Design study of a miniaturized displacement transducer (MDT) for an active middle ear implant system.

People suffering from moderate to severe hearing loss can be treated with active middle ear implants. A new approach in this field is to implant an electromechanical transducer onto the round window membrane in order to improve coupling and be able to treat patients with middle-ear problems. In this paper the design study for a miniaturized displacement transducer (MDT) for the round window is presented. Based on a requirement analysis, the basic principle and analytical modeling of the actuator is shown. A parameter variation study results in an optimized actuator configuration that is able to generate an amplification of 110 dB SPL theoretically. As a next step this actuator has to be manufactured and tested.

Painless intravenous catheterization by intradermal jet injection of lidocaine: a randomized trial.

STUDY OBJECTIVE: To compare efficacy and cost of lidocaine cutaneous anesthesia by two jet injectors to routine needle infiltration for pain relief of intravenous (i.v.) catheterization, hypothesizing that jet injection of lidocaine is less painful than its needle infiltration. DESIGN: Randomized, prospective, controlled trial. SETTING: University hospital outpatient surgical unit. PARTICIPANTS: 75 surgical patients ASA I and II. INTERVENTIONS: Three groups of 25 patients each were given intradermal lidocaine anesthesia via conventional 25-gauge needle/syringe; by MedEJet or Biojector jet injector prior to IV catheterization with an 18-gauge Jelco catheter. MEASUREMENTS AND MAIN RESULTS: Visual analogue pain scores (VAS) (0 = no pain, 10 = intolerable pain) and subjective pain intensity scores (PIS) (0 = not painful, 4 = intolerable pain) at lidocaine application and at i.v. catheterization, were recorded. Cost assessment of each method was made. At local anesthetic application, no pain by proportion of VAS = 0 with MedEJet: 25/25 (confidence interval [CI]: 0.868, 0.999) and Biojector: 24/25 (CI 0.804, 0.991) was noted, but-22 of 25 patients experienced pain with needle administration: (with VAS = 0; 3/25 [CI: 0.044, 0.302]) (posterior probability [PP] > 0.999). The corresponding VAS scores (means +/- SD) were 0.00 +/- 0.00, 0.04 +/- 0.20, and 2.4 +/- 2.23 (p < 0.001). No pain by proportion of PIS = 0 with MedEJet: 25/25 (CI: 0.868, 0.999 and Biojector: 23/25 (0.749, 0.976) was noted, but pain in 20/25 was felt with the needle: 5/25 (CI: 0.090, 0.394) (PP > 0.999). The corresponding PIS scores were 0.00 +/- 0.00, 0.16 +/- 0.55, and 1.24 +/- 1.00 (p < 0.001). At i.v. catheterization, no pain by proportion of VAS = 0 with MedEJet: 22/25 (CI: 0.698, 0.956) or Biojector: 21/25 (CI: 0.651, 0.934) was noted; but pain in 19/25 with needle administration was experienced: 6/25 (CI: 0.116, 0.436) (PP > 0.999). The corresponding scores were 0.12 +/- 0.33, 0.44 +/- 0.20, and 1.64 +/- 1.50 (p < 0.001). No pain by proportion of PIS = 0 with MedEJet: 24/25 (CI: 0.804, 0.991) or Biojector: 24/25 (CI: 0.804, 0.991) was noted, but pain was apparent in 12/25 with needle administration: 13/25 (CI: 0.334, 0.701) (PP > 0.999). The corresponding scores were 0.00 +/- 0.00, 0.00 +/- 0.00, and 0.76 +/- 0.88 (p < 0.001). Cost per application: MedEJet = $0.13; needle/syringe = $0.50; Biojector = $0.94. CONCLUSIONS: Almost completely painless i.v. catheterization was carried out by jet injection of lidocaine, but needle infiltration produced discomfort or pain and did not significantly reduce discomfort or pain at the i.v. needle insertion.

V. A new route, jet injection of lidocaine for skin wheal for painless intravenous catheterization.

OBJECTIVE: The objective of this study was to compare the efficacy of intradermal lidocaine anesthesia by two jet injectors to the routine needle infiltration and to the topical EMLA cream. SUBJECTS AND METHODS: In a randomized, prospective, controlled trial, 100 consenting surgicenter patients in a university hospital setting were divided into four groups (n = 25, each); intradermal lidocaine anesthesia was given either by the conventional 25 g needle/syringe or the Med-E-Jet or Biojector injector or EMLA cream was applied on the skin. Visual analogue pain scores (VAS) or verbal pain intensity scores (PIS) were reported by the patients at lidocaine application and i.v. catheterization. Cost was also assessed. RESULTS: At lidocaine application, no pain was reported, since proportions of VAS = 0 were 25/25 (CI: 0.868, 0.999) with Med-E-Jet; 24/25 (0.804, 0.991) with Biojector; 25/25 (0.868, 0.999) with EMLA; in contrast to pain, 3/25 (0.044, 0.302) with the needle (PP > 0.999). The VAS scores (mean +/- SD) were 0.00 +/- 0.00, 0.04 +/- 0.20, 0.00 +/- 0.00, and 2.4 +/- 2.2 respectively (p < 0.00 1). No pain was reported by proportions of PIS = 0 with Med-E-Jet: 25/25 (CI: 0.868, 0.999); with Biojector: 23/25 (0.749, 0.976); EMLA 25/25 (0,868, 0.999); but pain with the needle: 5/25 (0.090, 0.394) (PP > 0.999). The mean +/- SD PIS scores were 0.00 +/- 0.00, 0.16 +/- 0.55, 0.00 +/- 0.00, and 1.24 +/- 1.00, respectively (p < 0.001). At i.v. catheterization, the proportions of VAS = 0 scores were 22/25 with Med-E-Jet (0.698, 0.956); 21/25 (0.651, 0.934) with Biojector; but some pain with needle: 6/25 (0.116, 0.436) (PP > 0.999). The mean +/- SD VAS scores were: 0.12 +/- 0.33, 0.44 +/- 0.20, and 1.64 +/- 1.50, respectively (p < 0.001). No pain was reported by PIS = 0 scores in 24/25 (0.804, 0.991) with Med-E-Jet; 24/25 (0.804, 0.991) with the Biojector; but pain by zero PIS scores 13/25 (0.334, 0.703) in half of the patients in the needle group (PP > 0.999). The mean +/- SD scores were 0.00 +/- 0.00, 0.00 +/- 0.00, and 0.76 +/- 0.88, respectively (p < 0.001). The EMLA cream was not evaluated because of inadequate duration of application prior to anesthetic induction. Cost/application were: Med-E-Jet = $ 0.13; needle = $ 0.50; Biojector = $ 0.94 and EMLA = $ 3.76. CONCLUSION: Almost completely painless i.v. catheterization by jet injection of lidocaine was accomplished, while needle infiltration produced pain/discomfort and did not significantly reduce it at the i.v. needle insertion.