Soft Cannula Research Articles

Impact of X-Ray Exposure From Computed Tomography on Wearable Insulin Delivery Devices.

To investigate the impact of radiation exposure from a computed tomography (CT) scanner on the functional integrity of a wearable insulin delivery system. A total of 160 Omnipods and four personal diabetes managers (PDMs) were evenly divided into four groups: (1) control group (no radiation exposure), (2) typical radiation exposure group, (3) 4× typical radiation exposure group, and (4) scatter radiation group. Pods were attached to an anthropomorphic torso phantom on the abdomen (direct irradiation) or shoulder (scatter radiation) region. A third-generation dual-source CT scanner was used to scan the pods using either a typical exposure (used for routine CT abdominal study of a median size patient) or 4× typical exposure. A manufacturer-recommended 20-step functionality test was performed for all 160 Omnipods. The radiation dose (measured in volume CT Dose index) was 16 mGy for a typical exposure, and 64 mGy for 4× typical exposure. The scatter radiation is less than 0.1 mGy. All Pods passed the functionality test except one pod in the scatter radiation group, which sounded an alarm due to occlusion. The blockage to the fluid was due to a kink in the soft cannula, a mechanical issue not caused by the radiation exposure. This study suggests X-ray exposure levels used in radiological imaging procedures do not negatively impact the functional integrity of Omnipods. This finding may support the potential for the manufacturer to remove the warning that patients should remove the Pod for X-ray imaging procedures, which will have a huge impact on patient care.

Efficacy of indwelling trocar therapy for postherpetic neuralgia: A retrospective study of an acupuncture method.

Postherpetic neuralgia (PHN) is a common complication of herpes zoster. As a kind of continuous acupuncture, indwelling trocar therapy (ITT) involves inserting a trocar into the skin and retaining the soft cannula in the body for 24 h. However, the efficacy and safety of ITT on PHN require further verification. In this study, the medical records of 122 patients with PHN were retrospectively analyzed. Patients were divided into the control group (patients who received conventional drug therapy) and the ITT group (patients who underwent ITT combined with conventional drug therapy). The Visual Analog Scale (VAS), Quality of Sleep (QS), 36-Item Short Form Health Survey (SF-36), dosage of drug and adverse events were analyzed at days 1, 3, 7, 14, 28, 90, and 180 after treatment. The total efficiency rate (TER) was analyzed after 6months of follow-up. The VAS, QS and SF-36 scores in the ITT group improved substantially compared with those in the control group after 6months of follow-up (p < 0.001). The average dosage of anticonvulsants and analgesics decreased significantly in the ITT group (p < 0.001). The TER in the control group was 52.46%, compared with 73.77% in the ITT group (p < 0.05). There were no adverse events, such as bleeding and infection, observed in the ITT group. For PHN patients, the combination of ITT and medicine therapy reduced VAS, improved quality of life, increased the efficiency rate, remarkably reduced the dosage of traditional medicine, and had no significant side effects. In addition, ITT was more effective in patients with a short duration of PHN than in chronic PHN patients.

