Gotta ‘go’? There’s an app for that

Blue­tooth-op­er­ated bionic sphinc­ter con­troller close to hu­man trial phase.

The Star Malaysia - Star2 - - Technology - By RON HURTIBISE

Most of us don’t have to give much thought to the me­chan­ics of go­ing to the bath­room.

our bodies tell our brains when we have to go, and our brains tell our bodies when it’s ac­cept­able to do so.

But mil­lions of peo­ple with in­con­ti­nence have to cope nu­mer­ous times a day with the re­al­ity that the brain-to-body mes­sag­ing they once took for granted will never op­er­ate nor­mally again.

In a small of­fice build­ing in Fort Laud­erdale, in­ven­tor Peter H. sayet says he’s close to mar­ket­ing a de­vice that will en­able in­con­ti­nence suf­fer­ers to re­gain con­trol of their uri­nary func­tions.

sayet is pres­i­dent and CEo of Pre­ci­sion Med­i­cal De­vices, which he founded in 1998. In the past two decades, the com­pany has se­cured nine patents and spent Us$5mil (RM19.4mil) raised from about 200 in­vestors through pri­vate-place­ment stock of­fer­ings to de­velop a Blue­tooth-op­er­ated bionic sphinc­ter con­troller, which he calls the Flow Con­trol De­vice.

It’s an im­planted valve de­signed to fit around the ure­thra of a man or woman. the valve is opened and closed by a ca­ble con­nected to a bat­tery-op­er­ated con­troller in­serted on the pa­tient’s side, un­der the skin. When it’s time to uri­nate, the pa­tient – or in the case of an Alzheimer’s suf­ferer, a care­giver – uses a wire­less fob or phone app to tell the con­troller to open and close the valve. Bat­ter­ies are recharged wire­lessly and must be re­placed ev­ery five or six years.

sayet said he first thought of the idea two decades ago, walk­ing through a su­per­mar­ket and com­ing upon a large dis­play of adult di­a­pers. “I thought, ‘How many of those are fill­ing up our land­fills? there’s got to be a bet­ter so­lu­tion’,” he said.

In tri­als

In de­vel­op­ment for 20 years, the Flow Con­trol De­vice has been suc­cess­fully im­planted in two dozen dogs and should be com­mer­cially avail­able for dogs by year’s end, sayet said.

In ad­di­tion to ex­tend­ing dogs’ lives, the de­vice’s suc­cess with ca­nines could pave the way for the Us Food and Drug Ad­min­is­tra­tion to green-light hu­man tri­als some­time next year, fol­lowed – sayet and his in­vestors hope – by ap­proval of the de­vice for hu­man pa­tients by 2020.

the surgery to im­plant the de­vice should last no longer than 35 min­utes and re­quires a sin­gle in­ci­sion below the belt line, sayet said. Cost of the pro­ce­dure and de­vice should be no more than Us$15,000 (RM58,200), he said. It’s not yet known whether the de­vice would be cov­ered by health in­sur­ance.

sayet said the de­vice has the po­ten­tial to help 35 mil­lion to 40 mil­lion peo­ple with uri­nary in­con­ti­nence. they in­clude chil­dren with hered­i­tary dis­eases, in­clud­ing spina bi­fida, a birth de­fect that oc­curs when the spine and spinal cord don’t de­velop prop­erly and can in­ter­fere with op­er­a­tion of the nerves that sup­ply the bowel and blad­der.

seventy-five per­cent of pa­tients with spinal cord in­juries suf­fer in­con­ti­nence, as do para­plegics. Women of­ten de­velop uri­nary in­con­ti­nence be­cause their pelvic nerves and mus­cles can be dam­aged dur­ing vagi­nal child­birth.

Sim­pler, safer

the de­vice would also be a quan­tum leap, sayet said, over the two most com­monly im­planted in­con­ti­nence con­trollers cur­rently on the mar­ket.

one is a ure­thra valve for males that a pa­tient must con­trol man­u­ally by squeez­ing a con­troller in­serted in the scro­tum. sayet said that in ad­di­tion to re­quir­ing two to three hours of surgery, a ma­jor prob­lem with this valve is it can­not be im­planted into Alzheimer’s pa­tients be­cause they of­ten lack the men­tal ca­pac­ity to op­er­ate the con­troller.

the Flow Con­trol De­vice would over­come that hur­dle be­cause the pa­tient’s care­giver could op­er­ate the fob or the phone app af­ter the pa­tient is seated on the toi­let, he said.

For women, the most com­mon sur­gi­cal op­tion – the transvagi­nal mesh – has been be­set with prob­lems. It’s a piece of syn­thetic ma­te­rial, or mesh, that cre­ates a pelvic sling around the ure­thra and thick­ened mus­cle where the blad­der con­nects to the ure­thra, to keep the ure­thra closed, par­tic­u­larly when cough­ing or sneez­ing.

