6 months before sterilization. One woman was excluded. RESULTS: After the sterilization, all women reported unchanged menstrual pattern. The follicular rise in E2 unchanged, and FSH levels fell accordingly. Progesterone levels were ovulatory, but the midluteal P peak 3 months poststerilization was significantly decreased. Serial abdominal ultrasonography in women sterilized by Filshie-clips confirmed ovulation in all cycles except in one woman, who had an unruptured follicle in one cycle before and in the sixth cycle after sterilization. CONCLUSION: Laparoscopic sterilization by Falope-rings or Filshie-clips does not seem to interfere with menstrual pattern or ovulatory function.

Adult↗

The effect of metal clips on the tensile properties of healing skin wounds.

The effects of nylon sutures and metal skin clips on the tensile properties of healing skin wounds have been studied in the pig. Wounds closed with clips have significantly poorer mechanical properties at 5, 7 and 14 days after wounding than similar wounds in the same animal closed with interrupted nylon sutures. This difference increased progressively with the period of retention of the clips. It is also shown that in equivalent groups of 14-day wounds, those in which clips were retained after the seventh day had a lower tensile strength, poorer ability to absorb energy and a lower elastic modulus than similar wounds where clips had been removed early. No such adverse effect was noted with nylon sutures.

Animals↗

The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.

Adult↗

Synthesis and supramolecular properties of molecular clips with anthracene sidewalls.

Novel molecular clips with anthracene sidewalls (1 a-c) were synthesized; they form stable host-guest complexes with a variety of electron-deficient aromatic and quinoid molecules. According to single-crystal structure analyses of clip 1 c and 1,2,4,5-tetracyanobenzene (TCNB) complex 14@1 b, the clips' anthracene sidewalls have to be compressed substantially during the complex formation to provide attractive pi-pi interactions between the aromatic guest molecule and the two anthracene sidewalls in the complex. The compression and expansion of aromatic sidewalls are calculated by molecular mechanics to be low-energy processes, so the energy required for compression of the anthracene sidewalls during complex formation is apparently overcompensated by the gain in energy resulting from the attractive pi-pi interactions. The finding that complexes of the clips 1 a-c are more stable than those of the corresponding clips 2 a-c can be explained in terms of the larger van der Waals contact surfaces of the anthracene sidewalls in 1 a-c (relative to the naphthalene sidewalls in 2 a-c). Color changes resulting from charge-transfer (CT) bands are observed in complex formation by 1 a-c: from colorless to red or purple with TCNB (14), and from yellow to green with 2,4,7-trinitro-9-fluorenone TNF (17). Independently, the host 1 b and guest 14 fluoresce from their respective excited singlet states, whilst in the complex 14@1 b the charge-transfer state quenches the higher-energy singlet states of the two components, and as a result luminescence is only observed from this new CT state. To the best of our knowledge, complex 14@1 b is the first example of CT luminescence from a host-guest complex. The binding constant determined for the formation of the TCNB complex 14@1 b from a UV/Vis titration experiment (Ka = 12 400 m(-1)) agrees well with the value (K(a) = 12 800 m(-1)) obtained by 1H NMR titration.

Anthracenes↗

A review of the CLIP system for the quantitative analysis of two-dimensional electrophoresis gels.

This paper reviews the CLIP image processing system for the complete analysis of two-dimensional electrophoresis images. The analysis problem for two-dimensional gel images can be broken down into three issues: segmentation of individual gel images, alignment and comparison of pairs of gel images, and information storage and retrieval. This paper describes these problems and reviews how the CLIP system handles each of them. Segmentation is the location and isolation of each protein spot on an individual gel image and also the extraction of individual spot data such as position, area and volume. There are three basic stages: background field correction, noise filtering, spot detection and information extraction. Alignment and comparison of gel images involves matching protein spots between two gels. This can be quite difficult because there is not a simple relationship which can transform one gel image onto another. The database issues concern storing all the information which has been obtained from the above operations such that retrieval of this information can be readily performed. The advantage of the CLIP system over others is speed of processing. CLIP series computers use one processor for every pixel of the camera image such that image processing algorithms run in parallel. The main disadvantage is in the cost of these machines. With the declining trend in the cost of parallel processors, these machines will become more and more viable alternatives. This papers reviews the algorithms for the analysis of two-dimensional gels. It is shown that CLIP is flexible enough to perform more than one type of algorithm for a particular operation.

