Challenges faced in the clinical application of artificial anal sphincters

Wang, Minghui; Zhou, Ying; Luo, Yun

doi:10.1631/jzus.b1400242

Cited by 18 publications

(7 citation statements)

References 58 publications

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“…Fecal incontinence is an unresolved sociological and hygienic problem. 1 It refers to the clinical symptoms that patients cannot control the discharge of intestinal contents voluntarily, which brings great inconvenience and psychological pain to patients. 2,3 This is a complex clinical symptom caused by a variety of factors, and its incidence increases with age and decline in psychophysiological status.…”

Section: Introductionmentioning

confidence: 99%

Research on biomechanical compatibility for a novel artificial anal sphincter with constant force

et al. 2023

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BackgroundExisting artificial anal sphincter studies have shown that biomechanical compatibility problem between artificial anal sphincter and rectum caused by long‐term morphological changes of the tissue surrounding the implanted prosthesis can lead to device failure or tissue ischemic necrosis. In this article, a mechanical artificial anal sphincter with constant force clamping is designed based on the superelasticity of shape memory alloys, which improved the biomechanical compatibility of implantable artificial anal sphincter.MethodsFirstly, the anatomical structure and the biomechanical properties of the rectum are analyzed to obtain the size parameters and material parameters of the rectal model. Secondly, a novel artificial anal sphincter with constant force is designed to improve the biomechanical compatibility between the artificial sphincter and the rectum. Thirdly, the static analysis of artificial anal sphincter is carried out by finite element analysis.ResultsThe simulation results show that the artificial anal sphincter can maintain a constant clamping force of 4 N within a certain variation range of intestinal tissue thickness, which verifies the constant force characteristic of the artificial anal sphincter. The constant clamping force of the artificial anal sphincter to the rectum is 4 N that is greater than the clamping force 3.99 N required to close the rectum, which verifies the effectiveness the artificial anal sphincter. The surface contact stress and the minimum principal stress of the rectum in the clamping state are less than the pressure threshold, which verifies the safety of the artificial anal sphincter.ConclusionsThe novel artificial anal sphincter has better biomechanical compatibility and improves the mechanical match between artificial sphincter and intestinal tissue. This study may provide more reasonable and effective simulation data for in vivo experiments of artificial anal sphincter in future, which may provide theoretical and technical support for further research about clinical application of artificial anal sphincter.

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Section: Introductionmentioning

confidence: 99%

Research on biomechanical compatibility for a novel artificial anal sphincter with constant force

et al. 2023

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“…However, these treatment methods may be insufficient for patients having severe fecal incontinence. From an engineering perspective, the artificial anal sphincter is a potential treatment method for severe patients 4–6 …”

Section: Introductionmentioning

confidence: 99%

“…From an engineering perspective, the artificial anal sphincter is a potential treatment method for severe patients. [4][5][6] In 1999, the Acticon Neosphincter (AN) developed by the American Medical System received a humanitarian device exemption from the US Food and Drug Administration (FDA) and was formally FDA approved in 2001. 7 A systematic review on safety and effectiveness of the AN reports the indications for surgical revision, covering 535 patients, were device malfunction (36%), tissue erosion (29%), infection (28%), reimplantations (12%), and pain (10%).…”

mentioning

confidence: 99%

Experimental assessment of a novel artificial anal sphincter with shape memory alloy

et al. 2022

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Background Fecal incontinence caused by sphincter dysfunction is a difficult medical problem that has not been fully resolved. The artificial anal sphincter provides a new therapeutic strategy for fecal incontinence. In order to solve the biomechanical compatibility problem between the artificial anal sphincter and intestinal tissue in clinical application, a design of constant force artificial anal sphincter was assessed in this paper. Methods The constant force properties and safety of this novel device were evaluated by an experiment conducted in pig intestines with various thicknesses. The constant force characteristic of the device was evaluated by the intestinal pressure of the pig intestine. The safety of the device was evaluated by the surface contact stress of the pig intestine clamped by an artificial anal sphincter. Results The average measured value of the intestinal pressure of the pig intestines with three thicknesses is about 55.3 mm Hg, the maximum pressure difference is 1 mm Hg, and the fluctuation error of constant clamping load is about 1.8%. The constant clamping load fluctuation error of the four measuring points of the pig intestines with three thicknesses is less than 2%. Even if the thickness of the pig intestines is changed, the measured contact stress value is lower than 10 kPa, which may avoid bit damage for the intestinal tissue. Conclusions This study demonstrates that the novel artificial sphincter has constant force properties and safety, which prevent ischemic necrosis of soft tissues caused by excessive pressure. Therefore, this study raises the possibility of the long‐term efficacy of artificial anal sphincter.

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“…This type of sphincter provides an alternative way to treat fecal incontinence. But according to clinical reports, the system often fails because of liquid leakage, resulting in a high removal rate 16‐18 . Moreover, the tissue around the pump is ulcerated easily due to frequent squeezing by hand.…”

Section: Introductionmentioning

confidence: 99%

An artificial anal sphincter based on a novel clamping mechanism: Design, analysis, and testing

et al. 2021

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An artificial anal sphincter is a device to help patients with fecal incontinence rebuild the ability to control the excrement through the anus. In this article, an artificial anal sphincter based on a novel clamping mechanism (AASNCM) is proposed to improve the safety and reliability. The AASNCM, which is powered by a transcutaneous energy transfer system, consists of a novel clamping mechanism, a receiving coil and a control unit. According to design requirements, the novel clamping mechanism model was established. After that, its kinematics and dynamics were analyzed.The results of force tests on the prototype AASNCM show that the maximum values of clamping force and expanding force are 15.859 and 31.029 N, respectively.Comparing the experimental results with theoretical analysis, a good match can be concluded. Finally, in vitro experiments were conducted, and have verified the safety and reliability of the proposed AASNCM.

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Challenges faced in the clinical application of artificial anal sphincters

Cited by 18 publications

References 58 publications

Research on biomechanical compatibility for a novel artificial anal sphincter with constant force

Research on biomechanical compatibility for a novel artificial anal sphincter with constant force

Experimental assessment of a novel artificial anal sphincter with shape memory alloy

An artificial anal sphincter based on a novel clamping mechanism: Design, analysis, and testing

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