788-P: Development of an Extended-Wear Infusion Set with Angled Cannula

Objective: Medtronic Mio™ 30 infusion set (M30IS) is a single-use consumable for pump users with pre-loaded inserter, utilizing a 30° insertion angle, and labeled for 3-day use. The M30IS wear duration is impacted by initial local trauma caused by insertion &amp; cannula and sustained inflammation mostly by insulin infusion (especially insulin aggregates and other impurities in the infusate) , with the latter being predominant. Recently, a 7-day Medtronic Extended Infusion Set (MEIS) based on 3-day Mio™ Advance IS with a 90° soft cannula was developed and commercialized in Europe, by improving insulin formulation stability in the fluid path. This study is focused on applying the extended wear (EW) technology from MEIS to the M30IS to develop an EW set with angled cannula (the EM30IS) . Method: This is a cross over study of M30IS and EM30IS on drug-induced Type 1 diabetic Yucatan pigs. Each animal wore both sets multiple times with one each time on the abdomen that was continuously infused with Novolog™ subcutaneously via a pump for 1-week or until failure. Blood glucose were measured 5 times/day. Physical examination and serum panel tests were conducted for safety evaluation. Result: Fourteen wears were completed for each device. No significant safety concern was identified. Compared to the 90° cannula sets tested on the same model having occlusion alarm rate of 0∼20% for MEIS and ∼40% for 3-day sets at 7 days, no occlusion alarm was detected in either M30IS or EM30IS. Survival rate of EM30IS (86%, similar to MEIS) trended higher than that of M30IS (71%) . Average total daily dose of insulin increased with time for M30IS (Day 1: 14.4 U, Day 6: 18.1U) , whereas remained nearly unchanged for EM30IS (Day 1: 14.9 U, Day 6: 15.6 U) . Conclusion: The data indicated that the EM30IS is safe and efficacious on the diabetic porcine model for subcutaneous insulin infusion for 7 days. The EW technology is equally safe and effective on extending the wear duration of M30IS. The EM30IS is moving to the next phase of product development. Disclosure G.Zhang: Employee; Medtronic. E.Anselmo: Employee; Medtronic. J.L.Ortigoza: Employee; Medtronic. S.Chattaraj: Employee; Medtronic.

784-P: An Insulin Infusion Set with Novel Kink-Free Flexible Cannula: In-Vitro/In-Vivo Studies

Objective: The wear duration of insulin infusion sets (IIS) is impacted by initial local trauma caused by cannula insertion and sustained inflammation due mostly to insulin infusion, both of which affect insulin absorption. Efforts have been made to mitigate cannula kinking at insertion and during use, and other site reactions that contribute to IIS failures. This Medtronic preclinical study investigated performance of a novel flexible and kink-free soft cannula. Method: In-vitro tests (included buckling kink test, inflammatory macrophage cell culture, and insulin compatibility test by USP insulin monographic methods) were conducted on the Flexible cannula and commercial Teflon cannulas. In-vivo study of 3-day sets with both cannulas were conducted on diabetic swine by having animals wear one set multiple times (on the abdomen) while receiving Novolog™ insulin subcutaneously via a pump for 7 days or until set failure, determined by (1) blood glucose (BG) value not decreasing by ≥50 mg/dL an hour after a correction bolus for a BG level &amp;gt;350 mg/dL, or (2) evidence of infection at the infusion site. Result: Compared to the control Teflon cannula, kink resistance of the Flexible cannula was significantly improved (Kinked: Teflon 6/6, Flexible 0/6) . In the inflammatory in-vitro cell culture model, the pro-inflammatory cytokines generated by the Flexible cannula trended less (mean MCP-1: Teflon -9.7 ng/mL, Flexible - 7.7 ng/mL; mean MIP-1α: Teflon -24.1 ng/mL, Flexible - 24.0 ng/mL) . Tested by the USP methods, both cannulas were insulin compatible. In the swine diabetes model, the 3-day IIS with the Flexible cannula had a greater 7-day survival rate (50%, n=10) than the corresponding control (36%, n=56) , although not statistically different. No significant increase in total daily dose of insulin was observed. Conclusion: Preliminary in-vitro and in-vivo test results indicate that the novel Flexible cannula is ideally suited for IIS device performance. Further product development is ongoing. Disclosure C.Chiu: Employee; Medtronic. G.Zhang: Employee; Medtronic. S.Chattaraj: Employee; Medtronic. R.Gottlieb: Employee; Medtronic.

A Prospective Study of Insulin Infusion Set Use for up to 7 Days: Early Replacement Reasons and Impact on Glycemic Control.

