Objective: Hemodialysis patients usually receive an arteriovenous fistula (AVF) in the arm as vascular access conduit to allow dialysis 2-3 times a week. This AVF introduces the high flow necessary for dialysis, but over time the ever-present supraphysiological flow is the leading cause of complications. This study aims to develop an implantable device able to non-invasively remove the high flow outside dialysis sessions. Methods: The developed prototype features a magnetic ring allowing external coupling and torque transmission to non-invasively control an AVF valve. Mock-up devices were implanted into arm and sheep cadavers to test sizes and locations. The transmission torque, output force, and valve closure are measured for different representative skin thicknesses. Results: The prototype was placed successfully into arm and sheep cadavers. In the prototype, a maximum output force of 78.9 ± 4.2 N, 46.7 ± 1.9 N, 25.6 ± 0.7 N, 13.5 ± 0.6 N and 6.3 ± 0.4 N could be achieved non-invasively through skin thicknesses of 1-5 mm respectively. The fistula was fully collapsible in every measurement through skin thickness up to the required 4 mm. Conclusion: The prototype satisfies the design requirements. It is fully implantable and allows closure and control of an AVF through non-invasive torque transmission. In vivo studies are pivotal in assessing functionality and understanding systemic effects. Significance: A method is introduced to transfer large amounts of energy to a medical implant for actuation of a mechanical valve trough a closed surface. This system allows non-invasive control of an AVF to reduce complications related to the permanent high flow in conventional AVFs.

@en

Safe insertion of the Veress needle during laparoscopy relies on the surgeons’ technical skills in order to stop needle insertion just in time to prevent overshooting in the underlying organs. To reduce this risk, a wide variety of Veress needle systems were developed with safety mechanisms that limit the insertion speed, insertion depth or decouple the driving force generated by the surgeon’s hand on the needle. The aim of this study is to evaluate current surgeons’ perceptions related to the use of Veress needles and to investigate the relevance of preventing overshooting of Veress needles among members of the European Association of Endoscopic Surgery (EAES). An online survey was distributed by the EAES Executive Office to all active members. The survey consisted of demographic data and 14 questions regarding the use of the Veress needle, the training conducted prior to usage, and the need for any improvement. A total of 365 members residing in 58 different countries responded the survey. Of the responding surgeons, 36% prefer the open method for patients with normal body mass index (BMI), and 22% for patients with high BMI. Of the surgeons using Veress needle, 68% indicated that the reduction of overshoot is beneficial in normal BMI patients, whereas 78% indicated that this is beneficial in high BMI patients. On average, the members using the Veress needle had used it for 1448 (SD 3031) times and felt comfortable on using it after 22,9 (SD 78,9) times. The average years of experience was 17,6 (SD 11,1) and the surgeons think that a maximum overshoot of 9.4 (SD 5.5) mm is acceptable before they can safely use the Veress needle. This survey indicates that despite the risks, Veress needles are still being used by the majority of the laparoscopic surgeons who responded. In addition, the surgeons responded that they were interested in using a Veress needle with an extra safety mechanism if it limits the risk of overshooting into the underlying structures.

@en

Background:
Veress needles (VN) are commonly used in establishing pneumoperitoneum in laparoscopic surgery. Previously, a VN with a new safety mechanism ‘VeressPLUS’ needle (VN+) was developed to reduce the amount of overshoot.

Methods:
Eighteen participants (novices, intermediates, and experts) performed in total of 248 insertions in a systematic way on Thiel-embalmed bodies with wide and small bore versions of the conventional VN (VNc) and the VN+. Insertion depth was measured by recording the graduations on the needle under direct laparoscopic vision.

Results:
Participants graded the bodies and the procedures as lifelike. Overall, a significant reduction (P<0.001) in average insertion depth was found for the VN+ compared to the VNc of 26.0 SD16 mm versus 46.2 SD15 mm. The insertion depth difference in the novice group was higher compared to the intermediates and experts (P<0.001). The average insertion depth for both needle types was less (P<0.001) for female participants compared to male.

Conclusion:
This study indicated that the VN+ significantly reduced the insertion depth in all tested conditions. Whether the difference between female and male performance can be linked to differences in muscle control or arm mass should be further investigated. Useful technical information was gathered from this study to further improve the VN+.
@en