Algorithms↗

Rapid neurorrhaphy with titanium clips.

The purpose of this study was to evaluate the usefulness of titanium clips in the repair of transected peripheral nerves. The results of neurorrhaphy using titanium clips (VCS) were compared with the conventional technique of neurorrhaphy using nylon sutures. Transected sciatic nerves in 15 New Zealand white rabbits were repaired with VCS clips on one side and interrupted 9-0 nylon sutures on the other. The average time required for neurorrhaphy using the clip closure was 8.7 +/- 2.6 min, and this was shorter than the suture closure, which took 14.9 +/- 3.6 min (P < 0.01). Electromyographic studies revealed no significant differences in amplitudes of compound motor action potentials in both groups. Also, the number and extent of myelinizations of regenerated axons were not significantly different in both methods of nerorrhaphies. These results demonstrate that microscopic neurorrhaphy using titanium clips is a potential alternative to conventional neurorrhaphy using sutures.

Animals↗

Mechanical and metallurgical properties of vascular clips designed for temporary use.

Six commonly used surgical clips (Kleinert-Kutz, Pivot, Vari-Angle, Yasargil, Biemer, and Acland) that have been designated by their manufacturer as being suitable for temporary occlusion were studied in terms of their mechanical and metallurgical properties. Opening and closing forces were determined for all of the clips. Significant variations in clip force with respect to blade gap were found in all of the pivot-type clips. Metallurgical testing showed that all six clips exhibited properties that contraindicate long-term implantation.

Corrosion↗

T cell recognition of flanking residues of murine invariant chain-derived CLIP peptide bound to MHC class II.

The major site of interaction between MHC class II molecules and invariant chain has been mapped to occupancy of the class II peptide-binding site by the CLIP region of invariant chain. CLIP is also seen as a degradation product of invariant chain and can be found in association with class II as a processing intermediate. Here we analyzed the relative contribution of single amino acids in the murine CLIP (86-102) peptide for binding to I-Ab and I-Ad and for recognition by a CLIP-specific T cell hybridoma. Interestingly, the I-Ab-restricted murine T cell hybridoma that recognizes murine CLIP peptide (86-102) is dependent on Met 102 for activation. This amino acid is outside of the core binding region and in the CLIP/DR3 crystal structure extends outside of the class II peptide-binding site. These data suggest that a T cell epitope presented on CLIP/class II complexes can be located predominantly in flanking residues that extend out of the peptide binding groove of class II.

Alleles↗

Endovascular coiling compared with surgical clipping for the treatment of unruptured middle cerebral artery aneurysms: an update.

OBJECT: In 1999 we reported that 94% of unruptured middle cerebral artery (MCA) aneurysms managed prospectively between 1993 and 1997, according to a protocol favoring endovascular coiling, were best treated by surgical clipping. The goal of the current study was to delineate the most appropriate treatment option for unruptured MCA aneurysms today, considering the technical advances in imaging and in endovascular treatment. METHODS: 35 consecutive patients harboring 40 unruptured MCA aneurysms were treated between 1997 and December 2000. Patients with unruptured cerebral aneurysms are managed prospectively according to the same protocol as reported previously [1]: the primary treatment recommendation is endovascular packing with Guglielmi detachable coils (GDCs). Surgical clipping is recommended after failed attempt at coil placement or in the presence of angioanatomical features that contraindicate that type of endovascular therapy. RESULTS: One unruptured MCA aneurysm was treated by endovascular embolization, 37 unruptured MCA aneurysms were clipped, whereas 2 unruptured MCA aneurysms were trapped with simultaneous extracranial-intracranial revascularization. Postoperative angiography revealed complete exclusion of all aneurysms. Preservation of vascular permeability was demonstrated in all clip-reconstructed aneurysms, despite arterial branches frequently originating from the aneurysmal base. Cerebral revascularization of the distal MCA was successful in the 2 patients with giant aneurysms. None of the patients presented permanent disabling complications from the treatment of the unruptured MCA aneurysm. CONCLUSION: Despite major technical advances in imaging and in endovascular treatment of cerebral aneurysms, surgical clipping still is the most efficient treatment for unruptured MCA aneurysms at the beginning of the new millennium.