Background: There is limited evidence supporting a replacement interval of infusion sets for continuous subcutaneous insulin infusion (CSII). The aim of this study was to investigate if steel and soft cannula infusion sets can be used in CSII therapy for up to 7 days without negative impact on infusion sites or glycemic control. Methods: The insulin infusion sets YpsoPump® Orbit®micro (steel needle) and YpsoPump® Orbit®soft (soft cannula) were each used for up to 7 days by 40 adult subjects with CSII. Each subject used both infusion set types twice. Early replacement reasons were documented and glycemic control was monitored. Results: Of 160 inserted insulin infusion sets, 66% were used for 7 days with no obvious difference between steel and soft infusion sets. The mean wearing time was 6.2 ± 1.5 days. Main reasons for early infusion set replacements were occlusions (19%), plaster issues (4%), and accidental pull-out (4%). Comparing glycemic control during day 1-3 and 1-7, mean glucose was 146 ± 21 mg/dL versus 148 ± 18 mg/dL, coefficient of variation was 34% ± 7% versus 33% ± 5%, and insulin dose was 40 ± 11 U versus 41 ± 11 U. Only mild and nonserious infusion site reactions occurred. Conclusions: In this study, 7 days indwelling time of insulin infusion sets did not show a clinically relevant impact on glycemic control or insulin requirements and the infectious risk appeared to be low. The replacement interval of infusion sets may be individualized beyond the currently labeled maximum use duration.

Results of probing guided with soft cannula in children with nasolacrimal duct obstruction

Objectives To compare between the successes of probing using soft cannula (a 22 G) versus conventional probing in children with congenital nasolacrimal duct obstruction. Background Congenital obstruction of the nasolacrimal duct is a common problem in the early years of life. Obstruction can occur in 6–20% of neonates. The usual cause is failure of canalization of the epithelial cells that form the nasolacrimal duct as it enters the valve of Hasner. Patients and methods This prospective, randomized study was conducted on 36 children (48 eyes) having congenital nasolacrimal duct obstruction presented to the outpatient clinic of Menoufia University Hospital and Kafer El-Sheikh Ophthalmology Center from November 2016 to July 2018. The children were divided into two groups: group A, 18 children (24 eyes) operated by conventional probing and group B, 18 children (24 eyes) operated by probing using soft cannula. The patients were monitored for 6 months postoperatively. Results Clinically successful results were achieved in 20 eyes (83.4%) for conventional probing group and 19 eyes (79.2%) for soft cannula group. No significant complication occurred intraoperatively or postoperatively. Conclusion Soft cannula probing is an effective and simple method with no significant complication for the treatment of congenital nasolacrimal duct obstruction. This method allows probing in a more controlled way. However, there was no statistical difference between it and conventional probing.

Concept and Implementation of a Novel Patch Pump for Insulin Delivery.

With the motivation to provide a small and discreet patch pump that complies with several customer needs, the recently CE-marked Accu-Chek® Solo micropump system was designed. The system consists of a tubeless insulin pump wirelessly controlled by the so-called diabetes manager. Via diabetes manager, basal rates and boluses are programmed; an integrated blood glucose meter and bolus calculator supports users in bolusing and offers several diary functions. The micropump features a quick bolus button for bolus initiation directly on the pump and is complemented by a disposable reservoir holding up to 200 U of rapid-acting insulin. The assembled pump is attached to the body via a pump holder containing soft cannula. The modular principle enables independent replacement of the single components if necessary.

119-LB: Bolus Dosing Accuracy of Two Recent Insulin Pumps

In continuous subcutaneous insulin infusion (CSII) therapy, bolus doses are delivered to cover meals and to correct high blood glucose values. Data for bolus dosing accuracy were already presented for different insulin pump systems. In this study, two lately released insulin pumps were tested accordingly. Two new insulin pumps (MiniMed® 670G and mylife™ YpsoPump®) with soft cannula were tested. In an experimental setting following EN 60601-2-24, both pumps were installed with the tip of the cannula in a water-filled beaker placed on an electronic balance. To avoid evaporation an oil film was applied. After a run-in period, 25 successive 1.0 U and 0.1 U boluses and 12 successive 10 U boluses were delivered and weighed individually. In addition, time for a bolus delivery of 10 U was recorded. Each insulin pump was tested 9 times. While for 10 U and 1 U boluses 100% of deliveries of both pumps were within ±15% of target, only 85% (670G) and 88% (YpsoPump), respectively, of 0.1 U boluses were within these limits. Delivery time of a 10 U bolus was different between the two pumps, 6.7 min (standard speed) and 43 sec (quick) for 670G vs. 19 sec for YpsoPump, but complied with the respective manufacturer’s labeling. These results fit to the previously tested durable insulin pumps for which similar percentages of deliveries within ±15% of target (100% for 10 and 1 U and 71% to 96% for 0.1 U) were observed. As delivery accuracy decreases with smaller bolus doses, care should be given especially when treating small children with CSII. Disclosure R. Ziegler: Advisory Panel; Self; Abbott, Lilly Diabetes, Novo Nordisk A/S, Roche Diabetes Care. D. Waldenmaier: None. J. Mende: None. C. Haug: None. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker’s Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG. Funding Roche Diabetes Care GmbH

