{"id":33,"date":"2020-09-25T21:00:36","date_gmt":"2020-09-25T21:00:36","guid":{"rendered":"http:\/\/engprojects.tcnj.edu\/urinary-valve-device\/?p=33"},"modified":"2020-09-30T15:06:05","modified_gmt":"2020-09-30T15:06:05","slug":"update-9-30","status":"publish","type":"post","link":"https:\/\/engprojects.tcnj.edu\/urinary-valve-device\/2020\/09\/25\/update-9-30\/","title":{"rendered":"Update 9\/25"},"content":{"rendered":"\n

So far, the team has been discussing and finalizing requirements. Since this project consists of two main devices, an implantable valve and a catheter delivery mechanism, requirements were broken down as such and are as follows:<\/p>\n\n\n\n

Valve Requirements<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Requirement<\/td>\nSpecification<\/td>\nJustification<\/td>\n<\/tr>\n
\n

1.) The device must remain intact while it is serving its purpose in the patient\u2019s body.<\/p>\n<\/td>\n

\n

1.1) Must be able to support a large range of pH present in urine (pH 5-8)  [5].<\/p>\n<\/td>\n

1.1) pH changes can damage a material<\/td>\n<\/tr>\n
 <\/td>\n\n

1.2) Last at least 5 years [8]<\/p>\n<\/td>\n

\n

1.2) In children, VUR often fixed within 5 years [8]<\/p>\n<\/td>\n<\/tr>\n

\n

2.)  The device must support normal urine flow into the bladder<\/p>\n<\/td>\n

\n

2.1) The device must be able to support flow rates up to 25 mL\/hour<\/p>\n<\/td>\n

\n

2.1a) Flow rate is between 17.5-23.6 mL\/hour [12]<\/p>\n<\/td>\n<\/tr>\n

\n

 <\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n

\n

2.1b) Urine flow is pulsatile\/dynamic flow, not just steady state [12].<\/p>\n<\/td>\n<\/tr>\n

\n

 <\/p>\n<\/td>\n

\n

2.2) The device must be able to support intra-abdominal pressure up to 20 mmHg<\/p>\n<\/td>\n

\n

2.2) Intra-abdominal pressure  up to 5 mmHg is normal in adults, but with conditions such as obesity, it can get as high as 15 mmHg. Above 20 mmHg is associated with organ dysfunction [14].<\/p>\n<\/td>\n<\/tr>\n

\n

3.) The device must \u201cgrow\u201d with a child if a long-term fixture<\/p>\n<\/td>\n

\n

3.1) The material needs to be able to elastically strain 233%  to change with the ureter.<\/p>\n<\/td>\n

\n

3.1) The ureter starts at 3-5 mm in healthy kids, greater than 7 mm in kids with VUR [15]<\/p>\n<\/td>\n<\/tr>\n

\n

4.) The device must be biocompatible<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n

\n

4.) For any medical device approved by the FDA, biocompatibility testing must be doe following ISO 10993-1 [1].<\/p>\n<\/td>\n<\/tr>\n

\n

5.) The device must stay in place<\/p>\n<\/td>\n

\n

 <\/p>\n<\/td>\n

\n

5.) Movement of the valve will initiate an immune response [4]<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n

Catheter Requirements<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n
Requirement<\/td>\nSpecification<\/td>\nJustification<\/td>\n<\/tr>\n
\n

1.) The device must be able to reach the vesicoureteral junction.<\/p>\n<\/td>\n

\n

1.1) The placement device must be able to range in length from 2 cm to 30 cm to accommodate both males and females, children and adults.<\/p>\n<\/td>\n

\n

1.1a) The adult male urethra ranges from 15-30 cm long [2].<\/p>\n<\/td>\n<\/tr>\n

 <\/td>\n\n

1.1b) The average female child\u2019s urethra length is 2.59 cm [3]<\/p>\n<\/td>\n

 <\/td>\n<\/tr>\n
\n

2.)The device must be able to fit into the urethra.<\/p>\n<\/td>\n

\n

2.1) The catheter tubing must be less than 3 mm in diameter.<\/p>\n<\/td>\n

\n

2.1) In children, the average diameter of the urethra is 3-4 mm [9].<\/p>\n<\/td>\n<\/tr>\n

\n

3.1) The device must be able to place the valve correctly, and then be separated from the valve for removal from the body.<\/p>\n<\/td>\n

\n

3.1) Once placed, the valve does not move more than 2 mm once separated from the catheter.<\/p>\n<\/td>\n

\n

3.1a) This is the function of the device, as a catheter long-term would be uncomfortable for a child.<\/p>\n<\/td>\n<\/tr>\n

 <\/td>\n\n

3.1b) If the valve moves during placement, it needs to be close enough to still support the natural flap.<\/p>\n<\/td>\n

 <\/td>\n<\/tr>\n
\n

4.) The device must be biocompatible.<\/p>\n<\/td>\n

 <\/td>\n\n

4.) For any medical device approved by the FDA, biocompatibility testing must be doe following ISO 10993-1 [1].<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n\n\n\n

Additional Requirements<\/strong><\/p>\n\n\n\n\n\n\n\n
Requirement<\/td>\nJustification<\/td>\n<\/tr>\n
\n

1.) The delivery of the devices must be simple and does not require additional surgical training.<\/p>\n<\/td>\n

\n

1.) The goal of the company is to make the device usable internationally, especially in areas with fewer medical professionals.<\/p>\n<\/td>\n<\/tr>\n