Adult↗

A new, secure drainage method from the cystic duct after choledocholithotomy using the cystic tube and the cystic clip: an experimental study.

The effectiveness of the cystic tube (C-tube) and the cystic clip (C-clip) for primary closure of the common bile duct after choledocholithotomy was examined in 10 dogs, followed by an observation period of either 3 months (n = 6) or 1 year (n = 4). No early complications were observed in any of the animals either during or after surgery. The laboratory data were within the normal range during the observation period. No bile leakage or slippage of the C-clip was evident on fistulography from the C-tube in animals examined 5 days after surgery. The tube could be pulled out easily from the cystic duct without any bile leakage or slippage of the clip. A second operation to confirm late complications showed no adhesions around the common bile duct, no bile duct stenosis similar to the Mirizzi syndrome, and no cystic changes of the bile duct or biloma. Our newly designed C-clip for primary closure of the common bile duct after a choledocholithotomy therefore appears to be beneficial and applicable to clinical patients undergoing traditional as well as laparoscopic surgery.

Animals↗

Clinical experience with the use of a temporary clip for intracranial aneurysm surgery. Analysis of eighteen cases.

Although the use of a temporary clip in intracranial aneurysm surgery has been proposed by several Neurosurgeons in the past, its use today is not generally accepted. Modern surgical techniques have contributed to safer exposure and direct attack on the aneurysm. However, aneurysm surgery continues to be a direct attack on the aneurysm. However, aneurysm surgery continues to be a challenge to the Surgeon and occasionally demands the use of a temporary clip. Eighteen cases operated on with the use of a temporary clip have been analysed. The occlusion time of the feeding vessel and location of the temporary clip have been related to the outcome. There was no relationship between occlusion time of the feeding vessel and outcome in this material, whereas location of the temporary clip seemed to be of importance for the outcome in cases with aneurysms located in the middle cerebral artery.

Adult↗

Corrosion of aneurysm clips: evaluation and clinical implications. Part II: Individual performance.

The intracranial fracture of aneurysm clips due to stress corrosion failure is an increasingly common long term postoperative complication. To study the susceptibility of different clips to this process, we evaluated seven aneurysm clips (Mayfield, Yasargil, Vari-Angle McFadden, Scoville, Heifetz, and Pivot) in vitro. Microstructures, hardness, chemical composition, and susceptibility to stress corrosion failure were all measured by standard metallurgical techniques. Certain clips such as Heifetz, Pivot, and Vari-Angle showed a much greater propensity to stress corrosion failure than the others. As a result of our tests, we recommend that only the clips that show high stress corrosion resistance in in vitro testing should be considered for long term in vivo implantation.

Corrosion↗

Metallurgical evaluation of the compatibility of surgical clips with their appliers.

Five aneurysm clips and their respective appliers (Heifetz, Vari-Angle, McFadden, Scoville, and Yasargil) were tested for the production of small metal shards that could provoke a foreign body reaction or increase the risk of a stress-corrosion failure. Pivot and Vari-Angle-McFadden clips produced numerous large shards, the Scoville clip produced a few fine shards, and the Yasargil and Heifetz clips produced none. Metal shard production due to cold metal transfer is attributed to the abrasive mechanical interaction between clips and appliers made from metals with different degrees of hardness.

Aneurysm↗

Vascular Clips in Anastomoses of Femoropopliteal Arterial Reconstruction.