73-OR: Development of SteadiFlow Technology, an Advanced Insulin Delivery Cannula Featuring Extended Duration of Use, More Reliable Insulin Delivery, and Reduced Inflammatory Tissue Response

There is great clinical need for an insulin infusion set that produces reliable and consistent insulin absorption (PK) from dose to dose and functions reliably for 7 or more days. Capillary Biomedical, Inc. is developing SteadiFlow technology which features a soft yet kink-proof cannula with 1 distal orifice and 3 additional orifices distributed over the final 6 mm of the distal end of the cannula. We compared the performance of the SteadiSet to commercial insulin infusion sets with a Teflon cannula in large ambulatory swine. Investigational infusion sets featuring SteadiFlow technology and commercial Teflon infusion set were inserted into the subcutaneous tissue of swine’s abdomen every other day for 14 days. Insulin lispro (U-5) was infused through the catheters using the same basal/bolus pattern. On day # 14, a 70 ul bolus of insulin/x-ray contrast agent was infused through each CSII catheter. The tissue surrounding each CSII was excised 5 minutes later, frozen, and imaged using a high-resolution micro-CT scanner. The tissue was then processed and stained to produce high-resolution histology images. Histology images revealed a significantly thinner and smaller area of inflammatory tissue around the SteadiSet cannulas compared with the commercial Teflon cannulas. Micro-CT images revealed a significantly larger surface area of insulin/x-ray contrast agent delivered into the adjacent tissue when infused through the SteadiSet infusion sets compared with the commercial infusion sets with a Teflon cannula. A glucose clamp PK/PD study performed in swine using SteadiSet infusion sets implanted for 6 days showed reliable performance and relatively consistent insulin absorption into the circulation. Human clinical trials are planned for early 2019 to evaluate SteadiFlow technology for reliability, glucose control performance, and PK/PD metrics in patients with type 1 diabetes. Disclosure J.I. Joseph: Advisory Panel; Self; CapillaryBiomedical, Inc., Thermalin Diabetes, Inc. Research Support; Self; Capillary Biomedical, inc., Thermalin Diabetes, Inc. Stock/Shareholder; Self; Capillary Biomedical, Inc. M.C. Torjman: Other Relationship; Self; Capillary Biomedical, Inc. C. Loeum: Stock/Shareholder; Self; Capillary Biomedical, Inc. G.J. Eisler: None. P.J. Strasma: Employee; Self; Capillary Biomedical, Inc. A. Khalf: None. Funding JDRF; Capillary Biomedical, Inc.

Assessment of Infusion Set Survival of the Newly Developed Lantern Catheter in Type 1 Diabetes by Glucose CLA Technique

