УДК 616-71                                                                                                       

Technical and technological solutions for bedridden patients

Кича Екатерина Игоревна – генеральный директор Общество с ограниченной ответственностью «Ассоциация разработчиков и производителей систем мониторинга» член-корреспондент

Кича Максим Александрович – Член-корреспондент Международной академии наук экологии и безопасности жизнедеятельности

Трофимов Евгений Витальевич – представитель Общества с ограниченной ответственностью «Союзмед»

Abstract: Present study is concerned with rectal catheters. This study is aimed at substantiation the priority of technical and technological solutions for the removal of liquid and semi-liquid fecal matter in bedridden patients. The paper applies a common research methodology in the sphere of development and production of medical devices. The study’s output is the first developed working design documentation for the FaTrox medical device, intended to be inserted and retained in the patient’s rectum for the purpose of diversion of liquid and semi-liquid fecal matter, as well as administration of medical preparations into the patient’s rectum. The core technical and operational indicators of the device developed have the edge over well-known analogues by at least 20%.

Keywords: catheter, introducer, hygiene, silicone, Fatrox.

Acute or intractable diarrhea and fecal incontinence in the indoor patients caused by illness or medical intervention is a common presentation sign. Patients suffering from fecal incontinence reveal physiological and psychological response. Where fecal matter contacts the skin, irritation in the area of the perineal region and buttocks, even to the point of disruption of the skin integrity, by the impact of bacteria and enzymes contained in feces. On top of that, extensive long-term damage to the skin integrity, which, beginning with a superficial irritation up to heavy muscle disorder, induces septic fever and consequently causes death. Psychological aspects, including depression, body feeling distortion and extremely unfavorable self-perception have also been reported [1, 2]. Therefore, it is essential that healthcare institution is focused on the fecal incontinence issue to be properly addressed in order to retain patient comfort and dignity, and to maintain optimal skin integrity.

The issue of fecal incontinence is normally solved by means disposable hygiene products such as diapers or absorbent pads. The person caring for the patient is in charge for regular pad replacement and cleaning the skin in the buttock area. Untimely replacement exposes the patient to excess moisture and fecal irritation, which may result in the development of perineal dermatitis [3]. Consequently, poorly-timed changing of the pad and insufficient cleansing of the skin might become the cause of cross contamination. Additionally, the perceived fecal odor impacts the patient’s quality of life [4]. Another possible measure consists in the use of a balloon-catheter rectal tube. This system is inserted and fixed into the intestines using an inflatable balloon catheter and connects to a bed-attached drainage bag, thus removing liquid feces. Leaks in the tube and balloon area have been noted to prevent intestinal obstruction when diarrhea resolves [5, 6].

Over the last few years, it became possible to set forth the rules for the collection and disposal of the fecal matter [7]. Owing to the enclosed type of the product the risk of skin irritation and cross contamination was significantly reduced when using the system to drain feces directly from the rectum. The said system consists of a flexible catheter with a low-pressure balloon and dismountable bags. A catheter with saline or water is inserted into the patient's rectum and made immobilized with a balloon for the required period of time. The dismountable bag is replaced once full. It has been observed the new fecal drainage system, contributes to lesser the incidence of skin irritation or the development of soft tissue and bloodstream infections.

This study is aimed at substantiation the priority of technical and technological solutions for the removal of liquid and semi-liquid fecal matter in bedridden patients.

Materials and methods

The paper applies a common research methodology in the sphere of development and production of medical devices, with due consideration of modern requirements for the execution of technical documentation [8-10].

Results and discussion

FaTrox medical device (hereinafter referred to as the “Device”) is an ASM LLC developed product as part of the research and development work (R&D) “Detailed design and technological documentation for the manufacture of a pilot batch of the FaTrox medical device” (code “Fisht”) according to Soiuzmed LLC technical assignment.

The developed product is intended to be inserted and retained in the patient’s (over 18 years of age) rectum for the purpose of diversion of liquid and semi-liquid fecal matter, as well as administration of medical preparations into the patient’s rectum.