\n

2.) The cost of the procedure must be equivalent of already existing treatments<\/p>\n<\/td>\n

\n

2.) The goal of the company is to ensure that insurance companies cover most of the cost.<\/p>\n<\/td>\n<\/tr>\n

\n

3.) The devices must be manufactured at TCNJ<\/p>\n<\/td>\n

\n

3.) Rules of senior project <\/p>\n<\/td>\n<\/tr>\n

\n

4.) The devices must be as environmentally friendly as possible<\/p>\n<\/td>\n

\n

4.) The goal of the company is to ensure a low carbon footprint, which can be done through the use of recycled materials in packaging<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/p>\n\n\n\n

References<\/p>\n\n\n\n

[1] FDA, Special Considerations – Biocompatibility. 05\/22\/2020. https:\/\/www.fda.gov\/medical-devices\/premarket-notification-510k\/special-considerations#bio<\/p>\n\n\n\n

[2]Kohler, Tobias S et al. \u201cThe length of the male urethra.\u201d International braz j urol : official journal of the Brazilian Society of Urology vol. 34,4 (2008): 451-4; discussion 455-6. doi:10.1590\/s1677-55382008000400007<\/p>\n\n\n\n


[3]Halleran, Devin R., et al. \u201cUrethral Length in Female Infants and Its Relevance in the Repair of Cloaca.\u201d Journal of Pediatric Surgery, vol. 54, no. 2, 2019, pp. 303\u2013306., doi:10.1016\/j.jpedsurg.2018.10.094.<\/p>\n\n\n\n


[4] \u201cRecommendations.\u201d Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 5 Nov. 2015, www.cdc.gov\/infectioncontrol\/guidelines\/cauti\/recommendations.html.<\/p>\n\n\n\n

[5] Feher, Joseph. Quantitative Human Physiology. Elsevier. 2nd Edition. 2011<\/p>\n\n\n\n


[6] Burr, RG and Nuseibeh IM. Urinary catheter blockage depends on urine pH, calcium, and rate of flow. Spinal Cord. 35: 521-525. 1997. https:\/\/www.nature.com\/articles\/3100424<\/p>\n\n\n\n


[7] Gopferich A. Mechanisms of polymer degradation and erosion. Biomaterials. 17(2): 103-114. 1996. https:\/\/www.sciencedirect.com\/science\/article\/pii\/0142961296857553<\/p>\n\n\n\n


[8] (https:\/\/www.hopkinsmedicine.org\/health\/conditions-and-diseases\/vesicoureteral-refluxvur#:~:text=Most%20children%20who%20have%20grade,Surgical%20treatment%20is%20also%20available.)<\/p>\n\n\n\n

[9] Chow, Jeanne S., and Annemieke S. Littooij. \u201cUrogenital Pathologies in Children Revisited.\u201d SpringerLink<\/em>, Springer, Cham, 1 Jan. 1970, link.springer.com\/chapter\/10.1007\/978-3-319-75019-4_7.<\/p>\n\n\n\n

[10] Kakizaki H;Moriya K;Ameda K;Shibata T;Tanaka H;Koyanagi T; \u201cDiameter of the External Urethral Sphincter as a Predictor of Detrusor-Sphincter Incoordination in Children: Comparative Study of Voiding Cystourethrography.\u201d The Journal of Urology<\/em>, U.S. National Library of Medicine, pubmed.ncbi.nlm.nih.gov\/12544337\/.<\/p>\n\n\n\n

[11] B;, Reinking LN;Schmidt-Nielsen. \u201cPeristaltic Flow of Urine in the Renal Capillary Collecting Ducts of Hamsters.\u201d Kidney International<\/em>, U.S. National Library of Medicine, pubmed.ncbi.nlm.nih.gov\/7300113\/.<\/p>\n\n\n\n

[12] Kim, Kyung-Wuk, et al. \u201cAnalysis of Urine Flow in Three Different Ureter Models.\u201d Computational and Mathematical Methods in Medicine<\/em>, Hindawi, 4 June 2017, www.hindawi.com\/journals\/cmmm\/2017\/5172641\/.<\/p>\n\n\n\n

[13] Rollino, Cristiana, et al. \u201cVesicoureteral Reflux in Adults.\u201d Giornale Italiano Di Nefrologia : Organo Ufficiale Della Societa Italiana Di Nefrologia<\/em>, U.S. National Library of Medicine, 2011, www.ncbi.nlm.nih.gov\/pubmed\/22167611.<\/p>\n\n\n\n

[14<\/a>] Milanesi, Rafaela, and Rita Catalina Aquino Caregnato. \u201cIntra-Abdominal Pressure: an Integrative Review.\u201d Einstein (Sao Paulo, Brazil)<\/em>, Instituto Israelita De Ensino e Pesquisa Albert Einstein, 2016, www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5234758\/.<\/p>\n\n\n\n

[15] \u201cMegaureter & Ureter.\u201d Cleveland Clinic<\/em>, my.clevelandclinic.org\/health\/diseases\/16305-megaureter.<\/p>\n","protected":false},"excerpt":{"rendered":"

So far, the team has been discussing and finalizing requirements. Since this project consists of two main devices, an implantable valve and a catheter delivery mechanism, requirements were broken down as such and are as follows: Valve Requirements Requirement Specification Justification 1.) The device must remain intact while it is serving its purpose in the … <\/p>\n

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