The catheter-tissue interface is the bottle neck of insulin pump therapy (CSII). Currently infusion sets shall be changed every 2-3 days to avoid lipohypertrophy, fluctuations in insulin absorption and occlusion. Patients would prefer an extended wear time if stable insulin absorption could be achieved. The novel catheter featuring Lantern Technology shall allow more stable insulin delivery via slots in the shaft of the soft cannula even if kinking or clotting occurs. The aim of the present study was to investigate clinical performance of the coated Lantern catheter in 16 patients with type 1 diabetes using CSII over a period of up to 7 days. A combined design comprising inpatient (euglycemic clamps on days 1, 4 and 7) and outpatient phases (insulin pump therapy over 7 days) is chosen to allow assessment of performance and survival time of the Lantern catheter. 16 c-peptide negative patients (age 44.2 ± 15.4 years, BMI 24.5 ± 2.3 kg/m2, HbA1c 55 ± 8 mmol/mol, diabetes duration 20 ± 9 years) completed the 7-day study period. Geometric means of maximum glucose infusion rates (GIR) were similar for days 1, 4 and 7 (6.1 ± 1.5, 7.2 ± 1.3, 5.8 ± 1.4; p=0.14). Time to reach 50% of the maximum GIR were similar over time (31.5 ± 1.6 minutes vs. 29.3 ± 1.3 minutes vs. 27.3 ± 1.3 minutes for days 1, 4 and 7 respectively; p=0.51). Area under the log-transformed GIR curve did not significantly differ for the first 2 hours between days (343.7 ± 1.5 vs. 421.3 ± 1.6 vs. 350.6 ± 1.8; p=0.14; days 1, 4 and 7, respectively); however, there was a trend towards reduced area under the GIR curve over 8 hours over time (874.2 ± 1.4 vs. 744.5 ± 1.7 vs. 509.2 ± 2.0; days 1, 4 and 7, respectively; p&amp;lt;0.05). During outpatient care no severe hypoglycemic event or ketoacidosis occurred. The novel Lantern catheter could be safely used over an extended wear-time of 7 days. There was a trend towards reduced insulin action over time. The findings need to be confirmed in a larger scale trial under routine conditions. Disclosure A. Ajsic: None. M.C. Krasser: None. R. Juliussen: Employee; Self; ConvaTec Inc. P.K. Schøndorff: Employee; Spouse/Partner; ConvaTec Inc.. M. Heschel: None. T. Pöttler: None. D. Schwarzenbacher: None. T. Augustin: None. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. G. Treiber: None. J.K. Mader: Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions, Novo Nordisk A/S. Advisory Panel; Self; Eli Lilly and Company. Consultant; Self; Becton, Dickinson and Company. Speaker's Bureau; Self; Sanofi. Research Support; Self; ConvaTec Inc., Menarini Group. Speaker's Bureau; Self; Medtronic. Research Support; Self; Novo Nordisk A/S, Sanofi.

Investigation of two models of trinitrobenzenesulfonic acid-induced colitis in rats

PURPOSE: Тhe aim of this study was to comparatively evaluate rat experimental colitis resulting from administration of two different doses of trinitrobenzenesulfonic acid (TNBS) dissolved in different volumes of two ethanol concentrations. METHODS: TNBS was applied in the colon by a soft cannula at a depth of about 10 cm from anus. The first group (TNBS20) was treated with 20 mg TNBS dissolved in 0.4 ml of 40% ethanol solution. The second group (TNBS10) was treated with 10 mg TNBS dissolved in 0.25 ml of 50% ethanol solution. Тhe animals were sacrificed 24 hours after the treatment and the colon was examined macroscopically and histopathologically. RESULTS: There were no significant differences regarding the degree of hyperemia, total area of injury and thickening of the colon wall. The higher TNBS dose produced significantly more pronounced shortening of the colon and larger necrotic area. Histopathological evaluation showed similar degree of injuries in the two models. CONCLUSION: The two investigated models of TNBS-induced colitis were comparable according to the overall macroscopic and microscopic criteria for colitis evaluation.

Long-term results of probing guided with soft cannula in children with congenital nasolacrimal duct obstruction

To report the results of soft probing in children with congenital nasolacrimal duct obstruction (CNLDO). A prospective, non-randomised interventional study included 158 eyes of 122 children aged 2 months-5 years, with CNLDO. A plastic intravenous catheter sheath supported intraluminally with a guiding metal probe was introduced through the superior canaliculus. During intubation, the plastic cannula was gently introduced through the nasolacrimal system, while the metal probe inside was withdrawn concurrently. After the complete withdrawal of the metal probe, the duct was irrigated with a high pressure saline solution through the plastic cannula. Once the obstruction was totally dissolved and a patent passage was observed, the plastic cannula was withdrawn and the procedure was completed with a nasolacrimal lavage with a gentamycin and dexamethasone combination. Clinically successful results were achieved in 142 eyes (89.8 %). No significant complications occured intraoperatively or postoperatively. In children under age 5, our technique has a high success rate with no significant complications. This method allows probing in a more controlled way. This method may be particularly suitable for surgeons during training, when the most false lumen formation is observed.