The vascular anastomoses are usually made with sutures. Some mainly experimental studies have been published about a new method of doing the vascular anastomoses with metal clips. We studied the suitability of vascular closure staple (VCS) clip applier system for making the anastomoses in femoropopliteal and femorotibial arterial reconstruction. During an 11-month period, VCS clips were used in 17 out of 27 patients who were operated due to severe claudication or incipient gangrena of the foot. Altogether 26 anastomoses were made with VCS clips using either great saphenous vein or PTFE graft. The making of anastomosis was easy and reliable. No postoperative bleeding was noticed. All anastomoses were patent 4-6 weeks postoperatively studied by palpation and measured by ankle brachial pressure index (mean 0.96). In Duplex Doppler examination all studied patients had well patent anastomoses on an average 11 months after the operation. With VCS clip applier system, it is possible to do anastomoses in arteriosclerotic arteries like in femoropopliteal reconstructions. This method helps making reliable anastomoses more easily.

Journal Article↗

Artefact on MRA following aneurysm clipping: an in vitro study and prospective comparison with conventional angiography.

Using both an experimental model and clinical cases, we looked at the artefact produced by Aesculap titanium-alloy aneurysm clips on MRA. Experimentally, the volume affected by artefact was 50 % less when the clip was imaged lying parallel to the main ferromagnetic field than when lying perpendicular to it. Clinically, MRA was prospectively compared with digital subtraction angiography (DSA) in nine patients who had undergone aneurysm clipping. One patient with a non-diagnostic MRA due to movement artefact was excluded. In all other cases there was an area of signal loss surrounding the clips, obscuring the immediately adjacent vessel segments. There was good demonstration of the adjacent bifurcations in five cases and the contralateral circulation was seen well in all patients. In three cases in which the adjacent bifurcations were not seen, considerable vasospasm was suggested by MRA and confirmed with DSA. In one patient an unclipped contralateral ophthalmic artery aneurysm was identified using both modalities. In this series there were no adverse events relating to clips in either static or time-varying magnetic fields.

Adult↗

MR liver imaging and cholangiography in the presence of surgical metallic clips at 1.5 and 3 Tesla.

To evaluate whether clips from prior cholecystectomy impair image quality during magnetic resonance cholangiography (MRC) at 3 Tesla (T) compared with 1.5 T, surgical clips were embedded in a gel phantom and positioned at predefined distances from a fluid-filled tube designed to simulate the bile duct. The maximum clip distance was noted where susceptibility artifacts obscured the fluid-filled tube at 1.5 T and 3 T. Susceptibility artifact size was calculated for each sequence within each magnet class. In vivo analysis included 42 patients postcholecystectomy who underwent MRC at either 1.5 T or 3 T. In vitro, mean area of susceptibility artifacts was 104 mm2 on 3-T and 75 mm2 on 1.5-T MR imaging (MRI). While surgical clips within a 2-mm range impaired visualization of the fluid-filled tube on 1.5-T MRI, this range increased to 4 mm on 3-T MRI. In vivo, MRC image quality was impaired by susceptibility artifacts in three of 21 cases at 3 T and in two of 21 cases at 1.5 T. Overall, biliary pseudo-obstructions due to susceptibility artifacts from cholecystectomy surgical clips were not substantially more common on 3-T MRC in clinical practice, and patients with a history of prior cholecystectomy should not be excluded from a 3-T MRC.

Adult↗

Intraoperative localization of colorectal tumors in the early stages using a magnetic marking clip detector system (MMCDS).

BACKGROUND: In the laparoscopic surgical treatment of early stage colorectal carcinomas, intraoperative tumor site identification is often difficult. We developed a novel marking method using a magnetic marking clip and a modified magnetometer system. METHODS: We applied magnetic marking clips at the tumor site during preoperative colonoscopy and identified the clip site with a magnetic marking clip detector system (MMCDS) of our design. Eleven patients who underwent laparoscopic colectomy were studied. RESULTS: In a basic ex vivo study, magnetic bodies of more than 300 mT magnetic force were easily detected with a 100% detection ratio. In a clinical study, the marking site was detected in all 11 patients. The mean length between the detected site and clip along the longitudinal bowel axis was 14.1 mm (SD 5.6). The mean detection time was 2.4 min (SD 0.2). CONCLUSION: MMCDS accurately identifies tumor sites. This method may be useful for tumor site identification during laparoscopic colectomy.

Aged↗