Self-expanding intestinal expansion sleeves (IES) for short gut syndrome

Clayton, Sean; Alexander, J. Steven; Solitro, Giovanni F.; White, Luke A.; Villalba, Stephanie; Winder, E; Boudreaux, Mary K.; Veerareddy, P; Dong, Eugene; Minagar, Alireza; Dao, H N; Sorrells, Donald L.

doi:10.1007/s00383-021-05024-8

Cited by 3 publications

(3 citation statements)

References 21 publications

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“…Our proposed device is derived from another study focused on the use of distraction enterogenesis in the treatment of short gut syndrome through an intestinal expansion sleeve (IES) [ 21 ]. Distraction enterogenesis utilizes longitudinal expansion devices that inflict distractive mechanical force for an immediate increase in the small intestine length while maintaining tissue continuity and architecture [ 22 ].…”

Section: Discussionmentioning

confidence: 99%

“…Because of the potential surgical complications and difficulty of patient compliance, we proposed the use of a modification of our previously described intestinal expansion sleeve method [ 21 ] to expand the vaginal canal length in a single step procedure in rats. We hypothesized that the vaginal expansion sleeve (VES) would induce lengthening of the vaginal canal without lesion to the vaginal wall through the process of ‘distraction vaginogenesis’, a derivative of distraction enterogenesis described in studies focused on treating short gut syndrome with longitudinal expansion devices that lengthen the bowel through distractive mechanical forces [ 21 , 22 ]. In the attempt to evaluate a novel self-expanding device as a potential treatment option for vaginal agenesis, this proof-of-concept study aims to create and mechanically characterize the VES device and to histologically evaluate the expansion of the vaginal wall following deployment.…”

Section: Introductionmentioning

confidence: 99%

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‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats

et al. 2023

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Vaginal atresia is seen in genetic disorders such as Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, which can cause significant sexual dysfunction. Current treatments include surgical reconstruction or mechanical dilation of the vaginal canal. Mechanical dilation requires patients to be highly motivated and compliant while surgical reconstruction has high rates of complications. This study evaluated a novel vaginal expansion sleeve (VES) method as an alternative treatment for vaginal atresia. The proprietary cylindrical VES is a spring-like device consisting of polyethylene terephthalate helicoid trusses capped at each end with a fixed diameter resin cap for fixation within tissues. Following the development of the VES and mechanical characterization of the force–length relationships within the device, we deployed the VES in Sprague Dawley rat vaginas anchored with nonabsorbable sutures. We measured the VES length–tension relationships and post-implant vaginal canal expansion ex vivo. Vaginal histology was examined before and after implantation of the VES devices. Testing of 30 mm sleeves without caps resulted in an expansion force of 11.7 ± 3.4 N and 2.0 ± 0.1 N at 50% and 40%, respectively. The implanted 20 mm VES resulted in 5.36 mm ± 1.18 expansion of the vaginal canal, a 32.5 ± 23.6% increase (p = 0.004, Student t test). Histological evaluation of the VES implanted tissue showed a significant thinning of the vaginal wall when the VES was implanted. The novel VES device resulted in a significant expansion of the vaginal canal ex vivo. The VES device represents a unique alternative to traditional mechanical dilation therapy in the treatment of vaginal atresia and represents a useful platform for the mechanical distension of hollow compartments, which avoids reconstructive surgeries and progressive dilator approaches.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats

et al. 2023

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“…We originally described the approach of ‘distraction vaginogenesis,’ which was initially based on our report of ‘distraction enterogenesis,’ in a preliminary study using ex vivo tissue that investigated tissue remodeling produced by deliberate canal elongation [ 26 , 27 ]. This approach relies on applying distractive mechanical forces using longitudinal expansion devices to lengthen the vaginal canal without causing adverse effects on the tissue [ 26 , 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

Histologic Analysis of ‘Distraction Vaginogenesis’ in a Rat Model

Meyer,

Trosclair,

Clayton

et al. 2024

Pathophysiology

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Vaginal agenesis (VA) is frequently associated with mullerian agenesis. VA treatments include mechanical dilation and surgical vaginoplasty. We created a vaginal expansion sleeve (VES) as a novel device to progressively lengthen the vaginal canal. This study evaluated the histologic effects of the VES on rat vaginal tissue. The VES is a spring-like device made of proprietary woven cylindrical material and flat resin caps. The VESs were constructed as 25–30 mm, pre-contracted springs, which were secured into the vaginas of six Sprague Dawley rats and allowed to re-expand post-surgically. After one week, the VESs were removed, and the vaginas were harvested and measured in length. Test (n = 6) and control (n = 4) formalin-fixed paraffin-embedded tissues were stained with hematoxylin and eosin (H&E), Masson’s trichrome, and anti-Desmin antibodies. The VESs achieved significant vaginal lengthening. The mean vaginal canal length increased from 20.0 ± 2.4 mm to 23.8 ± 1.2 mm after removal of the VESs (n = 6, p < 0.001), a 19% increase. There was a positive correlation between the expander/tension generated in the vagina and the amount of acute and chronic inflammation. H&E staining revealed increased submucosal eosinophilia in five of the six test tissues. One VES sample that was lengthened to 30 mm long showed evidence of lymphocytic and neutrophilic inflammation. Desmin immunostaining and Masson’s trichrome stain revealed a thinner muscularis with more infiltrative fibrous tissue between muscle fibers in the test tissue compared to the control tissue. Although effective, the VES may provoke at least a transient increase in eosinophils consistent with a localized immune reaction during muscularis remodeling.

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Distraction Enterogenesis in Rats: A Novel Approach for the Treatment of Short Bowel Syndrome

O’Quin,

Clayton,

Trosclair

et al. 2024

Pathophysiology

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Background: Surgeons often encounter patients with intestinal failure due to inadequate intestinal length (“short bowel syndrome”/SBS). Treatment in these patients remains challenging and the process of physiologic adaptation may take years to complete, which frequently requires parenteral nutrition. We propose a proof-of-concept mechanical bowel elongation approach using a self-expanding prototype of an intestinal expansion sleeve (IES) for use in SBS to accelerate the adaptation process. Methods: IESs were deployed in the small intestines of Sprague Dawley rats. Mechanical characterization of these prototypes was performed. IES length–tension relationships and post-implant bowel expansion were measured ex vivo. Bowel histology before and after implantation was evaluated. Results: IES mechanical studies demonstrated decreasing expansive force with elongation. The deployment of IES devices produced an immediate 21 ± 8% increase in bowel length (p < 0.001, n = 11). Mechanical load testing data showed that the IESs expressed maximum expansive forces at 50% compression of the initial pre-contracted length. The small-intestine failure load in the rats was 1.88 ± 21 N. Intestinal histology post deployment of the IES showed significant expansive changes compared to unstretched bowel tissue. Conclusions: IES devices were scalable to the rat intestinal model in our study. The failure load of the rat small intestine was many times higher than the force exerted by the contraction of the IES. Histology demonstrated preservation of intestinal structure with some mucosal erosion. Future in vivo rat studies on distraction enterogenesis with this IES should help to define this organogenesis phenomenon.

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Self-expanding intestinal expansion sleeves (IES) for short gut syndrome

Cited by 3 publications

References 21 publications

‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats

‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats

Histologic Analysis of ‘Distraction Vaginogenesis’ in a Rat Model

Distraction Enterogenesis in Rats: A Novel Approach for the Treatment of Short Bowel Syndrome

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