Lower Rate of Initial Failures and Reduced Occurrence of Adverse Events with a New Catheter Model for Continuous Subcutaneous Insulin Infusion: Prospective, Two-Period, Observational, Multicenter Study

No recent clinical data on the incidence of catheter-related adverse events under insulin pump therapy have been reported. This was a prospective, two-period, observational, multicenter study in 45 diabetes outpatients (mean continuous subcutaneous insulin infusion [CSII] use, 6 years; mean hemoglobin A1c, 7.7%, at baseline). During the initial 1-month period (P1), the patients used their current catheter model, including a soft cannula in 98% of cases. They moved then to the new Accu-Chek FlexLink catheter model (Disetronic Medical Systems AG, Burgdorf, Switzerland) for a 3-month period. The primary end point, including insertion failures and unexplained hyperglycemia within the first 6h after catheter placement, was assessed from logbook records during P1 and the last month of the second period (P2). Secondary end points were catheter replacements for unexplained hyperglycemia and/or events at risk for immediate insulin delivery failure after the first 6h. Forty-five initial infusion failures occurred in 14 patients among 507 catheter insertions (8.9% of cases) during P1, whereas 15 similar events were seen in nine patients during P2 among 488 catheter insertions (3.1% of cases) (P<0.001). Catheters were replaced for later infusion troubles in 8% of cases during both P1 and P2. The overall rate of late cumulative events was, however, 113 of 507 (P1) versus 66 of 488 (P2) (P<0.001). The occurrence of pain, skin reaction, or redness at the infusion site was lower during P2. Incidences both of initial failures and of premature catheter replacements were 8–9% with current CSII catheters. Significantly reduced failures after insertion and adverse events at the infusion site were observed with the new catheter model.

Highly viscous fluid in macular holes

We describe a highly viscous fluid inside the macular hole and document that disappearance of this viscous fluid results in concentric macular hole closure. Twenty eyes of 20 patients (64.9 +/- 6.9, 54-73 years) with macular holes who underwent 25-gauge (25G) transconjunctival vitrectomy were studied. Macular holes were Gass stage 2 in 4 eyes, stage 3 in 11, and stage 4 in 5. After peeling the internal limiting membrane around the macular hole, fluid was aspirated from the edge of the macular hole using a 25G soft tip cannula while performing fluid-air replacement. During aspiration, a highly viscous fluid was observed in all cases irrespective of stage. After several aspirations of this viscous fluid, the fluid cuff flattened and the macular hole closed in a concentric manner. The viscous fluid showed the "sticky sign" resembling the thread formation of melted cheese. After replacing the vitreous with octafluoropropane and keeping the patient in a prone position for 1 day, the macular hole showed full closure in all cases. Disappearance of subretinal viscous fluid accompanied by flattening and concentric displacement of the fluid cuff is associated with closure of macular hole.

Power instrumentation in endoscopic sinus surgery

Power instrumentation is gaining widespread use in endonasal endoscopic surgery. The exacting nature of soft tissue and bone removal in a confined anatomic area with adjacent, important anatomic structures lends itself for consideration of anatomic contouring with these instruments. The soft tissue-shaving cannulas and new bone-cutting drills embody a potentially less traumatic and more precise method of soft tissue extraction and bone removal. The soft tissue-shaving cannula consists of a blunt cannula with an inner oscillating cutting blade that precisely cuts and extracts tissue as it is gently sucked through the side port of the cannula. The shafts of the bone-cutting burs are protected by a sheath that can also protect the back side of the bur. Suction is applied through the sheath, which provides for a clear surgical field. The increased precision, the ability to keep the endoscopic field clear of blood and debris, and the ability to precisely and safely drill bone endonasally may allow for the more widespread application of minimally invasive approaches to a variety of clinical problems. In this article, we describe the soft tissue shaver in the surgical treatment of severe polyposis, periorbital abscess secondary to sinusitis, and other clinical situations in which increased surgical bleeding is to be expected as well as for routine endoscopic sinus surgery. We discuss applications of the bone-cutting drills, including modified transnasal Lothrop procedure or frontal drillout, endoscopic septoplasty, and choanal atresia repair.