Fail­ure rates for the vagi­nal mesh have been un­ac­cept­ably high, sayet said. About one in 30 women have re­quired re­moval or re­vi­sions of the mesh af­ter ex­pe­ri­enc­ing prob­lems that in­clude ero­sion of the ma­te­rial into the vagi­nal tis­sue, Reuters re­ported. More than 50,000 women in the United states have joined class-ac­tion law­suits against man­u­fac­tur­ers of the de­vices.

sayet’s valve works for women and men in es­sen­tially the same man­ner, he said.

“We think ours will be the gold stan­dard,” he said.

Af­ter the ure­thral valve is on the mar­ket, he ex­pects to de­velop fur­ther ver­sions, in­clud­ing one with a larger valve to help pa­tients who have had colostomies to reroute their in­testines or colons to a port, called a stoma, in their ab­domens. Colostomy pa­tients cur­rently have no con­trol over their waste func­tions and must wear bags over their stomas that must be emp­tied mul­ti­ple times a day.

Fu­ture de­vices could also help con­trol of mor­bid obe­sity, Gas­troe­sophageal re­flux dis­ease (GERD), and erec­tile dys­func­tion, sayet said.

Most of the pro­to­type de­vel­op­ment and as­sem­bly takes place in con­tracted en­gi­neer­ing labs, he said, and the dog pro­to­types were im­planted by vet­eri­nary sur­geons at the Univer­sity of Mi­ami and Univer­sity of North Carolina.

sayet said he has cho­sen to in­vest money raised from in­vestors into re­search rather than waste it on ex­pen­sive and showy lab­o­ra­to­ries and of­fices.

Sup­ported by spe­cial­ists

sayet’s work has the sup­port of nu­mer­ous urol­ogy spe­cial­ists, in­clud­ing Dr An­gelo Gousse, a for­mer tenured pro­fes­sor of urol­ogy at the UM’s Miller school of Medicine, who now serves as the com­pany’s chief of surgery and mem­ber of its med­i­cal sci­en­tific board.

In late March, sayet an­nounced a strate­gic col­lab­o­ra­tion with the Mayo Clinic in Jack­sonville and its in­con­ti­nence ex­pert, Dr Paul Pet­tit, to help ad­vance the Flow Con­trol De­vice to the clin­i­cal tri­als phase.

Mayo Clinic spokesman Kevin Pun­sky con­firmed that Pet­tit and the clinic are col­lab­o­rat­ing with Pre­ci­sion Med­i­cal De­vices, but said the col­lab­o­ra­tion is in the early stages and that “Dr Pet­tit is not avail­able for com­ment at this time”.

one of Pre­ci­sion Med­i­cal De­vices’ ear­li­est in­vestors, Mi­amibased fam­ily prac­tice physi­cian Dr Vic­tor Krestow, said he hasn’t lost any en­thu­si­asm about the in­ven­tion over the 20 years it has been in de­vel­op­ment.

Krestow, who said he has in­vested “well into six fig­ures”, calls the project “thrilling”.

“I’ve been in pri­vate prac­tice here in my med­i­cal build­ing 48 years,” he said. “And I see pa­tients one at a time. this gives me an op­por­tu­nity to help mil­lions of peo­ple who suf­fer uri­nary in­con­ti­nence.”

He’s even ex­cited about the po­ten­tial to ex­tend the lives of dogs who will get the de­vice. In­con­ti­nence, he noted, is one of the ma­jor rea­sons own­ers eu­thanise their dogs. sayet said the im­plant and pro­ce­dure should cost about Us$3,500 (RM13,500) for dogs.

Krestow said he be­came aware of the need for a bet­ter so­lu­tion when he watched his mother suf­fer from in­con­ti­nence for 15 years be­fore dy­ing at 94.

“she had to wear (adult di­a­pers). she couldn’t leave the house. she couldn’t go out with her friends or go to movies,” he said.

Peo­ple with in­con­ti­nence are of­ten too em­bar­rassed to dis­cuss their sit­u­a­tions, even with their physi­cians, he said. When some have con­fided in him, Krestow said he tries to give them hope.

“I say, ‘Hang in there. We will have a so­lu­tion.’ — sun sen­tinel/ tri­bune News ser­vice

The de­vice has the po­ten­tial to ex­tend the lives of dogs as in­con­ti­nence is one of the ma­jor rea­sons own­ers eu­thanise their dogs. — Pho­tos: TNS

Sayet spent the past 20 years de­vel­op­ing the Flow Con­trol De­vice and hopes to get ap­proval for it to be used in hu­man pa­tients by 2020.

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