The product consists of:

  • hose with an introducer – 1 pc.;
  • bag with lid – 3 pcs., incl. 1 pc. with the product and 2 pcs. in reserve;
  • syringe 50 ml. (three-component) sterile (luer lock) – 1 pc.;
  • plastic packaging – 1 pc.;
  • cardboard packaging – 1 pc.;
  • unified accompanying document – passport – 1 pc.

The Figure shows the device appearance.

1

Figure No. 1, Appearance of the FaTrox medical device.

The device is designed to ensure contact of the patient’s colon with a bag intended to collect liquid and semi-liquid feces of the patient.

Contact and passing of the fecal matter is carried out through a silicone hose held in the patient using an inflatable cap. For the purpose of inflating the cap, the hose is accompanied with a white LUER LOCK port, and the delivery set is equipped with the relevant syringe. The fill of the holding cap is defined by the fullness of the control membrane of the white LUER LOCK port.

The introduction of solutions of medicinal preparations or a rinsing solution into the patient’s rectum is carried where necessary, and for this purpose a blue port is envisaged on the hose.

Technical and technological solutions for the removal of liquid and semi-liquid fecal matter from bedridden patients are given in the complete set of design documentation 0000.942272.001.

Technical requirements and control procedures for the device have been developed and presented in the draft working specifications 0000.942272.001 TU; the device passport 0000.942272.001 PS contains the expected technical parameters of the device, a description of its design and principle of operation, information about the main technical parameters, acceptance data, warranty obligations of the manufacturer and other information, essential for the profound use of the technical capabilities of FaTrox and ensuring its correct operation.

The core technical and operational indicators of the device developed have the edge over well-known analogues by at least 20%.

The study’s output is the first developed working design documentation for the FaTrox medical device. By a joint decision of ASM LLC and Soiuzmed LLC, the pilot batch documentation was approved good for production.

Conclusion

The study’s output is the first developed working design documentation for the FaTrox medical device intended to be inserted and retained in the patient’s rectum for the purpose of diversion of liquid and semi-liquid fecal matter, as well as administration of medical preparations into the rectum of patients (over 18 years of age).

The core technical and operational indicators of the device developed have the edge over well-known analogues by at least 20%.

It is advisable to use the research results in the manufacture of prototypes of the product and their subsequent testing.

Meeting ethical standards

The study does not require the submission of a biomedical ethics committee opinion or other documents.

Financial aspect

The work was commissioned by Soiuzmed LLC as part of the research and development work (R&D) “Detailed design and technological documentation for the manufacture of a pilot batch of the FaTrox medical device” (code “Fisht”) (Registration number 123071300002-9) [12]. The chief designer of the product: M.A. Kicha.

Conflict of interests

The authors declare no conflicts of interest to de disclosed in this article.

References

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  3. Grej, M. Prevention and treatment of perioral dermatitis: the overall goal of wound and incontinence treatment. Journal of Wound Ostomy & Continence Nursing. 2018; 31: 2–9.
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  9. Kicha E. I., Kicha M. A., Malovik D. S., Mihajlenko V. S., Zajceva V. V. Version of the document "List of non-metallic materials". Vestnik IAELPS. 2022; 27(2): 37-48. EDN: IWCJJH (In Rossian).
  10. Kicha, E. I., Kicha, M. A. Comparative analysis of the use of various criteria for assessing individual risk at the Navy facilities. Toxicological Review. 2023; 31(4): 226-231. https://doi.org/10.47470/0869-7922-2023-31-4-226-231 (In Rossian).
  11. Kicha, M. A., Kicha, E. I. Methodology for determining the level of technical and economic perfection of products. Vestnik IAELPS. 2022; 27(3): 84-89. EDN: ZGSPBF (In Rossian).
  12. Razrabotka rabochej konstruktorskoj i tekhnologicheskoj dokumentacii dlya izgotovleniya opytnoj partii medicinskogo izdeliya FaTroks [Informacionnaya karta NIOKTR]: https://rosrid.ru/nioktr/detail/Q5FNXND1BXUWEIW6EPEFK00D, date of application 15.08.2023 (In Rossian).

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