Maternal modulation of growth hormone secretion in the neonatal rat: involvement of mother–offspring interactions

Serum GH levels increased in 2- or 8-day-old rat pups when sucking mammary glands whose main milk ducts were ligated. Although intragastric administration of rat milk has been shown to increase serum GH levels in neonatal rats, ingestion of milk during suckling did not increase serum GH values further. In another experiment, 2-day-old pups obtained no milk when they were suckled by anaesthetized mothers, and in this instance the serum GH concentration of the pups decreased. This decrease was prevented if the mothers were injected with oxytocin to counteract the depressant effect of the anaesthesia on milk ejection; nevertheless, GH levels in neonatal animals failed to increase following suckling. Thus some aspect of maternal activity appears to be involved in the suckling-induced increase of serum GH in rat pups. To elucidate which components of maternal activity might be involved, the effects of manipulations of ambient temperature as well as stimulation of the oral or anogenital regions were examined. Exposing rat pups to 37 degrees C (nest temperature) during the 6-h separation period before suckling prevented the separation-induced decrease in serum GH levels of 2-day-old pups. Moreover, exposure to 37 degrees C for 30 min following a 6-h separation at room temperature (22 degrees C) mimicked the effect of suckling in increasing serum GH levels in the pups. Suckling following separation at 37 degrees C was unable to increase serum GH values further.(ABSTRACT TRUNCATED AT 250 WORDS)

Early office termination of pregnancy by soft cannula vacuum aspiration

This report documents the results of an ongoing study of the first 454 consecutive outpatient abortions by menstrual extraction technique performed by the author over a span of 8 years. All patients had positive preevacuation pregnancy tests and the procedure was employed up to 9+ weeks from the first day of the last menstrual period. All procedures were carried out in an outpatient setting under local anesthesia. Pathologic evaluation revealed decidua and villi in all but 10 cases. Major complications were encountered in 2.6% of cases and in only two was laparotomy necessitated—one for a ruptured corpus luteum cyst and the other for an unruptured ectopic cornual pregnancy. The current application for the procedure is suggested by its technical simplicity and relative safety in population presenting for early termination of pregnancy.

Left ventricular rupture as a complication of mitral valve replacement: Surgical experience with eight cases and a review of the literature

We are not the first to attempt repair of left ventricular rupture complicating mitral valve replacement, as 18 analogous cases have been reported earlier in the literature. Our series comprises 8 patients, 5 of who, survived. A review of these 26 cases provided several facts of interest to surgeons dealing with this complication. The rupture occurred either as a laceration in the posterior atrioventricular groove (type I, 16 of 26 patients) or as a perforation of the midportion of the left ventricle (type II, 10 of 26 patients). Intraoperative rupture (17 of 26 patients) was usually detected on termination of bypass, whereas delayed rupture (9 of 26 patients) occurred after chest closure or in the recovery room. The morality rate was about 50 per cent for the intraoperative type, and no patient survived a delayed rupture. The prognosis appeared to be most in intraoperative type II lesions. The main factors affecting the prognosis were (1) instant reinstitution of extracorporeal circulations and (2) avoidance of the circumflex coronary artery during repair of type I lesions located close to the anterolateral mitral commissure. Attempts to suture a ventricular rupture on the pressure-loaded, beating heart were always unsuccessful and frequently extended the laceration. Patients with the delayed type of rupture died of hemorrhage before they could again be placed on bypass. It may be preferable to reopen the lefr atrium in order to repair a type I laceration. In type II perforations, direct repair with buttressed sutures should be attempted from the exterior of the heart. The angulated metal cannula for drainage of the left ventricle was identified as a possible, but not previously reported, cause of myocardial perforation. It is hoped that the use of a soft cannula or a metal cannula with an angle of 60 degrees instead of 90 degrees will reduce the incidence of this complication.

Introduction of a Soft Cannula into the Carotid Artery by Direct Percutaneous Puncture

Introduction of a Soft Cannula into the Carotid Artery by Direct Percutaneous Puncture

Introduction of soft cannula into artery by direct percutaneous puncture. Observations on technique and cannula materials.

Introduction of soft cannula into artery by direct percutaneous puncture. Observations on technique and cannula materials.